Implantable medical device and implantable medical system

Abstract

The present application relates to an implantable medical device and an implantable medical system, and relates to the technical field of medical instruments. The implantable medical device comprises: a first tubular member; a second tubular member connected to the first tubular member through a point connection mode at the distal end of the first tubular member; and 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 be at least partially accommodated in the first lumen, the part of the sealing assembly accommodated in the first lumen is annular structure, and has a free end, the annular structure surrounds the longitudinal center axis of the first tubular member, and the sealing assembly can be expanded or contracted synchronously with the second tubular member, so that the outer wall of the part of the sealing assembly accommodated in the first lumen cooperates with the inner wall of the first tubular member to form an openable or closable channel. The implantable medical device of the present application can keep the blood flow unobstructed during the operation, and prevent the adverse effects on the health of the patient caused by the blood flow obstruction.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to an implantable medical device and an implantable medical system. BACKGROUND

[0002] This part provides only background information related to the present disclosure, which does not necessarily have to be prior art.

[0003] Aortic dissection, also known as aortic dissection aneurysm, is caused by various reasons, such as tearing of the aortic intima, blood flowing into the aortic wall, and the aortic wall being layered and separated, and forming a hematoma. Aortic dissection is a serious vascular disease that seriously endangers human health and has a high mortality rate.

[0004] Currently, the treatment of aortic dissection mainly has surgical treatment and minimally invasive treatment. Among them, surgical treatment is achieved by thoracotomy and laparotomy, resection of the intimal tear, and artificial blood vessel reconstruction of the blood flow channel, while minimally invasive intervention 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 intervention treatment has the advantages of small trauma, fast recovery, and fewer complications, and is more and more applied to routine treatment.

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

[0006] Generally, the implantation surgery is performed in the following manner: first, the main stent is delivered to the corresponding site, then the main stent is partially released, then the branch stent is delivered to the corresponding site, then the branch stent is released, the branch stent is cooperated with the main stent, and finally the main stent is completely released to complete the surgery. This results in that, during the release of the branch stent, the main stent is located in the blood vessel and is in a semi-released state and is not completely opened, so it will block the blood flow to some extent. When the time for releasing the branch stent is too long, the blood flow blocking time will also be relatively long, which will adversely affect the health of the patient and even seriously endanger life.

[0007] Therefore, it is important to keep the blood flow unobstructed during the operation. SUMMARY

[0008] Based on this, it is necessary to provide an implantable medical device capable of keeping the blood flow unobstructed during the operation.

[0009] Further, an implantable medical system capable of keeping the blood flow unobstructed during the operation is also provided.

[0010] An implantable medical device comprises: a first tubular member having a first lumen; a second tubular member having a second lumen, a distal end of the second tubular member being connected to a proximal end of the first tubular member in a point connection manner; and a sealing assembly, a proximal end of the sealing assembly being connected to the second tubular member, and a distal end of the sealing assembly extending axially away from the second tubular member to be at least partially accommodated in the first lumen, the part of the sealing assembly accommodated in the first lumen being in a ring structure and having a free end, the ring structure surrounding a longitudinal center axis of the first tubular member, the sealing assembly being synchronously expandable or contractible with the second tubular member, so that an outer wall of the part of the sealing assembly accommodated in the first lumen cooperates with an inner wall of the first tubular member to form an openable or closable passage, the passage being in an open state and being communicated with the first lumen when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, and the passage being in a closed state when the first tubular member and the second tubular member are both in a radially expanded state.

[0011] In one embodiment, the passage is a ring-shaped passage; or, the passage is a plurality of passages, the plurality of passages being arranged along a circumferential direction of the second tubular member; or, the passage is one, and the passage is a non-ring-shaped passage.

[0012] In one embodiment, the first tubular member comprises a first covered stent and a cover film, a distal end of the cover film being connected to a proximal end of the first covered stent, a proximal end of the cover film extending to the side where the second tubular member is located and forming a free end, and the passage being formed by cooperation of an inner wall of the cover film and an outer wall of the sealing assembly.

[0013] In one embodiment, the second tubular member comprises a second covered stent, a distal end of the second covered stent being abutted to a proximal end of the first tubular member; or, the second tubular member comprises a second covered stent and a connecting member, a distal end of the second covered stent being abutted to or spaced apart from a proximal end of the first tubular member, and a distal end of the connecting member being connected to the first tubular member, and a proximal end of the connecting member being connected to the second covered stent.

[0014] In one embodiment, the sealing assembly comprises: a partition membrane, a proximal end of which is connected to the second stent-graft, and a distal end of which extends axially to the side of the first tubular member to be at least partially accommodated in the first lumen, and a portion of the partition membrane accommodated in the first lumen has a free end, the partition membrane has an unfolded and folded state, and an outer wall of the portion of the partition membrane accommodated in the first lumen cooperates with an inner wall of the first tubular member to form the channel; and a driving member, a proximal end of which is connected to the second stent-graft, and a distal end of which extends axially to the side of the first tubular member to be at least partially accommodated in the first lumen, and a portion of the driving member accommodated in the first lumen has a free end, the driving member is connected to the partition membrane, and the driving member is used to drive the partition membrane to unfold with expansion of the second tubular member or to fold with contraction of the second tubular member.

[0015] In one embodiment, the driving member comprises a driving rod, and an extension direction of the driving rod satisfies: when the first tubular member and the second tubular member are both in a radial unfolded state, the portion of the driving rod accommodated in the first tubular member is fitted to the inner wall of the first tubular member.

[0016] In one embodiment, the connecting member comprises a plurality of connecting rods, the connecting rods are distributed along a circumference of the first lumen, and when the first tubular member and the second tubular member are both in a radial unfolded state, the extension direction of the connecting rods is parallel to the axial direction of the first tubular member, at least one driving rod is arranged between adjacent two connecting rods, and the partition membrane is connected to the connecting rods and the driving rods simultaneously along the circumference.

[0017] In one embodiment, the connecting member comprises a plurality of rod groups, each of the rod groups comprises two connecting rods, when the first tubular member and the second tubular member are both in a radial unfolded state, the extension directions of the two connecting rods form a non-zero included angle with the axial direction of the first tubular member, and the extensions of the proximal ends of the two connecting rods can converge at a same intersection point, at least one driving rod is arranged between the two connecting rods, and the partition membrane is connected to the connecting rods and the driving rods simultaneously along the circumference.

[0018] In one embodiment, the connecting rods are connected to each other to form a ring-shaped wave structure, the two connecting rods in the rod group are connected to form a wave trough of the ring-shaped wave structure, and the connecting rods in adjacent rod groups are connected to form a wave crest of the ring-shaped wave structure.

[0019] In one embodiment, the driving rod comprises a connecting portion and at least one abutting portion connected to the connecting portion, the connecting portion is connected to the second tubular member at its end away from the abutting portion, the abutting portion is free at its end away from the connecting portion, and the projection area of the abutting portion on the separation membrane is larger than the projection area of the connecting portion on the separation membrane.

[0020] In one embodiment, the abutting portion is provided in two, and the two abutting portions are arranged in axial symmetry, with the symmetry axis being a straight line parallel to the longitudinal central axis of the second tubular member and passing through the connecting end of the connecting portion.

