WO2024125225A1

WO2024125225A1 - Covered stent

Info

Publication number: WO2024125225A1
Application number: PCT/CN2023/132869
Authority: WO
Inventors: 孙星宇; 唐江峰
Original assignee: 先健科技(深圳)有限公司
Priority date: 2021-12-31
Filing date: 2023-11-21
Publication date: 2024-06-20
Also published as: WO2024125226A1; WO2024125224A1; CN116370167A; CN219439576U; CN116370142A

Abstract

Provided is a covered stent (10), which comprises a stent body (100) and a coating film (110) arranged on the stent body (100). The stent body (100) comprises a keel (200), a wave coil assembly (300) connected to the keel (200), and a sleeving assembly (400) for connecting the keel (200) to the wave coil assembly (300). The wave coil assembly (300) comprises at least one bent section (310), and the bent section (310) comprises a plurality of bent wave coils (311) sequentially arranged on the keel (200). The sleeving assembly (400) comprises a plurality of bent sleeves (410) which are in a bent shape and are used for connecting adjacent bent wave rings (311). The plurality of bent sleeves (410) have identical or different bending directions and/or bending amplitudes. The covered stent (10) can be arranged, according to the shape of a blood vessel, in a preset bent shape by means of the bent sleeves (410) in a bent shape, and the shapes of the bent sleeves (410) can be identical or different, so as to adapt to aortic blood vessels of different shapes, thereby reducing the pressure of the covered stent (10) on an inner wall of the blood vessel, reducing the stimulation of the covered stent (10) to the blood vessel, and preventing a rupture occurred in the blood vessel.

Description

A coated stent

Technical Field

The utility model belongs to the technical field of medical devices, and in particular relates to a stent graft.

Background technique

Aortic aneurysm and aortic dissection are diseases that currently pose a serious threat to human life safety. If not treated actively, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia and high diabetes, the incidence of aortic aneurysm and aortic dissection is also increasing significantly.

Traditional open surgery for aortic aneurysm and aortic dissection is highly invasive, has a high mortality rate, a long operation time, a high incidence of postoperative complications, and a high difficulty of surgery. However, endovascular treatment has the characteristics of less trauma, fewer postoperative complications, a shorter operation time, and a lower difficulty of surgery, and has gradually become the main method for treating aortic aneurysm and aortic dissection. By implanting a covered stent in the aorta, the vascular lesions are isolated outside the covered stent, and the blood flow is restricted from flowing through the covered stent, thereby achieving the purpose of protecting the blood vessels.

At present, the overall structure of aortic stent products is mostly a straight tube structure with a keel, but the shape of the aorta is not a regular straight tube, especially the aortic arch is curved. Therefore, after passive bending, the covered stent implanted in the aortic arch and the curved section near the aortic arch will generate elastic recoil force and the resulting stress, which can easily lead to new aortic ruptures. New aortic ruptures are the primary factor causing risks after endovascular repair of aortic dissection.

Therefore, a new technical solution is needed to solve the above problems.

Utility Model Content

The utility model aims at least to solve the problem that the restoring force of the stent graft and the stress formed thereby easily lead to new rupture of the aorta.

One aspect of the utility model proposes a coated stent, comprising a stent body and a coating arranged on the stent body, wherein the stent body comprises a keel, a wave coil assembly and a sleeve assembly for connecting the keel and the wave coil assembly; the wave coil assembly comprises at least one curved section connected to the keel, the curved section comprises a plurality of curved wave coils sequentially arranged on the keel, the sleeve assembly comprises a plurality of curved sleeves for connecting adjacent curved wave coils; the bending directions and/or bending amplitudes of the plurality of bending sleeves are the same or different.

According to the coated stent in the utility model, the coated stent can be set into a preset curved shape according to the shape of the blood vessel by means of a curved bending sleeve, and the shape of the bending sleeve can be the same or different, so as to adapt to aortic blood vessels of different shapes, reduce the pressure of the coated stent on the inner wall of the blood vessel, reduce the stimulation of the coated stent on the blood vessel, and prevent new ruptures in the blood vessel.

In addition, the stent graft according to the utility model may also have the following additional technical features:

In some embodiments of the present invention, the curved wave ring includes a high wave band and a low wave band connected end to end, the high wave band is arranged on a side close to the keel, the low wave band is arranged on a side away from the keel, and the axial height of the high wave band is greater than the axial height of the keel. The axial height of the dwarf band.

In some embodiments of the present invention, adjacent bending wave circles are connected by connecting rods, and the bending wave circles are fixedly connected to the connecting rods through the bending sleeves. A plurality of connecting rods are sequentially connected to form a part of the keel.

In some embodiments of the present invention, the bending wave coils and the connecting rod are integrally woven by braiding wires, and adjacent bending wave coils are connected end to end by the connecting rod.

In some embodiments of the present invention, the sleeve assembly also includes a pressure tooth groove recessed toward the interior of the bending sleeve, and the pressure tooth groove is used to connect and fix the bending section and the keel. The bending sleeve includes a first pressing surface and a second pressing surface arranged opposite to each other, and the pressure tooth groove is arranged on the first pressing surface and/or the second pressing surface.

In some embodiments of the present invention, the number and/or shape of the pressing tooth grooves arranged on the first pressing surface of the bending sleeve are different from those of the pressing tooth grooves arranged on the second pressing surface.

In some embodiments of the present invention, the pressing tooth groove includes a first pressing groove arranged on the first pressing surface and a second pressing groove arranged on the second pressing surface; the number of the first pressing grooves is less than the number of the second pressing grooves, and the first pressing groove and the second pressing groove are staggered.

In some embodiments of the present invention, the bending sleeve is bent toward the inner direction of the bracket body; the first pressing surface is arranged toward the inner side of the bracket body, and the second pressing surface is arranged toward the outer side of the bracket body.

In some embodiments of the present invention, the bracket body also includes a The connecting section at the proximal end of the curved section and the main body section arranged at the distal end of the curved section, the connecting section includes a connecting wave ring for connecting to the rear release device of the conveyor and a supporting wave ring for supporting the proximal edge of the coating, and the connecting wave ring is connected to the coating part.

In some embodiments of the present invention, the main body section is arranged in a straight cylindrical shape, and the main body section includes a plurality of main body wave coils sequentially connected to the keel, and the sleeve assembly also includes a connecting sleeve for connecting adjacent main body wave coils.

