CN111407463B

CN111407463B - Covered stent system

Info

Publication number: CN111407463B
Application number: CN202010197713.7A
Authority: CN
Inventors: 傅泽粮; 成正辉; 颜世平
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2020-03-19
Filing date: 2020-03-19
Publication date: 2022-08-12
Anticipated expiration: 2040-03-19
Also published as: CN111407463A

Abstract

The application provides a covered stent system, and this covered stent system simple structure, principle are clear, the combination is nimble various, the specification of required support is less, realizes that limited support specification satisfies different vascular anatomical structure's requirement. The release of each stent in the stent subsystem is rapid, blood flow, deep low temperature circulation and extracorporeal circulation do not need to be blocked, the operation difficulty is greatly reduced, the operation time is shortened, and the perioperative mortality and complications can be greatly reduced. In addition, due to the reduction of the operation time and the difficulty, the dosage of the contrast agent can be reduced, and meanwhile, the irradiation time of the radioactive rays received by doctors and patients is obviously reduced. The covered stent system provided by the application can realize the isolated treatment in the cavity from a single branch blood vessel to a multi-branch blood vessel, such as isolated treatment in the cavity from an aortic arch and the position from an abdominal trunk to a renal artery.

Description

Covered stent system

Technical Field

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

Background

With the improvement of living standard in China, the aging of population and the popularization of automobiles, the incidence of aortic diseases such as aortic dissection, aneurysm and hematoma and traumatic aortic diseases caused by automobile accidents is increasing. The aortic disease may cause clinical symptoms such as arteriosclerosis, arterial thrombosis, raynaud's syndrome, etc., and may cause heart failure, cardiogenic shock, death, etc. seriously depending on the condition of the disease.

At present, the treatment modes of aortic diseases mainly comprise drug conservation treatment, surgical open surgery treatment and aorta intracavity intervention treatment. The aorta intraluminal interventional therapy refers to a treatment mode that a covered stent is placed at a focus, blood vessels at the focus are isolated through the covered stent, and a blood flow channel is reconstructed by the covered stent. Because the aorta intraluminal interventional therapy has the advantages of small trauma, less complications, high safety and less pain for patients, it becomes the main way to treat aortic diseases and is mainly applicable to lesions without involvement of major branch arteries. The aorta vessels mostly have branch artery vessels, and because the branch artery vessels have complex anatomical structures and are impacted by blood flow with higher intensity, the incidence rate is higher. For the treatment of an aorta with multiple branches, the branches form a solid geometry without any obvious regularity, so that it is very difficult to align the branch openings by intraluminally accurately positioning and delivering stent graft branches to the branches or by custom windowing. In addition, the aorta is high in blood pressure and high in flow rate, and is not very favorable for accurate positioning. Thus, the precise positioning based intra-aortic interventional treatment is difficult to apply to the isolated treatment at the multi-branch aorta of complex anatomy.

At present, the treatment of the multi-branch aortic disease is mainly performed by a surgical operation, i.e., an artificial blood vessel replacement operation. Surgical treatment of multiple-branch aortic diseases has the disadvantages of complicated treatment, large trauma and extremely high mortality rate during operation, so that a treatment mode based on intra-aortic intervention becomes a main research in the industry for treating multiple-branch aortic diseases, such as a three-branch stent for an arterial arch and a chimney stent. Because the diameters of the branch vessels, the intervals among the branches and the included angles between the branch vessels and the aorta are obviously different on different human bodies, the stent for treating the multi-branch aortic disease generally has the defects of complex design, excessive specifications, narrow application range, difficult matching with the anatomical structures of the vessels and the like, and causes great operation difficulty, long operation time and difficult industrial production.

Disclosure of Invention

The invention provides a covered stent system, which aims to solve the problem that the existing stent for treating multi-branch aortic diseases has a narrow application range.

The invention provides a covered stent system, which comprises a stent subsystem and a delivery subsystem which are used in combination;

the stent subsystem comprises an aorta stent and a side branch stent, wherein the aorta stent comprises an aorta main stent and a branch conduit arranged on the side wall of the aorta main stent, and the branch conduit is communicated with the inside of the aorta main stent; the lateral branch stent is movably inserted into the branch catheter;

the delivery subsystem comprises a dispenser, an adjustable valve sheath and a conveyor, and the dispenser and the conveyor respectively deliver the aortic stent and the collateral stent through the adjustable valve sheath.

Preferably, the branch catheter comprises a catheter body and a metal stent disposed on the catheter body; the end of the catheter body is provided with a branch catheter mark.

Preferably, the delivery device comprises a delivery supporting tube and a delivery handle which are connected, and a main guide wire cavity, an auxiliary guide wire cavity and a delivery releasing device which are arranged in parallel are arranged in the delivery supporting tube and the delivery handle in a penetrating way; the front end of the main guide wire cavity is provided with a releasing conical head, and a releasing core wire in the releasing device is inserted into a releasing and receiving hole in the releasing conical head.

Preferably, the number of stent peaks at the inflow end of the aortic stent is higher than the number of stent peaks in the middle of the aortic stent.

Preferably, along the blood flow direction, the radial supporting force of the blood flow inlet end of the collateral branch stent is larger than that of the blood flow outlet end of the collateral branch stent.

Preferably, the diameter of the blood flow inlet end of the side branch stent is 105-130% of the diameter of the branch catheter.

Preferably, the support subsystem further comprises a chimney support used in combination with the aortic support, the collateral support, the conveyor;

the chimney support comprises a functional layer and a leakage-proof layer, the leakage-proof layer is positioned on the outer side of the functional layer, and the leakage-proof layer is close to the blood flow inlet end of the chimney support; the end surface of the leakage-proof layer close to the blood flow inlet end of the chimney support is provided with a through hole; along the length direction of the chimney support, a chimney fixing band is arranged outside the functional layer.

Preferably, the leakage-proof layer is an annular leakage-proof layer, and the chimney fixing band is positioned on two sides of the annular leakage-proof layer along the axial direction of the chimney support;

the annular leakage-proof layer comprises an annular bracket and an annular coating, the annular bracket is arranged between the functional layer and the annular coating, and the annular bracket protrudes out of the functional layer; the annular support is located in the middle parallel section of the annular coating, and the diameter of the end part of the annular coating is the same as that of the functional layer.

Preferably, the leakage-proof layer is a pocket-shaped leakage-proof layer, and the end surfaces of the pocket-shaped leakage-proof layer are positioned at two sides of the chimney fixing band along the radial direction of the chimney support;

the pocket-shaped leakage-proof layer comprises a pocket-shaped support and a pocket-shaped coating, the pocket-shaped support is arranged between the functional layer and the pocket-shaped coating, and the pocket-shaped support protrudes out of the functional layer; the pocket-shaped support is fixed on the boss section of the pocket-shaped coating, and the pocket-shaped coating is fixed on the functional layer.

Preferably, both ends of the functional layer and the outer edge of the leakage-proof layer are provided with marks.

