CN116407332A - Tectorial membrane support - Google Patents

Abstract

The invention belongs to the technical field of medical devices, and in particular relates to a covered stent comprising a main body support and a covered body arranged on the main body support, wherein the main body support includes a main stent segment and a main body support arranged on the main body support. The support frame section at the proximal end of the main stent section, the support frame section includes a connecting corrugated coil connected to the main body part of the film covering and a supporting corrugated coil arranged at the port of the supporting film covering, the wire of the supporting corrugated coil The diameter is smaller than the wire diameter of the connecting wave ring. According to the stent-graft of the present invention, the contact surface between the proximal end of the stent-graft and the inner wall of the blood vessel is softer, and the wall-attachment effect is better, which can avoid the occurrence of blood leakage at the edge of the stent-graft and reduce the stent-graft at the same time. Radial dimension when in compression.

Description

A covered stent

technical field

The invention belongs to the technical field of medical devices, in particular to a covered stent.

Background technique

Aortic aneurysm and aortic dissection are currently diseases that seriously endanger human life. If not actively treated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the continuous increase of patients with blood lipids and high diabetes, the incidence of aortic aneurysm and aortic dissection is also significantly increasing.

Traditional open surgery for aortic aneurysm and aortic dissection has the advantages of large trauma, high mortality, long operation time, high incidence of postoperative complications and high difficulty of operation, while endovascular treatment has the advantages of less trauma and fewer postoperative complications. Due to the short operation time and low operation difficulty, it has gradually become the main method for the treatment of aortic aneurysm and aortic dissection. By implanting a covered stent in the aorta, the vascular disease is isolated from the covered stent, and the blood flow is restricted from flowing through the covered stent, so as to achieve the purpose of protecting the blood vessel.

The stent-graft usually includes a stent made of a memory metal alloy and a film on the stent, and for the edge of the proximal end of the stent-graft (the side close to the heart after the stent-graft is released), it is easy to cause the film to The sealing of the proximal edge of the stent is not tight and blood leakage occurs, so that part of the blood flows to the outside of the membrane, causing aortic aneurysm and aortic dissection to reappear, and even leading to a new breach and new aortic dissection.

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

Contents of the invention

The purpose of the present invention is to at least solve the problem of easy blood leakage between the edge of the covered stent and the inner wall of the blood vessel.

One aspect of the present invention provides a stent graft, including a main body support and a graft body disposed on the main support, wherein the main body support includes a main stent segment and a stent graft disposed on the main stent segment The support frame segment at the proximal end, the support frame segment includes a connecting wave coil connected to the main body part of the film covering and a supporting wave coil arranged at the port of the supporting film film, and the wire diameter of the supporting wave coil is smaller than the The diameter of the wire connecting the wave coil is described.

According to the stent-graft of the present invention, the contact surface between the proximal end of the stent-graft and the inner wall of the blood vessel is softer, and the wall-attachment effect is better, which can avoid the occurrence of bleeding at the edge of the stent-graft. The diameter of the wire is set to be smaller than the diameter of the wire connecting the wave ring, thus reducing the radial dimension of the stent graft when it is in a compressed state.

In some embodiments of the present invention, the connecting corrugated coil includes several fixed waveform segments fixedly connected with the graft body and at least one movable waveform segment flexibly connected with the graft body.

In some embodiments of the present invention, the fixed wave segments include fixed crests, fixed troughs, and fixed rods connecting adjacent fixed crests and fixed troughs. the proximal edge is flush, or closer to the distal end of the graft body than the proximal edge of the graft body;

The active waveform segment includes an active wave crest, an active wave trough, and an active wave rod connecting the adjacent active wave peaks and active wave troughs, the active wave trough is fixedly connected with the coating body, the active wave peak and the active wave The rod is movably connected with the film covering body.

In some embodiments of the present invention, the movable probe is set at a preset angle with the coating body; or the movable probe includes a bent portion connected to the active peak, and the bent portion is connected to the active peak. The film covering body is arranged at a preset angle.

In some embodiments of the present invention, the movable probe is bent toward the inner side of the film-coated body, or the bending portion is bent toward the inner side of the film-coated body, and the predetermined angle is greater than 0° and less than or equal to 45°, the percentage of the ratio of the length of the bending portion to the length of the movable wave rod is greater than or equal to 10% and less than or equal to 60%.

In some embodiments of the present invention, the fixed waveform segment and the active waveform segment are sequentially arranged at intervals.

In some embodiments of the present invention, the number of bands of the supporting corrugated coil is greater than the number of bands of the connecting corrugated coil.

In some embodiments of the present invention, the supporting wave coil is fixedly connected to the coating body, or the supporting wave coil is fixedly connected to the connecting wave coil.

In some embodiments of the present invention, the proximal end of the supporting wave coil is flush with the proximal edge of the graft body, or the distal end of the supporting wave coil is flush with the distal edge of the connecting wave coil. aligned, or the supporting wave coil is arranged between the distal end of the connecting wave coil and the proximal end of the graft body.

In some embodiments of the present invention, the main body support is provided with a groove part that is recessed toward the inner side of the main body support, and the groove part includes a groove support connected to the main body support and a set Groove film on the groove support; a developer is provided on the main body support and/or the support film.

Description of drawings

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

Figure 2 is a schematic structural view of a branch stent in Embodiment 1 of the present invention

3 is a schematic structural view of the proximal part of the stent graft in Embodiment 1 of the present invention;

4 is a schematic structural view of another embodiment of the proximal part of the stent graft in Example 1 of the present invention;

Fig. 5 is a schematic structural view of the wave coil of the main support in Embodiment 1 of the present invention;

Fig. 6 is a schematic structural diagram of connecting corrugated coils in Embodiment 1 of the present invention;

Fig. 7 is a schematic diagram of the connecting structure connecting the corrugated coil and the coating body in Embodiment 1 of the present invention;

Fig. 8 is a structural schematic diagram of the supporting wave coil in Embodiment 1 of the present invention;

FIG. 9 is a schematic structural view of the stent graft in a half-release state in Embodiment 1 of the present invention;

10 is a schematic diagram of the connection structure between the delivery device and the stent-graft when the stent-graft is in a half-release state in Embodiment 1 of the present invention;

Fig. 11 is a schematic structural view of another embodiment of the wave coil of the main support in Embodiment 1 of the present invention;

Fig. 12 is a schematic diagram of the structure of the stent-graft in the sheath in Embodiment 1 of the present invention.

Fig. 13 is a cross-sectional view of the stent graft in the sheath according to Embodiment 1 of the present invention.

FIG. 14 is a structural schematic diagram of the half phase difference between the connecting wave coil and the supporting wave coil in Embodiment 1 of the present invention.

Figure 15 is a schematic structural view of the developing strip in Embodiment 1 of the present invention;

Fig. 16 is a structural schematic view of another viewing angle of the developing strip in Embodiment 1 of the present invention;

Fig. 17 is a schematic structural view of the connecting rod in Embodiment 2 of the present invention;

Fig. 18 is a side view of connecting corrugated coils in Embodiment 3 of the present invention;

Fig. 19 is a front view of connecting corrugated coils in Embodiment 3 of the present invention;

Fig. 20 is a side view of connecting corrugated coils in Embodiment 4 of the present invention;

Fig. 21 is a front view of connecting corrugated coils in Embodiment 4 of the present invention;

Fig. 22 is a schematic structural view of the proximal part of the covered stent in Embodiment 5 of the present invention;

Fig. 23 is a schematic structural view of the proximal part of the stent-graft in Embodiment 6 of the present invention;

Fig. 24 is a schematic structural view of the proximal part of the covered stent in Embodiment 7 of the present invention;

Fig. 25 is a schematic structural view of the proximal part of the stent graft in Embodiment 8 of the present invention;

Fig. 26 is a schematic structural view of the developing part of the stent-graft in Embodiment 9 of the present invention;

FIG. 27 is a structural schematic diagram of another viewing angle of the developing part of the stent-graft in Embodiment 9 of the present invention.