In some embodiments of the present invention, the main body wave coil located at the distal end of the stent body has a smaller radial dimension than the main body wave coil located at the proximal end of the stent body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of the overall structure of a stent graft in Embodiment 1 of the present invention;

FIG2 is a schematic diagram of the overall structure of the bracket body in the first embodiment of the present utility model;

FIG3 is a schematic structural diagram of a curved section in Embodiment 1 of the present invention;

FIG4 is an enlarged view of the structure at A in FIG1 in the first embodiment of the present utility model;

FIG5 is a schematic structural diagram of a bending sleeve in Embodiment 1 of the present invention;

FIG6 is a schematic diagram of the overall structure of the stent graft in the second embodiment of the present invention;

FIG7 is a schematic structural diagram of a connecting section in Embodiment 2 of the present utility model;

FIG8 is a schematic structural diagram of a connecting sleeve in Embodiment 2 of the present utility model;

FIG9 is a schematic structural diagram of a first implementation scheme of the bending sleeve in Example 3 of the present utility model;

FIG. 10 is a second embodiment of the bending sleeve structure in the third embodiment of the present utility model Schematic diagram;

FIG11 is a schematic structural diagram of a third implementation scheme of the bending sleeve in Example 3 of the present utility model;

FIG12 is a schematic diagram of the overall structure of the stent graft in the fourth embodiment of the present utility model;

FIG13 is a schematic structural diagram of the bracket body in the fourth embodiment of the present utility model;

FIG14 is a schematic structural diagram of another embodiment of the stent graft in Example 4 of the present utility model;

FIG15 is a schematic diagram of the structure of the stent graft after puncture in the fourth embodiment of the present invention;

FIG16 is a schematic structural diagram of a curved section in Embodiment 4 of the present invention;

FIG17 is a schematic structural diagram of a window section in Embodiment 4 of the present utility model;

FIG18 is a schematic diagram of the overall structure of the stent graft in Embodiment 5 of the present invention;

FIG19 is a schematic structural diagram of the overall structure of the stent graft in the fifth embodiment of the present invention from another perspective;

FIG20 is a schematic structural diagram of the stent graft in the fifth embodiment of the present invention in a naturally bent state;

FIG21 is a schematic structural diagram of a curved section in Embodiment 5 of the present invention;

FIG22 is a schematic diagram of the overall structure of a stent graft with a semi-releasing device in Embodiment 5 of the present invention;

FIG23 is an enlarged view of point B in FIG22 in Embodiment 5 of the present utility model;

FIG. 24 is a schematic diagram of a portion of the structure of the stent graft in Embodiment 5 of the present invention when the stent graft is in a semi-released state.

The reference numerals in the accompanying drawings represent the following:

10. Coated stent; 100. Stent body; 110. Coating; 120. Braided wire; 200. Keel; 210. Connecting rod; 300. Wave coil assembly; 310. Bending section; 311. Bending wave coil; 312. High wave band; 313. Low wave band; 320. Connecting section; 321. Connecting wave coil; 3211. Fixed waveform segment; 3212. Active waveform segment; 322. Supporting wave coil; 330. Main section; 331. Main wave coil; 400. Sleeve assembly; 410. Bending sleeve; 420. Connecting sleeve; 430. Pressing tooth groove; 431. First pressing groove ; 432, second pressing groove; 433, inclined groove; 440, first pressing surface; 450, second pressing surface; 500, window section; 510, window wave ring; 520, puncture hole; 530, window area; 540, non-window area; 550, reinforcing wire; 600, groove part; 610, groove bottom film; 620, through hole; 630, connecting tube; 640, developing ring; 650, groove support; 700, semi-release device; 710, restraining unit; 711, limiting ring; 712, restraining line; 713, buckle; 720, limiting unit; 721, limiting rod.

Detailed ways

The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

It should be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" as used herein may also be intended to include the plural forms. Number form.

Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and/or sections, these elements, components, regions, layers, and/or sections should not be limited by these terms. These terms may only be used to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms do not imply a sequence or order when used herein.

For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures.

For ease of description, the following description uses the terms "distal" and "proximal", where "distal" refers to the end far from the heart and "proximal" refers to the end close to the heart. The phrase "axial direction" should be understood in this patent to mean the direction in which the interventional device is pushed in and out, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

Embodiment 1, Embodiment 1 of the present application provides a stent graft 10, as shown in FIG. 1 and FIG. 2, comprising a stent body 100 and a coating 110 disposed on the stent body 100, wherein the stent body 100 comprises a keel 200, a wave coil assembly 300 and a sleeve assembly 400, wherein the wave coil assembly 300 is connected to the keel 200, and the sleeve assembly 400 is used to connect and fix the wave coil assembly 300 to the keel 200. The wave coil assembly 300 comprises at least one curved section 310, and the curved section 310 is used to bend the stent graft 10 to the blood vessel after being implanted in the blood vessel. It is suitable for curved parts, especially the aortic arch where the curvature is greater.

In this embodiment, the wave coil assembly 300 includes a curved segment 310. In other embodiments, the wave coil assembly 300 may also be provided with multiple curved segments 310 according to actual needs, and the shapes of the multiple curved segments 310 may be the same or different to adapt to the shapes of different blood vessel lumens.

The bending section 310 includes a plurality of bending coils 311, which are connected and fixed on the keel 200 in sequence. The sleeve assembly 400 includes a bending sleeve 410 for fixing the bending coils 311 and the keel 200. The bending sleeve 410 is curved, so that the bending sleeve 410 drives the keel 200 and the bending coils 311 to bend toward one side to make the entire bending section 310 bend to adapt to the curved part in the blood vessel.

As shown in FIG3 , this embodiment provides a curved bending sleeve 410 on the curved section 310, thereby driving the entire curved section 310 to be curved. When preparing the stent graft 10, the stent graft 10 can be preset into a curved shape according to the shape of the blood vessel, thereby adapting to the aortic blood vessel. Compared with the traditional straight-tube stent graft 10, the pre-bent stent graft 10 can better adapt to the shape of the blood vessel, reduce the pressure on the inner wall of the blood vessel caused by the resilience of the stent graft 10 itself, reduce the stimulation of the stent graft 10 on the blood vessel, and prevent new ruptures in the blood vessel.

The bending direction and/or bending amplitude of each bending sleeve 410 can be set to be the same or different. The greater the bending amplitude of the bending sleeve 410, the greater the angle between the tangents at both ends of the bending sleeve 410. In this embodiment, the bending sleeve 410 is curved, so the bending amplitude of the bending sleeve 410 is the bending curvature of the bending sleeve 410. In actual clinical practice, the shapes of blood vessels of different patients are different, especially aortic dissection. After a lesion occurs, the shape of the blood vessel usually changes. Since the stent graft 10 needs to be placed in the blood vessel for a long time, if the shape of the stent body 100 is too different from that of the blood vessel, the stent body 100 will compress the inner wall of the blood vessel for a long time, causing discomfort to the patient, and even causing changes in the blood vessel structure or new ruptures in the blood vessel due to vascular fatigue. Therefore, the use of a universal specification vascular stent cannot meet the needs of all patients, and it is necessary to select a stent graft 10 of different shapes according to the shape of the blood vessels of different patients to adapt to lesions of various degrees of curvature and different shapes.

Through the technical solution of the present application, the bending directions and bending amplitudes of different bending sleeves 410 can be set differently, and the shape of the bending section 310 can be flexibly set to adapt to blood vessels of different shapes. Doctors can select stent grafts 10 of different shapes according to the morphology of the patient's diseased blood vessels. In addition, the corresponding stent graft 10 can be customized according to the patient's special blood vessel morphology, thereby reducing the pressure of the stent body 100 on the inner wall of the blood vessel, so that when the stent graft 10 is placed in the blood vessel for a long time, the aorta will not be newly ruptured due to the stimulation caused by the stent body 100, effectively alleviating the risk of postoperative endovascular repair of aortic dissection.

In this embodiment, as shown in FIG. 3 , adjacent bending wave circles 311 are connected via a connecting rod 210 . The connecting rod 210 may be integrally woven with the bending wave circles 311 , or may be welded between two adjacent bending wave circles 311 to achieve connection of the bending wave circles 311 .

