Implantable prosthetic device and implantable prosthetic system

Abstract

The present application relates to an implantable prosthetic device and an implantable prosthetic system, and relates to the technical field of medical devices. The implantable prosthetic device comprises: a first tubular member having a first lumen; a second tubular member having a second lumen; the first tubular member is connected with the second tubular member, and the second tubular member is partially accommodated in the first lumen so that the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form an openable or closable passage; when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the passage is in an open state and is connected with the first lumen; when the first tubular member and the second tubular member are both in a radially expanded state, the passage is in a closed state. The implantable prosthetic device provided by the present application can keep the blood flow unobstructed during the operation process, and prevent the adverse effects on the health of the patient caused by the blood flow obstruction.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to an implantable prosthesis device and implantable prosthesis system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Aortic dissection, also known as aortic aneurysm, is caused by a tear in the aortic intima due to various reasons, allowing blood to flow into the aortic wall and causing it to separate into layers, forming a hematoma. Aortic dissection is a serious vascular disease that threatens life and health, with a high mortality rate.

[0004] Currently, there are two main treatment methods for aortic dissection: surgical treatment and minimally invasive treatment. Surgical treatment involves open-chest and open-abdomen surgery to remove the tear in the intima and reconstruct the blood flow pathway using an artificial vascular graft. Minimally invasive interventional treatment, on the other hand, involves implanting a endovascular stent graft at the lesion site to isolate the blood flow from the aortic dissection while maintaining normal blood flow. Compared to surgical treatment, minimally invasive interventional treatment is increasingly being used in routine care due to its advantages such as less trauma, faster recovery, and fewer complications.

[0005] Generally, covered stents are straight-tube stents. However, when the aortic dissection involves or is close to branch vessels, such as when the lesion of the ascending aorta involves or is close to the coronary arteries, the aortic arch branches, or the abdominal aorta is close to the renal arteries, the covered stent may cover or obstruct the openings of branch vessels, coronary vessels, or renal arteries in order to cover the lesion or to increase the anchoring area. In such cases, it is usually necessary to implant both the main stent and the branch stent (or bypass stent) at the lesion site for treatment. The main stent and the branch stent work together to maintain blood flow in the aorta and branch vessels. However, this also increases the difficulty of the implantation procedure.

[0006] Generally, the implantation procedure is performed as follows: first, the main stent is delivered to the appropriate site; then, the main stent is partially deployed; next, a branch stent is delivered to the appropriate site, and then the branch stent is deployed to engage with the main stent; finally, the main stent is fully deployed to complete the procedure. This process means that during the deployment of the branch stent, because the main stent is still in the blood vessel and partially deployed, it may obstruct blood flow to some extent. If the deployment of the branch stent takes too long, the blood flow obstruction will also be prolonged, which can adversely affect the patient's health and, in severe cases, even endanger their life.

[0007] Therefore, maintaining smooth blood flow is crucial during surgery. Summary of the Invention

[0008] Therefore, it is necessary to provide an implantable prosthesis device that can maintain blood flow during surgery.

[0009] Furthermore, an implantable prosthesis system that can maintain blood flow during surgery is also provided.

[0010] An implantable prosthesis device includes: a first tubular member having a first lumen; a second tubular member having a second lumen; the first tubular member is connected to the second tubular member, and the second tubular member is partially housed within the first lumen such that the outer wall of the second tubular member engages with the inner wall of the first tubular member to form an openable or closable channel; when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the channel is open and connected to the first lumen; when both the first tubular member and the second tubular member are in a radially expanded state, the channel is closed.

[0011] In one embodiment, the channel is an annular channel; or, there are multiple channels, which are spaced apart circumferentially along the second tubular member; or, there is one channel, which is a non-annular channel.

[0012] In one embodiment, the implantable prosthesis further includes a connector, one end of which is connected to the first tubular member and the other end of which is connected to the second tubular member.

[0013] In one embodiment, the connector is a flexible or rigid component. When the connector is flexible, one end of the connector is hinged or fixedly connected to the first tubular component, and the other end of the connector is hinged or fixedly connected to the second tubular component. When the connector is rigid, both ends of the connector are hinged to the first tubular component and the second tubular component, respectively.

[0014] In one embodiment, the connector includes a connecting segment and an assembly segment connected to the connecting segment. The assembly segment is connected to one of the first tubular member and the second tubular member, and one end of the connecting segment away from the assembly segment is connected to the other of the first tubular member and the second tubular member. The connecting segment is a cylindrical rod or a braided wire, and the assembly segment is a loop structure, a T-shaped rod, or a straight rod whose extension direction is perpendicular to the extension direction of the connecting segment.

[0015] In one embodiment, the distal end of the second tubular member is at least partially housed within the first lumen, and the implantable prosthesis further includes a sealing assembly, the proximal end of which is connected to the second tubular member, and the distal end of which extends axially away from the second tubular member to form a free end beyond the distal end face of the second tubular member. In a radially deployed state, the sealing assembly has an annular or discontinuous structure, and the sealing assembly surrounds the longitudinal central axis of the first tubular member or the second tubular member.

[0016] In one embodiment, the sealing assembly is more flexible than the second tubular member; or, in its natural state, the outer diameter of the sealing assembly after radial expansion is greater than the inner diameter of the first tubular member after radial expansion.

[0017] In one embodiment, the sealing assembly includes a drive member and a separator membrane. The proximal ends of the drive member and the separator membrane are connected to the second tubular member, and the distal ends of the drive member and the separator membrane are both free ends extending beyond the distal end face of the second tubular member. The separator membrane has an unfolded and folded state. In the unfolded state, the separator membrane is annular. Alternatively, there may be multiple separator membranes, which are spaced apart circumferentially along the second tubular member. In the unfolded state, the multiple separator membranes form a discontinuous structure. When unfolded, the separator membrane can adhere to the inner wall of the first tubular member. The drive member is connected to the separator membrane and is used to drive the separator membrane to unfold as the second tubular member expands or to drive the separator membrane to fold as the second tubular member contracts.

[0018] In one embodiment, the driving member includes a driving rod, the extension direction of which satisfies the following condition: when both the first tubular member and the second tubular member are in a radially extended state, the driving rod is in contact with the inner wall of the first tubular member.

[0019] In one embodiment, the connector includes a plurality of connecting rods, which are spaced apart circumferentially along the first tubular cavity. When both the first tubular member and the second tubular member are radially extended, the extension direction of the connecting rods is parallel to the axial direction of the first tubular member. At least one driving rod is provided between two adjacent connecting rods. When the separator membrane is annular in the extended state, the separator membrane is simultaneously connected to the connecting rods and the driving rods circumferentially. When there are multiple separator membranes, the two sides of the separator membrane are respectively connected to two adjacent connecting rods, and the non-side positions of the separator membrane are connected to the driving rods.

[0020] In one embodiment, the connector includes several rod groups, each rod group including two connecting rods. When both the first tubular member and the second tubular member are in a radially extended state, the extension directions of the two connecting rods form a non-zero angle with the axial direction of the first tubular member, and the extension lines of the proximal ends of the two connecting rods can converge at a single intersection point. At least one driving rod is disposed between the two connecting rods. When the separator membrane is in an annular shape in the extended state, the separator membrane is simultaneously connected to the connecting rods and the driving rods circumferentially. When there are multiple separator membranes, the two sides of the separator membrane are respectively connected to the two connecting rods in each rod group, and the non-side positions of the separator membrane are connected to the driving rods.

