occlusion device
The independent fixation and sealing assembly design solves the problem of poor compatibility of existing left atrial appendage occluders, enabling a wider range of size combinations and lower risks, thus reducing surgical costs.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2025-02-13
- Publication Date
- 2026-06-30
Smart Images
Figure CN122297010A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of interventional medical device technology, and in particular to an occlusion device. Background Technology
[0002] In interventional medicine, an occlusion device is an instrument used to close or block blood vessels or cavities. It is commonly used to treat vascular abnormalities or lesions to block abnormal blood flow or close abnormal pathways. Common occlusion devices include vascular occlusion devices, pore occlusion devices, and catheter occlusion devices. Among these, pore occlusion devices are mainly used to close pores 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, it is a long, narrow, curved, blind-ended structure extending anteroinferiorly along the anterior wall of the left atrium. It has active contraction, relaxation, and secretion functions. Atrial fibrillation-induced stroke mainly originates from the left atrial appendage. During interventional procedures, a left atrial appendage occluder is typically used to block the opening of the left atrial appendage to prevent thrombi within the left atrial appendage from entering the left atrium and causing atrial fibrillation-induced stroke, and also to block blood flow from the left atrium into the left atrial appendage.
[0003] Currently, there are two main types of left atrial appendage occluders on the market: plug type and double disc type. The double disc type left atrial appendage occluder usually includes a fixed disc and a sealing disc. In existing disc type left atrial appendage occluders, the fixed disc and the sealing disc are usually fixedly connected as one piece by welding or intermediate connectors.
[0004] However, the fixation plate and sealing plate 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 existing specifications of 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 are only accurately measured at the implantation stage. If there is no suitable left atrial appendage occluder, the surgery cannot be performed. If a new one is made, the patient needs to be re-implanted, which brings great risks. Summary of the Invention
[0005] Therefore, it is necessary to provide an improved occlusion device to address the problem of poor adaptability caused by the relatively fixed size of existing left atrial appendage occlusion devices, as follows:
[0006] The sealing part is provided with a first connecting part at its distal end, the first connecting part including a connector extending axially, and the fixing part is provided with a second connecting part at its proximal end, the second connecting part including a hollow tube structure. The connector extends into the second connecting part to realize the connection between the fixing part and the sealing part, or the first connecting part is provided on the fixing part and the second connecting part is provided on the sealing part.
[0007] In one embodiment, the connector includes a body and a stop extending from the proximal end to the distal end, the diameter of the stop being larger than the diameter of the body.
[0008] In one embodiment, the second connecting portion includes at least one set of baffles that extend obliquely from the tube structure toward the inner and distal sides and are arranged opposite each other in the circumferential direction. After the block passes over the baffles from the proximal end to the distal end, the free end of the baffle restricts the displacement of the block toward the proximal end.
[0009] In one embodiment, after the stop block passes the baffle, the stop block can rotate along the surface of the stop block in multiple directions.
[0010] In one embodiment, the second connecting portion is provided with a plurality of clearance grooves extending axially through the proximal end, the width of the clearance grooves being greater than the diameter of the main body, and the main body being able to enter or pass through the clearance grooves.
[0011] In one embodiment, the distal end of the second connection includes at least one set of auxiliary baffles extending obliquely toward the proximal end. When the block passes the baffles from the proximal end to the distal end, the block is held in place by the baffles and the auxiliary baffles.
[0012] In one embodiment, the distal end of the second connection includes a distal baffle that extends obliquely toward the proximal end, and the distal baffle and the baffle extend in opposite directions along the axial direction.
[0013] In one embodiment, the distance between the distal baffle and the free end of the baffle is greater than the axial thickness of the baffle.
[0014] In one embodiment, the distal side of the second connection portion includes at least one set of distal baffles, the distal baffles extending obliquely toward the distal end, and the distal baffles and the baffles extending in the same axial direction.
[0015] In one embodiment, the second connecting portion is provided with multiple sets of distal baffles along the axial direction, and all the distal baffles are located at different positions in the circumferential direction.
[0016] Compared with existing technologies, the present invention provides an occlusion device comprising a relatively independent fixing part and a sealing part. The proximal end of the fixing part is provided with a first connecting part, which includes a connector extending axially. The second connecting part includes a hollow tubular structure, and the connector extends into the second connecting part to connect the fixing part and the sealing part. Therefore, the fixing part and the sealing part can be manufactured, fabricated, and transported independently, and then assembled according to the required dimensions when implantation is needed. Consequently, the assembled left atrial appendage occlusion device has a wider range of size combinations, thus possessing better adaptability and fully capable of accommodating some special-sized left atrial appendage shapes. Attached Figure Description
[0017] Figure 1 This is a schematic diagram of the sealing device in its natural state according to one embodiment of the present invention;
[0018] Figure 2 This is a schematic diagram of the external structure of the sealing device in its natural state according to one embodiment of the present invention;
[0019] Figure 3 This is a schematic diagram of the structure of the fixing part of the sealing device in its natural state in one embodiment of the present invention;
[0020] Figure 4 This is a top view of the fixing part of the sealing device in a natural state according to one embodiment of the present invention;
[0021] Figure 4a This is a top view of a variant of the fixing part of the sealing device in one embodiment of the present invention;
[0022] Figure 4b This is a top view of a variant of the fixing part of the sealing device in one embodiment of the present invention;
[0023] Figure 4c This is a top view of a variant three of the fixing part of the sealing device in a natural state, according to one embodiment of the present invention.
