A sandwich rupture sealing system

Abstract

The present invention relates to a dissection rupture occluding system, the dissection rupture occluding system comprises a stent and at least one occluder, and the dissection rupture occluding system is configured such that, before implantation at a target position, the stent and the occluder are split structures, and after implantation at the target position, the occluder is connected to the stent. The advantages of the present invention are that the stent and the occluder are respectively delivered to the diseased blood vessel for release, effectively reducing the resistance during delivery and release of the stent and the occluder, and at the same time, when the occluder enters the false cavity, only the shape of the occluder needs to be adjusted, which reduces the difficulty of operation and improves the success rate of the operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a sandwich rupture sealing system. Background Art

[0002] Aortic dissection (AD) refers to a state in which the blood in the aorta enters the aortic media from the tear in the aortic intima, causing the media to separate and expand along the long axis of the aorta to form a state in which the true and false cavities of the aortic wall are separated. AD is an acute cardiovascular disease with an acute onset, rapid progression, and a very high mortality rate. Currently, endovascular aortic repair (EVAR) is the most widely used treatment for AD in clinical practice. Most patients with aortic dissection will have multiple ruptures at the same time, and the principle of EVAR is to use an implant to block the proximal rupture of AD, leaving the distal rupture open, and achieve the purpose of false lumen thrombosis by improving the blood supply to the vacuum cavity and reducing the blood flow in the false lumen.

[0003] Theoretically, in order to achieve better aortic remodeling and long-term prognosis, it is necessary to treat the distal rupture of aortic dissection simultaneously or in stages. However, the problems faced by interventional treatment of distal rupture of aortic dissection in the prior art are: (1) The number of distal ruptures of aortic dissection is large and complex. Most patients have more than three distal ruptures, which are difficult to treat. (2) The proportion of distal ruptures of aortic dissection in the abdominal aorta is high. Due to the presence of branch arteries, intraluminal treatment is difficult in this area. Due to the presence of distal ruptures, false lumen thrombosis cannot reach an ideal state. In some patients, the false lumen remains open and continues to grow, forming an aneurysm.

[0004] At present, false lumen tamponade (i.e., filling the false lumen with embolic materials, mostly coils) is often used clinically to promote false lumen thrombosis. Due to the large volume of the false lumen and the many distal ruptures, false lumen tamponade requires the use of a large number of coils, which is difficult to operate during surgery and has high medical costs. In addition, there is no fixing device after the traditional coil is released, which makes the coil at risk of displacement in the false lumen. In response to this, a treatment method of using a stent to embolize the rupture with a coil has emerged in the prior art, and the stent and coil are pre-assembled into an integrated occlusion system and then delivered to the blood vessel for release. This method has the following disadvantages: the integrated occlusion system has a large resistance during the release process, and in the process of adjusting the coil so that the coil enters the false lumen, it is necessary to control the two variables of the stent and the coil at the same time, which increases the difficulty of operation; in addition, the integrated occlusion system can only achieve the occlusion of one rupture within a certain range, and it is difficult to handle multiple ruptures at the same time. Summary of the invention

[0005] The purpose of the present invention is to provide a sandwich rupture plugging system, which has the advantages of small conveying and releasing resistance, simple operation, and the ability to process multiple ruptures at the same time.

[0006] To achieve the above-mentioned purpose, the present invention provides a dissection rupture sealing system, comprising a stent and at least one occluder, and the dissection rupture sealing system is configured such that, before implantation into a target position, the stent and the occluder are split structures, and after implantation into the target position, the occluder is connected to the stent.

[0007] Optionally, it further comprises a first introduction device, wherein the first introduction device is used to implant the occluder into the target position.

[0008] Optionally, the first introduction device includes a pre-placed tube and a pushing assembly, the pre-placed tube has an axially through-going first inner cavity, the first inner cavity is used to accommodate the occluder, and has a first proximal end and a first distal end relative to each other; the pushing assembly has a second proximal end and a second distal end relative to each other, the second distal end is used to extend into the first proximal end of the first inner cavity, and is used to connect with the occluder.

