CN117598835A

CN117598835A - Cross-arch thoracic aortic tectorial stent and system with same

Info

Publication number: CN117598835A
Application number: CN202311639532.5A
Authority: CN
Inventors: 傅泽粮
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2023-12-01
Filing date: 2023-12-01
Publication date: 2024-02-27

Abstract

The application provides a cross arch chest aorta tectorial membrane support, includes: a main body holder having a recess in a radial direction; the embedded bracket is provided with a co-drying outlet at the front end of the concave part; the embedded bracket comprises three embedded brackets and a co-drying main body; the embedded stent is used for communicating with the branch stent in the corresponding branch artery. The embodiment of the application also provides a trans-arch thoracic aortic stent-graft system, which comprises a trans-arch thoracic aortic stent-graft and a conveying system; the main body bracket is provided with a first binding piece and a second binding piece; the conveying system comprises a first core wire, a second core wire, a first wire pulling handle and a second wire pulling handle; the first core wire is used for pre-tightening/releasing the first binding piece; the second core wire is used for pre-tightening/releasing the second binding piece; the first stay wire handle is connected with the first core wire; the second wire pulling handle and the second core wire; the second stay wire handle has a special-shaped structure.

Description

Cross-arch thoracic aortic tectorial stent and system with same

Technical Field

The application relates to the technical field of medical equipment, in particular to a trans-arch thoracic aortic tectorial membrane stent and a system with the same.

Background

With aging population and increasing hypertension and arteriosclerosis, the number of patients suffering from aortic diseases increases year by year. The arcus lesions account for one third of the aortic diseases, and this part of patients still predominate in open surgery. However, the open operation is big in wound, needs extracorporeal circulation and even deep low-temperature stop circulation, and has long operation time. The longer the surgery time, the higher the complications and mortality rate after surgery. Minimally invasive treatment involving aortic arch diseases is that simple lesions achieve the pursuit goal of treatment of aortic diseases after minimally invasive treatment.

Current endoluminal isolation techniques are mainly used for treatment of non-major branch vessel segments such as the descending aorta and branch vessels such as the abdominal main-iliac arteries where critical requirements for surgical time and blood flow blockage are met. Three important branch vessels on the thoracic aortic arch are responsible for supplying blood to the brain and upper extremities. Ischemia exceeding ten minutes can lead to serious irreversible damage of the brain due to hypoxia, and the blood supply blocking time of the brain cannot be too long. The diameters, the intervals, the positions and the trend of the three branch blood vessels are different from person to person.

These factors determine that the adoption of a multi-branch design is difficult to meet most clinical requirements, and is difficult to operate and has high surgical complications.

Disclosure of Invention

In view of this, the present application aims to provide a trans-arch thoracic aortic stent graft and a system with the same.

Based on the above object, the present application provides a trans-arch thoracic aortic stent graft comprising:

the device comprises a main body bracket and an embedded bracket, wherein the main body bracket is a covered bracket and is provided with a concave part; the concave part is concave from the outer wall of the main body bracket to the center of the main body bracket; the embedded bracket is arranged in the main body bracket;

the binding piece is arranged on the main body support, one end of the binding piece is fixed on the main body support, and the other end of the binding piece is a free end; the tie down is used for tying down the main body support to a contracted state or releasing the main body support to an expanded state.

The embodiment of the application also provides a trans-arch thoracic aortic stent graft system, which comprises the trans-arch thoracic aortic stent graft and a conveying system; the arch-crossing thoracic aortic stent graft is preloaded on the conveying system, and the conveying system is provided with a handle with a cavity; the conveying system further comprises a stay wire handle which is arranged on the handle shell in a penetrating way; the stay wire handle is provided with a core wire which can pass through the restraint so as to restrain the main body bracket to a fully or partially contracted state through the restraint.

The binding member comprises a first binding member, one end of the first binding member is fixed on the main body support, and the other end of the first binding member is a free end; the first tie down is used for tying the main body support to a fully contracted state or releasing to an unbuckled state.

The binding member further comprises a second binding member, one end of the second binding member is fixed on the main body support, and the other end of the second binding member is a free end and is used for binding the main body support to be in a partially contracted state or completely released to be in an expanded state.

From the above, it can be seen that the trans-arch thoracic aortic stent graft and the system with the same provided by the present application, through the main body stent, the main body stent is a stent graft and has a concave portion; the concave part is concave from the outer wall of the main body bracket to the center of the main body bracket; the binding piece is arranged on the main body support, one end of the binding piece is fixed on the main body support, and the other end of the binding piece is a free end; the binding member is used for binding the main body support to a contracted state or releasing the main body support to an expanded state, after the main body support is released at the aortic arch through the binding member, the large bending side (namely the concave position of the main body support) of the main body support cannot be attached to the wall of the aortic arch, so that a space is reserved between the main body support and the vessel wall of the aortic arch, and therefore a small support in a guide wire and an on-arch branch artery can enter the corresponding branch support more easily, the operation time is shortened, and the operation complications are reduced. So that the blood flowing out of the main body stent can continuously perfuse the branch vessels on the arch of the aortic arch. Bridging of the branched blood vessel can be carried out easily without low-temperature circulation or extracorporeal circulation.

Drawings

In order to more clearly illustrate the technical solutions of the present application or related art, the drawings that are required to be used in the description of the embodiments or related art will be briefly described below, and it is apparent that the drawings in the following description are only embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort to those of ordinary skill in the art.

FIG. 1 is a schematic view of a first angle of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 2 is a schematic illustration of a second angle of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 3 is a schematic structural view of an embedded bracket according to an embodiment of the present application;

FIG. 4 is a schematic illustration of a third angle of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 5 is a schematic view of a fourth angle of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 6 is a schematic illustration of a fifth angle of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 7a is a schematic structural view of a constrained trans-arch thoracic aortic stent graft secured with a first core wire and a first tie down or a second core wire and a second tie down according to an embodiment of the present application;

FIG. 7b is a schematic view of the tie down in FIG. 7 a;

FIG. 8a is a schematic illustration of another configuration of a constrained trans-arch thoracic aortic stent graft secured with a first core wire and a first tie down or a second core wire and a second tie down in accordance with an embodiment of the present application;

FIG. 8b is a schematic view of the tie down in FIG. 8 a;

FIG. 9a is a schematic view of an angle of a conveyor system according to an embodiment of the present application;

FIG. 9b is a schematic view of another angle of the delivery system of an embodiment of the present application;

FIG. 10 is a schematic view of a cone head according to an embodiment of the present application;

FIG. 11 is a schematic view of an image state of a mark of a cone head according to an embodiment of the present application;

FIG. 12 is a schematic view of another image state of the mark of the cone head according to the embodiment of the present application;

FIG. 13 is a schematic view of still another image of the mark of the cone head according to the embodiment of the present application;

FIG. 14 is a schematic view of still another image of the mark of the cone head according to the embodiment of the present application;

FIG. 15 is a schematic view of a relationship between a core wire and support tube and mandrel tube in a stent loading zone according to an embodiment of the present application;

FIG. 16 is a schematic view of a holder according to an embodiment of the present application;

FIG. 17 is a schematic cross-sectional view of a support tube according to an embodiment of the present application;

FIG. 18 is a schematic cross-sectional view of a triple lumen tube according to an embodiment of the present application;

FIG. 19 is a combined schematic view of a first and second cord handles according to an embodiment of the present application;

FIG. 20 is a schematic illustration of a release process of a first and second wire handles according to an embodiment of the present application;

FIG. 21 is a schematic view of a first and second cord handles according to an embodiment of the present application;

FIG. 22a is another combined schematic view of a first and second wire handles according to an embodiment of the present application;

FIG. 22b is a cross-sectional view taken along the direction D-D in FIG. 22 a;

FIG. 23 is another structural schematic view of a first and second wire handles according to an embodiment of the present application;

FIG. 24 is a schematic illustration of a trans-aortic arch stent graft of an embodiment of the present application delivered to a target site;

FIG. 25 is a schematic view of a semi-expanded state of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 26 is a schematic blood flow diagram of a semi-deployed state of a trans-aortic arch stent graft in accordance with an embodiment of the present application;

FIG. 27 is a schematic illustration of a trans-arch thoracic aortic stent graft after release in accordance with an embodiment of the present application;

FIG. 28 is a cross-sectional view at AA' of FIG. 27;

FIG. 29 is a schematic view of blood flow after release of an aortic arch-crossing stent graft in accordance with an embodiment of the present application;

FIG. 30 is a schematic view of a trans-arch thoracic aortic stent-graft bridging brachiocephalic artery in accordance with embodiments of the present application;

FIG. 31 is a schematic illustration of a bridging left carotid artery of a trans-arch thoracic aortic stent graft in accordance with an embodiment of the present application;

FIG. 32 is a schematic illustration of a trans-arch thoracic aortic stent-graft bridging a left subclavian artery in accordance with an embodiment of the present application;

33 a-35 b are schematic views of other implementations of tie down elements of embodiments of the present application;

fig. 36 a-36 e are schematic views of handles according to embodiments of the present application.

