Intraoperative stent

Abstract

The application discloses an intraoperative stent, which comprises a main stent, an inlay body which is at least partially accommodated in the main stent, an inlay channel which is arranged in the inlay body and penetrates through a proximal end and a distal end of the inlay body, the inlay channel is used for cooperating with an implanted external branch stent, and the inlay channel comprises an input port which is located on the proximal end side, and a closure body which is detachably connected with the inlay body, wherein the closure body comprises a radial closure body which is used for locally closing the input port to form a closure part, and the radial closure body which closes the input port can be selectively removed. The application aims to solve the problems that the size of the inlay body in the intraoperative stent is single, the inlay body cannot be flexibly modified, the application range of the product is narrow, and the flexibility of the operation is low.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an intraoperative stent. Background Technology

[0002] Aortic dissection (AD), also known as aortic aneurysm, is a serious cardiovascular emergency. It occurs when a tear appears in the intima of an artery, allowing blood to enter the arterial wall and form a hematoma. This hematoma further tears apart the intima and media of the aorta, resulting in aortic dissection.

[0003] See Figure 1A Aortic dissection is classified into Stanford type A and type B based on the location of the tear. The incidence of Stanford type A aortic dissection (TAAD) is approximately twice that of Stanford type B aortic dissection (TBAD), and without timely treatment, the 24-hour mortality rate is as high as 50%. For TAAD, current guidelines recommend early open surgery to repair the torn aorta. Open surgery often requires a median thoracotomy and deep hypothermic circulatory arrest.

[0004] Currently, traditional surgery for type A aortic dissection requires the freeing of the autologous brachiocephalic trunk branches, left common carotid artery, and left subclavian artery (i.e., these three need to be cut and then anastomosed with the implanted artificial blood vessel through suturing). During the operation, a covered stent is placed into the true lumen of the descending aorta while the circulation is stopped. The covered stent and the four-branch artificial blood vessel (including the main branch of the artificial blood vessel, the artificial brachiocephalic trunk branch, the artificial left carotid artery branch, and the artificial perfusion branch) are set up separately. Therefore, it is necessary to suture the proximal end of the covered stent to the distal end of the four-branch artificial blood vessel and the autologous aortic wall. At the same time, each branch needs to be sutured to each other of the autologous branches. Exposure is difficult, there is backflow interference during suturing, and the space for free suturing is limited, which increases the difficulty of anastomosis, resulting in more suture points. This leads to a prolonged time of circulatory arrest, which affects the protection of brain tissue. In addition, the difficult surgical operation increases the risk of post-anastomosis hemorrhage, prolongs the overall operation time, increases the time of cardiopulmonary bypass, and is not conducive to postoperative recovery.

[0005] In addition, when using intraoperative stents with embedded branches for branch reconstruction, the following problems exist: 1. Existing embedded branch channels are uniform and completely fixed to the covered stent. However, in reality, human blood vessel morphology varies, and the angle between the vessel port and the vessel varies. Therefore, establishing guidewire access during replacement is challenging, and the flexibility of the branch stent with embedded branch channels is required. 2. Existing intraoperative stents are operated under direct vision without DSA assistance. The release of branched intraoperative stents is done without visual guidance, and the actual release status of the branch stent and the main stent is unknown. Furthermore, it is difficult to perform other operations based on the intraoperative stent procedure. 3. The dimensions of the covered stent and embedded branches are determined at the factory. The embedded dimensions cannot be further adjusted according to needs, and there is no flexibility in modification, reducing the product's applicability and the flexibility of the surgery. Summary of the Invention

[0006] This application provides an intraoperative stent designed to solve at least some of the aforementioned technical problems.

[0007] This invention proposes an intraoperative stent, comprising:

[0008] Main support frame;

[0009] An inlay, at least partially housed within the main support structure, having an inlay channel extending from its proximal end to its distal end, the inlay channel for engaging with an implanted external branch stent, the inlay channel including an inlet located on the proximal side; and

[0010] A closure body is removably connected to the embedded body; wherein the closure body includes a radial closure body for partially closing the input port to form a closure portion, and the radial closure body closing the input port can be selectively removed.

[0011] In one embodiment, the unclosed portion of the input port is referred to as an open portion, and the closed portion has one or more independent radial closure bodies, each of which can be selectively removed independently.

[0012] In one embodiment, when multiple independent radial closures are provided, the multiple radial closures can be sequentially removed in a direction radially away from the opening to gradually enlarge the opening and reduce the closure.

[0013] In one embodiment, when multiple independent radial enclosures are provided, the multiple independent radial enclosures are provided with different identification marks.

[0014] In one embodiment, the embedded channel includes a first channel and a second channel, which are isolated from each other; or, the embedded channel includes a first channel, a second channel, and a connecting port, the connecting port being located between the first channel and the second channel and extending along the axial direction of the embedded body, the first channel and the second channel being interconnected through the connecting port; the input port includes a first input port of the first channel and a second input port of the second channel, the second input port being completely closed to be configured as the closure portion.

[0015] In one embodiment, a portion of the first input port is closed to be configured as the closure portion.

[0016] In one embodiment, the unclosed portion of the first input port is referred to as the open portion, which is located between the closed portion of the first input port and the closed portion of the second input port in the initial state.

[0017] In one embodiment, the closure includes a suture that closes a portion of the inlet by stitching to form the closure, and the suture can be selectively removed.

[0018] In one embodiment, after the suture closes a portion of the inlet, its two ends extend from the outer peripheral surface of the main body support, and the extended suture is knotted to form an anti-unraveling knot.

[0019] In one embodiment, the anti-detachment knot includes a first anti-detachment knot, a second anti-detachment knot, and a third anti-detachment knot. The two ends of the protruding suture are knotted at the two ends of the closed portion to form the first anti-detachment knot and the second anti-detachment knot, respectively. After forming the first anti-detachment knot and the second anti-detachment knot, the two ends of the suture are knotted together to form the third anti-detachment knot. The third anti-detachment knot is further away from the closed portion than the first anti-detachment knot and the second anti-detachment knot.

[0020] In one embodiment, the closure further includes a transverse closure for cooperating with the radial closure. The transverse closure is disposed along the length of the inlay from the starting and / or ending ends of the radial closure and is removably connected to the inlay. The transverse closure is used to cooperate with the radial closure to partially close the inlay channel to form a closed channel. The transverse closure that closes the inlay channel can be selectively removed.

[0021] In one embodiment, the enclosed channel has one or more independent transverse enclosures, each of which can be selectively removed independently.

[0022] In one embodiment, when the enclosure has one or more independent radial enclosures and the enclosure channel has one or more independent transverse enclosures, the number of radial enclosures and transverse enclosures are the same and correspond one-to-one.

[0023] In this invention, the proximal inlet of the inlay in the intraoperative stent is sealed with a closure body, and the suture of the closure body is tied to the outer surface of the main stent. During the operation, the closure body can be selectively removed, thereby adjusting the inlet diameter of the inlay body, allowing the surgeon to flexibly select branch stents based on the diameter of the supra-arch branch vessels during the operation. Attached Figure Description

[0024] Figure 1A This is a schematic diagram showing the different types of aortic dissection.

[0025] Figure 1 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0026] Figure 2 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0027] Figure 2 (a) is a schematic diagram of the structure of an intraoperative stent provided in an embodiment, wherein the first convex stent in this embodiment includes a covered segment and a bare segment.

[0028] Figure 2 (b) is a schematic diagram of the structure of an intraoperative stent provided in an embodiment, wherein the first convex stent in this embodiment includes a covered segment and a bare segment.

[0029] Figure 3 for Figure 2 The diagram shows a three-dimensional structure of the intraoperative stent (the skeleton on the main stent is not shown in the diagram).

[0030] Figure 4 This is a schematic diagram of the structure of an intraoperative stent including reinforcing bone, provided as an embodiment.

[0031] Figure 5 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0032] Figure 6 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0033] Figure 7 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0034] Figure 8 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0035] Figure 9A three-dimensional structural schematic diagram of a first example inlay in an intraoperative stent provided in one embodiment.

[0036] Figure 10 A three-dimensional structural schematic diagram of a second example inlay in an intraoperative stent provided in one embodiment.

[0037] Figure 11 for Figure 10 A schematic diagram of the end face structure of the embedded part is shown.

[0038] Figure 12 This is a planar schematic diagram of the first step in the implantation process of an intraoperative stent, as provided in one embodiment.

[0039] Figure 13 This is a plan view of the second step of the intraoperative stent implantation process, as provided in one embodiment.

[0040] Figure 14 This is a plan view of the third step in the implantation process of an intraoperative stent, as provided in one embodiment.

[0041] Figure 15 This is a plan view of the fourth step of the intraoperative stent implantation process, as provided in one embodiment.

[0042] Figure 16 This is a plan view of the fifth step of the intraoperative stent implantation process, as provided in one embodiment.

[0043] Figure 17 This is a plan view of the sixth step in the implantation process of an intraoperative stent, as provided in one embodiment.

[0044] Figure 18 This is a plan view of the seventh step in the implantation process of an intraoperative stent, as provided in one embodiment.

[0045] Figure 19 This is a plan view of the eighth step of the intraoperative stent implantation process, as provided in one embodiment.

[0046] Figure 20 This is a schematic diagram of the intraoperative stent provided in one embodiment.

[0047] Figure 21 This is a three-dimensional structural diagram of an intraoperative stent provided in one embodiment.

[0048] Figure 22 This is a top view of a partial structure of an intraoperative stent provided in one embodiment.

[0049] Figure 23 This is a top view of a partial structure of an intraoperative stent provided in one embodiment.

[0050] Figure 24 for Figure 23The diagram shows a top view of a partial structure in which the first and second free units of the stent move in parallel during the procedure.

[0051] Figure 25 for Figure 23 The diagram shows a lateral view of a local structure in which the first and second free units of the stent move in parallel during the procedure.

[0052] Figure 26 for Figure 23 The diagram shows a top view of a partial structure where the first and second free units of the stent intersect during the swinging process.

[0053] Figure 27 for Figure 23 The diagram shows a partial lateral view of the structure where the first and second free units of the stent intersect during the swinging process.

[0054] Figure 28 This is a side view of a partial structure of an intraoperative stent provided in one embodiment.

[0055] Figure 29 This is a side view of a partial structure of an intraoperative stent provided in one embodiment.

[0056] Figure 30 for Figure 29 The diagram shows a partial structural diagram of the stent during the procedure.

[0057] Figure 31 This is a side view of a partial structure of an intraoperative stent provided in one embodiment.

[0058] Figure 32 This is a side view of a partial structure of an intraoperative stent provided in one embodiment.

[0059] Figure 33 This is a side view of a partial structure of an intraoperative stent provided in one embodiment.

[0060] Figure 34 for Figure 33 The diagram shows a DD cross-sectional view of the intraoperative stent.

[0061] Figure 35 for Figure 33 The diagram shows a partial cross-sectional view of the stent during the operation.

[0062] Figure 36 This is a schematic diagram of the cross-sectional structure of a stent during surgery, provided as an embodiment.

[0063] Figure 37 This is a schematic diagram of the structure of an intraoperative stent including a suture, provided as an embodiment.

[0064] Figure 38 This is a schematic diagram of the structure when the second segment of the aortic artery is cut along the axial direction to form a suture.

[0065] Figure 39 This is a schematic diagram of the structure when the second arterial segment is opened to a certain width along the incision.

[0066] Figure 40 This is a schematic diagram of the structure when an external branch stent is implanted, based on the width of the opening along the slit and by directly observing the exposed groove.

[0067] Figure 41 This is a schematic diagram of the structure when the patch is sutured to the second arterial segment at the cut.

[0068] Figure 42 This is a schematic diagram of the cross-sectional structure of an intraoperative stent provided in one embodiment.

[0069] Figure 43 This is a schematic diagram of the structure of an intraoperative stent including a suture, provided as an embodiment.

[0070] Figure 44 This is a schematic diagram of the cross-sectional structure of an intraoperative stent provided in one embodiment.

