Endovascular implant system

Abstract

The present invention relates to an endovascular implant system, comprising an endovascular prosthesis, which has a radially expanded state and a radially contracted state. The endovascular prosthesis comprises: a covered stent, a valve prosthesis and a flexible connecting tube. The covered stent has a tubular structure and comprises a main body section and a reduced-diameter section which are in communication with each other, wherein the main body section and the reduced-diameter section are arranged in the axial direction of the covered stent, and the cross-sectional area of a proximal end of the reduced-diameter section is smaller than that of a distal end of the reduced-diameter section. The covered stent is further provided with a window running through the side wall of the covered stent, the window being at least partially located in the reduced-diameter section. The valve prosthesis comprises a valve stent and prosthetic valve leaflets connected to the inside of the valve stent. The flexible connecting tube is of a tubular structure formed by a flexible membrane, wherein a distal end of the flexible connecting tube is connected to the reduced-diameter section, a proximal end of the flexible connecting tube is connected to the valve prosthesis, and two axial ends of the flexible connecting tube are respectively in communication with the covered stent and the valve prosthesis. During implantation of the endovascular prosthesis of the present invention, the relative positions of the valve prosthesis and the covered stent can be adjusted on the basis of a lumen structure, such that the endovascular prosthesis can better adapt to a variety of lumen structures. In addition, the provision of the flexible connecting tube can reduce the risk of expansion deformation of the distal end of the valve prosthesis caused by the expansion of the covered stent, and force generated by the valve prosthesis during expansion is not easily transmitted to the covered stent, thereby reducing the risk of obstruction of coronary blood flow caused by expansion of the proximal end of the covered stent.

Description

Intracavitary implantation system Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an intracavitary implantation system. Background Technology

[0002] Aortic dissection occurs when a localized tear in the intima, under the impact of strong blood flow, causes the intima to gradually peel away and expand, creating a true and false lumen within the artery. According to the Stanford classification, aortic dissection is divided into two types: Type A and Type B. Type A aortic dissection involves an intima tear located in the ascending aorta, aortic arch, or proximal descending aorta, extending to involve the ascending aorta or aortic arch, with or without extension to the descending aorta or even the abdominal aorta. Type B aortic dissection involves an intima tear located in the aortic isthmus, extending only to the descending aorta or reaching the abdominal aorta, but without affecting the ascending aorta or aortic arch. Acute Stanford type A aortic dissection (TAAD) is the most common and dangerous aortic emergency in cardiovascular surgery. For patients with aortic dissection involving the aortic root and ascending aorta, the usual treatment is to replace the aortic valve and ascending aorta using traditional open surgery. Open surgery has disadvantages such as high trauma, technical difficulty, long operation time, large intraoperative blood loss, and high morbidity and mortality rates. It is not suitable for elderly patients, high-risk patients, or patients with contraindications to open surgery. Thoracic endovascular aortic repair (TEVAR) is an alternative to open surgery. This technique can expand the true lumen and promote the closure of the false lumen. Compared with traditional open surgery, it has advantages such as less trauma, lower intraoperative complications and mortality, and faster patient recovery time. However, there is currently no endovascular prosthesis suitable for aortic valve involvement or lesions involving the aortic root. Summary of the Invention

[0003] One technical problem solved by the present invention is to provide an endovascular implantation system for endovascular repair of the aortic root.

[0004] An intracavitary implantation system includes an intracavitary prosthesis having a radially expanded state and a radially contracted state, the intracavitary prosthesis comprising:

[0005] A covered stent has a tubular structure, comprising a main body segment and a reduced diameter segment that are interconnected, the main body segment and the reduced diameter segment being arranged along the axial direction of the covered stent, the proximal cross-sectional area of ​​the reduced diameter segment being smaller than the distal cross-sectional area of ​​the reduced diameter segment, and the covered stent also having a window penetrating through the sidewall of the covered stent, at least a portion of the window being located in the reduced diameter segment;

[0006] A valve prosthesis includes a valve stent and an artificial leaflet connected within the valve stent;

[0007] A flexible connecting tube is a tubular structure formed by a flexible membrane. The distal end of the flexible connecting tube is connected to the reduced diameter section, and the proximal end of the flexible connecting tube is connected to the valve prosthesis. The flexible connecting tube also connects the covered stent and the valve prosthesis.

[0008] In one embodiment, the flexible connecting tube is a circumferentially closed structure, and when the intracavitary prosthesis is in a radially expanded state, the minimum inner diameter of the flexible connecting tube is greater than the minimum inner diameter of the valve prosthesis.

[0009] In one embodiment, the covered stent includes a first wave and a second wave, the first wave being located in the main body segment and the second wave being located in the narrowed segment. The distal cross-sectional area of ​​the second wave is larger than the proximal cross-sectional area of ​​the second wave. A plurality of circumferentially arranged rhomboid spaces are formed between the first and second wave. The window is disposed in the rhomboid spaces, and the distal end of the window is closer to the distal end of the first wave than the proximal end of the first wave, and the proximal end of the window is closer to the proximal end of the second wave than the distal end of the second wave.

[0010] In one embodiment, the intracavitary prosthesis further includes an internal branch stent and a guide structure. The internal branch stent is located in the inner cavity of the covered stent and communicates with the corresponding window. The guide structure includes a beveled structure connecting the window and the proximal opening of the internal branch stent.

[0011] In one embodiment, the window is elliptical, and the major axis of the ellipse extends from the proximal end to the distal end of the window; or, the shape of the window is one or more of an ellipse-like shape, a circle, or a polygon.

[0012] In one embodiment, the coating support includes two windows, a first window and a second window, which are respectively disposed on the radial sides of the coating support. The coating support also includes a development mark for indicating the first window and / or the second window.

[0013] In one embodiment, the covered stent and the inner branch stent are self-expanding stents, and the valve stent is a balloon-expandable stent.

[0014] In one embodiment, the covered stent includes two windows, namely a first window and a second window, and the intracavitary prosthesis also includes two internal branch stents disposed in the inner cavity of the covered stent, namely a first internal branch stent communicating with the first window and a second internal branch stent communicating with the second window, and the first window and the second window are respectively disposed on the radial sides of the covered stent.

[0015] The intracavitary implantation system further includes a delivery device for delivering the intracavitary prosthesis to the target lumen. The delivery device includes a pre-placed guidewire, which has an engaged state that engages with the intracavitary prosthesis and a disengaged state that separates from the intracavitary prosthesis. When in the engaged state, the pre-placed guidewire passes sequentially through the first internal branch stent, the first window, the second window, and the second internal branch stent.

[0016] In one embodiment, the delivery device further includes a first branch catheter and a second branch catheter. When in the mated state, the pre-placed guidewire includes a first guide segment, a second guide segment, and a connecting segment located between the first guide segment and the second guide segment. The first guide segment passes through the first window and the first inner branch stent, and the second guide segment passes through the second window and the second inner branch stent. The first branch catheter is slidably fitted onto the first guide segment and can enter the first inner branch stent along the first guide segment. The second branch catheter is slidably fitted onto the second guide segment and can enter the second inner branch stent along the second guide segment. The connecting segment is located outside the covered stent and extends between the first window and the second window.

[0017] In one embodiment, the intracavitary prosthesis further includes an inner branch support disposed inside the covered stent and communicating with the window. The delivery device further includes a constraint member and a control member. The control member is used to control the constraint member to radially constrain the intracavitary prosthesis, and the control member is also used to control the constraint member to release the constraint on the first segment and the second segment of the intracavitary prosthesis, respectively. The first segment includes the reduced diameter segment and the first main body segment. The first main body segment refers to the axial section of the main body segment in which the inner branch support member is located, and the second segment refers to the other axial sections of the main body segment excluding the first segment.

[0018] In one embodiment, the control element includes at least one control wire, and the constraint element has two axial edges, namely a first edge and a second edge, both of which extend along the axial direction of the constraint element. The first edge and the second edge can be fixed together by at least one of the control wires, such that the constraint element is curled to form a tubular constraint sleeve. At least a portion of the control wires can be separated from the constraint element to release the fixation of at least a portion of the first edge and the second edge.

[0019] In one embodiment, the delivery device includes a first control wire and a second control wire. The first control wire is used to control the mutual fixation and separation of the axial edges of the first region of the constraint member, and the second control wire is used to control the mutual fixation and separation of the axial edges of the second region of the constraint member. When the constraint member constrains the intracavitary prosthesis, the first region is used to radially constrain the reduced diameter section, the first main body section, the flexible connecting tube and the valve prosthesis, and the second region is used to radially constrain the second section.

[0020] In one embodiment, both the covered stent and the valve prosthesis are covered with a membrane, the thickness of the flexible connecting tube is greater than or equal to the thickness of the membrane of the covered stent, and the thickness of the flexible connecting tube is greater than or equal to the thickness of the membrane of the valve prosthesis.

[0021] In one embodiment, the flexible connecting tube includes a narrow waist portion, the radial dimension of which is smaller than the radial dimension of the proximal end of the flexible connecting tube and smaller than the radial dimension of the distal end of the flexible connecting tube.

[0022] In one embodiment, the distance from the narrow waist to the proximal end of the flexible connecting tube is less than or equal to the distance from the narrow waist to the distal end of the flexible connecting tube.

[0023] In one embodiment, the covered support further includes a limiting member disposed on the outer surface of the reduced diameter section, the limiting member being used to constrain the extension path of the connecting section.

