Implantable prosthesis device and implantable prosthesis system

Abstract

The invention relates to an implantable prosthesis device and an implantable prosthesis system, and relates to the technical field of medical instruments. The implantable prosthetic device includes: a first tubular member having a first lumen; a second tubular member having a second lumen; the first tubular component is connected with the second tubular component, and the second tubular component is partially contained in the first tubular cavity so that the outer wall of the second tubular component can be matched with the inner wall of the first tubular component to form a channel capable of being opened or closed. The channel is in an open state and is communicated with the first pipe cavity; when the first tubular component and the second tubular component are in the radial unfolding state, the channel is in the closed state. The implantable prosthesis device provided by the invention can keep the blood flow smooth in the operation process, and prevents the adverse effect on the health of a patient due to blood flow blockage.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implantable prosthesis device and an implantable prosthesis system. Background Art

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Aortic dissection, also known as aortic dissecting aneurysm, is caused by various reasons, the aortic intima is torn, blood flows into the arterial wall, causing the aortic wall to be layered and separated, and a hematoma is formed. Aortic dissection is a vascular disease that seriously endangers life and health, with a high mortality rate.

[0004] At present, there are two main ways to treat aortic dissection: surgical treatment and minimally invasive treatment. Among them, surgical treatment is achieved through thoracotomy and laparotomy, resection of the intimal tear, and reconstruction of the blood flow channel with artificial blood vessels, while minimally invasive interventional treatment is achieved by implanting a covered stent at the lesion site to isolate the blood flow of the aortic dissection and maintain the normal blood flow channel. Compared with surgical treatment, minimally invasive interventional treatment is increasingly used in conventional treatment because of its advantages such as less trauma, faster recovery, and fewer complications.

[0005] Generally, the covered prosthesis is usually a straight-tube stent. However, when the lesion site of aortic dissection involves or is close to the branch vessels, such as the dissection lesion site of the ascending aorta involves or is close to the aortic coronary vessels, the dissection lesion of the ascending aorta involves or is close to the branch vessels of the aortic arch, and the lesion site of the abdominal aorta is close to the renal artery, in order to cover the lesion site or to increase sufficient anchoring area, the covered stent may cover or block the opening of the branch vessels, coronary vessels or renal artery. In this case, it is usually necessary to implant the main stent and the branch stent (or bypass stent) at the same time at the lesion site for treatment. The main stent and the branch stent cooperate with each other to maintain the smooth blood flow of the aorta and the branch vessels. However, this also increases the difficulty of the implantation surgery.

[0006] Generally, the implantation operation is performed as follows: first, the main stent is delivered to the corresponding part, then the main stent is partially released, and then the branch stent is delivered to the corresponding part, and then the branch stent is released so that the branch stent cooperates with the main stent, and finally the main stent is completely released to complete the operation. As a result, during the release of the branch stent, since the main stent is located in the blood vessel and is in a semi-released state and is not fully opened, it will block the blood flow to a certain extent. When the time to release the branch stent is too long, the blood flow blockage time will also be longer, which will have an adverse effect on the patient's health, and in severe cases, it may even be life-threatening.

[0007] Therefore, it is crucial to maintain smooth blood flow during surgery. Summary of the invention

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

[0009] Furthermore, an implantable prosthesis system capable of maintaining smooth blood flow during surgery is provided.

[0010] An implantable prosthetic device comprises: a first tubular member having a first tubular cavity; a second tubular member having a second tubular cavity; the first tubular member is connected to the second tubular member, and the second tubular member is partially accommodated in the first tubular cavity 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 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 tubular cavity; when the first tubular member and the second tubular member are both in a radially expanded state, the channel is in a closed state.

[0011] In one embodiment, the channel is an annular channel; or, there are multiple channels, and the multiple channels are arranged at intervals along the circumference of the second tubular member; or, there is one channel, and the channel is a non-annular channel.

[0012] In one embodiment, the implantable prosthesis further comprises 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 connecting member is a flexible member or a rigid member. When the connecting member is a flexible member, one end of the connecting member is hinged or fixedly connected to the first tubular member, and the other end of the connecting member is hinged or fixedly connected to the second tubular member; when the connecting member is a rigid member, both ends of the connecting member are respectively hinged to the first tubular member and the second tubular member.

[0014] In one embodiment, the connecting member 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, and one 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 ring-shaped structure, a T-shaped rod, or a straight rod whose extension direction is perpendicular to the extension direction of the connecting section.

[0015] In one embodiment, the distal end of the second tubular member is at least partially accommodated in the first tubular cavity, and the implantable prosthetic device also includes a sealing assembly, the proximal end of the sealing assembly is connected to the second tubular member, and the distal end extends axially away from the second tubular member to form a free end that extends beyond the distal end surface of the second tubular member, and in a radially expanded state, the sealing assembly is an annular or discontinuous structure, and the sealing assembly surrounds the longitudinal center axis of the first tubular member or the second tubular member.

[0016] In one embodiment, the flexibility of the sealing assembly is greater than the flexibility of the second tubular member; or, in a 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 driving member and a separation membrane, the proximal ends of the driving member and the separation membrane are connected to the second tubular member, and the distal ends of the driving member and the separation membrane are both free ends that extend beyond the distal end surface of the second tubular member, the separation membrane has an expanded state and a folded state, the separation membrane is annular in the expanded state, or the separation membrane is multiple, the multiple separation membranes are arranged at intervals along the circumference of the second tubular member, the multiple separation membranes form a non-continuous structure in the expanded state, the separation membrane can be in contact with the inner wall of the first tubular member when expanded, the driving member is connected to the separation membrane, and the driving member is used to drive the separation membrane to expand as the second tubular member expands or to drive the separation membrane to fold as the second tubular member contracts.

[0018] In one embodiment, the driving member includes a driving rod, and an extending direction of the driving rod satisfies: when the first tubular member and the second tubular member are both in a radially expanded state, the driving rod fits against an inner wall of the first tubular member.

