Cross-arch thoracic aorta covered stent and system with same

Abstract

The utility model provides a cross-arch thoracic aorta covered stent, which comprises a main stent body, a cross-arch thoracic aorta covered stent body and a cross-arch thoracic aorta covered stent body, the embedded support and the outlet are formed in the front end of the concave part; wherein the embedded bracket comprises three embedded brackets and a common main body; the embedded stent is used for being communicated with the branch stent in the corresponding branch artery. The embodiment of the utility model further provides a cross-arch thoracic aorta covered stent system. The cross-arch thoracic aorta covered stent system comprises a cross-arch thoracic aorta covered stent and a conveying system. A first binding piece and a second binding piece are arranged on the main body bracket; the conveying system comprises a first core wire, a second core wire, a first stay wire handle and a second stay wire 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 is connected with the second core wire; and the second stay wire handle has a special-shaped structure.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a transthoracic aortic stent graft and a system having the same. Background Art

[0002] With the aging of the population and the increase in hypertension and arteriosclerosis, the number of patients with aortic diseases is increasing year by year. Arch lesions account for one-third of aortic diseases, and these patients are still mainly treated with open surgery. However, open surgery is traumatic and requires extracorporeal circulation or even deep hypothermic circulatory arrest, and the operation time is long. The longer the operation time, the higher the postoperative complications and mortality rate. Minimally invasive treatment of diseases involving the aortic arch is the goal of aortic disease treatment after simple lesions have been minimally invasively treated.

[0003] At present, intravascular isolation technology is mainly used for the treatment of non-major branch vessel segments such as the descending aorta and branch vessels with strict requirements on operation time and blood flow blockage, such as the abdominal aortoiliac artery. The three important branch vessels on the thoracic aortic arch are responsible for supplying blood to the brain and upper limbs. The blood supply blockage time of the brain cannot be too long. Ischemia of more than ten minutes will cause serious irreversible damage to the brain due to hypoxia. The diameter, spacing, position and direction of the three branch vessels vary from person to person.

[0004] These factors determine that the multi-branch design is difficult to meet most clinical needs, and it is difficult to operate and has a high surgical complication rate. Utility Model Content

[0005] In view of this, the purpose of the present application is to provide a transthoracic aortic covered stent and a system having the same.

[0006] Based on the above purpose, the present application provides a transthoracic aortic stent graft, comprising:

[0007] A main frame and an embedded frame, wherein the main frame is a coated frame and has a recessed portion; the recessed portion is recessed from the outer wall of the main frame toward the center of the main frame; the embedded frame is arranged in the main frame;

[0008] A restraining member is arranged on the main body support, one end of the restraining member is fixed on the main body support, and the other end is a free end; the restraining member is used to restrain the main body support to a contracted state or release it to an expanded state.

[0009] An embodiment of the present application also provides a trans-thoracic aortic covered stent system, comprising a trans-thoracic aortic covered stent and a delivery system as described in any of the preceding items; the trans-thoracic aortic covered stent is pre-installed on the delivery system, and the delivery system has a handle with a cavity; the delivery system also includes a pull-wire handle, and the pull-wire handle is passed through the handle shell; the pull-wire handle is provided with a core wire, and the core wire can pass through the restraining device, thereby restraining the main stent to a fully or partially contracted state through the restraining device.

[0010] The restraining member comprises a first restraining member, one end of which is fixed to the main body support and the other end is a free end; the first restraining member is used to restrain the main body support to a fully contracted state or release it to a released state.

[0011] The restraining member also includes a second restraining member, one end of which is fixed to the main body support and the other end is a free end, which is used to restrain the main body support to a partially contracted state or fully release it to an expanded state.

[0012] As can be seen from the above, the cross-arch thoracic aortic stent graft and the system having the same provided by the present application are provided with a main body stent, the main body stent is a stent graft and has a recessed portion; the recessed portion is recessed from the outer wall of the main body stent to the center of the main body stent; a restraining member is arranged on the main body stent, one end of the restraining member is fixed on the main body stent, and the other end is a free end; the restraining member is used to restrain the main body stent to a contracted state or release it to an expanded state, and after the stent is released at the aortic arch through the restraining member, the large curved side of the main body stent (that is, the recessed part of the main body stent) will not stick to the wall of the aortic arch, so that there is space between the main body stent and the vascular wall of the aortic arch, so that the guide wire and the small stent in the branch artery above the arch can enter the corresponding branch stent more easily, shortening the operation time and reducing surgical complications. In this way, the blood flowing out of the main body stent can continuously perfuse the branch blood vessels above the aortic arch. The bridging of the branch blood vessels can be carried out calmly without the need for low-temperature circulation or extracorporeal circulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to more clearly illustrate the technical solutions in the present application or related technologies, the drawings required for use in the embodiments or related technical descriptions are briefly introduced below. Obviously, the drawings described below are only embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0014] Figure 1 A schematic diagram of a first angle of the transthoracic aortic stent graft according to an embodiment of the present application;

[0015] Figure 2A schematic diagram of a second angle of the transthoracic aortic stent graft according to an embodiment of the present application;

[0016] Figure 3 This is a schematic diagram of the structure of the embedded bracket of an embodiment of the present application;

[0017] Figure 4 A schematic diagram of a third angle of the transthoracic aortic stent graft according to an embodiment of the present application;

[0018] Figure 5 It is a schematic diagram of the fourth angle of the transthoracic aortic stent graft according to an embodiment of the present application;

[0019] Figure 6 It is a schematic diagram of the fifth angle of the transthoracic aortic stent graft according to an embodiment of the present application;

[0020] Figure 7a A schematic diagram of a structure of a transthoracic aortic stent graft in which a first core wire and a first binding member or a second core wire and a second binding member are fixed and constrained in an embodiment of the present application;

[0021] Figure 7b for Figure 7a A schematic diagram of the structure of the restraining member in FIG.

[0022] Figure 8a Another structural schematic diagram of a transthoracic aortic stent graft in which a first core wire and a first restraining member or a second core wire and a second restraining member are fixed to be constrained according to an embodiment of the present application;

[0023] Figure 8b for Figure 8a A schematic diagram of the structure of the restraining member in FIG.

[0024] Figure 9a A schematic diagram of a conveying system according to an embodiment of the present application from one angle;

[0025] Figure 9b A schematic diagram of a conveying system according to an embodiment of the present application from another angle;

[0026] Fig.10 A schematic diagram of a conical head according to an embodiment of the present application;

[0027] Fig.11 A schematic diagram of an image state of a mark of a conical head according to an embodiment of the present application;

[0028] Fig.12 A schematic diagram of another image state of the mark of the conical head according to an embodiment of the present application;

[0029] Fig.13 A schematic diagram of another image state of the marking of the conical head of the embodiment of the present application;

[0030] Fig.14 A schematic diagram of another image state of the marking of the conical head according to an embodiment of the present application;

[0031] Fig.15 This is a schematic diagram of the relationship between the core wire, the support tube and the core shaft tube in the stent loading area of ​​the embodiment of the present application;

[0032] Fig.16 A schematic diagram of a fixator according to an embodiment of the present application;

[0033] Fig.17 A schematic cross-sectional view of a support tube according to an embodiment of the present application;

[0034] Fig.18 It is a cross-sectional schematic diagram of a three-lumen tube according to an embodiment of the present application;

[0035] Fig.19 A schematic diagram of a combination of a first pull-wire handle and a second pull-wire handle according to an embodiment of the present application;

[0036] Fig. 20 A schematic diagram of a release process of the first pull-wire handle and the second pull-wire handle of an embodiment of the present application;

[0037] Fig.21 A schematic diagram of the structure of the first pull-wire handle and the second pull-wire handle of the embodiment of the present application;