In the accompanying drawings, each label represents as follows:

001, covered stent; 002, main support; 003, branch support; 100, main support; 200, main support section; 300, support frame section; 400, branch support; 401, branch wave coil; 402, branch connection Rod; 403, developing ring; 500, branch coating;

10. Film body; 11. Developing part; 111. First developing point; 112. Second developing point; 113. Third developing point; 114. Fourth developing point; 115. Fifth developing point; 116. Sixth developing point Developing point; 117, the seventh developing point; 118, the eighth developing point; 119, developing bar; 20, main support wave circle; 21, main support wave crest; 22, main support connecting rod; 23, main support trough; 24, Connecting rod; 30, connecting wave coil; 301, connecting band part; 31, moving wave segment; 311, moving peak; 312, moving rod; 313, moving trough; 314, bending part; 315, moving distal part ; 316, movable proximal part; 32, fixed wave segment; 321, fixed crest; 322, fixed wave rod; 323, fixed wave trough; 33, suture point; 40, support wave ring; 41, support wave segment; 42 , support unit; 50, groove portion; 51, groove support member; 52, groove coating; 521, through hole; 53, sewing ring; 54, groove support frame; 541, groove support section; 542, Mesh hole; 60, release mechanism; 61, sheath tube; 62, sheath core; 63, hook claw; 64, guide part.

Detailed ways

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the drawings, it should be understood that the invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided for 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. As used herein, the singular forms "a", "an" and "the" may also be meant to include the plural forms unless the context clearly dictates otherwise. The terms "comprising", "comprising", "containing" and "having" are inclusive and thus indicate the presence of stated features, steps, operations, elements and/or parts but do not exclude the presence or addition of one or Various other features, steps, operations, elements, components, and/or combinations 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 specifically indicated. It should also be understood 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 referred to as These terms are limited. 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 the convenience of description, spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as "inner", "outer", "inner". ", "Outside", "Below", "Below", "Above", "Above", etc. 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 "beneath" the other elements or features. feature above". Thus, the example term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

For the convenience of description, the following description uses the terms "distal end" and "proximal end", wherein "distal end" refers to the end away from the heart, "proximal end" refers to the end near the heart, and the phrase "axial direction ", should be understood in this patent as the direction in which the interventional device is pushed and pushed out, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

Embodiment 1, as shown in FIG. 1 to FIG. 3 , the stent graft 001 of this embodiment is a hollow tubular structure with openings at both ends as a whole, including a main stent 002 and a branch stent 003, and the branch stent 003 is arranged on the side of the main stent 002. Inside, the main body stent 002 is used for implanting in the aortic vessel, and the branch stent 003 is used for implanting in the branch vessel. Wherein, the branch bracket 003 has a hollow cylindrical structure, and the branch bracket 003 is arranged along the length direction of the main body bracket 002 . Wherein, the axial direction of the branch bracket 003 is the same as that of the main body support 100 .

In other embodiments, the branch bracket 003 is set at a preset angle with the main body support 100, and the preset angle can be 3°, 5° or 10°, etc., and is set according to actual needs.

The surface of the main body bracket 002 is provided with a groove part 50 that is sunken toward the inside of the main body bracket 002. The edge of the groove part 50 is connected to the film body 10 of the main body bracket 002. Groove coating 52 on trough support 51 . Wherein, the groove support 51 is connected with the main body support 100 , and the groove coating 52 is connected with the coating body 10 .

In this embodiment, the edge of the groove coating 52 is connected to the coating body 10 by sewing. Specifically, a sewing ring 53 is provided between the groove coating 52 and the coating body 10 , and the groove coating 52 and the coating body are connected by the sewing ring 53 . A supporting ring (not shown in the figure) for strengthening the supporting strength of the groove portion 50 may be provided in the sewing ring 53 , and the supporting ring is an elastic metal ring.

In other embodiments, the groove coating 52 can also be integrally formed with the coating body 10 , and the groove coating 52 is fixed on the groove support 51 by means of sewing or the like. The groove support 51 is concave relative to the main body support 100 , and the groove support 51 is used to shape the groove coating 52 to form an overall concave groove portion 50 .

The groove coating 52 is provided with a through hole 521, and the branch bracket 003 communicates with the through hole 521, so that blood flows from the main body bracket 002 through the through hole 521 into the branch bracket 003, wherein the branch bracket 003 is fixedly connected by suturing in the through hole 521 . The main body bracket 002 includes one or more branch brackets 003, and the diameters of the plurality of branch brackets 003 can be the same or different, and can be set according to actual needs.

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

The branch stent 003 includes a branch support 400 and a branch coating 500 disposed on the branch support 400 , and the branch coating 500 is connected to the through hole 521 by suturing. Wherein, the outer edge of the through hole 521 is sutured with a developing ring 403 by a suture thread for displaying the position of the branch bracket 003 . Wherein, the branch support member 400 includes several branch wave coils 401 arranged at intervals, branch connecting rods 402 are arranged between adjacent branch wave coils 401 , and the branch wave coils 401 are wavy or diamond-shaped.

The coating body 10 is arranged on the main body support 100. It should be understood that the main body support 100 can be arranged on the inner surface of the coating body 10, or on the outer surface of the coating body 10, or a part of the main body support 100 It is arranged on the inner surface of the membrane main body 10 , and another part of the main body support 100 is arranged on the outer surface of the membrane main body 10 .

In this embodiment, the length of the main body support 10 is greater than or equal to the length of the main body support 100, so that the main body support 100 is completely covered by the main body support 100. After the stent 001 is implanted in the blood vessel, the damage to the inner wall of the blood vessel caused by the main body support 100 is avoided, and the greater stimulation of the inner wall of the blood vessel by the main body support 100 is avoided.

In other embodiments, the main body support 100 can also partially protrude from the graft body 10, and the part of the body support 100 beyond the graft body 10 is bent toward the central axis of the stent-graft 001, so that the body support The part of the stent graft 100 beyond the graft body 10 will not touch the inner wall of the blood vessel after the stent graft 001 is implanted in the blood vessel, so as to prevent the main body support 100 from causing great irritation to the inner wall of the blood vessel.

The groove portion 50 is provided on the coating body 10, and the groove portion 50 is located in the middle of the main body coating 10. The groove portion 50 forms a roughly rectangular shape on the coating body 10, that is, when the coating body 10 is unfolded, A window with a rectangle.

The membrane stent 001 further includes a groove support frame 54 disposed on the outside of the groove membrane 52 , and protrudes from the surface of the membrane body 10 toward the outside of the groove membrane 52 . Wherein, the groove support frame 54 is fixed on the edge of the groove portion 50 by suturing, and when the stent graft 001 is implanted at the position of the aortic arch, the groove support frame 54 can support the inner wall of the aortic vessel, thereby playing a more important role. Good fixation.

Specifically, the groove support frame 54 includes a plurality of groove support sections 541, the plurality of groove support sections 541 are connected to the edge of the groove portion 50, and the plurality of groove support sections 541 are connected by hooking each other, A mesh structure with mesh openings 542 is thus formed. That is, the vertices of the adjacent groove support sections 541 are connected by interlocking to prevent the groove support frame 54 from detaching when the stent graft 001 is deformed. At the same time, the mesh 542 formed by the adjacent groove support sections 541 The size can change when subjected to external force, thereby enhancing the elasticity of the groove support frame 54 and improving the wall-adherence of the groove support frame 54 .

In other embodiments, the groove support frame 54 can also be integrally formed with the main body bracket 002 , and the groove support frame 54 is wave-shaped, which can reduce the cost while satisfying the supporting property of the groove support frame 54 .

The body support 100 includes a main stent segment 200 and a support frame segment 300 disposed at a proximal end of the main stent segment 200 . The support frame section 300 includes a connecting corrugated coil 30 and a supporting corrugated coil 40. The connecting corrugated coil 30 is partially connected to the graft body 10. The connecting corrugated coil 30 is used to connect the release mechanism of the graft stent 001. The supporting corrugated coil 40 is arranged on the graft body 10. At the port of the body 10 , the supporting wave coil 40 is used to support the port of the film-covered body 10 .