[0024] In one embodiment, the delivery device further includes a sheath, a delivery conduit, and a push tube. The delivery conduit and the push tube are both inserted into the sheath, and the delivery conduit is inserted into the push tube. All three of the sheath, delivery conduit, and push tube can move relative to each other axially. When the intraluminal prosthesis is radially contracted and loaded into the sheath, the intraluminal prosthesis can be radially contracted and loaded into the receiving space formed between the sheath and the delivery conduit. The receiving space is located between the front end of the push tube and the front end of the delivery conduit. The push tube includes a main lumen for accommodating the delivery conduit, a first sub-lumen for accommodating the pre-placed guidewire and branch conduit, and a second sub-lumen for accommodating the control wire.

[0025] An assembly method, applicable to the endocavitary implantation system described in any one of the preceding claims, the assembly method comprising:

[0026] The pre-placed guidewire is threaded onto the intracavitary prosthesis;

[0027] The constraint and the intracavitary prosthesis are assembled together so that the constraint can at least radially constrain the covered stent;

[0028] The assembled constraint, intracavitary prosthesis, and pre-placed guidewire are radially compressed and loaded into the sheath.

[0029] In one embodiment, prior to radially compressing and loading the assembled constraint, intracavitary prosthesis, and pre-placed guidewire into the sheath, the method further includes:

[0030] The first and second guide segments of the pre-placed guidewire are inserted into the push tube. The first and second branch catheters are respectively fitted onto the first and second guide segments and inserted into the push tube. The front ends of the first and second branch catheters are located at the distal end of the intracavitary prosthesis or near the distal end of the intracavitary prosthesis.

[0031] An operating method applicable to the endocavitary implantation system described in any one of the above claims, the operating method comprising:

[0032] The sheath containing the intracavitary prosthesis is pushed into the target lumen, and then the sheath is withdrawn until the intracavitary prosthesis is completely released from the sheath and is in a state of radial constraint by the constraint member.

[0033] Release the constraint on the first segment of the intracavitary prosthesis, so that at least the reduced diameter segment and the first main body segment are released from the constraint, while the second segment of the intracavitary prosthesis remains constrained within the constraint;

[0034] Adjust the position of the intracavitary prosthesis so that the window of the reduced diameter section is aligned with a preset position;

[0035] After pushing the branch catheter to the vicinity of the preset position along the pre-placed guidewire, retract the pre-placed guidewire;

[0036] Insert a branch guidewire into the branch catheter until the branch guidewire enters the corresponding preset position, then withdraw the branch catheter.

[0037] dilatational valve prosthesis;

[0038] Release the constraint on the second segment of the intracavitary prosthesis until the intracavitary prosthesis is completely released;

[0039] The corresponding external stent is implanted along the path of the branch guidewire.

[0040] One technical advantage of one embodiment of the present invention is that, due to the flexible connecting tube, the valve prosthesis is allowed to adapt to the heart's pulsation after implantation, moving slightly relative to the covered stent without causing stent displacement, while the covered stent still effectively isolates the lesion area. Furthermore, the relative movement between the valve prosthesis and the covered stent allows for adjustment of their relative positions according to the luminal structure during implantation, better adapting to various luminal structures. Moreover, the flexible connecting tube prevents the force generated during the radial expansion of the covered stent from being easily transmitted to the valve prosthesis, reducing the risk of distal expansion and deformation of the valve prosthesis due to stent expansion. Additionally, the force generated during valve prosthesis expansion is also less likely to be transmitted to the covered stent, thus reducing the risk of proximal expansion of the covered stent obstructing coronary blood flow. Attached Figure Description

[0041] Figure 1 is a diagram showing the state of an intracavitary prosthesis implanted in the body according to an embodiment;

[0042] Figure 2 is a schematic diagram of the structure of an intracavitary prosthesis provided in one embodiment;

[0043] Figure 3 is a schematic diagram of the structure of an intracavitary prosthesis provided in one embodiment;

[0044] Figure 4 is a structural schematic diagram of an internal branch support and guide structure provided in an embodiment;

[0045] Figure 5 is a side view of Figure 4;

[0046] Figure 6 is a structural schematic diagram of the narrow waist section of a flexible connecting tube provided in one embodiment;

[0047] Figure 7 is a schematic cross-sectional view of the push tube provided in one embodiment;

[0048] Figure 8 is a schematic diagram of the cooperation between the pre-placed guidewire and the intracavitary prosthesis provided in one embodiment;

[0049] Figure 9 is a partial structural schematic diagram of an intracavitary prosthesis provided in an embodiment, wherein the intracavitary prosthesis is provided with a limiting member;

[0050] Figure 10 is a schematic diagram of the first and second edges of a constraint member provided in an embodiment being fixed to each other by a control wire;

[0051] Figures 11a to 11k are schematic diagrams of the implantation process of an intracavitary prosthesis provided in one embodiment (wherein, to better illustrate the internal structure of the intracavitary implantation system, Figure 11i does not show the support frame of the covered stent, and the local outer contour of the intracavitary implantation system is represented by a thick line). Detailed Implementation

[0052] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0053] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When 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. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementations. The term "axial" in this invention generally refers to the length direction of the medical device during delivery, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction. The "axial" and "radial" directions of any component of the medical device are defined accordingly. For intracavitary prostheses, "proximal" refers to the axial end relatively closer to the heart, and "distal" refers to the axial end relatively farther from the heart. For delivery systems, "rear end" refers to the axial end relatively closer to the operator, and "front end" refers to the axial end relatively farther from the operator.

[0054] The "wave loop" (also referred to as a wave-shaped ring) in this invention can be a closed or open ring structure, comprising multiple waves. The "wave loop" is woven or cut from a metallic elastic material or a polymer material. The metallic elastic material includes known materials used in implantable medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloys, or other biocompatible metallic elastic materials. The polymer material includes biocompatible materials such as polylactic acid. The "wave loop" has radial expansion capability, allowing it to radially contract under external force and recover its initial shape and maintain it after the external force is removed, either by self-expansion or mechanical expansion (e.g., balloon inflation). Thus, after implantation into a lumen, its radial support force allows it to adhere tightly to the inner wall of the lumen. The waveform of the waves in the "wave loop" is unrestricted, including Z-shaped waves, M-shaped waves, V-shaped waves, sine waves, etc. A "wave loop" consists of multiple crests, multiple troughs, and wave rods connecting adjacent crests and troughs. A single vertex (crest or trough) and the two wave rods connected to that vertex form a wave.

[0055] The "coating" in this invention can isolate liquids to a certain extent, and it can be made of polymer materials with good biocompatibility, such as polytetrafluoroethylene (PTFE) and polyethylene terephthalate (PET).

[0056] Referring to Figures 1 and 11a, an embodiment of the present invention provides an endovascular implantation system, which includes an endovascular prosthesis 100 and a delivery device 200. The endovascular prosthesis 100 has a radially expanded state and a radially contracted state. In the radially expanded state, the endovascular prosthesis 100 has a larger radial dimension (or radial width, diameter) than in the radially contracted state. The endovascular prosthesis 100 can be compressed and loaded into the delivery device 200, delivered to the target lumen through the delivery device 200, and then released from the delivery device 200 and deployed and anchored in the target lumen. In this embodiment, the lumen formed by the aortic valve 1, the aortic sinus 2, and the ascending aorta 3 is used as an example. In other embodiments, the target lumen can be any other suitable lumen within a living organism or an in vitro simulated lumen.

[0057] Please refer to Figures 2 and 3. The intracavitary prosthesis 100 includes a covered stent 110, a valve prosthesis 120, and a flexible connecting tube 130. The flexible connecting tube 130 is located between the covered stent 110 and the valve prosthesis 120, and connects the covered stent 110 and the valve prosthesis 120 into one unit.

[0058] The covered stent 110 is suitable for implantation into the lumen formed by the ascending aorta 3 and the aortic sinus to isolate the lesion area. The covered stent 110 has a tubular structure and includes a main body segment 111 and a narrowed segment 112 that are interconnected. The main body segment 111 and the narrowed segment 112 are arranged axially along the covered stent 110, and the proximal cross-sectional area of ​​the narrowed segment 112 is smaller than the distal cross-sectional area of ​​the narrowed segment 112. The covered stent 110 also has a window 114 penetrating the sidewall of the covered stent 110, at least a portion of which is located within the narrowed segment 112. After implantation, the constricted segment 112 of the covered stent 110 is partially or entirely located in the aortic sinus, and the opening of the coronary artery is located on the lateral wall of the aortic sinus. The smaller cross-sectional area of ​​the proximal end of the constricted segment 112 allows a gap to be formed between the constricted segment 112 and the lateral wall of the aortic sinus after the implantation of the intraluminal prosthesis 100, which can greatly reduce the probability of the covered stent 110 blocking the branch opening. In addition, at least part of the window 114 is located in the constricted segment 112, which allows the lumen of the covered stent 110 to communicate with the outside, ensuring that the blood flow in the lumen of the covered stent 110 can enter the coronary artery through the window 114, reducing the probability of myocardial ischemia.

[0059] The valve prosthesis 120 is suitable for implantation into the aortic valve 1. The valve prosthesis 120 includes a valve stent 121 and an artificial leaflet (not shown) connected inside the valve stent 121.

