Implantable medical device and system

Abstract

The invention relates to the technical field of medical instruments, in particular to an implantable medical device and system. The implantable medical device comprises a first tubular component and a second tubular component, the first tubular component is provided with a first tubular cavity, and the second tubular component is connected with the first tubular component and partially contained in the first tubular cavity so that the outer wall of the second tubular component can be matched with the inner wall of the first tubular component to form a channel capable of being opened or closed; and the at least one developing part is arranged on the first tubular component and corresponds to the channel, when the number of the developing parts is multiple, the developing parts are arranged at intervals in the circumferential direction of the first tubular component, and the shapes of the developing parts and / or the arrangement sequence of the multiple developing parts have circumferential direction indication. The implantable medical device can quickly and accurately guide the optimal channel suitable for implanting the branch stent, the branch stent is prevented from falling out of the channel in the implanting process, the operation difficulty is reduced, and the operation success rate is increased.

Description

Technical Field

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

[0002] The information provided in this section is only background information related to the present disclosure, and it is not necessarily prior art.

[0003] Aortic dissection, also known as aortic dissecting aneurysm, is a vascular disease that seriously endangers life and health and has a high fatality rate. It is caused by various reasons that lead to the tearing of the aortic intima and the blood flowing into the arterial wall, resulting in the stratification and separation of the aortic wall and the formation of a hematoma at the same time.

[0004] Currently, the main treatment methods for aortic dissection are surgical treatment and minimally invasive treatment. Among them, surgical treatment is achieved by performing thoracotomy and laparotomy to remove the intimal tear and reconstruct the blood flow channel with a prosthetic blood vessel. 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 a normal blood flow channel. Compared with surgical treatment, minimally invasive interventional treatment is increasingly applied to routine treatment due to 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 branch vessels, such as when the dissection lesion site in the ascending aorta involves or is close to the aortic coronary vessels, the dissection lesion in the ascending aorta involves or is close to the aortic arch branch vessels, or the lesion site in the abdominal aorta is close to the renal artery, etc., in order to cover the lesion site or to increase a sufficient anchoring area, the covered stent may cover or block the openings of branch vessels, coronary vessels, or renal arteries, etc. In this case, it is usually necessary to implant a main stent and a branch stent (or called a bypass stent) at the lesion site simultaneously for treatment. The main stent and the branch stent cooperate with each other to maintain the smooth blood flow in the aorta and branch vessels. However, this also increases the difficulty of the implantation surgery.

[0006] Generally, the implantation surgery needs to be carried out under a medical imaging device according to the following steps: first, deliver the main stent with a channel to the corresponding site, then partially release the main stent, then deliver the branch stent into the channel of the main stent, then release the branch stent to make the branch stent cooperate with the main stent, and finally completely release the main stent to complete the surgery.

[0007] Among them, the precise positioning of the stent in the body is one of the decisive factors for the success of the surgery. Since most current medical imaging devices are displayed in a planar form, the main stent located at the front end of the human anatomical structure and the main stent located at the rear end of the human anatomical structure will overlap in the image. As a result, from the image, it is impossible to distinguish whether the channel for implanting the branch stent is located at the front end or the rear end of the human anatomical structure. If the channel cannot be correctly distinguished as being located at the front end or the rear end of the human anatomical structure, it may lead to a situation where the branch blood vessel is located at the front end of the human anatomical structure, while the channel where the branch stent is actually implanted is located at the rear end of the human anatomical structure. At this time, since the channel where the branch stent is actually implanted is far from the branch blood vessel, and at the same time the length of the branch stent is limited, the tail end of the branch stent may fall out of the main stent during the process of implanting the branch blood vessel, resulting in the failure of the surgery. In addition, the falling out of the branch stent will cause the branch blood vessel to be blocked, which may endanger life in severe cases.

[0008] Therefore, it is crucial to accurately distinguish whether the channel for implanting the branch stent is located at the front end or the rear end of the human anatomical structure during the surgery. Summary of the Invention

[0009] Based on this, it is necessary to provide an implantable medical device that can accurately distinguish the position of the channel for implanting the branch stent during the surgery.

[0010] Furthermore, an implantable medical system that can accurately distinguish the position of the channel for implanting the branch stent during the surgery is also provided.

[0011] An implantable medical device includes: a first tubular member having a first lumen; a second tubular member having a second lumen, the first tubular member being connected to the second tubular member, and the second tubular member being partially received in the first lumen so that the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form an openable or closable 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 is in communication with the first lumen; when the first tubular member and the second tubular member are both in an expanded state, the channel is in a closed state; and at least one imaging member, the imaging member being disposed on the first tubular member and corresponding to the channel. When the number of the imaging members is multiple, the imaging members are circumferentially spaced along the first tubular member, and the shape of the imaging member itself and / or the arrangement order of the multiple imaging members has circumferential direction indication.

[0012] In one embodiment, the number of the developing members is one, and the developing member is at least asymmetric along the axial direction of the first tubular member; alternatively, the number of the developing members is at least two, and the shapes and arrangement manners of the developing members are the same, and the developing member is at least asymmetric along the axial direction of the first tubular member; alternatively, the number of the developing members is at least two, and at least two of the at least two developing members have different shapes.

[0013] In one embodiment, the developing member and the inlet of the channel are in the same radial plane; alternatively, the developing member and the outlet of the channel are in the same radial plane.

[0014] In one embodiment, the first tubular member includes a first covered stent and a connecting member. The first lumen is arranged on the first covered stent. The distal end of the connecting member is connected to the first covered stent, and the proximal end is connected to the second tubular member. The developing member is arranged at the proximal end of the first covered stent or the distal end of the connecting member.

[0015] In one embodiment, the first covered stent includes a frame, an inner membrane arranged inside the frame, and an outer membrane arranged outside the frame. The developing member is a developing film clamped by the inner membrane and the outer membrane, or the developing member is a developing tube sleeved on the frame or the connecting member.

[0016] In one embodiment, the developing film includes a body, and through holes are formed in the body. At the through holes, the inner membrane and the outer membrane are attached to each other.

[0017] In one embodiment, the developing tube is a sleeve or a coil spring.

[0018] In one embodiment, the developing tube includes a first developing section and a second developing section. The first developing section and the second developing section are connected or not connected, and the first developing section and the second developing section cooperate to form a geometric figure asymmetrically arranged along the axial direction of the first covered stent.

[0019] In one embodiment, the second tubular member includes a second covered stent and a sealing assembly. The second covered stent and / or the sealing assembly are connected to the first tubular member by point connection. ，The proximal end of the sealing assembly is connected to the second covered stent, and the distal end axially extends away from the second covered stent to at least partially accommodate in the first lumen. The portion of the sealing assembly accommodated in the first lumen is a ring structure and has a free end. The ring structure surrounds the longitudinal central axis of the first tubular member. The sealing assembly can be deployed or contracted synchronously with the second covered stent. The channel is formed by the inner wall of the first tubular member and the outer wall of the sealing assembly.

[0020] In one embodiment, the sealing assembly includes: a sealing film, the proximal end of which is connected to the second covered stent, and the distal end axially extends toward the side where the first tubular member is located to at least partially accommodate in the first lumen, and the portion of the sealing film accommodated in the first lumen has a free end. The sealing film has a deployed and a folded state. The outer wall of the portion of the sealing film accommodated in the first lumen and the inner wall of the first tubular member cooperate to form the channel; and at least two driving rods, the proximal ends of which are connected to the second covered stent, and the distal ends axially extend toward the side where the first tubular member is located to at least partially accommodate in the first lumen, and the portion of the driving rods accommodated in the first lumen has a free end. The driving rods are connected to the sealing film, and the driving rods are configured to drive the sealing film to deploy as the second covered stent expands or drive the sealing film to fold as the second covered stent contracts.