[0071] Figure 45 This is a schematic diagram of the cross-sectional structure of an intraoperative stent provided in one embodiment.

[0072] Figure 46 This is a schematic diagram of the cross-sectional structure of an intraoperative stent provided in one embodiment.

[0073] Figure 47 This is a schematic diagram of the cross-sectional structure of an intraoperative stent provided in one embodiment.

[0074] Figure 48 This is a schematic diagram of the intraoperative stent suture repair component provided in one embodiment.

[0075] Figure 49 This is a schematic diagram of the intraoperative stent suture repair component provided in one embodiment.

[0076] Figure 50 This is a partial planar structural diagram of an intraoperative stent provided in one embodiment, which includes a closure body and a radial closure body that partially closes the inlet to form a closure portion.

[0077] Figure 51 This is a schematic cross-sectional view of an intraoperative stent with a closure portion, provided as an embodiment.

[0078] Figure 52 This is a schematic diagram of a planar structure of an intraoperative stent with three radial closure bodies within the closure portion, provided as an embodiment.

[0079] Figure 53 for Figure 52 The diagram shows the planar structure when the first radial closure body in the closure section of the stent is cut during the operation.

[0080] Figure 54 for Figure 52 The diagram shows the planar structure of the first radial closure body being pulled after being cut in the closure section of the stent during the operation.

[0081] Figure 55 for Figure 52 The diagram shows the planar structure of the first closure body after the closure section of the stent is cut during the operation and then removed.

[0082] Figure 56 for Figure 52 The diagram shows the planar structure when the closure body in the closure section of the stent is completely removed during the operation.

[0083] Figure 57 This is a schematic diagram of a local planar structure of an intraoperative stent with an anti-unraveling suture in one embodiment.

[0084] Figure 58 This is a schematic diagram of a local planar structure of an intraoperative stent with three anti-unraveling sutures, provided as an embodiment.

[0085] Figure 59 This is a partial planar structural diagram of an intraoperative stent provided in one embodiment, where the second inlet port is closed by two sutures and one suture is schematically interrupted.

[0086] Figure 60 for Figure 59 The diagram shows a local planar structure when the suture is pulled after being cut in the stent during the operation.

[0087] Figure 61 for Figure 59 The diagram shows a partial planar structure when the sutures are completely removed after the stent is cut during the operation.

[0088] Figure 62 This is a schematic diagram of a partial planar structure of an intraoperative stent where the first inlet is partially closed and the second inlet is completely closed, as provided in one embodiment.

[0089] Figure 63 This is a partial top view of an intraoperative stent provided in one embodiment, which includes a radial closure body and a transverse closure body.

[0090] Figure 64 for Figure 63 Enlarged diagram of point A in the middle.

[0091] Figure 65 for Figure 63Enlarged diagram of point B in the middle.

[0092] Figure label:

[0093] Intraoperative stent 10, aorta 20, first arterial segment 21, second arterial segment 22, incision 23, left subclavian branch 31, brachiocephalic trunk 32, left common carotid branch 33, artificial blood vessel 40, external branch stent 50;

[0094] Main support 100, first section 110, membrane 100a, first membrane 100a1, second membrane 100a2, wave ring 100b, wave rod 100b1, first wave ring 100b2, second wave ring 100b3, through hole 100c, abutment section 111, skeleton 1111, connecting membrane 1112, second section 120, third section 130, groove 140, bottom wall surface 141, first plane 1411, second plane 1412, side wall surface 142, through hole 1421;

[0095] 200 artificial blood vessels;

[0096] First convex support 300, waveband 310, rod 320, coated section 300a, bare waveband 300b;

[0097] Embedded body 400, embedded channel 410, non-enclosed channel 410a, enclosed channel 410b, input port 411, enclosed part 4111, open part 4112, output port 412, first channel 413, first input port 4131, second channel 414, second input port 4141, connecting port 415, fixed section 400a, free section 400b, external part 400b2, first free unit b1, second free unit b2, built-in section 400c;

[0098] Reinforcing bone 500, first reinforcing segment 510, second reinforcing segment 520;

[0099] Polyester fabric 600;

[0100] Second protruding bracket 700

[0101] Closure body 800, radial closure body 800a, first radial closure body 801, second radial closure body 802, third radial closure body 803, transverse closure body 800b, suture 810, anti-loosening knot 810a, first anti-loosening knot 811, second anti-loosening knot 812, third anti-loosening knot 813, transverse closure body 800b, transverse anti-loosening knot 800b1,

[0102] 900, 910, 911, 910a, 912, 920, 930, 941, 942. Detailed Implementation

[0103] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0104] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0105] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0106] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0107] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0108] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0109] During implantation, the end of each component closer to the operator is the proximal end, and the end farther from the operator is the distal end.

[0110] Example 1

[0111] See Figure 1 and Figure 19 The exemplary intraoperative stent 10 of this application can be applied to the treatment of aortic dissection in humans, particularly type A dissection. During treatment, the intraoperative stent 10 is implanted into the blood vessel to isolate the aortic dissection 20, allowing blood to flow through the pathway established by the intraoperative stent 10 and preventing blood from entering the dissection. Figure 19 As shown, the aorta 20 typically has three branch vessels: the left subclavian branch 31, the brachiocephalic trunk 32, and the left common carotid branch 33. The left common carotid branch 33 is located between the left subclavian branch 31 and the brachiocephalic trunk 32, with the brachiocephalic trunk 32 being closer to the proximal end of the intraoperative stent 10 than the left subclavian branch 31. Figure 19 (Left side of the image). It should be noted that, provided there is no structural conflict, each exemplary solution in this embodiment can be combined with any exemplary solution in other embodiments below to obtain a new technical solution.

[0112] For details, please refer to Figure 1The exemplary intraoperative stent 10 of the present invention includes a main stent 100, an artificial blood vessel 200, a first outwardly protruding stent 300, and an inlay 400. The main stent 100 is generally tubular with a certain axial extension length and has a main lumen. A groove 140 is provided on the outer peripheral surface of the main stent 100. The artificial blood vessel 200 is connected to the proximal end of the main stent 100. The first outwardly protruding stent 300 protrudes from the outer peripheral surface of the main stent 100 and is further away from the artificial blood vessel 200 relative to the groove 140; that is, the artificial blood vessel 200 and the first outwardly protruding stent 300 are located on the proximal and distal sides of the groove 140, respectively. The first outwardly protruding stent 300 has branch tubes. The first outwardly protruding branch 300 has a branch lumen that communicates with the main lumen of the main body scaffold 100; the inlay 400 has a preset axial extension length, the inlay 400 has a proximal end and a distal end, at least a portion of the inlay 400 is housed in the main lumen of the main body scaffold 100, and the inlay 400 has an inlay channel 410 that communicates with its proximal end and distal end, at least a portion of the inlay 400 is housed in the main body scaffold 100, and the inlay channel 410 of the inlay 400 communicates with the groove 140, the inlay channel 410 is used for anchoring and engaging with the implanted external branch scaffold 50.

[0113] Continue reading Figure 19 During the surgery, the aorta 20 is cut to form the first arterial segment 21 and the second arterial segment 22. The left subclavian branch 31, the brachiocephalic trunk 32, and the left common carotid branch 33 are all connected to the second arterial segment 22. During the surgery, the stent 10 is implanted into the human body through the incision. The main stent 100 is inserted into the second arterial segment 22 and anchored to it. The first convex stent 300 connected to the main stent 100 enters the left subclavian branch 31 and is anchored to it. At least a portion of the inlay 400 is disposed within the main stent 100. External branch stents 50 are implanted into the brachiocephalic trunk 32 and the left common carotid branch 33 through the inlay channel 410 of the inlay 400, so that external branch stents 50 are respectively disposed in the brachiocephalic trunk 32 and the left common carotid branch 33. The proximal end of the external branch stent 50 is anchored to the inlay 400. The end of the first arterial segment 21 is sutured to an artificial blood vessel 40, and the artificial blood vessel 200 and the end of the artificial blood vessel 40 can be connected by suturing. Of course, the artificial blood vessel 40 can also be omitted, so that the end of the artificial blood vessel 200 is directly connected to the first arterial segment 21 by suturing.

[0114] The intraoperative stent of this invention features a first convex stent protruding outwardly on the outer side of the main stent. A groove is formed on the main stent, and an inlay, at least partially disposed within the main stent, is provided. The inlay's embedded channel communicates with the groove. A pathway is established by anchoring the first convex stent to one branch of the arch. The pathway reconstruction of other branches of the arch is completed by anchoring the inlay to the implanted external branch stent. Compared to existing methods, this invention reduces the risk of convex branch migration. The first convex stent enables rapid pathway positioning and reconstruction, reducing the requirements on the morphology of the patient's own blood vessels. Furthermore, it better adapts to the vascular morphology after implantation, avoiding the risk of endoleak or detachment and improving reliability. Simultaneously, the reconstruction of pathways for other branches of the arch is achieved by anchoring the external branch stent through the groove and the inlay, enabling rapid reconstruction of other branches of the arch. This significantly reduces intraoperative suturing and anastomosis time, shortens the overall surgical time for arch branch reconstruction, and reduces surgical difficulty and risk—a particularly important feature in surgical procedures under cardiopulmonary bypass.

[0115] For example, see Figure 1 , Figure 2 , Figure 3 and Figure 9 The groove 140 includes a bottom wall surface 141 and a side wall surface 142 near the artificial blood vessel 200. The side wall surface 142 has a through hole 1421 through which the inlay body 400 can pass. The external branch stent 50 can enter through the inlay channel 410 of the inlay body 400, pass through the groove 140, extend into the arch branch and be released. The groove 140 is recessed relative to the maximum outer peripheral wall of the main stent 100, providing the operator with operating space and providing sufficient space for the external branch stent.

[0116] See Figures 1-3 In one embodiment, the bottom wall surface 141 of the groove 140 is inclined relative to the central axis of the main support 100. The distance between the bottom wall surface 141 and the central axis of the main support 100 gradually increases from the end near the side wall surface 142 to the end away from the side wall surface 142 (i.e., from the proximal end to the distal end). In other words, the bottom wall surface 141 gradually slopes upwards from the proximal end to the distal end of the main support 100. Preferably, the distal end of the bottom wall surface 141 connects to the outer circumferential surface of the main support 100 after gradually sloping upwards. Furthermore, to achieve a smooth connection between the distal end of the bottom wall surface 141 and the outer circumferential surface of the main support 100, the width of the bottom wall surface 141 can gradually narrow from the proximal end to the distal end. This width is the length along the direction perpendicular to the central axis of the main support 100.

[0117] In this embodiment, the bottom wall surface 141 of the groove 140 is inclined. On the one hand, it can provide sufficient space for the external branch stent, while also ensuring the capacity of the main stent cavity as much as possible. On the other hand, since the anatomical shape of human blood vessels is diverse, the position and direction of branch vessels are uncertain. Setting a sloping groove can make it easier for the surgeon to select branches during the operation, and the branch stent can be better released, ensuring the release shape of the branch stent.

[0118] For example, see Figure 1 The bottom wall surface 141 is set at an acute angle to the central axis xx of the main support 100, and the angle α between the bottom wall surface 141 and the central axis xx of the main support 100 is between 15° and 45°. The actual value of the angle α between the bottom wall surface 141 and the central axis xx of the main support 100 can be 15°, 30° or 45°, etc. This angle range satisfies the accommodation requirements of the external branch support, while avoiding excessive loss of the main cavity space of the main support.

