Implantable medical device and system
By designing an implantable medical device including a first tubular member, a second tubular member and an anchor member, the problem of insufficient anchoring force of the coated stent in the ascending aorta is solved, and a more stable implantation and a higher success rate are achieved.
Patent Information
- Application Number
- CN202311816990.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-26
- Publication Date
- 2025-06-27
AI Technical Summary
In the ascending aorta, the existing coated stents have insufficient anchoring force to anchor against the radial support provided by the stent itself due to high blood flow pressure and fast flow rate, which is prone to problems such as stent slippage and translocation.
An implantable medical device is designed, including a first tubular member, a second tubular member and an anchor member. The first tubular member cooperates with the second tubular member to form an open or closed channel, the anchoring member being anchored by one end with the branch lumen anatomical structure, and the other end passing through the channel and being clamped by the first tubular member and the second tubular member to provide an axial anchoring force for the first tubular member.
By providing axial anchoring force, the risk of slippage and translocation of implantable medical devices under blood flow shock is reduced, and the anchoring effect and success rate of implant surgery is improved.
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Figure CN120203853A_ABST
Abstract
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 dissection aneurysm, is a vascular disease that seriously endangers life and health, with a relatively high fatality rate. It is caused by various reasons that lead to the tearing of the aortic intima, and the blood flows into the arterial wall, causing the aortic wall to be layered and separated, and at the same time forming a hematoma.
[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 an artificial blood vessel, 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 a normal blood flow channel. Compared with surgical treatment, minimally invasive interventional treatment has been increasingly applied to routine treatment due to its advantages such as less trauma, faster recovery, and fewer complications.
[0005] Generally, one of the commonly used anchoring methods of a covered stent in the anatomical structure is to anchor by the radial support force provided by the structure of the stent itself. However, this method cannot be used in some specific main lumen anatomical structures, such as the ascending aorta. The ascending aorta has a large bending angle, high blood flow pressure, fast blood flow velocity, and large pulsation and deformation amplitudes of the blood vessel wall. Therefore, relying solely on the radial support force provided by the structure of the stent itself for anchoring, the anchoring force is insufficient, and situations such as stent slippage and dislocation are likely to occur. Summary of the Invention
[0006] Based on this, it is necessary to provide an implantable medical device with strong anchoring ability.
[0007] Furthermore, an implantable medical system with strong anchoring ability is also provided.
[0008] An implantable medical device, 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 the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form an openable or closable passage. 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 both the first tubular member and the second tubular member are in an expanded state, the passage is in a closed state; and an anchoring member that can pass through the first lumen, with one end of the anchoring member penetrating into the passage and being clamped by the first tubular member and the second tubular member, and the other end passing out of the first lumen and being located at the distal end of the first tubular member. After the implantable medical device is implanted, the anchoring member is configured to provide an axial anchoring force for the first tubular member and the second tubular member.
[0009] In one embodiment, the anchoring member includes an anchoring section, a connecting section, and a limiting section, with the two ends of the connecting section respectively connecting the anchoring section and the limiting section; when the anchoring member passes through the first lumen, the anchoring section is located outside the first tubular member and at the distal end of the first tubular member; the connecting section is disposed within the first lumen, and the limiting section extends into the passage and is clamped by the inner wall of the first tubular member and the outer wall of the second tubular member, and the limiting section can abut against the first tubular member or the second tubular member.
[0010] In one embodiment, the anchoring section includes an anchoring frame that has self-expanding properties.
[0011] In one embodiment, the limiting section includes: a connecting portion connected to the connecting section; and a limiting portion, at least a part of which is located outside the first lumen, with the limiting portion being connected to the end of the connecting portion away from the connecting section, and the limiting portion being configured to prevent the limiting section from completely penetrating into the first lumen.
[0012] In one embodiment, the limiting portion is provided as a barb structure that has a fixed end and a free end. The fixed end of the barb structure is connected to the connecting portion, and the free end of the barb structure extends towards the anchoring section side and can hook the proximal end of the first tubular member to abut against the first tubular member.
[0013] In one embodiment, the limiting portion is provided as a flared structure, and the flared structure includes an end with a relatively small radial dimension and an end with a relatively large radial dimension which are oppositely arranged; the flared structure is sleeved on the connecting portion, and the end with the relatively small radial dimension of the flared structure is connected to the end of the connecting portion away from the connecting section, or the end with the relatively small radial dimension of the flared structure is connected to the end of the connecting portion away from the connecting section, and the end with the relatively large radial dimension extends away from the connecting portion; the relatively large radial dimension of the flared structure is greater than the radial dimension of the channel, the flared structure is located in the channel, and a part of the side wall of the flared structure abuts against the inner side wall of the first tubular member, and another part abuts against the outer side wall of the second tubular member; or, the flared structure is located outside the first tubular member and the flared structure abuts against the second tubular member.
[0014] In one embodiment, the connecting section is a connecting rod, a cutting bracket, a braided bracket or a connecting membrane.
[0015] In one embodiment, the first tubular member includes a first covered stent and a connecting member, the first lumen is provided 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.
[0016] In one embodiment, the second tubular member includes a second covered stent and a sealing assembly, and the second covered stent and / or the sealing assembly are connected to the first tubular member at points. , 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 sealing assembly can be deployed or contracted synchronously with the second covered stent, and the channel is formed by the inner wall of the first tubular member and the outer wall of the sealing assembly.
