CN118217067A

CN118217067A - Braided stent and stent system

Info

Publication number: CN118217067A
Application number: CN202211650865.3A
Authority: CN
Inventors: 黄云帆; 周炯; 王晓雯
Original assignee: Shentu Medical Technology Shanghai Co ltd
Current assignee: Shentu Medical Technology Shanghai Co ltd
Priority date: 2022-12-21
Filing date: 2022-12-21
Publication date: 2024-06-21
Also published as: WO2024131326A1

Abstract

The invention provides a woven stent and a stent system. The support system comprises a conveying system and a braiding support, wherein the conveying system comprises a conveying rod and an outer tube, the braiding support is used for being loaded between the conveying rod and the outer tube, and the conveying rod and the outer tube can relatively move along the axial direction. The braided stent comprises a braided main body and at least one connecting piece, wherein at least two spinning heads at the position of at least one end part of the braided main body are connected in a wrapping way by the connecting piece, the connecting piece comprises a bending part and two connecting parts, two ends of the bending part are respectively connected with one connecting part, and the connecting parts are connected with at least one spinning head in a wrapping way, so that the braided stent can be continuously braided, the braiding difficulty is reduced, the manufacturing efficiency of the braided stent is improved, and the material application range for preparing the braided stent is enlarged to improve the performance of the braided stent.

Description

Braided stent and stent system

Technical Field

The invention relates to the field of medical instruments, in particular to a braided stent and a stent system.

Background

Braided stents have been widely used in intravascular treatment and in recent years attention has been paid to damage to the vessel wall by wire cutting at the ends of the braided stent. The ends of the conventional braided stent have no special treatment or structural design, and the braided filaments at the ends are cut off to expose the spinneret. For this reason, woven stents have largely employed end-turn designs to reduce or completely eliminate exposure of the woven wire ends at both ends of the stent. The braiding wires at the end part of the braiding support are bent into an arc shape, so that the damage of the end part can be reduced, and the opening performance of the end part can be enhanced.

The structural design of the braided wire back braiding can improve the performance of the braided support, but greatly improves the complexity of the structure and the processing of the braided core rod, so that the braided support can not be continuously braided, the process difficulty is increased, the learning curve of workers is increased, the working hours are increased, and a doubling point (namely, two braided wires in different directions at the end part are fixed after being doubled) is introduced, so that the connection failure risk factor is introduced. Moreover, the arc-shaped form of the braided wire for braiding back has certain requirements on the bending resistance of the braided wire, for example, the fatigue performance of cobalt-chromium alloy in the form is extremely poor, and the fracture incidence rate is extremely high, so that the braided wire for braiding back a braided bracket is basically impossible to select, the selection of raw materials of the braided bracket is limited, and the applicable range of braided materials is reduced.

It should be noted that the information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

The invention provides a braided stent and a stent system, which can realize the noninvasive of the head end (namely the end part) of the braided stent, simultaneously, the braiding process can be continuous, the difficulty of the braiding process is reduced, the time of artificial braiding learning is shortened, and the manufacturing efficiency of the braided stent is improved.

In order to achieve the above object, the present invention provides a woven stent comprising a woven body and at least one connecting member, at least two spinnerets at least one end of the woven body being wrapped and connected by the connecting member, the connecting member comprising a bent portion and two connecting portions, both ends of the bent portion being respectively connected to one of the connecting portions, the connecting portion being wrapped and connected to at least one of the spinnerets.

Alternatively, the connection portion wraps one of the spinnerets when connecting monofilaments for knitting, or the connection 5 wraps two of the spinnerets at a knitting yarn doubling position when connecting double yarns for doubling for knitting.

Optionally, two of the connection portions wrap around and connect at least two non-adjacent ones of the spinnerets in different directions.

Optionally, part or all of the spinneret at least one end of the braided body is connected by the connection.

0 Optionally, the connecting portion has a configuration larger than a diameter of the braid wires, and the bending portion has a non-circular shape

A configuration smaller than the diameter of the braided wire.

Optionally, the two connecting parts are respectively provided with an inner cavity, the connecting parts are wrapped and connected with at least one spinneret through the inner cavities, and the bending part is of a solid structure or a hollow structure.

Optionally, when the bending part is of a hollow structure, the connecting piece is a hollow 5 sleeve which is integral or one-piece, and the inner cavity of the bending part is in a closed state.

Optionally, when the bending part is of a solid structure, the connecting piece is of a split structure, the bending part is a connecting wire, and the diameter of the connecting wire is not smaller than that of the braiding wire.

Optionally, when the bending part is of hollow structure, a reinforcing wire is provided in the inner cavity of the bending part, and/or the connecting piece is configured in a configuration with grooves on the surface.

0 Optionally, at least one of the inner side and the outer side of the connecting portion is provided with the notch, and +.

Or, at least one of the inner side and the outer side of the curved portion is provided with the notch.

Optionally, the connecting portion has a bending radius of 0.5mm to 5.0mm and/or the wall thickness of the inner cavity of the connecting member does not exceed the diameter of the braided wire.

To achieve the above object, the present invention also provides a stent system comprising a delivery system and the braided stent of any one of claims 5, the delivery system comprising a delivery rod and an outer tube, the braided stent being for loading between the delivery rod and the outer tube, and the delivery rod and the outer tube being relatively movable in an axial direction.