The technical scheme provided by the embodiment of the invention can have the following beneficial effects:

in the covered stent system provided by the application, the aorta stent, the collateral branch stent and the chimney stent can be flexibly combined according to an affected part, so that the reconstruction of a multi-branch blood vessel is realized. The application utilizes the characteristic that the arterial blood pressure is higher, and the reverse blood flow can be established by the side branch bracket leading to the branch blood vessel through the arrangement of the branch catheter on the aortic bracket, so that the branch blood vessel to be covered adopts reverse perfusion blood supply, the chimney bracket and the aortic bracket in the subsequent branch have enough anchoring length, the quantity of the branch blood vessel to be reconstructed is determined according to the requirement, and unnecessary branch covering is avoided. Through the combination of the branch catheter in the aortic stent and the auxiliary guide wire cavity in the delivery device, the guide wire in the auxiliary guide wire cavity is embedded in the branch catheter, so that the guide wire can smoothly enter a branch vessel from the aortic stent, the side branch stent can conveniently enter the branch vessel along the guide wire, and the stent is released to realize accurate positioning. The chimney support in this application has two-layer structure in functional layer and leak protection layer, can effectively reduce the interior risk of leaking of aorta support and chimney support combination department.

The covered stent system in the application has the advantages of simple structure, clear principle, flexible and various combination and less specification of the required stent, and the limited stent specification can meet the requirements of different blood vessel anatomical structures. The release of each stent in the stent subsystem is rapid, blood flow, deep low temperature circulation and extracorporeal circulation do not need to be blocked, the operation difficulty is greatly reduced, the operation time is shortened, and the perioperative mortality and complications can be greatly reduced. In addition, due to the reduction of the operation time and the difficulty, the dosage of the contrast agent can be reduced, and meanwhile, the irradiation time of the radioactive rays received by doctors and patients is obviously reduced. The covered stent system provided by the application can realize the isolated treatment in the cavity from a single branch blood vessel to a multi-branch blood vessel, such as isolated treatment in the cavity from an aortic arch and the position from an abdominal trunk to a renal artery.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

Drawings

In order to more clearly explain the technical solution of the present application, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious to those skilled in the art that other drawings can be obtained according to the drawings without any creative effort.

FIG. 1 is a schematic block diagram of a stent-graft system according to an embodiment of the present invention;

FIG. 2 is a schematic structural diagram of an aortic stent provided in an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a sidebranch stent provided in an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a chimney support according to an embodiment of the present invention;

FIG. 5 is a schematic view of another embodiment of a chimney support according to the present invention;

FIG. 6 is a cross-sectional view of an aortic stent and a double-layered chimney stent deployed in parallel in a blood vessel according to an embodiment of the present invention;

fig. 7 is a schematic structural diagram of a player according to an embodiment of the present invention;

FIG. 8 is a schematic structural diagram of a loader according to an embodiment of the present invention;

FIG. 9 is a schematic diagram of an overall structure of an adjustable valve sheath provided in an embodiment of the present invention;

FIG. 10 is a schematic structural view of a dilator with an adjustable valve sheath according to an embodiment of the present invention;

FIG. 11 is a schematic structural view of an outer tube of an adjustable valve sheath provided in accordance with an embodiment of the present invention;

FIG. 12 is a schematic structural diagram of a conveyor according to an embodiment of the present invention;

FIG. 13 is a schematic view of an aortic stent delivered to an aortic arch according to an embodiment of the present invention;

FIG. 14 is a schematic view of an aortic stent and a chimney stent delivered to an aortic arch according to an embodiment of the present invention;

FIG. 15 is a schematic view of an aortic stent and a chimney stent provided in accordance with an embodiment of the present invention after release;

FIG. 16 is a schematic illustration of an aortic stent, a chimney stent, and a collateral stent according to an embodiment of the present invention after release;

FIG. 17 is a schematic view of a stent graft system covering the two posterior branch vessels of the aortic arch, according to an embodiment of the present invention;

FIG. 18 is a schematic view of a stent graft system covering a left subclavian artery vessel according to an embodiment of the present invention;

the symbols represent:

01-a scaffold subsystem, 02-a delivery subsystem;

1-an aorta bracket, 2-a collateral branch bracket, 3-a releasing device, 4-an adjustable valve sheath, 5-a conveyor and 6-a chimney bracket;

101-main aortic stent, 102-branch catheter, 103-aortic securing band, 104-aortic stent marker, 105-branch catheter marker;

201-lateral branch main body support, 202-lateral branch fixing belt, 203-lateral branch support mark;

301-delivering a support tube, 302-delivering a handle, 303-a main guide wire cavity, 304-an auxiliary guide wire cavity, 305-a delivering and releasing device, 306-a conical head, 307-a delivering and receiving hole, 308-an auxiliary guide wire mark, 309-a tail end connector, 310-a loader;

401-dilator, 402-outer tube, 4021-tube body, 4022-hemostatic valve seat, 4023-side tube, 4024-hemostatic valve, 4025-adjustable valve sheath marker;

501-delivery device outer tube, 502-operation handle, 503-delivery device mark, 504-delivery device hemostatic valve seat, 505-delivery device side tube, 506-delivery device protective lock, 507-guide wire cavity, 508-delivery release device, 509-shuttle head, 510-end joint, 511-delivery receiving hole;

601-a functional layer, 602-a leakage-proof layer, 603-a through hole, 604-a chimney fixing band and 605-a mark;

1021-catheter body, 1022-metal stent;

3051-releasing and releasing a core wire, 3052-a stay wire ring, 3053-a release key and 3054-releasing a stay wire cavity;

5081-delivery release core wire, 5082-release handle, 5083-release protection lock, 5084-delivery pull wire cavity;

6021-Ring stent, 6022-Ring coated membrane, 6023-pocket stent, 6024-pocket coated membrane.

Detailed Description

Referring to FIG. 1, FIG. 1 is a schematic block diagram of a stent graft system provided in an embodiment of the present application. As can be seen from FIG. 1, the stent graft system provided by the embodiment of the application comprises a stent subsystem 01 and a delivery subsystem 02, wherein the stent subsystem 01 comprises an aortic stent 1 and a collateral stent 2, and the delivery subsystem 02 comprises a delivery device 3, an adjustable valve sheath 4 and a delivery device 5. The stent subsystem 01 in the embodiment of the present application performs reconstruction of an intraluminal multi-branch vessel in a combined manner, such as a combination of an aortic stent 1 and a collateral stent 2, or a combination of an aortic stent 1 and two collateral stents 2, according to the aortic vessels and/or important branch vessels involved in the diseased region of a patient, such as an aortic arch, a segment from the abdominal trunk to the renal artery, and the like. The delivery subsystem 02 is used for establishing an intracavity access channel for the stent subsystem 01, namely the dispenser 3 and the conveyor 5 are used for respectively delivering the aortic stent 1 and the collateral stent 2 to the diseased cavity of the patient through the adjustable valve sheaths 4, so that the combination of the stent subsystem 01 in the cavity becomes simple and feasible. FIG. 1 shows only one combination of the stent graft systems in the embodiments of the present application, which can be used to select different stents according to different diseased regions of a patient, so as to present different structural forms of the stent graft systems. The following describes the stent subsystem 01 and the delivery subsystem 02, respectively, by way of specific embodiments.