The bending wave coil 311 is fixedly connected to the connecting rod 210 through the bending sleeve 410, that is, the connecting rod 210 and a part of the bending wave coil 311 are sleeved and fixed through the bending sleeve 410, so that the connection between the bending wave coil 311 and the connecting rod 210 is more firm and stable.

In this embodiment, the keel 200 adopts a segmented design, and a plurality of connecting rods 210 are arranged in a The secondary connection forms a part of the keel 200, that is, the keel 200 is formed by connecting a plurality of connecting rods 210 in sequence, and the connecting rods 210 and the bending wave ring 311 are woven and formed as a whole. By adopting the above-mentioned structural setting, the keel 200 can be formed at the same radial height as the bending wave ring 311 during weaving and forming, and the keel 200 will not protrude relative to the bending section 310, so that the pressure of the keel 200 on the inner wall of the blood vessel is smaller than that of the protruding keel 200, further reducing the stimulation of the stent graft 10 on the inner wall of the blood vessel.

In other embodiments, as shown in FIG2 , the keel 200 may also be designed in an integrated manner, that is, after the bending corrugations 311 are woven and formed separately, all the bending corrugations 311 are sequentially fixed by a strip-shaped keel 200. The keel 200 in an integrated design has higher strength, better flexibility, simpler manufacturing process and lower cost.

In this embodiment, the wave coil assembly 300 is formed by weaving the braided wire 120, and the braided wire 120 is a nickel-titanium wire or other metal wire with shape memory. The bending wave coil 311 and the connecting rod 210 are integrally woven by the braided wire 120, and the adjacent bending wave coils 311 are connected end to end with the connecting rod 210 disposed therebetween. That is, the entire bending section 310 is integrally woven by the bending wave coil 311 and the connecting rod 210 connected end to end in sequence.

During the braiding process of the wave coil assembly 300, the sleeve assembly 400 is first sleeved on the braided wire 120, and then braided and formed. The sleeve assembly 400 can be bent and shaped before sleeved on the braided wire 120, or it can be bent and shaped after sleeved on the braided wire 120. In order to facilitate the braiding of the entire stent body 100, this embodiment adopts a method of sleeved on the braided wire 120 and then shaping.

As shown in FIG. 4 , the sleeve assembly 400 further includes a toothed groove 430 , which is recessed toward the interior of the bending sleeve 410 and closely abuts against the braided wire 120 of the wave coil assembly 300 . and on the keel 200 , thereby connecting and fixing the wave coil assembly 300 to the keel 200 .

As shown in Fig. 5, the socket assembly 400 includes two first pressing surfaces 440 and a second pressing surface 450 arranged opposite to each other, and at least one of the pressing surfaces is provided with a pressing tooth groove 430. That is, the first pressing surface 440 and the second pressing surface 450 are both provided with a pressing tooth groove 430, or one of the first pressing surface 440 and the second pressing surface 450 is provided with a pressing tooth groove 430.

The method of providing the pressing groove 430 only on the first pressing surface 440 or the second pressing surface 450 can achieve the purpose of pressing and fixing the wave coil assembly 300 and the keel 200 through the pressing groove 430, and the bending sleeve 410 is bent toward the side with the pressing groove 430.

When the first pressing surface 440 and the second pressing surface 450 are both provided with the pressing grooves 430 , since both sides of the bending sleeve 410 have the pressing grooves 430 , the bending sleeve 410 can fix the wave coil assembly 300 and the keel 200 more firmly.

In this embodiment, the shape of the bending sleeve 410 can be controlled by setting the number and position of the pressing tooth grooves 430 on the bending sleeve 410. Specifically, the number of the pressing tooth grooves 430 provided on the first pressing surface 440 of the sleeve assembly 400 is the same as the number of the pressing tooth grooves 430 provided on the second pressing surface, or the number of the pressing tooth grooves 430 provided on the first pressing surface 440 of the sleeve assembly 400 is different from the number of the pressing tooth grooves 430 provided on the second pressing surface.

Specifically, the first pressing surface 440 of the bending sleeve 410 is provided with a first pressing groove 431, and the second pressing surface 450 of the bending sleeve 410 is provided with a second pressing groove 432. In this embodiment, the first pressing groove 431 and the second pressing groove 432 are staggered, and the number of the first pressing groove 431 is set to be less than the number of the second pressing groove 432.

Since the first pressing groove 431 and the second pressing groove 432 are arranged in a staggered manner, and the first pressing groove 431 The number of the pressing grooves 430 is set to be smaller than the number of the second pressing grooves 432 , so after being pressed by tooth pressing, the bending sleeve 410 will bend toward the first pressing surface 440 with a smaller number of pressing tooth grooves 430 to form a curved bending sleeve 410 .

The bending sleeve 410 of the sleeve assembly 400 of this embodiment is a steel sleeve or other metal materials with good plastic deformation performance. Since the bending sleeve 410 has good plastic deformation performance, it has good deformation ability and stability after being pressed and bent. Specifically, the bending sleeve 410 is formed by cutting a stainless steel pipe.

Since the second groove 432 facing the blood vessel increases the surface roughness of the bending sleeve 410 and increases the friction between the stent graft 10 and the inner wall of the blood vessel as a whole, the stent graft 10 is not easily displaced after being placed in the blood vessel. In addition, since the second groove 432 is recessed toward the inside of the bending sleeve 410 and the bending sleeve 410 is curved, the side of the bending sleeve 410 can better fit the inner wall of the curved blood vessel, thereby accelerating the speed of endothelial attachment and further avoiding the displacement of the stent graft 10 under the flushing of blood. Among them, the axial width of the wave coil assembly 300 is 1.2 to 2 times the length of the sleeve assembly 400. That is, the axial width of the wave coil assembly 300 is greater than the length of the sleeve assembly 400, preferably 1.5 times.

In this embodiment, the number of the first pressing grooves 431 of the bending sleeve 410 is 4, and the number of the second pressing grooves 432 is 5. The plurality of second pressing grooves 432 are evenly arranged on the second pressing surface 450. The first pressing groove 431 is arranged in the middle of the first pressing surface 440, and the first pressing groove 431 and the second pressing groove 432 are staggered. Specifically, the width of the first pressing groove 431 is equal to that of the second pressing groove 432, and the ratio of the width of the first pressing groove 431 to the width of the second pressing groove 432 to the length of the sleeve assembly 400 is 5%-15%, preferably 8%. Therefore, the pressing tooth groove 430 will not affect the continuity of the entire end surface of the sleeve assembly 400 due to its too small width, nor will it The excessive width makes bending difficult.

In other embodiments, the number of the first pressing groove 431 and the second pressing groove 432 can be selected to be more or less. When the number of the first pressing groove 431 and the second pressing groove 432 set on the bending sleeve 410 is more, for example, the number of the first pressing groove 431 is 6 and the number of the second pressing groove 432 is 7, the overall transition of the end surface of the bending sleeve 410 is smoother, but the bending amplitude is smaller. When the number of the first pressing groove 431 and the second pressing groove 432 set on the bending sleeve 410 is less, for example, the number of the first pressing groove 431 is 2 and the number of the second pressing groove 432 is 3, the crease at the bend on the end surface of the bending sleeve 410 is larger, but the bending amplitude is larger.