[0024] Figure 5 This is a schematic diagram of the sealing part of the sealing device in its natural state according to one embodiment of the present invention;
[0025] Figure 6 This is a schematic diagram of the sealing device before assembly in one embodiment of the present invention;
[0026] Figure 7 This is a schematic diagram of the assembly parts of the sealing device in one embodiment of the present invention;
[0027] Figure 8This is a schematic diagram of the structure of the first tooling for assembling the sealing device in one embodiment of the present invention;
[0028] Figure 9 This is a schematic diagram of the first state of the tooling for assembling the sealing device in one embodiment of the present invention;
[0029] Figure 10 This is a schematic diagram of the second state of the first tooling for assembling the sealing device in one embodiment of the present invention;
[0030] Figure 11 This is a schematic diagram of the structure of the second tooling for assembling the sealing device in one embodiment of the present invention;
[0031] Figure 12 This is a schematic diagram of the operation of a fixture for assembling a second tooling for a sealing device in one embodiment of the present invention;
[0032] Figure 13 This is a schematic diagram of the operation of another fixture of the second tooling for assembling the sealing device in one embodiment of the present invention;
[0033] Figure 14 This is a schematic diagram of the blocking element in one embodiment of the present invention;
[0034] Figure 15 This is a schematic diagram of the operation of the second tooling for assembling the sealing device in one embodiment of the present invention;
[0035] Figure 16 This is a schematic diagram of the sealing device in another embodiment of the present invention;
[0036] Figure 17 This is a schematic diagram showing the connection between the fixing part and the sealing part of the sealing device in another embodiment of the present invention;
[0037] Figure 18 This is a schematic diagram of the sealing device in another embodiment of the present invention;
[0038] Figure 19 This is a schematic diagram showing the connection between the fixing part and the sealing part of the sealing device in another embodiment of the present invention;
[0039] Figure 20 This is a schematic diagram showing the connection between the fixing part and the sealing part of the sealing device in another embodiment of the present invention. Detailed Implementation
[0040] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.
[0041] 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 called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.
[0042] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.
[0043] The occlusion device provided in the embodiments of the present invention can be used to occlude the left atrial appendage, and can also be used to occlude other in vivo tissues with openings, including but not limited to atrial septal defects, patent ductus arteriosus, etc. The following will provide a detailed description of the occlusion device using the occlusion of the left atrial appendage as an example.
[0044] Please refer to Figure 1-2 , Figure 1 This is a schematic diagram of the sealing device 100 in its natural state according to one embodiment of the present invention. Figure 2 This is a schematic diagram of the external structure of the sealing device 100 in its natural state according to an embodiment of the present invention. The sealing device 100 includes a fixing part 120 and a sealing part 110 connected to the fixing part 120. The sealing part 110 and the fixing part 120 are spaced apart along the axial direction of the sealing device 100. The sealing part 110 is located at the proximal end of the sealing device 100, and the fixing part 120 is located at the distal end of the sealing device 100. The sealing device 100 has a compressed state housed within a sheath for easy delivery, and extends from the distal end of the sheath and expands upon self-expansion as... Figure 1 The deployed state is shown. The morphology of the occlusion device 100 after release within the left atrial appendage is similar to... Figure 1 They are identical or substantially the same. In other implementations, such as for closure of atrial septal defects, the sealing part 110 and the fixing part 120 can be brought close to each other after release to fix the closure device 100 to the septum between the left and right atria.
[0045] In this embodiment, the sealing part 110 is woven from multiple braided filaments 111 into a mesh tube. Both ends of the mesh tube are secured and fixed by a sleeve. The mesh tube is then heat-set into a disc, column, or plug shape to obtain the sealing part 110 used to seal the opening of the left atrial appendage. The sealing part 110 includes a distal disc surface 112 facing the fixing part 120 and a proximal disc surface 113 opposite to the distal disc surface 112. The interior of the sealing part 110 has at least one thin film (not shown) used as a flow-blocking membrane. The edge of the thin film is fixed to the braided filaments 111 at the edge of the sealing part 110, typically by stitching, and the thin film is located between the distal disc surface 112 and the proximal disc surface 113.
[0046] In another embodiment, the film body is attached to the proximal disk surface 113 or the distal disk surface 112. When there are multiple films, the position of the film body can be arbitrarily selected.
[0047] The membrane is used to prevent blood flow from one side of the seal 110 to the other side, thereby preventing blood flow between the left atrial appendage and the left atrium.
[0048] In another embodiment, the total number of braided filaments 111 used in the sealing part 110 is increased. On the one hand, the increased number of braided filaments can objectively better block blood flow and support the flow-blocking membrane, thereby achieving a better sealing effect. On the other hand, it can make the edge of the woven sealing part 110 composed of more filaments, thereby further filling the gaps at the edge and obtaining a smoother edge of the woven part. This makes it fit more tightly against the inner wall of the left atrial appendage than in the traditional setting. In another embodiment, the total number of braided filaments 111 exceeds 72 strands, that is, the sealing frame of the sealing part 110 is a dense mesh structure, preferably 114 strands.
[0049] In another embodiment, when the sealing frame of the sealing part 110 is a dense mesh structure, the mesh structure formed by the braided filaments 111 is dense enough to block the flow of thrombi from the auricle, thus eliminating the need for a flow-blocking membrane.
[0050] The fixing part 120 includes at least one support body 121 and a film covering the surface of the support body 121. The sealing part 110 is directly or indirectly connected to the fixing part 120. The support body 121 on the fixing part 120 can be a rod obtained by cutting a metal alloy tube or a polymer tube, or it can be a rod made by weaving or winding braided yarn. In this embodiment, the specific shape of the support body 121 is not limited. In order to improve the anchoring ability of the fixing part 120, an anchoring member 130 is provided on the fixing part 120 in this embodiment. The anchoring member 130 can be an anchor spike or a ball head that can be inserted into a predetermined position.
[0051] In this embodiment, the support body 121 of the fixing part 120 does not necessarily have to be a completely independent support rod structure. There may be cross-linking between adjacent support bodies 121, as long as the whole can play a supporting role. Multiple support bodies 121 extend from the central convergence point toward the far end and extend toward the near end after being flipped.
[0052] In this embodiment, further combined with the appendix Figure 3-4 , Figure 3 This is a schematic diagram of the fixing part 120 of the sealing device 100 in its natural state, according to one embodiment of the present invention. Figure 4 This is a top view of the fixing part 120 of the sealing device 100 in a natural state in one embodiment of the present invention. 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, integrally formed with the support body 121 or part of the support body 121), or it can be fixed to the proximal end of the support body 121 by welding, bonding and other methods.
[0053] In its natural state, the circumferential width of the blocking member 122 is greater than the width of the support body 121 near the blocking member 122. For ease of quantification, the root of the anchor member 130 is taken as the starting point, and the extension of the support body 121 from the root of the anchor member 130 to the nearest end of the support body 121 is recorded as the extension of the support body 121. The circumferential width of the blocking member 122 is greater than the width of the extension of the support body 121, so that when the fixing part 120 approaches the sealing part 110, the blocking member 122 can prevent or reduce the risk of the proximal side of the support body 121 getting stuck in the sealing part 110.