[0009] Optionally, the occluder comprises a body and an anchoring mechanism, the body having a first end and a second end opposite to each other, the first end being provided with the anchoring mechanism;

[0010] When the occluder is implanted at the target position, the occluder is stretched and accommodated in the first inner cavity, and the anchoring mechanism is located at the first distal end, and the second end of the body is located at the first proximal end and connected to the pushing assembly.

[0011] Optionally, the occluder comprises a body and an anchoring mechanism, the body having a first end and a second end opposite to each other, the first end being provided with the anchoring mechanism;

[0012] When the occluder is implanted at the target position, the occluder is stretched and accommodated in the first inner cavity, and the second end is located at the first distal end, and the anchoring mechanism is located at the first proximal end and connected to the pushing assembly.

[0013] Optionally, the first introduction device further comprises an introduction sheath having an axially penetrating second inner cavity, the introduction sheath being used to construct an introduction path for the occluder, and the pre-placed tube carries the occluder to the target position via the second inner cavity.

[0014] Optionally, a second introduction device is further included, and the second introduction device is used to implant the stent into the target position.

[0015] Optionally, the occluder includes a main body and an anchoring device, the main body includes a shaping wire and a spring coil, the shaping wire is a metal wire with resilience, and the shaping wire is configured to have a predetermined shape, the spring coil is sleeved on the shaping wire so that the main body has the predetermined shape; the anchoring device is made of metal with resilience, the anchoring device is arranged on the main body, and is used to connect with the stent.

[0016] Optionally, the anchoring device includes a positioning portion, which is a barb or a fixing plate; the bracket has a hollow structure, and the positioning portion is used to be inserted into the hollow structure and connected to the bracket.

[0017] Optionally, the shaping wire is coiled into a continuous curved structure to form the predetermined shape.

[0018] Optionally, the occluder further comprises thrombotic villi attached to the body.

[0019] Optionally, the stent is a cut stent or a woven stent; or the stent includes a skeleton, a perforated covering is provided on the skeleton, and the holes on the perforated covering constitute the hollow structure.

[0020] Compared with the prior art, the interlayer breach sealing system of the present invention has the following advantages:

[0021] First, the aforementioned interlayer rupture occlusion system includes a stent and an occluder, and the interlayer rupture occlusion system is configured such that, before implantation at the target position, the stent and the occluder are of a separate structure, and after implantation at the target position, the occluder is connected to the stent. In other words, the stent and the occluder are connected as one body only when implanted in the patient's body and reach the predetermined position, so that the stent and the occluder can be delivered and released separately to achieve the purpose of reducing resistance, and when the occluder enters the false cavity, only the occluder needs to be adjusted to reduce the difficulty of the surgical operation.

[0022] Second, the dissection rupture sealing system also includes a first introduction device, which includes a preset tube and a pushing assembly. According to the installation method of the occluder in the preset tube, the occluder can be transported to the target position from the true cavity or from the false cavity, so that the dissection rupture sealing system has a more flexible usage. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 1 is a schematic structural diagram of a dissection rupture plugging system provided according to an embodiment of the present invention, in which only a stent and an occluder are shown, and the stent is connected to the occluder;

[0024] Figure 2It is a cross-sectional view of the blood vessels in the patient's body in the area where the aortic dissection occurred;

[0025] Figure 3 is a schematic diagram of a sandwich breach plugging system provided by an embodiment of the present invention when plugging a breach;

[0026] Figure 4a This is a schematic structural diagram of an occluder of a dissection rupture sealing system provided by the present invention according to an embodiment;

[0027] Figure 4b This is another structural schematic diagram of an occluder of a dissection rupture occluding system provided by the present invention according to an embodiment;

[0028] Figure 5a This is a structural schematic diagram of an anchoring mechanism of an occluder of a dissection rupture occluding system provided by the present invention according to an embodiment;

[0029] Figure 5b This is another structural schematic diagram of an anchoring mechanism of an occluder of a dissection rupture sealing system provided by the present invention according to an embodiment;

[0030] Figure 6a This is a schematic structural diagram of a stent of a dissection rupture sealing system provided by the present invention according to an embodiment;

[0031] Figure 6b 1 is another structural schematic diagram of a stent of a dissection rupture sealing system provided by the present invention according to an embodiment;