[0019] In one embodiment, the connecting member includes a plurality of connecting rods, and the plurality of connecting rods are spaced apart along the circumference of the first tubular cavity. When the first tubular member and the second tubular member are both in a radially expanded state, the extension direction of the connecting rod is parallel to the axial direction of the first tubular member, and at least one driving rod is arranged between two adjacent connecting rods. When the partition membrane is annular in the expanded state, the partition membrane is simultaneously connected to the connecting rod and the driving rod along the circumferential direction; when there are multiple partition membranes, the two side edges of the partition membrane are respectively connected to the two adjacent connecting rods, and the non-side edge of the partition membrane is connected to the driving rod.

[0020] In one embodiment, the connecting member includes a plurality of rod groups, each of which includes two connecting rods. When the first tubular member and the second tubular member are in a radially expanded state, the extension direction of the two connecting rods forms 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 an intersection. At least one driving rod is arranged between the two connecting rods. When the partition membrane is annular in the expanded state, the partition membrane is circumferentially connected to the connecting rod and the driving rod at the same time; when there are multiple partition membranes, the two side edges of the partition membrane are respectively connected to the two connecting rods in each of the rod groups, and the non-side position of the partition membrane is connected to the driving rod.

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

[0022] In one embodiment, the driving rod includes a connecting portion and at least one supporting portion connected to the connecting portion, an end of the connecting portion away from the supporting portion is connected to the second tubular member, an end of the supporting portion away from the connecting portion is a free end, and a projection area of ​​the supporting portion on the separation membrane is larger than a projection area of ​​an end of the connecting portion connected to the second tubular member on the separation membrane.

[0023] In one embodiment, the number of the abutting portions is two, and the two abutting portions are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second tubular member where the connecting end of the connecting portion and the second tubular member is located.

[0024] In one embodiment, there are at least two abutting portions, and when the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, among two adjacent driving rods, one lateral abutting portion in one driving rod and another lateral abutting portion in the other driving rod adjacent to the lateral abutting portion abut against each other to clamp the separation membrane.

[0025] In one embodiment, the implantable prosthetic device further comprises a leaflet structure, wherein the leaflet structure is disposed in 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 comprises: a branch stent; and an implantable prosthesis device as described in any one of all the above embodiments, wherein one end of the branch stent can extend into the channel and be clamped by the first tubular member and the second tubular member.

[0027] In the implantable prosthetic device provided by an embodiment of the present invention, the first tubular member and the second tubular member are connected to form a channel that can be opened or closed. During the implantation operation, 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 has not been released, since the channel is connected to the first lumen, blood can still flow out through the channel along the first lumen, or blood can flow out through the first lumen along the channel, 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 an embodiment of the present invention uses an implantable prosthesis device that can maintain smooth blood flow during surgery in cooperation with a branch stent, so that the branch stent can be implanted when the blood flow is smooth. Compared with the prior art where the branch stent is implanted when the blood flow is blocked, more time can be gained for the implantation of the branch stent, thereby further improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0030] in:

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

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

[0033] Figure 3 It is a schematic diagram of assembling an implantable prosthetic device and a delivery sheath according to an embodiment of the present invention;

[0034] Figure 4 It is a structural schematic diagram of a connecting member in one embodiment of the present invention;

[0035] Figure 5 is a schematic structural diagram of a connecting member in another embodiment of the present invention;

[0036] Figure 6 is a schematic diagram of assembling an implantable prosthetic device and a delivery sheath in another embodiment of the present invention;

[0037] Figure 7 for Figure 6 A schematic diagram of the assembly of a partial structure of an implantable prosthetic device and a delivery sheath is shown;

[0038] Figure 8 for Figure 6 A top view of the implantable prosthetic device shown in a state where the channel is open;

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

[0040] Fig.10 is a schematic diagram of assembling an implantable prosthetic device and a delivery sheath in another embodiment of the present invention;

[0041] Fig.11 for Fig.10 A schematic diagram of the assembly of a partial structure of an implantable prosthetic device and a delivery sheath is shown;

[0042] Fig.12 is a cross-sectional view of an implantable prosthetic device in another embodiment of the present invention with the channel opened;

[0043] Fig.13 Schematic diagram of the structure of a driving rod in another embodiment of the present invention. DETAILED DESCRIPTION

[0044] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work 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 orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0046] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a replaceable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0047] In the field of interventional medical devices, the end of a medical device implanted in a 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". The "proximal end" and "distal end" of any component of the medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is not parallel to its "axial direction". The "axial" and "radial" of any component of the medical device are defined based on this principle. "Circumferential" refers to the circumferential direction, that is, the axial direction surrounding the lumen structure or column.

[0048] See also 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 to be implanted in the main lumen anatomical structure, such as implanted in the aorta, and the branch stent 2 is used in conjunction with the implantable prosthesis device 1. The branch stent 2 is used to be implanted in the branch lumen anatomical structure, such as implanted in the coronary branch blood vessel.

[0049] It is understandable that the application site of the implantable prosthesis system is not limited to the aorta, but can also be applied to other sites with branched blood vessels, for example, the renal artery.

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

[0051] The first tubular member 11 has a first tubular cavity 110. The second tubular member 12 has a second tubular cavity 120. The second tubular member 12 is connected to the first tubular member 11, and the second tubular member 12 is partially accommodated in the first tubular cavity 110, so that the first tubular member 11 and the second tubular member 12 form a partial sleeve structure, and the partial sleeve structure makes the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12 cooperate to form an openable or closed channel 14. When the first tubular member 11 is in a fully expanded state and the second tubular member 12 is in a compressed state, the inner wall of the first tubular member 11 is separated from the outer wall of the second tubular member 12, and the channel 14 is opened; when the first tubular member 11 and the second tubular member 12 are both in a fully expanded state, the inner wall of the first tubular member 11 fits with the outer wall of the second tubular member 12, and the channel 14 is closed.

[0052] The implantable prosthesis device 1 thus configured can release the first tubular member 11 during the implantation operation, and keep the second tubular member 12 in a radially compressed state (for example, 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 constrained 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 constrained by a limiting structure (not shown), for example, being constrained by a tether and being in a radially compressed state). At this time, the channel 14 is in an open state and connected 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 smooth blood flow during the implantation operation and preventing adverse effects on the patient's health due to blood flow blockage.

