General covered stent graft system for major iliac artery dilation or occlusion lesion

Abstract

The utility model discloses a general covered stent graft system for major iliac artery dilatation or occlusion lesion, which comprises a main covered stent, a columnar covered connecting pipeline is arranged in the main covered stent, and a funnel-shaped transition connecting part is arranged at the tail end of the columnar covered connecting pipeline; the columnar covered connection pipeline is fixedly connected with the inner wall of the main covered stent, and the bottom edge of the funnel-shaped transition connection part is fixedly connected with the bottom edge of the main covered stent; a first iliac artery covered stent opposite to the columnar covered connecting pipeline in direction is arranged on the surface layer of the funnel-shaped transition connecting part, and the first iliac artery covered stent extends in the axial direction of the main covered stent body; and a second iliac artery covered stent detachably connected with the columnar covered connecting pipeline is arranged on the inner wall of the columnar covered connecting pipeline. The columnar covered connection pipeline used for splicing the stent is arranged at the top end of the funnel-shaped transition connection part, the first iliac artery covered stent is arranged on the side wall of the funnel-shaped transition connection part, and the whole stent is convenient and reliable to install.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions. Background Art

[0002] Aortoiliac artery dilatation lesions mainly include infrarenal abdominal aortic aneurysms and isolated iliac artery aneurysms. When the proximal neck of an isolated iliac artery aneurysm is short and there is no sufficient anchoring area, endovascular treatment often uses the same stent system as infrarenal abdominal aortic aneurysms.

[0003] Aortoiliac occlusive disease, also known as aortoiliac occlusive disease, refers to an ischemic disease of the lower limbs and pelvic tissues and organs caused by stenosis or occlusion of the infrarenal abdominal aorta and iliac arteries.

[0004] At present, the stent graft systems for endovascular treatment of abdominal aortic aneurysms mainly include two types: single iliac branch and double iliac branch. The latter is divided into two types: integrated and split according to the different iliac branch connection methods.

[0005] Single iliac branch abdominal aortic stent graft is generally only used for emergency treatment of ruptured abdominal aortic aneurysm, with the advantages of simple release and rapid aneurysm cavity closure. However, it can only preserve blood flow in one lower limb artery, so additional surgery such as artificial vascular femoral-femoral switch is required to reconstruct blood flow in the contralateral lower limb artery, and the total operation time is often longer and the trauma is greater.

[0006] The split abdominal aortic covered stent is currently the most commonly used stent type for the treatment of abdominal aortic aneurysms. It can relatively easily reconstruct the blood flow of the bilateral iliac arteries and can meet the needs of endovascular treatment of most types of abdominal aortic aneurysms. However, after the opening of the short iliac branch is released, it often hangs in the aneurysm cavity. Especially when the aneurysm cavity is huge, it is sometimes very difficult to insert the guide wire retrogradely through the contralateral iliac artery approach, which takes a long time and even has to be inserted antegradely through the brachial artery puncture approach. Therefore, when it is used for emergency treatment of ruptured abdominal aortic aneurysms, there is a risk that the rupture cannot be quickly closed in the first time, which reduces the success rate of rescue. In addition, the iliac branch connection is often suspended in the aneurysm cavity and can only be fixed by the friction between the iliac branch stents. Therefore, the distal extension of the iliac branch stent is often displaced distally or even falls off, resulting in type III internal leakage.

[0007] The integrated abdominal aortic stent graft has no interface in the abdominal aorta segment, and the stent bifurcation straddles the aortoiliac bifurcation to play an anatomical fixation role, physically avoiding the occurrence of type III endoleak. However, the stent structure is complex, and the release process is special and cumbersome, that is, the stent needs to be rotated and pulled down as a whole after the main part is released, so it is difficult to achieve accurate proximal positioning of the stent, which limits its application in emergency treatment of lesions and ruptured abdominal aortic aneurysms that require accurate proximal positioning.

[0008] At present, there is a lack of dedicated stents for the endovascular treatment of aortoiliac artery occlusion. The lesion is often opened by simply combining and splicing the existing peripheral metal bare stents and straight tube covered stents, and the long-term efficacy is still uncertain. The abdominal aortic aneurysm covered stent system is occasionally used to treat such lesions, but because the lesions are non-expandable lesions, even after sufficient balloon pre-dilation, local stenosis may still exist, and the full expansion of the iliac branch is often limited, so the risk of early postoperative occlusion increases. It is generally believed that covered stents have a higher long-term patency rate than bare stents for the endovascular treatment of aortoiliac artery occlusion. Therefore, designing a covered stent system that is suitable for aortoiliac artery occlusion has become a more urgent clinical need.

