Aortic dissection rupture closure device

Abstract

The application provides an aortic dissection rupture sealing device, which comprises an anchoring part, a hollow flow channel, and an intima around the rupture, so as to prevent the fluid communication between the true lumen of the aorta and the false lumen formed at the rupture; a stent, which is adjustably coupled to the anchoring part, has a connecting end and a free end, and at least the free end of the stent is located in a branch blood vessel; and the stent has a hollow structure in communication with the hollow flow channel and is supported in the branch blood vessel to communicate the true lumen and the branch blood vessel. The above scheme can avoid the continuous expansion of the false lumen caused by the incomplete sealing of the rupture and residual shunt, and at the same time, the blood supply of the blood vessel channel is retained to ensure the stability of the blood supply of the branch blood vessel, which is beneficial to meet the blood supply demand of the internal organs, spinal cord and the like supplied by the branch blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a sealing device for aortic dissection rupture. Background Technology

[0002] Aortic dissection (AD) is a serious cardiovascular disease. The aorta consists of the intima, media, and adventitia from the inside out. An aortic dissection tear occurs when a tear appears in the intima of the aorta, allowing blood to enter the media and causing separation between the intima and adventitia. This separation extends along the long axis of the aorta, creating a true lumen and a false lumen. The true lumen is the space defined by the intima, while the false lumen is the space formed between the intima and adventitia due to the separation.

[0003] For example, the incidence of retro-thoracic and abdominal aortic aneurysms is high after endovascular thoracic aortic repair (TEVAR), with residual distal rupture being the main cause of persistent blood flow in the false lumen. Treatment of aortic dissection is a complex process involving a variety of different treatment strategies and techniques.

[0004] Existing treatment methods for aortic dissection tears have several drawbacks, including complex procedures, obstruction of branch vessels affecting other organs, spinal cord ischemia, and incomplete closure of the tear leading to residual shunts and continuous expansion of the false cavity. Summary of the Invention

[0005] The technical problems solved by the embodiments of the present invention are at least as follows: existing methods of sealing ruptures are complicated to operate, obstruct branch vessels and affect other organs, cause spinal cord ischemia, and cause residual shunting due to incomplete sealing of the rupture, resulting in continuous expansion of the false lumen.

[0006] To address the aforementioned technical problems, this invention provides a sealing device for aortic dissection ruptures, comprising: an anchoring portion having a hollow flow channel, anchored to the intima surrounding the rupture to prevent fluid communication between the true lumen of the aorta and the false lumen formed at the rupture; and a stent, positionably coupled to the anchoring portion, the stent having a connecting end and a free end, at least the free end of the stent being located within a branch vessel, the stent having a hollow structure communicating with the hollow flow channel, and being supported within the branch vessel to facilitate communication between the true lumen and the branch vessel.

[0007] Optionally, the aortic dissection closure device further includes a connecting part that is connected to both the anchoring part and the connecting end of the stent. The connecting part connects the hollow flow channel and the hollow structure. The connecting part is configured to adjust the relative position of the stent and the anchoring part so that the axial direction of the stent is adapted to the direction of the branch vessel.

[0008] Optionally, the connecting part is made of a deformable material; or the connecting part is a bendable or foldable structure; or the connecting part is angularly connected to the anchoring part; or the connecting part is angularly connected to the bracket.

[0009] Optionally, the stent may include a single stent, wherein the hollow structure of the single stent has a blood flow direction; or the stent may be a multi-branched stent, wherein the hollow structure of the multi-branched stent has multiple sub-hollow sections, each sub-hollow section being isolated from each other and communicating with the hollow flow channel.

[0010] Optionally, it also includes a bending adjustment structure connected to the bracket, the bending adjustment structure being configured to adjust the extension direction of the bracket.

[0011] Optionally, the bending structure includes a pull-out structure, the pull-out structure having at least two pull-out lines, the fixed end of each pull-out line being connected to the free end of the bracket and passing through at least a portion of the bracket, the pull-out end of the pull-out line being movable relative to the bracket, and the at least two pull-out lines being configured to be independently pullable.

[0012] Optionally, the bending structure has a locking structure, which is used to lock the pull end of the pull cable after the pull cable has adjusted the extension direction of the bracket by pulling.

[0013] Optionally, the anchoring portion includes: a first fixing portion surrounding the hollow flow channel, the size of the first fixing portion being larger than the size of the opening, and abutting against the inner membrane on the side facing the true cavity.

[0014] Optionally, the anchoring portion further includes: a second fixing portion surrounding the hollow flow channel, the size of the second fixing portion being larger than the size of the tear, abutting the inner membrane on the side facing the false cavity; and a clamping portion located between the first fixing portion and the second fixing portion, along the radial direction of the anchoring portion, the size of the clamping portion being smaller than the size of the first fixing portion and the second fixing portion, the tear being fitted onto the clamping portion, and the inner membrane at the tear being clamped within the clamping space between the first fixing portion and the second fixing portion.

[0015] Optionally, an elastic adjustment part is provided around the clamping part, and the elastic adjustment part is adjustable in size along the radial direction.

[0016] Optionally, the clamping space contracts radially away from the clamping portion, in a direction away from the clamping portion.

[0017] Optionally, the first fixing part has a first inclined surface facing the second fixing part; and / or the second fixing part has a second inclined surface facing the first fixing part.

