Closure device and closure system

By using a plugging device design without locking components, and by coordinating the internal cavity and path with adjusting and pushing components, the problem of increased conveying difficulty caused by locking components is solved. This enables axial stretching and position adjustment of the plugging device, improving its flexibility and adaptability.

CN116549030BActive Publication Date: 2026-03-17LIFETECH SCI (SHENZHEN) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2019-12-20
Publication Date
2026-03-17

AI Technical Summary

Technical Problem

In existing cardiac or vascular occluders, the presence of locking elements increases the rigidity of the occluder after stretching, leading to increased delivery difficulty and making it unsuitable for diseased vessels of different lengths, thus affecting the length adjustment of the occluder.

Method used

The occluder design employs a locking-free mechanism. By setting a path connecting the inner cavity, the first opening, and the second opening on the occluder frame, and utilizing the cooperation of the adjusting and pushing components, the occluder's axial tension and position adjustment can be achieved. The path of the pushing component is fixed by the fixing component to prevent the pushing component from deviating from its direction and damaging the occluder frame.

Benefits of technology

The occluder achieves axial tension and position adjustment, simplifies the loading process, reduces transportation difficulty, adapts to lesion sites of different shapes, and improves the flexibility and adaptability of the occluder.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention relates to a occluder and occlusion system. The occluder includes an occlusion frame comprising a first occlusion unit, a middle occlusion unit, a second occlusion unit, and a waist section. The two ends of the middle occlusion unit are connected to the first and second occlusion units respectively via the waist section. A fixing member is fitted onto the waist section, and a channel is formed in the middle of the fixing member. The occlusion frame has an inner cavity. A first opening is formed on the first occlusion unit, and a second opening is formed on the second occlusion unit. The first opening, the channel, the inner cavity, and the second opening communicate to form a path. This occluder eliminates the need for a locking element.
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Description

Technical Field

[0001] This invention relates to the field of interventional medical devices, and in particular to an occluder and occlusion system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Percutaneous interventional therapy is a rapidly developing treatment method in recent years, and its application areas are becoming increasingly wide. Transcatheter interventional therapy allows for the placement of devices and / or drugs into the heart, arteries, veins, and other parts of the body. The devices used can include cardiac occluders, vascular occluders, and vascular filters.

[0004] Traditional cardiac or vascular occluders are typically made of shape memory alloys. These materials are highly elastic, allowing them to recover their original shape after release and conform well to the tissue at the defect site. However, current shape memory alloys are generally non-corrosive or non-degradable in the body. Once endothelialization is achieved for complete occlusion, the occluder made of shape memory alloy will remain permanently in the body, potentially posing long-term clinical risks.

[0005] Occluders or other implantable devices made of absorbable polymer materials, while degradable within the body, allow for gradual degradation and absorption of degradation products, leaving no residue. However, polymers are relatively soft and difficult to mold, and their mesh stability is inferior to that of alloy-based occluders. Before delivery, the occluder needs to be axially stretched to fit into the delivery sheath. After delivery, the occluder must remain under axial stretching until accurate positioning is possible. To avoid damaging the occluder, excessive stretching during stretching should be avoided to prevent damage to the occlusion frame. To address this issue, existing occluders incorporate axially extending locking elements within the occlusion frame. During loading, a force is applied to the locking elements to straighten the occluder, achieving axial stretching. To achieve this function, the locking elements require sufficient rigidity and length to assist in straightening the occluder and achieving axial stretching.

[0006] However, the rigid locking element extends axially within the occlusion frame, which to some extent increases the rigidity of the occluder after stretching, making delivery more difficult and hindering its passage through tortuous blood vessels. Furthermore, for vascular occluders, the presence of the locking element affects the adjustment of the occluder's length due to the significant variation in the length of diseased vessels. Summary of the Invention

[0007] Therefore, it is necessary to provide a plugging device and plugging system that can omit the locking element.

[0008] An occlusion device includes an occlusion frame, a first end cap, and a second end cap, characterized in that the occlusion frame has an inner cavity and has opposing first and second openings, the first and second end caps are respectively located at the distal and proximal ends of the occlusion frame, and the inner cavity, the first opening, and the second opening communicate to form a path;

[0009] The first end cap has a first through hole, and the second end cap has a second through hole. The first through hole communicates with the first opening, and the second through hole communicates with the second opening. The second end cap is used for detachable connection with an external conveying device. The diameter of the first through hole is smaller than the diameter of the second through hole, so that the pusher of the external conveying device passes through the second through hole and abuts against the first end cap.

[0010] In one embodiment, the sealing frame includes a first sealing unit, a middle sealing unit, a second sealing unit, and a waist section. The two ends of the middle sealing unit are connected to the first sealing unit and the second sealing unit respectively through the waist section. A fixing member is fitted on the waist section, and a channel is formed in the middle of the fixing member. The first opening, the channel, the inner cavity, and the second opening communicate to form the path. The first end cap is disposed on the first sealing unit, and the second end cap is disposed on the second sealing unit.

[0011] In one embodiment, the fastener is a sleeve formed of polymer material or a ring structure formed by polymer thread wrapped around the outer periphery of the waist.

[0012] In one embodiment, the number of central blocking units is at least one, and the number of waist sections is at least two. When the number of central blocking units is greater than one, the number of waist sections is greater than two, and the plurality of central blocking units (greater than one) and the plurality of waist sections (greater than two) are alternately arranged along the axial direction.

[0013] In one embodiment, the axial length of the central blocking unit is greater than the axial length of the first blocking unit and the second blocking unit.

[0014] An occlusion system includes a delivery device and an occluder as described above, the delivery device including an adjustment member slidably extending along the path to a distal end extending out of the cavity, and the distal end of the adjustment member abutting against a first occlusion unit.