Detailed Description

For the purposes of making the objects, technical solutions and advantages of the present application more apparent, the present application will be further described in detail below with reference to the accompanying drawings.

It should be noted that unless otherwise defined, technical or scientific terms used in the embodiments of the present application should be given the ordinary meaning as understood by one of ordinary skill in the art to which the present application belongs. The terms "first," "second," and the like, as used in embodiments of the present application, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

The integrated aortic arch three-branch intracavity reconstruction technology is an intracavity reconstruction technology and is also the pursuit of tiredness of workers in the related field.

Currently, the ascending aorta is treated by an endoluminal prosthesis incorporating an embedded stent, although more branched stents are simpler to operate. However, the overlapping combination of a plurality of stents at the ascending aorta and the aortic arch causes serious loss of the elasticity of the ascending aorta and the aortic arch and loss of the blood pressure regulating function. In addition, a plurality of stents are overlapped and combined, so that continuous friction (due to pulsation) among the metal stents is brought, and the durability of the stents is obviously reduced. Meanwhile, the risk of internal air leakage between the overlapped interfaces is high, the difficulty of the guide wire entering the embedded bracket is high, and the operation time is too long. In addition, the number of the embedded stents is insufficient, and a branch vessel is required to be plugged or a diversion is required to be carried out. These problems limit the spread of endovascular exclusion treatment of the aortic arch.

The arch lesion is located in the thoracic aorta, and flows through all blood flows of the human body except coronary blood flow, the upper arch branch is responsible for the whole blood flow of the brain, and irreversible damage can be caused by intracranial hypoxia for 5 minutes; the arch part makes a 180-degree sharp turn, the ascending aorta is relatively fragile and easy to damage, and the conveying difficulty is high. Trans-arch endoluminal treatment has the following special requirements relative to endoluminal treatment of vessels below the site: 1) The operation time is required to be shortened as much as possible; 2) The branch blood flow is not blocked as far as possible, and the deep low-temperature circulation or the extracorporeal circulation is avoided; 3) The ascending aorta is a blood pressure buffer organ, and the effect of stent implantation is to the blood pressure buffer organ; 4) The arterial arch is a large curve formed by a blood vessel at 180 degrees, and the covered stent needs to conform to the anatomical structure of the blood vessel; 5) The diameter, the spacing and the included angle of each branch vessel are different, and the diameter difference of thoracic aorta is larger, and the lesion involved length is different, so that the specification of one stent can simultaneously adapt to the requirements of branch vessels on different arches, and the specification number of the stent is reduced as much as possible; 6) The ascending aorta has large blood flow impact force and high bracket accurate release difficulty; 7) Three supports are rebuilt in the cavity, so that important branch occlusion or branch reconstruction in surgery is avoided; reduces the conveying difficulty and avoids the damage of ascending aorta. 8) And meanwhile, the requirements of isolation from other cavities are the same, and the problem of internal leakage is avoided, wherein the difficulty of single implementation is higher.

In the prior art, the six special requirements cannot be completely solved in the treatment of the isolated arch artery in the cavity, and the method cannot be effectively popularized. Such as multi-branch technology cannot meet the needs of items 1), 2), 5) and 7); the pre-windowing technique does not meet the requirements of items 7) and 8) and the requirements of the lesion affliction branch side; the in vivo windowing technique does not meet the requirements of items 1), 2), 7) and 8); chimney technology does not meet the requirements of items 2) and 8); the combined bracket technology cannot meet the requirements of items 1), 3), 7) and 8); debranching and hybrid surgery techniques do not meet the needs of items 1), 2), 7) and 8); the embedded stent technology does not meet the needs of items 1), 2), 5), 7) and 8); the embedded stent plus platform stent technology does not meet the requirements of items 1), 4) and 7).

Based on this, the embodiment of the application provides a design of the co-drying branch of the embedded support and the collapse platform (i.e. the concave part) of the main support, which can solve the requirement 1), the collapse platform (i.e. the concave part) facilitates the entry of the guide wire, the smoothness from the co-drying branch main body to the embedded branch support greatly shortens the time required for the guide wire to enter the branching process during the most time in the operation, and the operation difficulty is also greatly reduced; demand 2), the collapse platform (namely the concave part) is opposite to the upper branch of the arch, and before the reconstruction of the branch blood vessel, after blood flows out of the embedded bracket, the blood smoothly flows into the upper branch of the arch outside the collapse platform (namely the concave part); requirement 5), the common trunk opening (namely the second opening 703 of the common trunk branch main body) of the embedded bracket is placed at the front end of the head arm trunk, the embedded branch brackets are not required to be aligned with the branch blood vessels one by one, the problem of different intervals and included angles of the three branch blood vessels is avoided, the embedded three branches (namely the three embedded branch brackets) of the bracket main bodies with different types and specifications are identical in design, the near ends of the branch brackets connected with the branch blood vessels are designed to be the corresponding sizes, and the branch brackets are further provided with different lengths and far end diameters, so that the problem of different diameters of different branch blood vessels is solved; requirement 7), embedding three branches (i.e. three embedded branch brackets) ensures that all branches can realize intra-cavity reconstruction; demand 8), the proximal end of the branch stent is released into the embedded branch stent, and the occurrence of internal leakage can be effectively avoided. The requirement 3) is solved through the integrated bracket main body, and the serious reduction of the compliance of the bracket section caused by the overlapping of the brackets brought by the combined bracket is avoided. The flat collapse part bracket keeps a single independent semicircular ring design, solves the requirement 4), and an independent bracket ring (namely a circular ring wave ring) keeps good flexibility of the flat collapse part bracket, and solves the problem that the requirement of compliance with arterial arch bending cannot be met due to strong straightening force brought by the interlinked bracket in the prior platform technology. The secondary release technology is arranged through the conveying system, the requirement 6) is solved, the arch-crossing thoracic aortic tectorial membrane stent can be further adjusted after the primary release, the whole release process can not block blood flow, and the wind cannon effect is avoided. Meanwhile, the conveying system adopts a sheath-free design, so that the flexibility of the conveying system is obviously improved; after the adjustable valve sheath is delivered in place, the delivery system is delivered from the sheath, so that the damage to the ascending aorta is avoided. The adjustable valve sheath and the conveying system are fed in twice, so that the difficulty in passing the bow of the conveying system is reduced.

Referring to fig. 1 and 2, an embodiment of the present application provides a trans-arch thoracic aortic stent graft, including: a main body holder 1, the main body holder 1 having a recess in a radial direction; the concave part is concave from the outer wall of the main body support to the center of the main body support.

The embedded bracket 2 is arranged in the main body bracket; wherein the embedded stent 2 comprises a common dry branch main body 204 and at least one embedded branch stent connected with the common dry branch main body; the embedded branch stent is used for communicating with the branch stent in the corresponding branch artery.