In this embodiment, the bending sleeve 410 is bent toward the inner direction of the stent body 100. The first pressing surface 440 is arranged toward the inner side of the stent body 100, and the second pressing surface 450 is arranged toward the outer side of the stent body 100. The number of the first pressing grooves 431 on the first pressing surface 440 is less than the number of the second pressing grooves 432 on the second pressing surface 450. The bending section 310 is bent toward the direction away from the keel 200 by the above arrangement, so as to adapt to the shape of the blood vessel at the aortic arch, for example.

In other embodiments, the angle and bending degree of the bending sleeve 410 can be adjusted to accommodate other blood vessels with curved parts, such as S-shaped or other irregular shapes.

It should be noted that the above examples of this embodiment are only for the convenience of understanding of technicians and are not intended to limit the present application.

Further, as shown in FIG. 2 and FIG. 3 , the curved wave circle 311 includes a high wave band 312 and a low wave band 313 connected end to end, and the high wave band 312 is located on a side close to the keel 200 . The short wave band 313 is located at the other side away from the keel 200 , and the axial height of the high wave band 312 is greater than the axial height of the short wave band 313 .

Specifically, when the stent graft 10 is implanted at the aortic arch, the stent graft 10 is arranged in a curved shape as a whole, and the side of the stent graft 10 facing the branch blood vessels of the aortic arch is usually defined as the greater curvature side of the stent graft 10, and the side of the stent graft 10 away from the branch blood vessels of the aortic arch is defined as the lesser curvature side of the stent graft 10. In the present application, the high band 312 and the keel 200 are arranged on the greater curvature side of the stent graft 10, and the short band 313 is arranged on the lesser curvature side of the stent graft 10.

Since the wave band corresponding to the lesser curved side is the short wave band 313, there is a larger displacement margin between adjacent wave circles. When the coated stent 10 is implanted in a blood vessel and is arranged in a curved shape, the lesser curved side has better compliance.

In summary, through the above-mentioned technical scheme of the present application, the stent graft can be set to a preset curved shape according to the shape of the blood vessel, thereby adapting the aortic vessel, reducing the pressure of the stent graft on the inner wall of the blood vessel, reducing the stimulation of the stent graft on the blood vessel, and preventing new ruptures in the blood vessel.

Embodiment 2. Embodiment 2 of the present application provides a stent graft 10, as shown in FIG6. The similarities between Embodiment 2 and Embodiment 1 are not repeated here. The difference between Embodiment 2 and Embodiment 1 is that the stent body 100 further includes a connecting section 320 disposed at the proximal end of the curved section 310 and a main section 330 disposed at the distal end of the curved section 310. Specifically, the main section 330 is disposed in a straight cylindrical shape as a whole. The connecting section 320 includes a connecting wave ring 321 and a supporting wave ring 322. The connecting wave ring 321 is used to connect the conveyor rear release device, and the supporting wave ring 322 is used to connect the conveyor rear release device. Used to support the proximal edge of the coating 110 .

The stent body 100 of this embodiment includes not only a curved section 310 in a curved shape, but also a main section 330 in a straight tube shape, and the main section 330 is arranged at the distal end of the curved section 310. In other embodiments, the main section 330 in a straight tube shape can also be arranged at the proximal end of the curved section 310, or the main section 330 is arranged at both the proximal end and the distal end of the curved section 310, and the selection is made according to the shape of the patient's blood vessel, so as to meet the needs of different patients.

As shown in FIG. 7 , the supporting wave ring 322 is disposed between the coating 110 and the connecting wave ring 321 . The supporting wave ring 322 is disposed on the inner side of the coating 110 and fixed to the coating 110 by suturing to enhance the supporting strength of the proximal end of the coating 110 and prevent internal leakage.

Among them, the wire diameter of the supporting wave ring 322 is smaller than the wire diameter of the connecting wave ring 321. After the coated stent 10 is implanted in the blood vessel, the supporting wave ring 322 supports the coating 110 so that the coating 110 fits the inner wall of the blood vessel. Therefore, the radial supporting force of the supporting wave ring 322 will directly affect the pressure of the coated stent 10 on the inner wall of the blood vessel.

In this embodiment, the wire diameter of the supporting wave ring 322 is set to be smaller than the wire diameter of the connecting wave ring 321, thereby reducing the radial supporting force of the supporting wave ring 322, making the contact surface between the supporting wave ring 322 and the inner wall of the blood vessel softer and less irritating to the inner wall of the blood vessel.

Further, in this embodiment, the wave number of the supporting wave ring 322 is set to be greater than the wave number of the connecting wave ring 321. Since the supporting wave ring 322 is arranged between the coating 110 and the connecting wave ring 321, and the radial supporting force of the connecting wave ring 321 is greater than that of the supporting wave ring 322, after the stent graft 10 is completely released, the connecting wave ring 321 supports the supporting wave ring 322 from the inside. The supporting wave ring 322 can disperse the radial supporting force provided by the connecting wave ring 321, so that the pressure on the inner wall of the blood vessel is more uniform.

The connecting wave ring 321 is partially connected to the coating 110. Specifically, the proximal end of the connecting wave ring 321 is retracted inside the coating 110, and the connecting wave ring 321 includes a plurality of fixed waveform segments 3211 fixedly connected to the coating 110 and at least one active waveform segment 3212 movably connected to the coating 110.

In this embodiment, the connecting wave ring 321 includes at least three active waveform segments 3212 that are movably connected to the coating 110, and the at least three active waveform segments 3212 are evenly arranged along the circumferential direction of the coating 110. The three active waveform segments 3212 are used to connect the rear release device of the conveyor and release after the coating support 10 is positioned.

Before the rear release device of the conveyor releases the connection wave ring 321, the active waveform segment 3212 is restrained by the rear release device and thus restrained in the middle of the stent body 100. Since the active waveform segment 3212 is movably connected to the coating 110, the coating 110 is pulled by the active waveform segment 3212 and moves inwardly of the coated stent 10. The fixed waveform segment 3211 is fixedly connected to the coating 110, and under the action of its own elastic force, the fixed waveform segment 3211 generates a radial support force to the outside of the coating 110, thereby expanding the coating 110 body.

Therefore, before the rear release device releases the connecting wave ring 321, the fixed waveform segment 3211 stretches the coating 110 outward, and the movable waveform segment 3212 pulls the coating 110 inward, so that the front end of the stent graft 10 forms a semi-released state. The stent graft 10 in the semi-released state has been partially unfolded, so when it is fully released, the instantaneous force on the inner wall of the blood vessel is small, which can protect the patient's blood vessels and prevent spasms of the blood vessels, or even cause new ruptures of the blood vessels.

Further, the main body section 330 includes a plurality of main body wave sections connected in sequence to the keel 200. The sleeve assembly 400 further comprises a connecting sleeve 420 for connecting adjacent main wave circles 331 .

As shown in FIG8 , the connecting sleeve 420 also includes a first pressing surface 440 and a second pressing surface 450, and the first pressing surface 440 is provided with a first pressing groove 431, and the second pressing surface 450 is provided with a second pressing groove 432. The connecting sleeve 420 is different from the bending sleeve 410 in that the connecting sleeve 420 has the same number of first pressing grooves 431 and second pressing grooves 432, and the first pressing grooves 431 and the second pressing grooves 432 are arranged opposite to each other. The connecting sleeve 420 formed by tooth pressing is in a flat straight cylindrical shape as a whole. Therefore, the main body section 330 is in a straight cylindrical shape as a whole.

