Plugging device, plugging system

Abstract

The plugging device and plugging system provided by the present invention are used for targeted plugging of distal ruptures, and include an anchoring and supporting component and an elastic component. The elastic component is sleeved on the anchoring and supporting component. Wherein, the elastic component includes an elastic bag and a graft. The elastic bag wraps the anchoring and supporting component, and the elastic bag has an opening. The graft is used to be loaded into the elastic bag from the opening. By wrapping the anchoring and supporting component with the elastic bag, and the elastic bag having an opening, and the graft being used to be loaded into the elastic bag from the opening, the present invention can adapt to the characteristics of high blood pressure and fast blood flow in the false lumen of aortic dissection. The plugging device can effectively plug the blood flow in the false lumen, and there is no risk of displacement after implantation, reducing the occurrence of endoleak, with a high treatment success rate, and also reducing the physical damage to the inner wall of the false lumen in the tail section located in the false lumen.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a plugging device and a plugging system for interventional treatment of distal aortic dissection rupture openings. Background Art

[0002] Aortic dissection (AD) refers to a state where the blood in the aortic lumen enters the aortic media from the tear of the aortic intima, causing the media to separate and extending along the long axis of the aorta to form a state of separation between the true and false lumens of the aortic wall. Aortic dissection is a serious acute and critical cardiovascular disease, with an acute onset, rapid progression, and extremely high mortality rate. Endovascular aortic repair (EVAR) is currently the most widely used clinical method for treating aortic dissection. Its principle is to occlude the primary rupture opening in the lumen, slow down or even stop the blood flow in the false lumen, thereby forming thrombosis and gradually organizing and absorbing, restoring the shape of the true lumen and the blood supply of visceral arteries, and ultimately achieving the purpose of aortic remodeling. Theoretically, after occluding the primary rupture opening in the lumen, the blood flow entering the false lumen from the primary rupture opening disappears, the pressure in the false lumen suddenly decreases, and the compression on the true lumen also decreases accordingly. As time goes by, the false lumen gradually forms thrombosis and organizes and absorbs, and the shape of the true lumen also gradually recovers. However, this is often not the case. After EVAR for some aortic dissections, the aorta cannot achieve ideal remodeling. The main reason is that EVAR only occludes the primary rupture opening at the proximal end, and most aortic dissection patients often have multiple rupture openings (i.e., distal rupture openings), and most of the rupture openings are located around visceral arteries. The continuous existence of these distal rupture openings poses a great potential risk.

[0003] Currently, there are mainly three views on the treatment of distal rupture openings: (1) adding a stent to close the distal rupture opening; (2) aortic replacement; (3) conservative treatment with close observation. If traditional stent graft treatment is used, it may lead to insufficient blood supply in the visceral area and endanger the patient's life safety; if an open abdomen + artificial blood vessel replacement operation is performed, the postoperative mortality rate and paraplegia rate are both relatively high, and the long-term effect is not good, and it is often difficult to be accepted by patients. Leaving the distal rupture opening of aortic dissection untreated may lead to poor dilation of the true lumen of the distal aorta after surgery, continuous perfusion of the false lumen, seriously affecting the benign remodeling of the distal aorta and the late prognosis of the patient.

[0004] Clinically, the false lumen filling technique is often used, in which embolization materials are filled into the false lumen to promote the formation of thrombus in the false lumen, and mostly grafts are used for embolization. Due to the large volume of the false lumen and multiple distal ruptures, the false lumen filling technique requires a large amount of grafts to densely fill the false lumen around the dissection rupture, resulting in difficult intraoperative operations and high medical costs. In addition, traditional grafts do not have a fixing device after release, which makes them have a risk of displacement in the false lumen, a low treatment success rate, and a risk of graft infection.

