CN116407326B

CN116407326B - A coated stent

Info

Publication number: CN116407326B
Application number: CN202111662163.2A
Authority: CN
Inventors: 林志鹏; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-12-30
Filing date: 2021-12-30
Publication date: 2025-07-04
Anticipated expiration: 2041-12-30
Also published as: CN116407326A

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a stent graft, including a main support member and a coating body arranged on the main support member, wherein the main support member includes a main stent segment and a support frame segment arranged at the proximal end of the main stent segment, the support frame segment includes a connecting wave ring connected to the coating body portion and a supporting wave ring arranged at the supporting coating port, and the main support member is provided with a groove portion recessed toward the inner side of the main support member. According to the stent graft in the present invention, it is possible to establish a connection with a branch blood vessel through the groove portion, thereby improving the efficiency of the branch blood vessel connection, reducing the difficulty of observation and operation of doctors, and improving the success rate of the operation.

Description

Tectorial membrane support

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a covered stent.

Background

Aortic aneurysms and aortic dissection are diseases which seriously endanger the life safety of human beings at present, if the aortic aneurysms and dissection are not actively treated, the aortic aneurysms and dissection are continuously increased, and finally the aortic aneurysms and the dissection are ruptured to cause serious complications and death, and along with the continuous increase of patients with hypertension, hyperlipidemia and high diabetes, the incidence of the aortic aneurysms and the aortic dissection is also obviously increased at present.

The traditional open surgery treatment aortic aneurysm and aortic dissection has the characteristics of large trauma, high mortality rate, long surgery time, high postoperative complication occurrence rate and high surgery difficulty, while the intracavity treatment has the characteristics of small trauma, less postoperative complication, short surgery time, low surgery difficulty and the like, so that the traditional open surgery treatment aortic aneurysm and aortic dissection gradually becomes the main mode for treating aortic aneurysm and aortic dissection at present. The covered stent is implanted in the aorta to isolate vascular lesions outside the covered stent, so that blood flow is restrained from flowing through the covered stent, and the purpose of protecting blood vessels is achieved.

Since the aorta has a plurality of branch vessels, blood flow in the aorta needs to be introduced into the branch vessels in order to ensure blood circulation. In the prior art, blood is usually introduced into a branch vessel by adopting a windowing mode on a covered stent, and in order to ensure the smoothness of the blood and the tightness of the covered stent at the same time, a branch stent for communicating the covered stent with the branch vessel is generally arranged at the windowing position.

In the case of connecting a branch stent to a stent graft, the operation in vivo is not easy for a doctor to observe, and the branch vessel is small in size and requires high operation accuracy, so that the connection of the branch stent becomes one of the difficulties in aortic aneurysm and aortic dissection.

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

Disclosure of Invention

The invention aims to at least solve the problem that a covered stent and a branch stent are difficult to connect.

An aspect of the present invention provides a stent graft, including a main support and a stent graft body disposed on the main support, where the main support includes a main support section and a support section disposed at a proximal end of the main support section, the support section includes a connection band connected to the stent graft body and a support band disposed at a port for supporting the stent graft, and the main support is provided with a groove portion recessed toward an inner side of the main support.

According to the covered stent, the connection with the branch blood vessel can be established through the groove part, so that the efficiency of the connection of the branch blood vessel is improved, the observation and operation difficulties of doctors are reduced, and the success rate of surgery is improved.

In some embodiments of the present invention, the groove part includes a groove support connected to the main body support and a groove cover provided on the groove support, and the groove part is provided with at least one through hole.

In some embodiments of the present invention, the main body support and/or the support film is provided with a developing member, the developing member includes a first developing point and a second developing point disposed on a center line of the groove portion, and a third developing point disposed on the other side with respect to the center line of the groove portion, the first developing point and the third developing point are located at edges of a proximal end of the support frame section, and the second developing point is located at an edge of the groove portion near one end of the support frame section.

In some embodiments of the invention, when the through hole is located near the support frame segment proximal end, a distance between the through hole and the support frame segment proximal end is less than or equal to a distance between the second development point and the support frame segment proximal end.

In some embodiments of the present invention, the wire diameter of the supporting wave ring is smaller than the wire diameter of the connecting wave ring, the number of wave bands of the supporting wave ring is larger than the number of wave bands of the connecting wave ring, and the supporting wave ring is fixedly connected with the film covering body or the supporting wave ring is fixedly connected with the connecting wave ring.

In some embodiments of the invention, the proximal end of the support band is flush with the proximal edge of the stent body, or the distal end of the support band is flush with the distal edge of the connecting band, or the support band is disposed between the distal end of the connecting band and the proximal end of the stent body.

In some embodiments of the present invention, the connection wave ring includes a plurality of fixed wave segments fixedly connected to the film covering body and at least one movable wave segment movably connected to the film covering body, where the fixed wave segments and the movable wave segments are sequentially spaced apart from each other.

In some embodiments of the invention, the stationary waveform segment comprises a stationary peak, a stationary trough, and a stationary wave bar connecting adjacent the stationary peak and stationary trough, the top of the stationary peak being flush with the proximal edge of the stent body or closer to the distal end of the stent body than the proximal edge of the stent body;

The movable wave section comprises a movable wave crest, a movable wave trough and a movable wave rod connected with the adjacent movable wave crest and the movable wave trough, the movable wave trough is fixedly connected with the tectorial membrane body, and the movable wave crest and the movable wave rod are movably connected with the tectorial membrane body.

In some embodiments of the present invention, the primary stent section comprises a plurality of primary stent turns disposed in spaced apart relation, the primary stent turns comprising primary stent peaks, primary stent valleys, and primary stent links connecting the primary stent peaks and primary stent valleys;

The wave rings of the main support are connected through a tectorial membrane body.

In some embodiments of the invention, the major curved side of the body support is provided with a fixed wave segment.

Drawings

FIG. 1 is a schematic view showing the overall structure of a stent graft according to an embodiment of the present invention;

FIG. 2 is a schematic view showing a branch stent according to an embodiment of the present invention

FIG. 3 is a schematic view showing the structure of a proximal portion of a stent graft according to an embodiment of the present invention;

FIG. 4 is a schematic view showing the structure of another embodiment of the proximal portion of the stent graft in example I of the present invention;

FIG. 5 is a schematic view of a main frame wave ring according to an embodiment of the present invention;

FIG. 6 is a schematic diagram of a connecting band according to an embodiment of the present invention;

FIG. 7 is a schematic diagram of a connection structure for connecting a wave ring and a film body according to an embodiment of the invention;

FIG. 8 is a schematic view of a supporting ring according to an embodiment of the present invention;

FIG. 9 is a schematic view of a stent graft in a semi-released state according to an embodiment of the present invention;

FIG. 10 is a schematic diagram showing a connection structure between a delivery device and a stent graft in a semi-release state according to an embodiment of the present invention;

FIG. 11 is a schematic view of another embodiment of a primary stent band in accordance with an embodiment of the present invention;

FIG. 12 is a schematic view showing the structure of a stent graft in a sheath according to an embodiment of the present invention;

FIG. 13 is a cross-sectional view of a stent graft in a sheath according to an embodiment of the present invention;

FIG. 14 is a schematic diagram of a structure of a connection wave ring and a support wave ring with a phase difference of half a phase difference according to a first embodiment of the present invention;

FIG. 15 is a schematic view showing the structure of a developing bar according to the first embodiment of the present invention;

FIG. 16 is a schematic view of a developing bar from another perspective according to an embodiment of the present invention;

FIG. 17 is a schematic diagram of a connecting rod in a second embodiment of the present invention;

FIG. 18 is a side view of a connecting band in a third embodiment of the invention;

FIG. 19 is a front view of a connecting band in a third embodiment of the invention;

FIG. 20 is a side view of a connecting band in a fourth embodiment of the invention;

FIG. 21 is a front view of a connecting band in a fourth embodiment of the invention;

FIG. 22 is a schematic view showing the structure of a proximal portion of a stent graft according to a fifth embodiment of the present invention;

FIG. 23 is a schematic view showing the structure of a proximal portion of a stent graft according to a sixth embodiment of the present invention;

FIG. 24 is a schematic view showing the structure of a proximal portion of a stent graft according to a seventh embodiment of the present invention;

FIG. 25 is a schematic view showing the structure of a proximal portion of a stent graft according to an eighth embodiment of the present invention;

FIG. 26 is a schematic view of a development member of a stent graft in accordance with a ninth embodiment of the present invention;

Fig. 27 is a schematic structural view of a developing member of a stent graft according to another embodiment of the present invention.

