Implantable medical device and implantable medical system

Abstract

The invention relates to an implantable medical device and an implantable medical system, and relates to the technical field of medical instruments. An implantable medical device includes: a first tubular member; the far end of the second tubular component is connected with the near end of the first tubular component in a point connection manner; the near end of the sealing assembly is connected with the second tubular component, the far end of the sealing assembly axially extends in the direction away from the second tubular component so as to be at least partially contained in the first tubular cavity, the part, contained in the first tubular cavity, of the sealing assembly is of an annular structure and is provided with a free end, and the annular structure surrounds the longitudinal central axis of the first tubular component; the sealing assembly can be synchronously expanded or contracted along with the second tubular component, so that the outer wall of the part, contained in the first tubular cavity, of the sealing assembly is matched with the inner wall of the first tubular component to form a channel capable of being opened or closed. The implantable medical device can keep the blood flow smooth in the operation process, and adverse effects on the health of a patient due to blood flow blockage are prevented.

Description

Technical Field

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

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

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

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

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

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

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

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

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

[0010] An implantable medical device comprises: a first tubular member having a first tubular cavity; a second tubular member having a second tubular cavity, the distal end of the second tubular member being connected to the proximal end of the first tubular member by a point connection; and a sealing assembly, the proximal end of the sealing assembly being connected to the second tubular member, the distal end extending axially in a direction away from the second tubular member to be at least partially accommodated in the first tubular cavity, the portion of the sealing assembly accommodated in the first tubular cavity being an annular structure and having a free end, the annular structure surrounding the longitudinal center axis of the first tubular member, the sealing assembly being able to be expanded or contracted synchronously with the second tubular member, so that the outer wall of the portion of the sealing assembly accommodated in the first tubular cavity cooperates with the inner wall of the first tubular member to form a channel that can be opened or closed, when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the channel is in an open state and connected to the first tubular cavity; when the first tubular member and the second tubular member are both in a radially expanded state, the channel is in a closed state.

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

[0012] In one embodiment, the first tubular member includes a first coated stent and a cover film, the distal end of the cover film is connected to the proximal end of the first coated stent, the proximal end extends toward the side where the second tubular member is located and forms a free end, and the channel is formed by the inner wall of the cover film and the outer wall of the sealing assembly.

[0013] In one embodiment, the second tubular member includes a second coated stent, and the distal end of the second coated stent abuts against the proximal end of the first tubular member; or, the second tubular member includes a second coated stent and a connecting piece, the distal end of the second coated stent abuts against or is spaced apart from the proximal end of the first tubular member, the distal end of the connecting piece is connected to the first tubular member, and the proximal end of the connecting piece is connected to the second coated stent.

[0014] In one embodiment, the sealing assembly includes: a separation membrane, a proximal end of which is connected to the second coated stent, a distal end of which extends axially toward the side of the first tubular member so as to be at least partially accommodated in the first lumen, and a portion of the separation membrane accommodated in the first lumen has a free end, the separation membrane has an expanded and folded state, an outer wall of the portion of the separation membrane accommodated in the first lumen cooperates with the 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 coated stent, a distal end of which extends axially toward the side of the first tubular member so as 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 separation membrane, and the driving member is used to drive the separation membrane to expand with the expansion of the second tubular member or to drive the separation membrane to fold with the contraction of the second tubular member.

[0015] In one embodiment, the driving member includes a driving rod, and the extension direction of the driving rod satisfies: when the first tubular member and the second tubular member are both in a radially expanded state, the portion of the driving rod accommodated in the first tubular member fits against the inner wall of the first tubular member.

[0016] In one embodiment, the connecting member includes a plurality of connecting rods, and the plurality of connecting rods are distributed at intervals along the circumference of the first tubular cavity. When the first tubular member and the second tubular member are in a radially expanded 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 two adjacent connecting rods, and the separation membrane is connected to the connecting rods and the driving rods simultaneously along the circumferential direction.

[0017] In one embodiment, the connecting member includes a plurality of rod groups, each of which includes two connecting rods. When the first tubular member and the second tubular member are in a radially expanded state, the extension direction of the two connecting rods forms a non-zero angle with the axial direction of the first tubular member, and the extension lines of the proximal ends of the two connecting rods can converge at an intersection. At least one driving rod is arranged between the two connecting rods, and the separation membrane is circumferentially connected to the connecting rod and the driving rod at the same time.

[0018] In one embodiment, the connecting rods are connected in pairs to form an annular waveform structure, the two connecting rods in the connecting group are connected to form a trough of the annular waveform structure, and the connecting rods in adjacent connecting groups are connected to form a peak of the annular waveform structure.

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

[0020] In one embodiment, the number of the abutting portions is two, and the two abutting portions are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second tubular member where the connecting end of the connecting portion and the second tubular member is located.

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

[0022] In one embodiment, the connecting member includes a connecting section and an assembly section connected to the connecting section, the assembly section is connected to one of the first tubular member and the second tubular member, and one end of the connecting section away from the assembly section is connected to the other of the first tubular member and the second tubular member; the connecting section is a cylindrical rod or a braided wire, and the assembly section is a ring-shaped structure, a T-shaped rod, or a straight rod whose extension direction is perpendicular to the extension direction of the connecting section.

[0023] In one embodiment, the implantable medical prosthesis further includes a leaflet structure, wherein the leaflet structure is disposed in the second tubular member, and the leaflet structure is openable or closable so that the second lumen of the second tubular member is in an open or closed state.

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

[0025] The implantable medical device provided in an embodiment of the present invention forms a channel through a sealing component and a first tubular member. During the implantation operation, the first tubular member can be released first without releasing the second tubular member. At this time, the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state. The second tubular member drives the sealing component to be in a radially compressed state, and the channel is opened. Since the channel is connected to the first tubular cavity, blood can flow out through the channel along the first tubular cavity, or blood can flow out through the first tubular cavity along the channel, thereby maintaining blood flow during the operation and preventing adverse effects on the patient's health due to blood flow blockage.