[0005] Therefore, during the process of occluding the distal rupture, issues such as whether the occluder structure can be properly fixed at the dissection rupture with irregular shape and non-tenacious septum in a timely manner, whether it can instantaneously and completely close the rupture, whether there is a risk of detachment, whether it can promote false lumen thrombosis, whether the occluding part located in the aorta will interfere with the true lumen blood flow and induce thrombus, etc., will be the key points that need to be solved at present. Summary of the Invention

[0006] One of the purposes of the present invention is to provide a occluding device and a occluding system, which can solve the problems of inability to quickly and effectively occlude the blood flow in the false lumen, the risk of displacement and endoleakage after implantation, and low treatment success rate.

[0007] Another purpose of the present invention is to solve the problems of the anatomical morphology and position distribution of various complex distal ruptures of aortic dissection and low treatment success rate.

[0008] To solve the above problems, the present invention provides a occluding device for targeted occlusion of distal ruptures, including an anchoring and supporting component and an elastic component, and the elastic component is sleeved on the anchoring and supporting component;

[0009] Wherein, the elastic component includes an elastic bag and a graft, the elastic bag wraps the anchoring and supporting component, and the elastic bag has an opening, and the graft is used to be loaded into the elastic bag from the opening.

[0010] Optionally, the anchoring and supporting component is formed by arranging multiple filamentous materials along the axial direction.

[0011] Further, the anchoring and supporting component is formed by equally dividing three wire materials along the radial direction of the anchoring and supporting component.

[0012] Optionally, the anchoring and supporting component sequentially includes a head section, a middle section and a tail section along its axial direction, and the elastic bag wraps the middle section, the tail section and at least part of the head section along the axial direction of the anchoring and supporting component.

[0013] Further, the shapes of the head section and the tail section are umbrella-shaped, and the middle section is frustum-shaped.

[0014] Further, the radial cross-sectional area of the head section is greater than that of the middle section and less than that of the tail section.

[0015] Optionally, the opening of the elastic bag is located at the head section of the anchoring and supporting component.

[0016] Optionally, the elastic bag is a polymer film wrapping the anchoring and supporting component, and / or the outer surface of the elastic bag has a plush-like structure.

[0017] Optionally, the graft includes a coil.

[0018] On the other hand, the present embodiment further provides a blocking system, including a support frame and at least one of the blocking devices, and the anchoring and supporting component of the blocking device is used for anchoring on the support frame.

[0019] Optionally, the support frame has a tubular mesh structure, and the head section is used for anchoring in the mesh of the support frame.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0021] The blocking device provided by the present invention is used for targeted blocking of distal ruptures, and includes an anchoring and supporting component and an elastic component, and the elastic component is sleeved on the anchoring and supporting component; wherein, the elastic component includes an elastic bag and a graft, the elastic bag wraps the anchoring and supporting component, and the elastic bag has an opening, and the graft is used to be loaded into the elastic bag from the opening. By wrapping the anchoring and supporting component with the elastic bag, and the elastic bag having an opening and the graft being used to be loaded into the elastic bag from the opening, the present invention can adapt to the characteristics of high blood pressure and fast blood flow in the false lumen of aortic dissection. The blocking device can effectively block the blood flow in the false lumen, and there is no risk of displacement after implantation, reducing the occurrence of endoleak, with a high treatment success rate, and also reducing the physical damage of the tail section located in the false lumen to the inner wall of the false lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic structural diagram of an anchoring and supporting component provided by an embodiment of the present invention;

[0023] Figure 2 Provided by an embodiment of the present invention Figure 1 Left view;

[0024] Figure 3 It is a schematic side view structure diagram of an elastic bag wrapped on an anchoring and supporting component provided by an embodiment of the present invention;

[0025] Figure 4 It is a schematic top view structure diagram of an elastic bag wrapped on an anchoring and supporting component provided by an embodiment of the present invention;

[0026] Figure 5 Schematic diagram of the state where the plugging device provided by an embodiment of the present invention is anchored at the break

[0027] Figure 6 Schematic diagram of the state where the plugging device provided by an embodiment of the present invention is anchored on the true lumen support stent.