[0018] Optionally, the angle between the first inclined surface and the radial direction of the anchoring part is in the range of [15°, 60°]; and / or the angle between the first inclined surface and the radial direction of the anchoring part is in the range of [30°, 45°]; and / or the angle between the second inclined surface and the radial direction of the anchoring part is in the range of [15°, 60°]; and / or the angle between the second inclined surface and the radial direction of the anchoring part is in the range of [30°, 45°]; and / or the area where the first inclined surface connects to the clamping part has a curved transition; and / or the area where the second inclined surface connects to the clamping part has a curved transition.

[0019] Optionally, the sealing device has a body having a retracted state and a sealing state. The body is configured to deform from the retracted state along the axial and radial directions of the hollow flow channel and switch to the sealing state. The anchoring part is formed after the body deforms and switches to the sealing state.

[0020] Optionally, the body includes a skeleton formed by a woven structure and / or a skeleton formed by a cutting process.

[0021] Optionally, the body may be configured as a multi-layer structure; and / or the clamping part may be a single-layer structure or a multi-layer structure; and / or the first fixing part may be a single-layer structure; and / or the second fixing part may be a single-layer structure.

[0022] Optionally, a flow-blocking portion is provided along the anchoring portion.

[0023] Optionally, the hollow channel is divided into multiple sub-channels along its own axis, and each sub-channel is used to connect the corresponding branch blood vessel.

[0024] Compared with the prior art, the technical solution of the embodiments of the present invention has the following beneficial effects: The anchoring portion allows the occlusion device to be anchored to the intima at the rupture site, preventing fluid communication between the true lumen and the false lumen formed at the rupture. This prevents blood from the true lumen from entering the false lumen, thus avoiding further expansion of the false lumen and promoting its recovery and shrinkage. The stent is adjustablely connected to the anchoring portion, allowing it to adapt to the axis of the branch vessel. The hollow structure of the stent communicates with the hollow flow channel of the anchoring portion, preserving the blood supply channel from the true lumen to the branch vessel. This improves the occlusion effect of the rupture, preventing residual shunting due to incomplete rupture closure and the resulting continuous expansion of the false lumen, while maintaining the blood supply channel and ensuring the stability of blood supply to the branch vessel. This is beneficial for meeting the blood supply needs of internal organs and the spinal cord supplied by branch vessels. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of a sealing device for an aortic dissection rupture according to an embodiment of the present invention; Figure 2 This is a schematic diagram of another aortic dissection rupture sealing device in an embodiment of the present invention; Figure 3 yes Figure 2 A schematic diagram along the direction of section line AA; Figure 4 This is a simplified structural diagram of a sealing device for an aortic dissection rupture according to an embodiment of the present invention. Figure 5 yes Figure 4 A schematic diagram along the BB direction of the cross section; Figure 6 This is a schematic diagram of the structure of another aortic dissection rupture sealing device in an embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of another aortic dissection rupture sealing device in an embodiment of the present invention; Figure 8 This is a cross-sectional view of a device for sealing aortic dissection rupture; Figure 9 This is a cross-sectional view of another type of aortic dissection closure device; Figure 10 This is a schematic diagram showing the adjustment of the support extension direction; Figure 11 This is a schematic diagram of the structure of another aortic dissection rupture sealing device in an embodiment of the present invention; Figure 12 This is a schematic diagram of the aortic dissection rupture in an embodiment of the present invention; Figure 13 This is a schematic diagram of the sealing device for aortic dissection rupture in an embodiment of the present invention. Detailed Implementation

[0026] To make the above-mentioned objectives, features and beneficial effects of the embodiments of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0027] See Figures 1 to 13This invention provides a sealing device 100 for aortic dissection rupture, comprising an anchoring portion 2 and a stent 3. The anchoring portion 2 has a hollow flow channel 20 and is anchored to the intima 201 surrounding the rupture 204 to prevent fluid communication between the true lumen 205 of the aorta 200 and the false lumen 206 formed at the rupture 204. The stent 3 is positionally coupled to the anchoring portion 2. The stent 3 has a connecting end 31 and a free end 32, at least the free end 32 of the stent is located within a branch vessel 300, and the stent 3 has a hollow structure 33 communicating with the hollow flow channel 20. The stent 3 is supported within the branch vessel 300 to facilitate communication between the true lumen 205 and the branch vessel 300.

[0028] It should be noted that the positive and negative directions of x in the figure are radial, and will be referred to as radial x in this article. The positive and negative directions of y are axial, and will be referred to as axial y in this article.

[0029] Using the above scheme, the occlusion device 100 can be anchored to the intima 201 at the rupture 204 via the anchoring part 2, thereby preventing fluid communication between the true lumen 205 and the false lumen 206 formed at the rupture 204. This prevents blood from the true lumen 205 from entering the false lumen 206, thus avoiding further expansion of the false lumen 206 and facilitating its recovery and shrinkage. The stent 3 is adjustablely connected to the anchoring part 2 via the connecting part 4, adapting to the axial direction of the branch vessel 300. The hollow structure 33 of the stent 3 communicates with the hollow flow channel 20 of the anchoring part 2, preserving the blood supply channel from the true lumen 205 to the branch vessel 300. This improves the occlusion effect of the rupture 204, preventing residual shunting due to incomplete occlusion of the rupture 204 and the continuous expansion of the false lumen, while preserving the blood supply channel and ensuring the stability of the blood supply to the branch vessel 300. This is beneficial for meeting the blood supply needs of internal organs, spinal cord, etc., supplied by the branch vessels.

