CN115919504B - Split type single embedded branch tectorial membrane support - Google Patents

Split type single embedded branch tectorial membrane support Download PDF

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Publication number
CN115919504B
CN115919504B CN202310155246.5A CN202310155246A CN115919504B CN 115919504 B CN115919504 B CN 115919504B CN 202310155246 A CN202310155246 A CN 202310155246A CN 115919504 B CN115919504 B CN 115919504B
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stent
branch
support
framework
embedded
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CN115919504A (en
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王永胜
尹玉杨
吴雅莎
肖添
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Hangzhou Wei Qiang Medical Technology Co ltd
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Hangzhou Wei Qiang Medical Technology Co ltd
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Abstract

The application relates to a split single embedded branch tectorial membrane bracket, which comprises a main body bracket provided with at least one windowing structure; one end of the embedded bracket is fixed on the windowing structure in a sealing way, so that the windowing structure is communicated with the communicating cavity of the main body bracket through the embedded bracket; the branch bracket is detachably inserted into the embedded bracket through a windowing structure; the branch support includes branch tectorial membrane and is fixed in branch tectorial membrane's branch skeleton subassembly, along the radial of branch support, branch tectorial membrane includes first layer membrane and second layer membrane, and first layer membrane is located the inboard of branch support's joint chamber, and the second layer membrane is located the outside of branch support, and branch skeleton subassembly is fixed in between first layer membrane and the second layer membrane, and the proximal end and the distal end of branch tectorial membrane are integrated into one piece respectively have a turn over section, turn over a section and be fixed in the inner peripheral wall of branch tectorial membrane. The method has the effects of reducing the damage stimulation of the branch stent to the LSA far-end vascular wall in the cardiac cycle and improving the long-term patency rate of the branch artery.

Description

Split type single embedded branch tectorial membrane support
Technical Field
The application relates to the field of medical instruments, in particular to a split type single embedded branch tectorial membrane bracket.
Background
With the improvement of endoluminal technology and the advancement of material science, endoluminal repair (Thoracic Endovascular Aortic Artery Repair, TEVAR) has become the treatment of choice for B-aortic dissection, but for lesions where a laceration or hematoma is close to a branch artery (e.g., left collarbone artery (LeftSubclavian Artery, LSA)) due to insufficient or unhealthy proximal anchoring area, conventional TEVAR needs to occlude the left collarbone artery to lengthen the proximal anchoring area, but complications such as left upper limb ischemia, subclavian arterial blood-stealing syndrome, vertebral artery type cerebral ischemia, etc. may occur after surgery, and increase the risk of paraplegia, so it is very important to preserve or reconstruct the left collarbone artery when performing TEVAR surgery to treat Stanford B-dissection.
Common surgical modes for reconstruction of the left subclavian artery include hybrid surgery, parallel stent technology, fenestration technology, branch stent technology, and the like. The hybridization operation has definite effect, but has the defects of large wound and long operation time compared with the full-cavity operation. The parallel stent technique is relatively simple and easy to operate, but because of the grooves (gutters) between the two stents, the probability of occurrence of I-shaped endoleaks is increased, and in addition, the risk of reverse tear interlayer and occlusion of the parallel stents is increased due to the interaction force between the stents and the aortic wall. The windowing technology mainly comprises the steps of reserving a side hole on an artificial vascular membrane of a bracket, designing the side hole or in-situ windowing before operation according to specific conditions, and reserving branch arterial blood supply through the side hole after the bracket is released, wherein the defects are inaccurate positioning, high technical difficulty and failure risk, and the probability of infection is increased in the process of modifying the bracket, or the risk of influencing the long-term patency rate of an LSA bracket, the stability of a main bracket structure and/or the service life is influenced. The branch stent technology is more in line with physiological anatomy, reduces the risk of I-type internal leakage and III-type internal leakage risk, can effectively isolate lesions with lacerations at LSA, and is expected to become a preferred mode for reconstructing LSA in the future.
The branch stent technology provides a technology of an integrated branch type aortic stent graft for treating a Stanford B-type interlayer patient, and the stent graft is radially compressed by a corresponding interventional instrument and then delivered to a lesion position and then released, so that the stent graft returns to a preset shape, thereby separating an interlayer breach or an enlarged cavity of a human blood vessel, remodelling a blood vessel true cavity, and restoring the correct flow direction of blood flow, and further achieving the treatment effect. In order to ensure the blood supply of the branch artery, the branch artery and the covered stent are generally connected through the branch stent, that is, the branch stent and the covered stent are integrally arranged, and the branch stent is released in the branch artery, so that the effect of ensuring the blood supply of the branch artery is achieved. However, the branch stent may cause damage to the inner wall of the artery when pulled into the branch artery.
Disclosure of Invention
In order to solve the problem that the branch stent of the existing covered stent can cause loss to the inner wall of an artery when being pulled into the branch artery, the application provides a split type single embedded branch covered stent.
The application provides a split type single embedded branch tectorial membrane support, which comprises a main body support, wherein the main body support is of a tubular structure with two ends open, the main body support is enclosed to form a communication cavity for communicating with a target blood vessel, and the main body support is provided with at least one windowing structure;
The embedded support is of a tubular structure with two open ends, and one end of the embedded support is fixed on the windowing structure in a sealing mode, so that the windowing structure is communicated with the communication cavity of the main body support through the embedded support; a kind of electronic device with high-pressure air-conditioning system
The branch support is of a tubular structure with two open ends, the branch support is enclosed into a connecting cavity for communicating with a branch artery, and the branch support is detachably inserted into the embedded support through the windowing structure so as to enable the connecting cavity of the branch support to be communicated with the connecting cavity;
the branch support includes branch tectorial membrane and is fixed in the branch skeleton subassembly of branch tectorial membrane, follows the radial of branch support, the branch tectorial membrane includes first layer membrane and second layer membrane, first layer membrane is located the inboard of the connection chamber of branch support, the second layer membrane is located the outside of branch support, branch skeleton subassembly is fixed in first layer membrane with between the second layer membrane, the proximal end and the distal end of branch tectorial membrane respectively integrated into one piece have a turn over section, turn over a section and be fixed in the inner peripheral wall of branch tectorial membrane.
In other embodiments, the main body stent comprises a tubular covered membrane, a bare stent and a plurality of supporting frameworks, wherein the bare stent and the supporting frameworks are in annular structures, the bare stent is fixed at the proximal end of the tubular covered membrane, the supporting frameworks are positioned at the distal end side of the bare stent, and the supporting frameworks are sequentially arranged and fixed along the axial direction of the tubular covered membrane; the bare support and the support framework comprise a plurality of support rods which are sequentially connected with each other in an included angle manner, two adjacent included angles are respectively a peak and a trough along the circumferential direction of the main body support, and the peak is closer to the proximal end of the main body support than the trough; at least part of the peaks, the troughs and the support rods of the support framework are all attached to and fixed on the peripheral wall of the tubular coating, at least part of the peaks of the support framework are provided with gaps with the tubular coating and can be separated from the tubular coating to form a free zone, and the axial length of the free zone is at least 2.5-4mm.
In other embodiments, the plurality of support frameworks include an adherent framework, a bundle diameter framework, an auxiliary framework and a distal framework which are sequentially arranged along the proximal end to the distal end of the tubular covering film, wherein the adherent framework and the bundle diameter framework are both positioned on the proximal end side of the windowing structure, and the auxiliary framework and the distal framework are both positioned on the distal end side of the windowing structure; the wave trough of the bare stent is fixed on the tubular tectorial membrane, and the wave crest of the bare stent and the supporting rod of the bare stent extend out of the proximal end of the tubular tectorial membrane at least partially; the axial lengths of the supporting rods on the adherence framework are the same; the plurality of beam diameter frameworks are arranged, and the axial lengths of all the support rods on at least one beam diameter framework are the same; the axial length of each supporting rod on the distal framework is the same;
The auxiliary frameworks are provided with at least two, the wave troughs of two adjacent auxiliary frameworks are opposite in the axial direction, and the wave crests of two adjacent auxiliary frameworks are opposite in the axial direction; along the circumferential direction of the main body support, two adjacent wave crests on the auxiliary skeleton comprise high waves and low waves, and the high waves are closer to the proximal end of the main body support than the low waves; in the peaks on the auxiliary skeleton, the high waves and the low waves are alternately arranged along the circumferential direction of the main body support.
In other embodiments, the trough of the bare stent is secured with a plurality of seaming loops by stitching to secure the trough of the bare stent to the tubular covering, the strut is secured with at least one seaming loop by stitching to secure the strut of the bare stent to the tubular covering, and the seaming loops on the strut of the bare stent are immediately adjacent to the seaming loops on the trough of the bare stent; the trough and the support rod of the bare stent are fixed on the axial length of the tubular tectorial membrane through the suture ring to form an anchoring zone, the axial length of the anchoring zone is at least 3-5mm, and the axial length of the anchoring zone is the superposition length of the bare stent and the wall-attached framework in the axial direction.
In other embodiments, the plurality of support frameworks further comprises at least one first reinforcement framework, at least one first reinforcement framework being located on a distal side of the fenestration; the beam diameter framework further comprises at least one second reinforcing framework, at least one second reinforcing framework is positioned at the far end side of at least one second full-fixed framework, the first reinforcing framework and the second reinforcing framework are adjacently arranged in the axial direction, and the first reinforcing framework and the second reinforcing framework are respectively positioned at two sides of the windowing structure in the axial direction; the axial lengths of the supporting rods on at least one first reinforcing framework are the same, the axial lengths of the supporting rods on at least one second reinforcing framework are the same, the wave crests, the wave troughs and the supporting rods on at least one first reinforcing framework are all adhered and fixed on the peripheral wall of the tubular coating, and the wave troughs on the first reinforcing framework are opposite to the wave crests on the second reinforcing framework in the axial direction.
