CN113712703B

CN113712703B - Aortic arch part covered stent and conveying device thereof

Info

Publication number: CN113712703B
Application number: CN202110960103.2A
Authority: CN
Inventors: 郑殿会; 陈聪; 刘颖
Original assignee: Beijing Huamai Taike Medical Instrument Co ltd
Current assignee: Beijing Huamai Taike Medical Instrument Co ltd
Priority date: 2021-08-20
Filing date: 2021-08-20
Publication date: 2022-03-01
Anticipated expiration: 2041-08-20
Also published as: CN113712703A

Abstract

The invention provides an aortic arch part covered stent and a conveying device thereof, which relate to the field of medical instruments and comprise a framework, a main covered membrane, a seam covered membrane and first to third fixing rings; the main covering film is connected with the framework to form a covering film stent main body, a first opening is formed in the near end of the main covering film, a first fixing ring is fixed on the edge of the first opening, and a developing mark is arranged around the first fixing ring; the window is arranged at the far end of the first opening on the main covering film, the seam splicing covering film comprises a window covering film, the window covering film covers the window and is connected with the main covering film in a sewing mode, the window covering film is provided with a second opening and a third opening, the second fixing ring is fixed at the edge of the second opening, and the third fixing ring is fixed at the edge of the third opening; the second fixing ring and the third fixing ring are both connected with developing rings. The invention solves the problems that the pre-fenestrated covered stent is difficult to match with a branch blood vessel of a human body, so that blood vessel flow interruption is easily caused, blood does not flow through the branch blood vessel before the fenestration of the surgical fenestrated covered stent, and the covered tissue is damaged due to membrane rupture, so that the covered strength is influenced.

Description

Aortic arch part covered stent and conveying device thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to an aortic arch part covered stent and a conveying device thereof.

Background

Aortic diseases such as aortic dissection, aortic aneurysm and the like are a serious disease threatening human health. With the coming of the aging society of China, the incidence of chronic diseases such as hypertension, atherosclerosis and the like is on a trend of increasing obviously, the incidence of thoracic aortic aneurysm and aortic dissection is increased obviously, and the life threat of a patient is great; especially, the aortic dissection which has wide range of pathological changes and affects blood supply of brain, spinal cord and multiple organs has large operation trauma, complex operation, long time, much blood consumption, high complication incidence rate of operation and high operation death rate. The reconstruction of the blood supply of the aorta and its branch arteries in as short a time as possible has always been the goal sought by vascular surgeons.

Currently, open-view aortic arch replacement surgery remains the only option for aortic lesions that involve the proximal ascending aorta and the aortic arch. At present, the most mature aortic arch replacement operation needs to replace diseased blood vessels with artificial blood vessels under deep low temperature circulation stopping, three branch blood vessels and distal aortic blood vessels are anastomosed one by one, the number of anastomotic stoma is large, the circulation stopping time is long, postoperative bleeding and systemic complications are large, and the aortic arch replacement operation is one of the most serious cardiovascular surgery operations.

At present, the reconstruction of an arch part blood vessel is clinically solved through an arch part stent windowing technology, and the used arch part covered stent mainly comprises a pre-windowed covered stent and a windowed covered stent in the operation process; however:

for the pre-fenestration covered stent, after being implanted into a human body, the pre-fenestration covered stent is difficult to correspond to the unknown artery, the left common carotid artery and the left subclavian artery, and even has possibility of being aligned, specifically, the distance, the arrangement angle and the thickness of each branch blood vessel of 3 branch blood vessel openings of the aortic arch part of each patient are different, so that the deviation between the pre-fenestration position of the blood vessel and the actual position of the blood vessel is caused, only a small part of the overlapped interface flows blood, and once the overlapped part is too small, even a little part of the overlapped part does not overlap, the blood vessel can be directly cut off;

for the covered stent which is windowed in the operation process, the covered stent opens holes at the correct position for the branch positions in a membrane breaking mode, and the problem of hole alignment is solved, but the following problems still exist: 1. blood does not flow through the blood vessel branch before windowing, so that blood supply of the blood vessel is intermittently stopped, and tissues without blood supply are greatly damaged or even necrotized; 2. although the position of the branch blood vessel can be ensured to be consistent with the position of the main body interface through a membrane breaking and punching mode, membrane breaking causes damage to the membrane covering tissue, membrane covering strength is affected, and fracture risk exists after long-time use.

Disclosure of Invention

The invention aims to provide an aortic arch part covered stent and a conveying device thereof, which are used for solving the technical problems that when the existing arch part covered stent in the prior art is used for treating aortic diseases, a pre-windowing covered stent is difficult to match with a branch blood vessel of a human body, so that blood vessel cutoff is easily caused, blood does not flow through the branch blood vessel before windowing of the surgical windowing covered stent, and the covered tissue is damaged due to membrane rupture, so that the covered strength is influenced.