[0054] In this embodiment, in order to avoid the blocking member 122 affecting the smoothness of the sealing device 100 entering and exiting the sheath, the blocking member 122 is preferably a hollow ring structure. Here, the ring does not mean a circle in the strict sense, but refers to the blocking member 122 being a closed ring with its ends closed, that is, the blocking member 122 has no opening.
[0055] In another embodiment, the blocking member 122 includes at least a portion of a pair of links that are far apart from each other. The blocking member 122 extends from the extension of the support 121 and branches off into a pair of links. There is a gap between the two links at least in a portion of their positions, and the ends of the two links approach and connect to each other. The ends formed by approaching and connecting are smooth and preferably spherical to avoid the risk of potential damage to the implantation site (such as the inner wall of the atrial appendage).
[0056] Preferably, in this embodiment, the blocking member 122 extends from the extension of the support 121 toward the distal end to form a U-shaped structure in conjunction with the extension of the support 121, thereby keeping the free end of the fixing part 120 away from the implantation site (such as the inner wall of the atrial appendage), thus avoiding stress concentration or damage to the implantation site.
[0057] In the prior art, without the blocking member 122 as in this embodiment, the extension of the support 121 (or the end of the support 121) is very likely to get stuck in the sealing part 110. Therefore, the prior art generally leaves a certain distance between the fixing part 120 and the sealing part 110, resulting in a relatively long overall length of the sealing device 100. Since the left atrial appendage position changes with the contraction and relaxation of the heart, the risk of the extension of the support 121 (or the end of the support 121) getting stuck in the sealing part 110 is always relatively high in the prior art. Therefore, the design of the blocking member 122 in this embodiment can significantly reduce or even avoid the extension of the support 121 (or the end of the support 121) getting stuck in the braid of the sealing part 110.
[0058] In another embodiment, the circumferential width of the blocking member 122 is greater than the mesh width (or diameter) of all the distal end faces of the braid of the sealing part 110, so that the blocking member 122 cannot be directly inserted into the sealing part 110.
[0059] In another embodiment, the blocking member 122 extends radially across at least two grids on the distal end face of the sealing portion 110, thereby preventing the blocking member 122 from directly engaging with the sealing portion 110.
[0060] In another embodiment, the blocking member 122 spans at least two grids on the distal end face of the sealing portion 110 in the circumferential direction, thereby preventing the blocking member 122 from directly engaging with the sealing portion 110.
[0061] In another embodiment, in its natural state, the blocking member 122 is located entirely near the anchor member 130.
[0062] In another embodiment, the circumferential width of the blocking member 122 is greater than twice the width of the maximum mesh on the far end face of the braid of the sealing part 110, so that even if the sealing part is deformed, the blocking member 122 is as far as possible not to be directly stuck into the sealing part 110.
[0063] In another embodiment, the blocking member 122 may have other shapes, see reference. Figure 4a , 4b 4c Figure 4a This is a top view of a variant of the fixing part of the sealing device in one embodiment of the present invention; Figure 4bThis is a top view of a variant of the fixing part of the sealing device in one embodiment of the present invention; Figure 4c This is a top view of a variant three of the fixing part of the sealing device in a natural state according to an embodiment of the present invention. In combination, the blocking member 122 can be configured as a ring-shaped blocking member 122a, which is smoother and less likely to get stuck in the sealing disc compared to the aforementioned blocking member 122. The blocking member 122b can be configured as a single blocking rod, and the projection of the blocking member 122b on the cross-section of the fixing part is arc-shaped. The free end of the blocking member 122b is located at the distal end of the starting end, and the projection of the blocking member 122b on the cross-section of the fixing part is a large arc, thus ensuring the proximal end of the blocking member 122b is continuous, thereby preventing the free end from getting stuck in the sealing part 110. The blocking member 122c can be configured as a single rod, and the projection of the blocking member 122c on the cross-section of the fixing part is at least one spiral circumference. The free end of the blocking member 122c is located at the distal end of the starting end, thus preventing the free end from getting stuck in the sealing part 110. It should be particularly emphasized that although the blocking components 122b and 122c are not closed structures, they are easier to manufacture and shape, and have lower costs.
[0064] In this embodiment, the sealing part 110 has also been optimized, and further reference is made to... Figure 5 , Figure 5 This is a schematic diagram of the sealing part 110 of the sealing device 100 in its natural state in one embodiment of the present invention. In terms of overall shape, the edge of the sealing part 110 is located at the farthest end of the sealing part 110 as a whole, so that the sealing part 110 as a whole presents a state of protruding towards the proximal end.
[0065] Specifically, in this embodiment, the proximal and distal surfaces of the sealing portion 110 are in close contact (in this embodiment, close contact does not mean constant contact; close contact is considered when the distance between them is close to 0 or the gap is less than 1 mm). The proximal surface of the sealing portion 110 includes a straight section 111 and a curved section 112. The curved section 112 is located outside the straight section 111, and the edge of the curved section 112 is located at the distal end of the straight section 111. In its 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.
[0066] Therefore, due to the presence of the curved section 112, the sealing part 110 has a longer axial length than the ordinary disc shape. It can even partially overlap with the fixing part 120 in the axial direction without contacting the fixing part 120, thereby shortening the overall axial length of the sealing device 100, which is more conducive to reducing the occurrence of rejection reaction. Combined with the previous setting of the fixing part 120, the axial length of the sealing device 100 can be even shorter.
[0067] Furthermore, since the edge of the sealing part 110 is located at the farthest end of the sealing part 110 as a whole, the sealing part 110 can either act as a cap to cover the opening of the atrial appendage or be inserted into the atrial appendage. Compression of the atrial appendage causes the outer edge of the sealing part 110 to have a certain axial length, thereby increasing the contact area between the sealing part 110 and the inner wall of the atrial appendage and improving the sealing effect of the sealing part 110. Therefore, when the atrial appendage is deep, it can be inserted into the atrial appendage, and when the atrial appendage is shallow, it can cover the opening of the atrial appendage, significantly increasing the adaptability of the occlusion device 100. Most importantly, due to the above design, the edge located on the proximal side of the occlusion device 100 is tightly attached to the inner wall or opening of the atrial appendage after implantation, thus preventing the formation of new thrombi due to gaps between the edge and the inner wall or opening of the atrial appendage.