The design can enable the large bending side to collapse inwards when the stent main body is positioned at the arch part, and prevent the main body stent 1 from blocking blood supply of the blood vessel of the branch artery after being unfolded. Before the blood vessel of the branch artery is bridged, the blood flowing out of the embedded bracket 2 can smoothly flow into the branch blood vessel on the arch without the need of intraoperative diversion. The large-bending side flat pedal design of the bracket main body can enable enough time to bridge the branch vessel on the bow in operation, and meanwhile, the phenomenon that the embedded bracket collapses and is blocked due to the fact that the main body bracket 1 presses the embedded bracket bridging the branch vessel on the bow is avoided. When the guide wire is communicated with the branch stent in the corresponding branch artery, the guide wire fed from the branch vessel can easily and naturally enter the common trunk branch main body 204 and then enter the corresponding embedded stent through super-selection, so that the time and difficulty for the guide wire to enter the corresponding embedded stent from the distal end of the branch vessel can be remarkably reduced. Because the smooth guiding of the guide wire into the corresponding embedded bracket from the branch vessel is the key and the difficulty of the operation and the time-consuming process is the most, the embodiment of the application can greatly shorten the time and the difficulty of the alignment of the guide wire, thereby remarkably reducing the operation difficulty and the time required by the operation. Meanwhile, after the covered stent is unfolded, the blood flow of the branch blood vessel is not blocked, and the branch blood vessel on the arch can continuously and normally supply blood. Therefore, the trans-arch thoracic aortic tectorial membrane stent can break the limitation condition on operation time, and does not need to perform extracorporeal circulation or cryogenic stop circulation, so that the operation skill requirement and operation complications of operators are reduced. Thereby promoting the rapid popularization of the intra-cavity isolated treatment involving the lesion of the arch.

The heights of the main body support 1 positioned at the two sides of the concave part can be the same or different, and the main body support is determined according to the thickness of blood vessels at the two sides of the three branches on the arch of the aortic arch which is matched with the specific requirements, so long as the main body support can be matched with the corresponding blood vessels at the two sides of the three branches on the arch of the aortic arch which is matched with the aortic arch. In some embodiments, as shown in fig. 1 and 2, the body stent 1 is located at a different height on both sides of the recess, wherein the height of the proximal portion of the body stent may be greater than the height of the distal portion of the body stent. In other embodiments, the body stent 1 may be of different heights on either side of the recess, wherein the proximal portion of the body stent may be of a lesser height than the distal portion of the body stent. In other embodiments, the body stent 1 is the same height on both sides of the recess, wherein the height of the proximal portion of the body stent may be equal to the height of the distal portion of the body stent.

The embedded bracket is a covered bracket, the common-dry branch main body 204 is provided with a first opening 704 and a second opening 703, and the common-dry branch main body 204 and the concave part are covered and anastomosed at the first opening (the covered and anastomosed definition is that the covered and anastomosed is formed or connected integrally); the embedded branch stent is a covered stent, one end of the embedded branch stent is connected with the common dry branch main body 204, and extends from the second opening 703 in a direction away from the recess; the cover of the embedded branch stent at the end of the second opening 703 is matched with the cover at the end of the common dry branch body. The embedded branch stent is attached to the inner wall of the main body stent 1, and as an embodiment, the cover at the end of the embedded branch stent far from the first opening 704 (i.e. the proximal end of the embedded branch stent) is connected with the cover at the adjacent position of the main body stent, for example, is connected by stitching.

The number of embedded branch stents may be set according to the specific application requirements, for example, may be set as one or more. In some embodiments, the embedded branch stent is a stent graft and is provided in plurality; the embedded branch brackets are arranged side by side. Specifically, as shown in fig. 3 and 28, the embedded branch stent may be provided in three, for example, including a first embedded branch stent 201, a second embedded branch stent 202 and a third embedded branch stent 203, so as to correspond one-to-one with three branch arterial vessels (for example, a brachiocephalic trunk 803 arterial vessel, a left carotid artery 804 vessel and a left subclavian artery 805 vessel), respectively.

In some embodiments, as shown in fig. 4, one end of the embedded branch stent is fixedly connected with the first end portion of the common trunk branch main body 204 far away from the concave portion, the proximal end of the peripheral covered stent (branch stent) is deployed in the embedded branch stent, the distal end of the peripheral covered stent is deployed into the corresponding branch vessel, so as to realize connection between the embedded branch and the corresponding branch artery, and preferably the proximal end of the peripheral covered stent exceeds the embedded branch by a small distance. The diameter of the proximal end of the peripheral covered stent is 5% -30% larger than the diameter of the corresponding embedded branch. That is, as shown in fig. 5, the outlet of the in-line branched stent (i.e., the opening through which the guide wire exits from the in-line stent 2) is directed toward the proximal end of the stent body 1. As shown in fig. 6 and 28, the embedded stent is provided with an integrated co-dry branch main body 204 and embedded branch stents, the embedded branch stents are arranged in parallel along the inner side of the stent main body 1 to match the direction of the branch vessels, the inlet (i.e. the second opening 703) of the embedded branch stent faces the far end of the stent main body, and during operation, as shown in fig. 25, before the opening (i.e. the first opening 704) of the embedded stent is placed to the front edge of the opening of the head wall, the problems of different spacing, angles and branch numbers of branches on the arch can be adapted. And the first opening 704 formed by the film-covered connection of the common trunk branch main body 204 and the collapse platform of the stent main body 1 can enable the guide wire sent from the branch vessel to easily and naturally enter the common trunk branch main body 204 and then enter the corresponding branch (i.e. the embedded branch stent) through super-selection, and the guide wire is sent into the small film-covered stent (i.e. the branch stent) along the guide wire and is respectively connected with the corresponding embedded branch stent to the corresponding branch vessel, so that the bridging of three branches of the artery is realized.

In some embodiments, the diameters of the plurality of embedded branch stents are respectively matched with the diameters of blood vessels of corresponding branch arteries; or the embedded branch stents are all provided with preset diameters, and the preset diameters are matched with the diameters of the blood vessels with the largest diameters in the branch arteries, so that the preset diameters of all the embedded branch stents can meet the normal blood supply of the blood vessels of the corresponding branch arteries; it can be understood that the diameters of the first embedded branch stent 201, the second embedded branch stent 202 and the third embedded branch stent 203 are respectively matched with the diameters of the corresponding blood vessels of one of the three branch arteries or the diameters of the first embedded branch stent 201, the second embedded branch stent 202 and the third embedded branch stent 203 are the same, so that the blood supply requirement of the branch arterial blood vessel with the largest diameter in the three branch arteries can be met.

The diameter of the proximal end of the branch stent is matched with the preset diameter of the corresponding embedded stent. In some embodiments, the diameters of the first embedded branch stent 201, the second embedded branch stent 202, and the third embedded branch stent 203 are each smaller than the diameters of the branch stents in the corresponding branch arterial vessel. Specifically, the diameter of the distal end of each embedded branch stent is smaller than the diameter of the proximal end of the corresponding branch stent, for example, can be 10-20% smaller than the diameter of the proximal end of the corresponding branch stent, so that sharp bends between the embedded branch stent and a branch vessel can be complied, the impact of blood flow is resisted, and the branch stent is prevented from being folded.

The diameter of the distal end of the branch stent is matched with the diameter of the corresponding branch arterial vessel. In some embodiments, the distal ends of the three branch stents may be individually provided in a variety of diameter gauges, such as a tapered diameter. The lengths of the three branch brackets can also be set into various length specifications. The three branch stents can be respectively spiral woven covered stents, so that good flexibility of the covered stent is maintained.

The main body bracket 1 may be a spiral bracket or a combination of a plurality of independent single ring brackets 302. In some embodiments, the body support 1 comprises a plurality of axially distributed annular wave rings comprising a plurality of wave crests and a plurality of wave troughs. It will be appreciated that the region of the body support 1 other than the recess comprises a plurality of axially distributed individual annular wave rings. Each circular ring wave ring of the main body support 1 can be a single-ring nickel titanium wire support respectively. In general, the plurality of axially distributed annular bands may include a plurality of peaks and a plurality of valleys.