[0021] In one embodiment, the projection of the developer on the sealing film is located on the portion of the sealing film accommodated in the first lumen.

[0022] In one embodiment, the implantable medical device further includes a valve leaflet structure disposed in the second tubular member, and the valve leaflet structure can be opened or closed to make the second lumen of the second tubular member in an open or closed state.

[0023] An implantable medical system includes: a branch stent; and the implantable medical device according to any one of the above embodiments. One end of the branch stent can extend into the channel and be clamped by the cooperation of the first tubular member and the second tubular member.

[0024] The implantable medical device provided by the embodiment of the present invention forms a channel by the cooperation of a first tubular member and a second tubular member. During the implantation surgery, the branch stent can be implanted from within the channel. By providing a developer on the first tubular member and the developer corresponding to the channel, since the shape and / or the arrangement order of the developer has circumferential direction indication, therefore, under the medical imaging device, the imaging presented when the developer is located at the front end of the human anatomical structure, at the rear end of the human anatomical structure, and at the side end of the human anatomical structure will be different. Therefore, it is possible to judge the specific position of the channel corresponding to the developer in the circumferential direction of the human anatomical structure according to the imaging presented by the developer, so as to quickly and accurately guide the optimal channel suitable for the implantation of the branch stent, avoid the branch stent falling out of the channel during the implantation process, reduce the surgical difficulty, and improve the surgical success rate.

[0025] The implantable medical system provided by the embodiment of the present invention enables the branch stent to be quickly positioned to the optimal implantation channel during implantation by applying the implantable medical device capable of quickly judging the position of the channel during the implantation surgery, thereby shortening the surgical time, reducing the surgical difficulty, and improving the surgical success rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained according to these drawings without creative efforts.

[0027] Among them:

[0028] Figure 1 is a schematic structural diagram of an implantable medical system according to an embodiment of the present invention;

[0029] Figure 2 is a cross-sectional view of an implantable medical device according to an embodiment of the present invention;

[0030] Figure 3 is a schematic structural diagram of an implantable medical system according to another embodiment of the present invention;

[0031] Figure 4 is a schematic structural diagram of a second tubular member according to an embodiment of the present invention;

[0032] Figure 5 is a schematic structural diagram of the implantable medical device according to an embodiment of the present invention in the channel open state;

[0033] Figure 6 is a schematic diagram of the imaging state of a part of the implantable medical device according to an embodiment of the present invention when the developer faces away from the operator;

[0034] Figure 7 Structural schematic diagram of a developing member according to an embodiment of the present invention;

[0035] Figure 8 Structural schematic diagram of a partial structure of an implantable medical device according to an embodiment of the present invention;

[0036] Figure 9 Structural schematic diagram of a partial structure of an implantable medical device according to another embodiment of the present invention;

[0037] Figure 10 Structural schematic diagram of a partial structure of an implantable medical device according to still another embodiment of the present invention;

[0038] Figure 11 Structural schematic diagram of a partial structure of an implantable medical system according to an embodiment of the present invention;

[0039] Figure 12 is Figure 11 Schematic diagram of a developing state of the implantable medical system shown;

[0040] Figure 13 Structural schematic diagram of a partial structure of an implantable medical device according to yet another embodiment of the present invention;

[0041] Figure 14 is Figure 13 Schematic diagram of a developing state of the implantable medical device shown;

[0042] Figure 15 is Figure 13 Another schematic diagram of a developing state of the implantable medical device shown. Detailed implementation manners

[0043] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0044] In the description of the embodiments of the present invention, it should be noted that, for terms indicating orientation or positional relationship such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., the orientation or positional relationship is based on the orientation or positional relationship shown in the drawings. This is only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on the embodiments of the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and should not be construed as indicating or implying relative importance.

[0045] In the description of the embodiments of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installation", "connection", and "coupling" 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 or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium; it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0046] In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or animal body that is closer to the operator is called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. The "axial direction" generally refers to the length direction of the medical device when it is being delivered, and the "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction", and the "axial direction" and "radial direction" of any component of the medical device are defined based on this principle. The "circumferential direction" refers to the circumferential direction, that is, the direction around the axis of the lumen structure or cylinder.

[0047] Please refer to Figure 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 used to be implanted into the main lumen anatomical structure, such as being implanted into the aorta, and the branch stent 2 is used in cooperation with the implantable medical device 1. The branch stent 2 is used to be implanted into the branch lumen anatomical structure, such as being implanted into the coronary artery branch vessel.

[0048] It can be understood that the application site of this implantable medical system is not limited to the aorta, and it can also be applied to other parts with branch blood vessels. For example, it can be applied to the renal artery.

[0049] Please refer to Figure 1-2 , in one embodiment, the implantable medical device 1 includes a first tubular member 11, a second tubular member 12, and a radiopaque member 13.

[0050] Among them, the first tubular member 11 has a first lumen 110. The second tubular member 12 has a second lumen 120. The second tubular member 12 is connected to the first tubular member 11, and the second tubular member 12 is partially accommodated in the first lumen 110, so that the outer wall of the second tubular member 12 cooperates with the inner wall of the first tubular member 11 to form a channel 14 that can be opened or closed. When the first tubular member 11 is in a radially expanded state and the second tubular member 12 is in a radially compressed state, the channel 14 is in an open state and is connected to the first lumen 110; when both the first tubular member 11 and the second tubular member 12 are in a radially expanded state, the channel 14 is closed. The imaging member 13 is disposed on the first tubular member 11. The number of the imaging members 13 is one, and the imaging member 13 is opposite to the channel 14. The shape of the imaging member 13 itself has circumferential direction indicativeness.

[0051] It should be noted that the fact that the shape of the imaging member 13 itself has circumferential direction indicativeness means that the imaging member 13 has a specific shape, and when this shape is at different positions (front end, rear end, and side) in the circumferential direction of the human anatomical structure, under the illumination of a light source at the same position of the medical imaging device, the imaging forms presented are different. Thus, the position of the imaging member 13 in the circumferential direction of the human anatomical structure can be distinguished according to the imaging form.

[0052] For the implantable medical device 1 configured in this way, the first tubular member 11 and the second tubular member 12 cooperate to form the channel 14. During the implantation operation, the branch stent 2 can be implanted from within the channel 14. By disposing the imaging member 13 on the first tubular member 11 and making the imaging member 13 correspond to the channel 14, since the shape of the imaging member 13 itself has circumferential direction indicativeness, therefore, under the medical imaging device, the imaging presented when the imaging member 13 is located at the front end of the human anatomical structure, at the rear end of the human anatomical structure, and at the side end of the human anatomical structure will be different. Thus, the specific position of the channel 14 corresponding to the imaging member 13 in the circumferential direction of the human anatomical structure can be determined according to the image presented by the imaging member 13, so as to quickly and accurately guide the optimal channel 14 suitable for the implantation of the branch stent 2, avoid the branch stent 2 falling out of the channel 14 during the implantation process, reduce the surgical difficulty, and improve the surgical success rate.

[0053] In other embodiments, the number of the imaging members 13 can also be set to two or more. Among them, when the number of the imaging members 13 is two or more, the imaging members 13 are distributed at intervals along the circumferential direction of the first tubular member 11 and correspond to the channel 14. At this time, to determine the position of the channel 14, it can be that the shape of the imaging member 13 itself has circumferential direction indicativeness, or the arrangement order of the imaging members 13 has circumferential direction indicativeness, or both the shape of the imaging member 13 itself and its arrangement order have circumferential direction indicativeness.

