Implanted stents and implanted prostheses

Abstract

The present application discloses an implantable stent and an implantable prosthesis. The implantable stent includes a connecting membrane, the connecting membrane forming a tubular connecting cavity; a plurality of supporting skeletons in a wavy ring structure, fixed to the wall surface of the connecting membrane and arranged along the axial direction of the connecting membrane; a fenestration structure, provided on the connecting membrane, the fenestration structure being connected to the connecting cavity; at least part of the fenestration structure being integrally provided with at least one supporting skeleton, ensuring that each supporting skeleton on the connecting membrane is an independent closed-loop structure, which is beneficial to improving the radial supporting force of the fenestration structure. When calcification or dissection occurs in the blood vessel and squeezes the implantable stent, the radial supporting force formed by each supporting skeleton being an independent closed-loop structure can slow down the squeezing of the implantable stent by the calcified area or the dissection area, resulting in a reduction in the radial size of the implantable stent or even occlusion, thereby helping to reduce the blood flow loss caused by squeezing of the implantable stent.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an implantable stent and an implantable prosthesis. Background Art

[0002] Aortic arch diseases include aneurysms, pseudoaneurysms, aortic dissection, aortic ulcers, and intramural hematomas. Treatment options for aortic arch diseases include surgery, hybrid surgery, and endovascular techniques.

[0003] The aortic arch has a complex anatomy, with its main vessels curved and providing the main blood supply to the head, internal organs, and lower limbs. The diameters of its branches vary significantly between individuals, as do the spacing between them. The challenge of endovascular interventional therapy lies in isolating the aortic arch disease while ensuring the patency of its branches. Prolonged ischemia of the brain can be fatal. Currently, existing endovascular products are difficult to implement, primarily resorting to surgery (total arch replacement). However, total arch replacement surgery is difficult and invasive, requiring deep hypothermia and extracorporeal circulation, and is associated with numerous postoperative complications. Some current techniques for reconstructing double-endovascular branches (i.e., at least two branches) require bypass surgery or resection of one of the branches. This is relatively invasive, time-consuming, and prone to long-term complications such as stenosis or occlusion of the graft, or cerebral ischemia. Among patients who undergo a bypass graft between the left common carotid artery and the left subclavian artery, 25% experience phrenic nerve palsy as a complication, so three-branch endovascular surgery has advantages.

[0004] Current technology primarily deploys a main stent in the aorta, inserting branch stents into the fenestrations within the main stent. This allows the main stent to isolate the aortic lesion while simultaneously reconstructing the important branch vessels. However, after branch vessel reconstruction, blood flow loss in the aorta and / or its branches is a common problem. Summary of the Invention

[0005] The present application provides an implant stent and an implant prosthesis that can reduce blood flux loss in blood vessels, so as to solve the problem of blood flux loss that is prone to occur in blood vessels during implant treatment.

[0006] In a first aspect, an embodiment of the present application provides an implantable stent, comprising:

[0007] A connecting bracket, the connecting bracket enclosing a tubular connecting cavity; the connecting bracket includes a connecting membrane and a plurality of annular support frames, the plurality of support frames being fixed to the wall surface of the connecting membrane and arranged along the axial direction of the connecting membrane, each support frame being an integrally formed independent closed loop structure;

[0008] a window structure, provided on the connecting film, the window structure being in communication with the connecting cavity;

[0009] At least part of the window structure is integrally arranged with at least one of the supporting frames.

[0010] In a second aspect, an embodiment of the present application provides an implant prosthesis, comprising a main body support and the implant support as described above, wherein the main body support forms a main body cavity, and the implant support is inserted into the main body cavity.

[0011] The implant stent and implant prosthesis provided by the present application, since at least part of the fenestration structure is integrally arranged with at least one of the supporting skeletons, ensures that each supporting skeleton on the connecting membrane is an independent closed-loop structure, which is beneficial to greatly improve the radial supporting force of the fenestration structure. When calcification or dissection occurs in the blood vessel and squeezes the implant stent, the radial supporting force formed by each supporting skeleton being an independent closed-loop structure can slow down the squeezing of the calcified area or the dissection area on the implant stent, resulting in a reduction in the radial size of the implant stent or even occlusion, thereby helping to reduce the blood flux loss caused by the squeezing of the implant stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the implementation methods of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the implementation methods or the description of the prior art. Obviously, the drawings described below are only some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0013] Figure 1 A three-dimensional schematic diagram of an implant prosthesis provided in the first embodiment of the present application;

[0014] Figure 2 A three-dimensional schematic diagram of removing the implant stent for implanting a prosthesis;

[0015] Figure 3a for Figure 2 A three-dimensional schematic diagram from another perspective;

[0016] Figure 3b Schematic diagram of the angle B formed by the surface PL where the sealing film is located and the central axis AX of the main support;

[0017] Figure 4 A side view of an implant stent provided in one embodiment of the present application;

[0018] Figure 5 for Figure 4 A cross-sectional view of the implanted stent along line AA is shown;

[0019] Figure 6 Schematic diagram of the deployment of the implanted stent;

[0020] Figure 7a for Figure 6 An enlarged schematic diagram of the region A where the stent is implanted;

[0021] Figure 7b The first part of the second skeleton and the window structure are connected along the central axis of the film. Figure 6 Schematic diagram of projection on the projection surface PP shown;

[0022] Figure 8a for Figure 4 A three-dimensional schematic diagram of the implanted stent is shown;

[0023] Figure 8b for Figure 8a An enlarged schematic diagram of the region B where the stent is implanted is shown;

[0024] Figure 9a is a three-dimensional schematic diagram of the embedded branches of the implanted stent;

[0025] Figure 9b for Figure 9a A perspective schematic diagram of another perspective of the embedded branch shown;

[0026] Figure 10 Schematic diagram of the scenario of implanting a stent for left subclavian artery reconstruction of the aortic arch;

[0027] Figure 11 Schematic diagram of the scenario of implanting a stent for renal artery reconstruction of the abdominal aorta;

[0028] Figure 12 Schematic diagram of the scenario of implanting a prosthesis to reconstruct the three branch vessels of the aortic arch;

[0029] Figure 13 Schematic diagram of the scene of implanting a prosthesis to reconstruct two branch blood vessels of the aortic arch

[0030] Figure 14 A schematic diagram of a planar expansion of an implant stent provided in the second embodiment of the present application;

[0031] Figure 15 for Figure 8a Schematic diagram of a possible implementation method of an oblique proximal port of an embedded branch in an implanted stent;

[0032] Figure 16 for Figure 15 Schematic diagram of the structure of the embedded branches in ;

[0033] Figure 17A schematic diagram of a possible implementation of the angles between the surface where the proximal end of the embedded branch is located, the surface where the distal end of the embedded branch is located, and the central axis of the embedded branch;

[0034] Figure 18 Schematic diagram of another possible implementation of the angle between the plane where the proximal end of the embedded branch is located, the plane where the distal end of the embedded branch is located, and the central axis of the embedded branch.

[0035] Explanation of the reference numerals: 1000, implant prosthesis; 100, implant stent; 50, fenestration structure; 52, first fenestration portion; 54, second fenestration portion; 56, annular member; 70, embedded branch; 72, branch coating; 726, slit; 720, connecting cavity; 722, proximal port; 724, distal port; 74, transition coating; 76, support ring; 77, positioning ring; 78, suture stitch; 20, connecting coating; 22, connecting cavity; 30, supporting skeleton; 31, supporting rod; 31a, wave crest; 312a, high wave; 314a, low wave; 31b, wave trough; 32, proximal supporting skeleton; 34, distal supporting skeleton; 36, first skeleton; 38, second skeleton; 382, ​​first part; 384, second part; 40, first supporting portion; 42, second supporting portion part; 420, anchoring hook; 44, third supporting skeleton; 200, main support; 201, main covering; 203, main supporting structure; 205, main cavity channel; 210, main cavity; 300, root opening; 400, separation support; 410, separation cavity; 401, separation covering; 4012, proximal opening; 4014, distal opening; 403, separation supporting structure; 404, separation positioning structure; 405, developing mark; 500, sealing covering; 501, main cavity opening; 503, sub-cavity opening; 700, leak-proof frame; 800, positioning rod; 2000, branch stent; 3000, aortic arch; 3001, left subclavian artery; 3002, left common carotid artery; 3003, brachiocephalic artery; 4000, abdominal aorta; 4001, renal artery. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0037] For implanted stents, the proximal end refers to the end of the implanted stent that is close to the human heart after the implanted stent is used for implantation treatment, and the distal end refers to the end of the implanted stent that is away from the human heart after the implanted stent is used for implantation treatment. The direction of the central axis of rotation of objects such as cylinders and tubes is defined as axial, and the direction perpendicular to the axial is defined as radial. Circumferential refers to the "circumferential direction", that is, the direction around the axis of the cylinder, tube, etc. (perpendicular to the axis and perpendicular to the cross-sectional radius). "Circumferential", "axial" and "radial" together constitute the three orthogonal directions of cylindrical coordinates. Circumferential length refers to the extension length of a structure or element along the circumferential direction of a cylinder, tube, etc. Axial length refers to the extension length of a structure or element along the axial direction of a cylinder, tube, etc. These definitions are only for convenience of expression and do not constitute a limitation to this application.