[0026] The implantable medical system provided by the embodiment of the present invention uses an implantable medical device that can maintain smooth blood flow during surgery in cooperation with a branch stent, so that the branch stent can be implanted when the blood flow is smooth. Compared with the prior art where the branch stent is implanted when the blood flow is blocked, more time can be gained for the implantation of the branch stent, thereby further improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0028] in:

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

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

[0031] Figure 3 A schematic diagram of the internal structure of an implantable medical device according to an embodiment of the present invention;

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

[0033] Figure 5 A schematic structural diagram of a connecting rod according to an embodiment of the present invention;

[0034] Figure 6 A schematic structural diagram of a connecting rod according to another embodiment of the present invention;

[0035] Figure 7 for Figure 2A top view of the implantable medical device shown in a state where the channel is open;

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

[0037] Fig. 9 It is a schematic diagram of assembling an implantable medical device and a delivery sheath according to another embodiment of the present invention;

[0038] Fig.10 is a cross-sectional view of an implantable medical system in a channel-closed state according to another embodiment of the present invention;

[0039] Fig.11 It is a schematic diagram of assembling an implantable medical device and a delivery sheath according to another embodiment of the present invention;

[0040] Fig.12 for Fig.11 A schematic diagram of the assembly of a partial structure of an implantable medical device and a delivery sheath is shown;

[0041] Fig.13 is a schematic structural diagram of an implantable medical device according to another embodiment of the present invention;

[0042] Fig.14 for Fig.13 A schematic diagram of the assembly of the first tubular member and the connecting member in the implantable medical device shown;

[0043] Fig.15 for Fig.13 A schematic diagram of the assembly of the second tubular component and the sealing component in the implantable medical device shown;

[0044] Fig.16 A schematic structural diagram of a driving rod according to another embodiment of the present invention;

[0045] Fig.17 FIG. 1 is a top view of an implantable medical device according to another embodiment of the present invention, with the channel in an open state. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] In the description of the embodiments of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0048] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a replaceable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0049] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end". The "proximal end" and "distal end" of any component of the medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is not parallel to its "axial direction". The "axial" and "radial" of any component of the medical device are defined based on this principle. "Circumferential" refers to the circumferential direction, that is, the axial direction surrounding the lumen structure or column.

[0050] See also Figure 1 The 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 used to be implanted in the anatomical structure of the main lumen, such as implanted in the aorta, and the branch stent 2 is used in conjunction with the implantable medical device 1. The branch stent 2 is used to be implanted in the anatomical structure of the branch lumen, such as implanted in the branch blood vessel of the coronary artery.

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

[0052] See also Figure 1-2 The implantable medical device 1 includes a first tubular member 11 , a second tubular member 12 and a sealing assembly 14 .

[0053] Among them, the first tubular member 11 has a first tubular cavity 110. The second tubular member 12 has a second tubular cavity 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, that is, the connection points (connection parts) between the first tubular member 11 and the second tubular member 12 are multiple discrete points (parts), which are not completely closed in the circumferential direction. The proximal end of the sealing component 14 is connected to the second tubular member 12, and the distal end extends axially away from the second tubular member 12 to be at least partially accommodated in the first tubular cavity 110. The portion of the sealing component 14 accommodated in the first tubular cavity 110 is an annular structure and has a free end. The annular structure surrounds the longitudinal center axis of the first tubular member 11. The sealing component 14 can be expanded or contracted synchronously with the second tubular member 12, so that the outer wall of the portion of the sealing component 14 accommodated in the first tubular cavity 110 cooperates with the inner wall of the first tubular member 11 to form a channel 15 that can be opened or closed (such as 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 from the inner wall of the first tubular member 11, so that the channel 15 is in an open state and connected to the first tubular cavity 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 fits with the inner wall of the first tubular member 11, so that the channel 15 is in a closed state.

[0054] During the implantation operation, the implantable medical device 1 can release the first tubular member 11 and keep the second tubular member 12 in a radially compressed state (e.g., Figure 2 As shown, the first tubular member 11 is pushed out of the delivery sheath 3, while the second tubular member 12 has not yet been released from the delivery sheath 3, and is still constrained by the delivery sheath 3 and is in a radially compressed state; or, the second tubular member 12 is pushed out of the delivery sheath 3, but is radially constrained by a limiting structure (not shown), for example, it is constrained by a tether and is in a radially compressed state). At this time, driven by 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 connected to the first tubular cavity 110, so that blood can flow out through the channel 15 along the first tubular cavity 110, or blood can flow out through the first tubular cavity 110 along the channel 15, thereby maintaining smooth blood flow during the implantation operation and preventing adverse effects on the patient's health due to blood flow blockage.

[0055] It should be noted that the sealing assembly 14 may be connected or disconnected with the first tubular member 11. In one embodiment, the channel 15 may be an annular channel, so that the blood flow is smoother and the effect is better. In other embodiments, there may be multiple channels 15, and the multiple channels 15 are arranged at intervals along the circumference of the second tubular member 12, or there may be only one channel 15, and the channel 15 is a non-annular channel.

[0056] Please continue reading Figure 2 In one embodiment, the first tubular member 11 is a first coated stent 1101 with openings at both ends. The first tubular member 11 includes a first frame 111 and a first coating 112. The first coating 112 is coated on the first frame 111 to form a first tubular cavity 110 with openings at both ends.

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

[0058] Please continue reading Figure 2 In one embodiment, the first support unit 1111 is a wave-shaped structure. In this embodiment, a plurality of first support units 1111 are arranged in an axial cross array, that is, the wave crest of one first support unit 1111 and the wave trough of another first support 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 good structural stability, ensuring that the first frame 111 has good radial support force and axial support force, so that the first frame 111 has good wall adhesion to the anatomical structure of the lumen. In other embodiments, the plurality of first stent units 1111 may also be arranged in an axially equidistant array, that is, the wave crest of a first stent unit 1111 and the wave crest of another first stent unit 1111 adjacent thereto are aligned on a straight line parallel to the axis, so that the first frame 111 has better bending performance, thereby being able to adapt to the anatomical structure of the lumen with a larger angle; or, the plurality of first stent units 1111 may also be arranged and connected in an axially displaced array, that is, the wave crest of a first stent unit 1111 and the wave crest of another first stent unit 1111 adjacent thereto are aligned on a straight line not parallel to the axis, and the wave trough with 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 axial support force of the first frame 111. By changing the arrangement of the first stent units 1111, the bending performance, axial support performance and radial support performance of the first frame 111 can be improved, so that the first frame 111 can adapt to different anatomical structures of the lumen for implantation.