[0038] Fig.22a This is another schematic diagram of a combination of the first pull-wire handle and the second pull-wire handle according to an embodiment of the present application;

[0039] Figure 22b for Fig.22a The cross-sectional view along DD direction;

[0040] Fig.23 Another structural schematic diagram of the first pull-wire handle and the second pull-wire handle of the embodiment of the present application;

[0041] Fig.24 A schematic diagram of delivering the transthoracic aortic stent graft according to an embodiment of the present application to a target location;

[0042] Fig.25 This is a schematic diagram of a semi-expanded state of the transthoracic aortic stent graft according to an embodiment of the present application;

[0043] Fig.26 A schematic diagram of blood flow in a semi-expanded state of the transthoracic aortic stent graft according to an embodiment of the present application;

[0044] Fig. 27 This is a schematic diagram of the transthoracic aortic stent graft after release according to an embodiment of the present application;

[0045] Fig.28 for Fig. 27 The cross-sectional view at AA';

[0046] Fig.29 A schematic diagram of blood flow after the transthoracic aortic stent graft is released according to an embodiment of the present application;

[0047] Fig.30 This is a schematic diagram of the transthoracic aortic stent graft bridging the brachial artery in an embodiment of the present application;

[0048] Fig.31 This is a schematic diagram of a transthoracic aortic stent graft bridging the left carotid artery according to an embodiment of the present application;

[0049] Fig.32 This is a schematic diagram of a transthoracic aortic stent graft bridging the left subclavian artery according to an embodiment of the present application;

[0050] Figure 33a-Figure 35b Schematic diagram of other implementations of the restraining member of the embodiment of the present application;

[0051] Figure 36a-Figure 36e This is a schematic diagram of a handle according to an embodiment of the present application. DETAILED DESCRIPTION

[0052] In order to make the objectives, technical solutions and advantages of the present application more clearly understood, the present application is further described in detail below in combination with specific embodiments and with reference to the accompanying drawings.

[0053] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in the embodiments of the present application should be the usual meanings understood by people with ordinary skills in the field to which the present application belongs. The "first", "second" and similar words used in the embodiments of the present application do not represent any order, quantity or importance, but are only used to distinguish different components. "Including" or "comprising" and similar words mean that the elements or objects appearing in front of the word cover the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0054] Integrated three-branch aortic arch endovascular reconstruction technology is the technical crown of endovascular reconstruction and is also the unremitting pursuit of workers in related fields.

[0055] Currently, endovascular repair of the ascending aorta is performed by combining embedded stents. Although the operation is simpler with more branch stents, the overlapping combination of multiple stents in the ascending aorta and the aortic arch leads to a serious loss of elasticity of the ascending aorta and the aortic arch, and the loss of blood pressure regulation function. In addition, the overlapping combination of multiple stents leads to continuous friction between the metal stents (due to pulsation), which significantly reduces the durability of the stents. At the same time, the risk of internal leakage between overlapping interfaces is relatively high, it is difficult for the guidewire to enter the embedded stent, and the operation time is too long. In addition, the number of embedded stents is insufficient, and a branch blood vessel needs to be blocked or diverted. These problems limit the promotion of endovascular isolation treatment of the aortic arch.

[0056] Arch lesions are located in the thoracic aorta, which carries all the blood in the human body except the coronary blood flow. The branches above the arch are responsible for all the blood flow to the brain. Five minutes of intracranial hypoxia will cause irreversible damage. The arch makes a sharp 180-degree turn, and the ascending aorta is relatively fragile and easily damaged, making delivery difficult. Compared with the intracavitary treatment of the lower-lying vessels, the cross-arch intracavitary treatment has the following special requirements: 1) The operation time is required to be shortened as much as possible; 2) The branch blood flow is not blocked as much as possible, and deep hypothermic circulation or extracorporeal circulation is avoided; 3) The ascending aorta is a blood pressure buffer organ, and the impact of stent implantation is not significant; 4) The aortic arch is a large bend of 180° in a blood vessel, and the covered stent needs to conform to the anatomical structure of the blood vessel; 5) There are differences in diameter, spacing, and angle between the branch vessels. In addition, the diameter of the thoracic aorta varies greatly and the length of the lesion involvement varies. Therefore, a stent specification is required to simultaneously meet the requirements of different arch branch vessels to reduce the number of stent specifications as much as possible; 6) The impact of the ascending aorta blood flow is large, and it is difficult to accurately release the stent; 7) Three stents are used for intracavitary reconstruction to avoid occlusion of important branches or the need for surgical reconstruction of branches; reduce the difficulty of delivery and avoid damage to the ascending aorta. 8) At the same time, the same requirements as other intracavitary isolation are met, but the problem of no internal leakage is more difficult to achieve.

[0057] In the existing technology, the treatment of intracavitary isolation of the arch artery cannot fully meet the above six special requirements and cannot be effectively promoted. For example, the multi-branch technology cannot meet the requirements of 1), 2), 5) and 7); the pre-fenestration technology cannot meet the requirements of 7) and 8) and the requirements of the lesion involving the branch side; the in vivo fenestration technology cannot meet the requirements of 1), 2), 7) and 8); the chimney technology cannot meet the requirements of 2) and 8); the combined stent technology cannot meet the requirements of 1), 3), 7) and 8); the branch removal and hybrid surgery technology cannot meet the requirements of 1), 2), 7) and 8); the embedded stent technology cannot meet the requirements of 1), 2), 5), 7) and 8); the embedded stent plus platform stent technology cannot meet the requirements of 1), 4) and 7).

[0058] Based on this, the embodiment of the present application provides a design of an inner collapsed platform (i.e., a recessed portion) through the common trunk branch of the embedded stent and the main stent, which can solve requirement 1), that is, the inner collapsed platform (i.e., the recessed portion) facilitates the entry of the guide wire, and the smooth transition from the common trunk branch body to the embedded branch stent greatly shortens the time required for the guide wire to enter the branch, which is the most time-consuming process during the operation, and also greatly reduces the difficulty of the operation; requirement 2), the inner collapsed platform (i.e., the recessed portion) is opposite to the supra-arch branch, and before the branch vessel is reconstructed, after the blood flows out of the embedded stent, it flows smoothly into the supra-arch branch outside the inner collapsed platform (i.e., the recessed portion); requirement 5), the common trunk opening of the embedded stent (i.e., the main body of the common trunk branch) The second opening 703) is inserted into the front end of the brachiocephalic trunk. There is no need to align the embedded branch stent with the branch blood vessels one by one, so as to avoid the problem of different spacing and angles between the three branch blood vessels. The embedded three branches (that is, three embedded branch stents) of the stent bodies of different models and specifications are designed in the same way. The proximal end of the branch stent connected to the branch blood vessels is designed to be of a corresponding size, and the branch stents are set with different lengths and distal diameters to meet the problem of different diameters of different branch blood vessels; Requirement 7), the embedded three branches (that is, three embedded branch stents) ensure that all branches can achieve intracavitary reconstruction; Requirement 8), the proximal end of the branch stent is released in the embedded branch stent, which can effectively avoid the occurrence of internal leakage. Requirement 3) is solved by an integrated stent body to avoid the overlap of the stents caused by the combined stents, which seriously reduces the compliance of the stent segment. The stent at the collapsed part maintains a single independent semicircular ring design, which solves requirement 4), and the independent stent ring (that is, the circular wave ring) maintains the good bending property of the stent at the collapsed part, which solves the problem that the existing platform technology cannot meet the requirements of conforming to the curvature of the arterial arch due to the strong straightening force brought by the linked stents. By setting up a secondary release technology in the delivery system, demand 6) is solved. The cross-arch thoracic aortic stent graft can be further adjusted after the first release. The entire release process will not block blood flow and there is no wind cannon effect. At the same time, the delivery system adopts a sheath-free design, which significantly improves the flexibility of the delivery system; after the adjustable valve sheath is delivered in place, the delivery system is delivered from the sheath to avoid damage to the ascending aorta. The adjustable valve sheath and delivery system are delivered twice, thereby reducing the difficulty of the delivery system crossing the arch.

