CN116407335A

CN116407335A - Tectorial membrane support and tectorial membrane support conveying system

Info

Publication number: CN116407335A
Application number: CN202111678608.6A
Authority: CN
Inventors: 刘彩萍; 郭平; 黄程; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The invention relates to a covered stent and a covered stent conveying system, wherein the covered stent comprises: the self-expanding type tubular body comprises an end section with an opening end, a deformable first wave ring and a second wave ring, wherein the first wave ring is movably connected with the end section, and the second wave ring is connected with the end section; when the end section is radially compressed to the first state, the first wave ring at least partially can pass through the opening end, and when the end section is radially expanded from the first state to the second state, the first wave ring is positioned in an axial area where the end section is positioned, and the axial area where the first wave ring is positioned and the axial area where the second wave ring is positioned at least partially overlap. The covered stent and the covered stent conveying system can improve the stimulation and damage to the blood vessel in the release process of the covered stent.

Description

Tectorial membrane support and tectorial membrane support conveying system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a covered stent and a covered stent conveying system.

Background

Over ten years ago, the endoluminal isolation of the covered stent has been widely applied to lesions such as aneurysms and aortic dissection of the thoracic and abdominal aorta, has definite curative effect, small trauma, quick recovery and fewer complications, and has become a first-line treatment method. The tectorial membrane support includes supporting framework and the tectorial membrane of covering on supporting framework. In the operation, the covered stent is radially compressed and loaded in a conveying sheath pipe of a conveyer, the covered stent is implanted to a lesion position after being conveyed to the lesion position by the conveyer, and the covered stent isolates blood flow from the lesion position, so that the influence of blood pressure on the lesion position is eliminated, and the purpose of healing is achieved.

However, for self-expanding stent grafts, under the effect of self-expanding deployment, the stent graft will radially outwardly abut against the inner wall of the sheath. In this case, the stent is released, and when the sheath is retracted, the stent graft is moved along with the sheath, so that the stent graft cannot be released at a predetermined lesion position.

Through setting up naked support section (i.e. the support skeleton section that does not have the tectorial membrane and cover) in tectorial membrane support's tip position, in the transportation, be connected naked ripples circle and conveyer and realize axial spacing to can prevent sheath withdrawal and drive tectorial membrane support and shift, the accuracy that has increased the support release. However, due to the self-expansion characteristic, the bare stent can generate larger radial outward elasticity in the release process, the elasticity directly acts on the inner wall of the blood vessel, and can cause larger stimulation to the blood vessel, in particular to the convex wave crest on the bare stent section, the bare stent is less constrained, and the damage to the blood vessel is more easy to cause in the release process.

Disclosure of Invention

Based on the above, the invention provides a covered stent and a covered stent conveying system, which aim to improve the stimulation and damage of the covered stent to blood vessels in the release process.

To achieve the purpose, the invention adopts the following technical scheme:

a stent graft comprising:

a self-expanding tubular body comprising an end section having an open end;

the deformable first wave ring is movably connected with the end section;

a second wave band connected with the end section;

the first pulsator may at least partially pass over the open end when the end section is radially compressed to a first state, the first pulsator is located within an axial region where the end section is located when the end section is radially expanded from the first state to a second state, and the axial region where the first pulsator is located at least partially overlaps with an axial region where the second pulsator is located.

In one embodiment, when the end section is in the second state, the axial region in which the first wave ring is located within the axial region in which the second wave ring is located.

In one embodiment, the second wave ring is fixedly connected with the end section, and the second wave ring is located in an axial region where the end section is located.

In one embodiment, the end section includes an end coating that covers the outer surfaces of the second wave band and the first wave band when the end section is in the second state.

In one embodiment, the end covering film comprises an outer covering film, the outer covering film is located on the outer side of the second wave ring, the second wave ring comprises an inner layer exposed section, the inner surface of the inner layer exposed section is exposed, and the first wave ring is connected with the second wave ring through the inner layer exposed section.

In one embodiment, at least one limiting channel is arranged between the second wave ring and the outer layer coating film, the first wave ring comprises a wave-shaped annular structure formed by a first supporting wire, and the first supporting wire passes through the limiting channel so that the first wave ring can be movably connected with the end section.

In one embodiment, the end covering film further comprises an inner covering film, the second wave ring further comprises an inner covering film section, the inner surface of the inner covering film section is covered by the inner covering film, two ends of the inner exposed section are connected with the inner covering film section, and the inner exposed section, the outer covering film and the inner covering film covered by the inner surface of the inner covering film section enclose to form the limit channel.

