WO2024131326A1 - Stent tressé et système de stent - Google Patents

Stent tressé et système de stent Download PDF

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Publication number
WO2024131326A1
WO2024131326A1 PCT/CN2023/129053 CN2023129053W WO2024131326A1 WO 2024131326 A1 WO2024131326 A1 WO 2024131326A1 CN 2023129053 W CN2023129053 W CN 2023129053W WO 2024131326 A1 WO2024131326 A1 WO 2024131326A1
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WO
WIPO (PCT)
Prior art keywords
braided
wire
diameter
stent
braided stent
Prior art date
Application number
PCT/CN2023/129053
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English (en)
Chinese (zh)
Inventor
黄云帆
周炯
王晓雯
Original Assignee
神途医疗科技(上海)有限公司
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Application filed by 神途医疗科技(上海)有限公司 filed Critical 神途医疗科技(上海)有限公司
Publication of WO2024131326A1 publication Critical patent/WO2024131326A1/fr

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  • the present invention relates to the field of medical devices, and in particular to a braided stent and a stent system.
  • Braided stents have been widely used in intravascular treatment, and in recent years, the damage to the blood vessel wall caused by the truncation of the wire at the end of the braided stent has gradually attracted attention.
  • the ends of ordinary braided stents have no special treatment or structural design, and the braided wire at the end is truncated to expose the wire head. For this reason, most braided stents adopt an end-return braiding design to reduce or completely eliminate the exposure of the braided wire heads at both ends of the stent.
  • the braided wire at the end of the re-braided stent is bent into an arc, which can reduce end damage and enhance the opening performance of the end.
  • the structural design of braided wire back-weaving can improve the performance of the braided stent, but it greatly increases the complexity of the braided core rod structure and processing, making the braided stent incontinuous, increasing the difficulty of the process, increasing the learning curve of workers, and increasing the working hours.
  • the wire joining point that is, two braided wires in different directions at the end are fixed after being joined
  • the arc shape of the braided wire back-weaving has certain requirements on the bending resistance of the braided wire. For example, the fatigue performance of cobalt-chromium alloy in this shape is extremely poor, and the fracture incidence rate is extremely high. Therefore, it is basically impossible to use cobalt-chromium alloy braided wire for back-weaving stents, which limits the selection of raw materials for braided stents and reduces the applicable range of braided materials.
  • the present invention proposes a braided stent and a stent system, which can realize the non-invasiveness of the head end (i.e., the end) of the braided stent while making the braiding process continuous, reducing the difficulty of the braiding process, shortening the learning time of manual braiding, and improving the production efficiency of the braided stent.
  • the present invention provides a braided stent, the braided stent comprising a braided main body and at least one connecting piece, at least two wire heads at at least one end of the braided main body are
  • the connecting piece is wrapped around and connected to the connecting piece, and the connecting piece includes a bending portion and two connecting portions, and both ends of the bending portion are respectively connected to one of the connecting portions, and each connecting portion wraps around and connects to at least one of the wire heads.
  • the connecting portion wraps around and connects one of the wire ends when a single wire is braided, or the connecting portion wraps around and connects two of the wire ends at the braided wire paralleling position when a double wire is braided.
  • the two connecting parts wrap around and connect at least two non-adjacent wire heads in different directions.
  • part or all of the wire heads at at least one end of the braided body are wrapped by the connecting piece and connected to the connecting piece.
  • the connecting portion has a configuration larger than a diameter of the braided wire, and the bent portion has a configuration not smaller than the diameter of the braided wire.
  • both of the two connecting parts are provided with an inner cavity, and the connecting part wraps and connects at least one of the wire heads through the inner cavity, and the curved part is a solid structure or a hollow structure.
  • the connecting piece is an integral or one-piece hollow sleeve, and the inner cavity of the curved portion is in a closed state.
  • the connecting piece is a split structure
  • the bent portion is a connecting wire
  • the diameter of the connecting wire is not less than the diameter of the braided wire
  • a reinforcing wire is provided in the inner cavity of the curved portion, and/or the connecting piece is configured to have a grooved surface.
  • At least one of the inner side and the outer side of the connecting portion is provided with the groove, and/or at least one of the inner side and the outer side of the bending portion is provided with the groove.
  • the bending radius of the connecting portion is 0.5 mm to 5.0 mm, and/or the wall thickness of the inner cavity of the connecting piece does not exceed the diameter of the braided wire.
  • the present invention also provides a stent system, which includes a delivery system and any one of the braided stents described, the delivery system includes a delivery rod and an outer tube, the braided stent is used to be loaded between the delivery rod and the outer tube, and the delivery rod and the outer tube can move relative to each other in the axial direction.