[0059] Please continue reading Figure 2In one embodiment, among the plurality of first bracket units 1111, a first bracket unit 1111 and another first bracket unit 1111 adjacent thereto are connected by means of a wave crest and a wave trough being mutually hung. In other embodiments, the plurality of first bracket units 1111 are connected by an axially extending assembly rod (not shown), so that the first frame 111 has directionality and is easy to bend on the side opposite to the assembly rod to adapt to the curved anatomical structure of the lumen. Alternatively, the plurality of first bracket units 1111 are connected by a plurality of assembly rods, each assembly rod connecting two adjacent first bracket units 1111, and the plurality of assembly rods form a straight line in the axial direction, which can also make the first frame 111 have directionality and be easy to bend on the side opposite to the assembly rod to adapt to the curved anatomical structure of the lumen. Alternatively, the plurality of first bracket units 1111 are connected by a plurality of assembly rods, each assembly rod connecting two adjacent first bracket units 1111, and the adjacent assembly rods are dislocated in the axial direction, so that the first frame 111 has better flexibility and is easy to reach the target position through the curved anatomical structure of the lumen.

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

[0061] In one embodiment, the first frame 111 is formed of a nickel-titanium alloy. In other embodiments, the material of the first frame 111 may also be stainless steel, cobalt-chromium alloy or polymer material, etc. The material selection only needs to satisfy the requirement that the first tubular member 11 can be expanded from a compressed state to an expanded state by balloon expansion or self-expansion, and at the same time have a certain support strength.

[0062] In one embodiment, the first frame 111 may be prepared by weaving a filamentary material and then shaping it, for example, by weaving a nickel-titanium alloy wire and then shaping it to form the first frame 111. In addition, in other embodiments, the first frame 111 may also be formed by laser cutting and then shaping a tubular material or by injection molding, or may also be formed by 3D printing.

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

[0064] Please go back Figure 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 separated by a predetermined distance from the proximal end of the first stent graft 1101, the distal end of the connector 13 is connected to the first stent graft 1101, and the proximal end of the connector 13 is connected to the second stent graft 1201, and the connector 13 is used to maintain the connection between the first stent graft 1101 and the second stent graft 1201.

[0065] The second stent graft 1201 includes a second frame 121 and a second graft 122 , and the second graft 122 is coated on the second frame 121 to form a second lumen 120 with openings at both ends.

[0066] Among them, the specific implementation method of the second frame 121 is the same as that of the first frame 111, and the specific implementation method of the second coating 122 is also the same as that of the first coating 112, so it is not repeated here. It should be noted that the first coating stent 1101 and the second coating stent 1201 themselves can be an integral equal-diameter structure or a variable-diameter structure, and the outer diameter of the distal end of the second coating stent 1201 can be equal to the outer diameter of the proximal end of the first coating stent 1101, or it can be smaller than the outer diameter of the proximal end of the first coating 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 a state of abutment or separation by a predetermined distance by the connector 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 easily pushed out of the delivery sheath 3, while the second stent graft 1201 has not yet been released from the delivery sheath 3 and is still bound by the delivery sheath 3 and is in a radially compressed state, so that the opening of the channel 15 is relatively smooth, and the blood flow can be quickly unblocked and it is helpful to shorten the operation time. In addition, the provision of the connector 13 allows the first stent graft 1101 to be indirectly connected to the second stent graft 1201, so that the channel 15 can be opened to a greater extent, thereby better ensuring the unblocked blood flow.

[0068] In other embodiments, the second tubular frame 1201 may also only include the second coated stent 1201. In this case, the proximal end of the second coated stent 1201 abuts against the distal end of the first coated stent 1101, and the second coated stent 1201 and the first coated stent 1101 can be point-connected by suture suturing.

[0069] See also Figure 2-3 In one embodiment, the distal end of the connector 13 is fixedly connected to the inner wall of the first frame 111, and the proximal end of the connector 13 is fixedly connected to the distal end of the second frame 122. The proximal end of the connector 13 can be connected to the inner wall, outer wall or distal end face of the second frame 121, thereby realizing the connection between the connector 13 and the first stent graft 1101 and the second stent graft 1201. In addition, in this embodiment, the connector 13 is a flexible member, for example, the connector 13 is made of polymer wire, so that the connector 13 can rotate around the connection point between the connector 13 and the first frame 111 as the second stent graft 1201 expands or contracts, thereby maintaining the connection between the first tubular member 11 and the second tubular member 12 without hindering the expansion or contraction of the second tubular member 12.

[0070] It should be noted that, in other embodiments, the distal end of the connector 13 may also be connected to the outer wall of the first frame 111, in which case the first coating 112 on the outer wall of the first frame 111 covers the connection point between the connector 13 and the first frame 111. The connector 13 may be connected to the first frame 111 and the second frame 121 by welding or by sutures. When the connector 13 is welded to the first frame 111 and the second frame 121, the coating may be provided on the first frame 111 and the second frame 121 before being connected to the connector 13, or the first frame 111 and the second frame 121 may be connected to the connector 13 before the coating is connected to each other. In other embodiments, the connector 13 may also be connected to the first coating 112 or the second coating 122 to achieve connection with the first coating support 1101 and the second coating support 1201. For example, the first coating 112 or the second coating 122 covers the first frame 111 and the second frame 121, and also covers the end of the connector 13, so as to achieve the connection between the connector 13 and the first coating support 1101 and the second coating support 1201. Alternatively, the connector 13 can also be connected to the first frame 111 and the first coating 112 at the same time to achieve the connection with the first coating support 1101, and the connector 13 can be connected to the second frame 121 and the second coating 122 at the same time to achieve the connection with the second coating support 1201. For example, the connector 13 is fixed to the first frame 111 and the first coating 112 at the same time by suture suturing, and is fixed to the second frame 121 and the second coating 122 at the same time by suture suturing.