[0059] See also Figure 1 and Figure 2 An embodiment of the present application provides a transthoracic aortic covered stent, comprising: a main body stent 1, wherein the main body stent 1 has a recessed portion in the radial direction; the recessed portion is recessed from the outer wall of the main body stent toward the center of the main body stent.

[0060] The embedded stent 2 is arranged in the main stent; wherein the embedded stent 2 includes a common trunk branch body 204 and at least one embedded branch stent connected thereto; the embedded branch stent is used to communicate with the branch stent in the corresponding branch artery.

[0061] The above design can make the large curved side of the stent body collapse inward when it is located in the arch, so as to avoid blocking the blood supply of the branch artery after the main stent 1 is deployed. Before the blood vessels of the branch artery are bridged, the blood flowing out of the embedded stent 2 can flow smoothly into the branch blood vessels on the arch without the need for intraoperative diversion. And the flat step design of the large curved side of the stent body can make it have enough time to bridge the branch blood vessels on the arch during the operation, while avoiding the main stent 1 from pressing the embedded stent bridging the branch blood vessels on the arch, causing the embedded stent to collapse and occlude. When connected with the branch stent in the corresponding branch artery, the guide wire sent from the branch blood vessel can easily and naturally enter the common trunk branch body 204 and then enter the corresponding embedded stent through superselection, which can significantly reduce the time and difficulty of the guide wire entering the corresponding embedded stent from the distal end of the branch blood vessel. Since the smooth introduction of the guide wire from the branch blood vessel into the corresponding embedded stent is the key and difficulty of this operation, and it is also the most time-consuming process, the embodiment of the present application can greatly shorten the time and difficulty of guide wire alignment, thereby significantly reducing the difficulty of the operation and the time required for the operation. At the same time, after the stent graft is deployed, the blood flow of the branch vessels will not be blocked, and the branch vessels on the arch can continue to supply blood normally. Therefore, the cross-arch thoracic aortic stent graft of the embodiment of the present application can break the restrictions on the operation time, and does not require extracorporeal circulation or deep hypothermic circulatory arrest, thereby reducing the operator's operating skills requirements and surgical complications. This can promote the rapid popularization of intracavitary isolation treatment of lesions involving the arch.

[0062] The heights of the main support 1 on both sides of the recessed portion may be the same or different, depending on the thickness of the blood vessels on both sides of the three branches of the aortic arch that need to be adapted, as long as they can be adapted to the corresponding blood vessels on both sides of the three branches of the aortic arch that need to be adapted. Figure 1 and Figure 2 As shown, the heights of the main support 1 on both sides of the recessed portion are different, wherein the height of the proximal portion of the main support may be greater than the height of the distal portion of the main support. In other embodiments, the heights of the main support 1 on both sides of the recessed portion are different, wherein the height of the proximal portion of the main support may be less than the height of the distal portion of the main support. In other embodiments, the heights of the main support 1 on both sides of the recessed portion are the same, wherein the height of the proximal portion of the main support may be equal to the height of the distal portion of the main support.

[0063] The embedded stent is a coated stent, the common trunk branch body 204 is provided with a first opening 704 and a second opening 703, and the common trunk branch body 204 and the recessed portion are coated and anastomosed at the first opening (the definition of coating anastomosis: integrally formed or connected by coating); the embedded branch stent is a coated stent, one end of the embedded branch stent is connected to the common trunk branch body 204, and extends from the second opening 703 in a direction away from the recessed portion; the coating of the embedded branch stent at the end of the second opening 703 is anastomosed with the coating at the end of the common trunk branch body. The embedded branch stent fits the inner wall of the main stent 1. As an embodiment, the coating at the end of the embedded branch stent away from the first opening 704 (i.e., the proximal end of the embedded branch stent) is connected to the coating at the adjacent part of the main stent, such as suture connection.

[0064] The number of embedded branch stents can be set according to specific application requirements, for example, it can be set to one or more. In some embodiments, the embedded branch stent is a coated stent, and is set to multiple; multiple embedded branch stents are arranged side by side. Figure 3 and Fig.28 As shown, the embedded branch stents can be set to 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, the brachiocephalic trunk 803 artery, the left carotid artery 804 vessel and the left subclavian artery 805 vessel).

[0065] In some embodiments, Figure 4 As shown, one end of the embedded branch stent is fixedly connected to the first end of the common trunk branch body 204 away from the recessed portion, the proximal end of the peripheral coated stent (branch stent) is deployed in the embedded branch stent, and the distal end of the peripheral coated stent is deployed into the corresponding branch blood vessel to achieve the connection between the embedded branch and the corresponding branch artery. Preferably, the proximal end of the peripheral coated stent exceeds the embedded branch by a small distance. The proximal diameter of the peripheral coated stent is 5%-30% larger than the corresponding embedded branch diameter. That is, Figure 5 As shown, the outlet of the embedded branch stent (i.e., the opening through which the guide wire exits the embedded stent 2) faces the proximal end of the stent body 1. Figure 6 and Fig.28 As shown, the embedded stent is provided with an integrated common trunk branch body 204 and an embedded branch stent, and the embedded branch stent is arranged in parallel along the inner side of the stent body 1 to match the orientation of the branch blood vessel, and the inlet of the embedded branch stent (i.e., the second opening 703) is toward the distal end of the stent body. During the operation, Fig.25As shown, by placing the opening of the embedded stent (i.e., the first opening 704) before the front edge of the head wall trunk opening, it can adapt to the different spacing, angles, and number of branches on the arch. In addition, the first opening 704 formed by connecting the common trunk branch body 204 with the inner collapsed platform coating of the stent body 1 can make the guide wire sent from the branch blood vessel easily and naturally enter the common trunk branch body 204 and then enter the corresponding branch (i.e., the embedded branch stent) through superselection, and send the small coated stent (i.e., the branch stent) along the guide wire, and then connect the corresponding embedded branch stent to the corresponding branch blood vessel, thereby achieving bridging of the three branches of the artery.

[0066] In some embodiments, the diameters of the multiple embedded branch stents are respectively adapted to the blood vessel diameters of the corresponding branch arteries; or the multiple embedded branch stents all have preset diameters, and the preset diameters are adapted to the blood vessel diameter with the largest diameter among the branch arteries, so that the preset diameters of all embedded branch stents can meet the normal blood supply 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 adapted to the blood vessel diameter of one of the three corresponding 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, and can all meet the blood supply needs of the branch artery with the largest diameter among the three branch arteries.

[0067] The diameter of the proximal end of the branch stent is adapted to 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 respectively smaller than the diameters of the branch stents in the corresponding branch arteries. 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, it can be 10 to 20% smaller than the diameter of the proximal end of the corresponding branch stent, so that it can adapt to the sharp bend from the embedded branch stent to the branch vessel, resist the impact of blood flow, and avoid the branch stent from being bent.

[0068] The diameter of the distal end of the branch stent is adapted to the diameter of the corresponding branch artery. In some embodiments, the distal ends of the three branch stents can be set to a variety of diameter specifications, such as a gradient diameter. The lengths of the three branch stents can also be set to a variety of length specifications. The three branch stents can be spirally woven coated stents to maintain good bending properties of the coated stents.

[0069] The main stent 1 can be a spiral stent or a combination of multiple independent single-ring stents 302. In some embodiments, the main stent 1 includes multiple circular wave rings distributed along the axial direction, and the circular wave rings include multiple wave crests and multiple wave troughs. It can be understood that the area of ​​the main stent 1 other than the recessed portion includes multiple independent circular wave rings distributed along the axial direction. Each circular wave ring of the main stent 1 can be a single-ring nickel-titanium wire stent. Generally, the multiple circular wave rings distributed along the axial direction can include multiple wave crests and multiple wave troughs.