The concave part of the main body bracket 1 comprises a plurality of circular arc wave rings which are distributed along the axial direction, the circular arc wave rings comprise a plurality of wave crests and a plurality of wave troughs, and the corner alpha of the circular arc wave rings is positioned at the vertex of the wave crests or the wave troughs, so that deformation of the bracket during shrinkage is facilitated; the chord length of the concave part and the arc length of the arc wave ring have a preset proportion. In some embodiments, the circular arc wave ring may be a semicircular wave ring, and it may be understood that the concave portion includes a plurality of independent semicircular wave rings distributed along the axial direction, and the chord length of the platform of the concave portion (i.e. the flat collapse portion of the concave portion) and the arc length of the semicircular wave ring have a preset proportion, where the preset proportion can enable the area of the concave portion of the semicircular shape in the main body support 1 to occupy a proper area, so that the outer semicircular space size above the concave portion (the inner diameter of the adaptive co-drying branch main body 204) can effectively achieve the branch bridging requirement.

In some embodiments, the predetermined ratio is near an integer. By controlling the ratio of the platform chord length to the semicircular arc length to be close to an integer ratio, for example, 2, the corner of the manufactured independent semicircular bracket 303 (namely, the semicircular wave ring) is just arranged on the same straight line with the crest or trough of the main bracket 1 (namely, the circular wave ring), and therefore, good symmetry of the bracket during compression or expansion can be maintained. Therefore, the design of the independent semicircular bracket is realized at the concave part, and the covered bracket of the platform area at the concave part is ensured to have good bending performance at the arch part and conform to the bending configuration of the blood vessel.

In some embodiments, the cross-sectional shape of the first opening 704 of the common-dry branch body 204 is semicircular or elliptical, and the shape of the first opening 704 is adapted to the shape of the corresponding circular arc wave ring, so that the center of the first opening 704 and the center of the corresponding circular arc wave ring are the same. When the circular arc wave ring is a semicircular wave ring, the cross section of the first opening 704 may be semicircular, and the two circles are overlapped, so that the main body support 1 has good flexibility and folding resistance.

In some embodiments, the circular arc wave ring and the circular ring wave ring may be independent nickel-titanium wires. As shown in fig. 1 and 2, the annular ring at the proximal end of the main body support 1 may be overlapped, so that the sealing effect is better, that is, when the first annular ring has a poor local sealing effect, the second annular ring has a supplementary sealing effect, and meanwhile, the requirement of the anchoring length is not increased. The wave crests and wave crests of the plurality of circular wave rings of the main body support are arranged on the same straight line, the wave troughs and the wave troughs are arranged on the same straight line, the compliance is good, the radial supporting force requirement of a single support is reduced, the edge effect of the support is reduced, and the reverse tearing risk is reduced.

In some embodiments, at least one of the at least one end of the body mount 1, the at least one end of the embedded mount, the body of the embedded branch mount, the first opening 704 of the common dry branch body 204, and the end of the recess remote from the common dry branch body 204 has a corresponding development mark. Through setting up the development sign, can have clear development under the X ray, be convenient for judge the position of corresponding structure in the specific arch chest aortic tectorial membrane support that strides.

In some embodiments, the two ends of the main body support 1 (i.e., the proximal end of the main body support 1 and the distal end of the main body support 1), the two ends of the embedded support (i.e., the entrance of the embedded support and the exit of the embedded support), the embedded branch support (i.e., the portion of the embedded branch support between the entrance and the exit), the first opening 704 of the common dry branch body 204, and the end of the recess away from the common dry branch body 204 are respectively provided with corresponding developing marks, and each developing mark is different. Therefore, each structure in the arch-crossing thoracic aortic tectorial membrane stent can be accurately judged under X rays, so that each embedded stent can be conveniently identified, and the time for smoothly guiding the guide wire into the corresponding embedded stent from the branch vessel is further shortened.

Specifically, as shown in fig. 1 and 2, a proximal indicator 701 may be provided at the proximal end of the main body stent 1, and a distal indicator 707 may be provided at the distal end of the main body stent 1. An embedded branch stent inlet indicator 702 may be provided at the inlet of the embedded branch stent, an embedded branch stent outlet indicator 703a may be provided at the outlet of the embedded branch stent (i.e., the second opening 703), and a corresponding embedded branch stent indicator 705 may be provided at a portion between the inlet and the outlet of the embedded branch stent. When the number of the embedded branch stents is plural, for example, three, different marks may be provided in the three embedded branch stents, respectively, or different marks may be provided in only two embedded branch stents, so as to better distinguish the respective embedded branch stents. A common trunk branch opening indicator 704a is provided at the first opening 704 of the common trunk branch body 204. A recess end indicator 706 is provided at the distal end of the recess.

Embodiments of the present application also provide a trans-arch thoracic aortic stent graft system comprising a trans-arch thoracic aortic stent graft and a delivery system as described in any of the preceding claims. The delivery system is used to deliver the trans-arch thoracic aortic stent graft to the thoracic aorta in the human body (as shown in fig. 24). Before use, the trans-arch thoracic aortic stent graft may be preloaded onto the delivery system, and the delivery system is withdrawn after the trans-arch thoracic aortic stent graft is fully released in the human body.

In order to solve the problems that the position and the angle of the stent cannot be adjusted after the stent is released, in some embodiments, the trans-arch thoracic aortic tectorial membrane stent provided by the invention is designed to have a secondary release function, and the principle is that the stent is released to a half-unfolding state firstly, and then the stent is released to a full-unfolding state after the position and the angle are adjusted. In particular, the trans-arch thoracic aortic stent graft may further comprise a first tie down 601 and a second tie down 602. Wherein the first tie down 601 and the second tie down 602 may be used to tie down the body scaffold 1 in a fully contracted state or a partially contracted state, respectively. Like this, when carrying, cooperation conveying system can realize striding arch chest aorta tectorial membrane support and carry, preliminary expansion and secondary expansion, effectively avoids the blood flow to block and because of the inaccurate release position that blood flow impact caused. After preliminary expansion, the device can also perform circumferential and axial movement according to the needs, so that the operation skill requirements on operators can be greatly reduced, the operators do not need to send guide wires into branches, the brain cutoff time is controlled, the left subclavian artery current transfer and the like are experienced, the operation difficulty is reduced, and the surgical type device is convenient to popularize rapidly.

In some embodiments, the first binding 601 and the second binding 602 may be provided in plurality, respectively, and spaced apart in the axial direction of the body stent 1, respectively. As shown in fig. 1 and 2, the first and second tethers 601 and 602 are in a fully deployed state of the trans-thoracic aortic stent graft.

The first binding 601 may be a loop structure sewn to the main body bracket 1. In some embodiments, the first tie-down 601 may include two closed first loop structures 6011 and 6012 disposed opposite to each other, as shown in fig. 7a and 7b, which are schematic structural views of the first tie-down 601 in a collapsed state of the trans-arch thoracic aortic stent graft. The first tie down may be disposed around the circumference of the main body stent, one end of the first loop structure 6011 and one end of 6012 may be fixed (e.g., sewn) to the main body stent 1, respectively, and the other end is a free end, respectively, and the first loop structures 6011 and 6012 are preloaded or released by the relevant structure of the delivery system (e.g., the first core wire 1101) after encircling or semi-encircling the main body stent 1, respectively. For example, first tie 601 may be pre-tensioned by first filament 1101 threaded through the free ends of first loop structure 6011 and 6012 to cooperate to secure first filament 1101 in the connected position of first loop structures 6011 and 6012. In this way, first loop structures 6011 and 6012 may be pre-tensioned by the associated structure of the delivery system (e.g., first core wire 1101) to restrain main body stent 1 in a contracted state. Upon withdrawal of the associated structure (e.g., first core wire 1101), the first loop structures 6011 and 6012 separate to partially release the trans-thoracic aortic stent graft to a partial deployment. By adopting the structure, the device has the advantages of simple operation, reliable pre-tightening and the like. The diameters of the first loop structures 6011 and 6012 may be the same or different, and may be set according to practical applications.