[0017] 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 of which axially extends toward the side where the first tubular member is located to be at least partially received in the first lumen, and the portion of the sealing film received in the first lumen has a free end. The sealing film has a deployed and a folded state, and the outer wall of the portion of the sealing film received 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 covered stent, and the distal ends of the driving rods axially extend toward the side where the first tubular member is located to be at least partially received in the first lumen, and the portion of the driving rods received 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.
[0018] In one embodiment, the implantable medical device further includes a valve leaflet structure disposed within the second tubular member, and the valve leaflet structure is openable or closable to render the second lumen of the second tubular member in an open or closed state.
[0019] An implantable medical system includes: a branch stent; and the implantable medical device according to any one of claims 1-11, one end of the branch stent being insertable into the channel and clamped by the cooperation of the first tubular member and the second tubular member.
[0020] The implantable medical device provided by the embodiments of the present invention includes a first tubular member, a second tubular member, and an anchoring member. Among them, the first tubular member and the second tubular member cooperate to form a channel. The anchoring member is anchored to the branch lumen anatomical structure at one end, passes through the channel at the other end, and is clamped by the first tubular member and the second tubular member to provide an anchoring force in the axial direction of the first tubular member. When the first tubular member and the second tubular member are impacted by blood flow, the anchoring force provided by the anchoring member can resist the impact caused by the blood flow, enabling the first tubular member and the second tubular member to be stable at the original implantation position, reducing the risk of slippage and dislocation of the implantable medical device, facilitating the improvement of the anchoring effect of the implantable medical device, and increasing the success rate of the implantation surgery.
[0021] The implantable medical system provided by the embodiments of the present invention can be stably located at the original implantation position after implantation by applying the implantable medical device with strong anchoring ability, thereby reducing the risk of slippage and dislocation of the implantable medical device and increasing the success rate of the implantation surgery. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the accompanying drawings required for the description of the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can be obtained based on these drawings.
[0023] Among them:
[0024] Figure 1 is a schematic structural diagram of an implantable medical system according to an embodiment of the present invention;
[0025] Figure 2 is a cross-sectional view of an implantable medical device according to an embodiment of the present invention;
[0026] Figure 3 is a schematic structural diagram of an implantable medical system according to another embodiment of the present invention;
[0027] Figure 4 is a schematic structural diagram of a second tubular member according to an embodiment of the present invention;
[0028] Figure 5 is a schematic structural diagram of an implantable medical device in an open channel state according to an embodiment of the present invention;
[0029] Figure 6 is a cross-sectional view of an implantable medical device in an open channel state according to an embodiment of the present invention;
[0030] Figure 7 is a schematic structural diagram of an anchoring member according to an embodiment of the present invention;
[0031] Figure 8 is a schematic structural diagram of an anchoring fastener according to another embodiment of the present invention;
[0032] Figure 9 is a schematic structural diagram of an anchoring fastener according to another embodiment of the present invention;
[0033] Figure 10 is a schematic structural diagram of an anchoring fastener according to another embodiment of the present invention;
[0034] Figure 11 is a cross-sectional view of an implantable medical device in an open channel state according to another embodiment of the present invention;
[0035] Figure 12 is a cross-sectional view of an implantable medical device in an open channel state according to another embodiment of the present invention;
[0036] Figure 13 is a schematic structural diagram of an anchoring fastener according to another embodiment of the present invention. Detailed implementation manners
[0037] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to 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. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.
[0038] In the description of the embodiments of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It 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, and therefore should not be construed as a limitation to the embodiments of the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.
[0039] In the description of the embodiments of the present invention, it should be noted that unless otherwise clearly defined 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 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 situations.
[0040] In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or an 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 the cylinder.
[0041] 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.
[0042] It is understandable that the application site of the implantable medical system is not limited to the aorta, and it can also be applied to other parts with branched blood vessels, such as the renal artery. Hereinafter, the ascending aorta is taken as an example of the application site for description.
[0043] Please refer to Figures 1 to 3 , in one embodiment, the implantable medical device 1 includes: a first tubular member 11, a second tubular member 12, and an anchoring member 13.
[0044] 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 an openable or closable channel 14. 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 anchoring member 13 can pass through the first lumen 110. One end of the anchoring member 13 passes out of the channel 14 and can be clamped by the first tubular member 11 and the second tubular member 12. The other end of the anchoring member 13 passes out of the first lumen 110 from the side away from the channel 14 (i.e., the distal end) and is located at the distal end of the first tubular member 11. After the implantable medical device 1 is implanted, the anchoring member 13 is used to provide an axial anchoring force for the first tubular member 11 and the second tubular member 12.
[0045] It should be noted that when the implantable medical device 1 is implanted in the ascending aorta, one end of the anchoring member 13 is anchored to the anatomical structure of the branched lumen on the distal side (for example: the brachiocephalic trunk artery), and the other end is connected to the proximal end of the first tubular member 11. After the implantable medical device 1 is implanted, when the ventricle contracts, the blood flow starts from the ventricle, passes through the aortic valve and then passes through the implantable medical device 1 in the anterograde direction. The blood flow impacts the implantable medical device 1, causing the implantable medical device 1 to have an impact force in the blood flow direction; when the ventricle relaxes and the aortic valve closes, the blood in the ascending aorta flows back under the action of gravity, forming an impact force on the implantable medical device 1 that is opposite to the blood flow direction; and during the above two periods, the anchoring member 13 can provide an axial anchoring force for the first tubular member 11 and the second tubular member 12 to resist a part of the impact force generated by the blood flow, thereby playing an axial anchoring role for the implantable medical device 1, improving the anchoring ability and reducing the risk of detachment.
