Implantable medical device and implantable medical system

Abstract

The invention relates to an implantable medical device and an implantable medical system.The implantable medical device comprises a first pipe section and a second pipe section, the first pipe section is provided with a first pipe cavity with the two ends open, the second pipe section comprises a pipe cavity supporting structure and a film body, and the film body is arranged on the pipe cavity supporting structure; the distal end of the film body extends out of the lumen supporting structure to form an extension part, the distal end of the extension part extends into the first lumen, the extension part is connected with the first tube section, a plurality of connecting parts are arranged between the extension part and the first tube section, and the adjacent connecting parts form a circumferential interval. When the implantable medical device is used in cooperation with the branch stent, the branch stent is clamped through the first pipe section and the second pipe section, the implantable medical device can adapt to different individuals, and therefore internal leakage can be well reduced.

Description

Technical Field

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

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

[0003] Aortic aneurysm and aortic dissection are vascular diseases that seriously endanger life and health, and have a high mortality rate. If not actively treated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the increasing number of patients with hypertension, high blood lipids and high diabetes, the incidence of aortic aneurysm and aortic dissection is also increasing significantly.

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

[0005] In general, a stent graft is usually a straight-tube stent with openings at both ends and circumferential closure. When the lesion site of aortic dissection involves or is close to branch vessels, such as the dissection lesion site of the ascending aorta involves or is close to the aortic coronary vessels, the dissection lesion of the ascending aorta involves or is close to the branch vessels of the aortic arch, and the lesion site of the abdominal aorta is close to the renal artery, in order to cover the lesion site or to increase sufficient anchoring area, the stent graft may cover or block the opening of the branch vessels, coronary vessels or renal artery, etc. In this case, it is usually necessary to implant the main stent and the branch stent (or bypass stent) at the same time at the lesion site for treatment.

[0006] One of the common ways to use the main stent and the branch stent together is the fenestration-branch stent technology. In the fenestration-branch technology, a window is opened on the coating of the main stent. In order to solve the problem of internal leakage, a branch stent with a skirt is usually used. The branch extends from the window of the main stent, and the skirt is located in the inner cavity of the main stent. The skirt fits the inner wall of the main stent near the window to avoid internal leakage. However, in the branch stent with a skirt, the angle between the skirt and the branch stent body is fixed. Generally, the two are perpendicular, that is, the skirt is perpendicular to the longitudinal center axis of the branch stent body. However, there are differences in the angles between the main anatomical structure and the branch anatomical structure of different individuals. This makes it impossible for the skirt of the branch stent to fit the inner wall of the main stent after the main stent and the branch stent are implanted, resulting in inevitable internal leakage or even more serious internal leakage. Summary of the invention

[0007] Based on this, it is necessary to provide an implantable medical device that can effectively reduce internal leakage when used in conjunction with a branch stent.

[0008] Furthermore, an implantable medical system is provided which can effectively reduce endoleakage.

[0009] An implantable medical device comprising:

[0010] A first tube segment, wherein the first tube segment has a first tube cavity with openings at both ends;

[0011] The second tube segment includes a tubular cavity support structure and a thin film body, wherein the thin film body is arranged on the tubular cavity support structure, and the distal end of the thin film body exceeds the tubular cavity support structure to form an extension portion, and the distal end of the extension portion extends into the first tubular cavity, the extension portion is connected to the first tube segment, and there are multiple connection parts between the extension portion and the first tube segment, and adjacent connection parts form a circumferential interval.

[0012] In one embodiment, the extension portion is connected to the first pipe segment via a plurality of suture points, and the plurality of suture points are arranged at intervals along the circumference of the first pipe segment, and adjacent suture points form the circumferential interval.

[0013] In one embodiment, the first tube segment includes a bare stent and a coating disposed on the bare stent, the proximal end of the coating extends beyond the proximal end of the bare stent to form a proximal extension region, and the proximal extension region and the extension portion overlap radially to form a radial overlapping portion.

[0014] In one embodiment, a plurality of first marker structures are disposed at the proximal end of the bare stent, and a projection of each of the first marker structures on the extension portion is 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 tubular cavity support structure.

[0016] In one embodiment, the connecting member is located inside the first tube segment and the second tube segment, and the distal end surface of the connecting member is located distal to the distal end surface of the extension portion; or, the connecting member is located outside the first tube segment and the second tube segment, and the connecting member abuts against the radial overlapping portion and the proximal end of the extension portion.

[0017] In one embodiment, the implantable medical device also includes a plurality of support rods, wherein the plurality of support rods are disposed on the extension portion, the proximal end of each support rod is connected to the tubular cavity support structure, the distal end extends axially and the distal end is located inside the first tubular cavity, and the distal end of the support rod is located within the circumferential interval.