In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:

in a first aspect, an embodiment of the present invention provides an aortic arch stent graft, including a framework, a main stent graft, a patchwork stent graft, a first fixing ring, a second fixing ring, and a third fixing ring;

the main covering membrane is connected with the framework to form a covering membrane stent main body, a first opening used for blood supply in butt joint with a first branch blood vessel is formed in the near end of the main covering membrane, the first fixing ring is fixed on the edge of the first opening, and developing marks are arranged on the first fixing ring or on the covering membrane stent main body at the position surrounding the first fixing ring;

a windowing film is arranged on the main film and is positioned at the far end of the first opening, the splicing film comprises a windowing film, the windowing film covers the windowing film and is connected to the main film in a sewing mode, a second opening and a third opening which are used for being in butt joint with a second branch blood vessel and a third branch blood vessel to supply blood are arranged on the windowing film, the second fixing ring is fixed to the edge of the second opening, and the third fixing ring is fixed to the edge of the third opening;

the second fixing ring and the third fixing ring are both connected with developing rings.

In an alternative embodiment, the fenestration overlay is made of a flexible but inelastic material; or: a support body connected with the framework is arranged inside the window; the windowing covering film covers and is connected to the support body, and the second opening and the third opening are not overlapped with the support body; the support body can deform and does not rebound under the condition of being pulled by external force so as to pull the fenestration covering film to enable the second opening to be in butt joint with the second branch blood vessel or enable the third opening to be in butt joint with the third branch blood vessel.

In an optional embodiment, the windowing comprises one, or the windowing comprises a first windowing and a second windowing, the second windowing is arranged at the far end of the first windowing, the first windowing and the second windowing are both connected with the windowing coating film in a sewing mode, the second opening is arranged on the windowing coating film in the first windowing, and the third opening is arranged on the windowing coating film in the second windowing.

In an optional embodiment, the patchwork covering film further comprises a first opening covering film, the first opening covering film covers the first opening and is connected to the main covering film in a sewing mode, and a blood supply opening used for being in butt joint with a first branch blood vessel for supplying blood is formed in the first opening covering film.

Further optionally, a first tubular branch stent is connected to the first opening covering membrane, one end of the first tubular branch stent is butted with the blood supply opening, and the other end of the first tubular branch stent can be butted and inserted into the interior of the first branch blood vessel.

In an alternative embodiment, a second tubular branch stent is connected to the fenestration covering membrane, one end of the second tubular branch stent is butted with the second opening, and the other end of the second tubular branch stent can be butted and inserted into the interior of a second branch blood vessel; and/or a third tubular branch stent is connected to the windowing covering film, one end of the third tubular branch stent is butted with the third opening, and the other end of the third tubular branch stent can be butted and inserted into the third branch blood vessel. Wherein "and/or" means that the aforementioned second tubular branch stent and third tubular branch stent are disposed alternatively or simultaneously.

In a second aspect, an embodiment of the present invention provides a device for delivering an aortic arch stent graft into a human body, wherein the device for delivering the aortic arch stent graft according to any one of the preceding embodiments to release the aortic arch stent graft comprises a delivery handle, a delivery outer tube and an alignment release assembly;

the alignment release assembly comprises an inner sheath tube, an outer sheath tube, a fixed outer tube, a first tube seat, a second tube seat, a first fixing piece and a second fixing piece;

the inner sheath tube penetrates through the outer sheath tube, the outer sheath tube penetrates through the fixed outer tube, and the fixed outer tube penetrates through the conveying outer tube; the rear end of the inner sheath tube, the rear end of the outer sheath tube, the rear end of the fixed outer tube and the rear end of the conveying outer tube are all connected to the conveying handle, and the conveying handle can control the front and back expansion of the outer sheath tube relative to the inner sheath tube, the front and back expansion of the fixed outer tube relative to the outer sheath tube and the front and back expansion of the conveying outer tube relative to the inner sheath tube, the outer sheath tube and the fixed outer tube;

the first fixing piece and the second fixing piece respectively comprise a fixing seat, a sleeve and a connecting wire; the fixed seat is fixedly connected to the rear end of the sleeve, the connecting wire is located on the outer peripheral surface of the sleeve, the rear end of the connecting wire is connected to the fixed seat, the front end of the connecting wire extends out of the front end of the sleeve, and a ferrule is arranged at the front end of the connecting wire; the fixed seat is provided with a central hole coaxial with the sleeve;

the fixed seat and the sleeve of the first fixed part are sleeved and fixed at the front end of the outer sheath tube, and the fixed seat and the sleeve of the second fixed part are sleeved and fixed at the front end of the fixed outer tube;

the first tube seat and the second tube seat respectively comprise a connecting seat and a connecting needle, and the front end of the connecting needle is connected to the rear end face of the connecting seat; the first pipe seat is sleeved and fixedly connected to the peripheral surface of the inner sheath pipe, and a connecting needle of the first pipe seat extends backwards along a direction parallel to the inner sheath pipe; the second tube seat is sleeved outside the outer sheath tube, the front end of the second tube seat is fixedly connected to the rear end of the fixed seat of the first fixed part, and a connecting needle of the second tube seat extends backwards along a direction parallel to the outer sheath tube;

in an assembled state: the connecting wire on the first fixing piece penetrates through the developing ring around the second fixing ring, the connecting wire on the second fixing piece penetrates through the developing ring around the third fixing ring, the connecting needle of the first tube seat is inserted into the ferrule at the front end of the connecting wire of the first fixing piece, and the connecting needle of the second tube seat is inserted into the ferrule at the front end of the connecting wire of the second fixing piece.