[0038] See also Figure 1 The first embodiment of the present application provides an implantable prosthesis 1000 that can be used in a lumen to perform intraluminal isolation to isolate a diseased area within the lumen. For example, the implantable prosthesis 1000 can be used to isolate an arterial dissection or aneurysm within the lumen of a blood vessel. It is understood that the blood vessel can be the aortic arch, thoracic aorta, or abdominal aorta. Those skilled in the art will appreciate that the use of a blood vessel for illustration is merely illustrative and does not limit the present application. The present invention is applicable to various human or animal lumens, such as the lumen of the digestive tract.

[0039] Please refer to Figure 2 and Figure 3a The implant prosthesis 1000 includes an implant stent 100, a main stent 200 and at least one spacer stent 400. The main stent 200 forms a tubular main cavity 210 for accommodating the spacer stent 400 and the implant stent 100. The spacer stent 400 is arranged in the main cavity 210. The spacer stent 400 forms a tubular spacer cavity 410 for inserting the branch stent so that the implant prosthesis 1000 and the branch stent can be used in conjunction with each other, thereby reconstructing the branch blood vessel through the branch stent. The outer wall of the spacer stent 400 and the inner wall of the main stent 200 form a main cavity channel 205, and the main cavity channel 205 is used to insert the implant stent 100. The implant stent 100 is inserted into the main cavity channel 205.

[0040] The implant bracket 100 is inserted into the main cavity channel 205, including the following possible implementation methods: the implant bracket 100 can be inserted into the openings at both ends along the axial direction of the main cavity channel 205; or the side wall of the main bracket 200 can be provided with a socket, and the implant bracket 100 can be inserted into the main cavity channel 205 from the socket on the side wall of the main bracket 200; or the outer side wall of the main bracket 200 can be provided with an embedded branch (not shown in the figure), and the implant bracket 100 is connected to the main cavity channel 205 through the embedded branch, etc.

[0041] Blood vessels include main vessels and branch vessels. When implant prosthesis 1000 is implanted in a blood vessel, main stent 200 and implant stent 100 are positioned within the main vessel, enabling stent 100 to communicate with the main vessel, while branch stents inserted within partition lumen 410 can communicate with corresponding branch vessels. For example, when implant prosthesis 1000 is used to reconstruct an aortic arch, main stent 200 and implant stent 100 are positioned within the main vessel of the aortic arch, while branch stents inserted within partition lumen 410 can communicate with corresponding branch vessels of the aortic arch.

[0042] In this embodiment, the main stent 200 is a tubular structure with two open ends. It has radial expansion capability, meaning it can be compressed by an external force and then, upon removal of the external force, expands itself or mechanically to return to its original shape and maintain its original shape. Thus, after implantation into a blood vessel, the main stent 200 adheres to the vessel wall through its radial support force.

[0043] The main stent 200 includes a tubular main covering 201 and a main support structure 203 provided on the main covering 201. The main covering 201 encloses a main cavity 210. The main support structure 203 is used to provide radial support force for the main stent 200. The main support structure 203 can shrink or expand along the radial direction of the main covering 201. The main support structure 203 can be a wavy ring, a mesh structure formed by weaving metal wires, or a cut mesh structure formed by cutting a metal tube. The present application does not limit the structure of the main support structure 203.

[0044] The spacer stent 400 has radial expansion capability and can be compressed under external force and then self-expand or recover to its original shape through mechanical expansion and maintain its original shape after the external force is removed. Thus, after being implanted into a blood vessel, the spacer stent can adhere to the blood vessel wall through its radial support force.

[0045] The separator bracket 400 includes a separator membrane 401 and a separator support structure 403 fixed to the separator membrane 401. The separator support structure 403 can be a plurality of wavy rings arranged along the axial direction of the separator membrane 401, a mesh structure formed by weaving metal wires, or a cut mesh structure formed by cutting a metal tube. The present application does not limit the structure of the separator support structure 403.

[0046] The separating membrane 401 is fixed to the main body membrane 201 and is located within the main body cavity 210. The separating membrane 401 encloses a tubular separating cavity 410. The outer wall of the separating membrane 401 and the inner wall of the main body cavity 210 together form the main cavity channel 205. The separating membrane 401 includes a proximal opening 4012 and a distal opening 4014, which are arranged in opposite directions along the axial direction of the separating membrane 401. The surface where the proximal opening 4012 is located is tilted, that is, the angle formed between the central axis of the separator bracket 400 and the surface where the proximal opening 4012 is located is not a right angle; the surface where the distal opening 4014 is located is tilted, that is, the angle formed between the central axis of the separator bracket 400 and the surface where the distal opening 4014 is located is not a right angle; that is, the proximal opening 4012 and the distal opening 4014 of the separator bracket 400 are both obliquely designed, which is beneficial to avoid stress concentration at the proximal opening 4012 and the distal opening 4014 of the separator bracket 400, which is not conducive to radial contraction transportation, and also facilitates the branch bracket to enter the separator bracket 400.

[0047] It can be understood that in other embodiments, the angle formed between the central axis of the separator bracket 400 and the surface where the proximal opening 4012 is located can be a right angle, and the angle formed between the central axis of the separator bracket 400 and the surface where the distal opening 4014 is located can be a right angle, that is, the proximal opening 4012 and the distal opening 4014 can both be flat-opening designs.

[0048] Both the proximal opening 4012 and the distal opening 4014 may be provided with an annular separation and positioning structure 404. The separation and positioning structure 404 can contract or expand radially along the separation membrane 401. The separation and positioning structure 404 may be an annular structure adapted to fit between the proximal opening 4012 and the distal opening 4014, thereby preventing wrinkles at the proximal opening 4012 and the distal opening 4014. The separation and positioning structure 404 contacts the outer surface of the branch stent, thereby improving the sealing of the branch stent after insertion into the separation stent 400, thereby preventing internal leakage.

[0049] The spacer support 400 may further include a radiopaque marker 405 disposed on the spacer positioning structure 404 to indicate the location of the spacer support 400. In this embodiment, the radiopaque marker 405 may be a ring-shaped structure disposed around the spacer positioning structure 404. In other embodiments, the spacer positioning structure 404 may comprise a radiopaque material. The radiopaque marker 405 and the radiopaque material in the spacer positioning structure 404 may be made of a material with excellent X-ray opacity, strong corrosion resistance, and good biocompatibility, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, or alloys of at least two of these materials.

[0050] The implant prosthesis 1000 also includes a sealing coating 500, which is located in the main cavity 210 and is fixed to the distal end of the main support 200. A gap is provided between one side of the sealing coating 500 and the main coating 201, so that the inner wall of the sealing coating 500 and the main coating 201 forms a main cavity opening 501. The main cavity opening 501 is connected to the main cavity channel 205 for the insertion of the implant support 100. The diameter of the main cavity opening 501 is smaller than the diameter of the implant support 100. In the released state, the implant support 100 is tightly plugged into the main cavity opening 501 to connect the implant support 100 and the main support 200. The implant support 100 and the sealing coating 500 fit tightly together, which helps to reduce the possibility of internal leakage.

[0051] At least one sub-cavity opening 503 can also be provided on the sealing film 500. The branch stent can be inserted into the separation cavity 410 through the sub-cavity opening 503. One separation stent 400 corresponds to one sub-cavity opening 503, that is, the number of sub-cavity openings 503 is the same as the number of separation stents 400. In this embodiment, the number of separation stents 400 is two. The sealing film 500 is sealed and fixed to the distal end opening 4014 of the separation stent 400 through the sub-cavity opening 503, so that the sub-cavity opening 503 is connected to the separation cavity 410 in the corresponding separation film 401. Please refer to Figure 3b The angle B between the surface PL of the sealing film 500 and the central axis AX of the main support 200 is not a right angle, that is, the angle B formed by the surface PL of the sealing film 500 and the central axis AX of the main support 200 is an acute angle or an obtuse angle.