[0032] Figure 6c 1 is another structural schematic diagram of a stent of a dissection rupture sealing system provided by the present invention according to an embodiment;

[0033] Figure 7 1 is a schematic structural diagram of a first introduction device of a sandwich breach plugging system provided by the present invention according to an embodiment;

[0034] Figure 8a yes Figure 7 A partial cross-sectional view of the first introduction device of the interlayer breach sealing system shown in FIG. 1 , in which the second end of the body is connected to the pushing assembly;

[0035] Figure 8b yes Figure 7 A partial cross-sectional view of a first introduction device of the interlayer breach sealing system shown, in which the anchoring mechanism is connected to the pushing assembly;

[0036] Fig. 9 1 is a schematic structural diagram of a second introduction device of a sandwich breach plugging system provided by the present invention according to an embodiment;

[0037] Fig.10 yes Fig. 9 A partial cross-sectional view of the second introduction device of the interlayer breach sealing system shown;

[0038] Figure 11a-Figure 11e A schematic diagram of the process of a method for sealing a dissection rupture provided by the present invention according to an embodiment is shown. The stent in the figure only covers one rupture, and the occluder is introduced from the false lumen to the target position;

[0039] Fig.12 1 is a schematic diagram of a sandwich breach plugging system provided by an embodiment of the present invention for plugging breaches, in which the sandwich breach plugging system plugs two breaches;

[0040] Figure 13a-13e It is a process schematic diagram of a method for sealing a dissection rupture provided by the present invention according to an embodiment. In the figure, the stent only covers one rupture, and the occluder is introduced into the target position from the true cavity.

[0041] [Description of reference numerals is as follows]:

[0042] 100-occluder;

[0043] 110-Ontology;

[0044] 111-ball head;

[0045] 120-anchoring mechanism;

[0046] 121-positioning portion, 122-sleeve;

[0047] 130-promote thrombus villi;

[0048] 200-Stand;

[0049] 210-hollow structure, 220-frame, 230-perforated film;

[0050] 300-first introduction device;

[0051] 310-pre-set tube;

[0052] 320-Push component;

[0053] 321-first ejection pipe, 322-release pipe, 323-connecting piece;

[0054] 330-push handle;

[0055] 340-Release handle;

[0056] 350-Introduction sheath;

[0057] 400 - second introduction device;

[0058] 410-conical head, 420-inner tube, 430-second ejector tube, 440-outer sheath tube, 450-fixing handle, 460-releasing handle;

[0059] 10-true lumen, 20-false lumen, 30-rupture. DETAILED DESCRIPTION

[0060] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0061] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The same or similar figure marks in the drawings represent the same or similar parts.

[0062] As used herein, the terms "proximal" and "distal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end that is closer to the doctor during normal operation, and "distal" generally refers to the end that first enters the patient's body.

[0063] Please refer to Figure 1 The embodiment of the present invention provides a dissection rupture blocking system, comprising an occluder 100 and a stent 200, wherein the number of the occluder 100 is at least one. The dissection rupture blocking system is configured such that, before implantation at a target position, the stent 200 and the occluder 100 are separate structures, and when the dissection rupture blocking system is implanted at a target position, the stent 200 is connected to the occluder 100.

[0064] Please refer to Figure 2 , Figure 2 A cross-sectional view of a blood vessel in a patient's body showing an area where an aortic dissection has occurred is shown. Figure 2As shown, when aortic dissection occurs in a patient, the aortic intima is torn, so that the media separates to form a true lumen 10 and a false lumen 20 in the blood vessel, and the true lumen 10 and the false lumen 20 are connected through the rupture 30. When the aortic dissection rupture sealing system is used to treat aortic dissection, the stent 200 is first delivered to the true lumen 10, and the stent 200 is used to support the true lumen 10 and compress the false lumen 20. Then, the occluder 100 is delivered to the rupture 30, and the occluder 100 is used to fill the false lumen 20 and block the rupture 30 to block the blood flow entering the false lumen 20 and promote the thrombosis of the false lumen 20. At the same time, the occluder 100 is connected to the stent 200 to ensure that the occluder 100 can be maintained at the rupture 30 to prevent the occluder 100 from shifting under the impact of blood flow and affecting the occlusion effect.

