Implantable medical device and implantable medical system

Abstract

The present application relates to an implantable medical device and an implantable medical system, the implantable medical device comprising a first tube segment and a second tube segment, the first tube segment having a first lumen with two open ends, the second tube segment comprising a lumen support structure and a membrane body, the membrane body being arranged on the lumen support structure, and a distal end of the membrane body extending beyond the lumen support structure to form an extension, a distal end of the extension extending into the first lumen, the extension being connected to the first tube segment, and the connection between the extension and the first tube segment being at multiple connection sites, adjacent connection sites being circumferentially spaced apart. When the implantable medical device is used in cooperation with a branch stent, the branch stent is clamped by the first tube segment and the second tube segment, and different individuals can be adapted, so that endoleak can be better reduced.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to an implantable medical device and an implantable medical system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Aortic aneurysm and aortic dissection are serious vascular diseases that threaten life and health, with a high mortality rate. Without prompt treatment, the aortic aneurysm and dissection will continue to grow, eventually rupturing, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia, and diabetes, the incidence of aortic aneurysm and aortic dissection is also significantly increasing.

[0004] Currently, there are two main treatment methods for aortic dissection: surgical treatment and minimally invasive treatment. Surgical treatment involves open-chest or open-abdomen surgery to remove the tear in the intima and reconstruct the blood flow pathway using an artificial blood vessel. Minimally invasive interventional treatment, on the other hand, involves implanting a endovascular stent graft at the lesion site to isolate the blood flow from the aortic dissection while maintaining normal blood flow. Compared to surgical treatment, minimally invasive interventional treatment is increasingly being used in routine treatment due to its advantages such as less trauma, faster recovery, and fewer complications.

[0005] Typically, covered stents are straight, cylindrical stents with openings at both ends and circumferential closure. When aortic dissection involves or is close to branch vessels, such as a dissection of the ascending aorta involving or near the coronary arteries, a dissection of the ascending aorta involving or near the branches of the aortic arch, or a dissection of the abdominal aorta near the renal artery, the covered stent may cover or obstruct the openings of the branch vessels, coronary vessels, or renal arteries in order to cover the lesion or to increase the anchoring area. In such cases, it is usually necessary to implant both the main stent and the branch stent (or bypass stent) at the lesion site for treatment.

[0006] One common method for using a main stent and a branch stent together is the fenestration-branch stent technique. In this technique, a window is created on the clasp of the main stent. To address the issue of endoleak, a branch stent with a skirt is typically used. The branch extends from the window in the main stent, and the skirt is located within the cavity of the main stent, fitting snugly against the inner wall of the main stent near the window to prevent endoleak. However, in branch stents with skirts, the angle between the skirt and the main body of the branch stent is fixed; generally, they are perpendicular, meaning the skirt is perpendicular to the longitudinal central axis of the branch stent. However, the angles between the main and branch anatomical structures vary among individuals. This can lead to a situation where, after implantation of the main and branch stents, the skirt of the branch stent cannot fit snugly against the inner wall of the main stent, resulting in unavoidable or even severe endoleak. Summary of the Invention

[0007] Therefore, it is necessary to provide an implantable medical device that can effectively reduce endoleak when used in conjunction with a branch stent.

[0008] Furthermore, an implantable medical system that can effectively reduce endoleaks is provided.

[0009] An implantable medical device, comprising:

[0010] The first pipe section has a first cavity with openings at both ends;

[0011] The second pipe section includes a cavity support structure and a membrane body. The membrane body is disposed on the cavity support structure, and the distal end of the membrane body extends beyond the cavity support structure to form an extension. The distal end of the extension extends into the first cavity. The extension is connected to the first pipe section, and there are multiple connection points between the extension and the first pipe section, with adjacent connection points forming a circumferential gap.

[0012] In one embodiment, the extension is connected to the first pipe segment by a plurality of stitching points, the plurality of stitching points being arranged at circumferential intervals along the first pipe segment, and adjacent stitching points forming the circumferential interval.

[0013] In one embodiment, the first tube segment includes a bare support and a membrane disposed on the bare support, the proximal end of the membrane extending beyond the proximal end of the bare support to form a proximal extension region, and the proximal extension region and the extension portion overlapping in the radial direction to form a radially overlapping portion.

[0014] In one embodiment, the proximal end of the bare stent is provided with a plurality of first marking structures, the projection of each first marking structure on the extension being located within the circumferential interval.

[0015] In one embodiment, the implantable medical device further includes a connector, one end of which is connected to the first tube segment and the other end of which is connected to the lumen support structure.

[0016] In one embodiment, the connector is located inside the first pipe segment and the second pipe segment, and the distal end face of the connector is located at the distal end of the distal end face of the extension; or, the connector is located outside the first pipe segment and the second pipe segment, and the connector abuts against the proximal end of the radially superimposed portion and the extension.

[0017] In one embodiment, the implantable medical device further includes a plurality of support rods disposed on the extension, the proximal end of each support rod being connected to the lumen support structure, the distal end extending axially and the distal end being located inside the first lumen, and the distal end of the support rod being located within the circumferential interval.

[0018] In one embodiment, the connector is a wave-shaped ring structure formed by connecting multiple wave rods end to end. At least two adjacent wave rods forming troughs and two connecting portions adjacent to the wave rods form an implantation area. The implantation area includes a portion of the extension and a portion of the radially superimposed portion. The connector abuts against a portion of the extension and a portion of the radially superimposed portion. In a portion of the extension, the wave rod is fixedly connected to the extension. In a portion of the radially superimposed portion, the wave rod is fixedly connected to both the extension and the proximal extension region.