[0068] 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 excessive axial length of the curved segment 112 will affect the anchoring of the anchoring member 130 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 prone to bulging towards the distal end when squeezed, thus achieving the opposite technical effect to that of this embodiment, affecting the good sealing of the sealing device 100. The length of the curved segment 112 from the proximal end to the distal end should be as close as possible to 3 mm. Considering process errors, the length of the curved segment 112 from the proximal end to the distal end can preferably be 2-4 mm.
[0069] In another embodiment, the proximal and distal surfaces of the sealing portion 110 are not completely fitted together, and 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, and the length of the curved section from the proximal end to the distal end is 1-5 mm, preferably 3 mm. The remaining settings are the same as in the aforementioned embodiment.
[0070] Reference Figure 6-7 , Figure 6 This is a schematic diagram of the sealing device 100 before assembly in one embodiment of the present invention. Figure 7This is a schematic diagram of the assembly parts of the occlusion device 100 in one embodiment of the present invention. In this embodiment, the sealing part 110 and the fixing part 120 are relatively independent before use, that is, they are assembled only when in use. Therefore, the sealing part 110 and the fixing part 120 can be transported and manufactured independently, reducing production processes and transportation costs. In addition to manufacturing and transportation, more importantly, in left atrial appendage occlusion surgery, the operator needs to first introduce a sheath and measure the size of the atrial appendage during the implantation process, and then implant an occlusion device of appropriate size according to the measurement results. That is to say, the special feature of left atrial appendage occlusion surgery is that the selection process of the left atrial appendage occluder is actually one of the surgical steps. Therefore, since the size required by the user cannot be accurately determined, the operator needs to prepare multiple or all sizes of left atrial appendage occluders in advance, which undoubtedly increases the cost. In addition, it should be noted that in the prior art, the dimensions of each part of the left atrial appendage occluder are fixed after the manufacturing is completed. The shape, meaning the corresponding specifications are determined before the operator uses it, is used by manufacturers to produce left atrial appendage occluders in various sizes to meet common atrial appendage shapes or sizes. However, since the atrial appendage size of each user cannot be predicted in advance, the common specifications of existing technology only vary in size (e.g., in 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 cannot perfectly match the size, then a larger size left atrial appendage occluder must be installed. Most importantly, if the patient's atrial appendage size is special (e.g., in some patients, the size of the atrial appendage opening and the internal size are basically the same, or the size of the atrial appendage opening is smaller than the internal size, so the required diameter of the fixing part and the sealing part are close to or even larger), then it exceeds the common preset specifications, and the user can only choose to stop implantation. The puncture and other steps before implantation undoubtedly become harm to the user. If a custom is made later, then a new surgery is required after the customization is completed, which brings huge risks. Therefore, in the prior art, the size of the left atrial appendage occluder often cannot perfectly fit the atrial appendage, and some sizes exceed the specifications of conventional left atrial appendage occluders. Thus, by utilizing the design of the assembleable fixing part 110 and sealing part 120 in this embodiment, after the operator measures the size of the atrial appendage, the fixing part 110 and sealing part 120 are assembled, thereby obtaining an occlusion device 100 that can better fit the user's atrial appendage. Undoubtedly, the occlusion device 100 in this embodiment has better adaptability.
[0071] Furthermore, since the sealing device 100 is assemblable, when manufacturing the same number of sealing parts 110 and fixing parts 120 as in the prior art, the number of dimensional combinations of the sealing device 100 that can be assembled is significantly increased. For example, by manufacturing M sets of sealing parts 110 and fixing parts 120, the operator only needs to prepare the corresponding specifications of fixing parts 1 and sealing parts 2 to achieve M*M specifications of sealing devices 100, while the prior art can only have M sets of sealing devices 100. This greatly improves the specification selection of the sealing device 100. Moreover, using the sealing device 100 of this embodiment, sealing parts 110 and fixing parts 120 of different sizes can be produced to meet different combinations (such as M sets of sealing parts 100 and N sets of fixing parts 120), thus eliminating the need for sealing parts 110 and fixing parts 120 to be produced one-to-one in batches, improving production convenience.
[0072] In another embodiment, the sealing part 110 and the fixing part 120 are connected by an intermediate member. Specifically, the fixing part 120 is mountably assembled to the intermediate member, and the sealing part 110 is mountably assembled to the intermediate member, thereby realizing the complete installation of the sealing device 100.
[0073] In another embodiment, the fixing part 120 and the sealing part 110 can rotate relative to each other.
[0074] In this embodiment, the far end of the sealing part 110 is provided with a first connecting part 130. The first connecting part 130 can be fixed to the gathering part of the braided mesh of the sealing part 110 (e.g., fixed to the sleeve position of the sealing part 110 by welding, threaded connection, etc.), or it can serve as the gathering part of the braided mesh of the sealing part 110.
[0075] The near end of the fixing part 120 is provided with a second connecting part 140. The second connecting part 140 can be fixed to the gathering part of the woven mesh of the fixing part 120 (welding, threaded connection, etc.) or it can be used as the gathering part of the support body 121 of the fixing part 120.
[0076] The first connecting part 130 and the second connecting part 140 are assembleable. Since the sealing device 100 formed after assembly is an implant, in order to reduce the risk of dislodgement, in this embodiment, the first connecting part 130 and the second connecting part 140 are not detachable after assembly. That is, the fixing part 120 and the sealing part 110 are assembleable, but not detachable after assembly. Furthermore, it should be noted that due to the special nature of the sealing device 100 in this embodiment, it is not a product type that can be reused or disassembled multiple times. In fact, disassembling and reassembling the sealing device 100 can easily affect the lifespan of the connection position, and the increased risk far outweighs the need to save costs. Since the detachable structure itself needs to leave a margin, which leads to a decrease in connection strength, this embodiment preferably allows the first connecting part 130 and the second connecting part 140 to be assembled, but not disassembled. This embodiment interprets this state as being able to be assembled to form a stable connection. Here, a stable connection only expresses that the assembled objects are not detachable from each other, rather than expressing that the objects are relatively fixed and stationary. In fact, in other embodiments, the first connecting part 130 and the second connecting part 140 can still rotate relative to each other after being assembled, which still falls within the scope of a stable connection.