[0018] In one embodiment, the connecting member is a wavy annular structure formed by connecting a plurality of wave rods end to end, and at least two adjacent wave rods forming a trough and two connecting parts adjacent to the wave rods form an implantation area, and the implantation area includes a partial area of ​​the extension portion and a partial area of ​​the radial overlapping portion, and the connecting member abuts against a partial area of ​​the extension portion and a partial area of ​​the radial overlapping portion, and in a partial area of ​​the extension portion, the wave rod is fixedly connected to the extension portion, and in a partial area of ​​the radial overlapping portion, the wave rod is fixedly connected to both the extension portion and the proximal extension area.

[0019] In one embodiment, the support rod is located in the implantation area, and the support rod extends axially from an end close to the trough to a distal end.

[0020] In one embodiment, the tubular cavity support structure includes a first support segment and a second support segment connected to the distal end of the first support segment, and 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 tubular cavity 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 is formed with a plurality of first hollow parts, the second support segment is formed with a plurality of second hollow parts, and the area of ​​each of the second hollow parts is greater than the area of ​​each of the first hollow parts.

[0022] In one embodiment, the implantable medical device also includes a connecting member, one end of which is connected to the second supporting segment, and the other end of which is connected to the first tube segment, and the connecting member is formed with a plurality of third hollow portions, and the area of ​​each of the third hollow portions is greater than the area of ​​each of the first hollow portions.

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

[0024] An implantable medical system comprises a branch stent and the above-mentioned 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 portion abuts against the branch stent.

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

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

[0027] The above-mentioned implantable medical device includes a first tube segment and a second tube segment, and the extension of the second tube segment extends into the first tube cavity of the first tube segment, and among the multiple connection parts between the extension and the first tube segment, adjacent connection parts form a circumferential interval. Due to the existence of the circumferential interval, 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, and the other end can extend into the circumferential interval and be clamped by the first tube segment and the second tube segment; and, the extension of the second tube segment is a thin film body, which has good flexibility and can wrap or fit the branch stent more tightly; at the same time, compared with the way the skirt of the branch stent fits the inner wall of the main stent, this method can adapt to different individuals. Therefore, when the implantable medical device is used in conjunction with the branch stent, it can better reduce internal leakage.

[0028] When the implantable medical device and the branch stent of the above-mentioned implantable medical system are used in combination, the implantable medical device can wrap or fit the branch stent more tightly and can adapt to different individuals, thereby effectively reducing internal leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0030] in:

[0031] Figure 1 is a structural schematic diagram of an implantable medical system according to an embodiment;

[0032] Figure 2 is a schematic structural diagram of an implantable medical device according to an embodiment;

[0033] Figure 3 is a schematic structural diagram of a first pipe section of an embodiment;

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

[0035] Figure 5 is a schematic structural diagram of a second pipe section in an embodiment;

[0036] Figure 6 This is a schematic diagram of the coordinated use of an implantable medical device and a branch stent according to an embodiment;

[0037] Figure 7 It is a schematic diagram of a state in which the first tube segment of an implantable medical device according to an embodiment is in a radially expanded state and the lumen support structure of the second tube segment is accommodated in a delivery sheath;

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

[0039] Fig. 9 for Figure 8 A partial enlarged view of

[0040] Fig.10 for Fig. 9 Structural schematics of alternatives to the structure shown;

[0041] Fig.11 This is a schematic diagram of the connection state of a support rod, a wave rod and an extension part according to an embodiment;

[0042] Fig.12 This is a schematic diagram of a state in which the first tube segment and the second tube segment clamp the branch stent in a radially expanded state in one embodiment;

[0043] Fig.13 It is a schematic diagram of the expanded state of the tubular cavity support structure of the second tubular segment of one embodiment;

[0044] Fig.14 is a schematic structural diagram of a valve structure according to an embodiment;

[0045] Fig.15 This is a schematic structural diagram of a branch support according to an embodiment;

[0046] Fig.16 A top view of a branch support according to an embodiment. DETAILED DESCRIPTION

[0047] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0048] In the description of the embodiments of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0049] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a replaceable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

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

[0051] See also Figure 1 An implantable medical system 1 of an 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 and is applied to a part with a branch, and the implantable medical device 100 covers the scene of the branch opening. The number of branch stents 200 is determined according to actual needs, for example, it can be one, two or three.

[0052] See also 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 tubular cavity structure with two ends opened. The tubular cavity structure can be a cylindrical structure with two ends opened, or a non-cylindrical structure with two ends opened.

