Occlusion device

Abstract

The present application relates to an occlusion device comprising a fixing portion and a sealing portion. The fixing portion comprises at least one support member. The occlusion device has an initial state and an assembled state. In the initial state, a first connection portion and a second connection portion are separated from each other. In the assembled state, the first connection portion is connected to the second connection portion to connect the fixing portion and the sealing portion. Therefore, the sealing portion and the fixing portion can be relatively independently packaged and produced, and assembled according to required dimensions when implantation is needed. Thus, the assembled left atrial appendage occlusion device exhibits relatively good adaptability and can also adapt to left atrial appendages with special shapes.

Description

Blocking device

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 29, 2023, with application number 202311868121.3 and invention name “Sealing Device”. Technical Field

[0002] The present application relates to the technical field of interventional medical devices, and in particular to a blocking device. Background Art

[0003] In interventional medicine, an occlusion device is an instrument used to seal or block a blood vessel or cavity. It is usually used to treat vascular abnormalities or lesions to block abnormal blood flow or close abnormal channels. Common occluders mainly include vascular occluders, hole occluders, and catheter occluders. Among them, hole occluders are mainly used to seal holes or defects in the heart, such as the left atrial appendage, atrial septal defect, or patent ductus arteriosus. Taking the left atrial appendage as an example, the left atrial appendage is a narrow, curved, blind-end structure extending forward and downward along the anterior wall of the left atrium. It has active contraction and secretion functions. Strokes caused by atrial fibrillation mainly originate from the left atrial appendage. During interventional surgery, a left atrial appendage occluder can usually be used to seal the mouth of the left atrial appendage to prevent blood clots in the left atrial appendage from entering the left atrium and causing strokes caused by atrial fibrillation, and also to block blood flow from the left atrium into the left atrial appendage.

[0004] Currently, there are two main structures of left atrial appendage occluders on the market: plug type and double-disc type. Among them, the double-disc left atrial appendage occluder usually includes a fixed disk and a sealing disk. In the existing disk-type left atrial appendage occluder, the fixed disk and the sealing disk are usually fixedly connected as one by welding or an intermediate connector.

[0005] However, the fixing disk and sealing disk of the left atrial appendage occluder implanted in the patient's body generally need to be adapted according to the shape and size of the corresponding position of the patient's left atrial appendage. On the one hand, the specifications of existing left atrial appendage occluders are limited and meet certain relative size restrictions; on the other hand, the size and shape of the patient's left atrial appendage will only be accurately measured during the implantation stage. If there is no suitable left atrial appendage occluder, the operation cannot be performed. If it is re-customized, the patient needs to be re-implanted, which brings greater risks. Summary of the Invention

[0006] Based on this, it is necessary to provide an improved occlusion device to solve the technical problems that the existing occlusion device has an integrated structure, which increases the difficulty of inventory and production management when the reserve is too large, and easily delays the timing of surgery when the reserve is too small. The specific details are as follows:

[0007] A sealing device is provided, comprising a fixing portion and a sealing portion, wherein the fixing portion comprises at least one supporting body, and the sealing device comprises an initial state and an assembled state, wherein in the initial state, the first connecting portion and the second connecting portion are separated from each other; in the assembled state, the first connecting portion is connected to the second connecting portion to connect the fixing portion and the sealing portion.

[0008] In one embodiment, the fixing portion and the sealing portion are stably connected after assembly.

[0009] In one embodiment, the first connecting portion includes a connecting head extending in the axial direction, the connecting head includes a main body and a stopper extending from a proximal end to a distal end, and a diameter of the stopper is larger than a diameter of the main body.

[0010] In one embodiment, the second connecting portion includes a hollow tubular structure, and the second connecting portion includes a plurality of at least two circumferentially oppositely arranged blocking pieces extending obliquely from the tubular structure toward the inner side and the distal end.

[0011] In one embodiment, the inner diameter of the tubular structure is larger than the outer diameter of the connector, and the inner diameter of the channel surrounded by the free ends of the plurality of baffles is smaller than the outer diameter of the baffles.

[0012] In one embodiment, the diameter of the stopper gradually decreases from the proximal end to the distal end.

[0013] In one embodiment, a step surface is provided at a connection position or transition area between the stopper and the main body.

[0014] In one embodiment, the first connecting portion includes at least one positioning member distributed along the circumferential direction, and the proximal side of the second connecting portion is provided with at least one positioning groove matching the positioning member.

[0015] In one embodiment, the proximal end surface or the distal end surface of the sealing portion includes a straight section and a curved section, the curved section is located outside the straight section, and the edge of the curved section is located at the distal end of the straight section.

[0016] In one embodiment, in a natural state, the length of the curved segment from the proximal end to the distal end ranges from 1 to 5 mm.

[0017] Compared to the prior art, the present application provides a closure device comprising a fixing portion and a sealing portion, wherein the fixing portion comprises at least one support body, and the closure device comprises an initial state and an assembled state. In the initial state, the first connecting portion and the second connecting portion are separated from each other; in the assembled state, the first connecting portion connects to the second connecting portion to connect the fixing portion and the sealing portion. Thus, the sealing portion and the fixing portion can be packaged and produced relatively independently, and then assembled according to the required size when implanted. Thus, the assembled left atrial appendage occluder has good adaptability and can also adapt to some special-sized left atrial appendage shapes. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG1 is a schematic structural diagram of a blocking device in a natural state according to an embodiment of the present application;

[0019] FIG2 is a schematic diagram of the external structure of the blocking device in a natural state according to an embodiment of the present application;

[0020] FIG3 is a schematic structural diagram of a fixing portion of a blocking device in a natural state in a front view according to an embodiment of the present application;

[0021] FIG4 is a schematic structural diagram of a fixing portion of a blocking device in a natural state as viewed from above in one embodiment of the present application;

[0022] FIG4a is a schematic structural diagram of a variant of a fixing portion of a blocking device in one embodiment of the present application, viewed from above in a natural state;

[0023] FIG4 b is a schematic structural diagram of a second variant of the fixing portion of the blocking device in a natural state as viewed from above, according to one embodiment of the present application;

[0024] FIG4c is a schematic structural diagram of a third variant of the fixing portion of the blocking device in a natural state as viewed from above, according to one embodiment of the present application;

[0025] FIG5 is a schematic structural diagram of a sealing portion of a blocking device in a natural state according to an embodiment of the present application;

[0026] FIG6 is a schematic structural diagram of a blocking device before assembly according to an embodiment of the present application;

[0027] FIG7 is a schematic diagram of the assembly position of the blocking device in one embodiment of the present application;

[0028] FIG8 is a schematic structural diagram of a first tool for assembling a blocking device according to an embodiment of the present application;

[0029] FIG9 is a schematic diagram of a first state of a first assembly tool for a blocking device according to an embodiment of the present application;

[0030] FIG10 is a schematic diagram of a second state of a first tool for assembling a blocking device according to an embodiment of the present application;

[0031] FIG11 is a schematic structural diagram of a second tool for assembling a blocking device according to an embodiment of the present application;