  • the delivery rod comprises a conical head and a push rod, the distal end of the push rod being in contact with the conical head.
  • the push rod is connected with a shaped head, and the proximal end of the push rod is placed in the inner cavity of the outer tube;
  • the push rod includes an axially connected thick-diameter section and a thin-diameter section, the outer diameter of the thin-diameter section is smaller than the outer diameter of the thick-diameter section, at least one end of the braided body can be accommodated between the thin-diameter section and the outer tube, and at least one connector at the end of the braided body can cooperate with the step between the thick-diameter section and the thin-diameter section to limit the braided stent.
  • the push rod includes one thick diameter section and one thin diameter section, the distal end of the thin diameter section is directly connected to the conical head, or the push rod includes two thick diameter sections and two thin diameter sections, the thin diameter sections and the thick diameter sections are alternately arranged in the axial direction of the push rod.
  • the braided stent provided by the present invention, at least two wire heads at at least one end of the braided main body are wrapped by a connector and connected to the connector, the connector includes a curved portion and two connecting portions, the two ends of the curved portion are respectively connected to a connecting portion, and each connecting portion wraps and connects at least one wire head.
  • the braiding process of the braided stent can be continuous, while realizing the non-invasiveness of the end of the braided stent, the braiding difficulty is reduced, the learning curve of the workers is shortened, the operation time is reduced, and the manufacturing efficiency of the braided stent is improved.
  • the connector directly constitutes the non-invasive structure of the end of the braided stent, the material selection of the braided wire of the braided stent is more diversified, so that the material that is prone to fatigue fracture in the arc shape can also be selected, and the application range of the material for preparing the braided stent is expanded to improve the performance of the braided stent.
  • the connector can select the corresponding material and structure according to the curvature design requirements, ensure the anti-fatigue performance of the connector while meeting the curvature design requirements, and can also improve the support of the end of the braided stent, and can better withstand the fatigue loss caused by physiological movements such as vascular pulsation, bending, and torsion.
  • the stent system provided by the present invention since the stent system provided by the present invention and the braided stent provided by the present invention belong to the same inventive concept, the stent system provided by the present invention has all the advantages of the braided stent provided by the present invention.
  • FIG1 is a partial schematic diagram of a three-dimensional structure of a braided stent according to an embodiment of the present invention
  • FIG2 is a partial schematic diagram of the main structure of a braided stent according to an embodiment of the present invention, and the circled area indicated by reference numeral A may be referred to;
  • FIG3a is a schematic axial cross-sectional view of a case where the connecting piece as a whole is a hollow sleeve according to an embodiment of the present invention
  • FIG3 b is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention when only two connecting parts are hollow and the inner cavity of the curved part is closed;
  • FIG3c is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention in which only two connecting parts are hollow and the bent part is a connecting wire;
  • FIG4a is a schematic cross-sectional view of a curved portion having a closed inner cavity according to an embodiment of the present invention
  • FIG4 b is a schematic cross-sectional view of a case where the bending portion is a solid body according to an embodiment of the present invention.
  • FIG5a is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention when only inner and outer sides of two connecting portions are provided with grooves;
  • 5b is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention in which a groove is provided on the inner side of a curved portion in addition to the grooves provided on the inner and outer sides of the two connecting portions;
  • 5c is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention in which grooves are provided on the inner and outer sides of the two connecting portions and grooves are provided on the inner and outer sides of the bending portion;
  • FIG5d is a schematic axial cross-sectional view of a connector according to an embodiment of the present invention when only grooves are provided on the outer sides of two connecting portions;
  • FIG. 6 is a schematic axial cross-sectional view of a connector having a reinforcing wire disposed therein according to an embodiment of the present invention
  • FIG7 is a schematic structural diagram of a conveying system according to Embodiment 1 of the present invention.
  • FIG8 is a schematic diagram of a loading state corresponding to the proximal end of a braided stent loaded on a delivery rod according to Embodiment 1 of the present invention.
  • FIG9 is a schematic diagram of a loading state corresponding to the distal end of a braided stent loaded on a delivery rod according to Embodiment 1 of the present invention.
  • FIG10a is a schematic structural diagram of a push rod when the connection between the thick-diameter section and the thin-diameter section is a sudden change in diameter step according to the first embodiment of the present invention
  • FIG10b is a schematic structural diagram of the push rod when the thin-diameter section has a gradually changing diameter according to the first embodiment of the present invention
  • FIG10c is a schematic structural diagram of a push rod when a linear tapered transition section is provided at the connection between the thick-diameter section and the thin-diameter section according to the first embodiment of the present invention
  • 10d is a schematic structural diagram of a push rod when a nonlinear conical transition is provided at the connection between the thick diameter section and the thin diameter section according to the first embodiment of the present invention
  • FIG. 11 is a schematic structural diagram of a push rod having a thin diameter section with a length of S according to Embodiment 1 of the present invention, wherein the length of the thin diameter section is not less than the length of the connecting member after folding;
  • FIG. 12 is a schematic structural diagram of a conveying system according to Embodiment 2 of the present invention.