The reference numerals in the drawings are as follows:

001. The stent comprises a stent cover, 002, a main body stent, 003, a branch stent, 100, a main body supporting piece, 200, a main support section, 300, a support frame section, 400, a branch supporting piece, 401, a branch wave ring, 402, a branch connecting rod, 403, a developing ring, 500 and a branch stent cover;

10. The film coating body, 11, the developing piece, 111, the first developing point, 112, the second developing point, 113, the third developing point, 114, the fourth developing point, 115, the fifth developing point, 116, the sixth developing point, 117, the seventh developing point, 118, the eighth developing point, 119, the developing strip, 20, the main support wave ring, 21, the main support wave crest, 22, the main support connecting rod, 23, the main support wave trough, 24, the connecting rod, 30, the connecting wave ring, 301, the connecting wave band part, 31, the movable wave segment, 311, the movable wave crest, 312, the movable wave rod, 313, the movable wave trough, 314, the bending part, 315, the movable distal end part, 316, the movable proximal end part, 32, the fixed wave segment, 321, the fixed wave crest, 322, the fixed wave trough, 323, the fixed wave trough, 33, the sewing point, 40, the supporting wave ring, 41, the supporting wave segment, 42, the supporting unit, 50, the groove part, 51, the groove supporting piece, 52, the groove coating film, 521, the through hole, 53, the sewing ring, 54, the groove supporting frame, the 542, the groove supporting frame, the groove supporting segment, the 542, the sheath, the 61, the guiding jaw, the sheath, the 64, the sheath.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various 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 be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

For ease of description, the following description uses the terms "distal" and "proximal", wherein "distal" refers to the end distal to the heart and "proximal" refers to the end proximal to the heart, and the phrase "axial direction" should be understood herein to mean the direction in which the interventional instrument is advanced and expelled, the direction perpendicular to the "axial direction" being defined as the "radial direction".

As shown in fig. 1 to 3, the stent graft 001 of the present embodiment is of a hollow tubular structure with openings at both ends, and includes a main body stent 002 and a branch stent 003, wherein the branch stent 003 is disposed inside the main body stent 002, the main body stent 002 is used for implantation into an aortic vessel, and the branch stent 003 is used for implantation into a branch vessel. Wherein, branch support 003 is hollow cylindrical structure, and branch support 003 sets up along the length direction of main part support 002, and main part support 002 includes main part support 100 and tectorial membrane body 10. Wherein the branch bracket 003 is the same as the axial direction of the main body support 100.

In other embodiments, the branch bracket 003 and the main support 100 are disposed at a predetermined angle, and the predetermined angle may be 3 °,5 ° or 10 °, etc., which is specifically set according to actual needs.

The surface of the main body support 002 is provided with a groove portion 50 recessed toward the inside of the main body support 002, the edge of the groove portion 50 is connected to the film coated body 10 of the main body support 002, the groove portion 50 includes a groove support 51 and a groove film 52 provided on the groove support 51. The groove support 51 is connected to the main support 100, and the groove cover 52 is connected to the cover body 10.

In the present embodiment, the edges of the groove cover 52 are connected to the cover body 10 by sewing. Specifically, a sewing ring 53 is disposed between the groove coating 52 and the coating body 10, and the groove coating 52 is connected with the coating body through the sewing ring 53. A support loop (not shown) for reinforcing the support strength of the groove portion 50 may be provided in the sewing ring 53, and the support loop is a metal loop having elasticity.

In other embodiments, the groove cover 52 may be integrally formed with the cover body 10, and the groove cover 52 is fixed on the groove support 51 by stitching or the like. The groove support 51 is recessed with respect to the main body support 100, and the groove support 51 is used to shape the groove cover 52, thereby forming the groove portion 50 that is recessed as a whole.

The groove cover film 52 is provided with a through hole 521, and the branch bracket 003 is communicated with the through hole 521, so that blood flows into the branch bracket 003 from the main body bracket 002 through the through hole 521, wherein the branch bracket 003 is fixedly connected with the through hole 521 by stitching. The main body bracket 002 comprises one or more branch brackets 003, and the diameters of the branch brackets 003 can be the same or different, and the branch brackets are arranged according to actual needs.

In the present embodiment, the stent graft 001 includes three branched stents 003, wherein two branched stents 003 are provided near the proximal end of the groove portion 50 and one branched stent 003 is provided near the distal end of the groove portion 50.

The branch stent 003 includes a branch stent 400 and a branch stent graft 500 disposed on the branch stent 400, and the branch stent graft 500 is connected to the through-hole 521 by sewing. The outer edge of the through hole 521 is stitched with a developing ring 403 by a suture line, so as to show the position of the branch bracket 003. The branch support 400 includes a plurality of branch wave rings 401 arranged at intervals, a branch connecting rod 402 is arranged between adjacent branch wave rings 401, and the branch wave rings 401 are in a wave shape or a diamond shape.

The film body 10 is disposed on the main body support 100, and it should be understood that the main body support 100 may be disposed on an inner surface of the film body 10, or may be disposed on an outer surface of the film body 10, or a portion of the main body support 100 may be disposed on an inner surface of the film body 10, and another portion of the main body support 100 may be disposed on an outer surface of the film body 10.

In this embodiment, the length of the stent graft body 10 is greater than or equal to the length of the main support 100, so that the stent graft body 10 completely covers the main support 100, i.e. the main support 100 does not have a bare stent portion, thereby avoiding the damage of the main support 100 to the inner wall of the blood vessel after the stent graft 001 is implanted in the blood vessel, and avoiding the main support 100 from generating a larger stimulus to the inner wall of the blood vessel.

In other embodiments, the main support 100 may also partially extend beyond the stent graft body 10 and extend beyond the main support 100 of the stent graft body 10, and bend toward the central axis direction of the stent graft 001, so that the portion of the main support 100 extending beyond the stent graft body 10 will not contact the inner wall of the blood vessel after the stent graft 001 is implanted in the blood vessel, thereby avoiding the main support 100 from generating a larger stimulus to the inner wall of the blood vessel.

The groove 50 is formed on the film-coated body 10, and the groove 50 is located at the middle of the main film-coated body 10, and the groove 50 forms a substantially rectangular shape on the film-coated body 10, i.e. has a rectangular window when the film-coated body 10 is unfolded.

The film covered stent 001 further comprises a groove supporting frame 54, the groove supporting frame 54 is arranged on the outer side of the groove film covered 52, and the groove supporting frame 54 protrudes out of the surface of the film covered body 10 towards the outer side of the groove film covered 52. The groove support frame 54 is fixed to the edge of the groove 50 by stitching, and when the stent graft 001 is implanted in the aortic arch, the groove support frame 54 can support the inner wall of the aortic vessel, thereby achieving a better fixing effect.

Specifically, the groove support frame 54 includes a plurality of groove support sections 541, the plurality of groove support sections 541 are connected to edges of the groove portion 50, and the plurality of groove support sections 541 are connected by hooking each other, thereby forming a net structure having meshes 542. Namely, the vertexes of the adjacent groove support sections 541 are connected in a mutually hanging manner, so that the groove support frame 54 is prevented from being separated when the tectorial membrane support 001 is deformed, and meanwhile, the size of the mesh 542 formed by the adjacent groove support sections 541 can be changed when the mesh is subjected to external force, so that the elasticity of the groove support frame 54 is enhanced, and the adherence of the groove support frame 54 is improved.

In other embodiments, the groove support 54 may be integrally formed with the main body support 002, and the groove support 54 is in a wave shape, so that the cost can be reduced while the support of the groove support 54 is satisfied.

The main body support 100 includes a main stent section 200 and a support stent section 300 disposed at a proximal end of the main stent section 200. The support frame section 300 includes a connection wave ring 30 and a support wave ring 40, the connection wave ring 30 is partially connected with the film covering body 10, the connection wave ring 30 is used for connecting a release mechanism of the film covering support 001, the support wave ring 40 is arranged at a port of the film covering body 10, and the support wave ring 40 is used for supporting the port of the film covering body 10.