[0021] In one embodiment, the connecting rods are connected in pairs to form a ring-shaped waveform structure, the two connecting rods in the rod group are connected to form the trough of the ring-shaped waveform structure, and the connecting rods in adjacent rod groups are connected to form the peak of the ring-shaped waveform structure.

[0022] In one embodiment, the drive rod includes a connecting portion and at least one abutting portion connected to the connecting portion. One end of the connecting portion away from the abutting portion is connected to the second tubular member. The end of the abutting portion away from the connecting portion is a free end, and the projected area of ​​the abutting portion on the separator membrane is greater than the projected area of ​​the connecting end of the connecting portion to the second tubular member on the separator membrane.

[0023] In one embodiment, the abutting part is provided as two parts, and the two abutting parts are arranged symmetrically, with the axis of symmetry being a straight line parallel to the longitudinal central axis of the second tubular member where the connecting end of the connecting part and the second tubular member are located.

[0024] In one embodiment, there are at least two abutting portions. When the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, in two adjacent drive rods, one of the outermost abutting portions of one drive rod and another outermost abutting portion of the other drive rod adjacent to the outermost abutting portion abut to clamp the separator membrane.

[0025] In one embodiment, the implantable prosthesis device further includes a leaflet structure disposed within the second tubular member, and the leaflet structure is openable or closable, so that the second lumen of the second tubular member is in an open or closed state.

[0026] An implantable prosthesis system includes: a branch stent; and an implantable prosthesis device as described in any of the above embodiments, wherein one end of the branch stent is extendable into the channel and is clamped by the first tubular member and the second tubular member.

[0027] The implantable prosthesis device provided in this embodiment of the invention has a first tubular member and a second tubular member connected to form an openable or closable channel. During the implantation surgery, the first tubular member can be released first without releasing the second tubular member. At this time, the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, and the channel is open. Although the second lumen cannot circulate blood because the second tubular member is not released, blood can still flow out along the first lumen through the channel because the channel is connected to the first lumen. Alternatively, blood can flow out along the channel through the first lumen, thereby maintaining smooth blood flow during the operation and preventing adverse effects on the patient's health due to blood flow blockage.

[0028] The implantable prosthesis system provided in this invention uses an implantable prosthesis device that can maintain blood flow during surgery in conjunction with a branch stent. This allows the branch stent to be implanted under conditions of unobstructed blood flow. Compared to the prior art where the branch stent is implanted under conditions of blood flow obstruction, this system can provide more time for the implantation of the branch stent, thereby further improving the success rate of the surgery. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] in:

[0031] Figure 1 This is a schematic diagram of the structure of an implantable prosthesis system according to an embodiment of the present invention;

[0032] Figure 2 This is a schematic diagram of the internal assembly of an implantable prosthesis device according to an embodiment of the present invention;

[0033] Figure 3 This is a schematic diagram of the assembly of an implantable prosthesis device and a delivery sheath according to an embodiment of the present invention;

[0034] Figure 4 This is a schematic diagram of the structure of the connector in one embodiment of the present invention;

[0035] Figure 5 This is a schematic diagram of the connector structure in another embodiment of the present invention;

[0036] Figure 6 This is a schematic diagram of the assembly of the implantable prosthesis device and the delivery sheath in another embodiment of the present invention;

[0037] Figure 7 for Figure 6 A schematic diagram showing the assembly of a portion of the implantable prosthesis device with its delivery sheath;

[0038] Figure 8 for Figure 6 A top view of the implantable prosthesis device with the channel open;

[0039] Figure 9 for Figure 6 A cross-sectional view of the implantable prosthesis device shown in the closed channel state;

[0040] Figure 10 This is a schematic diagram of the assembly of the implantable prosthesis device and the delivery sheath in another embodiment of the present invention;

[0041] Figure 11 for Figure 10 A schematic diagram showing the assembly of a portion of the implantable prosthesis device with its delivery sheath;

[0042] Figure 12 This is a cross-sectional view of an implantable prosthesis device in the channel open state according to another embodiment of the present invention;

[0043] Figure 13 This is a schematic diagram of the drive rod in another embodiment of the present invention. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0046] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0047] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, while "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. "Circumferential direction" refers to the circumferential direction, that is, the axial direction surrounding a tubular structure or cylinder.

[0048] Please see Figure 1 An embodiment of the present invention provides an implantable prosthesis system, which includes an implantable prosthesis device 1 and a branch stent 2. The implantable prosthesis device 1 is used for implantation in the main luminal anatomical structure, such as implantation in the aorta. The branch stent 2 is used in conjunction with the implantable prosthesis device 1 and is used for implantation in the luminal anatomical structure of a branch, such as implantation in a coronary branch vessel.

[0049] Understandably, the application site of this implantable prosthesis system is not limited to the aorta, but can also be applied to other sites with branching vessels, such as the renal artery.

[0050] Please continue reading. Figure 1 In one embodiment, the implantable prosthesis device 1 includes a first tubular member 11 and a second tubular member 12.

[0051] The first tubular member 11 has a first cavity 110. The second tubular member 12 has a second cavity 120. The second tubular member 12 is connected to the first tubular member 11, and the second tubular member 12 is partially housed within the first cavity 110, thereby forming a partially sleeved structure between the first tubular member 11 and the second tubular member 12. This partially sleeved structure allows the inner wall of the first tubular member 11 to engage with the outer wall of the second tubular member 12 to form an openable or closable channel 14. When the first tubular member 11 is fully extended and the second tubular member 12 is compressed, the inner wall of the first tubular member 11 separates from the outer wall of the second tubular member 12, and the channel 14 is open. When both the first tubular member 11 and the second tubular member 12 are fully extended, the inner wall of the first tubular member 11 adheres to the outer wall of the second tubular member 12, and the channel 14 is closed.

[0052] In this configuration, the implantable prosthesis device 1 can first release the first tubular member 11 during the implantation surgery, while keeping the second tubular member 12 in a radially compressed state (e.g., as shown in the image). Figure 3 As shown, the first tubular member 11 is pushed out of the delivery sheath 3, while the second tubular member 12 has not yet been released from the delivery sheath 3 and is still bound by the delivery sheath 3 and is in a radially compressed state; or, the second tubular member 12 is pushed out of the delivery sheath 3, but is radially bound by a restraining structure (not shown), for example, bound by a rope and in a radially compressed state. At this time, the channel 14 is open and connects to the first lumen 110, so that blood can flow out through the channel 14 along the first lumen 110, or blood can flow out through the first lumen 110 along the channel 14, thereby maintaining blood flow during the implantation surgery and preventing adverse effects on the patient's health due to blood flow blockage.

[0053] It is understandable that the first tubular member 11 and the second tubular member 12 can be directly connected or indirectly connected through other components.

[0054] In one embodiment, channel 14 may be presented as an annular channel, thereby allowing for smoother blood flow and better results. In other embodiments, there may be multiple channels 14, with the multiple channels 14 spaced apart circumferentially along the second tubular member 12, or there may be a single channel 14, which is a non-annular channel.