[0021] In one embodiment, the abutting portion is provided in at least two, and when the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, in the adjacent two driving rods, one of the most side abutting portions in one driving rod and another of the most side abutting portions adjacent to the most side abutting portion in the other driving rod abut to clamp the separation membrane.

[0022] In one embodiment, the connecting member comprises a connecting segment and an assembling segment connected to the connecting segment, the assembling segment is connected to one of the first tubular member and the second tubular member, and the connecting segment is connected to the other of the first tubular member and the second tubular member at its end away from the assembling segment; the connecting segment is a cylindrical rod or a woven wire, and the assembling segment is a ring structure, a T-shaped rod or a straight rod with its extension direction perpendicular to the extension direction of the connecting segment.

[0023] In one embodiment, the implantable medical device further comprises a leaflet structure arranged in the second tubular member, and the leaflet structure is openable or closable to make the second lumen of the second tubular member in an open or closed state.

[0024] An implantable medical system, comprising: a branch stent; and an implantable medical device as described in any one of all the above embodiments, one end of the branch stent can extend into the channel and be clamped by the first tubular member and the sealing assembly.

[0025] The implantable medical device provided by the embodiment of the present application forms a channel with the first tubular member through the sealing assembly. In the implantation operation, the first tubular member can be released without releasing the second tubular member. At this time, the first tubular member is in a radial expansion state and the second tubular member is in a radial compression state. The second tubular member drives the sealing assembly to be in a radial compression state as well, and the channel is opened. Since the channel is connected with the first lumen, blood flow can flow out along the first lumen through the channel, or blood flow can flow out along the channel through the first lumen. Therefore, the blood flow can be kept unobstructed during the operation, and the adverse effects on the health of the patient caused by the obstruction of the blood flow can be prevented.

[0026] The implantable medical system provided by the embodiment of the present application can cooperate with the implantable medical device and the branch stent, so that the branch stent can be implanted under the condition of unobstructed blood flow. Compared with the implantation of the branch stent in the prior art under the condition of obstructed blood flow, more sufficient time can be obtained for the implantation of the branch stent, so that the success rate of the operation is further improved. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0028] Among them:

[0029] Figure 1 It is a structural schematic diagram of the implantable medical system of an embodiment of the present application;

[0030] Figure 2 It is an assembly schematic diagram of the implantable medical device and the delivery sheath of an embodiment of the present application;

[0031] Figure 3 It is an internal structure schematic diagram of the implantable medical device of an embodiment of the present application;

[0032] Figure 4 It is Figure 2 It is an assembly schematic diagram of the partial structure of the implantable medical device and the delivery sheath shown;

[0033] Figure 5 It is a structural schematic diagram of the connecting rod of an embodiment of the present application;

[0034] Figure 6 It is a structural schematic diagram of the connecting rod of another embodiment of the present application;

[0035] Figure 7 It is Figure 2A top view of the implantable medical device in a passageway open state;

[0036] Figure 8 A cross-sectional view of the implantable medical device in a passageway closed state; Figure 2 A cross-sectional view of the implantable medical device in a passageway closed state;

[0037] Figure 9 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0038] Figure 10 A cross-sectional view of the implantable medical system in a passageway closed state for another embodiment of the present application;

[0039] Figure 11 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0040] Figure 12 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application; Figure 11 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0041] Figure 13 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0042] Figure 14 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application; Figure 13 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0043] Figure 15 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application; Figure 13 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0044] Figure 16 An assembly view of the implantable medical device and the delivery sheath for another embodiment of the present application;

[0045] Figure 17 A top view of the implantable medical device in a passageway open state. DETAILED DESCRIPTION

[0046] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0047] In the description of the embodiments of the present application, it should be noted that the orientation or positional relationship indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the embodiments of the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the embodiments of the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0048] In the description of the embodiments of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connection" should be understood broadly, for example, it can be fixed connection, or replaceable connection, or integral connection, it can be mechanical connection, or electrical connection, it can be direct connection, or indirect connection through intermediate medium, it can be internal communication of two elements. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0049] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to the operator is generally referred to as the "proximal end", and the end farther from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined according to this principle. "Axial" generally refers to the length direction of the medical device when it is being delivered, "radial" generally refers to the direction of the medical device that is not parallel to its "axial" direction, and the "axial" and "radial" directions of any component of the medical device are defined according to this principle. "Circumferential" refers to the circumferential direction, i.e. the direction around the axis of the lumen structure, the cylinder.

[0050] Referring to Figure 1 The present application provides an implantable medical system, which comprises an implantable medical device 1 and a branch stent 2. The implantable medical device 1 is used to be implanted in a main body lumen anatomical structure, such as an aorta, and the branch stent 2 is used in cooperation with the implantable medical device 1, and the branch stent 2 is used to be implanted in a branch lumen anatomical structure, such as a coronary branch blood vessel.

[0051] It can be understood that the application site of the implantable medical system is not limited to the aorta, and can also be applied to other sites with branch blood vessels, for example, to the renal artery.

[0052] Referring to Figures 1-2 The implantable medical device 1 comprises a first tubular member 11, a second tubular member 12 and a sealing assembly 14.

[0053] The first tubular member 11 has a first lumen 110. The second tubular member 12 has a second lumen 120, and the distal end of the second tubular member 12 is connected to the proximal end of the first tubular member 11 by a point connection, i.e., the connection point (connection site) between the first tubular member 11 and the second tubular member 12 is a plurality of discrete points (sites) and is not completely closed in the circumferential direction. The sealing assembly 14 is connected to the second tubular member 12 at the proximal end and extends axially away from the second tubular member 12 at the distal end to be at least partially accommodated in the first lumen 110. The portion of the sealing assembly 14 accommodated in the first lumen 110 is a ring structure having a free end, and the ring structure surrounds the longitudinal center axis of the first tubular member 11. The sealing assembly 14 can be expanded or contracted synchronously with the second tubular member 12, so that the outer wall of the portion of the sealing assembly 14 accommodated in the first lumen 110 cooperates with the inner wall of the first tubular member 11 to form an openable or closable passage 15 (as shown in Figure 3 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 outer wall of the sealing assembly 14 is spaced apart from the inner wall of the first tubular member 11, so that the passage 15 is in an open state and communicates with the first lumen 110. When the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the outer wall of the sealing assembly 14 is in contact with the inner wall of the first tubular member 11, so that the passage 15 is in a closed state.

[0054] The implantable medical device 1 thus arranged can be used in the following manner during an implantation operation. First, the first tubular member 11 is released, and the second tubular member 12 is kept in a radially compressed state (for example, as shown in Figure 2 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 restrained by the delivery sheath 3 in a radially compressed state, or the second tubular member 12 is pushed out of the delivery sheath 3 but is restrained in a radially compressed state by a restraining structure (not shown), for example, by a tether), at this time, the sealing assembly 14 is also in a radially compressed state under the action of the second tubular member 12, and therefore the passage 15 is in an open state and communicates with the first lumen 110, so that blood flow can flow out along the first lumen 110 through the passage 15, or blood flow can flow out along the passage 15 through the first lumen 110, thereby keeping the blood flow unobstructed during the implantation operation and preventing adverse effects on the health of the patient caused by blood flow obstruction.

