Multi-chamber covered stent

Abstract

The present invention discloses a multi - cavity covered stent, which includes a tubular main - body covered stent and a tubular connecting covered stent; the main - body covered stent includes a tubular main - body stent, the main - body stent includes a tubular main - body covering film and a main - body support frame fixed on the wall surface of the main - body covering film, and a main cavity and at least one sub - cavity are axially separated in the main - body stent by a separating covering film; in a released state, the proximal end of the connecting covered stent is inserted and tightly fitted with the main cavity at the distal end of the tubular main - body covered stent. There is provided a multi - cavity covered stent with a structure that is not prone to endoleakage and displacement, simplifies the surgical operation, reduces the surgical difficulty and risk, and has a wide range of adaptability.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and relates to a covered stent, in particular to a multi-lumen covered stent. Background Art

[0002] An aortic aneurysm refers to a local or diffuse abnormal dilation of the aortic wall, which compresses surrounding organs and causes symptoms. Rupture of the aneurysm is its main danger. It often occurs in the ascending aorta, aortic arch, descending thoracic aorta, thoracoabdominal aorta, and abdominal aorta. Aortic aneurysms can be classified into true aortic aneurysms and false aortic aneurysms according to their structure. An aortic aneurysm causes an increase in the medial pressure of the blood vessel, so it expands progressively. If it develops for a long time, it will eventually rupture. The larger the aneurysm, the greater the possibility of rupture. According to statistics, if no surgical treatment is performed, 90% of thoracic aortic aneurysms will die within 5 years, and 3 / 4 of abdominal aortic aneurysms will die within 5 years.

[0003] Aortic dissection is another serious cardiovascular disease. Aortic dissection refers to the destruction of the middle membrane of the thoracic aorta, bleeding within the blood vessel wall, and blood entering the space between the middle membrane and the outer membrane of the blood vessel wall. Due to the impact of blood flow, once an aortic dissection forms, the tear can extend along the direction of blood flow, the dissection and false lumen expand, and the true lumen is compressed. Therefore, the risks that aortic dissection patients may face include: (1) being on the verge of complete rupture of the blood vessel. Once the blood vessel completely ruptures, the mortality rate is extremely high; (2) the dissection gradually expands and compresses the true lumen, reducing blood supply to the distal part of the blood vessel. In most cases, aortic dissection is secondary to thoracic aortic aneurysm or coexists with aortic aneurysm.

[0004] All aortic diseases may involve branch arteries. Once branch arteries are involved, it will be extremely difficult to solve them through interventional methods. Currently, endovascular treatment of arteries has been carried out at home and abroad, that is, a minimally invasive method is used to implant a graft, namely an arterial covered stent, into the diseased artery through the blood vessel lumen to treat arterial diseases and improve blood supply, so as to achieve the treatment purpose. The so-called endovascular arterial covered stent is composed of a tubular rigid wire stent and an artificial blood vessel fixed on the outside of the stent. The tubular rigid wire stent is formed by surrounding a ring with elastic rigid wires after Z-shaped folding, and then sewing or bonding multiple rings together with the artificial blood vessel to form a tubular covered stent. When in use, the arterial covered stent is axially compressed and loaded into a delivery device, and the delivery device sends it through a smaller femoral artery, iliac artery, or brachial artery to the diseased artery and then releases it. Due to the elastic force of the metal wire stent, it automatically returns to a straight tubular shape and adheres tightly to the inner wall of the aorta, isolating the arterial diseased part from the blood flow, thus achieving the treatment purpose.

[0005] Limited by the current stent structure, there are inevitable problems in the treatment of existing products related to arterial branches, creating potential hazards of complications during or after treatment. The specific analysis is as follows:

[0006] 1. Chimney stent

[0007] The "chimney" technique, also known as the parallel stent technique, refers to implanting a stent into the occluded branch vessel and releasing it in parallel with the main stent in the aorta, so as to achieve the purpose of preserving the aortic arch branches. According to the position of the stent, it can be divided into subclavian artery "chimney", carotid artery "chimney" and brachiocephalic artery "chimney". According to the number of stents, it can be divided into "single chimney", "double chimney" and "triple chimney". The advantages of the "chimney stent" technique are: the surgical instruments used are all conventional instruments and are easily available clinically; the technical difficulty is relatively low; in selected appropriate cases, the incidence of endoleak is low and the occlusion effect is good. Its disadvantages are: there is a "groove" between the small stent and the aortic main stent, which is not a perfect occlusion technique and there is a risk of endoleak; on the other hand, the aortic main stent and the small stent are released in parallel, and the main stent may compress the small stent, resulting in poor blood flow in the small stent or even blockage.

[0008] 2. Fenestrated stent

[0009] Existing "fenestrated stents" mainly include in-situ fenestration during the operation and customized fenestration. Among them, in-situ fenestration is to first place the aortic main stent to cover the lesion and the pre-fenestrated vessel, and then introduce fenestration instruments (such as a stiff guide wire, laser, radiofrequency, etc.) into the pre-fenestrated branch vessel, puncture the aortic stent, and then assist with balloons and stents to open the branch vessel. The in-situ fenestration operation is complex and has certain requirements for the doctor's surgical level. In addition, the durability of the implanted stent and its long-term anti-fatigue performance are not good, and endoleak is likely to occur. The pre-fenestrated stent is individually manufactured by the stent manufacturer. Based on the preoperative imaging examination results, a stent that conforms to the aortic arch anatomical morphology of different patients is made. Therefore, this type of stent has better support force, apposition, and positioning ability. However, the customized stent requires a certain time period and is not suitable for emergency cases. In addition, the manufacture of the stent needs to consider technical details such as the curvature of the aortic arch, the relative position of the openings of the major vessels above the arch, the location of the lesion, the marking of the window, and the positioning of the stent.