[0054] It should be noted that the arrangement order of the developing members 13 has a circumferential direction indication, which means that the shapes of the developing members 13 have at least two types, and the two types of developing members 13 are arranged in the circumferential direction of the human anatomical structure in a clockwise or counterclockwise manner. Thus, the position (front end, rear end, and side) of a specified developing member 13 in the circumferential direction of the human anatomical structure can be determined according to the arrangement order relationship of the developing members 13 in the image under the light source irradiation at the same position of the medical imaging device.

[0055] It can be understood that the developing member 13 actually also has the function of indicating the axial position. Since the position of the developing member 13 on the first tubular member 11 is fixed, the position of the first tubular member 11 in the axial direction of the human anatomical structure can be assisted in determination by the distance between the developing member 13 and the distal end or proximal end of the first tubular member 11.

[0056] In addition, the implantable medical device 1 of the present embodiment can keep the blood flow unobstructed during the implantation surgery. Specifically, the channel 14 for implanting the branch stent 2 is formed by the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12. Therefore, during the implantation surgery, the first tubular member 11 can be released first, and the second tubular member 12 is kept in a radially compressed state (for example, the first tubular member 11 is pushed out of the delivery sheath (not shown in the figure), and the second tubular member 12 has not been released from the delivery sheath and is still restricted by the delivery sheath and in a radially compressed state; or, the second tubular member 12 is pushed out of the delivery sheath but is radially restricted by a restricting structure (not shown in the figure), such as being restricted by a tether and in a radially compressed state). At this time, the channel 14 is in an open state and communicates with the first lumen 110, so that the blood flow can flow out along the first lumen 110 through the channel 14, or the blood flow can flow out through the channel 14 along the first lumen 110. Thus, the blood flow can be kept unobstructed during the implantation surgery, preventing adverse effects on the patient's health due to blood flow blockage, and at the same time, more time can be gained for the implantation of the branch stent 2, thereby reducing the surgical difficulty and improving the surgical success rate.

[0057] It can be understood that the first tubular member 11 and the second tubular member 12 can be directly connected or indirectly connected through other components. The first tubular member 11 and the second tubular member 12 can be coaxially arranged or non - coaxially arranged. The channel 14 can be presented as an annular channel, so that the blood flow is smoother and the effect is better. There can also be multiple channels 14, and the multiple channels 14 are arranged at intervals in the circumferential direction of the second tubular member 12. The channel 14 can also be a non - annular channel.

[0058] The circumferential mounting position of the developing member 13 can correspond to the channel 14 to directly indicate the position of the channel 14, or the circumferential mounting position of the developing member 13 can also correspond to the connection point between the first tubular member 11 and the second tubular member 12 to indirectly indicate the position of the channel 14.

[0059] The number of the developing members 13 can correspond one-to-one with the number of the channels 14, or can be less than the number of the channels 14. The specific number of the channels 14 and the developing members 13 can be set according to the number of the branch stents 2 to be implanted and the convenience of implantation.

[0060] Please refer to Figure 3-5 , in an embodiment, the first tubular member 11 includes a first covered stent 111 and a connecting member 112, and the second tubular member 12 includes a second covered stent 121 and a sealing assembly 122.

[0061] Wherein, a first lumen 110 is arranged on the first covered stent 111, and a second lumen 120 is arranged on the second covered stent 121. The proximal end of the first covered stent 111 is spaced from the distal end of the second covered stent 121. The distal end of the connecting member 112 is connected to the proximal end of the first covered stent 111, and the proximal end of the connecting member 112 is connected to the distal end of the second covered stent 121. The connecting member 112 is used for connecting the first covered stent 111 and the second covered stent 121. The proximal end of the sealing assembly 122 is connected to the second covered stent 121, and the distal end axially extends away from the second covered stent 121 to at least partially be received in the first lumen 110. The part of the sealing assembly 122 received in the first lumen 110 is of an annular structure and has a free end. The annular structure surrounds the longitudinal central axis of the first covered stent 111. The sealing assembly 122 can be deployed or contracted synchronously with the second covered stent 121. The channel 14 is formed by the outer wall of the part of the sealing assembly 122 received in the first lumen 110 and the inner wall of the first covered stent 111. When the first covered stent 111 is in a radially deployed state and the second covered stent 121 is in a radially compressed state, a gap is formed between the outer wall of the sealing assembly 122 and the inner wall of the first covered stent 111, and the channel 14 is in an open state and is communicated with the first lumen 110 (as Figure 5 shown). When both the first covered stent 111 and the second covered stent 121 are in a radially deployed state, the outer wall of the sealing assembly 122 fits against the inner wall of the first covered stent 111, and the channel 14 is in a closed state.

[0062] It can be understood that in this embodiment, the first covered stent 111 and the second covered stent 121 are connected by the connecting member 112, so that the expansion or contraction movement between the first covered stent 111 and the second covered stent 121 can be carried out independently without mutual interference, thereby enabling the channel 14 to be opened more conveniently and quickly, quickly realizing the smooth blood flow and being beneficial to shortening the operation time. In addition, the setting of the connecting member 112 can enable the channel 14 to be opened to the maximum extent, thereby better ensuring the smooth blood flow. In other embodiments, the connecting member 112 can also be omitted, and the distal end of the first covered stent 111 is directly connected to the proximal end of the second covered stent 121 by a point connection method, that is, the connection points (connection parts) between the first covered stent 111 and the second covered stent 121 are multiple discrete points (parts), and are not completely closed in the circumferential direction.

[0063] In addition, in this embodiment, by providing the sealing assembly 122 and forming the channel 14 by the cooperation of the sealing assembly 122 and the first covered stent 111, the limitation of the radial dimension setting of the second covered stent 121 can be reduced, that is, the outer diameter of the distal end of the second covered stent 121 can be equal to the outer diameter of the proximal end of the first covered stent 111, and the outer diameter of the distal end of the second covered stent 121 can also be smaller than the outer diameter of the proximal end of the first covered stent 111. This can make the shape of the implantable medical device 1 more diversified, so as to adapt to more anatomies of different shapes for implantation. In other implementations, the sealing assembly 122 can also be omitted, and the channel 14 is formed by the cooperation of the inner wall of the first covered stent 111 and the outer wall of the second covered stent 121. It can be understood that at this time, the connection positions between the connecting member 112 and the first covered stent 111 and the second covered stent 121 will change accordingly to ensure that the second covered stent 121 can be at least partially accommodated in the first lumen 110. It should be noted that the first covered stent 111, the second covered stent 121, and the sealing assembly 122 themselves can be integral equal-diameter structures or variable-diameter structures, as long as the formation of the channel 14 can be ensured, the shapes of the first covered stent 111, the second covered stent 121, and the sealing assembly 122 themselves are not limited.

[0064] In other embodiments, the connecting member 112 and the sealing assembly 122 can also be omitted simultaneously, so that the first covered stent 111 and the second covered stent 121 are directly connected to form a channel 14. For example, the first covered stent 111 and the second covered stent 121 are connected at a plurality of discrete positions in the circumferential direction to form a plurality of channels 14 that can be opened and closed and are circumferentially spaced along the second covered stent 121; alternatively, the first covered stent 111 and the second covered stent 121 are directly connected and only partially connected, with some areas not connected, then a non-circular channel 14 is formed in the unconnected area. It can be understood that at this time, in the overlapping part of the first covered stent 111 and the second covered stent 121, the radial dimension of the second covered stent 121 can only be slightly smaller than the radial dimension of the first covered stent 111, so as to ensure that the channel 14 can be closed on the basis of forming the channel 14.