In other embodiments, the flexible beam member is a ring structure, and any at least two points on the ring of the beam member are fixed on the main body support to form two fixing points, so that the flexible beam member forms at least two flexible rings; alternatively, the flexible beam diameter member includes at least two flexible rings, one end of the flexible rings in the length direction is fixed to at least one of the tubular covering film and the supporting skeleton to form a fixing site;
Along the circumference of main part support, two the flexible ring is kept away from the one end of fixed site can coincide each other in order to form the wire loop that supplies the footpath seal wire to wear to establish, the length direction of flexible ring can be followed the circumference of main part support is arranged, and at least two the length direction of flexible ring can encircle the circumference of main part support is in order to make the main part support can radial compression.
In other embodiments, the fixation site is a fixation sleeve that secures the connecting bone to the split struts corresponding to each of the first undulating rings; alternatively, the at least partially fixed position is formed by spirally winding the branch bars of each first wavy ring on the connecting bones.
The split type single embedded branch tectorial membrane support that this application provided, branch support peg graft in embedded support through windowing structure to make branch support and intercommunication chamber intercommunication, thereby will flow through the blood flow of intercommunication intracavity and introduce branch support, rebuild branch artery, branch support and main part support's the cooperation of pegging graft of dismantling can reduce branch support in the heart cycle and amazing the damage of LSA distal end vascular wall, and then guarantee branch artery long-term patency rate. The structural design of the branch stent has great influence on the long-term patency rate of the branch artery, the branch tectorial membrane is a two-layer membranous substance, and the branch skeleton component is positioned between the two-layer membranous substance, so that the damage stimulation of the branch stent to the wall of the LSA far-end blood vessel in the cardiac cycle can be further reduced. The radial compression of the branch stent in the process of the interventional instrument or the radial compression of the branch stent in the process of separating from the interventional instrument to release in the branch artery, friction force between the branch stent and the interventional instrument, pulsation of the target blood vessel and the branch artery, improper release and positioning of the main stent and the branch stent, have different degrees of separation test on the two layers of membranous substances, namely, the two layers of membranous substances have risks of being at least partially separated from each other, so that the branch stent has risks of occlusion, and the long-term patency of the branch stent is influenced. The arrangement of at least two sections of turnover sections is beneficial to improving the problems that the proximal ends and the distal ends of the first layer of membrane and the second layer of membrane are impacted by high-flow blood flow, friction force between the proximal ends and the distal ends and the interventional instruments in the compression and release processes of the branch stent and the impact separation or improper operation of pulsation of a target blood vessel and the branch artery on the branch stent are at least partially separated, reducing the risk of occlusion of the branch stent and improving the long-term patency rate of the branch stent.
Drawings
Fig. 1 is a schematic structural view of a split single-embedded branched stent graft.
Fig. 2 is a schematic structural view of another view of the split single-embedded branched stent graft.
Fig. 3 is a schematic structural view of the main body stent (flexible beam diameter member not shown).
Fig. 4 is a plan expanded view of the body stent (the embedded stent is not shown).
Fig. 5 is a plan view of another possible embodiment of a body mount.
FIG. 6 is a schematic structural view of a flexible beam diameter member mated with an external beam diameter guidewire to radially compress a portion of a body stent.
Fig. 7 is a schematic structural view of the embedded bracket.
Fig. 8 is a schematic structural view of the branch stent.
Fig. 9 is a schematic view of another possible fixation means for connecting the bone to the first wavy ring.
Fig. 10 is a schematic view of a split single-embedded branched stent graft for reconstructing an aortic arch.
Fig. 11 is a schematic view of another exemplary structure of the main body stand.
Fig. 12 is an enlarged schematic view of the structure at a in fig. 11.
Reference numerals illustrate: 1. a main body bracket; 10. a tubular coating; 20. a bare stent; 201. an anchor region; 30. a support skeleton; 3001. a support rod; 3002. a peak; 3003. a trough; 31. adhering to the wall skeleton; 32. a beam diameter skeleton; 321. a first fully-fixed framework; 322. a second fully-fixed framework; 3221. a high wave; 3222. a low wave; 323. a second reinforcing skeleton; 33. a first reinforcing skeleton; 34. an auxiliary skeleton; 341. a free region; 35. a distal end armature; 36. a reinforcing part; 361. a first support bar; 362. a second support bar; 363. reinforcing the valleys; 364. the first adherence trough; 365. the second adherence trough; 366. a first avoidance peak; 367. a second avoidance peak; 40. a flexible beam diameter member; 401. a flexible ring; 402. a fixation site; 403. a wire loop; 404. a bundle diameter guide wire; 50. stitching the coil; 60. connecting nodes; 70. developing the mark; 2. a bracket is embedded; 21. embedding a coating film; 22. an embedded skeleton; 3. a branch bracket; 301. branching and coating; 302. a support section; 303. a flexible section; 304. an adherence section; 305. a turnover section; 306. supporting the bone ring; 3061. a first wave ring; 3062. a second wave ring; 3063. connecting bones; 3064. a branch rod; 3065. a fixed sleeve; 307. a flexible bone ring; 371. a waveform unit; 372. a unit bar; 308. a wall bone sticking ring; 4. a windowing structure; 5. aortic arch; 6. small curved sides; 7. left clavicle artery; 8. tumor cavity.
Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, based on the embodiments herein, which would be apparent to one of ordinary skill in the art without undue burden are within the scope of the present application.
For the field of interventional medical instruments, the proximal end refers to the end of the stent, which is close to the heart of a human body after being used for interventional therapy, and the distal end refers to the end of the stent, which is far away from the heart of the human body after being used for interventional therapy. The direction of the rotation center axis of the column body, the tube body and other objects is the axial direction, and the direction perpendicular to the axial direction is the radial direction. Circumferential refers to "circumferential direction", i.e., about the cylinder, the tube, and the like (perpendicular to the axis, and also perpendicular to the radius of the cross section). The "circumferential", "axial" and "radial" collectively form three orthogonal directions of the cylindrical coordinates. The circumferential length refers to the extension of the structure or element in the circumferential direction of the column, tube, etc. The axial length refers to the extension of the structure or element in the axial direction of the column, tube, etc. This description is made for the sake of convenience only, and is not intended to limit the present application. The following structure refers to the structure of the split single embedded branch stent graft after expansion.
In order to solve the problem that the branch stent of the existing stent graft will cause loss to the inner wall of an artery when being pulled into the branch artery, the first embodiment of the application provides a split type single-embedded branch stent graft which can be applied to a blood vessel to implement an intra-cavity isolation operation to isolate a lesion area or an isolated interlayer breach in the lumen, for example, the split type single-embedded branch stent graft can be adopted to isolate an arterial interlayer breach or an aneurysm in the lumen of the blood vessel. It will be appreciated that the vessel may be the aortic arch, thoracic aorta, or abdominal aorta, etc. It will be appreciated by those of ordinary skill in the art that the use of blood vessels is illustrated by way of example only and not by way of limitation of the present application, and that the present embodiments are applicable to a variety of human or animal lumens, such as the lumen of the digestive tract, and the like.
Referring to fig. 1 and 2, fig. 1 is a schematic structural diagram of a split single-embedded branch stent graft, and fig. 2 is a schematic structural diagram of another view of the split single-embedded branch stent graft. The split type single embedded branch tectorial membrane support comprises a main body support 1, an embedded support 2 fixed on the inner wall of the main body support 1 and a branch support 3 detachably connected to the main body support 1, wherein the branch support 3 is used for reconstructing a branch artery. The main body stent 1 has a tubular structure with two open ends, and the main body stent 1 is enclosed into a communication cavity (not shown in the figure) for communicating with a target blood vessel. The main body support 1 is provided with at least one windowing structure 4, and the windowing structure 4 can be round, oval or other irregular shapes, etc. The embedded support 2 is of a tubular structure with two open ends, and one end of the embedded support 2 is fixed on the windowing structure 4 in a sealing mode, so that the windowing structure 4 is communicated with the communicating cavity of the main body support 1 through the embedded support 2. The branch stent 3 has a tubular structure with two open ends, and the branch stent 3 is enclosed into a connecting cavity (not shown in the figure) for communicating with the branch artery. The branch stent 3 is inserted into the embedded stent 2 through the windowing structure 4 so that the branch stent 3 is communicated with the communication cavity, and thus, blood flowing through the communication cavity is introduced into the branch stent 3, and the branch artery is rebuilt. The detachable splicing cooperation of the branch stent 3 and the main body stent 1 can reduce the damage stimulation of the branch stent 3 to the LSA far-end vascular wall in the cardiac cycle, thereby ensuring the long-term patency rate of the branch artery.
Referring to fig. 3 and 4 in combination, fig. 3 is a schematic structural view of the main body stent 1 (the flexible beam member 40 is not shown), and fig. 4 is a plan-expanded view of the main body stent 1 (the embedded stent 2 is not shown). The main body stent 1 comprises a tubular covered film 10, a bare stent 20, a plurality of supporting skeletons 30 and a plurality of groups of flexible beam diameter members 40. The bare stent 20 and the supporting frameworks 30 are of annular structures, the bare stent 20 is fixed at the proximal end of the tubular tectorial membrane 10, the supporting frameworks 30 are located at the distal end side of the bare stent 20, and the supporting frameworks 30 are sequentially arranged and fixed along the axial direction of the tubular tectorial membrane 10. The bare stent 20 and the supporting framework 30 each comprise a plurality of supporting rods 3001 which are sequentially connected in an included angle manner, two adjacent included angles are respectively a peak 3002 and a trough 3003 along the circumferential direction of the main stent 1, and the peak 3002 is closer to the proximal end of the main stent 1 than the trough 3003. The bare stent 20 and the supporting framework 30 can be fixed on the tubular film 10 by sewing, pasting, stamping, pasting, embedding or hot pressing. The multiple groups of flexible beam diameter members 40 are all located at the proximal end side of the fenestration structure 4, the flexible beam diameter members 40 are used for radially compressing the local main body support 1 located at the proximal end side of the fenestration structure 4, that is, the area from the proximal end edge of the fenestration structure 4 to the proximal end edge of the main body support 1 can be radially compressed by the flexible beam diameter members 40 to be in a radial compression state, so that after the main body support 1 enters a target vessel, at least part of the main body support 1 which is radially compressed can still axially move or circumferentially rotate in the target vessel, thereby being convenient for accurately adjusting the position of the fenestration structure 4, enabling the fenestration structure 4 to be better centered with the root openings of branch arteries, and improving the positioning accuracy of the fenestration structure 4.