[0052] In some embodiments, the angle B formed between the surface PL of the sealing coating 500 and the central axis AX of the main stent 200 is an acute angle. The sealing coating 500 is tilted relative to the central axis of the main stent 200 to facilitate the insertion and mating of the branch stent with the separator stent 400 through the sub-cavity 503 and the distal opening 4014 of the separator coating 401, thereby improving positioning accuracy. In other embodiments, the surface PL of the sealing coating 500 can form a right angle with the central axis AX of the main stent 200, that is, the surface PL of the sealing coating 500 is perpendicular to the central axis AX of the main stent 200.

[0053] The implant prosthesis 1000 further includes a leak-proof frame 700 (e.g., Figure 2 and Figure 3aAs shown). The distal end surface of the leak-proof frame 700 is fixed to the sealing film 500, and the proximal end edge of the leak-proof frame 700 is sealed to the periphery of the proximal opening 4012 of the corresponding separation film 401 and the main body film 201. When the implant stent 100 is inserted into the main cavity opening 501, the edge of the main cavity opening 501 of the sealing film 500 can be tightly attached to the outer surface of the main body stent 200, and the leak-proof frame 700 can also be tightly attached to the outer surface of the main body stent 200, so that the distal and proximal ends of the implant prosthesis 1000 can be tightly attached to the outer surface of the implant stent 100 inserted into the main cavity opening 501, which can further effectively prevent internal leakage. In other embodiments, if there are multiple separation stents 400, the multiple separation stents 400 are regarded as an integral separation stent, and the number of leak-proof frames 700 can still be set to two, and the two leak-proof frames 700 are respectively located on both sides of the integral separation stent 400.

[0054] The implant prosthesis 1000 further includes a positioning rod 800 (eg, a positioning rod 800) disposed on one side of the sealing membrane 500 close to the main cavity opening 501. Figure 2 and Figure 3a As shown in the figure, the positioning rod 800 is used to position the implant stent 100 when the implant stent 100 is inserted into the main cavity channel 205. Rings can also be provided at both ends of the positioning rod 800 (not shown). A developing mark (not shown) can also be provided on the positioning rod 800 to indicate the position of the positioning rod 800, so as to facilitate the insertion and matching of the implant stent 100 with the main cavity channel 205. The two ends of the positioning rod 800 are respectively fixed to the main stent 200 (the main coating 201 or the main support structure 203). In the released state, when the implant stent 100 is plugged into the main cavity opening 501, the positioning rod 800 can be tightly attached to the outer surface of the implant stent 100, so that the sealing film 500 is tightly fitted to the outer surface of the implant stent 100, which is beneficial to prevent the occurrence of internal leakage, and also facilitates the insertion of the implant stent 100 into the main cavity opening 501, increases the compatibility of the implant stent 100 and the implant prosthesis 1000, and makes the implant stent 100 and the main stent 200 more stably connected.

[0055] It can be understood that in other embodiments of the present application, the sealing film 500, the leak-proof frame 700 and the positioning rod 800 can be omitted, the partition bracket 400 encloses the partition cavity 410, the partition bracket 400 and the inner wall of the main bracket 200 form the main cavity channel 205, and the implant bracket 100 is inserted into the main cavity channel 205.

[0056] It can be understood that in other embodiments of the present application, the separation bracket 400, the sealing film 500, the leak-proof frame 700 and the positioning rod 800 can be omitted, the main bracket 200 encloses the main cavity 210, and the implant bracket 100 is inserted into the main cavity 210.

[0057] The implant stent 100 is a straight tube or a tapered structure. Figure 4 and Figure 5 , taking the implant stent as a straight tubular structure as an example. The implant stent 100 includes a connecting stent, a fenestration structure 50, an embedded branch 70 and a transition coating 74. The connecting stent forms a tubular connecting cavity 22. The embedded branch 70 forms a tubular communicating cavity 720, the embedded branch 70 is fixed on the connecting stent and accommodated in the connecting cavity 22, and the communicating cavity 720 is communicated with the connecting cavity 22. The fenestration structure 50 is provided on the connecting stent, and the transition coating 74 is sealed and connected to one end of the embedded branch 70, and the transition coating 74 is sealed and connected to the fenestration structure 50, and the fenestration structure 50 is communicated with the communicating cavity 720. The fenestration structure 50 is used to be plugged in with the branch stent for reconstructing the branch blood vessel so that the branch stent is communicated with the connecting cavity 22 through the communicating cavity 720. When the implant stent 100 is inserted into the main cavity channel 205, the connecting cavity 22 and the main cavity channel 205 (such as Figure 2 shown) are connected.

[0058] This embodiment illustrates an example in which the transition coating 74 is sealed to the proximal end of the embedded branch 70. It is understood that, depending on the location of the embedded branch 70, the transition coating 74 may also be sealed to the distal end of the embedded branch 70, for example, when the embedded branch 70 is located proximal to the fenestration structure 50.

[0059] The axial extension direction of the embedded branch 70 is the same as the axial extension direction of the implanted stent 100, which can also be understood as the axial extension direction of the embedded branch 70 being the same as the axial extension direction of the connected stent, that is, the central axis of the embedded branch 70 is parallel to the central axis of the implanted stent 100. In other embodiments, the embedded branch 70 is arranged at an angle, that is, the central axis of the embedded branch 70 and the central axis of the implanted stent 100 can form an angle.

[0060] The connecting stent includes a connecting coating 20 and a plurality of supporting skeletons 30. The connecting cavity 22 is surrounded by the connecting coating 20. The plurality of supporting skeletons 30 are fixed on the wall surface of the connecting coating 20 and arranged at intervals along the axial direction of the connecting coating 20. Each supporting skeleton 30 is an independent closed-loop structure formed in one piece, that is, each supporting skeleton 30 does not rely on the window structure 50 to form a closed-loop structure. In other words, the setting of the window structure 50 does not destroy the closed-loop independence of each supporting skeleton 30. Each supporting skeleton 30 includes a plurality of supporting rods 31 connected in sequence at an angle, and the two adjacent angles along the circumference of the connecting coating 20 are the crest 31a and the trough 31b. The crest 31a is closer to the proximal end of the connecting coating 20 than the trough 31b. In this embodiment, the crest 31a and the trough 31b are provided with rounded corners, which is beneficial to reduce the risk of damage to the implanted stent 100 during radial contraction.

[0061] Please refer to Figure 6 , the embedded branch 70 includes a proximal port 722 and a distal port 724 that are relatively arranged along the axial direction of the embedded branch 70. Along the circumference of the connecting bracket, the circumferential length of the fenestration structure 50 is greater than the maximum circumferential length of at least one port of the embedded branch 70. The circumferential length of the fenestration structure 50 along the connecting bracket is greater than the circumferential length of the proximal port 722 of the embedded branch 70 along the connecting bracket. The circumferential length L1 of the fenestration structure 50 on the connecting coating 20 is 20% to 40% of the circumferential length of the connecting bracket. Along the axial direction of the connecting bracket, the axial length of the window structure 50 is greater than the maximum axial length of at least one port of the embedded branch 70. The axial length of the fenestration structure 50 along the connecting bracket is at least 40% of the circumferential length of the fenestration structure 50 along the connecting bracket.

[0062] The circumferential length L1 of the window structure 50 is 25 mm to 35 mm, and the axial length of the window structure 50 along the connection film 20 is in the range of 15 mm to 25 mm.

[0063] In some embodiments, the circumferential length L1 of the fenestration structure 50 is 28 to 32 mm, and the axial length L2 of the fenestration structure 50 along the connection film 20 is 18 to 22 mm. In this embodiment, the circumferential length L1 of the fenestration structure 50 is 30 mm, and the axial length L2 of the fenestration structure 50 along the connection film 20 is 20 mm.