[0065] Please continue to refer to Figure 3 , in one embodiment, the connecting member 112 is a corrugated rod, the distal end of which is interconnected with the first covered stent 111, so as to realize the hinged connection with the first covered stent 111, and the proximal end of which is fixedly connected to the second covered stent 121. Thus, the connecting member 112 can rotate around the connection point of the connecting member 112 and the first covered stent 111 with the expansion or contraction of the second covered stent 121, and further maintain the connection between the first covered stent 111 and the second covered stent 121 without hindering the expansion or contraction of the second covered stent 121.

[0066] In other embodiments, the connecting member 112 can also be set as a plurality of separate straight rods, one end of which is connected to the first covered stent 111 and the other end of which is connected to the second covered stent 121.

[0067] In addition, in this embodiment, the connecting member 112 is a flexible member. For example, the connecting member 112 is made of a polymer thread. It can be understood that when the connecting member 112 is a flexible member, to ensure the connection between the first covered stent 111 and the second covered stent 121 without hindering the expansion or contraction of the second covered stent 121, one end of the connecting member 112 can be fixedly connected to the first covered stent 111 or the second covered stent 121, and the other end is set as a hinge, or both ends are set as hinges. In other embodiments, the connecting member 112 can also be a rigid member, such as made of a metal wire. It can be understood that when the connecting member 112 is a rigid member, to ensure the connection between the first covered stent 111 and the second covered stent 121 without hindering the expansion or contraction of the second covered stent 121, both ends of the connecting member 112 need to be hinged to the first covered stent 111 and the second covered stent 121 respectively.

[0068] Please refer to Figure 4-5 , in one embodiment, the sealing assembly 122 includes a sealing film 1221 and at least two driving rods 1222.

[0069] Among them, the proximal end of the sealing film 1221 is connected to the second covered stent 121, and the distal end axially extends toward the side where the first covered stent 111 is located to be at least partially received in the first lumen 110. And the part of the sealing film 1221 received in the first lumen 110 has a free end. The sealing film 1221 has a deployed and a folded state. The outer wall of the part of the sealing film 1221 received in the first lumen 110 cooperates with the inner wall of the first covered stent 111 to form a channel 14. The proximal end of the driving rod 1222 is connected to the second covered stent 121, and the distal end axially extends toward the side where the first covered stent 111 is located to be at least partially received in the first lumen 110. And the part of the driving rod 1222 received in the first lumen 110 has a free end. The driving rod 1222 is connected to the sealing film 1221. The driving rod 1222 is used to drive the sealing film 1221 to deploy as the second covered stent 121 expands or drive the sealing film 1221 to fold as the second covered stent 121 contracts.

[0070] By setting the sealing assembly 122 to include the sealing film 1221 and the driving rod 1222, when a branch stent 2 is implanted in the channel 14, since there are no redundant stent units on the sealing film 1221 to block, the sealing film 1221 can be more closely wrapped around the side wall of the branch stent 2, thereby ensuring a better anti-endoleakage effect. In addition, since there are no redundant stent units on the sealing film 1221 and it has good flexibility, the branch stent 2 can be prevented from being jointly extruded by the first covered stent 111 and the sealing assembly 122, and the shape of the branch stent 2 can be better maintained.

[0071] It can be understood that the specific extension direction of the driving rod 1222 only needs to satisfy that when the first film-covered stent 111 and the second film-covered stent 121 are both in a radially expanded state, the part of the driving rod 1222 accommodated in the first film-covered stent 111 fits the inner wall of the first film-covered stent 111. For example, in an embodiment, the first film-covered stent 111 is a cylindrical structure with a constant diameter. When the first film-covered stent 111 and the second film-covered stent 121 are both in an expanded state, the driving rod 1222 is completely accommodated in the first film-covered stent 111, then the driving rod 1222 is a straight rod structure or other structures extending in the same plane; or, in other embodiments, the first film-covered stent 111 is still a cylindrical structure with a constant diameter, but when the first film-covered stent 111 and the second film-covered stent 121 are both in an expanded state, only a part of the driving rod 1222 is accommodated in the first film-covered stent 111, then the part of the driving rod 1222 accommodated in the first film-covered stent 111 is a straight rod or other structures extending in the same plane that fits the inner wall of the first film-covered stent 111, and the extension direction of the part of the driving rod 1222 not accommodated in the first film-covered stent 111 can form a non-zero angle with the extension direction of the part of the driving rod 1222 accommodated in the first film-covered stent 111. Or, the first film-covered stent 111 is a cylindrical structure with a variable diameter, then the part of the driving rod 1222 accommodated in the first film-covered stent 111 is a curved rod with a bending angle that fits the inner wall of the first film-covered stent 111, and its bending angle matches the internal shape of the first film-covered stent 111.

[0072] It should be noted that the proximal end of the driving rod 1222 can be fixed to the second film-covered stent 121 by means such as welding and suturing, or it can be derived and woven from the braided wires on the second film-covered stent 121, and its specific connection method can be selected according to the usage situation.

[0073] In one embodiment, the drive rod 1222 is a long rod-shaped structure with a rectangular cross-section. In other embodiments, the cross-section of the drive rod 1222 can also be circular, fan-shaped, oval or other polygonal shapes, or the drive rod 1222 can also be a spiral structure formed by winding braided wires. In one embodiment, the sealing film 1221 is integrally formed with the film on the second film covering stent 121. In other embodiments, the sealing film 1221 can also be sutured to the distal end of the second film covering stent 121 by sutures. The sealing film 1221 can be an integrally formed annular sheet, or can be formed by splicing and combining a plurality of arc-shaped sheets. It can be understood that the material of the sealing film 1221 can be a material with good biocompatibility such as nylon, polyester cloth or PTFE film. It should be noted that the material of the sealing film 1221 is not limited to the materials mentioned above, and the material of the sealing film 1221 can be selected as a flexible material that can block blood flow and is suitable for implantation into the human body. The connection between the sealing film 1221 and the drive rod 1222 can be achieved by suturing, heat treatment coating or bonding.

[0074] It should be noted that in other embodiments, the drive rod 1222 and the sealing film 1221 can also be connected to the middle or distal end of the second film covering stent 121. However, the connection method of the drive rod 1222 and the sealing film 1221 to the distal end of the second film covering stent 121 is more convenient to assemble and does not affect the shape of the second film covering stent 121.

[0075] Please continue to refer to Figure 4-5 , in one embodiment, the distal end of the sealing film 1221 is also connected to the first film covering stent 111 at points, that is, the sealing film 1221 is connected to the first film covering stent 111 at a plurality of discrete points and is not completely closed in the circumferential direction. And the connection points between the sealing film 1221 and the first film covering stent 111 and the connection points between the connecting member 112 and the first film covering stent 111 correspond to each other in position so that the channel 14 can be smoothly opened.

[0076] Before the implantation of the branch stent 2, the first covered stent 111 is in a radially expanded state, and the second covered stent 121 is in a radially compressed state. At this time, under the restriction of the second covered stent 121 or the delivery sheath, the driving rod 1222 drives the sealing film 1221 to form a folded state, the channel 14 is opened, and the folded sealing film 1221 divides the gap between the sealing assembly 122 and the first covered stent 111 due to the point connection with the first covered stent 111, that is, a plurality of different channels 14 are formed. When the branch stent 2 is implanted into a specific channel 14, by releasing the second covered stent 121, the proximal end of the connecting piece 112 and the driving rod 1222 will move towards the side close to the inner wall of the first covered stent 111 as the second covered stent 121 unfolds. Driven by the driving rod 1222, the sealing film 1221 also unfolds accordingly until the second covered stent 121 is in a radially expanded state. At this time, in the channel 14 implanted with the branch stent 2, the driving rod 1222 adheres to the side wall of the branch stent 2, and the sealing film 1221 wraps around the branch stent 2 under the combined action of the driving rod 1222 to wrap the branch stent 2, while in the channel 14 without the implanted branch stent 2, the driving rod 1222 drives the sealing film 1221 to adhere to the inner wall of the first covered stent 111 together to seal the channel 14.