[0015] In one embodiment, in its natural state, one end of the adjusting member has a pre-bent portion. When the adjusting member is slidably slidably along the path until the pre-bent portion is outside the sealing frame, the pre-bent portion returns to a bent state and can abut against the first sealing unit.

[0016] In one embodiment, the pre-bent portion is an arc-shaped rod or arc-shaped wire, and the angle of the arc-shaped rod or arc-shaped wire is 40° to 90°.

[0017] In one embodiment, the conveying device further includes a pusher having an inner cavity, the pusher being slidable along the path to its distal end abutting against the first end cap, and the adjusting member being slidably inserted through the pusher.

[0018] In one embodiment, the outer diameter of the pusher is 0.1 to 4 mm smaller than the radial width of the channel.

[0019] The aforementioned plug's inner cavity, first opening, second opening, and channel together form a path. During loading, the pusher of the conveying device enters the path formed by the inner cavity, first opening, second opening, and channel and moves to the distal end of the pusher to abut against the plug, thus straightening the plug and achieving axial tension. By fitting a fixing member on the waist, the fixing member further secures the path of the pusher's movement within the plugging frame, helping to prevent the pusher from deviating from the preset direction and puncturing the plugging frame, causing damage. Furthermore, due to the limiting effect of the fixing member, the pusher remains in abutment with the plug to maintain the axial tension of the plug, thereby enabling the plug's position to be adjustable. Therefore, even without omitting the locking member, the axial tension of the plug can be easily achieved, allowing the plug to be loaded into the conveying sheath and maintaining its axial tension state for easy position adjustment. Attached Figure Description

[0020] Figure 1 A schematic diagram of the structure of a blocking system according to one embodiment;

[0021] Figure 2 A schematic diagram of the structure of a plugging device according to one embodiment;

[0022] Figure 3 A schematic diagram of the structure of a plugging device according to one embodiment;

[0023] Figure 4 An exploded view of a conveying device according to one embodiment;

[0024] Figure 5 This is a schematic diagram of the external structure of a conveying device according to one embodiment;

[0025] Figure 6This is a schematic diagram of the structure of the adjusting member according to one embodiment;

[0026] Figure 7 This is a schematic diagram showing the positional relationship between the adjusting member and the pushing member in one embodiment;

[0027] Figures 8a-8b This is a schematic diagram of the morphology of an occluder implanted in a blood vessel according to one embodiment.

[0028] Figure 9 This is a schematic diagram showing the positional relationship between the plugging device, the adjusting member, and the pushing member in one embodiment.

[0029] Figure 10 This is a schematic diagram of the internal structure of a conveying device according to one embodiment;

[0030] Figures 11-12 This is a schematic diagram showing the connection relationship between the adjusting member, the pushing member, and the interlocking mechanism in one embodiment.

[0031] Figure 13 A schematic diagram showing the loading state of the plugging device according to one embodiment;

[0032] Figures 14-15 This is a schematic diagram showing the connection between the plug and the delivery device in one embodiment;

[0033] Figure 16 A schematic diagram showing the state of the plug after it exits the delivery sheath, according to one embodiment;

[0034] Figure 17 A schematic diagram of the structure of the first end cap and the pusher of the occluder according to one embodiment;

[0035] Figure 18 A schematic diagram of the structure of the first end cap and the pusher of the plugging device according to another embodiment;

[0036] Figure 19 A schematic diagram of the structure of the first end cap and the pusher of the plugging device according to another embodiment;

[0037] Figure 20 A schematic diagram of the transition piece in one embodiment;

[0038] Figure 21 A schematic diagram of the occluder according to another embodiment;

[0039] Figure 22 A schematic diagram of the occluder according to another embodiment;

[0040] Figure 23 This is a schematic diagram of the blocker according to another embodiment. Detailed Implementation

[0041] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0043] In the field of interventional medical devices, "distal" is defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device, and "radial" refers to the direction perpendicular to the aforementioned axial direction.

[0044] Please see Figure 1 One embodiment of the occlusion system 100 includes an occluder 20 and a delivery device 40. The occluder 20 and the delivery device 40 are detachably connected. After the occluder 20 is pushed to the lesion site in the body via the delivery device 40, the connection between the occluder 20 and the delivery device 40 is disconnected, and the delivery device 40 is withdrawn from the body, completing the implantation surgery.

[0045] Please see Figure 2 In one embodiment, the plugging device 20 includes a plugging frame 210. The plugging frame 210 is a mesh structure formed by weaving polymer materials or by other methods such as 3D printing.

[0046] In one embodiment, the material of the sealing frame 210 is at least one selected from polylactic acid (PLA), racemic PLA, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid, and polydioxanone.

[0047] In one embodiment, the material of the sealing frame 210 is a copolymer formed by copolymerizing at least two of the monomers selected from polylactic acid (PLA), racemic PLA, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid, and polydioxanone.

[0048] Please see Figure 3The sealing frame 210 has an inner cavity 211 (the inner cavity 211 is located inside the sealing frame 210, for ease of illustration). Figure 3 (A rough sketch of the inner cavity 211 is provided to show the positional relationship between the inner cavity 211 and the first opening 212 and the second opening 213.) The sealing frame 210 has opposing first openings 212 and second openings 213. The first opening 212 and the second opening 213 are located at the distal and proximal ends of the sealing frame 210, respectively, and the inner cavity 211, the first opening 212, and the second opening 213 are connected to form a path. In one embodiment, multiple braided filaments are woven to form the sealing frame 210, and the two free ends of the multiple braided filaments are respectively closed to form the first opening 212 and the second opening 213. In another embodiment, annular closing elements are used to close the two free ends of the multiple braided filaments.