[0055] It should be noted that the sealing assembly 14 can be connected to the first tubular member 11 or not. In one embodiment, the channel 15 can be an annular channel, so that the blood flow is smoother and the effect is better. In other embodiments, the channel 15 can be multiple, and the multiple channels 15 are arranged along the circumference of the second tubular member 12 at intervals, or the channel 15 is one, and the channel 15 is a non-annular channel.

[0056] Please continue to refer to Figure 2 In one embodiment, the first tubular member 11 is a first covered stent 1101 with two open ends, and the first tubular member 11 includes a first frame 111 and a first covering 112, and the first covering 112 is wrapped on the first frame 111 to form a first lumen 110 with two open ends.

[0057] Specifically, the first frame 111 includes a plurality of first stent units 1111 arranged in the axial direction.

[0058] Please continue to refer to Figure 2 In one embodiment, the first stent unit 1111 is a wave structure. In this embodiment, a plurality of first stent units 1111 are arranged in an axial cross array, that is, the wave crest of one 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 and the wave trough are connected, so that the first frame 111 has better structural stability, ensures that the first frame 111 has better radial support force and axial support force, so that the first frame 111 has better wall adhesion with the lumen anatomical structure. In other embodiments, a plurality of first stent units 1111 can also be arranged in an axial equidistant interval array, that is, the wave crest of one 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 better bending performance, so that it can adapt to lumen anatomical structures with larger angles; or, a plurality of first stent units 1111 can also be arranged in an axial staggered interval array, that is, the wave crest of one first stent unit 1111 and the wave crest of another first stent unit 1111 adjacent thereto are aligned on a straight line not parallel to the axis, and the wave trough of another first stent unit 1111 is aligned on another straight line not parallel to the axis, thereby reducing the bending performance of the first frame 111 while increasing the radial support force and the axial support force of the first frame 111. By changing the arrangement of the first stent unit 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 lumen anatomical structures for implantation.

[0059] Please continue to refer to Figure 2In one embodiment, among the plurality of first stent units 1111, one first stent unit 1111 and another first stent unit 1111 adjacent to it are connected by a wave crest and a wave trough in a manner of interlocking. In other embodiments, the plurality of first stent units 1111 are connected by an axially extending assembly rod (not shown in the figure), so that the first frame 111 has directionality and is easy to bend on the opposite side of the assembly rod to adapt to the curved lumen anatomical structure. Alternatively, the plurality of first stent units 1111 are connected by a plurality of assembly rods, each of which connects two adjacent first stent units 1111, and the plurality of assembly rods form a straight line in the axial direction, which also makes the first frame 111 have directionality and be easy to bend on the opposite side of the assembly rod to adapt to the curved lumen anatomical structure. Alternatively, the plurality of first stent units 1111 are connected by a plurality of assembly rods, each of which connects two adjacent first stent units 1111, and adjacent assembly rods are axially staggered, so that the first frame 111 has better flexibility and is easy to pass through the curved lumen anatomical structure to reach the target position.

[0060] Please continue to refer to Figure 2 In one embodiment, the waveform of the first stent unit 1111 is a sine wave, and in other embodiments, the waveform of the first stent unit 1111 can also be a Z-shaped wave, and the specific waveform shape is not limited and can be selected according to the required use performance of the first frame 111.

[0061] In one embodiment, the first frame 111 is formed of nickel-titanium alloy. In other embodiments, the material of the first frame 111 can also be selected from stainless steel, cobalt-chromium alloy or high polymer material, etc., and the selection of the material only needs to meet the requirement that the first tubular member 11 can be expanded from the compressed state to the expanded state by balloon expansion or self-expansion, while having a certain supporting strength.

[0062] In one embodiment, the first frame 111 can be prepared by weaving and setting the shape of the filament material, for example, the first frame 111 is formed by weaving and setting the shape of the nickel-titanium alloy wire. In addition, in other embodiments, the first frame 111 can also be formed by laser cutting and setting the shape of the tubular material or formed by injection molding, or can also be formed by 3D printing.

[0063] Please continue to refer to Figure 2In an embodiment, the first covering film 112 is arranged along the length direction of the first frame 111, the length of the first covering film 112 exceeds the wave crest on the distal end and the wave trough on the proximal end of the first frame 111, the inner side and the outer side of the first frame 111 are both provided with the first covering film 112, and the connection between the first covering film 112 and the first frame 111 is realized by the following way: the first covering film 112 on the outer side and the first covering film 112 on the inner side are fused into one by heat treatment so as to cover and fix the first frame 111. In other embodiments, the length of the first covering film 112 can also be shorter than the length of the first frame 111. In other embodiments, the first covering film 112 can 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 covering film 112 and the first frame 111 can also be fixed by the way of suturing with sutures, wherein the sutures can be made of biocompatible materials, such as PET (polyethylene terephthalate) sutures or PTFE (polytetrafluoroethylene) sutures, etc. In addition, the material of the first covering film 111 can be nylon or other materials suitable for manufacturing artificial blood vessels, and can also be polyester cloth or PTFE film. The material of the first covering film 111 is not limited to the above-mentioned materials, and a flexible material which can block blood flow and is suitable for implantation into the human body can be selected, which can be absorbable material or non-absorbable material.

[0064] Please go back to Figures 1-2 In an embodiment, the second tubular member 12 comprises a second covering stent 1201 and a connecting member 13. The distal end of the second covering stent 1201 abuts or is separated from the proximal end of the first covering stent 1101 by a predetermined distance, the distal end of the connecting member 13 is connected with the first covering stent 1101, the proximal end of the connecting member 13 is connected with the second covering stent 1201, and the connecting member 13 is used to maintain the connection between the first covering stent 1101 and the second covering stent 1201.

[0065] The second covering stent 1201 comprises a second frame 121 and a second covering film 122, and the second covering film 122 covers the second frame 121 to form a second lumen 120 with two open ends.

[0066] The specific implementation mode of the second frame 121 is the same as that of the first frame 111, and the specific implementation mode of the second covering film 122 is the same as that of the first covering film 112, which will not be described here. It should be noted that the first covering stent 1101 and the second covering stent 1201 can be integral isodiametric structures or variable-diameter structures, and the outer diameter of the distal end of the second covering stent 1201 can be equal to or smaller than the outer diameter of the proximal end of the first covering stent 1101.

[0067] It should be noted that the proximal end of the first stent-graft 1101 and the distal end of the second stent-graft 1201 are limited to the state of abutting or being separated by a predetermined distance through the connecting member 13, that is, the first stent-graft 1101 and the second stent-graft 1201 do not overlap in the axial direction, so that the first stent-graft 1101 can be conveniently pushed out of the delivery sheath 3, while the second stent-graft 1201 has not been released from the delivery sheath 3 and is still in a radially compressed state constrained by the delivery sheath 3, so that the opening of the passage 15 is more smooth, and the blood flow can be quickly unblocked and the operation time can be shortened. In addition, the connecting member 13 indirectly connects the first stent-graft 1101 and the second stent-graft 1201, so that the passage 15 can be opened to a greater extent, thereby better ensuring the unblocking of the blood flow.