[0009] Therefore, if a covered stent graft system can be designed that combines the advantages of the above three types of stents and avoids most of the disadvantages; and can be universally used for aortoiliac artery occlusion, it will greatly improve the intravascular diagnosis and treatment capabilities of these two diseases. Summary of the invention

[0010] In view of the problems existing in the prior art, the utility model designs a universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions. The utility model provides a funnel-shaped transition connection part in the main covered stent, the top of which is provided with a columnar covered connecting pipeline for splicing the stent, and the bottom side wall of the funnel-shaped transition connection part is provided with a first iliac artery covered stent that is continuous with the main covered stent; and the bottom area of ​​the funnel-shaped transition connection part is significantly larger than the bottom area of ​​the iliac branch of the traditional split abdominal aorta covered stent, so that the difficulty of retrograde selection of the guide wire through the contralateral iliac artery is greatly reduced, the second iliac artery covered stent can be quickly introduced and quickly released, and after release, it can adapt to the course of the artery and is not prone to being stuck.

[0011] The inventive objective of the utility model is achieved through the following technical solutions: a stent graft system for the aortoiliac arteries, comprising a main coated stent, a columnar coated connecting pipeline is arranged inside the main coated stent, the end of the columnar coated connecting pipeline is provided with a funnel-shaped transition connection part integrally formed therewith, the funnel-shaped transition connection part is in the shape of a funnel with equal wall thickness, and the opening of the funnel-shaped transition connection part gradually increases from top to bottom; the columnar coated connecting pipeline is fixedly connected to the inner wall of the main coated stent, and the bottom edge of the funnel-shaped transition connection part is fixedly connected to the bottom edge of the main coated stent; the surface layer of the funnel-shaped transition connection part is provided with a first iliac artery coated stent in the opposite direction to the columnar coated connecting pipeline, and the first iliac artery coated stent extends along the axial direction of the main coated stent; the inner wall of the columnar coated connecting pipeline is provided with a second iliac artery coated stent detachably connected thereto.

[0012] Preferably, part of the tube wall of the columnar coated connecting pipeline is fixedly connected to part of the tube wall of the main coated stent, or the overlapping parts share a layer of film. The columnar coated connecting pipeline is made of the coating material of the surgical stent in the prior art as a whole, without a metal stent. The columnar coated connecting pipeline is an elliptical or cylindrical structure, which facilitates the fitting or fusion of a larger area of ​​the tube wall with the main coated stent, and the connection between the two is more stable.

[0013] Preferably, a connection layer is provided on the outer side wall of the columnar coated connecting pipeline, the connection layer extends along the axial direction of the columnar coated connecting pipeline, and the connection layer is fixedly connected to the inner wall of the main coated stent.

[0014] The columnar coated connecting pipeline is an elliptical or cylindrical structure, which makes it easier for a larger area of ​​the tube wall to fit or fuse with the main coated stent, and the connection between the two is more stable.

[0015] Preferably, the axial length of the main coated bracket is 4-12 cm, the vertical height from the bottom opening of the funnel-shaped transition connection to the top opening of the funnel-shaped transition connection is 1-2 cm, the axial length of the columnar coated connecting pipeline is 2-3 cm, and the columnar coated connecting pipeline is integrally formed with the funnel-shaped transition connection.

[0016] The axial length of the main body of the main covered stent is 4-12cm, and different axial lengths are suitable for different lesions. The maximum length of the main covered stent is equivalent to or slightly shorter than the total length of the infrarenal abdominal aorta. When the main covered stent is inserted into the abdominal aorta, it is positioned and quickly released. After release, if the main end opening is located in the non-expanded abdominal aorta wall, it can achieve a rapid and immediate hemostasis effect similar to that of a single iliac branch abdominal aortic covered stent. If it is located in the expanded aneurysm cavity, retrograde selection of the funnel-shaped iliac branch opening through the contralateral iliac artery approach is also faster than the split abdominal aortic covering. The cross-section of the bottom of the funnel-shaped transition connection is crescent-shaped, and the overall area is much larger than the small circle at the end of the iliac branch of the original stent and is coplanar with the bottom of the main covered stent, so that the guide wire is easier to select through the contralateral iliac artery puncture retrograde approach, and naturally enters the connecting tube through the funnel-shaped transition connection. After replacing the exchange guide wire, the second iliac artery covered stent can be quickly introduced. The minimum length of the main covered stent is 4 cm, which is the minimum length of the funnel-shaped transition part plus the columnar connecting part. It is suitable for dilatation or occlusive lesions in the middle and upper abdominal aorta without lesions.