[0071] In other embodiments, when the connector 13 is a flexible member, one end of the connector 13 may be fixedly connected to the first tubular member 11 or the second stent graft 1201, and the other end may be hinged, or both ends may be hinged. In other embodiments, the connector 13 may also be a rigid member, such as made of a metal wire. It is understood that when the connector 13 is a rigid member, both ends of the connector 13 need to be hinged to the first tubular member 11 and the second stent graft 1201, respectively.

[0072] In other embodiments, the connection point positions of the connector 13 and the first tubular member 11 and the second coated stent 1201 are 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 coated stent 1201. In addition, the connector 13 can be connected to the inner wall, outer wall or proximal end face of the first tubular member 11, and the connector 13 can also be connected to the inner wall, outer wall or distal end face of the second coated stent 1201. That is, the connection method between the connector 13 and the first tubular member 11 and the second tubular member 12 only needs to be able to keep the first tubular member 11 and the second tubular member 12 from being separated, and the connector 13 itself does not affect the opening or closing of the channel 15.

[0073] Please continue reading Figure 3-4 In one embodiment, the connecting member 13 includes four connecting rods 130 .

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

[0075] See also Figure 5 , Figure 5 This is another implementation of the connecting rod 130. In this embodiment, the connecting rod 130 includes a connecting section 131 and an assembly section 132, wherein the connecting section 131 is the main part of the connector 13, and the assembly section 132 is used to connect the connecting section 131 to the first tubular member 11 or the second coated stent 1201. In this embodiment, the connecting section 131 is a long cylindrical body, and only one assembly section 132 is provided and is in a circular ring shape. Therefore, the assembly method of the connecting rod 130 and the first tubular member 11 and the second coated bracket 1201 can be: the distal end of the connecting rod 130 is connected to the first frame 111 by welding through the connecting section 131, and the proximal end of the connecting rod 130 is connected to the crest or trough of the distal end of the second coated bracket 1201 by the assembly section 132. Alternatively, the distal end of the connecting rod 130 can be connected to the crest or trough of the first frame 111 by the assembly section 132, and the proximal end of the connecting rod 130 is connected to the distal end of the second coated bracket 1201 by welding through the connecting section 131.

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

[0077] See also Figure 6 , Figure 6 Another implementation of the connecting rod 130 is shown in FIG. 1 . In this embodiment, the connecting rod 130 still includes a connecting section 131 and an assembly section 132. Figure 5The structure shown is different in that, in this embodiment, the connecting rod 130 is derived from the braided wire on the first frame 111, the connecting section 131 of the connecting rod 130 and the trough of the first bracket unit 1111 on the first frame 111 are an integral body, the connecting section 131 is formed by the two ends of the braided wire being intertwined, and the assembly section 132 is a ring or other irregular ring-shaped structure formed by bending the middle of the braided wire, and the assembly section 132 can be connected to the crest or trough of the second frame 121. Alternatively, the assembly section 132 and the second frame 121 are connected by welding or sewing. It is understood that in other embodiments, the connecting rod 130 can also be derived from the braided wire on the second frame 121, and the assembly section 132 is connected to the first frame 111, welded or sewn, or the connecting rod 130 can be directly woven from the braided wire into a shape with two assembly sections 132, and the two assembly sections 132 are respectively connected to the first frame 111 and the second frame 121. In other embodiments, the connector 13 may also be formed by folding the braided wire into a "U"-shaped structure, a "∽"-shaped structure, or an "O"-shaped structure, and the specific braiding shape may be selected according to actual usage.

[0078] It is understandable that there is no limit to the number of connecting rods 130 and they can be selected as needed. The more connecting rods 130 there are, the more stable the connection between the first tubular member 11 and the second tubular member 12 will be. However, at the same time, the possibility that the expansion process of the second tubular member 12 will be affected by the connecting rods 130 will also be greater.

[0079] Please go back Figure 1-3 ,exist Figure 1 In the implantable medical system shown, the channel 15 is an annular channel, and the branch bracket 2 cooperates with the implantable medical device 1 in that one end of the branch bracket 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.

[0080] On the one hand, the implantable medical system uses an implantable medical device 1 that can maintain smooth blood flow during surgery, so that the branch stent 2 can be implanted when the blood flow is smooth. Compared with the prior art in which the branch stent 2 is implanted under blood flow obstruction, more ample time can be gained for the implantation of the branch stent 2, thereby further improving the success rate of the operation. On the other hand, since the branch stent 2 is assembled with the implantable medical device 1 through an annular channel, during the implantation operation, it is only necessary to extend the branch stent 2 to different positions in the annular channel according to the direction of the corresponding branch lumen anatomical structure. Compared with the method of opening a side window on the implantable medical device 1 for the assembly of the branch stent 2, the annular channel is unobstructed in all directions in the circumferential direction, so that during the implantation of the branch stent 2, there is no need to adjust the angle of the fully expanded first tubular member 11, thereby reducing the difficulty of the operation and further improving the success rate of the operation.

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

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

[0083] Please continue reading Figure 1-2 In one embodiment, the flexibility of the sealing component 14 is greater than the flexibility of the second tubular structure 12, and the branch bracket 2 is clamped by the first tubular member 11 and the sealing component 14. On the one hand, the sealing component 14 has better flexibility and can adapt to the shape of the branch bracket 2, thereby providing a tighter wrapping for the branch bracket 2. On the other hand, it can also maintain the shape of the second tubular member 12 from being squeezed and changed to a certain extent.

[0084] In other embodiments, the sealing assembly 14 may also be such that, in a natural state, the outer diameter of the sealing assembly 14 after radial expansion is larger 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 installation stability of the branch stent 2.

[0085] See also Figure 3-4In one embodiment, the sealing assembly 14 includes a driving member 141 and a separation membrane 142 .