  • 200-braided body 201-braided wire; 202-wire head; 203-connector; 2031-connecting part; 2032- Bending part; 2033-groove; 204-reinforcement wire; 300-delivery system; 301-delivery rod; 3011-conical head; 3012-developing ring at the end of the conical head; 3013-push rod; 30131-thin diameter section; 30132-thick diameter section; 3014-push pad; 3015-proximal developing ring; 302-outer tube; 303-distal developing ring.
  • proximal and distal are the distance from the operator using the braided stent or stent system. The relative position, relative location, and direction of elements or actions relative to each other from a certain perspective.
  • proximal and distal are not restrictive, “proximal” generally refers to the end of the braided stent or stent system that is close to the operator during normal operation, and “distal” generally refers to the end that first enters the patient's body.
  • distal and proximal in this application document do not refer to the ends of the structure, but to relative positions. For example, the distal end of a braided stent is not the end of the braided stent, but a position relatively close to the end of the braided stent.
  • axial generally refers to the direction parallel to the central axis of the braided stent or stent system
  • radial generally refers to the diameter direction of the braided stent or stent system, that is, the direction perpendicular to the central axis
  • circumferential generally refers to the direction around the central axis of the braided stent or stent system.
  • Fig. 1 and Fig. 2 illustrate the local structure of the braided stent according to an embodiment of the present invention.
  • the braided stent includes a braided body 200, and the wire heads 202 of part or all of the braided wires 201 at at least one end of the braided body 200 are wrapped and connected to the wire heads 203.
  • the shape of the connecting member 203 after bending is not limited, and is preferably a curved shape with less trauma, such as an arc or other suitable shape.
  • the connecting member 203 includes two connecting portions 2031 and a curved portion 2032, and the two ends of the curved portion 2032 are respectively connected to a connecting portion 2031, and each connecting portion 2031 wraps and connects at least one wire head 202. It can be understood that at least two wire heads 202 at at least one end of the braided body 200 are wrapped and connected to the connecting member 203. It should be understood that when at least part of the wire ends of the braided wires are wrapped by and connected to the connector 203 , the wire ends that are not wrapped and connected can be exposed at the ends, or can be braided back and then connected to the braided body 200 .
  • the connecting portion 2031 can wrap around and connect one wire head 202 when the single wire is woven.
  • the connecting portion 2031 can wrap around and connect two wire heads 202 at the braided wire parallel wire when the double wires are woven, that is, two ends of a connecting piece 203 respectively wrap around two wire heads 202; in addition, two braided wires 201 in different directions can be merged at the end and then wrapped and connected by the connecting piece 203. It can be understood that at least two wire heads 202 in different directions at the end of the braided main body 200 are wrapped by and connected to the connecting piece 203.
  • the connecting portion 2031 at one end of the connecting piece 203 wraps around and connects at least one wire head 202
  • the connecting portion 203 at the other end wraps around and connects at least one wire head 202.
  • the connecting portion 2031 wraps and connects at least one other wire head 202, thereby preventing at least two wire heads 202 at the end from being exposed and damaging the blood vessel wall.
  • two connecting portions 2031 of a connector 203 wrap and connect at least two adjacent wire heads 202 in different directions, or two connecting portions 2031 of a connector 203 wrap and connect at least two non-adjacent wire heads 202 in different directions.
  • two connecting portions 2031 of a connector 203 wrap and connect adjacent wire heads 202 or two non-adjacent wire heads 202 in different directions;
  • double-filament parallel braiding as an example, two connecting portions 2031 of a connector 203 wrap and connect adjacent wire heads or two groups of non-adjacent wire heads in different directions.
  • the wire ends from different directions can be combined at the end of the braided body 200 to form a parallel wire unit, and the two connecting parts 2031 of a connecting piece 203 can respectively wrap a parallel wire unit.
  • the two connecting portions 2031 of a connector 203 wrap and connect at least two non-adjacent silk heads 202 in different directions, thereby reducing the process difficulty.
  • two unwrapped silk heads 202 are spaced apart between two non-adjacent silk heads 202 in different directions, such as shown in Figure 2, but the present application does not exclude the situation of spacing more unwrapped silk heads 202.
  • the braiding process of the braided stent can be continuous.
