CN113081386B

CN113081386B - Tectorial membrane support

Info

Publication number: CN113081386B
Application number: CN201911338763.6A
Authority: CN
Inventors: 刘彩萍
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-23
Filing date: 2019-12-23
Publication date: 2023-09-19
Anticipated expiration: 2039-12-23
Also published as: CN113081386A

Abstract

The application discloses a covered stent, which comprises a bare stent and a covered film connected to the bare stent, wherein an extrusion part is arranged on the inner wall of the covered stent, one end of the extrusion part is fixed on the bare stent, the extrusion part can move relative to the covered film, and after the covered stent is released, at least one part of the extrusion part is positioned in the end part area of the covered film and is used for extruding the covered film in the end part area outwards. The application has the beneficial effects that: according to the application, the coating in the end area of the coating is extruded outwards through the extrusion part, so that the adherence of the coating in the end area can be improved, and the coating in the end area of the coating bracket is prevented from being wrinkled after the coating bracket is implanted into a blood vessel.

Description

Tectorial membrane support

Technical Field

The application relates to the technical field of interventional medical instruments, in particular to a covered stent.

Background

Over ten years ago, aortic stent graft endoluminal isolation has been widely applied to lesions such as aneurysms and aortic dissection of the thoracic and abdominal aorta, has definite efficacy, small trauma, quick recovery and fewer complications, and has become a first-line treatment method. During operation, under X-ray perspective monitoring, the covered stent is sent to the lesion position through the corresponding conveying system, the covered stent isolates blood flow from the lesion position, and the influence of blood pressure on the lesion position is eliminated, so that the purpose of curing is achieved.

After implantation, the stent graft is fixed in the vessel by its own radial support force, so that the diameter of the stent graft is larger than the inner diameter of the vessel to resist the impact of the blood flow in order to avoid the displacement of the stent graft under the impact of the blood flow, which results in the stent graft always being in a compressed state in the vessel. As shown in fig. 1 and 2, the stent graft 100a is implanted in a blood vessel 200a, and the stent graft 101a at the end of the stent graft 100a is folded inwards in a compressed state, so that a gap 300a is formed between the stent graft 101a and the inner wall of the blood vessel 200a, and after blood flows into the gap 300a, thrombus is easily formed, which causes damage to the body of a patient. At the same time, after the blood flows into the gap 300a, the impact surface of the blood flow on the stent graft 100a is increased, so that the impact force of the blood flow on the stent graft 100a is increased, and the stent graft 100a is shifted, thereby failing to treat.

Disclosure of Invention

The application aims to solve the technical problem of providing a covered stent aiming at the defects in the prior art.

The technical scheme adopted for solving the technical problems is as follows:

the utility model provides a tectorial membrane support, includes the bare stent and connects the tectorial membrane on the bare stent, the inner wall of tectorial membrane support is provided with the extrusion piece, the one end of extrusion piece is fixed on the bare stent, the extrusion piece can be relative the tectorial membrane removes, after the tectorial membrane support release, at least a portion of extrusion piece is located the tip region of tectorial membrane, and outwards extrudees the tectorial membrane in the tip region.

In the stent graft of the present application, the extrusion is located on the same annular surface as the bare stent.

In the stent graft of the present application, the extrusion is entirely located in the end region after the stent graft is released.

In the stent graft of the present application, the extrusion member comprises a connecting section and an extrusion section which are connected, the connecting section is fixedly connected with the bare stent, and at least a part of the extrusion section extends into the end region after the stent graft is released.

In the covered stent disclosed by the application, the inner wall of the covered stent is also provided with a limiting piece, a limiting channel is arranged in the limiting piece, and the extrusion piece can movably pass through the limiting channel.

In the covered stent of the application, the spacing between the limiting piece and the end part of the covered film along the axial direction is 0.5 mm-2 mm, and the width of the limiting piece along the axial direction is 0.11 mm-1.5 mm.

In the covered stent of the application, the bare stent comprises a plurality of rings of wavy rings, and the limiting piece is arranged close to the wave crest of the wavy rings.

In the covered stent of the application, the bare stent comprises a plurality of rings of wave-shaped rings, wherein each wave-shaped ring comprises a plurality of wave crests, a plurality of wave troughs and a plurality of connecting rods respectively connecting adjacent wave crests and wave troughs;

two extrusion parts are arranged between two adjacent wave crests of the wavy annular object and are respectively fixed on the two adjacent connecting rods.