[0046] In other embodiments, the number of the anchoring members 13 is not limited, and the number can also be set to two, three or other integer numbers. Specifically, on the premise of not affecting the blood flow of the anatomical structure of the main lumen, the number of the anchoring members 13 can be set according to the specific shape of the lumen structure and the required anchoring ability at the specific implantation position of the implantable medical device 1.
[0047] For example, there are three branch arteries at the aortic arch, namely the brachiocephalic trunk artery, the left common carotid artery and the left subclavian artery. In this embodiment, the number of the anchoring members 13 can also be set to two or three. When the number of the anchoring members 13 is two, one ends of the two anchoring members 13 are anchored to two of the three branch arteries, and the other ends are hooked to the first tubular member 11; when the number of the anchoring members 13 is three, one ends of the three anchoring members 13 are anchored to the three branch arteries, and the other ends are hooked to the first tubular member 11.
[0048] In addition, the implantable medical device 1 of this embodiment can keep the blood flow unobstructed during the implantation operation. Specifically, the channel 14 for implanting the branch stent 2 and the anchoring member 13 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 operation, 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 along the channel 14 through the first lumen 110, so that the blood flow can be kept unobstructed during the implantation operation, preventing adverse effects on the health of the patient due to blood flow blockage, and at the same time, more time can be gained for the implantation of the branch stent 2 and the anchoring member 13, thereby reducing the surgical difficulty and improving the surgical success rate.
[0049] 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 along the circumferential direction of the second tubular member 12. The channel 14 can also be a non-annular channel, as long as it can pass through the branch stent 2 and the anchoring member 13 at the same time.
[0050] It should be noted that the total number of the branch stent 2 and the anchoring member 13 may correspond one-to-one to the number of the channels 14, or may be less than the number of the channels 14. Specifically, the number of the channels 14 can be set according to the number of the implanted branch stent 2 and the anchoring member 13, the required anchoring ability, and the convenience of implantation.
[0051] Please refer to Figures 3 to 6 , in one embodiment, the first tubular member 11 includes: a first covered stent 111 and a connecting member 112. The second tubular member 12 includes: a second covered stent 121 and a sealing assembly 122.
[0052] Specifically, the first lumen 110 is disposed on the first covered stent 111, and the second lumen 120 is disposed 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 to connect 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 accommodate in the first lumen 110. The portion of the sealing assembly 122 accommodated in the first lumen 110 is a ring structure. The ring structure has a free end and 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, and the channel 14 is formed by the outer wall of the portion of the sealing assembly 122 accommodated in the first lumen 110 cooperating with 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 in communication with the first lumen 110. 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.
[0053] It should be noted that, in this embodiment, by connecting the first covered stent 111 and the second covered stent 121 through the connecting member 112, the deployment or contraction movement between the first covered stent 111 and the second covered stent 121 can be carried out independently without interference with each other, so that the channel 14 can be opened more conveniently and quickly, the blood flow can be quickly unblocked, and it is beneficial to shorten the operation time. In addition, the setting of the connecting member 112 can enable the channel 14 to be opened to the greatest extent, thereby better ensuring the unblocked blood flow.
[0054] In one embodiment, 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 in a point connection manner, 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.
[0055] It should be noted that in this embodiment, by providing the sealing assembly 122, and the sealing assembly 122 cooperates with the first covered stent 111 to form the channel 14, the limitation on setting the radial dimension 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 diverse, so as to adapt to more tube cavity anatomical structures of different shapes for implantation.
[0056] In one embodiment, the sealing assembly 122 can be omitted, and the channel 14 is formed by the inner wall of the first covered stent 111 cooperating with 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 received in the first lumen 110. It should be noted that the first covered stent 111, the second covered stent 112, and the sealing assembly 122 themselves can be of a uniform diameter structure or a variable diameter structure, as long as the formation of the channel 14 can be ensured, the shapes of the first covered stent 111, the second covered stent 112, and the sealing assembly 122 are not limited.
[0057] In one embodiment, the connecting member 112 and the sealing assembly 122 can be omitted simultaneously, and the first covered stent 111 and the second covered stent 121 are directly connected to form the channel 14. For example, the first covered stent 111 and the second covered stent 121 are connected at multiple discrete positions in the circumferential direction to form multiple channels 14 that can be opened and closed and are arranged at intervals along the circumference of the second covered stent 121; or, the first covered stent 111 and the second covered stent 121 are directly connected and only partially connected, and there are 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 ensuring the formation of the channel 14.
[0058] Please continue to refer to Figures 3 to 6, 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 with the second covered stent 121. Thus, the connecting member 112 can rotate around the connection point between the connecting member 112 and the first covered stent 111 as the second covered stent 121 expands or contracts, thereby maintaining the connection between the first covered stent 111 and the second covered stent 121 and not hindering the expansion or contraction of the second covered stent 121.
[0059] It should be noted that 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.
[0060] In one embodiment, the connecting member 112 is a flexible member. For example, the connecting member 112 is made of a polymer wire. 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 and not hinder 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.
[0061] In one of the 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 and not hinder 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.
[0062] Please continue to refer to Figures 3 to 6 , in one embodiment, the sealing assembly 122 includes a sealing film 1221 and at least two driving rods 1222.