[0030] In specific implementation, the coupling of the bracket 3 to the anchoring part 2 in an adjustable position can refer to a direct connection or an indirect connection via a connecting part.

[0031] In some embodiments, the bracket 3 is directly connected to the anchoring part 2, and its position is adjustable relative to the anchoring part 2. There are various possibilities regarding the direct connection of the bracket 3 to the anchoring part 2. Examples are given below.

[0032] For example, the support 3 and the anchoring part 2 are integrally formed, meaning they are a single-piece structure. When the support 3 and the anchoring part 2 are integrally formed, the structure or density at different locations can be the same or different. The specific configuration can be determined based on the specific functional requirements of the support 3 and the anchoring part 2. The support 3 and the anchoring part 2 can be an integrally formed cut structure or an integrally formed woven structure. Taking the integrally formed woven structure as an example, the weaving density or number of layers of the support 3 and the anchoring part 2 can be the same or different.

[0033] For example, the support 3 and the anchoring part 2 are two relatively independent structures, with the support 3 connected to the anchoring part 2. The support 3 and the anchoring part 2 can be manufactured using the same type of process, such as both being cut structures or both being woven structures. Alternatively, the support 3 and the anchoring part 2 can be manufactured using different types of processes, such as one being a cut structure and the other a woven structure.

[0034] In other embodiments, the stent 3 is positionally adjustable to the anchoring portion 2 via a connecting portion 4. The connecting portion 4 connects to the anchoring portion 2 and the connecting end 31 of the stent 3, and conducts communication between the hollow flow channel 20 and the hollow structure 33. The connecting portion 4 is configured to adjust the relative position of the stent 3 and the anchoring portion 2, so that the axial direction of the stent 3 adapts to the orientation of the branch vessel 300.

[0035] In practice, various methods can be used to achieve an adjustable connection between the connecting part 4 and the stent 3. This allows for effective closure of the rupture 204 while also facilitating adaptation to large-angle branch vessels.

[0036] In some embodiments, the connecting portion 4 is made of a deformable material. The deformable material includes, but is not limited to, flexible materials. This allows the structural shape of the connecting portion 4 to be flexibly adjusted according to the actual course of the branch vessel 300, enabling the stent 3 to adapt to the branch vessel 300. For example, combined with... Figure 6 The connecting part 4 is a flexible structure made of a flexible material, such as a ring-shaped flexible membrane. Alternatively, the connecting part 4 may be a ring-shaped woven component formed by a braided structure. It should be noted that, to distinguish the connecting part 4 from the support 3 and the anchoring part 2, gray filler is used to differentiate the connecting part 4. This gray filler does not restrict the structure of the connecting part 4.

[0037] In other embodiments, the connecting portion 4 is a bendable structure (e.g., Figure 7The connecting part 4 can be a wavy, bent structure or a foldable structure formed by shaping the skeleton. The connecting part 4 can be bent and deformed under force or a portion of it can be folded to change its shape, thereby adjusting the axial direction of the stent 3 to match the orientation of the branch vessel 300.

[0038] In some other embodiments, the connecting portion 4 is angularly connected to the anchoring portion 2. Alternatively, the connecting portion 4 is angularly connected to the bracket 3. For example, the connecting portion 4 can be angularly connected to the anchoring portion 2 or the bracket 3 by means of hinge connection, stitching connection, or membrane connection.

[0039] It is understandable that the connecting part 4 can also be connected to the anchoring part 2 and the bracket 3 by other means such as snap-fitting or fitting.

[0040] In specific implementation, the connecting part 4 has a guide channel, which is used to connect the hollow flow channel 20 and the hollow structure 33 to ensure the flow and stability of blood. The guide channel can be a hollow structure, or a suitable structure such as a hole or gap, depending on the structural style of the connecting part 4.

[0041] In some embodiments, the anchoring part 2, the bracket 3, and the connecting part 4 can be a one-piece molded structure. For example, the anchoring part 2, the bracket 3, and the connecting part 4 can be a one-piece cut structure or a one-piece woven structure. In a one-piece molded structure, the structure or density at different locations can be different to meet the functional requirements of the anchoring part 2, the bracket 3, and the connecting part 4 in different parts. Of course, depending on actual needs, the structure or density at different locations in a one-piece molded structure can be the same.

[0042] In other embodiments, the anchoring part 2, the bracket 3, and the connecting part 4 can be relatively independent separate structures, with the anchoring part 2 and the bracket 3 connected by the connecting part 4.

[0043] The anchoring part 2, the bracket 3, and the connecting part 4 can be either a woven structure formed by weaving or a cut structure formed by cutting. When the anchoring part 2, the bracket 3, and the connecting part 4 are relatively independent separate structures, the anchoring part 2 and the bracket 3 can be formed in the same or different ways. For example, the anchoring part 2 is a woven structure, and the bracket 3 is a cut structure. Alternatively, both the anchoring part 2 and the bracket 3 can be cut structures. Yet another example is that the anchoring part 2 is a cut structure, and the bracket 3 is a woven structure.

[0044] In some embodiments, the stent 3 can be a single stent, wherein the hollow structure of the single stent has a blood flow direction. The single stent is suitable for a scenario where the rupture region 204 corresponds to a branch vessel 300.