[0028] Description of reference numerals:

[0029] 1 - Anchoring support member; 11, 12, 13 - Metal wires; 110 - Head section; 120 - Intermediate section; 130 - Tail section;

[0030] 2 - Elastic member; 21 - Elastic bag; 22 - Graft;

[0031] 3 - Support frame. Detailed implementation manners

[0032] The following will further describe in detail a plugging device and a plugging system of the present invention, in which preferred embodiments of the present invention are shown. It should be understood that those skilled in the art can modify the present invention described herein and still achieve the beneficial effects of the present invention. Therefore, the following description should be understood as a broad guidance for those skilled in the art and not as a limitation to the present invention.

[0033] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not described in detail because they would obscure the present invention with unnecessary details. It should be considered that in the development of any actual embodiment, a large number of implementation details must be made to achieve the specific goals of the developer, such as changing from one embodiment to another according to the relevant system or business limitations. Additionally, it should be considered that such development work may be complex and time-consuming, but it is only routine work for those skilled in the art.

[0034] To make the purpose and features of the present invention more obvious and understandable, the following further explains the specific implementation manners of the present invention with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and use non-precise ratios, only for conveniently and clearly assisting in explaining the purpose of the embodiments of the present invention.

[0035] It should be noted that a good shape of the distal break means that the shape of the anchoring support member 1 matches the shape of the distal break, so that the anchoring support member 1 can be directly anchored at the distal break. On the contrary, a bad shape of the distal break means that the shape of the anchoring support member 1 does not match the shape of the distal break, so that the anchoring support member 1 cannot be directly anchored at the distal break. Take Figure 3Taking the orientation as an example, from left to right is the axial direction, and from top to bottom is the radial direction.

[0036] Embodiment 1

[0037] As Figure 5 shown, this embodiment provides a plugging device, which targets and plugs the distal rupture opening, and is used to solve the problems of the distal rupture opening of aortic dissection being left untreated, still having blood reflux, the distal false lumen not healing for a long time after surgery, the false lumen continuing to increase or even rupture, etc.

[0038] When the shape of the distal rupture opening of aortic dissection is good, the plugging device may include an anchoring and supporting component 1 and an elastic component 2. The elastic component 2 is sleeved on the anchoring and supporting component 1. The anchoring and supporting component 1 is anchored in a predetermined area, that is, the distal rupture opening and the true lumen and false lumen areas connecting the distal rupture opening. The anchoring and supporting component 1 is made of a shape memory material, specifically, for example, made of a shape memory metal material, and the anchoring and supporting component 1 can be formed into a predetermined shape by multiple filamentous materials. The multiple filamentous materials can be arranged at equal intervals to form a predetermined shape, or can be arranged at unequal intervals to form a predetermined shape. In this embodiment, the anchoring and supporting component 1 is formed into a predetermined shape by three metal wires 11, 12, and 13 evenly divided along the radial direction. The predetermined shape is a gourd shape.

[0039] As Figure 1 and Figure 2 shown, the two ends of the three metal wires 11, 12, and 13 are respectively connected to form a gourd-shaped stent structure, so that the anchoring and supporting component 1 can be folded and compressed, so that the anchoring and supporting component 1 can be compressed and placed in the interventional catheter. Each metal wire is wavy in its axial direction. Preferably, each metal wire extends in a two-dimensional space, and the angle between two of the three metal wires 11, 12, and 13 can be 120°, so that the three metal wires 11, 12, and 13 are symmetrically arranged, so that the radial cross-section of the anchoring and supporting component 1 is an equilateral triangle. The angle between two of the three metal wires can be other angles, so that the radial direction of the anchoring and supporting component 1 is an acute triangle or an obtuse triangle. The angle between two of the three metal wires can be specifically set according to actual needs, so that the shape of the anchoring and supporting component 1 can match the shape of the distal rupture opening of aortic dissection, can adapt to the pathological structure of branch blood vessels near the distal rupture opening, reduce the occurrence of endoleak and the risk of the occluder falling off, and can also reduce the physical damage of the part of the anchoring and supporting component 1 located in the false lumen to the inner wall of the false lumen.