[0055] Please see Figure 2 When the first tubular member 11 and the second tubular member 12 are indirectly connected, the implantable prosthesis device 1 also includes a connector 13. One end of the connector 13 is connected to the first tubular member 11 and the other end is connected to the second tubular member 12. The connector 13 is used to prevent the second tubular member 12 from coming out of the first tubular member 11, thereby maintaining the nested structure of the first tubular member 11 and the second tubular member 12.

[0056] The first tubular member 11 and the second tubular member 12 are connected by a connector 13, allowing their expansion or contraction movements to occur independently without interference. This facilitates and rapidly opens the channel 14, ensuring unimpeded blood flow and shortening surgical time. Furthermore, this connection allows the channel 14 to open to a greater extent, further guaranteeing unimpeded blood flow.

[0057] It should be noted that when the first tubular member 11 and the second tubular member 12 are connected by the connector 13, but the first tubular member 11 and the second tubular member 12 are not directly connected, an openable and closable annular channel can be formed. When the connector 13 is omitted, the first tubular member 11 and the second tubular member 12 are directly connected, and the first tubular member 11 and the second tubular member 12 are connected at multiple discrete positions in the circumferential direction to form multiple openable and closable channels 14 spaced apart circumferentially along the second tubular member 12. When the connector 13 is omitted, the first tubular member 11 and the second tubular member 12 are directly connected, but only part of the area is connected and some areas are not connected, and a non-annular channel 14 is formed in the unconnected area.

[0058] Please see Figure 3 In one embodiment, the first tubular member 11 is a film-coated support with openings at both ends. The first tubular member 11 includes a first frame 111 and a first film 112. The first film 112 covers the first frame 111 to form a first cavity 110 with openings at both ends.

[0059] Specifically, the first frame 111 includes a plurality of first support units 1111 arranged along the axial direction.

[0060] Please continue reading. Figure 3In one embodiment, the first support unit 1111 has a wave-like structure. In this embodiment, multiple first support units 1111 are arranged in an axially cross array, that is, the crest of one first support unit 1111 and the trough of another adjacent first support unit 1111 are aligned on a straight line parallel to the axis, and the crests and troughs are connected, so that the first frame 111 has good structural stability and ensures that the first frame 111 has good radial and axial support forces, thereby making the first frame 111 fit well against the anatomical structure of the lumen. In other embodiments, multiple first support units 1111 can also be arranged in an axially equally or unequally spaced array, that is, the crest of one first support unit 1111 and the crest of another adjacent first support unit 1111 are aligned on a straight line parallel to the axis, so that the first frame 111 has good bending performance, thereby adapting to anatomical structures with large angles. Alternatively, multiple first support units 1111 can be arranged in an axially staggered array, where the crest of one first support unit 1111 and the crest of its adjacent first support unit 1111 are aligned on a straight line not parallel to the axis, and the trough of another first support unit 1111 is aligned on another straight line not parallel to the axis. This reduces the bending performance of the first frame 111 while increasing its radial and axial support forces. By changing the arrangement of the first support units 1111, the bending performance, axial support performance, and radial support performance of the first frame 111 can be improved, allowing the first frame 111 to adapt to different luminal anatomy structures for implantation.

[0061] Please continue reading. Figure 3 In one embodiment, among the plurality of first support units 1111, one first support unit 1111 and its adjacent first support unit 1111 are connected by a corrugated structure with crests and troughs. In other embodiments, the plurality of first support units 1111 are connected by an axially extending assembly rod (not shown), giving the first frame 111 directionality and allowing it to bend easily on the side opposite to the assembly rod to adapt to curved luminal anatomy. Alternatively, the plurality of first support units 1111 are connected by multiple assembly rods, each connecting two adjacent first support units 1111, with the multiple assembly rods forming a straight line in the axial direction. This also gives the first frame 111 directionality and allows it to bend easily on the side opposite to the assembly rod to adapt to curved luminal anatomy. Alternatively, the plurality of first support units 1111 are connected by multiple assembly rods, each connecting two adjacent first support units 1111, with the adjacent assembly rods offset in the axial direction. This results in better flexibility of the first frame 111, making it easier to reach the target position through curved luminal anatomy.

[0062] Please continue reading. Figure 3 In one embodiment, the waveform of the first support unit 1111 is a sine wave. In other embodiments, the waveform of the first support unit 1111 can also be a Z-shaped wave. The specific waveform shape is not limited and can be selected according to the required performance of the first frame 111.

[0063] In one embodiment, the first frame 111 is formed of a nickel-titanium alloy. In other embodiments, the material of the first frame 111 may also be stainless steel, cobalt-chromium alloy, or polymer materials, etc. The material selection only needs to satisfy the requirement that the first tubular member 11 can expand from a compressed state to an deployed state by means of balloon expansion or self-expansion, while having a certain supporting strength.

[0064] In one embodiment, the first frame 111 can be prepared by weaving and shaping filamentous material, for example, by weaving and shaping nickel-titanium alloy wire to form the first frame 111. In other embodiments, the first frame 111 can also be formed by laser cutting and shaping tubular material, or by injection molding, or by 3D printing.

[0065] Please continue reading. Figure 3 In one embodiment, the first covering 112 is disposed along the length of the first frame 111, and the length of the first covering 112 exceeds the peak at the distal end and the trough at the proximal end of the first frame 111. The first covering 112 is disposed on both the inner and outer sides of the first frame 111. The connection between the first covering 112 and the first frame 111 is achieved by heat treatment to fuse the outer first covering 112 and the inner first covering 112 together, thereby covering and fixing the first frame 111. In other embodiments, the length of the first covering 112 may be shorter than the length of the first frame 111. In other embodiments, the first covering 112 may be disposed only on the inner side of the first frame 111, or only on the outer side of the first frame 111. In other embodiments, the first covering 112 and the first frame 111 may also be fixed by suture stitching, wherein the suture may be made of a biocompatible material, such as PET (polyethylene terephthalate) suture or PTFE (polytetrafluoroethylene) suture. In addition, the material of the first membrane 111 can be nylon or other materials suitable for manufacturing artificial blood vessels, or it can be polyester fabric or PTFE film. It should be noted that the material of the first membrane 111 is not limited to the materials mentioned above. Any flexible material that can block blood flow and is suitable for implantation in the human body can be selected. It can be an absorbable material or a non-absorbable material.

[0066] Please return Figure 1In one embodiment, the second tubular member 12 is also a film-coated support with openings at both ends. The second tubular member 12 includes a second frame 121 and a second film 122, the second film 122 covering the second frame 121 to form a second cavity 120 with openings at both ends.

[0067] The second frame 121 is implemented in the same way as the first frame 111, and the second covering 122 is also implemented in the same way as the first covering 112, so it will not be described in detail here. However, the overall diameter of the second tubular member 12 differs slightly from that of the first tubular member 11. In one embodiment, the second tubular member 12 is a uniform diameter structure, and the outer diameter of the second tubular member 12 matches the inner diameter of the first tubular member 11. In other embodiments, the second tubular member 12 can also be configured as a variable diameter structure. Specifically, the outer diameter of the second tubular member 12 in the portion that overlaps with the first tubular member 11 matches the inner diameter of the first tubular member 11, while in the non-overlapping area, the outer diameter of the second tubular member 12 can match the outer diameter of the first tubular member 11, or match the inner diameter of the tubular anatomical structure at the implantation site. The outer diameter of the second tubular member 12 only needs to satisfy the requirement of forming an overlapping structure with the first tubular member 11 and being suitable for anchoring on the tubular anatomical structure.