[0086] Among them, the proximal end of the partition membrane 142 is connected to the second coated bracket 1201, and the distal end extends axially toward the side where the first tubular member 11 is located so as to be at least partially accommodated in the first tubular cavity 110, and the portion of the partition membrane 142 accommodated in the first tubular cavity 110 has a free end, and the partition membrane 142 has an unfolded and folded state. The partition membrane 142 in the unfolded state is a hollow cylinder, and the channel 15 is formed by the outer wall of the portion of the partition membrane 142 accommodated in the first tubular cavity 110 and the inner wall of the first tubular member 11. The proximal end of the driving member 141 is connected to the second coated support 1201, and the distal end extends axially toward the side of the first tubular member 11 to be at least partially accommodated in the first tubular cavity 110, and the portion of the driving member 141 accommodated in the first tubular cavity 110 has a free end. The driving member 141 is connected to the separation membrane 142, and the driving member 141 is used to drive the separation membrane 142 to radially expand as the second tubular member 12 expands, or the driving member 141 drives the separation membrane 142 to fold as the second tubular member 12 contracts.

[0087] The state where the partition membrane 142 is radially expanded so that the outer wall of the partition membrane 142 is in contact with the inner wall of the first tubular member 11 is the closed state of the channel 15. The state where the partition membrane 142 is folded or contracted so that the outer wall of the partition membrane 142 and the inner wall of the first tubular member 11 are spaced apart is the open state of the channel 15.

[0088] By configuring the sealing assembly 14 to include a driving member 141 and a separation membrane 142, when a branch stent 2 is implanted in the channel 15, since there are no extra stent units on the separation membrane 142 to block it, the separation membrane 142 can be more tightly wrapped on the side wall of the branch stent 2, thereby ensuring a better anti-internal leakage effect. In addition, since there are no extra stent units on the separation membrane 142, it has good flexibility, so it can prevent the branch stent 2 from being squeezed 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 reading Figure 3-4In one embodiment, the driving member 141 includes a plurality of driving rods 1410 connected 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 connected to the second stent graft 1201, and the distal ends are free ends. The extending direction of the driving rods 1410 satisfies that when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the portion of the driving rods 1410 accommodated in the first tubular member 11 is in contact with the inner wall of the first tubular member 11. For example, in one embodiment, the first tubular member 11 is an equal-diameter cylindrical structure, and the driving rod 1410 is completely accommodated in the first tubular member 11 when the first tubular member 11 and the second tubular member 12 are both in the expanded state, then the driving rod 1410 as a whole is a straight rod structure; or, in other embodiments, the first tubular member 11 is still an equal-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 both in the expanded state, then the portion of the driving rod 1410 accommodated in the first tubular member 11 is a straight rod that fits the inner wall of the first tubular member 11, and the extension direction of the portion of the driving rod 1410 not accommodated in the first tubular member 11 can form a right angle or an obtuse angle with the extension direction of the portion of the driving rod 1410 accommodated in the first tubular member. Alternatively, if the first tubular member 11 is a variable diameter cylindrical structure, the portion of the driving rod 1410 accommodated in the first tubular member 11 is a curved rod with a bending angle that fits the inner wall of the first tubular member 11 , and its bending angle 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 to the second coated support 1201 by welding, suturing, etc., or it can be woven from the braided wire of the second frame 121 on the second coated support 1201. The specific connection method can be selected according to the usage.

[0091] Please continue reading Figure 4 In one embodiment, the driving rod 1410 is a long rod-shaped structure with a rectangular cross-section. In other embodiments, the cross-section of the driving rod 1410 may be circular, fan-shaped, elliptical or other polygonal shapes, or the driving rod 1410 may be a spiral structure formed by winding a braided wire.

[0092] Please continue reading Figure 3-4In one embodiment, the separator 142 is integrally formed with the second coating 122 of the second tubular member 12. In other embodiments, the separator 142 may also be sutured to the distal end of the second coating 122 by sutures. The separator 142 may be an integrally formed annular sheet, or may be composed of a plurality of arcuate sheets spliced ​​together. It is understandable that the material of the separator 142 may be nylon or other materials suitable for making artificial blood vessels, or may be polyester cloth or PTFE film. It should be noted that the material of the separator 142 is not limited to the materials mentioned above, and the material of the separator 142 may be a flexible material that can block blood flow and is suitable for implantation in the human body. The connection between the separator 142 and the drive rod 1410 may be achieved by suturing, heat treatment coating or bonding.

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

[0094] Please continue reading Figure 3-4 In one embodiment, the separation 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 connector 13 is connected to the inner wall of the first coated stent 1101, and the proximal end of the connector 13 is connected to the distal end of the second coated stent 1201. The connector 13 includes four connecting rods 130, and the four connecting rods 130 are evenly distributed along the circumference of the first lumen 110, and the connecting rods 130 meet the following conditions: when the first coated stent 1101 and the second coated stent 1201 are both in the expanded state, the extension direction of the connecting rods 130 is parallel to the axial direction of the first coated stent 1101. A driving rod 1410 is arranged between two adjacent connecting rods 130, that is, the driving member 141 includes four driving rods 1410, and the separation membrane 142 is simultaneously connected to the connecting rods 130 and the driving rods 1410 along the circumference.

[0096] Please combine Figure 7-8Before the branch stent 2 is implanted, the first coated stent 1101 is in a radially expanded state, and the second coated stent 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 coated stent 1201 or the delivery sheath 3, and the channel 15 is opened. The folded partition membrane 142 divides the channel 15 due to the connection with the connecting rod 130, so that the annular channel exists in the form of multiple sub-channels 150 that are not connected to each other. After the branch stent 2 is implanted into the channel 15, by releasing the second coated stent 1201, the proximal end of the connecting rod 130 and the driving rod 1410 will move toward the side close to the inner wall of the first coated stent 1101 as the second coated stent 1201 is unfolded, and driven by the connecting rod 130 and the driving rod 1410, the separation membrane 142 will also unfold accordingly until the second coated stent 1201 is in a radially unfolded state. At this time, all the connecting rods 130 are attached to the side wall of the first coated stent 1101, and in the sub-channel 150 implanted with the branch stent 2, the driving rod 1410 is attached to the side wall of the branch stent 2, and the separation 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, and in the sub-channel 150 where the branch stent 2 is not implanted, the driving rod 1410 drives the separation membrane 142 to adhere to the inner wall of the first coated stent 1101 to seal the channel 15.