[0065] In this embodiment, before the dissection rupture occlusion system is implanted into the diseased blood vessel, the stent 200 and the occluder 100 are of a split structure, so that the two can be separately delivered to the blood vessel and then released, effectively reducing the resistance during delivery and release. At the same time, when adjusting the occluder 100 so that the occluder 100 enters the false lumen 20, only the occluder 100 needs to be adjusted, which reduces the difficulty of operation and improves the success rate of the operation.

[0066] The specific structure of the interlayer breach sealing system will be described below with reference to the accompanying drawings.

[0067] Please refer to Figure 4a The occluder 100 includes a body 110 and an anchoring mechanism 120. The body 110 includes a shaping wire (not marked in the figure) and a spring coil (not marked in the figure). The shaping wire is a metal wire with resilience and is configured to have a predetermined shape. The spring coil is sleeved on the shaping wire to form the body 110 into the predetermined shape. The anchoring mechanism 120 is arranged on the body 110 and is used to connect with the stent 200.

[0068] The shaping wire may be made of shape memory alloy (such as nickel-titanium alloy, etc.) or other metals (such as cobalt-chromium alloy, stainless steel, etc.), and the shaping wire is coiled in a curved structure to form the predetermined shape. Figure 4aAs shown, in one embodiment, the shaping wire is spirally wound along an axis to form a conical spiral structure (that is, the predetermined shape is a conical spiral structure), and is shaped by heat treatment so that the shaping wire presents the predetermined shape in a natural state. When the spring coil is set on the shaping wire, the main body 110 also presents the conical spiral structure. The advantage of such a setting is that, firstly, the occluder 100 will be stretched straight under the action of external force during the process of being introduced into the diseased blood vessel, and when the occluder 100 is released in the diseased blood vessel, the main body 110 can be restored to the predetermined shape under the action of the rebound force of the shaping wire, thereby avoiding the phenomenon that the rupture cannot be effectively blocked due to the loose structure of the spring coil. Secondly, the shaping wire is coiled in a curved structure, so that the main body 110 has no sharp corners. When the occluder 100 is released in the diseased blood vessel, the occluder 100 will not cause secondary damage to the rupture 30 due to scratching the blood vessel. In other embodiments, the predetermined shape can also be other forms, for example, Figure 4b As shown, the predetermined shape is a sphere (the body 110 is formed into a sphere) or a polyhedron (not shown in the figure). In addition, the body 110 has a first end and a second end opposite to each other, and the anchoring mechanism 120 is disposed on the first end.

[0069] The anchoring mechanism 120 has resilience and can be made of shape memory alloy (such as nickel-titanium alloy) or other metals (such as cobalt-chromium alloy, stainless steel, etc.). The anchoring mechanism 120 includes a positioning portion 121, such as Figure 5a As shown, the positioning portion 121 may be a plurality of barbs arranged around an axis, or as shown in Figure 5b As shown, the positioning portion may be a fixed disk, and the fixed disk may be composed of a plurality of V-shaped rods arranged in sequence around an axis. When the positioning portion 121 is subjected to a force directed toward the axis, the positioning portion 121 contracts toward the axis to reduce the volume of the anchoring mechanism 120, and when the force is removed, the positioning portion 121 can return to its original state.

[0070] Furthermore, if Figure 5a , 5bAs shown, the anchoring mechanism 120 is connected to the shaping wire. Specifically, the anchoring mechanism 120 also includes a sleeve 122, the positioning portion 121 is fixedly arranged at one end of the sleeve 122, the other end of the sleeve 122 is sleeved on the shaping wire, and the sleeve 122 and the shaping wire remain relatively stationary in the axial direction, and the sleeve 122 can rotate around the axis of the shaping wire. The sleeve 122 is rotated to offset the torsional effect brought by the shaping wire when the occluder 100 is released, so that the shape of the anchoring mechanism 120 can be better adjusted to ensure that the anchoring mechanism 120 and the stent 200 can be effectively connected.