[0068] In other embodiments, the second tubular frame 1201 can also only include the second stent-graft 1201, at this time, the proximal end of the second stent-graft 1201 abuts the distal end of the first stent-graft 1101, and the second stent-graft 1201 and the first stent-graft 1101 can be connected by suture stitching.

[0069] Please refer to Figures 2-3 In an embodiment, the distal end of the connecting member 13 is fixedly connected with the inner wall of the first frame 111, the proximal end of the connecting member 13 is fixedly connected with the distal end of the second frame 122, and the proximal end of the connecting member 13 can be connected with the inner wall, the outer wall or the distal end face of the second frame 121, so as to realize the connection of the connecting member 13 with the first stent-graft 1101 and the second stent-graft 1201. In addition, in this embodiment, the connecting member 13 is a flexible member, for example, the connecting member 13 is made of a high molecular silk thread, so that the connecting member 13 can rotate around the connection point of the connecting member 13 and the first frame 111 with the expansion or contraction of the second stent-graft 1201, thereby maintaining the connection of the first tubular member 11 and the second tubular member 12 and not hindering the expansion or contraction of the second tubular member 12.

[0070] It should be noted that in other embodiments, the distal end of the connecting member 13 can also be connected with the outer wall of the first frame 111, and at this time, the first film 112 on the outer wall of the first frame 111 covers the connecting point of the connecting member 13 and the first frame 111. The connecting member 13, the first frame 111 and the second frame 121 can be connected by welding or by sewing with a suture. When the connecting member 13, the first frame 111 and the second frame 121 are connected by welding, the film can be first arranged on the first frame 111 and the second frame 121 before being connected with the connecting member 13, or the first frame 111 and the second frame 121 can be first connected with the connecting member 13 before being connected with the film respectively. In other embodiments, the connecting member 13 can be connected with the first film 112 or the second film 122 to realize the connection with the first film stent 1101 and the second film stent 1201. For example, during the process of covering the first frame 111 and the second frame 121, the first film 112 or the second film 122 also covers the end of the connecting member 13, thereby realizing the connection of the connecting member 13 with the first film stent 1101 and the second film stent 1201. Alternatively, the connecting member 13 can be connected with the first frame 111 and the first film 112 at the same time to realize the connection with the first film stent 1101, and the connecting member 13 can be connected with the second frame 121 and the second film 122 at the same time to realize the connection with the second film stent 1201. For example, the connecting member 13 is fixed on the first frame 111 and the first film 112 at the same time by sewing with a suture, and is fixed on the second frame 121 and the second film 122 at the same time by sewing with a suture.

[0071] In other embodiments, when the connecting member 13 is a flexible member, one end thereof can be fixedly connected with the first tubular member 11 or the second film stent 1201, and the other end thereof can be hingedly connected, or both ends thereof can be hingedly connected. In another embodiment, the connecting member 13 can be a rigid member, for example, made of a metal wire. It can be understood that when the connecting member 13 is a rigid member, the two ends of the connecting member 13 need to be hingedly connected with the first tubular member 11 and the second film stent 1201 respectively.

[0072] In other embodiments, the positions of the connecting points of the connecting member 13 with the first tubular member 11 and the second film stent 1201 are not limited, for example, one end of the connecting member 13 is connected with the proximal end of the first tubular member 11, and the other end thereof is connected with the distal end of the second film stent 1201. In addition, the connecting member 13 can be connected with the inner wall, the outer wall or the proximal end face of the first tubular member 11, and the connecting member 13 can be connected with the inner wall, the outer wall or the distal end face of the second film stent 1201. That is, the connection mode between the connecting member 13, the first tubular member 11 and the second tubular member 12 only needs to meet the requirement that the first tubular member 11 and the second tubular member 12 can be kept from being separated, and the connecting member 13 itself does not affect the opening or closing of the passage 15.

[0073] Please continue to refer to Figures 3-4 In an embodiment, the connecting member 13 comprises four connecting rods 130.

[0074] In an embodiment, the connecting rod 130 is a cylindrical rod, and the cross-sectional shape thereof is rectangular. In other embodiments, the cross-sectional shape of the cylindrical rod can also be circular, sector, oval, or other polygonal shape.

[0075] Please refer to Figure 5 , Figure 5 For another implementation of the connecting rod 130, in this embodiment, the connecting rod 130 comprises a connecting segment 131 and an assembling segment 132, wherein the connecting segment 131 is the main body part of the connecting member 13, and the assembling segment 132 is used to connect the connecting segment 131 with the first tubular member 11 or the second covered stent 1201. In this embodiment, the connecting segment 131 is a long strip-shaped cylinder, and the assembling segment 132 is only provided with one and is in the form of a circular ring, so that the assembling mode of the connecting rod 130 with the first tubular member 11 and the second covered stent 1201 can be that the distal end of the connecting rod 130 is connected with the welding of the first frame 111 through the connecting segment 131, and the proximal end of the connecting rod 130 is connected with the wave crest or wave trough of the distal end of the second covered stent 1201 through the assembling segment 132, or the distal end of the connecting rod 130 can be connected with the wave crest or wave trough of the first frame 111 through the assembling segment 132, and the proximal end of the connecting rod 130 is welded with the distal end of the second covered stent 1201 through the connecting segment 131.

[0076] In other embodiments, the assembling segment 132 can also be provided with two, and the two assembling segments 132 are connected at the two ends of the connecting segment 131, so that the two ends of the connecting rod 130 can be respectively connected with the first frame 111 and the second frame 121. In other embodiments, the assembling segment 132 can also be provided with a T-shaped rod, which is connected with the connecting segment 131, so that the connecting rod 130 as a whole is in the shape of T. Alternatively, the assembling segment 132 is a straight rod, and the extension direction of the assembling segment 132 is perpendicular to the extension direction of the connecting segment 131, and the assembling segment 132 is connected with the connecting segment 131 to form the connecting rod 130 as a whole in the shape of T.

[0077] Please refer to Figure 6 , Figure 6 For another implementation of the connecting rod 130, in this embodiment, the connecting rod 130 still comprises a connecting segment 131 and an assembling segment 132, which are Figure 5The difference between the shown structure is that, in this embodiment, the connecting rod 130 is derived from the woven wire on the first frame 111, the connecting section 131 of the connecting rod 130 is integrated with the trough of the first support unit 1111 on the first frame 111, the connecting section 131 is formed by the mutual winding of the two ends of the woven wire, and the assembly section 132 is a circular ring or other irregular ring structure formed by the bending of the middle part of the woven wire. The assembly section 132 can be connected with the peak or trough of the second frame 121. Alternatively, the assembly section 132 and the second frame 121 can be connected by welding or sewing. It can be understood that in other embodiments, the connecting rod 130 can also be derived from the woven wire on the second frame 121, and the assembly section 132 can be connected with the first frame 111 by mutual hanging, welding or sewing. Alternatively, the connecting rod 130 can be directly woven from the woven wire into a shape with two assembly sections 132, and the two assembly sections 132 can be connected with the first frame 111 and the second frame 121 by mutual hanging, welding or sewing. In other embodiments, the connecting member 13 can also be a "u" shaped structure, a "∽" shaped structure or an "o" shaped structure formed by folding the woven wire, and the specific woven shape can be selected according to the actual use.