  • the connector 203 is used to connect the wire head 202 to achieve non-invasive treatment of the end of the braided stent, which not only reduces the risk of the wire cross section causing damage to the blood vessel wall, but also enhances the opening performance of the end of the braided stent.
  • the braided stent can be woven continuously, the braiding difficulty is effectively reduced, and the learning curve of the workers is also shortened, the operation hours are reduced, and the manufacturing efficiency of the braided stent is improved.
  • the connector 203 directly constitutes the end non-invasive structure instead of the braided wire, which makes the material selection of the braided wire of the braided stent more diversified, and makes it possible to choose materials such as cobalt-chromium alloys that are prone to fatigue fracture in an arc shape, thereby expanding the scope of application of braided materials to improve the performance of the braided stent.
  • the connector 203 can select corresponding materials and structures according to the curvature design requirements to ensure the anti-fatigue performance of the connector 203 while meeting the curvature design requirements, which can improve the compliance of the end of the braided stent.
  • the braided stent has good elasticity and support, which enables it to better withstand the fatigue loss caused by physiological movements such as blood vessel pulsation, bending, and torsion.
  • the connecting portion 2031 of the connector 203 has a structure larger than the diameter of the braided wire 201, so as to facilitate wrapping and connecting the wire head 202.
  • the curved portion 2032 of the connector 203 preferably has a structure not less than the diameter of the braided wire 201, so as to ensure the anti-bending performance of the connector 203 and reduce the risk of fracture and failure of the curved portion 2032 after bending.
  • the connector 203 can have various structures, and this application does not limit this.
  • the two connecting parts 2031 of the connecting piece 203 are both provided with an inner cavity, each connecting part 2031 wraps and connects at least one wire head 202 through the inner cavity, and the bending part 2032 can be a solid structure or a hollow structure.
  • the bending part 2032 is a hollow structure to improve the bending performance.
  • the connector 203 when the curved portion 2032 is a hollow structure, the connector 203 may be an integral or one-piece hollow sleeve, which has an inner cavity that is fully penetrated along its own axial direction, and the inner cavity of the curved portion 2032 is in a non-closed open state.
  • the hollow sleeve may be an equal diameter sleeve or a non-equal diameter sleeve.
  • An equal diameter sleeve may be understood as having the same inner diameter and outer diameter; a non-equal diameter sleeve may be understood as having the same inner diameter but different outer diameters, or the same outer diameter but different inner diameters, and the different inner diameters are preferably the same inner diameters of the two connecting portions 2031, and the inner diameter of the curved portion 2032 is different from the inner diameter of the connecting portion 2031, or the outer diameter and the inner diameter are different, such as the outer diameter of the connecting portion 2031 is greater than the outer diameter of the curved portion 2032, and the inner diameter of the connecting portion 2031 is greater than the inner diameter of the curved portion 2032.
  • the curved portion 2032 of the integral or one-piece hollow sleeve is processed so that the inner cavity of the curved portion 2032 is in a closed state (equivalent to being blocked).
  • a hollow tube can be prepared first, and then the hollow tube is compressed to form a curved portion 2032 with a closed inner cavity. The setting of this curved portion 2032 makes the elongation rate of the inner and outer layers of the integral or one-piece hollow sleeve different, and thus the fatigue fracture performance is more excellent.
  • the integral or one-piece hollow sleeve can achieve a smaller radius of curvature without fracture failure, so it has good anti-bending performance.
  • the curved portion 2032 of the connector 203 can be made of a solid pipe, so that the curved portion 2032 becomes a solid structure without an inner cavity.
  • the inner cavity is used to wrap and connect the wire head 202.
  • only the two connecting parts 2031 of the connecting member 203 have inner cavities, and the curved part 2032 is a solid structure.
  • the connector 203 is a split structure, and the curved portion 2032 is set as a connecting wire, and the two ends of the connecting wire are respectively connected to a connecting portion 2031 of a sleeve structure.
  • the connecting portion 2031 and the connecting wire are processed independently, and then the connecting wire is assembled and connected to the connecting portion 2031. Because the connecting wire needs to be bent and formed, in order to reduce the risk of its breakage, the diameter of the connecting wire is preferably not less than the diameter of the braided wire 201.
  • connection between the connecting wire and the connecting portion 2031, and the connection between the braided wire 201 and the connecting portion 2031 can be any suitable connection method, such as: laser welding, dispensing, silver soldering or riveting connection, etc., and one or more connection methods can be used when connecting.