The supporting frames 30 include an attaching frame 31, a beam-diameter frame 32, at least one first reinforcing frame 33, an auxiliary frame 34 and a distal frame 35, and the attaching frame 31, the beam-diameter frame 32, the at least one first reinforcing frame 33, the auxiliary frame 34 and the distal frame 35 are sequentially arranged and fixed along the proximal end of the tubular covering film 10 to the distal end of the tubular covering film 10. The wall skeleton 31 and the beam skeleton 32 are both located at the proximal side of the fenestration product 4, and the auxiliary skeleton 34, the distal skeleton 35, and the at least one first reinforcing skeleton 33 are all located at the distal side of the fenestration product 4.
The trough 3003 of the bare stent 20 is fixed on the tubular covering film 10, and the peak 3002 of the bare stent 20 and the supporting bar 3001 of the bare stent 20 extend at least partially out of the proximal end of the tubular covering film 10, i.e., at least part of the supporting bar 3001 of the bare stent 20 and the peak 3002 of the bare stent 20 are not covered by the tubular covering film 10, in other words, along the axial direction of the supporting bar 3001, the supporting bar 3001 is at least partially not covered by the tubular covering film 10, and the peak 3002 of the bare stent 20 is not covered by the tubular covering film 10. The wave trough 3003 of the bare stent 20 is fixedly secured with a plurality of seaming loops 50 by seaming to fix the wave trough 3003 of the bare stent 20 to the proximal end of the tubular cover 10 (i.e., closely adjacent between the plurality of seaming loops 50), the support rod 3001 is fixedly secured with at least one seaming loop 50 by seaming to fix the support rod 3001 of the bare stent 20 to the tubular cover 10, and the seaming loops 50 on the support rod 3001 are closely adjacent to the seaming loops 50 on the wave trough 3003 of the bare stent 20. The valleys 3003 and the support rods 3001 of the bare stent 20 are fixed to the axial length of the tubular stent graft 10 by the suture loops 50 to form an anchoring area 201, the axial length of the anchoring area 201 is at least 3-5mm, i.e., the axial length of the bare stent 20 covered by the tubular stent graft 10 is 3-5mm, and the portion of the bare stent 20 covered by the tubular stent graft 10 is fixed to the tubular stent graft 10 by the suture loops 50. In other embodiments, an exemplary formation of the seaming coil 50 may be: for example, the support frame 30 is fixed to the outer peripheral wall of the tubular film 10, two sides of the support rod 3001 in the length direction are named as a first side and a second side, one end of a suture is fixed to the outer peripheral wall of the tubular film 10, step S1, the other end of the suture penetrates into the inner peripheral wall of the tubular film 10 along the first side of the support rod 3001, step S2, then the suture penetrates out from the inner peripheral wall of the tubular film 10 to the outer peripheral wall of the tubular film 10 along the second side of the support rod 3001, step S3, and then the suture wraps around the support rod 3001 and penetrates into the inner peripheral wall of the tubular film 10 from the first side of the support rod 3001, and after step S1-step S3, a suture ring 50 with a substantially annular structure is formed. Finally, the steps S1 to S3 are repeated along the shape of the support frame 30 to fix the bare stent 20, the support frame 30 to the tubular covering film 10.
The wall-attaching frame 31, the beam-diameter frame 32, the peaks 3002, the troughs 3003 and the supporting rods 3001 of the at least one first reinforcing frame 33 and the distal end frame 35 are all fixed on the tubular covering film 10 through suture lines, for example, the peaks 3002 and the troughs 3003 are all fixed with a plurality of stitching coils 50 through suture line encryption stitching (i.e. the stitching coils 50 are closely adjacent to each other), the supporting rods 3001 are provided with at least one stitching coil 50 at intervals, so that the suture lines attach and fix the wall-attaching frame 31, the beam-diameter frame 32, the at least one first reinforcing frame 33 and the distal end frame 35 on the tubular covering film 10, and further the wall-attaching frame 31, the beam-diameter frame 32, the at least one first reinforcing frame 33 and the distal end frame 35 are almost completely attached to the tubular covering film 10, thereby improving the radial supporting force of the wall-attaching frame 31, the beam-diameter frame 32, the at least one first reinforcing frame 33 and the distal end frame 35, and being beneficial for avoiding hooking the beam-diameter frame 32 to the flexible beam-diameter member 40, thereby facilitating the release of the main body frame 1 and the main body frame 1 from expanding to the predetermined shape.
At least one stud 31 is located on the proximal side of the fenestration product 4. The waveform trend of the wall-attached skeleton 31 is consistent with that of the bare stent 20, namely, the wave crest 3002 of the wall-attached skeleton 31 is opposite to the wave crest 3002 of the bare stent 20 in the axial direction, and the wave trough 3003 of the first full-fixed skeleton 321 is opposite to the wave trough 3003 of the bare stent 20 in the axial direction, so that the wave crest 3002 of the wall-attached skeleton 31 can be positioned in the area between two adjacent support rods 3001 of the bare stent 20, which is beneficial to avoiding the occurrence of Ia-type internal leakage because the proximal end of the tubular tectorial membrane 10 is easy to wrinkle due to the bending of the anatomical structure of the target vessel after the proximal end of the tubular tectorial membrane 10 is implanted into the target vessel. The points where the support rods 3001 on the bare stent 20 cross the proximal edge of the tubular tectorial membrane 10 and the points where the peaks 3002 of the wall-attached skeleton 31 contact the tubular tectorial membrane 10 are named as connection nodes 60, and the axial length of the anchoring area 201 of the bare stent 20 is set, so that the connection nodes 60 are reasonably distributed along the circumferential direction of the tubular tectorial membrane 10, the fact that the interval between any two adjacent connection nodes 60 along the circumferential direction is too large is avoided, namely, the arrangement of the axial length of the anchoring area 201 enables the connection nodes 60 to be distributed more uniformly along the circumferential direction of the tubular tectorial membrane 10, the problem that wrinkling occurs after the proximal end of the tubular tectorial membrane 10 is implanted in a curved target blood vessel is further avoided, and the effect of preventing internal leakage is better achieved. The peak 3002 of the wall-attaching frame 31 is fixed at the position of the tubular covering film 10 near the proximal edge, so that the axial length of the anchoring area 201 is approximately equal to the overlapping length of the bare stent 20 and the wall-attaching frame 31 in the axial direction (i.e. the distance between the peak 3002 of the wall-attaching frame 31 and the proximal edge of the tubular covering film 10 allows an error of +/-1.5 mm), and the setting of the axial length of the anchoring area 201 of the bare stent 20 enables the waveform trend of the wall-attaching frame 31 to be consistent with the waveform trend of the bare stent 20 in the radial shrinkage or radial self-expansion process of the main stent 1, thereby being beneficial to avoiding the deformation of the proximal end of the main stent 1 in the radial shrinkage or radial self-expansion process, and further improving the wall-attaching performance between the main stent 1 and the vascular wall and further improving the inner leakage prevention effect. In the wall-attached scaffold 31, the support rods 3001 have the same axial length along the tubular covering film 10, so as to enhance the radial supporting force of the proximal end of the main body stent 1, thereby being beneficial to reducing the risk of displacement of the main body stent 1 due to the impact of high-flow blood flow after the main body stent 1 is implanted into a target blood vessel.
The beam diameter skeleton 32 comprises at least one first full-fixing skeleton 321, at least one second full-fixing skeleton 322 and at least one second reinforcing skeleton 323, and the at least one first full-fixing skeleton 321, the at least one second full-fixing skeleton 322 and the at least one second reinforcing skeleton 323 are sequentially arranged and fixed along the proximal end to the distal end of the tubular covering film 10. At least one first full fixation frame 321 may be located at the proximal side of the fenestration structure 4. The at least one first fully-fixed skeleton 321 is located at the distal end side of the at least one wall-mounted skeleton 31, and the wavelength of the first fully-fixed skeleton 321 is smaller than that of the other supporting skeletons 30, in other words, the waveforms of the at least one first fully-fixed skeleton 321 are denser than those of the other supporting skeletons 30, so that the proximal end of the body stent 1 better fits the vessel wall, and the risk of Ia-type internal leakage is reduced. The axial length of each supporting rod 3001 on the at least one first fully-fixed framework 321 along the main body stent 1 is the same, so as to further increase the radial supporting force at the proximal end of the main body stent 1, thereby being beneficial to reducing the risk of displacement of the main body stent 1 due to the impact of high-flow blood flow after the main body stent 1 is implanted into a target blood vessel.
At least one second fully-fixed armature 322 is located on the proximal side of the fenestration structure 4. The axial length of each support rod 3001 on at least one third fixed skeleton is different, specifically, in the circumferential direction of the main body support 1, two adjacent wave crests 3002 include a high wave 3221 and a low wave 3222, and the high wave 3221 is closer to the proximal end of the main body support 1 than the low wave 3222. Along the circumference of the main body support 1, the high waves 3221 and the low waves 3222 are alternately arranged, so that the return force of the proximal end of the main body support 1 is reduced, the flexibility of the proximal end of the main body support 1 is improved, the proximal end of the main body support 1 is better attached to a curved vascular anatomical structure, and the occurrence risk of Ia-type internal leakage is reduced.
In other embodiments, for example, referring to fig. 5, fig. 5 is a plan view of another possible embodiment of the main body support 1. The provision of the second full fixation frame 322 may also be omitted.