[0019] In one embodiment, the support rod is located within the implantation area, and the support rod extends axially from one end near the trough to the distal end.

[0020] In one embodiment, the lumen support structure includes a first support segment and a second support segment connected to the distal end of the first support segment, wherein the radial support force of the first support segment is greater than the radial support force of the second support segment.

[0021] In one embodiment, the lumen support structure includes a first support segment and a second support segment connected to the distal end of the first support segment. The first support segment has a plurality of first hollowed-out portions, and the second support segment has a plurality of second hollowed-out portions. The area of ​​each second hollowed-out portion is larger than the area of ​​each first hollowed-out portion.

[0022] In one embodiment, the implantable medical device further includes a connector, one end of which is connected to the second support segment and the other end of which is connected to the first tube segment. The connector has a plurality of third hollow portions, the area of ​​each third hollow portion being larger than the area of ​​each first hollow portion.

[0023] In one embodiment, the implantable medical device further includes a leaflet structure disposed within the second tube segment, and the leaflet structure is openable or closable.

[0024] An implantable medical system includes a branch stent and the aforementioned implantable medical device, wherein one end of the branch stent can be clamped at the circumferential interval by the first tube segment and the second tube segment, and the extension abuts against the branch stent.

[0025] In one embodiment, the branch stent includes a straight tube segment and a flared segment connected to one end of the straight tube segment. When the branch stent is used in conjunction with the implantable medical device, the flared segment is located within the first lumen and can be clamped by the first tube segment and the second tube segment.

[0026] In one embodiment, the number of circumferential intervals is greater than the number of branch supports.

[0027] The aforementioned implantable medical device includes a first segment and a second segment. An extension of the second segment extends into the first lumen of the first segment, and adjacent connection points between the extension and the first segment form circumferential gaps. Due to these circumferential gaps, when the implantable medical device is used in conjunction with a branch stent, one end of the branch stent extends into the branch anatomical structure, while the other end extends into the circumferential gap and is held by the first and second segments. Furthermore, the extension of the second segment is a thin film, which has good flexibility and can tightly wrap or conform to the branch stent. Simultaneously, compared to the method where the skirt of the branch stent conforms to the inner wall of the main stent, this method can accommodate different individuals. Therefore, when the implantable medical device is used in conjunction with a branch stent, it can effectively reduce endoleak.

[0028] When the implantable medical device and the branch stent of the above-mentioned implantable medical system are used together, the implantable medical device can wrap or fit the branch stent more tightly and can adapt to different individuals. Therefore, it can reduce endoleak better. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] in:

[0031] Figure 1 This is a schematic diagram of the structure of an implantable medical system according to one embodiment;

[0032] Figure 2 This is a schematic diagram of the structure of an implantable medical device according to one embodiment;

[0033] Figure 3 This is a schematic diagram of the structure of the first pipe section in one embodiment;

[0034] Figure 4 This is a schematic diagram of the structure of the first pipe section in another embodiment;

[0035] Figure 5 This is a schematic diagram of the structure of the second pipe section in one embodiment;

[0036] Figure 6 This is a schematic diagram illustrating the combined use of an implantable medical device and a branch stent according to one embodiment.

[0037] Figure 7 This is a schematic diagram of an implantable medical device according to an embodiment, showing the first segment in a radially expanded state and the lumen support structure of the second segment housed within a delivery sheath.

[0038] Figure 8 This is a schematic diagram of the structure of an implantable medical device according to another embodiment;

[0039] Figure 9 for Figure 8 A magnified view of a portion of the image;

[0040] Figure 10 for Figure 9 A schematic diagram of an alternative to the structure shown.

[0041] Figure 11 This is a schematic diagram showing the connection state of the support rod, wave rod, and extension in one embodiment.

[0042] Figure 12 This is a schematic diagram of the state in which the first pipe segment and the second pipe segment clamp the branch support in a radially expanded state, according to one embodiment.

[0043] Figure 13 This is a schematic diagram of the unfolded state of the cavity support structure of the second pipe segment in one embodiment;

[0044] Figure 14 This is a schematic diagram of a valve structure according to one embodiment;

[0045] Figure 15 This is a schematic diagram of the structure of a branch bracket according to one embodiment;

[0046] Figure 16 This is a top view of a branch bracket according to one embodiment. Detailed Implementation

[0047] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0048] In the description of the embodiments of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0049] In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a replaceable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention based on the specific circumstances.

[0050] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length of the medical device during delivery, while "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. "Circumferential direction" refers to the circumferential direction, that is, the axial direction surrounding a tubular structure or cylinder.

[0051] Please see Figure 1 An implantable medical system 1 according to one embodiment includes an implantable medical device 100 and a branch stent 200. The implantable medical device 100 is used in conjunction with the branch stent 200 in a scenario where there are branches and the implantable medical device 100 covers the branch opening. The number of branch stents 200 is determined according to actual needs, for example, one, two, or three.

[0052] Please see Figure 2 The implantable medical device 100 includes a first tube segment 10 and a second tube segment 30, which are connected to form a lumen structure with openings at both ends. This lumen structure can be a cylindrical structure with openings at both ends, or a non-cylindrical structure with openings at both ends.