The stent subsystem 01 in the embodiment of the present application comprises an aortic stent 1 and a collateral stent 2, wherein the aortic stent 1 is used for reconstructing an aortic blood vessel of a diseased part to provide a blood flow channel for an aorta; the side branch stent 2 is used for reconstructing a plurality of important branch vessels involved in an aorta vessel of a diseased part so as to provide blood flow channels for the plurality of important branch vessels respectively.

Referring to fig. 2, fig. 2 is a schematic structural diagram of an aortic stent provided in an embodiment of the present application. As can be seen from fig. 2, the aortic stent 1 comprises an aortic body stent 101 and a branch conduit 102 disposed on a side wall of the aortic body stent 101, and the branch conduit 102 communicates with the inside of the aortic body stent 101. The main aortic stent 101 is tubular and provides a blood flow path to the aorta. The branch catheter 102 is also tubular, and is used to provide a passage for the sidebranch stent 2, the transporter 5, and the like into a branch vessel. The junction of the main aortic body support 101 and the branch conduit 102 forms the inlet of the branch conduit 102, the outlet of the branch conduit 102 is toward the proximal end of the main aortic body support 101, the sidebranch support 2, the conveyor 5, etc. enter the branch conduit 102 from the inlet of the branch conduit 102, and enter the branch vessel from the outlet end of the branch conduit 102. In the present embodiment, proximal refers to the end of the stent where blood enters the stent in the direction of blood flow, and distal refers to the end where blood exits the stent in the direction of blood flow.

The main aortic stent 101 has low elastic straightening force, can well conform to the anatomical structure of a blood vessel, and effectively avoids the problem that the edge blood vessel of a large-bending side stent is affected by the elastic straightening force to generate stent-origin lacerations. In the embodiment of the application, the number of stent peaks at the blood flow inlet end of the aortic stent 1 is higher than the number of stent peaks at the middle part of the aortic stent 1, that is, the number of stent peaks at the proximal end of the aortic main stent 101 is higher than the number of stent peaks at the middle part of the aortic main stent 101, so that the requirement of the anchoring length of the proximal end of the aortic stent 1 can be effectively reduced, and meanwhile, the shape of the proximal end of the aortic stent 1 has better plasticity and can better conform to the sharp shape formed by the chimney stent 6.

The branch catheter 102 includes a catheter body 1021, and the catheter body 1021 forms a passage for the sidebranch stent 2, the delivery device 5, and the like into the branch vessel. The catheter main body 1021 is provided with a metal stent 1022, and the placement of the metal stent 1022 prevents the branch catheter 102 from being crushed by the main aortic stent 101 and causing problems such as collapse, occlusion, or stenosis.

The branch catheter 102 in the embodiment of the application has good bending performance, so that the position from the inlet of the branch catheter 102 to the branch blood vessel does not depend on strict axial alignment, the bending performance of the branch catheter 102 and the side branch stent 2 can be automatically adjusted, the requirement of aligning the outlet of the branch catheter 102 with the corresponding branch blood vessel opening is reduced, and the operation difficulty and the operation time are greatly reduced. In addition, the branch conduit 102 in the embodiment of the present application may be parallel to the aortic stent 1, or may form an angle with the aortic stent 1, which may be set according to practical situations.

In addition, the proximal end of the main aortic stent 101, the parallel section of the branch conduit 102, and the outlet of the branch conduit 102 are distributed away from the metal stent framework of the main aortic stent 101 within a certain distance, thereby further effectively preventing the branch conduit 102 and the sidebranch stent 2 from being crushed by the main aortic stent 101.

Referring to fig. 3, fig. 3 is a schematic structural diagram of a sidebranch stent provided in an embodiment of the present application. As can be seen from fig. 3, the collateral branch stent 2 includes a collateral branch main body stent 201. The main stent 201 is tubular and is used for providing a blood supply channel for branch vessels. The collateral branch support 2 in the embodiment of the application has good anti-extrusion capacity and lower elastic straightening force, and the collateral branch support 2 can well conform to the structure of a blood vessel and does not generate elastic straightening after entering a branch blood vessel. In addition, the side branch stent 2 does not have the closed lumen under the sharp turning condition, thereby ensuring that the side branch stent 2 is not collapsed by the aortic stent 1 when being parallel to the aortic stent 1.

Along the blood flow direction, the radial supporting force of the blood flow inlet end of the lateral branch stent 2 is larger than that of the blood flow outlet end of the lateral branch stent 2, namely the radial supporting force of the near end of the lateral branch stent 2 is larger than that of the far end of the lateral branch stent 2, so that the lateral branch stent 2 and the branch catheter 102 have good sealing performance. When the side branch stent 2 and the aortic stent 1 are parallel to each other in the aortic vessel for a distance and then enter the branch vessel, the larger radial supporting force of the proximal end of the side branch stent 2 can effectively avoid the situation that the side branch stent 2 is collapsed by the aortic stent 1, and meanwhile, the situation that the lumen of the stent is closed when the side branch stent 2 turns sharply to enter the branch vessel can be prevented. In addition, the small radial supporting force of the far end of the lateral branch stent 2 can also prevent the tail end of the lateral branch stent 2 from forming a new stent-derived breach.

In the embodiment of the present application, the aortic stent 1 applied to the same lesion site can be designed to have different specifications and meet the requirements of proximal and distal diameters and cumulative length of the aorta. However, the diameters of the branch conduits 102 of the aortic stent 1 are designed to be consistent to meet the blood supply requirements of different branch vessels. Since the sidebranch stent 2 can be inserted from the entrance of the branch catheter 102, the diameter of the branch catheter 102 should match the diameter of the proximal end of the sidebranch stent 2. Specifically, the diameter of the branch catheter 102 is generally the diameter of the blood flow supply of the largest branch vessel at the position of the patient, and the diameter of the blood flow inlet end of the sidebranch stent 2 is 105-130% of the diameter of the branch catheter 102, i.e. the diameter of the proximal end of the sidebranch stent 2 is 105-130% of the diameter of the branch catheter 102. The diameter of the far end of the side branch stent 2 can be designed into different diameters and length specifications so as to meet the difference between the diameters of different blood vessel branches and the required coverage length. Based on this, the aortic stent 1 with the same specification can be matched with the collateral stent 2 with different specifications through the branch catheter 102, so that the specification number of the aortic stent 1 and the collateral stent 2 is obviously reduced, the requirements of different anatomical structures of the blood vessel are met, and the product popularization is facilitated.

The stent subsystem 01 provided by the embodiment of the present application further includes a chimney stent 6, and the chimney stent 6 is used for establishing a blood flow channel of a branch blood vessel. The aorta stent 1, the collateral stent 2 and the chimney stent 6 are used in combination.

Referring to fig. 4, fig. 4 is a schematic structural diagram of a chimney support provided in an embodiment of the present application. As shown in fig. 4, the chimney holder 6 provided in the embodiment of the present application includes a functional layer 601 and a leakage-proof layer 602, and is a double-layer structure. The chimney support 6 has good radial supporting force and bending performance, the bending radius can be as low as 5mm, and the inner cavity is not closed, so that the chimney support 6 cannot be collapsed by the aortic support 1 when being parallel to the aortic support 1.