[0053] Please also read Figure 2 and Figure 3 The first tube section 10 includes a bare stent 110 and a coating 120 disposed on the bare stent 110. The coating 120 is a flexible structure. The coating 120 is connected to the inner surface of the bare stent 110 or the coating 120 is coated on the outer surface of the bare stent 110, thereby forming a circumferentially closed tubular cavity structure with openings at both ends. Alternatively, the coating 120 is a multi-layer structure, and part of the coating 120 is disposed on the inner surface of the bare stent 110, and part of the coating 120 is disposed on the outer surface of the bare stent 110, that is, the coating 120 clamps the bare stent 110, and a circumferentially closed tubular cavity structure with openings at both ends can also be formed.

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

[0055] like Figure 3 As shown, in one embodiment, the bare stent 110 includes a plurality of wave coils 111 arranged along the axial direction, and adjacent wave coils 111 are hooked and connected, that is, the crests or troughs of the wave coils 111 and the troughs or crests of the adjacent wave coils 111 are hooked with each other to realize the connection of the adjacent wave coils 111.

[0056] In another embodiment, the multiple coils 111 of the bare stent 110 are not connected by hooking, but by connecting rods. There can be one connecting rod, which extends axially and connects all the coils 111. Multiple connecting rods can also be used, each connecting rod connecting adjacent coils 111, and the multiple connecting rods can be staggered in the circumferential direction or aligned to form or roughly 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 that can satisfy the requirement that the first tube segment 110 can be radially compressed into the delivery sheath tube 300 (see Figure 7 ) and after releasing the restraint of the delivery sheath 300, any other structure that can radially expand and anchor at the target site can be used.

[0058] The material of the coating 120 may be polytetrafluoroethylene, polyester cloth, etc. The coating 120 is disposed on the bare stent 110 and forms a shape matching the contour of the bare stent 110 .

[0059] The coating 120 has a first edge 121 at the distal end and a second edge 122 at the proximal end. In one embodiment, the first edge 121 of the coating 120 is flush or substantially flush with the distal end surface of the most distal wave ring 111 of the bare stent 110, and the second edge 122 is flush or substantially flush with the proximal end surface of the most proximal wave ring 111 of the bare stent 110.

[0060] See also Figure 4 In another embodiment, the first edge 121 of the coating 120 is flush or substantially flush with the distal end surface of the most distal corrugation 111 of the bare stent 110, and the second edge 122 extends beyond the proximal end surface of the most proximal corrugation 111 of the bare stent 110 to form a proximal extension region 123. That is, the proximal end of the coating 120 extends beyond the proximal end of the bare stent 110 to form a proximal extension region 123.

[0061] like Figures 2 to 4 As shown, in one embodiment, a plurality of first marker structures 124 are provided on the proximal end of the bare stent 110. The first marker structure 124 can be provided on the corrugation 111 by winding or welding. In one embodiment, the first marker structure 124 is provided on the corrugation 111 at the most proximal end.

[0062] See also Figure 5 The second tube segment 30 includes a tubular cavity support structure 310 and a thin film body 320 disposed on the tubular cavity support structure 310 .

[0063] The tubular cavity support structure 310 is a tubular cavity hollow structure having a second tubular cavity 301. In one embodiment, the tubular material is cut and shaped to form the tubular cavity support structure 310. In another embodiment, the tubular support structure 310 is a tubular cavity hollow structure formed by axially connecting a plurality of corrugations, and the connection method of the corrugations may be the same as or different from the connection method of the corrugations 111 of the first tube section 10.

[0064] The film body 320 is a flexible structure. In one embodiment, the material of the film body 320 is a flexible material such as polytetrafluoroethylene, polyester cloth, etc. The film body 320 covers the tubular cavity support structure 310, and one end of the film body 320 exceeds the tubular cavity support structure 310 to form an extension portion 321, and the portion of the film body 320 that contacts the tubular cavity support structure 310 is a contact portion 322. The proximal end of the extension portion 321 is connected to the distal end of the contact portion 322. Alternatively, the extension portion 321 and the contact portion 322 are an integrated structure.

[0065] Please also read Figures 1-2 , Figure 5 and Figure 6 The distal end of the extension portion 321 extends into the first lumen 101 of the first tube segment 10, and the extension portion 321 is connected to the first tube segment 10, so that the second tube segment 30 is connected to the first tube segment 10, and the first lumen 101 is connected to the second lumen 301. Figure 2 As shown, the extension part 321 is connected to the first pipe segment 10 through a plurality of discrete connection parts 323, and the plurality of connection parts 323 are arranged at intervals along the circumference of the extension part 321 or along the circumference of the first pipe segment 10, that is, adjacent connection parts 323 form a circumferential interval 324. At the circumferential interval 324, the extension part 321 is not fixedly connected to the first pipe segment 10, but the first pipe segment 10 is merely sleeved outside the extension part 321, and the outer surface of the extension part 321 is not fixed to the inner surface of the first pipe segment 10. When the first pipe segment 10 is in a radially expanded state and the tubular cavity support structure 310 of the second pipe segment 30 is in a radially compressed state, the distal end of the extension part 321 is driven by the first pipe segment 10 and the tubular cavity support structure 310 to be in a radially compressed state to a certain extent, so that at the circumferential interval 324, the outer surface of the extension part 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, so that during the implantation process, the number of gaps 325 formed is greater than the number of branch stents 200, and there is no need to implant the gaps 325 of the branch stents 200 to form a blood flow channel, so as to avoid the second tube segment 30 that is not fully radially expanded during the implantation process blocking the blood flow.