[0064] The axial length of the fenestration structure 50 along the connecting stent is at least 40% of the circumferential length of the fenestration structure 50 along the connecting stent, and the circumferential length L1 of the fenestration structure 50 on the connecting coating 20 is 20% to 40% of the circumferential length of the connecting stent, so that the caliber of the fenestration structure 50 on the connecting stent is larger, and the size of the fenestration structure 50 is larger than the root opening 300 of the target branch vessel (the root opening 300 can refer to Figure 11-14 ), even if the proximal port 722 of the embedded branch 70 is difficult to be completely aligned with the root opening 300 of the target branch vessel (complete alignment means that the central axis of the embedded branch 70 coincides with the central axis of the root opening 300 of the target branch vessel), the larger fenestration structure 50 can also ensure that the root opening 300 of the branch vessel is covered, thereby improving the fault tolerance of the implanted stent 100 in the process of reconstructing the branch vessel, improving the positioning accuracy of the fenestration structure 50 on the target branch vessel, facilitating the assembly of the branch stent in the embedded branch 70 without affecting the radial compression size of the implanted stent 100, and greatly reducing the operator's operation difficulty and operation time.

[0065] Based on the axial position of the support frame 30 relative to the connection coating 20, the support frame 30 includes a proximal support frame 32, a distal support frame 34, a first frame 36, a second frame 38, a first support portion 40, and a second support portion 42. The first frame 36 and the second frame 38 are axially adjacent to each other. The first frame 36 is further away from the proximal end of the connection stent than the second frame 38. The fenestration structure 50 is disposed near the first frame 36 and the second frame 38.

[0066] The distal support frame 32 is located distally of the first frame 36. The first frame 36 and the distal support frame 34 are arranged adjacent to each other axially along the connection coating 20. The first support portion 40 is located distally of the distal support frame 34. The proximal support frame 32 is located proximally of the second frame 38. The second frame 38 and the proximal support frame 32 are arranged adjacent to each other axially along the connection coating 20. The second support portion 42 is located proximally of the proximal support frame 32. The maximum axial length of the fenestration structure 50 on the connection coating 20 is less than or equal to the maximum axial length between the proximal support frame 32 and the distal support frame 34. This increases the axial extension length of the fenestration structure 50 on the connection coating 20. In other words, the fenestration structure 50 is larger in both the circumferential and axial dimensions, thereby making the size of the fenestration structure 50 larger than the root opening 300 of the branch vessel, further improving the positioning accuracy and error tolerance of the fenestration structure 50 with respect to the branch vessel.

[0067] In the embodiment of the present application, the first support portion 40 adopts an isotropic wave setting, that is, the axial lengths of the multiple peaks 31a of the first support portion 40 on the connecting film 20 are roughly equal, so as to increase the radial support force of the implanted stent 100, improve the adhesion of the implanted stent 100 to the wall of the blood vessel, and help prevent internal leakage. It is understandable that the axial lengths of the multiple peaks 31a of the first support portion 40 on the connecting film 20 may not be equal. In the embodiment of the present application, the axial lengths of some peaks 31a of the second support portion 42 on the connecting film 20 are roughly equal, so as to increase the radial support force of the implanted stent 100, improve the adhesion of the implanted stent 100 to the wall of the blood vessel, and help prevent internal leakage. It should be noted that the axial length of the peaks 31a on the connecting film 20 mentioned in this application refers to the maximum axial length between the proximal end of the peak 31a and the distal end of the implanted stent 100. Some peaks 31a in the second support portion 42 protrude from the proximal end of the connecting film 20 to form anchor hooks 420, which facilitate the post-release process of the proximal end of the implanted stent 100. It can be understood that the axial lengths of the plurality of wave crests 31 a of the second supporting portion 42 in the connection film 20 may be equal or unequal.

[0068] The multiple wave peaks 31a on the first skeleton 36 include high waves 312a and low waves 314a, the multiple wave peaks 31a on the second skeleton 38 also include high waves 312a and low waves 314a, the proximal support skeleton 32 also includes high waves 312a and low waves 314a, and the distal support skeleton 34 also includes high waves 312a and low waves 314a. The axial length of the high wave 312a along the connecting coating 20 is greater than the axial length of the low wave 314a along the connecting coating 20, and the proximal end of the high wave 312a is closer to the proximal end of the connecting coating 20 than the proximal end of the low wave 314a. It should be noted that the axial length of the high wave 312a along the connecting coating 20 mentioned in this application refers to the maximum axial length between the proximal end of the high wave 312a and the distal end of the connecting stent; the axial length of the low wave 314a along the connecting coating 20 mentioned in this application refers to the maximum axial length between the proximal end of the low wave 314a and the distal end of the connecting stent. The first skeleton 36, the second skeleton 38, the proximal support skeleton 32 and the distal support skeleton 34 all adopt a high-low wave setting to improve the flexibility of the implanted stent 100, so that the implanted stent 100 can better conform to the curvature of the blood vessel, and it is also beneficial for the window structure 50 to bend better so as to fit closely with the root opening 300 of the branch blood vessel on the blood vessel with different curvature shapes.

[0069] In some embodiments, the first skeleton 36, the proximal support skeleton 32 and the distal support skeleton 34 are arranged in a periodic alternating arrangement of high and low waves, and the flexibility of the implanted stent 100 is more uniform, allowing the implanted stent 100 to better conform to the curvature of the blood vessel.

[0070] It can be understood that in other embodiments, the high waves 312a and the low waves 314a on the first skeleton 36, the proximal support skeleton 32 and the distal support skeleton 34 can be arranged in a periodic mixed manner or a non-periodic mixed manner, that is, the high waves 312a and the low waves 314a on the first skeleton 36, the proximal support skeleton 32 and the distal support skeleton 34 are non-alternatingly arranged, for example, at least two adjacent wave peaks 31a can be high waves 312a, or at least two adjacent wave peaks 31a can be low waves 314a, or the number of high waves 312a and low waves 314a arranged in the circumferential direction of the connecting coating 20 can be irregularly changed, etc.

[0071] Along the circumference of the connecting coating 20, at least one high wave 312a is provided on each side of the adjacent window structure 50, and the high wave 312a is located on a supporting skeleton integrally provided with the window structure 50; that is, along the circumference of the connecting coating 20, at least one high wave 312a is provided on each side of the adjacent window structure 50, and the high wave 312a is located on the first skeleton 36, so as to increase the radial supporting force around the window structure 50, which is beneficial to prevent the window structure 50 from being concave.

[0072] In some embodiments, along the circumference of the connecting coating 20, at least two adjacent high waves 312a are provided on each side of the adjacent window structure 50, and the high waves 312a are located on a supporting skeleton integrally provided with the window structure 50; that is, at least four of the multiple wave peaks 31a on the first skeleton 36 are wave peaks 31a adjacent to the window structure 50 are high waves 312a.

[0073] In some embodiments, there are at least four high waves 312a adjacent to the window structure 50, two of which are located at one end of the window structure 50 along the circumferential direction, and the other two are located at the other end of the window structure 50 along the circumferential direction, which can better ensure the radial support force requirements around the window structure 50 while taking into account the need for better flexibility.

[0074] Along the circumference of the connecting coating 20, the second skeleton 38 includes a first portion 382 and a second portion 384 that are connected to each other. The first portion 382 is closer to the proximal end of the connecting coating 20 than the second portion 384. This helps to prevent the troughs 31b on the first portion 382 from warping during assembly. It also reduces the radial support force of the first portion 382 on the proximal side of the fenestration structure 50, facilitating radial compression assembly of the implanted stent 100 in the conveyor. Specifically, the proximal end of the crest 31a of the first portion 382 is closer to the proximal end of the connection coating 20 than the proximal end of the crest 31a on the second portion 384, and the distal end of the trough 31b of the first portion 382 is closer to the proximal end of the connection coating 20 than the distal end of the trough 31b on the second portion 384. The distal end of the trough 31b of the first portion 382 is further away from the proximal end of the connection coating 20 than the distal end of the crest 31a on the second portion 384. This better reduces the risk of the trough 31b on the first portion 382 warping and bulging during assembly, and at the same time better reduces the radial support force of the first portion 382 on the proximal side of the fenestration structure 50, facilitating radial compression assembly of the implanted stent 100 in the conveyor. The crests 31a of the first portion 382 are all high waves 312a.

[0075] In some embodiments, the wave crests 31 a of the second portion 384 are periodically arranged to alternate between high waves 312 a and low waves 314 a .

[0076] It is understandable that, in other embodiments, the wave crest 31a of the first portion 382 may also be a mixed arrangement of high waves 312a and low waves 314a.