[0045] In other embodiments, reference is made to Figure 11 The stent 3 is a multi-branched stent, and the hollow structure 33 of the multi-branched stent has multiple sub-hollow sections 331. Each sub-hollow section 331 is isolated from each other and is connected to the hollow flow channel 20. Each sub-hollow section 331 corresponds to a branch vessel 300. Especially when the rupture 204 region corresponds to multiple branch vessels 300, the multi-branched stent with multiple sub-hollow sections 331 can achieve simultaneous blood supply to multiple branch vessels. The position of each sub-hollow section 331 relative to the anchoring part 2 can be independently adjusted so that each sub-hollow section 331 can adapt to the direction of the corresponding branch vessel 300. It should be noted that... Figure 11 The hollow structure 33 of the schematic multi-branched stent has two sub-hollow parts 331. In practice, the number of sub-hollow parts 331 of the hollow structure 33 can also be three or more, depending on the number of branch vessels corresponding to the rupture 204.

[0046] In some embodiments, the hollow flow channel 20 is divided into multiple sub-flow channels along its axial direction. Each sub-flow channel is used to connect to a corresponding branch blood vessel 300, and each sub-flow channel can be connected to a stent 3. Each sub-flow channel can be directly connected to the stent 3, or it can be connected to the stent 3 through a connecting part 4. In this way, when there are multiple branch blood vessels 300 corresponding to the rupture site, the blood supply needs of each branch blood vessel 300 can be met.

[0047] In some embodiments, the occlusion device 100 may further include a bending adjustment structure connected to the stent 3, the bending adjustment structure being configured to adjust the extension direction of the stent 3. Adjusting the extension direction of the stent 3 adjusts the fit between the stent 3 and the branch vessel 300. When the extension direction of the stent 3 changes, the blood flow direction guided by the hollow structure 33 also changes accordingly.

[0048] In some embodiments, combined with Figure 9 The bending adjustment structure includes a pull-out structure with at least two pull-out lines 61. The fixed end 611 of each pull-out line 61 is connected to the free end 32 of the bracket 3 and at least penetrates a portion of the bracket 3. The pull-out end 612 of each pull-out line 61 is movable relative to the bracket 3. The at least two pull-out lines 61 are configured to be independently pullable. Thus, the extension direction of the bracket 3 can be adjusted by adjusting the degree of pull-out of each pull-out line 61 relative to the free end 32 of the bracket 3. When the extension direction of the bracket 3 changes, the axial direction of the hollow structure 33 of the bracket 3 also changes accordingly. The axial direction of the hollow structure 33 can be straight or curved.

[0049] It should be noted that the extension direction of the support 3 (i.e., the hollow structure 33) in the schematic diagram is the same as the extension direction of the hollow flow channel 20 of the anchoring part 2. As the extension direction of the hollow structure 33 of the support 3 is adjusted, the extension direction of the hollow structure 33 and the direction of the hollow flow channel 20 can be different. For example, Figure 9 This is a schematic diagram of the extension direction of bracket 3 before adjustment. Figure 10 This is a schematic diagram showing the adjusted extension direction of bracket 3.

[0050] In some non-limiting embodiments, the pull-out wire 61 can be routed within the hollow structure 33 of the stent 3, that is, the pull-out wire 61 is located inside the stent 3, so that the pull-out wire 61 can avoid rubbing against the inner wall of the branch vessel 300 during the pulling process.

[0051] Furthermore, the pull end 612 of the pull cable 61 exposes the occlusion device 100 or is located at the anchoring part 2, so that the user can easily access and operate the pull end 612 within the true lumen 205 of the aorta to adjust the bending angle of the stent 3, that is, to adjust the extension direction of the stent 3.

[0052] The accompanying drawings provided in this application illustrate two pull-out cables 61 as an example. The two pull-out cables 61 can be arranged symmetrically. The pull-out cables 61 pass through the bracket 3, the connecting part 4, and the anchoring part 2.

[0053] The drawstring 61 can be made of metal or cotton or other materials that meet human safety requirements.

[0054] In some embodiments, the bending structure has a locking structure for locking the pull end 612 of the pull cable 61 after the pull cable 61 has adjusted the extension direction of the bracket 3 by pulling. This helps the bracket 3 maintain the adjusted bending shape.

[0055] In a specific implementation, the anchoring part 2 includes a first fixing part 21. The size of the first fixing part 21 is larger than the size of the opening 204. The first fixing part 21 surrounds the hollow flow channel 20 and abuts against the side of the inner membrane 201 facing the true cavity 205. In this way, the sealing device 100 is attached to the inner membrane 201 by the first fixing part 21, thereby improving the fixing stability of the sealing device 100 and reducing the probability of the sealing device 100 falling off from the opening 204.

[0056] The anchoring portion 2 further includes a second fixing portion 22 and a clamping portion 23. The second fixing portion 22 surrounds the hollow flow channel 20, and its size is larger than that of the tear 204, abutting against the side of the inner membrane 201 facing the false cavity 206. The clamping portion 23 is located between the first fixing portion 21 and the second fixing portion 22, along the radial x of the anchoring portion 2, and its size is smaller than that of the first fixing portion 21 and the second fixing portion 22. The tear 204 is fitted onto the clamping portion 23, and the inner membrane 201 at the tear 204 is clamped within the clamping space 24 between the first fixing portion 21 and the second fixing portion 22. The size of the clamping portion 23 is smaller than that of the tear 204 to achieve an edge seal of the tear 204, preventing blood from entering the false cavity 206 through the gap between the clamping portion 23 and the edge of the tear 204.