[0060] The flexible connecting tube 130 is a tubular structure formed by a flexible membrane. The distal end of the flexible connecting tube 130 is connected to the reduced-diameter section 112, and the proximal end is connected to the valve prosthesis 120. The axial ends of the flexible connecting tube 130 are respectively connected to the covered stent 110 and the valve prosthesis 120. The covered stent 110, the valve prosthesis 120, and the flexible connecting tube 130 together form a cavity for fluid (e.g., blood) to flow through. This cavity is the inner cavity of the intracavitary prosthesis 100. After implantation, blood can flow from the proximal end of the valve prosthesis 120 into the inner cavity of the intracavitary prosthesis 100 and flow out from the distal end of the covered stent 110 into the inner cavity of the intracavitary prosthesis 100. Furthermore, blood in the inner cavity of the intracavitary prosthesis 100 can also flow out through the window 114 to the coronary artery.

[0061] In this embodiment, the endovascular prosthesis 100, due to the flexible connecting tube 130, allows the valve prosthesis 120 to adapt to the heart's pulsation after implantation, with slight movement relative to the covered stent 110 without causing displacement of the covered stent 110, while the covered stent 110 still effectively isolates the lesion area. Furthermore, the relative movement between the valve prosthesis 120 and the covered stent 110 allows for adjustment of their relative positions according to the luminal structure during implantation, thus better adapting to various luminal structures. Moreover, the flexible connecting tube 130 prevents the force generated during radial expansion of the covered stent 110 from being transmitted to the valve prosthesis 120, reducing the risk of distal expansion and deformation of the valve prosthesis 120 due to the expansion of the covered stent 110. Additionally, the force generated during expansion of the valve prosthesis 120 is also less likely to be transmitted to the covered stent 110, thus reducing the risk of proximal expansion of the covered stent 110 obstructing coronary blood flow.

[0062] In this embodiment, the covered stent 110 can be a self-expanding stent; in other embodiments, the covered stent 110 can be a balloon-expandable stent. The covered stent 110 includes a supporting stent 1111 and a first covering 1112, wherein the first covering 1112 is tubular and used to isolate the lesion area. The supporting stent 1111 includes a plurality of corrugated coils 1113 spaced apart along the axial direction of the covered stent 110. The corrugated coils 1113 of the supporting stent 1111 can be connected and fixed to the outer surface of the first covering 1112, that is, the first covering 1112 covers the inner surface of the corrugated coils 1113. This arrangement facilitates firm anchoring of the covered stent 110 to the target lumen. In other embodiments, the corrugated coils 1113 of the supporting stent 1111 can be connected and fixed to the inner surface of the first covering 1112, that is, the first covering 1112 covers the outer surface of the corrugated coils 1113. In other embodiments, the supporting stent 1111 can also be other supporting structures formed by cutting or weaving, such as a mesh structure. The support bracket 1111 and the first coating 1112 can be connected by stitches, or they can be connected as one piece by hot pressing, bonding or other methods.

[0063] In this embodiment, the proximal end of the main body segment 111 of the covered stent 110 is connected to the distal end of the reduced diameter segment 112. The two can be an integral structure or fabricated separately and then joined together. The support stent 1111 extends from the proximal end to the distal end of the covered stent 110, providing support within the reduced diameter segment 112 and thus better maintaining its shape after implantation. For example, both the main body segment 111 and the reduced diameter segment 112 of the covered stent 110 are provided with a corrugated coil 1113 and a first covering 1112. The cross-sectional area of ​​each section of the main body segment 111 along the axial direction is substantially the same. For example, the main body segment 111 can be a cylindrical structure, and its diameter (or radial dimension, radial width) is relatively uniform along the axial direction. In other embodiments, the cross-sectional area of ​​each region of the main body segment 111 along the axial direction may also be different. The cross-sectional area of ​​the reduced-diameter segment 112 varies along its axial direction. For example, the cross-sectional area of ​​the reduced-diameter segment 112 decreases from its distal end to its proximal end. In one embodiment, the cross-sectional shape of the reduced-diameter segment 112 may be circular, with the diameter of the distal end of the reduced-diameter segment 112 being approximately the same as the diameter of the proximal end of the main body segment 111. The diameter of the reduced-diameter segment 112 gradually decreases from its distal end to its proximal end. In another embodiment, the cross-sectional area of ​​the distal end of the reduced-diameter segment 112 is approximately the same as the cross-sectional area of ​​the proximal end of the main body segment 111, and the cross-sectional area of ​​the reduced-diameter segment 112 gradually decreases from its distal end to its proximal end. When the main body segment 111 and the reduced-diameter segment 112 are projected onto the same radial plane, the proximal projection profile of the reduced-diameter segment 112 lies within the distal projection profile of the reduced-diameter segment 112. Alternatively, the proximal projection profile of the reduced-diameter segment 112 may also be said to lie within the proximal projection profile of the main body segment 111.

[0064] Understandably, in other embodiments, the cross-sectional shapes of the main body segment 111 and the reduced diameter segment 112 may be the same or different, and their cross-sectional shapes may also be elliptical or any other suitable shape. The cross-sectional area variation of each segment of the reduced diameter segment 112 along the axial direction may also be non-uniform. By setting a wave loop 1113 or other support structure on the reduced diameter segment 112, the shape of the reduced diameter segment 112 can be better maintained. Combined with the shape of the reduced diameter segment 112 gradually narrowing from the distal end to the proximal end, after implantation, a large annular septal space is formed between the circumference of the reduced diameter segment 112 and the inner wall of the aortic sinus 2. The entire annular septal space can be used for blood flow into the coronary artery, which helps to further reduce the risk of coronary blood flow obstruction after implantation of the intraluminal prosthesis 100.

[0065] In this embodiment, the window 114 of the covered stent 110 is partially or entirely located in the narrowed section 112, allowing blood flow to enter the annular septum and then flow into the coronary artery after implantation of the intraluminal prosthesis 100 and before coronary artery reconstruction, thus maintaining good blood supply in the coronary artery. Even if the area of ​​the window 114 located within the narrowed section 112 is deviated from the coronary ostium, blood can still flow into the coronary artery through the annular septum.

[0066] The covered stent 110 may be provided with two windows 114, namely a first window 114a and a second window 114b, which are respectively located on the radial sides of the covered stent 110 to correspond to the left and right coronary arteries. In other embodiments, the number of windows 114 can be set according to actual needs.

[0067] At least one window 114 of the covered stent 110 may also be provided with a corresponding imaging mark 115 for distinguishing the first window 114a and the second window 114b under imaging, so that the operator can identify them for alignment with the left and right coronary arteries. For example, the first imaging mark 115 may be provided at or near the edge of the first window 114a, while no additional imaging mark 115 may be provided at or near the edge of the second window 114b; or, no imaging mark 115 may be provided at or near the edge of the first window 114a, while a second imaging mark 115 may be provided at or near the edge of the second window 114b; or, for example, the first imaging mark 115 may be provided at or near the edge of the first window 114a, while a second imaging mark 115 may be provided at or near the edge of the second window 114b. The shapes of the first imaging mark 115 and the second imaging mark 115 may be selected from one or more of the shapes such as "C", "E", and "6". Understandably, when the first developing mark 115 and the second developing mark 115 exist simultaneously, their shapes, orientations, and positions must be different in order to distinguish the first window 114a and the second window 114b under developing conditions.

[0068] In this embodiment, window 114 is located between two wave loops 1113, namely a first wave loop 1113a and a second wave loop 1113b. The first wave loop 1113a is closer to the distal end of the covered support 110 than the second wave loop 1113b, and is located in the main body segment 111. The second wave loop 1113b is located in the tapered segment 112 and conforms to the shape of the tapered segment 112. The distal cross-sectional area of ​​the second wave loop 1113b is larger than its proximal cross-sectional area. Exemplarily, the diameter of the second wave loop 1113b gradually decreases from its distal end to its proximal end.

[0069] The wave containing a peak in the first wave loop 1113a and the wave containing a trough in the second wave loop 1113b enclose a rhombus-like space (also called a rhombus-like space), and the window 114 is located within this space. The peak in wave loop 1113 refers to the apex closer to the distal end of the intracavitary prosthesis 100 within the same wave loop 1113, and the trough in wave loop 1113 refers to the apex closer to the proximal end of the intracavitary prosthesis 100 within the same wave loop 1113. For example, as shown in FIG3, the crest of the first wave loop 1113a and the trough of the second wave loop 1113b are axially opposite, and the trough of the first wave loop 1113a and the crest of the second wave loop 1113b are axially opposite. In other words, the waveforms of the first wave loop 1113a and the second wave loop 1113b are out of phase. The first wave loop 1113a and the second wave loop 1113b enclose a plurality of circumferentially arranged rhomboid spaces, and the window 114 is located within these rhomboid spaces. In other embodiments, the crest of the first wave loop 1113a and the trough of the second wave loop 1113b may not be axially opposite, and the trough of the first wave loop 1113a and the crest of the second wave loop 1113b may not be axially opposite.