Wherein, the main body support member 100 is made of a material with good biocompatibility and good elasticity, such as nickel-titanium alloy, stainless steel, etc., and the film-covered body 10 is made of a film material with good biocompatibility, such as PET, PTFE, etc. The coating body 10 can be a single-layer structure or a multi-layer structure.

As shown in Figures 3 to 5, the main support section 200 includes several main support wave coils 20, the main support wave coil 20 is a Z-shaped wave coil structure, and the Z-shaped wave coil structure is formed by connecting a plurality of sub-wave coils end-to-end with peaks and troughs. closed-loop structure.

Specifically, the main stent wave coil 20 includes a main stent wave crest 21 , a main stent wave trough 23 , and a main stent connecting rod 22 connecting the main stent wave crest 21 and the main stent wave trough 23 . A plurality of main support wave coils 20 are arranged at intervals, and the main support wave coils 20 are connected and fixed to the main support body 10 . Among them, several main bracket wave coils 20 are only connected through the film-coated body 10, and the main bracket wave coils 20 and the film-covered body 10 are fixed by suturing or bonding, and the fixing method is based on actual needs. Make a selection.

In this embodiment, the main stent crest 21 of one main stent wave coil 20 is set corresponding to the main stent trough 23 of the adjacent main stent wave coil 20, and correspondingly, the main stent trough 23 of one main stent wave coil 20 and the The crests 21 of the adjacent main support corrugations are correspondingly arranged. Therefore, it is ensured that the stent graft 001 has better compliance at the corresponding position where the aortic arch is implanted.

The main stent section 200 is a variable-diameter structure, and the diameter of the distal end of the main stent section 200 is smaller than the diameter of the proximal end of the main stent section 200, that is, the diameter of the main stent wave coil 20 located at the distal end of the main stent section 200 is smaller than that located at the main stent section 200. The diameter of the main stent bellows 20 at the proximal end of the segment 200. Therefore, it can better adapt to the shape of the aortic vessel, so that the stent graft 001 can fit the inner wall of the aortic vessel better.

In other embodiments, when the stent graft 001 is suitable for other aortic vessel parts, the main stent segment 200 can also be a cylindrical hollow tube with equal diameter everywhere.

In this embodiment, the graft body 10 is attached to the main body support 100 and can change shape along with the body support 100 . The body support 100 is used to stretch the graft body 10 when the stent graft 001 is released. Each main stent corrugation ring 20 is a corrugated metal ring, so that after the stent graft 001 is released, the graft body 10 has a hollow cylindrical structure. Wherein, the diameters of the wave coils 20 of each main support are the same, or different diameters may be used according to actual needs.

Wherein, both ends of the covering body 10 are openings, and the middle is a closed lumen structure, and the covering body 10 may be a layer of film or a multi-layer film. When the coating body adopts a multi-layer film structure, two adjacent layers of films can be fixed together by glue bonding, direct firing or heat treatment. The materials of the two adjacent films may be the same or different.

The main support wave coil 20, the connecting wave coil 30 and the supporting wave coil 40 are all made of memory alloy. Formed by cutting and shaping. Nitinol has good fatigue life and strong corrosion resistance. At the same time, by using the memory alloy material to make the main body support 100, the main body support 100 returns to the preset shape at a preset temperature, such as 36°C, and the preset shape can be set according to actual needs, and this application does not make limited.

The connecting wave coil 30 can be arranged on the inner side of the membrane body 10, and the supporting wave coil 40 can be arranged on the inner side or the outer side of the membrane body 10, which is selected according to actual needs. When the supporting wave coil 40 is disposed on the outer side of the covering body 10 , the supporting wave coil 40 can be fixed on the covering body 10 by sewing or bonding. When the supporting wave coil 40 is arranged on the inner side of the coating body 10, the supporting wave coil 40 can be fixed on the coating body 10 by sewing or bonding, or can be fixedly connected with the connecting wave coil 30 by sewing or welding. .

In this embodiment, the connecting corrugated coil 30 is disposed inside the stent graft 001, the supporting corrugated coil 40 is disposed between the graft body 10 and the connecting corrugated coil 30, and the supporting corrugated coil 40 is fixed on the graft body 10 by suturing. To enhance the support strength of the proximal end of the graft body 10 and prevent internal leakage.

Wherein, as shown in FIG. 1 , the wire diameter of the supporting wave coil 40 is smaller than the wire diameter of the connecting wave coil 30 . After the stent graft 001 is implanted in the blood vessel, the support coil 40 supports the graft body 10 so that the graft body 10 fits on the inner wall of the blood vessel, so the radial support force of the support coil 40 will directly affect the stent graft 001. Pressure on the inner walls of blood vessels.

In this embodiment, the wire diameter of the supporting corrugated coil 40 is set to be smaller than the wire diameter of the connecting corrugated coil 30, thereby reducing the radial support force of the supporting corrugated coil 40, so that the contact surface between the supporting corrugated coil 40 and the inner wall of the blood vessel is softer. The inner wall of the blood vessel is less irritated, which reduces the occurrence of new stent-derived breaches at the proximal end of the covered stent graft 001 in the long term. In other embodiments, by changing the materials of the supporting wave ring 40 and the connecting wave ring 30, braiding the braided supporting wave ring 40 with a lower hardness can be selected, so that the radial support force of the supporting wave ring 40 is smaller than that of the connecting wave ring 30 radial support force. The hardness of the supporting wave coil 40 and the connecting wave coil 30 can also be adjusted by changing the processing technology, such as changing the temperature or time of heat treatment.

On the other hand, as shown in FIG. 9 and FIG. 10 , the release mechanism 60 of the delivery device includes a sheath tube 61 for accommodating and delivering the stent-graft 001 and a sheath core 62 arranged in the sheath tube 61 . When the 001 is delivered to the vascular lesion site, the stent graft 001 is loaded between the sheath tube 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 FIG. 13 .

Since the present application arranges the supporting wave coil 40 on the proximal edge of the membrane body 10, the supporting wave coil 40 enhances the supporting strength of the membrane body 10, thereby effectively preventing blood leakage. However, increasing the support wave coil 40 will increase the radial size of the stent graft 001 in the compressed state. In order to smoothly install the stent graft 001 into the sheath tube 61, the radial diameter of the sheath tube 61 needs to be adjusted to accommodate a larger diameter. Radial Diameter Stent Graft 001.

For the sheath tube 61 inserted into the blood vessel, the smaller the radial diameter of the sheath tube 61 is, the more favorable it is to deliver the stent graft 001 to the lesion site. Therefore, in this embodiment, the wire diameter of the supporting corrugated coil 40 is set to be smaller than the wire diameter of the connecting corrugated coil 30, which can not only reduce the radial support force of the supporting corrugated coil 40, but also make the contact surface between the supporting corrugated coil 40 and the inner wall of the blood vessel It is softer and can also reduce the radial dimension of the stent-graft 001 when it is in a compressed state, so that the stent-graft 001 can be easily loaded into the sheath tube 61 with a smaller radial dimension, thereby facilitating the delivery of the stent-graft 001 by the sheath tube 61 to the lesion site.

In this embodiment, the connecting wave coil 30 and the supporting wave coil 40 are fixed on the coating body 10 by sutures, and the supporting wave coil 40 is an integral structure, as shown in FIG. 8 . When testing the radial support force of the connecting wave coil 30 and the supporting wave coil 40, the sutures used to fix the connecting wave coil 30 and the supporting wave coil 40 are released, and the connecting wave coil 30 and the supporting wave coil 40 are removed from the main body 10 of the coating. The radial support force of the connecting wave coil 30 and the supporting wave coil 40 are tested respectively, and it can be obtained that the radial supporting force of the supporting wave coil 40 is smaller than the radial supporting force of the connecting wave coil 30 .