Wherein the main body support 100 is made of a material having good biocompatibility and good elasticity, for example, nickel-titanium alloy, stainless steel, etc., and the film body 10 is made of a film material having good biocompatibility, for example, PET, PTFE, etc. The film-coated body 10 may have a single-layer structure or a multilayer structure.

As shown in fig. 3 to 5, the main stent section 200 includes a plurality of main stent bands 20, and the main stent bands 20 are in a Z-shaped band structure, and the Z-shaped band structure is formed by connecting a plurality of sub-bands end to form a closed loop structure having peaks and valleys.

Specifically, the primary stent eyelet 20 includes a primary stent peak 21, a primary stent trough 23, and a primary stent link 22 connecting the primary stent peak 21 and the primary stent trough 23. The main support wave rings 20 are arranged at intervals, and the main support wave rings 20 are fixedly connected with the tectorial membrane body 10. The main support wave rings 20 are connected only through the film covering body 10, the main support wave rings 20 and the film covering body 10 are fixed in a sewing mode or in an adhesive mode, and the fixing mode is selected according to actual needs.

In this embodiment, the primary stent peaks 21 of one primary stent band 20 are disposed corresponding to the primary stent valleys 23 of an adjacent primary stent band 20, and correspondingly, the primary stent valleys 23 of one primary stent band 20 are disposed corresponding to the primary stent peaks 21 of an adjacent primary stent band. Thereby ensuring that the covered stent 001 has better compliance at the corresponding position of the aortic arch implantation.

The main stent section 200 is of variable diameter construction, the diameter of the distal end of the main stent section 200 being smaller than the diameter of the proximal end of the main stent section 200, i.e. the diameter of the main stent band 20 at the distal end of the main stent section 200 is smaller than the diameter of the main stent band 20 at the proximal end of the main stent section 200. Thereby better adapting to the shape of the aortic vessel so that the covered stent 001 can better fit the inner wall of the aortic vessel.

In other embodiments, the main stent section 200 may also be a cylindrical hollow tube of equal diameter throughout when the stent graft 001 is adapted for use in other aortic vascular sites.

In the present embodiment, the stent graft body 10 is attached to the main support 100, and the main support 100 is used to prop open the stent graft body 10 when the stent graft 001 is released as the main support 100 changes shape. Each of the main stent collars 20 is a wavy metal ring, so that the stent graft body 10 has a hollow cylindrical structure after the stent graft 001 is released. Wherein, the diameter of each main support wave ring 20 is the same, or the arrangement of different diameters is adopted according to actual needs.

Wherein, the two ends of the film-covered body 10 are openings, the middle is a closed tube cavity structure, and the film-covered body 10 can be a layer of film or a plurality of layers of films. When the laminated body adopts a multi-layer film structure, two adjacent layers of films can be fixed together by adopting modes of glue adhesion, direct firing or heat treatment and the like. The materials of two adjacent films may be the same or different.

The main support wave ring 20, the connecting wave ring 30 and the supporting wave ring 40 are all made of memory alloy, for example, the main support wave ring 20, the connecting wave ring 30 and the supporting wave ring 40 are all formed by adopting a nickel-titanium alloy wire braiding or nickel-titanium tube cutting and shaping mode. The nickel-titanium alloy has good fatigue life and strong corrosion resistance. Meanwhile, by adopting the memory alloy material to make the main body support 100, the main body support 100 is restored to a preset shape at a preset temperature, for example, 36 ℃, and the preset shape can be set according to actual needs, which is not limited by the present application.

The connection wave ring 30 may be disposed on the inner side of the film coated body 10, and the support wave ring 40 may be disposed on the inner side or the outer side of the film coated body 10, and may be selected according to actual needs. When the support wave ring 40 is disposed outside the film coated body 10, the support wave ring 40 may be fixed to the film coated body 10 by sewing or bonding. When the support wave ring 40 is disposed on the inner side of the film covering body 10, the support wave ring 40 may be fixed on the film covering body 10 by stitching or bonding, or may be fixedly connected with the connection wave ring 30 by stitching or welding.

In this embodiment, the connection wave ring 30 is disposed at the inner side of the stent graft 001, the support wave ring 40 is disposed between the stent graft body 10 and the connection wave ring 30, and the support wave ring 40 is fixed on the stent graft body 10 by stitching, so as to enhance the support strength of the proximal end of the stent graft body 10 and prevent internal leakage.

As shown in fig. 1, the wire diameter of the supporting wave ring 40 is smaller than the wire diameter of the connecting wave ring 30. After the stent graft 001 is implanted into a blood vessel, the supporting band 40 supports the stent graft 10 to make the stent graft 10 adhere to the inner wall of the blood vessel, so the radial supporting force of the supporting band 40 directly affects the pressure of the stent graft 001 to the inner wall of the blood vessel.

In this embodiment, the wire diameter of the supporting wave ring 40 is smaller than the wire diameter of the connecting wave ring 30, so that the radial supporting force of the supporting wave ring 40 is reduced, the contact surface between the supporting wave ring 40 and the inner wall of a blood vessel is softer, the stimulation to the inner wall of the blood vessel is small, and the new concurrent stent source break of the near end of the postoperative long-term covered stent 001 is reduced. In other embodiments, the supporting wave ring 40 may be woven by using a lower-hardness woven wire by changing the materials of the supporting wave ring 40 and the connecting wave ring 30, so that the radial supporting force of the supporting wave ring 40 is smaller than the radial supporting force of the connecting wave ring 30. The hardness of the support band 40 and the connection band 30 may also be adjusted by changing the processing process, for example, changing the temperature or time of the heat treatment, etc.

On the other hand, as shown in fig. 9 and 10, the release mechanism 60 of the delivery device includes a sheath 61 for accommodating and delivering the stent graft 001 and a sheath core 62 provided in the sheath 61, and when delivering the stent graft 001 to a vascular lesion site, the stent graft 001 is loaded between the sheath 61 and the sheath core 62, and the stent graft 001 is in a compressed state. The compressed state of the stent graft 001 is shown in fig. 12 and 13.

Since the present application enhances the supporting strength of the stent graft body 10 by the supporting pulsator 40 by providing the supporting pulsator 40 at the proximal end edge of the stent graft body 10, thereby effectively preventing blood leakage. However, the addition of the support band 40 increases the radial dimension of the stent graft 001 in a compressed state, and in order to smoothly load the stent graft 001 into the sheath 61, the radial diameter of the sheath 61 needs to be adjusted to accommodate the stent graft 001 having a larger radial diameter.

For the sheath 61 inserted into the blood vessel, the smaller the radial diameter of the sheath 61 is, the more advantageous the delivery of the stent graft 001 to the lesion site. Therefore, the wire diameter of the support wave ring 40 is set smaller than the wire diameter of the connection wave ring 30, so that the radial supporting force of the support wave ring 40 can be reduced, the contact surface between the support wave ring 40 and the inner wall of the blood vessel is softer, the radial dimension of the stent graft 001 in a compressed state can be reduced, the stent graft 001 can be conveniently installed in the sheath 61 with a smaller radial dimension, and the sheath 61 can be conveniently conveyed to a lesion position.

In the present embodiment, the connecting band 30 and the supporting band 40 are fixed to the film covering body 10 by sewing threads, and the supporting band 40 is of an integral structure, as shown in fig. 8. When the radial supporting forces of the connecting wave ring 30 and the supporting wave ring 40 are tested, the suture lines for fixing the connecting wave ring 30 and the supporting wave ring 40 are released, the connecting wave ring 30 and the supporting wave ring 40 are taken down from the tectorial membrane body 10, the radial supporting forces of the connecting wave ring 30 and the supporting wave ring 40 are tested respectively, and the radial supporting forces of the supporting wave ring 40 can be smaller than the radial supporting forces of the connecting wave ring 30.

In other embodiments, the support band 40 may be formed by stacking a plurality of sub-bands, for example, 2 sub-bands are respectively stitched to the film body 10 to form the support band 40. If the supporting band 40 is formed by overlapping a plurality of sub-bands, the suture line for fixing the connecting band 30 is released when the radial supporting force of the supporting band 40 is tested, the connecting band 30 is removed, and then the radial supporting force of the supporting band 40 and the whole body of the film body 10 is tested, and the suture line for fixing the supporting band 40 is released when the radial supporting force of the connecting band 30 is tested, and then the supporting band 40 is removed, and then the radial supporting force of the connecting band 30 and the whole body of the film body 10 is tested. It is possible to obtain that the radial supporting force of the supporting pulsator 40 and the whole of the film coated body 10 is smaller than the radial supporting force of the connecting pulsator 30 and the whole of the film coated body 10.