In the present embodiment, the first reinforcing frame 33 and the second reinforcing frame 323 are disposed adjacent to each other in the axial direction, the first reinforcing frame 33 and the second reinforcing frame 323 are located on both sides of the fenestration structure 4 in the axial direction, respectively, that is, the first reinforcing frame 33 is located on the distal end side of the fenestration structure 4, and the second reinforcing frame 323 is located on the proximal end side of the fenestration structure 4. The axial length of each support rod 3001 on the first reinforcement cage 33 is the same, and the axial length of each support rod 3001 on the second reinforcement cage 323 is the same. The arrangement of the first reinforcement ribs 33 and the second reinforcement ribs 323 serves to enhance the radial supporting force around the fenestration product 4, so that the fenestration product 4 can be more sufficiently contacted with the vessel wall, which is advantageous in improving the problem that the fenestration product 4 is deformed by extrusion (e.g., extrusion of calcified plaque, irregular vessel cross section, etc. to the main body stent 1). For the peaks 3002 and the valleys 3003 on the first reinforcing skeleton 33 and the second reinforcing skeleton 323, the peaks 3002 on the first reinforcing skeleton 33 and the valleys 3003 on the second reinforcing skeleton 323 are opposite in the axial direction, and the valleys 3003 on the first reinforcing skeleton 33 and the peaks 3002 on the second reinforcing skeleton 323 are opposite in the axial direction, so that the problem that the part of the main body support 1, which is close to the windowing structure 4, is axially shortened is solved, the windowing structure 4 is fully ensured to return to a preset shape from a radial compression state, meanwhile, more sufficient space can be reserved for the windowing structure 4, and the windowing structure 4 is further fully ensured to return to the preset shape from the radial compression state.
In other embodiments, the axial length of the first reinforcement cage 33 may be different, and the axial length of the second reinforcement cage 323 may be different, that is, the adjacent two peaks 3002 of the first reinforcement cage 33 and the second reinforcement cage 323 include a high wave 3221 and a low wave 3222, and the high wave 3221 is closer to the proximal end of the tubular covering film 10 than the low wave 3222 in the circumferential direction of the main body stent 1. Along the circumference of the main body support 1, high waves 3221 and low waves 3222 are alternately arranged to further improve the flexibility of the proximal end of the main body support 1 and improve the beak symptom effect.
According to exemplary embodiments of the present application, in some exemplary embodiments, the second reinforcement cage 323 may also be omitted such that the fenestration structure 4 is positioned between the at least one first full fixation cage 321 and the first reinforcement cage 33.
The auxiliary skeletons 34 are provided with at least two, the axial lengths of the support rods 3001 on at least two auxiliary skeletons 34 are not the same, that is, in the circumferential direction of the main body stent 1, high waves 3221 and low waves 3222 are included in two adjacent peaks 3002 on the auxiliary skeletons 34, the high waves 3221 being closer to the proximal end of the tubular covering film 10 than the low waves 3222. Along the circumferential direction of the tubular coating 10, high waves 3221 and low waves 3222 are alternately arranged. High wave 3221 on auxiliary skeleton 34 near the proximal end of tubular film 10 is axially opposite low wave 3222 on auxiliary skeleton 34 near the distal end of tubular film 10, and wave troughs 3003 on auxiliary skeleton 34 near the proximal end of tubular film 10 are axially opposite wave troughs 3003 on auxiliary skeleton 34 near the distal end of tubular film 10, such that the wave patterns of at least two auxiliary skeletons 34 are substantially identical.
The low wave 3222, the wave trough 3003 and the support rod 3001 of the auxiliary frame 34 are all fixed to the tubular covering film 10 by suture stitching, for example, the low wave 3222 and the wave trough 3003 are all fixed with a plurality of stitching coils 50 by suture encryption stitching (i.e., the plurality of stitching coils 50 are closely adjacent to each other), and at least one stitching coil 50 is arranged at intervals of the support rod 3001, so that the suture stitching secures the auxiliary frame 34 to the tubular covering film 10. The high wave 3221 of the auxiliary skeleton 34 and the tubular coating 10 have a gap therebetween and the high wave 3221 of the auxiliary skeleton 34 can be separated from the tubular coating 10 to form the free region 341, that is, the high wave 3221 of the auxiliary skeleton 34 does not need to be fixed to the tubular coating 10 by a suture, or the high wave 3221 of the auxiliary skeleton does not need to be fixed to the tubular coating 10 by means of pasting, stamping, pasting, embedding, hot pressing, or the like, so that the high wave 3221 of the auxiliary skeleton 34 has more deformation space than the low wave 3222 of the auxiliary skeleton 34. The axial length of the free region 341 is 2.5-4mm, ensuring that the high wave 3221 of the auxiliary skeleton 34 has sufficient moving space.
After the main body stent 1 is implanted into a curved target blood vessel, for example, after the main body stent 1 is implanted into the aortic arch 5, in order to adapt to the arch part of the arch of the aortic arch 5, the side, close to the small curved side 6 (refer to fig. 10), of the main body stent 1 needs to be adaptively curved, then the peaks 3002 and the troughs 3003 of the supporting frameworks 30 on the main body stent 1 can be axially close to each other, the alternating arrangement of the high waves 3221 and the low waves 3222 on the auxiliary frameworks 34 and the free areas 341 of the high waves 3221 are arranged, so that the side, close to the small curved side 6, of the auxiliary frameworks 34 has a larger deformation space, that is, the supporting rods 3001, close to the small curved side 6, of the adjacent two auxiliary frameworks 34 can be axially deformed to increase the axial superposition length, meanwhile, the high waves 3221 can be folded axially with the axially adjacent supporting frameworks 30 in the direction away from the central axis of the main body stent 1, and the free areas 341 of the high waves 3221 are arranged to drive the adjacent supporting frameworks 30 to be folded axially with the axially adjacent supporting frameworks 30 in the direction close to the main body stent 1, so that the side, close to the small curved side 6 of the small curved side of the main body stent 1 is more in the curve, and the leakage of the small curved side 6 is reduced. The greater the arch width of the target blood vessel, the greater the degree of axial deformation of the support rod 3001 of the auxiliary frame 34 on the side close to the small-curve side 6 of the blood vessel.
The distal end skeletons 35 are provided with at least two, and the at least two distal end skeletons 35 are sequentially arranged in the axial direction of the tubular covering film 10. The axial length of each supporting rod 3001 on the distal end skeleton 35 is the same, so as to increase the radial supporting force of the distal end of the main body stent 1, which is beneficial to improving the problem that the main body stent 1 is easy to displace after being implanted into a target blood vessel. The distal end of the tubular covering film 10 is provided with at least one developing mark 70, the developing mark 70 is positioned at the proximal end or the proximal side of at least two distal end skeletons 35 near the distal end port of the tubular covering film 10, that is, the developing mark 70 can be fixed on the distal end skeletons 35 so that the developing mark 70 is positioned at the proximal end of at least two distal end skeletons 35 near the distal end port of the tubular covering film 10; the development marks 70 may also be affixed to the tubular cover 10 such that the development marks 70 are located on the proximal side of at least two distal backbones 35 near the distal end of the tubular cover 10. The axial length of the development mark 70 and the distal edge of the tubular cover film 10 is at least 30-50mm. The developing mark 70 is used for indicating the position of the other external connection support inserted into the main body support 1, so that the external connection support and the main body support 1 have sufficient coincident axial length, and sufficient anchoring length is provided for the external connection support. The proximal end of the tubular cover 10 may also be affixed with at least one visualization mark 70 for indicating the proximal position of the body stent 1; the distal end of the tubular cover 10 may also be affixed with at least one visualization mark 70 for indicating the distal position of the body stent 1. A plurality of developing marks 70 may be fixed to the tubular film 10 around the circumference of the window structure 4. In other embodiments, the number of the development marks 70 around the circumference of the fenestration product 4 is four, wherein two development marks 70 are located on both sides of the fenestration product 4 in the axial direction of the main body support 1 and the other two development marks 70 are located on both sides of the fenestration product 4 in the circumferential direction of the main body support 1. The two developing marks 70 on the two axial sides of the windowing structure 4 are convenient for aligning the windowing structure 4 with the root opening edge of the branch artery to the maximum extent, so that an operator can conveniently judge the release completion degree of the windowing structure 4, namely, whether the windowing structure 4 is released to the maximum diameter; the two developing marks 70 on the two circumferential sides of the windowing structure 4 are convenient for an operator to judge the superposition condition of the two developing marks 70 after the main body support 1 is released, if the two developing marks 70 on the circumferential sides of the windowing structure 4 are not superposed, the operator can adjust the position of the main body support 1 again to adjust the position of the windowing structure 4 until the two developing marks 70 on the circumferential sides of the windowing structure 4 are superposed, so that the windowing structure 4 is better ensured to be more completely matched with the root opening of the branch artery, the positioning accuracy of the release of the branch support 3 is ensured, and the operation difficulty in operation is obviously reduced.
The material of the developing mark 70 may be made of a material having good X-ray impermeability, strong corrosion resistance, good biocompatibility, and may be gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium, or an alloy of these materials. It will be appreciated that the development mark 70 may also be understood as having development material at the corresponding distal end armature 35 or at the corresponding location of the tubular cover film 10; alternatively, the developing marks 70 may be provided at corresponding positions of the tubular covering film 10, or the developing marks 70 may be provided on the corresponding distal end frame 35 or the fenestration structure 4, respectively, and the developing marks 70 may be provided at least around a part of the distal end frame 35 or the fenestration structure 4.