[0010] 3. One-piece branched stent

[0011] The one-piece branched stent can avoid the "groove" brought about by the implantation of the chimney stent and can avoid problems such as endoleak caused by poor fenestration alignment. Its apposition is better and the probability of endoleak is less. However, affected by multiple technical problems such as the delivery, introduction, positioning, and release of the branched stent, there is still no mature and applicable stent product on the market so far. Summary of the Invention

[0012] The technical problem to be solved by the present invention is to provide a multi - cavity covered stent with a structure that is not prone to internal leakage and displacement, simplifies surgical operations, reduces surgical difficulty and risk, and has a wide range of adaptability in view of the defects of the prior art.

[0013] The technical solution adopted by the present invention to solve its technical problems is as follows:

[0014] A multi - cavity covered stent includes a tubular main - body covered stent and a tubular connecting covered stent;

[0015] The main - body covered stent includes a tubular main - body stent, the main - body stent includes a tubular main - body film and a main - body support frame fixed on the wall surface of the main - body film, and a main cavity and at least one sub - cavity are axially separated in the main - body stent by a partition film;

[0016] In the released state, the proximal end of the connecting covered stent is in plug - in tight - fit connection with the main cavity at the distal end of the tubular main - body covered stent.

[0017] Further, in the multi - cavity covered stent, preferably, a main - cavity orifice is provided at the distal end of the main cavity, and the outer diameter of the proximal end of the connecting covered stent is slightly larger than the main - cavity orifice of the main - body covered stent; in the released state, the proximal end of the connecting covered stent is in plug - in tight - fit connection with the main cavity through the main - cavity orifice.

[0018] Further, in the multi - cavity covered stent, preferably, the connecting covered stent is a non - equal - diameter stent or an equal - diameter stent.

[0019] Further, in the multi - cavity covered stent, preferably, the connecting covered stent is a non - equal - diameter stent composed of a first tubular body, a second tubular body, and a third tubular body in sequence from the proximal end to the distal end, and the diameter of the second tubular body is smaller than the diameters of the first tubular body and the third tubular body.

[0020] Further, in the multi - cavity covered stent, preferably, the connecting covered stent is an equal - diameter stent, and a window with an embedded small branch is opened on the side wall of the equal - diameter stent; when the main - body covered stent is plugged into the connecting covered stent, the window with the embedded small branch is arranged close to the sub - cavity of the main - body covered stent;

[0021] Or the connecting covered stent is a non - equal - diameter stent, and a window with an embedded small branch is opened on the second tubular body of the non - equal - diameter stent or on the transition part between the second tubular body and the third tubular body; when the main - body covered stent is plugged into the connecting covered stent, the window with the embedded small branch is arranged close to the sub - cavity of the main - body covered stent.

[0022] Further, in the multi - cavity covered stent, preferably, the connecting covered stent includes a connecting film and a connecting support frame fixed on the connecting film.

[0023] Further, in the multi - cavity covered stent, it is preferred that the connecting support frame is a high - low wave stent or an equal - height wave stent, and the high - low wave stent is a partially sutured stent.

[0024] Further, in the multi - cavity covered stent, it is preferred that a support rod is axially fixed along the outer wall of the connecting covering film.

[0025] Further, in the multi - cavity covered stent, it is preferred that the support rod is arranged on the connecting covering film close to the side of the sub - cavity.

[0026] Further, in the multi - cavity covered stent, it is preferred that there is at least one fixing point between the support rod and the connecting covering film for fixedly connecting the two together.

[0027] Further, in the multi - cavity covered stent, it is preferred that at least a transverse end covering film is provided between the distal end of the main body covering film and the partition covering film, and the transverse end covering film connects the main body covering film and the partition covering film together.

[0028] Further, in the multi - cavity covered stent, it is preferred that axially, the main cavity orifice, the sub - cavity orifice, and the end face of the main body covering film are at least flush at the distal end;

[0029] Or at least one of the main cavity orifice and the sub - cavity orifice is higher or lower than the end face of the main body covering film.

[0030] Further, in the multi - cavity covered stent, it is preferred that at least one of the main cavity and the sub - cavity extends a tubular extended covering film in the distal direction from the transverse end covering film;

[0031] The end face of the extended covering film forms the main cavity orifice, and this main cavity orifice is higher than, lower than, or flush with the end face of the main body covering film;

[0032] Or / and the end face of the extended covering film forms the sub - cavity orifice, and this sub - cavity orifice is higher than, lower than, or flush with the end face of the main body covering film.

[0033] Further, in the multi - cavity covered stent, it is preferred that an extended support frame for supporting the extended covering film is provided on the inner wall or the outer wall of the extended covering film.