[0067] In one embodiment, the connection portion 323 simultaneously connects the extension portion 321 , the coating 120 , and the corrugated ring 111 at the most proximal end of the first tube segment 10 , so that the structural stability of the implantable medical device 100 is better.

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

[0069] Please also read Figure 2 and Figure 6 When the implantable medical device 100 is used in conjunction with the branch stent 200, the first tube segment 10 is first released from the delivery sheath 300, and the lumen support structure 310 of the second tube segment 30 is at least partially radially constrained in the delivery sheath 300. The extension portion 321 is driven by the first tube segment 10 and the lumen support structure 310 to be in a certain degree of radial compression state, so that the outer surface of the extension portion 321 and the inner surface of the first tube segment 10 form a gap 325, and one end of the branch stent 200 extends into the gap 325, releasing the lumen support structure 310, so that the branch stent 200 is clamped by the first tube segment 10 and the second tube segment 30 at the circumferential interval 324, and the extension portion 321 abuts against the surface of the branch stent 200. In addition, since the extension portion 321 is a thin film, the thin film has good flexibility and can adapt to the shape of the branch stent 200, so that the branch stent 200 can be more tightly wrapped or fitted to reduce internal leakage.

[0070] Moreover, compared with the way that the skirt fits the inner wall of the main stent, the way that the first pipe section 10 and the second pipe section 30 are clamped and the flexible extension section 321 is used to abut or fit the surface of the branch stent 200 can adapt to different individuals and will not cause serious internal leakage due to individual anatomical differences. Therefore, the implantable medical device 100 can better reduce internal leakage when used in conjunction with the branch stent 200.

[0071] Furthermore, the way the skirt fits the inner wall of the main stent requires opening a window on the coating of the main stent. The skirt is equivalent to a patch for blocking the window. When the window is too large, it is easy to cause internal leakage. When the window is too small, during the implantation process, the window may be stretched open, causing the window to become larger or the coating to be damaged. Once the coating is damaged, there is a risk of further cracking and causing the window to become larger, which is easy to cause internal leakage. Compared with the way the skirt fits the inner wall of the main stent, the coating 120 and the film body 320 of the above-mentioned implantable medical device 100 remain intact, which helps to achieve the effect of continuously clamping the branch stent 200 and avoid internal leakage.

[0072] It should be noted that the size of the circumferential interval 324 can be matched with the outer diameter of the branch stent 200, so that the first pipe segment 10 and the second pipe segment 30 can clamp the branch stent 200 more tightly, which is conducive to reducing internal leakage.

[0073] In one embodiment, the proximal end of the coating 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 overlap in the radial direction to form a radial overlap 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 the branch stent 200 well on both sides, which is conducive to reducing internal leakage.

[0074] In one embodiment, the maximum dimension of the gap 325 is smaller than the radial dimension (e.g., outer diameter) of the branch stent 200 in a natural state, so that after one end of the branch stent 200 in a compressed state is extended into the gap 325, the branch stent 200 can be clamped more tightly 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 size (e.g., outer diameter) of the branch stent 200 in a natural state, and the materials of the coating 120 and the thin film body 320 are both materials with a certain degree of ductility, so that after the branch stent 200 is radially expanded, the proximal extension area 123 and the extension portion 321 can adapt to the shape of the branch stent 200 and fit the branch stent 200 tightly to improve the effect of reducing internal leakage. In one embodiment, the materials of the coating 120 and the thin film body 320 are both polytetrafluoroethylene.

[0076] In one embodiment, the extension portion 321 is connected to the first pipe segment 10 through a plurality of suture points, and the plurality of suture points are arranged at intervals along the circumference of the extension portion 321 or along the circumference of the first pipe segment 10, and adjacent suture points form a circumferential interval 324. That is, the connection portion 323 is a suture point. It should be noted that the connection portion 323 is a suture point, which means that the connection portion 323 is formed by suture, and a connection portion 323 does not necessarily have only one fixed point, and a connection portion 323 can be a single fixed point or multiple fixed points, but the gap between the multiple fixed points is significantly smaller than the distance between adjacent connection portions 323.

[0077] In one embodiment, the suture point simultaneously connects the extension portion 321 , the coating 120 , and the corrugated ring 111 at the most proximal end of the first tube segment 10 .

