CN119523683A

CN119523683A - Implantable medical devices and implantable medical systems

Info

Publication number: CN119523683A
Application number: CN202311128812.XA
Authority: CN
Inventors: 赖柳山
Original assignee: Shenzhen Baite Micro Medical Technology Co ltd
Current assignee: Shenzhen Baite Micro Medical Technology Co ltd
Priority date: 2023-08-31
Filing date: 2023-08-31
Publication date: 2025-02-28

Abstract

The invention 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, a distal end and a sealing assembly, wherein the distal end of the second tubular member is connected with the proximal end of the first tubular member in a point connection mode, the proximal end of the sealing assembly is connected with the second tubular member, the distal end of the sealing assembly axially extends in a direction away from the second tubular member to be at least partially accommodated in a first lumen, the part of the sealing assembly accommodated in the first lumen is of an annular structure and is provided with a free end, the annular structure surrounds the longitudinal central axis of the first tubular member, and the sealing assembly can be synchronously unfolded or contracted along with the second tubular member, so that the outer wall of the part of the sealing assembly accommodated in the first lumen and the inner wall of the first tubular member are matched to form an openable or closable channel. The implantable medical device can keep blood flow smooth in the operation process, and prevent adverse effects on the health of patients caused by blood flow blockage.

Description

Implantable medical device and implantable medical system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an implantable medical device and an implantable medical system.

Background

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

Aortic dissection, also known as aortic dissection aneurysms, is the delamination and separation of the aortic wall, as well as the formation of hematomas, due to the tearing of the aortic intima and the inflow of blood between the arterial walls, caused by various causes. Aortic dissection is a vascular disease which seriously endangers life health, and has high death rate.

At present, the modes for treating aortic dissection mainly comprise two modes of surgical treatment and minimally invasive treatment. The surgical operation treatment is realized by thoracotomy and thoracotomy, cutting off the endomembrane tear and reconstructing a blood flow channel by using an artificial blood vessel, and the minimally invasive intervention treatment is realized by implanting a covered stent in a lesion part to isolate the blood flow of an aortic dissection and maintain a normal blood flow channel. Compared with surgical treatment, minimally invasive interventional treatment is increasingly applied to conventional treatment due to the advantages of small trauma, rapid recovery, fewer complications and the like.

Generally, the stent graft is a generally straight stent, but when a lesion site of an aortic dissection is involved in or near a branch vessel, such as a dissection lesion site of an ascending aorta is involved in or near an aortic coronary vessel, a dissection lesion site of an ascending aorta is involved in or near a branch vessel of an aortic arch portion, an abdominal aortic lesion site is near a renal artery, etc., the stent graft may cover or block an opening of the branch vessel, a coronary vessel, a renal artery, etc. in order to cover the lesion site or to increase a sufficient anchoring area. In this case, it is generally necessary to implant a main stent and a branch stent (or referred to as a bypass stent) at the lesion site simultaneously for treatment, the main stent and the branch stent being engaged with each other, thereby maintaining the blood flow of the aorta and the branch vessel clear. But this also adds difficulty to the implantation procedure.

Generally, the implantation operation is performed by first transferring the main body stent to a corresponding position, then partially releasing the main body stent, then transferring the branch stent to a corresponding position, then releasing the branch stent to make the branch stent cooperate with the main body stent, and finally completely releasing the main body stent to complete the operation. This results in a certain degree of occlusion of blood flow during the release of the branch stent, since the main stent is in the vessel and in a semi-released state, and is not fully open. When the branched stent is released for too long, the blood flow blocking time is also long, so that the health of a patient is adversely affected, and the life is seriously and even endangered.

Therefore, it is important to maintain blood flow clear during the surgical procedure.

Disclosure of Invention

Based on this, there is a need to provide an implantable medical device that can maintain blood flow clear during a surgical procedure.

Further, an implantable medical system is provided that maintains blood flow during a surgical procedure.

An implantable medical device includes 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 by a point connection, and a seal assembly, the proximal end of the seal assembly being connected to the second tubular member, the distal end extending axially away from the second tubular member to be at least partially received within the first lumen, a portion of the seal assembly received within the first lumen being of annular configuration and having a free end, the annular configuration surrounding a longitudinal central axis of the first tubular member, the seal assembly being synchronously expandable or contractible with the second tubular member such that an outer wall of a portion of the seal assembly received within the first tubular member cooperates with an inner wall of the first tubular member to form an openable or closable passageway, the passageway being in an open state when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the passageway being in an open state and in communication with the first tubular member when the first tubular member is in a radially expanded state.

In one embodiment, the channels are annular channels, or a plurality of channels are arranged at intervals along the circumferential direction of the second tubular member, or one channel is arranged, and the channels are non-annular channels.

In one embodiment, the first tubular member includes a first stent graft and a cap, the distal end of the cap being connected to the proximal end of the first stent graft, the proximal end extending toward the side of the second tubular member and forming a free end, the passageway being formed by the inner wall of the cap cooperating with the outer wall of the seal assembly.

In one embodiment, the second tubular member comprises a second stent graft with a distal end abutting the proximal end of the first tubular member, or comprises a second stent graft with a distal end abutting or spaced from the proximal end of the first tubular member, and a connector with a distal end connected to the first tubular member and a proximal end connected to the second stent graft.

In one embodiment, the sealing assembly comprises a separation membrane, a driving piece and a driving piece, wherein the proximal end of the separation membrane is connected with the second tectorial membrane bracket, the distal end of the separation membrane extends axially to the side where the first tubular member is located to be at least partially contained in the first lumen, the part of the separation membrane contained in the first lumen is provided with a free end, the separation membrane is in an unfolding and folding state, the outer wall of the part of the separation membrane contained in the first lumen is matched with the inner wall of the first tubular member to form the channel, the proximal end of the separation membrane is connected with the second tectorial membrane bracket, the distal end of the separation membrane extends axially to the side where the first tubular member is located to be at least partially contained in the first lumen, the part of the driving piece contained in the first lumen is provided with a free end, the driving piece is connected with the separation membrane, and the driving piece is used for driving the separation membrane to unfold along with the second tubular member or driving the separation membrane to fold along with the second tubular member.

In one embodiment, the driver comprises a driving rod, and the extending direction of the driving rod is that when the first tubular member and the second tubular member are in a radial unfolding state, the part of the driving rod accommodated in the first tubular member is attached to the inner wall of the first tubular member.

In one embodiment, the connector comprises a plurality of connecting rods, the connecting rods are distributed at intervals along the circumferential direction of the first lumen, when the first tubular member and the second tubular member are in a radial unfolding state, the extending direction of each 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, and the separation membrane is connected with the connecting rods and the driving rods simultaneously along the circumferential direction.

In one embodiment, the connecting piece comprises a plurality of rod groups, each rod group comprises two connecting rods, when the first tubular member and the second tubular member are in a radial unfolding state, the extending directions of the two connecting rods and the axial direction of the first tubular member form a non-zero included angle, the extension lines of the proximal ends of the two connecting rods can be converged on one intersection point, at least one driving rod is arranged between the two connecting rods, and the separation membrane is connected with the connecting rods and the driving rods simultaneously along the circumferential direction.