[0032] FIG12 is a schematic diagram of a working embodiment of the present application of a clamp of the second tooling for assembling the blocking device;

[0033] FIG13 is a schematic diagram of another clamp of the second tooling for assembling the blocking device in one embodiment of the present application;

[0034] FIG14 is a schematic structural diagram of a blocking member in one embodiment of the present application;

[0035] FIG15 is a schematic diagram of the working of the second tool for assembling the plugging device in one embodiment of the present application;

[0036] FIG16 is a schematic structural diagram of a blocking device in another embodiment of the present application;

[0037] FIG17 is a schematic diagram showing the connection between the fixing portion and the sealing portion of the blocking device in another embodiment of the present application;

[0038] FIG18 is a schematic structural diagram of a blocking device in another embodiment of the present application;

[0039] FIG19 is a schematic diagram showing the connection between the fixing portion and the sealing portion of the blocking device in another embodiment of the present application;

[0040] FIG20 is a schematic diagram showing the connection between the fixing portion and the sealing portion of the blocking device in another embodiment of the present application. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solutions and advantages of this application more clearly understood, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0042] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device. "Axial" generally refers to the length of the medical device during delivery, and "radial" generally refers to the direction perpendicular to the "axial direction" of the medical device. This principle is used to define the "axial" and "radial" directions of any component of a medical device. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.

[0043] The technical solution of the present application will be further described in detail below with reference to specific embodiments.

[0044] The occlusion device provided in the embodiments of the present application can be used to occlude the left atrial appendage, and can also be used to occlude other body tissues with openings, including but not limited to atrial septal defects, patent ductus arteriosus, etc. The occlusion device will be described in detail below using the occlusion of the left atrial appendage as an example.

[0045] Please refer to Figures 1-2. Figure 1 is a schematic structural diagram of the occluding device 100 in a natural state in one embodiment of the present application. Figure 2 is a schematic external structural diagram of the occluding device 100 in a natural state in one embodiment of the present application. The occluding device 100 includes a fixing portion 120 and a sealing portion 110 connected to the fixing portion 120. The sealing portion 110 and the fixing portion 120 are spaced apart along the axial direction of the occluding device 100. The sealing portion 110 is located at the proximal end of the occluding device 100, and the fixing portion 120 is located at the distal end of the occluding device 100. The occluding device 100 has a compressed state housed in a sheath for easy transportation, and an expanded state as shown in Figure 1 after extending from the distal end of the sheath and self-expanding. The shape of the occluding device 100 after being released in the cavity of the left atrial appendage is exactly the same or substantially the same as that in Figure 1. In other implementations, such as when used for occluding atrial septal defects, the sealing portion 110 and the fixing portion 120 may be brought closer to each other after being released to fix the occlusion device 100 on the septum between the left atrium and the right atrium.

[0046] In this embodiment, the sealing portion 110 is woven into a mesh tube by a plurality of braided wires 111, and the ends of the braided wires 111 are respectively closed and fixed by a sleeve at both ends of the mesh tube. The mesh tube is then heat-formed into a disc-like, columnar or plug-like shape, thereby obtaining a sealing portion 110 for sealing the opening of the left atrial appendage. The sealing portion 110 includes a distal disk surface 112 facing the fixing portion 120, and a proximal disk surface 113 opposite to the distal disk surface 112. The interior of the sealing portion 110 is provided with at least one layer of a thin film body (not shown) used as a flow-blocking membrane, and the edge of the thin film body is fixed on the braided wire 111 at the edge of the sealing portion 110, generally fixed by sutures, and the thin film body is between the distal disk surface 112 and the proximal disk surface 113.

[0047] In another embodiment, the film body is in close contact with the proximal disk surface 113 or the distal disk surface 112. When there are multiple films, the positions of the films can be selected arbitrarily.

[0048] The thin film is used to prevent blood from flowing from one side of the sealing portion 110 to the other side, so as to prevent blood from flowing between the left atrial appendage and the left atrium.

[0049] In another embodiment, the total number of braided wires 111 used in the sealing portion 110 is increased. On the one hand, a larger number of braided wires can objectively better block the blood flow and support the flow-blocking membrane, thereby achieving a better sealing effect. On the other hand, the disk edge of the woven sealing portion 110 can be made up of more wires, thereby further filling the gaps at the edge, thereby obtaining a smoother disk edge, and then making it fit more closely with the inner wall of the left atrial appendage than the traditional setting. In another embodiment, the total number of braided wires 111 exceeds 72 strands, that is, the sealing frame of the sealing portion 110 is a dense mesh structure, preferably 114 strands of wire.

[0050] In another embodiment, when the sealing frame of the sealing portion 110 is a dense mesh structure, the mesh structure formed by the braided wires 111 is dense enough to prevent the blood clots in the atrial appendage from flowing out, thereby eliminating the need for a flow-blocking membrane.

[0051] The fixing portion 120 includes at least one support 121 and a coating covering the surface of the support 121. The sealing portion 110 is directly or indirectly connected to the fixing portion 120. The support 121 on the fixing portion 120 can be a rod obtained by cutting a metal alloy tube or a polymer tube, or can be a rod made by weaving or winding a braided wire. In this embodiment, the specific shape of the support 121 is not limited. In order to improve the anchoring ability of the fixing portion 120, an anchor 130 is provided on the fixing portion 120 in this embodiment. The anchor 130 can be a structure such as an anchor barb or a ball head that can be snapped into a predetermined position.

[0052] In this embodiment, the support body 121 of the fixing portion 120 does not necessarily have to be a completely independent support rod structure. There may also be cross-linking between adjacent support bodies 121, as long as the whole can play a supporting role. Multiple support bodies 121 extend toward the distal end from the central convergence point and extend toward the proximal end after being flipped.

[0053] In this embodiment, further combined with Figures 3-4, Figure 3 is a structural schematic diagram of the fixing portion 120 of the blocking device 100 in an embodiment of the present application in a natural state when viewed from the front, and Figure 4 is a structural schematic diagram of the fixing portion 120 of the blocking device 100 in an embodiment of the present application in a natural state when viewed from above. For a single support body 121, a blocking member 122 is provided at the proximal end of the support body 121. The blocking member 122 can be directly cut from the end of the support body 121 (that is, it can be integrally formed with the support body 121 or is part of the support body 121), or it can be fixed to the proximal end of the support body 121 by various means such as welding and bonding.

[0054] In the natural state, the circumferential width of the blocking member 122 is greater than the width of the support body 121 close to the blocking member 122. For the convenience of quantification, the root of the anchor 130 is taken as the starting point, and the position of the support body 121 from the root of the anchor 130 to the nearest end of the support body 121 is recorded as the extension section of the support body 121. The circumferential width of the blocking member 122 is greater than the width of the extension part of the support body 121, so that when the fixing part 120 is close to the sealing part 110, the blocking member 122 can prevent or reduce the risk of the proximal side of the support body 121 being stuck in the sealing part 110.