[0078] In other embodiments, the fixing method of the extension portion 321 and the first pipe segment 10 is not limited to suturing, for example, the fixing connection can be achieved by gluing or the like.

[0079] Please continue reading Figure 5In one embodiment, the contact portion 322 is in the shape of a hollow cylinder, the extension portion 321 is in the shape of a hollow truncated cone, and the outer diameter of the end of the extension portion 321 away from the contact portion 322 is larger, and the outer diameter of the end close to the contact portion 322 is smaller and equal to the outer diameter of the contact portion 322. In the naturally expanded state, the outer diameter of the portion of the end of the extension portion 321 extending into the first lumen 101 and in contact with 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, so that the implantable medical device 100 is suitable for a part with a branch and a larger inner diameter at one end and a smaller inner diameter at the other end.

[0080] In another embodiment, the extension portion 321 is in a hollow cylindrical shape, the contact portion 322 is in a hollow cylindrical shape, and the outer diameter of the extension portion 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, which are disposed on the extension portion 321 and adjacent support rods 50 are spaced apart in the circumferential direction of the extension portion 321. The proximal ends of the support rods 50 are connected to the tubular cavity support structure 310, and the distal ends extend along the axial direction of the implantable medical device 100 and the distal ends are located in the first tubular cavity 101. Furthermore, the distal ends of the support rods 50 are located in the circumferential intervals 324 of the adjacent connection portions 323. That is, the support rods 50 intersect with the lines connecting the adjacent connection portions 323.

[0082] The support rod 50 is disposed on the outer surface, inner surface or inside of the extension portion 321 (the extension portion 321 is a multi-layer structure). The distal end of the support rod 50 is a free end 510, which is located in the first lumen 101. The free end 510 is a blunt 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] See also Figure 7 , the first tube section 10 is in a radially expanded state, and the lumen support structure 310 of the second tube section 30 is radially constrained in the delivery sheath 300 (therefore Figure 7(not shown in Figure 310), one end of the support rod 50 connected to the tubular cavity support structure 310 is also radially constrained in the delivery sheath 300. The extension portion 321 is in a radial compression state to a certain extent under the coordinated drive of the first tube segment 10 and the tubular cavity support structure 310. Since the film body 320 is a flexible structure, the corresponding extension portion 321 of the film body 320 is also a flexible structure. A plurality of support rods 50 are arranged at intervals on the flexible extension portion 321. On the one hand, when the second tube segment 30 is radially compressed, the support rod 50 can promote the contraction of the extension portion 321, thereby forming a larger gap 325, and at the gap 325, the support rod 50 props up the flexible film body to avoid the formation of wrinkles or reduce the degree of wrinkles, which is beneficial to the implantation of the branch stent 200. On the other hand, the extension portion 321 has a better three-dimensional shape after radial expansion, avoiding internal leakage caused by the formation of a blood flow channel between the extension portion 321 and the inner wall of the first tube segment 10 due to the wrinkles of the extension portion 321 itself, so that in the area where the branch stent 200 is not implanted, the extension portion 321 can better fit with the inner surface of the first tube segment 10, and in the area where the branch stent 200 is implanted, the extension 321 can better fit with the branch stent 200, thereby better reducing internal leakage.

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

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

[0086] Please go back Figure 2 In one embodiment, the implantable medical device 100 further includes a connector 70 , which is used to further connect 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 connecting member 70 includes a plurality of connecting rods, which are 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 connecting member 70 is a wavy ring structure, the crest of the wavy ring structure is hooked and connected to the wave ring 111 at the nearest end of the first pipe segment 10, and the trough of the wavy ring structure is hooked and connected to the farthest wave ring of the second pipe segment 30 or the connecting structure at the far end of the second pipe segment 30.

[0089] Alternatively, the wave crest of the wave-shaped annular structure is hooked and connected to the wave ring 111 at the nearest end of the first pipe segment 10, and the wave-shaped annular structure is connected to the distal end of the second pipe segment 30 in a non-hooking manner.

[0090] Regardless of the structure of the connecting member 70 , the connecting member 70 may be located inside the first pipe segment 10 and the second pipe segment 30 or outside the first pipe segment 10 and the second pipe segment 30 .

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

[0092] When the connector 70 is located outside the first pipe segment 10 and the second pipe segment 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), abutting against the radial overlap portion and the proximal end of the extension portion 321 .