In other embodiments, as shown in fig. 8a and 8b, the first tie down 601 may comprise only one closed second loop structure 6013. Wherein the second loop structure 6013 is fixed (e.g. stitched) at one end to the main body stent 1 and at its other end (free end) surrounds said main body stent 1 and pretensions or releases the main body stent 1 by the relevant structure of the delivery system (e.g. the first core wire 1101). For example, first tie 601 may be pre-tensioned by first filaments 1101 simultaneously threaded into the free and fixed ends of second loop structure 6013, respectively, to form a loop of loop structure.

Similarly, in some embodiments, referring to fig. 7a and 7b, second binder 602 may be a loop structure, such as a structure similar to first binder 601 shown in fig. 7 a. In particular, the first and second tethers 601, 602 may comprise the same loop type, may be different, or a different combination selected, and the second tethers 602 may have a larger diameter than the first tethers 601. According to the actual application setting.

Meanwhile, the binding member may further use a single free end or a single rope (for example, a third rope loop structure 6015, a fourth rope loop structure 6016 or a fifth rope loop structure 6017) with small loops at two ends, wherein the middle part of the third rope loop structure 6015 is fixed on the main body support with reference to fig. 33 a-33 b, fig. 34 a-34 b and fig. 35 a-35 b, two ends are the free ends, one free end is a loop structure, and the other free end is a single rope structure with loops at the end. The middle part of the fourth rope loop structure 6016 is fixed on the main body support, the two ends are the free ends, and the free ends are single rope structures with end loops. One end of the fifth rope loop structure 6017 is fixed on the main body support, the other end is the free end, and the free end is a single rope structure with a ring at the end.

In some embodiments, as shown in fig. 9a and 9b, the delivery system may include a cone head, a marker, a first wire 1101, a second wire 1102, a first pull handle 1201, a second pull handle 1202, a holder, a mandrel tube, a support tube, a handle, a tail end fitting, a loader, and the like. Wherein the marking may be provided on the cone; the first core wire 1101 is used to pre-tighten the first tie 601; the second core wire 1102 is used to pre-tighten the second tie 602; the first pull wire handle is connected with the first core wire 1101 for controlling the first core wire 1101. Specifically, one end of the first core wire in the axial direction is connected with the first wire pulling handle. The second stay wire handle is connected with the second core wire 1102 and is used for controlling the second core wire 1102. Specifically, one end of the second core wire in the axial direction is connected with the second stay wire handle. The first stay wire handle and the second stay wire handle are respectively arranged on the handle shell in a penetrating way, namely, the first stay wire handle and the second stay wire handle are partially positioned in the handle and partially positioned outside the handle; the second stay wire handle is provided with a special-shaped structure, and is clamped on the handle through the special-shaped structure.

Specifically, the conical head 9 is provided with a marking 10. The mark may be a development mark, for example, capable of developing under X-ray imaging. As shown in fig. 10, the marker 10 may be composed of an axial marker 1001 and a radial marker 1002. Wherein the axial marker 1001 may be parallel to the core tube 14 and the radial marker 1002 may be perpendicular to the plane formed by the axial marker 1001 and the core tube 14. In the process of delivering the trans-arch thoracic aortic stent graft to the human body, in combination with the X-ray image, the cone head marker image may be as shown in FIGS. 11 and 12 when the opening of the embedded stent 702 is projected against the X-ray. The development shape of the axial mark 1001 may be a long strip shape, and may be parallel to the whole. While the radial mark 1002 may be circular in shape, parallel to the core wire. And the marker image at the cone head when projected with the opening of the embedded stent facing the large curved side of the aortic arch 802 can be as shown in fig. 13 and 14. The development shape of the axial marker 1001 may be elongated, parallel to the core wire, and substantially shielded by the core wire. While the radial mark 1002 may be rectangular in shape perpendicular to the plane of the core wire.

As shown in fig. 15 and 16, the core tube 14 extends from the interior of the conical head 9 through the entire delivery system to the end at the trailing end junction 17 of the tip, serves as a passageway for the tracking guidewire, and is capable of connecting to the entire delivery system. The arch-crossing thoracic aortic tectorial membrane stent is sleeved on the mandrel pipe 14, and the supporting pipe 15 is sleeved in the mandrel pipe 14 after the stent section to the inside of the handle 16. The fixing device 13 is composed of a fixing ring 1301 and a fixing core wire 1302, wherein the fixing ring 1301 is of a double-hole structure, and can be understood that two holes with different inner diameters are formed in the fixing ring, and the holes comprise punching holes and small holes. Wherein, the big hole is sleeved on the core shaft tube 14, and the tail end of the fixed core wire 1302 is inserted in the small hole. A fork-shaped structure is formed on the core tube 14 by the holder 13. In some embodiments, a coil may be further disposed inside the proximal end of the main body stent 1, the coil may be constrained (i.e., tethered) by a fixed core wire 1302, the main body stent 1 may be constrained by a fixator, and the stent graft may remain unchanged from the axial position of the delivery system during delivery and first release and complete deployment, ensuring accurate delivery of the stent graft.

As shown in fig. 17, support tube 15 includes a three-lumen tube 1501 and a thickening layer 1502 and a reinforcing steel tube 1503 over three-lumen tube 1501, the end of thickening layer 1502 distal from conical head 9 being connected to the end of reinforcing steel tube 1503 proximal to conical head 9. I.e., thickened layer 1502 encapsulates the portion of tri-lumen 1501 which is located in the body and reinforcing steel tube 1503 encapsulates the portion of tri-lumen 1501 which is located in the body. As shown in fig. 18, the three-lumen tube 1501 may be formed of one large lumen and two small lumens, extending through the entire support tube 15, at the innermost layer of the support tube 15. The three-cavity tube is of a tubular structure with three cavities, a large cavity in the three cavities can be coaxially arranged with the three-cavity tube, and the three-cavity tube is sleeved on the mandrel tube 14 through the large cavity, so that the mandrel tube 14 is arranged in the large cavity. The remaining two small cavities serve as channels for receiving the core wires 1101 and 1102, respectively. Three-lumen 1501 external reinforcing steel tube 1503 may be a metal tubing such as stainless steel tube for enhanced handling of the delivery system. The thickened layer 1502 sleeved on the proximal end of the three-cavity pipe 1501 can enable the reinforced steel pipe to be in smooth transition, so that the conveying system can be smoothly carried out when the conveying system enters the adjustable sheath or the adjustable valve sheath is retracted.

As shown in fig. 9a and 9b, the tail end of the supporting tube 15 is provided with a handle 16 and a stay wire handle, and the stay wire handle is arranged in the handle 16 in a penetrating way; the pull wire handle can release the tie. The grip 16 is used to facilitate handling to grasp and secure the first and second wire handles 1201, 1202. In some embodiments, as shown in fig. 20, a snap-fit portion 18 having a cavity may be provided at the trailing end of the handle. The clip 18 may protrude from the tail end of the handle. The first pull wire handle and the second pull wire handle are respectively penetrated from the outside of the handle to the inside of the cavity of the clamping part 18 of the handle 16. The sum of the thickness of the first wire handle 1201 and the thickness of the second wire handle 1202 is the same as the thickness of the cavity; the second wire pulling handle 1202 is inserted into the side wall of the handle by providing a special-shaped structure to limit the second wire pulling handle to be freely pulled out of the cavity; after the first wire pulling handle is pulled out of the cavity, the second wire pulling handle is pulled out of the cavity after being separated from the inner wall of the handle. The special-shaped structure of the second wire pulling handle 1202 is matched with the inner space of the clamping part of the handle 16, so that the first wire pulling handle 1201 and the second wire pulling handle 1202 are required to be pulled out in the back pulling sequence, the second wire pulling handle 1202 can be pulled out after the first wire pulling handle 1201 is pulled out, and the failure of the half release function which is unfolded for the first time due to the wrong operation sequence can be effectively avoided. The sum of the thickness of the first wire handle 1201 and the thickness of the second wire handle 1202 and the shaped structure is greater than the thickness of the cavity.