[0034] Further, in the multi - cavity covered stent, it is preferred that the transverse end covering film is a planar structure perpendicular to the central axis of the main body stent;

[0035] Or the transverse end covering film is an inclined plane structure non - perpendicular to the central axis of the main body stent;

[0036] Or the transverse end covering film includes at least one planar structure and at least one inclined plane structure, and the planar structure and the inclined plane structure are an integral structure as a whole or they are connected together to form a whole.

[0037] The multi-lumen covered stent of the present invention has the following beneficial effects:

[0038] The multi-lumen covered stent of the present invention includes a main body covered stent as the main body stent, a tubular connecting covered stent and a branch stent. The main body covered stent is provided with a sub-cavity. One to three windows are opened on the tubular connecting covered stent. Branches can be embedded in both the sub-cavity and the windows for use in reconstructing branches. For patients with type A dissection or aortic arch aneurysm, there are certain differences in the opening positions of the three branches on the aortic arch, the inner diameters of the branches, and the angles formed by the branch vessels and the aortic arch. If the differences are large, stent displacement, mismatch may occur, and even the surgical difficulty may increase. By using the multi-lumen covered stent of the present invention, the corresponding size stent can be selected according to the number, position and thickness of the aortic branch vessels to be reconstructed, so as to avoid mismatch. In the released state, the proximal part of the tubular connecting covered stent of the present invention is released and inserted into the main cavity of the main body covered stent and firmly abuts against the main cavity, and endoleakage is not likely to occur. The multi-lumen covered stent of the present invention is easy to operate, highly flexible, and has a wide range of applications, and is particularly suitable for endovascular treatment of Stanford type A dissection or aortic arch aneurysm. Description of the Drawings

[0039] The present invention will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0040] Figure 1 is a schematic structural diagram of the assembled multi-lumen covered stent of Embodiment 1;

[0041] Figure 2 is a schematic structural diagram of the unassembled multi-lumen covered stent of Embodiment 1;

[0042] Figure 3 is a schematic structural diagram of the first embodiment of the main body covered stent of Embodiment 1;

[0043] Figure 4 is a schematic structural diagram of the main body support frame of Embodiment 1;

[0044] Figure 5 is a schematic structural diagram of the connection between the main body support frame and the main body covering of Embodiment 1;

[0045] Figures 6 - 7 is a schematic structural diagram of the main body covered stent of Embodiment 1 in another direction;

[0046] Figure 8 is a schematic structural diagram of the end face of the main body covered stent of Embodiment 1;

[0047] Figures 8a - 8b is a schematic structural diagram of the end face of the main body covered stent in other embodiments of Embodiment 1;

[0048] Figures 9 - 10b Structural schematic diagram showing different implementation manners of the covered stent for Example 1;

[0049] Figure 11 Structural schematic diagram showing the assembly of the multi-lumen covered stent and the branch stent for Example 1;

[0050] Figure 12 Structural schematic diagram of the main body covered stent for Example 2;

[0051] Figures 13 - 14 Structural schematic diagram showing different implementation manners of the main body covered stent for Example 3;

[0052] Figure 15a Structural schematic diagram of the main body covered stent for Example 4;

[0053] Figure 15b Structural schematic diagram showing the corresponding relationship between the main body covered stent and the connecting covered stent for Example 4;

[0054] Figure 16 Structural schematic diagram of the connecting covered stent for Example 5;

[0055] Figure 17 Structural schematic diagram showing the connection between the main body support frame and the main body covering film for Example 5;

[0056] Figure 18 Structural schematic diagram of the connecting covered stent for Example 5;

[0057] Figure 19 Structural schematic diagram showing the assembly of the multi-lumen covered stent and the branch stent for Example 5;

[0058] Figure 20 Schematic diagram showing the multi-lumen covered stent released in the thoracic aorta for Example 5;

[0059] Figure 21 Structural schematic diagram of the connecting covered stent for Example 6. Detailed implementation manners

[0060] For a clearer understanding of the technical features, objectives, and effects of the present invention, the detailed implementation manners of the present invention will now be described in detail with reference to the accompanying drawings.

[0061] Definition of orientation: During the operation, the proximal end in the present invention refers to the end close to the heart, and the distal end refers to the end far from the heart. In the present invention, the terms "high" and "low" are relative to the main body covering film. The end face exceeding the main body covering film is called high, and the end face not exceeding the main body covering film end face is called low. This definition is only for convenience of expression and does not limit the direction of the multi-lumen covered stent itself.

[0062] Example 1, as Figures 1 - 3As shown, a multi-chamber covered stent includes a tubular main body covered stent 100 and a tubular connecting covered stent 500. The main body covered stent 100 includes a tubular main body stent 101. The main body stent 101 includes a tubular main body covering film 120 and a main body support frame 110 fixed on the wall surface of the main body covering film 120. A main cavity 140 and at least one sub-cavity are axially separated in the main body stent 101 by a separating covering film. In the released state, the proximal end of the connecting covered stent is inserted and tightly fitted with the main cavity 140 at the distal end of the tubular main body covered stent 100 and connected together.