In other embodiments, the supporting wave coil 40 can also be formed by stacking multiple sub-wave coils, for example, two sub-wave coils are respectively sewn on the coating body 10 to form the supporting wave coil 40 . If the supporting wave coil 40 is formed by stacking multiple sub-wave coils, when testing the radial support force of the supporting wave coil 40, release the suture used to fix the connecting wave coil 30, remove the connecting wave coil 30, and then test the supporting wave coil 40 and the overall radial support force of the coating body 10; when testing the radial support force of the connecting wave coil 30, release the suture used to fix the supporting wave coil 40, remove the supporting wave coil 40, and then test the connecting wave coil 30 The radial support force of the integral body 10 of the membrane. It can be obtained that the radial support force supporting the wave coil 40 and the film body 10 as a whole is smaller than the radial support force connecting the wave coil 30 and the film body 10 as a whole.

On the other hand, since the stent graft 001 of the present application is provided with the groove part 50 and the branch stent 003, the stent graft 001 can extend to the ascending aorta of the aorta, and the aortic arch can be secured by the groove part 50 and the branch stent 003. blood flow in branch vessels. Therefore, the stent graft 001 of the present application can be applied to the treatment of aortic aneurysm and aortic dissection in the ascending aorta.

However, the inner wall of the blood vessel at the ascending aorta is more sensitive, and the blood pressure at the ascending aorta is higher. If the stent graft 001 stimulates the inner wall of the blood vessel more, the patient is likely to feel uncomfortable under the impact of the higher blood pressure of the ascending aorta. . Therefore, the present application reduces the wire diameter of the supporting wave coil 40, so that the wire diameter of the supporting wave coil 40 is smaller than the wire diameter of the connecting wave coil 30, so as to ensure that the supporting wave coil 40 can make the coating body 10 stick to the wall On the one hand, the stimulation of the inner wall of the blood vessel by the supporting corrugated coil 40 is reduced, and the patient's discomfort is relieved.

Further, as shown in FIG. 6 to FIG. 8 , the number of wave bands of the supporting wave ring 40 is greater than the number of wave bands of the connecting wave ring 30 , wherein the supporting wave ring 40 includes several supporting wave segments 41 connected in sequence, and the supporting wave ring 40 The number of bands is the number of supporting wave segments 41, the number of bands connecting the wave ring 30 is the total number of the fixed wave segment 32 and the active wave segment 31, and the number of wave bands supporting the wave ring 40 is set to be greater than the number of connecting wave rings 30 the number of bands.

Since the supporting corrugated coil 40 is arranged between the graft body 10 and the connecting corrugated coil 30, and the radial support force of the connecting corrugated coil 30 is greater than that of the supporting corrugated coil 40, after the stent-graft 001 is completely released, the connecting corrugated coil 30 will The inner side supports the corrugated coil 40 . In this embodiment, the number of bands of the supporting corrugated coil 40 is set to be greater than the number of bands of the connecting corrugated coil 30, so as to disperse the radial support force provided by the connecting corrugated coil 30, so that the pressure on the inner wall of the blood vessel is more uniform. On the other hand, by increasing the number of wave bands of the supporting wave coil 40, more connection points between the supporting wave coil 40 and the proximal end of the coating body 10 can be made. The shape of the end is closer to a circle, thereby further reducing the risk of endoleak of the stent graft 001.

Specifically, the wire diameter of the supporting wave coil 40 is 0.1 mm to 0.5 mm, the wire diameter of the connecting wave coil 30 is 0.3 mm to 1 mm, and the number of bands of the supporting wave coil 40 is 2 times to 5 times that of the connecting wave coil 30 times. In this embodiment, the wire diameter of the supporting wave coil 40 is 0.2 mm, the wire diameter of the connecting wave coil 30 is 0.5 mm, and the number of bands of the supporting wave coil 40 is 3 times the number of bands of the connecting wave coil 30. Both 40 and the connecting wave ring 30 are made of nickel-titanium wire. As shown in FIG. 6 and FIG. 7 , the connecting wave coil 30 includes a plurality of connecting band parts 301 connected in sequence, and the connecting band parts 301 are sequentially connected to form a ring-shaped support structure. A number of fixed waveform segments 32 and at least one movable waveform segment 31 are connected to the band part 301, wherein the fixed waveform segment 32 is fixedly connected to the coating body 10, and the movable waveform segment 31 is movably connected to the coating body 10. The wave segment 31 is connected with the release mechanism of the stent graft 001 .

In this embodiment, the connecting band portion 301 includes three movable waveform segments 31 that are movably connected to the coating body 10, and the three movable waveform segments 31 are evenly arranged along the circumferential direction of the coating body 10, and can also be adjacent to each other. Set or set at intervals, the three movable waveform segments 31 are used to connect with the release mechanism of the delivery device, and release after the stent graft 001 is positioned.

In other embodiments, the connecting band part 301 may also include four or six active waveform segments 31 for adapting to release mechanisms of delivery devices of different specifications.

As shown in FIG. 9 and FIG. 10 , the sheath core 62 is provided with hooks 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 , and the hooks 63 are used to connect with the wave coil 30 To connect, during the delivery process of the stent graft 001, the hook claw 63 is hooked and fixed with the movable waveform segment 31 of the connecting wave, thereby limiting the position of the stent graft 001 in the conveyor, wherein the front end of the sheath tube 61 is also set There is a guide portion 64, and the front end of the guide portion 64 is tapered.

During the release process of the stent-graft 001, after the conveyor transports the stent-graft 001 to a predetermined position, the stent-graft 001 is completely released to in blood vessels.

The hook claw 63 is hooked and connected with the movable waveform segment 31 , and when the hook claw 63 is released from the connection with the movable waveform segment 31 , the stent graft 001 is completely released in the blood vessel. Before the hook claw 63 is released from the connection with the movable waveform segment 31 , the proximal end of the stent graft 001 is already in a semi-released state due to the structural setting of the connection wave coil 30 . Wherein, the half-released state refers to a state in which the proximal end of the stent-graft 001 is partially expanded.

In this embodiment, the connecting corrugated coil 30 includes three movable waveform segments 31 uniformly distributed in the circumferential direction. Since the sheath core 62 is located in the middle of the inner side of the stent graft 001, and the claws 63 are arranged on the sheath core 62, when the movable waveform segment 31 is hooked and fixed on the claws 63, the claws 63 divide the three movable waveforms simultaneously. Segment 31 is bound in the middle of the inside of stent-graft 001 .

The fixed waveform segment 32 includes a fixed peak 321 , a fixed trough 323 and a fixed probe 322 connecting adjacent fixed peaks 321 and fixed troughs 323 . The active waveform segment 31 includes an active wave crest 311, an active wave trough 313, and an active wave rod 312 connecting adjacent active wave peaks 311 and active wave troughs 313. The active wave trough 313 is fixedly connected with the coating body 10, and the active wave peak 311 and the active wave bar 312 are connected to the The coated body 10 is flexibly connected. In this embodiment, the fixed waveform segment 32 and the active waveform segment 31 are arranged at intervals.

Before the claw 63 is released from the connection with the movable waveform segment 31, the movable waveform segment 31 is bound by the claw 63, and the active peak 311 is connected to the claw 63, and the movable valley 313 is connected to the film body 10, and the active The graft body 10 connected by the troughs 313 is displaced toward the inner side of the stent graft 001 under the pulling action of the movable wave segment 31 . Under the action of its own elastic force, the fixed wave segment 32 generates an outward radial support force on the covering body 10 , thereby stretching the 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 stretches the graft body 10 outward, while the movable waveform segment 31 pulls the graft body 10 inward, so that the stent graft The front end of 001 forms a half-release state. Wherein, the top of the fixed peak 321 is flush with the proximal edge of the coating body 10, and the top of the movable peak 311 is flush with the proximal edge of the coating body 10. Compared with the bare stent connected with the release structure of the delivery device, it can reduce the stimulation of the graft body 10 to the inner wall of the blood vessel.

In the technical solution of the present application, the top edges of the fixed peak 321 and the movable peak 311 are flush with the proximal end of the graft body 10 , replacing the bare stent configuration of the traditional aortic stent graft 001 . Therefore, 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 secondary damage to the vessel wall caused by the bare stent portion or barbs of the traditional stent-graft 001 . While protecting the patient's arteries, it can also avoid the problem of blood leakage caused by the beak-like structure of the stent graft 001, and further improve the sealing performance of the stent graft 001.