In one embodiment, the stent graft further comprises a movable connecting member, the first wave ring is connected with the end section by the movable connecting member, and the first wave ring is movable relative to the end section in the axial direction.

In one embodiment, the movable connecting piece comprises an elongated connecting piece, one end of the elongated connecting piece is connected with the first wave ring, the other end of the elongated connecting piece is connected with the exposed section of the inner layer, and at least one end of the elongated connecting piece is a fixed connecting end.

In one embodiment, the first wave ring comprises a plurality of first wave troughs and first wave crests, wherein the first wave troughs are respectively connected to the inner layer exposed sections on two sides of the first wave troughs through two elongated connectors; and/or the first wave crest is respectively connected to the inner layer exposed sections at the two sides of the first wave crest through two slender connecting pieces.

In one embodiment, the first wave ring comprises a plurality of first wave troughs and a plurality of wave rods, the second wave ring comprises a plurality of second wave crests and a plurality of second wave troughs, and the first wave troughs are respectively connected to the second wave troughs on two sides of the first wave troughs through two slender connectors; and/or the second wave crest is respectively connected to the wave rods of the first wave circle positioned at two sides of the second wave crest through two slender connecting pieces.

In one embodiment, the wave angle of the second wave ring is smaller than the wave angle of the first wave ring, and the wave rod of the second wave ring is smaller than or equal to the wave rod of the first wave ring.

The stent graft delivery system comprises a conveyor and the stent graft according to any one of the above, wherein the conveyor is used for conveying the stent graft, the conveyor comprises a sheath core, an anchoring part is arranged at the distal end of the sheath core, and when the stent graft is loaded in the conveyor, the anchoring part is connected with the first wave ring crossing the opening end part.

According to the covered stent and the covered stent conveying system, the deformable first wave ring is arranged at the opening end part of the self-expanding covered stent, so that the first wave ring can deform and pass over the opening end part to be connected with the conveyor in a loading state, the covered stent can be prevented from being moved by the sheath tube after being withdrawn, and the releasing accuracy of the covered stent is improved; in addition, in the release process of the tectorial membrane support, the first wave ring deforms and returns to the axial region where the end section of the tubular main body is located, the end section of the tubular main body can form a certain degree of constraint on the first wave ring, and the stimulation and damage of the first wave ring to blood vessels in the release process are reduced.

Drawings

FIG. 1 is a schematic view of a stent graft according to an embodiment of the present invention in a natural state;

FIG. 2 is a schematic view of the stent graft of FIG. 1 in a radially compressed state;

FIG. 3 is a schematic plan view of the end section of FIG. 1;

FIG. 4 is a schematic plan view of the spacing channel of FIG. 3;

FIG. 5 is a schematic plan view of an end section according to another embodiment of the present invention;

FIGS. 6-8 are schematic plan views of an end section according to yet another embodiment of the present invention;

fig. 9 is a schematic structural diagram of a stent graft delivery system according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

In addition, for purposes of more clearly describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" means the end from which blood flows, and "proximal" means the end from which blood flows, for example, after implantation of a stent, blood flows from the proximal end toward the distal end of the stent; "axial" means its lengthwise direction and "radial" means a direction perpendicular to the "axial direction".

The wave ring is a closed wave ring structure, also called a wave ring, and is made of metal elastic material by braiding or cutting. The metallic elastic material includes known materials or combinations of various biocompatible materials implanted in medical devices, such as alloys of two or more single metals of cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nitinol, tantalum alloys, etc., or other biocompatible metallic elastic materials. The wave ring has radial expansion capability, can realize radial contraction under the action of external force, and can restore to the original shape and maintain the original shape by self-expansion or mechanical expansion (for example, balloon expansion) after the external force is removed, thereby being capable of being tightly attached to the inner wall of the lumen through the radial supporting force after being implanted into the lumen. The waveform of the wave ring is not limited, and includes Z-shaped wave, M-shaped wave, V-shaped wave, sine wave, etc. The wave ring comprises a plurality of wave crests (also known as proximal peaks), a plurality of wave troughs (also known as distal peaks), and wave rods connecting adjacent wave crests and wave troughs. Wherein one vertex (proximal or distal) and two wavebars connected to the vertex form one wave.

The wave number refers to the number of wave crests or wave troughs, and the number of wave crests and wave troughs in the same wave ring are the same. "wave height" refers to the vertical distance between a peak and two adjacent valley lines. The "wave angle" refers to the angle between two adjacent wavebars.