[0040] The anchoring and supporting component 1 sequentially includes a head section 110, a middle section 120, and a tail section 130 in its axial direction. The shapes of the head section 110 and the tail section 130 are generally umbrella-shaped, and have as Figure 3As shown, the umbrella shape is, for example, the shape of an umbrella without a handle after it is opened. The middle section 120 is generally frustum-shaped. The cross-sectional area of the head section 110 along its radial direction (radial cross-section) is larger than the radial cross-sectional area of the middle section 120 and smaller than the radial cross-sectional area of the tail section 130. As Figure 5 shown, the anchoring and supporting component 1 placed in the interventional catheter is in a compressed state. After it is released from the interventional catheter through a distal tear, the anchoring and supporting component 1 can expand to a predetermined structural shape. The head section 110 of the expanded anchoring and supporting component 1 is located in the true lumen, the middle section 120 is exactly stuck at the position of the distal tear, the tail section 130 is located in the false lumen, and the tail section 130 expands in the false lumen. This makes the anchoring and supporting component 1 of this embodiment have only three metal wires in its radial direction. These three metal wires can not only provide sufficient supporting force to support the elastic component, but also adjust its flexibility according to the shape of the tear, and there can also be a space for the graft to enter, so that the whole structure is flexible. Therefore, the occlusion device can adapt to the anatomical shapes and position distributions of various complex distal tears of aortic dissection, especially the endovascular treatment of distal tears of dissections involving the aortic branch vessel area.

[0041] As Figure 3 and 4 shown, the elastic component 2 includes an elastic bag 21 and a graft 22. The elastic bag 21 wraps around a partial area of the anchoring and supporting component 1 close to the false lumen. For example, it wraps around the tail section 130, the middle section 120 of the anchoring and supporting component 1, and a partial head section 110 along the axial direction of the anchoring and supporting component 1, so that the elastic bag 21 has an opening at the head section of the anchoring and supporting component 1. Specifically, an opening is left on the side of the head section 110 far from the tail section (i.e., the position of the anchoring and supporting component 1 close to the true lumen). The anchoring and supporting component 1 and the elastic bag 21 are contracted into the interventional catheter together. After the anchoring and supporting component 1 is released from the interventional catheter, the elastic bag 21 is expanded accordingly, and the graft 22 is loaded into the elastic bag 21 from the opening of the elastic bag 21. The material of the elastic bag 21 can form a film by hanging a polymer solution on the anchoring support device, or a polymer film can be wrapped around the anchoring and supporting component 1. The outer surface of the elastic bag 21 can be designed to have a fluffy structure, etc., so that it is beneficial for better sealing and forming thrombus on its surface. The graft 22 is, for example, a coil, which is wound into a single-layer or multi-layer spiral shape by several wire materials. The wire materials can be one or more of platinum-tungsten wire, nitinol wire, and stainless steel wire, or can also be common graft products on the market. The graft 22 can effectively occlude the blood flow in the false lumen, and there is no risk of displacement after implantation, reducing the occurrence of endoleak, thus realizing the endovascular treatment of the distal tear of aortic dissection, and the treatment success rate is high.

[0042] Usage method of the occlusion device: During the operation, with the aid of an imaging observation device, the occlusion device of this embodiment is moved to the blood vessel segment where the distal rupture opening of the aortic dissection is located through the arterial system using an interventional catheter. The interventional catheter slowly releases the anchoring and supporting component 1 wrapped with the elastic bag 21. When the head segment 110 of the anchoring and supporting component 1 is completely released in the false lumen, the catheter is slowly retracted, but the head segment of the catheter is not completely withdrawn from the false lumen. Then, the anchoring and supporting component 1 is continuously released until the middle segment 120 of the anchoring and supporting component 1 is completely released. The catheter is retracted so that the 120 is exactly stuck on the distal rupture opening of the blood vessel to form a fixation. At this time, the supporting component 1 is continuously released until the tail segment 130 is completely released. At this time, the head segment 110 is located in the true lumen, and the tail segment 130 is located in the false lumen. Then, through the graft injection system, the graft 22 is injected into the elastic bag 21 from the opening of the elastic bag 21 until enough graft 22 is injected to achieve the filling and sealing effect.