Specifically, the functional layer 601 is an inner layer structure of the chimney holder 6, and is used for establishing a branch blood vessel blood flow channel. The leakage-proof layer 602 is an outer layer structure of the chimney support 6 and is used for catching blood which may flow out from gaps on two sides of the matching part of the aortic support 1 and the functional layer 601. The leakage-proof layer 602 is located outside the functional layer 601, and the leakage-proof layer 602 is close to the blood flow inlet end of the chimney holder 6, i.e., the leakage-proof layer 602 is located at the proximal end of the functional layer 601. In this embodiment, a through hole 603 is provided on the end surface of the leakage-proof layer 602 close to the blood flow inlet end of the chimney holder 6, that is, a through hole 603 is provided on the end surface of the leakage-proof layer 602 close to the proximal end of the chimney holder 6. The through hole 603 can facilitate the blood leaking from the gap between the aortic stent 1 and the functional layer 601 to enter between the functional layer 601 and the leakage-proof layer 602, and further enter into the blood flow channel reestablished by the aortic stent 1 and the chimney stent 6, so as to prevent the internal leakage.

The leakage-proof layer 602 in the embodiment of the present application has two design structures, namely, an annular leakage-proof layer and a pocket-shaped leakage-proof layer, wherein fig. 4 shows the structure of the annular leakage-proof layer, and fig. 5 shows the structure of the pocket-shaped leakage-proof layer. As shown in fig. 4, the chimney fixing bands 604 are located on both sides of the annular leak-proof layer along the axial direction of the chimney holder 6. The annular leak-proof layer comprises an annular bracket 6021 and an annular coating 6022. The annular support 6021 is disposed between the functional layer 601 and the annular coating 6022, and the annular support 6021 protrudes from the functional layer 601. The annular support 6021 is positioned at the middle parallel section of the annular covering film 6022, and the annular leakage-proof layer forms a drum-shaped structure because the annular support 6021 protrudes out of the functional layer 601. Since the annular leak-proof layer has a drum-shaped structure, the annular cover film 6022 has an arch bridge structure in which the middle is parallel and both ends are sloped, as viewed from the side. In order to facilitate the provision of the annular leak-proof layer on the functional layer 601, the end portion diameter of the annular coating 6022 is the same as that of the functional layer 601, and the end portion of the annular coating 6022 is fixed around the functional layer 601.

As shown in fig. 5, the end surfaces of the pocket-shaped leakage-proof layer are located on two sides of the chimney fixing band 604 along the radial direction of the chimney support 6, so as to form a structure that semi-surrounds the functional layer 601. The pocket leakage prevention layer in the embodiment of the present application includes a pocket support 6023 and a pocket cover 6024. A pocket support 6023 is disposed between the functional layer 601 and the pocket cover 6024, and the pocket support 6023 protrudes from the functional layer 601. The pocket-shaped covering film 6024 is fixed to the functional layer 601 to form a boss-shaped structure with the middle part protruding outwards, and the pocket-shaped support 6023 is fixed to the boss section of the pocket-shaped covering film 6024.

In the embodiment of the present application, a chimney fastening band 604 is disposed outside the functional layer 601 along the length direction of the chimney holder 6, and the chimney fastening band 604 is used to compress the chimney holder 6. Similarly, the aortic main body support 101 is provided with an aortic fixing band 103, and the collateral branch main body support 201 is provided with a collateral branch fixing band 202, as shown in fig. 2 and 3. The aortic valve securing bands 103 are disposed on the outer surface of the aortic body stent 101 and arranged in a line to place the aortic body stent 101 in a compressed state. The side branch fixing bands 202 are disposed on the outer surface of the side branch main body stent 201 and arranged in a line shape so that the side branch main body stent 201 is in a compressed state.

Both ends of the functional layer 601 and the outer edge of the leakage-proof layer 602 are provided with marks 605, and the marks 605 are not penetrated under the irradiation of X-rays and are used for displaying the positions of the functional layer 601 and the leakage-proof layer 602 in the blood vessel under perspective. Similarly, both ends of the main aortic stent 101 are provided with the radiopaque aortic stent markers 104, both ends of the branch catheters 102 are provided with the radiopaque branch catheter markers 105, that is, the end of the catheter body 1021 is provided with the branch catheter markers 105, as shown in fig. 2. Both ends of the main collateral branch stent 201 are provided with X-ray opaque collateral branch stent markers 203, as shown in FIG. 3. The aortic stent markers 104, branch catheter markers 105, and collateral stent markers 203 function as markers 605.

In addition, the main aortic stent 101, the main collateral stent 102, and the functional layer 601 in the embodiment of the present application are each composed of a metal stent and a coating film coated on the metal stent. Wherein the metal stent is used for supporting the covering membrane. After the aortic fixation band 103, collateral fixation band 202, and chimney fixation band 604 are released, the metal stent is in an expanded state, while also providing stent anchoring. In the embodiment of the present application, the performance of the selected metal stent is different according to the adaptive positions and the bending performance of the main aortic stent 101, the side branch main stent 102 and the functional layer 601. The covering film is used for isolating the focus and forming a new blood flow channel. The film can not only reduce the blood pressure and speed of the focus, but also promote the blood thrombosis of the isolated part and prevent the rupture of the blood vessel of the lesion part.

The support of the anti-leakage layer 602 in the embodiment of the present application is a metal support with dense wave of filament. The thin-wire dense-wave metal support has weak radial supporting force, good deformability and good self-expansion performance, so that when the chimney support 6 is parallel to the aortic support 1, the leakage-proof layer 602 is easily collapsed under the extrusion of the aortic support 1, and a gap suitable for the chimney support 6 and the aortic support 1 is formed. Meanwhile, when the leakage-proof layer 602 is not pressed by an external force, the leakage-proof layer 602 will expand itself as much as possible, forming an expansion structure protruding from the functional layer 601.

Specifically, when the aortic stent 1 and the chimney stent 6 are parallel in the blood vessel, the functional layer 601 is pressed against the blood vessel wall and the aortic stent 1, and meanwhile, the leakage-proof layer 602 is also pressed against the blood vessel wall and the aortic stent 1, as shown in fig. 6. Because the cross sections of the blood vessel, the chimney stent 6 and the aorta stent 1 are both circular structures, when the chimney stent 6 and the aorta stent 1 are parallel in the blood vessel, gaps exist among the blood vessel, the chimney stent 6 and the aorta stent 1. Because the leakage-proof layer 602 has weak radial supporting force, good deformable performance and good self-expansion performance, when the leakage-proof layer 602 is extruded with the blood vessel wall, the contact positions among the functional layer 601, the leakage-proof layer 602 and the blood vessel wall are mutually attached, and meanwhile, the contact positions among the functional layer 601, the leakage-proof layer 602 and the aortic stent 1 are also mutually attached. The squeezed leak-proof layer 602 is squeezed to the gap formed by the blood vessel, the chimney support 6 and the aortic support 1 by its own deformability and self-expansion property, thereby filling the gap. When viewed from the cross section direction of the blood vessel, two pocket-shaped structures are formed between the functional layer 601 and the leakage-proof layer 602 at this time, and the pocket-shaped structures can pocket blood leaked from the gap to prevent internal leakage.