[0063] The multi-chamber covered stent includes two main parts: a tubular main body covered stent 100 and a tubular connecting covered stent 500. The structures of these two parts will be described in detail as follows:

[0064] I. Main body covered stent 100:

[0065] As Figure 3 shown, the main body covered stent 100 includes a tubular main body stent 101. The main body stent 101 includes a tubular main body covering film 120 and a main body support frame 110 fixed on the wall surface of the main body covering film 120. A main cavity 140 and at least one sub-cavity 130 are axially separated in the main body stent 101 by a separating covering film. At the distal end of the main cavity 140 of the main body covered stent 100, there is a main cavity opening 171, and at the distal end of the sub-cavity 130, there is a sub-cavity opening 172.

[0066] The main body stent 101 is the main structure of the main body covered stent 100, including a main body covering film 120 and a main body support frame 110. The main body covering film 120 is a tubular structure, and the shape of its cross-section is circular or oval to match the blood vessel.

[0067] The main body support frame 110 is sutured on the main body covering film 120, and there are various implementation manners of the main body support frame 110: The first implementation manner of the main body support frame 110: As Figure 4 shown, the main body support frame 110 is a plurality of annular corrugated support frames arranged axially. The annular corrugated support frames can be equal-height wave supports, high-low wave supports, etc. All structures suitable for covered stents are applicable to the present invention and will not be elaborated here. In this embodiment, as Figures 4 - 5As shown, the main support frame 110 is composed of multiple Z - shapes or sine waves. Each Z - shape or sine wave has 1 peak 111 and 1 adjacent trough 112, and there is 1 connecting rod 113 between the peak 111 and the adjacent trough 112. Each circular main support frame 110 is woven from a single super - elastic nickel - titanium wire. The selectable wire diameter (i.e., diameter) range of the super - elastic nickel - titanium alloy wire is 0.3mm - 0.55mm. In the first embodiment, it is woven from a nickel - titanium wire with a diameter of 0.5mm. The number of Z - shapes or sine waves is 9, and the vertical height of the circular support body bracket is 11mm. There is 1 connecting steel sleeve 114 on each circular main support frame 110. The two endpoints of the nickel - titanium wire are inside the connecting steel sleeve 114, and then the two endpoints of the nickel - titanium wire are fixed inside the steel sleeve by mechanical pressing or welding methods.

[0068] The second embodiment of the main support frame 110: It is a woven mesh structure or a cut - out mesh structure. This structure is also a common structure and will not be elaborated here.

[0069] The main body film 120 is made of polyester cloth or other polymer materials. The main body film 120 is straight - tube - shaped axially as a whole. The main support frame 110 is sutured to the main body film 120 through sutures 150. The main support frame 110 and the film 120 are connected by the suture method as Figure 5 shown. The suture 150 follows the waveform of the main support frame 110 along with the entire main support frame 110. The suture 150 sutures the main support frame 110 to the film 120 through several non - equally - spaced suture knots. The selectable diameter range of the suture 150 is 0.05mm - 0.25mm. In this embodiment, the diameter of the suture 150 is 0.1mm.

[0070] As Figure 6 shown, the distal inner cavity of the main body stent 101 is divided into a multi - cavity structure, that is, the inner cavity of the main body stent 101 is axially divided into a main cavity 140 and at least one sub - cavity 130 by a partition film 131. Generally, the sub - cavity 130 is independently surrounded by the partition film 131, and the cavity between the partition film 131 and the main body film 120 is the main cavity 140. This design can reduce the overall diameter of the stent in the crimped state and can reduce the diameter of the delivery system for assembling the sheath tube. The diameter of the main cavity 140 is larger than that of the sub - cavity 130, and the number of sub - cavities 130 can be set according to actual needs, generally 1 - 3. The cross - sectional shapes of the main cavity 140 and the sub - cavity 130 are circular, oval, fusiform or irregular curved surface shapes. As Figure 3 shown, in this embodiment, a circular main cavity 140 and two circular sub - cavities 130 are provided. As Figure 8aAs shown in Fig. 8a or 8b, in other embodiments, a circular main cavity 140 and one or three circular sub-cavities 130 may also be provided. A partition film may also be provided in the sub-cavity 130, and a support frame may be further fixed on the film.

[0071] As Figure 6 shown, the partition film 131 may be provided independently, or as Figure 7 shown, a support frame 132 is fixed on the wall surface of the partition film 131. The structure of the support frame 132 may be a woven mesh support frame respectively, or may be a plurality of annular corrugated support frames arranged axially respectively.

[0072] As Figure 3 、 6 -8 shown, a film for connecting and closing the inner cavity is provided between the partition film 131 and the main body film 120. That is, at least a transverse end film 180 is provided between the distal end of the main body film 120 and the partition film 131. The transverse end film 180 connects the main body film 120 and the partition film 131 together and closes the main cavity 140, that is, closes the gap between the main body stent 101 and the sub-cavity 130. The transverse end film 180 is provided at least at the distal end of the main body film 120, and may also be provided at both the proximal end and the distal end of the main body film 120. The transverse end film 180 is radially arranged or approximately radially arranged with respect to the main body film 120 and the partition film 131.

[0073] The transverse end film 180 is a structure for transverse closing. There are various implementation manners. The first implementation manner in this embodiment is: the transverse end film 180 is a planar structure perpendicular to the central axis of the main body stent 101. The transverse end film 180 is located at the distal end of the main body film 120 and is sutured to the main body film 120 by a suture method.