[0068] Please return Figure 1-2 In one embodiment, the distal end of the connector 13 is fixedly connected to the inner wall of the first frame 111, and the proximal end of the connector 13 is fixedly connected to the distal end of the second frame 121. The proximal end of the connector 13 can be connected to the inner wall, outer wall, or distal end face of the second frame 121, thereby achieving the connection between the connector 13 and the first tubular member 11 and the second tubular member 12. In this embodiment, the connector 13 is a flexible component, for example, made of polymer filaments, allowing it to rotate around the connection point between the connector 13 and the first frame 111 as the second tubular member 12 expands or contracts, thus maintaining the connection between the first tubular member 11 and the second tubular member 12 without hindering the expansion or contraction of the second tubular member 12.

[0069] It should be noted that in other embodiments, the distal end of the connector 13 can also be connected to the outer wall of the first frame 111. In this case, the first membrane 112 on the outer wall of the first frame 111 covers the connection point between the connector 13 and the first frame 111. The connector 13 can be connected to the first frame 111 and the second frame 121 by welding or by sewing. When the connector 13 is welded to the first frame 111 and the second frame 121, the membrane can be first applied to the first frame 111 and the second frame 121 before connecting them to the connector 13, or the first frame 111 and the second frame 121 can be connected to the connector 13 first, and then the membrane can be connected to each of them.

[0070] In other embodiments, the connector 13 can also be connected to the first tubular member 11 and the second tubular member 12 by connecting to the first covering film 112 or the second covering film 122. For example, the first covering film 112 or the second covering film 122 may cover the end of the connector 13 while covering the first frame 111 and the second frame 121, thereby connecting the connector 13 to the first tubular member 11 and the second tubular member 12. Alternatively, the connector 13 may be connected to both the first frame 111 and the first covering film 112 to connect to the first tubular member 11, and simultaneously connected to both the second frame 121 and the second covering film 122 to connect to the second tubular member 12. For example, the connector 13 may be simultaneously fixed to the first frame 111 and the first covering film 112 by suture stitching, and simultaneously fixed to the second frame 121 and the second covering film 122 by suture stitching.

[0071] In other embodiments, when the connector 13 is a flexible member, one end may be fixedly connected to the first tubular member 11 or the second tubular member 12, and the other end may be hinged, or both ends may be hinged. In other embodiments, the connector 13 may also be a rigid member, for example, made of metal wire. It is understood that when the connector 13 is a rigid member, both ends of the connector 13 need to be hinged to the first tubular member 11 and the second tubular member 12 respectively.

[0072] In other embodiments, the connection point of the connector 13 with the first tubular member 11 and the second tubular member 12 is not limited. For example, one end of the connector 13 is connected to the proximal end of the first tubular member 11, and the other end is connected to the distal end of the second tubular member 12. That is, the connection method between the connector 13 and the first tubular member 11 and the second tubular member 12 only needs to ensure that the first tubular member 11 and the second tubular member 12 do not detach, and the connector 13 itself does not affect the opening or closing of the channel 14.

[0073] Please continue reading. Figure 3 In one embodiment, the connector 13 includes four connecting rods 130.

[0074] In one embodiment, the connecting rod 130 is a cylindrical rod with a rectangular cross-section. In other embodiments, the cross-sectional shape of the cylindrical rod may also be circular, sector-shaped, elliptical, or other polygonal.

[0075] Please see Figure 4 , Figure 4In another implementation of the connecting rod 130, the connecting rod 130 includes a connecting section 131 and an assembly section 132. The connecting section 131 is the main body of the connecting rod 130, and the assembly section 132 connects the connecting section 131 to the first tubular member 11 or the second tubular member 12. In this embodiment, the connecting section 131 is a long, narrow column, and there is only one assembly section 132, which is annular. The connection rod 130 can be assembled with the first tubular member 11 and the second tubular member 12 in the following ways: the distal end of the connection rod 130 is welded to the first frame 111 through the connecting section 131, and the proximal end of the connection rod 130 is connected to the crest or trough of the distal end of the second frame 121 through the assembly section 132; or, the distal end of the connection rod 130 is connected to the crest or trough of the first frame 111 through the assembly section 132, and the proximal end of the connection rod 130 is welded to the distal end of the second frame 121 through the connecting section 131.

[0076] In other embodiments, the assembly section 132 can also be configured as two sections, each connected to one end of the connecting section 131, so that the two ends of the connecting rod 130 can be hooked to the first frame 111 and the second frame 121 respectively. In other embodiments, the assembly section 132 can also be configured as a T-shaped rod, which is connected to the connecting section 131, making the connecting rod 130 T-shaped overall. Alternatively, the assembly section 132 can be a straight rod, and the extension direction of the assembly section 132 is perpendicular to the extension direction of the connecting section 131, with the assembly section 132 and the connecting section 131 connected to form a T-shaped connecting rod 130.

[0077] Please see Figure 5 , Figure 5 In another implementation of the connecting rod 130, in this embodiment, the connecting rod 130 still includes a connecting section 131 and an assembly section 132, and... Figure 4The difference in the structure shown is that, in this embodiment, the connecting rod 130 is woven from the braided yarn on the first frame 111. The connecting segment 131 of the connecting rod 130 is integral with the trough of the first support unit 1111 on the first frame 111. The connecting segment 131 is formed by the two ends of the braided yarn intertwined. The assembly segment 132 is a ring or other irregular loop structure formed by bending the middle of the braided yarn. The assembly segment 132 can be interlocked with the crest or trough of the second frame 121. Alternatively, the assembly segment 132 can be connected to the second frame 121 by welding or sewing. It is understood that in other embodiments, the connecting rod 130 can also be woven from the braided yarn on the second frame 111, with the assembly segment 132 interlocked, welded, or sewn to the first frame 111. Alternatively, the connecting rod 130 can be directly woven from the braided yarn into a shape with two assembly segments 132, with the two assembly segments 132 interlocked, welded, or sewn to the first frame 111 and the second frame 121, respectively. In other embodiments, the connector 13 may also be formed by folding braided yarns into a "U" shape, a "∽" shape, or an "O" shape, and the specific braiding shape can be selected according to the actual use.

[0078] It is understandable that the number of connecting rods 130 is not limited and can be selected as needed. The more connecting rods 130 there are, the more stable the connection between the first tubular member 11 and the second tubular member 12 will be. However, at the same time, the second tubular member 12 is more likely to be affected by the connecting rods 130 during its expansion process.

[0079] Please return Figure 1 ,exist Figure 1 In the implantable prosthesis system shown, channel 14 is an annular channel. The branch stent 2 and the implantable prosthesis device 1 are coupled in such a way that one end of the branch stent 2 extends into the annular channel of the implantable prosthesis device 1, and is then clamped by the first tubular member 11 and the second tubular member 12.