[0070] The recessed portion of the main support 1 includes a plurality of circular arc waves distributed along the axial direction, and the circular arc waves include a plurality of wave crests and a plurality of wave troughs. The turning angle α of the circular arc waves is at the apex of the wave crest or the wave trough, which is conducive to deformation when the support contracts; the chord length of the recessed portion and the arc length of the circular arc waves have a preset ratio. In some embodiments, the circular arc waves can be semicircular waves, which can be understood as the recessed portion including a plurality of independent semicircular waves distributed along the axial direction, and the chord length of the platform of the recessed portion (that is, the flat part of the recessed portion) and the arc length of the semicircular waves have a preset ratio. The preset ratio can make the area of ​​the semicircular recessed portion in the main support 1 appropriate, so that the outer semicircular space size above the recessed portion (adapting to the inner diameter of the common trunk branch body 204) can effectively meet the branch bridging requirements.

[0071] In some embodiments, the preset ratio is close to an integer. By controlling the ratio of the platform chord length to the semicircular arc length to a ratio close to an integer, such as 2, the corner of the manufactured independent semicircular stent 303 (i.e., the semicircular wave ring) can be set just in the same straight line as the crest or trough of the main stent 1 (i.e., the annular wave ring), thereby maintaining good symmetry when the stent is compressed or expanded. In this way, the design of an independent semicircular stent is realized in the depression, ensuring that the coated stent in the platform area of ​​the depression has good bending performance in the arch, conforming to the curved configuration of the blood vessel.

[0072] In some embodiments, the cross-sectional shape of the first opening 704 of the common trunk branch body 204 is semicircular or elliptical, and the first opening 704 is adapted to the shape of the corresponding arc wave circle, so that the first opening 704 and the corresponding arc wave circle have the same center. When the arc wave circle is a semicircular wave circle, the cross-sectional shape of the first opening 704 can be semicircular, and the two circles are overlapped, so that the main support 1 has good bendability and anti-bending properties.

[0073] In some embodiments, the arc wave ring and the annular wave ring can both be independent nickel-titanium wires. Figure 1 and Figure 2As shown, the circular wave rings can be overlapped at the proximal end of the main stent 1, which can make the sealing effect better, that is, when the first circular wave ring has a poor local sealing effect, the second one can supplement the sealing effect without increasing the anchor length requirement. The peaks of the multiple circular wave rings of the main stent are arranged on the same straight line, and the troughs are arranged on the same straight line, which has good compliance, reduces the radial support force requirements of a single stent, reduces the edge effect of the stent, and reduces the risk of reverse tearing.

[0074] In some embodiments, at least one end of the main stent 1, at least one end of the embedded stent, the body of the embedded branch stent, the first opening 704 of the common trunk branch body 204, and at least one end of the recessed portion away from the common trunk branch body 204 have corresponding imaging marks. By setting the imaging marks, clear imaging can be achieved under X-rays, which is convenient for determining the position of the corresponding structure in the specific transthoracic aortic stent graft.

[0075] In some embodiments, both ends of the main stent 1 (i.e., the proximal end of the main stent 1 and the distal end of the main stent 1), both ends of the embedded stent (i.e., the entrance of the embedded stent and the exit of the embedded stent), the embedded branch stent (i.e., the part of the embedded branch stent between the entrance and the exit), the first opening 704 of the common trunk branch body 204, and the end of the recessed portion away from the common trunk branch body 204 are all provided with corresponding imaging marks, and each imaging mark is different. In this way, each structure in the cross-thoracic aortic stent graft can be more accurately judged under X-ray, so as to facilitate the identification of each embedded stent, and further shorten the time to smoothly introduce the guide wire from the branch blood vessel into the corresponding embedded stent.

[0076] Specifically, Figure 1 and 2 As shown, a proximal mark 701 may be provided at the proximal end of the main support 1, and a distal mark 707 may be provided at the distal end of the main support 1. An embedded branch support entrance mark 702 may be provided at the entrance of the embedded branch support, and an embedded branch support exit mark 703a may be provided at the exit (i.e., the second opening 703) of the embedded branch support, and a corresponding embedded branch support mark 705 may be provided at the portion between the entrance and the exit of the embedded branch support. When the number of embedded branch supports is set to multiple, for example, three, different marks may be provided in the three embedded branch supports respectively, or different marks may be provided in only two embedded branch supports, so as to better distinguish each embedded branch support. A common trunk branch opening mark 704a is provided at the first opening 704 of the common trunk branch body 204. A recessed portion end mark 706 is provided at the distal end of the recessed portion.

[0077] The present application also provides a transthoracic aortic stent graft system, comprising a transthoracic aortic stent graft as described in any of the preceding items and a delivery system. The delivery system is used to deliver the transthoracic aortic stent graft to a thoracic aorta (such as Fig.24 Before use, the transthoracic aortic stent graft may be pre-installed on the delivery system, and when the transthoracic aortic stent graft is completely released in the human body, the delivery system is withdrawn.

[0078] In order to solve the problem that the position and angle cannot be adjusted after the stent is released, in some embodiments, the cross-thoracic aortic stent graft provided by the utility model is designed to have a secondary release function, and its principle is to first release the stent to a semi-expanded state, adjust the position and angle, and then release the stent to a fully expanded state. Specifically, the cross-thoracic aortic stent graft may also include a first binding member 601 and a second binding member 602. Among them, the first binding member 601 and the second binding member 602 can be used to bind the main stent 1 to a fully contracted state or a partially contracted state, respectively. In this way, during transportation, in conjunction with the transportation system, the cross-thoracic aortic stent graft can be transported, initially deployed and secondarily deployed, effectively avoiding blood flow blockage and inaccurate release position caused by blood flow impact. After the initial deployment, circumferential and axial movement can also be performed as needed, which can greatly reduce the operator's operating skill requirements, and the operator does not need to send the guide wire into the branch, control the brain disconnection time, and have rich experience in left subclavian artery bypass, etc., which reduces the difficulty of the operation and facilitates the rapid promotion of the procedure.

[0079] In some embodiments, the first binding member 601 and the second binding member 602 can be provided in plurality, and are spaced apart in the axial direction of the main support 1. Figure 1 and Figure 2 As shown, the first restraint member 601 and the second restraint member 602 are in a state after the transthoracic aortic stent graft is fully deployed.

[0080] The first binding member 601 may be a rope loop structure, which is sewn on the main support 1. In some embodiments, the first binding member 601 may include two oppositely disposed closed first rope loop structures 6011 and 6012, such as Figure 7a and Figure 7bAs shown, it is a schematic diagram of the structure of a first binding member 601 in a transthoracic aortic stent graft in a contracted state. The first binding member can be arranged around the circumference of the main stent, and one end of the first rope loop structure 6011 and one end of 6012 can be fixed (for example, sutured) on the main stent 1, and the other ends are free ends. After the first rope loop structures 6011 and 6012 surround or semi-surround the main stent 1, they are pre-tightened or released by the relevant structure of the delivery system (for example, the first core wire 1101). For example, the first core wire 1101 can be inserted through the free end of the first rope loop structure 6011 and the free end of 6012 to cooperate with fixing the first core wire 1101 at the connection position of the first rope loop structure 6011 and 6012 to pre-tighten the first binding member 601. In this way, the first rope loop structures 6011 and 6012 can be pre-tightened by the relevant structure of the delivery system (for example, the first core wire 1101) to bind the main stent 1 to a contracted state. After the related structures (such as the first core wire 1101) are extracted, the first rope loop structures 6011 and 6012 are separated to partially release the transthoracic aortic stent graft to partially deploy. This structure has the advantages of easy operation and reliable pre-tightening. The diameters of the first rope loop structures 6011 and 6012 can be the same or different, which can be set according to the actual application.