[0074] The main cavity opening 171 is an opening provided at the distal end of the main cavity 140 for connection. Its diameter is smaller than the diameter of the main body film, and generally larger than the diameter of the sub-cavity 130 cavity. The sub-cavity opening 172 is provided at the distal end of the sub-cavity 130. The diameter of the sub-cavity opening 172 may be smaller than the diameter of the sub-cavity 130, or may be the same as the diameter of the sub-cavity 130. In this embodiment, it is selected that the diameter of the sub-cavity opening 172 is the same as the diameter of the sub-cavity 130. The main cavity opening 171 and the sub-cavity opening 172 are formed by opening on the transverse end film 180.

[0075] In this embodiment, the main cavity opening 171 and the sub-cavity opening 172 are provided on the transverse end film 180. The main cavity opening 171 and the sub-cavity opening 172 have different positional relationships with each other. The first implementation method is that there is a gap between the axial projections of the main cavity opening 171, the sub-cavity opening 172, and the main body stent 101; the second implementation method is that at least two of the axial projections of the main cavity opening 171, the sub-cavity opening 172, and the main body stent 101 are in contact with each other without a gap; the third implementation method is that the main cavity opening 171 is simultaneously composed of the side wall of the main body stent 101 and the partition film 131. The positional relationship between the main cavity opening 171 and the sub-cavity opening 172 in the radial direction is as Figure 8 shown. The main cavity opening 171 is arranged at a position close to the main body film 120, and the sub-cavity openings 172 are concentrated on one side of the main cavity opening 171. The number of sub-cavity openings 172 is 2. In order to reduce the radial size as a whole and maintain the sizes of the main cavity opening 171 and the sub-cavity opening 172 with fixed specifications, the main cavity opening 171 and the sub-cavity opening 172 are arranged tangentially.

[0076] Axially, the main cavity opening 171 and the sub-cavity opening 172 have different implementation methods. This embodiment is the first implementation method: the main cavity opening 171, the sub-cavity opening 172, and the end face of the main body film 120 are at least flush at the distal end; in this embodiment, the main cavity opening 171 and the sub-cavity opening 172 are opened on the transverse end film 180.

[0077] At the main cavity opening 171, the cavity opening can be defined by suture, or a ring-shaped support frame can be further provided. The structure of the ring-shaped support frame can be designed to adapt to the shape of the cavity opening, such as circular, to prevent the main cavity 140 from deforming the main cavity opening 171 after being compressed. The proximal end of the sub-cavity 130 and the distal sub-cavity opening 172 can also be sutured with a suture, or a ring-shaped support, or a combination of a ring and a ring-shaped support can be used to support the sub-cavity opening 172. The partition film 131 of the circumferential sub-cavity 130 extends from the distal end, that is, the sub-cavity opening 172, to the proximal end to form a tubular structure, as Figure 7 shown. A support frame 132 can be fixedly arranged on the outer surface or the inner surface of the partition film 131. The support frame 132 is a ring-shaped support film support frame or a braided mesh support frame.

[0078] For the convenience of surgical operation, the main cavity opening 171 and the sub-cavity opening 172 are respectively provided with a developing point 122 for displaying the positions of the cavity openings of the main body film stent 100 during the operation. The developing point 122 is made of a developing material. Specifically, it is preferably that the developing point 122 is a ring-shaped developing support ring; the support ring is preferably a super-elastic material with developing performance. Or as Figure 3 shown, a plurality of developing points 122 are spaced at intervals along a radial circle.

[0079] II. Connecting the film stent:

[0080] The connecting covered stent 500 includes a connecting covering membrane 501 and a connecting support frame 502 fixed on the connecting covering membrane 501. The structure of the connecting covered stent 500 can be a stent with equal diameter as shown in Figure 9 or a non-equal-diameter stent as shown in Figures 10a - 10b Among them, a stent with equal diameter means that at different positions in the axial direction, the diameters of the connecting covered stent 500 are the same. A non-equal-diameter stent means that at different positions in the axial direction, the diameters of the connecting covered stent 500 are different. As shown in Figures 10a - 10b , the connecting covered stent 500 is a non-equal-diameter stent successively including a first tubular body 510, a second tubular body 520, and a third tubular body 530 from the proximal end to the distal end, and the diameter of the second tubular body 520 is smaller than that of the first tubular body 510 and the third tubular body 530. Transition parts 521 and 522 can also be provided between the first tubular body 510, the second tubular body 520, and the third tubular body 530.

[0081] The connecting covering membrane 501 is made of polyester cloth or other polymer materials. The connecting covering membrane 501 of the stent with equal diameter is in a straight tube shape, and the connecting covering membrane 501 of the non-equal-diameter stent is a tubular structure with different diameters in the axial direction.

[0082] The connecting support frame 502 is a high-low wave stent or an equal-height wave stent. Among them, as shown in Figure 10b , the high-low wave stent is a partially sutured stent. The connecting support frame 502 is sutured to the connecting covering membrane 501 by sutures, and the specific suture method is the same as that between the main body covering membrane 120 and the main body support frame 110.