[0077] By point-connecting the sealing film 1221 with the first covered stent 111, the implantable medical device 1 has channels 14 in all implantation directions, and the boundaries of the channels 14 are obvious, which facilitates the rapid positioning and implantation of the branch stent 2. At the same time, the connection between the sealing film 1221 and the first covered stent 111 enables the first covered stent 111 to cooperate with the driving rod 1222 to better tension the sealing film 1221 and play a role in restricting the branch stent 2, thereby improving the assembly stability of the branch stent 2.

[0078] It can be understood that the size of the channel 14 matches the size of the branch stent 2 to be implanted.

[0079] It should be noted that in one embodiment, the distal ends of the sealing film 1221 and the driving rod 1222 are in the same radial plane. The radial plane refers to the plane perpendicular to the longitudinal central axis of the implantable medical device 1. In other embodiments, the distal end of the driving rod 1222 may also extend beyond the distal end of the sealing film 1221.

[0080] It can be understood that in other embodiments, the sealing film 1221 may also be only connected to the driving rod 1222, that is, the sealing film 1221 is not connected to the first film-covered stent 111. In the contracted state, the first film-covered stent 111 is in contact with the sealing film 1221, but there is no connection point between the two. In this way, the sealing component 122 can also play a good sealing role, and the first film-covered stent 111 and the sealing component 122 do not interfere with each other, so as not to affect the opening and closing of the channel 14.

[0081] It can be understood that in other embodiments, it may also be that the connecting member 112 is omitted. At the same time, the distal end of the sealing film 1221 is point-connected to the first film-covered stent 111, that is, through the connection between the sealing film 1221 and the first film-covered stent 111, the connection between the first tubular member 11 and the second tubular member 12 is realized. In this way, while the sealing film 1221 plays the role of covering the branch stent 2, it can also play a connecting role.

[0082] Please return to Figure 3 , in one embodiment, the first tubular member 11 further includes a covering film 113. The distal end of the covering film 113 is connected to the proximal end of the first film-covered stent 1101, and the proximal end extends toward the side close to the second film-covered stent 121 to form a free end. The covering film 113 is fixed to the connecting member 112 along the extending direction of the connecting member 112.

[0083] In this embodiment, the outer diameter of the second film-covered stent 121 is smaller than the outer diameter of the first film-covered stent 111. The outer diameter of the distal end of the sealing film 1221 matches the inner diameter of the first film-covered stent 111, and the outer diameter of the proximal end of the sealing film 1221 matches the outer diameter of the second film-covered stent 121. Therefore, when the sealing film 1221 is in the radially expanded state, it is in the shape of an inverted frustum. The channel 14 is formed by the cooperation of the outer wall of the sealing film 1221 and the inner wall of the covering film 113.

[0084] When the first covered stent 111 is in a radially expanded state and the second covered stent 121 is in a radially compressed state, the driving rod 1222 drives the sealing film 1221 to form a folded state. At this time, the proximal end of the connecting member 112 also shrinks together under the drive of the second covered stent 121, while the distal end of the connecting member 112 expands under the influence of the first covered stent 111 and drives the covering film 113 fixed on the connecting member 112 to expand, so that a plurality of non - communicating channels 14 are formed between the inner side of the covering film 113 and the outer side of the sealing film 1221. When the second covered stent 121 changes to a radially expanded state, the distal end of the connecting member 112 and the driving rod 1222 both expand outwards, driving the sealing film 1221 to abut against the covering film 113 to close the channel 14. With such a setting, when the branch stent 2 is implanted in the channel 14, both the inner and outer sides of the branch stent 2 are in contact with flexible membranes, that is, the covering film 113 and the sealing film 1221 can better conform to the shape of the branch stent 2, so that the branch stent 2 can obtain a more tight wrapping, making the anti - internal leakage effect of the implantable medical device 1 and the fixation effect of the branch stent 2 better.

[0085] It can be understood that the material of the covering film 113 can be selected from materials with good biocompatibility such as nylon, polyester cloth, and polytetrafluoroethylene.

[0086] In addition, please refer to Figure 3-4 , to further enhance the installation stability of the branch stent 2, an extension edge 1223 is further connected to the distal end of the sealing film 1221. The extending direction of the extension edge 1223 is parallel to the extending direction of the first covered stent 111, and the height of the distal end of the extension edge 1223 in the axial direction is higher than the height of the wave crest of the connecting member 112. The height of the distal end of the driving rod 1222 in the axial direction is flush with the distal end of the extension edge 1223. The extension edge 1223 is used to extend the axial length of the channel 14. Under the action of the extension edge 1223, the axial length of the channel 14 is extended to a certain extent, so that the structure of the channel 14 is more perfect, and further it is more conducive to the path establishment of the branch stent 2 and the maintenance of the stability of the branch stent 2.

[0087] Please continue to refer to Figure 3 , in an embodiment, the imaging member 13 is arranged on the first covered stent 111, and there is only one imaging member 13. The position of the imaging member 13 in the circumferential direction of the first covered stent 111 corresponds to one of the channels 14. In this embodiment, the imaging member 13 is in a "bullet - head shape", that is, the imaging member 13 is asymmetric along the axial direction of the first tubular member 11. And when the imaging member 13 is located at the front end of the human anatomical structure, the tip of the "bullet - head - shaped" imaging member 13 points to the right side of the first covered stent 111.

[0088] Please refer to Figure 3 and Figure 6, since the developing member 13 is asymmetric along the axial direction of the first tubular member 11, the developing form presented by the developing member 13 in the front end (the side close to the operator) in the circumferential direction of the human anatomical structure and the developing form presented by the developing member 13 in the rear end (the side away from the operator) in the circumferential direction of the human anatomical structure will be completely different in the developing device. If the developing form presented when the developing member 13 is located at the front end of the human anatomical structure is defined as the basic developing form of the developing member 13, specifically, when the developing member 13 is located at the front end of the human anatomical structure, its actual developing form is its basic developing form (as shown in Figure 3 ), when the developing member 13 is located at the rear end of the human anatomical structure, its actual developing form will present a shape completely opposite to its basic developing form (as shown in Figure 6 ), and when the developing member 13 is located on the side of the human anatomical structure, its actual developing form will be twisted to a certain extent on the basis of its basic developing form. Therefore, during the implantation operation, the operator only needs to observe whether the developing form actually presented by the developing member 13 is the same as, opposite to, or twisted from the basic developing form of the developing member 13, then it can be judged whether the channel 14 is located at the front end, rear end, or side in the circumferential direction of the human anatomical structure. Thus, the operator can rotate the implantable medical device 1 to make the channel 14 corresponding to the developing member 13 close to the branch blood vessel for implanting the branch stent 2.