[0077] In another embodiment, the proximal end of the fixing part 120 is provided with a first connecting part 130, and the distal end of the sealing part 110 is provided with a second connecting part 140, that is, the positions of the first connecting part 130 and the second connecting part 140 can be interchanged.
[0078] In this embodiment, the first connecting part 130 includes at least one positioning member 131 distributed circumferentially and a connector 132 extending axially. The connector 132 includes a main body 1321 and a stop 1322 extending from the proximal end to the distal end. The diameter of the stop 1322 is larger than the diameter of the main body 1321.
[0079] In this embodiment, the second connecting portion 140 includes a hollow tube structure 141. The second connecting portion 140 includes at least two circumferentially opposite baffles 142 that extend obliquely from the tube structure 141 toward the inward and distal ends, thereby forming a spring-loaded structure. Because they extend inward, the baffles 142 will not be exposed to the outside and contact the sheath or catch the support 121. For the tube structure 141, the inner diameter of the tube structure 141 is larger than the outer diameter of the connector 132, so that the connector 132 of the first connecting portion 130 can extend into the tube 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 baffles 142 arranged circumferentially opposite each other is smaller than the outer diameter of the baffle 142. In other words, the inner diameter of the channel enclosed by the free ends of the multiple baffles 142 is smaller than the outer diameter of the baffle 142.
[0081] In another embodiment, the diameter of the stop 1322 gradually decreases from the proximal end to the distal end, thereby facilitating the passage of the stop 1322 toward the distal end through the baffle 142.
[0082] In this embodiment, preferably, a stepped surface is left at the connection position or transition area between the stop block 1322 and the main body 1321 so that the free end of the stop plate 142 can abut against it.
[0083] In this embodiment, the proximal side of the tube structure 141 has at least one positioning groove 142 for a matching positioning member 131. After the positioning member 131 extends into the positioning groove 142 region along the axial direction, the first connecting part 130 is limited relative to the second connecting part 140 by the positioning member 131 and the positioning groove 142, so that the two cannot rotate freely. On the one hand, the positioning element 131 and the positioning groove 142 are distributed circumferentially. The one-to-one matching of multiple positioning elements 131 and multiple positioning grooves 142 makes the first connecting part 130 and the second connecting part 140 in the same axial position, thereby maintaining the centering (coaxiality) of the fixing part 120 and the sealing part 110. On the other hand, more importantly, since the first connecting part 130 and the second connecting part 140 are assembled during use, and they serve as the connection parts of the sealing part 110 and the fixing part 120, if the first connecting part 130 and the second connecting part 140 can rotate freely, it is easier for the connection between the first connecting part 130 and the second connecting part 140 to become loose and the gap to gradually widen, which is more likely to cause them to fall off. Therefore, the connection between the first connecting part 130 and the second connecting part 140 should be as stable and tight as possible. Objectively, the fixing part 120 can be designed to rotate relative to the sealing part 110. However, for this embodiment, the rotation structure of the sealing part 110 and the fixing part 120 should avoid the connection position of the first connecting part 130 and the second connecting part 140.
[0084] Furthermore, the design of the positioning member 131 and the positioning groove 142 ensures that the sealing part 110 can only be assembled with the fixing part 120 at 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 inserted into the positioning groove 142 after installation.
[0085] In another embodiment, the positioning element 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 element 131 is inclined along the circumference, and the positioning groove 142 matches the shape of the positioning element 131. Thus, the fixing part 120 needs to rotate 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 element 131 and the positioning groove 142 can also help to 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 proximal inner diameter of the tube structure 141 is larger than the distal inner diameter, that is, the tube structure 141 is configured as a flared shape, which makes the connection between the first connecting part 130 and the second connecting part 140 smoother. More importantly, when the proximal end of the tube structure 141 is flared, since the edges of the sealing part 110 and the fixing part 120 are close to the edge of the sheath when the sealing device is transported in the sheath, as long as the outer diameter of the tube structure 141 is smaller than the inner diameter of the sheath, the tube structure 141 is basically in the middle position of the sheath due to the support of the sealing part 110 and the fixing part 120, and the transport process will not be affected by the increase in diameter. In addition, since the distal end of the tube structure 141 leaves the sheath first when the sealing device is unsheathed, the unsheathing process of the tube 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 abut against the corresponding positioning grooves 142, the radial and circumferential relative positions of the first connecting part 130 and the second connecting part 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 part 110 and the fixing part 120 of the occlusion device 100 in this embodiment and related embodiments are relatively independent before use, and are only assembled during use. Conventionally, the operator can assemble and splice the sealing part 110 and the fixing part 120 separately. However, since the occlusion device 100 is an implant, it has high requirements for dimensional accuracy. Manual operation by the operator cannot meet the requirements for precise installation and is prone to displacement. Furthermore, the occlusion device 100 cannot undergo multiple large-scale deformations, and manual assembly can easily cause significant deformation, shortening the lifespan of the occlusion device 100. Simultaneously, it is impossible to uniformly and stably control the installation force of the occluder, easily causing damage to the device. Moreover, manual assembly is inconvenient to hold, cumbersome, and cannot quickly and accurately ensure the coaxiality of the fixing and sealing discs, resulting in a long assembly time. Since assembly usually occurs during surgery or pre-operative procedures, it affects the duration of the surgery. Therefore, to ensure reliable implantation, appropriate tooling is needed.
[0090] It should be noted that the assembly process of the occlusion device 100 in this embodiment requires high coaxial precision, that is, the sealing part 110 and the fixing part 120 need to be well aligned (or at a specific angle). Generally, the assembly process cannot be arranged after implantation into the human body, that is, it is not possible to use a sequential implantation method, that is, to implant the fixing part 120 first and then implant the sealing part 110 to complete the assembly simultaneously. In fact, objectively speaking, it is difficult to achieve the method of implanting the fixing part 120 first and then implanting the sealing part 110 to complete the assembly simultaneously, because the first implanted component will start to move with the heart, and the heart's contraction and relaxation are not along a straight line. The first implanted fixing part 120 will inevitably shift from the implantation position, and the second implanted sealing part 110 can hardly achieve normal assembly. For intracardiac implantation surgery, which has a high safety risk, such an assembly method is too risky and can only remain theoretically feasible.