Specifically, when the stent-graft 001 is implanted at the position of the aortic arch, the stent-graft 001 is arranged in a curved shape as a whole, and the side of the stent-graft 001 facing the aortic arch is usually defined as the greater curvature side of the stent-graft 001, and the stent-graft 001 is The side of the stent graft 001 away from the aortic arch is defined as the lesser curvature side of the stent graft 001 . In this application, the greater curvature side of the stent graft 001 is provided with a groove portion 50 .

Further, when the wave band on the small curvature side of the main support wave coil 20 is the main support peak 21, the main support peak 21 on the small curvature side is coaxial with the fixed peak 321 or the movable peak on the small curvature side and arranged along the same axial direction. When the main bracket trough 23 is located on the small bend side of the wave coil 20 of the main support, the main support trough 23 on the small bend side is coaxially arranged with the fixed trough 323 or the movable trough 313 on the small bend side along the same axial direction. In this embodiment, through the above settings, it is ensured that the stent graft 001 has better compliance at the position corresponding to the aortic arch and the lesser curvature side.

That is, when the wave band of the main support wave coil 20 is located on the other side of the groove portion 50, the main support wave peak 21 is located on the other side of the groove portion 50. The fixed peaks 321 or the movable peaks 311 on the other side of the groove portion 50 have the same direction and are on the same axis. When the wave band of the main support wave coil 20 is located on the other side of the groove portion 50, the main support wave trough 23 is located on the other side of the groove portion 50. The fixed trough 323 or the movable trough 313 on the other side of the groove portion 50 has the same direction and is on the same axis. When the wave coil 20 of the main bracket is located in the wave band of the major bending side, the peak 21 of the main bracket on the major bending side is in the same direction as the fixed trough 323 or the movable trough 313 on the major bending side, and they are on the same axis. When the wave coil 20 of the main bracket is located in the main bracket wave trough 23 on the big bend side, the main bracket wave trough 23 on the big bend side is in the same direction as the fixed peak 321 or the movable peak 311 on the big bend side, and they are on the same axis.

Through the above configuration, the present application ensures that the greater curvature side of the stent graft 001 has a higher hardness at the corresponding position where the aortic arch is implanted, thereby effectively preventing the stent from shortening. In this embodiment, the connecting corrugated coil portion 301 located on the large bending side of the main body support member 100 is a fixed wave segment 32 .

Specifically, one of the fixed crests 321 of the connecting wave coil 30 is set on the center line of the groove portion 50, and one of the main support wave peaks 21 of the main support wave coil 20 adjacent to the connecting wave coil 30 is set on the center line of the groove portion 30 In order to facilitate the implantation of the stent graft 001 at the position of the aortic arch, it has better compliance. Wherein, the midline of the groove part 30 in this embodiment is defined as follows: the connection line between the two vertices of the edge connecting the groove part 30 and the graft body 10, wherein the vertices are the most distant from the central axis of the stent graft 001 far away. In this embodiment, as shown in FIG. 11 , the axial height of the wave section of the main support wave coil 20 located on the large bending side is greater than the axial length of the wave section on the small bending side, so that the gap between adjacent main support wave coils 20 on the large bending side The distance is shorter than the distance between adjacent main support wave coils 20 on the small bending side. Therefore, the large curved side of the film-covered body 10 is not easy to be shortened, and the small curved side is more flexible.

In a specific implementation, the wire diameter D20 of the wave coil 20 of the main support is 0.3 to 0.45 mm, the wave height H20 is 6 to 15 mm, and the wave number T20 is 6 to 10. For example, the wire diameter D20 of the wave coil 20 of the main support is 0.3 mm, the wave height H20 is 8 mm, and the wave number T20 is 8. The wire diameter D30 connecting the wave coil 30 is 0.3 to 0.45 mm, the wave height H30 is 10 to 15 mm, and the wave number T30 is 4 to 8. For example, the wire diameter D30 connecting the wave coil 30 is 0.4 mm, the wave height H30 is 12 mm, and the wave number T30 is 6.

The interval between two adjacent main support wave coils 20 is 1 mm to 2 mm, and the interval between the main support wave coil 20 closest to the connecting wave coil 30 and the connecting wave coil 30 is 1 mm to 2 mm. The fixed trough 323 and the movable trough 313 connecting the corrugated coil 30 to the film body 10 are additionally provided with a suture point 33, and the suture point 33 covers the rounded corners of the fixed trough 323 and the movable trough 313, wherein the axial direction of the suture point 33 The length is set to be greater than 0 and less than or equal to 5mm, so as to ensure that the fixed band 32 of the connecting wave coil 30 assembled in the conveyor will not be displaced relative to the main body 10 of the coating, thereby preventing the connecting wave coil 30 from being released from the conveyor The main body 10 of the covering film protrudes from the back. Wherein, the suture point is used to sew the fixed trough 323 and the movable trough 313 on the main body 10 of the film.

In other embodiments, if the way of connecting the corrugated coil 30 to the covering body 10 is bonding, the stitching point 33 may also be replaced by a bonding point.

As shown in Figure 8, the supporting wave coil 40 includes several supporting wave segments 41 connected in sequence, the supporting wave segments 41 are arranged in an inverted 8 shape or a diamond shape, and a plurality of supporting wave segments 41 form a nickel-titanium alloy ring. To support the proximal end of the graft body 10 . The supporting strength of the supporting corrugated coil 40 is enhanced through the inverted 8-shaped or diamond-shaped supporting wave segment 41, so that the wall-attaching effect of the stent graft 001 is better. Wherein, the assembly allowable deviation of the supporting wave coil 40 is also ±1 mm, and the assembly allowable deviation of the fixed wave crest 321 is ±1 mm.

In this embodiment, as shown in FIG. 14 , the connecting band portion 301 and the supporting wave segment 41 are arranged in a circumferential direction in a misalignment. Specifically, the connecting wave coil 30 is set with half a phase difference with respect to the supporting wave coil 40 , so that the whole of the connecting wave coil 30 and the supporting wave coil 40 has a better supporting performance for the coating body 10 .

It should be noted that the size parameter setting of the above-mentioned stent graft is only an example of this implementation, and is applicable to most application scenarios, but does not constitute a limitation to this application. If there is a special size requirement, the technical solution of this application can also be adopted other size parameters.

The supporting wave coil 40 can be fixedly connected with the membrane main body 10 , and the supporting wave coil 40 is fixedly connected with the membrane main body 10 by suturing or bonding. The supporting wave coil 40 can also be fixedly connected to the connecting wave coil 30 , and the supporting wave coil 40 is fixedly connected to the connecting wave coil 30 by means of sewing, bonding or welding. In this embodiment, the supporting wave coil 40 is fixedly connected to the covering body 10 by suturing.

As shown in FIG. 3 and FIG. 5 , the proximal end of the supporting wave coil 40 is flush with the proximal end edge of the membrane body 10 ; or the distal end of the supporting wave coil 40 is flush with the distal end of the connecting wave coil 30 The edges are flush, and the proximal end of the supporting corrugated coil 40 is farther away from the proximal end of the covering body 10 than the proximal end of the connecting corrugated coil 30, which facilitates the connection between the connecting corrugated coil 30 and the conveyor; or the supporting corrugated coil 40 is set Between the distal end of the corrugated coil 30 and the proximal end of the graft body 10 is connected to both prevent internal leakage and facilitate connection.

In this embodiment, the supporting wave coil 40 is fixedly connected to the covering body 10 by suturing. The crest of the proximal end of the supporting corrugated ring 40 is flush with the proximal edge of the covering body 10 to enhance the support strength of the proximal end of the covering body 10 so as to better prevent endoleak.