In an alternative embodiment, the second fixing ring is connected with at least three developing rings, the first fixing member includes at least three connecting wires, the first tube seat includes at least three connecting needles, and in an assembled state, the at least three connecting needles are inserted into ferrules at the front ends of the at least three connecting wires in a one-to-one correspondence manner; and/or, the third fixing ring is connected with at least three developing rings, the second fixing piece comprises at least three connecting wires, the second tube seat comprises at least three connecting needles, and in an assembly state, the at least three connecting needles are inserted into ferrules at the front ends of the at least three connecting wires in a one-to-one correspondence manner, wherein the 'and/or' means that the structure before the 'and/or' and the structure after the 'and/or' are arranged alternatively or simultaneously.

In an alternative embodiment, the entirety of the connecting wire is formed as a coil.

In an alternative embodiment, in the first fixing member and/or the second fixing member:

the outer peripheral surface of the fixed seat is provided with a plurality of grooves which are spaced in pairs along the radial circumferential direction of the fixed seat, a protruding part is formed between every two adjacent grooves, a through hole is formed in the protruding part, and the rear end of the connecting wire penetrates through the through hole and is fixed on the fixed seat; and/or the front end of the fixing seat is provided with an inner cylinder, the sleeve is sleeved and fixed outside the inner cylinder, and an insertion gap capable of being inserted into the connecting needle is formed between the inner wall of the sleeve and the outer wall of the inner cylinder. In this alternative embodiment, two "and/or" means that either or both of the structure of the first attachment member and the structure of the second attachment member satisfy: "the outer peripheral face of fixing base is equipped with along two liang of spaced a plurality of recesses of radial circumferencial direction of fixing base, adjacent two form the bellying between the recess, be equipped with the perforation on the bellying, the rear end of connecting wire passes the perforation is fixed in the structure of fixing base" with the front end of fixing base is equipped with the inner tube, the sleeve suit is just fixed in the outside of inner tube, telescopic inner wall with form between the outer wall of inner tube and can insert the structure of the clearance of inserting of connecting the needle sets up simultaneously or an option.

The embodiment of the invention can realize the following beneficial effects:

in a first aspect, an embodiment of the present invention provides an aortic arch stent graft, including a framework, a main stent graft, a patchwork stent graft, a first fixing ring, a second fixing ring, and a third fixing ring; the main covering film is connected with the framework to form a covering film stent main body, a first opening for blood supply in butt joint with a first branch blood vessel is formed in the near end of the main covering film, a first fixing ring is fixed on the edge of the first opening, and a developing mark is arranged on the first fixing ring or on the covering film stent main body at a position surrounding the first fixing ring; the part, located at the far end of the first opening, of the covering film is provided with a windowing covering film, the splicing covering film comprises a windowing covering film, the windowing covering film covers the windowing covering film and is connected to the main covering film in a sewing mode, the windowing covering film is provided with a second opening and a third opening, the second opening and the third opening are used for blood supply in butt joint with a second branch blood vessel and a third branch blood vessel, the second fixing ring is fixed to the edge of the second opening, and the third fixing ring is fixed to the edge of the third opening; the second fixing ring and the third fixing ring are both connected with developing rings.

When the aortic arch stent graft is implanted into a human body, the development mark and the development ring are used as visual field aids, the first opening is used as a positioning hole for fixing the position of the aortic arch stent graft and is implanted into the arch stent graft, after the aortic arch stent graft is released, the first opening can pass through the first branch blood vessel to realize blood supply of the first branch blood vessel, avoid the risk of branch artery ischemia and ensure the blood supply of the aorta, the second opening and the third opening in a windowing area are used for being in butt joint with the second branch blood vessel and the third branch blood vessel to supply blood, and the first fixing ring, the second fixing ring and the third fixing ring are used as supporting structures of opening parts to ensure that the openings have the maximum flow area; considering that the difference between the second and third branch vessels of different people is large, the windowing region is provided with a section of abutted seam coating film, namely the windowing coating film, the windowing coating film can move along with the movement of the position of the fixing ring to adjust the positions of the second opening and the third opening on the windowing coating film, so that even if the windowing region and the branch vessels have position deviation, the windowing coating film of the bow-shaped coated stent can be adjusted through the conveyor to ensure that the bow-shaped coated stent is installed at the corresponding position, and the bow-shaped coated stent provided by the embodiment can be used in combination with the main stent.

The embodiment solves the technical problems that when the existing arch part covered stent in the prior art is used for treating aortic diseases, the pre-fenestrated covered stent is difficult to be matched with a human body branch blood vessel, the blood is not circulated in the branch blood vessel before the fenestration of the surgical fenestration covered stent, the membrane is broken to cause the damage of the covered tissue, and the covered strength is influenced.