[0057] The inner membrane 201 is held against the side facing the true cavity 205 by the first fixing part 21, and the inner membrane 201 is held against the side facing the false cavity 206 by the second fixing part 22. The tear 204 is fitted onto the clamping part 23 to improve the fixing firmness of the anchoring part 2 at the tear 204 and further reduce the probability of the sealing device 100 falling off. The inner membrane 201 at the tear 204 is clamped in the clamping space 24 between the first fixing part 21 and the second fixing part 22, which can prevent the tear size of the inner membrane 201 near the tear 204 from further increasing.

[0058] In some embodiments, the clamping space 24 contracts along the radial x of the anchoring portion 2, toward a direction away from the clamping portion 23. In other words, the distance between the first fixing portion 21 and the second fixing portion 22 gradually increases along the radial direction of the anchoring portion 2, toward the center of the anchoring portion 2. The first fixing portion 21 and the second fixing portion 22 are clamped in a region away from the edge of the tear 204, so that the force exerted by the first fixing portion 21 and the second fixing portion 22 on the inner membrane 201 when fixing the sealing device is away from the edge of the tear 204, thereby protecting the edge of the tear 204 and preventing further tearing of the tear 204 in the edge region, which would lead to a further increase in the size of the tear 204.

[0059] Furthermore, at least the edge portion of the first fixing part 21 and at least the edge region of the second fixing part 22 are in contact with the inner membrane 201. This not only improves the sealing effect on the rupture 204, but also enhances the fixation firmness of the sealing device 100.

[0060] In some non-limiting embodiments, the first fixing part 21 and the second fixing part 22 may be disc-shaped. For example, the first fixing part 21 and the second fixing part 22 may be disc-shaped.

[0061] In some embodiments, the first fixing part 21 has a first inclined surface 211 facing the second fixing part 22.

[0062] In some embodiments, the second fixing part 22 has a second inclined surface 221 facing the first fixing part 21.

[0063] Along the radial direction x of the anchoring part 2, from the anchoring part 2 toward the direction away from the body 1, the first inclined surface 211 and the second inclined surface 221 extend toward each other. The space between the first inclined surface 211 and the second inclined surface 221 is the clamping space 24.

[0064] The first fixing part 21 may be hollow, and the first fixing part 21 has a first outer surface 212 opposite to the first inclined surface 211. There is a gap between the first inclined surface 211 and the first outer surface 212.

[0065] Furthermore, at least a portion of the first inclined surface 211 and the first outer surface 212 are substantially parallel.

[0066] The second fixing part 22 may be hollow, and the second fixing part 22 has a second outer surface 222 opposite to the second inclined surface 221. There is a gap between the second inclined surface 221 and the second outer surface 222.

[0067] Furthermore, at least a portion of the second inclined surface 221 and the second outer surface 222 are substantially parallel.

[0068] In some embodiments, the area where the first inclined surface 211 connects with the clamping portion 23 has a curved transition.

[0069] In some embodiments, the area where the second inclined surface 221 connects with the clamping portion 23 has a curved transition.

[0070] In some embodiments, the angle between the first inclined surface 211 and the radial direction of the anchoring portion 2 is in the range of [15°, 60°].

[0071] In some embodiments, the angle between the first inclined surface 211 and the radial direction of the anchoring portion 2 is in the range of [30°, 45°].

[0072] In some embodiments, the angle between the second inclined surface 221 and the radial direction of the anchoring portion 2 is in the range of [15°, 60°].

[0073] In some embodiments, the angle between the second inclined surface 221 and the radial direction of the anchoring portion 2 is in the range of [30°, 45°].

[0074] In some embodiments, an elastic adjustment portion is sleeved around the periphery of the clamping portion 23, and the elastic adjustment portion is adjustable along the radial x dimension. This allows for the adaptation to punctures 204 of different sizes, improving the versatility of the sealing device 100. Furthermore, the edge of the puncture 204 is sleeved on the elastic adjustment portion, which improves the sealing effect on the puncture 204 and allows for flexible contact between the edge of the puncture 204 and the clamping portion 23, preventing further tearing of the edge of the puncture 204.

[0075] In some embodiments, the blocking device 100 has a body 1, which has a retracted state and a blocking state. The body 1 is configured to deform from the retracted state along the axial and radial directions of the hollow flow channel 20 and switch to the blocking state. The anchoring part 2 is formed after the body 1 deforms and switches to the blocking state, and part or all of the body 1 is deformed to serve as the anchoring part 2.

[0076] The radial dimension of the body 1 in the retracted state is smaller than that in the occlusion state. The body 1 in the retracted state can be cylindrical to adapt to the shape of the inside of the blood vessel, facilitating the movement of the occlusion device 100 within the aorta 200.

[0077] During the placement of the occlusion device 100, the main body 1 is in a retracted state, making the occlusion device 100 as a whole small in size, so that the occlusion device 100 can be more easily inserted into the aorta 200, and can be moved within the aorta 200 and smoothly placed into the rupture 204 area.