[0080] On the one hand, this implantable prosthesis system utilizes an implantable prosthesis device 1 that maintains unobstructed blood flow during surgery, allowing the branch stent 2 to be implanted under unobstructed blood flow conditions. Compared to the prior art where the branch stent 2 is implanted under obstructed blood flow conditions, this provides more time for the implantation of the branch stent 2, thereby further improving the success rate of the surgery. On the other hand, since the branch stent 2 is assembled with the implantable prosthesis device 1 through an annular channel, during the implantation surgery, the branch stent 2 only needs to be inserted into different positions in the annular channel according to the direction of the corresponding branch lumen anatomy. Compared to the method of opening a side window on the implantable prosthesis device 1 for the assembly of the branch stent 2, the annular channel is unobstructed in all directions around the circumference, so that during the implantation of the branch stent 2, it is not necessary to adjust the angle of the already fully expanded first tubular member 11, thereby reducing the difficulty of the surgery and further improving the success rate of the surgery.

[0081] It should be noted that the number of branch stents 2 is not limited and can be selected as needed. In addition, when the number of connecting rods 13 in the implantable prosthesis device 1 that cooperates with the branch stent 2 is greater than 2, the connecting rods 13 can also simultaneously divide the first lumen 110, so that the various implantation directions in the radial direction of the implantable prosthesis device 2 can be further subdivided, which is conducive to the rapid positioning of the branch stent 2 during implantation.

[0082] It should also be noted that, in Figure 1 In the implantable prosthesis device 1 shown, the first tubular member 11 and the second tubular member 12 are coaxially arranged. In other embodiments, the first tubular member 11 and the second tubular member 12 can also be designed to be coaxially arranged according to the number and position of the branch stents 2 to be implanted.

[0083] Please see Figure 6-7 In one embodiment, the distal end of the second tubular member 12 is at least partially accommodated within the first lumen 110, and the implantable prosthesis device 1 further includes a sealing assembly 15, the proximal end of which is connected to the second tubular member 12. Figure 6 In this configuration, the second tubular member 12 is housed within the delivery sheath 3. Its distal end extends axially along the first lumen 110 in a direction away from the second tubular member 12, forming a free end extending beyond the distal end face of the second tubular member 12. In the radially expanded state, the sealing assembly 15 is annular and surrounds the longitudinal central axis of the second tubular member 12. The sealing assembly 15 can move with the expansion or contraction of the second tubular member 12. When the second tubular member 12 is in a radially expanded state, the sealing assembly 15 adheres to the inner wall of the first tubular member 11 to seal the channel 14. When the second tubular member 12 is in a radially compressed state, the sealing assembly 15 separates from the first tubular member 11, releasing the seal on the channel 14.

[0084] When both the first tubular member 11 and the second tubular member 12 are in a radially extended state, the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12 are in contact (the radially opposite parts of the two are in contact), so that the channel 14 is closed. The sealing component 15 also moves with the second tubular member 12 to be attached to the inner wall of the first tubular member 11. Therefore, the sealing component 15 can assist the second tubular member 12 in providing additional sealing for the channel 14, thereby ensuring that the implantable prosthesis device 1 can have a better anti-internal leakage effect.

[0085] In other embodiments, the sealing assembly 15 may also surround the longitudinal central axis of the first tubular member 11.

[0086] In one embodiment, the sealing component 15 is more flexible than the second tubular member 12. This allows the sealing component 15 to adapt to deformation more readily than the second tubular member 12, enabling it to fit more snugly against the sidewall of the branch stent 2 when it is implanted in the channel 14, thereby clamping the branch stent 2 more tightly and further improving the anti-leakage effect of the implantable prosthesis system.

[0087] Please continue reading. Figure 6 In one embodiment, the sealing assembly 15 includes a drive member 151 and a separator membrane 152.

[0088] The proximal end of the driving member 151 is connected to the second tubular member 12, and the distal end of the driving member 151 extends axially along the first lumen 110 away from the second tubular member 12 to form a free end that extends beyond the distal end face of the second tubular member 12. The proximal end of the separator 152 is also connected to the second tubular member 12, and the distal end of the separator 152 extends axially along the first lumen 110 away from the second tubular member 12 to form a free end that extends beyond the distal end face of the second tubular member 12. The separator 152 has an unfolded state and a folded state. In the unfolded state, the separator 152 is annular, and when unfolded, the separator 152 can fit against the inner wall of the first tubular member 11. The driving member 151 is connected to the separator 152, and the driving member 151 is used to drive the separator 152 to unfold with the expansion of the second tubular member 12 or to drive the separator 152 to fold with the contraction of the second tubular member 11.

[0089] By configuring the sealing assembly 15 to include a drive member 151 and a septum 152, when the branch stent 2 is implanted in the channel 14, since there are no extra stent units on the septum 152 to obstruct it, the septum 152 can more tightly cover the sidewall of the branch stent 2, thus ensuring a better anti-internal leakage effect. In addition, since there are no extra stent units on the septum 152, it has good flexibility, thus preventing the branch stent 2 from being squeezed by the first tubular member 11 and the sealing assembly 15, and better maintaining the shape of the branch stent 2.

[0090] Please continue reading. Figure 6-7 In one embodiment, the driving member 151 includes at least one driving rod 1510 connected to the distal end of the second tubular member 12. The driving rod 1510 is disposed on the separating membrane 152, and the proximal end of the driving rod 1510 is connected to the second tubular member 12, while the distal end is a free end. The extension direction of the driving rod 1510 satisfies the following condition: when both the first tubular member 11 and the second tubular member 12 are in a radially extended state, the driving rod 1510 is in contact with the inner wall of the first tubular member 11. For example, in one embodiment, the first tubular member 11 is a cylindrical structure of equal diameter, then the driving rod 1510 is a straight rod, and when both the driving rod 1510 and the first tubular member 11 are in an extended state, the extension direction of the driving rod 1510 is parallel to the central axis of the first tubular member 11. Alternatively, in other embodiments, if the first tubular member 11 is a frustum-shaped structure, then the drive rod 1510 is a straight rod. When both the drive rod 1510 and the first tubular member 11 are in the extended state, the extension direction of the drive rod 1510 is parallel to the extension direction of the sidewall of the first tubular member 11. Alternatively, if the first tubular member 11 is a variable-diameter cylindrical structure, then the drive rod 1510 is a curved rod with a bending angle, and its bending angle matches the internal shape of the first tubular member 11, so that when both the drive rod 1510 and the first tubular member 11 are in the extended state, the drive rod 1510 is attached to the inner wall of the first tubular member 11.

[0091] It should be noted that the proximal end of the drive rod 1510 can be fixed to the second tubular member 12 by welding, sewing or other means, or it can be derived from the braided wire of the second frame 121 on the second tubular member 12. The specific connection method can be selected according to the usage.

[0092] Please continue reading. Figure 7 In one embodiment, the drive rod 1510 is a long rod-shaped structure with a rectangular cross-section. In other embodiments, the cross-section of the drive rod 1510 can also be circular, fan-shaped, elliptical, or other polygonal shapes. Alternatively, the drive rod 1510 can also be a spiral structure formed by winding braided filaments.