[0077] Please refer to Figure 7a and Figure 7b In this embodiment, the first part 382 is composed of six support rods 31 connected in sequence at an angle. Figure 7aThe range within the dashed rectangular box is determined to facilitate determination of the range of the first portion 382, ​​but does not limit the number of support rods 31 on the first portion 382. With the central axis 101 of the connecting bracket as the projection direction and PP as the projection plane (orthographic projection method), the projection of the first portion 382 along the central axis 101 of the connecting bracket (the central axis 101 is the axial extension direction of the connecting bracket) at least partially overlaps with the projection of the fenestration structure 50 along the central axis 101 of the connecting bracket.

[0078] In some embodiments, the projection of the first portion 382 along the central axis 101 of the connecting bracket completely overlaps with the projection of the fenestration structure 50 along the central axis 101 of the connecting bracket, thereby better ensuring the structural stability of the fenestration structure 50. In other embodiments, the width of the projection of the first portion 382 along the central axis 101 of the connecting bracket may be greater than the width of the projection of the fenestration structure 50 along the central axis 101 of the connecting bracket (the width refers to the circumferential length on the connecting bracket), which can also better ensure the structural stability of the fenestration structure 50.

[0079] The support frame 30 also includes a plurality of third support frames 44 (such as Figure 6 (As shown). A portion of the third support frame 44 is located between the proximal support frame 32 and the second support portion 42, while the remaining portion of the third support frame 44 is located between the distal support frame 34 and the first support portion 40. The third support frames 44 are arranged in a periodic pattern of alternating high and low waves. The provision of multiple third support frames 44 can further improve the compliance around the fenestration structure 50. It is understood that the third support frame 44 does not need to be provided between the first support portion 40 and the second support portion 42.

[0080] In the axial direction of the connecting stent, among the proximal support skeleton 32, the distal support skeleton 34, the first support part 40, the second support part 42 and multiple third support skeletons 39, the crests 31a of each adjacent two support skeletons 30 are opposite, and the troughs 31b of each adjacent two support skeletons 30 are opposite, so as to further improve the flexibility of the side of the implanted stent 100 close to the small bend side of the blood vessel.

[0081] Please refer to Figure 6 and Figure 7aThe fenestration structure 50 includes a first fenestration portion 52 and a second fenestration portion 54 connected along the axial direction of the connecting stent. The first fenestration portion 52 and the second fenestration portion 54 can enclose a closed loop structure. The first fenestration portion 52 is farther away from the proximal end of the implanted stent 100 than the second fenestration portion 54. The first fenestration portion 52 generally forms a concave arc structure (i.e., the first fenestration portion 52 is concave in the direction away from the proximal end of the connecting coating 20), and the second fenestration portion 54 generally forms an arc structure convex toward the proximal end of the connecting coating 20 (i.e., the second fenestration portion 54 convex in the direction toward the proximal end of the connecting coating 20). For example, the second fenestration portion 54 can be an arc structure of 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, etc. The first fenestration portion 52 and the second fenestration portion 54 form an irregular window shape. It can be understood that the present application does not limit the structure and shape of the window structure 50. For example, the first window portion 52 can be an arc-shaped structure, the second window portion 54 can include multiple arc-shaped structures, etc. The shape of the window structure 50 can also be some regular shapes, such as circular, elliptical, etc.

[0082] At least a portion of the port of the embedded branch 70 near the window structure 50 is fixed to the window structure 50. In this embodiment, the proximal end 722 of the embedded branch 70 is partially fixed to the first window portion 52. At least a portion of the port of the embedded branch 70 near the window structure 50 is fixed to the window structure 50, which allows the embedded branch 70 to be more stably plugged into the branch bracket.

[0083] The first portion 382 is located on the proximal side of the second window portion 54 . In other words, the second window portion 54 is located between the first portion 364 and the first window portion 52 .

[0084] At least part of the fenestration structure 50 is integrally provided with at least one of the support frames 30. It should be noted that the integral provision may mean that at least part of the fenestration structure 50 is part of at least one of the support frames 30, or may mean that at least part of the fenestration structure 50 is a frame bar that is fixed to the support frames 30 so as not to destroy the independent closed-loop structure of each support frame 30.

[0085] In this embodiment, the first fenestration portion 52 is integrally provided with the first skeleton 36, ensuring that the first skeleton 36 remains an independent closed-loop structure. This allows each support skeleton 30 on the connection coating 20 to be an independent closed-loop structure, which helps significantly increase the radial support force of the fenestration structure 50. When calcification or dissection occurs in a blood vessel and squeezes the implanted stent 100, the radial support force formed by each support skeleton 30 as an independent closed-loop structure can mitigate the squeezing of the calcified or dissected area on the implanted stent 100, which can reduce the radial size of the connecting cavity 22 of the implanted stent 100 or even cause it to become blocked, thereby helping to reduce the blood flow loss caused by the squeezing of the implanted stent 100. The first skeleton 36 and the first window portion 52 are arranged integrally, which is also beneficial to reducing the radial size of the implant stent 100, making it easier for the implant stent 100 to be radially compressed and assembled in the conveyor, thereby improving the release success rate of the implant stent 100 during implantation treatment; it is also beneficial to avoid the axially adjacent supporting skeletons squeezing the window structure 50 when the implant stent 100 is radially compressed and assembled in the conveyor, causing the window structure 50 to deform or even be unable to return to the preset shape, resulting in inaccurate positioning, and further leading to the failure of branch vessel reconstruction.

[0086] It should be noted that the first window portion 52 and the first frame 36 are integrally arranged, which may mean that the first window portion 52 is a part of the first frame 36, or it may mean that the first window portion 52 is a frame bar, which is fixed on the first frame 36 so as not to destroy the closed-loop structure of the first frame 36.

[0087] See also Figure 8a and Figure 8b The window structure 50 also includes two annular members 56, which are respectively fixed to the two ends of the second window portion 54 along the circumference of the connecting bracket; when the suture thread sutures the second window portion 54 to the connecting bracket, the setting of the annular members 56 is beneficial to preventing the second window portion 54 from shifting on the connecting bracket, and is also beneficial to avoiding wear of the two ends of the second window portion 54 on the implanted bracket 100.

[0088] See also Figure 8a 、 Figure 9a and Figure 9bThe embedded branch 70 includes a branch coating 72 and a support ring 76. The branch coating 72 is sealed and connected to the connecting coating 20. The support ring 76 is provided on the branch coating 72 to provide radial support for the embedded branch 70. The transition coating 74 is located in the connecting cavity 22. The transition coating 74 is sealed and connected to the proximal end of the branch coating 72. The transition coating 74 is sealed and connected to the fenestration structure 50 so that the fenestration structure 50 is connected to the connecting cavity 22 through the proximal port 722 of the branch coating 72 and the connecting cavity 720 in sequence, so that the leak-proof performance of the fenestration structure 50 is better. In this embodiment, the transition coating 74 is integrally formed with the branch coating 72 to improve the anti-internal leakage effect of the implanted stent 100.

[0089] It should be noted that the sealed connection mentioned in this application may refer to the two being set as one, or one being fixed to the other by a suture line, or one being fixed to the other by bonding, heat sealing, crimping, etc.

[0090] In some embodiments, the support ring 76 is an open-loop corrugated ring (i.e., the support ring 76 has an open-loop structure), which helps prevent stress concentration on the surface of the support ring 76 when the embedded branches 70 are radially compressed and converged within the conveyor, thereby preventing the support ring 76 from returning to its preset shape. This also helps reduce the resistance when the implanted stent 100 is released from the conveyor, thereby improving the smoothness of the release of the implanted stent 100 into the blood vessel. Specifically, the side of the support ring 72 with the open loop is fixed to the branch covering 72.

[0091] The structure of the support rings 76 can be similar to that of the support frame 30, that is, each support ring 76 can also include multiple support rods 31 connected in sequence at an angle. The two adjacent angles in the circumferential direction of the branch covering 72 are respectively a crest 31a and a trough 31b. The crest 31a is closer to the proximal end of the branch covering 72 than the trough 31b. Along the axial direction of the embedded branch 70, the crests 31a of each pair of adjacent support rings 76 face each other, and the troughs 31b of each pair of adjacent support rings 76 face each other.

[0092] For two support rings 76 adjacent in the axial direction of the embedded branch 70, the trough 31b of one support ring 76 and the peak 31a of the other adjacent support ring 76 can be fixedly connected to each other, which is beneficial to avoid shortening of the embedded branch 70 (that is, the axial length of the embedded branch 70 is shortened), thereby helping to ensure the required anchoring length of the branch stent released in the embedded branch 70.