In the stent graft of the present application, the bare stent comprises a connecting portion and an anchor portion connected to each other, the stent graft is fixed to the connecting portion, one end of the extrusion member is fixed to the anchor portion, and at least a portion of the extrusion member extends to an end region of the stent graft after the stent graft is released and extrudes the stent graft in the end region outward.

In the stent graft of the present application, the other end of the extrusion member extends to the outside of the anchor portion.

In summary, the implementation of the covered stent of the application has the following beneficial effects: according to the application, the coating in the end area of the coating is extruded outwards through the extrusion part, so that the adherence of the coating in the end area can be improved, and the coating in the end area of the coating bracket is prevented from being wrinkled after the coating bracket is implanted into a blood vessel.

Drawings

The application will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a schematic illustration of a prior art stent graft implanted in a blood vessel;

FIG. 2 is a cross-sectional view of the end of the stent graft shown in FIG. 1;

FIG. 3 is a schematic view of a stent graft provided in one embodiment of the present application;

FIG. 4 is an enlarged view of portion A of the stent graft shown in FIG. 3;

FIG. 5 is a schematic illustration of the stent graft of FIG. 3 with an extrusion attached to the wavy ring;

FIG. 6 is a schematic illustration of an extrusion of the stent graft of FIG. 3;

FIG. 7 is a schematic view of the stent graft of FIG. 3 after being radially compressed;

FIG. 8 is a schematic view of the stent graft of FIG. 3 implanted in a blood vessel;

FIG. 9 is a schematic view of a stent graft according to a second embodiment of the present application;

FIG. 10 is a schematic illustration of the stent graft of FIG. 9 with an extrusion attached to the wavy ring;

FIG. 11 is a schematic view of a stent graft according to a third embodiment of the present application;

FIG. 12 is a schematic view of an extrusion attached to the anchor portion of the stent graft of FIG. 11;

FIG. 13 is a schematic illustration of the extrusion of the stent graft of FIG. 11 mated with a stop;

fig. 14 is a schematic view of the stent graft of fig. 11 after being radially compressed.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the application, which is therefore not limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In the field of interventional medicine, it is generally defined that the end of the stent graft that is proximal to the heart after release is proximal and the end distal to the heart is distal.

Referring to fig. 3, one embodiment of the present application provides a stent graft 100, which includes a bare stent 101 and a stent graft 102 connected to the bare stent 101. The stent graft 100 has a hollow lumen structure, and the lumen of the stent graft 100 forms a blood flow channel.

The bare stent 101 is made of a material with good biocompatibility, such as nickel titanium, stainless steel, and the like. The coating 102 is made of a polymer material with good biocompatibility, such as PTFE, FEP, PET. The bare bracket 101 includes a plurality of loops of wavy rings 1011, each loop of wavy rings 1011 includes a plurality of peaks 1011a, a plurality of troughs 1011b and a plurality of connecting rods 1011c respectively connecting adjacent peaks 1011a and troughs 1011b, and the loops of wavy rings 1011 are arranged in sequence from the proximal end to the distal end, preferably in parallel at intervals. The wavy rings 1011 are in a closed cylindrical structure, and the wavy rings 1011 may have the same or similar wavy shape, and it is understood that the embodiment is not limited to the specific structure of the wavy rings 1011, the wavy rings 1011 may be arranged according to the requirement, and the number of the wavy rings 1011 and the wavy height may be arranged according to the requirement.

Referring to fig. 3 and 4, an extrusion 11 is disposed on an inner wall of a covered stent 100, and one end of the extrusion 11 is fixed on a bare stent 101 and movably connected with a covered stent 102, that is, the extrusion 11 and the covered stent 102 can move relatively. After the stent graft 100 is released, at least a portion of the extrusion 11 is located in the end region of the stent graft 102 and extrudes the stent graft 102 outwardly in the end region.

The term "end region of the film 102" refers to a region of the film 102 having an axial distance from the end of the film 102 in the range of 0 to 3.5 mm; "outwardly pressing" refers to pressing in a direction away from the centerline of the stent graft.

The application can improve the adherence of the coating 102 in the end area by extruding the coating in the end area of the coating 102 outwards through the extrusion 11, and avoid the wrinkling of the coating 102 in the end area of the coating bracket 100 after being implanted into a blood vessel.