In one embodiment, the connecting rods are connected in pairs to form a ring-shaped wave structure, two connecting rods in the connecting group are connected to form wave troughs of the ring-shaped wave structure, and connecting rods in adjacent connecting groups are connected to form wave crests of the ring-shaped wave structure.

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

In one embodiment, the two abutting portions are arranged in an axisymmetric manner, and the symmetry axis of the two abutting portions is a straight line parallel to the longitudinal central axis of the second tubular member, where the connecting end of the second tubular member and the connecting portion are located.

In one embodiment, the number of the abutting parts is 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, one of the two adjacent driving rods abuts against the other one of the two driving rods adjacent to the one of the two driving rods to clamp the partition film.

In one embodiment, the connector comprises a connecting section and an assembling section connected with the connecting section, the assembling section is connected with one of the first tubular member and the second tubular member, one end of the connecting section, which is far away from the assembling section, is connected with the other one of the first tubular member and the second tubular member, the connecting section is a cylindrical rod or a braiding wire, and the assembling section is a ring-shaped structure, a T-shaped rod or a straight rod with the extending direction perpendicular to the extending direction of the connecting section.

In one embodiment, the implantable prosthetic medical device further comprises a leaflet structure disposed within the second tubular member and the leaflet structure is openable or closable to place the second lumen of the second tubular member in an open or closed state.

An implantable medical system comprising a branched stent and an implantable medical device according to any one of the above embodiments, wherein one end of the branched stent is extendable into the channel and is cooperatively retained by the first tubular member and the sealing assembly.

The implantable medical device provided by the embodiment of the invention forms the channel with the first tubular member through the sealing component, the first tubular member can be released firstly without releasing the second tubular member in the implantation operation, at the moment, 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 component to be in a radial compression state, and the channel is opened, so that blood flow can flow out along the first lumen through the channel or flow can flow out along the channel through the first lumen, thereby keeping blood flow smooth in the operation process and preventing adverse effects on the health of a patient due to blood flow blockage.

According to the implantable medical system provided by the embodiment of the invention, the implantable medical device capable of keeping blood flow smooth in the operation process is matched with the branch stent, so that the branch stent can be implanted under the condition of blood flow smooth, and compared with the situation that the branch stent is implanted under the condition of blood flow blockage in the prior art, the implantable medical system can gain more time for the implantation of the branch stent, thereby further improving the success rate of the operation.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Wherein:

FIG. 1 is a schematic diagram of an implantable medical system according to an embodiment of the present invention;

FIG. 2 is a schematic view illustrating the assembly of an implantable medical device and a delivery sheath according to an embodiment of the present invention;

FIG. 3 is a schematic view illustrating an internal structure of an implantable medical device according to an embodiment of the present invention;

FIG. 4 is a schematic illustration of the assembly of a portion of the structure of the implantable medical device and delivery sheath shown in FIG. 2;

FIG. 5 is a schematic view of a connecting rod according to an embodiment of the present invention;

FIG. 6 is a schematic view of a connecting rod according to another embodiment of the present invention;

FIG. 7 is a top view of the implantable medical device shown in FIG. 2 in an open channel condition;

FIG. 8 is a cross-sectional view of the implantable medical device shown in FIG. 2 in a closed channel state;

FIG. 9 is a schematic view illustrating the assembly of an implantable medical device and a delivery sheath according to another embodiment of the present invention;

FIG. 10 is a cross-sectional view of an implantable medical system according to another embodiment of the present invention in a closed channel state;

FIG. 11 is a schematic view illustrating the assembly of an implantable medical device and a delivery sheath according to another embodiment of the present invention;

FIG. 12 is a schematic illustration of the assembly of a portion of the structure of the implantable medical device and delivery sheath of FIG. 11;

FIG. 13 is a schematic view of an implantable medical device according to another embodiment of the present invention;

FIG. 14 is a schematic view of an assembly of a first tubular member and a connector of the implantable medical device of FIG. 13;

FIG. 15 is a schematic view of an assembly of a second tubular member and a seal assembly in the implantable medical device of FIG. 13;

FIG. 16 is a schematic view of a driving rod according to another embodiment of the present invention;

Fig. 17 is a top view of an implantable medical device according to another embodiment of the present invention in a channel-open state.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the embodiments of the present invention, it should be noted that, as the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," and the like are used for convenience in describing the embodiments of the present invention and simplifying the description, only, and are not intended to indicate or imply that the apparatus or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In describing embodiments of the present invention, it should be noted that, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, interchangeably connected, integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected through an intermediary, or in communication between two elements. The specific meaning of the above terms in embodiments of the present invention will be understood in detail by those of ordinary skill in the art.

In the field of interventional medical devices, the end of the medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end", the end that is 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 in accordance with this principle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to a direction of the medical device that is not parallel to its "axial" direction, and defines the "axial" and "radial" directions of any of the components of the medical device in accordance with this principle. "circumferential" refers to the circumferential direction, i.e., the direction of the axis around the lumen structure, cylinder.

Referring to fig. 1, an embodiment of the present invention provides an implantable medical system, which includes an implantable medical device 1 and a branch stent 2. The implantable medical device 1 is for implantation in a body lumen anatomy, such as an aorta, and the branch stent 2 is for use with the implantable medical device 1, the branch stent 2 being for implantation in a branch lumen anatomy, such as a coronary branch vessel.

It will be appreciated that the site of application of the implantable medical system is not limited to the aorta, but may also be applied to other sites having branched blood vessels, for example, to the renal arteries.

Referring to fig. 1-2, an implantable medical device 1 includes a first tubular member 11, a second tubular member 12, and a seal assembly 14.

Wherein 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 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 seal assembly 14 is connected at a proximal end to the second tubular member 12 and at a distal end extends axially away from the second tubular member 12 for at least partial receipt within the first lumen 110. The portion of the seal assembly 14 that is received within the first lumen 110 is of annular configuration having a free end, the annular configuration surrounding the longitudinal central axis of the first tubular member 11, the seal assembly 14 being expandable or contractible in synchronism with the second tubular member 12 such that the outer wall of the portion of the seal assembly 14 that is received within the first lumen 110 cooperates with the inner wall of the first tubular member 11 to form an openable or closable passageway 15 (as shown in fig. 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 seal assembly 14 is spaced from the inner wall of the first tubular member 11 such that the passageway 15 is in an open state and in communication with the first lumen 110. When the first tubular member 11 and the second tubular member 12 are both in the radially expanded state, the outer wall of the seal assembly 14 is in contact with the inner wall of the first tubular member 11, such that the passage 15 is in the closed state.

The implantable medical device 1 thus configured may be configured to release the first tubular member 11 and maintain the second tubular member 12 in a radially compressed state during an implantation procedure (e.g., as shown in fig. 2, the first tubular member 11 is pushed out of the delivery sheath 3 while the second tubular member 12 is not yet released from the delivery sheath 3 and is still constrained by the delivery sheath 3 to be in a radially compressed state, or the second tubular member 12 is pushed out of the delivery sheath 3 and is constrained radially by a constraining structure (not shown), such as being constrained by a tether, to be in a radially compressed state), at which time, under the driving of the second tubular member 12, the sealing assembly 14 is also in a radially compressed state, so that the channel 15 is in an open state and is in communication with the first lumen 110, so that blood flow can flow out through the channel 15 along the first lumen 110, or blood flow can flow out through the first lumen 110 along the channel 15, so that blood flow is kept clear during an implantation procedure, thereby preventing adverse effects on the health of the patient due to blood flow blockage.