Further, since the proximal crest of the support wave coil 40 is flush with the proximal edge of the graft body 10, when the stent graft 001 is in the half-release state, the proximal edge of the graft body 10 is within the diameter of the support coil 40. The lateral displacement occurs under the action of the support force, so that the proximal edge of the graft body 10 can be closer to the inner wall of the blood vessel to a greater extent before the stent graft 001 is fully released.

Before the hook claw 63 is released from the connection with the movable waveform segment 31, the hook claw 63 binds the active peak 311 of the movable waveform segment 31 in the middle of the stent graft 001, so when the hook claw 63 is released and the movable waveform segment 31 At the moment of restraint, the movable wave segment 31 will rebound under the action of its own elastic force, especially the moving distance of the movable wave peak 311 at the proximal end is the largest. During the rebound process of the movable waveform segment 31 , the movable waveform segment 31 will first contact the covering body 10 , and then drive the covering body 10 to contact the inner wall of the blood vessel.

If the supporting wave coil 40 is not provided on the coating body 10, the movable waveform segment 31 will quickly drive the coating body 10 against the inner wall of the blood vessel at the moment of contact and restraint, causing an impact on the inner wall of the blood vessel, causing discomfort to the patient. even lead to vasospasm. In this embodiment, since the support wave coil 40 is provided at the proximal end of the membrane body 10, and the proximal peak of the support wave coil 40 is flush with the proximal edge of the membrane body 10, the proximal edge of the membrane body 10 is Before the stent graft 001 is fully released, it can approach the inner wall of the blood vessel to a large extent. Therefore, at the moment when the active waveform segment 31 contacts and restrains, the impact of the active waveform segment 31 , especially the active wave peak 311 on the inner wall of the blood vessel is greatly resolved.

In other embodiments, the supporting wave coil 40 can also be configured as a sine wave, a Z-shaped wave, an M-shaped wave or a V-shaped wave. Therefore, the above-mentioned structure supporting the corrugated coil 40 of the present application is only an example, and any other structure capable of supporting the coating body 10 can be applied to the present application. The main body support 100 and/or the supporting film 10 is provided with a developing part. When the developing part is arranged on the main body support 100, for example, when the developing part is arranged on the main support section 200, the developing part can be welded, sewn or bonded. on the main bracket segment 200 . When the developing member is disposed on the supporting film 10 , the developing member may be sewn or glued on the supporting film 10 .

There are multiple developing parts, and the developing parts can be set in O-shaped, 8-shaped or N-shaped, that is, they are distinguished by different shapes. Alternatively, the developing parts can be set as developing points with different blackness, that is, they can be distinguished by different color depths. By arranging a plurality of developing components on the stent-graft 001 , it is convenient for doctors and other operators to determine the position of the stent-graft 001 .

In this embodiment, the developing part 11 is arranged on the supporting membrane 10, and the developing part 11 includes a first developing point 111, a second developing point 112 and a third developing point 113, which are used to display the proximal end of the stent graft 001. position and the position of the groove portion 50. Wherein, the first developing point 111 is arranged on the center line of the groove part 50, and the first developing point 111 is arranged on the edge of the proximal end of the support frame segment 300, and the first developing point 111 can be arranged on the support frame segment 300 or on the On the film body 10. The second developing point 112 is set on the centerline of the groove portion 50 , and the second developing point 112 is set on the edge of the supporting frame segment 300 opposite to the groove portion 50 , and the second developing point 112 is set on the film body 10 . The third development point 113 is arranged on the other side of the center line of the groove portion 50, and the third development point 113 is arranged on the edge of the proximal end of the support frame segment 300. The third development point 113 can be arranged on the support frame segment 300 or set on the film 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, the shape of the second developing point 112 and the shape of the third developing point 113 can be The same may also be different. In this embodiment, the first developing point 111 is in the shape of 8, and the second developing point 112 and the third developing point 113 are in the shape of O.

Wherein, the first developing point 111 and the third developing point 113 are used to display the position of the proximal end of the stent graft 001 and the angle at which the groove portion 50 is placed. The second development point 112 is used to show the position of the edge of the groove portion 50 .

Since the first developing point 111 and the third developing point 113 are both arranged on the edge of the proximal end of the stent segment 300 , when the stent-graft 001 is implanted, the proximal position of the stent-graft 001 can be displayed. Moreover, the first imaging point 111 is placed toward the direction of the branch arteries of the aortic arch, and the third development point 113 is placed away from the direction of the branch arteries of the aortic arch. Since the first developing point 111 is arranged in the same direction as the groove portion 50 , the angle at which the groove portion 50 is arranged can also be displayed.

Wherein, the first developing point 111 is located at the proximal edge of the greater curvature side of the stent graft 001, indicating the position of the proximal greater curvature side of the stent graft 001, and the third developing point 113 is located at the proximal edge of the lesser curvature side of the stent graft 001 , indicating the position of the lesser curvature side of the stent graft 001.

In this embodiment, the groove portion 50 is facing the branch vessels of the aortic arch. After the stent graft 001 aorta, the stent graft 001 can cover the ascending aorta, and the branch stent 003 connected to the groove portion 50 can ensure that the aortic arch blood flow in branch vessels. Therefore, the aortic aneurysm or aortic dissection at the ascending aorta can be treated through the stent graft 001 of this embodiment.

When treating the aortic aneurysm or aortic dissection of the ascending aorta, the doctor can determine the position of the graft body 10 by observing the first development point 111 and the third development point 113, so as to ensure that the graft body 10 can completely cover the entire Aortic aneurysm or aortic dissection, to ensure the smooth progress of the operation.

In this embodiment, as shown in FIG. 15 and FIG. 16 , an eighth developing point 118 is also set on the coating body 10 , the eighth developing point 118 is set on the midpoint of the groove portion 50 , and the eighth developing point 118 It is arranged on the edge of the end opposite to the groove portion 50 away from the support frame segment 300 . Wherein, the two sides of the supporting ring set in the suturing ring 53 can also be provided with developing strips 119 for displaying the outline of the groove coating 52 , so as to facilitate the positioning when implanting the stent graft 001 .

In this embodiment, by setting the eighth development point 118 and the development strip 119 on the stent graft 001, the overall edge position of the groove part 50 can be indicated during the operation, and the relative position of the guide wire relative to the groove part 50 can be indicated, so that When assisting the doctor to confirm the guide wire approach, the guide wire is located inside the groove to ensure the success rate of the operation.

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

Since the branch bracket 003 is sewn to the groove portion 50 through the through hole 521 , there may be a seam edge between the through hole 521 and the groove portion 50 during sewing, or a retracted through hole 521 may be used in the design. Therefore, in the above case, the distance between the through hole 521 and the proximal end of the support frame segment 300 is set to be smaller than the distance between the second developing point 112 and the proximal end of the support frame segment 300 . Through the above arrangement, when the doctor passes the guide wire from the groove portion 50 through the through hole 521 into the branch bracket 003, he can accurately know the position of the edge of the groove portion 50, which provides convenience for the doctor's operation.

In summary, compared with the connecting coil structure of the existing aortic stent graft, the connecting coil avoids secondary damage to the inner wall of the blood vessel in the anchoring area by the exposed connecting coil, and the active waveform of the connecting coil 30 is The semi-connection between the section 31 and the graft body 10 satisfies the cooperative use of the release device behind the stent graft 001 . In addition, the supporting corrugated coil 40 can strengthen the support of the membrane, ensuring that the proximal end of the stent-graft 001 can completely adhere to the wall after release, and avoid the bird's beak shape at the proximal end of the stent and cause blood leakage.

Embodiment 2, Embodiment 2 of the present application provides a stent graft, as shown in FIG. 17 , the similarities between Embodiment 2 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 2 and Embodiment 1 The difference is that adjacent main bracket wave coils 20 are connected by connecting rods 24, and multiple connecting rods 24 are arranged on the same side as the groove portion 50, and the multiple connecting rods 24 are on the same side as the center line of the groove portion 50. on a straight line, thereby increasing the supporting strength of the stent graft 001. Wherein, the connecting rod 24 is connected to the wave coil 20 of the main support through a steel sleeve, or the connecting rod 24 is welded on the wave coil 20 of the main support.