Wherein the extrusion 11 is made of a material with good biocompatibility and elasticity, such as nickel titanium, stainless steel, etc. Since the extrusion 11 needs to extrude the coating 102 outwards so that the coating 102 is completely adhered to the vessel wall, if the wire diameter of the extrusion 11 is too small, the rebound resilience of the extrusion 11 is poor and insufficient radial supporting force is provided to extrude the wrinkles; if the wire diameter of the extrusion 11 is too large, the compression volume of the stent graft 100 as a whole increases, and the sheathing is affected. Therefore, the diameter of the circumscribed circle of the cross section of the extrusion 11 is preferably 0.1mm to 0.3mm, so that the extrusion 11 can better extrude the coating 102 outwards, and the adhesion of the coating 102 is improved.

Referring to fig. 5, in order to better press the folds on the cover film 102 outward from the extrusion 11, after the cover film holder 100 is released, the extrusion 11 is completely attached to the cover film 102, that is, the extrusion 11 and the bare holder 101 are located on the same annular surface, and the extrusion 11 is entirely located in the end region of the cover film 102.

Referring to fig. 5 and 6, the extrusion 11 includes a connecting section 111 and an extrusion section 112 connected to each other, the connecting section 111 being fixedly connected to the bare stent 101, at least a portion of the extrusion section 112 being located in an end region of the cover film 102 for extruding wrinkles on the cover film 102. By providing the connection section 111 on the extrusion 11, the extrusion 11 can be conveniently fixed on the bare bracket 101, and the connection section 111 can be fixedly connected with the bare bracket 101 by adopting the modes of welding, steel sleeve connection or cutting integrated formation and the like.

Referring to fig. 6, the angle α between the tangent line at any point on the connecting section 111 and the tangent line at any point on the extruding section 112 may be 5 ° to 180 °. However, if α is too large, the overlapping area of the connection section 111 and the bare stent 101 is too small, the extrusion 11 is inconvenient to be fixed on the bare stent 101, and the subsequent fatigue fracture resistance is poor, and the extrusion 11 is liable to be detached and broken. In addition, when the sheath is attached, the extrusion member 11 is extruded, and if α is too large, plastic deformation is likely to occur between the connection section 111 and the extrusion section 112, so that after the stent graft 100 is released, the extrusion member 11 cannot return to the initial predetermined state, and the function of extruding the stent graft fold is lost. Therefore, the included angle α is preferably 5 ° to 85 °.

The connection section 111 is preferably an arc-shaped section, and the bending radius R1 of the connection section 111 is 0.2mm to 2mm. It can be appreciated that if the bending radius R1 is too small, the connecting section 111 will form a crack during the bending process, resulting in poor fatigue resistance of the connecting section 111, and subsequent fatigue fracture is likely to occur, which causes injury to the patient; if the bending radius R1 is too large, plastic deformation of the connection section 111 is likely to occur when the sheathing tube is compressed, and the compression volume of the entire stent graft 100 is increased, affecting the sheathing. Therefore, when the bending radius R1 of the connecting section 111 is 0.2mm to 2mm, the extrusion 11 can be made to have good compression and rebound performance.

Referring to fig. 4 again, a limiting member 12 is disposed on an inner wall of the stent graft 100, a limiting channel is disposed in the limiting member 12, and the extrusion 11 movably passes through the limiting channel. When the extrusion 11 compresses and rebounds, the extrusion 11 and the limiting piece 12 move relatively, and the limiting piece 12 can prevent the extrusion 11 from moving randomly, so that at least part of the extrusion 11 is limited in the end area of the coating film 102. Preferably, the limiting member 12 is integrally located in the end region of the coating 102, and limits the extrusion 11 integrally in the end region of the coating 102.

The limiting member 12 may be made of a material with good biological properties, such as nickel-titanium alloy, stainless steel, polyester yarn, polyester cloth, PTFE yarn, and e-PTFE film. The limiting member 12 may be fixed to the inner wall of the stent graft 100 by sewing or the like.

The spacing H1 between the stopper 12 and the end of the coating film 102 in the axial direction is 0.5mm to 2mm. If the value of H1 is too small, the pressing member 11 easily slides out of the coating film 102, and wrinkles on the coating film 102 cannot be effectively pressed; if the value of H1 is too large, the pressing member 11 cannot press the wrinkles at the end portion of the coating film 102, resulting in poor pressing effect of the wrinkles.