[0055] In this embodiment, in order to prevent the blocking member 122 from affecting the smoothness of the overall entry and exit of the occluding device 100 into and out of the sheath, the blocking member 122 is preferably a hollow annular structure. The annular shape here is not a strictly circular ring shape, but refers to the blocking member 122 being a closed ring closed at both ends, that is, the blocking member 122 does not have an opening.

[0056] In another embodiment, the blocking member 122 includes a pair of connecting rods that are at least partially away from each other. The blocking member 122 extends from the extension portion of the support body 121 to form a pair of connecting rods. There is a gap between the two connecting rods at least in part, and the ends of the two connecting rods are close to and connected to each other. The ends formed by the close proximity and connection are smooth, preferably spherical, to avoid the risk of potential damage to the implantation site (such as the inner wall of the auricle)

[0057] Preferably, in this embodiment, the blocking member 122 extends from the extension portion of the support body 121 and extends toward the distal side, so as to cooperate with the extension portion of the support body 121 as a whole to form a U-shaped structure, so that the free end side of the fixing portion 120 is away from the implantation position (such as the inner wall of the auricle), thereby avoiding stress concentration or damage to the implantation position.

[0058] In the prior art, if the blocking member 122 is not designed as in the present embodiment, the extension portion of the support body 121 (or the end of the support body 121) is very likely to get stuck in the sealing portion 110. Therefore, the prior art generally leaves a certain distance between the fixing portion 120 and the sealing portion 110, resulting in a longer overall length of the occlusion device 100. Since the position of the left atrial appendage changes with the contraction and relaxation of the heart, the risk of the extension portion of the support body 121 (or the end of the support body 121) getting stuck in the sealing portion 110 is always high in the prior art. Therefore, the design of the blocking member 122 in the present embodiment can significantly reduce or even prevent the extension portion of the support body 121 (or the end of the support body 121) from getting stuck in the braided body of the sealing portion 110.

[0059] In another embodiment, the circumferential width of the blocking member 122 is greater than the mesh width (also understood as the diameter) of all distal end surfaces of the braided body of the sealing portion 110 , so that the blocking member 122 cannot be directly inserted into the sealing portion 110 .

[0060] In another embodiment, the blocking member 122 radially spans over at least two grids of the distal end surface of the sealing portion 110 , such that the blocking member 122 cannot be directly inserted into the sealing portion 110 .

[0061] In another embodiment, the blocking member 122 spans over at least two grids of the distal end surface of the sealing portion 110 in the circumferential direction, so that the blocking member 122 cannot be directly inserted into the sealing portion 110 .

[0062] In another embodiment, in a natural state, the blocking member 122 is entirely located at the proximal end of the anchor member 130 .

[0063] In another embodiment, the circumferential width of the blocking member 122 is greater than twice the width of the maximum grid of the distal end surface of the braided body of the sealing portion 110, so that even if the sealing portion is deformed, the blocking member 122 cannot be directly stuck in the sealing portion 110 as much as possible.

[0064] In another embodiment, the blocking member 122 has other shapes, referring to Figures 4a, 4b, and 4c. Figure 4a is a structural schematic diagram of a variant 1 of the fixing portion of the blocking device in one embodiment of the present application, viewed from above in a natural state; Figure 4b is a structural schematic diagram of a variant 2 of the fixing portion of the blocking device in one embodiment of the present application, viewed from above in a natural state; Figure 4c is a structural schematic diagram of a variant 3 of the fixing portion of the blocking device in one embodiment of the present application, viewed from above in a natural state; taken together, the blocking member 122 can be set to a ring-shaped blocking member 122a, which is smoother and more stable than the aforementioned blocking member 122. The blocking member 122b can be configured as a single blocking rod, with the blocking member 122b projecting an arc on the cross-section of the fixed portion. The free end of the blocking member 122b is located distally of the starting end, and the projection of the blocking member 122b on the cross-section of the fixed portion is a major arc. This allows the proximal end of the blocking member 122b to be continuous, thereby preventing the free end from being stuck in the sealing portion 110. The blocking member 122c can be configured as a single rod, with the projection of the blocking member 122c on the cross-section of the fixed portion forming at least one spiral circumference. The free end of the blocking member 122c is located distally of the starting end, thereby preventing the free end from being stuck in the sealing portion 110. It should be emphasized that although blocking members 122b and 122c are not closed structures, they are easier to manufacture and finalize, resulting in lower costs.

[0065] In this embodiment, the sealing portion 110 is also optimized. Further referring to Figure 5, Figure 5 is a structural schematic diagram of the sealing portion 110 of the sealing device 100 in an embodiment of the present application in a natural state. From the overall shape, the edge of the sealing portion 110 is located at the farthest end of the sealing portion 110 as a whole, so that the sealing portion 110 as a whole is in a state of protruding toward the proximal side.

[0066] Specifically, in this embodiment, the proximal surface and the distal surface of the sealing portion 110 are in close contact (the close contact in this embodiment does not mean that they are always in contact in a strict sense, and the distance between the two is close to 0 or the gap is less than 1 mm, which is considered to be in close contact). The proximal surface of the sealing portion 110 includes a straight section 111 and a curved section 112, wherein the curved section 112 is located on the outside of the straight section 111, and the edge of the curved section 112 is located at the distal end of the straight section 111. In a natural state, the length h of the curved section 112 from the proximal end to the distal end is 1-5 mm, preferably 3 mm.

[0067] Therefore, due to the presence of the curved segment 112, the axial length of the sealing portion 110 is longer than that of an ordinary disc, and it can even partially overlap with the fixing portion 120 in the axial direction without contacting the fixing portion 120, thereby shortening the axial length of the entire sealing device 100 as a whole, which is more conducive to reducing the occurrence of rejection reactions. Combined with the previous setting of the fixing portion 120, the axial length of the sealing device 100 can be shorter.

[0068] In addition, since the edge of the sealing portion 110 is located at the farthest end of the sealing portion 110 as a whole, the sealing portion 110 can be used as a cover to cover the opening of the atrial appendage, or it can be inserted into the interior of the atrial appendage. The squeezing of the atrial appendage will cause the outer edge of the sealing portion 110 to have a certain axial length, thereby expanding the contact area between the sealing portion 110 and the inner wall of the atrial appendage and improving the sealing effect of the sealing portion 110. Therefore, when the atrial appendage is deep, the sealing portion 110 can be inserted into the interior of the atrial appendage, and when the atrial appendage is shallow, the opening of the atrial appendage can be covered, which greatly increases the adaptability of the occluding device 100 to various environments. Most importantly, due to the above-mentioned design, the edge on the proximal side of the occluding device 100 is in close contact with the inner wall of the atrial appendage or the opening of the atrial appendage after implantation, so that new thrombus will not be generated due to the gap between the edge and the inner wall of the atrial appendage or the opening of the atrial appendage.