[0078] When the retracted body 1 is placed in the area of ​​the opening 204, the body 1 passes through the opening 204, the relative position of the body 1 and the opening 204 is adjusted, the body 1 expands, expands radially and contracts axially, forming the anchoring part 2. For example, the anchoring part 2 is formed by a first fixing part 21, a second fixing part 22, and a clamping part 23. The radial dimensions of the first fixing part 21, the second fixing part 22, and the clamping part 23 of the body 1 can be configured according to the size of the opening 204, the thickness of the inner membrane 201, etc. The radial direction of the body 1 and the radial direction of the anchoring part 2 are consistent.

[0079] In some embodiments, the anchoring portion 2 is integrally formed with the body 1 as part of the body 1. The body 1 expands radially and contracts axially to form the anchoring portion 2.

[0080] In other embodiments, the anchoring part 2 can be independent of the body 1 and connected to the body 1. The anchoring part 2 also has a retracted state and an extended state. During the placement of the sealing device 100, both the anchoring part 2 and the body 1 can be in the retracted state. When the position of the anchoring part 2 corresponds to the position of the body 1, the body 1 and the anchoring part 2 are expanded, so that the clamping part 23 in the anchoring part 2 supports the edge of the rupture 204, and the first fixing part 21 and the second fixing part 22 respectively abut against the two sides of the inner membrane 201, so that the anchoring part 2 in the extended state is anchored on the inner membrane 201.

[0081] In specific implementation, the body 1 can be made of shape memory alloy. Shape memory alloy has shape memory effect. The shape of the anchoring part 2 in the blocking state can be configured to its original shape. When the blocking device 100 is assembled in place, the blocking device 100 can be restored from the retracted state to the original state by applying force (expanding the body 1 through the expansion structure) or other means.

[0082] The body 1 can also be made of polymer materials or biodegradable materials. In this case, the shape of the anchoring part 2 or the original state of the sealing device 100 can be maintained in various ways to ensure the sealing effectiveness and stability of the sealing device 100.

[0083] Method 1 involves using a biodegradable material that can recover to its original shape under specific conditions, i.e., a biodegradable material with shape memory function. Alternatively, a material with shape memory function can be added to the biodegradable material used to prepare the sealing device 100, thereby using the material with shape memory function to drive the molding of the entire body 1 to obtain the anchoring part 2. It should be noted that, in this case, the original state of the sealing device 100 is taken as the state when effective sealing occurs.

[0084] Method Two: An auxiliary forming mechanism is used to assist the main body 1 in forming the anchoring part 2, allowing the main body 1 to switch from a retracted state to its original state, thereby effectively sealing the breach 204. The auxiliary forming mechanism can be withdrawn after the anchoring part 2 is formed on the main body 1. For example, the auxiliary forming mechanism can be a forming line that passes through the main body 1. When the main body 1 is in the retracted state, the forming line reaches the breach 204 along with the main body 1. After the sealing device 100 is released (also known as expansion), the forming line is pulled back, and the forming line assists the main body 1 in forming the anchoring part 2 before being withdrawn.

[0085] Method 3: The sealing device 100 is equipped with an adhesive component. The adhesive component can achieve adhesion after a set time following unsealing; or after a certain period of contact with blood; or the adhesive component can be sealed with a sealing layer before the sealing device 100 is released, and after the sealing device 100 is released, the sealing layer is torn or damaged, exposing the adhesive surface of the adhesive component, thus achieving adhesion. This method can bond a portion of the anchoring part 2 of the sealing device 100 to the inner membrane, and can also bond components at different locations of the sealing device 100 to maintain the formed anchoring part 2.

[0086] Method four: The sealing device 100 has riveting components. After the sealing device 100 is released, that is, after the anchoring part 2 is formed in the body 1, at least the components corresponding to the anchoring part 2 in the sealing device 100 are riveted to improve the shape stability of the anchoring part 2 and ensure the sealing effectiveness of the sealing device 100. A part of the body 1 has a magnetically conductive structure that can serve as a magnetic conductor and be magnetically attracted to a magnetic component. Alternatively, a magnetic conductor can be additionally provided at a corresponding position on the body 1.

[0087] Method 5: The sealing device 100 has a magnetic component. During the release process of the sealing device 100, the magnetic component and the corresponding magnetic conductor are magnetically attracted to maintain the shape of the anchoring part 2, thereby achieving the stability of the shape of the formed anchoring part 2 and ensuring the sealing effectiveness of the sealing device 100.

[0088] Method 6: The sealing device 100 has a traction locking structure. After the sealing device 100 is formed to obtain the anchoring part 2, the traction locking structure is locked by interference fit or snap-fit ​​to maintain the shape of the formed anchoring part 2 and improve the stability of the shape of the anchoring part 2.

[0089] It is understandable that the shape of the anchoring part 2 obtained by molding can also be maintained in other ways, which will not be listed here.

[0090] The body 1 includes a skeleton formed by a woven structure and / or a skeleton formed by a cutting process. For example, the entire body 1 can be a skeleton formed by a woven structure. Alternatively, the entire body 1 can be a skeleton formed by a cutting process. Yet another example is that a portion of the body 1 is a skeleton formed by a woven structure, and another portion is a skeleton formed by a cutting process. The specific structural style of the body 1 is configured according to actual needs.

[0091] In some embodiments, the body 1 may be made of metal, polymer, biodegradable material, or other materials suitable for human safety.

[0092] In some embodiments, the sealing device 100 may be a single-layer structure as a whole. The sealing device 100 may also be a multi-layer structure as a whole. The sealing device 100 may have a portion that is a single-layer structure and another portion that is a multi-layer structure. The single-layer structure includes, but is not limited to, a single-layer braided structure. The multi-layer structure includes, but is not limited to, a multi-layer braided structure.