It should be noted that the seal assembly 14 may or may not be connected to the first tubular member 11. In one embodiment, the channel 15 may be in the form of an annular channel, thereby providing a more unobstructed blood flow and a better effect. In other embodiments, the channels 15 may be plural, with the plural channels 15 being circumferentially spaced along the second tubular member 12, or the channels 15 may be one, with the channels 15 being non-annular channels.

With continued reference to fig. 2, in one embodiment, the first tubular member 11 is a first stent graft 1101 having two open ends, the first tubular member 11 includes a first frame 111 and a first coating 112, and the first coating 112 is coated on the first frame 111 to form a first lumen 110 having two open ends.

Specifically, the first frame 111 includes a plurality of first rack units 1111 arranged in an axial direction.

With continued reference to fig. 2, in one embodiment, the first rack unit 1111 has a wave-shaped structure. In this embodiment, the plurality of first rack units 1111 are arranged in an axially crossed array, that is, the peaks of one first rack unit 1111 and the troughs of another adjacent first rack unit 1111 are aligned on a straight line parallel to the axis, and the peaks are connected with the troughs, so that the first frame 111 has better structural stability, and better radial supporting force and axial supporting force of the first frame 111 are ensured, so that the adhesion between the first frame 111 and the lumen anatomy is better. In other embodiments, the plurality of first rack units 1111 may be arranged in an axially equidistant array, i.e. the peaks of one first rack unit 1111 and the peaks of another adjacent first rack unit 1111 are aligned on a straight line parallel to the axis, so that the first frame 111 has better bending performance and can adapt to the anatomical structure of the lumen with a larger angle, or the plurality of first rack units 1111 may be connected in an axially staggered array, i.e. the peaks of one first rack unit 1111 and the peaks of another adjacent first rack unit 1111 are aligned on a straight line not parallel to the axis, and the troughs of another first rack unit 1111 are aligned on another straight line not parallel to the axis, so that the radial supporting force and the axial supporting force of the first frame 111 are increased while the bending performance of the first frame 111 is reduced. 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 may be improved, so that the first frame 111 may be adapted to different luminal anatomies for implantation.

With continued reference to fig. 2, in one embodiment, among the plurality of first rack units 1111, one first rack unit 1111 and another first rack unit 1111 adjacent thereto are connected by means of hanging peaks and troughs. In other embodiments, the plurality of first rack units 1111 are connected by an axially extending mounting bar (not shown) such that the first frame 111 has directionality and is easily bent on the opposite side of the mounting bar to accommodate the bent lumen anatomy. Or the plurality of first rack units 1111 are connected by a plurality of fitting bars, each of which connects two adjacent first rack units 1111, the plurality of fitting bars are formed in a straight line in the axial direction, and the first frame 111 can be made directional as well, and can be easily bent at the opposite side to the fitting bars to adapt to the bent lumen anatomy. Or the plurality of first rack units 1111 are connected by a plurality of fitting bars, each fitting bar connects two adjacent first rack units 1111, and the adjacent fitting bars are offset in the axial direction, so that the first frame 111 has better flexibility and is easy to reach the target position through the curved lumen anatomy.

With continued reference to fig. 2, in one embodiment, the waveform of the first rack unit 1111 is sinusoidal, and in other embodiments, the waveform of the first rack unit 1111 may be a Z-shaped waveform, and the specific waveform shape is not limited and may be selected according to the required usage performance of the first frame 111.

In one embodiment, the first frame 111 is formed of nitinol. In other embodiments, the material of the first frame 111 may be stainless steel, cobalt-chromium alloy, or polymer, which is selected so as to allow the first tubular member 11 to expand from a compressed state to an expanded state by balloon expansion or self-expansion, and to have a certain supporting strength.

In one embodiment, the first frame 111 may be prepared by braiding a wire-like material and shaping, for example, nickel titanium alloy wire may be braided and shaped to form the first frame 111. In other embodiments, the first frame 111 may be formed by cutting a tubular material with a laser and shaping, or by injection molding, or may be formed by 3D printing.

With continued reference to fig. 2, in one embodiment, the first covering film 112 is disposed along the length direction of the first frame 111, the length of the first covering film 112 exceeds the peak on the distal end and the trough on the proximal end of the first frame 111, and the first covering film 112 is disposed on the inner side and the outer side of the first frame 111, and the first covering film 112 is connected to the first frame 111 by heat treatment to integrate the outer side first covering film 112 with the inner side first covering film 112 so as to fix the first frame 111 in a wrapping manner. In other embodiments, the length of the first cover film 112 may also be shorter than the length of the first frame 111. In other embodiments, the first cover film 112 may be disposed only inside the first frame 111, or only outside the first frame 111. In other embodiments, the first cover 112 and the first frame 111 may be fixed by suture, where the suture may be made of biocompatible materials, such as PET (polyethylene terephthalate) suture or PTFE (polytetrafluoroethylene) suture. The material of the first film 111 may be a material suitable for manufacturing an artificial blood vessel, such as nylon, or a polyester cloth or PTFE film, and the material of the first film 111 is not limited to the above-mentioned material, and may be a flexible material suitable for implantation into a human body, which may be an absorbable material or a non-absorbable material.

Returning to fig. 1-2, in one embodiment, the second tubular member 12 includes a second stent graft 1201 and a connector 13. The distal end of the second stent graft 1201 abuts against or is spaced apart from the proximal end of the first stent graft 1101 by a predetermined distance, the distal end of the connecting member 13 is connected to the first stent graft 1101, the proximal end of the connecting member 13 is connected to the second stent graft 1201, and the connecting member 13 is used to maintain the connection of the first stent graft 1101 to the second stent graft 1201.

The second stent graft 1201 includes a second frame 121 and a second stent graft 122, and the second stent graft 122 is wrapped on the second frame 121 to form a second lumen 120 having two open ends.

The specific implementation manner of the second frame 121 is the same as that of the first frame 111, and the specific implementation manner of the second film 122 is also the same as that of the first film 112, so that the description thereof will be omitted herein. It should be noted that, the first stent graft 1101 and the second stent graft 1201 may have an integral constant diameter structure or a variable diameter structure, and the outer diameter of the distal end of the second stent graft 1201 may be equal to or smaller than the outer diameter of the proximal end of the first stent graft 1101.

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 defined by the connecting member 13 to be in a state of abutting or being separated by a predetermined distance, that is, the first stent graft 1101 and the second stent graft 1201 do not overlap in the axial direction, so that it is convenient for the first stent graft 1101 to be pushed out of the delivery sheath 3, while the second stent graft 1201 is not released from the delivery sheath 3 yet is still bound by the delivery sheath 3 and is in a radially compressed state, so that the opening of the channel 15 is smoother, the blood flow is able to be quickly achieved, and the surgical time is facilitated to be shortened. In addition, the first stent graft 1101 and the second stent graft 1201 are indirectly connected by the connecting member 13, so that the channel 15 can be opened to a greater extent, and the smooth blood flow can be better ensured.