[0053] It can be understood that the first tubular member 11 and the second tubular member 12 can be directly connected to each other, or can be indirectly connected through other components.

[0054] In one embodiment, the channel 14 can be presented as an annular channel, so that the blood flow is smoother and the effect is better. In other embodiments, the channel 14 can also be multiple, and the multiple channels 14 are arranged at intervals along the circumference of the second tubular member 12, or the channel 14 is one, and the channel 14 is a non-annular channel.

[0055] See also Figure 2 When the first tubular member 11 is indirectly connected to the second tubular member 12, the implantable prosthetic device 1 further 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 escaping from the first tubular member 11, thereby maintaining the overlapping 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 the connecting member 13, so that the expansion or contraction movement between the first tubular member 11 and the second tubular member 12 can be performed independently without interfering with each other, so that the channel 14 can be opened more conveniently and quickly, thereby quickly achieving smooth blood flow and helping to shorten the operation time. In addition, such a connection can enable the channel 14 to be opened to a greater extent, thereby better ensuring smooth 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, and the first tubular member 11 and the second tubular member 12 are not directly connected, an annular channel that can be opened and closed 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 channels 14 that can be opened and closed and are arranged at intervals along the circumference of 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, and only some areas are connected, and some areas are not connected, and a non-annular channel 14 is formed in the unconnected area.

[0058] See also Figure 3 In one embodiment, the first tubular member 11 is a coated stent with openings at both ends. The first tubular member 11 includes a first frame 111 and a first coating 112. The first coating 112 is coated on the first frame 111 to form a first tubular cavity 110 with openings at both ends.

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

[0060] Please continue reading Figure 3In one embodiment, the first stent unit 1111 is a wave-shaped structure. In this embodiment, a plurality of first stent units 1111 are arranged in an axial cross array, that is, the wave crest of a first stent unit 1111 and the wave trough of another first stent unit 1111 adjacent thereto are aligned on a straight line parallel to the axis, and the wave crest is connected to the wave trough, so that the first frame 111 has good structural stability, ensuring that the first frame 111 has good radial support and axial support, so that the first frame 111 has good wall adhesion to the luminal anatomical structure. In other embodiments, a plurality of first stent units 1111 may also be arranged in an axially equidistant or unequally spaced array, that is, the wave crest of a first stent unit 1111 and the wave crest of another first stent unit 1111 adjacent thereto are aligned on a straight line parallel to the axis, so that the first frame 111 has good bending performance, so that it can adapt to luminal anatomical structures with larger angles. Alternatively, multiple first stent units 1111 may also be arranged in an axially staggered array, that is, the wave crest of a first stent unit 1111 is aligned with the wave crest of another first stent unit 1111 adjacent thereto on a straight line that is not parallel to the axis, and the wave trough of another first stent unit 1111 is aligned with another straight line that is not parallel to the axis, thereby reducing the bending performance of the first frame 111 while increasing the radial support force and axial support force of the first frame 111. By changing the arrangement of the first stent units 1111, the bending performance, axial support performance and radial support performance of the first frame 111 can be improved, so that the first frame 111 can adapt to different luminal anatomical structures for implantation.

[0061] Please continue reading Figure 3 In one embodiment, among the plurality of first bracket units 1111, a first bracket unit 1111 and another first bracket unit 1111 adjacent thereto are connected by means of a wave crest and a wave trough being mutually hung. In other embodiments, the plurality of first bracket units 1111 are connected by an axially extending assembly rod (not shown), so that the first frame 111 has directionality and is easy to bend on the side opposite to the assembly rod to adapt to the curved anatomical structure of the lumen. Alternatively, the plurality of first bracket units 1111 are connected by a plurality of assembly rods, each assembly rod connecting two adjacent first bracket units 1111, and the plurality of assembly rods form a straight line in the axial direction, which can also make the first frame 111 have directionality and be easy to bend on the side opposite to the assembly rod to adapt to the curved anatomical structure of the lumen. Alternatively, the plurality of first bracket units 1111 are connected by a plurality of assembly rods, each assembly rod connecting two adjacent first bracket units 1111, and the adjacent assembly rods are dislocated in the axial direction, so that the first frame 111 has better flexibility and is easy to reach the target position through the curved anatomical structure of the lumen.

[0062] Please continue reading Figure 3 In one embodiment, the waveform of the first bracket unit 1111 is a sine wave. In other embodiments, the waveform of the first bracket unit 1111 may 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 material, etc. The material selection only needs to satisfy the requirement that the first tubular member 11 can be expanded from a compressed state to an expanded state by balloon expansion or self-expansion, and at the same time have a certain support strength.

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

[0065] Please continue reading Figure 3 In one embodiment, the first coating 112 is arranged along the length direction of the first frame 111, and the length of the first coating 112 exceeds the crest on the distal end and the trough on the proximal end of the first frame 111. The first coating 112 is arranged on the inner and outer sides of the first frame 111, and the connection between the first coating 112 and the first frame 111 is achieved by the following method: the outer first coating 112 and the inner first coating 112 are integrated by heat treatment so as to cover and fix the first frame 111. In other embodiments, the length of the first coating 112 may also be shorter than the length of the first frame 111. In other embodiments, the first coating 112 may also be arranged 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 coating 112 and the first frame 111 may also be fixed by suturing with sutures, wherein the sutures may be made of biocompatible materials, such as PET (polyethylene terephthalate) sutures or PTFE (polytetrafluoroethylene) sutures. In addition, the material of the first coating 111 can be nylon or other materials suitable for making artificial blood vessels, or polyester cloth or PTFE film. It should be noted that the material of the first coating 111 is not limited to the materials mentioned above, and a flexible material that can block blood flow and is suitable for implantation in the human body can be selected, and it can be an absorbable material or a non-absorbable material.

[0066] Please go back Figure 1In one embodiment, the second tubular member 12 is also a stent graft with openings at both ends. The second tubular member 12 includes a second frame 121 and a second graft 122, and the second graft 122 is coated on the second frame 121 to form a second lumen 120 with openings at both ends.