[0071] Alternatively, if Figure 4a and Figure 4b As shown, the occluder 100 further includes thrombus-promoting villi 130, which are made of polymer materials (such as PET, PA, PU, ​​PP, etc.) and are wound around the body 110. The thrombus-promoting villi 130 can increase the filling area of ​​the occluder 100, improve the occluding effect of the body 110, and further promote thrombosis of the false lumen 20.

[0072] Please refer to Figures 6a to 6c , the bracket 200 has a hollow structure 210. The bracket 200 can be formed in a variety of ways, for example, Figure 6a As shown, the stent 200 may be a tube mesh structure formed by laser cutting of a shape memory alloy tube, and the mesh thereon constitutes the hollow structure 210. The stent 200 has the characteristic of self-expansion after heat setting. Figure 6b As shown, the stent 200 may be a tubular mesh structure woven from braided wires, the mesh holes on which constitute the hollow structure 210, and the braided wires may be made of shape memory alloy. Similarly, the stent 200 has the characteristic of self-expansion after being shaped by heat treatment. Figure 6c As shown, the stent 200 can also be formed by heat-setting a shape memory alloy wire into a W-shaped skeleton 220, and then setting a perforated coating 230 on the skeleton 220 by sewing or gluing, wherein the holes on the perforated coating 230 constitute the hollow structure 210.

[0073] The stent 200 is a self-expanding stent. After being implanted in the true lumen 10 of the diseased blood vessel, the stent 200 opens to continuously support the true lumen 10, compress the false lumen 20, and promote thrombosis of the false lumen 20. At the same time, blood flow can pass through the stent 200 without affecting the blood supply of important branch arteries such as the celiac trunk, superior mesenteric artery, renal artery, and intercostal artery. In addition, the hollow structure 210 on the stent 200 is also used for the anchoring mechanism 120 of the occluder 100 to pass through and realize the connection between the two. It can be understood that in order to effectively connect the anchoring mechanism 120 with the stent 200, the size of the hollow structure 210 should be smaller than the radial size of the anchoring mechanism 120 in the natural state, and the size of the hollow structure 210 should also be larger than the radial size of the anchoring mechanism 120 when it is contracted under force, so that the anchoring mechanism 120 can pass through the hollow structure 210.

[0074] Furthermore, the interlayer occlusion system further includes a first introduction device 300, and the first introduction device 300 is used to transport the occluder 100 to the target position. Figure 7 and Figure 8a The first introduction device 300 includes a pre-placement tube 310 and a push assembly 320. The pre-placement tube 310 has a first inner cavity that is axially through, and the first inner cavity is used to accommodate the occluder 100, and has a first proximal end and a first distal end that are opposite. The push assembly 320 has a second proximal end and a second distal end that are opposite, wherein the second distal end extends into the first proximal end of the first inner cavity and is used to connect with the occluder 100.

[0075] In one embodiment, the push assembly 320 is mechanically connected to the occluder 100. Specifically, the push assembly 320 includes a first ejection tube 321 and a release tube 322, wherein the release tube 322 is a hollow structure and is sleeved on the outside of the first ejection tube 321, and relative axial movement can be generated between the release tube 322 and the first ejection tube 321. The first ejection tube 321 has a third proximal end and a third distal end relative to each other, and the release tube 322 has a fourth proximal end and a fourth distal end relative to each other. A connector 323 is provided on the third distal end of the first ejection tube 321, and the connector 323 is L-shaped, so that the axial cross-section between the connector 323 and the first ejection tube 321 is "П"-shaped, and an opening is formed on the wall where the connector 323 and the end of the first ejection tube 321 are arranged opposite to each other. The fourth distal end of the release tube 322 may be flush with the end of the connector 323 away from the first ejection tube 321, and the inner wall of the release tube 322, the connector 323 and the end of the third distal end of the first ejection tube 321 together form a limiting area. Figure 8aAs shown, the occluder 100 is stretched and placed in the first inner cavity of the pre-placed tube 310. According to actual needs, the anchoring mechanism 120 of the occluder 100 can be located at the first distal end of the first inner cavity. A ball head 111 can be provided on the second end of the body 110 of the occluder 100. When the ball head 111 is provided in the limiting area, the occluder 100 is connected to the pushing assembly 320. Alternatively, Figure 8b As shown, the ball head 111 is arranged at the first distal end of the first inner cavity, and the anchoring mechanism 120 is arranged in the limiting area, so that the connection between the occluder 100 and the pushing assembly 320 can be achieved. According to the setting position of the occluder 100 in the pre-placed tube 310, the occluder 100 is delivered to the rupture 30 via different routes, which will be described in detail later.