[0053] Please refer to the following: Figure 2 and Figure 3 The first pipe segment 10 includes a bare support 110 and a membrane 120 disposed on the bare support 110. The membrane 120 is a flexible structure. The membrane 120 is connected to the inner surface of the bare support 110 or covers the outer surface of the bare support 110, thereby forming a circumferentially closed, open-ends lumen structure. Alternatively, the membrane 120 is a multi-layered structure, with part of the membrane 120 disposed on the inner surface of the bare support 110 and part of it disposed on the outer surface of the bare support 110, that is, the membrane 120 clamps the bare support 110, which can also form a circumferentially closed, open-ends lumen structure.

[0054] The first pipe segment 10 has a first cavity 101, which is open at both ends and extends along the axial direction of the first pipe segment 10.

[0055] like Figure 3 As shown, in one embodiment, the bare support 110 includes a plurality of wave loops 111 arranged along the axial direction. Adjacent wave loops 111 are hooked together, that is, the crest or trough of the wave loop 111 is hooked together with the trough or crest of its adjacent wave loop 111 to achieve the connection of adjacent wave loops 111.

[0056] In another embodiment, the multiple corrugations 111 of the bare support 110 are not connected by hooks, but by connecting rods. There can be one connecting rod, extending axially and connecting all the corrugations 111. Alternatively, multiple connecting rods can be used, each connecting adjacent corrugations 111. These connecting rods can be staggered circumferentially or aligned to form or approximately form a straight line.

[0057] It should be noted that, in other embodiments, the structure of the bare stent 110 is not limited to the structure described above, and can be other lumen structures, which can satisfy the requirement that the first tube segment 110 can be radially compressed into the delivery sheath 300 (see...). Figure 7 In addition, after the delivery sheath 300 is released from its restraints, other structures that can expand radially and be anchored to the target location are also acceptable.

[0058] The material of the coating 120 can be polytetrafluoroethylene, polyester fabric, etc. The coating 120 is disposed on the bare support 110 and forms a shape that matches the contour of the bare support 110.

[0059] The overlay 120 has a first edge 121 located at the distal end and a second edge 122 located at the proximal end. In one embodiment, the first edge 121 of the overlay 120 is flush or substantially flush with the distal end face of the distal end of the wavelet 111 of the bare stent 110, and the second edge 122 is flush or substantially flush with the proximal end face of the wavelet 111 of the proximal end of the bare stent 110.

[0060] Please see Figure 4 In another embodiment, the first edge 121 of the overlay 120 is flush with or substantially flush with the distal end face of the farthest corrugation 111 of the bare stent 110, and the second edge 122 extends beyond the proximal end face of the nearest corrugation 111 of the bare stent 110 to form a proximal extension region 123. That is, the proximal end of the overlay 120 extends beyond the proximal end of the bare stent 110 to form the proximal extension region 123.

[0061] like Figures 2-4 As shown, in one embodiment, a plurality of first marking structures 124 are provided on the proximal end of the bare support 110. The first marking structures 124 can be disposed on the waveguide 111 by means of winding or welding. In one embodiment, the first marking structures 124 are disposed on the waveguide 111 closest to the end.

[0062] Please see Figure 5 The second pipe section 30 includes a pipe support structure 310 and a thin film 320 disposed on the pipe support structure 310.

[0063] The tubular support structure 310 is a hollowed-out tubular structure with a second tubular cavity 301. In one embodiment, the tubular material is cut and shaped to form the tubular support structure 310. In another embodiment, the tubular support structure 310 is a hollowed-out tubular structure formed by axially connecting multiple corrugated coils, and the connection method of the corrugated coils can be the same as or different from the connection method of the corrugated coils 111 of the first pipe segment 10.

[0064] The film body 320 is a flexible structure. In one embodiment, the film body 320 is made of flexible materials such as polytetrafluoroethylene or polyester fabric. The film body 320 covers the lumen support structure 310, and one end of the film body 320 extends beyond the lumen support structure 310 to form an extension 321. The portion of the film body 320 that contacts the lumen support structure 310 is a contact portion 322. The proximal end of the extension 321 is connected to the distal end of the contact portion 322. Alternatively, the extension 321 and the contact portion 322 are an integral structure.

[0065] Please refer to the following: Figures 1-2 , Figure 5 and Figure 6 The distal portion of the extension 321 extends into the first cavity 101 of the first pipe segment 10. The extension 321 is connected to the first pipe segment 10, thereby connecting the second pipe segment 30 to the first pipe segment 10, and the first cavity 101 and the second cavity 301 are in communication. Figure 2 As shown, the extension 321 is connected to the first pipe segment 10 through multiple discrete connecting parts 323. The multiple connecting parts 323 are spaced apart along the circumference of the extension 321 or along the circumference of the first pipe segment 10, that is, adjacent connecting parts 323 form a circumferential gap 324. At the circumferential gap 324, the extension 321 and the first pipe segment 10 are not fixedly connected; the first pipe segment 10 is simply sleeved on the outside of the extension 321. The outer surface of the extension 321 is not fixed to the inner surface of the first pipe segment 10. When the first pipe segment 10 is in a radially extended state and the cavity support structure 310 of the second pipe segment 30 is in a radially compressed state, the distal end of the extension 321 is in a certain degree of radial compression state due to the coordinated action of the first pipe segment 10 and the cavity support structure 310. Thus, at the circumferential gap 324, the outer surface of the extension 321 and the inner surface of the first pipe segment 10 form a gap 325.

[0066] In one embodiment, the number of circumferential intervals 324 is greater than the number of branch stents 200 used in conjunction with the implantable medical device 100, such that the number of gaps 325 formed during implantation is greater than the number of branch stents 200, and the gaps 325 of the implanted branch stents 200 do not need to form blood flow channels, so as to avoid the second tube segment 30 that is not fully radially expanded during implantation from blocking blood flow.