On the other hand, since the stent graft 001 of the present application is provided with the groove portion 50 and the branch stent 003, the stent graft 001 can be extended to the ascending aorta of the aorta, and the blood circulation of the branch vessel at the aortic arch is ensured by the groove portion 50 and the branch stent 003. Thus, the stent graft 001 of the present application can be applied to the treatment of aortic aneurysms and aortic dissection of the ascending aorta.

However, the inner wall of the blood vessel at the ascending aorta is sensitive, and the blood pressure at the ascending aorta is high, so that if the stent graft 001 has large stimulation to the inner wall of the blood vessel, the patient is easy to feel uncomfortable under the impact of the high blood pressure of the ascending aorta. Therefore, the wire diameter of the supporting wave ring 40 is reduced, so that the wire diameter of the supporting wave ring 40 is smaller than the wire diameter of the connecting wave ring 30, and the irritation of the supporting wave ring 40 to the inner wall of the blood vessel is reduced on the basis of ensuring that the supporting wave ring 40 can enable the tectorial membrane body 10 to be attached, and the uncomfortable feeling of a patient is relieved.

Further, as shown in fig. 6 to 8, the number of wave bands of the supporting wave band 40 is larger than the number of wave bands of the connecting wave band 30, wherein the supporting wave band 40 includes a plurality of supporting wave segments 41 connected in sequence, the number of wave bands of the supporting wave band 40 is the number of the supporting wave segments 41, the number of wave bands of the connecting wave band 30 is the total number of the fixed wave segments 32 and the movable wave segments 31, and the number of wave bands of the supporting wave band 40 is set to be larger than the number of wave bands of the connecting wave band 30.

Since the support band 40 is provided between the stent graft body 10 and the connection band 30 and the radial supporting force of the connection band 30 is greater than that of the support band 40, the connection band 30 supports the support band 40 from the inside after the stent graft 001 is completely released. In this embodiment, the number of the wave bands of the supporting wave band 40 is set to be greater than the number of the wave bands of the connecting wave band 30, so that the radial supporting force provided by the connecting wave band 30 is dispersed, and the pressure applied to the inner wall of the blood vessel is more uniform. On the other hand, by increasing the number of the wave bands of the supporting wave band 40, the number of connection points between the supporting wave band 40 and the proximal end of the stent graft body 10 can be increased, and after the supporting wave band 40 is completely released and unfolded, the proximal end of the stent graft body 10 is more nearly circular, so that the risk of internal leakage of the stent graft 001 is further reduced.

Specifically, the wire diameter of the supporting wave ring 40 is 0.1mm to 0.5mm, the wire diameter of the connecting wave ring 30 is 0.3mm to 1mm, and the number of wave bands of the supporting wave ring 40 is 3 times to 5 times the number of wave bands of the connecting wave ring 30. In this embodiment, the wire diameter of the supporting wave ring 40 is 0.2mm, the wire diameter of the connecting wave ring 30 is 0.5mm, the number of wave bands of the supporting wave ring 40 is 3 times the number of wave bands of the connecting wave ring 30, and the supporting wave ring 40 and the connecting wave ring 30 are made of nickel titanium wires. As shown in fig. 6 and 7, the connection band 30 includes a plurality of connection band portions 301 connected in sequence, and the plurality of connection band portions 301 are connected in sequence to form a ring-shaped support structure. The connecting band part 301 comprises a plurality of fixed waveform segments 32 and at least one movable waveform segment 31, wherein the fixed waveform segments 32 are fixedly connected with the tectorial membrane body 10, the movable waveform segments 31 are movably connected with the tectorial membrane body 10, and the movable waveform segments 31 are connected with a release mechanism of the tectorial membrane bracket 001.

In this embodiment, the connection band portion 301 includes three movable waveform segments 31 movably connected to the stent graft body 10, where the three movable waveform segments 31 are uniformly disposed along the circumferential direction of the stent graft body 10, or may be disposed adjacently or at intervals, and the three movable waveform segments 31 are used for connecting with a release mechanism of the delivery device, and release after the stent graft 001 is positioned.

In other embodiments, the connection band portion 301 may also include four or six movable waveform segments 31 for adapting to the release mechanisms of different sized delivery devices.

As shown in fig. 9 and 10, the sheath core 62 is provided with a hook 63, the sheath core 62 passes through the inner side of the stent graft 001 and is located in the middle of the stent graft 001, the hook 63 is used for being connected with the connection wave ring 30, and the hook 63 is hooked and fixed with the movable wave segment 31 of the connection wave in the conveying process of the stent graft 001, so as to limit the position of the stent graft 001 in the conveyor, wherein the front end of the sheath 61 is further provided with a guide part 64, and the front end of the guide part 64 is in a conical shape.

In the release process of the stent graft 001, after the stent graft 001 is conveyed to a predetermined position by the conveyor, the stent graft 001 is completely released into the blood vessel by releasing the hooking fixation of the hooking claw 63 and the movable wave segment 31.

The hook claw 63 is hooked with the movable waveform segment 31, and when the hook claw 63 is disconnected from the movable waveform segment 31, the covered stent 001 is completely released in the blood vessel. Before the fingers 63 are released from the connection with the movable wave segment 31, the proximal end of the stent graft 001 is already in a semi-released state due to the structural arrangement of the connecting band 30. Wherein the semi-released state refers to the proximal end of the stent graft 001 in a partially deployed state.

In this embodiment, the connection band 30 comprises three circumferentially evenly distributed active waveform segments 31. Since the sheath core 62 is located in the middle of the inside of the stent graft 001, the hooking claw 63 is provided on the sheath core 62, so that when the movable waveform segment 31 is hooked and fixed on the hooking claw 63, the hooking claw 63 simultaneously binds the three movable waveform segments 31 in the middle of the inside of the stent graft 001.

The stationary wave segment 32 includes stationary wave crests 321, stationary wave troughs 323, and stationary wave rods 322 connecting adjacent stationary wave crests 321 and stationary wave troughs 323. The movable waveform segment 31 comprises a movable peak 311, a movable trough 313 and a movable wave rod 312 connected with the adjacent movable peak 311 and the movable trough 313, the movable trough 313 is fixedly connected with the tectorial membrane body 10, and the movable peak 311 and the movable wave rod 312 are movably connected with the tectorial membrane body 10. In the present embodiment, the fixed waveform segment 32 is disposed at a distance from the movable waveform segment 31.

Before the hook claw 63 is released from the connection with the movable waveform segment 31, the movable waveform segment 31 is connected to the hook claw 63 under the constraint action of the hook claw 63, the movable wave crest 311 is connected to the film covered body 10, and the film covered body 10 connected to the movable wave crest 313 generates displacement towards the inner side direction of the film covered stent 001 under the traction action of the movable waveform segment 31. The fixed waveform segment 32 generates an outward radial supporting force on the film covering body 10 under the action of the self elastic force, so as to prop open the film covering body 10.

Therefore, before the hook claw 63 is released from the connection with the movable waveform segment 31, the fixed waveform segment 32 expands the film covered body 10 to the outside, and the movable waveform segment 31 pulls the film covered body 10 to the inside, so that the front end of the film covered stent 001 forms a half release state. The top of the fixed peak 321 is flush with the proximal edge of the stent-graft body 10, and the top of the movable peak 311 is flush with the proximal edge of the stent-graft body 10, so that the irritation of the stent-graft body 10 to the inner wall of the blood vessel can be reduced compared with a bare stent protruding out of the proximal end of the stent-graft body 10 and connected with the release structure of the delivery device.

In the technical scheme of the application, the arrangement that the top edges of the fixed wave crest 321 and the movable wave crest 311 are flush with the proximal end of the tectorial membrane body 10 is adopted, and the bare stent arrangement of the traditional aortic tectorial membrane stent 001 is replaced. Thus, after the stent graft 001 is released, there is no bare stent portion beyond the proximal end of the stent graft body 10, thus avoiding the problem of secondary damage to the vessel wall due to the bare stent portion or barbs of the conventional stent graft 001. The problem of blood leakage caused by the beak-shaped structure of the covered stent 001 can be avoided while protecting arterial blood vessels of a patient, and the sealing performance of the covered stent 001 is further improved.