[0093] In some embodiments, the clamping portion 23 may be a single-layer structure. For example, the clamping portion 23 may be a single-layer woven structure.

[0094] In other embodiments, the clamping part 23 can be a multi-layered structure. For example, the clamping part 23 is a multi-layered braided structure. In the radial direction of the body 1, the diameter of the innermost braided structure is smaller than the diameter of the outermost braided structure. The outermost braided structure is supported by the opening 204, and the diameter of the outermost braided structure matches the size of the opening 204. The innermost braided structure can be connected to the support 3, and the diameter of the outermost braided structure matches the expanded diameter of the support 3.

[0095] The difference between the diameter of the outermost braided structure and the diameter of the innermost braided structure is the thickness of the clamping part 23. By configuring different thicknesses of the clamping part 23, sealing devices 100 of different specifications can be obtained to adapt to different sizes of ruptures 204 and different types of brackets 3.

[0096] In some embodiments, the first fixing part 21 is a single-layer structure. For example, the first fixing part 21 is a single-layer woven structure.

[0097] In some embodiments, the second fixing part 22 is a single-layer structure. For example, the second fixing part 22 is a single-layer woven structure.

[0098] In some embodiments, the anchoring portion 2 is provided with a flow-blocking portion 5. The flow-blocking portion 5 can prevent blood from seeping out of the hollow channel 20, thereby ensuring the blood flow supplied to the branch blood vessel 300 through the hollow channel 20. Wherein, when the anchoring portion 2 is obtained by deforming the body 1, the flow-blocking portion 5 is also provided on the body 1.

[0099] In some non-limiting embodiments, the flow-blocking portion 5 may be a flow-blocking membrane. This application does not limit the specific material of the flow-blocking portion 5.

[0100] In some non-limiting embodiments, the flow-blocking part 5 can be connected to the anchoring part 2 by means of stitching, hot pressing (e.g., double-sided hot pressing), or by means of dip coating.

[0101] The flow-blocking part 5 can be disposed on the inner wall surface, outer wall surface, or fill the gaps in the body 1 or be embedded in the anchoring part 2. The relative position of the flow-blocking part 5 and the anchoring part 2 depends on their connection method. Specifically, when the flow-blocking part 5 is connected to the anchoring part 2 by stitching, it can be located inside, outside, or embedded in the anchoring part 2; that is, it can be connected to the inner wall surface or the outer wall surface of the anchoring part 2. When the flow-blocking part 5 is connected to the anchoring part 2 by hot pressing, it can be located on the inner or outer wall surface, and the interface between the flow-blocking part 5 and the anchoring part 2 can be physically fused together. When the flow-blocking part 5 is connected to the anchoring part 2 by dip coating, the gaps in the flow-blocking part 5 fill the pores in the anchoring part 2, achieving a flow-blocking effect by filling the pores.

[0102] In some embodiments, the flow-blocking part 5 may be made of a biodegradable material or a metallic material.

[0103] It is understandable that the blocking device 100 may not have the flow-blocking part 5. When the blocking device 100 does not have the flow-blocking part 5, the blood can be blocked by the structure of the anchoring part 2. For example, the anchoring part 2 is a multi-layer dense mesh woven structure, and the density of the dense mesh woven structure blocks the blood flow.

[0104] In some embodiments, the occlusion device 100 may be provided with a connecting reinforcement portion, which is used to strengthen the connection strength of the occlusion device 100 at the rupture 204 or to strengthen the connection strength of the stent 3 within the branch blood vessel. The connecting reinforcement portion may be a protrusion provided on the outer surface of the stent 3, protruding beyond the outer surface of the stent 3 to enhance the friction between the stent 3 and the branch blood vessel, thereby preventing the stent 3 from moving relative to the branch blood vessel under continuous blood flow impact, and thus preventing the rupture 204 from being torn due to the positional change of the anchoring portion 2 caused by the movement of the stent 3, thereby improving the stability of the fixed position of the occlusion device 100.

[0105] The protrusion can be a regular structural shape or an irregular, irregular structural shape.

[0106] The connecting reinforcement can be integrally formed into the bracket 3. Alternatively, the connecting reinforcement can be connected to the bracket 3 as a separate component.

[0107] The occlusion device 100 provided in this application can not only close the false lumen but also preserve the blood supply channels of branch vessels. Especially when the branch vessels are branch arteries supplying blood to the visceral area, while achieving precise and effective closure of the false lumen, the hollow flow channel 20 and the hollow structure 33 work together to avoid blocking the branch vessels, greatly reducing the coverage of the healthy aorta by foreign objects and lowering the risk of spinal cord ischemia.

[0108] Furthermore, the sealing device 100 is expected to achieve complete cure of the aortic dissection, avoid the need for visceral artery revascularization, greatly simplify the surgical operation of aortic dissection rupture, and reduce surgical risks.

[0109] It should be understood that the term "and / or" in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article indicates that the preceding and following related objects have an "or" relationship.

[0110] In the embodiments of this application, "multiple" refers to two or more.

[0111] The descriptions of "first," "second," etc., appearing in the embodiments of this application are for illustrative purposes and to distinguish the objects being described. They have no order and do not indicate any special limitation on the number of devices in the embodiments of this application, nor do they constitute any limitation on the embodiments of this application.