[0093] Please see Figure 8-9In one embodiment, the diaphragm 152 is a hollow cylindrical film with a diameter matching the inner diameter of the first tubular member 11. The proximal end of the diaphragm 152 is connected to the distal end of the second tubular member 12, and the diaphragm 152 is connected to the drive rod 1510 at the contact point. It is understood that the diaphragm 152 can be integrally formed with the second covering membrane 122 of the second tubular member 12, or it can be sewn to the distal end of the second covering membrane 122. The diaphragm 152 can be a monolithically formed annular sheet, or it can be composed of multiple arc-shaped sheets joined together. The material of the diaphragm 152 can be nylon or other materials suitable for manufacturing artificial blood vessels, or it can be polyester fabric or PTFE film. It should be noted that the material of the diaphragm 152 is not limited to the materials mentioned above; the material of the diaphragm 152 can be a flexible material that can block blood flow and is suitable for implantation in the human body. The connection between the diaphragm 152 and the drive rod 1510 can be achieved by suturing, heat treatment covering, or bonding.

[0094] It should be noted that in other embodiments, the sealing assembly 15 can also be a discontinuous structure, that is, the number of septa 152 in the sealing assembly 15 can be two or more, and the multiple septa 152 are arranged circumferentially along the second tubular member 12, so that the multiple septa 152 cooperate to form a discontinuous structure in the unfolded state. In this case, the septa 152 is a sheet-like body with a certain curvature, and the septa 152 can be set according to the formation position of the channel 14. That is, the septa 152 and the drive rod 1510 are set at the position where the channel 14 needs to be set, while the drive rod 1510 and the septa 152 are not set at the position where the channel 14 does not need to be set. It can be understood that the number of channels 14 can be equal to or greater than the number of branch stents 2. When the number of channels 14 is greater than the number of branch stents 2, the channels 14 at the positions where no branch stents 2 are implanted can play the role of maintaining blood flow. It can also be understood that when the sealing assembly 15 is annular, its sealing effect on the channel 14 is better than when the sealing assembly 15 is a discontinuous structure.

[0095] In other embodiments, the sealing assembly 15 may also have an outer diameter that is larger than the inner diameter of the first tubular member 11 when it is radially expanded in its natural state. This allows the sealing assembly 15 to form an interference fit with the first tubular member 11, thereby clamping the branch bracket 2 more tightly and ensuring the installation stability of the branch bracket 2.

[0096] It should also be noted that in other embodiments, the drive rod 1510 and the separator 152 can also be connected to the middle or the distal end of the second tubular member 12. However, the method of connecting the drive rod 1510 and the separator 152 to the distal end of the second tubular member 12 is more convenient to assemble and does not affect the opening and closing of the channel 14.

[0097] Please continue reading. Figure 6-7 In one embodiment, the diaphragm 152 unfolds into a ring shape and is simultaneously connected to the drive rod 1510 and the connector 13. On one hand, the diaphragm 152 can extend the channel 14 to a certain extent at the distal end of the channel 14. On the other hand, since the diaphragm 152 is connected to the connector 13, the extension segment formed by the diaphragm 152 to the channel 14 actually exists in the form of multiple non-interconnected sub-channels 140, thereby further facilitating the establishment of the implantation path of the branch stent 2. Furthermore, the arrangement of the sub-channels 140 can maintain the parallelism between the fixed end of the branch stent 2 and the axis of the implantable prosthesis device 1, improving the assembly stability of the branch stent 2.

[0098] In other embodiments, the separator 152 may only be connected to the drive rod 1510, that is, the separator 152 is not connected to the connecting rod 130. In the contracted state, the connecting rod 130 is in contact with the separator 152, but there is no connection point between them. In this way, the sealing component 15 can also play a good supplementary sealing role, and the presence of the sealing component 15 does not interfere with the connecting rod 130, thus not affecting the opening and closing of the channel 14. It is understood that when the separator 15 needs to be connected to the connecting rod 130, the connection position of the connecting rod 130 on the first tubular member 11 and the second tubular member 12 also needs to be considered so as not to affect the expansion or contraction of the separator 152. For example, in Figure 6 In the illustrated embodiment, the proximal end of the connecting rod 130 is connected to the distal end of the second tubular member 12, and the distal end of the connecting rod 130 is connected to the first tubular member 11. The connection point between the connecting rod 130 and the first tubular member 11 extends beyond the distal end face of the second tubular member 12. This allows the connecting rod 130, the driving rod 1510, and the separating membrane 152 to all be located on the distal side of the second tubular member 12. During the expansion or contraction of the second tubular member 12, the connecting rod 130 can cooperate with the driving rod 1510 to jointly drive the expansion or contraction of the separating membrane 152. The radial compression state of the second tubular member 12 is not necessarily achieved through the delivery sheath 3; it can also be achieved through a restraining structure.

[0099] Please continue reading. Figure 6-7In one embodiment, the distal end of the connector 13 is connected to the inner wall of the first tubular member 11, and the proximal end of the connector 13 is connected to the distal end of the second tubular member 12. The connector 13 includes four connecting rods 130, which are evenly distributed circumferentially along the first cavity 110. The connecting rods 130 satisfy the following condition: when both the first tubular member 11 and the second tubular member 12 are in a radially extended state, the extension direction of the connecting rods 130 is parallel to the axial direction of the first tubular member 11. A driving rod 1510 is provided between two adjacent connecting rods 130, that is, the driving member 151 includes four driving rods 1510. When the separator 152 is extended, it is a hollow cylinder. The separator 152 is connected to both the connecting rods 130 and the driving rods 1510.

[0100] Please combine Figure 8-9 Before the branch stent 2 is implanted, the first tubular member 11 is radially expanded and the second tubular member 12 is radially compressed. At this time, the channel 14 is opened, and the septum 152 is folded under the combined action of the drive rod 1510 and the connecting rod 130. The folded septum 152 extends the channel 14 to a certain extent at the distal end of the channel 14. The extended section exists in the form of multiple non-interconnected sub-channels 140. After the branch stent 2 is implanted into the channel 14, by releasing the second tubular member 12, the proximal end of the connecting rod 130 and the driving rod 1510 will move towards the side closer to the inner wall of the first tubular member 11 as the second tubular member 12 unfolds. Driven by the connecting rod 130 and the driving rod 1510, the septal membrane 152 also unfolds until the second tubular member 12 is in a radially unfolded state. At this time, the connecting rod 130 is completely attached to the inner wall of the first tubular member 11. In the position where the branch stent 2 is implanted, the driving rod 1510 is attached to the outer wall of the branch stent 2. The septal membrane 152 is wrapped around the branch stent 2 under the joint action of the connecting rod 130 and the driving rod 1510 to wrap the branch stent 2. In the position where the branch stent 2 is not implanted, the driving rod 1510 drives the septal membrane 152 to be attached to the inner wall of the first tubular member 11 to perform a secondary seal on the channel 14.

[0101] Compared to the second tubular member 12, the septum 152 does not have any extra support units to obstruct it. Therefore, the septum 152 can provide a more fitting coverage of the branch stent 2, thereby providing tighter protection against peritoneal leakage and reducing or avoiding the occurrence of endoleak after implantation.