In addition, since the leakage-proof layer 602 has weak radial supporting force, good deformability, and good self-expansion performance, the leakage-proof layer 602 does not affect the molding of the chimney support 6 and the aortic support 1 in the blood vessel, and thus does not affect the flow of blood in the reconstructed blood vessel. Because both ends of the leakage-proof layer 602 are fixed to the outside of the functional layer 601, the chimney holder 6 can be effectively prevented from being turned over during the assembling and releasing processes. After blood is solidified between the functional layer 601 and the leakage-proof layer 602, the thrombus can be effectively prevented from falling off to enter the aorta in the pulsation process, and the chimney stent 6 can be conveniently adjusted in position after the adjustable valve sheath is withdrawn from the blood vessel.

The delivery subsystem 02 in the present embodiment of the application includes a dispenser 3, an adjustable valve sheath 4 and a transporter 5. Wherein, the releaser 3 is used for delivering and releasing the aortic stent 1; the conveyor 5 is used for conveying and releasing the lateral branch support 2 or the chimney support 6; the adjustable valve sheath 4 is used for providing a passage for the delivery of the dispenser 3 and the conveyor 5.

Referring to fig. 7, fig. 7 is a schematic view showing a structure of a dispenser. As shown in fig. 7, the dispenser 3 provided in the embodiment of the present application includes a delivery support tube 301 and a delivery handle 302 connected to each other. The delivery support tube 301 is used to provide a threading channel for components such as the main guide wire lumen 303. The delivery handle 302 is used to provide a grip for the dispenser 3, and also to provide different access to the main guidewire lumen 303, the delivery release 305, and the like. The inside of the delivery support tube 301 and the delivery handle 302 is provided with a main guide wire cavity 303, an auxiliary guide wire cavity 304 and a delivery release device 305 in a penetrating way, wherein the main guide wire cavity 303, the auxiliary guide wire cavity 304 and the delivery release device 305 are arranged in parallel.

Specifically, a main guide wire is placed inside the main guide wire cavity 303, and the main guide wire cavity 303 is used for pushing the aortic stent 1 to the target blood vessel. The front end of the main guide wire cavity 303 is provided with a delivery cone 306, and the delivery cone 306 is a flexible X-ray-tight cone. The placement of the delivery cone 306 can facilitate the display of the position of the aortic stent 1 in the blood vessel, and can also display the position of the front end of the delivery device 3 in the blood vessel. A guide wire is placed inside the guide wire lumen 304, and the guide wire lumen 304 is used to deliver the sidebranch stent 2 or the chimney stent 6 into the branch vessel. The leading end of the guidewire lumen 304 is provided with a guidewire marker 308, the guidewire marker 308 being capable of guiding the position of the guidewire lumen 304 within the blood vessel. The tail ends of the main guide wire cavity 303 and the auxiliary guide wire cavity 304 are provided with tail end connectors 309, namely tail end connectors 309 are arranged at the end parts close to the releasing handle 302, and the tail end connectors 309 are used for flushing the main guide wire cavity 303 and the auxiliary guide wire cavity 304 respectively.

The deployment release device 305 is a component that releases the aortic securing band 103. The payout release mechanism 305 in the embodiment of the present application includes a payout release core wire 3051, a pull wire ring 3052, a release key 3053, and a payout pull wire cavity 3054. The releasing and pulling wire cavity 3054 is positioned inside the releasing and pulling support pipe 301 and the releasing and pulling handle 302, and the releasing and releasing core wire 3051 is placed inside the releasing and pulling wire cavity 3054. The stay wire ring 3052 and the release key 3053 are located outside the releasing handle 302, and the releasing stay wire cavity 3054, the stay wire ring 3052 and the release key 3053 are connected in series one by one through the releasing release core wires 3051. The delivery taper head 306 is provided with a delivery and storage hole 307, and the other end of the delivery and release core wire 3051 is inserted into the delivery and storage hole 307 to store the delivery and release core wire 3051 through the delivery and storage hole 307.

When the releasing core wire 3051 is serially connected with the releasing wire pulling cavity 3054, the wire pulling ring 3052 and the releasing key 3053, the releasing core wire 3051 penetrates through the releasing wire pulling cavity 3054 after being connected with the wire pulling ring 3052 and the releasing key 3053. When the stent passes through the releasing wire cavity 3054 at the releasing support tube 301, the releasing wire cavity 3054 is tied at two sides of the aorta fixing belt 103. At this time, the aortic fixing band 103 puts the aortic stent 1 in a compressed state. The payout release core wire 3051 is further advanced, and the payout release core wire 3051 is inserted into the payout receiving hole 307, whereby the aortic stent 1 is fastened to the payout 3.

When the aortic stent 1 and the delivery device 3 in the embodiment of the present application are assembled, the delivery tapered head 306 at the front end of the main guidewire lumen 303 is inserted into the aortic body stent 101 from the distal end of the aortic stent 1, and at the same time, the auxiliary guidewire lumen 304 is inserted into the branch catheter 102 through the inside of the aortic body stent 101. At this point, the leading end of the guidewire lumen 304 is substantially flush with or behind the outlet end of the branch conduit 102. The aortic fixing band 103 of the aortic stent 1 is tied to the delivery device 3 by delivering the release core 3051 to form the combined aortic stent 1 and delivery device 3. After the combined aortic stent 1 and the delivery device 3 are delivered into the blood vessel, the guide wire in the auxiliary guide wire cavity 304 is pushed towards the branch catheter 102 before the aortic stent 1 is deployed until the front end of the guide wire in the auxiliary guide wire cavity 304 is positioned outside the branch catheter 102. Therefore, before the aortic stent 1 is released, the guide wires can be released into the corresponding branch vessels, the blocking time of the branch vessels is effectively shortened, meanwhile, whether the direction of the branch catheter 102 in the releasing process is consistent with the direction needing to be placed or not can be effectively judged, and the releasing accuracy is improved.

The dispenser 3 provided in the embodiment of the present application further includes a loader 310, as shown in fig. 8. A loader 310 is provided at the front end of the deployment cone 306, the loader 310 being used for flushing the aortic stent 1 and also for guiding the aortic stent 1 into the adjustable valve sheath 2. After the stent aorta 1 is fastened on the releaser 3 by the releasing core wire 3051, the loader 310 is sleeved on the releasing conical head 306, and the stent aorta 1 is positioned outside the loader 310. The loader 310 in the embodiment of the present application may be an existing loader as long as it is capable of guiding the aortic stent 1 into the adjustable valve sheath 2.

The adjustable valve sheath 4 is used for establishing a blood vessel channel of the putting device 3 and the conveyor 5, reducing repeated penetration of the putting device 3 and the conveyor 5 to a punctured part and effectively reducing complications of the approach. Referring to fig. 9-11, fig. 9 is a schematic view showing the overall structure of the adjustable valve sheath, fig. 10 is a schematic view showing the structure of the dilator of the adjustable valve sheath, and fig. 11 is a schematic view showing the structure of the outer tube of the adjustable valve sheath. As can be seen from fig. 9 to 11, the adjustable valve sheath 4 provided in the embodiment of the present application includes a dilator 401 and an outer tube 402, and the dilator 401 and the outer tube 402 are detachable. Such as when the adjustable valve sheath 4 is not in use, the dilator 401 is inserted inside the outer tube 402 for ease of placement and portability.