In addition, a second aspect of the embodiments of the present invention further provides a device for delivering the aortic arch stent graft, which is used for delivering and aligning and releasing the aortic arch stent graft provided by the first aspect into a human body; the specific structure and mode of use are described in the detailed description of the invention.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic view of the overall structure of an aortic arch stent graft according to an embodiment of the present invention;

FIG. 2 is a schematic illustration of the aortic arch stent graft shown in FIG. 1 released into the human body;

FIG. 3 is an isometric view of the overall structure of the alignment release assembly in the assembled state of the delivery device for the aortic arch stent graft according to the embodiment of the invention;

FIG. 4 is a schematic view of an axial explosion of the alignment release assembly of FIG. 3;

FIG. 5 is a schematic diagram of a further exploded view of FIG. 4;

FIG. 6 is a front view of the overall structure of the alignment release assembly in the assembled state of the aortic arch stent graft delivery apparatus according to the embodiment of the present invention;

FIG. 7 is a schematic view of an axial explosion of the alignment release assembly of FIG. 6;

FIG. 8 is a schematic diagram of a further exploded view of FIG. 7;

FIG. 9 is a schematic view of the overall structure of the first fixing element of the alignment release assembly in the aortic arch stent graft delivery apparatus according to the embodiment of the present invention;

FIG. 10 is a schematic illustration of the exploded structure of FIG. 9;

FIG. 11 is a schematic view of the overall structure of the second fixing element of the alignment release assembly in the aortic arch stent graft delivery apparatus according to the embodiment of the present invention;

fig. 12 is a schematic diagram of the exploded structure of fig. 11.

Icon: 11-a backbone; 1201-main film covering; 1202-windowing and film covering; 121 — a first opening; 122-a second opening; 123-a third opening; 124-first windowing; 125-second windowing; 13-a first retaining ring; 14-a second retaining ring; 15-a third retaining ring; 16-development marking; 17-a developing ring; 2-inner sheath; 3-outer sheath; 4-fixing the outer tube; 5-a first stem; 6-second tube seat; 51-a connecting seat; 52-connecting needle; 7-a first fixing member; 8-a second fixing piece; 71-a fixed seat; 711-groove; 712-a bump; 713-inner cylinder; 72-a sleeve; 73-connecting lines; 731-a ferrule; 74-insert gap.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "upper", "lower", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships conventionally laid out when products of the present invention are used, and are only for convenience of description and simplicity of description, and do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

In particular, in the present invention, the term "proximal" refers to the end closer to the human heart during surgery, and "distal" refers to the end opposite the "proximal".

Furthermore, the terms "horizontal", "vertical" and the like do not imply that the components are required to be absolutely horizontal or pendant, but rather may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, e.g., as meaning fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

Example one

The present embodiment provides an aortic arch stent graft, which, referring to fig. 1 and 2, includes a frame 11, a main stent graft 1201, a patchwork stent graft, a first fixing ring 13, a second fixing ring 14 and a third fixing ring 15; specifically, the main stent graft 1201 is connected to the framework 11 to form a stent graft main body, a first opening 121 for blood supply in butt joint with a first branch blood vessel is arranged at the proximal end of the main stent graft 1201, a first fixing ring 13 is fixed at the edge of the first opening 121, and a developing mark 16 is arranged on the first fixing ring 13 or on the portion, surrounding the first fixing ring 13, of the stent graft main body; a windowing membrane 1202 is arranged on the main membrane 1201 and positioned at the far end of the first opening 121, the windowing membrane 1202 covers the windowing membrane and is connected to the main membrane 1201 in a sewing mode, a second opening 122 and a third opening 123 for blood supply in butt joint with a second branch blood vessel and a third branch blood vessel are arranged on the windowing membrane 1202, a second fixing ring 14 is fixed on the edge of the second opening 122, and a third fixing ring 15 is fixed on the edge of the third opening 123; the developing rings 17 are attached to both the second fixing ring 14 and the third fixing ring 15, the number of the developing rings 17 is not particularly limited, and for the convenience of implantation, it is preferable, but not limited to, that at least three developing rings 17 are attached to both the second fixing ring 14 and the third fixing ring 15.

When the aortic arch stent graft is implanted into a human body, the development marker 16 and the development ring 17 are used as visual field aids, the first opening 121 is used as a positioning hole for fixing the position of the aortic arch stent graft, the aortic arch stent graft is implanted into the arch stent graft, after release, the first opening 121 can realize blood supply of a first branch blood vessel through the first branch blood vessel, the risk of branch artery ischemia is avoided, the blood supply of the aorta is ensured, the second opening 122 and the third opening 123 in the windowing area are used for butt joint blood supply of the second branch blood vessel and the third branch blood vessel, and the first fixing ring 13, the second fixing ring 14 and the third fixing ring 15 are used as supporting structures of opening parts to ensure that the openings have the maximum flow area; considering that the difference between the second and third branch vessels of different people is large, the windowing region is provided with a section of patchwork coating, namely the windowing coating 1202, so that the windowing coating 1202 can be guaranteed to move along with the movement of the position of the fixed ring, and the positions of the second opening 122 and the third opening 123 on the windowing coating 1202 can be adjusted, therefore, even if the windowing region and the branch vessels have position deviation, the windowing coating 1202 of the arch part coating stent can be adjusted through a conveyor to guarantee that the arch part coating stent is installed at a corresponding position, and the arch part coating stent provided by the embodiment can be used in combination with the main stent.