[0119] For further details, please refer to [link / reference]. Figure 2 and Figure 3 In other embodiments, the bottom wall surface 141 includes a first plane 1411 and a second plane 1412. The first plane 1411 and the second plane 1412 are arranged at different angles to the central axis xx of the main support 100, that is, the first plane 1411 and the second plane 1412 are planes with different inclination angles. One end of each of the first plane 1411 and the second plane 1412 can be connected to the side wall surface 142, and the other end of each can be connected to the outer peripheral surface of the main support 100. For example, as shown... Figure 2 and Figure 3As shown, the inclination angle of the first plane 1411 is smaller than that of the second plane 1412, meaning the first plane 1411 is more gently sloping than 1412. The angle A between the first plane 1411 and the central axis xx of the main support 100 is between 15° and 40°, and the actual angle A between the first plane 1411 and the central axis xx of the main support 100 can be 15°, 30°, or 40°, etc. The angle B between the second plane 1412 and the central axis xx of the main support 100 is between 20° and 45°, and the actual angle B between the second plane 1412 and the central axis xx of the main support 100 can be 20°, 35°, or 45°, etc. Given that the left common cervical branch 33 is located between the left subclavian branch 31 and the brachiocephalic trunk 32, and the brachiocephalic trunk 32 is closer to the proximal end of the intraoperative stent 10 than the left subclavian branch 31, the first plane 1411 with a relatively small tilt angle corresponds to the left common cervical branch 33. The external branch stent 50 can smoothly enter the left common cervical branch 33 through the guiding effect of the first plane 1411. The second plane 1412 with a relatively large tilt angle corresponds to the brachiocephalic trunk 32. The external branch stent 50 can smoothly enter the brachiocephalic trunk 32 through the guiding effect of the second plane 1412. That is, in the circumferential direction, the second plane 1412 is located inside the first plane 1411. The brachiocephalic trunk branches and the left carotid trunk branch have different path lengths. By setting a first plane 1411 and a second plane 1412 with different tilt angles at the groove position, different branch release paths are obtained. This method greatly reduces the occupation of the main stent's lumen while ensuring that the external branch stent can be released completely. In addition, the tilt angles of the planes are set in a targeted manner for the positions of different branch vessels, so as to make more reasonable use of the guiding role of the first plane 1411 and the second plane 1412 for the external branch stent 50, further improving the convenience and accuracy of the release of the external branch stent 50.

[0120] As mentioned above, the insert 400 is at least partially housed within the main tube cavity of the main support 100. A through hole 1421 is provided on the side wall 142 of the main support 100, through which the insert 400 can pass. As one embodiment of this structure, see [reference needed]. Figure 3The embedded body 400 is placed entirely within the main tube cavity of the main support 100, and the proximal end of the embedded body 400 is fixed relative to the inner wall of the main support 100. A membrane is provided on the side wall surface 142 of the main support 100, and a through hole 1421 is provided on the membrane. The distal end face of the embedded body 400 passes through the through hole 1421 on the side wall surface 142 of the main support 100, and the distal end face of the embedded body 400 is connected to the membrane around the through hole 1421, so that the distal end face of the embedded body 400 plays a supporting and shaping role on the side wall surface 142 of the groove 140. In this way, the distal end face of the embedded body 400 and the through hole 1424 on the side wall surface 142 can be approximately or completely identical in shape. When the distal end face of the inlay 400 is connected to the side wall 142 of the main stent 100, the distal output port 412 of the inlay channel 410 can be aligned with the through hole 1421, and the output port 412 can be sutured to the periphery of the through hole 1421. The through hole 1421 communicates with the inlay channel 410 through the output port 412, thereby making the groove 140 communicate with the inlay channel 410. During the implantation of the external branch stent 50, the external branch stent 50 entering through the inlay channel 410 can enter the branch vessels such as the brachiocephalic trunk 32 or the left common carotid branch 33 through the through hole 1421 and the groove 140. After the external branch stent 50 is implanted, the proximal end of the external branch stent 50 forms an anchoring effect with the inlay 400. Obviously, one end of the bottom wall surface 141 is connected to the side wall surface 142 and the other end is connected to the outer peripheral surface of the main support 100, and one end of the side wall surface 142 is connected to the bottom wall surface 141 and the other end is connected to the outer peripheral surface of the main support 100.

[0121] See Figure 3 , Figure 9 and Figure 16 To ensure that the external branch stent delivery device can better select the corresponding supra-arc branch vessel after entering the embedded channel 410, and to ensure that the surgeon's line of sight is not obstructed, in some embodiments, the sidewall surface 142 is inclined relative to the cross-section perpendicular to the central axis of the main stent 100, and the end of the sidewall surface 142 connected to the outer peripheral surface is closer to the artificial blood vessel 200 than the end of the sidewall surface 142 connected to the bottom wall surface 141; preferably, the inclined sidewall surface 142 has a smooth transition. This configuration reduces the obstruction of the surgeon's line of sight by the sidewall surface 142 during the process of the external branch passing through the through hole 1421 on the sidewall surface 142 to the supra-arc branch vessel, facilitates superselection, and also ensures the flexibility of the external branch stent.

[0122] See Figures 1-3 as well as Figure 9The inlay 400 is at least partially housed within the main support 100. For example, the inlay 400 can be fixed to the first segment 110 of the main support 100 by stitching. The inlay 400 has an inlay channel 410 that extends through the entire inlay 400 along its axial direction, such that the inlay channel 410 has openings on both end faces along the axial direction of the inlay 400. The inlay channel 410 forms an inlet 411 on the proximal end face along the axial direction of the inlay 400 and an outlet 412 on the distal end face along the axial direction of the inlay 400, and blood flows from the inlet 411 to the outlet 412.

[0123] In some embodiments, see Figure 9 For example, the embedded channel 410 includes a first channel 413 and a second channel 414, which are isolated from each other, maintaining a certain degree of independence, i.e., the two channels are arranged in parallel. For instance, the two channels can be isolated by a separating membrane. In this manner, to minimize the occupation of the proximal cavity of the main stent, the proximal ports of the two channels are compressed during the connection with the main stent, minimizing the size of the main stent cavity. Preferably, the height of the compressed proximal ports of the two channels is less than or equal to 10 mm. In this embodiment, contrast rings can be provided at both the inlet and outlet ends of the two channels. The contrast rings can mark the location of the branch stent after surgery and provide support for the branch channels.

[0124] See Figure 10 and Figure 11 In other embodiments, the embedded channel 410 includes a first channel 413, a second channel 414, and a connecting port 415. The connecting port 415 is located between the first channel 413 and the second channel 414. This can be understood as the connecting port 415 being located at the point where the first channel 413 and the second channel 414 are tangent to or intersect. The connecting port 415 extends axially along the embedded body 400, such that the axial length of the embedded body 400 is equal to the axial length of the first channel 413 and the second channel 414. The first channel 413 and the second channel 414 are interconnected through the connecting port 415, meaning there is no insulating membrane between the two channels; it can be considered as a large through channel. This approach allows for the minimization of the size of the embedded channel 410, thereby reducing the volume of the embedded body 400 and minimizing the space occupied by the embedded body 400 within the main support 100. On the other hand, the two external branch stents 50 after implantation will be anchored in the relevant through first channel 413 and second channel 414. After release, the two external branch stents 50 can contact and squeeze each other to form a stronger anchoring force, reducing the displacement or twisting of the external branch stents 50 under blood flushing and improving the reliability of the operation.

[0125] Continue reading Figure 1 The first convex stent 300 protrudes from the outer circumferential surface of the main stent 100. For example, the first convex stent 300 can extend a certain length radially along the main stent 100. When the main stent 100 is engaged with the aorta 20, the first convex stent 300 is inserted into the left subclavian branch 31 and anchored to it, thus establishing a pathway.

[0126] Since the stent is released during the procedure while the patient's circulation is stopped, there is no blood in the blood vessel lumen at this time. Direct release of the external branch stent may cause occlusion at the root of the first convex stent 300.

[0127] To avoid occlusion at the root of the first convex support (300mm), refer to... Figure 4 In some embodiments, the intraoperative stent 10 may further include a reinforcing bone 500, which connects the first protruding stent 300 and the main stent 100 on one side. Preferably, the reinforcing bone 500 is integrally formed. The reinforcing bone 500 is provided on one side and connects the first protruding stent 300 and the main stent 100 simultaneously. The reinforcing bone 500 provides support at the connection point and ensures flexibility at the connection point, effectively preventing vascular occlusion near the root of the first protruding stent 300 close to the main stent 100, ensuring smooth blood flow within the first protruding stent 300. For example, as... Figure 4 As shown, the reinforcing bone 500 includes a first reinforcing segment 510 and a second reinforcing segment 520 arranged at an angle. For example, the first reinforcing segment 510 and the second reinforcing segment 520 can be arranged perpendicular to each other. The first reinforcing segment 510 extends along the axial direction of the first outward-protruding bracket 300, and the second reinforcing segment 520 extends along the axial direction of the main bracket 100. As one embodiment for achieving the connection, for example, the first outward-protruding bracket 300 includes a plurality of corrugated coils 310. The corrugated coils 310 can be sinusoidal corrugated coils, etc. Each corrugated coil 310 has a plurality of peaks and troughs. The corrugated coils 310 can be approximately circular closed loops. The plurality of corrugated coils 310 can be arranged sequentially along the length direction of the first outward-protruding bracket 300. At least one of the three corrugated coils closest to the main bracket 100 is connected to the first reinforcing segment 510, and the second reinforcing segment 520 is connected to the main bracket 100. The second reinforcing segment 520 can be located on the side of the first protruding bracket 300 near the distal end of the main bracket, or on the side of the first protruding bracket 300 near the proximal end of the main bracket. Preferably, the second reinforcing segment 520 is located on the distal end side. In other embodiments, the first reinforcing segment 510 and the second reinforcing segment 520 can also be arranged at other angles.

[0128] To avoid occlusion at the root of the first convex support (300mm), refer to... Figure 1In some embodiments, the first protruding support 300 includes multiple corrugated coils 310, which can be sinusoidal or similar. Each corrugated coil 310 has multiple peaks and troughs and can be approximately circular closed loops. The multiple corrugated coils 310 are arranged sequentially along the length of the first protruding support 300. These sequentially arranged corrugated coils 310 can be spaced apart or hooked together along the length of the first protruding support 300. The distance H between the corrugated coil 310 closest to the main support 100 and the main support 100 can be 2mm to 3mm. For example, the distance H can be 2mm, 2.5mm, or 3mm. This arrangement allows the first protruding support 300 to have reasonable flexibility while ensuring a certain degree of support at its root, effectively preventing pipe blockage at the root of the first protruding support 300 near the main support 100.

[0129] To avoid occlusion at the root of the first convex support (300mm), refer to... Figure 5 In some embodiments, the first protruding support 300 includes a corrugated coil 310, which can be a sinusoidal corrugated coil or the like. The corrugated coil 310 has multiple peaks and troughs, and its extension direction is set at an acute angle to the axial direction of the first protruding support 300, thereby causing the corrugated coil 310 to extend in a spiral shape. During the release of the main support 100, this also effectively prevents pipe blockage caused by bending or radial compression at the root of the first protruding support 300 near the main support 100.

[0130] To avoid occlusion at the root of the first convex support (300mm), refer to... Figure 6 In some embodiments, the first protruding support 300 includes a plurality of rods 320, which are interconnected to form a mesh structure. See also... Figure 7 In other embodiments, for example, the first protruding support 300 includes multiple corrugated coils 310, which can be sinusoidal or similar. Each corrugated coil 310 has multiple peaks and troughs. The corrugated coil 310 closest to the main support 100 extends at an acute angle to the axial direction of the first protruding support 300, making it spiral-shaped. Other corrugated coils 310 extend perpendicular to the axial direction of the first protruding support 300, forming a circular closed loop, and are spaced apart along the axial direction of the first protruding support 300. (See also...) Figure 8For example, the first outward-protruding support 300 includes multiple rods 320 and multiple corrugated coils 310. The corrugated coils 310 are further away from the main support 100 than the rods 320. The multiple rods 320 are positioned close to the main support 100. The multiple rods 320 are interconnected to form a mesh structure. The corrugated coils 310 can be sinusoidal or similar, and each corrugated coil has multiple peaks and troughs. The corrugated coils 310 extend along the axial direction perpendicular to the first outward-protruding support 300, forming a circular closed loop, and are spaced apart along the axial direction of the first outward-protruding support 300. As another example, the first outward-protruding support 300 includes multiple rods 320 and multiple corrugated coils 310. The corrugated coils 310 are further away from the main support 100 than the rods 320. The multiple rods 320 are positioned close to the main support 100. The multiple rods 320 are interconnected to form a mesh structure. From the main support 100 to the first outward-protruding support 300, the cross-sectional dimension of this mesh structure first gradually decreases and then remains constant. The corrugated coil 310 can be a sinusoidal corrugated coil, etc., with multiple peaks and troughs. The corrugated coil 310 extends along the axial direction perpendicular to the first protruding support 300, forming a circular closed loop, and is spaced apart along the axial direction of the first protruding support 300. This arrangement also allows the first protruding support 300 to have reasonable flexibility and rigidity, effectively preventing pipe blockage due to bending or radial compression at the root of the first protruding support 300 near the main support 100 during the release of the main support 100.