Specifically, the dilator 401 is used for pre-dilation of the access vessel, and is matched with the outer tube 402 of the adjustable valve sheath 4 to form a smooth insertion position into the access vessel. The outer tube 402 includes a tube 4021, a hemostatic valve seat 4022 disposed at a distal end of the tube 4021, and a side tube 4023 disposed on the hemostatic valve seat 4022, and a hemostatic valve 4024 is disposed inside the hemostatic valve seat 4022. The tube 4021 is a passage for a transporter 5, a guide wire, and the like. The hemostatic valve seat 4022 is used to secure and adjust the hemostatic valve 4024. A valve is provided in side tube 4023 and side tube 4023 is used to flush outer tube 402. The front end of the tube body 4021 is provided with an adjustable valve sheath marker 4025 which is opaque to X-rays, and the adjustable valve sheath marker 4025 is used for marking the position of the front end of the adjustable valve sheath 4 in the blood vessel.

The aperture on the hemostasis valve 4024 in the embodiments of the present application may be adjustable. By adjusting the aperture on the hemostatic valve 4024, the delivery device 5 with a larger volume can pass through the hemostatic valve 4024, and the guide wire with a smaller diameter can also pass through the hemostatic valve 4024, thereby achieving the compatibility of passing through different sized instruments. In addition, after the delivery device 5 withdraws from the hemostatic valve 4024, the aperture of the hemostatic valve 4024 is rapidly adjusted, so that blood can be prevented from leaking through the adjustable valve sheath 4, and the blood loss in the surgical process is reduced.

The conveyor 5 provided by the embodiment of the application is used for conveying and releasing the collateral branch stent 2 and can be fed from the adjustable valve sheath 4. Referring to fig. 12, fig. 12 is a schematic structural diagram of a conveyor provided in an embodiment of the present application. As can be seen in FIG. 12, the transporter 5 provided by the embodiment of the present application includes an outer transporter tube 501 and an operating handle 502 connected thereto. The outer layer of the outer conveyor pipe 501 is provided with a hydrophilic coating, which can effectively reduce the difficulty of the conveyor 5 in withdrawing a tortuous blood vessel. The front end of the outer conveyor tube 501 is provided with an X-ray opaque conveyor marker 503, and the conveyor marker 503 is used to mark the position of the front end of the conveyor 5 in the blood vessel. The end of the outer transporter tube 501 is provided with a transporter hemostasis valve seat 504, i.e. the transporter hemostasis valve seat 504 is arranged at the joint of the outer transporter tube 501 and the operating handle 502. The delivery device hemostasis valve seat 504 is internally provided with a hemostasis valve, and the delivery device side tube 505 is arranged outside the delivery device hemostasis valve seat. Wherein the transporter-side tube 505 is used to flush the lumen of the transporter 5 as well as to flush the sidebranch stent 2. Further, a transporter safety lock 506 is provided at the junction of the transporter hemostasis valve seat 504 and the operating handle 502, the transporter safety lock 506 being used to lock the hemostasis valve inside the transporter hemostasis valve seat 504.

The guide wire cavity 507 and the delivery release device 508 are arranged inside the outer conveyor tube 501, and the guide wire cavity 507 and the delivery release device 508 penetrate through the outer conveyor tube 501 and the operating handle 502. The front end of the guide wire cavity 507 is provided with a fusiform head 509 which is not transparent to X-ray, and a guide wire is arranged inside the guide wire cavity 507. The shuttle 509 has good flexibility and bending resistance, and can follow the guide wire in the guide wire lumen 507 to carry the sidebranch stent 2 into the branch catheter 102 and the branch vessel, or make a sharp turn from the branch vessel into the aorta. Further, the distal end of the shuttle 509 is tapered gently to ensure that the shuttle 509 does not catch the sidebranch frames 2 when the conveyor 5 is withdrawn, while also preventing the conveyor 5 from displacing the sidebranch frames 2 during withdrawal. At the rear end of the guidewire lumen 507, i.e., the end near the operating handle 502, there is provided a tip connector 510, the tip connector 510 being used to flush the guidewire lumen 507.

Delivery release device 508 is a component that releases collateral fixation band 202. The delivery release 508 in the present embodiment includes a delivery release core 5081, a release handle 5082, a release guard lock 5083, and a delivery pull wire lumen 5084. A delivery pull-wire lumen 5084 is located inside the outer transporter tube 501 and operating handle 502, and a delivery release core 5081 is disposed within the delivery pull-wire lumen 5084. The release handle 5082 and release guard lock 5083 are located on the exterior of the operating handle 502, and the delivery pull wire lumen 5084, release handle 5082 and release guard lock 5083 are serially connected one by a delivery release core 5081. The shuttle 509 is provided with a delivery receiving hole 511, and the delivery receiving hole 511 is used for receiving a delivery release core 5081 to prevent the delivery release core 5081 from damaging the blood vessel. The carrying release cord 5081, which is connected in series to the carrying cord chamber 5084, is inserted into the carrying storage hole 511 after passing through the carrying cord chamber 5084, so that the carrying storage hole 511 stores the carrying release cord 5081.

The delivery release core 5081 is threaded through the delivery pull wire lumen 5084 after the delivery release core 5081 is attached to the release handle 5082 and the release guard 5083 while the delivery pull wire lumen 5084, the release handle 5082 and the release guard 5083 are in tandem. While passing out of the delivery wire lumen 5084, the delivery release core wire 5081 is tied to both sides of the sidebranch fixing band 202 of the sidebranch stent 2. At this time, the collateral fixing band 202 puts the collateral stent 2 in a compressed state. The advancement of the delivery release core wire 5081 is continued and the delivery release core wire 5081 is caused to be inserted into the delivery accommodating hole 511, whereby the tethering of the sidebranch stent 2 to the transporter 5 is effected. In the present embodiment, the delivery release core 5081 is point-contacted with the sidebranch fastening tape 202, and the sidebranch stent 2 is in a compressed state. The contact mode and the design mode of the lateral branch support 2 can obviously reduce the friction force when the conveyor 5 withdraws, so that the lateral branch support 2 is accurately and reliably released.

In the present embodiment, the outer diameter of the delivery device 5 is significantly smaller than the outer diameter of the delivery device 3, whereby the delivery device 5 can pass in parallel with a plurality of guide wires inside the adjustable valve sheath 4.

In the stent graft system provided by the embodiment of the application, the aortic stent 1, the collateral branch stent 2 and the chimney stent 6 in the stent subsystem 01 can be flexibly combined, so that the combined stent subsystem 01 covers a plurality of important branch vessels on the basis of the matching of the delivery subsystem 02. For example, when it is desired to cover the entire aortic arch, the stent subsystem 01 takes the form of a combination of one aortic stent 1, one collateral stent 2 and two chimney stents 6; when only the back two branch vessels on the artery arch need to be covered, the bracket subsystem 01 adopts a combined form of an aorta bracket 1, a side branch bracket 2 and a chimney bracket 6; when only the left subclavian artery needs to be covered, the stent subsystem 01 takes the form of a combination of an aortic stent 1 and a collateral stent 1-2.