[0017] Preferably, an annular connecting portion is provided at the bottom of the funnel-shaped transition connection portion, and the annular connecting portion is fixedly connected to or fused into one with the inner wall of the main coated stent; the top of the funnel-shaped transition connection portion and the columnar connecting portion are smoothly connected, and blood can only flow along the first iliac artery coated stent and the columnar coated connecting pipeline.

[0018] Preferably, the first iliac artery covered stent is in the shape of an elliptical column or a cylinder, the columnar covered connecting pipeline is in the shape of a cylinder, and the inner diameter of the first iliac artery covered stent is the same as or similar to the inner diameter of the columnar covered connecting pipeline; in this way, the blood flow in the first iliac artery covered stent and the columnar covered connecting pipeline is basically consistent.

[0019] Preferably, the second iliac artery covered stent is in the shape of a hollow truncated cone, and the opening of the second iliac artery covered stent gradually becomes smaller from top to bottom; the columnar covered connecting pipeline is in the shape of a cylinder, and the outer diameter of the upper opening of the second iliac artery covered stent is larger than the inner diameter of the columnar covered connecting pipeline.

[0020] By setting up a second iliac artery covered stent, it is convenient to connect and extend the columnar covered connecting pipeline. The second iliac artery covered stent is cylindrical and the opening gradually becomes smaller from top to bottom, so that the second iliac artery covered stent can be firmly installed in the columnar covered connecting pipeline; as the blood flows, the connection between the second iliac artery covered stent and the columnar covered connecting pipeline becomes tighter.

[0021] Preferably, the main stent graft comprises a coating layer and a bare metal stent, the bare metal stent is installed in the coating layer, and the coating layer is cylindrical. The top rear wall coating layer of the main stent graft is provided with an arc-shaped notch, which can protect the lumbar artery.

[0022] The columnar coated connecting pipe and the funnel-shaped transition connection part in the main covered stent are only covered layers without bare metal stents, thus reducing the diameter of the stent when compressed in the sheath. The first iliac artery covered stent and the second iliac artery covered stent both have bare metal stents and covered layers.

[0023] Preferably, the columnar coated connecting pipeline is arranged close to the top edge of the funnel-shaped transition connection portion, and the first iliac artery coated stent is arranged close to the bottom edge of the funnel-shaped transition connection portion.

[0024] Preferably, a transition slope is provided between the top and bottom of the funnel-shaped transition connection portion, and the columnar graft connection pipeline is coaxially arranged with the main graft stent. The transition slope is provided to facilitate the guidance of the second iliac artery graft stent inserted into the main graft stent, so that it can be quickly extended into the columnar graft connection pipeline.

[0025] Compared with the prior art, the utility model has the following beneficial effects: the utility model is provided with a funnel-shaped transition connection part in the main stent graft, and a first iliac artery stent graft is provided on one side of the funnel-shaped transition connection part; a columnar coating connection pipeline is provided on the other side of the funnel-shaped transition connection part, and it is spliced ​​with the second iliac artery stent graft through the columnar coating connection pipeline; the main stent graft, the first iliac artery stent graft and the second iliac artery stent graft are convenient and quick to install as a whole, and the user operation is simple. Since the funnel-shaped transition connection part is funnel-shaped, the bottom area is significantly larger than the bottom area of ​​the iliac branch of the traditional split abdominal aorta stent graft, so the difficulty of retrograde selection of the guide wire through the contralateral iliac artery is greatly reduced, and the operation time is shortened. At the same time, the lower opening of the funnel-shaped transition connection part is larger, and the second iliac artery stent graft has better implant compliance and is not prone to compression. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a three-dimensional diagram of the utility model;

[0027] Figure 2 A three-dimensional diagram of another viewing angle of the present invention;

[0028] Figure 3 It is a top view of the utility model;

[0029] Figure 4 It is the internal structure diagram of the utility model;

[0030] Figure 5 It is an exploded view of the utility model.