[0063] Specifically, 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 accommodated in the first lumen 110, and the portion of the sealing film 1221 accommodated in the first lumen 110 has a free end. The sealing film 1221 has a deployed state and a folded state. The outer wall of the portion of the sealing film 1221 accommodated 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 accommodated in the first lumen 110, and the portion of the driving rod 1222 accommodated in the first lumen 110 has a free end. The driving rod 1222 is connected to the sealing film 1221, and the driving rod 1222 is configured 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.
[0064] By setting the sealing assembly 122 to include the sealing film 1221 and the driving rod 1222, when the branch stent 2 and the anchoring member 13 are implanted in the channel 14, since there are no redundant stent units on the sealing film 1221 to block, the sealing film 1221 can wrap more closely around the side walls of the branch stent 2 and the anchoring member 13, 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 and the anchoring member 13 can be prevented from being jointly squeezed by the first covered stent 111 and the sealing assembly 122, and the shapes of the branch stent 2 and the anchoring member 13 can be better maintained.
[0065] It can be understood that the specific extending direction of the driving rod 1222 only needs to satisfy that when both the first covered stent 111 and the second covered stent 121 are in a radially deployed state, the portion of the driving rod 1222 accommodated in the first covered stent 111 fits against the inner wall of the first covered stent 111.
[0066] For example, in one embodiment, the first covered stent 111 is a cylindrical structure with a constant diameter. When both the first covered stent 111 and the second covered stent 121 are in a deployed state, the driving rod 1222 is entirely accommodated in the first covered stent 111, and then the driving rod 1222 is an overall straight rod structure or other structures extending in the same plane.
[0067] For another example, in one embodiment, the first covered stent 111 is still a cylindrical structure with a constant diameter. However, when both the first covered stent 111 and the second covered stent 121 are in the deployed state, only a part of the drive rod 1222 is accommodated in the first covered stent 111. Then, the part of the drive rod 1222 accommodated in the first covered stent 111 is a straight rod that fits the inner wall of the first covered stent 111 or other structures extending in the same plane. The extending direction of the part of the drive rod 1222 not accommodated in the first covered stent 111 can form a non-zero angle with the extending direction of the part of the drive rod 1222 accommodated in the first covered stent 111.
[0068] For yet another example, in one embodiment, the first covered stent 111 is a cylindrical structure with a variable diameter. Then, the part of the drive rod 1222 accommodated in the first covered stent 111 is a curved rod with a bending angle that fits the inner wall of the first covered stent 111, and its bending angle matches the internal shape of the first covered stent 111.
[0069] It should be noted that the proximal end of the drive rod 1222 can be fixed to the second covered stent 121 by means such as welding or suturing, or it can also be derived and woven from the braided wires on the second covered stent 121. The specific connection method can be selected according to the usage situation.
[0070] In one embodiment, the drive rod 1222 is a long strip-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.
[0071] In one embodiment, the sealing film 1221 is integrally formed with the covering film on the second covered stent 121. In other embodiments, the sealing film 1221 can also be sutured to the distal end of the second covered stent 121 by sutures. The sealing film 1221 can be an integrally formed annular sheet body, or it can also be formed by splicing and combining multiple arc-shaped sheet bodies. 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.
[0072] It should be noted that the material of the sealing film 1221 is not limited to the materials mentioned above. The material of the sealing film 1221 can be selected as a flexible material that can block blood flow and is suitable for implantation in 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.
[0073] It should also be noted that in other embodiments, the drive rod 1222 and the sealing film 1221 may also be connected to the middle or distal end of the second covered stent 121. However, the method of connecting the drive rod 1222 and the sealing film 1221 to the distal end of the second covered stent 121 is more convenient for assembly and does not affect the shape of the second covered stent 121.
[0074] In one embodiment, the distal end of the sealing film 1221 is also connected to the first covered stent 111 at points, that is, the sealing film 1221 is connected to the first covered stent 111 at multiple discrete points and is not completely closed in the circumferential direction. And the connection points between the sealing film 1221 and the first covered stent 111 correspond one-to-one in position to the connection points between the connecting member 112 and the first covered stent 111, so that the channel 14 can be opened smoothly.
[0075] It should be noted that before the anchoring member 13 and the branch stent 2 are implanted, 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, the drive rod 1222 drives the sealing film 1221 to form a folded state under the restriction of the second covered stent 121 or the delivery sheath, the channel 14 is opened, and the folded sealing film 1221 divides the pores 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.
[0076] When all the channels 14 are opened, a channel 14 suitable for implanting the branch stent 2 is preferentially selected, and the branch stent 2 is passed through the selected channel 14 and into the first lumen 110 through the delivery sheath, and the branch stent 2 is released. Then, a channel 14 suitable for implanting the anchoring member 13 is selected from the remaining channels 14, and the anchoring member 13 is passed through the selected channel 14 and into the first lumen 110 through the delivery sheath, and exits from the distal side of the first lumen 110 and enters the branch lumen anatomical structure (for example: brachiocephalic artery, left common carotid artery, etc.), and the anchoring member 13 is released, so that its distal end is anchored in the branch lumen anatomical structure through its own radial expansion performance, and the proximal end is hooked to the proximal side of the first tubular member 11.
[0077] After the anchoring member 13 and the branch stent 2 are implanted into the predetermined channel 14, by releasing the second covered stent 121, the proximal end of the connecting member 112 and the drive rod 1222 will move closer to the inner wall of the first covered stent 111 as the second covered stent 121 unfolds. Driven by the drive rod 1222, the sealing film 1221 also unfolds accordingly until the second covered stent 121 is in a radially expanded state. At this time, within the channel 14 implanted with the branch stent 2 and the anchoring member 13, the drive rod 1222 drives the sealing film 1221 to adhere to the inner wall of the first covered stent 111 together, thereby sealing the channel 14.