[0070] The rhomboid space formed between the crest of the first wave loop 1113a and the trough of the second wave loop 1113b provides ample space for the placement of the window 114, allowing the area of ​​the window 114 to be sufficiently large. For example, the distal end of the window 114 is closer to the distal end of the first wave loop 1113a than the proximal end, and the proximal end of the window 114 is closer to the proximal end of the second wave loop 1113b than the distal end. In other words, the window 114 extends into the waves of both the first and second wave loops 1113a and 1113b. The waves surrounding the window 114 provide good support, which helps maintain the open shape of the window 114 to a certain extent after the intracavitary prosthesis 100 is implanted, reducing the risk of blood flow obstruction due to window deformation. In other embodiments, the window 114 is not necessarily placed between the two wave loops 1113; its position can be set according to actual needs. To better maintain the shape of window 114, a window support member (not shown) can be provided along the edge of window 114. The shape of the window support member is adapted to the shape of window 114. For example, the window support member can be ring-shaped and set along the edge of window 114, and can be connected to the edge of window 114 by means of sewing, gluing, etc. In this embodiment, the window support member can be a closed structure, which is beneficial to better maintain the open shape of window 114. In other embodiments, the window support member can also be a non-closed structure. In other embodiments, the window support member can be omitted.

[0071] The window 114 can be elliptical in shape, with its major axis extending from the proximal end to the distal end. This design allows the window 114 to have a larger area, enabling alignment with the coronary artery ostium within a larger operating space. Particularly along the axial direction of the intraluminal prosthesis 100, the covered stent 110 has a longer positioning area, ensuring good alignment with the coronary artery ostium even with adjustments to the axial position of the covered stent 110. Understandably, in other embodiments, the window 114 can also be circular, quadrilateral, or any other suitable shape.

[0072] Referring to Figures 3, 4, and 5, in this embodiment, the intraluminal prosthesis 100 may further include an internal branch stent 116 disposed within the lumen of the covered stent 110. The internal branch stents 116 may be configured in a one-to-one correspondence with windows 114. For example, the intraluminal prosthesis 100 may have two internal branch stents 116: a first internal branch stent 116a communicating with the first window 114a and a second internal branch stent 116b communicating with the second window 114b. The internal branch stents 116 extend approximately along the axial direction of the intraluminal prosthesis 100. During coronary artery reconstruction, a coronary stent can be implanted in the coronary artery. The coronary stent is inserted into the corresponding internal branch stent 116 through the window 114 to establish a blood flow channel between the lumen of the covered stent 110 and the coronary artery. The internal branch stent 116 provides an anchoring space between the coronary stent and the covered stent 110, allowing for better mutual anchoring and connection between the two. In other embodiments, the internal branch stent 116 may be replaced by an external branch stent disposed outside the covered stent 110. Compared to external branch stents, since the internal branch stent 116 is located in the lumen of the covered stent 110, it can avoid encroaching on the annular septal space formed between the constricted segment 112 and the inner wall of the aortic sinus 2. Therefore, it can ensure that blood flow can enter the coronary artery more smoothly before coronary artery reconstruction, and maintain good blood supply in the coronary artery.

[0073] In this embodiment, the cross-sectional area of ​​the window 114 is larger than the cross-sectional area of ​​the inner branch stent 116. The larger window 114 area can provide more operating space to align the window 114 with the coronary artery opening, and can also provide more space for the coronary stent to enter the inner branch stent 116.

[0074] The internal branch stent 116 may be a self-expanding stent; in other embodiments, it may also be a balloon-expandable stent. The internal branch stent 116 includes a branch support structure 1161 and a branch covering 1162. The branch covering 1162 of the internal branch stent 116 is generally tubular, and the branch support structure 1161 is connected to the branch covering 1162 to maintain the shape of the internal branch stent 116. The branch support structure 1161 may include multiple corrugated coils arranged along the axial direction of the internal branch stent 116, or it may be a mesh structure or any other suitable support structure. The branch covering 1162 of the internal branch stent 116 is disposed on the inner wall and / or outer wall of the support structure.

[0075] The distal opening of the internal branch stent 116 can be a beveled structure 1163, making it easier for the guidewire or catheter to enter the internal branch stent 116 through the distal opening.

[0076] The intracavitary prosthesis 100 may further include a guide structure 117, which includes a beveled structure 1171 connected to the proximal openings of the window and the internal branch stent, respectively. The guide structure 117 may be made of a membrane, on which support structures such as corrugations or mesh structures may be provided, or no additional support structures may be provided. The guide structure 117 without support structures not only allows for flexible deformation itself, but also allows the internal branch stent 116 connected to it to move to a certain extent relative to the window 114. Therefore, during guidewire and catheter insertion, the guide structure 117 can adaptively deform, and the internal branch stent 116 can adaptively adjust its relative position to the window 114, thereby facilitating the rapid insertion of the guidewire or catheter into the channel formed by the guide structure 117, the internal branch stent 116, and the window 114. In other embodiments, the guide structure 117 may also be a tubular structure similar to a frustum, a funnel-shaped structure, or an eccentric funnel-shaped structure.

[0077] Referring to Figures 2 and 3, in this embodiment, the valve prosthesis 120 functions as a one-way valve, allowing blood flow in one direction. The valve stent 121 of the valve prosthesis 120 can be a balloon-expandable stent. The valve stent 121 may include multiple coils 1113 arranged axially along the inner branch stent 116, or it may be a mesh structure or other suitable support structure. In other embodiments, the valve stent 121 may also be a self-expanding stent. When the valve stent 121 is a balloon-expandable stent, it has advantages such as accurate implantation positioning, small axial dimension, and no extension to the coronary ostium after implantation, thus preventing coronary artery obstruction.

[0078] Artificial valve leaflets can be made from one or more biological tissue materials selected from porcine pericardium, bovine pericardium, porcine aortic valve, and fish swim bladder, or they can be made from polymer materials.

[0079] The valve prosthesis 120 may also include a tubular second cover 122, which covers the inner and / or outer surfaces of the valve stent 121 and can be connected to the valve stent 121 by suturing, bonding or other means.

[0080] The intracavitary prosthesis 100 may further include an anchor 123 located proximal to the valve prosthesis 120. The anchor 123 is disposed on the outside of the valve prosthesis 120 and protrudes from the outer surface of the valve prosthesis 120. After the intracavitary prosthesis 100 is implanted and positioned, the anchor 123 abuts against the ventricular side of the aortic valve annulus, thereby limiting the range of movement of the valve prosthesis 120 away from the ventricle and helping to prevent excessive displacement of the valve prosthesis 120. In this embodiment, the proximal end of the anchor 123 is connected to the proximal end of the valve prosthesis 120 by means of suturing, welding, bonding, etc. When the intracavitary prosthesis 100 is in a radially expanded state, the anchor 123 extends toward the distal end of the valve prosthesis 120, and from the proximal end to the distal end, the anchor 123 tilts toward the direction gradually away from the central axis of the valve prosthesis 120. The distal end of the anchor 123 may be a free end. For example, the anchor 123 includes one or more barbs pointing towards the distal end of the valve prosthesis 120. In other embodiments, the anchor 123 includes a wavering surrounding the valve prosthesis 120, the proximal end of which is connected to the proximal end of the valve stent 121 or the proximal end of the second cover 122 of the valve prosthesis 120. When the intracavitary prosthesis 100 is in a radially expanded state, the wavering gradually tilts away from the central axis of the valve prosthesis 120 from the proximal end to the distal end of the anchor 123, creating a gap between the wavering and the valve prosthesis 120. In other embodiments, the wavering in the anchor 123 may also be replaced by an annular elastomer surrounding the valve prosthesis 120, and the anchor 123 may be any other suitable structure.

[0081] The flexible connecting tube 130 can be connected to the first covering 1112 of the covered stent 110 and the second covering 122 of the valve prosthesis 120 by means of suturing, bonding, or other methods. The flexible connecting tube 130 has a circumferentially closed structure, and when the intracavitary prosthesis 100 is in a radially expanded state, the minimum inner diameter of the flexible connecting tube 130 is larger than the minimum inner diameter of the valve prosthesis 120. For example, the flexible connecting tube 130 can be in the shape of a cylindrical tube, and along the axial direction of the flexible connecting tube 130, the flexible connecting segment 130 includes a first flexible segment 130a and a second flexible segment 130b. The first flexible segment 130a has its proximal end connected to the distal end of the valve prosthesis 120, and has a uniform inner diameter along its axial direction. The second flexible segment 130b has its proximal end connected to the distal end of the first flexible segment 130a, and its distal end connected to the proximal end of the covered stent 110. The inner diameter of the proximal end of the second flexible segment 130b is smaller than that of the distal end. From the proximal end to the distal end, the inner diameter of the second flexible segment 130b gradually increases, and the inner diameter of the proximal end of the second flexible segment 130b is approximately equal to that of the first flexible segment 130a. When the intracavitary prosthesis 100 is in a radially expanded state, the minimum inner diameter of the flexible connecting tube 130 is the inner diameter of the first flexible segment 130a, and the inner diameter of the first flexible segment 130a is larger than the minimum inner diameter of the valve prosthesis 120. During balloon dilation of the valve prosthesis 120, the balloon used to dilate the valve prosthesis 120 may extend into the lumen of the flexible connecting tube 130. A larger inner diameter of the flexible connecting tube 130 helps reduce the probability of damage to the flexible connecting tube 130 during balloon inflatation to dilate the valve prosthesis 120. In other embodiments, the flexible connecting tube 130 may be cylindrical, with a uniform inner diameter along its axial direction. When the intraluminal prosthesis 100 is in a radially dilated state, the inner diameter of the flexible connecting tube 130 is greater than the minimum inner diameter of the valve prosthesis 120. In other embodiments, the flexible connecting tube 130 is not necessarily cylindrical, and the inner diameter of different axial segments of the flexible connecting tube 130 may vary.