Optionally, the delivery rod comprises a conical head end and a push rod, a distal end of the push rod is connected with the conical head end, and a proximal end of the push rod is placed in the inner cavity of the outer tube; the push rod comprises a thick-diameter section and a thin-diameter section which are axially connected, the outer diameter of the thin-diameter section is smaller than that of the thick-diameter section, at least one end of the braided body can be contained between the thin-diameter section and the outer tube, and at least one connecting piece at the end of the braided body can be matched with a step between the thick-diameter section and the thin-diameter section to limit the braided support.

Optionally, the pushing rod includes one thick diameter section and one thin diameter section, the distal end of the thin diameter section is directly connected with the conical head end, or the pushing rod includes two thick diameter sections and two thin diameter sections, and the thin diameter section and the thick diameter section are alternately arranged in the axial direction of the pushing rod.

In the braided stent provided by the invention, at least two spinning heads at least one end part of a braided main body are connected in a wrapping way by a connecting piece, the connecting piece comprises a bending part and two connecting parts, two ends of the bending part are respectively connected with one connecting part, and the connecting parts are connected with at least one spinning head in a wrapping way. The setting like this for the weaving process of weaving the support can serialization, when realizing the tip noninvasive of weaving the support, reduced the degree of difficulty of weaving, also shortened workman's study curve, reduced the operation man-hour, improved the preparation efficiency of weaving the support, especially because the connecting piece directly constitutes the noninvasive structure of weaving the support tip, this makes the material selection of the silk of weaving the support more diversified, make the material that easily takes place fatigue fracture under the arc form originally also selectable, enlarged the material application scope of preparation weaving the support improves the performance of weaving the support. In addition, the connecting piece can be according to radian design requirement, selects corresponding material and structure, guarantees the fatigue resistance of connecting piece when realizing satisfying radian design requirement, still can promote the support nature of weaving support tip, can bear the fatigue loss that physiological motion such as vascular pulsation, bending, torsion brought better.

Because the stent system provided by the invention and the woven stent provided by the invention belong to the same invention conception, the stent system provided by the invention has all the advantages of the woven stent provided by the invention, and the beneficial effects of the stent system provided by the invention are not repeated here.

Drawings

The drawings provided by the invention are not necessarily to scale and some components and structures have been exaggerated for clarity. Variations of the illustrated embodiments are contemplated. Thus, the description of the various aspects and elements of the embodiments in the drawings is not intended to limit the scope of the invention. In the drawings:

FIG. 1 is a partial schematic view of a three-dimensional structure of a braided stent in accordance with an embodiment of the invention;

FIG. 2 is a schematic partial view of a front view of a braided stent in accordance with an embodiment of the present invention, and may be referenced by the area of the infusion indicated by reference numeral A;

FIG. 3a is a schematic axial cross-section of a connector according to an embodiment of the present invention as a whole being a hollow sleeve;

FIG. 3b is a schematic axial cross-section of a connector according to an embodiment of the invention with only two connectors hollow and the lumen of the bend closed;

FIG. 3c is a schematic axial cross-section of a connector according to an embodiment of the invention where only two connectors are hollow and the bends are wires;

FIG. 4a is a schematic cross-sectional view of a bend having a closed lumen according to an embodiment of the present invention;

FIG. 4b is a schematic cross-sectional view of a curved portion in a solid form according to an embodiment of the present invention;

FIG. 5a is a schematic axial cross-section of a connecting member with grooves on the inner and outer sides of only two connecting portions according to an embodiment of the present invention;

FIG. 5b is a schematic axial cross-sectional view of a connecting member according to an embodiment of the present invention, wherein notches are formed on the inner side of the curved portion in addition to notches formed on the inner and outer sides of the two connecting portions;

FIG. 5c is a schematic axial cross-sectional view of a connecting member according to an embodiment of the present invention, wherein notches are provided on the inner and outer sides of the curved portion in addition to notches provided on the inner and outer sides of the two connecting portions;

FIG. 5d is a schematic axial cross-section of a connecting member with grooves on the outer sides of only two connecting portions according to an embodiment of the present invention;

FIG. 6 is a schematic axial cross-section of a connector with reinforcing filaments disposed therein according to an embodiment of the present invention;

Fig. 7 is a schematic structural view of a conveying system according to a first embodiment of the present invention;

FIG. 8 is a schematic view showing a loading state in which a braided stent according to a first embodiment of the present invention is loaded on a transport rod and corresponds to a proximal end;

FIG. 9 is a schematic view showing a loading state in which a braided stent according to a first embodiment of the present invention is loaded on a transport rod and corresponds to a distal end;

fig. 10a is a schematic structural diagram of a push rod when a connection part between a thick diameter section and a thin diameter section is a diameter step abrupt change according to the first embodiment of the present invention;

Fig. 10b is a schematic structural view of a push rod when the diameter of the small-diameter section is gradually changed according to the first embodiment of the present invention;

FIG. 10c is a schematic structural view of a push rod when a linear tapered transition section is provided at the junction of a large diameter section and a small diameter section according to the first embodiment of the present invention;

FIG. 10d is a schematic structural view of a push rod when a nonlinear tapered transition is provided at the connection between a large diameter section and a small diameter section according to the first embodiment of the present invention;

fig. 11 is a schematic structural view of a push rod according to a first embodiment of the present invention, wherein the push rod has a small diameter section with a length S, and the length of the small diameter section is not less than the folded length of the connecting piece;

fig. 12 is a schematic structural diagram of a conveying system according to a second embodiment of the present invention.