[0067] Among them, the specific implementation of the second frame 121 is the same as the first frame 111, and the specific implementation of the second coating 122 is also the same as the first coating 112, so it is not repeated here. However, the second tubular member 12 is slightly different from the first tubular member 11 in the setting of the overall diameter. In one embodiment, the second tubular member 12 is an overall equal 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 set as a variable diameter structure. Specifically, the outer diameter of the second tubular member 12 in the part that overlaps with the first tubular member 11 matches the inner diameter of the first tubular member 11, and 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 of the implantation site. The outer diameter setting of the second tubular member 12 only needs to meet 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 go back 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, and 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, so as to realize 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 member, for example, the connector 13 is made of polymer wire, so that the connector 13 can rotate around the connection point of the connector 13 and the first frame 111 with the expansion or contraction of the second tubular member 12, thereby 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 may also be connected to the outer wall of the first frame 111, in which case the first coating 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 may be connected to the first frame 111 and the second frame 121 by welding or by suturing with sutures. When the connector 13 is connected to the first frame 111 and the second frame 121 by welding, the coating may be provided on the first frame 111 and the second frame 121 before being connected to the connector 13, or the first frame 111 and the second frame 121 may be connected to the connector 13 before the coating is connected to each of them.

[0070] In other embodiments, the connector 13 may also be connected to the first coating 112 or the second coating 122 to achieve connection with the first tubular member 11 and the second tubular member 12. For example, the first coating 112 or the second coating 122 also covers the end of the connector 13 during the process of covering the first frame 111 and the second frame 121, thereby achieving connection between the connector 13 and the first tubular member 11 and the second tubular member 12. Alternatively, the connector 13 may also be connected to the first frame 111 and the first coating 112 at the same time to achieve connection with the first tubular member 11, and the connector 13 may be connected to the second frame 121 and the second coating 122 at the same time to achieve connection with the second tubular member 12. For example, the connector 13 is fixed to the first frame 111 and the first coating 112 at the same time by suture suturing, and is fixed to the second frame 121 and the second coating 122 at the same time by suture suturing.

[0071] In other embodiments, when the connecting member 13 is a flexible member, one end of the connecting member 13 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 connecting member 13 may also be a rigid member, such as made of a metal wire. It is understood that when the connecting member 13 is a rigid member, both ends of the connecting member 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 positions of the connector 13 and the first tubular member 11 and the second tubular member 12 are not restricted. 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 be able to keep the first tubular member 11 and the second tubular member 12 from detaching, 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 connecting member 13 includes four connecting rods 130 .

[0074] In one embodiment, the connecting rod 130 is a cylindrical rod, and its cross-section is rectangular. In other embodiments, the cross-section of the cylindrical rod can also be circular, fan-shaped, elliptical or other polygonal.

[0075] See also Figure 4 , Figure 4Another implementation of the connecting rod 130 is shown in FIG. 1 . In this embodiment, the connecting rod 130 includes a connecting section 131 and an assembly section 132, wherein the connecting section 131 is the main body of the connecting rod 130, and the assembly section 132 is used to connect 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 cylindrical body, and only one assembly section 132 is provided and is annular. The assembly method of the connecting rod 130 and the first tubular member 11 and the second tubular member 12 can be: the distal end of the connecting rod 130 is welded to the first frame 111 through the connecting section 131, and the proximal end of the connecting rod 130 is connected to the crest or trough of the distal end of the second frame 121 through the assembly section 132. Alternatively, the distal end of the connecting 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 connecting rod 130 is connected to the distal end of the second frame 121 through the connecting section 131.

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

[0077] See also Figure 5 , Figure 5 Another implementation of the connecting rod 130 is shown in FIG. 1 . In this embodiment, the connecting rod 130 still includes a connecting section 131 and an assembly section 132. Figure 4The structure shown is different in that, in this embodiment, the connecting rod 130 is derived from the braided wire on the first frame 111, the connecting section 131 of the connecting rod 130 and the trough of the first bracket unit 1111 on the first frame 111 are an integral body, the connecting section 131 is formed by the two ends of the braided wire being intertwined, and the assembly section 132 is a ring or other irregular ring-shaped structure formed by bending the middle of the braided wire, and the assembly section 132 can be connected to the crest or trough of the second frame 121. Alternatively, the assembly section 132 and the second frame 121 are connected by welding or sewing. It is understood that in other embodiments, the connecting rod 130 can also be derived from the braided wire on the second frame 111, and the assembly section 132 is connected to the first frame 111, welded or sewn, or the connecting rod 130 can be directly woven from the braided wire into a shape with two assembly sections 132, and the two assembly sections 132 are respectively connected to the first frame 111 and the second frame 121. In other embodiments, the connector 13 may also be formed by folding the braided wire into a "U"-shaped structure, a "∽"-shaped structure, or an "O"-shaped structure, and the specific braiding shape may be selected according to actual usage.

[0078] It is understandable that there is no limit to the number of connecting rods 130 and they 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 expansion process of the second tubular member 12 is more likely to be affected by the connecting rods 130.

[0079] Please go back Figure 1 ,exist Figure 1 In the implantable prosthesis system shown, the channel 14 is an annular channel, and the branch stent 2 cooperates with the implantable prosthesis device 1 in 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, the implantable prosthesis system uses an implantable prosthesis device 1 that can maintain smooth blood flow during surgery, so that the branch stent 2 can be implanted under smooth blood flow. Compared with the prior art in which the branch stent 2 is implanted under blood flow obstruction, more ample time can be gained for the implantation of the branch stent 2, thereby further improving the success rate of the operation. On the other hand, since the branch stent 2 is assembled with the implantable prosthesis device 1 through an annular channel, during the implantation operation, it is only necessary to extend the branch stent 2 to different positions in the annular channel according to the direction of the corresponding branch lumen anatomical structure. Compared with 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 in the circumferential direction, so that during the implantation of the branch stent 2, there is no need to adjust the angle of the fully expanded first tubular member 11, thereby reducing the difficulty of the operation and further improving the success rate of the operation.