[0082] Furthermore, the flexible connecting tube 130 may also include a constraint portion 1301 disposed circumferentially along the flexible connecting tube 130. This constraint portion 130 is disposed on the first flexible segment 130a to better constrain the shape and diameter of the first flexible segment 130a, further preventing the force generated by the covered stent 100 during radial expansion from being transmitted to the valve prosthesis 120. This reduces the risk of distal expansion and deformation of the valve prosthesis 120 caused by the expansion of the covered stent 110. For example, the constraint portion 1301 may be disposed at the distal end of the first flexible segment 130a or in other areas of the first flexible segment 130a. The constraint portion 1301 can be a closed annular structure or a non-closed structure. For example, the constraint portion 1301 may be a suture loop sewn onto the flexible connecting tube 130 and extending circumferentially along the flexible connecting tube 230. In other embodiments, the constraint portion 1301 may be a strip or band structure made of other materials, as long as it can constrain the radial structure of the flexible connecting tube 130 to a certain extent. In other embodiments, the constraint part 1301 may be omitted.

[0083] Referring to Figure 6, in other embodiments, the flexible connecting tube 130 may include a narrow waist 131. The radial dimension of the narrow waist 131 is smaller than the radial dimension of the proximal end of the flexible connecting tube 130 and smaller than the radial dimension of the distal end of the flexible connecting tube 130. For example, the flexible connecting tube 130 includes a proximal end and a distal end along the axial direction, and the narrow waist 131 located between the proximal end and the distal end. Specifically, from the proximal end to the distal end, the radial dimension of the proximal end gradually decreases, and the distal end of the proximal end connects to the proximal end of the narrow waist 131 and has the same radial dimension as the narrow waist 131. From the proximal end to the distal end, the radial dimension of the distal end gradually increases, and the proximal end of the distal end connects to the distal end of the narrow waist 131 and has the same radial dimension as the narrow waist 131.

[0084] After implantation, the valve prosthesis 120 adapts to the heart's pulsation. When it moves slightly towards the covered stent 110 relative to the covered stent 110, the flexible connecting tube 130 can fold and shorten to a certain extent. By setting a narrow waist 131, the folded area formed by the flexible connecting tube 130 is concentrated in or near the narrow waist 131, reducing the risk of internal blood flow disturbance caused by irregular folding on the flexible connecting tube 130. Furthermore, the distance from the narrow waist 131 to the proximal end of the flexible connecting tube 130 is less than or equal to the distance from the narrow waist 131 to the distal end of the flexible connecting tube 130. This setting ensures that the folded area formed by the flexible connecting tube 130 is relatively far away from the reduced diameter section 112, preventing the outward bulging of the folds from obstructing blood flow into the coronary artery ostium.

[0085] In some embodiments, the thickness of the flexible connecting tube 130 may be greater than the first membrane 1112 of the covered stent 110 and the second membrane 122 of the valve prosthesis 120. This configuration helps to improve the fatigue resistance of the flexible connecting tube 130 and reduce the risk of breakage. In other embodiments, the thickness of the flexible connecting tube 130 may be equal to the first membrane 1112 of the covered stent 110 and the second membrane 122 of the valve prosthesis 120, or the thickness of the flexible connecting tube 130 may be set according to actual needs.

[0086] In this embodiment, the delivery device 200 includes a sheath 210, a delivery conduit 220, and a pre-placed guide wire 230. The delivery conduit 220 is inserted into the sheath 210, and the sheath 210 and the delivery conduit 220 can move relative to each other along the axial direction. The intracavitary prosthesis 100 can be radially contracted and loaded into the receiving space formed between the sheath 210 and the delivery conduit 220.

[0087] Referring to Figures 11a to 11e, the delivery device 200 may further include a push tube 240, which passes through the sheath 210, and a delivery conduit 220 passes through the push tube 240. The push tube 240 and the delivery conduit 220 are axially movable relative to each other, and the push tube 240 and the sheath 210 are also axially movable relative to each other. When the intracavitary prosthesis 100 retracts radially and is loaded in the sheath 210, the intracavitary prosthesis 100 is loaded in the receiving space formed between the sheath 210 and the delivery conduit 220, and this receiving space is located between the front end of the push tube 240 and the front end of the delivery conduit 220.

[0088] Please refer to Figures 8 and 11a to 11e simultaneously. The pre-placed guidewire 230 has a mating state with the intracavitary prosthesis 100 and a disengaged state with the intracavitary prosthesis 100. When in the mating state, the pre-placed guidewire 230 passes sequentially through the first internal branch support 116a, the first window 114a, the second window 114b, and the second internal branch support 116b. The pre-placed guidewire 230 is used to guide the branch catheter 260 (which can be used to deliver coronary stents) into the inner branch stent 116. Since the pre-placed guidewire 230 passes through the first inner branch stent 116a and the second inner branch stent 116b in sequence, two branch catheters 260 can be guided into the corresponding inner branch stents 116 simultaneously with one pre-placed guidewire 230. Moreover, the pre-placed guidewire 230 is not easy to displace during the operation, which can prevent the pre-placed guidewire 230 from falling out of the inner branch stent 116. In addition, after guiding the branch catheter 260 into the inner branch stent 116, only one pre-placed guidewire 230 needs to be withdrawn to separate the pre-placed guidewire 230 from the intracavitary prosthesis 100. There is no need to withdraw the pre-placed guidewire 230 multiple times, making the surgical operation more convenient and efficient.

[0089] The delivery device 200 includes a first branch catheter 261 and a second branch catheter 262. When in the mated state, the pre-placed guidewire 230 includes a first guide section 231, a second guide section 232, and a connecting section 233 located between the first guide section 231 and the second guide section 232. The first guide section 231 passes through the first window 114a and the first inner branch support 116a, and the second guide section 232 passes through the second window 114b and the second inner branch support 116b. The first branch catheter 261 is slidably fitted onto the first guide section 231 and can enter the first inner branch support 116a along the first guide section 231. The second branch catheter 262 is slidably fitted onto the second guide section 232 and can enter the second inner branch support 116b along the second guide section 232. The connecting section 233 is located outside the covered stent 110 and extends from the first window 114a to the second window 114b. The pre-placed guidewire 230 forms a U-shaped configuration. Since the first guide segment 231 penetrates the first window 114a and the first internal branch stent 116a, and the second guide segment 232 penetrates the second window 114b and the second internal branch stent 116b, the first branch catheter 261 sleeved on the first guide segment 231 can slide relative to the first guide segment 231 from the rear end to the front end, and enter through the distal end of the first internal branch stent 116a and exit through the first window 114a. The second branch catheter 262 sleeved on the second guide segment 232 can slide relative to the second guide segment 232 from the rear end to the front end, and enter through the distal end of the second internal branch stent 116b and exit through the second window 114b. This allows the first branch catheter 261 and the second branch catheter 262 to more accurately approach the corresponding coronary artery ostia, providing more precise positioning for subsequent coronary stent implantation. The connecting segment 233, located outside the covered stent 110, extends between the first window 114a and the second window 114b, and connects the first guide segment 231 and the second guide segment 232 respectively. This helps maintain the shape of the internal channel between the first window 114a and the first internal branch stent 116a, and also maintains the shape of the internal channel between the second window 114b and the second internal branch stent 116b. This allows blood flow to remain between the first window 114a and the first internal branch stent, and between the second window 114b and the second internal branch stent, thereby reducing the probability of coronary ischemia. The tip of the first branch catheter 261 and / or the second branch catheter 262 can be a pre-bent structure facing one side, giving the first branch catheter 261 and / or the second branch catheter 262 a "J"-shaped structure when not constrained by external forces. The pre-bent tip facilitates better access to branch vessels (e.g., coronary arteries).In the working state, the pre-placed guide wire 230 with a "U"-shaped structure can effectively constrain the front ends of the first guide section 231 and the second guide section 232 through the connecting section 233, reducing the risk of displacement of the front end of the guide section caused by the bending deformation of the front end of the guide section when the pre-bent branch conduit is pushed to the position near the front end of the guide section.

[0090] The first guide segment 231, the second guide segment 232, and the connecting segment 233 of the aforementioned pre-placed guidewire 230 can be integrally formed, or they can be manufactured separately and then spliced ​​together. The structure, shape, and wire diameter of the first guide segment 231, the second guide segment 232, and the connecting segment 233 can be the same or different. When the pre-placed guidewire 230 is separated from the intracavitary prosthesis 100, the pre-placed guidewire 230 can be a straight structure, and there can be no obvious boundary between the first guide segment 231, the second guide segment 232, and the connecting segment 233. Alternatively, the first guide segment 231, the second guide segment 232, and the connecting segment 233 can be marked in advance. The operator can use any suitable segment of the pre-placed guidewire 230 as the first guide segment 231, the second guide segment 232, and the connecting segment 233 according to actual needs.