[0093] See also Figure 8 In one embodiment, the tubular cavity 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. The first support segment 311 and the second support segment 312 are both tubular cavity structures. In addition, the radial support force of the first support segment 311 is greater than the radial support force of the second support segment 312. The radial support force of the first support segment 311 is relatively large to provide sufficient radial support force, which is conducive to improving the anchoring force of the implantable medical device 100 in the body. The radial support force of the second support segment 312 is relatively small, so that during the implantation process, it is easier to compress the second support segment 312 so that the extension portion 321 is in a radial contraction state to a certain extent, while the first tube segment 10 is in a radial expansion state, thereby forming a gap 325, which is convenient for inserting the branch stent 200, so that the branch stent 200 is clamped by the first tube segment 10 and the second tube 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, and 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 segment 312, and the other end is connected to the first tube segment 10. In one embodiment, the connector 70 is a wave-shaped ring structure, and the connector 70 forms a plurality of third hollow parts 710, and the area of ​​each third hollow part 710 is greater than the area of ​​each first hollow part 3111. The first hollow part 3111 has a smaller area, which is conducive to improving the radial support force of the first support segment 311, while the third hollow part 710 has a larger area, which is conducive to making the operation of implanting the branch stent 200 smoother (to be described in detail below).

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

[0097] Please also read Figure 8 and Fig. 9 In one embodiment, the connector 70 is a wave-shaped ring structure formed by connecting a plurality of wave rods 711 end to end. The proximal end of the connector 70 is connected to the tubular cavity support structure 310, and the distal end of the connector 70 is hooked and connected to the trough of the wave ring 111 at the nearest end of the first tube segment 10 through the wave crest. At the same time, the connecting portion 323 of the extension portion 321 and the first tube segment 10 is simultaneously connected to the trough of the wave ring 111 at the nearest end that is hooked to the connector 70.

[0098] When the connector 70 is a wave-shaped ring structure formed by connecting a plurality of wave rods 711 end to end, the connector 70 and the tubular cavity support structure 310 may be an integrated structure, or the connector 70 and the tubular cavity support structure 310 may be connected in a manner known to those skilled in the art. The connection manner includes but is not limited to welding, suturing, and the like.

[0099] Further, the connector 70 is fixed to the surface of the extension portion 321. The fixing method may be pasting, for example, using glue to paste the connector 70 on the outer surface of the extension portion 321. The fixing method may also be suturing, using sutures to fix the connector 70 on the outer surface of the extension portion 321. For example, sutures are used to form a plurality of suture points 302 to fix the connector 70 to the surface of the extension portion 321.

[0100] like Fig. 9As shown, two adjacent connection parts 323 and two wave rods 711 of the connector 70 enclose an implantation area A, and the two wave rods 711 are connected to form a trough of a wave-shaped annular structure. The branch stent 200 is clamped by the first tube segment 10 and the second tube segment 30 in the implantation area A. The circumferential interval 324 is located in the implantation area A. Since the connector 70 is fixed on the surface of the extension portion 321 in the implantation area A, when the connector 70 is radially compressed, it is easy to drive the extension portion 321 to contract, so as to form a gap 325, so that one end of the branch stent 200 can pass through the gap 325 to enter the first lumen 101. Furthermore, in implantation area A, since the extension portion 321 is connected to the nearest wave coil 111 and the coating 120 via the connection portion 323, the distance between the outer surface of the portion of the extension portion 321 located in implantation area A and the inner surface of the portion of the first tube segment 10 located in implantation area A (for example, the inner surface of the coating 120) is limited. Thus, 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] Two adjacent wave rods 711 surround a third hollow portion 710 . The third hollow portion 710 has a larger area, and the corresponding implantation region A has a larger area, so that the branch stent 200 is more easily implanted.

[0102] In one embodiment, the wave rods 711 of the wave-shaped annular structure formed by all the connections of the connector 70 form an implant area A, so that during the implantation of the branch stent 200, when the first tube segment 10 is in a radially expanded state and the lumen support structure 310 of the second tube segment 30 is radially constrained in the delivery sheath 300, a plurality of gaps 325 are formed. In the gaps 325 where the branch stent 200 is not implanted, blood can enter the first lumen 101 through the gaps 325 and flow out of the first lumen 101. Alternatively, blood flows from the first lumen 101 through the gaps 325 to the direction of the second tube segment 30. Therefore, during the implantation process, blood flow is not blocked, thereby improving the safety of the operation.

[0103] In another embodiment, the wave rod 711 of the wavy ring structure formed by partial connection of the connector 70 forms the implant area A, that is, the number of circumferential intervals 324 is less than the number of troughs of the connector 70, but the number of circumferential intervals 324 is greater than the number of branch stents 200, so as to better balance the blood flow and anti-endoleakage effects.