[0078] It can be understood that the number of connecting rods 130 is not limited and can be selected as needed. The more the number of connecting rods 130, the more stable the connection between the first tubular member 11 and the second tubular member 12, but at the same time, the possibility of the second tubular member 12 being affected during the expansion process is also greater.

[0079] Please refer back to Figures 1-3 In Figure 1 In the shown implantable medical system, the channel 15 is a ring-shaped channel, and the cooperation mode of the branch stent 2 and the implantable medical device 1 is that one end of the branch stent 2 extends into the channel 15 of the implantable medical device 1, and then is clamped by the first tubular member 11 and the sealing assembly 14.

[0080] In one aspect, the implantable medical system applies the implantable medical device 1 capable of keeping the blood flow unobstructed during the operation, so that the branch stent 2 can be implanted with unobstructed blood flow, which can win more time for the implantation of the branch stent 2 compared with the implantation of the branch stent 2 in the prior art under the condition of blood flow obstruction, thereby further improving the success rate of the operation. On the other hand, since the branch stent 2 is assembled with the implantable medical device 1 through the annular channel, during the implantation operation, only the branch stent 2 needs to be stretched into different positions in the annular channel according to the direction of the corresponding branch lumen anatomical structure, compared with the way of opening a side window on the implantable medical device 1 for the assembly of the branch stent 2, the annular channel is fully open in the circumferential direction, so that the angle of the first tubular member 11 which has been fully expanded does not need to be adjusted during the implantation of the branch stent 2, thereby reducing the difficulty of the operation and further improving the success rate of the operation.

[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 medical device 1 cooperating with the branch stent 2 is greater than 2, the connecting rod 13 can also simultaneously play a role in dividing the first lumen 110, so that each implantation direction in the radial direction of the implantable medical device 1 can be further subdivided, thereby facilitating the rapid positioning of the branch stent 2 during implantation.

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

[0083] Please continue to refer to Figures 1-2 In one embodiment, the flexibility of the sealing assembly 14 is greater than the flexibility of the second tubular structure 12, and the branch stent 2 is clamped by the cooperation of the first tubular member 11 and the sealing assembly 14. On the one hand, the flexibility of the sealing assembly 14 is better, so it can better adapt to the shape of the branch stent 2, thereby providing the branch stent 2 with more secure wrapping, and on the other hand, it can also maintain the shape of the second tubular member 12 to a certain extent without being compressed.

[0084] In other embodiments, the sealing assembly 14 can also be in a natural state, the outer diameter of the sealing assembly 14 after radial expansion is greater than the inner diameter of the first tubular member 11 after radial expansion. Thus, the sealing assembly 14 can form an interference fit with the first tubular member 11, thereby clamping the branch stent 2 more tightly and ensuring the stability of the installation of the branch stent 2.

[0085] Please refer to Figures 3-4In an embodiment, the sealing assembly 14 comprises a driving member 141 and a partition membrane 142.

[0086] The partition membrane 142 is connected to the second covered stent 1201 at a proximal end and extends axially to the side of the first tubular member 11 to be at least partially accommodated in the first lumen 110 at a distal end, and the portion of the partition membrane 142 accommodated in the first lumen 110 has a free end. The partition membrane 142 has an unfolded state and a folded state. In the unfolded state, the partition membrane 142 is in a hollow cylindrical shape, and the passage 15 is formed by the outer wall of the portion of the partition membrane 142 accommodated in the first lumen 110 and the inner wall of the first tubular member 11. The driving member 141 is connected to the second covered stent 1201 at a proximal end and extends axially to the side of the first tubular member 11 to be at least partially accommodated in the first lumen 110 at a distal end, and the portion of the driving member 141 accommodated in the first lumen 110 has a free end. The driving member 141 is connected to the partition membrane 142, and the driving member 141 is used to drive the partition membrane 142 to expand radially, or the driving member 141 is used to drive the partition membrane 142 to fold.

[0087] The radial expansion of the partition membrane 142 makes the outer wall of the partition membrane 142 fit the inner wall of the first tubular member 11, which is the closed state of the passage 15. The folding or contraction of the partition membrane 142 makes the outer wall of the partition membrane 142 form a gap with the inner wall of the first tubular member 11, which is the open state of the passage 15.

[0088] By setting the sealing assembly 14 to comprise the driving member 141 and the partition membrane 142, when the branch stent 2 is implanted in the passage 15, the partition membrane 142 can be more closely wrapped on the side wall of the branch stent 2 because there is no extra stent unit on the partition membrane 142 to block it, thereby ensuring better anti-leakage effect. In addition, because there is no extra stent unit on the partition membrane 142, the flexibility is better, so that the branch stent 2 can be prevented from being squeezed together by the first tubular member 11 and the sealing assembly 14, and the shape of the branch stent 2 can be better maintained.

[0089] Please continue to refer to Figures 3-4In an embodiment, the driving member 141 comprises a plurality of driving rods 1410 connected to the distal end of the second tubular member 12, the driving rods 1410 are arranged on the partition membrane 142, and the proximal end of the driving rod 1410 is connected to the second covered stent 1201, and the distal end is a free end. The extension direction of the driving rod 1410 satisfies: when the first tubular member 11 and the second tubular member 12 are both in a radial expansion state, the part of the driving rod 1410 accommodated in the first tubular member 11 is in contact with the inner wall of the first tubular member 11. For example, in an embodiment, the first tubular member 11 is a constant-diameter cylindrical structure, and the driving rod 1410 is entirely accommodated in the first tubular member 11 when the first tubular member 11 and the second tubular member 12 are both in an expanded state, so that the driving rod 1410 is a straight rod structure as a whole; or, in other embodiments, the first tubular member 11 is still a constant-diameter cylindrical structure, but only part of the driving rod 1410 is accommodated in the first tubular member 11 when the first tubular member 11 and the second tubular member 12 are both in an expanded state, so that the part of the driving rod 1410 accommodated in the first tubular member 11 is a straight rod in contact with the inner wall of the first tubular member 11, and the extension direction of the part of the driving rod 1410 not accommodated in the first tubular member 11 can form a straight angle or an obtuse angle with the extension direction of the part of the driving rod 1410 accommodated in the first tubular member. Or, the first tubular member 11 is a variable-diameter cylindrical structure, then the part of the driving rod 1410 accommodated in the first tubular member 11 is a curved rod with a bending angle which matches the internal shape of the first tubular member 11.

[0090] It should be noted that the proximal end of the driving rod 1410 can be fixed on the second covered stent 1201 by welding, sewing or other methods, or it can be woven from the woven wire of the second frame 121 of the second covered stent 1201, and the specific connection method can be selected according to the use.

[0091] Please continue to refer to Figure 4 In an embodiment, the driving rod 1410 is a long rod structure, and the cross section is rectangular. In other embodiments, the cross section of the driving rod 1410 can also be circular, sector, oval or other polygonal shape, or the driving rod 1410 can also be a spiral structure formed by winding the woven wire.