In this embodiment, the main body wave coil 331 at the distal end of the stent body 100 has a smaller radial dimension than the main body wave coil 331 at the proximal end of the stent body 100, so as to better adapt to the inner diameter of the aortic arch or other blood vessel locations.

In other embodiments, different main body coils 331 may be set to have the same size according to actual needs, or the main body coil 331 at the distal end of the stent body 100 may have a larger radial size than the main body coil 331 at the proximal end of the stent body 100. The selection is made according to actual needs.

In summary, the stent body 100 of the present embodiment includes not only a curved section 310 but also a main section 330. Since the main section 330 is arranged in a straight cylindrical shape, the length and number of the curved section 310 can be coordinated with those of the main support section. Through flexible configuration, the stent graft 10 can be more adaptable to patients with different blood vessel shapes, thereby making the adaptability of the stent graft 10 better and reducing the pressure of the stent graft 10 on the inner wall of the patient's blood vessel.

Embodiment 3: Embodiment 3 of the present application provides a stent graft 10, as shown in FIG. As shown in FIG. 11 , the similarities between the third embodiment and the first embodiment are not repeated. The difference between the third embodiment and the first embodiment is that the number of the pressing tooth grooves 430 on the first pressing surface 440 on the socket assembly 400 is the same as the number of the pressing tooth grooves 430 on the second pressing surface 450 .

In this embodiment, the bending sleeve 410 can be bent toward the inside of the stent body 100 or toward the outside of the stent body 100, so that the molded coated stent 10 can adapt to the shape of the patient's blood vessels, and is specifically set according to the shape of the patient's blood vessels.

Furthermore, the number of the first pressing grooves 431 and the second pressing grooves 432 on the bending sleeve 410 are the same, but the shapes are different.

As shown in Figure 9, when the same number of first pressing grooves 431 and second pressing grooves 432 are set on the bending sleeve 410, in order to enable the bending sleeve 410 to be bent according to a preset bending degree, the groove depth of the first pressing groove 431 on the bending sleeve 410 is different from the groove depth of the second pressing groove 432, the groove depth of the first pressing groove 431 is greater than the groove depth of the second pressing groove 432, and the bending sleeve 410 bends toward the side of the pressing tooth groove 430 with a larger groove depth, that is, it bends toward the direction of the first pressing groove 431.

In other embodiments, as shown in Figure 10, the tooth height of the first pressing groove 431 on the bending sleeve 410 is different from the groove width of the second pressing groove 432, the groove width of the first pressing groove 431 is smaller than the groove width of the second pressing groove 432, and the bending sleeve 410 bends toward the side of the pressing tooth groove 430 with a smaller groove width, that is, it bends toward the direction of the first pressing groove 431.

In other embodiments, as shown in FIG. 11 , the tooth-pressing grooves 430 at both ends of the bending sleeve 410 are inclined grooves 433 , and the inclination of the inclined grooves 433 is set according to the actual bending degree required by the bending sleeve 410 .

It should be noted that the shape of the bending sleeve 410 mentioned above in the present application is only an example and does not constitute a limitation. Any bending sleeve 410 that is curved by adjusting the shape, number and position of the pressure tooth grooves 430 is within the protection scope of the present application.

Embodiment 4, Embodiment 4 of the present application provides a stent graft 10, as shown in Figures 12 and 13, the similarities between Embodiment 4 and Embodiment 1 are not repeated, and the difference between Embodiment 4 and Embodiment 1 is that the stent body 100 includes a connecting section 320, a window section 500, and a curved section 310. The connecting section 320 and the curved section 310 are respectively arranged at the proximal end and the distal end of the window section 500, and the curved section 310 is used for the stent graft 10 to adapt to the position with a greater degree of curvature near the aortic arch after being implanted in the blood vessel.

The covered stent 10 of this embodiment is used for treating vascular lesions across the aortic arch and near the aortic arch. After being implanted into the blood vessel, the covered stent 10 penetrates the ascending aorta and the descending aorta. After the covered stent 10 is implanted into the blood vessel, the connecting section 320, the window section 500 and the curved section 310 are respectively located at the ascending aorta, the aortic arch and the descending aorta. Therefore, the covered stent 10 can be used to isolate vascular lesions across the aorta, such as aortic aneurysm, aortic dissection, etc.

In other embodiments, as shown in FIG. 14 , the connecting segment 320 and the window segment 500 may also be respectively disposed at the proximal and distal ends of the curved segment 310 , so that the curved segment 310 can isolate vascular lesions in the ascending aorta and better cope with vascular lesions mainly located in the ascending aorta.

The window section 500 includes a plurality of window coils 510, which are arranged at intervals and connected by a coating 110. The distance between adjacent window coils 510 is greater than the distance between adjacent curved coils 311, and a puncture coating is reserved between adjacent window coils 510. 110. As shown in FIG. 15, the fenestration section 500 forms a puncture hole 520 after the puncture coating 110 is fenestrated. The puncture hole 520 is used for implanting a branch stent (not shown in the figure), and the branch stent corresponds to the branch blood vessel on the aortic arch. On the other hand, since the fenestration section 500 is arranged corresponding to the aortic arch, the interval-arranged fenestration wave rings 510 are connected by the coating 110, which can ensure the flexibility of the fenestration section 500 and reduce the stimulation of the stent body 100 to the inner wall of the blood vessel.

In this embodiment, the fenestration section 500 includes at least four fenestration waves 510. During puncture and fenestration, the puncture device punctures between adjacent fenestration section waves to form three puncture holes 520 for adapting to three branch vessels corresponding to the aortic arch.

After the stent graft 10 is placed in a blood vessel, it needs to cover the lesion site such as aortic dissection. When the vascular lesion is located at the aortic arch or across the aortic arch and other curved blood vessels, the straight-tube stent graft 10 will generate elastic recoil force and the stress formed by it after passive bending, which can easily lead to new aortic ruptures. In addition, in order to ensure that the stent graft 10 can completely cover the vascular lesion site, a keel 200 needs to be provided to prevent the stent from shortening, so as to avoid the stent from being unable to cover the lesion site due to shortening.

The bending section 310 includes a plurality of bending coils 311 and a keel 200. The plurality of bending coils 311 are connected and fixed on the keel 200 in sequence. A bending sleeve 410 is provided on the keel 200 between adjacent bending coils 311, and the bending sleeve 410 is curved so that the keel 200 bends along with the bending sleeve 410, thereby driving the bending section 310 to bend, thereby adapting to the curved part in the blood vessel.

In this embodiment, the stent body 100 is provided with a curved section 310 so as to conform to the shape of the blood vessel and reduce the damage to the blood vessel caused by the straightening force of the stent. The squeezing force between the outside and the blood vessels is reduced, preventing the blood vessels from undergoing structural changes or rupture due to fatigue.

As shown in FIG. 15 , the window wave coil 510 is formed by weaving the braided wires 120 , the braided wires 120 are connected end to end, and the connection of the braided wires 120 is fixedly connected by a connecting sleeve 420 .