[0091] In conjunction with the entire implantation process, after selecting the dimensions of the sealing part 110 and the fixing part 120 of the occlusion device 100, the occlusion device 100 is assembled and sheathed, followed by normal subsequent operations. Since the traditional sheathing process of the occlusion device 100 involves first inserting the loader, and then pushing it into the sheath via the loader, the assembly of the occlusion device 100 can be performed in two ways to meet different surgical needs:
[0092] 1. After assembly using tooling, the sealing device 100 is installed into the loader, and then the sealing device 100 is pushed into the sheath tube by the push rod to achieve sheathing. The assembly of the sealing device 100 occurs before loading.
[0093] 2. At least a portion of the sealing part 110 and the fixing part 120 of the sealing device 100 are installed into a tooling that also serves a loading function. The assembly of the sealing device 100 is completed simultaneously with the loading. Then, the sealing device 100 is pushed into the sheath tube by a push rod to achieve sheathing. The assembly and loading of the sealing device 100 occur simultaneously.
[0094] As mentioned earlier, the sealing device 100 cannot undergo multiple, significant deformations. The compression from its natural state into the loader and the subsequent sheathing process already constitute significant deformation. This deformation is unavoidable during the sheathing stage. When a secondary release is required after sheathing, it needs to be retracted into the sheath, which also involves significant deformation. After 4-6 significant deformations, the physical properties and service life of a typical sealing device 100 may be affected. While not all sealing devices 100 may experience significant impacts on their physical properties or service life, the increased risk generally leads to the assumption that the sealing device 100 no longer meets implantation requirements and is scrapped. Therefore, during assembly, the sealing part 110 and the fixing part 120 of the sealing device 100 should not be subjected to significant compression or deformation during steps other than the sheathing process.
[0095] For the tooling of method 1, such as Figure 8-10 , Figure 8 This is a schematic diagram of the structure of the first tooling for assembling the sealing device in one embodiment of the present invention. Figure 9 This is a schematic diagram of the first state of the tooling for assembling the sealing device in one embodiment of the present invention. Figure 10 This is a schematic diagram of the second state of the first tooling for assembling the sealing device in one embodiment of the present invention. In the first state, the first tooling 200 loads the fixing part 120 and the sealing part 110 into the corresponding fixtures. In the second state, the first tooling 200 drives the fixing part 120 and the sealing part 110 to achieve assembly.
[0096] The first tooling 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. The first clamp 210 has an annular barrier 211 facing the second clamp 220, and the annular barrier 211 encloses an open receiving cavity 212 facing the second clamp 220. The receiving cavity 212 is used to receive the fixing part 120. Preferably, the first clamp 210 is located vertically below the second clamp 220, so that the fixing part 120 can be directly placed into the receiving cavity 212 without falling out, thereby minimizing the contact deformation between the fixing part 120 and the receiving cavity 212. In fact, since the assembly process of the fixing part 120 and the sealing part 110 is in the vertical direction, the fixing part 120 does not need to be completely pressed against or abut against the annular barrier 211; it only needs to be aligned with the sealing part 110 during assembly.
[0097] If it is necessary to further improve the installation accuracy or installation efficiency, the fixing part 120 can be fixed in the receiving cavity 212 with a small degree of deformation. The inner diameter of the receiving cavity 212 is slightly smaller than the outer diameter of the fixing part 120 (within 2 mm), thereby achieving the fixing of the fixing part 120.
[0098] In another embodiment, the inner surface of the receiving cavity 212 includes an anchoring layer (a flexible material with elasticity, such as silicone or rubber), and the anchor structure of the fixing part 120 can be anchored to the anchoring layer to achieve better fixation without causing damage to the fixing part 120.
[0099] In another embodiment, an anchoring layer is detachably fitted inside the receiving cavity 212. The anchor structure of the fixing part 120 can be anchored to the anchoring layer to achieve better fixation. The anchoring layer can be pushed out of the receiving cavity 212 and removed from the first clamp 210, thereby facilitating subsequent removal.
[0100] In another embodiment, the annular enclosure 211 of the receiving cavity 212 is of variable diameter, thereby accommodating various sizes of the fixing part 120.
[0101] The second clamp 220 has a platform 221 facing the first clamp 210. A bolt head (not shown in the figure) is located at the center 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 included angle 220 facing the first clamp 210. The platform 221 can rotate relative to its own central axis, which facilitates the fixing and release of the sealing part 110.
[0102] The first tooling 200 also includes a first arm 231 and a second arm 232 respectively connected to the first clamp 210 and the second clamp 220. The first arm 231 and the second arm 232 rotate relative to each other around a common fulcrum 233, thereby causing the first clamp 210 and the second clamp 220 to move closer and further apart. The first clamp 210 and the second clamp 220 are located on one side of the fulcrum 233, and the operating parts of the first arm 231 and the second arm 232 are on the other side of the fulcrum 233. An elastic structure 240 is provided between the operating parts of the two arms. When an external force is applied to the operating part of arm 232 to bring them closer together, the elastic structure 240 is compressed, and the first arm 231 and the second arm 232 move closer together, thereby bringing the first clamp 210 and the second clamp 220 closer together to achieve the assembly of the sealing 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 return of the elastic structure 240 to its original state will drive the fixing part 120 to directly detach from the receiving cavity 212, thereby facilitating the removal of the sealing device.
[0103] In this embodiment, the outer periphery of the first clamp 210 and the second clamp 220 is provided with at least two sets of coaxial limiting members. Specifically, the outer periphery of the first clamp 210 is provided with a plurality of vertically distributed columnar members, and the outer periphery of the second clamp 220 is provided with a plurality of mating holes corresponding to the columnar members. The columnar members move within the mating holes to form coaxial limiting members, thereby limiting the coaxial accuracy of the first clamp 210 and the second clamp 220.
[0104] For the tooling in method 2, please refer to Figure 11-15 ,in, Figure 11 This is a schematic diagram of the structure of the second tooling for assembling the sealing device in one embodiment of the present invention. Figure 12 This is a schematic diagram of the operation of a fixture in the second tooling for assembling the sealing device according to one embodiment of the present invention. Figure 13 This is a schematic diagram of the operation of another fixture of the second tooling for assembling the sealing device in one embodiment of the present invention. Figure 14 This is a schematic diagram of the blocking member in one embodiment of the present invention. Figure 15 This is a schematic diagram of the operation of the second tooling for assembling the sealing device in one embodiment of the present invention.