[0102] It should be noted that in this embodiment, the distal ends of the separator 152 and the drive rod 1510 are on the same radial plane as the distal end of the connecting rod 130. The opening of the channel 14 can be achieved by successively withdrawing the conveying sheath 3, so that the first tubular member 11 is completely released. Since there is an overlapping portion between the first tubular member 11 and the second tubular member 12, the overlapping portion of the second tubular member 12 with the first tubular member 11 is also released simultaneously. The other portion of the second tubular member 12 remains compressed within the conveying sheath 3. At this time, by moving the conveying sheath 3 forward, the overlapping portion of the second tubular member 12 can be recompressed, thereby opening the channel 14. In other embodiments, the distal ends of the separator 152 and the drive rod 1510 may not be on the same radial plane as the distal end of the connecting rod 130.

[0103] It should also be noted that the number of connecting rods 130 and driving rods 1510 is not limited and can be selected according to the actual situation. The number of connecting rods 130 and the number of driving rods 1510 do not need to correspond. For example, at the location where the branch stent 2 needs to be implanted, the number of driving rods 1510 arranged between two adjacent connecting rods 130 may be 3 or 4. Furthermore, in other embodiments, the connecting rods 130 may also be arranged radially and unevenly along the first lumen 110. For example, in the direction where the branch stent 2 needs to be implanted, the connecting rods 130 are more densely distributed, while in the direction where the branch stent 2 does not need to be implanted, the connecting rods 130 are more sparsely distributed. In other embodiments, the separator 152 may be a plurality of arc-shaped sheets. The specific number of separators 152 may be set according to the formation position of the channel 14. The plurality of separators 152 are arranged circumferentially along the second tubular member 12. Each separator 152 is connected to two connecting rods 130 at adjacent positions on both sides. The non-side positions of the separators 152 are connected to the drive rods 1510 located between the connecting rods 130.

[0104] Please continue reading. Figure 10-11This is another implementation of the implantable prosthesis device 1. In this embodiment, the distal end of the connector 13 is connected to the inner wall of the first tubular member 11, and the proximal end of the connector 13 is connected to the distal end of the second tubular member 12. The connector 13 includes four rod groups, each rod group including a connecting rod 130a and a connecting rod 130b. When both the first tubular member 11 and the second tubular member 12 are in a radially extended state, the extension directions of the connecting rods 130a and 130b form a non-zero angle with the axial direction of the first tubular member 11, and the extension lines of the proximal ends of the connecting rods 130a and 130b can converge at a single intersection point. The connecting rods 130a and 130b are symmetrical about an axis parallel to the longitudinal central axis of the second tubular member 12 at the intersection point. The arrangement is such that, with both the first tubular member 11 and the second tubular member 12 radially extended, the distance between the connecting rods 130a and 130b on the first tubular member 11 is greater than the distance between the connecting rods 130a and 130b on the second tubular member 12. A driving rod 1510 is provided between the connecting rods 130a and 130b, but no driving rod 1510 is provided between adjacent rod groups. When the separator 152 is in the extended state, it is a hollow cylindrical film. The separator 152 is simultaneously connected to the connecting rods 130a, 130b, and the driving rod 1510.

[0105] With this configuration, before the branch stent 2 is implanted, when the first tubular member 11 is radially expanded and the second tubular member 12 is radially compressed, the channel 14 opens. At this time, the septal membrane 152 is taut under the action of the connecting rods 130a, 130b, and 1510, thus preventing the folds of the septal membrane 15 from blocking the sub-channel 140 and further reducing the difficulty of establishing the implantation path of the branch stent 2. In addition, since the distance between the connecting rods 130a and 130b on the first tubular member 11 is greater than the distance between their connecting rods on the second tubular member 12, the sub-channel 140 formed will form a conical pocket shape with a large distal opening and a small proximal opening. The wider distal opening of the sub-channel 140 facilitates the insertion of the branch stent 2 from the distal end into the sub-channel 140, while the narrower proximal opening allows the septal membrane 152 to adhere more tightly to the sidewall of the branch stent 2, thereby improving the anti-internal leakage effect.

[0106] In other embodiments, connecting rods 130a and 130b may not be symmetrically distributed about an axis parallel to the longitudinal central axis of the second covered support 1201, where the intersection of the extensions of the proximal ends of connecting rods 130a and 130b is located. In other embodiments, there may be multiple separators 152, which may be disposed only within each rod group and not between adjacent rod groups.

[0107] Please continue reading. Figure 11 In one embodiment, the distal end of connecting rod 130a in a rod group is connected to the distal end of connecting rod 130b in an adjacent rod group. In other embodiments, the proximal ends of connecting rods 130a and 130b within the same rod group can also be connected, thereby enabling the rod groups to cooperate to form an annular waveform structure. The connecting rods 130a and 130b within each rod group connect to form the trough of the annular waveform structure, and the connecting rods 130a and 130b in adjacent rod groups connect to form the peak of the annular waveform structure. When the connector 13 forms an annular waveform structure, it can be connected to the first tubular member 11 and the second tubular member 12 by hooking them together.

[0108] Please see Figure 12-13 This is another embodiment of the implantable prosthesis device 1, and... Figure 10 Compared to the illustrated embodiment, the drive rod 1510 in this embodiment differs slightly. The drive rod 1510 includes a connecting portion 15101 and a supporting portion 15102. The end of the connecting portion 15101 furthest from the supporting portion 15102 is connected to the second tubular member 12. The end of the supporting portion 15102 furthest from the connecting portion 15101 is a free end, and the projected area of ​​the free end of the supporting portion 15102 on the separator membrane 152 is larger than the projected area of ​​the connecting section of the connecting portion 15101 to the second tubular member 12 on the separator membrane 152. The supporting portion 15102 increases the contact area between the distal end of the drive rod 1510 and the separator membrane 152.

[0109] Specifically, in one embodiment, the abutment portion 15102 is annular or circular, and there are two abutment portions 15102, which are arranged symmetrically. The axis of symmetry is a straight line parallel to the longitudinal central axis of the second tubular member 12, where the connection end of the connecting portion 15101 and the second tubular member 12 is located. The connecting portion 15101 is Y-shaped to connect the two abutment portions 15102 at the same time. The diameter of the abutment portion 15102 is greater than the width of the distal end of the connecting portion 15101.

[0110] By setting the abutment portion 15102 to increase the contact area between the drive rod 1510 and the septum 152, on the one hand, the drive rod 1510 can better drive the septum 152 to contract, so as to smoothly open the channel 14; on the other hand, after the branch stent 2 is implanted, the septum 152 can more tightly wrap the inner side of the branch stent 2, thereby improving the stability of the branch stent 2 and reducing the risk of peripheral leakage.

[0111] Please continue reading. Figure 12In one embodiment, when the first tubular member 11 is in a radially expanded state and the second tubular member 12 is in a radially contracted state, in two adjacent drive rods 1510, the outermost abutment portion 15102 of one drive rod 1510 and the outermost abutment portion 15102 of the other drive rod 1510 adjacent to the outermost abutment portion 15102 abut against each other, thereby cooperating to clamp the septum 152. This arrangement allows the septum 152 to be stretched taut under the action of the drive rods 1510, thereby eliminating the gaps between the sub-channels 1401, thus facilitating the establishment of the branch stent 2 implantation path.

[0112] It is understood that the specific shape of the connecting part 15101 and the specific shape and number of the supporting part 15102 are not limited and can be selected according to the actual situation.