In some embodiments, as shown in fig. 20 and 21, the second wire handle 1202 may have a first boss structure, i.e., the shaped structure is a first boss 1203a, and the side wall of the clamping portion may be provided with a first groove that mates with the first boss 1203 a. The first boss 1203a is inserted into the first recess, and the first and second wire handles 1201 and 1202 are simultaneously received in the cavity, at which time the cavity is of sufficient thickness to pull out the second wire handle 1202 only after the first wire handle 1201 is pulled out.

In other embodiments, as shown in fig. 22a, 22b and 23, the first pull wire handle 1201 is a first distance d1 from the second pull wire handle 1202; the second wire pulling handle 1202 may have a special-shaped structure (i.e. a second boss 1203 b), and the housing of the handle has a second boss channel adapted to the second boss 1203 b; the length d2 of the second boss 1203b is greater than the first distance, and if the first pull wire handle 1201 is not pulled out, the second pull wire handle 1202 cannot be rotated until the second boss 1203b coincides with the second boss channel 1208. In this way, the pulling sequence of the pulling handles 1201 and 1202 must be that the pulling handle 1202 is pulled out after the first pulling handle 1201 is pulled out, that is, after the first tie 601 is released, the second pulling handle 1202 is rotated until the second boss 1203b coincides with the second boss channel 1208, so that the pulling handle 1202 can be pulled out again, and the failure of the half release function of the first deployment due to the incorrect operation sequence can be effectively avoided. Further, an abutment 1204 is disposed below the second boss 1208 for limiting the rotation angle of the second wire handle 1202, so as to be smoothly pulled out from the second boss 1208.

Preferably, the first pull wire handle 1201 has a special-shaped structure (i.e. has an L-shaped second groove 1203 c), the housing of the handle has a third boss 1207 (which may be located at the edge of the through hole formed when the first pull wire handle 1201 is inserted into the handle housing), and the first pull wire handle 1201 can be pulled out backward (i.e. pulled out along the long side of the second groove 1203 c) after the pull wire handle is rotated until the third boss 1207 is pulled out from one end to the other end of the short side of the second groove 1203c, so as to prevent the bracket from being released or mishandled during transportation. Through the structural design of the first pull wire handle 1201 and the second pull wire handle 1202, the release after the belt and the secondary release of the conveying system are realized, and the accurate positioning in the release process is ensured. The tectorial membrane support in compression state is tethered to cooperation in main part support 1 department adoption double binding adds wire (i.e. first tie down 601, second tie down 602, first seal wire and second seal wire), and the release structure can realize striding arch chest aorta tectorial membrane support's preliminary expansion (i.e. partial expansion) and secondary expansion (i.e. full expansion) after the cooperation, and preliminary expansion and secondary expansion process all can not block the blood flow, effectively avoid causing release position inaccurate because of blood flow impact.

Specifically, the steps of rotating the wire pulling handle and withdrawing the core wire can be illustrated by fig. 36a, 36b, 36c and 36 d. Referring to fig. 22a, 22b and 23, as shown in fig. 36d, a third boss 1207 adapted to the second groove 1203c of the first wire pulling handle 1201 and a second boss channel 1208 adapted to the special-shaped structure (i.e. the second boss 1203 b) of the second wire pulling handle 1202 may be provided on the housing of the handle, and left and right ends of the second boss channel 1208 are respectively communicated with through holes formed when the first wire pulling handle 1201 and the second wire pulling handle 1202 penetrate through the housing of the handle. Before the first wire pulling handle 1201 starts to be pulled out, as shown in fig. 36a and 36b, the long side of the second groove 1203c of the first wire pulling handle 1201 is not matched with the third boss 1207 (the third boss 1207 is located at the end of the short side of the second groove 1203c away from the long side), and since the length d2 of the special-shaped structure of the second wire pulling handle 1202 (i.e. the second boss 1203 b) is longer than the length d1 of the second boss channel 1208 (i.e. the distance between the first wire pulling handle 1201 and the second wire pulling handle 1202), the end of the second boss 1203b can only abut against the first wire pulling handle 1201 even if the second wire pulling handle 1202 is attempted to be pulled out, and cannot abut against the abutment boss 1204, i.e. cannot be rotated to be matched with the second boss channel 1208. When the tie is to be released, as shown in fig. 36b and 36d, the first wire pulling handle 1201 may be rotated first, and the third boss 1207 slides in the short side of the second groove 1203c at the L-shaped corner thereof, so that the first wire pulling handle 1207 may be pulled out (the third boss 1207 slides out in the long side of the second groove 1203 c). When the first wire pulling handle 1201 is completely withdrawn, the second wire pulling handle 1202 is rotated again in the housing, and the shaped structure of the second wire pulling handle (i.e., the second boss 1203 b) can be engaged with the second boss channel 1208, so that the second wire pulling handle is withdrawn. In this way, the pulling sequence of the pulling handles 1201 and 1202 must be that the first pulling handle 1201 to the third boss 1207 are rotated first to be pulled out from the second groove 1203c of the first pulling handle, that is, the first tie 601 is released first, and then the second pulling handle 1202 is rotated until the second boss 1203b is matched with the second boss channel 1208, so that the pulling handle 1202 can be pulled out again, and the failure of the half release function of the first deployment caused by the wrong operation sequence can be effectively avoided.

Wherein, as shown in fig. 36e, the loader 80 is used for flushing and exhausting the tectorial membrane, and the hemostatic valve for making the stent pass through the adjustable valve sheath smoothly. Preferably, the loader may include a tube body 81, a side tube 82, a valve 83, a seat 84, and a hemostatic valve 85.

A schematic representation of the thoracic aorta may be shown in fig. 24. Before the use of the arch-crossing thoracic aortic stent-graft system, the arch-crossing thoracic aortic stent-graft system is preassembled and fixed on a conveying system, and the direction of the side of the embedded stent 2 of the stent-graft is consistent with that of the radial mark 1002. Wherein, the stent graft is a self-expanding stent, and two kinds of fixed rope loops (i.e. binding pieces) with different sizes can be arranged on the stent graft 4 before being loaded to the conveying system, the small rope loop is a first binding piece 601, and the large rope loop is a second binding piece 602. When the stent graft is loaded onto the delivery system, the first tie-down 601 is wrapped on the stent graft and tightened, then the first tie-down 601 is tied by the first core wire 1101 (for example, two ends of two fixing rope rings respectively encircle the stent graft, the core wire passes through the overlapping position of two free ends of the two encircling first tie-down 601, so that the first tie-down 601 is kept as a complete ring for restraining the stent graft, or for example, the free end of one fixing rope ring encircles the stent graft and bypasses the fixed end thereof, then a ring for restraining the stent graft is formed, and the core wire passes through the fixing rope ring and forms a limiting structure, so that the tie-down cannot be released), so that the stent graft is kept in a compressed state and fixed on the delivery system. After the stent graft is bound by the first binding member 601, the second binding member 602 is wrapped around the stent graft in a manner similar to the first binding member 601 described above, and the second core wire 1102 is passed through the free end of the second binding member 602 to limit the inability of the binding member to be released. Meanwhile, the coil at the inner side of the front end of the stent main body 1 can be fastened through the fixed core wire 1302 on the fixer 13 to fix the proximal end of the covered stent.

When the trans-arch thoracic aortic stent graft is implanted in the thoracic aorta, the perspective view can be adjusted to maximize the view of the aortic arch. When the delivery system pushes the trans-arch thoracic aortic stent graft to the conical head near the aortic arch, the delivery system is rotated so that the radial mark 1002 faces the greater curvature side, and the axial mark 1001 is developed to substantially overlap with the development of the stiffening guidewire, representing the opening of the embedded stent 2 facing the top of the aortic arch.