[0043] The preparation method of the occlusion device is as follows: First, the elastic bag 21 is wrapped around the anchoring and supporting component 1, and an opening is left at the head segment 110 of the anchoring and supporting component 1. Then, the anchoring and supporting component 1 and the elastic bag 21 are contracted and placed into the interventional catheter. Then, the anchoring and supporting component 1 and the elastic bag 21 are anchored at the distal rupture opening, and the anchoring and supporting component 1 is exactly stuck on the distal rupture opening of the blood vessel to form a fixation. At this time, the head segment 110 is located in the true lumen, and the tail segment 130 is located in the false lumen. Then, through the graft injection catheter, the graft 22 is injected into the elastic bag 21 from the opening of the elastic bag 21, and the preparation of the occlusion device can be completed after enough graft 22 is injected.

[0044] Embodiment Two

[0045] Since the shape of the distal rupture opening of the aortic dissection in this embodiment is not good or the rupture opening of the distal rupture opening is too large, the anchoring and supporting component 1 cannot be directly anchored at the distal rupture opening. Therefore, compared with Embodiment One, this embodiment provides a occlusion system, which includes a support frame and at least one occlusion device, and the anchoring and supporting component of the occlusion device is anchored on the support frame. The support frame 3 is arranged in the true lumen, and the anchoring and supporting component 1 is anchored on the support frame. Specifically, the head segment 110 of the anchoring and supporting component 1 is anchored on the support frame.

[0046] Specifically, Figure 6 is a schematic diagram of the state where the occlusion device provided in this embodiment is anchored on the true lumen support stent. As Figure 6 shown, at the same time, please refer to Figures 1-4, the support frame 3 has a tubular mesh structure, which can be formed by cutting metal pipes, can also be formed by weaving metal wires, or can be a perforated film-covered stent. The support frame 3 is a self-expanding stent, which is made of shape memory material or metal material. After heat setting, the support frame 3 can maintain the shaped state in the natural state. The support frame 3 has a blood vessel that opens and continuously supports the true lumen of the aortic dissection, compresses the lumen of the false lumen of the aortic dissection, and at the same time does not affect the blood supply of important organ branch vessels such as the celiac trunk, superior mesenteric artery, and renal artery. And because it has a hollowed-out feature in its structure, it provides a passage and an anchoring space for the anchoring support device.

[0047] Usage method of the occlusion system: During the operation, with the aid of imaging observation equipment, first implant a section of the support frame 3 in the true lumen, and the support frame 3 covers the distal rupture opening. Then, use an interventional catheter to move the occlusion device of this embodiment to the blood vessel segment where the distal rupture opening of the arterial dissection is located through the arterial system. The head section of the interventional catheter extends into the distal rupture opening through the mesh holes of the support frame 3, and slowly release the anchoring support component 1 wrapped with the elastic bag 21. When the head section 110 of the anchoring support component 1 is completely released in the false lumen, slowly withdraw the catheter, but the head section of the catheter does not completely withdraw from the false lumen, and then continue to release the anchoring support component 1 until the middle section 120 of the anchoring support component 1 is completely released. Withdraw the catheter so that 120 just gets stuck in the mesh holes of the support frame 3 to form a fixation. At this time, continue to release the support component 1 until 110 is completely released. At this time, the head section 110 is located in the true lumen, and the tail section 130 is located in the false lumen. Then, inject the graft 22 into the elastic bag 21 through the opening of the elastic bag 21 by the graft injection system until enough graft 22 is injected to achieve the filling and sealing effect.

[0048] The preparation method of the occlusion system is as follows: First, wrap the elastic bag 21 around the anchoring support component 1 and leave an opening at the head section 110 of the anchoring support component 1; then, contract the anchoring support component 1 and the elastic bag 21 and put them into the interventional catheter; then, anchor the anchoring support component 1 on the support frame 3, and the middle section 120 of the anchoring support component 1 just gets stuck in the mesh holes of the support frame 3 to form a fixation. At this time, the head section 110 is located in the true lumen, and the tail section 130 is located in the false lumen; then, inject the graft 22 into the elastic bag 21 through the opening of the elastic bag 21 by the graft injection catheter until enough graft 22 is injected to complete the preparation of the occlusion device.