In the accompanying drawings:

200-braiding a body; 201-braiding wires; 202-a spinneret; 203-a connector; 2031-a connection; 2032-bends; 2033-grooving; 204-reinforcing wires; 300-a conveying system; 301-conveying rod; 3011-a conical head end; 3012-a headend developer ring; 3013-pushing rod; 30131-small diameter section; 30132-a thick diameter section; 3014-pushing pad; 3015-a proximal developer ring; 302-an outer tube; 303-distal developer ring.

Detailed Description

Various example embodiments are described below. These examples are non-limiting and it should be understood that they are intended to illustrate the broader application aspects of the apparatus, system, and method. The embodiments may be modified in numerous ways and equivalents without departing from the true spirit and scope of the present invention. In addition, many variations may be made to adapt a particular situation, material, composition of matter, process action or step, to the objective, spirit or scope of the present invention. All such variations are intended to be within the scope of the present invention.

Any dimensions described in the summary or detailed description are to be considered merely examples and are not limiting of the inventive subject matter unless set forth in the various example embodiments. Moreover, the various structures of the embodiments described herein will complement each other rather than be purely alternating unless so stated. In other words, structures from one embodiment may be freely combined with structures of other embodiments, as will be readily appreciated by those of ordinary skill in the art, unless such structures are described for substitution only.

In the present document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of an operator using the braided stent or stent system, although "proximal" and "distal" are not limiting, "proximal" generally refers to an end of the braided stent or stent system that is proximal to the operator during normal operation, and "distal" generally refers to an end that first enters the patient. The "distal" and "proximal" in the present document are not directed to the ends of the structure, but rather are relative positions, e.g. the distal end of the braided stent is not the end of the braided stent, but rather is a position relatively close to the end of the braided stent.

In the present document, "axial" generally refers to a direction parallel to the central axis of the braided stent or stent system; "radial" generally refers to the diametrical direction of a braided stent or stent system, i.e., the direction perpendicular to the central axis; "circumferential" generally refers to a direction about the central axis of a braided stent or stent system.

The application will be further described with reference to specific examples. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

Fig. 1 and 2 illustrate a partial structure of a braided stent according to an embodiment of the present invention. As shown in fig. 1 and 2, the braided stent includes a braided body 200, and a spinneret 202 of part or all of braided filaments 201 at least one end of the braided body 200 is wrapped and connected by a connecting member 203. At least one connecting piece 203 is provided, and the connecting piece 203 is in a bending shape. The shape of the connecting member 203 after bending is not limited, and is preferably a bending shape with little trauma, such as an arc shape or other suitable shape. Specifically, the connector 203 includes two connection portions 2031 and one bending portion 2032, and both ends of the bending portion 2032 are respectively connected to one connection portion 2031, and each connection portion 2031 is wrapped around and connected to at least one spinneret 202. It will be appreciated that at least two of the spinnerets 202 at least one end of the woven body 200 are connected in a wrap by a connector 203. It should be understood that, in the case where at least part of the filaments are wrapped and connected by the connector 203, the non-wrapped and connected filaments may be exposed at the head end or may be connected to the woven body 200 after being rewound.

If the woven body 200 is woven from filaments, the connecting portion 2031 may be wrapped around one of the spinneret 202 when the filaments are connected. For example, when the braiding main body 200 is formed by braiding two filaments, the connecting portion 2031 wraps two filament heads 202 at the braiding filament doubling position when the two filaments are connected and braided, that is, two ends of one connecting piece 203 wrap two filament heads 202 respectively; alternatively, two filaments 201 in different directions may be joined together at their ends and then wrapped by a connecting member 203. It will be appreciated that at least two of the spinnerets 202 at different directions at the end of the woven body 200 are connected in a wrap by a connector 203. That is, one end connection 2031 of the connection 203 is wrapped around and connected to at least one of the filaments 202, and the other end connection 2031 is wrapped around and connected to another at least one of the filaments 202, thereby avoiding damage to the vessel wall due to exposure of at least two filaments 202 at the ends. At the end of either end of the braiding body 200, two connection parts 2031 of one connection member 203 wrap-connect at least two adjacent filaments 202 in different directions, or two connection parts 2031 of one connection member 203 wrap-connect at least two non-adjacent filaments 202 in different directions. The different directions herein are understood to be the two directions of extension of the braiding filaments 201 when they meet braiding. Taking monofilament braiding as an example, two connecting parts 2031 of one connecting piece 203 wrap two adjacent filaments 202 or two non-adjacent filaments 202 connected in different directions; taking double-silk doubling weaving as an example, two connecting parts 2031 of one connecting piece 203 wrap two adjacent sets of filaments or two non-adjacent sets of filaments in different directions. In addition, the spinnerets from different directions may be combined at the head end of the braiding body 200 to form a doubling unit, and two connection parts 2031 of one connection member 203 may wrap one doubling unit, respectively.