[0078] It should be noted that the sealing film 1221 is connected to the first covered stent 111 at points. When the first tubular member 11 is in the deployed state and the second tubular member 12 is in the compressed state, the sealing film 1221 divides the annular channel 14 located between the first covered stent 111 and the second covered stent 121 into multiple channels, so that the implantable medical device 1 has sub-channels in each implantation direction. The boundary of the sub-channel is formed by the outer wall of the sealing film 1221 and the inner wall of the covered stent 111, making the sub-channel have an obvious boundary, which facilitates the rapid positioning and implantation of the branch stent 2 and the anchoring member 13. 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 limiting role on the branch stent 2 and the anchoring member 13, thereby improving the assembly stability of the branch stent 2 and the anchoring member 13.
[0079] It can be understood that the size of the channel 14 matches the sizes of the branch stent 2 and the anchoring member 12 to be implanted.
[0080] In one embodiment, the distal end of the sealing film 1221 and the distal end of the driving rod 1222 are in the same radial plane. The radial plane refers to a plane perpendicular to the longitudinal central axis of the implantable medical device 1. It should be noted that in other embodiments, the distal end of the driving rod 1222 can also extend beyond the distal end of the sealing film 1221.
[0081] In one embodiment, the sealing film 1221 can also be only connected to the driving rod 1222, that is, the sealing film 1221 is not connected to the first covered stent 111. In the contracted state, the first 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 14 can also play a good sealing role, and there is no interference between the first covered stent 111 and the sealing component 14, thus not affecting the opening and closing of the channel 14.
[0082] In one embodiment, the connecting member 12 can be omitted. At the same time, the distal end of the sealing film 1221 is connected to the first covered stent 111 at points, that is, through the connection between the sealing film 1221 and the first 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 a role in covering the branch stent 2 and the anchoring member 13, it can also play a connecting role.
[0083] Please continue to refer to Figures 3 to 6, 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 covered stent 111, and the proximal end extends toward the side close to the second 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.
[0084] In this embodiment, the outer diameter of the second covered stent 121 is smaller than the outer diameter of the first covered stent 111. The outer diameter of the distal end of the sealing film 1221 matches the inner diameter of the first covered stent 111, and the outer diameter of the proximal end of the sealing film 1221 matches the outer diameter of the second covered stent 121. Therefore, when the sealing film 1221 is in a 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.
[0085] It should be noted that 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 contracts 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.
[0086] 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 outward, driving the sealing film 1221 to abut against the covering film 113 to close the channel 14. With this arrangement, when the branch stent 2 and the anchoring member 13 are implanted in the channel 14, the inner and outer sides of the branch stent 2 and the anchoring member 13 are in contact with flexible membranes, that is, the covering film 113 and the sealing film 1221 can better conform to the shapes of the branch stent 2 and the anchoring member 13, so that the branch stent 2 and the anchoring member 13 can be more tightly wrapped, and further, the connection between the branch stent 2 and the anchoring member 13 and the first tubular member 11 and the second tubular member 12 is more firm. At the same time, the anti - internal leakage effect of the implantable medical device 1 can also be improved.
[0087] 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.
[0088] In addition, to further enhance the installation stability of the branch stent 2 and the anchoring member 13, 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 13. 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 length of the channel 14 in the axial direction is extended to a certain extent, so that the structure of the channel 14 is more perfect, and thus it is more conducive to improving the installation stability of the branch stent 2 and the anchoring member 13.
[0089] Please refer to Figure 1 and Figure 3 , in one embodiment, the first covered stent 111 includes a first stent body 1111, a first inner membrane 1112, and a first outer membrane (not shown in the drawings). The second covered stent 121 includes a second stent body 1211, a second inner membrane 1212, and a second outer membrane (not shown in the drawings).
[0090] Specifically, the first inner membrane 1112 is disposed inside the first stent body 1111, and the first outer membrane is wrapped outside the first stent body 1111. The first inner membrane 1112 and the first outer membrane are integrated by heat treatment, so as to wrap and fix the first stent body 1111, and the forming operation is simple and convenient. Similarly, the second inner membrane 1212 is disposed inside the second stent body 1211, and the second outer membrane is wrapped outside the second stent body 1211. The second inner membrane 1212 and the second outer membrane are integrated by heat treatment, so as to wrap and fix the second stent body 1211, and the forming operation is simple and convenient.
[0091] Please refer to Figure 3 , in one of the embodiments, the anchoring member 13 includes: an anchoring section 131, a connecting section 132, and a limiting section 133. Wherein, both ends of the connecting section 132 are respectively connected to the anchoring section 131 and the limiting section 133.
[0092] Specifically, please refer to Figure 5 and Figure 6, when the anchoring member 13 penetrates through the first lumen 110, the anchoring section 131 is located outside the first tubular member 11 and on the distal side of the first tubular member 11. The anchoring section 131 is used to anchor to the anatomical structure of the branch lumen. The connecting section 132 is arranged in the first lumen 110, and the distal end of the connecting section 132 is connected to the anchoring section 131. The limiting section 133 extends into the channel 14 and is clamped by the inner wall of the first tubular member 11 forming the channel 14 and the outer wall of the second tubular member 12. The limiting section 133 can be hooked to one end (i.e., the proximal end) of the first tubular member 11 close to the second tubular member 12.