  • the bending radius R of the connector 203 should not be too large or too small. If the bending radius R is too small, it is easy to increase the process difficulty. If the bending radius R is too large, it is easy to affect the anchoring performance of the stent end. For this reason, the bending radius R of the connector 203 is preferably 0.5 mm to 5.0 mm. Furthermore, the wall thickness of the inner cavity of the connector 203 does not exceed the diameter of the braided wire 201, so as to reduce the volume of the braided stent in the grip state, thereby reducing the size of the delivery device. If the wall thickness of the connector 203 is large, it is easy to limit the curvature radius of the connector 203.
  • the material for preparing the connector 203 can be any medical material with good biocompatibility, such as metal material or polymer material for preparing the connector 203, and the connector 203 can also be a combination of a metal structure and a polymer structure.
  • the metal material for preparing the connector 203 can be selected from nickel-titanium alloy, cobalt-chromium alloy or stainless steel, etc., and the connector 203 can be prepared by a combination of one or more metal materials.
  • the polymer material for preparing the connector 203 can be selected from PC (polycarbonate), PTFE (polytetrafluoroethylene) or HDPE (high-density polyethylene), etc., and the connector 203 can be prepared by a combination of one or more polymer materials.
  • the connector 203 can be configured as a structure without grooves 2033 on the surface or a structure with grooves 2033 on the surface.
  • the exemplary structure of the connector 203 without grooves 2033 can be referred to Figures 3a to 3c. It should be noted that after the grooves 2033 are set on the surface of the connector 203, the elasticity of the connector 203 can be increased, so that the flexibility of the connector 203 with grooves 2033 is better than that of the connector 203 without grooves 2033, thereby making the end of the braided stent more compliant and better able to withstand fatigue losses caused by physiological movements such as vascular pulsation, bending, and torsion.
  • the inner side and the inner side of the connecting portion 2031 are connected to the connector 2033.
  • At least one of the outer sides is provided with a groove 2033, and/or at least one of the inner side and the outer side of the curved portion 2032 is provided with a groove 2033, please refer to FIG. 5a to FIG. 5d for details.
  • the grooves 2033 are preferably provided on the surfaces of the two connectors 2031, and further the grooves 2033 are provided on the surface of the curved portion 2032 of the connector 203.
  • the grooves 2033 are preferably provided on the outer side of the connector 2031, and further the grooves 2033 are provided on both the inner side and the outer side of the connector 2031.
  • the grooves 2033 are preferably provided on the inner side of the curved portion 2032, and further the grooves 2033 are provided on both the inner side and the outer side of the curved portion 2032.
  • the shape of the grooves 2033 such as spiral grooves, arc grooves, linear grooves or other suitable shapes.
  • the grooves 2033 are connected with the inner cavity of the connector 203.
  • the inner side of the connecting member 203 refers to the side of the connecting member 203 that is subjected to compression when the connecting member 203 is bent
  • the outer side of the connecting member 203 refers to the side of the connecting member 203 that is subjected to tension when the connecting member 203 is bent.
  • a schematic description is given with an integral or one-piece hollow sleeve.
  • the inner and outer sides of the two connecting parts 2031 of the connecting member 203 are both provided with grooves 2033, and the curved part 2032 does not have any grooves 2033.
  • a groove 2033 is also provided on the inner side of the curved part 2032.
  • a groove 2033 is also provided on the inner and outer sides of the curved part 2032.
  • a groove 2033 is also provided on the inner and outer sides of the curved part 2032.
  • only the outer sides of the two connecting parts 2031 of the connecting member 203 are provided with grooves 2033, and the curved part 2032 does not have any grooves 2033.
  • the reinforcing wire 204 can improve the fracture strength of the connector 203 at the grooved portion.
  • the reinforcing wire 204 can be made of a metal material with good elasticity and high strength, such as stainless steel, nickel-titanium alloy, etc.
  • the wire heads 202 of part or all of the braided wires 201 at any end of the braided body 200 can be wrapped and connected to the connector 203. It should also be understood that the present application does not limit the use of the braided stent.
  • the braided stent is a carotid stent. In other embodiments, the braided stent can also be configured as a valve stent, a coronary stent, a vascular stent, and other components.
  • the braided stent described in the present application needs to be delivered into the body through a delivery system 300. Furthermore, the present invention also provides a delivery system 300 and a stent system including the delivery system 300 and the braided stent.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • Figure 7 illustrates an exemplary structure of a delivery system 300 according to the first embodiment of the present invention
  • Figure 8 illustrates a loading state corresponding to the proximal end when a braided stent is loaded on the delivery rod 301 according to the first embodiment of the present invention
  • Figure 9 illustrates a loading state corresponding to the distal end when a braided stent is loaded on the delivery rod 301 according to the first embodiment of the present invention.