It is to be understood that if at least two of the spinneret 202 that are not adjacent are connected by wrapping with two connection portions 2031 of the same connection member 203, there are at least two of the spinneret 202 that are not wrapped between the spinneret 202 connected by the two connection portions 2031 of the connection member 203. In view of the proximity of two adjacent filaments 202 or two groups of adjacent filaments 202 in different directions, the difficulty of arranging the connector 203 is easily increased, and therefore, it is preferable that the two connecting portions 2031 of one connector 203 wrap-connect at least two non-adjacent filaments 202 in different directions, thereby reducing the process difficulty. Illustrated as monofilament braiding, typically two unwrapped filaments 202 are spaced between two non-adjacent filaments 202 in different directions, such as shown in fig. 2, although the present application does not exclude spacing more unwrapped filaments 202.

It should be understood that, by introducing the connecting piece 203, the braiding process of the braided stent can be continuous, after braiding is completed, the wire head 202 is connected by the connecting piece 203, so that the non-invasive treatment of the end part of the braided stent is realized, the risk of damage to the vascular wall caused by the section of the wire material is reduced, the opening performance of the end part of the braided stent is enhanced, and particularly, the braiding difficulty is effectively reduced due to the continuous braiding of the braided stent, meanwhile, the learning curve of workers is shortened, the operation time is reduced, and the manufacturing efficiency of the braided stent is improved. Moreover, the connecting piece 203 directly forms an end non-invasive structure instead of a braiding wire, so that the braiding wire of the braiding bracket is more diversified in material selection, and cobalt-chromium alloy and other materials which are easy to fatigue fracture under an arc shape can be selected, thereby expanding the application range of the braiding material and improving the performance of the braiding bracket. In addition, the connecting piece 203 can select corresponding materials and structures according to the radian design requirement, so that the fatigue resistance of the connecting piece 203 is ensured while the radian design requirement is met, the compliance and the supportability of the end part of the braided stent can be improved, and the braided stent can better bear fatigue loss caused by physiological movements such as vascular pulsation, bending, torsion and the like.

Further, the connection portion 2031 of the connection member 203 has a larger diameter than the braided wire 201 to facilitate wrapping of the connection spinneret 202. The curved portion 2032 of the connection member 203 preferably has a configuration not smaller than the diameter of the braid 201 to ensure bending resistance of the connection member 203 and reduce the risk of fracture failure after bending of the curved portion 2032. The connection member 203 may have various configurations, and the present application is not limited thereto.

In this embodiment, two connecting portions 2031 of the connecting piece 203 are each provided with an inner cavity, each connecting portion 2031 is wrapped by the inner cavity to connect with at least one spinneret 202, and the bending portion 2032 may be a solid structure or a hollow structure, preferably, the bending portion 2032 is a hollow structure to enhance bending performance.

As shown in fig. 3a, in an embodiment, when the bending portion 2032 is of a hollow structure, the connection member 203 may be a hollow sleeve, which is integral or unitary, and has an inner cavity that is completely penetrated along its own axis, and the inner cavity of the bending portion 2032 is in a non-closed open state. The hollow sleeve may be an isodiametric sleeve or a non-isodiametric sleeve. An isodiametric sleeve is understood to have the same inner and outer diameters; a non-constant diameter sleeve is understood to have the same inner diameter, but different outer diameters, or different inner diameters, but different inner diameters, preferably the inner diameters of the two connecting portions 2031 are the same, 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, e.g., 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.

In another embodiment, as shown in fig. 3b, the curved portion 2032 of the integral or unitary hollow cannula is treated so that the lumen of the curved portion 2032 is in a closed state (equivalent to being occluded). In order to make the curved portion 2032 of the hollow sleeve have a closed cavity, a hollow tube is prepared and then pressed to form the curved portion 2032 with a closed cavity, as shown in fig. 4 a. The arrangement of the bending portion 2032 makes the inner and outer layer ductility of the hollow sleeve different in whole or in one piece, and further is more excellent in fatigue fracture performance. Moreover, compared with a hollow sleeve which is completely penetrated in the axial direction, when the inner cavity of the bending part 2032 is closed, the whole or integrated hollow sleeve can reach smaller curvature radius without breaking failure, and therefore, the bending resistance is good.

Alternatively, as shown in fig. 4b, the bending portion 2032 of the connector 203 may be made of a solid tube, so that the bending portion 2032 is a solid structure without an inner cavity, and at this time, only the inner cavity needs to be machined at both ends of the connector 203 to wrap the connection spinneret 202. In this embodiment, only two connecting portions 2031 of the connecting member 203 have an inner cavity, and the curved portion 2032 has a solid structure.

As shown in fig. 3c, when the bending portion 2032 is of a solid structure, the connector 203 is of a split structure, the bending portion 2032 is provided as a connecting wire, and two ends of the connecting wire are respectively connected with the connecting portions 2031 of one sleeve structure. At this time, the connection portion 2031 and the connection wire are each independently processed, and then the connection wire is assembled and connected with the connection portion 2031. Because the connecting wire needs to be bent and formed, the diameter of the connecting wire is preferably not smaller than the diameter of the braid 201 in order to reduce the risk of breakage thereof. The connection between the connection wire and the connection portion 2031, and the connection between the braid 201 and the connection portion 2031 may be any suitable connection, such as: laser welding, dispensing, silver soldering or press riveting, and the like, and one or more connecting modes can be adopted during the connection.