[0081] It should be noted that there is no limit to the number of branch stents 2, and it can be selected as needed. In addition, when the number of connecting rods 13 in the implantable prosthetic device 1 that cooperates with the branch stent 2 is greater than 2, the connecting rod 13 can also simultaneously play the role of dividing the first lumen 110, so that each radial implantation direction of the implantable prosthetic device 2 can be further subdivided, thereby facilitating the rapid positioning of the branch stent 2 during implantation.

[0082] It should also be noted that in Figure 1 In the implantable prosthetic 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 non-coaxially arranged according to the number and position of the branch stents 2 to be implanted.

[0083] See also Figure 6-7 In one embodiment, the distal end of the second tubular member 12 is at least partially accommodated in the first lumen 110, and the implantable prosthetic device 1 further includes a sealing component 15, the proximal end of the sealing component 15 is connected to the second tubular member 12 ( Figure 6 The second tubular member 12 is received in the delivery sheath 3) and connected, and the distal end extends axially along the first tubular cavity 110 in a direction away from the second tubular member 12 to form a free end beyond the distal end surface of the second tubular member 12. In the radially expanded state, the sealing component 15 is annular, and the sealing component 15 surrounds the longitudinal center axis of the second tubular member 12. The sealing component 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 component 15 is attached 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 component 15 is separated from the first tubular member 11 to unseal the channel 14.

[0084] In the above-mentioned implantable prosthetic device 1, when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the inner wall of the first tubular member 11 fits with the outer wall of the second tubular member 12 (the radially opposite parts of the two fit together), so that the channel 14 is closed, and 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 to additionally seal the channel 14, thereby ensuring that the implantable prosthetic device 1 can have a better anti-internal leakage effect.

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

[0086] In one embodiment, the sealing component 15 is more flexible than the second tubular member 12. Therefore, the sealing component 15 can be more easily adaptively deformed than the second tubular member 12, so that when the branch stent 2 is implanted in the channel 14, the sealing component 15 can be more closely wrapped on the side wall of the branch stent 2, thereby more tightly clamping the branch stent 2, further improving the anti-endoleak effect of the implantable prosthesis system.

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

[0088] Among them, 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 tubular cavity 110 to a side away from the second tubular member 12 to form a free end beyond the distal end surface of the second tubular member 12. The proximal end of the separating membrane 152 is also connected to the second tubular member 12, and the distal end of the separating membrane 152 extends axially along the first tubular cavity 110 to a side away from the second tubular member 12 to form a free end beyond the distal end surface of the second tubular member 12. The separating membrane 152 has an expanded state and a folded state. The separating membrane 152 is annular in the expanded state, and the separating membrane 152 can be attached to the inner wall of the first tubular member 11 when expanded. The driving member 151 is connected to the separating membrane 152, and the driving member 151 is used to drive the separating membrane 152 to expand as the second tubular member 12 expands or to drive the separating membrane 152 to fold as the second tubular member 11 contracts.

[0089] By configuring the sealing assembly 15 to include a driving member 151 and a separation membrane 152, when a branch stent 2 is implanted in the channel 14, since there are no extra stent units on the separation membrane 152 to block it, the separation membrane 152 can be more tightly wrapped on the side wall of the branch stent 2, thereby ensuring a better anti-internal leakage effect. In addition, since there are no extra stent units on the separation membrane 152, it has good flexibility, so the branch stent 2 can be prevented from being squeezed by the first tubular member 11 and the sealing assembly 15, and the shape of the branch stent 2 can be better maintained.

[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 separation membrane 152, and the proximal end of the driving rod 1510 is connected to the second tubular member 12, and the distal end is a free end. The extension direction of the driving rod 1510 satisfies: when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the driving rod 1510 fits the inner wall of the first tubular member 11. For example, in one embodiment, the first tubular member 11 is an equal-diameter cylindrical structure, and the driving rod 1510 is a straight rod, and when the driving rod 1510 and the first tubular member 11 are both in an expanded 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, the first tubular member 11 is a truncated cone structure, and the driving rod 1510 is a straight rod, and when the driving rod 1510 and the first tubular member 11 are both in an extended state, the extension direction of the driving rod 1510 is parallel to the extension direction of the side wall of the first tubular member 11. Alternatively, the first tubular member 11 is a variable diameter cylindrical structure, and the driving 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 the driving rod 1510 and the first tubular member 11 are both in an extended state, the driving 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 driving rod 1510 can be fixed to the second tubular member 12 by welding, suturing, etc., or it can be woven 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 driving rod 1510 is a long rod-shaped structure with a rectangular cross-section. In other embodiments, the cross-section of the driving rod 1510 may be circular, fan-shaped, elliptical or other polygonal shapes, or the driving rod 1510 may be a spiral structure formed by winding a braided wire.

[0093] See also Figure 8-9In one embodiment, the partition membrane 152 is a hollow cylindrical film whose diameter matches the inner diameter of the first tubular member 11, and the proximal end of the partition membrane 152 is connected to the distal end of the second tubular member 12, and the partition membrane 152 is connected to the driving rod 1510 at the position in contact with the driving rod 1510. It is understandable that the partition membrane 152 can be integrally formed with the second coating 122 of the second tubular member 12, or can be sutured to the distal end of the second coating 122 by sutures. The partition membrane 152 can be an integrally formed annular sheet body, or it can be composed of a plurality of arc-shaped sheet bodies spliced ​​together. The material of the partition membrane 152 can be nylon or other materials suitable for making artificial blood vessels, or it can be polyester cloth or PTFE film. It should be noted that the material of the partition membrane 152 is not limited to the materials mentioned above, and the material of the partition membrane 152 can be a flexible material that can block blood flow and is suitable for implantation in the human body. The connection between the partition membrane 152 and the driving rod 1510 can be achieved by suturing, heat treatment coating or bonding.