  • the delivery system 300 includes a delivery rod 301 and an outer tube 302, the proximal end of the delivery rod 301 is placed in the inner cavity of the outer tube 302, and the delivery rod 301 and the outer tube 302 can move relative to each other in the axial direction, so as to realize the loading, releasing and recovery of the braided stent through the relative movement between the delivery rod 301 and the outer tube 302.
  • the braided stent is loaded between the delivery rod 301 and the outer tube 302, and the braided stent is mainly released and recovered by the friction between the braided stent and the delivery rod 301.
  • the braided main body 200 can be woven by braided wires 201 of the same wire diameter, and can also be mixed by braided wires 201 of different wire diameters, or the braided main body 200 is a double-layer braided body, the outer braided body is woven by thick wires, and the inner braided body is woven by thin wires, and at least two thick wire heads 202 at the ends of the outer braided body are wrapped with a connector 203 and connected thereto.
  • the delivery rod 301 may include a conical head 3011 and a push rod 3013, the distal end of the push rod 3013 is connected to the conical head 3011, and the proximal end of the push rod 3013 is placed in the inner cavity of the outer tube 302.
  • the braided stent is loaded on the push rod 3013, and the friction between the braided stent and the push rod 3013 is utilized to release and recycle the braided stent.
  • the conical head 3011 is arranged at the farthest end of the delivery rod 301, and is made of a relatively soft material to reduce damage to blood vessels.
  • a conical head end developing ring 3012 is arranged on the proximal side of the conical head 3011, and the distal end of the push rod 3013 is placed in the inner hole of the conical head 3011 and the conical head end developing ring 3012 and fixedly connected.
  • the push rod 3013 includes a thin-diameter section 30131 and a thick-diameter section 30132 connected axially, and the outer diameter of the thin-diameter section 30131 is smaller than the outer diameter of the thick-diameter section 30132.
  • the thin-diameter section 30131 and the thick-diameter section 30132 are both one, and one thin-diameter section 30131 is located between the thick-diameter section 30132 and the conical head 3011, and is directly connected to the proximal end of the conical head 3011.
  • the distal end of one thin-diameter section 30131 is directly inserted into the inner cavity of the conical head end developing ring 3012 and the conical head 3011, and the proximal end of the thick-diameter section 30132 is directly inserted into the inner cavity of the outer tube 302.
  • the provision of the thin-diameter section 30131 is not only convenient for accommodating the increased volume portion at the distal end of the braided stent, but can also limit the distal end of the braided stent to a certain extent, so as to assist in the release of the braided stent, reduce the risk of relative displacement between the braided stent and the delivery rod 301 during the release process, ensure the release accuracy of the braided stent, and improve surgical efficiency.
  • the push rod 3013 is generally provided with an axially penetrating guidewire lumen, and the guidewire lumen of the thin-diameter section 30131 is connected and coaxially arranged with the guidewire lumen of the thick-diameter section 30132.
  • a guidewire such as a 0.0014-inch guidewire, can pass through the guidewire lumen.
  • the outer tube 302 can be pushed toward the distal end to cover the braided stent, so that the braided stent is accommodated between the outer tube 302 and the delivery rod 301.
  • the braided stent is constrained by the outer tube 302 and compressed and loaded on the delivery rod 301.
  • the delivery system 300 of this embodiment can be further loaded with an intermediate catheter, which establishes a surgical channel in the body, and delivers the braided stent to the target position in the body through the surgical channel.
  • the delivery rod 301 may also include a push pad 3014, which is sleeved on the thick diameter section 30132 to increase the friction between the push rod 3013 and the braided stent.
  • a push pad 3014 which is sleeved on the thick diameter section 30132 to increase the friction between the push rod 3013 and the braided stent.
  • the braided wire 201 and the connector 203 at the end corresponding to the distal end of the braided stent can be just accommodated between the thin diameter section 30131 and the outer tube 302, and the connector 203 can be particularly stuck at the step between the thin diameter section 30131 and the thick diameter section 30132 (i.e., the position marked by the rectangular dotted frame B) to reduce the risk of the braided stent being unloaded during the release process.
  • the step between the thin-diameter section 30131 and the thick-diameter section 30132 can also help release the braided stent, that is, during the stent release process, the step can press against the proximal end of the connector 203 and promote the release of the braided stent.
  • a distal developing ring 303 may be provided on the inner wall of the distal end of the outer tube 302.
  • the distal developing ring 303 determines the position of the farthest end of the outer tube 302.
  • the distal developing ring 303 can overlap with the conical head end developing ring 3012, thereby determining the position of the distal end of the outer tube 302 relative to the distal end of the delivery rod 301.