Referring to fig. 4 and 6 in combination, fig. 6 is a schematic structural view of the flexible beam diameter member 40 and the external beam diameter guide wire 404 in cooperation to radially compress a portion of the main body stent 1. The flexible beam member 40 is a ring structure, and any two points on the ring of the flexible beam member 40 are fixed on the supporting frame 30 to form two fixing points 402 (for example, the fixing points 402 are formed by sewing, attaching, stamping, attaching, embedding or hot pressing, etc. to fix on the supporting frame 30), so that the flexible beam member 40 forms at least two flexible rings 401. The two fixation sites 402 may be substantially coincident to enable the lengthwise direction of the flexible ring 401 to be aligned along the circumferential direction of the tubular cover 10. The two fixing sites 402 may also be misaligned, for example, the two fixing sites 402 may be circumferentially spaced apart, axially spaced apart, or both circumferentially and axially spaced apart, such that at least a portion of the length of the flexible ring 401 is aligned in the circumferential direction of the tubular cover 10. In this embodiment, at least two fixing points 402 on the flexible beam member 40 may be substantially coincident to form coincident fixing points, and a plurality of coincident fixing points formed by a plurality of groups of flexible beam members 40 may extend substantially in an axial direction of the main body stent 1. It will be appreciated that in other embodiments, at least two flexible loops 401 may be formed independently of each other, rather than being separated from the same annular structure by providing at least two fixation sites 402, for example, flexible beam diameter member 40 includes at least two flexible loops 401 with one longitudinal end of flexible loops 401 being secured to at least one of tubular cover 10 and support frame 30 to form fixation sites 402.
The multiple groups of flexible beam members 40 are arranged in sequence from the proximal end to the distal end of the tubular covering film 10, and the multiple groups of flexible beam members 40 are all located at the proximal end side of the fenestration structure 4. For the same flexible beam member 40, one ends of at least two flexible rings 401 far away from the fixing site 402 are close to each other along the circumferential direction of the main body support 1 until one ends of at least two flexible rings 401 far away from the fixing site 402 can be mutually overlapped to form a wire ring 403 for the beam diameter guide wire 404 to penetrate, the length directions of the flexible rings 401 can be distributed along the circumferential direction of the main body support 1, and the length directions of the at least two flexible rings 401 can encircle the circumferential direction of the main body support 1 so that the main body support 1 can be radially compressed. The plurality of wire loops 403 formed by the plurality of groups of flexible beam diameter members 40 are arranged and extended along the axial direction of the main body support 1, and a beam diameter guide wire 404 sequentially penetrates through each wire loop 403 along the axial direction of the main body support 1, so that at least two flexible loops 401 on each flexible beam diameter member 40 can form a ring surrounding the main body support 1 along the circumferential direction of the main body support 1, and the beam diameter guide wire 404 plays a role of maintaining the ring, so that part of the axial length of the main body support 1 is in a radial compression state. After the main body support 1 is implanted into a target blood vessel, the radially compressed main body support 1 can still axially move or circumferentially rotate in the target blood vessel, so that the position of the windowing structure 4 can be accurately adjusted, the windowing structure 4 can be better centered with the root opening of a branch artery, and the positioning accuracy of the windowing structure 4 is improved.
Along the axial direction of the main body support 1, at least one trough 3003 of the bare support 20 is provided with a flexible beam diameter member 40, at least one trough 3003 of the wall-mounted skeleton 31 is provided with a flexible beam diameter member 40, and at least one trough 3003 and at least one crest 3002 adjacent to each beam diameter skeleton 32 are provided with a flexible beam diameter member 40. In other words, along the axial direction of the main body support 1, the overlapping fixed points of the multiple groups of flexible beam diameter members 40 are respectively located in at least one wave trough 3003 of the bare support 20, at least one wave trough 3003 of the wall-attached skeleton 31, at least one wave crest 3002 and at least one wave trough 3003 adjacent to each other on the first full-fixed skeleton 321, at least one wave crest 3221 and at least one wave trough 3003 adjacent to each other on the second full-fixed skeleton 322, and at least one wave crest 3002 and at least one wave trough 3003 adjacent to each other on the second reinforcing skeleton 323. Compared with the arrangement of the coincident fixed points on the support rod 3001 and the arrangement of the coincident fixed points on the adjacent wave crests 3002 and wave troughs 3003 of the support framework 30, the problem that the wave crests 3002 and the wave troughs 3003 tilt towards the direction far away from the central axis of the main body support 1 after the main body support 1 is radially assembled in an interventional instrument is solved, so that the friction between the proximal end of the main body support 1 and the inner wall of the interventional instrument is reduced, and the proximal end of the main body support 1 can be separated from the interventional instrument and released to a target blood vessel more smoothly. Along the axial direction of the main body support 1, each overlapping fixed point is located on a similar wave crest 3002 and a similar wave trough 3003 on each supporting framework 30, so that a plurality of overlapping fixed points formed by a plurality of groups of flexible beam diameter members 40 are arranged and extended along the axial direction of the main body support 1.
It will be appreciated that if the main body bracket 1 may omit the second full-fixing skeleton 322 and/or the second reinforcing skeleton 323, the flexible beam members 40 on the second full-fixing skeleton 322 and/or the second reinforcing skeleton 323 are omitted accordingly.
Referring to fig. 4 and fig. 7 in combination, fig. 7 is a schematic structural diagram of the embedded bracket 2. The proximal end of the embedded bracket 2 is fixed on the windowing structure 4 in a sealing way, so that the windowing structure 4 is communicated with the communicating cavity through the embedded bracket 2. The distal end of the embedded bracket 2 extends to the distal end of the main body bracket 1, so that a guide wire access way in the process of the intra-luminal interventional therapy is more convenient, and a more ideal intra-luminal interventional therapy effect is achieved. The embedded stent 2 comprises an embedded coating 21 and a plurality of embedded frameworks 22, wherein the embedded coating 21 is in a tubular structure, and the embedded frameworks 22 are sequentially arranged along the axial direction of the embedded coating 21. The distal end of the inner covering film 21 is a bevel, so that the side of the distal end of the inner covering film 21, which is close to the central axis of the main body stent 1, is closer to the proximal end of the main body stent 1 than the side of the distal end of the inner covering film 21, which is far away from the central axis of the main body stent 1. The design that the distal end mouth of embedded tectorial membrane 21 is the bevel connection is favorable to avoiding the too concentrated stress of the distal end mouth of embedded tectorial membrane 21, and the too concentrated stress leads to embedded support 2 distal end mouth after the radial compression of embedded support 2 to be difficult to self-expanding and resume predetermined form easily. The embedded framework 22 is of an open-loop structure, and an open-loop opening of the embedded framework 22 is positioned on one side of the embedded covering film 21, which is close to the inner wall of the main body bracket 1. The open-loop structure of the embedded skeleton 22 is beneficial to reducing the radial dimension of the main body stent 1, so that the main body stent 1 can be released from the interventional instrument more smoothly.
The branch stent 3 is inserted into the embedded stent 2 so that the branch stent 3 is communicated with the communication cavity, and thus, the blood flowing through the communication cavity is introduced into the branch stent 3, and the branch artery is rebuilt. The structural design of the branch stent 3 has great influence on the long-term patency rate of the branch artery, the technology of the integrated branch aortic tectorial membrane stent is provided in the technology of the branch stent 3 to treat a Stanford B-type interlayer patient, but the problems of high-flow blood flow impact, wide pulse range of the vessel wall, release and positioning of the incorrect main stent 1 and the branch stent 3, irregular shape of the vessel cross section and the like can be possibly caused, the structural limitation of the branch stent 3 is difficult to ensure the long-term patency rate of the branch stent 3, the risk of occlusion of the branch stent 3 is possibly caused, the medium-term and long-term curative effect of interventional therapy is difficultly ensured, and the bare stent 20 is possibly placed in the branch stent 3 for branch arterial intervention in the later stage to ensure the patency rate of the branch stent 3, and the occurrence risk of complications is increased.
In order to solve the problem that the long-term unobstructed rate of the branch support 3 is difficult to ensure after the branch support 3 is inserted into the main support 1, different areas of the branch support 3 adopt different structural designs along the axial direction of the branch support 3.
Referring to fig. 1 and 8 in combination, fig. 8 is a schematic structural view of the branch stent 3. The branch stent 3 includes a branch stent graft 301 and a branch stent-graft assembly fixed to the branch stent graft 301. Along the radial direction of the branch stent 3, the branch coating 301 includes a first layer of film (not shown in the figure) located inside the connection lumen of the branch stent 3 and a second layer of film located outside the branch stent 3, the first layer of film being for contact with blood flow and the second layer of film being for contact with the blood vessel wall. The branching frame members are fixed between the first and second films, for example, by being fixed between the first and second films by means of heat pressing.
Along the axial direction of the branch stent 3, the branch stent 3 comprises a supporting section 302, a flexible section 303 and an adherence section 304 which are sequentially connected from the proximal end to the distal end, wherein the supporting section 302 and the adherence section 304 are of an equal diameter structure, and the flexible section 303 adopts a taper design. It will be appreciated that the constant diameter configuration of support segment 302 and wall segments 304 is a relatively flexible segment 303 that allows for a tolerance of + -10% during actual production, or that support segment 302 and wall segments 304 may have a small magnitude taper design at the time of design such that support segment 302 and wall segments 304 may not be a complete constant diameter configuration. The radial dimension of the support section 302 is greater than the radial dimension of the abutment section 304, and the radial dimension of the support section 302 is greater than the radial dimension of the embedded bracket 2. The proximal radial dimension of flexible segment 303 is greater than the distal radial dimension of flexible segment 303, the proximal end of flexible segment 303 is coupled to support segment 302, and the distal end of flexible segment 303 is coupled to wall segment 304.
The branched stent 3 further comprises a turnover section 305, the turnover section 305 is provided with at least two sections, the at least two sections of turnover sections 305 are respectively located at the proximal end and the distal end of the branched stent 301, the turnover section 305 is located in the connecting cavity, and the turnover section 305 is fixed to the inner peripheral wall of the branched stent 301, for example, the turnover section 305 can be fixed to the inner peripheral wall of the branched stent 301 by stitching, laminating, stamping, attaching, inlaying or hot pressing. The folded sections 305 are formed by folding the proximal and distal ends of the branched cover 301 inwardly into the connecting lumen, i.e., at least one folded section 305 is integrally formed with the proximal end of the branched cover 301 and at least one folded section 305 is integrally formed with the distal end of the branched cover 301. Since the branch covering film 301 includes the first layer film and the second layer film, the branch covering film 301 is a two-layer film, and the branch skeleton assembly is located between the two-layer film, the branch stent 3 is radially compressed in the process of the interventional device, or the friction force between the branch stent 3 and the interventional device, pulsation of the target blood vessel and the branch artery, improper release and positioning of the main stent 1 and the branch stent 3 in the process of separating the branch stent 3 from the interventional device, have different degrees of separation test on the two-layer film, that is, the two-layer film has a risk of being at least partially separated from each other, resulting in the branch stent 3 having a risk of being blocked, and affecting the long-term patency of the branch stent 3. The arrangement of at least two sections of turnover sections 305 is beneficial to improving the problems that the proximal ends and the distal ends of the first layer of membrane and the second layer of membrane are impacted by high-flow blood, friction force between the proximal ends and the distal ends and the insertion instruments in the compression and release processes of the branch stent 3, impact separation or improper operation of pulsation of a target blood vessel and the branch artery on the branch stent 3 are at least partially separated, reducing the risk of occlusion of the branch stent 3 and improving the long-term patency rate of the branch stent 3. The axial length of the folded-over section 305 is 1-5mm.