[0105] The second tooling 300 includes a set 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 sealing 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 the inlet for the sealing part 110. The other side of the third clamp 310 extends into a first connector 312, which passes through the inner side of the third clamp 310 and extends out from the first inlet 311. The free end of the first connector 312 includes a threaded structure, and the first connector 312 is fixed to the proximal center of the sealing part 110 through the threaded structure, thereby fixing the sealing part 110 to the first connector 312. Based on this, pulling the first connector 312 to the left in the figure causes the sealing part 110 to be housed in the third clamp 310. 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 housed 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 on the axis of the sealing part 110, stable on the axis, 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 entry point for the fixing part 120. A second connector 313 extends into the other side of the fourth clamp 320. The second connector 313 passes through the inner side of the fourth clamp 320 and is fixedly connected to the fixing part 120. It should be noted that the second connector 313 is preferably a pull wire, which is fixed by winding around the hole of the second connecting part 140 of the fixing part 120, or the cavity of the second connecting part 140, or by passing through the central area of the rod of the fixing part 120.
[0108] In another embodiment, the inner side of the second connecting portion 140 of the fixing portion 120 is provided with a portion of threaded ring, and the second connecting member 313 also has a structure similar to that of a push steel cable, which can be stably and reliably connected to the second connecting portion 140.
[0109] Pulling the second connector 313 to the left in the diagram causes the fixing part 120 to be housed in the fourth clamp 320. The second connector 140 of the fixing part 120 is located on the left side of the diagram. Since the entire fixing part 120 is housed 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 connector 140, which is located on the axis of the fixing part 120, stable on the axis, that is, it has good centering.
[0110] It should be noted that after the fixing part 120 is stored, the second connector 313 of the fourth clamp 320 needs to be released from the fixing part 120 and withdrawn.
[0111] Furthermore, in order to ensure that the second connecting part 140 of the fixing part 120 extends 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. By inserting the tube 331 of the blocking member 330 into the fourth clamp 320 from the second inlet 321 and maintaining the position of the operating part 332, the position of the distal end of the fixed part 120 that has been stored can be changed, and the movement of the fixed part 120 toward the second inlet 321 can also be restricted.
[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, it is because the sealing part 110 itself has reserved the 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 part 110 and the fixing part 120 are retracted, the third clamp 310 and the fourth clamp 320 need to be spliced together. At this time, the first inlet 311 of the third clamp 310 and the second outlet 322 of the fourth clamp 320 are arranged adjacent to each other. The first connecting part 130 of the sealing part 110 extends from the first inlet 311, and the second connecting part 140 of the fixing part 120 extends from the second outlet 322. The first inlet 311 of the third clamp 310 and the second outlet 322 of the fourth clamp 320 include a matching threaded connection structure. When the first inlet 311 of the third clamp 310 and the second outlet 322 of the fourth clamp 320 are spliced together, the assembly of the sealing part 110 and the fixing part 120 is driven. Since the first inlet 311 of the third clamp 310 and the second outlet 322 of the fourth clamp 322 have good coaxiality, the assembly process of the sealing part 110 and the fixing part 120 also has good coaxiality, so it is almost impossible for misalignment to occur. Meanwhile, the assembled third clamp 310 and fourth clamp 320 can also function as loaders, saving an operation step and thus greatly improving work efficiency.
[0114] In another embodiment, the length of the fourth clamp 320 can be preferred such that the second connecting portion 140 after the fixing portion 120 is housed slightly exceeds the fourth clamp 320, and the fixing portion 120 can be limited simply by the operator blocking the second inlet 321 with their hand.
[0115] Example 2
[0116] This embodiment is a further optimization based on Embodiment 1. The specific difference lies in the connection between the fixing part and the sealing part, as detailed below. Figure 16-17 , Figure 16 This is a schematic diagram of the sealing device in Embodiment 2 of the present invention. Figure 17 This is a schematic diagram of the connection between the fixing part and the sealing part of the sealing device in Embodiment 2 of the present invention. The first connecting part 430 of the sealing part 410 and the second connecting part 440 of the fixing part 420 have been improved. The first connecting part 430 still includes a connector 432 extending axially. The connector 432 includes a main body 4321 and a stop 4322 extending from the proximal end to the distal end. The diameter of the stop 4322 is larger than the diameter of the main body 4321. In addition, the stop 4322 is a ball head, so that after assembly, after the stop 4322 passes over the baffle 442, the stop 4322 can rotate along the surface of the baffle 442 in multiple directions.
[0117] It should be noted that the rotation in this embodiment also includes radial deflection. That is, the sealing part 410 can rotate in multiple radial directions relative to the fixing part 420. Thus, in addition to the stop block 4322 being able to rotate, the linked main body 4321 also needs to have room for rotation. Therefore, the second connecting part 440 is provided with multiple clearance grooves (not shown) that extend axially through the proximal end. The width of the clearance groove is greater than the diameter of the main body 4321, so that the main body 4321 can enter or pass through the clearance groove to achieve overall rotation. At the same time, only when the clearance groove is provided can the main body 4321 rotate freely along that position. Thus, the specific direction of the radial rotation of the sealing part 410 relative to the fixing part 420 can be defined.
[0118] However, it should be noted that in the absence of a clearance groove, since the diameter of the stop 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. Thus, the main body 4321 can also rotate radially at a small angle within the second connecting part 440. The clearance groove is designed to allow the sealing part 410 to rotate radially relative to the fixing part 420 at a large amplitude.
[0119] In this embodiment, to avoid the risk of displacement and separation of the sealing part 410 and the fixing part 420 due to rotation, and to make the connection between the fixing part 420 and the sealing part 410 more stable, a set of baffles 443 extending obliquely towards the proximal end is added to the distal end of the second connecting part 440. That is, the baffles 443 and the baffles 442 extend in opposite directions along the axial direction, 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 stop block 4322. When the stop block 4322 passes the baffles 442 from the proximal end to the distal end, the stop block 4322 is held in place by the baffles 442 and the baffles 443, keeping the stop block 4322 centered in the middle of the second connecting part 440, so that the stop block 4322 can rotate smoothly.