[0089] It should be noted that the basic developing form is related to the shape of the developing member 13 itself and the setting method of the developing member 13 on the first tubular member 11. Taking the "bullet-shaped" developing member 13 as an example, when the developing member 13 is set at the front end of the first tubular member 11, when facing the front end of the first tubular member 11, if the tip of the "bullet-shaped" developing member 13 points to the right, then in the basic developing form, the tip of the "bullet-shaped" developing member 13 also points to the right. Similarly, if the tip of the "bullet-shaped" developing member 13 points to the left, then in the basic developing form, the tip of the "bullet-shaped" developing member 13 also points to the left.

[0090] It should also be noted that when the number of the developing members 13 is multiple and the shapes of the multiple developing members 13 are the same, the setting methods of all the developing members 13 on the first tubular member 11 are the same. That is, by rotating the first tubular member 11, each developing member 13 is in a state where it is located at the front end of the first tubular member 11, and the directions of each developing member 13 are the same. Still taking the "bullet-shaped" developing member 13 as an example, the tips of each developing member 13 located at the front end all point to the right or left.

[0091] It can be understood that the solution of only providing one developing member 13 is more suitable for an implantable medical system that only needs to implant one branch stent 2. Additionally, when only one developing member 13 is provided, as long as the shape of the developing member 13 itself is at least asymmetric along the axial direction of the first tubular member 11, the above-mentioned circumferential direction indication effect can be achieved. Its specific shape is not limited to the shapes listed in the embodiments. In other embodiments, the shape of the developing member 13 can also be ">", "<", "B", "→", or a parallelogram, a right trapezoid, etc. Additionally, in other embodiments, the developing member 13 can also be a non-axisymmetric structure, that is, it does not have a symmetry axis in any direction, so that the change in the developing form of the developing member 13 at different positions can be more obvious, making it easier to distinguish.

[0092] Please continue to refer to Figure 3 , in one embodiment, the developing member 13 is located at the proximal end of the first covered stent 111, so as to play a role in indicating the outlet of the channel 14. In other embodiments, the axial position of the developing member 13 can also be set to be in the same radial plane as the distal end of the sealing assembly 122, so as to play a role in indicating the inlet of the channel 14. When the sealing assembly 122 is omitted, the axial position of the developing member 13 can be set to be in the same radial plane as the distal end of the second covered stent 121, so as to indicate the inlet of the channel 14. That is, the axial setting position of the developing member 13 is not limited, but when it is located at the inlet or outlet of the channel 14, its "multiple indication" effect will be better, which can better assist the operator in distinguishing the position and the inlet and outlet of the channel 14. The operator can judge whether the instrument or the branch stent 2 has entered the channel 14 or has protruded from the channel 14 according to whether the proximal end of the instrument or the branch stent 2 exceeds the developing member 13, thus making it more convenient for the implantation of the branch stent 2.

[0093] In other embodiments, the developing member 13 can also be provided on the connecting member 112. It should be noted that when the developing member 13 is provided on the connecting member 112, it should be located as much as possible on the distal side of the connecting member 112, so as to prevent the situation that the developing member 13 is compressed and cannot show its specific shape due to the compression of the proximal end of the connecting member 112 driven by the compression of the second tubular member 12.

[0094] Please continue to refer to Figure 3 , in one embodiment, the first covered stent 111 includes a frame 1111, an inner membrane 1112, and an outer membrane (not shown in the figure).

[0095] The inner membrane 1112 is arranged inside the frame 1111, and the outer membrane covers the outside of the frame 1111. The developing member 13 is a developing film, that is, the developing member 13 is a sheet-like body, and the developing member 13 is located between the inner membrane 1112 and the outer membrane. The developing member 13 is clamped and fixed by the cooperation of the inner membrane 1112 and the outer membrane.

[0096] In this embodiment, the inner membrane 1112 and the outer membrane are integrated by heat treatment to wrap and fix the frame 1111 and the imaging member 13, and the forming operation is simple and convenient. In other embodiments, the inner membrane 1112, the outer membrane, the frame 1111, and the imaging member 13 can also be fixed by sutures. Among them, the sutures can be made of biocompatible materials, such as PET (polyethylene terephthalate) sutures or PTFE (polytetrafluoroethylene) sutures, etc. In addition, the materials of the inner membrane 1112 and the outer membrane can be biocompatible materials such as nylon, polyester cloth, and PTFE film. The materials of the inner membrane 1112 and the outer membrane are not limited to the materials mentioned above, and flexible materials that can block blood flow and are suitable for implantation into the human body can be selected. They can be absorbable materials or non-absorbable materials. The imaging member 13 is made of materials that can be clearly distinguishable on medical imaging devices. For example, materials visible on X-ray transmission medical imaging devices are selected. Materials visible on X-ray transmission medical imaging devices can be platinum-iridium alloy, tantalum metal, gold, etc. The materials of the imaging member 13 are not limited to the materials mentioned above, and metal materials with good imaging functions can be selected.

[0097] Please refer to Figure 7 , in one embodiment, the imaging member 13 includes a body 131a, and a through hole 132a is formed in the body 131a.

[0098] The setting of the through hole 132a can reduce the area of the imaging member 13 while ensuring the size of the imaging member 13. On the one hand, the flexibility of the imaging member 13 can be increased. On the other hand, the inner membrane 1112 and the outer membrane can be adhered at the through hole 132a, so that along the circumferential direction of the imaging member 13, there is a clamping and fixing effect of the inner membrane 1112 and the outer membrane on the outside of the imaging member 13 and at the through hole 132a, thereby preventing the separation of the inner membrane 1112 and the outer membrane and the dropping of the imaging member 13 due to the too large area of the imaging member 13 during the repeated expansion and contraction of the imaging member 13 with the first covered stent 111.

[0099] In this embodiment, the number of the through holes 132a is one, and the shape of the through hole 132a is the same as the shape of the outer peripheral edge of the imaging member 13, and the through hole 132a is coaxially arranged with the imaging member 13, so that the area of the designable through hole 132a can be maximized, thereby better increasing the bonding force between the inner membrane 1112 and the outer membrane. In other embodiments, the number of the through holes 132a can also be set to be multiple, and its shape can also be different from the shape of the outer peripheral edge of the imaging member 13.

[0100] It can be understood that the line corners at the outer peripheral edge of the imaging member 13 can all be processed into rounded corner shapes, so as to prevent the imaging member 13 from forming a tip and piercing the inner membrane 1112 or the outer membrane.

[0101] See also Figure 8 In another embodiment, the developing member 13 is still disposed on the first coating support 111 . Different from the previous embodiment, in this embodiment, the developing member 13 is a developing tube sleeved on the frame 1111 .

[0102] Specifically, the frame 1111 is formed by a plurality of corrugated bracket units that are connected to each other. The developing member 13 is a spring coil woven from metal wires through a winding and heat setting process. The developing member 13 is wound on the frame 1111 to form a predetermined shape.

[0103] In this embodiment, the developing member 13 includes a first developing section 131b and a second developing section 132b. The first developing section 131b and the second developing section 132b are respectively located on two adjacent bracket units, and the first developing section 131b and the second developing section 132b only cover a straight rod section in a waveform of the bracket unit. The first developing section 131b cooperates with the second developing section 131b, so that the developing member 13 is in a “>” shape when it is located at the front end in the circumferential direction of the human anatomical structure, and is in a “<” shape when it is located at the rear end, so that the developing member 13 has circumferential direction indication, and can indicate the front end and rear end in the circumferential direction of the human anatomical structure.

[0104] In other embodiments, the first developing segment 131b and the second developing segment 132b may also cooperate to make the developing member 13 present a "<", "\" or " / " shape when the front end is located in the circumferential direction of the human anatomical structure, or only the first developing segment 131b is provided to make the developing member 13 present a "\" shape when the front end is located in the circumferential direction of the human anatomical structure, or only the second developing segment 132b is provided to make the developing member 13 present a " / " shape when the front end is located in the circumferential direction of the human anatomical structure, thereby making the developing member 13 have circumferential direction indication.