Referring to fig. 13-16, the detailed procedure of the stent graft system will be described below as applied to the entire aortic arch, in which the stent subsystem 01 is a combination of an aortic stent 1, a collateral stent 2 and two chimney stents 6. In the case of covering the posterior two branches of the aortic arch, and the left subclavian artery, the released stent subsystem 01 is shown in fig. 17 and 18 and will not be described in detail herein.

Step S01: the diameter and morphology of each segment of the arterial arch are preliminarily determined by a CTA (CT angiography) measurement technique. The diameter and the shape comprise the diameter and the shape of the tail end of the ascending aorta, the front end of the descending aorta and the anchoring parts of the front part and the rear part of the aorta, and the aortic arch angulation; the diameter, morphology of the innominate artery, the left common carotid artery, and the left subclavian artery, and the spacing and angulation between adjacent branches. And making a preoperative tectorial membrane stent implantation plan according to the diameter of each branch, the diameter of the aorta at the position of each branch, the distance between adjacent branches and angulation. The intra-cavity isolation needs to select the specifications of an aorta stent 1 with proper length and taper, a side branch stent 2 and a chimney stent 6. Selecting an aorta stent 1 with the diameter of the near-far end of the aorta stent 1 being more than or equal to 5-30% of the diameter of the blood vessel of the corresponding aorta anchoring area, and selecting a collateral stent 2 and a chimney stent 6 with the diameter of the far-end of the collateral stent 2 and the chimney stent 6 being 5-30% of the diameter of the branch artery where the diameters of the far-end of the collateral stent 2 and the chimney stent 6 are corresponding. The proper length specification is selected for each stent.

Step S02: after selecting the aortic stent 1 and the like, the patient is anesthetized and in the supine position. An adjustable valve sheath 4 is selected to mate with the dispenser 3. After the preparation is completed, a chimney support 6 access channel is established under the left carotid artery and the left clavicle, and an aorta support 1 access channel is established at the femoral artery. After the instruments are washed, the femoral artery approach blood vessel is pre-dilated through the dilator 401 of the adjustable valve sheath 4, and after the dilation is finished, the adjustable valve sheath 4 is inserted into the femoral artery. The aortic stent 1, the main guide wire lumen 303, the auxiliary guide wire lumen 304 and other lumens are flushed by the loader 310 of the delivery device 3. After irrigation is complete, the dilator 401 is withdrawn and the hemostatic valve 4024 is tightened. The guide wire in the main guide wire cavity 303 is pushed to the hemostatic valve 4024 of the adjustable valve sheath 4, and the hemostatic valve 4024 is adjusted to be loose. The delivery cone 306 then pushes the shuttle 310 along the guidewire within the main guidewire lumen 303 inside the hemostasis valve 4024. The pusher 3 is further pushed so that the aortic stent 1 on the pusher 3 bound by the release core 3051 and the aortic fixing band 103 is delivered to the aortic arch, as shown in fig. 13.

Step S03: whether the outlet end of the branch catheter 102 is in the major curve of the blood vessel is determined based on the branch catheter marker 105 on the branch catheter 102. If the outlet end of the branch conduit 102 is not located at the major curve of the blood vessel, the outlet end of the branch conduit 102 is adjusted to the major curve of the blood vessel. When the outlet end of the branch catheter 102 is at the side of the great curve of the blood vessel, the position of the adjusted aortic stent 1 is adjusted to the state that the outlet end of the branch catheter 102 is substantially flush with the open end of the brachiocephalic trunk. If the position of the aortic stent 1 cannot be adjusted clearly, the judgment can be assisted by injecting contrast agent through the guidewire lumen 304. The guide wire in the auxiliary guide wire cavity 304 is pushed through the tail end connector 309 at the tail end of the auxiliary guide wire cavity 304 until the front end of the guide wire enters the brachiocephalic artery for a certain distance so as to avoid the guide wire which enters the branch blood vessel being taken out by the delivery device 3 when the blood vessel is withdrawn.

Step S04: the hard guide wire is delivered by establishing a chimney support 6 access channel under the left carotid artery and the left clavicle. Preferably, two hard guide wires are distributed on two sides of the aortic stent 1 and the conveyor 5, so that the aortic stent 1 and the chimney stent 6 have better matching effect. The chimney stent 6 is fed over the hard guidewire so that the aortic stent markers 104 at the proximal end of the aortic stent 1 are located between the markers 605 at the proximal end of the functional layer 601 and the markers 605 at the proximal end of the leak-proof layer 602, e.g., the markers 605 at the proximal end of the chimney stent 6 are about 10mm beyond the proximal tectorial edge of the aortic stent 1. At the same time, it is also necessary to keep the anti-leakage layer 602 substantially parallel to the adjacent aortic wall so that the anti-leakage layer 602 can sufficiently fill the gap between the vessel wall and the aortic stent 1 in the later stage, as shown in fig. 14.

Step S05: the adjustable valve sheath 4 and the delivery apparatus 5 are withdrawn rearwardly until the shaft 4021 of the outer tube 402 of the adjustable valve sheath 4 is at the branch vessel. At this time, the leakage-proof layer 602 is in the expanded state, and the chimney stent 6 does not affect the adhesion of the aortic stent 1 to the aortic vessel wall. During the backward withdrawal of the adjustable valve sheath 4 and the delivery device 5, it is again determined that the leak-proof layer 602 is substantially parallel to the adjacent aortic wall. If the anti-leak layer 602 is not parallel to the adjacent aortic wall, the relationship between the anti-leak layer 602 and the adjacent aortic wall is adjusted by slowly rotating the adjustable valve sheath 4 and the transporter 5.

Step S06: the release key 3053 of the delivery release device 305 of the delivery device 3 is pressed and the pull-wire ring 3052 is slowly pulled backward to expand the front end of the aortic stent 1 by a small amount. At this time, it is confirmed again whether the open end of the branch duct 102 is on the large curve side, and at the same time, whether the positioning thereof is accurate. If the open end of branch conduit 102 is not in a tight bend or is not precisely positioned, a corresponding adjustment is made. After the open end of the branch catheter 102 is at the side of the major bend and is positioned accurately, the release core 3051 is pulled back quickly to allow the aortic stent 1 to be deployed quickly. The conveyor 5 is then quickly retracted to the end of the chimney tray 6 and the conveyor release device 508 is activated to deploy the chimney tray 6, as shown in figure 15. At this point, the transporter 5 needs to be withdrawn further to ensure the branch blood flow supply. After securing the guidewire in the main guidewire lumen 303 and the auxiliary guidewire lumen 304, the dispenser 3 is carefully withdrawn while the hemostatic valve 4024 of the adjustable valve sheath 4 is adjusted.

Step S07: the sidebranch stent 2 and the transporter 5, which are bundled together by the sidebranch securing band 202 and the delivery release core 5081, are fed into the inside of the aortic stent 1 along the guide wire in the guidewire lumen 304 until the sidebranch stent marker 203 at the distal end of the sidebranch stent 2 is close to the entrance of the branch catheter 102. The outer tube 501 of the delivery device is retracted to the back of the sidebranch stent 2 by operating the handle 502, the release protection lock 5083 in the delivery release device 508 is pressed, and the delivery release core 5081 is pulled back, so as to release the sidebranch stent 2, as shown in fig. 16. The guide wire in the guide wire lumen 304 is secured and the transporter 5 is withdrawn.