[0093] Please refer to Figure 6 and Figure 7aThe circumferential length L1 of the fenestration structure 50 on the connecting stent is 1 to 5 times the maximum diameter of the embedded branch 70. The diameter of the embedded branch 70 can be 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, or 16 mm, depending on the diameter of the branch vessel to be reconstructed in different patients.

[0094] Since the circumferential length of the window structure 50 on the connecting stent is 1 to 5 times the diameter of the embedded branch 70, the circumferential diameter of the window structure 50 on the connecting stent is larger, thereby improving the positioning accuracy and fault tolerance of the window structure 50 for the branch blood vessels. For example, when the implant stent 100 is used for aortic arch implantation treatment, the window structure 50 can improve the positioning accuracy of the implant stent 100 for the root opening 300 of the branch blood vessel, facilitate the assembly of the branch stent and do not affect the radial compression size of the implant stent 100.

[0095] In the related art, since the size of the fenestration structure is relatively small, for example, the fenestration structure is the proximal port of the embedded branch (for example, it can be the fenestration in the related art CN111227990A), the fenestration structure can directly serve as the proximal port of the embedded branch and align with the root opening of the target branch vessel. It may be necessary to adopt a bundle diameter design (for example, it can be at least two rows of connectors in the related art CN109984862A) to make the implanted stent radially contract and present a semi-expanded state, thereby facilitating the operator to adjust the position of the implanted stent multiple times until the fenestration structure and the root opening of the target branch vessel are aligned. That is, after the fenestration structure and the root opening of the target branch vessel are accurately aligned, the bundle diameter design is released from the implanted stent, and then the branch stent is released in the embedded branch to restore blood flow to the target vessel. The design of the fenestration structure 50 of this embodiment can eliminate the bundle diameter design in the related art, simplify the size and structure of the conveyor, reduce the operator's learning curve and operation difficulty, and help improve the release success rate of the implanted stent 100.

[0096] Taking the left subclavian artery for reconstruction of the aortic arch as an example, when the root opening 300 of the left subclavian artery and the innominate artery or the left common carotid artery are not in the same cross section, the window structure 50 is easier to locate at the root opening 300 of any branch vessel, and the error tolerance rate is higher.

[0097] The main body coating 201, the separator coating 401, the sealing coating 500, the connecting coating 20, the branch coating 72, and the transition coating 74 are all biocompatible fabrics, including but not limited to woven or knitted polyesters, such as polyethylene terephthalate, polylactide, polyglycolide, and their copolymers; fluorinated polymers, such as polytetrafluoroethylene, expanded or electrospun polytetrafluoroethylene, and polyvinylidene fluoride; polysiloxanes, such as polydimethylsiloxane; polyurethanes, such as polyether polyurethane, polyurethane urea, polyether polyurethane urea, polyurethanes containing carbonate bonds, braided nickel titanium and polyurethane containing siloxane segments; silicone, ultra-high molecular weight polyethylene, or other suitable materials. This application does not limit the materials of the main body coating 201, the separator coating 401, the connecting coating 20, the branch coating 72, and the transition coating 74.

[0098] The main support structure 203, the separation support structure 403, the support skeleton 30, the support ring 76 and the positioning rod 800 are made of elastic materials, including but not limited to one or more of nickel-titanium alloy, nickel-titanium superelastic alloy, cobalt-chromium-nickel-molybdenum alloy, copper-based shape memory alloy, iron-based shape memory alloy, medical stainless steel alloy or various polymers (such as polynorbornene, polyurethane, polylactic acid copolymer, etc.), which are not limited here.

[0099] See also Figure 6 、 Figure 8a and Figure 8b , a slit 726 is provided at the proximal end of the branch coating 72. The slit 726 is located on the distal side of the fenestration structure 50 (i.e., the distal side of the first fenestration portion 52). The slit 726 is fixed to the connecting coating 20 to reduce the risk of wrinkles at the junction of the transition coating 74 and the connecting coating 20, and to ensure that there is sufficient space when the branch blood vessel is inserted into the embedded branch 70, thereby reducing the risk of internal leakage. Along the circumference of the connecting coating 20, the proximal length of the slit 726 is greater than the distal length of the slit 726. For example, the length of the slit 726 in the circumferential direction of the connecting stent may be gradually increased from the distal end of the slit 726 to the proximal end of the slit 726. In other embodiments, the slit 726 may be in other shapes such as T-shape, V-shape, inverted V-shape, dumbbell shape, etc.

[0100] A suture 78 is formed at the connection between the branch coating 72 and the inner wall of the connecting coating 20. The suture 78 is connected to the distal end of the slit 726. The suture 78 extends axially along the embedded branch 70. The suture 78 extends axially along the embedded branch 70 for a length of no less than 15 mm to improve the connection stability between the branch coating 72 and the connecting coating 20.

[0101] like Figure 10As shown, the blood vessel can be the aortic arch 3000. Taking the left subclavian artery 3001 of the reconstructed aortic arch 3000 as an example, the implanted stent 100 is released into the aortic arch 3000, and the branch stent 2000 is released into the embedded branch 70. Since the axial extension length of the suture stitch 78 along the branch covering 72 is not less than 15 mm, the branch stent 2000 can be firmly inserted into the embedded branch 70 of the implanted stent 100 and reduce the risk of internal leakage of the branch stent 2000.

[0102] like Figure 11 As shown, the blood vessel may be the abdominal aorta 4000. Taking the renal artery 4001 of the reconstructed abdominal aorta 4000 as an example, a branch stent 2000 is released in the embedded branch 70. Since the axial extension length of the suture stitch 78 along the branch covering 72 is not less than 15 mm, the branch stent 2000 can be firmly inserted into the embedded branch 70 of the implanted stent 100 and reduce the risk of internal leakage of the branch stent 2000.

[0103] In other embodiments, a plurality of embedded branches 70 and a corresponding number of fenestration structures 50 may be provided in the implant stent 100, thereby enabling reconstruction of a plurality of branch blood vessels.

[0104] Please refer again Figure 6 、 Figure 8a and Figure 8b In this embodiment, the distance L3 between the suture stitch 78 and the first window portion 52 ranges from 2.5 to 3.5 mm to reduce the possibility of wrinkling of the transitional coating 74, ensure the blood supply of the branch vessels, and reduce the risk of endoleak. If the distance between the proximal end of the suture stitch 78 and the distal end of the first window portion 52 is too small, it is easy to cause wrinkling of the transitional coating 74 near the window structure 50. If the distance between the proximal end of the suture stitch 78 and the distal end of the first window portion 52 is too large, it is easy to cause the position of the support ring 76 on the branch coating 72 to move downward, which indirectly causes the axial length of the branch coating 72 to be too long. Blood flow usually enters the embedded branch 70 from the distal port 724 of the embedded branch 70, and then passes through the branch stent inserted into the embedded branch 70 to ensure the blood supply of the branch vessels. The increase in the axial length of the embedded branch 70 will lead to a longer retrograde distance of blood flow, which is not conducive to ensuring the blood supply of the branch vessels. In addition, if the axial length of the embedded branch 70 is too long, the radial supporting force at the branch coating 72 between the proximal side of the support ring 76 and the distal end of the first window portion 52 may be insufficient, making it easy for the branch stent to leak internally after being inserted into the embedded branch 70 through the window structure 50.

[0105] The proximal port 722 of the embedded branch 70 and the distal port 724 of the embedded branch 70 are both provided with a positioning ring 77. The embedded branch 70 is provided with a developing mark on the positioning ring 77 of the proximal port 722 to indicate the position of the embedded branch 70 for super-selective positioning. The developing mark can also be provided on the positioning ring 77 of the distal port 724. Among them, the positioning ring 77 on the proximal port 722 can be roughly semi-annular in structure. It is understood that the positioning ring 77 can also be of other shapes, for example, the positioning ring 77 can be a closed loop structure. When the positioning ring 77 is roughly semi-annular in structure, an annular member 56 (not shown) can also be fixed at each end of the positioning ring 77 along the circumference of the embedded branch 70. When the positioning ring 77 is sutured and fixed to the transition coating 74 by sutures, the annular objects at both ends of the positioning ring 77 help prevent the positioning ring 77 from shifting, and also help avoid the transition coating 74 from being worn at both ends of the positioning ring.