The branched framework assembly comprises a supporting bone ring 306, a flexible bone ring 307 and an adherent bone ring 308 which are sequentially arranged along the axial direction of the branched bracket 3, wherein the supporting bone ring 306 is positioned on the supporting section 302, the flexible bone ring 307 sequentially extends from at least part of the supporting section 302, the flexible section 303 and at least part of the adherent section 304, and the adherent bone ring 308 is positioned on the adherent section 304.
The supporting bone 306 comprises a plurality of first wavy rings 3061, at least one second wavy ring 3062 and a connecting bone 3063, wherein the plurality of first wavy rings 3061 and the at least one second wavy ring 3062 are sequentially arranged along the axial direction of the branched stent 3, the second wavy ring 3062 is positioned at the distal end side of the first wavy ring 3061, in other words, the first wavy ring 3061 is closer to the proximal end of the branched stent 3 than the second wavy ring 3062. The union 3063 connects together a plurality of first wave rings 3061. The first wave ring 3061 and the second wave ring 3062 each include a plurality of branch bars 3064 connected in sequence at angles, two adjacent angles are respectively a peak 3002 and a trough 3003 along the circumferential direction of the branch stent 3, and the peak 3002 is closer to the proximal end of the branch stent 3 than the trough 3003. Each first wave ring 3061 is provided with at least one fixation location fixed with the connecting bone 3063 such that the connecting bone 3063 axially connects the plurality of first wave rings 3061. A fixed location is located on the branch 3064 of each first wave ring 3061. The fixing location may be formed by stitching, overlaying, stamping, attaching, embedding, welding, or hot pressing, and in this embodiment, the fixing location is a fixing sleeve 3065, and the fixing sleeve 3065 fixes the connecting bone 3063 on the branching rod 3064 on each first waveform ring 3061. Along the axial direction of the branch stent 3, the connecting bones 3063 extend along adjacent support rods 3001 connecting the two first undulating rings 3061 such that the connecting bones 3063 are of an inclined linear shape extending from the proximal end to the distal end of the support segment 302. The setting of the linking bone 3063 is beneficial to improving the problem that the branch stent 3 is shortened due to the friction of the interventional instrument, the pulsation of the blood vessel, the impact of the blood flow and the like, or reducing the amplitude of the shortening, and simultaneously has the effect of enhancing the radial supporting force of the supporting section 302. The provision of the connecting bone 3063 in an inclined linear configuration is advantageous in reducing the risk of the connecting bone 3063 bursting through the first and second membranes during the return to the predetermined configuration due to friction with the stent of the interventional instrument or due to radial compression and self-expansion of the branch stent 3.
In other implementations, for example, referring to fig. 9, fig. 9 is a schematic structural view of another possible fixation of the connecting bone 3063 to the first waveform ring 3061 (only a portion of the first waveform ring 3061 and a portion of the connecting bone 3063 are shown), according to an exemplary embodiment of the present application. The at least partially fixed position is formed by spirally winding the branch 3064 of the connecting frame 3063 on each first wavy ring 3061 around the connecting frame 3063, that is, the branch 3064 of the fixed position on each first wavy ring 3061 may be spirally wound around the connecting frame 3063, so that the connecting frame 3063 can connect a plurality of first wavy rings 3061 together more stably, which is beneficial to further improving the problem of shortening of the branched stent 3 or further reducing the shortening amplitude. The setting mode that the branch rod 3064 where the fixed position is located on each first waveform ring 3061 can be spirally wound on the connecting rib 3063, and the effect of reducing the number of the fixed positions is also achieved, for example, only the fixed sleeves 3065 on two ends of the connecting rib 3063 in the length direction are reserved, the reduction of the number of the fixed positions can reduce the friction force between the branch support 3 and the interventional instrument, the risk that the fixed sleeves 3065 possibly burst the branch covering film 301 is reduced, the radial size of the interventional instrument is reduced, and the like. It can be understood that on the basis of spiral winding, fixing modes such as stitching, overlaying, stamping, attaching, embedding, welding or hot pressing can be overlapped.
The flexible bone ring 307 comprises a plurality of wave-shaped units 371, and the flexible bone ring 307 is a tubular structure formed by the plurality of wave-shaped units 371 which are connected end to end and are continuously and spirally arranged along the periphery of the first layer of film. The wave-shaped unit 371 includes a plurality of unit bars 372 connected in sequence in an included angle, and two adjacent included angles are a peak 3002 and a trough 3003 respectively along the circumferential direction of the branch stent 3, wherein the peak 3002 is closer to the proximal end of the branch stent 3 than the trough 3003. A branch 3064 on the second wavy ring 3062 is provided with a fixing position, and the fixing position on the second wavy ring 3062 fixes one end of the flexible bone ring 307 near the proximal end of the branch stent 3 on the second wavy ring 3062, which is beneficial to improving the structural stability of the flexible bone ring 307 in the axial direction of the branch stent 3.
The construction of the stud ring 308 is the same as that of the support ring 306 and will not be described in detail herein. It is understood that the construction of the stud ring 308 is the same as the construction of the support bone ring 306, but the number of first and second wave rings 3061, 3062 may be different. For the stud ring 308, the plurality of first wavy rings 3061 and the at least one second wavy ring 3062 of the stud ring 308 are sequentially arranged along the axial direction of the branch stent 3, and the second wavy ring 3062 of the stud ring 308 is located on the proximal end side of the first wavy ring 3061 of the stud ring 308, in other words, the first wavy ring 3061 of the stud ring 308 is closer to the distal end of the branch stent 3 than the second wavy ring 3062 of the stud ring 308. A fixing position is arranged on a branch rod 3064 of the second wavy ring 3062 of the wall-attached bone ring 308, and the fixing position on the second wavy ring 3062 of the wall-attached bone ring 308 fixes one end of the flexible bone ring 307, which is close to the distal end of the branch bracket 3, on the second wavy ring 3062 of the wall-attached bone ring 308, so that the structural stability of the flexible bone ring 307 in the axial direction of the branch bracket 3 is further improved.
The branch stent 3 is inserted into the embedded stent 2 through at least part of the supporting section 302, and one end of the supporting section 302, which is far away from the wall attaching section 304, extends out of the far end of the embedded stent 2, so that the branch stent 3 can be inserted into the embedded stent 2 more stably, the problem of displacement of an implanted stent is solved, and the problem that the branch stent 3 is extruded due to displacement is solved, so that at least partial occlusion caused by the displacement is avoided, and the long-term patency rate of a branch artery is improved; meanwhile, the radial dimension of the supporting section 302 is larger than that of the embedded stent 2, so that the embedded stent 2 can be well expanded, and the influence on the blood flux of the branch artery can be avoided. At least part of the flexible section 303, the wall-engaging section 304 of the branch stent 3 is intended for implantation in a branch artery. If the included angle between the branch artery (e.g. the left collarbone artery) and the target vessel (e.g. the aortic arch 5) is acute (the acute angle is the included angle between the branch artery and the target vessel on the side far away from the heart end), the flexible segment 303 has better flexibility, can adapt to the curved vascular anatomy structure, and is beneficial to reducing the risk of occlusion of the branch stent 3 when the branch artery and the target vessel form an acute angle. The adherent segments 304 can reduce irritation to the vessel wall and provide good adhesion. Different areas along the axial direction of the branch stent 3 are designed differently, so that the branch stent 3 can adapt to different requirements of different branch blood vessels on the structure of the branch stent 3.
Tubular cover film 10, embedded cover film 21, and branched cover film 301 are all biocompatible fabrics including, but not limited to, woven or knitted polyesters such as polyethylene terephthalate, polylactide, polyglycolide, and copolymers thereof; fluorinated polymers such as polytetrafluoroethylene, expanded or electrospun polytetrafluoroethylene and polyvinylidene fluoride; polysiloxanes such as polydimethylsiloxane; polyurethanes, such as polyether polyurethanes, polyurethaneureas, polyether polyurethaneureas, polyurethanes containing carbonate linkages, wound nickel titanium containing silicone segments, and polyurethanes; silicone, ultra high molecular weight polyethylene, fluorinated ethylene propylene copolymers, or other suitable materials. The present embodiment is exemplified by the use of PET material for the tubular film 10 and the embedded film 21, and e-PTFE material for the branched film 301, and is not limited to the materials used for the tubular film 10, the embedded film 21, and the branched film 301.
The supporting frame 30, the embedded frame 22 and the branched frame are made of elastic materials, so that the supporting frame, the embedded frame 22 and the branched frame assembly can be contracted or expanded in the radial direction, namely, the supporting frame 30, the embedded frame 22 and the branched frame assembly have radial expansion capability, can be compressed under the action of external force and self-expand or recover to an original shape and keep the original shape through mechanical expansion after the external force is withdrawn, and can be attached to the vascular wall through the radial supporting force after being implanted into a blood vessel. The elastic material includes, but is not limited to, 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 one or more of various polymers (e.g., polynorbornene, polyurethane, polylactic acid copolymer, etc.), etc.