[0049] In one embodiment, the plugging device 20 further includes a first end cap 220 and a second end cap 230. The first end cap 220 and the second end cap 230 are respectively disposed at opposite ends of the plugging frame 210. The first end cap 220 has a first through hole 221, which communicates with a first opening 212. The second end cap 230 has a second through hole 231, which communicates with a second opening 213.

[0050] In one embodiment, a first end cap 220 and a second end cap 230 are used to close the two free ends of multiple braided filaments, forming a first opening 212 communicating with the first through hole 221 and a second opening 213 communicating with the second through hole 231. For example, the first end cap 220 and the second end cap 230 respectively form receiving grooves, and the two free ends of the multiple braided filaments are respectively embedded and fixed in the receiving grooves of the first end cap 220 and the second end cap 230, forming the first opening 212 communicating with the first through hole 221 and the second opening 213 communicating with the second through hole 231.

[0051] In one embodiment, both the first end cap 220 and the second end cap 230 are located outside the sealing frame 210, which facilitates processing.

[0052] In one embodiment, the first end cap 220 and the second end cap 230 are both located inside the occlusion frame 210. This arrangement helps to avoid thrombosis and also helps to prevent the first end cap 220 and / or the second end cap 230 from scratching tissue due to improper operation during the release process.

[0053] In one embodiment, the first end cap 220 is disposed inside the occlusion frame 210, and the second end cap 230 is disposed outside the occlusion frame 210 to avoid thrombosis and to prevent the first end cap 220 from scratching the tissue, while facilitating the detachable connection between the delivery device 40 and the second end cap 230.

[0054] In one embodiment, an external thread 232 is formed on the outer wall of the second end cap 230 to facilitate connection with the conveying device 40.

[0055] In one embodiment, the first end cap 220 may be omitted. In another embodiment, both the first end cap 220 and the second end cap 230 may be omitted when the proximal end of the sealing frame 210 contains other components that can be detachably connected to the conveying device 40.

[0056] In one embodiment, both the first end cap 220 and the second end cap 230 are made of biodegradable polymer materials. The materials of the first end cap 220 and the second end cap 230 may be the same as or different from the material of the sealing frame 210.

[0057] The first end cap 220 and the second end cap 230 are generally rigid polymer tubes. Since the sealing frame 210 is relatively flexible, the first end cap 220 and the second end cap 230 are provided to facilitate the loading, pushing, releasing and forming of the sealing device 20.

[0058] The diameter of the first through hole 221 is D1, and the diameter of the second through hole 231 is D2.

[0059] Please continue reading. Figure 3 The sealing frame 210 includes a first sealing unit 214, a middle sealing unit 215, and a second sealing unit 216. The two opposite ends of the middle sealing unit 215 are connected to the first sealing unit 214 and the second sealing unit 216, respectively. A first opening 212 is formed on the first sealing unit 214, and a second opening 213 is formed on the second sealing unit 216.

[0060] In one embodiment, the sealing frame 210 further includes waist sections 217. There are two waist sections 217. One waist section 217 is connected at both ends to the first sealing unit 214 and the middle sealing unit 215, respectively, while the other waist section 217 is connected at both ends to the middle sealing unit 215 and the second sealing unit 216, respectively. The radial dimension of each waist section 217 is smaller than the radial dimensions of the first sealing unit 214, the middle sealing unit 215, and the second sealing unit 216.

[0061] In one embodiment, the axial length of the middle occlusion unit 215 is greater than the axial length of the first occlusion unit 214 and the second occlusion unit 216, so that after implantation, the contact area between the occluder 20 and the lesion site (such as the blood vessel wall) is larger, which is beneficial to improving the anchoring of the occluder 20 at the lesion site.

[0062] In one embodiment, both the first occlusion unit 214 and the second occlusion unit 216 are disc-shaped, and the intermediate occlusion unit 215 is columnar. The columnar intermediate occlusion unit 215 is connected to the disc-shaped first occlusion unit 214 and the second occlusion unit 216 via a waist section 217 with a smaller radial dimension. On the one hand, the combination of the columnar intermediate occlusion unit 215 and the disc-shaped first occlusion unit 214 and the second occlusion unit 216 ensures sufficient contact area with the lesion site (such as the blood vessel wall). On the other hand, the intermediate occlusion unit 215 is connected to both the first occlusion unit 214 and the second occlusion unit 216 via the waist section 217 with a smaller radial dimension, allowing the angles between the first occlusion unit 214 and the intermediate occlusion unit 215, and between the intermediate occlusion unit 215 and the second occlusion unit 216, to be adjustable. This facilitates the occluder 20's adaptation to lesion sites of different shapes, thus adapting to different individuals. On the other hand, the above-mentioned connection method makes the occluder 20 more flexible after axial stretching, which is conducive to its smooth delivery to the lesion site through the tortuous blood vessels.

[0063] In other embodiments, at least one of the two waist sections 217 may be omitted.

[0064] Please see Figure 4 The conveying device 40 includes an operating handle 410, an adjusting member 420, a pushing member 430, and a conveying member 440. The adjusting member 420 has a distal end and a proximal end, the proximal end of which is connected to the operating handle 410. The pushing member 430 has a distal end and a proximal end, the proximal end of which is connected to the operating handle 410. The conveying member 440 has a distal end and a proximal end, the proximal end of which is connected to the operating handle 410. The loading, pushing, releasing, and shaping of the occluder 20 are achieved by controlling the displacement of the adjusting member 420, the pushing member 430, and the conveying member 440 through operation on the operating handle 410.

[0065] The operating handle 410 includes a housing 411 and a top cover 412. The housing 411 and the top cover 412 are detachably connected, and when the housing 411 and the top cover 412 are connected, the housing 411 and the top cover 412 form an accommodating cavity.