Specifically, when the stent graft 001 is implanted at the aortic arch position, the stent graft 001 is provided in a curved shape as a whole, and generally, a side of the stent graft 001 facing the branched blood vessel of the aortic arch is defined as a large curved side of the stent graft 001, and a side of the stent graft 001 facing away from the branched blood vessel of the aortic arch is defined as a small curved side of the stent graft 001. In the present application, the groove portion 50 is provided on the large curved side of the stent graft 001.

Further, when the band on the small curved side of the main stent band 20 is the main stent peak 21, the main stent peak 21 on the small curved side is coaxial with the fixed peak 321 or the movable peak on the small curved side and is disposed along the same axial direction. When the wave band of the small curved side of the main support wave ring 20 is the main support wave trough 23, the main support wave trough 23 of the small curved side is coaxial with the fixed wave trough 323 or the movable wave trough 313 of the small curved side and is arranged along the same axial direction. Through the arrangement, the embodiment ensures that the small-curve side of the covered stent 001 has better compliance at the position corresponding to the aortic arch implantation.

That is, when the band of the primary stent band 20 located at the other side opposite to the groove portion 50 is the primary stent peak 21, the primary stent peak 21 located at the other side opposite to the groove portion 50 is in the same direction and on the same axis as the fixed peak 321 or the movable peak 311 located at the other side opposite to the groove portion 50. When the wave band of the main support wave ring 20 on the other side opposite to the groove part 50 is the main support wave trough 23, the main support wave trough 23 on the other side opposite to the groove part 50 is in the same direction and on the same axis as the fixed wave trough 323 or the movable wave trough 313 on the other side opposite to the groove part 50. When the wave band of the main support wave ring 20 on the large curved side is the main support wave peak 21, the direction of the large curved side main support wave peak 21 is the same as the direction of the large curved side fixed wave trough 323 or the movable wave trough 313, and the main support wave peak and the movable wave trough are on the same axis. When the wave band of the main support wave ring 20 on the large curved side is the main support wave trough 23, the direction of the large curved side main support wave trough 23 is the same as the direction of the large curved side fixed wave crest 321 or the movable wave crest 311, and the directions are on the same axis.

By the arrangement, the application ensures that the covered stent 001 has higher hardness at the position corresponding to the implantation aortic arch, thereby effectively preventing the stent from shrinking. In the present embodiment, the connection bead portion 301 located on the large curved side of the main body support 100 is a fixed waveform segment 32.

Specifically, one of the fixing peaks 321 of the connection band 30 is disposed on the middle line of the recess 50, and one of the main stent peaks 21 of the main stent band 20 adjacent to the connection band 30 is disposed on the middle line of the recess 30, so that the stent graft 001 has better compliance after being implanted in the aortic arch position. The center line of the groove 30 in this embodiment is defined as a connecting line between two vertices of the edge where the groove 30 is connected to the stent graft 10, where the vertex is the point farthest from the center line of the stent graft 001. In this embodiment, as shown in fig. 11, the axial height of the band of the main stent bead 20 on the large curved side is greater than that of the band of the small curved side, so that the distance between the adjacent main stent beads 20 on the large curved side is shorter than that between the adjacent main stent beads 20 on the small curved side. Therefore, the large-curve side of the film-covered body 10 is not easily contracted, and the small-curve side is more flexible.

In particular, the primary stent bead 20 has a wire diameter D20 of 0.3 to 0.45mm, a wave height H20 of 6 to 15mm, and a wave number T20 of 6 to 10. For example, the wire diameter D20 of the primary stent wave ring 20 is 0.3mm, the wave height H20 is 8mm, and the wave number T20 is 8. The wire diameter D30 of the connecting wave ring 30 is 0.3 to 0.45mm, the wave height H30 is 10 to 15mm, and the wave number T30 is 4 to 8. For example, the wire diameter D30 of the connection wave ring 30 is 0.4mm, the wave height H30 is 12mm, and the wave number T30 is 6.

The space between two adjacent main stent bands 20 is 1mm to 2mm, and the space between the main stent band 20 closest to the connection band 30 and the connection band 30 is 1mm to 2mm. The fixed trough 323 and the movable trough 313 which are fixedly connected with the connecting wave ring 30 and the film covering body 10 are additionally provided with a joint point 33, the joint point 33 covers round corners of the fixed trough 323 and the movable trough 313, wherein the axial length of the joint point 33 is set to be more than 0 and less than or equal to 5mm, so that the fixed wave band 32 of the connecting wave ring 30 assembled in the conveyor is prevented from being displaced relative to the film covering body 10, and the connecting wave ring 30 is prevented from protruding out of the film covering body 10 after being released from the conveyor. Wherein, the stitching points stitch the fixed trough 323 and the movable trough 313 on the tectorial membrane body 10 by adopting stitching.

In other embodiments, if the connecting band 30 is fixedly connected to the film covering body 10 by bonding, the seam point 33 may be replaced by a bonding point.

As shown in fig. 8, the supporting wave ring 40 includes a plurality of supporting wave segments 41 connected in sequence, the supporting wave segments 41 are arranged in an inverted 8 shape or in a diamond shape, and the plurality of supporting wave segments 41 form a nickel-titanium alloy ring for supporting the proximal end of the tectorial membrane body 10. The support strength of the support wave ring 40 is enhanced by the inverted-8-shaped or diamond-shaped support wave segments 41, so that the adherence effect of the tectorial membrane bracket 001 is better. Wherein, the assembly allowable deviation of the supporting wave ring 40 is also + -1 mm, and the assembly allowable deviation of the fixed wave peak 321 is + -1 mm.

In the present embodiment, as shown in fig. 14, the connection band portion 301 and the support waveform segment 41 are arranged offset in the circumferential direction. Specifically, the connection wave ring 30 is set with half a phase difference with respect to the support wave ring 40, so that the whole of the connection wave ring 30 and the support wave ring 40 has better support performance for the film covering body 10.

It should be noted that, the setting of the size parameters of the stent graft is merely an example of the implementation, and is applicable to most application scenarios, but the application is not limited thereto, and other size parameters may be adopted in the technical scheme of the application if a special size is required.

The support wave ring 40 can be fixedly connected with the film covering body 10, and the support wave ring 40 is fixedly connected with the film covering body 10 by stitching or bonding. The supporting wave ring 40 can also be fixedly connected with the connecting wave ring 30, and the supporting wave ring 40 is fixedly connected with the connecting wave ring 30 by stitching, bonding or welding. In the present embodiment, the supporting band 40 is fixedly connected to the film covering body 10 by stitching.

As shown in fig. 3 and 5, the proximal end of the supporting band 40 is flush with the proximal edge of the covering film body 10, or the distal end of the supporting band 40 is flush with the distal edge of the connecting band 30, and the proximal end of the supporting band 40 is further away from the proximal end of the covering film body 10 than the proximal end of the connecting band 30, so as to facilitate the connection of the connecting band 30 and the conveyor, or the supporting band 40 is disposed between the distal end of the connecting band 30 and the proximal end of the covering film body 10, so as to prevent internal leakage and facilitate the connection.

In the present embodiment, the supporting band 40 is fixedly connected to the film covering body 10 by stitching. The proximal peak of the supporting band 40 is flush with the proximal edge of the stent graft body 10 to enhance the supporting strength of the proximal end of the stent graft body 10, thereby better preventing internal leakage.

Further, since the proximal peak of the supporting band 40 is flush with the proximal edge of the stent graft body 10, when the stent graft 001 is in the semi-release state, the proximal edge of the stent graft body 10 is displaced outward under the radial supporting force of the supporting band 40, so that the proximal edge of the stent graft body 10 can be relatively close to the inner wall of the blood vessel to a relatively large extent before the stent graft 001 is completely released.

Before the hook claw 63 is released from the connection with the movable wave segment 31, the hook claw 63 binds the movable wave peak 311 of the movable wave segment 31 at the middle part of the tectorial membrane bracket 001, so that at the moment that the hook claw 63 is released from the binding with the movable wave segment 31, the movable wave segment 31 can rebound under the action of the elastic force of the hook claw 63, and especially the moving distance of the movable wave peak 311 at the near end is the largest. In the rebound process of the movable waveform segment 31, the movable waveform segment 31 will first contact the tectorial membrane body 10, and then drive the tectorial membrane body 10 to contact the inner wall of the blood vessel.