[0081] In other embodiments, Figure 8a and Figure 8b As shown, the first restraint 601 may only include a closed second rope loop structure 6013. One end (fixed end) of the second rope loop structure 6013 is fixed (e.g., sutured) on the main support 1, and the other end (free end) thereof surrounds the main support 1, and pre-tightens or releases the main support 1 through the relevant structure of the delivery system (e.g., the first core wire 1101). For example, the first restraint 601 may be pre-tightened by the first core wire 1101 being respectively and simultaneously inserted into the free end and the fixed end of the second rope loop structure 6013 to form a loop structure.

[0082] Similarly, in some embodiments, reference Figure 7a and Figure 7b The second binding member 602 may be a rope loop structure, for example Figure 7a Specifically, the first tie 601 and the second tie 602 may include the same rope loop type, or different rope loop types, or different combinations, and the diameter of the second tie 602 may be larger than that of the first tie 601. The configuration can be based on actual application.

[0083] At the same time, the tie can also use a single free end or a single rope with small rings at both ends (such as the third rope loop structure 6015, the fourth rope loop structure 6016 or the fifth rope loop structure 6017), the structure reference Figure 33a to Figure 33b , Figure 34a to Figure 34b , Figure 35a-35b The middle part of the third rope loop structure 6015 is fixed on the main frame, and both 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. The middle part of the fourth rope loop structure 6016 is fixed on the main frame, and both ends are the free ends, and the free end is a single rope structure with a ring at the end. One end of the fifth rope loop structure 6017 is fixed on the main frame, and the other end is the free end, and the free end is a single rope structure with a ring at the end.

[0084] In some embodiments, Figure 9a and Figure 9b As shown, the delivery system may include a conical head, a marker, a first core wire 1101, a second core wire 1102, a first pull-wire handle 1201, a second pull-wire handle 1202, a fixer, a core shaft tube, a support tube, a handle, a tail end connector and a loader. The marker may be set on the conical head; the first core wire 1101 is used to pre-tighten the first binding member 601; the second core wire 1102 is used to pre-tighten the second binding member 602; the first pull-wire handle is connected to 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 to the first pull-wire handle. The second pull-wire handle is connected to the second core wire 1102 for controlling the second core wire 1102. Specifically, one end of the second core wire in the axial direction is connected to the second pull-wire handle. The first pull-wire handle and the second pull-wire handle are respectively passed through the handle shell, that is, the first pull-wire handle and the second pull-wire handle are partially located inside the handle and partially located outside the handle; the second pull-wire handle has a special-shaped structure, and the second pull-wire handle is clamped on the handle through the special-shaped structure.

[0085] Specifically, a mark 10 is provided on the conical head 9. The mark can be a development mark, for example, which can be developed under X-ray images. Fig.10 As shown, the marker 10 may be composed of an axial marker 1001 and a radial marker 1002. The axial marker 1001 may be parallel to the mandrel tube 14, and the radial marker 1002 may be perpendicular to the plane formed by the axial marker 1001 and the mandrel tube 14. In the process of delivering the transthoracic aortic stent graft to the human body, when the opening of the embedded stent 702 is facing the X-ray, the marker image at the cone head may be projected as shown in FIG. Fig.11 and Fig.12 As shown. The axial mark 1001 may be in the shape of a long strip parallel to the whole. The radial mark 1002 may be in the shape of a circle parallel to the core wire. When the opening of the embedded stent is facing the greater curvature of the aortic arch 802, the image of the mark at the cone head may be as shown. Fig.13 and Fig.14 The axial mark 1001 may be in the shape of a strip, parallel to the core wire and substantially blocked by the core wire, while the radial mark 1002 may be in the shape of a rectangle perpendicular to the plane where the core wire is located.

[0086] like Fig.15 and Fig.16 As shown, the mandrel tube 14 runs through the entire delivery system from the inside of the conical head 9 to the tail end connector 17 at the end, serving as a channel for tracking the guidewire, and can connect the entire delivery system. The transthoracic aortic stent graft is sleeved on the mandrel tube 14, and the support tube 15 is sleeved after the stent section of the mandrel tube 14 to the inside of the handle 16. The fixer 13 is composed of a fixing ring 1301 and a fixed core wire 1302. The fixing ring 1301 is a double-hole structure, which can be understood as a fixing ring with two holes of different inner diameters, including perforations and small holes. Among them, the large hole is sleeved on the mandrel tube 14, and the end of the fixed core wire 1302 is inserted in the small hole. A clothes fork-shaped structure is formed on the mandrel tube 14 by the fixer 13. In some embodiments, a coil may be provided on the inner side of the proximal end of the main stent 1, and the coil may be constrained (i.e., tied) by a fixed core wire 1302. The main stent 1 may be constrained by a fixator, and the coated stent may maintain an unchanged axial position with the delivery system during delivery, initial release, and full deployment, thereby ensuring accurate release of the coated stent.

[0087] like Fig.17 As shown, the support tube 15 includes a three-lumen tube 1501 and a thickened layer 1502 and a reinforced steel tube 1503 sleeved on the three-lumen tube 1501. The end of the thickened layer 1502 away from the conical head 9 is connected to the end of the reinforced steel tube 1503 close to the conical head 9. That is, the thickened layer 1502 covers the part of the three-lumen tube 1501 located in the body, and the reinforced steel tube 1503 covers the part of the three-lumen tube 1501 located outside the body. Fig.18 As shown, the three-lumen tube 1501 can be composed of a large cavity and two small cavities, which runs through the entire support tube 15 and is located in the innermost layer of the support tube 15. The three-lumen tube is a tubular structure with three cavities. The large cavity among the three cavities can be coaxially arranged with the three-lumen tube. The three-lumen tube is sleeved on the core shaft tube 14 through the large cavity, so that the core shaft tube 14 is arranged in the large cavity. The remaining two small cavities serve as channels for accommodating core wires 1101 and 1102 respectively. The external reinforced steel pipe 1503 of the three-lumen tube 1501 can be made of metal pipes such as stainless steel pipes to enhance the operability of the conveying system. The thickened layer 1502 sleeved at the proximal end of the three-lumen tube 1501 can make a smooth transition at the reinforced steel pipe, so that the conveying system can smoothly proceed when entering the adjustable sheath or the adjustable valve sheath is withdrawn.

[0088] like Figure 9a and Figure 9bAs shown, the rear end of the support tube 15 is provided with a handle 16 and a wire pull handle, and the wire pull handle is inserted into the handle 16; the wire pull handle can release the binding member. The handle 16 is used to facilitate the operation process to grasp and fix the first wire pull handle 1201 and the second wire pull handle 1202. In some embodiments, as Fig. 20 As shown, a clamping portion 18 having a cavity may be provided at the tail end of the handle. The clamping portion 18 may protrude from the tail end of the handle. Both the first pull-wire handle and the second pull-wire handle are inserted from the outside of the handle into the cavity of the clamping portion 18 of the handle 16. The sum of the thickness of the first pull-wire handle 1201 and the thickness of the second pull-wire handle 1202 is the same as the thickness of the cavity; the second pull-wire handle 1202 is inserted into the side wall of the handle by providing a special-shaped structure to limit the second pull-wire handle from being freely withdrawn from the cavity; after the first pull-wire handle is withdrawn from the cavity, the second pull-wire handle is withdrawn from the cavity after being detached from the inner wall of the handle. The special-shaped structure of the second wire-pull handle 1202 can be matched with the internal space of the clamping part of the handle 16, so that the first wire-pull handle 1201 and the second wire-pull handle 1202 can be pulled back in the order that the first wire-pull handle 1201 is pulled out before the second wire-pull handle 1202 can be pulled back, which can effectively avoid the failure of the first half-release function due to the wrong operation sequence. The sum of the thickness of the first wire-pull handle 1201 and the thickness of the second wire-pull handle 1202 and the special-shaped structure is greater than the thickness of the cavity.