[0091] Referring to Figure 9, in some embodiments, the covered stent 110 may further include a limiting member 280 disposed on the outer surface of the reduced diameter section 112. The limiting member 280 is used to constrain the extension path of the connecting section 233. For example, along the circumference of the covered stent 110, one or more limiting rings 281 (e.g., 2 to 5 limiting rings 281) may be disposed on the outer surface of the reduced diameter section 112. The limiting rings 281 can be fixed to the outer surface of the reduced diameter section 112 by means of sewing, bonding, etc. When in the assembled state, the connecting section 233 of the pre-placed guidewire 230 can pass through one or more limiting rings 281 in sequence, thereby constraining the extension path of the connecting section 233 on the outer surface of the covered stent 110. The connecting section 233 located on the outer surface of the covered stent 110 can also constrain the shape of the reduced diameter section 112 to a certain extent, reducing the risk of deformation of the reduced diameter section 112 causing blockage of the coronary artery ostium. When the pre-placed guidewire 230 is retracted, one end of the pre-placed guidewire 230 is pulled towards the operator. The other end of the pre-placed guidewire 230 (also referred to as the free end or the end that is retracted later) can retract along the path defined by the limiting member 280 during the retraction process. For example, if the rear end of the first guide segment 231 is pulled towards the operator, the rear end of the second guide segment 232 moves towards the front end and moves sequentially through the second inner branch stent 116b and the second window 114b to the outside of the covered stent 110. Then, it continues to move along the path defined by the limiting ring 281, and then sequentially enters the inner cavity of the first window 114a, the first inner branch stent 116a, and the covered stent 110, and moves towards the rear end until it separates from the covered stent 110, and finally is withdrawn from the body. By setting the limiting member 280, the limiting member 280 can limit the movement path and elastic deformation of the pre-placed guidewire 230 during the process of the free end of the pre-placed guidewire 230 moving outside the covered stent 110 through the window 114. This can reduce the risk that the free end of the pre-placed guidewire 230 will bounce against the inner wall of the lumen (such as a blood vessel) or the intraluminal prosthesis 100 due to elastic deformation during the retraction process. Therefore, it is beneficial to protect the inner wall tissue of the lumen and the intraluminal prosthesis 100.

[0092] The aforementioned limiting ring 281 may include a ring-shaped structure made of polymer or metal materials. The material used for the ring-shaped structure can be biodegradable or non-biodegradable. For example, the material of the ring-shaped structure can be selected from one or more materials such as polyester surgical sutures, nickel-titanium wire, and stainless steel wire. The limiting ring 281 has a certain degree of deformability and does not affect the insertion of the intracavitary prosthesis 100 into the sheath 210. Especially when using surgical sutures to make the ring-shaped structure, the limiting ring 281 is relatively soft and not easily scratched or damaged on the inner wall of the sheath 210.

[0093] In other embodiments, the limiting ring 281 may be replaced by a tubular limiting structure, an outwardly protruding limiting structure, or the like.

[0094] Referring to Figures 11a to 11i, the delivery device 200 may further include a constraint member 250. The constraint member 250 is used to radially constrain the intracavitary prosthesis 100 and can release the constraint member 250 from the intracavitary prosthesis 100. By setting the constraint member 250, the intracavitary prosthesis 100 can be radially constrained after it is released from the sheath tube 210. This allows the release position of the intracavitary prosthesis 100 to be adjusted according to the actual lumen structure, achieving more precise positioning of the intracavitary prosthesis 100. In particular, since the flexible connecting tube 130 is relatively soft, the constraint member 250 constrains the intracavitary prosthesis 100 as a whole, which helps to better transmit the force applied by the operator at the rear end to the front end. This allows the front end of the delivery device 200 to respond more sensitively and accurately to the operator's operation, achieving more efficient and accurate positioning of the intracavitary prosthesis 100. Exemplarily, the constraint member 250 can be rolled up to form a constraint sleeve, which includes an inner cavity for accommodating the intracavitary prosthesis 100 and a front opening and a rear opening communicating with the inner cavity. The covered stent 110 can be accommodated in the inner cavity of the constraint sleeve and is radially constrained. The intracavitary prosthesis 100 and the constraint sleeve can be jointly compressed and loaded into the sheath 210. When the constraint sleeve and the intracavitary prosthesis 100 located in the inner cavity of the constraint sleeve are jointly released from the sheath 210, the intracavitary prosthesis 100 cannot expand to a fully expanded state without radial constraint due to the constraint of the constraint sleeve. The radial dimension of the intracavitary prosthesis 100 covered by the constraint sleeve is smaller than the radial dimension of the intracavitary prosthesis 100 in the fully expanded state. The rear opening of the constraint sleeve allows the delivery conduit 220 to pass through, and the delivery conduit 220 can axially penetrate the constraint sleeve. The intracavitary prosthesis 100 can be loaded into the accommodating space between the delivery conduit 220 and the inner wall of the constraint sleeve.

[0095] In some embodiments, the delivery device 200 further includes a control element for controlling the constraint element 250 to radially constrain the intracavitary prosthesis 100, and the control element is also used to control the constraint element 250 to release the constraint on the first segment and the second segment of the intracavitary prosthesis 100, respectively. The first segment includes a reduced-diameter segment 112 and a first main body segment, which refers to the axial section in the main body segment 111 where the inner branch support 116 is located; it can be understood that the distal end of the first segment may be flush with the distal end of the first main body segment, or it may be closer to the distal end of the main body segment 111 than the distal end of the first main body segment. The second segment refers to the other axial sections in the main body segment 111 besides the first segment, and may also be called the second main body segment. In some embodiments, the second segment may also be other axial sections in the main body segment 111 besides the first main body segment.

[0096] Exemplarily, the control element includes a control wire 251. The constraint element 250 has two axial edges, a first edge 252 and a second edge 253, both extending axially along the constraint element 250. The first edge 252 and the second edge 253 can be fixed together by at least one control wire 251, causing the constraint element 250 to curl into a tubular constraint sleeve. When the tubular constraint sleeve is fitted over the film-coated support 110, it radially constrains the film-coated support 110. At least a portion of the control wire 251 can be separated from the constraint element 250 to release its fixation on at least a portion of the first edge 252 and the second edge 253. When the first edge 252 and the second edge 253 of the constraint element 250 are completely released from their fixation, the constraint element 250 releases its constraint on the film-coated support 110, and the constraint element 250 can unfold into a quadrilateral sheet structure (e.g., rectangular, square, etc.). For example, the control wire 251 may be a surgical suture or other fiber thread, metal wire, etc. The control wire 251 may suture the first edge 252 and the second edge 253 together along the axial direction of the constraint member 250 to form a suture fixing part on the constraint member 250, and form a slip knot on the rear end side of the suture fixing part. When a tension is applied to the rear end of the control wire 251, the slip knot can be released, and the control wire 251 can be separated from the constraint member 250.

[0097] In this embodiment, the delivery device 200 includes a first control wire and a second control wire. The first control wire is used to control the mutual fixation and separation of the axial edges of the first region of the constraint member 250, and the second control wire is used to control the mutual fixation and separation of the axial edges of the second region of the constraint member 250. When the constraint member 250 radially constrains the intracavitary prosthesis 100, the reduced diameter section 112, the flexible connecting tube 130, and the valve prosthesis 120 are located in the first region. That is, the first region is used to radially constrain the reduced diameter section 112, the first main body section, the flexible connecting tube 130, and the valve prosthesis 120. The second main body section is located in the second region. That is, the second region is used to radially constrain the second main body section.

[0098] During the process of releasing the constraint sleeve on the covered stent 110, the reduced diameter section 112, the flexible connecting tube 130, and the valve prosthesis 120 can be released first through the first control wire, so that the window 114 on the reduced diameter section 112 can be opened. Since the radial dimension of the reduced diameter section 112 is small, it will not directly adhere to the inner wall of the blood vessel. The valve stent 121 of the valve prosthesis 120 is a bulb expansion stent and will not be fully expanded. The flexible connecting tube 130 will also not be fully expanded because it has no support structure. The second main body section is still constrained in the second region. At this time, the position of the covered stent 110 can be adjusted in the axial and circumferential directions so that the window 114 on the reduced diameter section 112 can be more accurately aligned with the coronary artery ostium.

[0099] In other embodiments, when the valve prosthesis 120 is a balloon-expandable stent, the restraint member 250 may only restrain the covered stent 110. That is, when the restraint member 250 cooperates with the intracavitary prosthesis 100, the front end of the restraint member 250 only needs to extend to the proximal end of the covered stent 110, and does not need to extend to the valve prosthesis 120 to radially restrain the valve prosthesis 120.

[0100] In other embodiments, when the valve stent 121 is a self-expanding stent, the constraint member 250 needs to have the ability to individually release the constraint on the valve prosthesis 120. For example, the delivery device 200 includes a first control wire, a second control wire, and a third control wire. The first control wire is used to control the mutual fixation and separation of the axial edges of region A of the constraint member 250, the second control wire is used to control the mutual fixation and separation of the axial edges of region B of the constraint member 250, and the third control wire is used to control the mutual fixation and separation of the axial edges of region C of the constraint member 250. When the constraint member 250 is sleeved outside the covered stent 110, the reduced diameter section 112, the first main body section, and the flexible connecting tube 130 are located in region A. That is, region A is used for radial constraint and release of the reduced diameter section 112, the first main body section, and the flexible connecting tube 130. The second main body section is located in region B. That is, region B is used for radial constraint and release of the second main body section. The valve prosthesis 120 is located in region C. That is, region C is used for radial constraint and release of the valve prosthesis 120. In other embodiments, the conveyor 200 may include only one control wire 251, or more than three control wires 251 to control different areas of the constraint 250 respectively.

[0101] The restraint member 250 can be fixed to the intracavitary prosthesis 100 through one or more fixation points (e.g., fixation points formed by suturing or bonding), so that even after the intracavitary prosthesis 100 is completely released, the restraint member 250 remains fixed to the intracavitary prosthesis 100, without needing to be removed from the body or falling into other areas of the organism that are not desired to be entered. In other embodiments, the restraint member 250 may not be fixed to the intracavitary prosthesis 100, and can be removed from the body after the intracavitary prosthesis 100 is completely released.