If the supporting wave ring 40 is not arranged on the tectorial membrane body 10, the movable wave segment 31 can rapidly drive the tectorial membrane body 10 to be abutted against the inner wall of the blood vessel at the moment of contact constraint, so that the inner wall of the blood vessel is impacted, the patient is uncomfortable, and even the blood vessel is spastic. In this embodiment, the supporting wave ring 40 is disposed at the proximal end of the stent graft body 10, and the proximal peak of the supporting wave ring 40 is flush with the proximal edge of the stent graft body 10, so that the proximal edge of the stent graft body 10 can be relatively close to the inner wall of a blood vessel before the stent graft 001 is completely released. Therefore, at the moment of contact constraint of the active waveform segment 31, the impact of the active waveform segment 31, particularly the active peak 311, on the inner wall of the blood vessel is greatly reduced.

In other embodiments, the support wave ring 40 may also be in a sinusoidal wave configuration, a Z-wave configuration, an M-wave configuration, or a V-wave configuration. Accordingly, the above-described structure of the supporting wave ring 40 of the present application is merely an example, and any other structure capable of supporting the film coated body 10 can be applied to the present application. The main body support 100 and/or the support film 10 are provided with a developing member, which may be welded, sewn or adhered to the main support section 200 when the developing member is provided on the main body support 100, for example, when the developing member is provided on the main support section 200. When the developing member is provided on the support film 10, the developing member may be sewn or adhered to the support film 10.

The developing member is provided in plurality, and the developing member may be provided in an O-shape, an 8-shape or an N-shape, that is, different in shape to distinguish. Or the developing member may be provided as developing points different in blackness, that is, distinguished by different color depths. By arranging a plurality of developing parts on the covered stent 001, the covered stent 001 is convenient for operators such as doctors to determine the position of the covered stent 001.

In the present embodiment, the developing member 11 is provided on the supporting film 10, and the developing member 11 includes a first developing point 111, a second developing point 112, and a third developing point 113 for displaying the position of the proximal end of the film support 001 and the position of the recessed portion 50. Wherein the first developing point 111 is disposed on the center line of the groove portion 50, and the first developing point 111 is disposed at the edge of the proximal end of the support frame section 300, the first developing point 111 may be disposed on the support frame section 300 or on the film coated body 10. The second developing point 112 is disposed on the middle line of the groove portion 50, and the second developing point 112 is disposed at an edge of one end of the support frame section 300 opposite to the groove portion 50, and the second developing point 112 is disposed on the film coated body 10. The third developing point 113 is disposed at the other side opposite to the center line of the groove portion 50, and the third developing point 113 is disposed at the edge of the proximal end of the support frame section 300, and the third developing point 113 may be disposed on the support frame section 300 or on the film coated body 10.

The shape of the first developing point 111 is different from the shape of the second developing point 112, the shape of the first line developing point is different from the shape of the third developing point 113, and the shape of the second developing point 112 may be the same as or different from the shape of the third developing point 113. In the present embodiment, the first developing point 111 has an 8-shape, and the second developing point 112 and the third developing point 113 have an O-shape.

The first developing point 111 and the third developing point 113 are used for displaying the proximal position of the stent graft 001 and the placement angle of the groove 50. The second developing point 112 is for displaying the position of the edge of the groove portion 50.

Since the first developing point 111 and the third developing point 113 are both disposed at the edge of the proximal end of the support frame segment 300, the proximal end position of the stent graft 001 can be displayed when the stent graft 001 is implanted. And, the first visualization point 111 is placed in a direction toward the branch artery of the aortic arch, and the third visualization point 113 is placed in a direction away from the branch artery of the aortic arch. Since the first developing point 111 and the groove portion 50 are disposed in the same direction, the angle at which the groove portion 50 is disposed can also be displayed.

Wherein, the first developing point 111 is located at the proximal edge of the large curved side of the stent graft 001, indicating the position of the large curved side of the proximal end of the stent graft 001, and the third developing point 113 is located at the proximal edge of the small curved side of the stent graft 001, indicating the position of the small curved side of the stent graft 001.

In the present embodiment, the groove portion 50 is faced to the branch vessel of the aortic arch, and after the aortic arch is covered with the stent graft 001, the stent graft 001 can be covered to the ascending aorta, and the branch stent 003 connected to the groove portion 50 can ensure the blood circulation of the branch vessel at the aortic arch. Thus, with the stent graft 001 of the present embodiment, treatment can be performed against aortic aneurysm or aortic dissection at the ascending aorta.

When the aortic aneurysm or aortic dissection is treated for the ascending aorta, a doctor can determine the position of the tectorial membrane body 10 by observing the first developing point 111 and the third developing point 113, so that the tectorial membrane body 10 can completely cover the whole aortic aneurysm or aortic dissection, and the smooth operation is ensured.

In this embodiment, as shown in fig. 15 and 16, the film covering body 10 is further provided with an eighth developing point 118, the eighth developing point 118 is disposed at a midpoint of the groove portion 50, and the eighth developing point 118 is disposed at an edge of an end of the opposite groove portion 50 away from the support frame section 300. Wherein, the two sides of the supporting ring arranged in the sewing ring 53 can be provided with a developing strip 119 for displaying the outline of the groove covered film 52, thereby facilitating the positioning when the covered film bracket 001 is implanted.

In this embodiment, the eighth developing point 118 and the developing strip 119 are disposed on the stent graft 001, so that the overall edge position of the groove portion 50 can be indicated in the operation, and the relative position of the guide wire with respect to the groove portion 50 can be indicated, thereby assisting the doctor in confirming the guide wire approach, the guide wire is located inside the groove, and ensuring the success rate of the operation.

Further, when the through hole 521 is located near one end of the support frame section 300, the distance between the through hole 521 and the proximal end of the support frame section 300 is less than or equal to the distance between the second developing point 112 and the proximal end of the support frame section 300, so that the positional relationship between the edge of the groove portion 50 and the through hole 521 is displayed by the second developing point 112.

Since the branch bracket 003 is stitched to the groove portion 50 through the through hole 521, there may be a stitched edge between the through hole 521 and the groove portion 50 at the time of stitching, or a retracted through hole 521 may be employed at the time of design. Therefore, in the above case, the distance between the through hole 521 and the proximal end of the supporting frame section 300 is set smaller than the distance between the second developing point 112 and the proximal end of the supporting frame section 300. Through the arrangement, when a doctor penetrates the guide wire from the groove part 50 into the branch bracket 003 through the through hole 521, the doctor can accurately know the position of the edge of the groove part 50, and the operation of the doctor is facilitated.

In summary, compared with the connecting wave ring structure of the existing aortic stent graft, the connecting wave ring structure of the application avoids secondary damage to the inner wall of the blood vessel in the anchoring area caused by the exposed connecting wave ring, and the semi-connection mode of the movable wave section 31 of the connecting wave ring 30 and the stent graft body 10 meets the requirement of the matched use of the release device after the stent graft 001. In addition, the supporting wave ring 40 can play a role in reinforcing and supporting the tectorial membrane, so that the near end of the tectorial membrane bracket 001 can be completely adhered to the wall after being released, and the phenomenon that the near end of the bracket has a beak shape to cause blood leakage is avoided.

In the second embodiment of the present application, as shown in fig. 17, the second embodiment of the present application is the same as the first embodiment in that the adjacent main support wave rings 20 are connected by the connecting rods 24, the plurality of connecting rods 24 are disposed on the same side as the groove portion 50, and the plurality of connecting rods 24 are on the same line with the center line of the groove portion 50, so that the support strength of the film-coated support 001 is increased. The connecting rod 24 is connected with the main support wave ring 20 through a steel sleeve, or the connecting rod 24 is welded on the main support wave ring 20.

It should be understood that in other embodiments, the plurality of connecting rods 24 may be arranged in a staggered manner, and two adjacent main support wave rings 20 are connected by one connecting rod 24, and the connecting rods 24 may be arranged on the same side of the groove portion 50.

In this embodiment, the connecting rod 24 is disposed between the adjacent main stent wave rings 20, so that the bending direction of the stent graft 001 after implantation is ensured, and the support property of the stent graft 001 is improved.