Example 1

Referring to fig. 1, the present embodiment exemplarily provides a stent graft 100, and the stent graft 100 includes a self-expanding tubular body 10. The tubular body 10 has a hollow lumen structure, and the lumen of the tubular body 10 forms a blood flow passage. The tubular body 10 comprises an end section 1 and a body section 2 connected to the end section 1, the end section 1 being located at the proximal end of the body section 2 or the end section 1 being located at the distal end of the body section 2.

The main body section 2 includes a tubular main body skeleton 121 and a main body cover film 122 connected to the main body skeleton 121. The body skeleton 121 has radial expansion capability, can be radially contracted by external force, and is self-expanded to return to an original shape and maintain the original shape after the external force is removed, so that the body skeleton 121 can be tightly attached to the inner wall of the lumen by the radial supporting force after being implanted into the lumen. The body frame 121 is made of a material having good tensile and elastic properties and good biocompatibility, such as nickel titanium, stainless steel, etc. In this embodiment, the body skeleton 121 includes a plurality of axially arranged wavy rings. In other embodiments, the body skeleton 121 may also be a mesh structure, a spiral structure, or the like formed by braiding or cutting.

The main body covering film 122 may be made of a polymer material with good biocompatibility, such as polytetrafluoroethylene (Polytetra fluoroethylene, abbreviated as PTFE), polyethylene terephthalate (Polyethylene terephthalate, abbreviated as PET), and the main body covering film 122 may be fixed on the inner surface and/or the outer surface of the main body skeleton 121 by stitching, bonding, hot melting, and the like, so as to play roles in reconstructing a fluid channel, isolating a lesion region of a lumen, and the like.

The end section 1 comprises a tubular end coating 20 and the end section 1 has an open end which can be formed by the edge closure of the end coating 20. Further, the end section 1 is provided with an end support assembly, wherein the end support assembly comprises a first wave ring 30 and a second wave ring 40 connected with the end section 1. Generally, the tubular body 10 has at least one proximal open end 10a and one distal open end 10b. The first wave ring 30 and the second wave ring 40 may be disposed on the end section 1 where the proximal open end 10a of the tubular body 10 is located, or the end section 1 where the distal open end 10b is located, or the end sections 1 disposed at both ends of the tubular body 10 at the same time, and may be selectively disposed according to actual needs. In the present embodiment, the first and second pulsators 30 and 40 are provided at the proximal open end 10a of the tubular body 10.

Referring to fig. 2, there is at least a first state and a second state of the end section 1. When the end section 1 is radially compressed to the first state, the end section 1 has a first radial dimension r (the radial dimension may be obtained by measuring the diameter of a circle circumscribing the end section 1, the same applies below), and the first bead 30 at least partially passes over the open end forming the pass-over portion 21. The axial length of the passing portion 21 is greater than 1mm. When the end section 1 is radially expanded from the first condition to the second condition, the end section 1 has a second radial dimension R. The end section 1 in the second state has a larger radial dimension than in the first state, i.e. the second radial dimension R is larger than the first radial dimension R, and the end section 1 may be in a naturally expanded state (i.e. a naturally expanded state without being subjected to an artificial external force) or may be in a state of being radially compressed to some extent and not yet fully expanded. Referring to fig. 3, when the end section 1 is in the second state, the first wave ring 30 is located in the axial area A1 where the end section 1 is located, and the axial area A2 where the first wave ring 30 is located at least partially overlaps the axial area A3 where the second wave ring 40 is located. When the stent graft 100 is in the loading state, the first wave ring 30 can deform and pass over the opening end to be connected with the conveyor, so that the sheath tube can be prevented from being retracted to drive the stent graft 100 to shift, and the releasing accuracy of the stent graft 100 is improved. In the release process of the covered stent 100, the first wave ring 30 deforms and retreats to the axial region where the end section 1 of the tubular main body 10 is located, the end section 1 of the tubular main body 10 can form a certain degree of constraint on the first wave ring 30, and the irritation and damage of the first wave ring 30 to the blood vessel in the release process are reduced. Because the first wave ring 30 is movably connected with the end section 1, and the first wave ring 30 and the second wave ring 40 have overlapped axial regions, when the covered stent 100 is implanted into a blood vessel with a large bending degree, the first wave ring 30 can move relative to the end section 1 to a certain degree, so that the covered stent is better suitable for the bent blood vessel, and the covered stent is matched with the second wave ring 40 to jointly enhance the adherence between the end section 1 and the bent blood vessel.