[0102] In other embodiments, the control wire 251 may be omitted, the restraint member 250 is a tubular sleeve structure, the control member includes a tubular pull rod, the tubular pull rod can be inserted into the sheath 210 and sleeved on the outside of the delivery conduit 220, and can move axially relative to the sheath 210 and the delivery conduit 220. When the control member moves relative to the delivery conduit 220 toward the direction closer to the operator, it can drive the restraint member 250 to move relative to the covered support 110 toward the direction closer to the operator, thereby partially or completely releasing the intracavitary prosthesis 100.

[0103] The restraint element 250 can be made of a biocompatible polymer film material such as polytetrafluoroethylene or polyethylene terephthalate, or other film materials, giving it good flexibility and preventing the restraint element 250, which encloses the intracavitary prosthesis 100, from being difficult to load into the sheath 210. In other embodiments, the restraint element 250 can be replaced by a restraint rope, a mesh restraint structure, etc. Regardless of the structure of the restraint element 250, it is sufficient as long as it can restrain the intracavitary prosthesis 100 radially.

[0104] Referring to Figure 7, the push tube 240 includes multiple lumens. For example, the push tube 240 may include a main lumen 241 for accommodating the delivery catheter 220, a first sub-lumen 242 for accommodating the pre-placed guidewire 230 and the branch catheter 260, and a second sub-lumen 243 for accommodating the control wire 251. Two first sub-lumens 242 may be provided, one for accommodating the first guide segment 231 of the pre-placed guidewire 230 and the first branch catheter 261, and the other for accommodating the second guide segment 232 of the pre-placed guidewire 230 and the second branch catheter 262. Two second sub-lumens 243 may also be provided, one for accommodating the first control wire, and the other for accommodating the second control wire. By setting multiple sub-lumens on the push tube 240, interference between the branch catheter 260, the pre-placed guidewire 230, and the control wire 251 can be prevented, allowing the operator to more accurately and independently control the branch catheter 260, the pre-placed guidewire 230, and the control wire 251, thereby improving the success rate and efficiency of the surgery.

[0105] The aforementioned constraint 250 is applicable to the self-expanding covered stent 110. For the covered stent 110 with balloon dilation, the constraint 250 can be omitted.

[0106] When the valve prosthesis 120 is a balloon-expandable stent, the delivery catheter 220 can be a balloon catheter, which includes a deflateable and inflatable balloon. When in the loaded state, the valve prosthesis 120 is fitted onto the deflate balloon. When the valve prosthesis 120 is released from the sheath 210 and radial expansion of the valve prosthesis 120 is required, the balloon can be inflated by filling it with a medium (e.g., a liquid or gas such as saline), thereby causing the valve prosthesis 120 to expand radially. In other embodiments, when the valve prosthesis 120 is a self-expanding stent, the delivery catheter 220 does not need to be a balloon catheter and can be replaced by other types of catheters (e.g., a sheath core).

[0107] The following example illustrates the assembly method of an intracavitary implantation system, using a self-expanding covered stent 110 and a bulb-expanding stent for the valve prosthesis 120. This assembly method includes the following steps:

[0108] S10, the pre-placed guide wire 230 is inserted into the intracavitary prosthesis 100.

[0109] The above-mentioned method of inserting the pre-placed guide wire 230 includes: passing the pre-placed guide wire 230 sequentially through the first internal branch support 116a, the first window 114a, the second window 114b and the second internal branch support 116b of the intracavitary prosthesis 100; or, passing the pre-placed guide wire 230 sequentially through the second internal branch support 116b, the second window 114b, the first window 114a and the first internal branch support 116a of the intracavitary prosthesis 100, so that the pre-placed guide wire 230 forms a U-shaped shape with two free ends. The pre-placed guidewire 230 includes a first guide segment 231, a second guide segment 232, and a connecting segment 233 located between the first guide segment 231 and the second guide segment 232. The first guide segment 231 passes through the first window 114a and the first internal branch stent 116a of the covered stent 110. The second guide segment 232 passes through the second window 114b and the second internal branch stent 116b of the covered stent 110. The rear ends of the first guide segment 231 and the rear ends of the second guide segment 232 extend from the distal end of the intracavitary prosthesis 100 to form free ends.

[0110] S20, the constraint 250 and the intracavitary prosthesis 100 are assembled together such that the constraint 250 can at least radially constrain the covered stent 110.

[0111] Step S20 may include steps S21 to S23:

[0112] S21, radially compress the intracavitary prosthesis 100 into the cannula;

[0113] S22, the constraint member 250 is sleeved outside the sleeve (not shown). The constraint member 250 includes a first region and a second region along the axial direction. The first region controls the constraint and release of a part of the intracavitary prosthesis 100 through a first control wire. The second region controls the constraint and release of a part of the intracavitary prosthesis 100 through a second control wire.

[0114] The connection method of the first control wire and the second control wire and the constraint member 250, as well as the constraint and release method of the intracavitary prosthesis 100 in a certain area, are described in the previous text.

[0115] S23, remove the sleeve located between the constraint 250 and the intracavitary prosthesis 100, so that the constraint 250 and the intracavitary prosthesis 100 are assembled together.

[0116] S30, the assembled constraint 250, intracavitary prosthesis 100 and pre-placed guide wire 230 are radially compressed and loaded into the sheath 210.

[0117] Prior to step S30, the following may also be included:

[0118] S40, the first guide segment 231 and the second guide segment 232 of the pre-placed guidewire 230 are inserted into the push tube 240. The first branch catheter 261 and the second branch catheter 262 are respectively fitted onto the first guide segment 231 and the second guide segment 232 and inserted into the push tube 240. The tips of the first branch catheter 261 and the second branch catheter 262 are located at or near the distal end of the intracoronary prosthesis 100. This arrangement facilitates the rapid insertion of the first branch catheter 261 and the second branch catheter 262 into the vicinity of the coronary artery ostium, thereby improving surgical efficiency.

[0119] Prior to step S30, the following may also be included:

[0120] S50, the first control wire and the second control wire are inserted into the push tube 240 so that the operator can operate the first control wire and the second control wire externally.

[0121] Please refer to Figures 11a to 11k. The following example illustrates the operation method of the endovascular implantation system, which includes the following steps:

[0122] S110, the sheath 210 carrying the intracavitary prosthesis 100 is pushed to the target lumen (see Figure 11a), and then the sheath 210 is withdrawn until the intracavitary prosthesis 100 is completely released from the sheath 210 and is in a state of radial constraint by the constraint member 250 (see Figure 11b).

[0123] S120, release the constraint of the constraint member 250 on the first segment of the intracavitary prosthesis 100, so that at least the reduced diameter segment 112 and the first main body segment are released from the constraint member 250, while the second segment of the intracavitary prosthesis 100 is still constrained in the constraint member 250 (see Figure 11c).

[0124] S130, adjust the position of the intracavitary prosthesis 100 so that the window 114 of the reduced diameter section 112 is aligned with the preset position (see Figure 11d).

[0125] The preset location can be the coronary artery ostium.

[0126] S140, push the branch catheter 260 to the vicinity of the preset position along the pre-placed guide wire 230 (see Figure 11e).

[0127] For example, the first branch catheter 261 is pushed into the first internal branch stent 116a along the first guide section 231 of the pre-placed guidewire 230 and the tip of the first branch catheter 261 is passed through the first window 114a to approach the corresponding coronary artery ostium. The second branch catheter 262 is pushed into the second internal branch stent 116b along the second guide section 232 of the pre-placed guidewire 230 and the tip of the second branch catheter 262 is passed through the second window 114b to approach the corresponding coronary artery ostium.

[0128] S150, retract the pre-positioned guide wire 230 (see Figure 11f).

[0129] For example, one end of the pre-placed guidewire 230 is pulled toward the operator until the pre-placed guidewire 230 is withdrawn from the body.

[0130] S160, insert the branch guidewire into the branch catheter 260 until the branch guidewire enters the corresponding preset position, then withdraw the branch catheter 260 (refer to Figures 11g and 11f).

[0131] For example, a first branch guidewire 271 and a second branch guidewire 272 are inserted into the first branch catheter 261 and the second branch catheter 262 respectively, until the first branch guidewire 271 and the second branch guidewire 272 enter the corresponding preset positions (e.g., the coronary artery ostium), and then the first branch catheter 261 and the second branch catheter 262 are withdrawn.

[0132] S170, dilated valve prosthesis 120 (see Figure 11i).

[0133] In this embodiment, before the valve prosthesis 120 is dilated, there is a gap between the valve prosthesis 120 and the inner wall of the lumen. Blood can pass through this gap to enter the area around the reduced diameter section 112 of the covered stent 110. Because the overall radial dimension of the reduced diameter section 112 is small, a large annular space is formed between its circumference and the inner wall of the aortic sinus 2. The entire annular space can be used for blood flow into the coronary arteries. After the valve prosthesis 120 is dilated, blood can still sequentially pass through the valve prosthesis 120, the flexible connecting tube 130, the covered stent 110, the inner branch stent 116, and the window 114 into the corresponding coronary arteries, ensuring a constant blood flow supply to the coronary arteries.

[0134] S180, release the constraint of the constraint member 250 on the second segment of the intracavitary prosthesis 100 until the intracavitary prosthesis 100 is completely released (see Figure 11j).

[0135] S190, implant the corresponding external stent 300 along the path of the branch guidewire (see Figure 11k).