In this embodiment, in some optional embodiments, the windowing coating film 1202 is made of a flexible but inelastic material, so that the windowing coating film 1202 moves along with the fixing ring and does not rebound after the upper opening of the windowing coating film 1202 is aligned with the branch blood vessel, thereby ensuring good blood vessel docking stability and avoiding complications such as blood leakage; in other alternative embodiments, the fenestration coating 1202 may be made of a flexible but inelastic material, or a material with certain elasticity, and in these alternative embodiments, a support body connected to the framework 11 is provided inside the fenestration; the windowing coating film 1202 covers and is connected to the support body, and neither the second opening 122 nor the third opening 123 coincides with the support body; the support body can deform and does not rebound under the condition of being pulled by external force so as to pull the windowing coating film 1202 to enable the second opening 122 to be in butt joint with the second branch blood vessel or enable the third opening 123 to be in butt joint with the third branch blood vessel.

In some optional embodiments of this embodiment, the windowing portion includes one windowing portion, the whole windowing portion may be in an oval shape, a square shape, or another shape, in some optional embodiments of this embodiment, as shown in fig. 1 and fig. 2, the windowing portion includes a first windowing portion 124 and a second windowing portion 125, the second windowing portion 125 is disposed at a distal end of the first windowing portion 124 at intervals, a windowing covering film 1202 is sewn and connected inside each of the first windowing portion 124 and the second windowing portion 125, the second windowing covering film 1202 is disposed in the first windowing portion 124 in the opening 122, and the third windowing covering film 1202 is disposed in the second windowing portion 125 in the opening 123. The first fenestration 124 and the second fenestration 125 are oval or circular or square or other shapes.

In addition, in some optional embodiments of the present embodiment, the patchwork covering film further includes a first opening covering film (not shown) covering the first opening and connected to the main covering film by suturing, and the first opening covering film is provided with a blood supply opening (not shown) for supplying blood to be butted with the first branch blood vessel; further optionally, a first tubular branch stent is connected to the first opening covered stent, one end of the first tubular branch stent is butted with the blood supply opening, the other end of the first tubular branch stent can be butted and inserted into the interior of the first branch blood vessel, and the first tubular branch stent can be, but is not limited to, a bare stent or a covered stent.

In some optional embodiments of this embodiment, a second tubular branch stent (not shown) is connected to the fenestration covering membrane, one end of the second tubular branch stent is butted with the second opening, and the other end of the second tubular branch stent can be butted and inserted into the second branch vessel; and/or a third tubular branch stent (not shown) is connected to the fenestration covering membrane, one end of the third tubular branch stent is butted with the third opening, and the other end of the third tubular branch stent can be butted and inserted into the third branch blood vessel. Wherein "and/or" means that the second tubular branch stent and the third tubular branch stent are alternatively or simultaneously arranged, and the second tubular branch stent and the third tubular branch stent can adopt but are not limited to a bare stent or a covered stent.

Example two

The present embodiment provides a device for delivering an aortic arch stent graft, which is used for delivering the aortic arch stent graft provided in any one of the optional embodiments of the present embodiment into a human body and releasing the aortic arch stent graft in an aligned position.

The conveying device of the aortic arch part covered stent comprises a conveying handle, a conveying outer tube and an alignment release assembly; specifically, referring to fig. 3 to 12, in conjunction with fig. 1 and 2, the alignment release assembly includes an inner sheath tube 2, an outer sheath tube 3, a fixed outer tube 4, a first tube holder 5, a second tube holder 6, a first fixing member 7, and a second fixing member 8; wherein: the inner sheath 2 passes through the outer sheath 3, the outer sheath 3 passes through the fixed outer tube 4, and the fixed outer tube 4 passes through the conveying outer tube (not shown); the rear end of the inner sheath 2, the rear end of the outer sheath 3, the rear end of the fixed outer tube 4 and the rear end of the outer delivery tube are all connected to a delivery handle (not shown), and the delivery handle can control the outer sheath 3 to extend back and forth relative to the inner sheath 2, the fixed outer tube 4 to extend back and forth relative to the outer sheath 3, and the outer delivery tube to extend back and forth relative to the inner sheath 2, the outer sheath 3 and the fixed outer tube 4. The first fixing part 7 and the second fixing part 8 respectively comprise a fixing seat 71, a sleeve 72 and a connecting wire 73; the fixed seat 71 is fixedly connected to the rear end of the sleeve 72, the connecting wire 73 is located on the outer peripheral surface of the sleeve 72, the rear end of the connecting wire 73 is connected to the fixed seat 71, the front end of the connecting wire 73 extends out of the front end of the sleeve 72, and the front end of the connecting wire 73 is provided with a ferrule 731; the fixed seat 71 is provided with a central hole coaxial with the sleeve 72; the fixed seat 71 and the sleeve 72 of the first fixed part 7 are sleeved and fixed at the front end of the outer sheath tube 3, and the fixed seat 71 and the sleeve 72 of the second fixed part 8 are sleeved and fixed at the front end of the fixed outer tube 4. The first tube seat 5 and the second tube seat 6 respectively comprise a connecting seat 51 and a connecting needle 52, and the front end of the connecting needle 52 is connected with the rear end surface of the connecting seat 51; the first tube holder 5 is sleeved and fixedly connected with the outer peripheral surface of the inner sheath tube 2, and the connecting needle 52 of the first tube holder 5 extends backwards along the direction parallel to the inner sheath tube 2; the second tube holder 6 is sleeved outside the outer sheath tube 3, the front end of the second tube holder 6 is fixedly connected to the rear end of the fixed seat 71 of the first fixing piece 7, and the connecting needle 52 of the second tube holder 6 extends backwards in a direction parallel to the outer sheath tube 3.