[0069] It should be noted that when the length h of the curved segment 112 from the proximal end to the distal end is greater than 5 mm, the curved segment 112 will affect the anchoring of the anchor 130 due to its excessive axial length and may interfere with and wear the film on the fixing part 120; when the length h of the curved segment 112 from the proximal end to the distal end is less than 1 mm, the curved segment 112 is likely to bulge toward the distal side when squeezed, thereby achieving a technical effect that is completely opposite to that of the present embodiment, affecting the good sealing of the occluding device 100. The length of the curved segment 112 from the proximal end to the distal end should be as close to 3 mm as possible. Taking into account the process error, the length of the curved segment 112 from the proximal end to the distal end can preferably be 2-4 mm.

[0070] In another embodiment, the proximal and distal surfaces of the sealing portion 110 are not completely in contact with each other, but the above-mentioned effect is more dependent on the distal surface. Therefore, in this embodiment, a straight section and a curved section are provided on the distal surface of the sealing portion, so that the length of the curved section from the proximal end to the distal end is 1-5 mm, preferably 3 mm, and the remaining settings are the same as in the aforementioned embodiment.

[0071] 6-7, FIG6 is a schematic diagram of the structure of the occlusion device 100 before assembly in one embodiment of the present application, and FIG7 is a schematic diagram of the assembly part of the occlusion device 100 in one embodiment of the present application. In this embodiment, the sealing portion 110 and the fixing portion 120 are relatively independent before use, that is, the two are assembled when in use. Thus, the sealing portion 110 and the fixing portion 120 can be transported and manufactured independently, reducing the production process and transportation costs. In addition to manufacturing and transportation, more importantly, during the left atrial appendage occlusion surgery, the operator is required to first introduce the sheath and measure the atrial appendage size during the implantation process, and then implant the occlusion device of the appropriate size according to the measurement results. That is to say, the special feature of the left atrial appendage occlusion surgery is that the selection process of the left atrial appendage occluder is essentially one of the steps of the surgery. Therefore, since it is impossible to accurately determine the size required by the user, the operator needs to prepare a variety of specifications or all specifications of left atrial appendage occluders in advance, which undoubtedly increases the cost. In addition, it should also be noted that the left atrial appendage occlusion in the prior art is not suitable for the operation. After the occluder is manufactured, the dimensions of each part are fixed, that is, the corresponding specifications have been determined before the operator uses it. Manufacturers produce left atrial appendage occluders of various specifications to meet the common atrial appendage shape or size requirements. However, since the atrial appendage size of each user cannot be predicted in advance, the common specifications of the existing technology only have size variations (for example, in the common specifications, the diameter of the fixing part of the left atrial appendage occluder is about 6-10mm smaller than the diameter of the sealing part). If the user's atrial appendage size does not perfectly match the size, only a left atrial appendage occluder of a larger model and specification can be installed. Most importantly, if the patient's atrial appendage size is relatively special (for example, the atrial appendage opening and internal dimensions of some patients are basically the same, or the atrial appendage opening is smaller than the internal dimensions of the atrial appendage, so that the required diameters of the fixing part and the sealing part are similar or even larger), then it exceeds the common preset specifications. The user can only choose to cancel the implantation. The puncture and other steps before implantation will undoubtedly become harmful to the user. If customization is required later, the surgery will be required again after the customization is completed, which brings huge risks. Therefore, in the prior art, the size of the left atrial appendage occluder is often unable to perfectly fit the atrial appendage, and some sizes exceed the specifications of conventional left atrial appendage occluders. Therefore, by utilizing the assemblable design of the fixing portion 110 and the sealing portion 120 in this embodiment, after the operator measures the size of the atrial appendage, the fixing portion 110 and the sealing portion 120 are assembled to obtain an occlusion device 100 that can better fit the user's atrial appendage. Undoubtedly, the occlusion device 100 in this embodiment has better adaptability.

[0072] In addition, because the blocking device 100 is assemblable, when the same number of sealing parts 110 and fixing parts 120 as in the prior art are manufactured, the number of size combinations of the blocking device 100 that can be assembled is greatly increased. For example, to manufacture M sets of sealing parts 110 and fixing parts 120, the operator only needs to prepare the fixing parts 1 and sealing parts 2 of the corresponding specifications to achieve M*M specifications of blocking devices 100, while the prior art can only have M sets of blocking devices 100, which greatly increases the specification selection of the blocking device 100. Furthermore, using the blocking device 100 of this embodiment, different sizes and quantities of sealing parts 110 and fixing parts 120 can be produced to meet different combinations (such as M sets of sealing parts 100 and N sets of fixing parts 120), so there is no need to produce the sealing parts 110 and fixing parts 120 in batches, thereby improving the convenience of production.

[0073] In another embodiment, the sealing portion 110 and the fixing portion 120 are connected by an intermediate piece. Specifically, the fixing portion 120 can be installed on the intermediate piece, and the sealing portion 110 can be installed on the intermediate piece, thereby achieving complete installation of the blocking device 100.

[0074] In another embodiment, the fixing portion 120 and the sealing portion 110 can rotate relative to each other.

[0075] In this embodiment, a first connecting portion 130 is provided at the distal end of the sealing portion 110. The first connecting portion 130 can be fixed to the gathering portion of the woven mesh of the sealing portion 110 (such as fixed to the sleeve position of the sealing portion 110 by welding, threaded connection, etc.), and can also serve as the gathering portion of the woven mesh of the sealing portion 110.

[0076] A second connecting portion 140 is provided at the proximal end of the fixing portion 120 . The second connecting portion 140 can be fixed to the convergent portion of the woven mesh of the fixing portion 120 (welded, threaded, etc.), or can serve as the convergent portion of the support body 121 of the fixing portion 120 .

[0077] The first connecting part 130 and the second connecting part 140 can be assembled. Since the occluding device 100 formed after assembly is an implant, in order to reduce the risk of falling off, in this embodiment, the first connecting part 130 and the second connecting part 140 cannot be disassembled after assembly, that is, the fixing part 120 and the sealing part 110 can be assembled, but cannot be disassembled after assembly. In addition, it should be noted that due to the particularity of the blocking device 100 in this embodiment, it does not belong to the type of product that can be reused or disassembled and assembled multiple times. In fact, disassembling and reassembling the blocking device 100 is likely to affect the life of the connection position, and the increased risk far exceeds the need to save costs. Since the detachable structure itself needs to leave a margin, resulting in a decrease in connection strength, this embodiment preferably allows the first connection part 130 and the second connection part 140 to be assembled but not disassembled. This embodiment interprets this state as being able to be assembled to form a stable connection, wherein a stable connection only expresses that the assembled objects are not removable from each other, rather than expressing that the objects are relatively fixed and stationary. In fact, in other embodiments, the first connection part 130 and the second connection part 140 can still rotate relative to each other after assembly, which still falls within the scope of a stable connection.

[0078] In this embodiment, the first connecting portion 130 includes at least one positioning member 131 distributed along the circumferential direction, and a connecting head 132 extending axially. The connecting head 132 includes a main body 1321 and a stop block 1322 extending from the proximal end to the distal end. The diameter of the stop block 1322 is larger than the diameter of the main body 1321.