[0031] Markings in the figure: 1. Main body covered stent; 2. Columnar covered connecting pipeline; 3. Funnel-shaped transition connection; 4. First iliac artery covered stent; 5. Second iliac artery covered stent; 6. Connection layer; 7. Annular connection; 8. Covering layer; 9. Bare metal stent; 10. Arc-shaped notch; 11. Transition slope. Implementation

[0032] The present invention will be further described below with reference to the embodiments shown in the accompanying drawings:

[0033] like Figures 1 to 5As shown, the present embodiment discloses a universal stent graft system for aortoiliac artery dilatation or occlusive lesions, comprising a main stent graft 1, wherein a columnar coated connecting pipeline 2 is provided inside the main stent graft 1, and a funnel-shaped transition connection portion 3 integrally formed therewith is provided at the end of the columnar coated connecting pipeline 2, wherein the funnel-shaped transition connection portion 3 is in the shape of a funnel with equal wall thickness, and the opening of the funnel-shaped transition connection portion 3 gradually becomes larger from top to bottom; the columnar coated connecting pipeline 2 is fixedly connected to the inner wall of the main stent graft 1, and the bottom edge of the funnel-shaped transition connection portion 3 is fixedly connected to the bottom edge of the main stent graft 1; the surface layer of the funnel-shaped transition connection portion 3 is provided with a first iliac artery coated stent 4 in the opposite direction to the columnar coated connecting pipeline 2, and the first iliac artery coated stent 4 extends along the axial direction of the main stent graft 1; and a second iliac artery coated stent 5 detachably connected thereto is provided on the inner wall of the columnar coated connecting pipeline 2.

[0034] Part of the tube wall of the columnar coated connection pipeline 2 is fixedly connected to part of the tube wall of the main coated support 1, or the overlapping parts share a layer of film; the cross-section of the columnar coated connection pipeline 2 is an elliptical or cylindrical structure. A connecting layer 6 is provided on the outer wall of the columnar coated connection pipeline 2, and the connecting layer 6 extends along the axial direction of the columnar coated connection pipeline 2, and the connecting layer 6 is fixedly connected to the inner wall of the main coated support 1; the cross-section of the columnar coated connection pipeline 2 is an elliptical or cylindrical structure. The axial length of the main coated support 1 is 4-12cm, the vertical height from the bottom opening of the funnel-shaped transition connection part 3 to the top opening of the funnel-shaped transition connection part 3 is 1-2cm, the axial length of the columnar coated connection pipeline 2 is 2-3cm, and the columnar coated connection pipeline 2 is integrally formed with the funnel-shaped transition connection part 3. An annular connecting part 7 is provided at the bottom of the funnel-shaped transition connection part 3, and the annular connecting part 7 is fixedly connected or fused to the inner wall of the main coated support 1. The first iliac artery stent graft 4 is cylindrical, the columnar coated connecting pipeline 2 is cylindrical, and the inner diameter of the first iliac artery stent graft 4 is the same as or similar to the inner diameter of the columnar coated connecting pipeline 2. The second iliac artery stent graft 5 is hollow truncated cone-shaped, and the opening of the second iliac artery stent graft 5 gradually decreases from top to bottom; the columnar coated connecting pipeline 2 is cylindrical, and the outer diameter of the upper opening of the second iliac artery stent graft 5 is larger than the inner diameter of the columnar coated connecting pipeline 2. The main body stent graft 1 includes a coating layer 8 and a bare metal stent 9, and the bare metal stent 9 is installed in the coating layer 8, the coating layer 8 is cylindrical, and an arc-shaped notch 10 is provided on the top opening of the coating layer 8. The columnar coated connecting pipeline 2 is arranged near the top edge of the funnel-shaped transition connection part 3, and the first iliac artery stent graft 4 is arranged near the bottom edge of the funnel-shaped transition connection part 3. A transition slope 11 is provided between the top and the bottom of the funnel-shaped transition connection portion 3 , and the columnar coating connection pipeline 2 is coaxially arranged with the main coating support 1 .

[0035] The specific operation process of this embodiment is as follows: first, the main covered stent 1 is introduced into the predetermined position in the abdominal aorta through the delivery sheath, and the bottom of the funnel-shaped transition connection part 3 is ensured to be located above the junction of the aorta and the iliac artery, and the front and rear midpoints thereof are aligned with the opening of the contralateral iliac artery, so as to ensure that the opening of the contralateral iliac artery is not blocked and facilitate the selection of the guide wire. The main section of the main covered stent 1 is unfolded to make it fit the inner wall of the abdominal aorta.