[0106] The material of the imaging marker can be made of a material with good X-ray opacity, strong corrosion resistance and good biocompatibility, and can be gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium or alloys of these materials.

[0107] It can be understood that the development mark can also be understood as at least one positioning ring 77 having a development material, so that the positioning ring 77 does not need to be provided with a development mark; or, at least one support ring 76 can be provided with a development mark, and the development mark is set at least around part of the positioning ring 77.

[0108] Please refer to Figure 12 In an application scenario of an implanted prosthesis 1000, taking the reconstruction of three branch vessels on the aortic arch 3000 as an example, the three branch vessels can be the left subclavian artery 3001, the left common carotid artery 3002 and the brachiocephalic artery 3003. Two spacer stents 400 are provided. The implanted stent 100 is released into the main cavity channel 205 through the main cavity opening 501, and then the branch stents 2000 are released into the embedded branch 70 and the two spacer stents 400 respectively. The state of the main stent 200, the spacer stent 400 and the branch stent 2000 after being released into the aortic arch 3000 is as shown in FIG. Figure 12 shown.

[0109] Please refer to Figure 13In other embodiments of the present application, the number of the spacer stent 400 can also be one. Taking the reconstruction of two branch blood vessels of the aortic arch 3000 as an example, such as the reconstruction of the left subclavian artery 3001 and the left common carotid artery 3002, or the reconstruction of the left subclavian artery 3001 and the brachiocephalic artery 3003, the spacer stent 400 is set as one, and the implanted stent 100 is released into the main cavity channel 205 through the main cavity opening 501, and then the branch stent 2000 is released in the embedded branch 70 and the spacer stent 400 respectively. The state of the main stent 200, the spacer stent 400 and the branch stent 2000 after being released in the aortic arch 3000 is as shown in FIG. Figure 13 shown.

[0110] The implant stent 100b provided in the second embodiment of the present application has a substantially similar structure to the implant stent 100 provided in the first embodiment of the present application. Figure 14 The implant stent 100 provided in the second embodiment of the present application is different from the implant stent 100 provided in the first embodiment of the present application in that the arrangement of the window structure 50 and the structure of part of the supporting skeleton are different.

[0111] In this embodiment, the first skeleton 36 is integrally provided with the first fenestration portion 52, and the second skeleton 38 is integrally provided with the second fenestration portion 54, ensuring that the first skeleton 36 and the second skeleton 38 are still each an independent closed-loop structure, thereby making each support skeleton 30 on the connection coating 20 an independent closed-loop structure, which is conducive to greatly improving the radial support force of the fenestration structure 50. When calcification or dissection occurs in the blood vessel and squeezes the implanted stent 100, the radial support force formed by each support skeleton 30 as an independent closed-loop structure can reduce the squeezing of the implanted stent 100 by the calcified area or dissection area, resulting in a reduction in the radial size of the connecting cavity 22 of the implanted stent 100 or even occlusion, thereby helping to reduce the blood flow loss caused by the squeezing of the implanted stent 100. The first skeleton 36 is integrally provided with the first window portion 52, and the second skeleton 38 is integrally provided with the second window portion 54, which is also beneficial to reducing the radial size of the implant stent 100, making it easier for the implant stent 100 to be radially compressed and assembled in the conveyor, thereby improving the release success rate of the implant stent 100 during implantation treatment; it is also beneficial to avoid the axially adjacent supporting skeletons squeezing the window structure 50 when the implant stent 100 is radially compressed and assembled in the conveyor, causing the window structure 50 to deform or even be unable to return to the preset shape, resulting in inaccurate positioning, and further leading to the failure of branch vessel reconstruction.

[0112] It should be noted that the first window portion 52 and the first frame 36 being integrally provided may mean that the first window portion 52 is part of the first frame 36, or that the first window portion 52 is a frame bar that is fixed to the first frame 36 so as not to disrupt the closed-loop structure of the first frame 36. The second frame 38 and the second window portion 54 being integrally provided may mean that the second window portion 54 is part of the second frame 38, or that the second window portion 54 is a frame bar that is fixed to the second frame 38 so as not to disrupt the closed-loop structure of the second frame 38. Ultimately, each support frame 30 is ensured to have an integrally formed independent closed-loop structure.

[0113] The first frame 36 and the second frame 38 can be spaced apart in the axial direction, and the two ends of the first window portion 52 in the circumferential direction are fixed to the two ends of the second window portion 54 in the circumferential direction by means of sutures, so that the window structure 50 forms a closed loop structure.

[0114] The multiple wave peaks 31a on the first skeleton 36 include high waves 312a and low waves 314a. The multiple wave peaks 31a on the second skeleton 38 also include high waves 312a and low waves 314a. The high waves 312a are longer along the axial direction of the stent than the low waves 314a, and the proximal ends of the high waves 312a are closer to the proximal end of the stent than the proximal ends of the low waves 314a. The high and low wave configuration of the first and second skeletons 36 and 38 improves the flexibility of the implanted stent 100, allowing the implanted stent 100 to better conform to the curvature of the blood vessel.

[0115] Along the circumference of the connecting coating 20, at least one high wave 312a is provided on each side of the adjacent window structure 50, and the high wave 312a is located on the supporting skeleton 30 integrally provided with the window structure 50; that is, along the circumference of the connecting coating 20, at least one high wave 312a is provided on each side of the adjacent window structure 50, and the high wave 312a is located on the first skeleton 36 and the second skeleton 36; in other words, at least one of the multiple wave peaks 31a on the first skeleton 36 is a wave peak 31a adjacent to the window structure 50 is a high wave 312a, and at least one of the multiple wave peaks 31a on the second skeleton 38 is a wave peak 31a adjacent to the window structure 50 is a high wave 312a, so as to increase the radial supporting force around the window structure 50, which is beneficial to prevent the window structure 50 from being concave.

[0116] In some embodiments, along the circumference of the connecting coating 20, at least two high waves 312a are provided on both sides of the adjacent window structure 50, and the high waves 312a are located on the supporting skeleton 30 integrally provided with the window structure 50; that is, along the circumference of the connecting coating 20, at least two high waves 312a are provided on both sides of the adjacent window structure 50, and the high waves 312a are located on the first skeleton 36 and the second skeleton 36; in other words, at least four of the multiple wave peaks 31a on the first skeleton 36 that are adjacent to the window structure 50 are high waves 312a, of which two high waves 312a are located at one end of the window structure 50 along the circumference, and the other two high waves 312a are located at the other end of the window structure 50 along the circumference.

[0117] In some embodiments, at least four of the multiple wave peaks 31a on the second skeleton 38 that are adjacent to the window structure 50 are high waves 312a, two of which are located at one end of the window structure 50 along the circumferential direction, and the other two are located at the other end of the window structure 50 along the circumferential direction, which can better ensure the radial support force requirements around the window structure 50.

[0118] The implant stent 100b provided in the third embodiment of the present application has a substantially similar structure to the implant stent 100 provided in the first or second embodiment of the present application. Figure 15 The implant stent 100 provided in the third embodiment of the present application is structurally different from the implant stent 100 provided in the first embodiment or the second embodiment of the present application in that at least one of the proximal port 722 and the distal port 724 of the embedded branch 70 can be an oblique port.

[0119] See also Figure 15 and Figure 16 , Figure 15 for Figure 8a The schematic diagram of a possible implementation method of an oblique opening of the proximal port 722 of the embedded branch 70 in the implant stent 100 is shown; Figure 16 for Figure 15Schematic diagram of the structure of the embedded branch 70 in FIG. The proximal port 722 of the embedded branch 70 is an oblique port, and the side of the proximal port 722 close to the central axis 101 of the connecting stent can accordingly extend toward the proximal end of the implanted stent 100, which is beneficial to improving the visibility of the proximal port 722, facilitating better insertion of the branch stent into the corresponding embedded branch 70, and improving the positioning accuracy of the branch vessel; it is also beneficial to improving the support force at the position of the transition coating 74, reducing the problem of wrinkling of the transition coating 74, making the blood flow in the connecting cavity 22 of the connecting stent smoother, reducing the occurrence of thrombosis, and also facilitating a tighter insertion of the branch stent into the embedded branch 70. Accordingly, the proximal port 722 of the embedded branch 70 is an oblique port, and the side of the support ring 76 close to the proximal port 722 close to the central axis 101 of the connecting stent can accordingly extend toward the proximal end of the connecting stent, so as to improve the radial support force near the proximal port 722, and help reduce wrinkling of the branch coating 72.