[0105] See also Figure 9 In other embodiments, the first developing section 131b or the second developing section 132b may also cover not only one straight rod segment, but two straight rod segments and the crests or troughs in the two straight rod segments, wherein the lengths of the two straight rod segments covered are different, so that the developing member 13 presents a “√” or “√” when located at the front end of the human anatomical structure. When located at the back end, Or "√" and other forms, so that the developing member 13 still has the circumferential direction indication.

[0106] The developing member 13 in the form of the above-mentioned developing tube is formed as follows: First, a wire is woven into a spring coil through a wire winding and heat setting process; then, the spring coil is sleeved on the support unit to be used for weaving the frame; then the support units are interconnected. While interconnecting the support units, the spring coil is moved so that the spring coil moves to a suitable position to form a geometric pattern with circumferential direction indication.

[0107] By using a woven wire material to form the developing member 13, it will not affect other components when sleeved on the frame 1111. After the developing member 13 is formed, it can be pressed and unfolded together with the first film-covered support 11, and even when pressed to the extreme state, it will not cause damage to the inner film 1112 or the outer film.

[0108] Please refer to Figure 10 , in other embodiments, the developing member 13 can also be a sleeve formed by cutting a tubular metal material. When sleeved on the frame 1111 or the connecting member 112, it has better firmness and a better developing effect.

[0109] Please refer to Figure 11-12 , in an embodiment, the developing member 13 is still in the shape of a "bullet head" that is asymmetric along the axial direction of the first tubular member 11. However, different from the previous embodiment, in this embodiment, six developing members 13 are provided, and the developing members 13 correspond to the channels 14 one by one.

[0110] This embodiment can accommodate the implantation of one branch stent 2 or multiple branch stents 2. At the same time, due to the relatively large number of channels 14 and imaging members 13 in this embodiment, when implanting the branch stent 2, this embodiment can find a suitable implantation channel 14 for the branch stent 2 without rotating the implantable medical device 1, thereby avoiding scratching the inner wall of the blood vessel during the rotation of the implantable medical device 1. It can be understood that when the number of imaging members 13 is relatively large, multiple imaging members 13 may overlap under the imaging device. However, since the imaging forms presented by the imaging members 13 at the front end and the rear end of the human anatomical structure are exactly opposite, a device such as a guide wire or an adjustable bending sheath used to establish the implantation path of the branch stent 2 can first enter one of the channels 14, and the device drives the imaging member 13 on this channel 14 to vibrate. Then, by observing whether the imaging form presented by the vibrating imaging member 13 is the same as or opposite to the basic imaging form of the imaging member 13, it can be determined whether the channel 14 currently entered by the device is at the front end or the rear end of the human anatomical structure. Alternatively, after the device enters one of the channels 14, the light source of the imaging device can be rotated so that the light source projects onto the implantable medical device 1 from the side. Then, based on the imaging position of the device used to establish the implantation path, it can be determined whether the channel 14 is at the front end or the rear end of the human anatomical structure. For example, if the light source projects from the right side, if the imaging of the device used to establish the implantation path is on the left, it means that the channel 14 entered by the device is at the front end; if the imaging of the device used to establish the implantation path is on the right, it means that the channel 14 entered by the device is at the rear end. If the light source projects from the left side, the situation is opposite.

[0111] For example, in this embodiment, the number of branch stents 2 to be implanted is two. First, when implanting the first branch stent 2, its corresponding branch blood vessel is on the left side of the operator. Therefore, the position and number of the imaging members 13 closest to the branch blood vessel and on the left side of the image can be observed through the X-ray fluoroscopy image, as Figure 12 shown. There is imaging on the left side closest to the branch blood vessel and there is no overlap in the image, indicating that there is exactly one imaging member 13 here. This shows that at this time, there is also exactly one channel 14 closest to the branch blood vessel. Therefore, it can be determined that this channel 14 is the best implantation channel 14 at the branch blood vessel, and then the branch stent 2 can be directly implanted into this channel 14. It can be understood that before implanting the first branch stent 2, the implantable medical device 1 is still in a rotatable state. That is, if it is found in the imaging device that all the channels 14 are far from the branch blood vessel, the method of rotating the implantable medical device 1 can still be used to make one of the channels 14 close to the branch blood vessel to become the best implantation channel 14.

[0112] However, when implanting the second branch stent 2, due to the presence of the first branch stent 2, at this time, the implantable medical device 1 can no longer be rotated. Therefore, it is necessary to select the channel 14 closest to the second branch blood vessel from the remaining channels 14 for implantation.

[0113] Please continue to refer to Figure 12 , for example, the second branch blood vessel is located in the right front of the operator. In the observed X-ray fluoroscopy image, the imaging members 13 located on the right side and close to the branch blood vessel overlap in the image, indicating that there is a channel 14 in front and behind in the circumferential direction at this position. However, at this time, only the front channel 14 is the optimal implantation position. Therefore, an instrument for assisting in establishing the implantation path of the branch stent 2, such as a guide wire or an adjustable bending sheath, can be used to poke the imaging member 13 or pry the first tubular member 11 to drive one of the imaging members 13 to vibrate, so that the imaging form of the imaging member 13 changes. Then, it can be judged whether the imaging member 13 is in front of or behind the human anatomical structure according to the shape of the original form of the changed imaging. If the original form of the vibrating imaging is consistent with the basic imaging form of the imaging member 13, it means that the imaging member 13 is in front of the human anatomical structure, and the channel 14 corresponding to the imaging member 13 is the optimal implantation channel 14. If the original form of the vibrating imaging is opposite to the basic imaging form of the imaging member 13, it means that the imaging member 13 is behind the human anatomical structure, and the channel 14 corresponding to the imaging member 13 is not the optimal implantation channel 14. At this time, the instrument for assisting in establishing the implantation path of the branch stent 2 needs to be withdrawn and the above steps of the instrument entering the channel 14 and driving the imaging member 13 to vibrate are repeated until the correct implantation path is determined.

[0114] Please refer to Figure 14 , in another embodiment, there are three channels 14 and imaging members 13, and the channels 14 and the imaging members 13 are in one-to-one correspondence and are evenly distributed along the circumference of the first tubular member 11. Different from other embodiments, in this embodiment, the shapes of the three imaging members 13 are different from each other, and the three imaging members 13 are arranged in a certain order, but the specific shapes of the imaging members 13 are not limited. For example, the shapes of the three imaging members 13 are circular, triangular, and figure-eight respectively. Starting from the circular imaging member 13, the three imaging members 13 are arranged counterclockwise on the first tubular member 11 in the order of circular, triangular ( Figure 13 The dotted line used in the figure only indicates that it is behind the first covered stent 11, and the dotted line has no other meaning), figure-eight. Such a setting can distinguish the orientation of the channel 14 through the imaging arrangement order in the X-ray fluoroscopy image. For example, taking the triangular imaging member 13 as an example, as Figure 14As shown, when the developing arrangement seen in the X-ray fluoroscopic image is, from left to right: circle, triangle, figure-eight, it indicates that the developing member 13 in the shape of a triangle is located at the front end of the human anatomical structure, such as Figure 15 As shown, if the developing arrangement seen in the X-ray fluoroscopic image is, from left to right: figure-eight, triangle, circle, it indicates that the developing member 13 in the shape of a triangle is located at the rear end of the human anatomical structure. At the same time, since the shapes of the respective developing members 13 are all different, therefore, when the development of a developing member 13 overlaps, it is still possible to distinguish which of the two overlapping developing members 13 is at the front end of the human anatomical structure and which is at the rear end of the human anatomical structure by means of making the development vibrate.