In addition, in the present embodiment, in order to further improve the adhesion of the end section 1, when the end section 1 is in the second state, the axial region A2 in which the first wave ring 30 is located in the axial region A3 in which the second wave ring 40 is located.

In this embodiment, the first wave ring 30 includes a first wave ring structure formed by a first supporting wire, the first wave ring structure includes a plurality of first substantially parallel direction wave rods 32 and a plurality of second substantially parallel direction wave rods 33, adjacent first direction wave rods 32 and second direction wave rods 33 are connected to one first wave crest 34 to form a first wave, and adjacent first direction wave rods 32 and second direction wave rods 33 are connected to one first wave trough 35 to form a second wave. The first wave ring 30 is elastically deformable. Which may be made partly or entirely of an elastic material. For example, the first wave ring 30 may be made of a material having good tensile and elastic properties and good biocompatibility, such as nickel titanium, stainless steel, etc. It has elastic force for recovering deformation due to its good stretching and rebound performance. The elastic deformation performance can ensure that the elastic deformation performance can quickly pass through the opening end part and retract into the opening end part in the deformation process, and on the other hand, the radial anchoring force of the tubular main body 10 is increased, and the stability of the tectorial membrane stent in the use process is improved. In other embodiments, the first wave ring 30 may be made of an inelastic material, for example, the adjacent wave rods in the first wave ring 30 made of an inelastic material are rotatably connected by a pivot member. The first wave ring 30 has no elastic force, and the deformation is driven by the self-expanding tubular main body 10 and/or the second wave ring 40.

The second wave ring 40 includes a second wavy annular structure formed of a second supporting wire and has a self-expansion property. The second wavy annular structure comprises a plurality of substantially parallel third direction wave rods 42 and a plurality of substantially parallel fourth direction wave rods 43, wherein adjacent third direction wave rods 42 and fourth direction wave rods 43 are connected with the same second wave crest 44 to form a third wave, and adjacent third direction wave rods 42 and fourth direction wave rods 43 are connected with the same second wave trough 45 to form a fourth wave. The second wave band 40 is fixedly connected to the end section 1 and is located in the axial region A1 in which the end section 1 is located. As shown, the second band 40 is not only located in the axial region A1 of the end section 1, but also has peaks almost flush with the proximal open end 10a, so that the proximal open end 10a better maintains its shape and better conforms to the inner wall of the blood vessel. In addition, in the present embodiment, the first wave crest 34 of the first wave ring 30 is located between the third direction wave rod 42 and the fourth direction wave rod 43 of the third wave, and one third wave exists between two adjacent first wave crests 34, and the first wave trough 35 of the first wave ring 30 is located between two adjacent first wave crests 34, and is located in the third wave between the two adjacent first wave crests 34.

The end portion coating 20 of the end section 1 includes an inner layer coating located inside the second pulsator 40 and an outer layer coating located outside the second pulsator 40. In this embodiment, the second wave ring 40 is fixedly connected between the inner coating and the outer coating. For example, the outer layer coating and the inner layer coating are made of PTFE film, and the inner layer coating and the outer layer coating are bonded to each other by heat fusion to wrap and fix the second wave ring 40 therebetween. In other embodiments, the inner and outer covers may be fixedly connected to the second pulsator 40 by bonding, sewing, or the like.

The second band 40 includes an inner coated section 46 and an inner bare section 47. Wherein, the outer surface of the inner layer coating section 46 is covered with an outer layer coating, the inner surface is covered with an inner layer coating, the inner surface of the inner layer exposed section 47 is not covered with an inner layer coating, only the outer surface is covered with an outer layer coating, and a gap is formed between the inner layer exposed section 47 and the outer layer coating. Referring to fig. 4, two ends of the inner exposed section 47 are connected to the inner film coating section 46, the inner exposed section 47, the outer film coating, and the inner film coating covered by the inner surface of the inner film coating section 46 are enclosed together to form the limiting channel 22, and the width W of the limiting channel 22 (along the length direction of the wave rod of the second wave ring 40, the size of the limiting channel 22) is not more than 1/3 of the wave rod length of the second wave ring 40. The first supporting wire of the first wave ring 30 can slidably pass through the limiting channel 22 to be movably connected with the second wave ring 40 and the end covering film 20.