[0066] The edge of the housing 411 is provided with a first groove, and the edge of the upper cover 412 is provided with a second groove. The first groove and the second groove form a first track 4112, such as... Figure 5 As shown. In one embodiment, there are two first grooves and two second grooves, forming two opposing and parallel first tracks 4112.

[0067] Please see Figure 6 The adjusting element 420 is a slender rod. For example, the adjusting element 420 is a slender metal rod or wire with a certain degree of rigidity.

[0068] In one embodiment, the adjusting member 420 is made of shape memory metal or shape memory alloy. In another embodiment, the adjusting member 420 is made of nickel-titanium alloy.

[0069] In its natural state, the distal end of the adjusting member 420 (i.e., the end furthest from the operating handle 410) has a pre-bent portion 422. When the adjusting member 420 is restrained, for example, when restrained within a tubular structure, the pre-bent portion 422 is substantially straightened. When the restraint is released, the pre-bent portion 422 returns to its natural state, i.e., its bent shape.

[0070] The pre-bending portion 422 is an arc-shaped rod or an arc-shaped wire. One end of a slender shape memory metal rod or wire, or a shape memory alloy rod or wire, is bent and shaped to obtain an adjusting member 420 with the pre-bending portion 422.

[0071] Please see Figure 7 The pusher 430 is a hollow tube. The pusher 430 has an inner cavity 432 extending axially from its distal end to its proximal end. The adjusting member 420 is slidably received within the inner cavity 432 of the pusher 430, i.e., the adjusting member 420 slidably passes through the pusher 430. When the pre-bent portion 422 of the adjusting member 420 is located within the inner cavity 432, the pre-bent portion 422 is substantially straightened, such as... Figure 8a As shown. When the pre-bent portion 422 of the adjusting member 420 is located outside the inner cavity 432, the pre-bent portion 422 returns to its natural bending state, as shown. Figure 7 and Figure 8b As shown.

[0072] Please refer to the following: Figure 3 and Figure 8b By controlling the operating handle 410, the pusher 430 enters the path formed by the inner cavity 211, the first opening 212 and the second opening 213 of the sealing frame 210 through the second through hole 213 of the second end cap 230. The pusher 430 can slide from the second through hole 213 to the far end of the pusher 430 abutting against the first end cap 220.

[0073] Please see Figure 9 The outer diameter of pusher 430 is D3, and the inner diameter is D4. The outer diameter of adjusting component 420 is D5. Please refer to the above. Figure 3 and Figure 9 The order D2>D3>D1>D4>D5 enables the occluder 20, the adjusting component 420, and the pushing component 430 to work together to achieve the loading, pushing, releasing, and shaping of the occluder 20.

[0074] It should be noted that when the first through hole 221 and the second through hole 223 are irregularly shaped through holes, the diameter D1 of the first through hole 221 refers to the diameter at the smallest position. The diameter D2 of the second through hole 223 also refers to the diameter at the smallest position.

[0075] Please return Figure 1 The conveying component 440 is a hollow tube. In one embodiment, the conveying component 440 is a hollow stainless steel spring tube. In another embodiment, the conveying component 440 is a hollow nickel-titanium cable.

[0076] In one embodiment, the distal end of the conveyor 440 is provided with a connecting portion 442, and the inner wall of the connecting portion 442 is provided with an internal thread. Figure 1 (Not shown), the internal thread engages with the external thread 232 of the second end cap 230, making the second end cap 230 detachably connected to the conveyor 440.

[0077] Please refer to it again. Figure 4 The proximal end of the conveyor 440 extends into the operating handle 410 and is fixedly connected to the operating handle 410 via a fixing member 401. The fixing member 401 is disposed in the housing 411. The pusher 430 slidably passes through the conveyor 440. The adjusting member 420 slidably passes through the pusher 430.

[0078] The conveying device 40 also includes an adjustment control element 450 and a push control element 460. The adjustment control element 450 is partially located within the cavity formed by the housing 411 and the upper cover 412, and is disposed on the housing 411; a portion is located outside the operating handle 410. The push control element 460 is partially located within the cavity formed by the housing 411 and the upper cover 412, and is disposed on the housing 411; a portion is located outside the operating handle 410. Please refer to the following: Figure 5 The adjustment control member 450 includes a first operating portion 452, which is the portion of the adjustment control member 450 located outside the operating handle 410. The push control member 460 includes a second operating portion 462, which is the portion of the push control member 460 located outside the operating handle 410.

[0079] The housing 411 contains a second track 4114, with the first track 4112 and the second track 4114 parallel to each other. Operating the first operating part 452 and the second operating part 462 allows the adjusting control member 450 and the pushing control member 460 to move axially along the first track 4112 and the second track 4114. When there are two first tracks 4112, there are correspondingly two first operating parts 452 and two second operating parts 462 for ease of operation.

[0080] The proximal end of the adjusting member 420 is connected to the adjusting control member 450 so that the displacement of the adjusting member 420 can be controlled by operating the adjusting control member 450. The proximal end of the pushing member 430 is connected to the pushing control member 460 so that the displacement of the pushing member 430 can be controlled by operating the pushing control member 460.

[0081] In one embodiment, the conveying device 40 further includes an interlocking mechanism for keeping the adjusting member 420 and the pushing member 430 in a removable lock.