[0094] It should be noted that, in other embodiments, the sealing component 15 may also be a discontinuous structure, that is, the number of the separation membranes 152 in the sealing component 15 may be two or more, and the plurality of separation membranes 152 are arranged at intervals along the circumference of the second tubular member 12, so that the plurality of separation membranes 152 cooperate to form a discontinuous structure in the unfolded state. At this time, the separation membrane 152 is a sheet-like body with a certain curvature, and the separation membrane 152 can be arranged according to the formation position of the channel 14. That is, the separation membrane 152 and the driving rod 1510 are arranged at the position where the channel 14 needs to be arranged, and the driving rod 1510 and the separation membrane 152 are not arranged at the position where the channel 14 does not need to be arranged. It can be understood that the number of channels 14 can be equal to the number of branch stents 2, or it can be 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 position where the branch stents 2 are not implanted can play a role in maintaining blood flow. It can also be understood that when the sealing component 15 is annular, the sealing effect of the channel 14 is better than when the sealing component 15 is a discontinuous structure.

[0095] In addition, in other embodiments, the sealing component 15 may also be such that, in a natural state, the outer diameter of the sealing component 15 after radial expansion is larger than the inner diameter of the first tubular member 11 after radial expansion. Thus, the sealing component 15 can form an interference fit with the first tubular member 11, thereby clamping the branch stent 2 more tightly and ensuring the installation stability of the branch stent 2.

[0096] It should also be noted that in other embodiments, the driving rod 1510 and the separation membrane 152 may also be connected to the middle or distal end of the second tubular member 12. However, the way in which the driving rod 1510 and the separation membrane 152 are connected 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 partition membrane 152 is annular when unfolded, and the partition membrane 152 is connected to the driving rod 1510 and the connecting member 13 at the same time. On the one hand, the partition membrane 152 can extend the channel 14 to a certain extent at the distal end of the channel 14. On the other hand, since the partition membrane 152 is connected to the connecting member 13, the extension section of the channel 14 formed by the partition membrane 152 actually exists in the form of multiple sub-channels 140 that are not connected to each other, thereby further facilitating the establishment of the implantation path of the branch stent 2. The setting of the sub-channels 140 can maintain the parallelism between the fixed end of the branch stent 2 and the axis of the implantable prosthetic device 1, thereby improving the assembly stability of the branch stent 2.

[0098] In other embodiments, the partition membrane 152 may also be connected only to the driving rod 1510, that is, the partition membrane 152 is not connected to the connecting rod 130. In the retracted state, the connecting rod 130 is in contact with the partition membrane 152, but there is no connection point between the two. In this way, the sealing component 15 can also better play a role in supplementing the seal, and the presence of the sealing component 15 does not interfere with the connecting rod 130, thereby not affecting the opening and closing of the channel 14. It is understandable that when the partition membrane 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 partition membrane 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, and the connection point between the connecting rod 130 and the first tubular member 11 is located beyond the distal end surface of the second tubular member 12, so that the connecting rod 130, the driving rod 1510 and the separation membrane 152 are all 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 separation membrane 152. The radial compression state of the second tubular member 12 is not necessarily achieved by the delivery sheath 3, but can also be achieved by a limiting structure.

[0099] Please continue reading Figure 6-7In one embodiment, the distal end of the connecting member 13 is connected to the inner wall of the first tubular member 11, and the proximal end of the connecting member 13 is connected to the distal end of the second tubular member 12. The connecting member 13 includes four connecting rods 130, which are evenly distributed along the circumference of the first tubular cavity 110, and the connecting rods 130 meet the following conditions: when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the extending direction of the connecting rods 130 is parallel to the axial direction of the first tubular member 11. A driving rod 1510 is arranged between two adjacent connecting rods 130, that is, the driving member 151 includes four driving rods 1510, and the separation membrane 152 is hollow cylindrical when expanded, and the separation membrane 152 is connected to the connecting rods 130 and the driving rods 1510 at the same time.

[0100] Please combine Figure 8-9 Before the branch stent 2 is implanted, the first tubular member 11 is in a radially expanded state, and the second tubular member 12 is in a radially compressed state. At this time, the channel 14 is opened, and the partition membrane 152 is in a folded state under the joint action of the driving rod 1510 and the connecting rod 130. The partition membrane 152 in the folded state extends the channel 14 to a certain extent at the distal end of the channel 14, and the extended section exists in the form of multiple sub-channels 140 that are not connected to each other. 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 toward the side close to the inner wall of the first tubular member 11 as the second tubular member 12 is unfolded, and driven by the connecting rod 130 and the driving rod 1510, the partition membrane 152 will also unfold accordingly 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, and at the position where the branch stent 2 is implanted, the driving rod 1510 is attached to the outer wall of the branch stent 2, and the partition membrane 152 is covered on the branch stent 2 under the joint action of the connecting rod 130 and the driving rod 1510 to wrap the branch stent 2, and at the position where the branch stent 2 is not implanted, the driving rod 1510 drives the partition membrane 152 to adhere to the inner wall of the first tubular member 11, thereby performing a secondary sealing on the channel 14.

[0101] Compared with the second tubular member 12, there are no extra stent units on the separation membrane 152 to hinder it. Therefore, the separation membrane 152 can provide a more fitting covering effect on the branch stent 2, thereby providing a more stringent anti-leakage protection, thereby reducing or avoiding the occurrence of internal leakage after the implantation operation.

[0102] It should be noted that, in this embodiment, the distal ends of the partition membrane 152 and the driving rod 1510 are in the same radial plane as the distal end of the connecting rod 130. The opening of the channel 14 can be achieved in the following steps: the delivery sheath 3 is withdrawn first, 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 portion of the second tubular member 12 that overlaps with the first tubular member 11 is also released synchronously, and the other portion of the second tubular member 12 is still kept in a compressed state in the delivery sheath 3. At this time, the overlapping portion of the second tubular member 12 can be recompressed by moving the delivery sheath 3 forward, so that the channel 14 is opened. In other embodiments, the distal ends of the partition membrane 152 and the driving rod 1510 may not be in 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 actual conditions. The number of connecting rods 130 and the number of driving rods 1510 do not need to correspond. For example, at the position where the branch stent 2 needs to be implanted, the number of driving rods 1510 set between two adjacent connecting rods 130 is 3 or 4. In addition, in other embodiments, the connecting rods 130 can also be arranged only at radial intervals along the first lumen 110 and distributed unevenly. For example, in the direction where the branch stent 2 needs to be implanted, the distribution of the connecting rods 130 is more dense, while in the direction where the branch stent 2 does not need to be implanted, the distribution of the connecting rods 130 is relatively sparse. In addition, in other embodiments, the partition membrane 152 can be a plurality of arc-shaped sheets, and the specific number of the partition membranes 152 can be set according to the formation position of the channel 14. The plurality of partition membranes 152 are arranged at circumferential intervals along the second tubular member 12, and the two sides of each partition membrane 152 are respectively connected to two connecting rods 130 at adjacent positions, and the non-side position of the partition membrane 152 is connected to the driving rod 1510 located between the connecting rods 130.