In a possible application scenario of the integrated single-embedded branch stent graft, please refer to fig. 10, fig. 10 is a schematic diagram of a scenario in which the integrated single-embedded branch stent graft is used to reconstruct the aortic arch 5. The vessel may be the aortic arch 5, with the split single-embedded branch stent-graft released into the aortic arch 5 and at least one branch artery (e.g., brachiocephalic trunk artery, left common carotid artery, left collarbone artery 7, etc.) on the aortic arch 5 reconstructed as an example. The split type single embedded branch tectorial membrane stent is released in the aortic arch 5, and can isolate a tumor cavity 8 or an interlayer breach formed by the aortic arch 5. The fenestration structure 4 on the split single embedded branch stent graft is aligned with the root opening of the branch artery, one end of the branch stent 3 is released in the embedded stent 2 through the fenestration structure 4, and the other end of the branch stent 3 is released in the branch artery to reconstruct at least one branch artery (such as the brachiocephalic trunk artery, the left common carotid artery, the left collarbone artery 7 and the like) on the aortic arch 5. This example exemplifies reconstruction of the left subclavian artery.
Referring to fig. 11, fig. 11 is another exemplary structural schematic diagram of a body stent 1. The difference between the split single embedded branch stent graft provided in this embodiment and the first embodiment is that the structure of at least one first fully-fixed framework 321 in this embodiment is different, and along the axial direction of the main body stent 1, the windowing structure 4 is located between at least one wall-mounted framework 31 and at least one first fully-fixed framework 321, in other words, at least one first fully-fixed framework 321 is located at the distal end side of the windowing structure 4. The present embodiment may omit the second full fixation frame 322, the first reinforcement frame 33, and the second reinforcement frame 323.
In this embodiment, two adjacent support rods 3001 forming the trough 3003 on at least one first fully-fixed frame 321 are enclosed to form the reinforcement portion 36, and for convenience of distinction, the two support rods 3001 forming the reinforcement portion 36 are respectively named as a first support rod 361 and a second support rod 362, and the trough 3003 formed by connecting the distal end of the first support rod 361 with the distal end of the second support rod 362 is a reinforced trough 363. The first support rod 361, the second support rod 362 and the reinforcing trough 363 form a semi-annular structure surrounding at least part of the windowing structure 4, which is beneficial to improving the adherence of the windowing structure 4 and playing a better role in preventing internal leakage.
Referring to fig. 12 in combination, fig. 12 is an enlarged schematic view of fig. 11 a. An adherence area is formed on one side of the at least one first full-fixing framework 321 far from the proximal end of the main body bracket 1, and a avoidance area is formed on one side of the at least one first full-fixing framework near to the proximal end of the main body bracket 1. Specifically, in the circumferential direction of the main body stent 1, at least two wave troughs 3003 adjacent to both sides of the reinforcing wave trough 363 and the reinforcing wave trough 363 are farther from the proximal end of the main body stent 1 than other wave troughs 3003 on the first full-fixation skeleton 321, at least two wave crests 3002 adjacent to both sides of the reinforcing wave trough 363 are farther from the proximal end of the main body stent 1 than other wave crests 3002 on the first full-fixation skeleton 321, for convenience of distinction, at least two wave troughs 3003 adjacent to both sides of the reinforcing wave trough 363 are named as a first adherence wave trough 364 and a second adherence wave trough 365, respectively, and at least two wave crests 3002 adjacent to both sides of the reinforcing wave trough 363 are named as a first avoidance wave crest 366 and a second avoidance wave crest 367, respectively. Along the circumferential direction of the main body stent 1, the first adherence trough 364 and the second adherence trough 365 are located at both sides of the reinforcement trough 363, respectively, and the first avoidance crest 366 and the second avoidance crest 367 are located at both sides of the reinforcement trough 363, respectively. The axial length between the proximal ends of the two support rods 3001 forming the first avoidance peak 366 and the proximal ends of the two support rods 3001 forming the second avoidance peak 367 and the proximal ends of the support rods 3001 forming the other peaks 3002 in the first fully-fixed skeleton 321 is the axial length of the avoidance zone, the length of the avoidance zone can be 2-4mm, and the avoidance zone is beneficial to avoiding the extrusion of the windowing structure 4 in the process of radially compressing or self-expanding and returning to the preset shape of the main body support 1, and is beneficial to smoothly returning to the preset shape after the self-expanding of the windowing structure 4. The axial length between the distal ends of the two support rods 3001 forming the first attachment trough 364, the two support rods 3001 forming the second attachment trough 365 and the two support rods 3001 forming the reinforcing trough 363 and the distal ends of the support rods 3001 forming the other troughs 3003 in the first fully-fixed skeleton 321 is the axial length of the attachment region, the length of the attachment region can be 3-5mm, the attachment region has the effect of increasing the attachment property of the support skeleton 30 around the fenestration structure 4, and is beneficial to reducing the occurrence of bird's beak symptoms after the proximal end of the tubular coating 10 is implanted in a curved target vessel, i.e. to reducing the occurrence of Ia-type internal leakage caused by the easy occurrence of a gap between the small curved side 6 of the proximal end of the main body support 1 and the vessel wall after the proximal end of the tubular coating 10 is implanted in a curved target vessel.
The foregoing are all preferred embodiments of the present application, and are not intended to limit the scope of the present application in any way, therefore: all equivalent changes in structure, shape and principle of this application should be covered in the protection scope of this application.

Claims (21)

1. A split single embedded branch stent graft, comprising:
the main body support is of a tubular structure with two open ends, the main body support is enclosed into a communication cavity for communicating with a target blood vessel, and the main body support is provided with at least one windowing structure;
the embedded support is of a tubular structure with two open ends, and one end of the embedded support is fixed on the windowing structure in a sealing mode, so that the windowing structure is communicated with the communication cavity of the main body support through the embedded support; a kind of electronic device with high-pressure air-conditioning system
The branch support is of a tubular structure with two open ends, the branch support is enclosed into a connecting cavity for communicating with a branch artery, and the branch support is detachably inserted into the embedded support through the windowing structure so as to enable the connecting cavity of the branch support to be communicated with the connecting cavity;
the main body support comprises a tubular tectorial membrane and a plurality of supporting frameworks, the supporting frameworks are sequentially arranged and fixed along the axial direction of the tubular tectorial membrane, each supporting framework comprises a plurality of supporting rods which are sequentially connected with each other in an included angle, two adjacent included angles are respectively a wave crest and a wave trough along the circumferential direction of the main body support, and the wave crest is closer to the proximal end of the main body support than the wave trough; the supporting framework comprises at least one first full-fixed framework, two adjacent supporting rods forming the trough on the at least one first full-fixed framework are enclosed to form a reinforcing part, the trough formed by connecting the distal ends of the two supporting rods on the reinforcing part is a reinforcing trough, and the two supporting rods on the reinforcing part and the reinforcing trough form a semi-annular structure surrounding at least part of the windowing structure;
Along in the circumference direction of main part support, at least two of the trough of strengthening the trough both sides is first adherence trough and second adherence trough respectively, first adherence trough, second adherence trough with strengthen the trough compare other on the first full fixed skeleton the trough is more kept away from the proximal end of main part support is in order to form the adherence district.
2. The split type single-embedded branch stent-graft of claim 1, wherein the branch stent comprises a branch stent-graft and a branch skeleton assembly fixed to the branch stent-graft, the branch stent-graft comprises a first layer of film and a second layer of film along the radial direction of the branch stent, the first layer of film is positioned at the inner side of the connecting cavity of the branch stent, the second layer of film is positioned at the outer side of the branch stent, the branch skeleton assembly is fixed between the first layer of film and the second layer of film, the proximal end and the distal end of the branch stent-graft are respectively integrally formed with a turnover section, and the turnover section is fixed to the inner peripheral wall of the branch stent-graft; the axial length of the turnover section is 1-5mm.
3. The split type single embedded branch stent graft of claim 2, wherein the main body stent comprises a tubular stent graft, a bare stent and a plurality of supporting frameworks, the bare stent and the supporting frameworks are in annular structures, the bare stent is fixed at the proximal end of the tubular stent graft, the supporting frameworks are positioned at the distal end side of the bare stent, and the supporting frameworks are sequentially arranged and fixed along the axial direction of the tubular stent graft; the bare support and the support framework comprise a plurality of support rods which are sequentially connected with each other in an included angle manner, two adjacent included angles are respectively a peak and a trough along the circumferential direction of the main body support, and the peak is closer to the proximal end of the main body support than the trough; at least part of the peaks, the troughs and the support rods of the support framework are all attached to and fixed on the peripheral wall of the tubular coating, at least part of the peaks of the support framework are provided with gaps with the tubular coating and can be separated from the tubular coating to form a free zone, and the axial length of the free zone is at least 2.5-4mm.
4. The split type single embedded branched stent graft of claim 3, wherein a plurality of said supporting frameworks comprise an adherent framework, a bundle diameter framework, an auxiliary framework and a distal framework which are sequentially arranged from the proximal end to the distal end of said tubular stent graft, said adherent framework and said bundle diameter framework are both positioned on the proximal side of said fenestration, and said auxiliary framework and said distal framework are both positioned on the distal side of said fenestration; the wave trough of the bare stent is fixed on the tubular tectorial membrane, and the wave crest of the bare stent and the supporting rod of the bare stent extend out of the proximal end of the tubular tectorial membrane at least partially; the axial lengths of the supporting rods on the adherence framework are the same; the plurality of beam diameter frameworks are arranged, and the axial lengths of all the support rods on at least one beam diameter framework are the same; the axial length of each supporting rod on the distal framework is the same;
the auxiliary frameworks are provided with at least two, the wave troughs of two adjacent auxiliary frameworks are opposite in the axial direction, and the wave crests of two adjacent auxiliary frameworks are opposite in the axial direction; along the circumferential direction of the main body support, two adjacent wave crests on the auxiliary skeleton comprise high waves and low waves, and the high waves are closer to the proximal end of the main body support than the low waves; in the peaks on the auxiliary skeleton, the high waves and the low waves are alternately arranged along the circumferential direction of the main body support.