In the present embodiment, the plurality of limiting channels 22 are arranged at regular intervals in the circumferential direction, and the plurality of limiting channels 22 are located on substantially the same radial plane (a plane perpendicular to the axis). The first direction wave rods 32 of the first wave ring 30 all pass through the corresponding limiting channels 22, and the second direction wave rods 33 all do not pass through the limiting channels 22. The arrangement has the advantages that the limiting channels 22 form uniform constraint on the first wave ring 30 in the circumferential direction, and the first wave ring 30 can be stably connected to the end section 1 no matter what state the limiting channels are in, so that the limiting channels are not easy to separate; in addition, since only the first direction wave rod 32 in the first wave ring 30 passes through the corresponding limit channel 22, and the second direction wave rod 33 is not bound by the limit channel 22, the first wave ring 30 can move in the axial direction of the end section 1 more flexibly, so that the end section 1 can be better attached to the curved inner wall of the blood vessel. In other embodiments, the second direction wave rods 33 of the first wave ring all pass through the corresponding limiting channels 22, and none of the first direction wave rods 32 pass through the limiting channels 22.

It should be noted that, since the tubular body 10 also extends to some extent due to compression during compression of the tubular body 10, it is necessary to ensure that the first band 30 provided at the open end of the tubular body 10 is able to at least partially pass over the open end when compressed, after sheathing (i.e. when compressed), that the axial extension of the first band 30 is greater than the sum of the axial extension of the end section 1 and the distance from the peak of the first band 30 to the open end. Illustratively, it is possible to provide the first pulsator 30 near the open end. For example, in the natural deployment state, the peaks of the first wave ring 30 are flush with or slightly lower than the open end of the tubular body 10, which effectively reduces the distance between the peaks of the first wave ring 30 and the open end, thereby reducing the requirement for the elongation of the first wave ring 30 and facilitating the first wave ring 30 to pass over the open end. It will be appreciated that the length of the wave rod of the first wave ring 30 is made greater than or equal to the length of the wave rod of the second wave ring 40, and the wave angle of the first wave ring 30 is made greater than the wave angle of the second wave ring 40, in such a way that the first wave ring 30 can have a longer elongation in the axial direction than the tubular body 10 when compressed, thereby ensuring that it can pass over the open end. The axial elongation or the axial elongation in the present embodiment means the amount of increase in the axial direction of the first eyelet 30 and the end section 1 due to compression when the sheath is fitted, that is, the difference between the axial length when compressed and the axial length in the natural state; the axial length refers to the distance between the proximal end and the distal end of the tubular body of the first band 30 or wave in the axial direction. It will be appreciated that the above is merely illustrative, and not limiting, as long as it is possible to achieve a length that extends when the waverods of the first wave ring 30 are pressed close to being approximately parallel, which is greater than the sum of the length that extends when the end section 1 is compressed and the distance of the peaks of the first wave ring 30 from the open end. The above-mentioned modes can be alternatively arranged, and can also be combined and arranged in a plurality of modes, and the mode is specific according to the requirement. Furthermore, in other embodiments, the object of the present invention can be achieved if the first pulsator 30 cannot automatically pass over the open end when being pressed, but if the first pulsator 30 movably connected to the end section 1 can move toward and pass over the open end under the axial force applied toward the open end.

Further, for the scheme that the limiting channel 22 only constrains one of the first directional waverods 32 and the second directional waverods 33, in order to ensure that the first wavering 30 can completely retract into the axial region of the end section 1 in the naturally unfolded state of the end section 1, at least one shortest distance from the limiting channel 22 to the proximal open end 10a may be set to be greater than or equal to the wave height of the first wavering 30.

Example 2

The present embodiment specifically proposes another arrangement mode of the limiting channel 22 based on embodiment 1. Referring to fig. 5, each first wave of the first wave ring 30 has a wave rod passing through the corresponding spacing channel 22. For example, in a certain first wave, the first directional waverod 32 passes through the first spacing channel 22a, and the second directional waverod 33 of the wave passes through the second spacing channel 22b, where the first spacing channel 22a and the second spacing channel 22b are arranged at intervals, the proximal end points of the first spacing channel 22a and the second spacing channel 22b are located on the same radial plane, and the distance between the proximal end points of the first spacing channel 22a and the second spacing channel 22b is d. The distance from the proximal end point of the first spacing channel 22a to the proximal open end 10a and the distance from the proximal end point of the second spacing channel 22b to the proximal open end 10a are approximately equal, both being h. The wave angle α of the first wave ring 30 should satisfy the following relationship:

wherein the units of d and h are the same, e.g., the units are millimeters. When the wave angle α of the first wave ring satisfies the above-described relationship, it is ensured that the first wave ring 30 is completely retracted into the axial region of the end section 1 in the naturally expanded state of the end section 1. It will be appreciated that in other embodiments, the proximal end points of the first limiting channel 22a and the second limiting channel 22b and the proximal end point of the second limiting channel 22b may be located on different radial planes, and the wave angle of the first wave ring 30 may also be specifically set according to the specific application scenario, however, the proximal end points of the limiting channels 22 and the wave angle of the first wave ring 30 are set, at least to ensure that the first wave ring 30 is completely retracted into the axial region of the end section 1 in the naturally deployed state of the end section 1.

Further, in order to ensure that the first wave ring 30 is located in the axial region of the second wave ring 40 in the naturally unfolded state of the end section 1, the wave angle α of the first wave ring 30 should also satisfy the following relationship:

wherein, the distance between the distal end point of the first limiting channel 22a and the distal end point of the second limiting channel 22b is D. The axial distance from the distal end point of the first limiting channel 22a to the trough of the second wave ring 40 and the axial distance from the distal end point of the second limiting channel 22b to the trough of the second wave ring 40 are approximately equal, and are H, and D and H are the same in units, for example, millimeter.

It will be appreciated that in other embodiments, the distal end points of the first limiting channel 22a and the second limiting channel 22b and the distal end point of the second limiting channel 22b may be located on different radial planes, and the wave angle of the first wave ring 30 may also be specifically set according to the specific application scenario, however, the distal end points of the limiting channels 22 and the wave angle of the first wave ring 30 are set, at least to ensure that the first wave ring 30 is located in the axial region of the second wave ring 40 in the naturally deployed state of the end section 1.

In this embodiment, since each of the first direction wave rod 32 and the second direction wave rod 33 of the first wave ring 30 passes through the corresponding limiting channel 22, the movement range of the first wave ring 30 in the axial direction can be better restrained, and the first wave ring 30 is further ensured to be restored to the axial region of the second wave ring 40 during the expansion process of the end section 1.

Example 3

Referring to fig. 6, on the basis of embodiment 1 and embodiment 2, the stent graft 100 of this embodiment further includes a movable connector, through which the first wave ring 30 is movably connected with the end section 1. The articulating member includes an elongated connector 51 having one end connected to the first pulsator 30 and the other end connected to the inner exposed section 47 of the second pulsator 40.

In this embodiment, each first trough 35 in the first wave ring 30 is connected to the exposed inner-layer sections 47 (refer to fig. 3) on both sides of the first trough 35 through two elongated connectors 51, one end of each elongated connector 51 is fixedly connected to the first trough 35 of the first wave ring 30, and the other end is fixedly connected to the exposed inner-layer sections 47 on the second wave ring 40. The elongated connectors 51 are made of flexible, soft materials such as rods, wires, threads, etc. formed of soft polymer materials, inorganic materials, flexible metals, etc., or are formed of flexible materials. The manner of securing the elongated connector 51 to the first pulsator 30 or the second pulsator 40 includes one or more of bonding, sewing, welding, entanglement, and heat staking.

The movable connecting piece of the embodiment can limit the axial movement range of the first wave ring 30 within a certain range, so that the axial movement range of the first wave ring 30 can be better restrained, the first wave ring 30 can be ensured to be restored to the axial region of the end section 1 in the expansion process of the end section 1 by adjusting the length and the position of the movable connecting piece, and the first wave ring 30 can be further ensured to be restored to the axial region of the second wave ring 40 in the expansion process of the end section 1 without excessively limiting the position and the size of the limiting channel 22 (refer to fig. 4), the wave angle, the wave height and other parameters of the first wave ring 30. In other embodiments, if a movable connector is provided, the limiting channel 22 in

embodiments

1 and 2 may be omitted, and the movable connector may perform the functions of connection and limiting at the same time.

In other embodiments, the connection location of the elongated connector 51 may be different. As shown in fig. 7, one end of the elongated connector 51 is fixedly connected to the first trough 35 of the first pulsator 30, and the other end is fixedly connected to the second trough 45 of the second pulsator 40. As shown in fig. 8, one end of the elongated connecting member 51 is fixedly connected to the first directional beam 32 and the second directional beam 33 of the first wave ring 30, and the other end is fixedly connected to the second wave crest 44 of the second wave ring 40.