[0131] Continue reading Figure 1 In other embodiments, for the wave loop 310 of the first convex support 300 furthest from the main support 100, a portion of this wave loop 310 is not covered by the membrane, forming an exposed portion. Obviously, the other wave loops 310 on the first convex support 300 are all covered by the membrane. The exposed portion is located at the end of the first convex support 300, and the length of the exposed portion on the axis of the first convex support 300 is 1 / 4 to 1 / 2 of the wave height of the wave loop 310. The wave height of the wave loop 310 can be defined as the distance between the peak and trough of the wave loop 310 on the axis of the first convex support 300. By providing the exposed portion, an anchoring effect can be achieved between the exposed portion and the left subclavian branch 31, thereby ensuring sufficient anchoring force between the first convex support 300 and the left subclavian branch 31, preventing the first convex support 300 from detaching from the left subclavian branch 31, and thus improving the reliability of the surgery.

[0132] Continue reading Figure 1 In some embodiments, the main support 100 includes a first segment 110, a second segment 120, and a third segment 130. For clarity, in... Figure 1In the diagram, multiple dotted lines are used to indicate the segments. It can be understood that each dotted line is not the structure of the stent 10 itself during the operation. The second segment 120 is connected between the first segment 110 and the third segment 130, that is, the two ends of the second segment 120 are connected to the first segment 110 and the third segment 130 respectively. The first segment 110 is connected to the artificial blood vessel 200. The groove 140 is set on the second segment 120. The first convex stent 300 can also be set on the second segment 120. The first segment 110 is closer to the artificial blood vessel 200 than the first convex stent 300. It can be understood that the first segment 110 is located between the artificial blood vessel 200 and the first convex stent 300. The inlay 400 is at least partially housed in the main stent of the first segment 110. The axial length of each of the first section 110, the second section 120, and the third section 130 of the main support 100 can be set as needed, and the outer diameter of each section can also be set as needed. For example, the main support 100 is cylindrical, and the maximum outer diameter of the first section 110, the second section 120, and the third section 130 is basically the same.

[0133] Preferably, the outer diameter D1 of the first segment 110 is greater than the maximum outer diameter D2 of the second segment 120, and the outer diameter D2 of the second segment 120 can be greater than or equal to the outer diameter D3 of the third segment 130. For example, the difference between D1 and D2 is less than or equal to 2 mm, and when D2 is greater than D3, the difference between D2 and D3 is between 2 mm and 4 mm. This ensures that the main stent can match the arched vessel immediately after deployment, completing anchoring while providing sufficient anchoring force for the branch stent, and minimizing the occupancy of the embedded branch channel on the main stent. In other embodiments, the third segment 130 of the main stent 100 can have a taper of 2 or 4 cones, that is, the outer diameter of the third segment 130 gradually decreases from proximal to distal.

[0134] The main support 100 includes a main body membrane and a main body skeleton connected to the main body membrane. In other embodiments, such as... Figure 1 As shown, the intraoperative stent 10 may also include polyester cloth 600, which covers a distal segment of the third segment 130 of the main stent 100. This can provide some protection for the blood vessel, as the balloon can protect this segment of the blood vessel from damage after inflation. On the other hand, after the balloon is blocked, the patient's lower limb begins to receive blood, and the presence of a layer of polyester cloth on the outer surface of the stent can increase the sealing effect between the stent and the blood vessel.

[0135] The implantation process of the intraoperative stent 10 using the above-described exemplary method of the present invention mainly includes the following steps: (See attached document) Figure 12 The first step involves open-chest surgery to establish an extracorporeal blood circulation system. The aorta 20 is severed, and the main guidewire is implanted. The intraoperative stent 10 is then delivered via a delivery device along the main guidewire into the aorta 20. (See also...) Figure 13The second step involves releasing the intraoperative stent 10 from the delivery device, so that the main stent 100 is located in the aorta 20, while the first convex stent 300 is located in the left subclavian branch 31. (See also...) Figure 14 The third step involves opening the main balloon, releasing the distal end of the intraoperative stent 10 from the delivery device, and inserting a branch guidewire into the left subclavian branch 31. (See also...) Figure 15 The fourth step is to insert the branch balloon along the branch guidewire and then inflate the branch balloon. (See also...) Figure 16 The fifth step involves guiding the branch guidewire along the embedded channel 410 into the brachiocephalic trunk 32 and / or the left common carotid branch 33, where the external branch stent 50 needs to be implanted. This is essentially overselecting the branch vessels where the external branch stent 50 needs to be implanted. In other words, the external branch stent 50 can be implanted only in the brachiocephalic trunk 32, only in the left common carotid branch 33, or simultaneously in both the brachiocephalic trunk 32 and the left common carotid branch 33. See also... Figure 17 Step six: Insert the external branch stent 50 into the designated branch vessel through the embedded channel 410 along the branch guidewire. (See also...) Figure 18 Step 7: Release the external branch support 50. (See attached document) Figure 19 The eighth step is to suture the artificial blood vessel 200 to the artificial blood vessel 40 or the first arterial segment 21.

[0136] If the intraoperative stent is designed with multiple first convex stents integrated onto the main stent, and these stents are implanted into the left subclavian branch 31, the brachiocephalic trunk 32, and the left common cervical branch 33 respectively, then, firstly, the spacing between adjacent first convex stents and the length of the first convex stents are constant. Due to anatomical differences in the morphology of human blood vessels, it is difficult for multiple first convex stents to accurately enter the designated branch vessels, thus affecting the efficiency of the operation. Even if the first convex stents can barely enter the branch vessels, the precision of the fit between the first convex stents and the branch vessels will be affected. Given the low precision of the fit between the first convex stents and the branch vessels, the first convex stents are prone to displacement and detachment from the branch vessels, thus losing the therapeutic effect of the stent and ultimately affecting the reliability of the operation. Secondly, if a branch vessel does not require the implantation of a first convex stent, the first convex stent corresponding to that branch vessel needs to be removed and sutured, which will further prolong the operation time and affect the efficiency of the operation.

[0137] In this embodiment, the intraoperative stent 10, with the first convex stent 300 implanted first, followed by the other external branch stents 50, eliminates the influence of anatomical differences in blood vessel morphology during the implantation of the first convex stent 300 into the left subclavian branch 31. This also eliminates interference from other convex stents integrally connected to the main stent 100, ensuring the first convex stent 300 smoothly enters the left subclavian branch 31, thereby improving surgical efficiency. It also improves the precision of the fit between the first convex stent 300 and the left subclavian branch 31, preventing the first convex stent 300 from dislodging from the left subclavian branch 31, thus enhancing surgical reliability. After the first convex stent 300 is implanted, on the one hand, an external branch stent 50 can be selectively implanted in the brachiocephalic trunk 32 and the left common carotid branch 33. This eliminates the need to remove and suture other excess convex stents connected to the main stent 100, thereby reducing surgical time and improving surgical efficiency. On the other hand, the external branch stent 50 can be implanted separately from the first convex stent 300, thus avoiding interference caused by simultaneous implantation of both. This improves the smoothness of the external branch stent 50 implantation, increases surgical efficiency, and enhances the precision of the external branch stent 50 implantation. It also prevents the external branch stent 50 from dislodging from the branch vessels due to displacement, thereby improving the reliability of the surgery.

[0138] See Figure 20 In some embodiments, the intraoperative stent 10 may further include a second convex stent 700, which protrudes from the outer peripheral surface of the artificial blood vessel 200 and is connected to the supra-arc branch by suturing. For example, the second convex stent 700 may be positioned close to the distal end of the artificial blood vessel 200, and may be sutured to one of the supra-arc branches to establish a supra-arc branch pathway. After the main stent is implanted into the aorta 20, the first convex stent 300 will be implanted into the left subclavian branch 31, while the second convex stent 700 will be connected to the brachiocephalic trunk 32. The external branch stent 50 can be implanted into the left common carotid branch 33 through the embedded channel 410 in the inlay body 400. In this case, the number of embedded channels 410 in the inlay body can be one. This method shortens the suturing time and is more flexible compared to the method of complete suturing.

[0139] See Figure 2 (a) and Figure 2(b) In other embodiments, to further enhance the anchoring stability of the first convex stent 300, the first convex stent 300 includes a covered section 300a and a bare band 300b. The covered section 300a is connected to the main stent 100, and the bare band 300b is connected to the end of the covered section 300a away from the main stent 100. The bare band 300b includes at least one wave loop. In other embodiments, the bare band 300b has multiple wave loops, and these multiple wave loops are arranged sequentially along the axial direction of the first convex stent 300. Preferably, the length Hb of the bare band is between 20mm and 40mm. At this length, the first convex stent 300 has a longer anchoring force without affecting the blood supply to the left conical branch. For example, as shown... Figure 2 As shown in (a), multiple wave loops 300b1 arranged sequentially in bare band 300b are interconnected, or as shown in (a). Figure 2 As shown in (b), multiple wave coils 300b1 are connected by connectors 300c.

[0140] In other embodiments, the intraoperative stent of the present invention further includes a skirt (not shown), which is arranged circumferentially between the main stent and the artificial blood vessel, and extends radially along the main stent. The skirt can be sutured to the incision of the second arterial segment of the aorta to form a seal and prevent blood leakage from the anastomosis between the proximal end of the main stent and the blood vessel.

[0141] Example 2

[0142] When using an intraoperative stent with an inlay for branch reconstruction, the angle between the vessel port and the vessel varies due to differences in the morphology of human blood vessels. Therefore, if the inlay channel is consistent and completely fixed on the main stent, it will be difficult to establish a guidewire access during the replacement process. In addition, there are high requirements for the flexibility of the external branch stent that is matched with the inlay channel.

[0143] In view of this, see Figure 21 This embodiment exemplarily provides an intraoperative stent 10, which includes at least a main stent 100 and an inlay 400. In other embodiments, without structural conflict, the intraoperative stent 10 may optionally include an artificial blood vessel 200, a first outward-protruding stent 300, a second outward-protruding stent 700, and a skirt, etc. The specific structures of the artificial blood vessel 200, the first outward-protruding stent 300, the second outward-protruding stent 700, and the skirt, etc., can be referred to in Embodiment 1, and will not be repeated here.

[0144] Furthermore, some structures of the main support 100 and the embedded body 400 in this embodiment can also refer to other embodiments. This embodiment mainly focuses on the differences between the main support 100 and the embedded body 400 and other embodiments. It should be understood that, where there is no structural conflict, the exemplary solutions in this embodiment can also be combined with any exemplary solution in other embodiments to obtain new technical solutions.

[0145] Reference Figure 21 Similarly, in this embodiment, the outer peripheral surface of the main support 100 is provided with a groove 140; the inlay 400 has a preset axial length, and an inlay channel 410 is provided in the inlay 400 to pass through its proximal end and distal end. The inlay 400 is at least partially housed in the main support 100 and the inlay channel 410 communicates with the groove 140. The inlay channel 400 is used to cooperate with the implanted external branch support.