5. The split single-embedded branched stent graft of claim 4, wherein said troughs of said bare stent are secured with a plurality of seaming loops by stitching to secure said troughs of said bare stent to said tubular stent, said strut is secured with at least one seaming loop by stitching to secure said strut of said bare stent to said tubular stent, and said seaming loops on said strut of said bare stent are immediately adjacent to said seaming loops on said troughs of said bare stent; the trough and the support rod of the bare stent are fixed on the axial length of the tubular tectorial membrane through the suture ring to form an anchoring zone, the axial length of the anchoring zone is at least 3-5mm, and the axial length of the anchoring zone is the superposition length of the bare stent and the wall-attached framework in the axial direction.
6. The split type single embedded branched stent graft of claim 4, wherein said wall-attached framework, said beam-diameter framework and said peaks, said troughs and said support bars of said distal framework are all affixed to the peripheral wall of said tubular stent graft; the trough, the support rod and the low wave of the auxiliary framework are all attached and fixed to the peripheral wall of the tubular coating, and a gap is reserved between the high wave of the auxiliary framework and the tubular coating and can be separated from the tubular coating so as to form a free zone.
7. The split type single embedded branched stent graft of any one of claims 4-6, wherein at least one of said wall-mounted frameworks is provided, at least one of said wall-mounted frameworks is positioned on a distal side of said bare stent, and the waveform profile of at least one of said wall-mounted frameworks is consistent with the waveform profile of said bare stent, such that said peaks of said wall-mounted frameworks can be positioned in an area between two adjacent support struts on said bare stent.
8. The split single-embedded branched stent graft of claim 7, wherein at least one of said first fully-fixed struts is distal to at least one of said wall-engaging struts; the axial length of each supporting rod on at least one first full-fixed framework is the same, and the wavelength of at least one first full-fixed framework is smaller than that of other supporting frameworks.
9. The split single-embedded branched stent graft of claim 8, wherein said bundle diameter scaffold further comprises at least a second fully secured scaffold, at least one of said second fully secured scaffold being distal to at least one of said first fully secured scaffold; along the circumferential direction of the main body support, two adjacent wave crests on at least one second full-fixed framework comprise high waves and low waves, and the high waves are closer to the proximal end of the main body support than the low waves; and in the wave crest on at least one second full-fixed framework, the high waves and the low waves are alternately arranged along the circumferential direction of the main body support.
10. The split single-embedded branched stent graft of claim 9, wherein a plurality of said struts further comprise at least a first reinforcement matrix, at least one of said first reinforcement matrix being located on a distal side of said fenestration; the beam diameter framework further comprises at least one second reinforcing framework, at least one second reinforcing framework is positioned at the far end side of at least one second full-fixed framework, the first reinforcing framework and the second reinforcing framework are adjacently arranged in the axial direction, and the first reinforcing framework and the second reinforcing framework are respectively positioned at two sides of the windowing structure in the axial direction; the axial lengths of the supporting rods on at least one first reinforcing framework are the same, the axial lengths of the supporting rods on at least one second reinforcing framework are the same, the wave crests, the wave troughs and the supporting rods on at least one first reinforcing framework are all adhered and fixed on the peripheral wall of the tubular coating, and the wave troughs on the first reinforcing framework are opposite to the wave crests on the second reinforcing framework in the axial direction.
11. The split single-embedded branched stent graft of claim 1, wherein the axial length between the distal ends of the two struts forming the first wall-attached trough, the two struts forming the second wall-attached trough, and the two struts forming the reinforcing trough to the distal ends of the struts forming the other trough in the first fully-fixed frame is the axial length of the wall-attached region, and the axial length of the wall-attached region is 3-5mm.
12. The split type single embedded branch stent graft according to claim 1, wherein in the circumferential direction of the main body stent, at least two peaks at two sides of the reinforcing trough are a first avoidance peak and a second avoidance peak, the first avoidance peak and the second avoidance peak are further away from the proximal end of the main body stent than other peaks on the first fully fixed skeleton to form a avoidance zone, and the axial length between the proximal ends of the two support rods forming the first avoidance peak and the proximal ends of the two support rods forming the second avoidance peak to the proximal ends of the support rods forming other peaks in the first fully fixed skeleton is the axial length of the avoidance zone, and the axial length of the avoidance zone is 2-4mm.
13. The split single-embedded branched stent graft of claim 6, wherein at least two distal end frames are provided, at least two distal end frames are sequentially arranged along the axial direction of the tubular stent graft, the distal end of the tubular stent graft is provided with at least one development mark, the development mark is positioned at least one of the proximal end and the proximal end side of at least two distal end frames near the distal end port of the tubular stent graft, the axial length of the development mark and the distal end edge of the tubular stent graft is at least 30-50mm, and the development mark is used for indicating the position of another external stent graft in the communication cavity of the main body stent.
14. The split single embedded branched stent graft of claim 4, further comprising a plurality of sets of flexible beam diameter members on the proximal side of the fenestration, said flexible beam diameter members for radially compressing a portion of said main body stent on the proximal side of said fenestration; the wall-attaching framework and the wave crests, the wave troughs and the supporting rods of the beam-diameter framework are all attached and fixed to the peripheral wall of the tubular tectorial membrane, at least one wave trough of the bare stent is provided with a flexible beam-diameter member, at least one wave trough of the wall-attaching framework is provided with a flexible beam-diameter member, at least one wave trough and at least one wave crest adjacent to each beam-diameter framework are all provided with flexible beam-diameter members, a plurality of flexible beam-diameter members are approximately arranged and extend along the axial direction of the main body stent, and the beam-diameter members are used for radially compressing local parts located at the proximal end side of the windowing structure.
15. The split single-embedded branched stent graft of claim 14, wherein said flexible beam member is of a loop configuration, any at least two points on the loop of said beam member being secured to said main body stent to form two securing points, thereby forming said flexible beam member into at least two flexible loops; alternatively, the flexible beam diameter member includes at least two flexible rings, one end of the flexible rings in the length direction is fixed to at least one of the tubular covering film and the supporting skeleton to form a fixing site;
Along the circumference of main part support, two the flexible ring is kept away from the one end of fixed site can coincide each other in order to form the wire loop that supplies the footpath seal wire to wear to establish, the length direction of flexible ring can be followed the circumference of main part support is arranged, and at least two the length direction of flexible ring can encircle the circumference of main part support is in order to make the main part support can radial compression.
16. The split single-embedded branched stent graft of claim 1, wherein the embedded stent graft comprises an embedded stent graft and a plurality of embedded frameworks, the embedded frameworks are sequentially arranged along the axial direction of the embedded stent graft, the far end opening of the embedded stent graft is an inclined opening, the embedded frameworks are in an open-loop structure, and the open-loop opening of the embedded frameworks is positioned on one side of the embedded stent graft close to the inner wall of the main body stent graft.
17. The split single-embedded branch stent graft of claim 3, wherein said branch stent graft comprises a support section, a flexible section and an attachment section connected in sequence from a proximal end to a distal end, said branch stent graft assembly comprising a support bone ring, a flexible bone ring and an attachment bone ring arranged in sequence along an axial direction of said branch stent graft, said support bone ring being positioned at said support section, said flexible bone ring extending in sequence from at least a portion of said support section, said flexible section, at least a portion of said attachment section, said attachment bone ring being positioned at said attachment section;
The flexible support comprises a flexible section, a support section and an adherence section, wherein the support section and the adherence section are of an equal-diameter structure, the flexible section adopts a taper design, the radial size of the proximal end of the flexible section is larger than the radial size of the distal end of the flexible section, the proximal end of the flexible section is connected with the support section, the distal end of the flexible section is connected with the adherence section, the radial size of the support section is larger than the radial size of the adherence section, and the radial size of the support section is larger than the radial size of the embedded bracket.
18. The split type single-embedded branch stent graft of claim 17, wherein said supporting bone ring comprises a plurality of first wavy rings, at least one second wavy ring and a connecting bone, said plurality of first wavy rings and said at least one second wavy ring are sequentially arranged along the axial direction of said branch stent, said second wavy rings are positioned at the distal end side of said first wavy rings, said first wavy rings and said second wavy rings each comprise a plurality of branching bars which are sequentially connected in an included angle, and in the circumferential direction of said branch stent, adjacent two included angles are a peak and a trough, respectively, said peak being closer to the proximal end of said branch stent than said trough; each first wavy ring is provided with at least one fixing position which is fixed with the connecting bone, so that the connecting bone axially connects a plurality of first wavy rings, and the fixing position is positioned on the branch rod of each first wavy ring; the structure of the wall-attached bone ring is the same as that of the supporting bone ring.
19. The split single-embedded branched stent graft of claim 18, wherein said anchor is a sleeve that secures said connecting bone to said split struts corresponding to each of said first undulating rings; alternatively, at least part of the fixation sites are formed by spirally winding the branch bars of each of the first wavy rings on the connective bone to the connective bone.
20. The split single-embedded branched stent graft of any one of claims 18-19, wherein said connecting bone extends along adjacent said support struts connecting two of said first undulating rings in the axial direction of said branched stent such that said connecting bone is of an oblique linear shape extending from the proximal end to the distal end of said support segments.
21. The split type single embedded branch stent graft of claim 20, wherein said flexible bone ring comprises a plurality of wave units, said flexible bone ring is a tubular structure formed by a plurality of wave units connected end to end and continuously and spirally arranged along the periphery of said first layer of membrane, said wave units comprise a plurality of unit rods connected in sequence with included angles, two adjacent included angles are respectively a peak and a trough along the periphery of said branch stent, said peak is closer to the proximal end of said branch stent than said trough; the fixing position is arranged on one of the branch rods on the second wavy ring of the supporting bone ring, and the fixing position on the second wavy ring of the supporting bone ring is used for fixing one end, close to the proximal end of the branch bracket, of the flexible bone ring on the second wavy ring of the supporting bone ring; one end of the flexible bone ring, which is close to the distal end of the branch bracket, is fixed on the wall-attached bone ring.
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