[0136] For example, corresponding external stents 300 (e.g., coronary stents) are implanted along the paths of the first branch guidewire 271 and the second branch guidewire 272, so that the external stents 300 connect the coronary artery and the corresponding internal branch stent 116 respectively.

[0137] 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.

[0138] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An endoluminal implant system, characterized by, An endoluminal prosthesis having a radially expanded state and a radially collapsed state, the endoluminal prosthesis comprising: A covered stent having a tubular structure, the covered stent comprising a main body section and a reduced diameter section in communication with each other, the main body section and the reduced diameter section being arranged along an axial direction of the covered stent, a cross-sectional area of a proximal end of the reduced diameter section being smaller than a cross-sectional area of a distal end of the reduced diameter section, the covered stent further comprising a window penetrating a side wall of the covered stent, the window being located at least partially in the reduced diameter section; A valve prosthesis comprising a valve stent and artificial valve leaflets connected to an inside of the valve stent; A flexible connecting tube having a tubular structure enclosed by a flexible membrane, a distal end of the flexible connecting tube being connected to the reduced diameter section, a proximal end of the flexible connecting tube being connected to the valve prosthesis, and the flexible connecting tube being in communication with the covered stent and the valve prosthesis.

2. The endoluminal implant system of claim 1, wherein, The flexible connecting tube has a circumferentially closed structure, and when the endoluminal prosthesis is in the radially expanded state, a minimum inner diameter of the flexible connecting tube is greater than a minimum inner diameter of the valve prosthesis.

3. The endoluminal implant system of claim 1, wherein, The covered stent comprises a first wave and a second wave, the first wave being located in the main body section, and the second wave being located in the reduced diameter section, a cross-sectional area of a distal end of the second wave being greater than a cross-sectional area of a proximal end of the second wave, a plurality of circumferentially arranged rhomboid-like spaces being formed between the first wave and the second wave, the window being located in the rhomboid-like space, and a distal end of the window being closer to a distal end of the first wave than a proximal end of the first wave, and a proximal end of the window being closer to a proximal end of the second wave than a distal end of the second wave.

4. The endoluminal implant system of claim 1, wherein, The endoluminal prosthesis further comprises an inner branch stent and a guide structure, the inner branch stent being located in an inner cavity of the covered stent and being in communication with a corresponding window, and the guide structure comprising an inclined surface structure connecting a proximal opening of the window and the inner branch stent.

5. The endoluminal implant system of claim 1, wherein, The window is in an elliptical shape, and a long axis of the elliptical shape extends from the proximal end to the distal end of the window; or the window is in one or more of an elliptical shape, a circular shape, and a polygonal shape.

6. The endoluminal implant system of claim 1, wherein, The covered stent comprises two windows, a first window and a second window, the first window and the second window being arranged on two radial sides of the covered stent, and the covered stent further comprises a developing mark for indicating the first window and / or the second window.

7. The endoluminal implant system of any of claims 1 to 6, wherein, The covered stent and the inner branch stent are self-expandable stents, and the valve stent is a balloon-expandable stent.

8. The endoluminal implant system of claim 1, wherein, The covered stent comprises two windows, a first window and a second window, and the endoluminal prosthesis further comprises two inner branch stents located in an inner cavity of the covered stent, a first inner branch stent being in communication with the first window, and a second inner branch stent being in communication with the second window, the first window and the second window being arranged on two radial sides of the covered stent. The intraluminal implant system further comprises a delivery device for delivering the intraluminal prosthesis to a target lumen, the delivery device comprising a pre-positioned guide wire having a cooperating state with the intraluminal prosthesis and a separated state from the intraluminal prosthesis, when in the cooperating state, the pre-positioned guide wire sequentially passes through the first inner branch stent, the first window, the second window and the second inner branch stent.

9. The endoluminal implant system of claim 8, wherein, The delivery device further comprises a first branch catheter and a second branch catheter, when in the cooperating state, the pre-positioned guide wire comprises a first guide section, a second guide section and a connecting section between the first guide section and the second guide section, the first guide section penetrates through the first window and the first inner branch stent, the second guide section penetrates through the second window and the second inner branch stent, the first branch catheter is slidably sleeved on the first guide section and can enter the first inner branch stent along the first guide section, the second branch catheter is slidably sleeved on the second guide section and can enter the second inner branch stent along the second guide section, the connecting section is located outside the covered stent and extends between the first window and the second window.

10. The endoluminal implant system of claim 9, wherein, The intraluminal prosthesis further comprises an inner branch stent arranged inside the covered stent and communicating with the windows, the delivery device further comprises a constraining member and a control member, the control member is used to control the constraining member to radially constrain the intraluminal prosthesis, and the control member is further used to control the constraining member to respectively release the constraint on a first section and a second section of the intraluminal prosthesis, the first section comprises the reduced diameter section and a first main body section, the first main body section refers to an axial section of the main body section where the inner branch stent is located, and the second section refers to other axial sections of the main body section except the first section.

11. The endoluminal implant system of claim 10, wherein, The control member comprises at least one control wire, the constraining member has two axial edges, namely a first edge and a second edge, both of which extend in the axial direction of the constraining member, the first edge and the second edge can be fixed together by at least one control wire, so that the constraining member is curled to form a tubular constraining sleeve, and at least part of the control wire can be separated from the constraining member to release the fixation of at least part of the area of the first edge and the second edge.

12. The endoluminal implant system of claim 11, wherein, The delivery device comprises a first control wire and a second control wire, the first control wire is used to control the mutual fixation and separation of the axial edges of a first region of the constraining member, and the second control wire is used to control the mutual fixation and separation of the axial edges of a second region of the constraining member, when the constraining member constrains the intraluminal prosthesis, the first region is used to radially constrain the reduced diameter section, the first main body section, the flexible connecting tube and the valve prosthesis, and the second region is used to radially constrain the second section.

13. The endoluminal implant system of claim 1, wherein, Both the covered stent and the valve prosthesis are provided with a covering, the thickness of the flexible connecting tube is greater than or equal to the thickness of the covering of the covered stent, and the thickness of the flexible connecting tube is greater than or equal to the thickness of the covering of the valve prosthesis.

14. The endoluminal implant system of claim 1 or 13, wherein, The flexible connecting tube comprises a narrow waist portion, the radial dimension of which is smaller than the radial dimension of the proximal end of the flexible connecting tube and smaller than the radial dimension of the distal end of the flexible connecting tube.

15. The endoluminal implant system of claim 14, wherein, The distance from the narrow waist portion to the proximal end of the flexible connecting tube is smaller than or equal to the distance from the narrow waist portion to the distal end of the flexible connecting tube.

16. The endoluminal implant system of claim 9, wherein, The stent further comprises a limiting member arranged on the outer surface of the reduced diameter section, which is used to restrict the extension path of the connecting section.

17. The endoluminal implant system of claim 11, wherein, The delivery device further comprises a sheath tube, a delivery catheter and a push tube, the delivery catheter and the push tube are arranged in the sheath tube, the delivery catheter is arranged in the push tube, and the sheath tube, the delivery catheter and the push tube can move axially relative to each other, when the intraluminal prosthesis is radially contracted and loaded in the sheath tube, the intraluminal prosthesis can be radially contracted and loaded in the accommodating space formed between the sheath tube and the delivery catheter, and the accommodating space is located between the front end of the push tube and the front end of the delivery catheter, the push tube comprises a main cavity for accommodating the delivery catheter, and a first sub-cavity for accommodating a preset guide wire and a branch catheter, and a second sub-cavity for accommodating the control wire.

18. An assembly method for the endoluminal implant system of claim 10, characterized in that, The assembly method comprises: arranging a preset guide wire on the intraluminal prosthesis; assembling the restraining member and the intraluminal prosthesis together, so that the restraining member can at least radially constrain the stent; radially compressing and loading the assembled restraining member, intraluminal prosthesis and preset guide wire into the sheath tube.

19. The method of assembling of claim 18, wherein, Before the restraining member, the intraluminal prosthesis and the preset guide wire are radially compressed and loaded into the sheath tube, the method further comprises: arranging the first guide section and the second guide section of the preset guide wire into the push tube, arranging the first branch catheter and the second branch catheter on the first guide section and the second guide section respectively, and arranging the first branch catheter and the second branch catheter into the push tube, and the front ends of the first branch catheter and the second branch catheter are located at or near the distal end of the intraluminal prosthesis.

20. A method of operation for the endoluminal implant system of claim 10, wherein, The operation method comprises: pushing the sheath tube loaded with the intraluminal prosthesis to the target lumen, and then withdrawing the sheath tube until the intraluminal prosthesis is completely released from the sheath tube and is in a state of being radially constrained by the restraining member; releasing the restraint of the restraining member on the first section of the intraluminal prosthesis, so that at least the reduced diameter section and the first main body section are released from the restraining member, and the second section of the intraluminal prosthesis is still constrained in the restraining member; adjusting the position of the intraluminal prosthesis so that the window of the reduced diameter section is aligned with the preset position; after pushing the branch catheter to the vicinity of the preset position along the preset guide wire, withdrawing the preset guide wire; inserting a branch guide wire into the branch catheter until the branch guide wire enters the corresponding preset position, and then withdrawing the branch catheter; expanding the valve prosthesis; releasing the restraint of the restraining member on the second section of the intraluminal prosthesis until the intraluminal prosthesis is completely released; implanting a corresponding external stent along the path of the branch guide wire.

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