[0146] The difference lies in the fact that the distal end of the inlay 400 in this embodiment can swing relative to its proximal end. Due to differences in the anatomical morphology of human blood vessels, different people will have different blood vessel morphologies. Therefore, the roots of the left subclavian branch 31, the brachiocephalic trunk 32, and the left common cervical branch 33 do not correspond to the same generatrix in the main stent 100. During the implantation of the external branch stent 50 into the supra-arc branch vessel through the inlay channel 410, the distal end of the inlay 400 swings relative to its proximal end. This allows for a wider range of options in the inlay branch reconstruction process. The external branch stent 50 can swing at a certain angle to adjust the optimal implantation direction, allowing the external branch stent 50 to accurately locate and smoothly enter the corresponding supra-arc branch vessel, reducing the adjustment time for the implantation direction, thereby improving the efficiency of the operation and reducing the difficulty of reconstruction. On the other hand, this allows the external branch stent 50 to be inserted into the supra-arch branch vessel at the optimal position, thereby improving the matching accuracy between the external branch stent 50 and the supra-arch branch vessel, that is, improving the matching degree between the external branch stent 50 and the branch vessel. This avoids displacement or even detachment of the external branch stent 50 relative to the branch vessel due to poor matching, thus improving the reliability of the surgery and reducing the requirement for the flexibility of the branch stent. Preferably, the swing angle of the distal end of the inlay 400 relative to its proximal end is between 5° and 20°. This swing angle satisfies the reconstruction requirements while ensuring the reliability of the inlay 400 relative to the main stent 100 as much as possible.

[0147] To allow the distal end of the insert 400 to swing relative to its proximal end, in one embodiment, the proximal end of the insert 400 is connected to and fixed relative to the main support 100, while the distal end is free, meaning it is not fixed to the main support 100. For details, see [link to relevant documentation]. Figures 21-27An inlay 400 with a preset axial length includes a fixed segment 400a and a free segment 400b connected axially. The fixed segment 400a is located on the proximal side of the inlay 400, and the free segment 400b is located on the distal side of the inlay 400. The fixed segment 400a is placed inside the main support 100 and fixed relative to the main support 100. The free segment 400b can swing relative to the fixed segment 400a and the main support 100. That is, the fixed segment 400a is fixed in the main cavity of the main support 100, and the free segment 400b is not fixedly connected to the main support 100. Therefore, the free segment 400b can swing relative to the fixed segment 400a and the main support 100, thereby allowing the distal end of the inlay 400 to swing relative to the proximal end of the inlay 400 in any direction. Therefore, during the process of implanting the external branch stent 50 into the branch vessel through the embedded channel 410, the implantation direction and position of the external branch stent 50 can be quickly and accurately adjusted, reducing the difficulty of establishing the access, thereby improving the efficiency and reliability of the operation, and also reducing the requirements for the flexibility of the branch stent.

[0148] Continue reading Figure 21 Understandably, when the free segment 400b of the embedded body 400 is movably positioned relative to the main support 100, in order to ensure the range of motion of the free segment 400b of the embedded body 400, the side wall surface 142 of the groove 140 may not be covered with a membrane. At this time, the through hole 1421 is formed around the outer edge of the side wall surface 142. The proximal end of the bottom wall surface 141 of the groove 140 can extend into the main tube cavity of the main support 100, and the proximal extension end of the bottom wall surface 141 is enclosed and sealed with the proximal end of the embedded body 400 and the inner wall of the main support 100, so that only the proximal end of the embedded channel 410 of the embedded body 400 communicates with the main tube cavity of the main support 100, and the distal end of the embedded channel 410 communicates with the groove 140.

[0149] See Figure 22 In some embodiments, the length L2 of the free segment 400b of the inlay 400 is greater than or equal to the length L1 of the fixed segment 400a. This allows for a reasonable increase in the relative swing amplitude of the distal end of the inlay 400 to the proximal end, thereby increasing the adjustment space and selection range of the external branch stent 50. This enables rapid and accurate adjustment of the implantation direction and position of the external branch stent 50, improving the efficiency and reliability of the surgery. The sum of the lengths of the fixed segment 400a and the free segment 400b can be equal to the length L of the inlay 400. It can be understood that when the length L2 of the free segment 400b is greater than or equal to the length L1 of the fixed segment 400a, the length L2 of the free segment 400b can be greater than or equal to half the length L of the inlay 400, i.e., L2 ≥ L / 2; while the length L1 of the fixed segment 400a can be less than or equal to half the length L of the inlay 400, i.e., L1 ≤ L / 2.

[0150] See Figure 23 To achieve a wider range of motion, in other embodiments, at least a portion of the free segment 400b of the insert 400 extends into the recess 140 through the sidewall surface 142. For example... Figure 23 As shown, the free segment 400b includes an external portion 400b2 placed within the groove 140. The external portion 400b2 extends into the groove 140, so that the external portion 400b2 is not hidden within the main tube lumen of the main support 100, but is exposed in the groove 140. Obviously, the distal end of the free segment 400b is the distal end of the inlay 400. By setting the external portion 400b2 exposed in the groove 140, the constraint of the main support 100 on the swing of the external portion 400b2 relative to the fixed segment 400a can be reduced, making the swing of the external portion 400b2 more free and flexible, thereby further increasing the swing amplitude of the distal end of the inlay 400 relative to the proximal end, which can further improve the efficiency and reliability of the surgery.

[0151] Continue reading Figure 23 In this configuration, the external portion 400b2 can be part of the free segment 400b. Specifically, a portion of the free segment 400b is within the main cavity of the main support 100, while the remaining portion of the external portion 400b2 extends out of the main cavity and rests within the groove 140. It is understood that the length L3 of the external portion 400b2 is less than or equal to the length L2 of the free segment 400b. In some embodiments, the length L3 of the external portion 400b2 is greater than or equal to half the length L of the inlay 400, i.e., L3 ≥ L / 2. When the length L2 of the free segment 400b is greater than or equal to the length L1 of the fixed segment 400a, the entire free segment 400b can be the external portion 400b2, meaning the entire free segment 400b extends into the groove 140. Alternatively, a small portion of the free segment 400b can be located within the main support 100, while the majority of the free segment 400b extends into the groove 140 to form the external portion 400b2. Since the length L3 of the external part 400b2 is greater than or equal to half the length L of the inlay 400, the swing amplitude of the distal end of the inlay 400 relative to the proximal end can be further increased, thereby improving the efficiency and reliability of the surgery. At this time, in order to ensure that the inlay 400 and the main support 100 have sufficient connection strength, the length of the fixing segment 400a can be greater than or equal to 5mm.

[0152] See Figure 22 , Figure 23 and Figure 24In some embodiments, the free segment 400b includes a first free unit b1 and a second free unit b2, which are spaced apart, and can be understood as the free segment 400b being bifurcated. The embedded channel 410 includes a first channel 413 and a second channel 414, with the first free unit b1 having the first channel 413 and the second free unit b2 having the second channel 414. When it is necessary to implant external branch stents 50 into both the brachiocephalic trunk 32 and the left cervical common branch 33, that is, when there are two external branch stents 50, the two external branch stents 50 can be inserted into the first channel 413 and the second channel 414 respectively. Given that the first free unit b1 and the second free unit b2 are spaced apart, the first free unit b1 and the second free unit b2 are independent of each other, thereby eliminating the linkage and interference caused by their interconnection, thereby increasing the swing amplitude of the first free unit b1 and the second free unit b2, increasing the adjustment space and selection range of the two external branch stents 50, and ultimately improving the efficiency and reliability of the surgery. Figure 24 and Figure 25 In the process, the first free unit b1 and the second free unit b2 are arranged in parallel during the oscillation; Figure 26 and Figure 27 In the process, the first free unit b1 and the second free unit b2 are arranged in an alternating manner during the swinging process.

[0153] To allow the distal end of the insert 400 to swing relative to its proximal end, in one embodiment, the insert 400 can be swung to a certain extent by means of the main support 100. For details, see [link to relevant documentation]. Figure 28 In some embodiments, the main support 100 includes a first segment 110. In other embodiments, the main support 100 may also include a second segment 120 and a third segment 130. The first segment 110 can be twisted about the central axis of the main support 120, that is, the first segment 110 of the main support 100 is a twistable segment. The embedded body 400 includes a built-in segment 400c disposed in the first segment 110. During the twisting process of the first segment 110, the distal end of the built-in segment 400c can be driven to swing circumferentially relative to its proximal end.

[0154] like Figure 28 As shown, the built-in segment 400c is fixedly disposed within the first segment 110, so that the built-in segment 400c is concealed within the first segment 110. The first segment 110 can rotate around the central axis xx of the main support 100, that is, it can rotate along... Figure 28The direction indicated by the dashed arrow is twisted. For example, the entire inlay 400 is located within the first segment 110, the entire inlay 400 is a built-in segment 400c, and the entire inlay 400 is fixedly connected to the first segment 110. Alternatively, a portion of the inlay 400 can extend into the groove 110 to form a free segment 400b, and the fixed segment 400a of the inlay 400 forms the built-in segment 400c. Furthermore, the entire built-in segment 400c is fixedly connected to the first segment 110; or, a portion of the built-in segment 400c can be fixedly connected to the first segment 110, while another portion of the built-in segment 400c may not be fixedly connected to the first segment 110. Since the first segment 110 can twist around the central axis of the main support 100, and the built-in segment 400c is at least partially fixedly connected to the first segment 110, the built-in segment 400c will follow the first segment 110 to twist around the central axis of the main support 100. In this way, the distal end of the inlay 400 can swing relative to the proximal end of the inlay 400, thereby quickly and accurately adjusting the implantation direction and position of the branch support 50, improving the efficiency and reliability of the surgery.

[0155] See Figure 28 In some embodiments, the first segment 110 of the main support 100 includes only a membrane 100a, which is arranged around the central axis of the main support 100. Corrugated rings 122 can be provided on the membrane 100a in other parts of the main support 100. These corrugated rings can be made of metal and are curved, forming crests and troughs. Corrugated rings 122 also surround the central axis of the main support 100. Since corrugated rings 122 are provided in other parts of the main support 100, while the first segment 110 of the main support 100 only includes the membrane 100a, corrugated rings 122 are not provided on the first segment 110. This makes the first segment 110 more flexible than other parts of the main support 100, allowing the first segment 110 to twist around the central axis of the main support 100.

[0156] See Figure 29 and Figure 30In some embodiments, the first segment 110 includes a covering film 100a and a wavering coil 100b. The covering film 100a and the wavering coil 100b are arranged around the central axis xx of the main support 100. The covering film 100a and the wavering coil 100b are relatively fixed. Multiple wavering coils 100b are arranged along the axial direction of the first segment 100. The multiple wavering coils 100b include a proximal wavering coil 100b2 located on the proximal side of the first segment, a distal wavering coil 100b3 located on the distal side of the first segment, and a spiral wavering coil 100b4 disposed between the proximal wavering coil 100b2 and the distal wavering coil 100b3. The proximal end of the proximal wavering coil 100b2... The plane where the distal end of the first segment 110 is located and the plane where the distal end of the distal waveguide 100b3 is located are both basically perpendicular to the axis of the main support 100. The distal ends of the proximal waveguide 100b2 and the proximal ends of the distal waveguide 100b3 are both spirally arranged along the circumference of the first segment 110, so that the proximal waveguide 100b2 and the distal waveguide 100b3 are set with non-uniform wave heights in the circumference. The spiral waveguide 100b4 is spirally arranged in the circumference of the first segment 110, and the spiral directions of the distal ends of the proximal waveguide 100b2, the proximal ends of the distal waveguide 100b3, and the spiral waveguide 100b3 are the same. Multiple spiral waveguides 100b4 can be set. In this way, the first segment 110 can also be twisted around the central axis of the main support 100. It is understood that the corrugations of other parts of the main support 100 can extend in a direction perpendicular to the central axis of the main support 100, that is, the circumference of the corrugations 100b of other parts of the main support 100 is set perpendicular to the central axis of the main support 100.

[0157] See Figure 31 In some embodiments, the first segment 110 includes a covering film 100a and a wavering coil 100b, which are arranged around the central axis of the main support 100. The covering film 100a and the wavering coil 100b are relatively fixed. The wavering coil 100b has crests and troughs, which are inclined relative to the central axis of the main support 100. The wavering coil 100b includes two wave rods 100b1 forming the same crest or trough. The angle bisector of the angle formed by the two wave rods 100b1 and the central axis of the main support 100 form an acute angle C. This also allows the first segment 110 to twist around the central axis of the main support 100. It is understood that the wave rings of other parts of the main support 100 can extend in a direction perpendicular to the central axis of the main support 100. That is, the circumference of the wave rings of other parts of the main support 100 is set perpendicular to the central axis of the main support 100, and the angle bisector of the angle formed by two wave rods forming the same wave crest or the same wave trough on the wave rings of other parts of the main support 100 can be set parallel to the central axis of the main support 100.