[0082] In one implementation, please refer to Figure 10 The interlocking mechanism includes magnetic components 470. In one embodiment, the interlocking mechanism includes at least two magnetic components 470. When there are two magnetic components 470, one magnetic component 470 is disposed on the adjusting control member 450, and the other magnetic component 470 is disposed on the pushing control member 460, with the two magnetic components 470 facing each other. The opposing portions of the two magnetic components 470 have opposite polarities, allowing them to attract each other and causing the adjusting control member 450 and the pushing control member 460 to adhere together, thereby locking the adjusting member 420 and the pushing member 430. In the locked state, the adjusting member 420 and the pushing member 430 cannot undergo relative displacement. When relative displacement of the adjusting member 420 and the pushing member 430 is required, a force greater than the attraction force of the magnetic components 470 is applied to the adjusting control member 450 or the pushing control member 460.

[0083] In one embodiment, when the number of magnetic components 470 is greater than two, the arrangement of the magnetic components 470 is the same as described above, and they should all satisfy the attraction between opposite poles. The number of magnetic components 470 on the adjustment control member 450 and the push control member 460 may be equal or unequal, and as long as the attraction between opposite poles is satisfied, a detachable connection can be achieved.

[0084] By setting the magnetic component 470, locking and unlocking the adjustment control component 450 and the push control component 460 are made more convenient, and the internal structure of the operating handle 410 is made more compact.

[0085] The magnetic component 470 is made of magnets or other magnetic materials.

[0086] In one embodiment, the magnetic component 470 is omitted. Please refer to [the relevant documentation / reference]. Figure 11 and Figure 12The interlocking mechanism includes a locking member 480. The locking member 480 is located outside the operating handle 410 and is detachably connected to the first operating part 452 of the adjusting control member 450 and the second operating part 462 of the pushing control member 460. When the locking member 480 is connected to both the adjusting control member 450 and the pushing control member 460, the locking member 480 integrates the adjusting control member 450 and the pushing control member 460, preventing relative displacement between them, thus locking the adjusting member 420 and the pushing member 430. When relative displacement between the adjusting member 420 and the pushing member 430 is required, the locking member 480 is released, allowing operation of either the adjusting control member 450 or the pushing control member 460 to achieve relative displacement.

[0087] It should be noted that the detachable connection between the locking member 480 and the adjusting control member 450, and the detachable connection between the locking member 480 and the pushing control member 460, can be achieved using methods known to those skilled in the art, such as snap-fit ​​connection, hinge connection, etc.

[0088] When it is necessary to lock the adjusting member 420 and the pushing member 430, the locking member 480 is simultaneously connected to both the adjusting member 420 and the pushing member 430. When it is necessary to release the locking of the adjusting member 420 and the pushing member 430, the locking member 480 is released from connection with at least one of them. This locking and unlocking occurs on the outside of the operating handle 410, making the operation more reliable. Even if improper force is applied, it will not affect the inside of the operating handle 410, thereby preventing undesirable phenomena such as displacement of the plug 20.

[0089] When performing the implantation procedure, the occluder 20 should first be transferred to the delivery sheath 490 (see...). Figure 13 First, the conveying member 440 (with an adjusting member 420 and a pushing member 430 internally inserted) is passed through the conveying sheath 490, with the distal end of the conveying member 440 extending out of the conveying sheath 490. Further, the connecting portion 442 of the conveying member 440 is connected to the second end cap 230 of the sealing device 20 (e.g., ...). Figure 14 and Figure 15Next, the adjusting control 450 and the pushing control 460 are locked. The adjusting control 450 and the pushing control 460 are then axially translated along the first track 4112 and the second track 4114 towards the distal end. This causes the pushing member 430 to axially translate towards the distal end into the path formed by the pushing member 430 entering the inner cavity 211 of the sealing frame 210 from the second end cap 230, the first opening 212, and the second opening 213, and continues to translate until the distal end of the pushing member 430 abuts against the first end cap 220. The pushing control 460 is then operated to continue translating the pushing member 430 towards the distal end. When the axial distance between the first end cap 220 and the second end cap 230 is at its maximum, the sealing device 20 is in a fully axially stretched state. At this time, the pushing control 460 and the adjusting control 450 remain locked. Displace the operating handle 410 proximally to pull the occluder 20, which is in an axially stretched state, into the inner cavity of the delivery sheath 490, as follows. Figure 13 As shown.

[0090] After the delivery sheath 490 delivers the occluder 20 to the lesion site, the operating handle 410 is displaced distally to push the occluder 20 out of the delivery sheath 490. After the occluder 20 is pushed out of the delivery sheath 490, because the distal end of the pusher 430 is still in contact with the first end cap 220 and the position of the pusher control 460 remains unchanged, the occluder 20 remains in a stretched state. Figure 16 As shown. Therefore, it is necessary to change the plug 20 to the expanded state. Release the locking of the adjusting control 450 and the pushing control 460, so that the adjusting control 450 is axially displaced in the distal direction, thereby causing the adjusting member 420 to be axially displaced in the distal direction, so that the pre-bent portion 422 of the adjusting member 420 protrudes from the first through hole 221 of the first end cap 220 and is displaced outside the plug 20. The pre-bent portion 422 returns to its natural state, that is, the bent state, as shown. Figure 16 As shown. Further, simultaneously operate the adjusting control 450 and the pushing control 460, causing the adjusting member 420 and the pushing member 460 to simultaneously move axially towards the proximal end. Since the distal end of the adjusting member 420 is provided with a pre-bent portion 422, during the displacement of the adjusting member 420, the pre-bent portion 422 hooks onto the first end cap 220, that is, the inner surface of the pre-bent portion 422 abuts against the distal surface of the first end cap 220, causing the length of the occluder 20 to shorten as the adjusting member 420 moves proximally. Even as the occluder 20 gradually returns to its expanded state, the outer peripheral surfaces of the first occlusion unit 214, the intermediate occlusion unit 215, and the second occlusion unit 216 of the occluder 20 abut against the inner wall of the blood vessel 200, as... Figure 8bAs shown. After the occluder 20 returns to the expanded state, the interlock mechanism is opened, releasing the locking of the adjusting control 450 and the pushing control 460. The adjusting control 450 is then operated to slide the adjusting member 420 proximally, so that the distal end of the adjusting member 420 returns to the inner cavity 432 of the pushing member 430, as shown. Figure 8a As shown. Lock the adjustment control 450 and the push control 460 again to simultaneously retract the adjustment 420 and the push control 430, or, without locking the adjustment control 450 and the push control 460, retract the adjustment 420 and the push control 430 respectively to complete the implantation surgery.