In other embodiments, the second tubular frame 1201 may also include only the second stent graft 1201, where the proximal end of the second stent graft 1201 abuts the distal end of the first stent graft 1101, and where the second stent graft 1201 is attached to the first stent graft 1101 by suture.

Referring to fig. 2-3, in an embodiment, the distal end of the connecting member 13 is fixedly connected to the inner wall of the first frame 111, the proximal end of the connecting member 13 is fixedly connected to the distal end of the second frame 122, and the proximal end of the connecting member 13 may be connected to the inner wall, the outer wall or the distal end face of the second frame 121, so as to connect the connecting member 13 to the first stent graft 1101 and the second stent graft 1201. In addition, in this embodiment, the connection piece 13 is a flexible piece, for example, the connection piece 13 is made of a polymer wire, so that the connection piece 13 can rotate around the connection point of the connection piece 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 without obstructing the expansion or contraction of the second tubular member 12.

In other embodiments, the distal end of the connecting member 13 may be connected to the outer wall of the first frame 111, where the first cover 112 on the outer wall of the first frame 111 covers the connection point between the connecting member 13 and the first frame 111. The connecting member 13 may be connected to the first frame 111 and the second frame 121 by welding or by sewing. When the connecting member 13 is welded to the first frame 111 and the second frame 121, the first frame 111 and the second frame 121 may be covered with a film and then connected to the connecting member 13, or the first frame 111 and the second frame 121 may be connected to the connecting member 13 and then connected to the film. In other embodiments, the connector 13 may also be connected to the first stent graft 1101 and the second stent graft 1201 by connecting to the first stent graft 112 or the second stent graft 122. For example, the first cover film 112 or the second cover film 122 also covers the end portions of the connection members 13 in the process of covering the first frame 111 and the second frame 121, thereby realizing the connection of the connection members 13 with the first cover film bracket 1101 and the second cover film bracket 1201. Or the connecting piece 13 may be connected to the first frame 111 and the first film coating 112 at the same time to connect to the first film coating bracket 1101, and the connecting piece 13 may be connected to the second frame 121 and the second film coating 122 at the same time to connect to the second film coating bracket 1201. For example, the connecting member 13 is fixed to both the first frame 111 and the first cover film 112 by sewing, and is fixed to both the second frame 121 and the second cover film 122 by sewing.

In other embodiments, when the connecting element 13 is a flexible element, one end may be fixedly connected to the first tubular member 11 or the second stent graft 1201, the other end may be hinged, or both ends may be hinged. In a further embodiment, the connecting piece 13 can also be provided as a rigid piece, for example made of wire. It will be appreciated that when the connecting member 13 is a rigid member, the two ends of the connecting member 13 need to be hinged to the first tubular member 11 and the second stent graft 1201, respectively.

In other embodiments, the location of the connection point of the connector 13 to the first tubular member 11 and the second stent graft 1201 is not limited, for example, one end of the connector 13 is connected to the proximal end of the first tubular member 11 and the other end is connected to the distal end of the second stent graft 1201. In addition, the connector 13 may be connected to the inner wall, outer wall or proximal end face of the first tubular member 11, and the connector 13 may also be connected to the inner wall, outer wall or distal end face of the second stent graft 1201. That is, the connection manner between the connector 13 and the first tubular member 11 and the second tubular member 12 only needs to be enough to keep the first tubular member 11 and the second tubular member 12 from being separated, and the connector 13 does not affect the opening or closing of the channel 15.

With continued reference to fig. 3-4, in one embodiment, the connector 13 includes four connecting rods 130.

In one embodiment, the connecting rod 130 is a cylindrical rod having a rectangular cross-sectional shape. In other embodiments, the cross-sectional shape of the cylindrical rod may also be circular, scalloped, oval, or other polygonal shape.

Referring to fig. 5, fig. 5 is another implementation of the connecting rod 130, in this embodiment, the connecting rod 130 includes a connecting section 131 and a fitting section 132, where the connecting section 131 is a main body portion of the connecting piece 13, and the fitting section 132 is used to connect the connecting section 131 with the first tubular member 11 or the second stent graft 1201. In this embodiment, the connecting section 131 is an elongated cylinder, and the assembling section 132 is provided with only one and is circular, so that the connecting rod 130 and the first tubular member 11 and the second stent graft 1201 may be assembled in such a manner that the distal end of the connecting rod 130 is connected to the first frame 111 by welding through the connecting section 131, the proximal end of the connecting rod 130 is connected to the peak or trough of the distal end of the second stent graft 1201 by interconnecting the assembling section 132, or the distal end of the connecting rod 130 is connected to the peak or trough of the first frame 111 by interconnecting the assembling section 132, and the proximal end of the connecting rod 130 is connected to the distal end of the second stent graft 1201 by welding through the connecting section 131.

In other embodiments, two fitting sections 132 may be provided, and the two fitting sections 132 are connected to both ends of the connection section 131, respectively, so that both ends of the connection bar 130 may be hooked with the first frame 111 and the second frame 121, respectively. In other embodiments, the mounting section 132 may also be configured as a T-bar that is coupled to the connecting section 131 such that the connecting bar 130 is generally T-shaped. Or the assembling section 132 is a straight rod, and the extending direction of the assembling section 132 is perpendicular to the extending direction of the connecting section 131, and the assembling section 132 is connected with the connecting section 131 to form a connecting rod 130 with a T shape integrally.

Referring to fig. 6, fig. 6 shows a further implementation of the connecting rod 130, in which the connecting rod 130 still includes a connecting section 131 and an assembling section 132, unlike the structure shown in fig. 5, in this embodiment, the connecting rod 130 is formed by weaving a woven wire on the first frame 111, the connecting section 131 of the connecting rod 130 is integral with a trough of the first bracket unit 1111 on the first frame 111, the connecting section 131 is formed by winding two ends of the woven wire with each other, the assembling section 132 is a ring formed by bending a middle part of the woven wire or other irregular ring-shaped structure, and the assembling section 132 can be inter-hung with a crest or trough of the second frame 121. Or by welding or sewing the mounting section 132 to the second frame 121. It will be appreciated that in other embodiments, the connecting rod 130 may be woven from a derivative of the woven wire on the second frame 121, the mounting section 132 may be interconnected with the first frame 111, welded or sewn, or the connecting rod 130 may be woven directly from the woven wire into a shape having two mounting sections 132, the two mounting sections 132 being interconnected with the first frame 111 and the second frame 121, respectively, welded or sewn. In other embodiments, the connecting piece 13 may also be formed by folding a knitting yarn into a u-shaped structure, a S-shaped structure or an O-shaped structure, and the specific knitting shape of the connecting piece may be selected according to actual use situations.

It will be appreciated that the number of the connecting rods 130 is not limited, and may be selected according to need, wherein the more the number of the connecting rods 130, the more stable the connection between the first tubular member 11 and the second tubular member 12 will be, but at the same time, the greater the possibility that the expansion process of the second tubular member 12 will be affected by the connecting rods 130.

Referring back to fig. 1-3, in the implantable medical system shown in fig. 1, the channel 15 is an annular channel, and the branch stent 2 and the implantable medical device 1 are matched in such a way that one end of the branch stent 2 extends into the channel 15 of the implantable medical device 1, and is then clamped by the first tubular member 11 and the sealing assembly 14 in a matched manner.