In an assembled state: the connection wire 73 of the first fixing member 7 passes through the developing ring 17 around the second fixing ring 14, the connection wire 73 of the second fixing member 8 passes through the developing ring 17 around the third fixing ring 15, the connection pin 52 of the first socket 5 is inserted into the ferrule 731 of the front end of the connection wire 73 of the first fixing member 7, and the connection pin 52 of the second socket 6 is inserted into the ferrule 731 of the front end of the connection wire 73 of the second fixing member 8.

The operation method of the delivery device of the aortic arch part covered stent provided by the embodiment is as follows:

the first step is as follows: the method comprises the steps that when a conveying device is in an assembled state, an arch part covered stent is conveyed to a lesion position through a femoral artery, a conveying outer tube is withdrawn through a conveying handle, a developing mark 16 around a first fixing ring 13 at the near end of the arch part covered stent is exposed, the whole conveying device is moved, the first opening 121 is positioned through the developing mark 16 of the arch part covered stent, the first opening 121 is aligned with a first branch blood vessel, then the conveying outer tube is withdrawn continuously to completely withdraw the arch part covered stent to be released to the conveying outer tube, and after release is guaranteed, the first opening 121 can realize blood supply of the first branch blood vessel through the first branch blood vessel, so that the risk of ischemia of the branch artery is avoided, and the blood supply amount of an aorta is guaranteed;

second, the second opening 122 and the second branch vessel are aligned, in the process: the first tube seat 5 and the first fixing part 7 which are assembled together can be driven to move back and forth simultaneously by moving the whole conveying device back and forth, and the connecting wire 73 on the first fixing part 7 penetrates through the developing ring 17 around the second fixing ring 14, so that the developing ring 17 around the second fixing ring 14 can be driven to move back and forth, and the front and back positions of the second opening 122 can be adjusted; then, the sheath tube 3 is rotated by the conveying handle to drive the connecting wire 73 on the sleeve 72 of the first fixing member 7 to rotate, and further drive the developing ring 17 around the second fixing ring 14 to rotate, so as to adjust the left and right positions of the second opening 122, and finally, the function of aligning the second opening 122 on the windowing tectorial membrane 1202 of the bow tectorial membrane stent with the second branch blood vessel can be achieved;

thirdly, the outer sheath tube 3 and the fixed outer tube 4 are withdrawn, the first tube seat 5 is separated from the first fixing piece 7, and the developing ring 17 around the second fixing ring 14 of the arch part covered stent is released to the conveying device;

fourthly, aligning the third opening 123 with the third branch blood vessel, wherein in the process: the second tube seat 6 and the second fixing part 8 which are assembled together can be driven to move back and forth simultaneously by moving the whole conveying device back and forth, and the connecting wire 73 on the second fixing part 8 passes through the developing ring 17 around the third fixing ring 15, so that the developing ring 17 around the third fixing ring 15 can be driven to move back and forth, and the front and back positions of the third opening 123 can be adjusted; then, the outer tube 4 is fixed by the conveying handle, the connecting wire 73 on the sleeve 72 of the second fixing piece 8 is driven to rotate, and the developing ring 17 around the third fixing ring 15 is further driven to rotate, so that the left and right positions of the third opening 123 are adjusted, and finally, the function of aligning the third opening 123 on the windowing coating 1202 of the bow stent-graft with the third branch blood vessel can be achieved;

fifthly, the fixed outer tube 4 is withdrawn, the second tube seat 6 is separated from the second fixed part 8, and the developing ring 17 around the third fixed ring 15 of the bow part covered stent is released to the conveying device;

and sixthly, withdrawing the whole conveying device out of the body.