And then the embedded bracket 2 is combined with the display mark 704a at the opening position, and is sent to the front edge of the opening of the head arm stem 803, so that the accurate positioning of the covered bracket is realized, as shown in fig. 25. Because the proximal end of the covered stent is fixed by the fixator, the covered stent can be pushed in the sheath by the conveying system and can be accurately positioned at the focus (the covered stent is prevented from moving backwards relative to the conveying system when the core wire 11 is pushed and withdrawn).

When the delivery system delivers the stent graft in place, the pull wire handle 1201 of the first core wire 1101 is pulled first (the tie, core wire, and pull wire handle have no specific correspondence to each other), and this embodiment is only used to illustrate the secondary release process of the main body stent. The core wire 1101 is withdrawn from the second binder 601, the second binder 601 loses its constraint on the stent graft, and the stent graft is deployed to be constrained by the second binder 602, at which point the stent graft is in a partially deployed state (e.g., a semi-deployed state), as shown in fig. 25 and 26.

When the first pull wire handle 1201 is pulled away, the limit of the pull wire handle 1202 is released, and after the special-shaped structure is moved to a specified position, the pull wire handle 1202 connected with the core wire 1102 can be pulled back, the second core wire 1102 is pulled out from the second binding member 602, the second binding member 602 loses the constraint on the covered stent, and the covered stent is fully unfolded by itself, as shown in fig. 27. Because the coil inside the front end of the stent body 1 is fastened by the fixed core wire 1302 on the fixer 13, the proximal end of the stent graft is fixed, and thus, under the condition that the front end of the stent graft is constrained by the fixer, the axial position of the stent graft and the conveying system can be kept unchanged when the stent graft is conveyed, released for the first time and fully unfolded, and the precise release of the stent graft is ensured. After the stent graft is fully released, the stent graft is anchored within the vessel. When the delivery system is retracted, the fixing core wire 1302 on the fixing device 13 withdraws the coil inside the front end of the stent body 1, and the stent graft is released from the delivery system, as shown in fig. 28, 29 and 30.

The conveying system of the embodiment of the application does not have an outer sheath, so that the conveying system has good flexibility, and the arch-crossing thoracic aortic tectorial membrane stent pushed by the conveying system can easily cross an arterial arch. When the arch-crossing thoracic aortic stent-graft is implanted, the adjustable valve sheath is firstly conveyed to the ascending aorta 801, then the stent conveying system is conveyed from the adjustable valve sheath, and the stent conveying system is not contacted with the vessel wall in the process of conveying to a target vessel, so that the damage to the vessel wall in the process of conveying the arch-crossing thoracic aortic stent-graft is effectively avoided. When the delivery system is pushed to the aortic arch, the embedded stent 2 and the concave part of the trans-thoracic aortic stent are confirmed whether to be positioned on the large curved side of the aortic arch 802 by the marks 10 on the conical head 9. If not, the conveyor system is rotated to align it. The delivery system is then advanced to bring the trans-arch thoracic aortic stent graft into the target site, i.e., the co-dry branch body 204 is positioned before the opening of the brachiocephalic trunk 803 and the proximal end of the branch stent has sufficient anchoring length. After the trans-arch thoracic aortic tectorial stent is delivered in place, the adjustable valve sheath is withdrawn back to the tail end of the stent at the front end of the sheath tube. And then the first wire handle 1201 connected with the first core wire 1101 is pulled back to complete the first release of the trans-thoracic aortic stent graft, so that the main body stent 1 is in a semi-expanded state. Because the arch-crossing thoracic aortic stent graft is not attached with the vessel wall after first release, the proximal end of the stent graft is also fixed by the fixator, and the release position of the arch-crossing thoracic aortic stent graft can be further adjusted under the condition, so that the accurate positioning of the axial direction and the circumferential direction of the stent graft 4 can be easily realized through the conveying system. And then pulling back on the second wire handle 1202 attached to the second core wire 1102 to complete the secondary release. The blood flow can not be blocked in the first release and the second release processes (the blood flow outside the arch-crossing thoracic aortic stent can be kept smooth continuously in the first release process, and the blood flow inside the arch-crossing thoracic aortic stent can be kept smooth continuously in the second release process), and the device has the function of a fixer, so that the stent displacement caused by blood flow impact can be avoided, and the accurate release can be easily realized. The method provides convenience for bridging of subsequent branch blood vessels and avoids bridging failure and branch blood vessel occlusion.

The trans-arch thoracic aortic tectorial membrane stent system adopting the embodiment of the application has the advantages of low operation difficulty, short operation time, contribution to operation popularization, promotion of postoperative effect and reduction of complications.

According to the arch-crossing thoracic aortic tectorial membrane stent system, as the embedded stent 2 is integrally formed and is co-dried in three branches, after the arch-crossing thoracic aortic tectorial membrane stent is released at the arch-crossing position, the first opening 704 of the co-dried branch main body 204 is positioned before the front edge of the opening of the brachiocephalic trunk 803, the arch-crossing thoracic aortic tectorial membrane stent is positioned at the arch-crossing position, the opposite sides of the collapse position (namely the collapse position of the concave part) of the arch-crossing thoracic aortic tectorial membrane stent are attached to the small curved side of the aortic arch 802, the collapse position is opposite to the three branch arteries on the arch, and a cavity is formed between the collapse position and the large curved side of the aortic arch. Blood flows from the three branch openings into the common trunk branch body 204, into the cavity on the greater curvature side, and into the three branch vessels on the arch, ensuring that the intracranial and upper limb blood supply is not interrupted. As shown in fig. 31, 32 and 32, three guide wires are fed from corresponding branch blood vessels through vascular sheaths, and pushed to the front end after entering the cavity on the large curved side, the guide wires can easily enter the common dry branch main body 204, and then the guide wires are super-selected to enter the corresponding embedded bracket 2. Then the small-diameter covered stent (namely, branch stent) with proper specification is sent into the embedded stent 2 along the guide wire to be communicated with the branch vessel, thereby realizing the intracavity reconstruction of the three branch vessels. Because the large bending side of the arch part is flat inwards, the main body of the arch thoracic aortic tectorial membrane bracket can not be attached to the large bending side after the bracket is unfolded. So that the blood flowing out of the three branches can continuously perfuse the three branch blood vessels on the arch. The bridging of three branch blood vessels can be carried out easily without low-temperature circulation or extracorporeal circulation. Meanwhile, the space between the bracket and the vessel wall enables the guide wire and the small bracket to enter the corresponding branch more easily, thereby shortening the operation time and reducing the operation complications. The whole metal stent of the arch-crossing thoracic aortic tectorial membrane stent adopts a single-ring nickel-titanium wire stent, including a flat collapse position. The flat collapse stent is designed into a single independent semicircular closed loop, so that the main body of the covered stent has good flexibility and can conform to any sharp-bending arterial arch.

Three branches in the embodiment of the application are combined into a common dry main body, namely a common dry branch main body 204, a large opening (namely a first opening 704) is formed by the common dry branch main body 204, the first opening 704 is positioned on the outer side of the front end of the flat collapse part of the main body bracket 1, the embedded common dry main body opening is like a large pocket, the front ends of the flat collapse part and the large bending side of the arch part of the arch-crossing thoracic aortic tectorial membrane bracket are completely covered by the large pocket, a guide wire sent from a branch arterial vessel can only enter the common dry branch main body 204 when advancing forwards, and then the guide wire can be selected from the common dry branch main body 204 to enter the branch of the corresponding embedded bracket relatively easily. The three-branch co-drying design avoids the problems that the three-branch co-drying design cannot adapt to different branch intervals, angles, sizes and branch numbers (the situation that a part of people have branch blood vessels to be co-dried), and only needs to place the co-drying opening (namely the first opening 704) of the embedded bracket branch at the front edge of the opening of the head arm trunk 803.