[0067] In one embodiment, the connection portion 323 simultaneously connects the extension portion 321, the membrane 120, and the bevel coil 111 at the nearest end of the first tube segment 10, thereby improving the structural stability of the implantable medical device 100.

[0068] like Figure 2 As shown, the projection of each first mark structure 124 on the extension 321 is located within the circumferential spacing 324 of the adjacent connection portions 323.

[0069] Please refer to the following: Figure 2 and Figure 6 When the implantable medical device 100 is used in conjunction with the branch stent 200, the first segment 10 is first released from the delivery sheath 300. The lumen support structure 310 of the second segment 30 is at least partially radially constrained within the delivery sheath 300. The extension 321 is radially compressed to a certain extent by the combined action of the first segment 10 and the lumen support structure 310, thus forming a gap 325 between the outer surface of the extension 321 and the inner surface of the first segment 10. One end of the branch stent 200 extends into the gap 325, releasing the lumen support structure 310. The branch stent 200 is then clamped between the first segment 10 and the second segment 30 at a circumferential interval 324, with the extension 321 abutting against the surface of the branch stent 200. Furthermore, since the extension 321 is a thin film, its flexibility allows it to adapt to the shape of the branch stent 200, thus enabling it to more tightly wrap or conform to the branch stent 200, effectively reducing internal leakage.

[0070] Furthermore, compared to the method of fitting the skirt to the inner wall of the main support, the method of clamping with the first tube segment 10 and the second tube segment 30, and cooperating with the flexible extension 321 to abut or fit against the surface of the branch support 200, can adapt to different individuals and will not cause serious endoleak due to individual differences in anatomical structure. Therefore, when the implantable medical device 100 is used in conjunction with the branch support 200, endoleak can be reduced more effectively.

[0071] Furthermore, the way the skirt is fitted to the inner wall of the main support requires opening a window in the membrane of the main support. The skirt acts as a patch to seal the window. If the window is too large, it can easily lead to internal leakage; if the window is too small, it may expand during implantation, causing the window to enlarge or the membrane to be damaged. Once the membrane is damaged, there is a risk of further cracking, causing the window to become larger and larger, which can easily lead to internal leakage. Compared to the way the skirt is fitted to the inner wall of the main support, the membrane 120 and the thin film 320 of the implantable medical device 100 remain intact, which helps to achieve a continuous clamping effect on the branch stent 200 and avoid internal leakage.

[0072] It should be noted that the circumferential spacing 324 can be matched with the outer diameter of the branch support 200, so that the first pipe section 10 and the second pipe section 30 can clamp the branch support 200 more tightly, which helps to reduce internal leakage.

[0073] In one embodiment, the proximal end of the covering 120 extends beyond the proximal end of the bare stent 110 to form a proximal extension region 123, and the proximal extension region 123 and the extension portion 321 are radially superimposed to form a radially superimposed portion. Since both the proximal extension region 123 and the extension portion 321 are flexible structures, when one end of the branch stent 200 extends into the gap 325, the flexible proximal extension region 123 and the flexible extension portion 321 can fit well against the branch stent 200 on both sides, which is beneficial for mitigating endoleak.

[0074] In one embodiment, the maximum size of the gap 325 is smaller than the radial size (e.g., outer diameter) of the branch support 200 in its natural state, such that when one end of the compressed branch support 200 is inserted into the gap 325, the branch support 200 can be more tightly clamped by the first pipe segment 10 and the second pipe segment 30 after radial expansion.

[0075] In one embodiment, the maximum size of the gap 325 is smaller than the radial dimension (e.g., outer diameter) of the branch support 200 in its natural state. Furthermore, both the coating 120 and the film body 320 are made of materials with a certain degree of ductility, allowing the proximal extension region 123 and the extension portion 321 to adapt to the shape of the branch support 200 and fit tightly against it after radial expansion, thereby improving the effect of reducing internal leakage. In one embodiment, both the coating 120 and the film body 320 are made of polytetrafluoroethylene (PTFE).

[0076] In one embodiment, the extension 321 is connected to the first pipe segment 10 through multiple stitching points. These stitching points are spaced apart along the circumference of the extension 321 or along the circumference of the first pipe segment 10, with adjacent stitching points forming a circumferential gap 324. That is, the connecting portion 323 is a stitching point. It should be noted that "connecting portion 323 is a stitching point" means that the connecting portion 323 is formed by stitching. A connecting portion 323 does not necessarily have only one fixing point; it can have a single fixing point or multiple fixing points. However, the gap between multiple fixing points is significantly smaller than the distance between adjacent connecting portions 323.

[0077] In one embodiment, the suture point simultaneously connects the extension 321, the membrane 120, and the corrugated coil 111 at the nearest end of the first tube segment 10.

[0078] In other embodiments, the method of fixing the extension 321 to the first pipe segment 10 is not limited to stitching; for example, it can be fixed by means of adhesive or other methods.

[0079] Please continue reading. Figure 5In one embodiment, the contact portion 322 is a hollow cylinder, and the extension portion 321 is approximately a hollow frustum. The outer diameter of the end of the extension portion 321 furthest from the contact portion 322 is larger, while the outer diameter of the end closer to the contact portion 322 is smaller and equal to the outer diameter of the contact portion 322. In its naturally unfolded state, the outer diameter of the portion of the extension portion 321 that extends into the first lumen 101 and fits against the inner wall of the first tube segment 10 matches the inner diameter of the first tube segment 10. The outer diameter of the second tube segment 30 is smaller than the outer diameter of the first tube segment 10, and the extension portion 321 forms a transition, making the implantable medical device 100 suitable for sites with branches and an inner diameter that is larger at one end and smaller at the other.