[0158] See Figure 32In some embodiments, the first segment 110 includes a membrane 100a and a wavering coil 100b, which are arranged around the central axis of the main support 100. The membrane 100a and the wavering coil 100b are relatively fixed, and the wavering coil 100b has crests and troughs. The wavering coil 100b includes a wave rod 100b1 that forms crests or troughs. The wave rod 100b1 has a serrated bending structure, which is elastic, thus enabling the first segment 110 to twist around the central axis of the main support 100.

[0159] See Figure 33 , Figure 34 and Figure 35 In some embodiments, the first segment 110 includes a first membrane 100a1, a second membrane 100a2, and a wave coil 100b stacked around the central axis of the main support 100. The materials of the first membrane 100a1 and the second membrane 100a2 may be the same or different. The first membrane 100a1 is sleeved on the outside of the second membrane 100a2, that is, the first membrane 100a1 is the outer membrane and the second membrane 100a2 is the inner membrane. The inlay 400 is disposed in the cavity enclosed by the second membrane 100a2. The wave coil 100b has crests and troughs and is movably located between the first coating 100a1 and the second coating 100a2. Along the circumference of the main support 100, the wave coil 100b can be left unrestricted, allowing it to be in a free state. That is, the wave coil 100b can rotate relative to the first coating 100a1 and the second coating 100a2. A through hole 100c is formed on the second coating 100a2, penetrating the second coating 100a2 radially along the main support 100. The through hole 100c extends a predetermined length along the axial and circumferential directions of the main support 100, and can be positioned near the proximal end of the first segment 110. At least a portion of the built-in segment of the insert 400 passes through the through hole 100c and is fixed relative to the wave coil 100b. The circumferentially rotatable wave coil 100b drives the connected built-in segment to move within the circumferential range of the through hole. This configuration also allows the distal end of the internal segment to swing relative to its proximal end. Furthermore, to avoid blood flow impact at the through-hole 100c, closure can be achieved using a stretchable membrane M (see...). Figure 34 The stretchable membrane M can be stretched or compressed circumferentially. The stretchable membrane M is connected to the second membrane 100a2 and the inlay along the edge of the through hole 100c, thereby achieving a sealed connection while providing the wave coil 100b with the circumferential movement of the built-in section.

[0160] See Figure 36In some embodiments, the inlet 411 of the embedded channel 410 is flat, for example, it can be similar to an ellipse. This allows the portion of the embedded channel 410 located on the fixed segment 400a to be flat, ensuring sufficient space for blood flow while minimizing its footprint within the main body cavity. Furthermore, the flat, non-circular shape of the inlet 411 provides better anchoring between the embedded body and the external branch support. In other embodiments, the diameter of the inlet 411 is larger than the diameter of the outlet 412, and the diameter of the embedded channel 410 gradually decreases from the inlet 411 to the outlet 412. This can be understood as the embedded channel 410 having a certain taper. This reduces the space occupied by the embedded body 400 within the main support 100 cavity and increases the movement space at the distal end of the embedded body 400, thereby increasing the swing amplitude of the distal end of the embedded body 400.

[0161] Example 3

[0162] Generally, intraoperative stenting is performed under direct vision without DSA assistance. Intraoperative stenting with branches is released under non-visual conditions, and the actual release status of the branch stent and the main stent is unknown. Furthermore, it is difficult to perform other operations based on the intraoperative stenting procedure.

[0163] In view of this, see Figure 37 This embodiment exemplarily provides an intraoperative stent 10, which includes at least a main stent 100, an artificial blood vessel 200, an inlay 400, and a suture 900. In other embodiments, without structural conflict, the intraoperative stent 10 may optionally include a first outward-protruding stent 300, a second outward-protruding stent 700, and a skirt, etc. The specific structures of the first outward-protruding stent 300, the second outward-protruding stent 700, and the skirt, etc., can be referred to in Embodiment 1, and will not be repeated here.

[0164] Furthermore, the structures of the main support 100, artificial blood vessel 200, and inlay 400 in this embodiment can also refer to other embodiments. This embodiment mainly focuses on the detailed description of the structure of the suture piece 900. It should be understood that, where there is no structural conflict, the exemplary solutions in this embodiment can be combined with any exemplary solution in other embodiments to obtain new technical solutions.

[0165] Reference Figure 37Similarly, in this embodiment, the outer peripheral surface of the main support 100 is provided with a groove 140, the artificial blood vessel 200 is connected to the proximal end of the main support 100, the inlay 400 has a preset axial length, and an inlay channel 410 is provided in the inlay 400 to pass through its proximal and distal ends. The inlay 400 is at least partially housed in the main support 100 and the inlay channel 410 communicates with the groove 140. The inlay channel 400 is used to cooperate with the implanted external branch stent.

[0166] The difference is that you should continue reading. Figure 37 In this embodiment, the intraoperative stent 10 also includes a suture patch 900. At least a portion of the suture patch 900 is fixed relative to the outer peripheral surface of the main stent 100. The suture patch 900 is located on the adjacent side of the groove 140 along the circumferential direction of the main stent 100, and the suture patch 900 has a preset length in both the axial and circumferential directions of the main stent 100. When a suture is provided on the autologous blood vessel (e.g., the aorta) opposite to the groove 140, the suture patch 900 and the autologous blood vessel at the suture can be sutured together to close the suture on the autologous blood vessel and simultaneously fix the intraoperative stent 10 relative to the autologous blood vessel.

[0167] At least a portion of the patch 900 is fixed relative to the main support 100. The patch 900 may be provided on only one side of the groove 140, or on both adjacent sides of the groove 140. Preferably, the patch 900 is provided on the side of the groove 140 closer to the operator.

[0168] Continue reading Figure 37 In some embodiments, the main support 100 includes a first segment 110, a second segment 120, and a third segment 130 connected in sequence. The first segment 110 is connected to the artificial blood vessel 200. A groove 140 is disposed on the second segment 120. A suture 900 is at least fixedly disposed on the outer peripheral surface of the second segment 120 of the main support 100. The suture 900 is located on the adjacent side of the groove 140, that is, outside the coverage area of ​​the groove 140. The suture 900 has a certain extension length within the second segment 120. In other embodiments, the suture 900 may also extend into the first segment 110, or appropriately into the third segment 130. The specific extension length can be set as needed.

[0169] See Figures 38-41During the surgery, the aorta 20 is first cut to form a first arterial segment 21 and a second arterial segment 22. After the main stent 100 and the first convex stent 300 are implanted, the second arterial segment 22 is then cut open at the incision site to form a slit 23. The slit 23 on the second arterial segment 22 extends a certain length along the axial direction of the main stent 100, so that the distal end of the slit 23 extends to the distal end of the suture piece 900. By forming a slit 23 with a certain axial length at the incision site of the second arterial segment 22, and the slit 23 corresponding to the groove 140, the surgeon can open the second arterial segment 22 along the slit 23 to a certain width (e.g., Figure 39 (As shown), thus exposing the location of the groove 140. See also Figure 40 During the implantation of the external branch stent 50, the surgeon can directly observe the location of the supra-arch branch vessels and the implantation dynamics of the external branch stent 50 through the exposed groove. This allows for quick and accurate determination of the implantation angle and position of the external branch stent 50, improving the implantation efficiency and the precision of its coordination with the branch vessels, ultimately enhancing the efficiency and reliability of the surgery. (See also...) Figure 41 After the external branch stent 50 is implanted, the suture piece 900 is fixed to the second arterial segment 22 at the incision 23 by suturing. The incision 23 of the second arterial segment 22 is sutured using the suture piece 900. The suture piece 900 serves two purposes: firstly, it sutures the incision 23 on the aorta 20; secondly, it fixes the entire stent 10 to the aorta 20 during the operation, preventing displacement of the stent 10 relative to the aorta 20 and thus improving the reliability of the surgery.

[0170] In this embodiment, the intraoperative stent solves the problems of branch overselection and branch stent release and positioning when reconstructing the brachiocephalic trunk and left common carotid branch with embedded branches. By setting a suture piece on the side of the main stent, the surgeon can cut open the proximal end of the main stent during the operation to expose the groove part of the intraoperative stent in the blood vessel. Then, the branch overselection and branch stent positioning are completed under direct vision. After the operation, the cut position of the main stent is sutured with the suture piece, which simultaneously fixes the main stent and the autologous blood vessel.

[0171] Continue reading Figure 37In some embodiments, the suture patch 900 includes a suture patch 910, which, in its flattened state, can be approximately rectangular and can be made of PET film. The suture patch 910 has a central fixing position 911 and suture portions 910a. The central fixing position 911 is positioned along the axial extension direction of the suture patch 910 and can be directly and securely connected to the main support 100 by suturing. For example, the length of the central fixing position 911 can be equal to the length of the suture patch 900. The suture portions 910a are located circumferentially on both sides of the central fixing position 911 and are used for suturing to autologous blood vessels at the incision site. For example, the circumferential extension lengths of the suture portions 910a on both sides of the central fixing position 911 are the same, thus making the central fixing position 911 a line of symmetry of the suture patch 910. Of course, the distances between the central fixing position 911 and the two edges can also be unequal. When it is necessary to suture the suture 23 on the aorta 20 using the suture patch 910, the suture portions 910a on both sides of the suture patch 910 located in the middle fixed position 911 can be used to suture the autologous blood vessels on both sides of the suture 23 on the aorta 20.

[0172] See Figure 42 In some embodiments, the suture patch 900 further includes a protrusion 920, which protrudes relative to the suture patch 910 along the thickness direction of the patch 910. The protrusion 920 is located at the intermediate fixing position 911, and one end of the protrusion 920 away from the patch 910 is fixedly connected to the main support 100. After the protrusion 920 is fixedly connected to the main support 100, the suture portions 910a on both sides of the intermediate fixing position 911 can maintain a non-contact relationship with the main support 100, so that there is a gap between the suture portions 910a and the outer surface of the main support 100 along the radial direction of the main support 100. Given the existence of this gap, during the suturing of the incision 23 on the aorta 20 through the suture patch 910, this gap can provide good clearance for the suture needle, preventing the suture needle and suture from mistakenly passing through the membrane on the main segment 101, thereby preventing the suture needle and suture from shifting the main segment 101 and the entire main support 100, ultimately improving the reliability of the operation.

[0173] See Figure 43 In some embodiments, the patch 900 includes a patch sheet 910, which has an edge fixing position 912 fixedly connected to the main support 100 and a sewing portion 910a. The edge fixing position 912 is disposed along the periphery of the patch sheet 910 and is used to configure the fixed connection with the main support 100. In simpler terms, the edge of the patch 900 is fixedly connected to the main support 100. During the process of fixing the patch 900 to the main support 100 by sewing, refer to... Figure 44For example, the middle portion of the patch 900 may not be fixedly connected to the main support 100 at all, and there may be a gap between the middle portion of the patch 900 and the main support 100 along the radial direction of the main support 100. See reference. Figure 45 For example, a portion of the suture patch 900 can be fixedly connected to the main support 100, while the unfixed portion of the suture patch 900 can have a gap with the main support 100 along its radial direction. This results in a partially fitted state between the suture patch 900 and the main support 100, creating the aforementioned gap. This gap also provides ample space for the suture needle to avoid accidental passage of the suture needle and suture through the covering on the main support 100, thereby preventing displacement of the suture needle and suture relative to the main support 100 and improving post-implantation stability. (See also...) Figure 46 In other embodiments, the middle part of the suture patch 900 can be completely fitted to the main support 100, so that there is no gap between the suture patch 900 and the main support 100 along the radial direction of the main support 100. In this case, if the thickness of the suture patch 900 is large enough, the suture needle and suture thread can pass through the suture patch 900 without affecting the main support 100. This can also effectively prevent the main support 100 from shifting and improve the reliability of the operation.