[0093] It should be noted that the limiting section 133 is clamped by the inner wall of the first tubular member 11 and the outer side wall of the second tubular member 12, which can not only improve the tightness of the combination of the anchoring member 13 and the first tubular member 11, but also improve the firmness of the hooking of the anchoring member 13 and the first tubular member 11.
[0094] It can be understood that the anchoring section 131 can be anchored to the anatomical structure of the branch lumen through its own radially expandable performance, or can be anchored to the anatomical structure of the branch lumen through other anchoring structures (such as: anchoring spines), as long as the anchoring section 131 can be anchored to the anatomical structure of the branch lumen and does not affect the blood flow in the branch lumen structure.
[0095] Please refer to Figure 7 , in one embodiment, the anchoring section 131 includes an anchoring frame. Among them, the anchoring frame has self-expanding properties. The anchoring frame has a radially compressed state and a radially expanded state. When the anchoring frame is in the radially compressed state, it can be received in the delivery sheath to reach the anchoring site; when the anchoring frame is in the radially expanded state, it abuts against the inner wall of the anatomical structure of the branch lumen through the radially expanding force to achieve anchoring.
[0096] It should be noted that the anchoring section 131 arranged in this way has a large frictional force on the outer surface, and it is more firmly anchored to the anatomical structure of the branch lumen through the radial supporting force, which is beneficial to improving the reliability of the anchoring member 13, thereby providing a more reliable axial anchoring force for the first tubular member 11 and the second tubular member 12, and at the same time facilitating the smooth inflow of blood into the anatomical structure of the branch lumen.
[0097] In one embodiment, a first membrane structure may also be provided at the distal end of the anchoring frame. The first membrane structure may be a single-layer membrane, and the single-layer membrane covers the outer wall of the distal end of the anchoring frame 1311 to reduce the friction on the outer surface of the distal end of the anchoring frame and protect the inner wall of the branched lumen anatomical structure at the anchoring position. Moreover, the first membrane structure is only provided at the distal portion of the anchoring frame, so that the proximal portion of the anchoring frame does not block the blood flow in the branched anatomical structure. In other embodiments, the first membrane structure 1312 is a double-layer membrane, and the anchoring end is covered between the double-layer membranes. In one of the embodiments, the connecting section 132 is a flexible member. For example, a connecting membrane made of a polymer material. It can be understood that the material of the connecting membrane can be a biocompatible material such as nylon, polyester cloth or PTFE film. When the connecting section 132 is a flexible member, after the implantable medical device 1 (please refer to Figure 1 ) is implanted, the anchoring member 13 does not have axial support force and can only provide axial tensile force. At this time, the anchoring member 13 can only lift and anchor the implantable medical device 1 when the ventricle is in diastole, the aortic valve is closed, and the blood in the ascending aorta flows back under the action of gravity, so as to form a force opposite to the direction of blood flow impact, achieving the effect of stabilizing the implantable medical device 1.
[0098] It should be noted that the connection between the connecting membrane and the anchoring section 131 and the limiting section 133 can be achieved by suture, heat treatment coating or bonding. The material of the connecting membrane is not limited to the materials mentioned above. The connecting membrane material can be selected as a flexible material suitable for implantation into the human body. Obviously, the connecting membrane is located in the first lumen 110. In order to reduce the influence on the blood flow in the first lumen 110, the connecting membrane preferably selects a flexible material with good blood passing ability.
[0099] In other embodiments, the connecting section 132 is a rigid member. For example, made of a metal wire or cut from a metal. It can be understood that when the connecting section 132 is a rigid member, after the implantable medical device 1 is implanted, the anchoring member 13 can provide both axial support force and axial tensile force. At this time, when the ventricle contracts, the blood flows from the ventricle, passes through the aortic valve and then passes through the implantable medical device 1 in the forward direction, causing the implantable medical device 1 to have an impact force along the blood flow direction, the anchoring member 13 provides axial support force to prevent the implantable medical device 1 from moving along the blood flow, thereby achieving the effect of stabilizing the implantable medical device 1; when the ventricle is in diastole, the aortic valve is closed, and the blood in the ascending aorta flows back under the action of gravity, the anchoring member 13 provides axial tensile force to lift and anchor the implantable medical device 1, so as to form a force opposite to the direction of blood flow impact, achieving the effect of stabilizing the implantable medical device 1.
[0100] Please refer to Figure 7, in one embodiment, the connecting section 132 is a connecting rod, and the number of connecting rods can be set according to the different anatomical structures of the main lumen, and the number can be one or more. In this embodiment, the number of connecting rods is two, and the two connecting rods have good axial support ability and have little influence on the blood flow in the first lumen 110 (please refer to Figure 5 ).
[0101] Please refer to Figure 8 , in one embodiment, the connecting section 132 is a cutting stent or a braided stent coated with a membrane structure. The connecting section 132 arranged in this way can effectively improve the axial support force of the anchoring member 13, and further improve the axial anchoring ability of the anchoring member 13. In other embodiments, in order to reduce the influence of the connecting section 132 on the blood flow in the first lumen 110, the connecting section 132 is a cutting stent or a braided stent without a membrane structure.
[0102] Please refer back to Figures 5 to 7 , in one of the embodiments, the limiting section 133 includes a connecting portion 1331 and a limiting portion 1332. Among them, the connecting portion 1331 is connected to the proximal end of the connecting section 132. The limiting portion 1332 is connected to the connecting portion 1331. At least a part of the limiting portion 1332 is located outside the first lumen 110. The limiting portion 1332 is used to hook the proximal end of the first tubular member 11 to prevent the limiting section 133 from completely penetrating into the first lumen 110 and easily causing the anchoring member 13 to be separated from the first tubular member 11.