On the one hand, the implantable medical system uses the implantable medical device 1 capable of keeping blood flow smooth in the operation process, so that the branch stent 2 can be implanted under the condition of blood flow smooth, and compared with the situation that the branch stent 2 is implanted under the condition of blood flow blockage in the prior art, the implantable medical system can gain more time 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 medical device 1 through the annular channel, in the implantation operation process, the branch stent 2 only needs to be stretched into different positions in the annular channel according to the direction of the corresponding anatomical structure of the branch lumen, and compared with the mode of opening a side window on the implantable medical device 1 for assembling the branch stent 2, the annular channel is unblocked in all directions in the circumferential direction, so that the angle of the first tubular member 11 which is completely expanded is not required to be adjusted in the implantation operation process of the branch stent 2, thereby reducing the operation difficulty and further improving the operation success rate.

It should be noted that the number of the branch brackets 2 is not limited and may be selected as required. In addition, when the number of the connecting rods 13 in the implantable medical device 1 mated with the branch stent 2 is greater than 2, the connecting rods 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 rapid positioning when the branch stent 2 is implanted.

It should be noted that, in the implantable medical device 1 shown in fig. 1, the first tubular member 11 and the second tubular member 12 are coaxially disposed, and in other embodiments, the first tubular member 11 and the second tubular member 12 may be configured to be non-coaxially disposed according to the number and positions of the branch stents 2 to be implanted.

With continued reference to fig. 1-2, in one embodiment, the flexibility of the seal assembly 14 is greater than the flexibility of the second tubular structure 12, and the branch stent 2 is cooperatively held by the first tubular member 11 and the seal assembly 14, so that, on the one hand, the seal assembly 14 is more flexible and thus can better conform to the shape of the branch stent 2, thereby providing a tighter packing of the branch stent 2, and, on the other hand, maintaining the morphology of the second tubular member 12 to a certain extent without being subject to extrusion changes.

In other embodiments, the seal assembly 14 may be such that the radially expanded outer diameter of the seal assembly 14 is greater than the radially expanded inner diameter of the first tubular member 11 in the natural state. So that 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 mounting stability of the branch stent 2.

Referring to fig. 3-4, in one embodiment, the seal assembly 14 includes a driver 141 and a separator 142.

The proximal end of the separation membrane 142 is connected to the second stent graft 1201, the distal end extends axially to the side of the first tubular member 11 to be at least partially accommodated in the first lumen 110, the portion of the separation membrane 142 accommodated in the first lumen 110 has a free end, the separation membrane 142 has an unfolded and folded state, the separation membrane 142 in the unfolded state has a hollow cylindrical shape, and the channel 15 is formed by matching the outer wall of the portion of the separation membrane 142 accommodated in the first lumen 110 with the inner wall of the first tubular member 11. The proximal end of the driving element 141 is connected to the second stent graft 1201, the distal end extends axially to the side of the first tubular member 11 to be at least partially accommodated in the first lumen 110, and the portion of the driving element 141 accommodated in the first lumen 110 has a free end, the driving element 141 is connected to the separation membrane 142, and the driving element 141 is configured to drive the separation membrane 142 to radially expand with the expansion of the second tubular member 12 or the driving element 141 is configured to drive the separation membrane 142 to fold with the contraction of the second tubular member 12.

The radially expanded separation membrane 142 is such that the outer wall of the separation membrane 142 is in contact with the inner wall of the first tubular member 11, and the closed state of the passage 15. The state in which the separation membrane 142 is folded or contracted such that the outer wall of the separation membrane 142 is spaced from the inner wall of the first tubular member 11 is the open state of the passage 15.

By arranging the sealing assembly 14 to comprise the driving piece 141 and the separation membrane 142, when the branch stent 2 is implanted in the channel 15, the separation membrane 142 can be coated on the side wall of the branch stent 2 more closely due to the fact that no redundant stent units are blocked on the separation membrane 142, so that a better inner leakage prevention effect is ensured. In addition, since there is no redundant stent unit on the separation membrane 142, the flexibility is better, so that the co-extrusion of the branch stent 2 by the first tubular member 11 and the sealing assembly 14 can be avoided, and the shape of the branch stent 2 can be better maintained.

With continued reference to fig. 3-4, in one embodiment, the driving member 141 includes a plurality of driving rods 1410 coupled to the distal end of the second tubular member 12, the driving rods 1410 are disposed on the separation membrane 142, and the proximal ends of the driving rods 1410 are coupled to the second stent graft 1201, and the distal ends are free ends. The extending direction of the driving rod 1410 is such that when the first tubular member 11 and the second tubular member 12 are both in the radially expanded state, the portion of the driving rod 1410 housed within the first tubular member 11 is in abutment with the inner wall of the first tubular member 11. For example, in one embodiment, the first tubular member 11 is in a constant diameter cylindrical structure, the driving rod 1410 is fully accommodated in the first tubular member 11 when the first tubular member 11 and the second tubular member 12 are in a unfolded state, and the driving rod 1410 is in a straight rod structure as a whole, or in other embodiments, the first tubular member 11 is still in a constant diameter cylindrical structure, but the driving rod 1410 is only partially accommodated in the first tubular member 11 when the first tubular member 11 and the second tubular member 12 are in a unfolded state, and the portion of the driving rod 1410 accommodated in the first tubular member 11 is a straight rod attached to the inner wall of the first tubular member 11, and the extending direction of the portion of the driving rod 1410 not accommodated in the first tubular member 11 may form a right angle or an obtuse angle with the extending direction of the portion of the driving rod 1410 accommodated in the first tubular member. Or the first tubular member 11 is of a tapered cylindrical structure, the portion of the driving rod 1410 accommodated in the first tubular member 11 is a curved rod having a bending angle which is fitted to the inner wall of the first tubular member 11, and the bending angle thereof matches the inner shape of the first tubular member 11.

The proximal end of the driving rod 1410 may be fixed to the second stent graft 1201 by welding, suturing, or the like, or may be formed by weaving a woven wire of the second frame 121 on the second stent graft 1201, and the specific connection manner may be selected according to the use condition.

With continued reference to fig. 4, in one embodiment, the driving rod 1410 has a rectangular rod-shaped structure, and in other embodiments, the driving rod 1410 may have a circular, fan-shaped, oval or other polygonal shape, or the driving rod 1410 may have a spiral structure formed by winding a braided wire.

With continued reference to fig. 3-4, in one embodiment, the separation membrane 142 is integrally formed with the second cover membrane 122 of the second tubular member 12. In other embodiments, the separation membrane 142 may also be sewn to the distal end of the second cover membrane 122 by a suture. The separation membrane 142 may be an integrally formed annular sheet, or may be formed by splicing and combining a plurality of arc-shaped sheet bodies. It is understood that the material of the separation membrane 142 may be nylon or the like suitable for manufacturing artificial blood vessels, or dacron cloth or PTFE film. The material of the separation membrane 142 is not limited to the above-mentioned material, and the separation membrane 142 may be made of a flexible material that can block blood flow and is suitable for implantation into a human body. The connection between the separation membrane 142 and the driving rod 1410 may be achieved by sewing, heat treatment cladding or bonding.

It should be noted that, in other embodiments, the driving rod 1410 and the separation membrane 142 may be connected to the middle or distal end of the second tubular member 12. The drive rod 1410 and the separation membrane 142 are conveniently assembled to the distal end of the second tubular member 12 without affecting the morphology of the second tubular member 12.