The bending radius R of the connection 203 should not be too large or too small; if the bending radius R is too small, the process difficulty is easy to increase; if the bending radius R is too large, the anchoring performance of the end part of the bracket is easily affected; for this reason, the bending radius R of the connection member 203 is preferably 0.5mm to 5.0mm. Further, the wall thickness of the inner cavity of the connecting member 203 does not exceed the diameter of the braided wire 201, so as to reduce the volume of the braided stent in a crimped state, thereby reducing the size of the delivery device, and if the wall thickness of the connecting member 203 is large, the radius of curvature of the connecting member 203 is easily limited.

The material for preparing the connection member 203 may be any medical material with good biocompatibility, for example, a metal material or a polymer material may be used for preparing the connection member 203, and the connection member 203 may be a combination of a metal structure and a polymer structure. For example, the metal material from which the connector 203 is made may be selected from nickel-titanium alloy, cobalt-chromium alloy, stainless steel, etc., and the connector 203 may be made from a combination of one or more metal materials. For example, the polymer material used to make the connection member 203 may be PC (polycarbonate), PTFE (polytetrafluoroethylene), HDPE (high density polyethylene), or the like, and the connection member 203 may be made of one or a combination of polymer materials.

The connection 203 may be configured in a configuration with no score 2033 on the surface or a configuration with score 2033 on the surface. Exemplary structures of the connection member 203 without the notch 2033 may refer to fig. 3a to 3c. It should be noted that, after the notch 2033 is formed on the surface of the connecting piece 203, the elasticity of the connecting piece 203 can be increased, so that the flexibility of the connecting piece 203 with the notch 2033 is better than that of the connecting piece 203 without the notch 2033, and further, the end part of the braided stent has better flexibility, and can better bear fatigue loss caused by physiological movements such as vascular pulsation, bending, torsion and the like. When the surface of the connection member 203 is provided with the notch 2033, at least one of the inner side and the outer side of the connection portion 2031 is provided with the notch 2033, and/or at least one of the inner side and the outer side of the curved portion 2032 is provided with the notch 2033, referring to fig. 5a to 5d in particular.

When the notch 2033 is provided on the surface of the connection member 203, the notch 2033 is preferably provided on the surface of the two connection portions 2031, and the notch 2033 is further provided on the surface of the curved portion 2032 of the connection member 203. When providing the notches 2033 in the two connection portions 2031 of the connection member 203, the notches 2033 are preferably provided on the outer side of the connection portion 2031, and the notches 2033 are further provided on both the inner side and the outer side of the connection portion 2031. When the notch 2033 is provided on the surface of the curved portion 2032 of the connector 203, the notch 2033 is preferably provided on the inner side of the curved portion 2032, and the notch 2033 is further provided on both the inner side and the outer side of the curved portion 2032. The shape of the score groove 2033 is not particularly limited, such as a spiral score groove, an arcuate score groove, a linear groove, or other suitable shape. The notch 2033 is communicated with the inner cavity of the connector 203. It will be appreciated that the inside of the connection member 203 refers to the side of the connection member 203 that is compressed when the connection member 203 is bent, and the outside of the connection member 203 refers to the side that is pulled when the connection member 203 is bent.

In more detail, the schematic illustration is given as a hollow cannula, either integral or unitary. As shown in fig. 5a, the connecting member 203 is provided with notches 2033 on both the inner and outer sides of the two connecting portions 2031, and the curved portions 2032 are free of any notches 2033. Alternatively, as shown in fig. 5b, in addition to the notches 2033 provided on the inner and outer sides of the two connection portions 2031 of the connection piece 203, notches 2033 are provided on the inner side of the curved portion 2032. As shown in fig. 5c, in addition to the notches 2033 formed on the inner and outer sides of the two connecting portions 2031 of the connector 203, notches 2033 are formed on the inner and outer sides of the curved portion 2032. As shown in fig. 5d, the connecting member 203 is provided with notches 2033 only on the outer sides of the two connecting portions 2031, and the bending portion 2032 has no notches 2033.

In view of the large stress on the bending portion 2032 and the easiness of breakage, it is preferable to provide an inner cavity of the bending portion 2032

Reinforcing wires 204 are provided as shown in fig. 6. In this embodiment, the reinforcing wire 204 can improve the breaking strength of the connection member 203 at the 5-groove portion. The reinforcing wire 204 may be made of a metallic material having good elasticity and high strength, such as stainless steel, nickel-titanium alloy, etc.

It should be understood that some or all of the filaments 202 of the braided body 200 at either end thereof may be wrapped with a connector 203. It should also be understood that the application is not limited in its use to weave stents.

In this embodiment, the braided stent is a carotid stent. In other embodiments, the braided stent may also be provided 0 as a valve stent, coronary stent, vascular stent, etc.

As shown in fig. 7-9, 10 a-10 d, and 11-12, the braided stent of the present application needs to be delivered into the body by a delivery system 300. Further, the present application also provides a delivery system 300 and a stent system comprising the delivery system 300 and a braided stent.