[0120] Example 3
[0121] This embodiment is a further optimization based on Embodiment 1. The specific difference lies in the connection between the fixing part and the sealing part, as detailed below. Figure 18-19 , Figure 18 This is a schematic diagram of the sealing device in Embodiment 3 of the present invention. Figure 19This is a schematic diagram of the connection between the fixing part and the sealing part of the sealing device in Embodiment 3 of the present invention. The first connecting part 530 of the sealing part 510 and the second connecting part 540 of the fixing part 520 have been improved. The first connecting part 530 still includes a connector 532 extending along the axial direction. The connector 532 includes a main body 5321 and a stop 5322 extending from the proximal end to the distal end. The diameter of the stop 5322 is larger than the diameter of the main body 5321, and also larger than the diameter of the opening formed by the baffle 542 of the second connecting part 540 in its natural state. Therefore, after assembly, after the stop 5322 passes the baffle 542, the stop 5322 cannot detach from the surface of the baffle 542 along the proximal end, thereby maintaining the connection between the sealing part 510 and the fixing part 520.
[0122] Additionally, a distal baffle 543 is provided on the distal side of the second connecting portion 540. The distal baffle 543 extends obliquely toward the proximal end. The distal baffle 543 and the baffle 542 extend in opposite directions along the axial direction, and the distance between the free ends of the baffle 543 and the baffle 542 is greater than the axial thickness of the stop block 5322. Thus, when the stop block 5322 passes the baffle 542 from the proximal end to the distal end, the stop block 5322 can move axially between the distal baffle 543 and the baffle 542, thereby allowing relative axial movement between the sealing portion 510 and the fixing portion 520, i.e., axially movable. Thus, when the sealing device is implanted, space is provided between the sealing portion 510 and the fixing portion 520 for movement, allowing the sealing portion 510 and the fixing portion 520 to be misaligned at the connection. Since it is almost impossible for the fixing part 520 and the sealing part 510 to be on the same axis when the sealing device is implanted, that is, stress concentration will almost inevitably occur at the connection between the sealing part 510 and the fixing part 520. The design of this embodiment can eliminate this stress concentration caused by the coaxial design of the sealing part 510 and the fixing part 520 to the greatest extent.
[0123] In another embodiment, reference is made to Figure 20 , Figure 20This is a schematic diagram of the connection between the fixing part and the sealing part of the sealing device in another embodiment of Embodiment 3 of the present invention. In this embodiment, the second connecting part 540 includes at least one set of distal baffles 544. The distal baffles 544 and the baffles 542 extend in the same axial direction, that is, the distal baffles 544 extend obliquely toward the distal end. Thus, after the block 5322 passes the baffles 542 from the proximal end to the distal end, it can further pass the distal baffles 544, further shortening the distance between the fixing part 520 and the sealing part 510. It should be noted that, on the one hand, in this embodiment, during implantation, the fixing part 520 is released first, followed by the sealing part 510. If it is deformed by compression after implantation, the stop block 5322 will further cross the distal stop plate 544 from the proximal end, shortening the distance between the fixing part 520 and the sealing part 510. Since the position of the fixing part 520 remains unchanged, it will further tighten the sealing part 510, thus promoting a tighter seal. On the other hand, since the fixing part 520 is released first and the sealing part 510 is released later, the fixing part 520 has been anchored after release. The operator can select the desired distance between the fixing part 520 and the sealing part 510. If it needs to be shortened, the sealing part 510 can be pushed further towards the distal end to continue crossing the distal stop plate 544, thereby achieving the desired result.
[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 levels of adjustment, all distal baffles 544 are located at different positions in the circumferential direction.
[0125] It should be noted that the technical features of the above embodiments can be combined arbitrarily and can also be applied simultaneously to various left atrial appendage occluders and left atrial appendage occluders with similar structures. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described; however, as long as the combination of these technical features is not contradictory, it should be considered within the scope of this specification.
[0126] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.
Claims
1. A sealing device, characterized in that, It includes a fixing part and a sealing part. The sealing part has a first connecting part at its distal end, which includes a connector extending axially. The fixing part has a second connecting part at its proximal end, which includes a hollow tube structure. The connector extends into the second connecting part to connect the fixing part and the sealing part. Alternatively, the first connecting part is disposed on the fixing part, and the second connecting part is disposed on the sealing part.
2. The sealing device according to claim 1, characterized in that, The connector includes a main body and a stop extending from the proximal end to the distal end, wherein the diameter of the stop is larger than the diameter of the main body.
3. The sealing device according to claim 2, characterized in that, The second connecting portion includes at least one set of baffles that extend obliquely from the tube structure toward the inner and distal sides and are arranged opposite each other in the circumferential direction. After the block passes over the baffles from the proximal end to the distal end, the free end of the baffle restricts the displacement of the block toward the proximal end.
4. The sealing device according to claim 3, characterized in that, After the stop block passes the baffle plate, the stop block can rotate along the surface of the stop block in multiple directions.
5. The sealing device according to claim 4, characterized in that, The second connecting part is provided with a plurality of clearance grooves that extend axially through the proximal end. The width of the clearance groove is greater than the diameter of the main body, and the main body can enter or pass through the clearance groove.
6. The sealing device according to claim 5, characterized in that, The distal end of the second connection includes at least one set of auxiliary baffles extending obliquely toward the proximal end. When the block passes the baffles from the proximal end to the distal end, the block is held in place by the baffles and the auxiliary baffles.
7. The sealing device according to claim 3, characterized in that, The distal end of the second connection includes a distal baffle that extends obliquely toward the proximal end, and the distal baffle and the baffle extend in opposite directions along the axial direction.
8. The sealing device according to claim 7, characterized in that, The distance between the distal baffle and the free end of the baffle is greater than the axial thickness of the baffle.
9. The sealing device according to claim 3, characterized in that, The distal side of the second connection portion includes at least one set of distal baffles, which extend obliquely toward the distal end, and the distal baffles and the baffles extend in the same axial direction.
10. The sealing device according to claim 9, characterized in that, The second connecting part is provided with multiple sets of distal baffles along the axial direction, and all the distal baffles are located at different positions in the circumferential direction.