The arch-crossing thoracic aortic tectorial membrane stent system provided by the embodiment of the application has the following advantages; three branches of embedded co-drying: all branch arterial vessels can be reconstructed without ischemia or diversion. All branch arterial vessels are reconstructed, and branch vessel internal leakage does not exist. Thus, through the embedded three-branch co-drying (namely the embedded bracket 2), the problem that branches on the arch of the foot are different in distance and angle and branch blood vessels are co-dried can be solved, and the specification of the embedded three-branch can meet the requirements. By providing a large opening (i.e., the first opening 704) formed by the common trunk branch body 204, a guidewire fed from a branch vessel can be easily fed into the common trunk branch body 204. The three branches (i.e. the three embedded stents) of the common trunk make the anastomosis between the covered membranes as little as possible. Can avoid the adverse effects of excessive anastomotic sites on the durability of the stent, leakage and the like.

The design of the bow part concave part, the bracket at the platform of the concave part is an independent semicircular closed loop. The blood flow supply of all branches on the arch of the operator is not affected, and the operator can bridge branch vessels on the arch from the container. Avoiding intraoperative fluid transfer, extracorporeal circulation and the like. The adverse events such as collapse, stenosis and occlusion of the small covered stent caused by the compression of the main body stent 1 on the bridging small covered stent (namely the branch stent) are avoided. The independent closed loop support enables the bow to have good flexibility and can conform to any bow. The platform has good radial supporting force, so that the collapse and the folding of the bracket main body can be avoided.

The integrated main body bracket 1 has the advantages of simpler operation, shorter operation time and less blood loss. The method avoids the loss of elasticity of the ascending aorta 801 and the aortic arch caused by the combined overlapping of a plurality of aortic stents on the ascending aorta 801 and the aortic arch, and maintains the blood pressure regulating function of the ascending aorta 801 as much as possible. The durability reduction and the internal leakage risk at the joint caused by the combination and overlapping of a plurality of aortic stents are avoided.

The delivery system is delivered to the ascending aorta 801 through the adjustable valve sheath, has good flexibility and can easily cross the arterial arch; the damage to the vessel wall can not be caused in the pushing process.

Branch direction positioning function: the conical head is provided with a radial mark embedded in the direction of the bracket 2. The conical head is provided with an axial mark embedded in the direction of the bracket 2 to assist in confirmation and ensure accurate positioning.

Secondary release function: the release process does not block blood flow, and the release is more accurate. The position of the bracket can be further adjusted after the bracket is unfolded for the first time, and the bracket is more accurate, easier and safer to release.

Secondary release error proofing function: when the first release operation is not performed, the second release operation cannot be performed, and the failure of the second release operation caused by the first second release operation is avoided.

Those of ordinary skill in the art will appreciate that: the discussion of any of the embodiments above is merely exemplary and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples; the technical features of the above embodiments or in the different embodiments may also be combined under the idea of the present disclosure, the steps may be implemented in any order, and there are many other variations of the different aspects of the embodiments of the present disclosure as described above, which are not provided in details for the sake of brevity.

While the present disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations of those embodiments will be apparent to those skilled in the art in light of the foregoing description.

The disclosed embodiments are intended to embrace all such alternatives, modifications and variances which fall within the broad scope of the appended claims. Accordingly, any omissions, modifications, equivalents, improvements, and the like, which are within the spirit and principles of the embodiments of the disclosure, are intended to be included within the scope of the disclosure.

Claims

1. A trans-arch thoracic aortic stent graft, comprising:

the device comprises a main body bracket and an embedded bracket, wherein the main body bracket is a covered bracket and is provided with a concave part; the concave part is concave from the outer wall of the main body bracket to the center of the main body bracket; the embedded bracket is arranged in the main body bracket; the main body support is provided with a binding piece, the binding piece binds the main body support to a contracted state, and the main body support is released to an unfolding state by the releasing of the binding piece.

2. The trans-arch thoracic aortic stent graft of claim 1, wherein the tie down is disposed on the main body stent, the tie down having a free end; the free end of the tie down encircles the body scaffold and is used to tie down the body scaffold to a fully or partially contracted state, or to release to an unbound state.

3. The trans-arch thoracic aortic stent graft of claim 2, wherein a plurality of said tie-downs are provided, a plurality of said tie-downs being provided axially along the main body stent, each of said tie-downs being provided circumferentially around the main body stent; the free end of the binding piece is fixed by the core wire in a penetrating way; after the core wire is drawn out, the main body support is unbound and unfolded.

4. The trans-arch thoracic aortic stent graft of claim 2, wherein the tie comprises a loop structure having a central portion secured to the main body stent and two ends being the free ends; or (b)

One end of the rope loop structure is fixed on the main body bracket, and the other end is the free end; or (b)

The middle part of the rope loop structure is fixed on the main body support, the two ends are the free ends, one free end is a coil structure, and the other free end is a single rope structure with a ring at the end; or (b)

The middle part of the rope loop structure is fixed on the main body support, the two ends are the free ends, and the free ends are single rope structures with end loops; or (b)

One end of the rope loop structure is fixed on the main body support, the other end of the rope loop structure is the free end, and the free end is a single rope structure with a ring at the end.

5. The trans-arch thoracic aortic stent graft according to claim 1, wherein,

the embedded support comprises a common dry branch main body and a plurality of embedded branch supports; the common dry branch main body is provided with a first opening and a second opening, the common dry branch main body is anastomosed with the concave part at the first opening, one end of the embedded branch bracket is connected with the common dry branch main body, and the embedded branch bracket extends from the second opening to a direction far away from the concave part.

6. The trans-arch thoracic aortic stent graft of claim 5, wherein said co-dry branch body is a stent graft; the embedded branch bracket is a covered bracket, and a covered at the end part of the embedded branch bracket, which is close to the second opening, is connected with a covered at the end part of the common dry branch main body.

7. The trans-arch thoracic aortic stent graft of claim 1, wherein the recess comprises a plurality of axially distributed circular arc wave rings, the circular arc wave rings comprising corners; the chord length of the concave part and the arc length of the arc wave ring have a preset proportion.

8. The trans-arch thoracic aortic stent graft of claim 7, wherein the corners of the circular arc wave ring are located at the peaks or troughs of the circular arc wave ring.

9. A trans-aortic arch stent graft system comprising a trans-aortic arch stent graft as claimed in any one of claims 1 to 8 and a delivery system; the arch-crossing thoracic aortic stent graft is preloaded on the conveying system, and the conveying system is provided with a handle with a cavity; the conveying system further comprises a stay wire handle which is arranged on the handle shell in a penetrating way; the pull wire handle is provided with a core wire which passes through the tie down so as to tie down the main body support to a fully or partially contracted state by the tie down.

10. The trans-arch thoracic aortic stent system of claim 9, wherein the pull wire handle comprises a first pull wire handle and the core wire comprises a first core wire; one end of the first core wire in the axial direction is connected with the first stay wire handle; and/or

The stay wire handle comprises a second stay wire handle, and the core wire comprises a second core wire; one end of the second core wire in the axial direction is connected with the second stay wire handle.

11. The trans-arch thoracic aortic stent system of claim 10, wherein the second wire handle has a profiled structure and is captured between the first wire handle and the inner wall of the handle by the profiled structure.

12. The trans-arch thoracic aortic stent system of claim 11, wherein a clamping portion is provided at a trailing end of the handle, the cavity being provided at the clamping portion; the sum of the thickness of the first stay wire handle and the thickness of the second stay wire handle is the same as the thickness of the cavity; the special-shaped structure is a first boss, and a first groove matched with the first boss is formed in the inner wall of the clamping part; or (b)

A first distance is reserved between the first stay wire handle and the second stay wire handle; the special-shaped structure is a second boss, and the shell of the handle is provided with a second boss channel matched with the second boss; the length of the second boss is greater than the length of the second boss channel.

13. The trans-arch thoracic aortic stent system of claim 10, wherein the first pull wire handle has a second groove and the handle housing has a third boss that slides in the second groove to enable the first pull wire handle to be withdrawn from the handle to release the tie.