In the third embodiment, as shown in fig. 18 and 19, the same points as those of the first embodiment are not repeated, and the difference between the third embodiment and the first embodiment is that the movable wave rod 312 is disposed at a predetermined angle with respect to the stent body 10. Wherein, the movable wave rod 312 is bent toward the inner side of the film covering body 10, and the preset angle is greater than 0 ° and less than or equal to 45 °, for example, 30 °. So that the movable wave crest 311 is bent toward the inside of the film coated body 10 following the movable wave rod 312. The distance between the movable wave crest 311 and the circle center of the connecting wave ring 30 is smaller than the distance between the fixed wave crest 321 and the circle center of the connecting wave ring 30.

Since the unstitched movable waveform segment 31 has a radial elastic force before the post-release process, a resilient force is generated toward the outside of the stent graft 001 during the post-release process. In this embodiment, the movable wave rod 312 movably connected to the stent graft 10 is bent from the root portion toward the inner side of the stent graft 001, so that the impact of the resilience force of the movable wave segment 31 on the blood vessel in the post-release process is avoided. Compared with the traditional connection wave ring setting of the tectorial membrane bracket 001, the movable wave rod 312 is inwards bent, and long-term stimulation on the inner wall of the blood vessel caused by long-term propping of the movable wave crest 311 on the inner wall of the blood vessel can be reduced.

In the fourth embodiment, as shown in fig. 20 and 21, the fourth embodiment of the present application is the same as the second embodiment in that the movable wave rod 312 includes a bending portion 314 connected to the movable wave crest 311, and the bending portion 314 is disposed at a predetermined angle with respect to the film covering body 10. Wherein, the bending portion 314 is bent toward the inner side of the film-coated body 10, and the preset angle is greater than 0 ° and less than or equal to 45 °, for example, 30 °, and the length ratio of the bending portion 314 to the movable wave rod 312 is greater than or equal to 30% and less than or equal to 60%. So that the movable peak 311 is bent toward the inside of the film-coated body 10 following the bending portion 314. The distance between the movable wave crest 311 and the circle center of the connecting wave ring 30 is smaller than the distance between the fixed wave crest 321 and the circle center of the connecting wave ring 30.

The present embodiment sets the section length of 30% to 60% of the proximal end of the movable beam 312 as the bending portion 314. Since the bending portion 314 is provided between the movable peak 311 and the movable trough 313, and the bending portion 314 is close to the movable peak 311, the movable wave rod 312 can provide a supporting force at a position close to the root of the movable trough 313.

It should be noted that, in order to avoid the impact of the rebound force on the blood vessel during the post-release process of the movable waveform segment 31, the present embodiment adopts a manner of providing the bending portion 314 on the movable waveform rod 312, so as to reduce the impact force of the movable waveform segment 31 on the inner wall of the blood vessel instantaneously during the rebound process.

In addition, if the length of the bending portion 314 is too long, the support of the movable waveform segment to the inner wall of the blood vessel is seriously reduced, and if the length of the bending portion 314 is too short, the impact force of the movable waveform segment during rebound cannot be effectively reduced. Therefore, the section length of the proximal end of the movable wave rod 312 ranging from 10% to 60% is set as the bending portion 314, so that the impact force on the inner wall of the blood vessel in the rebound process of the movable wave segment 31 can be reduced, and the movable wave segment 31 can be ensured to have enough supporting force on the inner wall of the blood vessel. In the present embodiment, the section length of 45% of the proximal end of the movable beam 312 is set as the bending portion 314.

Further, since the bending portion 314 is bent toward the inner side of the stent graft body 10, thrombus may be accumulated on the bending portion 314 having a bent shape after the stent is implanted for a long time, and there is a risk that the thrombus on the bending portion 314 having an excessively large bending angle falls off, so that the bending angle of the bending portion 314 is not easily excessively large. Therefore, the preset angle of bending of the bending portion 314 is set to 0 ° to 45 °, so that it is ensured that the bending portion 314 is bent toward the inner side of the film-coated body 10, and the thrombus accumulated for a long time is not removed, thereby avoiding the risk of arterial embolism. In the present embodiment, the preset angle of the bending portion 314 is set to 15 °.

On the other hand, the larger the length of the bending portion 314 of the present embodiment, the smaller the preset angle

Since the branch stent 003 is provided in the main body stent 002 of the present application, in establishing a path between the branch stent 003 and the main body stent 002, a path needs to be established by the guide wire, and if the gap between the bending portion 314 and the stent graft body 10 is too large, the guide wire may erroneously pass through the gap between the bending portion 314 and the stent graft body 10 when establishing the path, and the path establishment fails. Therefore, the larger the length of the bending portion 314, the smaller the preset angle is, so as to ensure that the gap between the bending portion 314 and the film-covered body 10 will not cause the guide wire to pass through by mistake, thereby causing the failure of establishing the passage.

From above, this embodiment can also play a supporting role on the film covered body 10 in avoiding the impact of the rebound force of the movable waveform segment 31 on the blood vessel in the post-release process, enhance the adherence effect of the film covered body 10, and further improve the effect of avoiding blood leakage. Compared with the traditional connection wave ring setting of the tectorial membrane bracket 001, the movable wave rod 312 is inwards bent, and long-term stimulation on the inner wall of the blood vessel caused by long-term propping of the movable wave crest 311 on the inner wall of the blood vessel can be reduced.

In the fifth embodiment of the present application, as shown in fig. 22, the fifth embodiment of the present application is the same as the first embodiment in that the shape of the supporting wave ring 40 is the same as the shape of the connecting wave ring 30, and the supporting wave ring 40 and the connecting wave ring 30 are staggered, and the supporting wave ring 40 and the covering film body 10 are completely fixed.

In the present embodiment, the supporting wave ring 40 and the connecting wave ring 30 are both sinusoidal, and the position of the supporting wave ring 40 corresponds to the half period of the circumferential rotation of the connecting wave ring 30, and the supporting wave ring 40 is fixed with the film covering body 10 by stitching.

The supporting wave ring 40 is arranged on the outer side of the tectorial membrane body 10 (at this time, in the radial direction, the tectorial membrane body 10 is positioned between the connecting wave ring 30 and the supporting wave ring 40), or in the radial direction, the supporting wave ring 40 is arranged on the inner side of the tectorial membrane body 10, and the supporting wave ring 40 is arranged between the tectorial membrane body 10 and the connecting wave ring 30, so that the supportability of the proximal end of the tectorial membrane body 10 is ensured while the movable wave section 31 of the connecting wave ring 30 can be connected to a release mechanism of a conveying device, the risk of blood leakage is reduced, and the stimulation of the connecting wave ring 30 to blood vessels is reduced.

In the sixth embodiment, as shown in fig. 23, the same points as those of the first embodiment are not repeated, and the difference between the sixth embodiment and the first embodiment is that the supporting wave ring 40 includes a plurality of independent supporting units 42, and each independent supporting unit 42 is distributed between the crest and the trough of the connecting wave ring 30.

The supporting wave ring 40 of the present embodiment includes a plurality of supporting units 42 circumferentially and uniformly distributed between the peaks and the troughs of the connecting wave ring 30, the supporting units 42 are ring-shaped ring structures, and the proximal ends of the supporting units 42 are flush with the proximal ends of the film covering body 10. In the present embodiment, the supporting unit 42 is diamond-shaped, and the long axis of the diamond-shaped is parallel to the longitudinal center axis of the stent graft. In other embodiments, the support element 42 may be oval with its long axis parallel to the longitudinal center axis of the stent graft.

By providing the diamond-shaped or oval-shaped support units 42 with a long axis parallel to the longitudinal center axis of the stent graft, a balance is achieved between reducing the compressed radial dimension of the stent graft and improving the strength of the proximal end of the stent graft 10, so that the proximal end of the stent graft 10 is better in support, the risk of blood leakage is reduced, and the radially compressed dimension is smaller.

In the seventh embodiment of the present application, as shown in fig. 24, the seventh embodiment of the present application is the same as the first embodiment and is not repeated, and the seventh embodiment is different from the first embodiment in that the connection band 30 includes a plurality of connection band portions 301 sequentially connected, the connection band portions 301 include a fixed waveform segment 32 and a movable waveform segment 31 sequentially arranged at intervals, and the connection band portions 301 are all disposed on the inner surface of the film covering body 10.