With continued reference to fig. 3 to 12, in an alternative embodiment of the present embodiment, at least three developing rings 17 are connected to the second fixing ring 14, the first fixing member 7 includes at least three connecting wires 73, the first socket 5 includes at least three connecting pins 52, and in an assembled state, the at least three connecting pins 52 are inserted into the ferrules 731 at the front ends of the at least three connecting wires 73 in a one-to-one correspondence; and/or, the third fixing ring 15 is connected with at least three developing rings 17, the second fixing member 8 comprises at least three connecting wires 73, the second tube holder 6 comprises at least three connecting needles 52, and in the assembled state, the at least three connecting needles 52 are inserted into the ferrules 731 at the front ends of the at least three connecting wires 73 in a one-to-one correspondence manner, so that the second fixing ring 14 and the third fixing ring 15 can be adjusted from multiple directions during adjustment, and the adjustment difficulty is reduced. Wherein "and/or" means "and/or" the preceding structure is set alternatively or simultaneously with "and/or" the following structure.

With continued reference to fig. 3-12, in an alternative embodiment of the present embodiment, the entirety of the connecting wire 73 is formed as a coil.

With continued reference to fig. 3 to 12, in an alternative embodiment of the present embodiment, in the first fixing member 7 and/or the second fixing member 8: the outer peripheral surface of the fixing seat 71 is provided with a plurality of grooves 711 which are spaced in pairs along the radial circumferential direction of the fixing seat 71, a protrusion 712 is formed between every two adjacent grooves 711, the protrusion 712 is provided with a through hole, and the rear end of the connecting wire 73 penetrates through the through hole and is fixed on the fixing seat 71. Here, "and/or" means that the first fixing member 7 and the second fixing member 8 are alternatively or simultaneously provided in this structure.

With continued reference to fig. 3 to 12, in an alternative embodiment of the present embodiment, in the first fixing member 7 and/or the second fixing member 8: the front end of the fixed seat 71 is provided with an inner cylinder 713, the sleeve 72 is sleeved and fixed outside the inner cylinder 713, and an insertion gap 74 capable of inserting the connecting needle 52 is formed between the inner wall of the sleeve 72 and the outer wall of the inner cylinder 713, so that the assembly stability during assembly is further improved. Here, "and/or" means that the first fixing member 7 and the second fixing member 8 are alternatively or simultaneously provided in this structure.

With reference to fig. 3 to 12, in an alternative embodiment of the present embodiment, in the first fixing member 7, the second socket 6 is integrally formed on the fixing seat 71 of the first fixing member 7.

Finally, it should be noted that: the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An aortic arch part tectorial membrane bracket is characterized by comprising a framework (11), a main tectorial membrane (1201), a patchwork tectorial membrane, a first fixing ring (13), a second fixing ring (14) and a third fixing ring (15);

the main covering membrane (1201) is connected to the framework (11) to form a covered stent main body, a first opening (121) used for being in butt joint with a first branch blood vessel for supplying blood is arranged at the proximal end of the main covering membrane (1201), the first fixing ring (13) is fixed on the edge of the first opening (121), and a developing mark (16) is arranged on the first fixing ring (13) or the covered stent main body at a position surrounding the first fixing ring (13);

a windowing membrane (1202) is arranged on the main membrane (1201) and is positioned at the position of the far end of the first opening (121), the windowing membrane (1202) covers the windowing membrane and is connected to the main membrane (1201) in a sewing mode, a second opening (122) and a third opening (123) which are used for being in butt joint with a second branch blood vessel and a third branch blood vessel for supplying blood are formed in the windowing membrane (1202), the second fixing ring (14) is fixed to the edge of the second opening (122), and the third fixing ring (15) is fixed to the edge of the third opening (123);

the second fixing ring (14) and the third fixing ring (15) are both connected with developing rings (17).

2. The aortic arch stent graft of claim 1,

the fenestration membrane (1202) is made of a flexible but inelastic material;

or:

a support body connected with the framework (11) is arranged in the window opening; the windowing coating film (1202) covers and is connected to the support body, and neither the second opening (122) nor the third opening (123) coincides with the support body; the support is capable of deforming without springing back when pulled by an external force to pull the fenestration membrane (1202) to dock the second opening (122) with a second branch vessel or dock the third opening (123) with a third branch vessel.

3. The aortic arch stent graft of claim 1, wherein the fenestration comprises one or more of a first fenestration (124) and a second fenestration (125), the second fenestration (125) is spaced apart from the distal end of the first fenestration (124), the fenestration (1202) is sutured to the inside of each of the first fenestration (124) and the second fenestration (125), the fenestration (1202) is open to the first fenestration (124), and the fenestration (1202) is open to the second fenestration (125) is open to the third fenestration (123).

4. The aortic arch stent graft of claim 1, wherein the commissure stent graft further comprises a first opening stent graft covering the first opening (121) and sutured to the main stent graft (1201), and wherein the first opening stent graft is provided with a blood supply opening for docking with a first branch vessel.

5. The aortic arch stent graft of claim 4, wherein a first tubular branch stent is attached to the first opening graft, one end of the first tubular branch stent is in abutment with the blood supply opening, and the other end of the first tubular branch stent is capable of being inserted in abutment inside a first branch vessel.