[0076] Furthermore, if Fig. 9 As shown, the interlayer occlusion system further includes a first handle assembly, which includes a push handle 330 and a release handle 340. The fourth proximal end of the release tube 322 is connected to the release handle 340, and the third proximal end of the first ejection tube 321 extends along the axial direction of the release tube 322 until it passes through the release handle 340 and is connected to the push handle 330. When the occluder 100 is released, the first handle assembly pushes the first ejection tube 321 and the release tube 322 to move toward the first distal end at the same time to push the occluder 100 out of the first inner cavity. After the occluder 100 is completely released, the first handle assembly drives the release tube 322 or the first ejection tube 321 to move axially, so that the connecting member 323 extends from the fourth distal end of the release tube 322, thereby releasing the connection between the push assembly 320 and the occluder 100.

[0077] In addition, the first introduction device 300 also includes an introduction sheath 350 (such as Fig.11c As shown), the introduction sheath 350 has an axially extending second inner cavity, and the introduction sheath 350 is used to construct a path for the occluder 100 to enter the blood vessel, that is, the pre-placed tube 310 carries the occluder 100 from the second inner cavity of the introduction sheath 350 into the blood vessel and reaches the rupture 30.

[0078] Furthermore, the interlayer breach sealing system further comprises a second introduction device 400, and the second introduction device 400 is used to deliver the stent 200 into the true cavity 10. Fig. 9 and Fig.10As shown, the second introduction device 400 includes a conical head 410, an inner tube 420, a second ejector tube 430 and an outer sheath tube 440. The inner tube 420 has a relative fifth proximal end and a fifth distal end, the second ejector tube 430 is a hollow structure and has a relative sixth proximal end and a sixth distal end, and the outer sheath tube 440 is a hollow structure and has a relative seventh proximal end and a seventh distal end. The inner tube 420, the second ejector tube 430 and the outer sheath tube 440 are nested in sequence from the inside to the outside, and the fifth distal end of the inner tube 420 extends from the sixth distal end of the second ejector tube 430 and is connected to the conical head 410, and the seventh distal end of the outer sheath tube 440 is flush with the fifth distal end of the inner tube 420. In this way, a receiving area is formed between the inner tube 420, the second ejection tube 430 and the outer sheath tube 440, and the stent 200 can be sleeved on the inner tube 420 and accommodated in the receiving area (at this time, the stent 200 is compressed by the wall of the outer sheath tube 440).

[0079] Optionally, the second introduction device 400 further includes a second handle assembly, which includes a fixed handle 450 and a release handle 460. The fixed handle 450 is connected to the fifth proximal end of the inner tube 420 and the sixth proximal end of the second ejection tube 430, and the release handle 460 is connected to the seventh proximal end of the outer sheath tube 440. The fixed handle 450 and the release handle 460 can rotate relative to each other, and the release handle 460 can drive the outer sheath tube 440 to make axial movement relative to the inner tube 420 and the second ejection tube 430 through a spiral transmission mechanism, thereby releasing the stent 200. It can be understood that for those skilled in the art, it is common knowledge to use the release handle 460 to drive the outer sheath tube 440 to make axial movement relative to the inner tube 420 and the second ejection tube 430, so it will not be described in detail here.

[0080] As mentioned above, the occluder 100 has two different configurations in the pre-placed tube 310. Depending on the configuration, there are two delivery methods for delivering the dissection rupture occluding system to the diseased blood vessel, which are described in detail below in conjunction with the accompanying drawings.

[0081] Method 1: When the ball head 111 of the occluder 100 is disposed in the limiting area and connected to the pushing assembly 320, the delivery method of the interlayer rupture sealing system is as follows:

[0082] Step S1, using the second introduction device 400 to introduce the stent 200 into the true lumen 10 of the diseased blood vessel (eg, Fig.11a shown).