As shown in FIG16 , the keel 200 of the curved wave ring 311 is correspondingly arranged on the large curved side of the stent graft 10, and the curved wave ring 311 includes a high band 312 and a low band 313 connected end to end, the high band 312 is located on one side close to the keel 200, and the low band 313 is located on the other side away from the keel 200, that is, the low band 313 is correspondingly arranged on the small curved side of the stent graft 10. The axial height of the high band 312 is greater than the axial height of the low band 313, and the axial height of the window wave ring 510 is less than or equal to the axial height of the low band 313.

The present application sets the short wave band 313 on the small curved side, so that there is a larger displacement margin between adjacent curved wave circles 311. When the stent graft 10 is implanted in a blood vessel and is set in a curved shape, the small curved side has better compliance. In addition, since the curvature of the aortic arch is greater than that of the ascending aorta and the descending aorta, when the axial height of the fenestration wave circle 510 is set to be less than or equal to the axial height of the short wave circle 313, it can avoid the adjacent wave circles from interfering with each other and causing the bending to be restricted, so that the fenestration segment 500 can achieve a greater degree of curvature and better fit the inner wall of the blood vessel at the aortic arch.

In addition, the axial height of the window wave ring 510 is less than or equal to the axial height of the short band 313, so that the gap between adjacent window wave rings 510 is larger, which can reserve a larger position for the puncture device to open the window, making it easier for the doctor to adjust the puncture position during the operation; at the same time, it can reduce the release accuracy of the coated stent 10, thereby reducing the difficulty of the operation.

As shown in FIG. 17 , the window wave ring 510 includes a window area 530 for puncture windowing and a window area 540 for puncture windowing. The non-fenestration area 540 and the fenestration area 530 are arranged on the greater curvature side of the stent graft 10. When implanted, the fenestration area 530 is arranged at the branch vessel opening of the aortic arch. A reinforcing wire 550 is arranged on the graft 110 arranged in the non-fenestration area 540, and the reinforcing wire 550 is arranged around the radial direction of the graft 110. In this embodiment, a plurality of reinforcing wires 550 are arranged on the graft 110, and the plurality of reinforcing wires 550 are arranged axially at intervals.

Among them, since the curved section 310 is curved under the action of the bending sleeve 410, the stress on the curved section 310 will increase when the coated stent 10 is installed in the sheath, making it difficult to sheath the curved section 310. Since the friction between the coated stent 10 with the curved section 310 and the sheath is greater, the coated stent 10 is easy to shift when released. The present application sets a plurality of reinforcing wires 550 on the coating 110 to balance the forces on the curved section 310 and other non-curved sections of the coated stent 10, so that the assembly and release of the coated stent 10 are more stable and smooth.

In addition, since the bending sleeve 410 is provided on the stent graft 10, the stent graft 10 with the bending sleeve 410 has a faster endothelial attachment speed than the traditional stent, and the bending sleeve 410 is provided on one side of the keel 200. On the other side of the stent graft 10 where the keel 200 is not provided, especially in the blood vessel area covered by the non-fenestrated area 540, the anchoring force between the stent graft 10 and the blood vessel is relatively weak. After the stent graft 10 is placed in the blood vessel for a long time, the non-fenestrated area 540 is at risk of displacement, shortening and other adverse conditions. The present application adds a plurality of axially spaced reinforcing wires 550 in the non-fenestrated area 540, which can increase the overall support strength of the non-fenestrated area 540 and the fenestrated area 530 after puncture, and avoid the occurrence of partial displacement, shortening or even bleeding of the stent graft 10.

Since the strength of the coating 110 will be affected after the window is opened, for vascular lesions across the aortic arch and near the aortic arch, it is necessary to consider the blood flow of the branch vessels on the aortic arch. Liquid flow and the support strength of the coated stent 10. Therefore, this embodiment sets a reinforcing wire 550 on the coating 110 in the non-fenestration area 540, thereby increasing the overall strength of the coating 110 after the fenestration, avoiding the coating 110 from breaking due to insufficient strength under the long-term scouring of blood after puncture, and ensuring the strength of the coating 110 in the fenestration section 500 after the coated stent 10 is implanted in the blood vessel for a long time. In this embodiment, the bending direction and/or bending amplitude of each bending sleeve 410 may be the same or different. Since the shapes of blood vessels of different patients are different, especially when the vascular lesions are located near the aortic arch, the blood vessels near the aortic arch are usually deformed due to the lesions. Through the above-mentioned technical solution of the present application, the shape of each bending sleeve 410 can be set separately, so that the stent body 100 is adapted to the shape of the patient's vascular lumen after molding, further reducing the stimulation of the stent body 100 to the blood vessel and reducing the probability of secondary damage to the patient's blood vessel.

As shown in Figure 12, the connecting section 320 includes a connecting wave ring 321 and a supporting wave ring 322, wherein the connecting wave ring 321 is a bare wave ring, the distal end of the connecting wave ring 321 is connected to the proximal end of the coating 110, the proximal end of the connecting wave ring 321 is used to connect to the rear release device of the conveyor, and the supporting wave ring 322 is used to support the proximal edge of the coating 110.

The stent body 100 of the present embodiment is provided with a window section 500 and a curved section 310, and a position for puncturing the coating 110 is reserved on the window section 500, and a position for implanting a branch stent is reserved. The branch stent corresponds to the branch blood vessels on the aortic arch, so that after the coated stent 10 is implanted in the blood vessel, the blood circulation of the branch blood vessels on the aortic arch is not obstructed, thereby adapting to vascular lesions across the aortic arch and near the aortic arch.

Furthermore, the curved section 310 can set the stent graft 10 to a preset curved shape according to the shape of the blood vessel, thereby adapting the blood vessel near the aortic arch, reducing the pressure of the stent graft 10 on the inner wall of the blood vessel, reducing the stimulation of the stent graft 10 on the blood vessel, and preventing the blood vessel from being deformed. Make a breach.

Embodiment 5. Embodiment 5 of the present application provides a stent graft 10, as shown in FIGS. 18 to 19. The similarities between Embodiment 5 and Embodiment 1 are not repeated here. The difference between Embodiment 5 and Embodiment 1 is that a groove portion 600 is provided on the curved section 310, and the groove portion 600 is recessed toward the inner side of the stent body 100. The stent graft 10 of this embodiment is used for blood vessel treatment around the aortic arch. After the stent graft 10 is placed in the blood vessel, the groove portion 600 is correspondingly arranged at the aortic arch. Among them, the groove portion 600 is provided on the coating 110, and the groove portion 600 forms a roughly rectangular shape on the coating 110, that is, when the coating 110 is unfolded, it has a rectangular window.

The groove portion 600 includes a groove bottom film 610 connected to the covering film 110, a through hole 620 provided between the groove bottom film 610 and the covering film 110, and a connecting tube 630 connected to the through hole 620. After the curved section 310 is implanted into a blood vessel, the groove portion 600 is correspondingly provided at the aortic arch, and the connecting tube 630 is used to connect a branch stent corresponding to a branch blood vessel on the aortic arch.

In this embodiment, the connecting tube 630 is fixedly connected to the through hole 620 by suturing. The groove portion 600 includes three connecting tubes 630, two connecting tubes 630 are arranged at the proximal end of the groove portion 600, and one connecting tube 630 is arranged at the distal end of the groove portion 600, and the three connecting tubes 630 correspond to the three branch vessels on the aortic arch respectively. The edge of the through hole 620 is sutured with a developing ring 640 by suture thread, which is used to display the position of the connecting tube 630, so as to facilitate the connection of the branch stent with the stent graft 10 and the placement of the branch vessel.