[0104] Please also read Fig. 9 and Fig.10In one embodiment, the implantation area A includes a first sub-area A1 and a second sub-area A2. The proximal end of the coating 120 extends beyond the proximal end of the bare stent 110 to form a proximal extension area 123. In the implantation area A, the first sub-area A1 is a partial area of ​​the radial superposition portion formed by the superposition of the proximal extension area 123 and the extension portion 321, that is, the area of ​​the radial superposition portion located between two adjacent wave rods 711 forming a trough. The second sub-area A2 is a partial area of ​​the extension portion 321, that is, the area of ​​the extension portion 321 located between two adjacent wave rods 711 forming a trough and located below the first sub-area A1. The proximal extension area 123 of the first sub-area A1 forms a gap 325 when the extension portion 321 forms a distance in the radial direction. The two adjacent wave rods 711 surrounding the implantation area A simultaneously press or abut the radial superposition portion and the extension portion 321, that is, the wave rods 711 simultaneously press or abut the first sub-area A1 and the second sub-area A2. Furthermore, the suture point 302 fixedly connects the wave rod 711 with the extension part 321 in the second sub-region A2, and the suture point 302 fixedly connects the wave rod 711, the extension part 321 and the 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 part 321, when the connector 70 is compressed, it is conducive to promoting the formation of the gap 325 to facilitate the implantation of the branch stent 200; after one end of the branch stent 200 is inserted into the gap 325, when the luminal support structure 310 and the connector 70 are released, the wave rod 711 abuts against the proximal extension region 123, so that the coating 120 is close to the surface of the branch stent 200, thereby improving the anti-internal leakage effect.

[0105] See also Fig.11 In one embodiment, the support rod 50 is located in 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 toward the distal end along the implantation area A. In one embodiment, the support rod 50 extends axially toward the distal end along the implantation area A, extending from the second sub-area A2 to the first sub-area A1, and the support rod 50 is fixed on the extension portion 321, and the connecting line of the support rod 50 and the two connecting parts 323 of the implantation area A intersects. At the same time, the wave rod 711 of the connector 70 is fixedly connected to the proximal extension area 123 and the extension portion 321 at the same time, so that in the radially expanded state, as shown in FIG. Fig.12As shown, driven by the wave rod 711 and the support rod 50, the proximal extension area 123 and the extension portion 321 can fit the branch stent 200 more closely to reduce internal leakage. The support rod 50 and the wave rod 711 are both fixedly connected to the extension portion 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 at circumferential intervals along the extension portion 321. This arrangement, on the one hand, maintains the flexibility of the extension portion 321 at the intervals to fit the branch stent 200 and thus reduce internal leakage; on the other hand, the support rod 50 and the wave rod 711 can enable the radially expanded extension portion 321 to maintain a three-dimensional configuration and drive the extension portion 321 to abut against the inner surface of the first pipe segment 10, so that, in a portion where the branch stent 200 is not implanted, the extension portion 321 can better fit with the inner surface of the first pipe segment 10, and in a portion where the branch stent 200 is implanted, the extension 321 can better fit with the branch stent 200, thereby better reducing internal leakage.

[0106] See also Fig.13 In one embodiment, the first support section 311, the second support section 312 and the support rod 50 are an integrated structure, the proximal end 512 of the support rod 50 is connected to the second support section 312, and the support rod 50 extends in the axial direction. The first support section 311, the second support section 312 and the support rod 50 are an integrated structure, which is conducive to the radial contraction of the support rod 50 with the radial contraction of the first support section 311 and the second support section 312, so as to promote the contraction of the extension portion 321, thereby forming a gap 325, and avoiding the formation of wrinkles or reducing the degree of wrinkles at the gap 325. In addition, the support rod 50 expands with the radial expansion of the first support section 311 and the second support section 312, so that the support rod 50 supports the extension portion 321 on the inner wall of the first pipe section 10, so that the internal leakage is reduced in the part where the branch stent 200 is not implanted; in the part where the branch stent 200 is implanted, the extension portion 321 and the first pipe section 10 clamp the branch stent 200 to reduce the internal leakage.

[0107] See also Fig.14 In one embodiment, the implantable medical device 100 further includes a leaflet structure 90, which is disposed in the second lumen 301 of the second tube segment 30 and can be opened or closed, so that the implantable medical device 100 can be used to replace a diseased natural valve. The leaflet structure 90 includes 2, 3 or more leaflets.

[0108] The implantable medical device 100 including the leaflet structure 90 can be used in conjunction with the branch stent 200 to treat aortic valve disease combined with aortic dissection.

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

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

[0111] In one embodiment, a second marking structure 221 is provided on the horn section 220 , and 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 section 210 includes a coated section 211 and a bare stent section 212 connected to the distal end of the coated section 211, and the radial support force of the bare stent section 212 is greater than the radial support force of the coated section 211. The bare stent section 212 is provided to provide sufficient radial force, and the bare stent section 212 does not block the blood flow of the small branches of the branch.