[0091] One end of the adjusting member 420 of the aforementioned sealing system 100 has a pre-bent portion 422. When the pre-bent portion 422 returns to its bent state and abuts against the sealing device 20, the adjusting member 420 is pulled axially in the proximal direction, causing the pre-bent portion 422 to drive the distal end of the sealing device 20 to move proximal, thereby causing the sealing device 20 to return to its expanded state.

[0092] In one embodiment, the diameter D1 of the first through hole 221 ranges from 0.3mm to 0.85mm, and the angle of the pre-bent portion 422 ranges from 40° to 90° (referring to the central angle of the sector where the pre-bent portion 422 of the arc-shaped rod structure is located). In this way, on the one hand, it ensures that the pre-bent portion 422 and the first end cap 220 have sufficient contact area to facilitate the adjustment of the length of the plug 20 and promote the return of the plug 20 to the expanded state, but on the other hand, it avoids that the pre-bent portion 422 bends too much relative to the rest of the adjusting member 420, which would make it difficult to retract the pre-bent portion 422 into the first end cap 220. On the other hand, the size of the pre-bent portion 422 is matched with that of the first through hole 221 so that the pre-bent portion 422 can pass smoothly through the first through hole 221, and the size of the first end cap 220 is not required to be increased accordingly due to the size of the first through hole 221 being too large. At the same time, the size of the first through hole 221 is not too small, which would make it difficult for the pre-bent portion 422 to extend out of the first end cap 220 and retract into the first end cap 220.

[0093] The aforementioned plugging system 100 achieves loading, pushing, releasing, and shaping of the plugging device 20 by incorporating an adjusting component 420 and a pushing component 430 within the conveying device 40 that cooperate with the plugging device 20. This eliminates the need for additional components within the plugging device 20 to achieve loading, pushing, releasing, and shaping, resulting in a simpler structure, simpler manufacturing process, higher manufacturing efficiency, and lower manufacturing cost for the plugging device 20.

[0094] Furthermore, the elimination of the need for additional components in the occluder 20 facilitates a reduction in the radial dimension of the stretched occluder 20, allowing for delivery using a smaller outer diameter delivery sheath 490. Simultaneously, it enhances the flexibility of the stretched occluder 20, facilitating its passage through tortuous vascular pathways.

[0095] It should be noted that, in Figure 4 , Figure 5 and Figures 10-12 In the illustrated embodiment, the adjustment control 450 is located at the distal end of the push control 460. In other embodiments, the positions of the adjustment control 450 and the push control 460 may be interchanged.

[0096] For the smaller-sized plug 20, the first end cap 220 is smaller, and correspondingly, the diameter of the first through hole 221 is smaller. The outer diameters of the matching adjusting member 420 and pushing member 430 are also smaller. This makes loading the plug 20 more difficult.

[0097] Furthermore, in actual use, whether before or after leaving the factory, after the occluder 20 is loaded into the delivery sheath 490 as described above, it is sometimes necessary to remove the occluder 20 from the delivery sheath 490 and reinstall it. For example, before leaving the factory, the occluder 20 may need to be removed from the delivery sheath 490 and reloaded due to inspection requirements. After leaving the factory, for example during surgery, it may need to be removed due to poor release, and the occluder 20 may need to be reloaded into the delivery sheath 490 before the implantation surgery.

[0098] During loading or reloading, it cannot be guaranteed that the pusher 430 and the first through hole 221 in the first end cap 220 are perfectly aligned (the axial central axis coincides), which makes loading difficult. When the axial central axis of the pusher 430 deviates significantly from the axial central axis of the first through hole 221, the adjusting member 420 is prone to rubbing against the first end cap 220 as it slides towards the distal end to extend from the first end cap 220. This may damage the first end cap 220 made of polymer material or cause some damage to the adjusting member 420 itself. Even if the pusher 430 and the first through hole 221 are perfectly aligned, the distal end of the adjusting member 420 is a pre-bent portion 422. Even when constrained, the pre-bent portion 422 is straightened, but it naturally tends to return to its bent state. This increases the difficulty of passing through a straight small hole (first through hole 221), making loading or reloading more difficult.

[0099] In one implementation, please refer to Figure 17The first through-hole 221 is a trapezoidal hole, with the larger end located proximally and the smaller end located distally. The distal end of the pusher 430 is trapezoidal to match the shape of the first through-hole 221. During loading, pushing, and releasing, the distal end of the pusher 430 extends into the first through-hole 221 and abuts against the wall of the first through-hole 221. This helps to slow down or prevent deviation between the pusher 430 and the first through-hole 221 during loading and operation, allowing the adjuster 420 to smoothly extend from the first through-hole 221 outside the first end cap 220.

[0100] In one implementation, please refer to Figure 18 The first through-hole 221 is a stepped hole, with the larger end located proximally and the smaller end located distally. The wall of the stepped hole has steps. The distal end of the pusher 430 is stepped to match the shape of the first through-hole 221. The distal end of the pusher 430 also has steps. During loading, pushing, and releasing, the distal end of the pusher 430 extends into the first through-hole 221, and the steps of the pusher 430 abut against the steps of the first through-hole 221. This facilitates keeping the pusher 430 and the first through-hole 221 aligned during loading and operation, allowing the adjusting member 420 to smoothly extend from the first through-hole 221 outside the first end cap 220. Furthermore, even during operation, if improper force is applied, the step at the far end of the pusher 430 abuts against the step of the first through hole 221, preventing the pusher 430 from extending out of the first through hole 221 and damaging the first end cap 220.