[0080] In another embodiment, the extension 321 is a hollow cylinder, the contact portion 322 is a hollow cylinder, and the outer diameter of the extension 321 is equal to the outer diameter of the contact portion 322.

[0081] Please continue reading. Figure 5 In one embodiment, the implantable medical device 100 further includes a plurality of support rods 50 disposed on the extension 321, with adjacent support rods 50 spaced apart circumferentially from the extension 321. The proximal end of each support rod 50 is connected to the lumen support structure 310, and the distal end extends axially along the implantable medical device 100, with the distal end located within the first lumen 101. Furthermore, the distal ends of the support rods 50 are located within the circumferential spacing 324 of adjacent connection portions 323. That is, the lines connecting the support rods 50 and adjacent connection portions 323 intersect.

[0082] The support rod 50 is disposed on the outer surface, inner surface, or inside the extension 321 (the extension 321 has a multi-layer structure). The distal end of the support rod 50 is a free end 510, which is located within the first lumen 101. The free end 510 has a passivated structure to avoid damaging tissue. The proximal end of the support rod 50 is a connecting end 520, which is connected to the distal end of the lumen support structure 310.

[0083] Please see Figure 7 The first pipe section 10 is radially extended, and the lumen support structure 310 of the second pipe section 30 is radially bound within the delivery sheath 300 (therefore...). Figure 7(Not shown 310), the end of the support rod 50 connected to the lumen support structure 310 is also radially bound in the delivery sheath 300. The extension 321 is in a state of radial compression to a certain extent under the coordinated drive of the first tube segment 10 and the lumen support structure 310. Since the membrane body 320 is a flexible structure, the corresponding extension 321 of the membrane body 320 is also a flexible structure. Multiple support rods 50 are spaced apart on the flexible extension 321. On the one hand, when the second tube segment 30 is radially compressed, the support rods 50 can promote the contraction of the extension 321, thereby forming a larger gap 325. Furthermore, at the gap 325, the support rods 50 expand the flexible membrane body, preventing wrinkles or reducing the degree of wrinkling, which is beneficial for the implantation of the branch stent 200. On the other hand, the radially expanded extension 321 has a better three-dimensional shape, avoiding the formation of a blood flow channel between the extension 321 and the inner wall of the first tube segment 10 due to its own wrinkles, which would lead to endoleak. This allows the extension 321 to fit well with the inner surface of the first tube segment 10 in the area where the branch stent 200 is not implanted, and to fit well with the branch stent 200 in the area where the branch stent 200 is implanted, thereby reducing endoleak.

[0084] In one embodiment, the support rod 50 is made of a material visible under medical imaging equipment. The support rod 50 cooperates with the first marking structure 124 to facilitate guiding the branch stent 200 into the gap 325 and being clamped by the first tube segment 10 and the second tube segment 30.

[0085] In one embodiment, the number of support rods 50 corresponds one-to-one with the number of circumferential intervals 324. A support rod 50 is provided at each circumferential interval 324, so that during the implantation process, a gap 325 is well formed at each circumferential interval 324, thereby reducing the positioning requirements and making it easier to implant the branch stent 200.

[0086] Please return Figure 2 In one embodiment, the implantable medical device 100 further includes a connector 70 for further connecting the first tube segment 10 and the second tube segment 30 to improve the reliability of the connection between the first tube segment 10 and the second tube segment 30.

[0087] In one embodiment, the connector 70 includes a plurality of connecting rods spaced apart in the circumferential direction. One end of each connecting rod 70 is connected to the first pipe segment 10, and the other end is connected to the second pipe segment 30.

[0088] In one embodiment, the connector 70 is a wave-shaped ring structure. The crest of the wave-shaped ring structure is hooked and connected to the wave loop 111 at the nearest end of the first pipe segment 10, and the trough of the wave-shaped ring structure is hooked and connected to the wave loop at the farthest end of the second pipe segment 30 or the connecting structure at the far end of the second pipe segment 30.

[0089] Alternatively, the crest of the waveform ring structure is hooked to the nearest end of the first pipe segment 10, and the waveform ring structure is connected to the far end of the second pipe segment 30 in a non-hooking manner.

[0090] Regardless of the structure of the connector 70, the connector 70 can be located inside the first pipe section 10 and the second pipe section 30 or outside the first pipe section 10 and the second pipe section 30.

[0091] When the connector 70 is located inside the first pipe section 10 and the second pipe section 30, the distal end face of the connector 70 is located at the distal end of the distal end face of the extension 321, that is, the distal end of the connector 70 extends beyond the distal end of the extension 321. The connector 70 abuts against the extension 321, so that the extension 321 fits against the inner wall of the first pipe section 10, reducing internal leakage.

[0092] When the connector 70 is located outside the first pipe section 10 and the second pipe section 30, the connector 70 extends from the radial overlap portion to the proximal end of the extension portion 321 (the portion where the radial overlap portion is not formed), and abuts against the radial overlap portion and the proximal end of the extension portion 321.