[0104] Please continue reading Figure 10-11, which is another implementation form of the implantable prosthetic 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 of which includes a connecting rod 130a and a connecting rod 130b. When the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the extension directions of the connecting rod 130a and the connecting rod 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 rod 130a and the connecting rod 130b can converge at an intersection. The connecting rod 130a and the connecting rod 130b are symmetrically divided about an axis parallel to the longitudinal center axis of the second tubular member 12 where the intersection is located. The arrangement is such that when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the connecting distance between the connecting rod 130a and the connecting rod 130b on the first tubular member 11 is greater than the connecting distance between the two on the second tubular member 12, a driving rod 1510 is arranged between the connecting rod 130a and the connecting rod 130b, and no driving rod 1510 is arranged between adjacent rod groups, and the separation membrane 152 is a hollow cylindrical film in the expanded state, and the separation membrane 152 is connected to the connecting rod 130a, the connecting rod 130b and the driving rod 1510 at the same time.

[0105] With such arrangement, before the branch stent 2 is implanted, when the first tubular member 11 is in a radially expanded state and the second tubular member 12 is in a radially compressed state, the channel 14 is opened, and at this time, the partition membrane 152 is in a taut state under the action of the connecting rod 130a, the connecting rod 130b and the driving rod 1510, so that the wrinkles of the partition membrane 15 can be prevented from blocking the sub-channel 140, further reducing the difficulty of establishing the implantation path of the branch stent 2. In addition, since the connecting line distance between the connecting rod 130a and the connecting rod 130b on the first tubular member 11 is greater than the connecting line distance between the two on the second tubular member 12, the sub-channel 140 formed by them will form a conical pocket shape with a large distal opening and a small proximal opening, wherein the distal opening of the sub-channel 140 is wider, which can facilitate the branch stent 2 to be sent into the sub-channel 140 from the distal end, and the proximal opening of the sub-channel 140 is narrower, so that the partition membrane 152 can be more closely attached to the side wall of the branch stent 2, thereby improving the anti-internal leakage effect.

[0106] In other embodiments, the connecting rods 130a and 130b may not be symmetrically distributed about an axis parallel to the longitudinal center axis of the second stent graft 1201 at the intersection where the extension lines of the proximal ends of the connecting rods 130a and 130b converge. In other embodiments, there may be multiple separation membranes 152, and the separation membranes 152 may be only provided in each rod group, but not provided between adjacent rod groups.

[0107] Please continue reading Fig.11 In one embodiment, the connecting rod 130a in one rod group is connected to the distal end of the connecting rod 130b in the adjacent rod group. In other embodiments, the proximal ends of the connecting rods 130a and 130b in the same rod group can also be connected, so that each rod group cooperates to form an annular wave structure, wherein the connecting rods 130a and 130b in each rod group are connected to form the trough of the annular wave structure, and the connecting rods 130a and 130b in the adjacent rod groups are connected to form the peak of the annular wave structure. When the connecting member 13 forms an annular wave structure, it can be connected to the first tubular member 11 and the second tubular member 12 by hanging with the first tubular member 11 and the second tubular member 12.

[0108] See also Figure 12-13 , which is another embodiment of the implantable prosthetic device 1, and Fig.10 Compared with the embodiment shown in FIG. 1 , the driving rod 1510 of this embodiment is slightly different. The driving rod 1510 includes a connecting portion 15101 and a resisting portion 15102, wherein one end of the connecting portion 15101 away from the resisting portion 15102 is connected to the second tubular member 12, and one end of the resisting portion 15102 away from the connecting portion 15101 is a free end, and the projection area of ​​the free end of the resisting portion 15102 on the separation membrane 152 is larger than the projection area of ​​the connecting section of the connecting portion 15101 and the second tubular member 12 on the separation membrane 152. The resisting portion 15102 is used to increase the contact area between the distal end of the driving rod 1510 and the separation membrane 152.

[0109] Specifically, in one embodiment, the supporting portion 15102 is annular or circular, two supporting portions 15102 are provided, and the two supporting portions 15102 are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second tubular member 12 where the connecting end of the connecting portion 15101 and the second tubular member 12 is located, and the connecting portion 15101 is in a "Y" shape to simultaneously connect the two supporting portions 15102, and the diameter of the supporting portion 15102 is greater than the width of the distal end of the connecting portion 15101.

[0110] By providing the abutment portion 15102, the abutment area between the driving rod 1510 and the separation membrane 152 is increased. On the one hand, the driving rod 1510 can better drive the separation membrane 152 to contract so as to smoothly open the channel 14. On the other hand, after the branch stent 2 is implanted, the separation membrane 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 Fig.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, one of the two adjacent driving rods 1510, a most lateral abutting portion 15102 of one driving rod 1510 abuts against another most lateral abutting portion 15102 of the other driving rod 1510 adjacent to the abutting portion 15102, thereby cooperating to clamp the separation membrane 152. In this arrangement, the separation membrane 152 can be pulled and tightened under the action of the driving rod 1510, thereby eliminating the gaps between the sub-channels 1401, thereby making it easier to establish the implantation path of the branch stent 2.