[0083] Step S2, withdrawing the outer sheath 440 to release the stent 200, so that the stent 200 covers at least one of the breaches 30 (such as Fig.11b shown).

[0084] Step S3, using the first introduction device 300 to introduce the occluder 100 into the rupture 30. Specifically, firstly, the introduction sheath 350 is made to reach one of the ruptures 30 (such as Fig.11c Then, the pre-placed tube 310 carries the occluder 100 from the second inner cavity of the introduction sheath tube 350 to the breach 30 (as shown in FIG. Fig.11d shown).

[0085] Step S4, the pushing assembly 320 pushes the occluder 100, so that the anchoring mechanism 120 is released first, and the anchoring mechanism 120 passes through the breach 30 and the hollow structure 210 on the stent 200 into the stent 200 and is connected to the stent 200, and then continues to release the occluder 100 (such as Fig.11e shown).

[0086] Step S5: disconnecting the occluder 100 from the pushing assembly 320. Specifically, the first handle assembly drives the release tube 322 or the first ejection tube 321 to move axially, so that the connecting member 323 extends from the fourth distal end of the release tube 322, and the body 110 can be separated from the pushing assembly under the action of the resilience of the shaping wire (this is actually a mechanical release method).

[0087] In other embodiments, the occluder 100 and the pushing assembly 320 may be connected in other ways. According to different connection methods, the occluder 100 and the pushing assembly 320 are disconnected by electrolysis (in this case, the occluder 100 and the pushing assembly 320 are connected by metal wires), thermal melting (in this case, the occluder 100 and the pushing assembly 200 may be connected by polymer wires) or hydrolysis. It is understood that the electrolysis, thermal melting and hydrolysis are all prior arts known to those skilled in the art.

[0088] In addition, the above-mentioned method of use only describes the case where the interlaminar rupture occluding system has one occluder 100. In fact, each interlaminar rupture occluding system may include two, three or even more occluders 100, depending on the patient's condition. When the interlaminar rupture system has multiple occluders 100, its method of use is basically the same as the above, except that the steps S3, S4 and S5 are repeated according to the number of occluders 100. Fig.12That is, it shows the use of the interlayer rupture sealing system with two occluders 100, and the steps S3 and S4 are performed twice. Preferably, the stent 200 covers all the ruptures 30, and the number of the occluders 100 is the same as the number of the ruptures 30, so that each of the ruptures 30 can be blocked.

[0089] Method 2: When the anchoring mechanism 120 of the occluder 100 is disposed in the limiting area and connected to the pushing assembly 320, the delivery method of the interlayer rupture occluding system is as follows:

[0090] Step S10, using the second introduction device 400 to introduce the stent 200 into the true lumen 10 of the diseased blood vessel (eg, Fig.13a shown).

[0091] Step S20, withdrawing the outer sheath 440 to release the stent 200, so that the stent 200 covers at least one of the breaches 30 (such as Fig.13b shown).

[0092] Step S30, using the first introduction device 300 to introduce the occluder 100 into the breach 30. Specifically, firstly, the introduction sheath 350 is passed through the true cavity 10 and the inside of the stent 200, and through the hollow structure 210 to reach one of the breaches 30 (such as Fig.13c Then, the pre-placed tube 310 carries the occluder 100 from the second inner cavity of the introduction sheath tube 350 to the breach 30 (as shown in FIG. Fig.13d shown).

[0093] In step S40, the pushing assembly 320 pushes the occluder 100, so that the second end of the body 110 of the occluder 100 is first released, so that the occluder 100 partially passes through the breach 30 and enters the false lumen 20. Then, the occluder 100 is continuously released until the anchoring mechanism 120 is released and connected to the stent 200 (e.g., Fig.13e shown).

[0094] Finally, according to the connection mode between the pushing component 320 and the occluder 100 , a suitable release method (i.e., any one of mechanical release, electrolytic release, thermal melt release or hydrolytic release) is selected to release the connection between the occluder 100 and the pushing component 320 .