[0103] Please refer to Figure 7 , Figure 8 , Figure 9 or Figure 10 , in one of the embodiments, the connecting portion 1331 includes: a frame 13311 and a second membrane structure 13312. Among them, the frame 13311 has self-expansion property. The frame 13311 has a radially compressed state and a radially expanded state. The second membrane structure 13312 is coated on the frame 13311.
[0104] In one embodiment, the radial dimension of the frame 13311 in the expanded state is larger than the radial dimension of the channel 14. When in use, when the channel 14 (please refer to Figure 1 ) is opened, the frame 13311 enters the channel 14 through the delivery sheath and expands. When the channel 14 is closed, the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12 form radial extrusion on the frame 13311, which is beneficial to improving the connection reliability between the anchoring member 13 and the first tubular member 11.
[0105] In one embodiment, the connecting portion 1331 may omit the second membrane structure 13312. In this way, the force that radially contracts the frame 13311 can be reduced, so that the connecting portion 1331 is more easily radially compressed, improving the sealing performance between the anchoring member 13 and the first tubular member 11.
[0106] Please refer to Figure 6 , Figure 7 and Figure 8 , in one embodiment, the limiting portion 1332 is a barb structure. The barb structure has a radially folded state and a radially unfolded state. The barb structure has a free end and a fixed end. The fixed end of the barb structure is connected to the connecting portion 1331, and the free end of the barb structure is located outside the first tubular member 11 and extends distally. The free end of the barb structure cooperates with the outer side wall of the connecting portion 1331 to hook the proximal end of the first tubular member 11.
[0107] It can be understood that after the first tubular structure 11 is implanted, it is not desirable to have a gap between the first tubular member 11 and the anatomical structure of the main body lumen. And the free end of the barb structure is exactly located between the inner wall of the anatomical structure of the main body lumen and the outer wall of the first tubular member 11. Therefore, the better the free end of the barb structure adheres to the wall, the better the wall attachment effect of the first tubular member 11 and the more reliable the implantation. In this embodiment, there is one barb structure, which cooperates with the connecting portion 1331 to hook the distal end of the first tubular member 11.
[0108] Please refer to Figure 7 and Figure 8 , in one embodiment, the barb structure is composed of two connected metal rods. There are multiple barb structures, and multiple barb structures form a skirt structure at the proximal end of the connecting portion 1331, which is beneficial for the limiting section 133 of the anchoring member 13 to hook the first tubular member 11 (please refer to Figure 1 ), thereby reducing the implantation time of the anchoring member 13.
[0109] In one embodiment, each barb structure is coated with a membrane structure, but there is no membrane structure in the gap between adjacent barb structures to avoid hindering the hooking of the barb structure and the first tubular member 11. The membrane structure can reduce the friction between the barb structure 13321 and the inner wall of the anatomical structure of the main body lumen, so as to reduce the damage to the inner wall of the anatomical structure of the main body lumen.
[0110] In one embodiment, there are multiple barb structures, but the radial supporting force of the second covered stent 121 or the sealing component 122 is relatively large, so that when the second covered stent 121 or the sealing component 122 expands, it can squeeze the barb structures located in the channel 14, making the barb structures adhere to the inner wall of the first tubular member 11, which is beneficial for closing the channel 14.
[0111] Please return to Figure 9 , in other embodiments, the limiting portion 1332 is provided with a flared structure having self-expanding properties. The flared structure includes a support structure composed of a plurality of support rods 13321 and a film 13320 coated on the support structure. The flared structure is sleeved on the connecting portion 1331, and one end of the flared structure is connected to the connecting portion 1331, and the other end is a free end. In the radially expanded state, the radial dimension of the end of the flared structure connected to the connecting portion 1331 is larger than the radial dimension of the free end. When one end of the anchoring member 13 extends into the channel 14, the flared structure can better abut against the first tubular member 11 and the second tubular member 12, which is beneficial to improving the reliability of the connection between the anchoring member 12 and the first tubular member 11 and the second tubular member 12, so as to prevent the limiting section 133 from completely penetrating into the first lumen 110, thereby reliably and continuously providing an axial anchoring force for the first tubular member 11 and the second tubular member 12.
[0112] In this embodiment, the support structure is formed by braiding braided wires. With such a setting, it is easier to be radially folded and is more beneficial to the closing of the channel 14.
[0113] Please refer to Figure 10 and Figure 11 , in one of the embodiments, the flared structure is not sleeved on the connecting portion 1331, but the flared structure is connected to the end of the connecting portion 1331 far from the connecting section 132, and the other end extends in a direction away from the connecting section 132. And, the radial dimension of the end of the flared structure connected to the connecting portion 1331 is smaller than the radial dimension on the side away from the connecting portion 1331. When the flared structure partially penetrates into the channel 14, the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12 form extrusion on the flared structure, which is beneficial to improving the reliability of the connection between the flared structure and the first tubular member 11 and the second tubular member 12. At the same time, it is also beneficial to improving the sealing performance at the joint of the flared structure and the channel 14 (refer to Figure 5 ), thereby reducing the blood leakage amount at the channel 14 when blood flows through.