With continued reference to fig. 3-4, in one embodiment, the separation membrane 142 is coupled to both the drive rod 1410 and the connecting rod 130.

Specifically, in this embodiment, the distal end of the connector 13 is connected to the inner wall of the first stent graft 1101, and the proximal end of the connector 13 is connected to the distal end of the second stent graft 1201. The connecting piece 13 comprises four connecting rods 130, the four connecting rods 130 are uniformly distributed along the circumferential direction of the first lumen 110, and the connecting rods 130 meet the requirement that when the first stent graft 1101 and the second stent graft 1201 are in the unfolded state, the extending direction of the connecting rods 130 is parallel to the axial direction of the first stent graft 1101. A driving rod 1410 is disposed between two adjacent connecting rods 130, that is, the driving member 141 includes four driving rods 1410, and the separation film 142 is connected to the connecting rods 130 and the driving rods 1410 at the same time in the circumferential direction.

Referring to fig. 7-8, before the branch stent 2 is implanted, the first stent graft 1101 is radially expanded, the second stent graft 1201 is radially compressed, at this time, the driving member 1410 drives the separation 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 separation membrane 142 divides the channel 15 due to the connection with the connection rod 130, so that the annular channel exists in the form of a plurality of sub-channels 150 which are not communicated with each other. After the branch stent 2 is implanted into the channel 15, by releasing the second stent graft 1201, the proximal end of the connecting rod 130 and the driving rod 1410 move along with the deployment of the second stent graft 1201 to a side close to the inner wall of the first stent graft 1101, and under the driving of the connecting rod 130 and the driving rod 1410, the separation membrane 142 is also deployed until the second stent graft 1201 is in a radially deployed state, at this time, all the connecting rods 130 are attached to the side wall of the first stent graft 1101, in the sub-channel 150 in which the branch stent 2 is implanted, the driving rod 1410 is attached to the side wall of the branch stent 2, the separation membrane 142 is wrapped on the branch stent 2 under the combined action of the connecting rod 130 and the driving rod 1410 to wrap the branch stent 2, and in the sub-channel 150 in which the branch stent 2 is not implanted, the driving rod 1410 drives the separation membrane 142 to be attached to the inner wall of the first stent graft 1101 together to seal the channel 15.

Through being connected separation membrane 142 and connecting rod 130 for each implantation direction of passageway 15 can be distinguished by separation membrane 142 more clearly, thereby make things convenient for branch frame 2's quick location and implantation, simultaneously, separation membrane 142 is connected with connecting rod 130, makes the effect of connecting rod 130 not just be limited to connect first tubular member 11 and second tubular member 12, but can also cooperate actuating lever 1410 to play better tensioning effect to separation membrane 142, and play the restriction effect to branch frame 2, thereby improve branch frame 2's assembly stability.

In this embodiment, the distal end of the separation membrane 142 and the distal end of the driving rod 1410 are on the same radial plane with the distal end of the connecting rod 130. In other embodiments, the distal end of the drive rod 1410 may also extend beyond the distal end of the connecting rod 130 or below the distal end of the connecting rod 130.

It should be noted that the number of the connecting rods 130 and the driving rods 1410 is not limited, and may be selected according to practical situations. The number of the connection rods 130 does not need to correspond to the number of the driving rods 1410, for example, the number of the driving rods 1410 provided between two adjacent connection rods 130 is 3 or 4, etc. at a position where the branch stent 2 is to be implanted. In addition, in other embodiments, the connection rods 130 may be disposed only along the circumferential direction of the first lumen 110 at intervals and unevenly distributed, for example, the distribution of the connection rods 130 is more dense in the direction in which the branch stent 2 needs to be implanted, and the distribution of the connection rods 130 is more sparse in the direction in which the branch stent 2 does not need to be implanted.

It will be appreciated that in other embodiments, the separator 142 may be connected to the drive rod 1410 only, i.e., the separator 142 may not be connected to the connecting rod 130, and in the contracted state, the connecting rod 130 is in contact with the separator 142, but there is no connection point therebetween. In this manner, the seal assembly 14 also provides a good seal, and the connecting rod 130 and the seal assembly 14 do not interfere with each other, thereby not affecting the opening and closing of the passageway 15.

It will be appreciated that when the separation membrane 14 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 needs to be considered without affecting the expansion or contraction of the separation membrane 142. For example, in the embodiment shown in fig. 3-4, the proximal end of the connecting rod 130 is connected to the distal end of the second stent graft 1201, the distal end of the connecting rod 130 is connected to the first stent graft 1101, and the connection point of the connecting rod 130 to the first stent graft 1101 is located beyond the distal end face of the second stent graft 1201, so that the connecting rod 130, the driving rod 1410, and the separation membrane 142 are all located on the distal side of the second stent graft 1201, and during the expansion or contraction of the second stent graft 1201, the connecting rod 130 and the driving rod 1410 cooperate to drive the expansion or contraction of the separation membrane 142 together. The radially compressed state of the second stent graft 1201 is not necessarily achieved by the delivery sheath 3, but may also be achieved by a restriction structure.

Referring to fig. 9-10, another implementation of the implantable medical device 1 is shown. Which differs from the structure of the implantable medical device 1 shown in fig. 8 in the connection location of the connector 13 with the first tubular member 11. In this embodiment, the distal end of the connector 13 is connected to the peak of one of the first rack units 1111 of the most proximal end of the first frame 111 on the first tubular member 11, and the distal end face of the seal assembly 14 is flush with the distal end face of the connector 13. That is, in this embodiment, the overlapping area of the seal assembly 14 and the first tubular member 11 defines a first stent unit 1111 at the proximal most end of the first tubular member 11 to the proximal end face of the first tubular member 11. After the branch stent 2 is implanted, one end connected with the implantable medical device 1 is clamped by the overlapping area, the cross-section view of the first tubular member 11 is shown in fig. 10, and because the trough of the first stent unit 1111 on the first tubular member 11 in the overlapping area is a free end, and no other first stent units 1111 are hung, the first tubular member 11 in the overlapping area has larger flexibility, and can deform to the side far 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, and the peripheral leakage risk of the implantable medical device 1 is further reduced.

It will be appreciated that in other embodiments, the distal end surface of the sealing assembly 14 may extend further distally, so long as the end of the branch stent 2 is clamped by the sealing assembly 14 in cooperation with the more flexible region on the first tubular member 11 (from the most proximal first stent unit 1111 of the first tubular member 11 to the proximal end surface of the first tubular member 11), the above-mentioned effect that the branch stent 2 is more tightly wrapped may still be obtained. When the distal end face of the sealing member 14 exceeds the end face of the clamped end of the branch stent 2 after implantation, the sealing member 14 is arranged in consideration of not blocking the blood flow of the branch stent 2 when fully deployed in the radial direction.