[0101] In one implementation, please refer to Figure 19 The first through hole 221 is a stepped hole, with the larger end located proximally and the smaller end located distally. The hole wall has steps. The pusher 430 is a hollow cylindrical tube. The conveying device 40 also includes a transition member 402. (See also...) Figure 20, the transition member 402 is a hollow columnar structure with a "convex" cross-sectional shape. A step 4021 is formed at the distal end of the outer wall of the transition member 402, and the step 4021 surrounds the outer peripheral surface of the distal end of the transition member 402. An opening 4022 extending axially from the distal end to the proximal end of the transition member 402 is provided in the middle of the transition member 402. The cross-section of the opening 4022 is generally in the shape of a "convex", and the small end of the opening 4012 is located at the distal end and the large end is located at the proximal end. The shape and size of the large end of the opening 4022 match the shape and size of the distal end of the pusher 430, so that the transition member 402 can be sleeved on the distal end of the pusher 430 and fixedly connected to the pusher 430. During the loading process, the pushing process and the releasing process, the distal end of the transition member 402 extends into the first through hole 221, and the step 4021 of the transition member 402 abuts against the step of the first through hole 221. In this way, it is not only convenient for operation, but also avoids damaging the first end cap 220 and / or the adjusting member 420. At the same time, the outer diameter of the pusher 430 is very small, usually less than 1 mm, and it is very difficult to process a step on the outer wall of the pusher 430, with high process requirements and difficult to guarantee accuracy. By additionally providing the transition member 402, it is avoided to process the distal end of the pusher 430 to form a step. Therefore, additionally providing the transition member 402 can reduce the processing difficulty, is beneficial to improving the preparation efficiency, ensure the accuracy, and improve the production yield.

[0102] It can be understood that when the first through hole 221 is a trapezoidal hole, the aperture D1 of the first through hole 221 refers to the minimum width in the radial direction of the first through hole 221. When the first through hole 221 is a stepped hole, the aperture D1 of the first through hole 221 refers to the aperture of the smaller part of the first through hole 221, that is, the radial width of the part of the first through hole 221 away from the second end cap 230 is D1.

[0103] Please refer to again Figure 4 and Figure 5 , the conveying device 40 further includes a limiting component 403, and the limiting component 403 is used to limit the adjusting member 420 and the pusher 430 to avoid poor release of the occluder 20 caused by misoperation.

[0104] The limiting component 403 includes a clamping member 4031 and a locking member 4032 connected to the clamping member 4031. The locking member 4032 is used to adjust the clamping force of the clamping member 4031 to achieve limiting or non-limiting. The clamping member 4031 is disposed in the housing 411. In one embodiment, the clamping member 4031 includes a first clamping part and a second clamping part, forming a receiving area between the first clamping part and the second clamping part, into which the pusher 430 extends. The locking member 4032 is a locking wheel, which is simultaneously sleeved on the first clamping part and the second clamping part. By rotating the locking member 4032, the proximity of the first clamping part and the second clamping part can be adjusted, thereby making the size of the receiving area controllable. When the radial dimension of the receiving area is greater than the radial dimension of the pusher 430, the pusher 430 can be displaced with the displacement of the pusher control member 460. When the size of the receiving area is smaller than the radial dimension of the pusher 430, the pusher 430 cannot move, i.e., it is limited. Based on this, when the locking member 4032 is rotated further to lock the first clamping part and the second clamping part, the adjusting member 420 is clamped and cannot move, i.e., it is limited.

[0105] The operating handle 410 has a first operating window on its housing 411 and a second operating window on its upper cover 412, with the first and second operating windows facing each other. A locking member 4032 is disposed in the housing 411 and extends from the first and second operating windows for easy operation.

[0106] The delivery device 40 of the aforementioned occlusion system 100 can deliver the occluder 20 to the lesion site. After pushing the occluder 20 out of the delivery sheath 490, the displacement of the adjusting member 420 is controlled to restore the occluder 20 to its expanded state, thus achieving the shaping of the occluder 20. Operation is convenient and reliable. Furthermore, the structure of the occluder 20 is relatively simple, requiring no additional shaping auxiliary structures.

[0107] In one embodiment, the occluder 20 is a cardiac occluder, such as an atrial septal defect occluder, a ventricular septal defect occluder, or a left atrial appendage occluder.

[0108] In one embodiment, the occluder 20 is a vascular occluder, which can be used to block blood flow to treat vascular malformations or to block blood flow to treat tumors, etc.

[0109] Please see Figure 21 In one embodiment, the occluder 20 further includes a retainer 218. The retainer 218 is fitted onto the waist 217 of the occluder frame 210. A channel 219 is formed in the middle of the retainer 218, extending axially from the distal end of the retainer 218 to the retainer 218. The inner cavity 211 of the occluder frame 210 ( Figure 21 (Not shown), the first opening 212, the second opening 213 and the channel 219 are connected to form a path.

[0110] The number of fasteners 218 corresponds to the number of waist parts 217. Figure 21 In the embodiment shown, there are two waist sections 217, and correspondingly, there are two fasteners 218.

[0111] In another embodiment, there are multiple central blocking units 215 and more than two waist sections 217, with the multiple central blocking units 215 and multiple waist sections 217 arranged alternately along the axial direction. The central blocking unit 215 located at the farthest end is connected to the first blocking unit 214 via a waist section 217, and the central blocking unit 215 located at the nearest end is connected to the second blocking unit 216 via a waist section 217. Multiple fasteners 218 are respectively fitted onto the multiple waist sections 217. The channel 219 should be large enough that after the fasteners 218 are fitted onto the waist sections 217, there is still space in the middle of the channel 219.