The edge of the groove bottom film 610 is connected to the covering film 110 by sewing, and a groove support member 650 is provided on the groove bottom film 610. The supporting rod of the curved section bracket, the groove bottom film 610 is sewn on the supporting rod, or the groove support member 650 is a suture sewn on the groove bottom film 610, and the suture is used to increase the supporting strength of the bottom film.

As shown in Fig. 20 and Fig. 21, the stent body 100 includes a keel 200, and the bending section 310 includes a plurality of bending waves 311, and the plurality of bending waves 311 are sequentially connected and fixed to the keel 200, and adjacent bending waves 311 are connected by a bending sleeve 410, and the bending sleeve 410 is sleeved on the keel 200. The bending sleeve 410 is curved, so that the bending sleeve 410 drives the keel 200 and the bending waves 311 to bend the entire bending section 310 to adapt to the shape of the aortic arch.

Among them, the groove portion 600 is arranged on a side close to the keel 200. Due to the keel 200, therefore. Since the stent graft 10 of this embodiment is used to be implanted in the aortic arch, and the curvature of the blood vessel at the aortic arch is relatively large, by arranging the keel 200 toward the large curvature side of the aortic arch, the support of the stent graft 10 to the aortic arch as a whole can be enhanced to avoid displacement of the stent graft 10. However, after the stent graft 10 is implanted in the blood vessel for a long time, the resilience of the keel 200 will irritate the inner wall of the blood vessel, which is likely to cause new ruptures in the aorta. The present application drives the keel 200 to bend the entire curved section 310 through the bending sleeve 410 to better fit the shape of the blood vessel. Not only is the overall support of the stent graft 10 guaranteed by setting the keel 200 to achieve the purpose of protecting the blood vessel, but the bending sleeve 410 is also used to reduce the elastic resilience of the keel 200 and the curved section 310 and the stress formed thereby, thereby avoiding new ruptures in the aorta.

The curved wave ring 311 includes a high wave band 312 and a low wave band 313 connected end to end. The high wave band 312 is arranged on a side close to the keel 200, and the low wave band 313 is arranged on a side away from the keel 200. The axial height of the high wave band 312 is greater than the axial height of the low wave band 313. In other embodiments, the axial height of the high band 312 is greater than or equal to the axial height of the main wave circle 331, and the distance between adjacent high bands 312 is larger, so that the branch stent can pass through the adjacent curved wave circles 311 more easily, thereby facilitating the implantation of the branch stent, saving operation time and improving the success rate of the operation.

Compared with the existing stent graft 10, this embodiment provides a groove portion 600 on the curved section 310, and the groove portion 600 corresponds to the aortic arch after the stent graft 10 is implanted in the blood vessel. A connecting tube 630 is provided in the groove portion 600, and the connecting tube 630 is used to adapt to the branch stent, and connect the stent graft 10 and the branch blood vessel on the aortic arch through the branch stent. In addition, the curved wave ring 311 can better support the inner wall of the blood vessel at the aortic arch under the support of the keel 200, and the curved bending sleeve 410 is provided on the curved section 310, so that the entire curved section 310 is curved to adapt to the shape of the aortic arch, reduce the pressure caused by the stent graft 10 on the inner wall of the blood vessel, reduce the stimulation of the stent graft 10 on the blood vessel, and prevent new ruptures.

Around the aortic arch, the vascular lesions can be isolated and treated by other parts of the non-groove portion 600 of the stent graft 10, thereby well adapting to the vascular lesions around the aortic arch, taking into account the blood circulation of the branch vessels on the aortic arch and the treatment of the vascular lesions around the aortic arch.

In this embodiment, the stent body may further include a plurality of curved segments 310 , and the groove portion 600 is disposed on one of the curved segments 310 , so as to adapt to vascular lesions at different locations around the aortic arch, such as the ascending aorta.

As shown in FIG. 20 , the stent body 100 further includes a main body section 330, the main body section 330 includes a plurality of main body coils 331 arranged at intervals, the sleeve assembly 400 includes a connecting sleeve 420 for fixing the main body coils 331 on the keel 200, and the covering 110 and the main body coils 331 are connected to each other. As shown in FIG8 , the connection sleeve 420 is provided with a pressure tooth groove 430 , and when the coating 110 is fixed on the main body wave ring 331 , the suture is bound in the pressure tooth groove 430 on the connection sleeve 420 , and the suture stuck in the pressure tooth groove 430 can increase its fixing strength, and avoid relative movement between the coating 110 and the main body wave ring 331 due to pulling force.

In this embodiment, the stent body 100 further includes a connecting section 320, which is connected to the keel 200 via a connecting sleeve 420. Since the bending wave ring 311 at the groove portion 600 is separately provided from the coating 110, in this embodiment, the bending section 310 and the connecting section 320 are connected via the keel 200, so that the transition of the bending wave ring 311 on the groove portion 600 is smoother, and when the coated stent 10 is bent, the bending wave ring 311 is prevented from tilting outwards, which causes the bending wave ring 311 to cause excessive stimulation to the inner wall of the blood vessel, thereby avoiding other adverse consequences such as new ruptures in the blood vessel.

As shown in Figures 22 to 24, a semi-release device 700 is provided on the bracket body 100. The semi-release device 700 includes a binding unit 710 for binding the bracket body 100 and a limiting unit 720 movably connected to the binding unit 710. The limiting unit 720 controls the release of the binding unit 710.

The restraining unit 710 includes a limiting ring 711 provided on the wave coil assembly 300 and a restraining line 712 passing through the limiting ring 711. The limiting unit 720 includes a limiting rod 721. At least two limiting rings 711 are provided on the wave coil assembly 300. Both ends of the restraining line 712 pass through the limiting rings 711 respectively. The restraining line 712 and the limiting rod 721 are adapted to each other and are used to circumferentially restrain the stent graft 10.

In this embodiment, the binding unit 710 includes a plurality of limiting rings 711 arranged along the circumference of the stent graft 10 so that the binding wire 712 can be more firmly fixed on the stent graft 10 . The limiting ring 711 is sleeved on the wave coil assembly 300 and is sutured and fixed on the coating 120 .

Buckles 713 are provided at both ends of the binding line 712 , and the limiting rod 721 is used to simultaneously pass through the buckles 713 at both ends of the binding line 712 . Meanwhile, the length of the binding line 712 is smaller than the circumference of the cross section of the bracket body 100 .

In other embodiments, the limiting unit 720 may further include a limiting wire for simultaneously passing through the buckles 713 at both ends of the binding line 712 .

In this embodiment, a semi-release device 700 is provided on the surface of the stent graft 10. After the stent graft 10 is completely released from the conveyor, the stent graft 10 is in a semi-released state under the constraint of the semi-release device 700. The stent graft 10 in the semi-released state is under the circumferential constraint of the binding line 712. At this time, the binding line 712 binds the stent graft 10 in the circumferential direction around the stent graft 10, and the limiting rod 721 passes through the buckles 713 at both ends of the binding line 712 at the same time.