[0079] In this embodiment, the second connecting portion 140 includes a hollow tubular structure 141. The second connecting portion 140 includes at least two circumferentially opposed blocking pieces 142 that extend obliquely from the tubular structure 141 toward the inner side and distal end, thereby forming a spring structure. Because the blocking pieces 142 extend inward, they are not exposed to the outside world and do not contact the sheath or catch the support body 121. The inner diameter of the tubular structure 141 is larger than the outer diameter of the connector 132, thereby allowing the connector 132 of the first connecting portion 130 to extend into the tubular structure 141.

[0080] For the baffle 142, the diameter of the incomplete circle formed by the distal ends (i.e., free ends) of at least two circumferentially opposite baffles 142 is smaller than the outer diameter of the baffle 142. In other words, the inner diameter of the channel surrounded by the free ends of multiple baffles 142 is smaller than the outer diameter of the baffle 142.

[0081] In another embodiment, the diameter of the stopper 1322 gradually decreases from the proximal end to the distal end, thereby facilitating the stopper 1322 to pass through the blocking piece 142 toward the distal end.

[0082] In this embodiment, preferably, a step surface is left at the connection position or transition area between the stopper 1322 and the main body 1321 to facilitate the abutment of the free end of the blocking piece 142 .

[0083] In this embodiment, at least one positioning groove 142 matching the positioning member 131 is left on the proximal side of the tubular body structure 141. After the positioning member 131 penetrates into the positioning groove 142 area axially, the first connecting part 130 is limited by the positioning member 131 and the positioning groove 142 relative to the second connecting part 140, so that the two cannot rotate freely. On the one hand, the positioning members 131 and the positioning grooves 142 are distributed along the circumference, and the one-to-one matching of multiple positioning members 131 and multiple positioning grooves 142 makes the first connection part 130 and the second connection part 140 in the same axial position, thereby maintaining the concentricity (coaxiality) of the fixing part 120 and the sealing part 110. On the other hand, more importantly, since the first connection part 130 and the second connection part 140 are assembled during use, and the two serve as the connection parts of the sealing part 110 and the fixing part 120, if the first connection part 130 and the second connection part 140 can be rotated at will, it is easier to cause the connection between the first connection part 130 and the second connection part 140 to become loose and the gap gradually expands, which is easier to cause it to fall off. Therefore, the combination of the first connection part 130 and the second connection part 140 should be as stable and tight as possible. Objectively, the fixing part 120 can also be designed to be rotatable relative to the sealing part 110, but for this embodiment, the rotation structure of the sealing part 110 and the fixing part 120 should avoid the connection position of the first connection part 130 and the second connection part 140.

[0084] Furthermore, the positioning member 131 and the positioning groove 142 are designed so that the sealing part 110 can only be assembled with the fixing part 120 along a specific angle. In this embodiment, the fixing part 120 needs to be connected to the sealing part 110 along the axial direction, and at the same time, the positioning member 131 is always stuck in the positioning groove 142 after installation.

[0085] In another embodiment, the positioning member 131 and the positioning groove 142 can also adapt to certain special situations where the fixing part 120 and the sealing part 110 need to be installed at a specific angle. The positioning member 131 is arranged to be inclined along the circumferential direction, and the positioning groove 142 matches the shape of the positioning member 131, so that the fixing part 120 needs to be rotated along a specific angle to connect with the sealing part 110. The sealing device formed by this combination has higher tightness, and the combination of the assembled positioning member 131 and the positioning groove 142 can also help prevent the relative movement of the fixing part 120 and the sealing part 110 to a certain extent, thereby improving the stability of the sealing device.

[0086] In another embodiment, the inner diameter of the proximal end of the tubular structure 141 is larger than the inner diameter of the distal end, that is, the tubular structure 141 is configured as a trumpet-shaped configuration, so that the combination of the first connecting portion 130 and the second connecting portion 140 is smoother. It is worth noting that when the proximal end of the tubular structure 141 is flared, since the edges of the sealing portion 110 and the fixing portion 120 are close to the edges of the sheath when the occluding device as a whole is transported in the sheath, as long as the outer diameter of the tubular structure 141 is smaller than the inner diameter of the sheath, due to the support of the sealing portion 110 and the fixing portion 120, the tubular structure 141 is basically in the middle position of the sheath, and the transportation process will not be affected by the increase in diameter. In addition, since the distal end of the tubular structure 141 leaves the sheath first when the occluding device is unsheathed, the unsheathing process of the tubular structure 141 is also relatively smooth due to the guidance of its distal end.

[0087] In another embodiment, the positioning groove 142 does not penetrate the side wall of the tube structure 141, so that after the multiple positioning members 131 are respectively pressed against the corresponding positioning grooves 142, the radial and circumferential relative positions of the first connecting portion 130 and the second connecting portion 140 are fixed.

[0088] In another embodiment, the second connecting portion 140 is disposed at the distal end of the sealing portion 110 , and the first connecting portion 130 is disposed at the proximal end of the fixing portion 120 .

[0089] It should be noted that the sealing portion 110 and the fixing portion 120 of the occluding device 100 of this embodiment and related embodiments are relatively independent before use and are assembled only when in use. Conventionally, the operator can assemble and splice the sealing portion 110 and the fixing portion 120 by holding them separately. However, since the occluding device 100 is an implant, it requires high dimensional accuracy. The operator's manual operation cannot meet the requirements of precise installation and is prone to deviation. In addition, the occluding device 100 cannot be deformed multiple times or to a large extent, and manual assembly is also prone to large deformation, which can easily shorten the life of the occluding device 100. At the same time, it is impossible to evenly and stably control the installation force of the occluding device, which can easily cause damage to the device. Furthermore, when assembled by hand, the occluding device is inconvenient to hold and the operation is cumbersome. It is also impossible to quickly and accurately ensure the coaxiality of the fixing disk and the sealing disk. The assembly time is long, and assembly usually occurs during surgery or preparatory surgery, which affects the duration of the operation. Therefore, in order to ensure the reliability of implantation, it is necessary to introduce corresponding tooling.

[0090] It should be noted that the assembly process of the occluding device 100 of this embodiment requires a high degree of coaxial precision, that is, the sealing portion 110 and the fixing portion 120 need to be well aligned (or facing a specific angle). Generally, the assembly process cannot be arranged after implantation in the human body, that is, it is impossible to adopt a sequential implantation method, that is, implanting the fixing portion 120 first and then implanting the sealing portion 110 to complete the assembly at the same time. In fact, objectively speaking, the method of implanting the fixing portion 120 first and then implanting the sealing portion 110 to complete the assembly at the same time is difficult to implement because the component implanted first will begin to move with the heart, and the heart's contraction and relaxation are not linear movements. The fixing portion 120 implanted first will inevitably deviate from the implantation position, and the sealing portion 110 implanted later will almost be impossible to assemble normally. For intracardiac implantation surgery, which has a high safety risk, the risk of such an assembly method is too high and can only remain in a theoretically feasible state.