With continued reference to fig. 11-12, which are another implementation of the implantable medical device 1, in this embodiment, the separation membrane 142 is still connected to the connector 13, which differs from the structure of the embodiment shown in fig. 4 in the arrangement of the connector 13. In this embodiment, the connector 13 comprises four rod groups, each comprising a connecting rod 130a and a connecting rod 130b, wherein when the first tubular member 11 and the second tubular member 12 are in the radially expanded state, the extending directions of the connecting rod 130a and the connecting rod 130b form a non-zero included 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 be converged at an intersection point, the connecting rod 130a and the connecting rod 130b are located about the intersection point, and an axis parallel to the longitudinal central axis of the second stent graft 1201 (in fig. 11-12, the second stent graft 1201 is contracted in the delivery sheath 3) is symmetrically distributed, so that the connecting rod 130a and the connecting rod 130b are connected at a connecting distance on the first tubular member 11 greater than the connecting distance on the second tubular member 12, a driving rod 1410 is arranged between the connecting rod 130a and the connecting rod 130b, and no driving rod 1410 is arranged between the adjacent rod groups, and the driving rods 142 are connected in the circumferential directions of the connecting rods 130a and 1410 b.

In this way, when the first tubular member 11 is in the radially expanded state and the second stent graft 1201 is in the radially compressed state before the stent graft 2 is not implanted, the channel 15 is opened, and at this time, the separation membrane 142 is in the tense state under the action of the connecting rod 130a, the connecting rod 130b and the driving rod 1410, so that the blockage of the sub-channel 150 by the folds of the separation membrane 14 can be avoided, and the difficulty in establishing the implantation path of the stent graft 2 can be further reduced. In addition, since 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 connecting rod and the connecting rod on the second tubular member 12, the sub-channel 150 is formed into a conical pocket shape with a large distal opening and a small proximal opening, wherein the distal opening of the sub-channel 150 is wider, so that the branch stent 2 can be conveniently sent into the sub-channel 150 from the distal end, and the proximal opening of the sub-channel 150 is narrower, so that the separating membrane 142 can be more tightly attached to the side wall of the branch stent 2, thereby improving the inner leakage preventing effect.

In other embodiments, the connecting rods 130a and 130b may not be symmetrically distributed about an axis parallel to the longitudinal central axis of the second stent graft 1201 at the intersection of the collections of extension lines of the proximal ends of the connecting rods 130a and 130 b.

With continued reference to fig. 12, in one embodiment, the connecting rods 130a in one rod set are connected together with the distal ends of the connecting rods 130b in the rod set adjacent thereto. In other embodiments, the proximal ends of the connecting rods 130a and 130b in each rod set may also be connected such that the rod sets cooperate to form an annular wave structure, wherein the connecting rods 130a and 130b in each rod set are connected to form a trough of the annular wave structure and the connecting rods 130a and 130b in adjacent rod sets are connected to form a peak of the annular wave structure. When the connector 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 hooked to the first tubular member 11 and the second tubular member 12.

Referring to fig. 13-14, another implementation of the implantable medical device 1 is shown. In this embodiment, the first tubular member 11 includes a first stent graft 1101 and a cover membrane 1102, the distal end of the cover membrane 1102 being connected to the proximal end of the first stent graft 1101, and the distal end extending to a side proximal to the second tubular member 12 to form a free end, and the middle of the cover membrane 1102 also being connected to the connector 13.

The connecting piece 13 comprises a connecting rod 130a and a connecting rod 130b, and the adjacent connecting rods 130a and 130b are connected end to end, so that the connecting piece 13 forms an annular wave structure. Wherein the peaks of the connectors 13 are inter-hung with the most proximal valleys of the first stent graft 1101, and the valleys of the connectors 13 are inter-hung with the most distal peaks of the second stent graft 1201.

The outer diameter of the second stent graft 1201 is smaller than the outer diameter of the first stent graft 1101, and the distal outer diameter of the separation membrane 142 matches the inner diameter of the first stent graft 1101, and the proximal outer diameter of the separation membrane 142 matches the outer diameter of the second stent graft 1201, so that the separation membrane 142 has an inverted circular truncated cone shape in the radially expanded state, as shown in FIG. 15. The separation membrane 142 is provided with a bead seam edge 1421, and the bead seam edge 1421 is used for serving as a mark for connecting the separation membrane 142 with the connecting piece 13. The channel 15 is formed by the cooperation of the outer wall of the separation membrane 142 with the inner wall of the cover membrane 1102. The connection point of the driving rod 1410 to the second tubular member 12 coincides with the lowest point of the trough of the connecting piece 13.

When the first stent graft 1101 is in a radially expanded state and the second stent graft 1201 is in a radially compressed state, the driving rod 1501 drives the separation 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 stent graft 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 separation membrane 142. When the second tubular member 12 is shifted to the radially expanded state, the distal end of the connector 13 and the driving rod 1401 are both expanded outwardly, thereby driving the separation membrane 142 to abut against the cover membrane 1102 to close the sub-channel 1501. By the arrangement, when the branch stent 2 is clamped by the sub-channel 1501, the cover film 1102 and the separation film 142 can be better attached to the shape of the branch stent 2 due to the flexible films on the inner side and the outer side, so that the branch stent 2 can be more tightly wrapped, and the effect of preventing inner leakage of the implantable medical device 1 and fixing the branch stent 2 is better.

It will be appreciated that the material of the cover 1102 may be nylon, polyester cloth, or any other conventional cover material that may be used to make a stent graft.

In addition, as shown in fig. 15, to further enhance the mounting stability of the branch stent 2, an extension 143 is further attached to the distal end of the partition film 142. The extending direction of the extending edge 143 is parallel to the extending direction of the first film covered stent 1101, the height of the distal end of the extending edge 143 in the axial direction is higher than the height of the peak 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 extending edge 143, and the extending edge 143 is used for extending the axial length of the annular channel 15. The extending side 143 is provided with an extending suture side 1431, the extending suture side 1431 extending in the axial direction, the extending suture side 1431 being used for fixing the extending side 143 to the first tubular member 11. Under the action of the extending edges 143, the length of each sub-channel 1501 in the axial direction is prolonged to a certain extent, so that the structure of the sub-channels 1501 is more perfect, and the path establishment of the branch stent 2 and the stability of the branch stent 2 are more facilitated.

Referring to fig. 16-17, another embodiment of an implantable prosthetic device 1 is shown, which has a slightly different drive rod 1410 than the embodiment shown in fig. 13. The driving rod 1410 includes a connection portion 14101 and an abutting portion 14102, wherein an end of the connection portion 14101 away from the abutting portion 14102 is connected to the second film coating bracket 1201, an end of the abutting portion 14102 away from the connection portion 14101 is a free end, and a projection area of the free end of the abutting portion 14102 on the separation film 142 is larger than a projection area of a connection section of the connection portion 14101 and the second tubular member 12 on the separation film 142. The abutment 14102 serves to increase the contact area of the distal end of the driving rod 1410 with the separation film 142.

Specifically, in an embodiment, the supporting portions 14102 are annular, two supporting portions 14102 are provided, the two supporting portions 14102 are axisymmetrically arranged, the symmetry axis of the two supporting portions 14102 is a straight line parallel to the longitudinal central axis of the second film coating bracket 1201 where the connecting end of the second tubular member 12 is located, the connecting portion 14101 is in a Y shape to simultaneously connect the two supporting portions 14102, and the diameter of the supporting portion 14102 is larger than the width of the distal end of the connecting portion 14101.

By providing the abutting portion 14102 to increase the abutting area of the driving rod 1410 and the separation film 142, the separation film 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 circumferential leakage.