[0097] By connecting the partition membrane 142 with the connecting rod 130, the various 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. At the same time, the partition membrane 142 is connected to the connecting rod 130, so that the function of the connecting rod 130 is no longer limited to connecting the first tubular member 11 and the second tubular member 12, but can also cooperate with the driving rod 1410 to better tension the partition membrane 142, and play a limiting role on the branch stent 2, thereby improving the assembly stability of the branch stent 2.

[0098] It should be noted that, in this embodiment, the distal ends of the separation membrane 142 and the driving rod 1410 are on the same radial plane as the distal end of the connecting rod 130. In other embodiments, the distal end of the driving rod 1410 may also be beyond the distal end of the connecting rod 130 or lower than the distal end of the connecting rod 130.

[0099] It should also 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 correspond. For example, at the position where the branch stent 2 needs to be implanted, the number of driving rods 1410 set between two adjacent connecting rods 130 is 3 or 4. In addition, in other embodiments, the connecting rods 130 can also be arranged only at circumferential intervals along the first lumen 110 and unevenly 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 is understandable that in other embodiments, the partition membrane 142 may be connected only to the driving rod 1410, that is, the partition membrane 142 is not connected to the connecting rod 130. In the retracted state, the connecting rod 130 is in contact with the partition membrane 142, but there is no connection point between the two. In this way, the sealing component 14 can also play a better sealing role, and the connecting rod 130 and the sealing component 14 do not interfere with each other, so as not to affect the opening and closing of the channel 15.

[0101] It is understandable 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 also needs to be considered not to affect the expansion or contraction of the separation membrane 142. Figure 3-4 In the illustrated embodiment, the proximal end of the connecting rod 130 is connected to the distal end of the second stent graft 1201, and the distal end of the connecting rod 130 is connected to the first stent graft 1101, and the connection point between the connecting rod 130 and the first stent graft 1101 is located beyond the distal end surface 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. During the expansion or contraction of the second stent graft 1201, the connecting rod 130 can cooperate with the driving rod 1410 to jointly drive the expansion or contraction of the separation membrane 142. The radial compression state of the second stent graft 1201 is not necessarily achieved by the delivery sheath 3, but can also be achieved by a limiting structure.

[0102] See also Figure 9-10 , which is another implementation of the implantable medical device 1. Figure 8The difference in the structure of the implantable medical device 1 shown lies in the connection position between the connector 13 and the first tubular member 11. In this embodiment, the distal end of the connector 13 is connected to the crest of a first bracket unit 1111 at the nearest end of the first frame 111 on the first tubular member 11, and the distal end face of the sealing component 14 is flush with the distal end face of the connector 13. That is, in this embodiment, the overlapping area between the sealing component 14 and the first tubular member 11 is limited to the proximal end face from the first bracket unit 1111 at the nearest end of the first tubular member 11 to the first tubular member 11. After the branch stent 2 is implanted, its end connected to 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 FIG. Fig.10 As shown, since the trough of the first bracket unit 1111 on the first tubular member 11 in the overlapping area is a free end and no other first bracket units 1111 are hung, the first tubular member 11 in the overlapping area is relatively flexible and can be deformed toward the side away from the sealing assembly 14 under the extrusion of the branch bracket 2, so that the side of the branch bracket 2 close to the first tubular member 11 is also wrapped more tightly, thereby further reducing the risk of peripheral leakage of the implantable medical device 1.

[0103] It is understandable that in other embodiments, the distal end face of the sealing component 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 component 14 and the more flexible area on the first tubular member 11 (referring to the first stent unit 1111 at the most proximal end of the first tubular member 11 to the proximal end face of the first tubular member 11), the above-mentioned effect of the branch stent 2 being more tightly wrapped can still be achieved. It should be noted that when the distal end face of the sealing component 14 exceeds the end face of the clamped end of the implanted branch stent 2, the setting of the sealing component 14 needs to be considered so as not to cause blockage to the blood flow of the branch stent 2 when it is fully expanded radially.

[0104] Please continue reading Figure 11-12 , which is another implementation form of the implantable medical device 1. In this embodiment, the separation membrane 142 is still connected to the connecting member 13. Figure 4 The difference in the structure of the embodiment shown is the arrangement of the connecting member 13. In this embodiment, the connecting member 13 includes four rod groups, each of which includes a connecting rod 130a and a connecting rod 130b. When the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the extension directions of the connecting rods 130a and 130b form a non-zero angle with the axial direction of the first tubular member 11, and the extension lines of the proximal ends of the connecting rods 130a and 130b can converge at an intersection, and the connecting rods 130a and 130b are about the intersection where the second stent graft 1201 (at Figure 11-12In the embodiment, the second coated support 1201 is retracted in the delivery sheath 3) and is symmetrically distributed along an axis parallel to the longitudinal center axis, so that when the first tubular member 11 and the second tubular member 12 are both in a radially expanded state, the connecting distance between the connecting rod 130a and the connecting rod 130b on the first tubular member 11 is greater than the connecting distance between the two on the second tubular member 12, a driving rod 1410 is arranged between the connecting rod 130a and the connecting rod 130b, and no driving rod 1410 is arranged between adjacent rod groups, and the partition membrane 142 is circumferentially connected to the connecting rod 130a, the connecting rod 130b and the driving rod 1410 at the same time.