[0114] Please refer to Figure 12 , in other embodiments, the flared structure can also be completely located outside the first lumen 110. At this time, the inner wall of the first tubular member 11 and the outer wall of the second tubular member 12 form a radially contracting extrusion force on the connecting portion 1331, which is beneficial to improving the sealing performance at the joint of the connecting portion 1331 and the channel 14 (refer to Figure 5 ), thereby reducing the blood leakage amount at the channel 14 when blood flows through. And, since the radial dimension of the flared structure located outside the first lumen 110 away from the connecting portion 1331 is larger, it is beneficial to improving the reliability of the connection between the anchoring member 13 and the first tubular member 11 and the second tubular member 12.
[0115] In one embodiment, the flaring structure may be a cutting stent or a braided stent with a membrane; it may also be a cutting stent or a braided stent without a membrane. That is, the membrane 13320 may be omitted.
[0116] Please refer to Figure 13 , in one embodiment, the connecting section 132 is two connecting rods. The proximal sides of the two connecting rods have bending portions, so that the two connecting rods are connected at the proximal ends to form a connecting portion 1331, and there is an opening 1330 on the connecting portion 1331. The limiting portion 1332 is a barb structure, and the fixed end of the barb structure is connected to the proximal end of the opening 1330. The free end of the barb structure is set to be arc-shaped to reduce the damage to the inner wall of the anatomical structure of the main body lumen by the barb structure. It can be understood that the connecting portion 1331 arranged in this way can reduce the size of the channel 14 it expands, which is beneficial to the closing of the channel 14, thereby reducing the blood leakage amount at the channel 14 when blood flows through. And in this embodiment, the outer membrane structure 13320 is omitted.
[0117] It should be noted that when transporting the anchoring member 13, the free end of the barb structure approaches the side of the connecting rod, so that the barb structure is partially accommodated in the opening 1330 and is radially constrained for transportation through the delivery sheath.
[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 to be within 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 the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form an openable or closable passage. 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 is in communication 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 an anchoring member that can pass through the first lumen, and one end of the anchoring member penetrates into the passage and can be clamped by the first tubular member and the second tubular member, and the other end passes out of the first lumen and is located at the distal end of the first tubular member. After the implantable medical device is implanted, the anchoring member is used to provide an axial anchoring force for the first tubular member and the second tubular member.
2. The implantable medical device according to claim 1, wherein The anchoring member includes an anchoring section, a connecting section, and a limiting section, and the two ends of the connecting section are respectively connected to the anchoring section and the limiting section; When the anchoring member passes through the first lumen, the anchoring section is located outside the first tubular member and at the distal end of the first tubular member; the connecting section is disposed within the first lumen, and the limiting section extends into the passage and is clamped by the inner wall of the first tubular member and the outer wall of the second tubular member, and the limiting section can abut against the first tubular member or the second tubular member.
3. The implantable medical device according to claim 2, wherein The anchoring section includes an anchoring frame having self-expanding properties.
4. The implantable medical device according to claim 2, wherein, The limiting section includes: A connecting portion connected to the connecting section; and A limiting portion, at least a part of which is located outside the first lumen, the limiting portion being connected to one end of the connecting portion away from the connecting section, and the limiting portion being used to prevent the limiting section from completely penetrating into the first lumen.
5. The implantable medical device according to claim 4, wherein, The limiting portion is provided with a barb structure having a fixed end and a free end. The fixed end of the barb structure is connected to the connecting portion, and the free end of the barb structure extends toward the anchoring section side and can hook the proximal end of the first tubular member and abut against the first tubular member.
6. The implantable medical device according to claim 4, characterized in that, The limiting portion is provided with a flared structure including a relatively small radial dimension end and a relatively large radial dimension end disposed opposite to each other; the flared structure is sleeved on the connecting portion, and the relatively small radial dimension end of the flared structure is connected to the end of the connecting portion away from the connecting section, or the relatively small radial dimension end of the flared structure is connected to the end of the connecting portion away from the connecting section, and the relatively large radial dimension end extends away from the connecting portion; The larger radial dimension of the flared structure is greater than the radial dimension of the channel. The flared structure is located in the channel, and a part of the side wall of the flared structure abuts against the inner wall of the first tubular member, and another part abuts against the outer wall of the second tubular member; alternatively, the flared structure is located outside the first tubular member and the flared structure abuts against the second tubular member.
7. The implantable medical device according to claim 2, wherein, The connecting section is a connecting rod, a cutting bracket, a braided bracket or a connecting membrane.
8. The implantable medical device according to claim 1, wherein The first tubular member includes a first covered stent and a connecting member. The first lumen is provided 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.
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 connected to the first tubular member at points. , 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 be at least partially received in the first lumen. The sealing assembly can be deployed or contracted synchronously with the second covered stent, and 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 membrane, 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 be at least partially received in the first lumen. And the part of the sealing membrane received in the first lumen has a free end. The sealing membrane has a deployed state and a folded state. The outer wall of the part of the sealing membrane received 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 covered stent, and the distal ends axially extend toward the side where the first tubular member is located to be at least partially received in the first lumen. And the part of the driving rods received in the first lumen has a free end. The driving rods are connected to the sealing membrane. The driving rods are used to drive the sealing membrane to deploy or fold with the expansion of the second covered stent or drive the sealing membrane to fold with the contraction of the second covered stent.
11. The implantable medical device according to claim 1, characterized in that, The implantable medical device further includes a leaflet structure. The leaflet structure is disposed in the second tubular member, and the leaflet structure can be opened or closed to make the second lumen of the second tubular member in an open or closed state.
12. An implantable medical system, characterized in that, including: a branch stent; and the implantable medical device according to any one of claims 1-11, 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.