[0093] Please see Figure 8 In one embodiment, the lumen support structure 310 includes a first support segment 311 and a second support segment 312 connected to the distal end of the first support segment 311. Both the first support segment 311 and the second support segment 312 are lumen structures. Furthermore, the radial support force of the first support segment 311 is greater than that of the second support segment 312. The relatively large radial support force of the first support segment 311 provides sufficient radial support, which is beneficial for improving the anchoring force of the implantable medical device 100 within the body. The relatively small radial support force of the second support segment 312 makes it easier to compress the second support segment 312 during implantation, so that the extension 321 is in a radially contracted state while the first segment 10 is in a radially extended state, thereby forming a gap 325, which facilitates the insertion of the branch stent 200, allowing the branch stent 200 to be clamped by the first segment 10 and the second segment 30.

[0094] like Figure 8 As shown, in one embodiment, the first support segment 311 includes a plurality of first hollow portions 3111, and the second support segment 312 includes a plurality of second hollow portions 3121. The area of ​​each second hollow portion 3121 is larger than the area of ​​each first hollow portion 3111, so that the radial support force of the second support segment 312 is relatively small and the radial support force of the first support segment 311 is relatively large.

[0095] One end of the connector 70 is connected to the second support section 312, and the other end is connected to the first tube section 10. In one embodiment, the connector 70 has a wave-shaped annular structure, forming multiple third hollow portions 710, each with an area larger than the area of ​​each first hollow portion 3111. The smaller area of ​​the first hollow portions 3111 is beneficial for increasing the radial support force of the first support section 311, while the larger area of ​​the third hollow portions 710 facilitates smoother operation of implanting the branch stent 200 (which will be described in detail below).

[0096] In one embodiment, the first support section 311, the second support section 312, and the connector 70 are an integral structure, and the end of the connector 70 away from the second support section 312 is connected to the first pipe section 10.

[0097] Please refer to the following: Figure 8 and Figure 9 In one embodiment, the connector 70 is a wave-shaped ring structure formed by connecting multiple wave rods 711 end to end. The proximal end of the connector 70 is connected to the lumen support structure 310, and the distal end of the connector 70 is hooked to the trough of the nearest wave ring 111 of the first pipe segment 10 through a wave crest. At the same time, the connection portion 321 of the extension 321 and the connection portion 323 of the first pipe segment 10 are simultaneously connected to the trough of the nearest wave ring 111 that is hooked to the connector 70.

[0098] When the connector 70 is a wave-shaped ring structure formed by connecting multiple wave rods 711 end to end, the connector 70 and the cavity support structure 310 can be an integral structure, or the connector 70 and the cavity support structure 310 can be connected in a manner known to those skilled in the art. The connection method includes, but is not limited to, welding, sewing, etc.

[0099] Furthermore, the connector 70 is fixed to the surface of the extension 321. The fixing method can be adhesive bonding, for example, using glue to attach the connector 70 to the outer surface of the extension 321. Alternatively, the fixing method can be sewing, using thread to fix the connector 70 to the outer surface of the extension 321. For example, multiple stitching points 302 are formed using thread to fix the connector 70 to the surface of the extension 321.

[0100] like Figure 9As shown, two adjacent connecting portions 323 and the two wave rods 711 of the connector 70 form the implantation area A. The two wave rods 711 connect to form the trough of the waveform ring structure. The branch stent 200 is held in the implantation area A by the first tube segment 10 and the second tube segment 30. The circumferential gap 324 is located in the implantation area A. Since the connector 70 is fixed to the surface of the extension 321 in the implantation area A, when the connector 70 is radially compressed, it easily causes the extension 321 to contract, so as to form a gap 325, allowing one end of the branch stent 200 to enter the first lumen 101 through the gap 325. Furthermore, in the implantation area A, since the extension 321 is connected to the nearest end of the bevel coil 111 and the covering membrane 120 through the connection portion 323, the distance between the outer surface of the portion of the extension 321 located in the implantation area A and the inner surface of the portion of the first tube segment 10 located in the implantation area A (e.g., the inner surface of the covering membrane 120) is limited. As a result, after the branch stent 200 is inserted into the gap 325, it can be clamped more tightly by the first tube segment 10 and the second tube segment 30, thereby improving the anti-internal leakage effect.

[0101] The two adjacent wave rods 711 form the third hollow part 710. The area of ​​the third hollow part 710 is relatively large, and the corresponding implantation area A is relatively large, making it easier to implant the branch stent 200.

[0102] In one embodiment, all the wave-shaped annular structures formed by the connections of the connector 70 form the implantation area A. Thus, during the implantation of the branch stent 200, when the first tube segment 10 is radially expanded and the lumen support structure 310 of the second tube segment 30 is radially constrained within the delivery sheath 300, multiple gaps 325 are formed. In the gaps 325 where the branch stent 200 is not implanted, blood flow can enter and exit the first lumen 101 through the gaps 325. Alternatively, blood flow can flow from the first lumen 101 through the gaps 325 towards the location of the second tube segment 30. This prevents blood flow obstruction during implantation, improving surgical safety.

[0103] In another embodiment, the wave rods 711 of the wave-shaped annular structure formed by the partial connection of the connectors 70 form the implant area A. That is, the number of circumferential intervals 324 is less than the number of wave troughs of the connectors 70, but the number of circumferential intervals 324 is greater than the number of branch stents 200, so as to better balance blood flow and internal leakage prevention.