[0049] In summary, the occlusion device provided by the present invention is used for targeted occlusion of distal ruptures, and includes an anchoring and supporting component and an elastic component. The elastic component is sleeved on the anchoring and supporting component. Among them, the elastic component includes an elastic bag and a graft. The elastic bag wraps the anchoring and supporting component, and the elastic bag has an opening. The graft is used to be loaded into the elastic bag from the opening. By wrapping the anchoring and supporting component with the elastic bag, and the elastic bag having an opening, and the graft being used to be loaded into the elastic bag from the opening, the present invention can adapt to the characteristics of high blood pressure and fast blood flow in the false lumen of aortic dissection. The occlusion device can effectively occlude the blood flow in the false lumen, and there is no risk of displacement after implantation, reducing the occurrence of endoleak, with a high treatment success rate, and also reducing the physical damage to the inner wall of the false lumen in the tail segment located in the false lumen.

[0050] Furthermore, in the present invention, the anchoring and supporting component is formed by three wire materials evenly distributed along the radial direction of the anchoring and supporting component, which can adapt to the complex anatomical morphology and position distribution of the distal rupture of aortic dissection. The graft can effectively occlude the blood flow in the false lumen, and there is no risk of displacement after implantation, realizing endovascular treatment of the dissection rupture, and can also adapt to the pathological structure with branch vessels near the distal rupture.

[0051] The present embodiment provides a occlusion system, which includes a support frame and at least one occlusion device. The anchoring and supporting component is anchored in the mesh holes of the support frame, reducing the risk of endoleak occurrence and occluder detachment.

[0052] In addition, it should be noted that unless otherwise specifically stated or indicated, the terms "first", "second", "third" in the specification are only used to distinguish each component, element, step, etc. in the specification, rather than to represent the logical relationship or sequential relationship, etc. between each component, element, step. It can be understood that although the present invention has been disclosed above with preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, many possible changes and modifications can be made to the technical solution of the present invention by using the technical content disclosed above, or modified into equivalent embodiments with equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the protection of the technical solution of the present invention.

Claims

1. A plugging device for targeted plugging of a distal break, characterized in that, It comprises an anchoring support component and an elastic component, wherein the elastic component is sleeved on the anchoring support component; Wherein, the elastic component comprises an elastic bag and a graft, the elastic bag wraps the anchoring support component, and the elastic bag has an opening, the graft is used to be loaded into the elastic bag from the opening, and the anchoring support component is made of shape memory material; The anchoring support component is formed by multiple filamentary materials arranged axially, and the anchoring support component includes a head section, a middle section and a tail section in sequence in the axial direction. The elastic bag wraps the middle section, the tail section and at least part of the head section along the axial direction of the anchoring support component. The head section and the tail section are umbrella-shaped, and the middle section is truncated cone-shaped. The radial cross-sectional area of the head section is larger than the radial cross-sectional area of the middle section, and smaller than the radial cross-sectional area of the tail section, so that the anchoring support component is anchored in a predetermined area through the middle section.

2. The plugging device according to claim 1, characterized in that, The anchoring support component is formed by three wires that are evenly divided along the radial direction of the anchoring support component.

3. The plugging device according to claim 1, characterized in that, The opening of the elastic bag is located at the head section of the anchoring support member.

4. The plugging device according to claim 1, characterized in that, The elastic bag is a polymer film that wraps the anchoring support component, and / or the outer surface of the elastic bag has a plush structure.

5. The plugging device according to claim 1, characterized in that The implant includes a coil.

6. A plugging system, characterized in that, It comprises a support frame and at least one occluding device according to any one of claims 1 to 5, wherein the anchoring support component of the occluding device is used to be anchored on the support frame.

7. The plugging system according to claim 6, wherein, The support frame is in a tubular mesh structure, and the head section is used to be anchored in the mesh of the support frame.

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