The delivery system 300 and the manner in which the braided stent of the present application are delivered will be further described.

Embodiment one:

fig. 7 illustrates an exemplary structure of a delivery system 300 according to a first embodiment of the present invention, and fig. 8 illustrates a loading shape corresponding to a proximal end when a braided stent is loaded on a delivery rod 301 according to a first embodiment of the present invention

In this state, fig. 9 illustrates a loading state corresponding to the distal end 0 when the braided stent is loaded on the transport rod 301 according to the first embodiment of the present invention.

As shown in fig. 7 to 9, the delivery system 300 includes a delivery rod 301 and an outer tube 302, wherein a proximal end of the delivery rod 301 is disposed in an inner cavity of the outer tube 302, and the delivery rod 301 and the outer tube 302 are relatively movable in an axial direction, so that loading, releasing, and retrieving operations of the braided stent can be performed by the relative movement between the delivery rod 301 and the outer tube 302. Specifically, the braided stent is loaded between the delivery rod 5301 and the outer tube 302 in the radial direction of the braided stent, and is released and recovered mainly by friction between the braided stent and the delivery rod 301

And (5) weaving the bracket. As shown in fig. 8, the woven body 200 may be woven from the woven filaments 201 having the same filament diameter, or may be woven from the woven filaments 201 having different filament diameters, or the woven body 200 may be a double-layer woven body, the outer-layer woven body may be woven from thick filaments, the inner-layer woven body may be woven from thin filaments, and at least two thick filament heads 202 at the end portions of the outer-layer woven body may be wrapped and connected by a connecting member 203.

As shown in fig. 7, the delivery rod 301 may include a tapered head end 3011 and a push rod 3013, the distal end of the push rod 3013 being connected to the tapered head end 3011, the proximal end of the push rod 3013 being disposed within the lumen of the outer tube 302. The braided stent is loaded on the push rod 3013 and released and recovered by using friction between the braided stent and the push rod 3013. A tapered head end 3011 is provided at the distal-most end of the delivery rod 301, which is made of a softer material, which reduces trauma to the vessel. Typically, the proximal side of the tapered head end 3011 is provided with a head end development ring 3012, and the distal end of the push rod 3013 is placed in the bores of the tapered head end 3011 and head end development ring 3012 and fixedly attached.

In particular, the push rod 3013 includes a small diameter section 30131 and a large diameter section 30132 that are axially connected, with the small diameter section 301311 having an outer diameter that is smaller than the outer diameter of the large diameter section 30132. In this embodiment, the small diameter section 30131 and the large diameter section 30132 are both one, and one small diameter section 30131 is located between the large diameter section 30132 and the tapered head end 3011 and directly connected to the proximal end of the tapered head end 3011. In this embodiment, the distal end of one small diameter section 30131 is inserted directly into the lumens of the head end development ring 3012 and tapered head end 3011, and the proximal end of the large diameter section 30132 is inserted directly into the lumen of outer tube 302.

In this embodiment, as shown in fig. 9, the arrangement of the small-diameter section 30131 is not only convenient for accommodating the volume increasing portion at the position corresponding to the distal end portion of the braided stent, but also can limit the distal end portion of the braided stent to a certain extent, so as to assist the release of the braided stent, reduce the risk of relative displacement between the braided stent and the conveying rod 301 in the release process, ensure the release precision of the braided stent, and improve the operation efficiency.

The push rod 3013 is generally provided with an axially-extending guidewire lumen, and the guidewire lumen of the small diameter section 30131 and the guidewire lumen of the large diameter section 30132 are in communication and coaxially disposed. The guidewire lumen may pass over a guidewire, such as a guidewire of 0.0014 inch.

The outer tube 302 may be advanced distally to encase the braided stent such that the braided stent is received between the outer tube 302 and the delivery rod 301. The braided stent is constrained by the outer tube 302 to be compressively loaded onto the delivery rod 301. The delivery system 300 of this embodiment may further incorporate an intermediate catheter that establishes a surgical pathway within the body through which the braided stent is delivered to a target location within the body.

Further, the delivery rod 301 may further include a pushing pad 3014 that is sleeved on the large diameter section 30132 to increase friction between the pushing rod 3013 and the braided stent. As shown in fig. 8 and 9, when the braided stent is loaded on the delivery rod 301, the gap between the small diameter section 30131 and the outer tube 302 and the gap between the large diameter section 30132 and the outer tube 302 just accommodates the braided stent, and the push pad 3014 is located between the push rod 3013 and the inner wall of the braided stent, at this time, the braided wire 201 and the connecting piece 203 at the end of the braided stent corresponding to the distal end just can be accommodated between the small diameter section 30131 and the outer tube 302, and in particular the connecting piece 203 can be clamped at the step (i.e., the position marked by the rectangular dotted line frame B) between the small diameter section 30131 and the large diameter section 30132 to reduce the risk of the braided stent being unloaded during the release process. Thin section 30131 and thick section 30132

The step therebetween may also assist in the release of the braided stent, i.e., during stent release, the step may push against the proximal end of the link 5 203 and push the release of the braided stent.