[0095] Similarly, the step S30 and the step S40 are repeated according to the number of the occluders 100 in the interlayer rupture sealing system.

[0096] Each time aortic dissection is treated, method one or method two may be used alone, or the two methods may be used in combination, depending on the actual situation.

[0097] The interlayer rupture sealing system provided in the embodiment of the present invention includes a stent and an occluder, and the interlayer rupture sealing system is configured such that, before implantation into the target position, the stent and the occluder are split structures, and after implantation into the target position, the occluder is connected to the stent. In other words, the stent and the occluder are connected as one body only when they are implanted into the patient's body and reach the predetermined position, so that the stent and the occluder can be transported and released separately to reduce resistance, and when the occluder enters the false cavity, only the occluder needs to be adjusted to reduce the difficulty of the surgical operation. At the same time, one stent can be used in conjunction with multiple occluders to achieve the purpose of treating all ruptures at one time during the same period.

[0098] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A sandwich breach sealing system, characterized in that: The interlayer rupture occluding system comprises a stent and at least one occluder, and the stent and the occluder are configured such that, before implantation at a target position, the stent and the occluder are separate structures, and after implantation at the target position, the occluder is connected to the stent; It also includes a first introduction device, which is used to implant the occluder at the target position; the first introduction device includes a pre-placement tube and a pushing assembly, the pre-placement tube has an axially through first inner cavity, the first inner cavity has a first proximal end and a first distal end relative to each other; the pushing assembly includes a first ejection tube and a release tube, the release tube is a hollow structure and is sleeved on the outside of the first ejection tube, the release tube has a fourth proximal end and a fourth distal end relative to each other, and relative axial movement can be generated between the release tube and the first ejection tube; the first ejection tube has a third proximal end and a third distal end relative to each other, a connecting piece is provided on the third distal end of the first ejection tube, the connecting piece is L-shaped, so that the axial cross-section between the connecting piece and the first ejection tube is Π-shaped, and an opening is formed on the wall where the connecting piece and the end of the first ejection tube are arranged opposite to each other; when the fourth distal end of the release tube is flush with the end of the connecting piece away from the first ejection tube, the inner wall of the release tube and the end of the third distal end of the first ejection tube together form a limiting area; The occluder includes a body and an anchoring mechanism, the body has a first end and a second end opposite to each other, and the first end is provided with the anchoring mechanism; when the occluder is implanted at the target position, the occluder is stretched and accommodated in the first inner cavity, and the second end of the body is located at the first distal end of the first inner cavity, the anchoring mechanism is located at the first proximal end of the first inner cavity and in the limiting area, and is connected to the pushing assembly.

2. The interlayer breach sealing system according to claim 1, characterized in that: The first introduction device also includes an introduction sheath having an axially extending second inner cavity, the introduction sheath is used to construct an introduction path for the occluder, and the pre-placed tube carries the occluder to the target position via the second inner cavity.

3. The interlayer breach sealing system according to claim 1 or 2, characterized in that: Also included is a second introduction device, which is used to implant the stent into the target position.

4. The interlayer breach sealing system according to claim 1, characterized in that: The main body includes a shaping wire and a spring coil, the shaping wire is a metal wire with resilience, and the shaping wire is configured to have a predetermined shape, and the spring coil is sleeved on the shaping wire to make the main body have the predetermined shape; the anchoring mechanism is made of metal with resilience, the anchoring mechanism is arranged on the main body, and is used to connect with the bracket.

5. The interlayer breach sealing system according to claim 4, characterized in that: The anchoring mechanism comprises a positioning portion, which is a barb or a fixing plate; the bracket has a hollow structure, and the positioning portion is used to be inserted into the hollow structure and connected with the bracket.

6. The interlayer breach sealing system according to claim 4, characterized in that: The shaping wire is coiled into a continuous curve structure to form the predetermined shape.

7. The interlayer breach sealing system according to claim 4, characterized in that: The occluder further comprises thrombotic villi attached to the body.

8. The interlayer breach sealing system according to claim 5, characterized in that: The stent is a cut stent or a woven stent; or, the stent includes a skeleton, a perforated covering film is provided on the skeleton, and the holes on the perforated covering film constitute the hollow structure.

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