[0091] In conjunction with the entire implantation process, after selecting the sizes of the sealing portion 110 and the fixing portion 120 of the occluding device 100, the occluding device 100 is assembled and sheathed, and then normal subsequent operations are carried out. Since the traditional sheathing process of the occluding device 100 is to first load it into the loader and then push it into the sheath tube through the loader to achieve sheathing, the occluding device 100 can be assembled in the following two ways to meet different surgical requirements:

[0092] 1. After the occlusion device 100 is assembled using the tooling, it is loaded into the loader, and then the occlusion device 100 is pushed into the sheath tube using a push rod to complete the sheathing. The occlusion device 100 is assembled before loading.

[0093] 2. Place at least a portion of the sealing portion 110 and the fixing portion 120 of the occluding device 100 into a tooling that also serves as a loading device. The occluding device 100 is then assembled and loaded simultaneously. The occluding device 100 is then pushed into the sheath tube using a push rod to complete the sheathing process. The occluding device 100 is assembled and loaded simultaneously.

[0094] As previously mentioned, the occluding device 100 cannot undergo multiple, significant deformations. The compression from its natural state into the loader and the subsequent sheathing process already constitute a state of significant deformation. This deformation cannot be avoided during the sheathing stage. When the device needs to be released a second time after unsheathing, it must be retracted into the sheath and released again, which also requires significant deformation. A typical occluding device 100 may experience significant changes in physical properties and service life after undergoing 4-6 significant deformations. Although not all occluding devices 100 may experience significant changes in physical properties or service life, due to the significantly increased risk, it is generally believed that the occluding device 100 no longer meets implant requirements and will be scrapped. Therefore, during assembly, the sealing portion 110 and the fixing portion 120 of the occluding device 100 should not be subjected to significant compression or deformation during any step other than the sheathing process.

[0095] For the tooling of method 1, as shown in Figures 8-10, Figure 8 is a structural schematic diagram of the first tooling for assembling a sealing device in an embodiment of the present application, Figure 9 is a first state schematic diagram of the first tooling for assembling a sealing device in an embodiment of the present application, and Figure 10 is a second state schematic diagram of the first tooling for assembling a sealing device in an embodiment of the present application, wherein, in the first state, the first tooling 200 respectively installs the fixing part 120 and the sealing part 110 into corresponding fixtures, and in the second state, the first tooling 200 drives the fixing part 120 and the sealing part 110 to achieve assembly.

[0096] The first fixture 200 includes a first clamp 210 and a second clamp 220, wherein the first clamp 210 and the second clamp 220 are arranged opposite to each other, and the first clamp 210 is provided with an annular enclosure 211 in the direction of the second clamp 220, and the annular enclosure 211 is arranged in the direction of the second clamp 220 to enclose an accommodating cavity 212 with an opening, and the accommodating cavity 212 is used to accommodate the fixing portion 120. Preferably, the first clamp 210 is located vertically below the second clamp 220, so that the fixing portion 120 can be directly placed in the accommodating cavity 212 without falling out, thereby making the contact deformation between the fixing portion 120 and the accommodating cavity 212 smaller. In fact, since the assembly process of the fixing portion 120 and the sealing portion 110 is along the vertical direction, the fixing portion 120 does not need to be completely close to or against the annular enclosure 211, and it only needs to ensure that it is facing the sealing portion 110 during assembly.

[0097] If it is necessary to further improve the installation accuracy or efficiency, the fixing part 120 can be fixed to the accommodating cavity 212 with a smaller degree of deformation, and the inner diameter of the accommodating cavity 212 is slightly smaller than the outer diameter of the fixing part 120 (less than 2 mm of the outer diameter of the fixing part 120), thereby achieving the fixation of the fixing part 120.

[0098] In another embodiment, the inner surface of the accommodating cavity 212 includes an anchoring layer (a flexible material with elasticity, such as silicone, rubber, etc.), and the anchor structure of the fixing part 120 can be anchored in the anchoring layer to achieve better fixation without causing damage to the fixing part 120.

[0099] In another embodiment, an anchoring layer is detachably provided on the inner side of the accommodating cavity 212, and the anchoring structure of the fixing portion 120 can be anchored in the anchoring layer to achieve better fixation, and the anchoring layer can be pushed out of the accommodating cavity 212 and detached from the first clamp 210, thereby facilitating subsequent removal.

[0100] In another embodiment, the annular enclosure 211 of the accommodating cavity 212 has a variable diameter, so as to accommodate various sizes of the fixing portion 120 .

[0101] The second clamp 220 is provided with a platform 221 in the direction toward the first clamp 210, and a bolt head (not shown in the figure) is provided at the center position of the platform 221. The bolt head can be screwed into the proximal end of the sealing part 110, so that the sealing part 110 can be fixed on the side of the second angle 220 facing the first clamp 210. The platform 221 can rotate relative to its own central axis, thereby facilitating the fixing and release of the sealing part 110.

[0102] The first fixture 200 further includes a first arm 231 and a second arm 232 connected to the first fixture 210 and the second fixture 220, respectively. The first arm 231 and the second arm 232 rotate relative to each other around a common fulcrum 233, thereby driving the first fixture 210 and the second fixture 220 to move closer to or farther from each other. The first fixture 210 and the second fixture 220 are located on one side of the fulcrum 233. On the other side of the fulcrum 233 are operating parts of the first arm 231 and the second arm 232. An elastic structure 240 is provided between the operating parts of the first arm 231 and the second arm 232. When the operating part of the arm 232 applies an external force to bring it closer together, the elastic structure 240 is compressed, and the first arm 231 and the second arm 232 move closer to each other, so that the first clamp 210 and the second clamp 220 move closer together, realizing the assembly of the blocking device. When the applied external force disappears, the elastic structure 240 returns to its original state. Since the fixing part 120 and the sealing part 110 have been assembled, and the sealing part 110 and the platform 221 are threadedly fixed, the elastic structure 240 returns to its original state, which will drive the fixing part 120 to directly detach from the accommodating cavity 212, thereby facilitating the removal of the blocking device.

[0103] In this embodiment, at least two groups of coaxial limit members are provided on the periphery of the first clamp 210 and the second clamp 220. Specifically, a plurality of vertically distributed columnar members are provided on the periphery of the first clamp 210, and a plurality of matching holes corresponding to the columnar members are provided on the periphery of the second clamp 220. The columnar members move in the matching holes to form coaxial limit members, thereby limiting the coaxial accuracy of the first clamp 210 and the second clamp 220.

[0104] For the tooling of method 2, please refer to Figures 11-15, wherein Figure 11 is a structural schematic diagram of the second tooling for assembling the blocking device in one embodiment of the present application, Figure 12 is a working schematic diagram of a clamp of the second tooling for assembling the blocking device in one embodiment of the present application, Figure 13 is a working schematic diagram of another clamp of the second tooling for assembling the blocking device in one embodiment of the present application, Figure 14 is a structural schematic diagram of the blocking member in one embodiment of the present application, and Figure 15 is a working schematic diagram of the second tooling for assembling the blocking device in one embodiment of the present application.