[0089] In some embodiments, Fig. 20 and Fig.21 As shown, the second wire-pulling handle 1202 may have a first boss structure, that is, the special-shaped structure is a first boss 1203a, and the side wall of the clamping portion may be provided with a first groove that matches the first boss 1203a. The first boss 1203a is inserted into the first groove, and the first wire-pulling handle 1201 and the second wire-pulling handle 1202 are simultaneously accommodated in the cavity. At this time, only when the first wire-pulling handle 1201 is pulled out, the cavity has enough thickness to pull out the second wire-pulling handle 1202.

[0090] In other embodiments, Fig.22a , Figure 22b and Fig.23As shown, there is a first distance d1 between the first wire-pull handle 1201 and the second wire-pull handle 1202; the second wire-pull handle 1202 may have a special-shaped structure (i.e., a second boss 1203b), and the housing of the handle has a second boss channel adapted to the second boss 1203b; the length d2 of the second boss 1203b is greater than the first distance, and if the first wire-pull handle 1201 is not pulled out, the second wire-pull handle 1202 cannot be rotated to the point where the second boss 1203b matches the second boss channel 1208. In this way, the order of pulling back the wire-pull handles 1201 and 1202 must be to pull out the first wire-pull handle 1201 first, that is, to release the first restraining member 601 first, and then rotate the second wire-pull handle 1202 to the point where the second boss 1203b matches the second boss channel 1208, and then the wire-pull handle 1202 can be pulled back and pulled out, which can effectively avoid the failure of the semi-release function of the first deployment due to an incorrect operation sequence. Furthermore, a supporting protrusion 1204 is provided below the second boss channel 1208 to limit the rotation angle of the second wire pulling handle 1202 so as to be smoothly pulled out from the second boss channel 1208 .

[0091] Preferably, the first pull-wire handle 1201 has a special-shaped structure (i.e., has an L-shaped second groove 1203c), and the outer shell of the handle has a third boss 1207 that matches the second groove 1203c (which can be located at the edge of the through hole opened when the first pull-wire handle 1201 passes through the handle outer shell), and the first pull-wire handle 1201 needs to be rotated until the third boss 1207 is pulled from one end of the short side of the second groove 1203c to the other end before it can be pulled backwards (i.e., pulled out along the long side of the second groove 1203c), to prevent the bracket from being released during transportation or released by mistake. Through the structural design of the first pull-wire handle 1201 and the second pull-wire handle 1202, the belt post-release and secondary release of the conveying system are realized, ensuring precise positioning during the release process. In conjunction with the use of double binding and metal wires (i.e., the first binding piece 601, the second binding piece 602, the first guide wire and the second guide wire) at the main stent 1 to tie down the covered stent in a compressed state, the rear release structure can realize the initial deployment (i.e., partial deployment) and secondary deployment (i.e., complete deployment) of the transthoracic aorta covered stent, and neither the initial deployment nor the secondary deployment process will block the blood flow, effectively avoiding inaccurate release position due to blood flow impact.

[0092] Specifically, the step of rotating the wire pulling handle and extracting the core wire can be performed by Fig.36a , Fig.36b , Fig.36c and Fig.36d Description. Combine Fig.22a , Figure 22b and Fig.23 ,like Fig.36dAs shown, a third boss 1207 adapted to the second groove 1203c of the first pull-wire handle 1201 and a second boss channel 1208 adapted to the special-shaped structure (i.e., the second boss 1203b) of the second pull-wire handle 1202 may be provided on the outer shell of the handle, and the left and right ends of the second boss channel 1208 are respectively connected to the through holes opened when the first pull-wire handle 1201 and the second pull-wire handle 1202 are penetrated through the handle outer shell. Before starting to pull out the first pull-wire handle 1201, as shown in FIG. Fig.36a and Fig.36b , the long side of the second groove 1203c of the first pull-wire handle 1201 does not coincide 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). Since the length d2 of the special-shaped structure of the second pull-wire handle 1202 (i.e., the second boss 1203b) is greater than the length d1 of the second boss channel 1208 (i.e., the distance between the first pull-wire handle 1201 and the second pull-wire handle 1202), even if an attempt is made to rotate and pull out the second pull-wire handle 1202, the end of the second boss 1203b can only abut against the first pull-wire handle 1201, and cannot abut against the abutting protrusion 1204, that is, it cannot be rotated to coincide with the second boss channel 1208. When the restraining member needs to be released, such as Fig.36b and Fig.36d As shown, the first wire-pull handle 1201 can be rotated first until the third boss 1207 slides in the short side of the second groove 1203c at its L-shaped corner, so that the first wire-pull handle 1207 can be pulled out (the third boss 1207 slides out in the long side of the second groove 1203c). When the first wire-pull handle 1201 is completely pulled out, the second wire-pull handle 1202 is rotated again in the shell, and the special-shaped structure of the second wire-pull handle (i.e., the second boss 1203b) can be matched with the second boss channel 1208, so that the second wire-pull handle can be pulled out. In this way, the pulling order of the pull wire handles 1201 and 1202 must be to first rotate the first pull wire handle 1201 until the third boss 1207 is pulled out from the second groove 1203c of the first pull wire handle, that is, first release the first restraining member 601, and then rotate the second pull wire handle 1202 until the second boss 1203b is aligned with the second boss channel 1208, and then the pull wire handle 1202 can be pulled out, which can effectively avoid the failure of the semi-release function of the first deployment due to the wrong operation sequence.

[0093] Among them, Fig.36e As shown, the loader 80 is used to flush and exhaust the membrane and allow the stent graft to pass smoothly through the hemostatic valve of the adjustable valve sheath. Preferably, the loader may include a tube body 81, a side tube 82, a valve 83, a seat 84 and a hemostatic valve 85.

[0094] A schematic diagram of the thoracic aorta can be shown as Fig.24As shown. Before use of the transthoracic aortic stent graft system of the embodiment of the present application, the transthoracic aortic stent graft is pre-installed and fixed on the delivery system, and the side of the stent graft where the embedded stent 2 is located is consistent with the direction of the radial mark 1002. Among them, the stent graft is a self-expanding stent. Before being loaded into the delivery system, two fixed rope loops (i.e., restraints) of different sizes can be set on the coating 4. The small rope loop is the first restraint 601, and the large rope loop is the second restraint 602. When the stent graft is loaded into the delivery system, after the first restraint 601 is wrapped around the stent graft and tightened, the first restraint 601 (with the first core wire 1101) is tied to the stent graft. Figure 7a For example, the two ends of the two fixed rope loops respectively embrace the stent graft, and the core wire passes through the overlapping parts of the two free ends of the two first restraining members 601 after the embrace, so that the first restraining members 601 remain in a complete ring constraining the stent graft; or Figure 8a For example, after the free end of a fixed rope loop embraces the stent graft and passes around its fixed end, a ring is formed to constrain the stent graft, and the core wire passes through the fixed rope loop to form a limiting structure so that the restraining member cannot be released), thereby keeping the stent graft in a compressed state and fixed on the delivery system. After the stent graft is bound and restrained by the first restraining member 601, the second restraining member 602 is surrounded by the stent graft in a similar manner to the first restraining member 601, and the second core wire 1102 is passed through the free end of the second restraining member 602 to limit the restraining member so that it cannot be released. At the same time, the coil on the inner side of the front end of the stent body 1 can also be tied by the fixed core wire 1302 on the fixer 13 to fix the proximal end of the stent graft.