[0113] It should be noted that, in one embodiment, the implantable prosthesis 1 may further include a leaflet structure (not shown), which is connected to the second tubular member 12. The leaflet structure includes three leaflets that can be closed and opened. When the implantable prosthesis 1 is implanted in the body, the three leaflets close and open with the diastole and systole of the heart, thereby closing or opening the second lumen 120. The leaflets can be made of biomaterials or polymer materials. When aortic dissection patients also have aortic valve disease and need to replace their natural aortic valve, the implantable prosthesis 1 can be used to treat aortic dissection and replace the natural aortic valve simultaneously. It is understood that in other embodiments, the number of leaflets is not limited to three; for example, it can be two or four. In addition, when the implantable prosthesis 1 is applied to other sites such as the renal artery where natural valve replacement is not required, the leaflet structure can be omitted.

[0114] 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.

[0115] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An implantable prosthesis device, characterized in that, include: A first tubular member having a first lumen; The second tubular member has a second lumen; The first tubular member is connected to the second tubular member, and the second tubular member is partially housed within the first cavity so that the outer wall of the second tubular member and the inner wall of the first tubular member cooperate to form an openable or closable channel. When the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the channel is in an open state and connected to the first cavity; when both the first tubular member and the second tubular member are in a radially expanded state, the channel is in a closed state.

2. The implantable prosthesis device according to claim 1, characterized in that, The channel is an annular channel; or, there are multiple channels, which are spaced apart circumferentially along the second tubular member; or, there is a single channel, which is a non-annular channel.

3. The implantable prosthesis device according to claim 1, characterized in that, The implantable prosthesis also includes a connector, one end of which is connected to the first tubular member and the other end of which is connected to the second tubular member.

4. The implantable prosthesis device according to claim 3, characterized in that, The connector can be a flexible or rigid component. When the connector is flexible, one end of the connector is hinged or fixedly connected to the first tubular component, and the other end of the connector is hinged or fixedly connected to the second tubular component. When the connector is rigid, both ends of the connector are hinged to the first tubular component and the second tubular component, respectively.

5. The implantable prosthesis device according to claim 3, characterized in that, The connector includes a connecting section and an assembly section connected to the connecting section. The assembly section is connected to one of the first tubular member and the second tubular member. The end of the connecting section away from the assembly section is connected to the other of the first tubular member and the second tubular member. The connecting section is a cylindrical rod or a braided wire, and the assembly section is a loop structure, a T-shaped rod, or a straight rod whose extension direction is perpendicular to the extension direction of the connecting section.

6. The implantable prosthesis device according to any one of claims 3-5, characterized in that, The distal end of the second tubular member is at least partially housed within the first lumen. The implantable prosthesis device further includes a sealing assembly, the proximal end of which is connected to the second tubular member, and the distal end of which extends axially away from the second tubular member to form a free end beyond the distal end face of the second tubular member. In a radially deployed state, the sealing assembly has an annular or discontinuous structure and surrounds the longitudinal central axis of the first tubular member or the second tubular member.

7. The implantable prosthesis device according to claim 6, characterized in that, The sealing assembly is more flexible than the second tubular member; or, in its natural state, the outer diameter of the sealing assembly after radial expansion is greater than the inner diameter of the first tubular member after radial expansion.

8. The implantable prosthesis device according to claim 6, characterized in that, The sealing assembly includes a driving member and a separating membrane. The proximal ends of the driving member and the separating membrane are connected to the second tubular member, and the distal ends of the driving member and the separating membrane are both free ends extending beyond the distal end face of the second tubular member. The separating membrane has an unfolded and a folded state. In the unfolded state, the separating membrane is annular. Alternatively, there may be multiple separating membranes, which are spaced apart circumferentially along the second tubular member. In the unfolded state, the multiple separating membranes form a discontinuous structure. When unfolded, the separating membrane can adhere to the inner wall of the first tubular member. The driving member is connected to the separating membrane and is used to drive the separating membrane to unfold as the second tubular member expands or to drive the separating membrane to fold as the second tubular member contracts.

9. The implantable prosthesis device according to claim 8, characterized in that, The driving component includes a driving rod, and the extension direction of the driving rod satisfies the following condition: when both the first tubular component and the second tubular component are in a radially extended state, the driving rod is in contact with the inner wall of the first tubular component.

10. The implantable prosthesis device according to claim 9, characterized in that, The connector includes multiple connecting rods, which are spaced apart circumferentially along the first tubular cavity. When both the first tubular member and the second tubular member are radially extended, the extension direction of the connecting rods is parallel to the axial direction of the first tubular member. At least one driving rod is provided between two adjacent connecting rods. When the separator membrane is annular in the extended state, it is simultaneously connected to the connecting rods and the driving rods circumferentially. When there are multiple separator membranes, the two sides of the separator membrane are respectively connected to two adjacent connecting rods, and the non-side positions of the separator membrane are connected to the driving rods.

11. The implantable prosthesis device according to claim 9, characterized in that, The connector includes several rod groups, each rod group including two connecting rods. When both the first tubular member and the second tubular member are in a radially extended state, the extension directions of the two connecting rods form a non-zero angle with the axial direction of the first tubular member, and the extension lines of the proximal ends of the two connecting rods can converge at a single intersection point. At least one driving rod is provided between the two connecting rods. When the separator membrane is in an annular shape in the extended state, the separator membrane is simultaneously connected to the connecting rods and the driving rods along the circumference. When there are multiple separator membranes, the two sides of the separator membrane are respectively connected to the two connecting rods in each rod group, and the non-side positions of the separator membrane are connected to the driving rods.

12. The implantable prosthesis device according to claim 11, characterized in that, The connecting rods are connected in pairs to form a ring-shaped waveform structure. The connection of two connecting rods in the rod group forms the trough of the ring-shaped waveform structure, and the connection of connecting rods in adjacent rod groups forms the peak of the ring-shaped waveform structure.

13. The implantable prosthesis device according to any one of claims 9-12, characterized in that, The drive rod includes a connecting portion and at least one abutting portion connected to the connecting portion. One end of the connecting portion away from the abutting portion is connected to the second tubular member. The end of the abutting portion away from the connecting portion is a free end, and the projected area of ​​the abutting portion on the separator membrane is greater than the projected area of ​​the connecting end of the connecting portion to the second tubular member on the separator membrane.

14. The implantable prosthesis device according to claim 13, characterized in that, The abutting part is provided in two parts, and the two abutting parts are arranged symmetrically, with the axis of symmetry being a straight line parallel to the longitudinal central axis of the second tubular member where the connecting end of the connecting part and the second tubular member are located.

15. The implantable prosthesis device according to claim 13, characterized in that, The abutment portion is at least two. When the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, in two adjacent drive rods, one of the outermost abutment portions of one drive rod and another outermost abutment portion of the other drive rod adjacent to the outermost abutment portion abut against each other to clamp the separator membrane.

16. The implantable prosthesis device according to claim 1, characterized in that, The implantable prosthesis device also includes a leaflet structure disposed within the second tubular member, and the leaflet structure can be opened or closed, so that the second lumen of the second tubular member is in an open or closed state.

17. An implantable prosthesis system, characterized in that, include: Branch support; And, in any one of claims 1-16, one end of the branch stent can extend into the channel and be clamped by the first tubular member and the second tubular member.

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