6. The aortic arch stent graft of claim 1,

a second tubular branch stent is connected to the windowing covering film, one end of the second tubular branch stent is butted with the second opening (122), and the other end of the second tubular branch stent can be butted and inserted into the second branch blood vessel;

and/or a third tubular branch stent is connected to the windowing covering film, one end of the third tubular branch stent is butted with the third opening (123), and the other end of the third tubular branch stent can be butted and inserted into the third branch blood vessel.

7. An aortic arch part covered stent conveying device, which is used for conveying and contraposition releasing the aortic arch part covered stent of any one of claims 1 to 6 into a human body, and is characterized in that the conveying device of the aortic arch part covered stent comprises a conveying handle, a conveying outer tube and a contraposition releasing component;

the alignment release assembly comprises an inner sheath tube (2), an outer sheath tube (3), a fixed outer tube (4), a first tube seat (5), a second tube seat (6), a first fixing piece (7) and a second fixing piece (8);

the inner sheath (2) passes through the outer sheath (3), the outer sheath (3) passes through the fixed outer tube (4), and the fixed outer tube (4) passes through the conveying outer tube; the rear end of the inner sheath tube (2), the rear end of the outer sheath tube (3), the rear end of the fixed outer tube (4) and the rear end of the conveying outer tube are connected to the conveying handle, and the conveying handle can control the front and rear expansion of the outer sheath tube (3) relative to the inner sheath tube (2), the front and rear expansion of the fixed outer tube (4) relative to the outer sheath tube (3) and the front and rear expansion of the conveying outer tube relative to the inner sheath tube (2), the outer sheath tube (3) and the fixed outer tube (4);

the first fixing piece (7) and the second fixing piece (8) respectively comprise a fixing base (71), a sleeve (72) and a connecting wire (73); the fixed seat (71) is fixedly connected to the rear end of the sleeve (72), the connecting wire (73) is located on the outer peripheral surface of the sleeve (72), the rear end of the connecting wire (73) is connected to the fixed seat (71), the front end of the connecting wire (73) extends out of the front end of the sleeve (72), and a ferrule (731) is arranged at the front end of the connecting wire (73); the fixed seat (71) is provided with a central hole coaxial with the sleeve (72);

the fixing seat (71) and the sleeve (72) of the first fixing piece (7) are sleeved and fixed at the front end of the outer sheath tube (3), and the fixing seat (71) and the sleeve (72) of the second fixing piece (8) are sleeved and fixed at the front end of the fixed outer tube (4);

the first tube seat (5) and the second tube seat (6) respectively comprise a connecting seat (51) and a connecting needle (52), and the front end of the connecting needle (52) is connected to the rear end face of the connecting seat (51); the first pipe seat (5) is sleeved and fixedly connected to the peripheral surface of the inner sheath pipe (2), and a connecting needle (52) of the first pipe seat (5) extends backwards along a direction parallel to the inner sheath pipe (2); the second tube seat (6) is sleeved outside the outer sheath tube (3), the front end of the second tube seat (6) is fixedly connected to the rear end of a fixed seat (71) of the first fixed part (7), and a connecting needle (52) of the second tube seat (6) extends backwards along a direction parallel to the outer sheath tube (3);

in an assembled state: connecting wire (73) on first mounting (7) pass development ring (17) around second solid fixed ring (14), connecting wire (73) on second mounting (8) pass development ring (17) around third solid fixed ring (15), connecting needle (52) of first tube socket (5) insert in lasso (731) of the front end of connecting wire (73) of first mounting (7), connecting needle (52) of second tube socket (6) insert in lasso (731) of the front end of connecting wire (73) of second mounting (8).

8. The aortic arch stent graft delivery apparatus of claim 7, wherein,

the second fixing ring (14) is connected with at least three developing rings (17), the first fixing piece (7) comprises at least three connecting wires (73), the first tube seat (5) comprises at least three connecting needles (52), and in an assembling state, the at least three connecting needles (52) are inserted into ferrules (731) at the front ends of the at least three connecting wires (73) in a one-to-one correspondence manner;

and/or, be connected with at least three development ring (17) on third solid fixed ring (15), second mounting (8) include three piece at least connecting wires (73), include three piece at least connecting pins (52) on second tube socket (6), under the assembled state, three piece at least connecting pin (52) one-to-one insert in three piece at least in lasso (731) of the front end of connecting wire (73).

9. The aortic arch stent graft delivery apparatus of claim 7, wherein the connecting wire (73) is integrally formed as a coil.

10. The aortic arch stent graft delivery apparatus of claim 7, wherein the first fixing element (7) and/or the second fixing element (8) comprises:

the outer peripheral surface of the fixed seat (71) is provided with a plurality of grooves (711) which are spaced in pairs along the radial circumferential direction of the fixed seat (71), a protrusion (712) part is formed between every two adjacent grooves (711), a through hole is formed in the protrusion (712), and the rear end of the connecting wire (73) penetrates through the through hole and is fixed on the fixed seat (71); and/or the front end of the fixed seat (71) is provided with an inner cylinder (713), the sleeve (72) is sleeved and fixed outside the inner cylinder (713), and an insertion gap (74) capable of being inserted into the connecting needle (52) is formed between the inner wall of the sleeve (72) and the outer wall of the inner cylinder (713).