[0095] When the cross-arch thoracic aortic stent graft is implanted into the thoracic aorta, the perspective field of view can be adjusted to maximize the field of view of the aortic arch. When the delivery system pushes the cross-arch thoracic aortic stent graft to the point where the conical head is close to the aortic arch, the delivery system is rotated so that the radial mark 1002 faces the greater curvature, and when the axial mark 1001 is basically overlapped with the hardened guide wire, it means that the opening of the embedded stent 2 is facing the top of the aortic arch.

[0096] Combined with the mark 704a at the opening of the embedded stent 2, it is sent to the front edge of the opening of the brachiocephalic trunk 803 to achieve accurate positioning of the coated stent. Fig.25 As shown, since the fixator fixes the proximal end of the stent graft, the delivery system can push the stent graft in the sheath and accurately position the stent graft at the lesion (to prevent the stent graft from moving backward relative to the delivery system when pushing and withdrawing the core wire 11).

[0097] When the delivery system delivers the stent graft to the right place, first pull the wire handle 1201 of the first core wire 1101 (there is no specific correspondence between the restraining member, the core wire and the wire handle, and this embodiment is only used to illustrate the secondary release process of the main stent). The core wire 1101 is pulled out from the second restraining member 601, and the second restraining member 601 loses its restraint on the stent graft. The stent graft is unfolded to a state constrained by the second restraining member 602. At this time, the stent graft is in a partially unfolded state (e.g., a semi-expanded state), such as Fig.25 and Fig.26 shown.

[0098] When the first pull handle 1201 is pulled out, the limit of the pull handle 1202 is released, and the special-shaped structure can be moved to the specified position, and then the pull handle 1202 connected to the core wire 1102 can be pulled back to pull the second core wire 1102 out of the second binding member 602. The second binding member 602 loses its constraint on the stent graft, and the stent graft is fully deployed by itself. Fig. 27 As shown. Since the fixed core wire 1302 on the fixator 13 tethers the coil on the inner side of the front end of the stent body 1 and fixes the proximal end of the stent graft, under the condition that the front end of the stent is constrained by the fixator, the stent graft can maintain an unchanged axial position with the delivery system during delivery, initial release and full deployment, ensuring the precise release of the stent graft. After the stent graft is fully released, the stent graft is anchored in the blood vessel. When the delivery system is withdrawn, the fixed core wire 1302 on the fixator 13 is pulled out of the coil on the inner side of the front end of the stent body 1, and the stent graft is released from the delivery system, as shown. Fig.28 , Fig.29 and Fig.30 shown.

[0099] The delivery system of the embodiment of the present application has no outer sheath itself, so it has good flexibility, so that the delivery system can push the cross-arch thoracic aortic stent graft to easily cross the arterial arch. When the cross-arch thoracic aortic stent graft is implanted, the adjustable valve sheath is first delivered to the ascending aorta 801, and then the stent delivery system is delivered from the adjustable valve sheath. It does not contact the vascular wall during delivery to the target blood vessel, effectively avoiding damage to the vascular wall during the delivery process of the cross-arch thoracic aortic stent graft. When the delivery system is pushed to the arterial arch, the mark 10 on the conical head 9 is used to confirm whether the embedded stent 2 and the recessed part of the cross-arch thoracic aortic stent graft are located on the greater curvature side of the aortic arch 802. If not, rotate the delivery system to align it. Then continue to advance the delivery system so that the cross-arch thoracic aortic stent graft enters the target position, that is, the common trunk branch body 204 is located before the opening of the brachiocephalic trunk 803 and the proximal end of the branch stent has sufficient anchoring length. After the cross-arch thoracic aortic stent graft is delivered to the target position, the adjustable valve sheath is first withdrawn to the end of the stent at the front end of the sheath tube. Then pull back the first pull handle 1201 connected to the first core wire 1101 to complete the first release of the cross-thoracic aortic stent graft, so that the main stent 1 is in a semi-expanded state. Since the cross-thoracic aortic stent graft is not attached to the blood vessel wall after the first release, the fixator also fixes the proximal end of the stent graft. Under this condition, the release position of the cross-thoracic aortic stent graft can be further adjusted, so that the coating 4 can be easily positioned in the axial and circumferential directions through the delivery system. Then pull back the second pull handle 1202 connected to the second core wire 1102 to complete the secondary release. Neither the first release nor the secondary release process will block the blood flow (during the first release, the blood flow outside the cross-thoracic aortic stent graft can continue to remain unobstructed, and during the secondary release, the blood flow inside the cross-thoracic aortic stent graft can continue to remain unobstructed) and the role of the fixator can avoid the displacement of the stent caused by the impact of blood flow, and easily achieve accurate release. Provide convenience for the subsequent bridging of branch vessels and avoid bridging failure and branch vessel occlusion.

[0100] The transthoracic aortic stent graft system using the embodiment of the present application has low surgical difficulty and short operation time, which is conducive to the promotion of surgery, improves postoperative effects, and reduces complications.

[0101] In the cross-thoracic aortic stent graft system of the present embodiment of the present application, since the embedded stent 2 is an integrated three-branch common trunk, after the cross-thoracic aortic stent graft is released at the cross-arterial arch, the first opening 704 of the common trunk branch body 204 is located before the leading edge of the opening of the brachiocephalic trunk 803. The cross-thoracic aortic stent graft is at the arterial arch, and the collapsed part of the cross-thoracic aortic stent graft (that is, the collapsed part of the concave part) fits the lesser curvature of the aortic arch 802 on the opposite side, and the collapsed part faces the three branch arteries on the arch, forming a cavity with the greater curvature of the arterial arch. Blood flows from the three branch openings into the common trunk branch body 204, then flows into the cavity on the greater curvature, and then flows into the three branch blood vessels on the arch, ensuring that the blood supply to the skull and upper limbs is not interrupted. Fig.31 , Fig.32 As shown in the figure, three guide wires are then sent through the vascular sheath from the corresponding branch blood vessels, and after entering the cavity on the greater curvature side, they are pushed to the front end, and the guide wire can easily enter the common trunk branch body 204, and then superselect into the corresponding embedded stent 2. Then a small-diameter covered stent (also known as a branch stent) of suitable specifications is sent along the guide wire to connect the embedded stent in the embedded stent 2 with the branch blood vessels, thereby realizing the intracavitary reconstruction of three-branch blood vessels. Since the greater curvature side of the arch collapses inward, it is ensured that after the stent is deployed, the main body of the cross-arch thoracic aorta covered stent will not adhere to the wall on the greater curvature side. In this way, the blood flowing out of the three branches can continuously perfuse the three branch blood vessels on the arch. The bridging of the three branch blood vessels can be carried out calmly without the need for cryogenic circulation or extracorporeal circulation. At the same time, the space between the stent and the blood vessel wall makes it easier for the guide wire and the small stent to enter the corresponding branch, shortening the operation time and reducing surgical complications. The metal stent of the entire cross-arch thoracic aorta covered stent adopts a single-ring nickel-titanium wire stent, including the collapsed part. The stent at the collapsed part is designed as a single independent semicircular closed loop, so that the stent graft body has good flexibility and can conform to any sharp bend of the arterial arch.

[0102] The three branches in the embodiment of the present application are merged into a common trunk body - a common trunk branch body 204. The common trunk branch body 204 forms a large opening (i.e., the first opening 704), and the first opening 704 is located outside the front end of the collapsed part of the main stent 1. The embedded common trunk main body opening is like a large pocket, which completely holds the front end of the cross-arch thoracic aortic covered stent at the collapsed part of the arterial arch and the large bend side of the arch. The guide wire sent from the branch artery can only enter the common trunk branch body 204 when it is pushed forward, and it will be relatively easy to super-select from the common trunk branch body 204 to enter the corresponding branch of the embedded stent. The three-branch common trunk design avoids the problem of not being able to adapt to different branch spacings, angles, sizes, and branch numbers (some people have branch blood vessels with common trunks). It only needs to move the common trunk opening (i.e., the first opening 704) of the embedded stent branch to the front edge of the opening of the brachiocephalic trunk 803.