The stent graft 10 in the semi-released state does not adhere to the vessel wall. The operator can adjust the axial and circumferential positions of the stent graft 10 according to the actual situation. After accurate positioning, the constraint of the semi-release device 700 is released to allow the stent graft 10 to be deployed and adhere to the vessel wall. When the constraint of the semi-release device 700 is released, the limit rod 721 is pulled out from the ring buckles at both ends of the binding line 712, and the stent graft 10 without constraint expands under the action of its own elastic force, thereby completely adhering to the vessel wall.

In this embodiment, a restraining unit 710 is provided on each wave coil assembly 300 so that the stent graft 10 is subjected to uniform force when in a semi-released state.

When the stent graft 10 of this embodiment is implanted in a blood vessel, the groove 600 needs to correspond to the branch blood vessel on the aortic arch, and when the stent graft 10 is released, it is difficult to ensure that the groove 600 is aligned with the branch blood vessel on the aortic arch. A semi-releasing device 700 is provided on the upper side, and the position adjustment of the coating support 10 is realized by the semi-releasing device 700.

Since a groove portion 600 is provided on the bending section 310 of the present application, and the groove portion 600 is provided on the coating 110 and recessed into the stent body 100, the keel 200 in the groove portion 600 is in direct contact with the inner wall of the blood vessel, and the stent body 100 with the bending sleeve 410 has a stronger anchoring force after the coated stent 10 is unfolded and attached to the wall, which can prevent the coated stent 10 from shifting under long-term erosion of blood flow.

However, since the coated stent 10 has a curved section 310, compared to a traditional straight-tube stent, if the coated stent 10 is not positioned accurately when released, the curved section 310 will stick to the wall in advance, making it difficult to adjust the position of the coated stent 10. The present application provides a semi-release device 700 on the coated stent 10. The coated stent 10 is in a semi-released state after being released from the delivery system. At this time, the curved section 310 is in a restrained state and has not yet adhered to the blood vessel wall. Therefore, the coated stent 10 can move without scraping the blood vessel wall. The operator can adjust the axial and circumferential position of the coated stent 10 according to the situation, so that the groove portion 600 is directly opposite the branch blood vessel on the aortic arch.

In addition, the present application drives the entire bending section 310 to bend through the bending sleeve 410, so that the bending of the entire bending section 310 is more uniform, which facilitates the smoother transition of the limiting rod 721 of the binding unit 710 when passing through the limiting ring 711 in sequence. At the same time, the binding line 712 can be hooked in the pressure tooth groove 430 on the bending sleeve 410, which can prevent the binding line 712 from shifting during the movement of the limiting rod 711.

In this embodiment, when the stent graft 10 is in a semi-released state, the buckles 713 at both ends of the binding line 712 are located in the middle of the groove portion 600, so that the force on the groove portion 600 is more Uniform. At the same time, the keel 200 is axially arranged along the middle part of the groove portion 600. When the binding line 712 is in a semi-released state, it can be hooked in the pressure tooth groove 430 on the bending sleeve 410, and the limiting rod 721 passes through the buckle 713 of the limiting unit 720 in sequence. At this time, the limiting rod 721 has the same bending shape as the keel 200 under the binding effect of multiple groups of buckle rings 713, thereby preventing the limiting rod 721 from scratching the blood vessel wall when adjusting the position of the coated stent 10 in the semi-released state, thereby ensuring the safety of the operation.

Through the above technical solution of this embodiment, by providing the groove portion 600 corresponding to the aortic arch on the curved section 310, the stent graft 10 can effectively deal with the vascular lesions around the aortic arch. In addition, the setting of the curved section 310 can well adapt to the shape of the aortic arch and reduce the stimulation of the stent graft 10 on the inner wall of the blood vessel. The blood circulation of the branch vessels on the aortic arch and the treatment of vascular lesions around the aortic arch are taken into account.

In summary, the coated stent prepared by the above-mentioned preparation method of the present application has good physical properties, and the stent can be specifically manufactured according to the shape of the specific diseased blood vessel, so that the stent can better fit the shape of the blood vessel itself, and can reduce the elastic recoil force generated by the passive bending of the existing stent in the curved parts such as the aortic arch, as well as the stress formed thereby, thereby reducing and preventing new aortic ruptures caused by the stent.

The above are only preferred specific implementations of the utility model, but the protection scope of the utility model is not limited thereto. Any changes or substitutions that can be easily thought of by a technician familiar with the technical field within the technical scope disclosed by the utility model should be included in the protection scope of the utility model. Therefore, the protection scope of the utility model should be based on the protection scope of the claims.

Claims

A coated stent comprises a stent body and a coating arranged on the stent body, characterized in that the stent body comprises a keel, a wave coil assembly and a sleeve assembly for connecting the keel and the wave coil assembly; the wave coil assembly comprises at least one curved section connected to the keel, the curved section comprises a plurality of curved wave coils sequentially arranged on the keel, the sleeve assembly comprises a plurality of curved sleeves which are curved and used to connect adjacent curved wave coils; the bending directions and/or bending amplitudes of the plurality of bending sleeves are the same or different.
The coated stent according to claim 1 is characterized in that the bending wave ring includes a high band and a short band connected end to end, the high band is arranged on a side close to the keel, the short band is arranged on a side away from the keel, and the axial height of the high band is greater than the axial height of the short band.
The coated stent according to claim 1 is characterized in that adjacent bending wave coils are connected by connecting rods, the bending wave coils are fixedly connected to the connecting rods through the bending sleeves, and a plurality of connecting rods are connected in sequence to form a part of the keel.
The coated stent according to claim 3 is characterized in that the bending wave coils and the connecting rod are integrally woven by braiding wires, and adjacent bending wave coils are connected end to end by the connecting rod.
The coated bracket according to claim 1 is characterized in that the sleeve assembly also includes a pressure tooth groove recessed toward the interior of the bending sleeve, the pressure tooth groove is used to connect and fix the bending section and the keel, the bending sleeve includes a first pressing surface and a second pressing surface arranged opposite to each other, and the pressure tooth groove is arranged on the first pressing surface and/or the second pressing surface.
The coated support according to claim 5 is characterized in that the number and/or shape of the pressing grooves arranged on the first pressing surface of the bending sleeve are different from those of the pressing grooves arranged on the second pressing surface.
The coated bracket according to claim 6 is characterized in that the pressure tooth groove includes a first pressure groove arranged on the first pressing surface and a second pressure groove arranged on the second pressing surface; the number of the first pressure grooves is less than the number of the second pressure grooves, and the first pressure groove and the second pressure groove are staggered.
The coated stent according to claim 7 is characterized in that the bending sleeve is bent toward the inner direction of the stent body; the first pressing surface is arranged toward the inner direction of the stent body, and the second pressing surface is arranged toward the outer direction of the stent body.
The coated stent according to claim 1 is characterized in that the stent body also includes a connecting section arranged at the proximal end of the bending section and a main section arranged at the distal end of the bending section, the connecting section includes a connecting wave ring for connecting to a rear release device of a conveyor and a supporting wave ring for supporting the proximal edge of the coating, and the connecting wave ring is connected to the coating part.
The coated stent according to claim 9 is characterized in that the main body section is arranged in a straight cylindrical shape, the main body section includes a plurality of main body coils connected to the keel in sequence, and the sleeve assembly also includes a connecting sleeve for connecting adjacent main body coils.
The coated stent according to claim 10 is characterized in that the radial dimension of the main body wave coil located at the distal end of the stent body is smaller than that of the main body wave coil located at the proximal end of the stent body.