[0083] As shown in Figure 1 , when the tubular main body covered stent 100 is combined with the connecting covered stent 500 and used, the proximal end of the connecting covered stent 500 is released into the main cavity 140 of the tubular main body covered stent 100, that is, the main cavity of the main body covered stent 100. The diameter of the main cavity opening 171 is smaller than the diameter of the proximal part of the connecting covered stent 500 after partial release. The main cavity 140 compresses the proximal part of the connecting covered stent 500, so that the tubular body of the connecting covered stent 500 fits against the wall of the main cavity 140 to prevent endoleakage.

[0084] Upon release, the delivery device is pushed along the super-elastic guide wire to push the pre-mounted main covered stent 100 to the location of the thoracic aortic dissection lesion. Positioning is performed through the imaging ring at the front end of the outer sheath tube and the imaging point 122 at the distal end of the main covered stent 100. The main covered stent 100 is released by operating the fixed handle and the sliding handle of the delivery device. Then, the tubular connecting covered stent 500 is released in the same steps, such that the proximal end of the connecting covered stent 500 is inserted into the main lumen 140 of the main covered stent 100. After expansion, the proximal end of the connecting covered stent 500 is clamped by the main lumen 140 and the main lumen orifice 171 to form a tight fit, preventing the connecting covered stent 500 from detaching from the main covered stent 100. Finally, the small woven stent is released. After release, as Figure 11 shown.

[0085] Example 2, as Figure 12 shown. This example is an improvement based on Example 1. That is, the difference lies in: the second implementation manner of the transverse end covering film 180 is that the transverse end covering film 180 includes at least one planar structure 181 and at least one inclined surface structure 182, that is, the transverse end covering film 180 is a combination of the planar structure 181 and the inclined surface structure 182. The combination manner is that the planar structure 181 and the inclined surface structure 182 are an integral structure as a whole or they are connected together to form a whole. Due to the existence of the inclined surface structure 182, at least one of the main lumen orifice 171 and the sub-lumen orifice 172 is higher or lower than the end surface of the main covered film 120.

[0086] Regarding the inclined surface structure 182, when the end surface of the main lumen 140 is higher than the end surface of the sub-lumen 130, the inclined surface structure 182 is inclined from the main lumen 140 towards the sub-lumen 130. That is, the main lumen orifice 171 is higher than the sub-lumen orifice 172. According to the different starting positions of the inclination, the inclined surface structure 182 can be inclined from the outer edge of the main lumen orifice 171 or the tangent of the outer wall surface of the extended covering film or outside the tangent towards the sub-lumen 130; the inclined surface structure can also be inclined from the intersection of the main lumen orifice 171 and the main covered film 120 towards the sub-lumen 130. As Figure 12 shown, in this example, it is inclined from the tangent of the outer edge of the main lumen orifice 171 towards the sub-lumen 130. The axially concave length of the sub-lumen orifice 172 relative to the main lumen orifice 171 is 5 mm. At the same time, the connection of the sub-lumen 130 with the main lumen 140 and the main covered film 120 is sutured inward relative to the distal end surface of the main stent 101, which can further enhance the connection stability after the branch stent is introduced. The covering film at the position of the distal end of the main covered film 120 corresponding to the sub-lumen orifice 172 can be cut into two V-shaped or U-shaped shapes. When the main stent 101 is used in cooperation with the small woven stent or the cuff stent or other branch stents, the visibility of the circumferential sub-lumen 130 is increased, which is more conducive to the accurate release of the branch stent.

[0087] The above structure can be adapted to the distal end of the main body stent 101 and is also applicable to the proximal end of the main body stent 101.

[0088] The remaining structures are the same as those in Embodiment 1 and will not be elaborated here.

[0089] Embodiment 3, as Figures 13 - 14 shown, this embodiment is an improvement based on Embodiment 2. That is, at least one of the main cavity 140 and the sub-cavity 130 extends a cylindrical extended film 190 from the transverse end film 180 in the distal direction. The axial length of the extended film 190 is 5-10 mm.

[0090] The extended film 190 can be formed by directly extending the partition film 131 in the distal direction, or can be formed by extending from an opening provided on the transverse end film 180 corresponding to the main cavity 140 in the distal direction. The end face of the extended film 190 forms the main cavity orifice 171, and the main cavity orifice 171 is higher than, lower than, or flush with the end face of the main body film 120; the end face of the extended film forms the sub-cavity orifice 172, and the sub-cavity orifice 172 is higher than, lower than, or flush with the end face of the main body film 120. Another is that the distal opening of the extended film 190 is the main cavity orifice 171. The sub-cavity orifice 172 is the distal opening of the extended film. As Figure 13 shown, the main cavity 140 and the sub-cavity 130 are respectively provided with the extended film 190.

[0091] The extended film 190 can be provided separately, or as Figure 14 shown, an extended support frame 191 for supporting the extended film 190 is provided on the inner wall or the outer wall of the extended film 190. The extended support frame 191 is a corrugated support frame or a braided support frame.

[0092] When the multi-cavity film stent is used in combination with a branch stent, the extended film 190 can further improve the connection stability between the main cavity 140 and the branch stent.

[0093] The remaining structures are the same as those in Embodiment 2 and will not be elaborated here.