[0113] See also Fig.16 In one embodiment, the trumpet section 220 includes a plurality of petal portions 221, and the plurality of petal portions 221 form the trumpet section 220. Each petal portion 221 is wound by a metal wire, and a coating is provided on each petal portion 221. Furthermore, there is no coating between adjacent petal portions 221, that is, a gap is formed between adjacent petal portions 221. The petal portions 221 can better fill the gap between the first tube segment 10 and the second tube segment 30, and the gap formed between adjacent petal portions 221 is beneficial to reducing the outer diameter of the delivery sheath 300 used to deliver the branch stent 200, which is beneficial to delivering the branch stent 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 wrap or fit the branch stent more tightly and can adapt to different individuals. Therefore, internal leakage can be reduced better.

[0115] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0116] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.

Claims

1. An implantable medical device, characterized in that: include: A first tube segment, wherein the first tube segment has a first tube cavity with openings at both ends; The second tube segment includes a tubular cavity support structure and a thin film body, wherein the thin film body is arranged on the tubular cavity support structure, and the distal end of the thin film body exceeds the tubular cavity support structure to form an extension portion, and the distal end of the extension portion extends into the first tubular cavity, the extension portion is connected to the first tube segment, and there are multiple connection parts between the extension portion and the first tube segment, and adjacent connection parts form a circumferential interval.

2. The implantable medical device according to claim 1, characterized in that: The extension portion is connected to the first pipe segment via a plurality of suture points, and the plurality of suture points are arranged at intervals along the circumference of the first pipe segment, and adjacent suture points form the circumferential interval.

3. The implantable medical device according to claim 1, characterized in that: The first tube segment includes a bare stent and a coating arranged on the bare stent, the proximal end of the coating extends beyond the proximal end of the bare stent to form a proximal extension area, and the proximal extension area and the extension part are radially overlapped to form a radial overlapping part.

4. The implantable medical device according to claim 3, characterized in that: A plurality of first marking structures are disposed at the proximal end of the bare stent, and a projection of each of the first marking structures on the extension portion is located within the circumferential interval.

5. 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.

6. The implantable medical device according to claim 5, characterized in that: The connecting member is located inside the first tube segment and the second tube segment, and the distal end surface of the connecting member is located distal to the distal end surface of the extending portion; or, the connecting member is located outside the first tube segment and the second tube segment, and the connecting member abuts against the proximal ends of the radial overlapping portion and the extending portion.

7. The implantable medical device according to claim 5, characterized in that: The implantable medical device also includes a plurality of support rods, which are arranged on the extension portion, the proximal end of each support rod is connected to the tubular cavity support structure, the distal end extends axially and the distal end is located inside the first tubular cavity, and the distal end of the support rod is located within the circumferential interval.

8. The implantable medical device according to claim 7, characterized in that: The connecting member is a wavy annular structure formed by connecting a plurality of wave rods end to end, and at least two adjacent wave rods forming a trough and two connecting parts adjacent to the wave rods form an implantation area, and the implantation area includes a partial area of ​​the extension part and a partial area of ​​the radial overlapping part, and the connecting member abuts against a partial area of ​​the extension part and a partial area of ​​the radial overlapping part, and in a partial area of ​​the extension part, the wave rod is fixedly connected to the extension part, and in a partial area of ​​the radial overlapping part, the wave rod is fixedly connected to both the extension part and the proximal extension area.

9. The implantable medical device according to claim 8, characterized in that: The support rod is located in the implantation area, and the support rod axially extends from an end close to the trough to a distal end.

10. The implantable medical device according to claim 1, characterized in that: The tubular cavity support structure includes a first support segment and a second support segment connected to the distal end of the first support segment, and the radial support force of the first support segment is greater than the radial support force of the second support segment.

11. The implantable medical device according to claim 1, characterized in that: The tubular cavity 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 is formed with a plurality of first hollow parts, the second support segment is formed with a plurality of second hollow parts, and the area of ​​each of the second hollow parts is greater than the area of ​​each of the first hollow parts.

12. The implantable medical device according to claim 11, characterized in that: The implantable medical device also includes a connector, one end of which is connected to the second supporting segment, and the other end of which is connected to the first tube segment, and the connector is formed with a plurality of third hollow portions, and the area of ​​each third hollow portion is greater than the area of ​​each first hollow portion.

13. The implantable medical device according to claim 1, characterized in that: The implantable medical device further comprises a leaflet structure, wherein the leaflet structure is arranged in the second tube segment and the leaflet structure can be opened or closed.

14. An implantable medical system, characterized in that: It comprises a branch stent and an implantable medical device as described in any one of claims 1 to 13, 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 portion abuts against the branch stent.

15. The implantable medical system according to claim 14, characterized in that: The branch stent includes a straight tube section and a horn section connected to one end of the straight tube section. When the branch stent is used in conjunction with the implantable medical device, the horn section is located in the first tube cavity, and the horn section can be clamped by the first tube section and the second tube section.

16. The implantable medical system according to claim 14, characterized in that: The number of the circumferential intervals is greater than the number of the branch supports.

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