[0174] See Figure 47 In some embodiments, the suture patch 900 includes a suture patch 910 and a sealing sheet 930, with the sealing sheet 930 stacked between the main support 100 and the suture patch 910. The suture patch 910 may be made of PET film, and the sealing sheet 930 may be made of silicone. By providing the sealing sheet 930, the sealing performance of the entire suture patch 900 on the aortic 20 suture 23 can be effectively improved.

[0175] In other embodiments, the surface of the patch 900 is coated with a sealing coating, such as a silicone coating or a collagen coating, to ensure the seal after suturing.

[0176] It should be understood that the method of fixing the patch 910 is not limited to the above. It can also be fixed to the main support 100 along the periphery of the patch 910. Alternatively, a circumferentially extending fixing position can be set in the middle area of ​​the patch 910. Multiple circumferentially extending fixing positions can also be set, and the multiple circumferentially extending fixing positions are spaced apart axially upwards.

[0177] See Figure 48 and Figure 49In some embodiments, the suture patch 900 is provided with wave loop marks 941 and / or suture marks 942, which mark the surgeon to identify the suture position and suture area during the surgical procedure. The wave loop mark 941 can be a marking line, used as a reference to the wave loops on the main stent 100. For example, the wave loop mark 941 can cover the wave loops on the main stent 100, so that the position of the wave loop mark 941 is approximately the same as the position of the wave loops on the main stent 100. Therefore, during the suturing of the suture patch 900 to the aorta 20, the wave loop mark 941 can serve as a guide for the surgeon, preventing the suture needle and suture thread from contacting the wave loops on the main stent 100, thereby reducing suturing time, improving surgical efficiency, and shortening the overall surgical time. The suture mark 942 is used as a reference for the suture position between the suture patch 900 and the human blood vessel. For example, the position of the suture mark 942 is the suture position between the suture patch 900 and the human blood vessel, or the position at a set distance from the suture mark 942 is the suture position between the suture patch 900 and the human blood vessel. By setting the suture mark 942, the suture position of the suture patch 900 can be quickly and accurately located, thereby improving the efficiency of the surgery. The suture mark 942 can be a marking line or a contrast ring.

[0178] Example 4

[0179] In existing intraoperative stents, the dimensions of the main stent and the inlay are fixed at the factory. The size of the inlay cannot be adjusted according to needs, and it cannot be flexibly modified, which reduces the applicability of the product and the flexibility of the operation.

[0180] In view of this, combined with Figure 1 and Figure 50 This embodiment exemplarily provides an intraoperative stent 10, which includes at least a main stent 100, an inlay 400, and a closure 800. In other embodiments, where the structures do not conflict, the intraoperative stent 10 may optionally include an artificial blood vessel 200, a first outward-protruding stent 300, a second outward-protruding stent 700, and a skirt, etc. The specific structures of the artificial blood vessel 200, the first outward-protruding stent 300, the second outward-protruding stent 700, and the skirt, etc., can be referred to in Embodiment 1, and will not be repeated here.

[0181] Furthermore, the structures of the main support 100 and the embedded body 400 in this embodiment can also be referred to other embodiments. This embodiment mainly focuses on the structure of the closed body 800 and the connection structure between the closed body 800 and the embedded body 400. It should be understood that, where there is no structural conflict, the exemplary solutions in this embodiment can be combined with any exemplary solution in other embodiments to obtain new technical solutions.

[0182] Combination Figure 1and Figure 50 Similarly, in this embodiment, the outer peripheral surface of the main support 100 is provided with a groove 140; the inlay 400 has a preset axial length, and an inlay channel 410 is provided in the inlay 400 to pass through its proximal end and distal end. The inlay 400 is at least partially housed in the main support 100 and the inlay channel 410 communicates with the groove 140. The inlay channel 400 is used to cooperate with the implanted external branch support. The inlay channel 410 includes an input port 411 located on the proximal side.

[0183] The difference is, see Figures 50-52 In this embodiment, the intraoperative stent 10 includes a closure body 800, which is detachably connected to the inlay body 400. The closure body 800 includes a radial closure body 800a, which radially closes at least a portion of the inlet 411 of the inlay body 400. This radial closure can be achieved by suturing the inlay body 400 to the peripheral wall of the main stent 100 after radial compression of the inlet 411, thus sealing the inlet 400 and preventing blood flow. The radial closure body 800a partially closes the inlet 411 to form a closed portion 4111, and the unclosed portion of the inlet 411 is designated as an open portion 4112. The radial closure body 800a closing the inlet 411 can be selectively removed. When the radial closure 800a is removed from the insert 400, the radial closure 800a will cease its partial sealing effect on the inlet 411. At this time, at least a portion of the closure 4111 will no longer exist, thereby increasing the effective diameter of the inlet 411. For example, the closure 800 can be a suture 810, an adhesive, or a snap fastener, etc.

[0184] In this embodiment, the proximal inlet of the inlay within the stent is sealed with a closure, and the suture of the closure is knotted on the outer surface of the main stent. During the procedure, the closure can be selectively removed to adjust the inlet diameter of the inlay, allowing the surgeon to flexibly select branch stents based on the diameter of the supra-arc branch vessels. For example, if single-channel treatment is chosen during the procedure, it is not necessary to unseal one side of the branch channel. If the procedure requires dual-channel treatment using two branch stents, the unseal one side of the branch channel needs to be unsealed. The unsealing process simply involves cutting the closure between the outer surface of the main stent and the anti-detachment knot, then pulling out the cut closure to release the inlay hole on one side of the inlay, thus transforming a single inlay into a double inlay. This removable design of the stent in this embodiment increases product applicability and provides surgeons with more flexible choices and operating methods. Simultaneously, this method also achieves a more stable anchoring effect to some extent, avoiding branch stent displacement and detachment from branch vessels due to size mismatch, thereby improving the reliability of the procedure.

[0185] See Figures 50-63 The enclosure 4111 has one or more independent radial enclosures 800a, each of which can be selectively removed independently.

[0186] like Figure 51 and Figure 52 In some embodiments, for example, the closure 4111 may have a radial closure body 800a. When the radial closure body 800a is removed, the closure 4111 completely disappears, and the effective diameter of the inlet 411 increases to its maximum. For example... Figures 53-55 The closed portion 4111 can contain multiple radial closures 800a. These radial closures 800a are relatively independent; the removal of any one radial closure 800a will not affect the others, allowing each radial closure 800a to be removed sequentially and individually. The number of radial closures 800a can be two, three, or four, etc. The unclosed portion of the inlet 411 is designated as the open portion 4112. Along the direction away from the open portion 4112, multiple radial closures 800a can be removed sequentially to gradually enlarge the open portion 4112 and reduce the closed portion 4111. This gradually increases the effective diameter of the inlet 411, reaching its maximum after all radial closures 800a have been removed. (See also...) Figures 52-56 For ease of description, three radial closures 800a are used, referred to as the first radial closure 801, the second radial closure 802, and the third radial closure 803. The second radial closure 802 is located between the first radial closure 801 and the third radial closure 803. In the initial state, the first radial closure 801 is closest to the opening 4112, the second radial closure 802 is next, and the third radial closure 803 is furthest from the opening 4112. When the first radial closure 801 is removed, the opening 4112 increases while the closure 4111 decreases, and the effective diameter of the inlet 411 increases. When the second radial closure 802 is removed, the opening 4112 continues to increase while the closure 4111 continues to decrease, and the effective diameter of the inlet 411 continues to increase. After the third radial enclosure 803 is removed, the opening 4112 increases to its maximum and the enclosure 4111 disappears, and the effective diameter of the inlet 411 increases to its maximum.

[0187] See Figure 52In some embodiments, when the closure portion 4111 has multiple radial closure bodies 800a, the radial closure length E formed by the radial closure body 800a closest to the opening portion 4112 on the closure portion 4111 is the largest, while the radial closure lengths formed by the other radial closure bodies 800a on the closure portion 4111 are relatively small. Therefore, when the radial closure body 800a closest to the opening portion 4112 is removed, the increase in the opening portion 4112 is the largest, which also results in the largest increase in the effective diameter of the inlet port 411. This can reasonably reduce the number and frequency of removal of radial closure bodies 800a, allowing the effective diameter of the inlet port 411 to quickly increase to a reasonable level, thereby improving the efficiency of the surgery.

[0188] Therefore, when the closure portion 4111 has multiple radial closure bodies 800a, the number of radial closure bodies 800a to be removed can be reasonably considered according to the number of branch stents 50 to be implanted, ensuring that the inlet 411 of the embedded channel 410 meets the passage requirements of the branch stents 50. That is, the effective diameter of the inlet 411 can be adjusted to adapt to the number and size of the branch stents 50 implanted, greatly improving selectivity and flexibility. It can also improve the matching degree between the branch stents 50 and the branch vessels, avoid the displacement of the branch stents 50, and improve the reliability of the operation.

[0189] See Figure 57 In some embodiments, the closure 800 includes a suture 810, which radially closes a portion of the inlet 411 and / or laterally closes a portion of the embedded channel 410 by stitching. After the suture 810 closes the portion of the inlet 411 and / or laterally closes the portion of the embedded channel 410, both ends extend from the outer peripheral surface of the main support 100, and the extended suture 810 is knotted to form an anti-unraveling knot, thereby forming a closure. In other embodiments, the closure 800 may also be an adhesive body or a snap-fit ​​body, etc. Removing the adhesive body or snap-fit ​​body can increase the effective diameter of the inlet 411 and / or the effective inner diameter of the embedded channel 410.

[0190] Continue reading Figure 57In some embodiments, the two ends of the suture 810 are connected to form an anti-loosening knot 810a. There is only one anti-loosening knot 810a, thus forming a closed-loop structure. The anti-loosening knot 810a maintains a small gap with the closing portion 4111, allowing the suture 810 to exert a reasonable sealing force on the closing portion 4111 for effective closure. When the suture 810 needs to be removed, the suture 810 between the anti-loosening knot 810a and the closing portion 4111 can be cut. Then, the entire suture 810 can be pulled through the anti-loosening knot 810a, thereby pulling the suture 810 out of the entire inlay 400 and removing it. At this point, the closing portion 4111 will disappear. By forming anti-loosening knots 810a at both ends of the suture 810, during the removal of the suture 810, the user can directly hold the anti-loosening knot 810a to apply pulling force to the suture 810, thereby quickly removing the suture 810 and ultimately improving surgical efficiency.

[0191] See Figure 58 In some embodiments, the suture 810 extends out of the outer peripheral surface of the main support 100 to form three anti-detachment knots, which can be sequentially referred to as the first anti-detachment knot 811, the second anti-detachment knot 812, and the third anti-detachment knot 813. The two ends of the extended suture 810 are knotted at the two ends of the closing portion to form the first anti-detachment knot 811 and the second anti-detachment knot 812, respectively. After forming the first and second anti-detachment knots 811 and 812, the two ends of the suture are then knotted together to form the third anti-detachment knot 813. The third anti-detachment knot 813 is further away from the closing portion than the first and second anti-detachment knots 811 and 812. By setting the first and second anti-detachment knots 811 and 812, the entire suture 810 can be prevented from detaching from the closing portion 4111, and the suture 810 can also exert a reasonable sealing force on the closing portion 4111 to achieve an effective sealing effect. The third anti-detachment knot 813 is further away from the closing portion 4111 than the first anti-detachment knot 811 and the second anti-detachment knot 812. The third anti-detachment knot 813 is used to connect the two ends of the suture 810, thereby making the entire suture 810 form a closed loop structure. When it is necessary to remove the suture 810, the portion of the suture 810 located between the first anti-detachment knot 811 and the closing portion 4111 or between the second anti-detachment knot 812 and the closing portion 4111 is cut off. The entire suture 810 is then pulled through the third anti-detachment knot 813, thereby pulling the suture 810 out of the entire inlay 400 and removing it. At this time, the closing portion 4111 will disappear. In this embodiment, the first anti-detachment knot 811 and the second anti-detachment knot 812 form a constraint limit, ensuring the reliability of the closure. Then, the free ends of the two are tied together to form a third anti-detachment knot 813. This method makes it easier for the surgeon to pull out the suture and facilitates removal. In addition, the cut suture is still a whole and will not be divided into two parts, so that the entire radial closure can be removed in one pull.