As shown in fig. 7, the inner wall at the distal-most end of the outer tube 302 may be provided with a distal developing ring 303, and the position of the distal-most end of the outer tube 302 is determined by the distal developing ring 303. Distal developer ring 303 may be coincident with head developer ring 3012 to thereby determine the position of the distal end of outer tube 302 relative to the distal end of delivery rod 301. Distal developer ring 303

May coincide with the proximal visualization ring 3015 on the push rod 3013 to thereby determine 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 further positioned

On the proximal side of push pad 3014. In this embodiment, the distance the outer tube 302 slides in the axial direction is physically limited;

When the outer tube 302 is slid distally until the distal developer ring 303 is coincident with the headend developer ring 3012, for example, the distal developer ring 303 may be sleeved on the headend developer ring 3012; as outer tube 302 slides proximally until

Distal developer ring 303 is blocked when it coincides with proximal developer ring 3015. It is to be appreciated that the tip development rings 3012, 5 distal development ring 303, and proximal development ring 3015 are each made of an X-ray opaque material.

The junction between the small diameter section 30131 and the large diameter section 30132 may be smooth or non-smooth, preferably smooth.

Specifically, the junction between the small diameter section 30131 and the large diameter section 30132 may satisfy one of the following conditions

One or two of:

0 (1) As shown in FIG. 10a, the junction between the small diameter section 30131 and the large diameter section 30132 (rectangular dotted line

The position marked by the wire frame B) has no transition;

(2) As shown in fig. 10b, the small diameter section 30131 is configured as a tapered section such that the diameter of the small diameter section 30131 gradually decreases in a linear fashion distally from the large diameter section 30132;

(3) As shown in FIG. 10c, a linear tapered transition 5 is provided between the small diameter section 30131 and the large diameter section 30132, where the small diameter section 30131 and the large diameter section 30132 are both straight sections and pass through the linear tapered transition

Smoothly transition the small diameter section 30131 and the large diameter section 30132;

(4) As shown in fig. 10d, a nonlinear tapered transition section is provided between the small diameter section 30131 and the large diameter section 30132, at this time, the small diameter section 30131 and the large diameter section 30132 are both flat sections, and the small diameter section 30131 and the large diameter section 30132 are smoothly transitioned through the nonlinear tapered transition section.

The setting of toper changeover portion or non-toper changeover portion has realized the smooth transition between two adjacent straight sections, prevents that great stress concentration from appearing between two adjacent straight sections, reduces the push rod 3013 and appears buckling or cracked risk.

The length of the reduced diameter section 30131 should be dependent on the folded length of the connector 203 at the end. As shown in FIG. 11, the length of the reduced diameter section 30131 is S, and the length of the connector 203 after folding is L, S.gtoreq.L. It is to be noted that the pushing rod 3013 can more conveniently accommodate the volume increasing portion at the end of the knitting rack due to the thin diameter section 30131, and can limit the knitting rack, and the thick diameter section 30132 can raise the breaking strength of the whole pushing rod 3013, so that the knitting rack can be reliably loaded and conveyed, and the strength of the pushing rod 3013 can be ensured.

The materials of the small diameter section 30131 and the large diameter section 30132 may be the same or different, and specifically, the material for preparing the push rod 3013 is not limited in the present application, and any suitable conventional material may be used for preparing the push rod, such as a metal material or a polymer material.

Embodiment two:

Fig. 12 illustrates an exemplary structure of a conveying system 300 according to a second embodiment of the present invention. As shown in fig. 12, the structure of the conveying system 300 of the present embodiment differs from that of the first embodiment in that the pushing rod 3013 includes two small-diameter sections 30131 and two large-diameter sections 30132, and the small-diameter sections 30131 and the large-diameter sections 30132 are alternately arranged in the axial direction of the pushing rod 3013, that is, the small-diameter sections 30131, the large-diameter sections 30132, the small-diameter sections 30131 and the large-diameter sections 30132 are arranged in this order from the distal end to the proximal end. Further, the pushing pad 3014 is sleeved on the thick-diameter section 30132 between the two thin-diameter sections 30131. Further, the proximal developer ring 3015 is sleeved over a proximal-most one of the large diameter sections 30132.

In this embodiment, when the braided stent is loaded on the delivery rod 301, the braided wire 201 and the connecting member 203 at the end portion of the braided stent corresponding to the proximal end can be just accommodated between the proximal-most small diameter section 30131 and the outer tube 302, especially, the connecting member 203 at the proximal end can be clamped at the step between the proximal-most small diameter section 30131 and the large diameter section 30132 to reduce the risk of unloading the braided stent during the recovery process, so the proximal-most small diameter section 30131 can perform an auxiliary recovery function, while the braided wire 201 and the connecting member 203 at the end portion of the braided stent corresponding to the distal end can be just accommodated between the distal-most small diameter section 30131 and the outer tube 302, especially, the connecting member 203 at the distal end can be clamped at the step between the distal-most small diameter section 30131 and the large diameter section 30132 to reduce the risk of unloading the braided stent during the release process, and perform an auxiliary pushing function during the release process of the braided stent.