[0092] Please continue to refer to Figures 3-4In one embodiment, the partition membrane 142 is integrally formed with the second covering film 122 of the second tubular member 12. In other embodiments, the partition membrane 142 can also be sewn to the distal end of the second covering film 122 by a suture. The partition membrane 142 can be an integrally formed annular sheet or a plurality of arcuate sheets assembled together. It can be understood that the material of the partition membrane 142 can be nylon or other suitable material for manufacturing artificial blood vessels, or polyester cloth or PTFE film. It should be noted that the material of the partition membrane 142 is not limited to the above-mentioned materials, and the material of the partition membrane 142 can be selected from flexible materials that can block blood flow and are suitable for implantation in the human body. The connection between the partition membrane 142 and the driving rod 1410 can be achieved by sewing, heat treatment coating or adhesion.

[0093] It should be noted that in other embodiments, the driving rod 1410 and the partition membrane 142 can also be connected to the middle or distal end of the second tubular member 12. However, the driving rod 1410 and the partition membrane 142 are connected to the distal end of the second tubular member 12, which is more convenient to assemble and can not affect the shape of the second tubular member 12.

[0094] Please continue to refer to Figures 3-4 In one embodiment, the partition membrane 142 is connected to the driving rod 1410 and the connecting rod 130 at the same time.

[0095] Specifically, in this embodiment, the distal end of the connecting member 13 is connected to the inner wall of the first covering film stent 1101, and the proximal end of the connecting member 13 is connected to the distal end of the second covering film stent 1201. The connecting member 13 includes four connecting rods 130, which are uniformly distributed along the circumference of the first lumen 110, and the connecting rod 130 satisfies: when the first covering film stent 1101 and the second covering film stent 1201 are both in an unfolded state, the extension direction of the connecting rod 130 is parallel to the axial direction of the first covering film stent 1101. One driving rod 1410 is arranged between two adjacent connecting rods 130, i.e. the driving member 141 includes four driving rods 1410, and the partition membrane 142 is connected to the connecting rod 130 and the driving rod 1410 at the same time along the circumference.

[0096] Please refer to Figures 7-8Before the implantation of the branch stent 2, the first stent graft 1101 is in a radially expanded state, and the second stent graft 1201 is in a radially compressed state. At this time, the driving member 1410 drives the partition membrane 142 to form a folded state under the restriction of the second stent graft 1201 or the delivery sheath 3, the channel 15 is opened, and the folded partition membrane 142 divides the channel 15 into a plurality of sub-channels 150 due to the connection with the connecting rod 130. After the implantation of the branch stent 2 into the channel 15, the proximal end of the connecting rod 130 and the driving rod 1410 move towards the side close to the inner wall of the first stent graft 1101 due to the expansion of the second stent graft 1201. Under the driving of the connecting rod 130 and the driving rod 1410, the partition membrane 142 also expands until the second stent graft 1201 is in a radially expanded state. At this time, all the connecting rods 130 are attached to the side wall of the first stent graft 1101, the driving rod 1410 is attached to the side wall of the branch stent 2 in the sub-channel 150 where the branch stent 2 is implanted, and the partition membrane 142 is wrapped around the branch stent 2 under the joint action of the connecting rod 130 and the driving rod 1410 to wrap the branch stent 2. In the sub-channel 150 where the branch stent 2 is not implanted, the driving rod 1410 drives the partition membrane 142 to be attached to the inner wall of the first stent graft 1101 to seal the channel 15.

[0097] By connecting the partition membrane 142 with the connecting rod 130, the implantation directions of the channel 15 can be more clearly distinguished by the partition membrane 142, thereby facilitating the rapid positioning and implantation of the branch stent 2. Meanwhile, the connection of the partition membrane 142 with the connecting rod 130 enables the connecting rod 130 to not only connect the first tubular member 11 and the second tubular member 12, but also cooperate with the driving rod 1410 to better tension the partition membrane 142 and limit the branch stent 2, thereby improving the assembly stability of the branch stent 2.

[0098] It should be noted that, in the present embodiment, the distal end of the partition membrane 142 and the distal end of the driving rod 1410 are in the same radial plane as the distal end of the connecting rod 130. In other embodiments, the distal end of the driving rod 1410 can be above or below the distal end of the connecting rod 130.

[0099] It should be noted that the number of connecting rods 130 and driving rods 1410 is not limited and can be selected according to actual conditions. The number of connecting rods 130 and the number of driving rods 1410 do not need to be corresponding, for example, at the position where the branch stent 2 needs to be implanted, the number of driving rods 1410 arranged between two adjacent connecting rods 130 is 3 or 4, etc. In addition, in other embodiments, the connecting rods 130 can also be arranged only along the circumference of the first lumen 110 and not uniformly distributed, for example, in the direction where the branch stent 2 needs to be implanted, the distribution of the connecting rods 130 is more dense, and in the direction where the branch stent 2 does not need to be implanted, the distribution of the connecting rods 130 is relatively sparse.

[0100] It can be understood that in other embodiments, the separation membrane 142 can also be connected only with the driving rod 1410, that is, the separation membrane 142 is not connected with the connecting rod 130, and in the contracted state, the connecting rod 130 is in contact with the separation membrane 142, but there is no connecting point between them. In this way, the sealing assembly 14 can also better play the role of sealing, and the connecting rod 130 and the sealing assembly 14 do not interfere with each other, so as not to affect the opening and closing of the channel 15.

[0101] It can be understood that when the separation membrane 14 needs to be connected with the connecting rod 130, the connecting position of the connecting rod 130 on the first tubular member 11 and the second tubular member 12 also needs to consider not affecting the expansion or contraction of the separation membrane 142. For example, in the embodiment shown in Figures 3-4 In the embodiment shown, the proximal end of the connecting rod 130 is connected with the distal end of the second covered stent 1201, the distal end of the connecting rod 130 is connected with the first covered stent 1101, and the connecting point of the connecting rod 130 and the first covered stent 1101 is located beyond the distal end face of the second covered stent 1201, so that the connecting rod 130, the driving rod 1410 and the separation membrane 142 are all located on the distal end side of the second covered stent 1201, and in the process of expansion or contraction of the second covered stent 1201, the connecting rod 130 can cooperate with the driving rod 1410 to drive the expansion or contraction of the separation membrane 142. Among them, the radial compression state of the second covered stent 1201 does not necessarily be achieved by the delivery sheath 3, but also can be achieved by the limiting structure.

[0102] Please refer to Figures 9-10 which is another implementation of the implantable medical device 1. It is similar to Figure 8The difference of the structure of the implantable medical device 1 shown in the figure is the connection position of the connector 13 and the first tubular member 11. In this embodiment, the distal end of the connector 13 is connected with the crest of one first stent cell 1111 of the nearest end of the first frame 111 on the first tubular member 11, and the distal end face of the sealing assembly 14 is flush with the distal end face of the connector 13. That is, in this embodiment, the overlapping area of the sealing assembly 14 and the first tubular member 11 is defined between the first stent cell 1111 of the nearest end of the first tubular member 11 and the proximal end face of the first tubular member 11. After the branch stent 2 is implanted, the end connected with the implantable medical device 1 is clamped by the overlapping area, and the cross-sectional view of the first tubular member 11 is as shown in Figure 10 Since the trough of the first stent cell 1111 on the first tubular member 11 in the overlapping area is a free end and no other first stent cell 1111 is hung, the flexibility of the first tubular member 11 in the overlapping area is larger, and the first tubular member 11 can be deformed to the side away from the sealing assembly 14 under the extrusion of the branch stent 2, so that the side of the branch stent 2 close to the first tubular member 11 is also wrapped more tightly, thereby further reducing the risk of leakage of the implantable medical device 1.