[0192] See Figure 21 , Figure 55 and Figure 56 In some embodiments, for example, the embedded channel 410 includes a first channel 413 and a second channel 414, which are isolated from each other, thus maintaining a certain degree of independence between the first channel 413 and the second channel 414. See also... Figure 10 and Figure 11 For example, the embedded channel 410 includes a first channel 413, a second channel 414, and a connecting port 415. The connecting port 415 is located between the first channel 413 and the second channel 414. This can be understood as the connecting port 415 being located at a position where the first channel 413 and the second channel 414 are tangent or intersecting. The connecting port 415 extends along the axial direction of the embedded body 400, such that the axial length of the embedded body 400 is equal to the axial length of the first channel 413 and the second channel 414. The first channel 413 and the second channel 414 are interconnected through the connecting port 415. In other embodiments, the embedded channel 410 may also include three interconnected or independent channels, or it may include only one channel.

[0193] In the case where the first channel 413 and the second channel 414 are interconnected through the connecting port 415, the proximal openings of the first channel 413 and the second channel 414 may not be closed, and the proximal openings of the first channel 413 and the second channel 414 will constitute the input port 411 of the entire embedded channel 410, that is, the input port 411 of the embedded channel 410 is not closed at all.

[0194] See Figures 59-61 In some embodiments, the proximal port of the first channel 413 forms a first input port 4131, and the proximal port of the second channel 414 forms a second input port 4141. The first input port 4131 and the second input port 4141 constitute the input port 411 of the entire embedded channel 410, that is, the input port 411 of the entire embedded channel 410 includes the first input port 4131 and the second input port 4141. The second input port 4141 is completely closed to be configured as a closure portion 4111, while the first input port 4131 may not be closed. One or more sutures 810 may be provided on the closure portion 4111 of the second input port 4141, so that the closure portion 4111 disappears all at once or gradually disappears in multiple stages, and the effective diameter of the second input port 4141 is increased to the maximum all at once or gradually to the maximum in multiple stages.

[0195] For example, when two sutures 810 are provided on the closing portion 4111 of the second input port 4141, the effective diameter of the second input port 4141 can be 8mm after the suture 810 closest to the first input port 4131 is removed, and the effective diameter of the second input port 4141 can reach 10mm after the other suture 810 is removed. As another example, when three sutures 810 are provided on the closing portion 4111 of the second input port 4141, the effective diameter of the second input port 4141 can be 8mm after the suture 810 closest to the first input port 4131 is removed; the effective diameter of the second input port 4141 can increase to 10mm after the suture 810 adjacent to the suture 810 closest to the first input port 4131 is removed; and the effective diameter of the second input port 4141 can increase to 12mm after the suture 810 furthest from the first input port 4131 is removed.

[0196] During operation, since the first inlet 4131 is not closed, the branch stent 50 can be implanted through the first channel 413. When it is not necessary to implant the branch stent 50 through the second channel 414, the closure portion 4111 can remain closed. When it is necessary to implant the branch stent 50 through the second channel 414, if there is only one suture 810 in the closure portion 4111, the suture 810 can be removed, thereby maximizing the second inlet 4141 at once. If there are multiple sutures 810 in the closure portion 4111, the suture 810 closest to the first inlet 4131 can be removed. Then, depending on the specific size of the branch stent 50, it can be considered whether other sutures 810 need to be removed. For example, if the effective diameter of the second inlet 4141 meets the implantation requirements of the branch stent 50 after the suture 810 closest to the first inlet 4131 is removed, then it is not necessary to remove other sutures 810. For example, after the suture 810 closest to the first inlet 4131 is removed, the effective diameter of the second inlet 4141 cannot meet the implantation requirements of the branch stent 50. At this time, the next suture 810 needs to be removed. If the effective diameter of the second inlet 4141 meets the requirements at this time, the next suture 810 does not need to be removed. If the effective diameter of the second inlet 4141 still cannot meet the requirements at this time, the next suture 810 needs to be removed.

[0197] See Figure 62In some embodiments, in the initial state before implantation, the second inlet 4141 is completely closed, and the first inlet 4131 is partially closed. The closed portion of the first inlet 4131 is also configured as a closed portion 4111. At this time, the unclosed portion of the first inlet 4131 is referred to as an open portion 4112, which is located between the closed portion 4111 of the first inlet 4131 and the closed portion 4111 of the second inlet 4141. Similarly, when the first inlet 4131 has a closed portion 4111, if the effective diameter of the first inlet 4131 meets the implantation requirements of the branch stent 50, the sutures 810 in the closed portion 4111 need not be removed. Conversely, if the effective diameter of the first inlet 4131 does not meet the implantation requirements of the branch stent 50, the sutures 810 in the closed portion 4111 need to be removed. The closure portion 4111 of the first input port 4131 may contain only one suture 810 or multiple sutures 810.

[0198] See Figures 63-65 Based on any of the above-described intraoperative stents 10, the closure body 800 further includes a transverse closure body 800b for cooperating with the radial closure body 800a. The transverse closure body 800b is disposed along the length direction of the inlay body 400 from the closure start end and / or end end of the radial closure body 800a and is removably connected to the inlay body 400. The transverse closure body 800b is used to cooperate with the radial closure body 800a to partially close the inlay channel 410 to form a closed channel 410b. The transverse closure body 800b closing the inlay channel 410 can be selectively removed. Preferably, the closed channel 410b has one or more independent transverse closure bodies 800b, and each transverse closure body 800b can be independently and selectively removed. When the closure portion 4111 has one or more independent radial closure bodies 800a, and the closed channel 410b has one or more independent transverse closure bodies 800b, the number of radial closure bodies 800a and transverse closure bodies 800b are the same and correspond one-to-one.

[0199] For example, such as Figure 63 and Figure 64As shown, three radial closures 800a are arranged sequentially along the radial direction. These three radial closures 800a can be selectively removed. Simultaneously, a transverse closure 800b extends a certain length along the length of the inlay 400 from the starting and / or ending ends of the radial closures 800a. In this embodiment, "transverse" refers to a direction parallel to the central axis of the main support 100. The transverse extension length of the transverse closure 800b can be set as needed; for example, it can extend to the distal end of the inlay 400, i.e., the transverse closure 800b extends from the proximal to the distal end of the inlay 400. Of course, the extension length of the transverse closure 800b can be less than the extension length of the inlay 400.

[0200] Multiple radial closures 800a and multiple transverse closures 800b divide the embedded channel 410 of the inlay 400, forming a non-closed channel 410a that allows blood flow and a closed channel 410b that is closed. At the same time, the closed channel 410b includes multiple channels, such as the first closed channel 410b1, the second closed channel 410b2 and the third closed channel 410b3 as shown in the figure. The surgeon can select an appropriate external branch according to the actual situation of the patient's supra-arch branch, and then selectively remove the radial closures 800a and the corresponding transverse closures 800b according to the size of the external branch 50 and the implantation position to be connected.

[0201] For example, when the diameter of a branch vessel in the human arch is large, a larger diameter external branch stent is required. If the diameter of the non-closed channel 410a is insufficient, the adjacent radial closure body 800a and transverse closure body 800b can be removed, thus enlarging the corresponding input diameter and non-closed channel, allowing for anchoring with the larger diameter external branch stent. When the diameter of a branch vessel in the human arch is small, a smaller diameter external branch stent is required. In this case, a radial closure body 800a with a smaller radial length can be removed, forming an independent non-closed channel with a smaller diameter for anchoring with the smaller diameter external branch stent. This method allows the surgeon to implant branch stents 50 of different sizes according to individual differences, improving the matching degree between the branch stent 50 and the branch vessel, thereby improving the efficiency and reliability of the surgery, and greatly expanding the applicability of the product, making the surgical procedure more flexible and reliable.

[0202] See Figure 65 The transverse closure 800b can be a suture, which can be extended axially and then folded back to suture, and form a transverse anti-loosening knot 800b1 at the proximal end. When it needs to be removed, the suture is interrupted from the proximal end near the surgeon, and then the suture can be pulled out as a whole.

[0203] In other embodiments, when multiple independent radial and / or transverse closures are provided, each independent radial and / or transverse closure is provided with different identification marks. The identification marks can be implemented by setting different colors for the sutures.

[0204] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0205] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An intraoperative stent, characterized in that, include: Main support frame; An inlay, at least partially housed within the main support structure, having an inlay channel extending from its proximal end to its distal end, the inlay channel for engaging with an implanted external branch stent, the inlay channel including an inlet located on the proximal side; and A closure body is removably connected to the embedded body; wherein the closure body includes a radial closure body for partially closing the input port to form a closure portion, and the radial closure body closing the input port can be selectively removed.

2. The intraoperative stent according to claim 1, characterized in that, The unsealed portion of the input port is referred to as the open portion, and the sealed portion has one or more independent radial closure bodies, each of which can be selectively removed independently.

3. The intraoperative stent according to claim 2, characterized in that, When multiple independent radial closures are provided, the multiple radial closures can be removed sequentially in a direction radially away from the opening to gradually enlarge the opening and reduce the closure.

4. The intraoperative stent according to claim 2, characterized in that, When multiple independent radial enclosures are provided, each independent radial enclosure is provided with a different identification mark.

5. The intraoperative stent according to claim 1, characterized in that, The embedded channel includes a first channel and a second channel, which are isolated from each other; or, the embedded channel includes a first channel, a second channel, and a connecting port, which is located between the first channel and the second channel and extends along the axial direction of the embedded body, and the first channel and the second channel are connected to each other through the connecting port; the input port includes a first input port of the first channel and a second input port of the second channel, and the second input port is completely closed to be configured as the closed portion.

6. The intraoperative stent according to claim 5, characterized in that, The first input port is partially closed to be configured as the closed portion.

7. The intraoperative stent according to claim 6, characterized in that, The unclosed portion of the first input port is referred to as the open portion. In the initial state, the open portion is located between the closed portion of the first input port and the closed portion of the second input port.

8. The intraoperative stent according to claim 1, characterized in that, The closure includes a suture that closes a portion of the inlet by stitching to form the closure, and the suture can be selectively removed.

9. The intraoperative stent according to claim 8, characterized in that, After the suture closes the portion of the inlet, its two ends extend from the outer circumferential surface of the main body support, and the extended suture is knotted to form an anti-loosening knot.

10. The intraoperative stent according to claim 9, characterized in that, The anti-detachment knot includes a first anti-detachment knot, a second anti-detachment knot, and a third anti-detachment knot. The two ends of the protruding suture are tied at the two ends of the closed portion to form the first anti-detachment knot and the second anti-detachment knot, respectively. After forming the first anti-detachment knot and the second anti-detachment knot, the two ends of the suture are then tied together to form the third anti-detachment knot. The third anti-detachment knot is further away from the closed portion than the first anti-detachment knot and the second anti-detachment knot.

11. The intraoperative stent according to any one of claims 1 to 10, characterized in that, The enclosure further includes a transverse enclosure for cooperating with the radial enclosure. The transverse enclosure is arranged along the length of the inlay from the starting end and / or ending end of the radial enclosure and is removably connected to the inlay. The transverse enclosure is used to cooperate with the radial enclosure to partially close the inlay channel to form a closed channel. The transverse enclosure that closes the inlay channel can be selectively removed.

12. The intraoperative stent according to claim 11, characterized in that, The enclosed passage contains one or more independent transverse enclosures, each of which can be selectively removed independently.

13. The intraoperative stent according to claim 12, characterized in that, When the enclosed portion has one or more independent radial enclosed bodies, and the enclosed channel has one or more independent transverse enclosed bodies, the number of radial enclosed bodies and transverse enclosed bodies are the same and correspond one-to-one.

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