[0094] Embodiment 4, as Figures 15a - 15b shown, this embodiment is an improvement based on Embodiment 2 or 3. The improvement lies in: the transverse end film 180 is a third implementation manner: the transverse end film 180 is an inclined plane structure that is not perpendicular to the central axis of the main body stent 101; the inclined plane structure is inclined from the intersection of the main cavity orifice 171 and the main body film 120 towards the sub-cavity 130. The main cavity orifice is composed of the side wall of the main body stent 101 and the partition film 131 at the same time, that is, the main cavity orifice 171 is a structure jointly formed by the partition film 131 and the main body film 120, and this structure is in the shape of a spindle, or an oblate circle, or a semi-circle, etc.

[0095] The proximal and distal ends of the main body membrane 120 may also be provided with a bare stent 121. The structure of the bare stent 121 is a corrugated support frame, which is fixed on the main body membrane 120 by suture.

[0096] Figure 15b shows the corresponding relationship between the main body membrane stent 100 and the connecting membrane stent 500. The proximal end of the connecting membrane stent 500 corresponds to the main cavity 140 of the main body membrane stent 100, and the insertion position is at the position of the second tubular body 520 of the connecting membrane stent 500.

[0097] The remaining structures are the same as those in Embodiment 2 or 3, and will not be described in detail here.

[0098] Embodiment 5, as Figures 16 - 17 shown, this embodiment is an improvement based on Embodiments 1-4. The improvement lies in that the connecting membrane stent 500 is provided with a window 550 with an embedded small branch. Specifically, the window 550 is opened on the connecting membrane 501, and there is no fixed connecting support frame 502 at the position corresponding to the window 550.

[0099] As Figure 16 shown, for the equal-diameter stent, a window 550 with an embedded small branch is opened on the side wall of the equal-diameter stent; when the main body membrane stent 100 is inserted into the connecting membrane stent 500, the window 550 with the embedded small branch is arranged close to the sub-cavity 130 of the main body membrane stent 100, see Figure 17 . The position of the window 550 is located at the position of 1 / 3 - 2 / 3 from the proximal end of the tubular connecting membrane stent 500. When the tubular connecting membrane stent 500 is assembled to the aortic arch, the window 550 can establish a channel with the innominate artery.

[0100] As Figures 18 - 19 shown, for the non-equal-diameter stent, a window 550 with an embedded small branch is opened on the second tubular body 520. When the main body membrane stent 100 is inserted into the connecting membrane stent 500, the window 550 with the embedded small branch is arranged close to the sub-cavity 130 of the main body membrane stent 100. A window 550 with an embedded small branch can also be opened at the transition part arranged between the second tubular body 520 and the third tubular body 530.

[0101] As Figure 19 shown, in this embodiment, the connecting membrane stent 500 and the main stent 101 in the main body membrane stent 100 are combined together. The two sub-cavities 130 in the main body membrane stent 100 are respectively connected to the small braided stent 600 or other CUFF stents to establish a channel between the left subclavian artery and the left common carotid artery. The window 550 of the tubular connecting membrane stent 500 is joined with the innominate artery to establish an innominate artery channel.

[0102] As Figure 19As shown, when the proximal part of the covered bridging stent 500 is released within the main lumen 140 of the main stent 101, the position of the window 550 should be on the same side as the sub-lumen 130 of the main stent 101, facilitating the establishment of an innominate artery channel by embedding a small branch and connecting a small woven stent within the window 550.

[0103] In another embodiment, as Figure 20 shown, it is also possible to select a tubular covered bridging stent 500 with a fenestration and an embedded branch for combined use with a suitable main covered stent 100. During use, the tubular covered bridging stent 500 can be released within the main lumen 140 of the main covered stent 100. The distal mating position of the branched tubular covered bridging stent 500 and the main lumen 140 of the main covered stent 100 is the first tubular body 510 or the transition section between the first tubular body 510 and the second tubular body 520. The diameter of the main lumen 140 is smaller than the diameter of the first tubular body 510 of the branched tubular covered bridging stent 500. The main lumen 140 compresses the first tubular body 510, and the first tubular body 510 fits against the wall of the main lumen 140 to prevent endoleakage.

[0104] During release, the delivery device is pushed along the ultra-stiff guide wire to push the pre-mounted main covered stent 100 to the location of the thoracic aortic dissection lesion. Positioning is performed through the imaging ring at the front end of the outer sheath tube and the imaging point 122 at the distal end of the main covered stent 100. The main covered stent 100 is released by operating the fixed handle and the sliding handle of the delivery device. Then, the tubular covered bridging stent 500 is released in the same steps, such that the proximal end of the covered bridging stent 500 is inserted into the main lumen 140 of the main covered stent 100. After inflation, the proximal end of the covered bridging stent 500 is clamped tightly by the main lumen 140 and the main lumen orifice 171 to form a tight fit, preventing the covered bridging stent 500 from detaching from the main covered stent 100. Finally, the small woven stent is released. After release, as Figure 20 shown.

[0105] The diameter of the second tubular body 520 of the covered bridging stent 500 is smaller than that of the first tubular body 510. When assembling small woven branch stents in the two sub-lumens 130 of the main covered stent 100, the position of the second tubular body 520 of the covered bridging stent 500 can provide sufficient space to avoid stent stacking.