The axial width H2 of the limiting piece 12 is 0.11 mm-1.5 mm. If the width H2 is too small, the movable space of the pressing member 11 in the limiting member 12 is small, and the pressing member 11 receives a large friction force during compression and rebound, so that the pressing member 11 cannot rebound completely; if the width H2 is too large, the compression volume of the stent graft 100 as a whole increases, and the sheathing is affected.

One end of the extrusion 11 is fixed to the bare stent 101, and the other end is a free end. After the covered stent 100 is released, the distance H3 between the movable end and the limiting piece 12 along the circumferential direction is more than or equal to 2mm. If the distance H3 is too small, the pressing member 11 easily slides out of the limiting member 12 during compression and rebound, which affects the limiting effect of the limiting member 12.

Fig. 7 is a schematic view of a radially compressed stent graft 100 according to the present application, where the extrusion 11 is compressed and deformed along with the bare stent 101, and the limiting member 12 prevents the extrusion 11 from being compressed and wound around each other, thereby affecting the subsequent rebound deformation of the extrusion 11. Fig. 8 is a schematic diagram showing that after the stent graft 100 of the present application is released in a blood vessel 200, the extrusion member 11 extrudes the folds in the end region of the stent graft 102 against the wall of the blood vessel, and as can be seen from fig. 8, the extrusion member 11 can make the stent graft in the end region of the stent graft 102 completely adhere to the inner wall of the blood vessel, so as to avoid the formation of a gap between the end of the stent graft 102 and the inner wall of the blood vessel.

In the embodiment shown in fig. 3 to 8, the bare stent 101 includes a connecting portion 101a and an anchor portion 101b connected to each other, the coating 102 is fixed to the connecting portion 101a, and the pressing member 11 is fixed to the connecting portion 101a and movable relative to the coating 102. Two pressing members 11 are provided between two adjacent peaks 1011a of the wavy annular object 1011, the two pressing members 11 being fixed to the adjacent connecting rods 1011c, respectively, each pressing member 11 being located between the two peaks 1011a. By providing two pressers 11 between two adjacent peaks 1011a, it is ensured that the pressers 11 adhere the coating film between the two peaks 1011a to the inner wall of the blood vessel completely.

It will be appreciated that this embodiment is not limited to the number of extrusions 11 attached to the wavy annulus 1011, and that in other embodiments the extrusions 11 may comprise only one, or a plurality.

Referring to fig. 9 and 10, a stent graft 100 is provided in a second embodiment of the present application, which is substantially the same as the stent graft in the first embodiment, and the second embodiment differs from the first embodiment only in that one end of the extrusion 11 is fixed on the wavy annular object 1011 and the other end spans at least one peak 1011a of the wavy annular object 1011.

An extrusion 11 and a limiting member 12 are arranged on the inner wall of the film coating bracket 100, one end of the extrusion 11 is fixed on a connecting rod 1011c of the wavy annular object 1011, and the other end spans at least one wave crest 1011a of the wavy annular object 1011 and movably penetrates through a limiting channel in the limiting member 12.

Wherein the limiter 12 is disposed near the peak 1011a of the wavy annular object 1011, i.e., the limiter 12 is located near the peak 1011a of the wavy annular object 1011. Because the limiting member 12 is fixed on the inner wall of the stent graft 100, when the stent graft 100 is deployed, the wave crest 1011a of the wavy annular object 1011 provides a force to the limiting member 12 towards the direction of the vessel wall, and when the limiting member 12 moves towards the direction of the vessel wall, the extrusion member 11 in the limiting member 12 is driven to move towards the direction of the vessel wall, which is beneficial to the extrusion member 11 to extrude the coating film in the end region of the coating film 102 outwards, so that the coating film in the end region is completely attached on the inner wall of the vessel.

Referring to fig. 11 to 14, a stent graft 100 according to a third embodiment of the present application is substantially the same as the stent graft according to the first embodiment, in that the bare stent 101 includes a connecting portion 101a and an anchoring portion 101b connected to each other, and the stent graft 102 is fixed to the connecting portion 101 a.