[0104] Please refer to the following: Figure 9 and Figure 10In one embodiment, the implantation region A includes a first sub-region A1 and a second sub-region A2. The proximal end of the covering 120 extends beyond the proximal end of the bare stent 110 to form a proximal extension region 123. In the implantation region A, the first sub-region A1 is a portion of the radially superimposed portion formed by the superposition of the proximal extension region 123 and the extension portion 321, that is, the region of the radially superimposed portion located between two adjacent wave bars 711 forming a trough. The second sub-region A2 is a portion of the extension portion 321, that is, the region of the extension portion 321 located between two adjacent wave bars 711 forming a trough and located below the first sub-region A1. When the proximal extension region 123 and the extension portion 321 of the first sub-region A1 form a radial distance, a gap 325 is formed. The two adjacent wave bars 711 surrounding the implantation region A simultaneously press against or abut against the radially superimposed portion and the extension portion 321, that is, the wave bars 711 simultaneously press against or abut against the first sub-region A1 and the second sub-region A2. Furthermore, suture point 302 fixes the wave rod 711 and extension 321 in the second sub-region A2, and suture point 302 fixes the wave rod 711, extension 321 and proximal extension region 123 in the first sub-region A1. During the implantation of the branch stent 200, since the wave rod 711 is fixed on the surface of the extension 321, compressing the connector 70 helps to promote the formation of the gap 325, which facilitates the implantation of the branch stent 200. After one end of the branch stent 200 is inserted into the gap 325, when the lumen support structure 310 and connector 70 are released, the wave rod 711 abuts against the proximal extension region 123, so that the covering 120 adheres tightly to the surface of the branch stent 200, thereby improving the anti-internal leakage effect.

[0105] Please see Figure 11 In one embodiment, the support rod 50 is located within the implantation area A. One end of the support rod 50 is connected to the trough of the connector 70, and the other end extends axially distally along the implantation area A. In another embodiment, the support rod 50 extends axially distally along the implantation area A, from the second sub-region A2 to the first sub-region A1, and is fixed to the extension portion 321. The line connecting the support rod 50 and the two connecting portions 323 of the implantation area A intersects. Simultaneously, the wave-shaped rod 711 of the connector 70 is fixedly connected to both the proximal extension region 123 and the extension portion 321, such that in the radially extended state, as... Figure 12As shown, driven by the wave rod 711 and the support rod 50, the proximal extension region 123 and the extension 321 can fit more tightly against the branch bracket 200, reducing internal leakage. Both the support rod 50 and the wave rod 711 are fixedly connected to the extension 321, and each support rod 50 is located between two adjacent wave rods 711, so that multiple support rods 50 and multiple wave rods 711 are distributed circumferentially at intervals along the extension 321. This arrangement, on the one hand, maintains the flexibility of the extension 321 at the intervals to fit the branch support 200 and thus reduce internal leakage; on the other hand, the support rod 50 and the wave rod 711 enable the radially expanded extension 321 to maintain its three-dimensional configuration and drive the extension 321 to abut against the inner surface of the first pipe section 10. Thus, in the part where the branch support 200 is not implanted, the extension 321 can fit well against the inner surface of the first pipe section 10, and in the part where the branch support 200 is implanted, the extension 321 can fit well against the branch support 200, thereby effectively reducing internal leakage.

[0106] Please see Figure 13 In one embodiment, the first support segment 311, the second support segment 312, and the support rod 50 are integrally formed. The proximal end 512 of the support rod 50 is connected to the second support segment 312, and the support rod 50 extends axially. This integral structure facilitates the radial contraction of the support rod 50 as the first and second support segments 311 and 312 contract, promoting the contraction of the extension 321 and forming a gap 325. This also prevents wrinkles from forming or reduces the degree of wrinkling at the gap 325. Furthermore, the support rod 50 expands as the first and second support segments 311 and 312 expand radially, so that the support rod 50 holds the extension 321 against the inner wall of the first tube segment 10. This reduces internal leakage in areas where the branch stent 200 is not implanted; and in areas where the branch stent 200 is implanted, the extension 321 and the first tube segment 10 clamp the branch stent 200 to reduce internal leakage.

[0107] Please see Figure 14 In one embodiment, the implantable medical device 100 further includes a leaflet structure 90 disposed within the second lumen 301 of the second tube segment 30, and the leaflet structure 90 is openable or closureable, allowing the implantable medical device 100 to replace diseased natural valves. The leaflet structure 90 includes two, three, or more leaflets.

[0108] An implantable medical device 100, including a leaflet structure 90, can be used in conjunction with a branch stent 200 to treat aortic valve disease complicated with aortic dissection.

[0109] Please refer to 15. In one embodiment, the branch support 200 includes a straight pipe section 210 and a flared section 220 connected to one end of the straight pipe section 210. The flared section 220 has a smaller outer diameter end connected to the straight pipe section 210, while the larger outer diameter end is a free end. The flared section 220 includes a flared support structure and a membrane disposed on the flared support structure.

[0110] When the branch stent 200 is used in conjunction with the implantable medical device 100, the horn segment 220 is located inside the first lumen 101, and the horn segment 220 can be clamped by the first tube segment 10 and the second tube segment 30, so that the horn segment 220 can fill the gap between the first tube segment 10 and the second tube segment 30 well, providing an anti-internal leakage effect.

[0111] In one embodiment, a second marking structure 221 is provided on the horn segment 220. The second marking structure 221 cooperates with the first marking structure 124 to guide the implantation of the branch stent 200, which helps to avoid excessive delivery of the branch stent 200 and separation of the branch stent 200 from the implantable medical device 100.