[0120] See also Figure 17 A first angle C is formed between the surface where the proximal port 722 is located and the central axis 101 of the connecting stent, so that the proximal port 722 of the embedded branch 70 is located within the connecting cavity 22, that is, the proximal port 722 of the embedded branch 70 is not provided on the circumferential surface of the connecting stent, thereby forming a first angle C between the surface where the proximal port 722 is located and the central axis 101 of the embedded branch 70. The proximal port 722 of the embedded branch 70 is located within the connecting cavity 22, providing more sufficient space for the branch stent used to reconstruct the target branch vessel, which helps prevent the implanted stent 100 from squeezing the branch stent, causing stenosis or even occlusion of the branch stent, and affecting the blood supply of the branch vessel; at the same time, the sufficient space provided for the branch stent used to reconstruct the target branch vessel is also conducive to providing a larger pivot angle for the branch stent, that is, the branch stent can be twisted by a certain angle in the circumferential direction and axial direction of the fenestration structure 50, better adapting to blood vessels with different anatomical morphologies.

[0121] In this embodiment, the surface where the proximal port 722 is located can be inclined relative to the central axis 101 of the connecting bracket, that is, the first angle C can be set at a non-right angle. In other words, the proximal port 722 of the embedded branch 70 can be an oblique port; taking the distal end of the connecting bracket as the bottom point, the inclination direction of the surface where the proximal port 722 is located can be that the side of the proximal port 722 away from the central axis 101 of the connecting bracket is sunken toward the distal end of the connecting bracket relative to the side of the proximal port 722 close to the central axis 101 of the connecting bracket (that is, the side of the proximal port 722 away from the central axis 101 of the connecting bracket is closer to the distal end of the connecting bracket relative to the side of the proximal port 722 close to the central axis 101 of the connecting bracket), or it can be that the side of the proximal port 722 close to the central axis 101 of the connecting bracket is sunken toward the distal end of the connecting bracket relative to the proximal port 722 away from the central axis 101 of the connecting bracket (that is, the side of the proximal port 722 away from the central axis 101 of the connecting bracket is farther away from the distal end of the connecting bracket relative to the side of the proximal port 722 close to the central axis 101 of the connecting bracket).

[0122] See also Figure 18 In other embodiments of the present application, the first angle C is approximately a right angle, that is, the proximal end 722 of the embedded branch 70 can be a flat end.

[0123] See also Figure 17 and Figure 18 A second angle D is formed between the surface where the distal end 724 of the embedded branch 70 is located and the central axis 101 of the connecting bracket. In this embodiment, the second angle D is greater than 0 degrees and less than 90 degrees, that is, the distal end 724 of the embedded branch 70 can also be an oblique opening.

[0124] In some embodiments, with the proximal end of the connecting bracket as the bottom point, the inclination direction of the surface of the distal port 724 is such that the side of the distal port 724 away from the fenestration structure 50 sinks toward the proximal end of the connecting bracket relative to the side of the distal port 724 closer to the fenestration structure 50 (i.e., the side of the distal port 724 away from the fenestration structure 50 is closer to the proximal end of the connecting bracket than the side of the distal port 724 closer to the fenestration structure 50). In other embodiments of the present application, the second angle D can be set at a right angle, that is, the distal port 724 of the embedded branch 70 can also be flat.

[0125] The above disclosure is only a preferred embodiment of the present application, and certainly cannot be used to limit the scope of rights of the present application. Therefore, equivalent changes made according to the claims of the present application are still within the scope covered by the present application.

Claims

1. An implantable stent, characterized in that: The implantable stent is a straight tubular or tapered structure, comprising: The connecting bracket forms a tubular connecting cavity; the connecting bracket includes a connecting membrane and a plurality of annular support skeletons, the plurality of support skeletons being fixed to the wall surface of the connecting membrane and arranged along the axial direction of the connecting membrane, and each support skeleton is an independent closed-loop structure formed as an integral body; the support skeleton includes a plurality of support rods connected in sequence at an angle, and two adjacent angles along the circumference of the support skeleton are respectively a crest and a trough, and the crest is closer to the proximal end of the connecting membrane than the trough; the plurality of crests on at least one of the support skeletons include high waves and low waves, the axial length of the high wave along the connecting membrane is greater than the axial length of the low wave along the connecting membrane, and the high wave is closer to the proximal end of the connecting membrane than the low wave; a window structure, provided on the connecting film, the window structure being in communication with the connecting cavity; At least part of the window structure is integrally arranged with at least one of the supporting frames.

2. The implant stent according to claim 1, wherein: Along the circumference of the connecting membrane, at least one high wave is provided on each of the two sides adjacent to the window structure, and the high wave is located on the supporting frame integrally provided with the window structure.

3. The implant stent according to any one of claims 1 to 2, wherein: The window structure is integrally arranged with one or two of the supporting frames.

4. The implant stent according to claim 3, wherein: The fenestration structure is integrally provided with one of the support frames: the multiple support frames include a first frame and a second frame, the first frame and the second frame are adjacently provided along the axial direction of the connection covering, and the first frame is further away from the proximal end of the implanted stent than the second frame; The fenestration structure includes a first fenestration portion and a second fenestration portion connected along the axial direction of the connection covering, wherein the first fenestration portion is further away from the proximal end of the implanted stent than the second fenestration portion; The first frame and the first window portion are integrally provided, and the second window portion is located at a distal end side of the second frame.

5. The implant stent according to claim 4, wherein: Along the circumference of the connecting film, both ends of the second window portion are fixedly connected with annular parts.

6. The implant stent according to claim 4, wherein: The second skeleton also includes a first part and a second part connected along the circumference of the connecting membrane, the first part is closer to the proximal end of the connecting membrane than the second part, and the projection of the first part along the axial direction of the connecting membrane at least partially overlaps with the projection of the window structure along the axial direction of the connecting membrane.

7. The implant stent according to claim 3, wherein: The fenestration structure is integrally provided with the two support frames: the multiple support frames include a first frame and a second frame, the first frame and the second frame are adjacently provided along the axial direction of the connection membrane, and the first frame is further away from the proximal end of the implanted stent than the second frame; The fenestration structure includes a first fenestration portion and a second fenestration portion connected along the axial direction of the connection covering, wherein the first fenestration portion is further away from the proximal end of the implanted stent than the second fenestration portion; The first frame is integrally provided with the first window portion, and the second frame is integrally provided with the second window portion.

8. The implant stent according to claim 1, wherein: An embedded branch is provided in the connecting cavity, and the embedded branch forms a tubular connecting cavity. The embedded branch is fixed on the connecting bracket. The proximal end of the embedded branch is sealed with a transition coating, and the transition coating is sealed with the window structure. The window structure is connected with the connecting cavity through the connecting cavity. The window structure is used to be plugged into and matched with the branch bracket of the reconstructed branch blood vessel so that the branch bracket is connected with the connecting cavity through the connecting cavity.

9. The implant stent according to claim 8, wherein: An angle is formed between the surface where the proximal end of the embedded branch is located and the central axis of the connecting membrane, so that the proximal end of the embedded branch is located in the connecting cavity.

10. The implant stent according to claim 9, wherein: At least one of the proximal end and the distal end of the embedded branch is an oblique end.

11. The implant stent according to claim 9, wherein: At least one of the proximal port and the distal port of the embedded branch is provided with a positioning ring.

12. The implant stent according to claim 11, wherein: At least one of the positioning rings is provided with a developing mark.

13. The implant stent according to claim 12, wherein: The embedded branch includes a branch covering and at least one support ring, and the support ring is fixedly connected to the branch covering; The proximal end of the branch covering is provided with a split, the split is located at the distal end of the fenestration structure, and the split is fixedly connected to the connecting covering; Along the circumference of the connecting membrane, the circumferential length of the proximal end of the slit is greater than the circumferential length of the distal end of the slit.

14. An implant prosthesis, characterized in that: It comprises a main body support and an implant support according to any one of claims 1 to 13, wherein the main body support forms a tubular main body cavity, and the implant support is inserted into the main body cavity.

15. The implant prosthesis according to claim 14, wherein: A partition bracket is provided in the main cavity, the partition bracket forms a tubular partition cavity, the partition bracket and the inner wall of the main bracket form a main cavity channel, the implant bracket is inserted in the main cavity channel, and the window structure is located outside the main cavity channel.

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