[0103] It can be understood that in other embodiments, the distal end face of the sealing assembly 14 can be further extended distally, as long as after the branch stent 2 is implanted, one end of the branch stent 2 is clamped by the sealing assembly 14 and the area with larger flexibility (i.e. the first stent cell 1111 of the nearest end of the first tubular member 11 to the proximal end face of the first tubular member 11) on the first tubular member 11, the branch stent 2 can still have the above-mentioned effect of being wrapped more tightly. It should be noted that when the distal end face of the sealing assembly 14 exceeds the end face of the clamped end of the implanted branch stent 2, the arrangement of the sealing assembly 14 needs to consider that it will not block the blood flow of the branch stent 2 when it is fully expanded in the radial direction.

[0104] Please continue to refer to Figures 11-12 which is another implementation form of the implantable medical device 1. In this embodiment, the separation membrane 142 is still connected with the connector 13, and the structure of the connector 13 is different from that shown in Figure 4 The difference of the structure of the embodiment shown in the figure is the arrangement of the connector 13. In this embodiment, the connector 13 includes four rod groups, each rod group 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 the radial expansion 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 one intersection point, the connecting rod 130a and the connecting rod 130b are about the intersection point and the second membrane stent 1201 (in Figures 11-12In the embodiment, the second covered stent 1201 is symmetrically distributed along an axis parallel to the longitudinal central axis of the second covered stent 1201, so that when the first tubular member 11 and the second tubular member 12 are both in the radially expanded state, the connecting rods 130a and 130b are arranged in a manner that the connecting rods 130a and 130b are closer to each other on the first tubular member 11 than on the second tubular member 12. A driving rod 1410 is arranged between the connecting rods 130a and 130b, and no driving rod 1410 is arranged between adjacent rod groups. The partition membrane 142 is circumferentially connected to the connecting rods 130a, 130b and the driving rod 1410.

[0105] In this way, when the first tubular member 11 is in the radially expanded state and the second covered stent 1201 is in the radially compressed state before the branch stent 2 is implanted, the channel 15 is open. At this time, the partition membrane 142 is in a taut state under the action of the connecting rods 130a, 130b and the driving rod 1410, so as to avoid the blocking of the sub-channel 150 caused by the wrinkles of the partition membrane 142, and further reduce the difficulty of establishing the implantation path of the branch stent 2. In addition, since the connecting rods 130a and 130b are closer to each other on the first tubular member 11 than on the second tubular member 12, the sub-channel 150 formed thereby has a tapered shape with a large distal opening and a small proximal opening. The wider distal opening of the sub-channel 150 facilitates the insertion of the branch stent 2 into the sub-channel 150 from the distal end, and the narrower proximal opening of the sub-channel 150 allows the partition membrane 142 to be more closely attached to the side wall of the branch stent 2, thereby improving the anti-leakage effect.

[0106] In other embodiments, the connecting rods 130a and 130b can also be symmetrically distributed along an axis parallel to the longitudinal central axis of the second covered stent 1201 with respect to the intersection of the extension lines of the proximal ends of the connecting rods 130a and 130b.

[0107] Please continue to refer to Figure 12 In an embodiment, the distal ends of the connecting rods 130a in one rod group and the connecting rods 130b in the adjacent rod group are connected together. In other embodiments, the proximal ends of the connecting rods 130a and 130b in each rod group can also be connected, so that each rod group cooperates to form a ring-shaped wave structure. The connecting rods 130a and 130b in each rod group form troughs of the ring-shaped wave structure, and the connecting rods 130a and 130b in adjacent rod groups form peaks of the ring-shaped wave structure. When the connecting member 13 forms a ring-shaped wave structure, it can be connected to the first tubular member 11 and the second tubular member 12 by being hung on the first tubular member 11 and the second tubular member 12.

[0108] Please refer to Figures 13-14 , which is another implementation form of the implantable medical device 1. In this embodiment, the first tubular member 11 comprises a first covered stent 1101 and a cover membrane 1102, the distal end of the cover membrane 1102 is connected with the proximal end of the first covered stent 1101, and the distal end extends to the side close to the second tubular member 12 to form a free end, and the middle part of the cover membrane 1102 is also connected with the connecting member 13.

[0109] The connecting member 13 comprises connecting rods 130a and 130b, and adjacent connecting rods 130a and 130b are connected end to end, so that the connecting member 13 forms a ring-shaped wave structure. Among them, the wave crest of the connecting member 13 is connected with the wave trough of the proximal end of the first covered stent 1101, and the wave trough of the connecting member 13 is connected with the wave crest of the distal end of the second covered stent 1201.

[0110] The outer diameter of the second covered stent 1201 is smaller than the outer diameter of the first covered stent 1101, and the outer diameter of the distal end of the partition membrane 142 matches the inner diameter of the first covered stent 1101, and the outer diameter of the proximal end of the partition membrane 142 matches the outer diameter of the second covered stent 1201, so that the partition membrane 142 is in a radially expanded state, as shown in Figure 15 The wave coil suture edge 1421 is provided on the partition membrane 142, which is used for identification for connecting the partition membrane 142 with the connecting member 13. The channel 15 is formed by the outer wall of the partition membrane 142 and the inner wall of the cover membrane 1102. The connecting point of the driving rod 1410 and the second tubular member 12 coincides with the lowest point of the wave trough of the connecting member 13.

[0111] When the first covered stent 1101 is in a radially expanded state and the second covered stent 1201 is in a radially compressed state, the driving rod 1501 drives the partition membrane 142 to form a folded state, the proximal end of the connecting member 13 is also in a contracted state, and the distal end of the connecting member 13 is in an expanded state under the influence of the first covered stent 1101, and drives the cover membrane 1102 fixed on the connecting member 13 to be in an expanded state, so that a plurality of sub-channels 1501 in an open state are formed between the inner side of the cover membrane 1102 and the outer side of the partition membrane 142. When the second tubular member 12 changes to a radially expanded state, the distal end of the connecting member 13 and the driving rod 1401 are both expanded outward, thereby driving the partition membrane 142 to abut against the cover membrane 1102 to close the sub-channels 1501. In this way, when the branch stent 2 is clamped by the sub-channels 1501, the cover membrane 1102 and the partition membrane 142 can better fit the shape of the branch stent 2 because both the inner and outer sides are flexible membranes, so that the branch stent 2 can obtain a more compact wrapping, and the effect of preventing internal leakage and fixing the branch stent 2 of the implantable medical device 1 is better.

[0112] It can be understood that the material of the cover film 1102 can be selected from materials suitable for manufacturing artificial blood vessels such as nylon, polyester cloth or other conventional cover film materials that can be used to manufacture a covered stent.