[0112] In one embodiment, the straight tube segment 210 includes a covered segment 211 and a bare stent segment 212 connected to the distal end of the covered segment 211, wherein the radial support force of the bare stent segment 212 is greater than that of the covered segment 211. The bare stent segment 212 is configured to provide sufficient radial force and does not obstruct blood flow to the small branches of the branch.

[0113] Please see Figure 16 In one embodiment, the trumpet segment 220 includes a plurality of petal portions 221, which together form the trumpet segment 220. Each petal portion 221 is made of wound metal wire and has a coating. Furthermore, there is no coating between adjacent petal portions 221, i.e., gaps are formed between adjacent petal portions 221. The petal portions 221 can effectively fill the gap between the first tube segment 10 and the second tube segment 30, and the gaps between adjacent petal portions 221 help reduce the outer diameter of the delivery sheath 300 used for delivering the branch support 200, thus facilitating the delivery of the branch support 200.

[0114] The implantable medical device 100 in the above-mentioned implantable medical system 1 is used in conjunction with the branch stent 100. The implantable medical device can tightly wrap or fit the branch stent and can adapt to different individuals. Therefore, it can better reduce endoleak.

[0115] The technical features of the above embodiments can be combined in any way. For the sake of brevity, 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, they should be considered to be within the scope of this specification.

[0116] The above description discloses only preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Therefore, equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An implantable medical device, characterized in that, include: The first tube segment has a first lumen open at both ends, and the first tube segment includes a bare stent, the proximal end of which is provided with a plurality of first marking structures; The second pipe segment includes a lumen support structure and a membrane body. The membrane body is disposed on the lumen support structure, and the distal end of the membrane body extends beyond the lumen support structure to form an extension. The distal end of the extension extends into the first lumen. The extension is connected to the first pipe segment through multiple discrete connection points. The multiple connection points are spaced apart along the circumference of the extension or along the circumference of the first pipe segment. Adjacent connection points form a circumferential interval. The projection of each first marking structure on the extension is located within the circumferential interval.

2. The implantable medical device according to claim 1, characterized in that, The extension is connected to the first pipe segment through multiple stitching points, which are spaced apart circumferentially along the first pipe segment, with adjacent stitching points forming the circumferential interval.

3. The implantable medical device according to claim 1, characterized in that, The first tube segment includes a membrane disposed on the bare stent, the proximal end of the membrane extending beyond the proximal end of the bare stent to form a proximal extension region, and the proximal extension region and the extension portion overlapping in the radial direction to form a radially overlapping portion.

4. The implantable medical device according to claim 3, characterized in that, The implantable medical device also includes a connector, one end of which is connected to the first tube segment and the other end of which is connected to the lumen support structure.

5. The implantable medical device according to claim 4, characterized in that, The connector is located inside the first pipe segment and the second pipe segment, and the distal end face of the connector is located at the distal end of the distal end face of the extension; or, the connector is located outside the first pipe segment and the second pipe segment, and the connector abuts against the proximal end of the radially superimposed portion and the extension.

6. The implantable medical device according to claim 4, characterized in that, The implantable medical device further includes a plurality of support rods disposed on the extension portion. The proximal end of each support rod is connected to the lumen support structure, the distal end extends axially and the distal end is located inside the first lumen, and the distal end of the support rod is located within the circumferential interval.

7. The implantable medical device according to claim 6, characterized in that, The connector is a wave-shaped ring structure formed by connecting multiple wave rods end to end. At least two adjacent wave rods forming troughs and two connecting parts adjacent to the wave rods form an implantation area. The implantation area includes a portion of the extension and a portion of the radially superimposed portion. The connector abuts against a portion of the extension and a portion of the radially superimposed portion. In a portion of the extension, the wave rod is fixedly connected to the extension. In a portion of the radially superimposed portion, the wave rod is fixedly connected to both the extension and the proximal extension region.

8. The implantable medical device according to claim 7, characterized in that, The support rod is located within the implantation area, and the support rod extends axially from the end closest to the trough to the distal end.

9. The implantable medical device according to claim 1, characterized in that, The lumen support structure includes a first support section and a second support section connected to the distal end of the first support section, wherein the radial support force of the first support section is greater than the radial support force of the second support section.

10. The implantable medical device according to claim 1, characterized in that, The lumen support structure includes a first support section and a second support section connected to the distal end of the first support section. The first support section has a plurality of first hollowed-out portions, and the second support section has a plurality of second hollowed-out portions. The area of ​​each second hollowed-out portion is larger than the area of ​​each first hollowed-out portion.

11. The implantable medical device according to claim 10, characterized in that, The implantable medical device further includes a connector, one end of which is connected to the second support segment and the other end of which is connected to the first tube segment. The connector has multiple third hollowed-out portions, and the area of ​​each third hollowed-out portion is larger than the area of ​​each first hollowed-out portion.

12. The implantable medical device according to claim 1, characterized in that, The implantable medical device also includes a leaflet structure, which is disposed within the second tube segment and is openable or closable.

13. An implantable medical system, characterized in that, The device includes a branch stent and an implantable medical device as described in any one of claims 1 to 12, wherein one end of the branch stent can be clamped at the circumferential interval by the first tube segment and the second tube segment, and the extension abuts against the branch stent.

14. The implantable medical system according to claim 13, characterized in that, The branch stent includes a straight tube segment and a flared segment connected to one end of the straight tube segment. When the branch stent is used in conjunction with the implantable medical device, the flared segment is located within the first lumen and can be clamped by the first tube segment and the second tube segment.

15. The implantable medical system according to claim 13, characterized in that, The number of circumferential intervals is greater than the number of branch supports.

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