In other embodiments, the elongated connecting member 51 may be movably connected to the first wave ring 30 and the second wave ring 40, for example, a movable collar or a movable sleeve is disposed at an end of the elongated connecting member 51, and the end of the elongated connecting member 51 may slide along a first supporting wire of the first wave ring 30 and/or the end of the elongated connecting member 51 may slide along a second supporting wire of the second wave ring 40 through the movable connection between the movable member and the first wave ring 30 and the second wave ring 40. The advantage of this is that the first band 30 can be moved more flexibly relative to the end section 1, and its position can be adjusted to better adapt to the curved vessel morphology, so that the end section 1 better fits the vessel inner wall.

It will be appreciated that in other embodiments, the number of elongated connectors 51 may be different from the present embodiment, for example, each first trough 35 of the first wave ring 30 is connected to the inner exposed sections 47 on both sides of the first trough 35 by two elongated connectors 51, and each first peak 34 of the first wave ring 30 is connected to the inner exposed sections 47 on both sides of the first peak 34 by two elongated connectors 51. This has the advantage of making the first pulsator 30 more stably connected to the second pulsator 40, preventing the first pulsator 30 from being turned over.

Further, the present embodiment also provides another movable connection member, through which the first wave ring 30 is movably connected with the end section 1. The articulating member includes an elongated connector 51 having one end connected to the first pulsator 30 and the other end connected to the inner exposed section 47 of the second pulsator 40.

In this embodiment, each first peak 34 in the first wave band 30 is connected to the exposed inner-layer sections 47 on both sides of the first peak 34 by two elongated connectors 51. The elongated connectors 51 are made of hard materials, for example, the elongated connectors 51 may be rod-shaped structures made of hard metals, hard polymer materials, and the like.

One end of the elongated connector 51 is fixedly connected to the first peak 34 of the first wave ring 30 by one or more of bonding, stitching, welding, entanglement, and heat staking. The other end is movably connected with an inner exposed section 47 on the second wave ring 40 through a movable piece. The movable piece comprises one or more of a movable sleeve ring and a movable sleeve. The movable member is movably sleeved on the exposed section 47 of the inner layer and fixedly connected with the end part of the slender connecting member 51. Since the movable member is slidable on the inner exposed section 47, the first band 30 connected thereto is movable in the axial direction relative to the

end sections

1, 40.

The elongated connecting member 51 of this embodiment is made of a hard material, and during the expansion of the end section 1, the second wave ring 40 drives the first wave ring 30 to retract through the elongated connecting member 51, so that the first wave ring 30 can be restored to the axial region of the end section 1 more quickly during the expansion of the end section 1. In addition, the elongated connectors 51 of hard material provide radially outward support to the end cover 20, further improving the adhesion of the end segment 1.

In other embodiments, the connection locations of the elongated connector 51 and the moveable member may be different. As shown, the first trough 35 of the first wave ring comprises an arc structure, the movable member is sleeved on the arc structure of the first trough 35 in the first wave ring 30 and can slide along the arc structure, one end of the elongated connecting member 51 is fixedly connected with the movable member, and the other end is fixedly connected with the second trough 45 on the second wave ring 40.

Example 4

Referring to fig. 9, the present embodiment exemplarily provides a stent graft delivery system including a stent graft 100 and a conveyor 200. For a specific structure of the stent graft 100, reference is made to embodiments 1-3. The transporter 200 is used for transporting the stent graft 100, the transporter 200 includes a sheath core 201 and a sheath tube 202, the stent graft 100 is compressed and then accommodated between the sheath core 201 and the sheath tube 202, and an anchor portion 201a is provided on the sheath core 201. When the stent graft 100 is radially compressed and loaded in the sheath 202 of the delivery device 200, the anchor portion 201a of the sheath core 201 is connected to the first balloon 30 passing over the open end, that is, the anchor portion 201a is connected to the passing portion 21.