It should be understood that, in other embodiments, a plurality of connecting rods 24 can also be arranged in a misplaced position, and two adjacent main support wave coils 20 are connected by a connecting rod 24, and the connecting rod 24 is arranged at the groove part 50 Just the same side.

In this embodiment, the connecting rods 24 are provided between adjacent main stent coils 20 , so as to ensure the bending direction of the stent graft 001 after implantation, and improve the supportability of the stent graft 001 at the same time.

Embodiment 3. Embodiment 3 of the present application provides a stent graft, as shown in FIG. 18 and FIG. 19 . The similarities between Embodiment 3 of the present application and Embodiment 1 will not be repeated here. One difference is that the movable probe 312 is set at a preset angle with the film covering body 10 . Wherein, the movable probe 312 is bent toward the inner side of the film-covered body 10 , and the preset angle is greater than 0° and less than or equal to 45°, for example, 30°. Therefore, the movable crest 311 follows the movable wave rod 312 and bends towards the inner side of the coating body 10 . The distance between the active peak 311 and the center of the connecting wave 30 is smaller than the distance between the fixed peak 321 and the center of the connecting wave 30 .

Since there is radial elastic force in the unstitched movable wave segment 31 before the post-release process, a rebound force will be 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 graft body 10 is bent from the root toward the inner side of the stent graft 001 , thereby avoiding the impact of the elastic force of the movable waveform segment 31 on the blood vessel during the post-release process. Compared with the connection wave coil setting of the traditional stent graft 001, the movable wave rod 312 is bent inward, which can also reduce the long-term stimulation to the inner wall of the blood vessel caused by the active wave crest 311 standing against the inner wall of the blood vessel for a long time.

Embodiment 4. Embodiment 4 of the present application provides a stent graft, as shown in FIG. 20 and FIG. 21 . The similarities between Embodiment 4 and Embodiment 2 of the present application will not be repeated here. The difference between the three is that the movable wave rod 312 includes a bent portion 314 connected to the movable peak 311 , and the bent portion 314 is set at a preset angle with the coating body 10 . Wherein, the bending portion 314 is bent towards the inner side of the film-coated body 10, 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 10% and less than equal to 60%. Therefore, the movable peak 311 follows the bending portion 314 and bends towards the inner side of the membrane body 10 . The distance between the active peak 311 and the center of the connecting wave 30 is smaller than the distance between the fixed peak 321 and the center of the connecting wave 30 .

In this embodiment, 30% to 60% of the length of the proximal end of the movable wave rod 312 is set as the bending portion 314 . Since the bent portion 314 is disposed between the movable peak 311 and the movable trough 313 , and the bent portion 314 is close to the movable crest 311 , the movable wave rod 312 can provide supporting force near the root of the movable trough 313 .

It should be noted that, in order to avoid the impact of the elastic force on the blood vessel during the post-release process of the active waveform segment 31, this embodiment adopts the method of setting the bending part 314 on the active wave rod 312, thereby reducing the active waveform The instantaneous impact force of segment 31 on the inner wall of the blood vessel during the rebound process.

In addition, if the length of the bending portion 314 is too long, the support of the active waveform segment to the inner wall of the blood vessel will be seriously reduced; in the impact force. Therefore, setting the interval length from 10% to 60% of the proximal end of the active wave rod 312 as the bending portion 314 can reduce the impact force of the active wave segment 31 on the inner wall of the blood vessel during the rebound process, while ensuring the active wave segment. Section 31 still has sufficient supporting force for the inner wall of the blood vessel. In this embodiment, 45% of the section length at the proximal end of the movable wave rod 312 is set as the bent portion 314 .

Further, since the bent portion 314 is bent toward the inner side of the graft body 10, thrombus may accumulate on the bent portion 314 after the stent has been implanted for a long time, and the bent portion with an excessively large bending angle The thrombus on 314 may fall off, so the bending angle of the bending portion 314 is not easy to be too large. Therefore, the preset bending angle of the bending part 314 in the present application is set to 0° to 45°, which can ensure that the bending part 314 is set to be bent toward the inner side of the membrane body 10, and at the same time, the long-term accumulated thrombus will not fall off. , to avoid the risk of branch vessel embolism. In this embodiment, the preset angle of the bending portion 314 is set to 15°.

On the other hand, the greater the length of the bending portion 314 in this embodiment, the smaller the preset angle.

Since the main body stent 002 of the present application is provided with a branch stent 003, in the process of establishing the path between the branch stent 003 and the main body stent 002, it is necessary to establish a path through the guide wire. If the gap between them is too large, the guide wire will mistakenly pass through the gap between the bending portion 314 and the graft body 10 when establishing the access pathway, resulting in failure to establish the pathway. Therefore, the greater the length of the bent portion 314 in this embodiment, the smaller the preset angle, so as to ensure that the gap between the bent portion 314 and the graft body 10 will not allow the guide wire to pass through by mistake, resulting in failure to establish the passageway. .

From the above, in addition to avoiding the impact of the elastic force on the blood vessel during the post-release process of the movable waveform segment 31, this embodiment can also support the film-covered body 10, enhance the wall-attachment effect of the film-covered body 10, and further improve To avoid the role of bleeding. Compared with the connection wave coil setting of the traditional stent graft 001, the movable wave rod 312 is bent inward, which can also reduce the long-term stimulation to the inner wall of the blood vessel caused by the active wave crest 311 standing against the inner wall of the blood vessel for a long time.

Embodiment 5, Embodiment 5 of the present application provides a stent graft, as shown in Figure 22, the similarities between Embodiment 5 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 5 and Embodiment 1 The advantage is that the shape of the supporting corrugated coil 40 is the same as that of the connecting corrugated coil 30, both of which are wave-shaped, and the supporting corrugated coil 40 and the connecting corrugated coil 30 are arranged in a misaligned manner, and the supporting corrugated coil 40 and the coating body 10 are completely fixed .

In this embodiment, both the supporting corrugated coil 40 and the connecting corrugated coil 30 are sinusoidal, and the position of the supporting corrugated coil 40 is the position corresponding to the half cycle of the circumferential rotation of the connecting corrugated coil 30, and the supporting corrugated coil 40 is stitched The way is fixed with the film body 10.

The supporting wave coil 40 is arranged on the outer side of the coating body 10 (at this time, in the radial direction, the coating body 10 is located between the connecting wave coil 30 and the supporting wave coil 40), or in the radial direction, the supporting wave coil 40 It is arranged on the inner side of the covering body 10, and the supporting wave coil 40 is arranged between the covering film body 10 and the connecting wave coil 30, so as to ensure that the movable wave segment 31 of the connecting wave ring 30 can be connected to the release mechanism of the delivery device. At the same time, the support of the proximal end of the covering body 10 is ensured, the risk of blood endoleak is reduced, and the stimulation of the connecting corrugated coil 30 to blood vessels is reduced.

Embodiment 6, Embodiment 6 of the present application provides a stent graft, as shown in FIG. 23 , the similarities between Embodiment 6 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 6 and Embodiment 1 The advantage is that the supporting wave coil 40 includes several independent supporting units 42 , and each independent supporting unit 42 is combined and distributed between the crests and troughs of the connecting wave coil 30 .

The supporting wave coil 40 of this embodiment includes a number of supporting units 42 uniformly distributed in the circumferential direction between the crests and troughs of the connecting wave coil 30. The proximal end of the membrane body 10 is flush. In this embodiment, the supporting unit 42 is rhomboid, and the major axis of the rhombus is parallel to the longitudinal central axis of the stent-graft. In other embodiments, the support unit 42 may be elliptical, and its long axis is parallel to the longitudinal central axis of the stent-graft.

By setting the rhomboid or elliptical support unit 42 whose major axis is parallel to the longitudinal central axis of the stent-graft, the radial dimension of the stent-graft after compression is reduced and the strength of the proximal end of the stent-graft body 10 is improved. A balance makes the proximal end of the covering body 10 not only have better support, which reduces the risk of blood endoleak, but also has a smaller size after radial compression.