  • the distal developing ring 303 can overlap with the proximal developing ring 3015 on the push rod 3013, thereby determining the position of the proximal end of the push rod 3013 relative to the distal end of the outer tube 302.
  • the proximal developing ring 3015 is sleeved on the thick diameter section 30132 and is further located on the proximal side of the push pad 3014.
  • the distance that the outer tube 302 slides in the axial direction is physically limited; when the outer tube 302 slides toward the distal end, it is blocked until the distal developing ring 303 overlaps with the conical head end developing ring 3012, such as the distal developing ring 303 can be sleeved on the conical head end developing ring 3012; when the outer tube 302 slides toward the proximal end, it is blocked until the distal developing ring 303 overlaps with the proximal developing ring 3015.
  • the conical head end developing ring 3012, the distal developing ring 303, and the proximal developing ring 3015 are all made of X-ray opaque materials.
  • connection between the thin diameter section 30131 and the thick diameter section 30132 may be a smooth transition or a non-smooth transition, preferably a smooth transition.
  • connection between the thin diameter section 30131 and the thick diameter section 30132 may satisfy one of the following conditions:
  • the thin diameter section 30131 is set to a tapered section so that the diameter of the thin diameter section 30131 gradually decreases linearly from the thick diameter section 30132 to the distal end;
  • a linear tapered transition section is provided between the thin diameter section 30131 and the thick diameter section 30132 .
  • the thin diameter section 30131 and the thick diameter section 30132 are both straight sections, and the thin diameter section 30131 and the thick diameter section 30132 are smoothly transitioned through the linear tapered transition section.
  • a nonlinear tapered transition section is provided between the thin diameter section 30131 and the thick diameter section 30132 .
  • the thin diameter section 30131 and the thick diameter section 30132 are both straight sections, and the thin diameter section 30131 and the thick diameter section 30132 are smoothly transitioned through the nonlinear tapered transition section.
  • the setting of the tapered transition section or the non-tapered transition section realizes a smooth transition between adjacent straight sections, prevents a large stress concentration between two adjacent straight sections, and reduces the risk of bending or breaking of the push rod 3013.
  • the length of the thin-diameter section 30131 should be determined according to the length of the connecting piece 203 at the end after folding. As shown in FIG. 11 , the length of the thin-diameter section 30131 is S, and the length of the connector 203 after folding is L, where S ⁇ L. It should be noted that the push rod 3013 can conveniently accommodate the volume increase portion at the end of the braided stent due to the thin-diameter section 30131, and can also limit the braided stent, while the thick-diameter section 30132 can improve the overall breaking strength of the push rod 3013, so that the braided stent can be reliably loaded and transported, and the strength of the push rod 3013 can be ensured.
  • the materials of the thin-diameter section 30131 and the thick-diameter section 30132 may be the same or different. Specifically, the present application does not limit the material used to prepare the push rod 3013, and the push rod 3013 may be prepared using any suitable conventional material, such as metal material or polymer material.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • FIG12 illustrates an exemplary structure of a conveying system 300 according to the second embodiment of the present invention.
  • the structure of the conveying system 300 of this embodiment is different from that of the first embodiment in that the push rod 3013 includes two thin diameter sections 30131 and two thick diameter sections 30132, and the thin diameter sections 30131 and the thick diameter sections 30132 are alternately arranged in the axial direction of the push rod 3013, that is, the thin diameter section 30131, the thick diameter section 30132, the thin diameter section 30131 and the thick diameter section 30132 are arranged in sequence from the far end to the near end.
  • the push pad 3014 is sleeved on the thick diameter section 30132 between the two thin diameter sections 30131.
  • the near-end developing ring 3015 is sleeved on a thick diameter section 30132 at the nearest end.
  • the braided wire 201 and the connector 203 at the proximal end of the braided stent can be accommodated between the thin-diameter section 30131 at the nearest end and the outer tube 302, especially the connector 203 at the proximal end can be clamped at the step between the thin-diameter section 30131 at the nearest end and the thick-diameter section 30132, so as to reduce the risk of the braided stent being unloaded during the recovery process.
  • the thin-diameter section 30131 at the nearest end can play an auxiliary recovery function, and the braided wire 201 and the connector 203 at the distal end of the braided stent can be accommodated between the thin-diameter section 30131 at the farthest end and the outer tube 302, especially the connector 203 at the distal end can be clamped at the step between the thin-diameter section 30131 at the farthest end and the thick-diameter section 30132, so as to reduce the risk of the braided stent being unloaded during the release process, and play an auxiliary pushing role in the release process of the braided stent.