Referring to fig. 1, when the tubular body 10 in the stent graft 100 of the present embodiment is in a natural deployment state, the first balloon 30 does not pass over the proximal open end 10a of the tubular body 10. When assembled, as shown in fig. 2, the tubular body 10 in the natural expanded state is compressed radially when receiving a radially external force, at this time, the first wave ring 30 is compressed along with the tubular body 10 by a radially compressive force, and the wave rods of the first wave ring 30 are close to each other, so that the first wave ring 30 extends out of the proximal opening end portion 10a to form the crossing portion 21. Further, as shown in fig. 9, the stent graft 100 is connected to the sheath core 201 and is fitted into the sheath tube 202, and at this time, the anchor portion 201a of the sheath core 201 is connected to the crossing portion 21, and when the sheath tube 202 is withdrawn (the sheath tube is retracted in a direction away from the proximal open end portion 10 a), the first collar 30 is connected to the sheath core 201, and the sheath core 201 provides axial support, so that the stent graft 100 remains still as the sheath tube 202 is withdrawn. When released, the tubular body 10 expands itself under its own resilience or is driven by the tubular body 10 to expand, at which time the waverods of the first wave ring 30 move away from each other and cause the first wave ring 30 to retract to the end section 1 of the tubular body 10, and the crossing portion 21 disappears.

The stent graft delivery system of the embodiment can not only rapidly, efficiently and accurately complete the release of the self-expanding stent graft, but also can prevent the sheath from withdrawing to drive the stent graft 100 to shift in the release process because the stent graft is connected with the sheath core 201 only through the first wave ring 30, thereby increasing the release accuracy of the stent graft 100; in addition, during the release process of the stent graft 100, the first wave ring 30 deforms and retreats to the axial region where the end section 1 of the tubular main body 10 is located, and the end section 1 of the tubular main body 10 can form a certain degree of restraint on the first wave ring 30, so as to reduce the irritation and damage of the first wave ring 30 to the blood vessel during the release process.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. Tectorial membrane support, its characterized in that includes:

a self-expanding tubular body comprising an end section having an open end;

the deformable first wave ring is movably connected with the end section;

a second wave band connected with the end section;

2. The stent graft of claim 1, wherein when said end segment is in the second state, the axial region in which said first band is located is within the axial region in which said second band is located.

3. The stent graft of claim 1, wherein said second band is fixedly connected to said end segment and said second band is located in an axial region where said end segment is located.

4. The stent graft of claim 1, wherein said end segment comprises an end coating, said end coating covering an outer surface of said second band and said first band when said end segment is in a second state.

5. The stent graft of claim 4, wherein said end coating comprises an outer coating, said outer coating being positioned outside of said second band, said second band comprising an inner exposed section, said inner surface of said inner exposed section being exposed, said first band being connected to said second band by said inner exposed section.

6. The stent graft of claim 5, wherein at least one spacing channel is disposed between said second collar and said outer stent graft, said first collar comprising a wavy annular structure formed from a first support wire, said first support wire passing through said spacing channel to permit said first collar to be movably connected to said end section.

7. The stent graft of claim 6, wherein said end coating further comprises an inner coating, said second band further comprises an inner coating segment, said inner coating segment inner surface covers said inner coating, said inner coating segment is connected to said inner exposed segment at both ends, said inner exposed segment, said outer coating, and said inner coating covering the inner surface of said inner coating segment enclose said spacing channel.

8. The stent graft of claim 1, further comprising a moveable connector, wherein said first collar is connected to said end segment by said moveable connector, and wherein said first collar is moveable axially relative to said end segment.

9. The stent graft of claim 8, wherein said flexible connector comprises an elongated connector having one end connected to said first band and another end connected to said exposed segment of said inner layer, and at least one of said elongated connectors has a fixed connector end.

10. The stent graft of claim 9, wherein said first band comprises a plurality of first troughs and first peaks, said first troughs being connected to the inner exposed segments on either side of said first troughs by two elongated connectors, respectively; and/or the first wave crest is respectively connected to the inner layer exposed sections at the two sides of the first wave crest through two slender connecting pieces.

11. The stent graft of claim 9, wherein said first band comprises a plurality of first troughs and a plurality of struts, said second band comprises a plurality of second peaks and a plurality of second troughs, said first troughs being connected to second troughs on either side of said first troughs by two elongated connectors, respectively; and/or the second wave crest is respectively connected to the wave rods of the first wave circle positioned at two sides of the second wave crest through two slender connecting pieces.

12. The stent graft of claim 1, wherein the wave angle of said second wave band is less than the wave angle of said first wave band and the wave bars of said second wave band are less than or equal to the wave bars of the first wave band.

13. A stent graft delivery system comprising a delivery device and a stent graft according to any one of claims 1 to 12, the delivery device being adapted to deliver the stent graft, the delivery device comprising a sheath core having an anchor at a distal end thereof, the anchor being connected to the first band beyond the open end when the stent graft is loaded into the delivery device.