[0103] The cross-arch thoracic aortic stent graft system of the embodiment of the present application has the following advantages: embedded three branches in the common trunk: all branch arterial vessels can be reconstructed, and there is no ischemia or diversion. All branch arterial vessels have been reconstructed, and there is no leakage in the branch vessels. In this way, by embedding three branches in the common trunk (that is, the embedded stent 2), the problems of different spacing, angles and common trunks of the branches on the arch can be met, and one embedded three-branch specification can meet the requirements. By setting a large opening (that is, the first opening 704) formed by the common trunk branch body 204, the guide wire sent from the branch blood vessel can be easily sent into the common trunk branch body 204. The three branches of the common trunk (that is, three embedded stents) minimize the anastomosis between the coatings. It can avoid the adverse effects of too many anastomotic sites on the durability of the stent and leakage.

[0104] The arch is designed with a concave part, and the stent at the platform of the concave part is an independent semicircular closed loop. The blood supply of all branches on the arch will not be affected, and the operator can easily bridge the branch blood vessels on the arch. Avoid intraoperative diversion, extracorporeal circulation, etc. Avoid the main stent 1 from compressing the bridging small covered stent (also known as the branch stent) to cause adverse events such as collapse, stenosis, and occlusion of the small covered stent. The independent single closed-loop stent makes the arch have good flexibility and can conform to any arch shape. There is good radial support force at the platform to prevent the main body of the stent from collapsing and folding.

[0105] The integrated main stent 1 has the advantages of simpler operation, shorter operation time and less blood loss. It avoids the loss of elasticity of the ascending aorta 801 and the aortic arch caused by the overlapping of multiple aortic stents, and retains the blood pressure regulating function of the ascending aorta 801 as much as possible. It avoids the reduction of durability and the risk of internal leakage at the connection caused by the overlapping of multiple aortic stents.

[0106] The delivery system is delivered to the ascending aorta through an adjustable valve sheath. The 801 delivery system has good flexibility and can easily cross the arterial arch; it will not cause damage to the blood vessel wall during the delivery process.

[0107] Branch direction positioning function: The conical head is equipped with radial marks in the direction of the embedded bracket 2. The conical head is equipped with axial marks in the direction of the embedded bracket 2 to assist in confirmation and ensure accurate positioning.

[0108] Secondary release function: The release process does not block blood flow, and the release is more accurate. The position of the stent can be further adjusted after the first deployment, making the release more accurate, easier and safer.

[0109] Secondary release error prevention function: before the first release operation, the secondary release operation cannot be performed, to avoid the failure of the secondary release operation caused by the secondary release operation being performed first.

[0110] Those skilled in the art should understand that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of the present disclosure (including the claims) is limited to these examples. Based on the concept of the present disclosure, the technical features in the above embodiments or different embodiments may be combined, 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 detail for the sake of simplicity.

[0111] While the disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications and variations of these embodiments will be apparent to those skilled in the art in light of the foregoing description.

[0112] The embodiments of the present disclosure are intended to cover all such substitutions, modifications and variations that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the embodiments of the present disclosure should be included in the scope of protection of the present disclosure.

Claims

1. A transthoracic aortic stent graft, characterized in that: include: A main body bracket and an embedded bracket, the main body bracket is a coated bracket and has a recessed portion; the recessed portion is recessed 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; a restraining piece is provided on the main body bracket, the restraining piece restrains the main body bracket to a contracted state, and releasing the restraining piece releases the main body bracket to an expanded state.

2. The transthoracic aortic stent graft according to claim 1, characterized in that: The restraining member is arranged on the main body support and has a free end; the free end of the restraining member surrounds the main body support and is used to restrain the main body support to a fully or partially contracted state, or release it to a released state.

3. The transthoracic aortic stent graft according to claim 2, characterized in that: The restraining members are provided in plurality, and the plurality of restraining members are arranged axially along the main support, and each restraining member is arranged circumferentially around the main support; the free ends of the restraining members are fixed by passing through a core wire; after the core wire is pulled out, the main support is released from the restraint and unfolded.

4. The transthoracic aortic stent graft according to claim 2, characterized in that: The restraining member comprises a rope loop structure, the middle portion of the rope loop structure is fixed to the main support, and both ends are the free ends; or One end of the rope loop structure is fixed to the main support, and the other end is the free end; or The middle part of the rope loop structure is fixed on the main frame, and 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 The middle part of the rope loop structure is fixed on the main frame, and the two ends are free ends, and the free ends are single rope structures with rings at the ends; or One end of the rope loop structure is fixed on the main frame, and the other end is the free end, and the free end is a single rope structure with a ring at the end.

5. The transthoracic aortic stent graft according to claim 1, characterized in that: The embedded branch bracket includes a common trunk branch body and a plurality of embedded branch brackets; the common trunk branch body is provided with a first opening and a second opening, the common trunk branch body and the recessed portion are matched at the first opening, one end of the embedded branch bracket is connected to the common trunk branch body, and extends from the second opening in a direction away from the recessed portion.

6. The transthoracic aortic stent graft according to claim 5, characterized in that: The common trunk branch body is a coated stent; the embedded branch stent is a coated stent, and the coating at the end of the embedded branch stent close to the second opening is connected to the coating at the end of the common trunk branch body.

7. The transthoracic aortic stent graft according to claim 1, characterized in that: The recessed portion includes a plurality of circular arc wave circles distributed along the axial direction, and the circular arc wave circles include a corner; the chord length of the recessed portion and the arc length of the circular arc wave circle have a preset ratio.

8. The transthoracic aortic stent graft according to claim 7, characterized in that: The turning corner of the circular arc wave circle is located at the crest or trough of the circular arc wave circle.

9. A transthoracic aortic stent graft system, characterized in that: It comprises the trans-thoracic aortic covered stent and delivery system as described in any one of claims 1-8; the trans-thoracic aortic covered stent is preinstalled on the delivery system, and the delivery system has a handle with a cavity; the delivery system also includes a pull-wire handle, and the pull-wire handle is passed through the handle shell; the pull-wire handle is provided with a core wire, and the core wire passes through the restraint, so as to restrain the main stent to a fully or partially contracted state through the restraint.

10. The transthoracic aortic stent graft system according to claim 9, characterized in that: The wire pulling handle comprises a first wire pulling handle, and the core wire comprises a first core wire; one end of the first core wire along the axial direction is connected to the first wire pulling handle; and / or The wire pulling handle includes a second wire pulling handle, and the core wire includes a second core wire; one end of the second core wire along the axial direction is connected to the second wire pulling handle.

11. The transthoracic aortic stent graft system according to claim 10, characterized in that: The second wire pull handle has a special-shaped structure, and is clamped between the first wire pull handle and the inner wall of the handle through the special-shaped structure.

12. The transthoracic aortic stent graft system according to claim 11, characterized in that: A clamping portion is provided at the tail end of the handle, and the cavity is provided at the clamping portion; the sum of the thickness of the first wire-pulling handle and the thickness of the second wire-pulling handle is the same as the thickness of the cavity; the special-shaped structure is a first boss, and the inner wall of the clamping portion is provided with a first groove adapted to the first boss; or There is a first distance between the first pull-wire handle and the second pull-wire handle; the special-shaped structure is a second boss, and the shell of the handle has a second boss channel adapted to the second boss; the length of the second boss is greater than the length of the second boss channel.

13. The transthoracic aortic stent graft system according to claim 10, characterized in that: The first wire-pulling handle has a second groove, and the handle shell has a third boss. The third boss slides in the second groove to enable the first wire-pulling handle to be pulled out of the handle to release the binding member.

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