With continued reference to fig. 17, in one embodiment, when the first tubular member 11 is in the radially expanded state and the second tubular member 12 is in the radially contracted state, one of the two adjacent driving rods 1410 abuts against the abutment 14102 on the outermost side of one of the driving rods 1410 and the abutment 14102 on the other driving rod 1410 adjacent to the abutment 14102, so as to cooperatively clamp the separation membrane 142. By the arrangement, the separation membrane 142 can be pulled and tightened under the action of the driving rod 1410, so that gaps among the sub-channels 1501 disappear, and the establishment of implantation paths of the branch stent 2 is facilitated.

It is to be understood that the specific shape and number of the abutment portions 14102 are not limited, and may be selected according to practical situations.

It should be noted that in one embodiment, the implantable medical device 1 may further comprise a leaflet structure (not shown) attached to the second tubular member 12, the leaflet structure comprising three closable and openable leaflets. When the implantable medical device 1 is implanted in the body, the three leaflets close and open as the heart expands and contracts, thereby closing or opening the second lumen 120. The material of the valve leaflet can be biological material or polymer material. When aortic dissection patients simultaneously develop aortic valve lesions and require replacement of the native aortic valve, aortic dissection and replacement of the native aortic valve can be simultaneously treated using the implantable medical device 1. It will be appreciated that in other embodiments, the number of leaflets is not limited to three, for example, two or four, and that the leaflet structure may be omitted when the implantable medical device 1 is applied to renal arteries or the like other locations where replacement of the native valve is not desired.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The foregoing disclosure is illustrative of the present invention and is not to be construed as limiting the scope of the invention, which is defined by the appended claims.

Claims

1. An implantable medical device, comprising:

A first tubular member having a first lumen;

A second tubular member having a second lumen, the distal end of the second tubular member being connected to the proximal end of the first tubular member by means of a point connection;

The sealing assembly is connected with the second tubular member, the distal end of the sealing assembly extends axially in a direction away from the second tubular member to be at least partially accommodated in the first lumen, the portion of the sealing assembly accommodated in the first lumen is of an annular structure and is provided with a free end, the annular structure surrounds the longitudinal central axis of the first tubular member, the sealing assembly can be synchronously unfolded or contracted along with the second tubular member, so that the outer wall of the portion of the sealing assembly accommodated in the first lumen and the inner wall of the first tubular member form an openable or closable channel in a matching manner, and the channel is in an opened state and is communicated with the first lumen when the first tubular member is in a radial unfolded state and the second tubular member is in a radial compressed state, and is in a closed state when the first tubular member and the second tubular member are in a radial unfolded state.

2. The implantable medical device according to claim 1, wherein the channel is an annular channel, or a plurality of the channels are arranged at intervals along the circumference of the second tubular member, or one channel and the channel is a non-annular channel.

3. The implantable medical device according to claim 1, wherein the first tubular member comprises a first stent graft and a cap, a distal end of the cap being connected to a proximal end of the first stent graft, the proximal end extending to a side of the second tubular member and forming a free end, the passageway being formed by an inner wall of the cap mated with an outer wall of the seal assembly.

4. The implantable medical device according to claim 1, wherein the second tubular member comprises a second stent graft, the distal end of which abuts the proximal end of the first tubular member, or wherein the second tubular member comprises a second stent graft and a connector, the distal end of which abuts 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 stent graft.

5. The implantable medical device according to claim 4, wherein the sealing assembly comprises:

a separation membrane, the proximal end of which is connected with the second tectorial membrane bracket, the distal end of which extends axially to the side where the first tubular member is located so as to be at least partially accommodated in the first lumen, the part of the separation membrane accommodated in the first lumen is provided with a free end, the separation membrane is in an unfolding and folding state, and the outer wall of the part of the separation membrane accommodated in the first lumen is matched with the inner wall of the first tubular member to form the channel;

And the driving piece is connected with the second tectorial membrane bracket, the far end extends axially to the side where the first tubular component is located so as to be at least partially accommodated in the first lumen, the part of the driving piece accommodated in the first lumen is provided with a free end, the driving piece is connected with the separation membrane, and the driving piece is used for driving the separation membrane to be unfolded along with the expansion of the second tubular component or driving the separation membrane to be folded along with the contraction of the second tubular component.

6. The implantable medical device according to claim 5, wherein the driver comprises a driving rod extending in a direction such that a portion of the driving rod received within the first tubular member engages an inner wall of the first tubular member when the first tubular member and the second tubular member are both in a radially expanded state.

7. The implantable medical device according to claim 6, wherein the connector comprises a plurality of connecting rods, the plurality of connecting rods are distributed at intervals along the circumferential direction of the first lumen, when the first tubular member and the second tubular member are in a radially-unfolded state, the extending direction of each 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, and the separation membrane is connected with the connecting rods and the driving rods simultaneously along the circumferential direction.

8. The implantable medical device according to claim 6, wherein the connector 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 in a radial unfolding state, an extending direction of the two connecting rods forms a non-zero included angle with an axial direction of the first tubular member, extension lines of proximal ends of the two connecting rods can be converged on an intersection point, at least one driving rod is arranged between the two connecting rods, and the separation membrane is connected with the connecting rods and the driving rods simultaneously along a circumferential direction.

9. The implantable medical device according to claim 8, wherein two of said connection bars are connected in pairs to form a ring-shaped wave structure, two connection bars in said connection group being connected to form a trough of said ring-shaped wave structure, connection bars in adjacent connection groups being connected to form a peak of said ring-shaped wave structure.

10. The implantable medical device according to any one of claims 6-9, wherein the driving rod comprises a connecting portion and at least one abutting portion connected to the connecting portion, an end of the connecting portion, which is far away from the abutting portion, is connected to the second tubular member, an end of the abutting portion, which is far away from the connecting portion, is a free end, and a projected area of the abutting portion on the separation membrane is larger than a projected area of the connecting portion, which is far away from the abutting portion, on the separation membrane, of a connecting end of the connecting portion, which is connected to the second tubular member.

11. The implantable medical device according to claim 10, wherein the number of the abutment portions is two, and the two abutment portions are axisymmetrically arranged, and the symmetry axis thereof is a straight line of the connection portion and the connection end of the second tubular member, which is parallel to the longitudinal central axis of the second tubular member.

12. The implantable medical device according to claim 11, wherein the number of the abutments is 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, one of the two adjacent drive rods abuts against the other of the two drive rods adjacent to the one of the two drive rods to clamp the separator.

13. The implantable medical device according to claim 4, wherein the connector comprises a connecting section and an assembling section connected with the connecting section, the assembling section is connected with one of the first tubular member and the second tubular member, one end of the connecting section far away from the assembling section is connected with 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 assembling section is a ring-shaped structure, a T-shaped rod or a straight rod with an extending direction perpendicular to the extending direction of the connecting section.

14. The implantable medical device of claim 1, wherein the implantable prosthetic medical further comprises a leaflet structure disposed within the second tubular member and the leaflet structure is openable or closable to place a second lumen of the second tubular member in an open or closed state.

15. An implantable medical system, comprising:

a branch bracket;

And the implantable medical device of any one of claims 1-14, one end of the branched stent being extendable into the channel and cooperatively retained by the first tubular member and the seal assembly.