[0113] In addition, as Figure 15 shown, in order to further enhance the installation stability of the branch stent 2, an extension edge 143 is further connected to the distal end of the partition film 142. The extension direction of the extension edge 143 is parallel to the extension direction of the first covered stent 1101, and the height of the distal end of the extension edge 143 in the axial direction is higher than the height of the wave crest of the connecting piece 13. The height of the distal end of the driving rod 1401 in the axial direction is flush with the distal end of the extension edge 143, and the extension edge 143 is used to extend the axial length of the annular channel 15. The extension edge 143 is provided with an extension suture edge 1431 extending in the axial direction, and the extension suture edge 1431 is used to fix the extension edge 143 on the first tubular member 11. Under the action of the extension edge 143, the length of each sub-channel 1501 in the axial direction is extended to a certain extent, so that the structure of the sub-channel 1501 is more perfect, and the path establishment of the branch stent 2 and the stability of the branch stent 2 are more favorable.

[0114] Please refer to Figures 16-17 , which is another embodiment of the implantable medical device 1, compared with Figure 13 the embodiment shown, the driving rod 1410 of this embodiment is slightly different. The driving rod 1410 includes a connecting portion 14101 and an abutting portion 14102, wherein the end of the connecting portion 14101 away from the abutting portion 14102 is connected to the second covered stent 1201, the end of the abutting portion 14102 away from the connecting portion 14101 is a free end, and the projected area of the free end of the abutting portion 14102 on the partition film 142 is greater than the projected area of the connecting segment of the connecting portion 14101 and the second tubular member 12 on the partition film 142. The abutting portion 14102 is used to increase the contact area of the distal end of the driving rod 1410 and the partition film 142.

[0115] Specifically, in an embodiment, the abutting portion 14102 is circular, the abutting portion 14102 is provided with two, and the two abutting portions 14102 are arranged symmetrically about an axis, which is a straight line parallel to the longitudinal center axis of the second covered stent 1201 where the connecting end of the connecting portion 14101 is located. The connecting portion 14101 is in the shape of "Y" to simultaneously connect the two abutting portions 14102, and the diameter of the abutting portion 14102 is greater than the width of the distal end of the connecting portion 14101.

[0116] The abutting portion 14102 increases the contact area between the driving rod 1410 and the separation membrane 142, so that the separation membrane 142 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 leakage.

[0117] Please continue to refer to Figure 17 In an 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, among the two adjacent driving rods 1410, the abutting portion 14102 of one of the most side edges in one of the driving rods 1410 and the abutting portion 14102 of the other of the most side edges adjacent to the abutting portion 14102 in the other of the driving rods 1410 abut, thereby clamping the separation membrane 142. In this way, the separation membrane 142 can be pulled and tightened under the action of the driving rod 1410, so that the gap between the sub-channels 1501 disappears, thereby facilitating the establishment of the implantation path of the branch stent 2.

[0118] It can be understood that the specific shape and number of the abutting portion 14102 are not limited and can be selected according to actual conditions.

[0119] It should be noted that in an embodiment, the implantable medical device 1 can further include a leaflet structure (not shown in the figure), which is connected to the second tubular member 12. The leaflet structure includes three leaflets that can be closed and opened. When the implantable medical device 1 is implanted in the body, the three leaflets are closed and opened with the diastole and systole of the heart, so that the second lumen 120 is closed or opened. The material of the leaflets can be biological material or high polymer material. When aortic dissection patients also have aortic valve disease and need to replace the natural aortic valve, the use of the implantable medical device 1 can treat aortic dissection and replace the natural aortic valve at the same time. It can be understood that in other embodiments, the number of leaflets is not limited to three, for example, it can be two or four, and in addition, when the implantable medical device 1 is applied to other parts such as the renal artery that does not need to replace the natural valve, the leaflet structure can be omitted.

[0120] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, and as long as the combinations of the technical features do not contradict, they should be considered as within the scope of the present disclosure.

[0121] The above disclosure is only the preferred embodiments of the present application, and of course cannot limit the scope of the present application, so equivalent changes made according to the claims of the present application are still within the scope of the present application.

Claims

1. An implantable medical device, characterized in that, include: A first tubular member having a first lumen; The second tubular member has a second lumen, and the distal end of the second tubular member is connected to the proximal end of the first tubular member by a point connection. And a sealing assembly, the proximal end of which is connected to the second tubular member, and the distal end which extends axially away from the second tubular member to be at least partially accommodated within the first cavity. The portion of the sealing assembly accommodated within the first cavity is an annular structure with a free end. The annular structure surrounds the longitudinal central axis of the first tubular member. The sealing assembly can expand or contract synchronously with the second tubular member, such that the outer wall of the portion of the sealing assembly accommodated within the first cavity 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 open 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 closed.

2. The implantable medical 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 medical device according to claim 1, characterized in that, The first tubular member includes a first covered support and a cover film. The distal end of the cover film is connected to the proximal end of the first covered support, and the proximal end extends toward the side where the second tubular member is located and forms a free end. The channel is formed by the inner wall of the cover film and the outer wall of the sealing assembly.

4. The implantable medical device according to claim 1, characterized in that, The second tubular member includes a second covered stent, the distal end of which abuts against the proximal end of the first tubular member; or, the second tubular member includes a second covered stent and a connector, the distal end of which abuts against or is spaced from the proximal end of the first tubular member, the distal end of which is connected to the first tubular member, and the proximal end of which is connected to the second covered stent.

5. The implantable medical device according to claim 4, characterized in that, The sealing assembly includes: The diaphragm is connected to the second covered support at its proximal end and extends axially toward the side where the first tubular member is located to be at least partially accommodated in the first lumen. The portion of the diaphragm accommodated in the first lumen has a free end. The diaphragm has an unfolded and folded state. The outer wall of the portion of the diaphragm accommodated in the first lumen cooperates with the inner wall of the first tubular member to form the channel. Additionally, the drive member has a proximal end connected to the second membrane support and a distal end extending axially toward the side where the first tubular member is located to be at least partially accommodated within the first lumen, and the portion of the drive member accommodated within the first lumen has a free end. The drive member is connected to the diaphragm and is used to drive the diaphragm to unfold as the second tubular member expands or to drive the diaphragm to fold as the second tubular member contracts.

6. The implantable medical device according to claim 5, 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 portion of the driving rod housed within the first tubular component is in contact with the inner wall of the first tubular component.

7. The implantable medical device according to claim 6, 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. The separator membrane is simultaneously connected to the connecting rods and the driving rods circumferentially.

8. The implantable medical device according to claim 6, characterized in that, The connector includes several rod groups, each rod group including two connecting rods. When the first tubular member and the second tubular member are both in a radially extended 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 a single intersection point. At least one driving rod is provided between the two connecting rods, and the separator membrane is simultaneously connected to the connecting rods and the driving rods in the circumferential direction.

9. The implantable medical device according to claim 8, 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.

10. The implantable medical device according to any one of claims 6-9, 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.

11. The implantable medical device according to claim 10, 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.

12. The implantable medical device according to claim 11, 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.

13. The implantable medical device according to claim 4, 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.

14. The implantable medical device according to claim 1, characterized in that, The implantable medical 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.

15. An implantable medical system, characterized in that, include: Branch support; And, in any one of claims 1-14, one end of the branch stent can extend into the channel and be clamped by the first tubular member and the sealing assembly.

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