[0115] It can be understood that the number of the developing members 13 and the channels 14 is not limited. Among them, when there is only one developing member 13, the shape of the developing member 13 itself can be set to have circumferential direction indication, and then by rotating the implantable medical device 1, the channel 14 corresponding to the developing member 13 is made to approach the branch blood vessel and then the branch stent 2 is implanted. When the number of the developing members 13 and the channels 14 is two or more, only the developing members 13 need to be set to have circumferential direction indication, and then during implantation, the channel 14 closest to the branch blood vessel can be directly selected according to the image of the developing device for implantation. And the way of directly selecting the channel 14 makes the operation during implantation simpler and more convenient, and is suitable for the situation where at least two branch stents 2 need to be implanted. Among them, when the number of the developing members 13 and the channels 14 is two or more, the circumferential direction indication can be achieved by at least two methods: one is that the shapes of all the developing members 13 are the same and are all asymmetric at least along the axial direction of the first tubular member 11, so that the direction can be distinguished by the change in the developing form of a single developing member 13; the other is that the developing members 13 have at least two shapes. At this time, the specific shapes of the developing members 13 are not limited, and by arranging the developing members 13 with different shapes in a certain order, the direction can be distinguished according to the developing arrangement order of the multiple developing members 13. It can be understood that when the direction is distinguished by the developing arrangement order of the developing members 13, the shape of a single developing member 13 itself can still be set to be asymmetric at least along the axial direction of the first tubular member 11.

[0116] It should be noted that, in one embodiment, the implantable medical device 1 may further include a leaflet structure (not shown in the figure). The leaflet structure is connected to the second tubular member 12 and includes three leaflets that can be closed and opened. When the implantable medical device 1 is implanted into the body, with the diastole and systole of the heart, the three leaflets close and open, thereby closing or opening the second lumen 120. The material of the leaflets can be a biological material or a polymer material. When a patient with aortic dissection also has aortic valve disease and needs to replace the natural aortic valve, using this implantable medical device 1 can treat aortic dissection and replace the natural aortic valve simultaneously. It can be understood that, in other embodiments, the number of leaflets is not limited to three, for example, it can be two or four. In addition, when the implantable medical device 1 is applied to other parts such as the renal artery where natural valve replacement is not required, the leaflet structure can be omitted.

[0117] The implantable medical system provided in this embodiment enables the branch stent 2 to be quickly positioned at the optimal implantation channel during implantation by applying the implantable medical device 1 that can quickly determine the position of the channel 14 during the implantation surgery, thereby shortening the operation time, reducing the operation difficulty, and improving the operation success rate.

[0118] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0119] The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. An implantable medical device, characterized in that, comprising: a first tubular member having a first lumen; a second tubular member having a second lumen, the first tubular member being connected to the second tubular member, and the second tubular member being partially received within the first lumen such that an outer wall of the second tubular member cooperates with an inner wall of the first tubular member to form an openable or closable passage, and when the first tubular member is in a radially expanded state and the second tubular member is in a radially compressed state, the passage is in an open state and communicates with the first lumen; when the first tubular member and the second tubular member are both in an expanded state, the passage is in a closed state; and at least one radiopaque member disposed on the first tubular member and corresponding to the passage, and when the number of the radiopaque members is plural, the radiopaque members are circumferentially spaced along the first tubular member, and a shape of the radiopaque member itself and / or an arrangement order of the plural radiopaque members has circumferential direction indicativeness.

2. The implantable medical device according to claim 1, characterized in that, the number of the radiopaque members is one, and the radiopaque member is at least asymmetric along an axial direction of the first tubular member; or, the number of the radiopaque members is at least two, and shapes and arrangement manners of the radiopaque members are the same, and the radiopaque members are at least asymmetric along the axial direction of the first tubular member; or, the number of the radiopaque members is at least two, and there are at least two radiopaque members having at least two different shapes among the at least two radiopaque members.

3. The implantable medical device according to claim 1 or 2, characterized in that, the radiopaque member and an inlet of the passage are in the same radial plane; or, the radiopaque member and an outlet of the passage are in the same radial plane.

4. The implantable medical device according to claim 1, characterized in that, the first tubular member includes a first covered stent and a connecting member, the first lumen is disposed on the first covered stent, a distal end of the connecting member is connected to the first covered stent, and a proximal end of the connecting member is connected to the second tubular member, and the radiopaque member is disposed at a proximal end of the first covered stent or a distal end of the connecting member.

5. The implantable medical device according to claim 4, characterized in that, the first covered stent includes a frame, an inner membrane disposed inside the frame, and an outer membrane disposed outside the frame, the radiopaque member is a radiopaque film clamped by the inner membrane and the outer membrane, or the radiopaque member is a radiopaque tube sleeved on the frame or the connecting member.

6. The implantable medical device according to claim 5, characterized in that, the radiopaque film includes a body, and a through hole is formed in the body, and at the through hole, the inner membrane and the outer membrane are attached to each other.

7. The implantable medical device according to claim 5, characterized in that, the radiopaque tube is a sleeve or a coil.

8. The implantable medical device according to claim 7, characterized in that, The developing tube includes a first developing section and a second developing section. The first developing section is connected or not connected to the second developing section. The first developing section and the second developing section cooperate to form a geometric figure that is asymmetrically arranged along the axial direction of the first film covering bracket.

9. The implantable medical device according to claim 1, wherein, The second tubular member includes a second covered stent and a sealing assembly, and the second covered stent and / or the sealing assembly are point-connected to the first tubular member. ， The proximal end of the sealing assembly is connected to the second covered stent, and the distal end axially extends away from the second covered stent to at least partially accommodate in the first lumen. The portion of the sealing assembly accommodated in the first lumen is a ring structure and has a free end. The ring structure surrounds the longitudinal central axis of the first tubular member. The sealing assembly can be deployed or contracted synchronously with the second covered stent. The channel is formed by the inner wall of the first tubular member and the outer wall of the sealing assembly.

10. The implantable medical device according to claim 9, wherein, The sealing assembly includes: a sealing film, the proximal end of which is connected to the second film covering bracket, and the distal end axially extends towards the side where the first tubular member is located to at least partially accommodate in the first lumen. And the part of the sealing film accommodated in the first lumen has a free end. The sealing film has a deployed and a folded state. The outer wall of the part of the sealing film accommodated in the first lumen cooperates with the inner wall of the first tubular member to form the channel; and at least two driving rods, the proximal ends of the driving rods are connected to the second film covering bracket, and the distal ends axially extend towards the side where the first tubular member is located to at least partially accommodate in the first lumen. And the part of the driving rods accommodated in the first lumen has a free end. The driving rods are connected to the sealing film. The driving rods are used to drive the sealing film to deploy or fold along with the expansion of the second film covering bracket or drive the sealing film to fold along with the contraction of the second film covering bracket.

11. The implantable medical device according to claim 10, wherein, The projection of the developing member on the sealing film is located at the part of the sealing film accommodated in the first lumen.

12. The implantable medical device according to claim 1, wherein, The implantable medical device further includes a valve leaf structure, which is arranged in the second tubular member, and the valve leaf structure can be opened or closed to make the second lumen of the second tubular member in an open or closed state.

13. An implantable medical system, wherein, comprising: a branch stent; and the implantable medical device according to any one of claims 1-12, one end of the branch stent can extend into the channel and be clamped by the cooperation of the first tubular member and the second tubular member.

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