[0105] The second tooling 300 includes a group of tubular clamps with the same inner diameter, which are divided into a third clamp 310 and a fourth clamp 320. When the third clamp 310 and the fourth clamp 320 are combined, the second tooling 300 can also act as a loader. That is to say, after the occluding device is assembled through the second tooling 300, it is also loaded into the loader and prepared for sheathing.

[0106] Specifically, one side of the third clamp 310 includes a first inlet 311, which serves as an entrance to the sealing part 110. A first connecting member 312 extends into the other side of the third clamp 310. The first connecting member 312 passes through the inner side of the third clamp 310 and extends from the first inlet 311. The free end of the first connecting member 312 includes a threaded structure, and the first connecting member 312 is fixed to the proximal center of the sealing part 110 through the threaded structure, so that the sealing part 110 is fixed to the first connecting member 312. On this basis, the first connecting member 312 is pulled to the left as shown in the figure to drive the sealing part 110 to be received into the third clamp 310, and the first connecting part 130 of the sealing part 110 is located on the right side of the figure. Since the entire sealing part 110 is received in the third clamp 310, the sealing part 110 itself is elongated and contacts the inner wall of the third clamp 310 in the circumferential direction. The mutual support makes the first connecting part 130, which is located at the axial position of the sealing part 110, stable at the axial position, that is, it has good centering.

[0107] Similarly, the fourth clamp 320 includes a second inlet 321 and a second outlet 322. The second inlet 321 serves as the entrance to the fixed part 120. A second connecting member 313 extends into the other side of the fourth clamp 320. The second connecting member 313 passes through the inner side of the fourth clamp 320 to fix the fixed part 120. It should be noted that the second connecting member 313 is preferably a pull wire, which is fixed by being wrapped around the hole of the second connecting part 140 of the fixed part 120, or the cavity of the second connecting part 140, or passing through the center area of ​​the rod of the fixed part 120.

[0108] In another embodiment, a portion of threaded ring is provided inside the second connection portion 140 of the fixing portion 120 , and the second connection member 313 is also a structure similar to a push cable, which can be stably and reliably connected to the second connection portion 140 .

[0109] Pulling the second connecting member 313 to the left as shown in the figure drives the fixing part 120 to be received into the fourth clamp 320, and the second connecting part 140 of the fixing part 120 is located on the left side of the figure. Since the entire fixing part 120 is received in the fourth clamp 320, the fixing part 120 itself is elongated and contacts the inner wall of the fourth clamp 320 in the circumferential direction. The mutual support makes the second connecting part 140, which is located at the axial position of the fixing part 120, stable at the axial position, that is, it has good centering.

[0110] It should be noted that after the fixing portion 120 is accommodated, the second connecting member 313 of the fourth clamp 320 needs to be released from the fixing portion 120 and withdrawn.

[0111] Furthermore, in order to ensure that the second connecting part 140 of the fixing part 120 extends out from the second outlet 322 and is limited, a blocking member 330 is introduced. The blocking member 330 includes a tube 331 with an inner diameter slightly smaller than the inner diameter of the fourth clamp 320 and an operating part 332. The tube 331 of the blocking member 330 is inserted into the fourth clamp 320 from the second inlet 321. Maintaining the position of the operating part 332 can change the position of the far end of the fixing part 120 that has been accommodated, and at the same time, it can also limit the movement of the fixing part 120 toward the second inlet 321.

[0112] For the third clamp 310, the blocking member 330 can also be used. However, if the first connecting member 312 is preferably a conveying steel cable, this is because the sealing part 110 itself has reserved a connection structure for the conveying steel cable, and the steel cable itself has a certain strength. In this case, the steel cable itself can both adjust the position and limit the position, achieving the same effect.

[0113] After the sealing portion 110 and the fixing portion 120 are completely accommodated with each other, the third fixture 310 and the fourth fixture 320 need to be assembled. At this time, the first inlet 311 of the third fixture 310 and the second outlet 322 of the fourth fixture 320 are adjacently positioned. The first connecting portion 130 of the sealing portion 110 extends from the first inlet 311, and the second connecting portion 140 of the fixing portion 120 extends from the second outlet 322. The first inlet 311 of the third fixture 310 and the second outlet 322 of the fourth fixture 320 include matching threaded connection structures. When the first inlet 311 of the third fixture 310 and the second outlet 322 of the fourth fixture 320 are assembled, the sealing portion 110 and the fixing portion 120 are assembled smoothly. Since the first inlet 311 of the third fixture 310 and the second outlet 322 of the fourth fixture 320 are well coaxial, the sealing portion 110 and the fixing portion 120 are also well coaxial during assembly, making it unlikely that they will deviate from each other. At the same time, the assembled third fixture 310 and fourth fixture 320 can function as a loader, saving an operation step and thus greatly improving work efficiency.

[0114] In another embodiment, the length of the fourth clamp 320 can be preferably adjusted so that the second connecting portion 140 slightly exceeds the fourth clamp 320 after the fixing portion 120 is accommodated, and the operator only needs to block the second inlet 321 by hand to limit the fixing portion 120. It should be noted that the various technical features of the above-mentioned embodiments can be combined arbitrarily and can also be applied to the various types of left atrial appendage occluders and left atrial appendage occluders with similar structures described above. In order to make the description concise, not all possible combinations of the various technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0115] Example 2

[0116] This embodiment is further optimized based on embodiment 1, and the specific difference is reflected in the connection between the fixing part and the sealing part, with specific reference to Figures 16-17. Figure 16 is a structural schematic diagram of the blocking device in embodiment 2 of the present application, and Figure 17 is a connection schematic diagram of the fixing part and the sealing part of the blocking device in embodiment 2 of the present application. The first connection part 430 of the sealing part 410 and the second connection part 440 of the fixing part 420 are both improved. The first connection part 430 still includes a connecting head 432 extending axially, and the connecting head 432 includes a main body 4321 and a stopper 4322 extending from the proximal end to the distal end. The diameter of the stopper 4322 is larger than the diameter of the main body 4321. In addition, the stopper 4322 is a ball head, so that after the assembly is completed, after the stopper 4322 passes over the stopper 442, the stopper 4322 can rotate in multiple directions along the surface of the stopper 442.

[0117] It should be noted that the rotation of this embodiment also includes radial deflection, that is, the sealing part 410 can rotate in multiple radial directions relative to the fixed part 420. Therefore, in addition to the stop block 4322 being able to rotate, the linked main body 4321 must also leave space for rotation. Therefore, the second connecting part 440 is provided with a plurality of avoidance grooves (not shown) extending axially through the proximal end. The width of the avoidance groove is greater than the diameter of the main body 4321, so that the main body 4321 can enter or pass through the avoidance groove to achieve overall rotation. At the same time, only at the position where the avoidance groove is set, the main body 4321 can rotate freely along the position, thereby limiting the specific direction of radial rotation of the sealing part 410 relative to the fixed part 420.