[0112] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A sealing device for aortic dissection rupture, characterized in that, include: An anchoring portion, having a hollow flow channel, is anchored to the intima around the rupture to prevent fluid communication between the true lumen of the aorta and the false lumen formed at the rupture. A stent, positionably coupled to the anchoring portion, the stent having a connecting end and a free end, at least the free end of the stent being located within the branch vessel, the stent having a hollow structure communicating with the hollow flow channel, and being supported within the branch vessel to communicate the true lumen and the branch vessel.

2. The sealing device for aortic dissection rupture according to claim 1, characterized in that, It also includes a connecting part that is connected to both the anchoring part and the connecting end of the stent. The connecting part connects the hollow flow channel and the hollow structure. The connecting part is configured to adjust the relative position of the stent and the anchoring part so that the axial direction of the stent is adapted to the direction of the branch blood vessel.

3. The sealing device for aortic dissection rupture according to claim 2, characterized in that, The connecting part is made of a deformable material; or the connecting part is a bendable or foldable structure; or the connecting part is angularly connected to the anchoring part; or the connecting part is angularly connected to the bracket.

4. The sealing device for aortic dissection rupture according to any one of claims 1 to 3, characterized in that, The stent may include a single stent, wherein the hollow structure of the single stent has a blood flow direction; or the stent may be a multi-branched stent, wherein the hollow structure of the multi-branched stent has multiple sub-hollow sections, each sub-hollow section being isolated from each other and communicating with the hollow flow channel.

5. The sealing device for aortic dissection rupture according to any one of claims 1 to 3, characterized in that, It also includes a bending adjustment structure connected to the bracket, the bending adjustment structure being configured to adjust the extension direction of the bracket.

6. The sealing device for aortic dissection rupture according to claim 5, characterized in that, The bending structure includes a pull-out structure, which has at least two pull-out lines. The fixed end of each pull-out line is connected to the free end of the bracket and passes through at least a portion of the bracket. The pull-out end of the pull-out line can move relative to the bracket, and the at least two pull-out lines are configured to be pull-out independently.

7. The sealing device for aortic dissection rupture according to claim 6, characterized in that, The bending structure has a locking structure, which is used to lock the pull end of the pull line after the pull line has adjusted the extension direction of the bracket by pulling.

8. The sealing device for aortic dissection rupture according to any one of claims 1 to 3, characterized in that, The anchoring part includes: A first fixing part surrounds the hollow flow channel. The size of the first fixing part is larger than the size of the opening, and it abuts against the inner membrane on the side facing the true cavity.

9. The sealing device for aortic dissection rupture according to claim 8, characterized in that, The anchoring part further includes: A second fixing part surrounds the hollow flow channel, and the size of the second fixing part is larger than the size of the opening, abutting against the inner membrane on the side facing the false cavity; A clamping part is located between the first fixing part and the second fixing part, along the radial direction of the anchoring part. The size of the clamping part is smaller than the size of the first fixing part and the second fixing part. The opening is fitted onto the clamping part, and the inner membrane at the opening is clamped in the clamping space between the first fixing part and the second fixing part.

10. The sealing device for aortic dissection rupture according to claim 9, characterized in that, An elastic adjustment part is sleeved around the clamping part, and the elastic adjustment part is adjustable in size along the radial direction.

11. The sealing device for aortic dissection rupture according to claim 9, characterized in that, Along the radial direction of the anchoring portion, toward a direction away from the clamping portion, the clamping space contracts.

12. The sealing device for aortic dissection rupture according to claim 9, characterized in that, The first fixing part has a first inclined surface facing the second fixing part; and / or the second fixing part has a second inclined surface facing the first fixing part.

13. The sealing device for aortic dissection rupture according to claim 12, characterized in that, The angle between the first inclined surface and the radial direction of the anchoring part ranges from [15°, 60°]; and / or The angle between the first inclined surface and the radial direction of the anchoring part ranges from [30°, 45°]; and / or The angle between the second inclined plane and the radial direction of the anchoring part ranges from [15°, 60°]; and / or The angle between the second inclined plane and the radial direction of the anchoring part ranges from [30°, 45°]; and / or The area where the first inclined surface connects to the clamping part has a curved transition; and / or The area where the second inclined surface connects to the clamping part has a curved transition.

14. The sealing device for aortic dissection rupture according to claim 9, characterized in that, The sealing device has a body, which has a retracted state and a sealing state. The body is configured to deform along the axial and radial directions of the hollow flow channel from the retracted state to the sealing state. The anchoring part is formed after the body deforms and switches to the sealing state.

15. The sealing device for aortic dissection rupture according to claim 14, characterized in that, The body includes a skeleton formed by a woven structure and / or a skeleton formed by a cutting process.

16. The sealing device for aortic dissection rupture according to claim 14, characterized in that, The body can be configured as a multi-layer structure; and / or The clamping part is a single-layer structure or a multi-layer structure; and / or The first fixing part is a single-layer structure; and / or The second fixing part is a single-layer structure.

17. The sealing device for aortic dissection rupture according to claim 1, characterized in that, A flow-blocking part is provided along the anchoring part.

18. The sealing device for aortic dissection rupture according to claim 1, characterized in that, The hollow channel is divided into multiple sub-channels along its own axis, and each sub-channel is used to connect the corresponding branch blood vessel.

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