[0106] In this embodiment, the two sub-lumens 130 of the main covered stent 100 are respectively connected to small woven stents or other CUFF stents to establish a left subclavian artery and left common carotid artery channel. The fenestration part of the branched tubular covered bridging stent 500 is connected to a small woven stent to establish an innominate artery channel.

[0107] It is possible to select a suitable main covered stent 100 and a combination of covered bridging stents for combined use according to the specific conditions of the opening positions of the three branches on the aortic arch of the patient, the inner diameters of the branches, and the angles formed by the branch vessels and the aortic arch.

[0108] The remaining structures are the same as those in Embodiments 1-4, and will not be elaborated here.

[0109] Embodiment 6, as Figure 21 shown, this embodiment is an improvement based on Embodiments 1-5. The improvement lies in that: a support rod 560 is axially fixed to the outer wall of the connecting film 501. The support rod 560 is arranged on the connecting film 501 on the side close to the sub-chamber 130.

[0110] There is at least one fixing point 561 between the support rod 560 and the connecting film 501 for fixedly connecting the two together.

[0111] The remaining structures are the same as those in Embodiments 1-5, and will not be elaborated here.

Claims

1. A multi-chamber covered stent, characterized in that, It includes a tubular main body covered stent and a tubular connecting covered stent; The main body covered stent includes a tubular main body stent, the main body stent includes a tubular main body covering film, and a main body support frame fixed on the wall surface of the main body covering film. A main cavity and at least one sub-cavity are axially separated in the main body stent by a separating covering film. The sub-cavity is independently surrounded by the separating covering film. The cavity between the separating covering film and the main body covering film is the main cavity. A main cavity opening is provided at the distal end of the main cavity; At least a transverse end covering film is provided between the distal end of the main body covering film and the separating covering film. The transverse end covering film connects the main body covering film and the separating covering film together and closes the main cavity. The main cavity opening is opened on the transverse end covering film; In the released state, the proximal end of the connecting covered stent is inserted and tightly fitted with the main cavity at the distal end of the tubular main body covered stent; wherein, the diameter of the main cavity opening is smaller than the diameter of the proximal part of the connecting covered stent after release. The main cavity compresses and connects the proximal part of the covered stent, so that the tubular body of the connecting covered stent fits against the wall of the main cavity. The proximal end of the connecting covered stent is clamped by the main cavity and the main cavity opening to form a tight fit; The transverse end covering film includes at least one planar structure and at least one inclined surface structure. The planar structure and the inclined surface structure are an integral structure as a whole or are connected together to form a whole.

2. The multi-chamber covered stent according to claim 1, wherein The connecting covered stent is a non-uniform diameter stent or a uniform diameter stent.

3. The multi-lumen covered stent according to claim 2, wherein The connecting covered stent is a non-uniform diameter stent composed of a first tubular body, a second tubular body, and a third tubular body in sequence from the proximal end to the distal end. The diameter of the second tubular body is smaller than the diameters of the first tubular body and the third tubular body.

4. The multi-chamber covered stent according to claim 3, wherein The connecting covered stent is a uniform diameter stent. Windows with embedded small branches are opened on the side wall of the uniform diameter stent; when the main body covered stent is inserted into the connecting covered stent, the windows with embedded small branches are arranged close to the sub-cavity of the main body covered stent; Or the connecting covered stent is a non-uniform diameter stent. Windows with embedded small branches are opened on the second tubular body of the non-uniform diameter stent or on the transition part between the second tubular body and the third tubular body; when the main body covered stent is inserted into the connecting covered stent, the windows with embedded small branches are arranged close to the sub-cavity of the main body covered stent.

5. The multi-chamber covered stent according to claim 1, wherein The connecting covered stent includes a connecting covering film and a connecting support frame fixed on the connecting covering film.

6. The multi-chamber covered stent according to claim 5, wherein, The connecting support frame is a high-low wave stent or an equal-height wave stent, and the high-low wave stent is a partially sutured stent.

7. The multi-lumen covered stent according to claim 5, wherein Support rods are axially fixed on the outer wall of the connecting covering film.

8. The multi-lumen covered stent according to claim 7, wherein The support rods are arranged on the connecting covering film close to the side of the sub-cavity.

9. The multi-lumen covered stent according to claim 7, wherein, There is at least one fixing point between the support rods and the connecting covering film for fixedly connecting the two together.

10. The multi-lumen covered stent according to claim 1, characterized in that, Axially, the main cavity opening, the sub-cavity opening, and the end face of the main body covering film are at least flush at the distal end; Or at least one of the main cavity opening and the sub-cavity opening is higher or lower than the end face of the main body covering film.

11. The multi-chamber covered stent according to claim 10, characterized in that, At least one of the main cavity and the sub-cavity extends distally from the transverse end covering film with a tubular extended covering film; The end face of the extended covering film forms a main cavity opening, and this main cavity opening is higher than, lower than, or flush with the end face of the main body covering film; Or / and the end face of the extended film coating forms an orifice of the sub-cavity, and the orifice of the sub-cavity is higher than, lower than or flush with the end face of the main body film coating.

12. The multi-lumen covered stent according to claim 11, wherein An extended support frame for supporting the extended film coating is provided on the inner wall or the outer wall of the extended film coating.

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