Embodiment 7, Embodiment 7 of the present application provides a stent graft, as shown in Figure 24, the similarities between Embodiment 7 of the present application and Embodiment 1 will not be repeated, and the differences between Embodiment 7 and Embodiment 1 The difference is that the connecting wave coil 30 includes several connecting band parts 301 connected in sequence, and the connecting band parts 301 include fixed waveform segments 32 and movable waveform segments 31 arranged at intervals in sequence, and the connecting band parts 301 are all arranged on the coating body 10 of the inner surface.

The fixed waveform segment 32 is arranged in a ring shape, and the fixed waveform segment 32 is completely fixedly connected to the film body 10. The movable waveform segment 31 is arranged between the adjacent fixed waveform segments 32, and the movable waveform segment 31 is arranged in a strip shape. The movable waveform segment 31 is movably connected to the covering body 10 .

Specifically, the movable waveform segment 31 protrudes toward the proximal end of the film-graft body 10 to form an active peak 311 for connecting to the release mechanism of the delivery device, and the proximal end of the active wave peak 311 is flush with the proximal end of the film-graft body 10 Or the inside of the active peak 311 (that is, the active peak 311 is closer to the distal end of the graft body 10 than the proximal end of the graft body 10). Both sides of the movable wave crest 311 are respectively provided with movable wave rods 312, and the movable wave rods 312 on both sides are respectively fixedly connected with the fixed waveform segments 32 on the corresponding sides.

The fixed wave segment 32 is fixedly connected to the covering body 10 by sewing, and the movable wave segment 31 is connected to the fixed wave segment 32 by welding.

In this embodiment, the active peak 311 located inside the graft body 10 is connected to the release structure of the delivery device, so as to reduce the stimulation of the active peak 311 to the inner wall of the blood vessel and achieve the purpose of releasing the stent.

Embodiment 8, Embodiment 8 of the present application provides a stent graft, as shown in Figure 25, the similarities between Embodiment 8 of the present application and Embodiment 7 will not be repeated, and the differences between Embodiment 8 and Embodiment 7 The difference is that the movable waveform segment 31 is arranged in a ring shape, and part of the movable waveform segment 31 is fixedly connected to the coating body 10 , and part is separated from the coating body 10 . The fixed waveform segment 32 is set between the adjacent movable waveform segments 31, the fixed waveform segment 32 is arranged in a strip shape, and the fixed waveform segment 32 is completely fixedly connected to the film body 10, and the fixed waveform segment 32 can be a straight line The segment shape, which can also be a curved segment shape.

Specifically, the movable waveform segment 31 includes a side near the proximal end of the graft body 10 and is movably connected to a movable proximal portion 316 of the graft body 10, and a side away from the proximal end of the graft body 10 and is fixedly connected to the graft body 10. The movable distal portion 315 of the membrane body 10 . The movable proximal portion 316 is flush with the proximal end of the graft body 10 , or a predetermined indentation distance is set between the movable proximal portion 316 and the graft body 10 . Wherein, the predetermined indentation distance is 0.5 mm to 2 mm. By setting the predetermined indentation distance, there is a sufficient installation gap between the movable proximal part 316 and the film body 10, thereby ensuring that the movable proximal part 316 and the film The bodies 10 will not separate from each other.

In this embodiment, the movable proximal portion 316 located at the proximal end of the movable waveform segment 31 is connected to the release structure of the delivery device, so as to realize the storage of the connecting coil 30 inside the graft body 10 to reduce the stimulation of the bare stent to the inner wall of the blood vessel. At the same time, the purpose of releasing the bracket is accomplished.

Embodiment 9, Embodiment 9 of the present application provides a stent graft, as shown in Figure 26 and Figure 27 , the similarities between Embodiment 9 of the present application and Embodiment 1 will not be repeated, and Embodiment 9 and Embodiment The first difference is that, as shown in FIG. 1 , the developing member 11 also includes a fourth developing point 114 and a fifth developing point 115 arranged on the film body 10, the fourth developing point 114 and the fifth developing point 115 are respectively Two sides of the film covering body 10 near the proximal end of the groove portion 50 are provided.

Wherein, the fourth developing point 114 and the fifth developing point 115 are respectively set on both sides of the proximal end of the groove coating 52 to indicate the positions of the two proximal sides of the groove coating 52 . In this embodiment, through the fourth development point 114 and the fifth development point 115, the doctor can accurately know the position of the proximal end of the groove coating 52 at the bottom of the groove part 50, which provides convenience for the doctor's observation and operation.

Further, in this embodiment, the sixth development point 116 and the seventh development point 117 are also provided on the groove coating film 52 of the groove part 50, and the sixth development point 116 and the seventh development point 117 are respectively arranged on the groove surface. The middle portion of the proximal and distal ends of the membrane 52 .

Wherein, the shape of the first developing point 111 is different from that of the third developing point 113, the shape of the sixth developing point 116 is different from that of the second developing point 112, the shape of the seventh developing point 117 is different from that of the eighth developing point 118, thus It is more obvious to distinguish each developing point.

In this embodiment, by setting the sixth development point 116 and the seventh development point 117, the depth of the branch bracket 003 embedded in the proximal and distal ends of the groove part 50 can be indicated during the operation, and by cooperating with the eighth development point 118, It assists the doctor to find the position of the embedded branch stent 003 when confirming the guide wire approach, which provides convenience for the doctor's operation and improves the success rate and efficiency of the operation. To sum up, the present application provides a stent graft. Compared with the connection coil structure of the existing aortic stent graft, it avoids secondary damage to the inner wall of the vessel in the anchoring area by the exposed connection coil. The semi-connection mode between the active waveform segment of the corrugated coil and the graft body satisfies the cooperative use of the release device after the stent graft.

The above is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Anyone skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present invention. All should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims (10)

1. The utility model provides a tectorial membrane support, includes main part support piece and sets up tectorial membrane body on the main part support piece, its characterized in that, main part support piece includes main support section and sets up the support frame section of main support section proximal end, the support frame section include with the connection ripples circle that tectorial membrane body part is connected and set up support ripples circle that support tectorial membrane port department, the silk footpath of support ripples circle is less than the silk footpath of connection ripples circle.

2. The stent graft of claim 1, wherein said connecting band comprises a plurality of stationary wave segments fixedly connected to said stent graft body and at least one movable wave segment movably connected to said stent graft body.

3. The stent graft of claim 2, wherein said fixed wave segments comprise fixed wave crests, fixed wave troughs, and fixed wave rods connecting adjacent said fixed wave crests and fixed wave troughs, the tops of said fixed wave crests being flush with the proximal edge of said stent graft body or closer to the distal end of said stent graft body than the proximal edge of said stent graft 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.

4. A stent graft as in claim 3, wherein the movable waver is disposed at a predetermined angle to the stent graft body; or the movable wave rod comprises a bending part connected with the movable wave crest, and the bending part and the tectorial membrane body are arranged at a preset angle.

5. The stent graft of claim 4, wherein said movable struts are bent toward the inside of said stent graft body or said bent portions are bent toward the inside of said stent graft body, said predetermined angle is greater than 0 ° and equal to or less than 45 °, and the percentage of the ratio of the length of said bent portions to the length of said movable struts is greater than or equal to 10% and less than or equal to 60%.

6. The stent graft of claim 2, wherein said stationary waveform segments are sequentially spaced apart from said movable waveform segments.

7. The stent graft of claim 1, wherein the number of bands of said support band is greater than the number of bands of said connection band.

8. The stent graft of claim 1, wherein said support collar is fixedly connected to said stent graft body or said support collar is fixedly connected to said connection collar.

9. The stent graft of claim 8, wherein the proximal end of the support band is flush with the proximal edge of the stent graft 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 graft body.

10. The stent graft of any one of claims 1-9, wherein said main body support has a recessed portion recessed toward the inside of said main body support, said recessed portion comprising a recessed support connected to said main body support and a recessed stent disposed on said recessed support; and the main body support piece and/or the support coating film are/is provided with a developing piece.

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