[0105] In this way, before the branch stent 2 is implanted, the first tubular member 11 is in a radially expanded state and the second coated stent 1201 is in a radially compressed state, and the channel 15 is opened. At this time, the partition membrane 142 is in a taut state under the action of the connecting rod 130a, the connecting rod 130b and the driving rod 1410, thereby preventing the folds of the partition membrane 14 from blocking the sub-channel 150, further reducing the difficulty of establishing the implantation path of the branch stent 2. 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 two on the second tubular member 12, the sub-channel 150 formed thereby will form 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, which can facilitate the delivery of the branch stent 2 into the sub-channel 150 from the distal end, while the proximal opening of the sub-channel 150 is narrower, which can allow the separation membrane 142 to be more closely attached to the side wall of the branch stent 2, thereby improving the anti-internal leakage effect.

[0106] In other embodiments, the connecting rod 130a and the connecting rod 130b may not be symmetrically distributed about an axis parallel to the longitudinal center axis of the second coated support 1201 and located at the intersection of the extension lines of the proximal ends of the connecting rod 130a and the connecting rod 130b.

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

[0108] See also Figure 13-14 , which is another implementation form of the implantable medical device 1. In this embodiment, the first tubular member 11 includes a first stent graft 1101 and a cover film 1102, the distal end of the cover film 1102 is connected to the proximal end of the first stent graft 1101, and the distal end extends to a side close to the second tubular member 12 to form a free end, and the middle part of the cover film 1102 is also connected to the connector 13.

[0109] The connector 13 includes a connector rod 130a and a connector rod 130b, and the adjacent connector rods 130a and 130b are connected end to end, so that the connector 13 forms a ring-shaped wave structure. The wave crest of the connector 13 is connected to the wave trough at the nearest end of the first stent graft 1101, and the wave trough of the connector 13 is connected to the wave crest at the farthest end of the second stent graft 1201.

[0110] The outer diameter of the second stent graft 1201 is smaller than that of the first stent graft 1101, while the outer diameter of the distal end of the separation membrane 142 matches the inner diameter of the first stent graft 1101, and the outer diameter of the proximal end of the separation membrane 142 matches the outer diameter of the second stent graft 1201. Therefore, when the separation membrane 142 is in the radially expanded state, it is in the shape of an inverted truncated cone, as shown in FIG. Fig.15 The separation membrane 142 is provided with a corrugated suture edge 1421, which is used to mark the separation membrane 142 and the connection member 13. The channel 15 is formed by the outer wall of the separation membrane 142 and the inner wall of the cover membrane 1102. The connection point between the driving rod 1410 and the second tubular member 12 coincides with the lowest point of the wave valley of the connection member 13.

[0111] 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, and the proximal end of the connector 13 is also in a contracted state, while the distal end of the connector 13 is in an expanded state under the influence of the first stent graft 1101, and drives the cover membrane 1102 fixed on the connector 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 transformed into a radially expanded state, the distal end of the connector 13 and the driving rod 1401 will expand outward, thereby driving the separation membrane 142 to abut against the cover membrane 1102 to close the sub-channels 1501. By such arrangement, when the branch stent 2 is clamped by the sub-channel 1501, since both the inner and outer sides are flexible membranes, the cover membrane 1102 and the separation membrane 142 can better fit the shape of the branch stent 2, so that the branch stent 2 can be more tightly wrapped, thereby making the implantable medical device 1 better in preventing internal leakage and fixing the branch stent 2.

[0112] It is understandable that the material of the cover film 1102 can be nylon or other materials suitable for manufacturing artificial blood vessels, polyester cloth or other conventional covering materials that can be used to manufacture covered stents.

[0113] In addition, if Fig.15 As shown, in order to further enhance the installation stability of the branch stent 2, an extension edge 143 is also connected to the distal end of the separation membrane 142. The extension direction of the extension edge 143 is parallel to the extension direction of the first coated stent 1101, and the axial height of the distal end of the extension edge 143 is higher than the height of the crest of the connector 13. The axial distal height of the driving rod 1401 is flush with the distal end of the extension edge 143. The extension edge 143 is used to extend the axial length of the annular channel 15. An extension suture edge 1431 is provided on the extension edge 143, and the extension suture edge 1431 extends axially. 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 axial length of each sub-channel 1501 is extended to a certain extent, so that the structure of the sub-channel 1501 is more perfect, which is more conducive to the path establishment of the branch stent 2 and maintaining the stability of the branch stent 2.

[0114] See also Figure 16-17 , which is another embodiment of the implantable prosthetic device 1, and Fig.13 Compared with the embodiment shown in FIG. 1 , the driving rod 1410 of this embodiment is slightly different. The driving rod 1410 includes a connecting portion 14101 and a resisting portion 14102, wherein one end of the connecting portion 14101 away from the resisting portion 14102 is connected to the second stent graft 1201, and one end of the resisting portion 14102 away from the connecting portion 14101 is a free end, and the projection area of ​​the free end of the resisting portion 14102 on the separation membrane 142 is larger than the projection area of ​​the connecting section of the connecting portion 14101 and the second tubular member 12 on the separation membrane 142. The resisting portion 14102 is used to increase the contact area between the distal end of the driving rod 1410 and the separation membrane 142.

[0115] Specifically, in one embodiment, the supporting portion 14102 is annular, two supporting portions 14102 are provided, and the two supporting portions 14102 are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second coated stent 1201 where the connection end of the connecting portion 14101 and the second tubular member 12 is located, and 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 greater than the width of the distal end of the connecting portion 14101.

[0116] By providing the abutting portion 14102 , the abutting area between the driving rod 1410 and the separation membrane 142 is increased, 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 peripheral leakage.

[0117] Please continue reading Fig.17 In one embodiment, when the first tubular member 11 is in a radially expanded state and the second tubular member 12 is in a radially contracted state, one of the two adjacent driving rods 1410, a most lateral abutting portion 14102 of one driving rod 1410 abuts against another most lateral abutting portion 14102 of the other driving rod 1410 adjacent to the abutting portion 14102, thereby cooperating to clamp the separation membrane 142. In this arrangement, the separation membrane 142 can be pulled and tightened under the action of the driving rod 1410, thereby eliminating the gaps between the sub-channels 1501, thereby making it easier to establish the implantation path of the branch stent 2.