[0118] However, it should be noted that when there is no avoidance groove, since the diameter of the stop block 4322 is larger than the diameter of the main body 4321, there is a gap between the main body 4321 and the second connecting part 440, so that the main body 4321 can also rotate radially at a small angle in the second connecting part 440. The avoidance groove is designed to meet the requirements of large-scale radial rotation of the sealing part 410 relative to the fixing part 420.

[0119] In this embodiment, in order to avoid the risk of the sealing portion 410 and the fixing portion 420 being displaced from each other and detached due to rotation, that is, to make the connection between the fixing portion 420 and the sealing portion 410 more stable, a group of baffles 443 extending obliquely toward the proximal end are additionally provided on the distal side of the second connecting portion 440, that is, the baffles 443 and the baffles 442 have opposite axial extension directions, and the distance between the free ends of the baffles 443 and the baffles 442 is less than or equal to the diameter of the block 4322. When the block 4322 passes over the baffle 442 from the proximal end to the distal end, the block 4322 is held by the baffles 442 and the baffles 443 to keep the block 4322 centered in the middle of the second connecting portion 440, thereby allowing the block 4322 to rotate smoothly.

[0120] Example 3

[0121] This embodiment is further optimized based on Example 1. The specific difference is reflected in the connection between the fixing part and the sealing part. Referring to Figures 18-19, Figure 18 is a structural schematic diagram of the blocking device in Example 3 of the present application, and Figure 19 is a connection schematic diagram of the fixing part and the sealing part of the blocking device in Example 3 of the present application. The first connection part 530 of the sealing part 510 and the second connection part 540 of the fixing part 520 are both improved. The first connection part 530 still includes a connecting head 532 extending axially, and the connecting head 532 includes a main body 5321 and a stopper 5322 extending from the proximal end to the distal end. The diameter of the stopper 5322 is larger than the diameter of the main body 5321, and is also larger than the diameter of the opening surrounded by the stopper 542 of the second connection part 540 in the natural state. Therefore, after the assembly is completed, after the stopper 5322 passes over the stopper 542, the stopper 5322 cannot separate from the surface of the stopper 542 along the proximal end, thereby maintaining the connection between the sealing part 510 and the fixing part 520.

[0122] In addition, a distal baffle 543 is provided on the distal side of the second connecting portion 540, and the distal baffle 543 extends obliquely toward the proximal end. The distal baffle 543 and the baffle 542 have opposite axial extension directions, and the distance between the free ends of the baffle 543 and the baffle 542 is greater than the axial width of the block 5322, so that when the block 5322 passes over the baffle 542 from the proximal end to the distal end, the block 5322 can move axially between the distal baffle 543 and the baffle 542, so that relative axial movement can occur between the sealing portion 510 and the fixing portion 520, that is, axial movable. Therefore, when the occluding device is implanted, space for movement is provided between the sealing portion 510 and the fixing portion 520, allowing the sealing portion 510 and the fixing portion 520 to be misaligned at the connection. Since it is almost impossible for the fixing portion 520 and the sealing portion 510 to be located on the same axis when the occlusion device is implanted, stress concentration is almost inevitable at the connection between the sealing portion 510 and the fixing portion 520. The design of this embodiment can eliminate the stress concentration caused by the coaxial design of the sealing portion 510 and the fixing portion 520 to the greatest extent.

[0123] In another embodiment, referring to Figure 20, Figure 20 is a schematic diagram of the connection between the fixing portion and the sealing portion of the sealing device in another embodiment of Example 3 of the present application. In this embodiment, the second connecting portion 540 includes at least one group of distal baffles 544, and the distal baffles 544 and the baffles 542 have the same axial extension direction, that is, the distal baffles 544 extend obliquely toward the distal end. Therefore, after the block 5322 passes over the baffle 542 from the proximal end to the distal end, it can further pass over the distal baffle 544, further shortening the distance between the fixing portion 520 and the sealing portion 510. It should be noted that, on the one hand, when this embodiment is implanted, the fixing portion 520 is released first and the sealing portion 510 is released later. If it is squeezed and deformed after implantation, the block 5322 will further pass over the distal baffle 544 from the proximal end to the distal end, shortening the distance between the fixing portion 520 and the sealing portion 510. Since the position of the fixing portion 520 remains unchanged, the sealing portion 510 will be further tightened, which in turn promotes a tighter closure. On the other hand, since the fixing portion 520 is released first and the sealing portion 510 is released later, the fixing portion 520 has been anchored after release. The operator can select the required distance between the fixing portion 520 and the sealing portion 510. If it needs to be shortened, the sealing portion 510 can be pushed further toward the distal end to continue to pass over the distal baffle 544, thereby meeting the requirement.

[0124] In another embodiment, the second connecting portion 540 is provided with multiple sets of distal baffles 544 along the axial direction, thereby enabling multi-level adjustment of the distance between the fixing portion 520 and the sealing portion 510. Furthermore, to achieve even more multi-level adjustment, all distal baffles 544 are located at different positions in the circumferential direction.

[0125] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art could make various modifications and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A plugging device, characterized in that, It includes a fixing part and a sealing part. A first connecting part is provided at the proximal end of the fixing part, and a second connecting part is provided at the distal end of the sealing part. The plugging device includes an initial state and an assembled state. In the initial state, the first connecting part and the second connecting part are separated from each other; in the assembled state, the first connecting part connects the second connecting part to connect the fixing part and the sealing part.

2. The plugging device according to claim 1, characterized in that, The fixing part and the sealing part are stably connected after assembly.

3. The plugging device according to claim 1, characterized in that, The first connecting part includes a connecting head extending axially. The connecting head includes a main body and a stop block extending and distributed from the proximal end to the distal end. The diameter of the stop block is larger than that of the main body.

4. The plugging device according to claim 3, characterized in that, The second connecting part includes a hollow tube structure. The second connecting part includes at least two blocking pieces that are circumferentially oppositely arranged and obliquely extend from the tube structure toward the inner side and the distal side.

5. The plugging device according to claim 4, characterized in that, The inner diameter of the tube structure is larger than the outer diameter of the connecting head, and the inner diameter of the channel formed by the free ends of the plurality of blocking pieces is smaller than the outer diameter of the blocking pieces.

6. The plugging device according to claim 3, characterized in that, From the proximal end to the distal end, the diameter of the stop block gradually decreases.

7. The plugging device according to claim 3, wherein A stepped surface is provided at the connection position or transition area between the stop block and the main body.

8. The plugging device according to claim 1, characterized in that, The first connecting part includes at least one positioning member distributed circumferentially, and at least one positioning groove for matching the positioning member is provided on the proximal side of the second connecting part.

9. The plugging device according to claim 1, characterized in that, The proximal end face or the distal end face of the sealing part includes a straight section and a curved section. The curved section is located outside the straight section, and the edge of the curved section is located at the distal end of the straight section.

10. The plugging device according to claim 9, characterized in that, In the natural state, the length range of the curved section from the proximal end to the distal end is 1-5 mm.

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