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

[0113] It should be noted that, in one embodiment, the implantable prosthetic device 1 may also include a leaflet structure (not shown), which is connected to the second tubular member 12, and the leaflet structure includes three leaflets that can be closed and opened. After the implantable prosthetic device 1 is implanted in the body, the three leaflets close and open as the heart relaxes and contracts, thereby closing or opening the second lumen 120. The material of the leaflets may be a biomaterial or a polymer material. When a patient with aortic dissection also has aortic valvular disease and needs to replace the natural aortic valve, the implantable prosthetic device 1 can be used to simultaneously treat aortic dissection and replace the natural aortic valve. It is understandable that in other embodiments, the number of leaflets is not limited to three, for example, it may be two or four. In addition, when the implantable prosthetic device 1 is applied to other parts such as the renal artery where the natural valve does not need to be replaced, the leaflet structure may be omitted.

[0114] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described 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 disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. An implantable prosthetic device, characterized in that: include: 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 accommodated in the first tubular cavity 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 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 tubular cavity; when the first tubular member and the second tubular member are both in a radially expanded state, the channel is in a closed state.

2. The implantable prosthetic device according to claim 1, characterized in that: The channel is an annular channel; or, there are multiple channels, and the multiple channels are arranged at intervals along the circumference of the second tubular member; or, there is one channel, and the channel is a non-annular channel.

3. The implantable prosthetic device according to claim 1, characterized in that: The implantable prosthesis further comprises a connecting member, 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 prosthetic device according to claim 3, characterized in that: The connecting member is a flexible member or a rigid member. When the connecting member is a flexible member, one end of the connecting member is hinged or fixedly connected to the first tubular member, and the other end of the connecting member is hinged or fixedly connected to the second tubular member; when the connecting member is a rigid member, both ends of the connecting member are respectively hinged to the first tubular member and the second tubular member.

5. The implantable prosthetic device according to claim 3, characterized in that: The connecting piece 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, and one 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 ring-shaped 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 prosthetic device according to any one of claims 3 to 5, characterized in that: The distal end of the second tubular member is at least partially accommodated in the first tubular cavity. The implantable prosthetic device also includes a sealing assembly, the proximal end of the sealing assembly is connected to the second tubular member, and the distal end extends axially away from the second tubular member to form a free end that exceeds the distal end surface of the second tubular member. In a radially expanded state, the sealing assembly is an annular or discontinuous structure, and the sealing assembly surrounds the longitudinal center axis of the first tubular member or the second tubular member.

7. The implantable prosthetic device according to claim 6, characterized in that: The flexibility of the sealing component is greater than the flexibility of the second tubular member; or, in a natural state, the outer diameter of the sealing component after radial expansion is greater than the inner diameter of the first tubular member after radial expansion.

8. The implantable prosthetic device according to claim 6, characterized in that: The sealing assembly includes a driving member and a separation membrane, the proximal ends of the driving member and the separation membrane are both connected to the second tubular member, and the distal ends of the driving member and the separation membrane are both free ends that extend beyond the distal end surface of the second tubular member, the separation membrane has an expanded state and a folded state, the separation membrane is annular in the expanded state, or the separation membrane is multiple, the multiple separation membranes are arranged at intervals along the circumference of the second tubular member, the multiple separation membranes form a non-continuous structure in the expanded state, the separation membrane can be fitted with the inner wall of the first tubular member when expanded, the driving member is connected to the separation membrane, and the driving member is used to drive the separation membrane to expand as the second tubular member expands or to drive the separation membrane to fold as the second tubular member contracts.

9. The implantable prosthetic device according to claim 8, characterized in that: The driving member includes a driving rod, and an extending direction of the driving rod satisfies that when the first tubular member and the second tubular member are both in a radially expanded state, the driving rod is in contact with an inner wall of the first tubular member.

10. The implantable prosthetic device according to claim 9, characterized in that: The connecting member includes a plurality of connecting rods, and the plurality of connecting rods are distributed at intervals along the circumference of the first tubular cavity. When the first tubular member and the second tubular member are both in a radially expanded state, the extension direction of the connecting rod is parallel to the axial direction of the first tubular member. At least one driving rod is arranged between two adjacent connecting rods. When the partition membrane is annular in the expanded state, the partition membrane is simultaneously connected to the connecting rod and the driving rod along the circumferential direction. When there are multiple partition membranes, the two side edges of the partition membrane are respectively connected to the two adjacent connecting rods, and the non-side position of the partition membrane is connected to the driving rod.

11. The implantable prosthetic device according to claim 9, characterized in that: The connecting member includes a plurality of rod groups, each of which includes two connecting rods. When the first tubular member and the second tubular member are in a radially expanded state, the extension direction of the two connecting rods forms 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 an intersection. At least one driving rod is arranged between the two connecting rods. When the separation membrane is annular in the expanded state, the separation membrane is circumferentially connected to the connecting rod and the driving rod at the same time; when there are multiple separation membranes, the two side edges of the separation membrane are respectively connected to the two connecting rods in each of the rod groups, and the non-side position of the separation membrane is connected to the driving rod.

12. The implantable prosthetic device according to claim 11, characterized in that: The connecting rods are connected in pairs to form an annular waveform structure, the two connecting rods in the connecting group are connected to form a trough of the annular waveform structure, and the connecting rods in adjacent connecting groups are connected to form a peak of the annular waveform structure.

13. The implantable prosthetic device according to any one of claims 9 to 12, characterized in that: The driving rod includes a connecting portion and at least one abutting portion connected to the connecting portion, an end of the connecting portion away from the abutting portion is connected to the second tubular member, an end of the abutting portion away from the connecting portion is a free end, and a projection area of ​​the abutting portion on the separation membrane is larger than a projection area of ​​an end of the connecting portion connected to the second tubular member on the separation membrane.

14. The implantable prosthetic device according to claim 13, wherein: The number of the abutting portions is two, and the two abutting portions are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second tubular member where the connecting end of the connecting portion and the second tubular member is located.

15. The implantable prosthetic device according to claim 13, wherein: There are at least two abutting portions, and when the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, among two adjacent driving rods, one lateral abutting portion of one driving rod and another lateral abutting portion of the other driving rod adjacent to the lateral abutting portion abut against each other to clamp the separation membrane.

16. The implantable prosthetic device according to claim 1, wherein: The implantable prosthetic device further comprises a valve leaflet structure, which is disposed in the second tubular member and 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 bracket; And, in the implantable prosthetic device as described 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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