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

[0119] It should be noted that, in one embodiment, the implantable medical device 1 may also include a leaflet structure (not shown), which is connected to the second tubular member 12, and the leaflet structure includes three leaflets that can be closed and opened. When the implantable medical device 1 is implanted in the body, as the heart dilates and contracts, the three leaflets close and open, thereby closing or opening the second lumen 120. The material of the leaflets may be a biomaterial or a polymer material. When a patient with aortic dissection also has aortic valvular disease and needs to replace the natural aortic valve, the implantable medical device 1 can be used to simultaneously treat aortic dissection and replace the natural aortic valve. It is understandable that in other embodiments, the number of leaflets is not limited to three, for example, it may be two or four. In addition, when the implantable medical device 1 is applied to other parts such as the renal artery where no natural valve replacement is required, the leaflet structure may be omitted.

[0120] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0121] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. An implantable medical device, characterized in that: include: a first tubular member having a first lumen; a second tubular member having a second lumen, wherein 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 of which extends axially in a direction away from the second tubular member to be at least partially accommodated in the first tubular cavity, the portion of the sealing assembly accommodated in the first tubular cavity is an annular structure with a free end, the annular structure surrounds the longitudinal center axis of the first tubular member, the sealing assembly can be synchronously expanded or contracted with the second tubular member, so that the outer wall of the portion of the sealing assembly accommodated in the first tubular 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 in an open state and connected to the first tubular cavity; when the first tubular member and the second tubular member are both in a radially expanded state, the channel is in a closed state.

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

3. The implantable medical device according to claim 1, characterized in that: The first tubular member includes a first coated stent and a cover film, the distal end of the cover film is connected to the proximal end of the first coated stent, the proximal end extends toward the side where the second tubular member is located and forms a free end, and 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 coated stent, the distal end of which abuts against the proximal end of the first tubular member; or, the second tubular member includes a second coated stent and a connector, the distal end of which abuts against or is spaced apart from the proximal end of the first tubular member, the distal end of the connector is connected to the first tubular member, and the proximal end of the connector is connected to the second coated stent.

5. The implantable medical device according to claim 4, characterized in that: The sealing assembly comprises: A separation membrane, the proximal end of which is connected to the second stent graft, the distal end of which is axially extended toward the side where the first tubular member is located so as to be at least partially accommodated in the first lumen, and the portion of the separation membrane accommodated in the first lumen has a free end, the separation membrane has an unfolded state and a folded state, and the outer wall of the portion of the separation membrane accommodated in the first lumen cooperates with the inner wall of the first tubular member to form the channel; And, a driving member, the proximal end of which is connected to the second coated stent, and the distal end of which extends axially toward the side of the first tubular member so as to be at least partially accommodated in the first tubular cavity, and the portion of the driving member accommodated in the first tubular cavity has a free end, the driving member is connected to the separation membrane, and the driving member is used to drive the separation membrane to unfold as the second tubular member expands or to drive the separation membrane to fold as the second tubular member contracts.

6. The implantable medical device according to claim 5, characterized in that: The driving member includes a driving rod, and an extending direction of the driving rod satisfies that when the first tubular member and the second tubular member are both in a radially expanded state, a portion of the driving rod accommodated in the first tubular member fits against an inner wall of the first tubular member.

7. The implantable medical device according to claim 6, characterized in that: The connecting member includes a plurality of connecting rods, which are spaced apart along the circumference of the first tubular cavity. When the first tubular member and the second tubular member are in a radially expanded state, the extending direction of the connecting rods 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 to the connecting rods and the driving rods simultaneously along the circumference.

8. The implantable medical device according to claim 6, characterized in that: The connecting member includes a plurality of rod groups, each of which includes two connecting rods. When the first tubular member and the second tubular member are in a radially expanded state, the extension directions of the two connecting rods form a non-zero angle with the axial direction of the first tubular member, and the extension lines of the proximal ends of the two connecting rods can converge at an intersection. At least one driving rod is arranged between the two connecting rods, and the separation membrane is connected to the connecting rod and the driving rod at the same time along the circumferential direction.

9. The implantable medical device according to claim 8, characterized in that: The connecting rods are connected in pairs to form an annular waveform structure, the two connecting rods in the connecting group are connected to form a trough of the annular waveform structure, and the connecting rods in adjacent connecting groups are connected to form a peak of the annular waveform structure.

10. The implantable medical device according to any one of claims 6 to 9, characterized in that: The driving rod includes a connecting portion and at least one abutting portion connected to the connecting portion, an end of the connecting portion away from the abutting portion is connected to the second tubular member, an end of the abutting portion away from the connecting portion is a free end, and a projection area of ​​the abutting portion on the separation membrane is larger than a projection area of ​​an end of the connecting portion connected to the second tubular member on the separation membrane.

11. The implantable medical device according to claim 10, characterized in that: The number of the abutting portions is two, and the two abutting portions are axially symmetrically arranged, and the axis of symmetry is a straight line parallel to the longitudinal center axis of the second tubular member where the connecting end of the connecting portion and the second tubular member is located.

12. The implantable medical device according to claim 11, characterized in that: There are at least two abutting portions, and when the first tubular member is in a radially expanded state and the second tubular member is in a radially contracted state, among two adjacent driving rods, one lateral abutting portion of one driving rod and another lateral abutting portion of the other driving rod adjacent to the lateral abutting portion abut against each other to clamp the separation membrane.

13. The implantable medical device according to claim 4, characterized in that: The connecting piece includes a connecting section and an assembly section connected to the connecting section, the assembly section is connected to one of the first tubular member and the second tubular member, and one end of the connecting section away from the assembly section is connected to the other of the first tubular member and the second tubular member; the connecting section is a cylindrical rod or a braided wire, and the assembly section is a ring-shaped structure, a T-shaped rod or a straight rod whose extension direction is perpendicular to the extension direction of the connecting section.

14. The implantable medical device according to claim 1, characterized in that: The implantable prosthesis also includes a leaflet structure, which is disposed in the second tubular member and can be opened or closed to make the second lumen of the second tubular member open or closed.

15. An implantable medical system, characterized in that: include: Branch bracket; And, in the implantable medical device as described 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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