And for the condition that the aneurysm and the like need to expand the near end and the far end of the stent by the balloon, the balloon is sent along the corresponding guide wire to be correspondingly expanded. Then, a contrast catheter is sent to the ascending aorta along the guide wire remained in the aorta for contrast, and the isolation effect of the main body and the branch is confirmed. If further processing is needed, the corresponding instrument is sent along the corresponding guide wire for processing. If the effect is good or after the treatment is completed. The contrast catheter, the guide wire and the adjustable valve sheath 4 are withdrawn, and the puncture site is closed.

In the stent graft system provided by the embodiment of the application, the aorta stent 1, the collateral branch stent 2 and the chimney stent 6 can be flexibly combined according to an affected part, so that the reconstruction of a multi-branch blood vessel is realized. The application utilizes the characteristic of high arterial blood pressure, and the arrangement of the branch catheter 102 on the aortic stent 1 can establish reverse blood flow on the side branch stent 2 leading to the branch vessel to ensure that the branch vessel needing to be covered adopts reverse perfusion blood supply, thereby ensuring that the chimney stent 6 and the aortic stent 1 in the subsequent branches have enough anchoring length, realizing the quantity of reconstruction of the branch vessel determined according to the requirement and avoiding unnecessary branch coverage. Through the combination of the branch catheter 102 in the aortic stent 1 and the auxiliary guide wire cavity 304 in the delivery device 3, the guide wire in the auxiliary guide wire cavity 304 is embedded in the branch catheter 102, so that the guide wire can smoothly enter a branch blood vessel from the aortic stent 1, the collateral stent 2 can conveniently enter the branch blood vessel along the guide wire, and the stent is released to realize accurate positioning. The chimney support 6 in the embodiment of the application has a structure with two layers, namely a functional layer 601 and a leakage-proof layer 602, and can effectively reduce the risk of internal leakage at the joint of the aorta support 1 and the chimney support 6.

The covered stent system in the embodiment of the application has the advantages of simple structure, clear principle, flexible and various combination and less specification of the required stent, and the limited specification of the stent meets the requirements of different blood vessel anatomical structures. The release of each stent in the stent subsystem 01 is rapid, blood flow, deep low temperature circulation and extracorporeal circulation do not need to be blocked, the operation difficulty is greatly reduced, the operation time is shortened, and the perioperative mortality and complications can be greatly reduced. In addition, due to the reduction of the operation time and the difficulty, the dosage of the contrast agent can be reduced, and meanwhile, the irradiation time of the radioactive rays received by doctors and patients is obviously reduced. The stent graft system provided by the embodiment of the application can realize the intra-cavity isolation treatment from a single branch blood vessel to a multi-branch blood vessel, such as the intra-cavity isolation treatment from an aortic arch, an abdominal trunk to a renal artery.

Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure herein. This application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

It is to be understood that relational terms such as "first" and "second," and the like, may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The invention is not limited to the precise arrangements described above and shown in the drawings, and various modifications and changes may be made without departing from the scope thereof. The scope of the invention is limited only by the appended claims.

Claims

1. A stent-graft system, comprising a stent subsystem (01) and a delivery subsystem (02) in combination;

the stent subsystem (01) comprises an aorta stent (1) and a side branch stent (2), wherein the aorta stent (1) comprises an aorta main body stent (101) and a branch conduit (102) arranged on the side wall of the aorta main body stent (101), and the branch conduit (102) is communicated with the inside of the aorta main body stent (101); the side branch bracket (2) is movably inserted into the branch conduit (102);

the support subsystem (01) further comprises a chimney support (6), and the chimney support (6) is combined with the main artery support (1), the side branch support (2) and the conveyor (5) for use;

the chimney support (6) comprises a functional layer (601) and an anti-leakage layer (602), wherein the anti-leakage layer (602) is positioned on the outer side of the functional layer (601), and the anti-leakage layer (602) is close to the blood flow inlet end of the chimney support (6); the end surface of the leakage-proof layer (602) close to the blood flow inlet end of the chimney support (6) is provided with a through hole (603); along the length direction of the chimney support (6), a chimney fixing belt (604) is arranged outside the functional layer (601);

the conveying subsystem (02) comprises a delivery device (3), an adjustable valve sheath (4) and a conveyor (5), wherein the delivery device (3) and the conveyor (5) respectively convey the aortic stent (1) and the collateral branch stent (2) through the adjustable valve sheath (4).

2. The stent graft system of claim 1, wherein the branch catheter (102) comprises a catheter body (1021) and a metal stent (1022) disposed on the catheter body (1021); the end of the catheter body (1021) is provided with a branch catheter mark (105).

3. The stent graft system according to claim 1, wherein the delivery device (3) comprises a delivery support tube (301) and a delivery handle (302) which are connected, and a main guide wire cavity (303), an auxiliary guide wire cavity (304) and a delivery release device (305) which are arranged in parallel are arranged in the delivery support tube (301) and the delivery handle (302) in a penetrating way; the front end of the main guide wire cavity (303) is provided with a releasing conical head (306), and a releasing core wire (3051) in the releasing device (305) is inserted into a releasing and receiving hole (307) in the releasing conical head (306).

4. The stent-graft system according to claim 1, wherein the number of stent peaks at the inflow end of the aortic stent (1) is higher than the number of stent peaks in the middle of the aortic stent (1).

5. The stent graft system according to claim 1, wherein the radial supporting force of the blood flow inlet end of the lateral branch stent (2) is larger than that of the blood flow outlet end of the lateral branch stent (2) along the blood flow direction.

6. The stent graft system according to claim 1, wherein the blood flow inlet end of the side branch stent (2) has a diameter of 105-130% of the diameter of the branch catheter (102).

7. The membrane bracket system according to claim 1, wherein the leakage-proof layer (602) is an annular leakage-proof layer, and the chimney fixing bands (604) are located on both sides of the annular leakage-proof layer along the axial direction of the chimney bracket (6);

the annular leakage-proof layer comprises an annular support (6021) and an annular coating film (6022), wherein the annular support (6021) is arranged between the functional layer (601) and the annular coating film (6022), and the annular support (6021) protrudes out of the functional layer (601); the annular support (6021) is positioned at the middle parallel section of the annular coating film (6022), and the diameter of the end part of the annular coating film (6022) is the same as that of the functional layer (601).

8. The membrane-covered support system according to claim 1, wherein the leakage-proof layer (602) is a pocket-shaped leakage-proof layer, and the end surfaces of the pocket-shaped leakage-proof layer are positioned at two sides of the chimney fixing band (604) along the radial direction of the chimney support (6);

the pocket-shaped leakage-proof layer comprises a pocket-shaped support (6023) and a pocket-shaped coating (6024), the pocket-shaped support (6023) is arranged between the functional layer (601) and the pocket-shaped coating (6024), and the pocket-shaped support (6023) protrudes out of the functional layer (601); the pocket-shaped support (6023) is fixed on the boss section of the pocket-shaped coating film (6024), and the pocket-shaped coating film (6024) is fixed on the functional layer (601).

9. The stent graft system of claim 1, wherein both ends of the functional layer (601) and the outer edges of the leak-proof layer (602) are provided with markings (605).