[0036] The guide wire is retrogradely selected through the contralateral iliac artery into the bottom of the funnel-shaped transition connection part 3 and then enters the aorta through the columnar connection part. After replacing the super-hard guide wire, the second iliac artery stent graft 5 is introduced, and the proximal end is aligned with the top of the columnar coated connection pipeline 2 and released to ensure at least 2 cm overlap. Finally, the first iliac artery stent graft 4 is released. In this way, the entire stent system is installed.

[0037] The specific embodiments described herein are merely examples of the spirit of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in similar ways, but they will not deviate from the spirit of the present invention or exceed the scope defined by the appended claims.

Claims

1. A universal stent graft system for aortoiliac artery dilatation or occlusive lesions, comprising a main stent graft (1), characterized in that: The main body stent graft (1) is provided with a columnar stent graft connection pipeline (2), and the end of the columnar stent graft connection pipeline (2) is provided with a funnel-shaped transition connection portion (3) integrally formed therewith, and the funnel-shaped transition connection portion (3) is in the shape of a funnel with equal wall thickness, and the opening of the funnel-shaped transition connection portion (3) gradually increases from top to bottom; the columnar stent graft connection pipeline (2) is fixedly connected to the inner wall of the main body stent graft (1), and the bottom edge of the funnel-shaped transition connection portion (3) is fixedly connected to the bottom edge of the main body stent graft (1); the surface layer of the funnel-shaped transition connection portion (3) is provided with a first iliac artery stent graft (4) facing opposite to the columnar stent graft connection pipeline (2), and the first iliac artery stent graft (4) extends along the axial direction of the main body stent graft (1); and the inner wall of the columnar stent graft connection pipeline (2) is provided with a second iliac artery stent graft (5) detachably connected thereto.

2. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: Part of the tube wall of the columnar coated connecting pipeline (2) is fixedly connected to part of the tube wall of the main coated support (1), or the overlapping parts share a layer of film; the cross-section of the columnar coated connecting pipeline (2) is an elliptical or cylindrical structure.

3. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: A connecting layer (6) is provided on the outer wall of the columnar coated connecting pipeline (2), the connecting layer (6) extends along the axial direction of the columnar coated connecting pipeline (2), and the connecting layer (6) is fixedly connected to the inner wall of the main coated support (1); the cross-section of the columnar coated connecting pipeline (2) is an elliptical or cylindrical structure.

4. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: The axial length of the main coated support (1) is 4-12 cm, the vertical height from the bottom opening of the funnel-shaped transition connection part (3) to the top opening of the funnel-shaped transition connection part (3) is 1-2 cm, the axial length of the columnar coated connection pipeline (2) is 2-3 cm, and the columnar coated connection pipeline (2) and the funnel-shaped transition connection part (3) are integrally formed.

5. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: An annular connecting portion (7) is provided at the bottom of the funnel-shaped transition connecting portion (3), and the annular connecting portion (7) is fixedly connected to or integrated with the inner wall of the main coated stent (1).

6. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: The first iliac artery covered stent (4) is cylindrical, the columnar covered connecting pipeline (2) is cylindrical, and the inner diameter of the first iliac artery covered stent (4) is the same as or similar to the inner diameter of the columnar covered connecting pipeline (2).

7. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: The second iliac artery covered stent (5) is in the shape of a hollow truncated cone, and the opening of the second iliac artery covered stent (5) gradually becomes smaller from top to bottom; the columnar covered connecting pipeline (2) is in the shape of a cylinder, and the outer diameter of the upper opening of the second iliac artery covered stent (5) is larger than the inner diameter of the columnar covered connecting pipeline (2).

8. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: The main coated stent (1) comprises a coated layer (8) and a bare metal stent (9), wherein the bare metal stent (9) is installed in the coated layer (8), the coated layer (8) is cylindrical, and an arc-shaped notch (10) is provided on the top opening of the coated layer (8).

9. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: The columnar coated connecting pipeline (2) is arranged close to the top edge of the funnel-shaped transition connecting portion (3), and the first iliac artery coated stent (4) is arranged close to the bottom edge of the funnel-shaped transition connecting portion (3).

10. The universal covered stent graft system for aortoiliac artery dilatation or occlusive lesions according to claim 1, characterized in that: A transition slope (11) is provided between the top and the bottom of the funnel-shaped transition connection portion (3), and the columnar coated connection pipeline (2) is coaxially arranged with the main coated support (1).

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