Therefore, in the solution provided by the present invention, at least the following advantages are obtained by introducing the connecting piece 203:

Firstly, the knitted body 200 can be continuously knitted, that is, after the continuous knitting of the knitted body 200 is completed, the cut-off yarn heads 202 are connected by the connectors 203, and finally, the non-invasive treatment and design of the end of the knitted body 200 are realized, so that the risk of damage to the vascular wall caused by the wire section is reduced, and the opening performance of the end of the knitted stent is enhanced. Also, since the braiding main body 200 can be continuously braided, braiding difficulty is also reduced, a worker's learning curve is shortened, operation man-hour is reduced, and manufacturing efficiency of the braided stent is improved.

Secondly, since the connection member 203 directly constitutes the non-invasive structure at the end of the woven body 200 instead of the atraumatic design of the woven wire, the material selection of the woven wire of the woven body 200 is more diversified, so that the cobalt-chromium alloy and other materials which are easily subject to fatigue fracture in the arc-shaped form can be selected, and the application range of the material for preparing the woven stent is enlarged to improve the performance of the woven stent.

Furthermore, the connecting piece 203 can select corresponding materials and structures according to the radian design requirement, so that the fatigue resistance of the connecting piece 203 is ensured while the radian design requirement is met, the compliance and the supportability of the end part of the braided stent can be improved, and the braided stent can better bear fatigue loss caused by physiological movements such as vascular pulsation, bending, torsion and the like.

In addition, the connecting piece 203 is also used for being matched with steps at the small-diameter section and the large-diameter section of the pushing rod during conveying or recycling so as to further limit the braided stent, and the conveying performance or recycling performance of the braided stent is improved.

It should be noted that, in the present description, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different manner from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the system disclosed in the embodiment, the description is relatively simple because of corresponding to the method disclosed in the embodiment, and the relevant points refer to the description of the method section.

It should be further noted that although the present invention has been disclosed in the preferred embodiments, the above embodiments are not intended to limit the present invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.

It should also be understood that the terminology described herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses, and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood as having the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates the contrary. Furthermore, implementation of the methods and/or apparatus in embodiments of the invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. The braided support is characterized by comprising a braided main body and at least one connecting piece, wherein at least two spinning heads at least one end part of the braided main body are connected by wrapping the connecting piece, the connecting piece comprises a bending part and two connecting parts, two ends of the bending part are respectively connected with one connecting part, and the connecting parts wrap and connect at least one spinning head.

2. The braided stent of claim 1, wherein said connecting portion wraps one of said filaments when braided with a connecting monofilament or said connecting portion wraps two of said filaments at a braiding yarn doubling when braided with a connecting multifilament yarn.

3. The braided stent of claim 1, wherein two of said connecting portions wrap connect at least two non-adjacent ones of said spinnerets in different directions.

4. The braided stent of claim 1, wherein some or all of the spinnerets at least one end of the braided body are connected by the connector wrap.

5. The braided stent of claim 1, wherein the connecting portion has a configuration that is larger than a braided wire diameter and the curved portion has a configuration that is not smaller than a braided wire diameter.

6. The braided stent of claim 1, wherein both of said connecting portions are provided with an inner lumen, said connecting portions are wrapped through said inner lumen to connect at least one of said spinnerets, and said curved portions are of solid or hollow construction.

7. The braided stent of claim 6, wherein when the curved portion is a hollow structure, the connecting member is a unitary or one-piece hollow sleeve and the lumen of the curved portion is in a closed state.

8. The braided stent of claim 6, wherein when the curved portion is of solid construction, the connecting member is of split construction and the curved portion is a connecting wire having a diameter not less than the diameter of the braided wire.

9. The braided stent of claim 6, wherein when the curved portion is of hollow construction, reinforcing wires are disposed within the lumen of the curved portion and/or the connector is configured with a grooved configuration on a surface.

10. The braided stent of claim 9, wherein at least one of an inner side and an outer side of the connecting portion is provided with the notch, and/or at least one of an inner side and an outer side of the curved portion is provided with the notch.

11. The braided stent of claim 6, wherein the bend has a bend radius of 0.5mm to 5.0mm and/or the lumen of the connector has a wall thickness that does not exceed the diameter of the braided filaments.

12. A stent system comprising a delivery system and a braided stent according to any one of claims 1 to 11, the delivery system comprising a delivery rod and an outer tube, the braided stent being for loading between the delivery rod and the outer tube and being relatively axially movable between the delivery rod and the outer tube.

13. The stent system of claim 12, wherein the delivery rod comprises a tapered head end and a push rod, a distal end of the push rod being connected to the tapered head end, a proximal end of the push rod being disposed within the lumen of the outer tube; the push rod comprises a thick-diameter section and a thin-diameter section which are axially connected, the outer diameter of the thin-diameter section is smaller than that of the thick-diameter section, at least one end of the braided body can be contained between the thin-diameter section and the outer tube, and at least one connecting piece at the end of the braided body can be matched with a step between the thick-diameter section and the thin-diameter section to limit the braided support.

14. The stent system of claim 13, wherein the push rod comprises one of the large diameter section and one of the small diameter section, the distal end of the small diameter section being directly connected to the tapered head end, or the push rod comprises two of the large diameter section and two of the small diameter section, the small diameter section and the large diameter section being alternately arranged in an axial direction of the push rod.