  • the braided main body 200 can be braided continuously, that is, after the braided main body 200 is braided continuously, the truncated wire head 202 is connected with the connecting piece 203, and finally the end of the braided main body 200 is non-invasively processed and designed, thereby reducing the risk of the wire cross section causing damage to the blood vessel wall and enhancing the opening performance of the braided stent end. Because the braided main body 200 can be braided continuously, the braiding difficulty is reduced, the worker learning curve is shortened, the operation time is reduced, and the manufacturing efficiency of the braided stent is improved.
  • the connector 203 directly constitutes the non-invasive structure at the end of the braided body 200 instead of the non-invasive design of the braided wire, the material selection of the braided wire of the braided body 200 is more diversified, so that materials such as cobalt-chromium alloy that are prone to fatigue fracture in an arc shape can also be selected, thereby expanding the applicable range of materials for preparing the braided stent to improve the performance of the braided stent.
  • the connector 203 can select corresponding materials and structures according to the curvature design requirements to ensure the fatigue resistance of the connector 203 while meeting the curvature design requirements. This also improves the compliance and support of the end of the braided stent, allowing the braided stent to better withstand fatigue losses caused by physiological movements such as blood vessel pulsation, bending, and torsion.
  • the connector 203 also functions to cooperate with the steps at the thin-diameter section and the thick-diameter section of the push rod during transportation or recovery to further limit the braided stent, thereby improving the transportation performance or recovery performance of the braided stent.

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Abstract

L'invention concerne un stent tressé et un système de stent. Le système de stent comprend un système de pose (300) et le stent tressé. Le système de pose (300) comprend une tige d'administration (301) et un tube externe (302). Le stent tressé est utilisé pour être chargé entre la tige d'administration (301) et le tube externe (302), et la tige d'administration (301) et le tube externe (302) peuvent se déplacer l'un par rapport à l'autre dans une direction axiale. Le stent tressé comprend un corps principal tressé (200) et au moins un élément de liaison (203) ; au moins deux têtes de fil (202) au niveau d'au moins une extrémité du corps principal tressé (200) sont enveloppées par l'élément de liaison (203) et sont reliées à l'élément de liaison (203) ; l'élément de liaison (203) comprend une partie courbée (2032) et deux parties de liaison (2031) ; les deux extrémités de la partie courbée (2032) sont chacune reliées à l'une des parties de liaison (2031) ; chacune des parties de liaison (2031) enveloppe et est reliée à au moins l'une des têtes de fil (202), de telle sorte que le stent tressé peut être tressé en continu, ce qui permet de réduire la difficulté de tressage, d'améliorer l'efficacité de fabrication du stent tressé, et d'élargir la gamme de matériaux applicables pour préparer le stent tressé pour améliorer les performances du stent tressé.
PCT/CN2023/129053 2022-12-21 2023-11-01 Stent tressé et système de stent WO2024131326A1 (fr)

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CN202211650865.3 2022-12-21
CN202211650865.3A CN118217067A (zh) 2022-12-21 2022-12-21 编织支架及支架系统

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1201381A (zh) * 1995-11-01 1998-12-09 生物相容有限公司 编织扩张管
US6019779A (en) * 1998-10-09 2000-02-01 Intratherapeutics Inc. Multi-filar coil medical stent
CN108992221A (zh) * 2018-09-09 2018-12-14 上海医立泰生物科技有限公司 一种支架输送系统
CN210144810U (zh) * 2019-05-28 2020-03-17 南微医学科技股份有限公司 一种腔内支架
CN113523159A (zh) * 2021-07-08 2021-10-22 东华大学 面向机械编织型金属丝和高分子丝混编管道的收边工艺
CN114533338A (zh) * 2020-11-26 2022-05-27 深圳市先健畅通医疗有限公司 覆膜支架
CN219184351U (zh) * 2022-12-21 2023-06-16 神途医疗科技(上海)有限公司 编织支架及支架系统

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1201381A (zh) * 1995-11-01 1998-12-09 生物相容有限公司 编织扩张管
US6019779A (en) * 1998-10-09 2000-02-01 Intratherapeutics Inc. Multi-filar coil medical stent
CN108992221A (zh) * 2018-09-09 2018-12-14 上海医立泰生物科技有限公司 一种支架输送系统
CN210144810U (zh) * 2019-05-28 2020-03-17 南微医学科技股份有限公司 一种腔内支架
CN114533338A (zh) * 2020-11-26 2022-05-27 深圳市先健畅通医疗有限公司 覆膜支架
CN113523159A (zh) * 2021-07-08 2021-10-22 东华大学 面向机械编织型金属丝和高分子丝混编管道的收边工艺
CN219184351U (zh) * 2022-12-21 2023-06-16 神途医疗科技(上海)有限公司 编织支架及支架系统

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