The third embodiment is different from the first embodiment in that the pressing member 11 is fixed to the anchor portion 101b and is movable relative to the cover film 102, and after the cover film holder 100 is released, at least a part of the pressing member 11 extends to an end region of the cover film 102 and presses the cover film 102 in the end region outward. The end region of the film 102 is a region of the film 102 having an axial distance from the end of the film 102 in the range of 0 to 3.5 mm.

Referring to fig. 11, 12 and 13, the pressing member 11 includes a connecting section 111 and a pressing section 112 connected to each other, one end of the connecting section 111 is fixed to the anchor portion 101b, one end of the pressing section 112 is connected to the connecting section 111, and the other end extends to one side of the connecting portion 101a and extends to an end region of the coating film 102 of the connecting portion 101a, and is movably connected to the coating film in the end region.

A limiting member 12 is arranged in the end region of the covering film 102, a limiting channel is arranged in the limiting member 12, and the other end of the extrusion section 112 movably passes through the limiting channel. When the extrusion 11 compresses and rebounds, the extrusion 11 and the limiting piece 12 move relatively, the limiting piece 12 can prevent the extrusion 11 from moving randomly, and at least part of the extrusion 11 is limited in the end area of the coating film 102.

The other end of the pressing section 112 extends from the stopper passage in the stopper 12 to one side of the anchor portion 101b after passing through. Preferably, the other end of the extruded section 112 spans at least one connecting rod 1011c of the anchoring portion 101b, and the extruded section 112 is located outside the anchoring portion 101b, i.e., the extruded section 112 is located between the anchoring portion 101b and the inner wall of the blood vessel. Because the extrusion section 112 is located outside the anchoring portion 101b, when the stent graft 100 is deployed, the anchoring portion 101b provides a force to the extrusion section 112 in the direction of the vessel wall, which is beneficial for the extrusion 11 to extrude the coating in the end region of the coating 102 outwards, so that the coating in the end region is completely adhered to the vessel wall.

Fig. 14 is a schematic view of a radially compressed stent graft 100 according to the third embodiment, in which the pressing members 11 are compressed and deformed along with the bare stent 101, and the limiting members 12 prevent the pressing members 11 from being compressed and then intertwined with each other, so as to affect the subsequent rebound deformation of the pressing members 11.

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 application, which are described in detail and are not to be construed as limiting the scope of the application. 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 application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

1. The film covered bracket comprises a bare bracket and a film covered connected to the bare bracket, and is characterized in that an extrusion part is arranged on the inner wall of the film covered bracket, one end of the extrusion part is fixed on the bare bracket, the other end of the extrusion part is a movable end, the extrusion part can move relative to the film covered, after the film covered bracket is released, the extrusion part and the bare bracket are positioned on the same annular surface, and at least one part of the extrusion part is positioned at the end part area of the film covered and is used for extruding folds on the film covered in the end part area outwards;

the inner wall of tectorial membrane support still is provided with the locating part, be provided with spacing passageway in the locating part, the extrusion piece is mobilizable follow pass in the spacing passageway.

2. The stent graft of claim 1, wherein said extrusion is on the same annular face as said bare stent.

3. The stent graft of claim 1, wherein upon release of said stent graft, said extrusion is entirely within said end region.

4. The stent graft of claim 1, wherein said extrusion comprises a connecting segment and an extrusion segment connected thereto, said connecting segment being fixedly connected to said bare stent, and wherein at least a portion of said extrusion segment extends into said end region upon release of said stent graft.

5. The stent graft of claim 1, wherein the spacing element is axially spaced from the end of the stent graft by 0.5mm to 2mm and the spacing element has an axial width of 0.11mm to 1.5mm.

6. The stent graft of claim 1, wherein said bare stent comprises a multi-turn wavy annulus, and wherein said stop is disposed proximate to a peak of said wavy annulus.

7. The stent graft of claim 1, wherein said bare stent comprises a multi-turn wavy annulus comprising a plurality of peaks, a plurality of valleys and a plurality of connecting rods connecting adjacent said peaks and said valleys, respectively;

8. The stent graft of claim 1, wherein said bare stent comprises a connecting portion and an anchoring portion connected thereto, said stent graft being secured to said connecting portion, one end of said extrusion being secured to said anchoring portion, at least a portion of said extrusion extending to and pressing outwardly against an end region of said stent graft after said stent graft is released.

9. The stent graft of claim 8, wherein the other end of said extrusion extends outside of said anchor.