The fixed waveform segments 32 are annularly arranged, the fixed waveform segments 32 are completely and fixedly connected to the tectorial membrane body 10, the movable waveform segments 31 are arranged between the adjacent fixed waveform segments 32, the movable waveform segments 31 are arranged in a strip shape, and the movable waveform segments 31 are movably connected to the tectorial membrane body 10.

Specifically, the movable wave segment 31 protrudes toward the proximal end of the stent body 10, forming a movable peak 311 for connection to a release mechanism of the delivery device, the proximal end of the movable peak 311 being flush with the proximal end of the stent body 10 or inside the movable peak 311 (that is, the movable peak 311 is closer to the distal end of the stent body 10 than the proximal end of the stent body 10). The movable wave rods 312 are respectively arranged at two sides of the movable wave crest 311, and the movable wave rods 312 at two sides are respectively fixedly connected with the fixed wave segments 32 at the corresponding sides.

The fixed waveform segment 32 is fixedly connected with the tectorial membrane body 10 by stitching, and the movable waveform segment 31 is connected with the fixed waveform segment 32 by welding.

In this embodiment, the movable peak 311 inside the film-covered body 10 is connected with the release structure of the delivery device, so that the purpose of releasing the stent is achieved while the stimulation of the movable peak 311 to the inner wall of the blood vessel is reduced.

Embodiment eight of the present application provides a stent graft, as shown in fig. 25, the embodiment eight of the present application is the same as the embodiment seven in that the embodiment eight is different from the embodiment seven in that the movable waveform segment 31 is disposed in a ring shape, and a part of the movable waveform segment 31 is fixedly connected to the stent graft body 10, and a part of the movable waveform segment is separated from the stent graft body 10. The fixed waveform segments 32 are arranged between the adjacent movable waveform segments 31, the fixed waveform segments 32 are arranged in a strip shape, the fixed waveform segments 32 are completely and fixedly connected to the tectorial membrane body 10, and the fixed waveform segments 32 can be in a straight line segment shape or a curve segment shape.

Specifically, the movable waveform segment 31 includes a movable proximal portion 316 that is adjacent to the proximal end of the stent graft body 10 and is movably connected to the stent graft body 10, and a movable distal portion 315 that is remote from the proximal end of the stent graft body 10 and is fixedly connected to the stent graft body 10. The movable proximal end 316 is flush with the proximal end of the stent graft body 10 or a predetermined setback distance is provided between the movable proximal end 316 and the stent graft body 10. Wherein, the predetermined setback distance is 0.5mm to 2mm, and by setting the predetermined setback distance, a sufficient installation clearance is provided between the movable proximal portion 316 and the film covering body 10, thereby ensuring that the movable proximal portion 316 and the film covering body 10 are not separated.

In this embodiment, the movable proximal end 316 located at the proximal end of the movable waveform segment 31 is connected with the release structure of the delivery device, so as to achieve the purpose of receiving the connection waveform ring 30 inside the tectorial membrane body 10 to reduce the stimulation of the bare stent to the inner wall of the blood vessel and simultaneously complete the release of the stent.

In the ninth embodiment of the present application, as shown in fig. 26 and 27, the same points as those of the first embodiment of the present application are not repeated, and the difference between the ninth embodiment and the first embodiment is that, in combination with fig. 1, the developing member 11 further includes a fourth developing point 114 and a fifth developing point 115 disposed on the film covering body 10, and the fourth developing point 114 and the fifth developing point 115 are disposed on two sides of the film covering body 10 near the proximal end of the recess 50.

Wherein, the fourth developing point 114 and the fifth developing point 115 are respectively disposed at two sides of the proximal end of the groove coating film 52 for indicating the positions of two sides of the proximal end of the groove coating film 52. The present embodiment enables a doctor to accurately know the position of the proximal end of the groove cover film 52 located at the bottom end of the groove portion 50 through the fourth developing point 114 and the fifth developing point 115, thereby providing convenience for the doctor's observation and operation.

Further, in the present embodiment, the groove coating film 52 of the groove portion 50 is further provided with a sixth developing point 116 and a seventh developing point 117, and the sixth developing point 116 and the seventh developing point 117 are provided in the middle of the proximal end and the distal end of the groove coating film 52, respectively.

The first developing point 111 and the third developing point 113 are different in shape, the sixth developing point 116 is different in shape from the second developing point 112, and the seventh developing point 117 and the eighth developing point 118 are different in shape, so that the developing points are more clearly distinguished.

In this embodiment, by setting the sixth developing point 116 and the seventh developing point 117, the depth of the branch stent 003 embedded in the proximal end and the distal end of the groove portion 50 can be indicated in the operation, and by matching with the eighth developing point 118, the doctor is assisted in finding the position of the embedded branch stent 003 when confirming the guide wire approach, thereby providing convenience for the doctor to operate and improving the success rate and efficiency of the operation. In summary, compared with the connecting wave ring structure of the existing aortic stent graft, the stent graft provided by the application avoids secondary damage to the inner wall of the blood vessel in the anchoring area caused by the exposed connecting wave ring, and the semi-connection mode of the movable wave section of the connecting wave ring and the stent graft body meets the requirement of the matched use of the release device after the stent graft.

The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims

1. A coated stent, the coated stent comprising a main stent and a branch stent, the main stent comprising a main support member and a coated body arranged on the main support member, characterized in that the main support member comprises a main stent segment and a support frame segment arranged at the proximal end of the main stent segment, the support frame segment comprises a connecting wave ring connected to the coating body portion and a supporting wave ring arranged at the port of the coating body, and the main support member is provided with a groove portion recessed toward the inner side of the main support member;

The groove portion comprises a groove support member connected to the main body support member and a groove coating disposed on the groove support member, and at least one through hole is disposed on the groove portion;

The branch bracket is arranged inside the main bracket and communicated with the through hole.

2. The coated support according to claim 1 is characterized in that a developing member is provided on the main support member and/or the coating body, and the developing member includes a first developing point and a second developing point arranged on the midline of the groove portion, and a third developing point arranged on the other side of the midline of the groove portion; the first developing point and the third developing point are located at the edge of the proximal end of the support frame segment, and the second developing point is located at the edge of the groove portion close to one end of the support frame segment.

3. The coated support according to claim 2 is characterized in that when the through hole is located close to the proximal end of the support frame segment, the distance between the through hole and the proximal end of the support frame segment is less than or equal to the distance between the second developing point and the proximal end of the support frame segment.

4. The coated bracket according to claim 1 is characterized in that the wire diameter of the supporting wave coil is smaller than the wire diameter of the connecting wave coil, the number of wave bands of the supporting wave coil is greater than the number of wave bands of the connecting wave coil, and the supporting wave coil is fixedly connected to the coating body, or the supporting wave coil is fixedly connected to the connecting wave coil.

5. The coated stent according to claim 1 is characterized in that the proximal end of the supporting wave ring is flush with the proximal edge of the coating body, or the distal end of the supporting wave ring is flush with the distal edge of the connecting wave ring, or the supporting wave ring is arranged between the distal end of the connecting wave ring and the proximal end of the coating body.

6. The coated bracket according to claim 1 is characterized in that the connecting wave ring includes a plurality of fixed waveform segments fixedly connected to the coating body and at least one movable waveform segment movably connected to the coating body, and the fixed waveform segments and the movable waveform segments are arranged in sequence at intervals.

7. The stent graft according to claim 6, characterized in that the fixed wave segment comprises a fixed wave crest, a fixed wave trough, and a fixed wave rod connecting adjacent fixed wave crests and fixed wave troughs, and the top of the fixed wave crest is flush with the proximal edge of the graft body, or is closer to the distal end of the graft body than the proximal edge of the graft body;

The active waveform segment includes an active crest, an active trough, and an active wave rod connecting adjacent active crests and active troughs. The active trough is fixedly connected to the coating body, and the active crest and the active wave rod are movably connected to the coating body.

8. The stent graft according to claim 7, characterized in that the main stent segment comprises a plurality of main stent wave rings arranged at intervals, the main stent wave rings comprising a main stent wave crest, a main stent wave trough, and a main stent connecting rod connecting the main stent wave crest and the main stent wave trough;

The main support coils are connected through the coating body.

9. The coated support according to claim 8, characterized in that a fixed wave-shaped segment is provided on the large curved side of the main support member.