[0112] The axial lengths of the multiple central blocking units 215 may be equal or unequal. Among the multiple central blocking units 215, all of the central blocking units 215 may have an axial length greater than that of the first blocking unit 214 and the second blocking unit 216, or some of the central blocking units 215 may have an axial length greater than that of the first blocking unit 214 and the second blocking unit 216, while some of the central blocking units 215 may have an axial length equal to that of the first blocking unit 214 and the second blocking unit 216.

[0113] The first opening 212, the second opening 213, the channel 219, the first through hole 221, and the second through hole 231 are coaxial, so that during loading, when the pusher 430 makes axial displacement, it enters the inner cavity 211 through the second through hole 231, and the path formed by the connection of the first opening 212, the second opening 213, and the channel 219, until the distal end of the pusher 430 abuts against the first end cap 220, thus assisting in loading and subsequent molding. By fitting a fixing member 218 on the waist 217, the fixing member 218 further fixes the above-mentioned path, that is, further fixes the path of the pusher 430 moving inside the sealing frame 210, which helps to prevent the pusher 430 from deviating from the preset direction and poking the sealing frame 210, thus preventing damage to the sealing frame 210.

[0114] Therefore, the locking element of the aforementioned occluder 20 can be omitted, and the occluder 20 can still be installed relatively easily without the locking element. The occluder 20 without the locking element has better flexibility, which is beneficial for passing through tortuous blood vessel paths or adapting to tortuous vascular lesion sites.

[0115] In one embodiment, the fixing member 218 is a sleeve made of a polymer material, and a channel extending from the distal end to the proximal end of the sleeve is formed in the middle of the sleeve. The sleeve is fitted onto the waist portion 217, with the inner wall of the sleeve contacting the outer peripheral surface of the waist portion 217. The channel should be large enough that after the sleeve is fitted onto the waist portion 217, there is still enough space in the channel to facilitate the passage of the pusher 430. However, the channel should not be too large, otherwise the limiting effect on the pusher 430 will be weak. The polymer material forming the sleeve is a bio-absorbable polymer material, so that the entire occluder 20 can be absorbed by the body.

[0116] The axial length of the sleeve is less than or equal to the axial length of the waist 217. In one embodiment, the ratio of the axial length of the sleeve to the axial length of the waist 217 is 1:(2 to 5) to avoid the axial length of the sleeve being too large and affecting the overall flexibility of the plugger 20, while at the same time avoiding the axial length of the sleeve being too small and causing difficulty in processing.

[0117] In one implementation, please refer to Figure 22 The fixing element 218 is a ring-shaped structure formed by wrapping polymer threads around the outer periphery of the waist portion 217. The polymer threads can be flexible threads such as polymer fiber threads or polymer medical sutures. In one embodiment, the polymer threads are absorbable polymer threads, allowing the occluder 20 to be absorbed by the body. The polymer threads, such as polymer fiber threads or polymer medical sutures, are relatively soft, and the ring-shaped structure formed by the polymer threads wrapping around the outer periphery of the waist portion 217 is also relatively soft. This ensures that the fixing element 218 does not significantly increase the overall rigidity of the occluder 20, and even if the number of fixing elements 218 is greater than two, the occluder 20 can still maintain sufficient flexibility. Furthermore, the method of forming the fixing element 218 around the waist portion 217 using polymer threads is relatively simple to prepare or process and easy to operate.

[0118] The polymer thread is wrapped around the waist 217 one or more times (e.g.) Figure 23 As shown, a fixing member 218 is formed. It is understood that the tightness of the polymer thread winding should be appropriate, on the one hand, so that the polymer thread can be reliably fixed to the waist 217, and on the other hand, after the polymer thread is wound around the waist 217, the channel formed by the polymer thread should be large enough to facilitate the passage of the pusher 430.

[0119] When the polymer thread is wound once around the waist 217, the diameter of the polymer thread is correspondingly larger. When the polymer thread is wound multiple times around the waist 217, a polymer thread with a smaller diameter can be used. The polymer thread being wound multiple times around the waist 217 to form the fastener 218 facilitates a reliable connection between the fastener 218 and the waist 217.

[0120] In one embodiment, regardless of whether the fastener 218 is a sleeve made of polymer material or an annular structure formed by polymer threads wound around the outer periphery of the waist 217, the width of the channel of the fastener 218 is D6, and the radial width of the waist is D7 in its natural state. The outer diameter D3 of the pusher 430 is smaller than D6 to allow the pusher 430 to pass smoothly through the fastener 218. D7 is larger than D6, which facilitates a reliable connection between the fastener 218 and the waist 217.

[0121] In one embodiment, D3 is 0.1 to 4 mm smaller than D6, and D7 is 2 to 60 mm larger than D6, so that the pusher 430 can pass smoothly through the fixing member 218, and the fixing member 218 is reliably connected to the waist 217, so as to prevent the fixing member 218 from falling off the waist 217 when the plugger 20 is axially stretched and loaded into the delivery sheath 490. This is especially important for embodiments where the fixing member 218 is a ring structure formed by polymer thread wrapped around the outer periphery of the waist 217.

[0122] Polymer materials lack elasticity and shape memory characteristics. Although the occlusion frame 210 made of polymer material is shaped, its stability is inferior to that of shape memory metal or alloy occlusion frames due to the inherent properties of the polymer material. This is especially true when the locking element is omitted, further reducing the stability of the polymer-based occlusion frame 210. Furthermore, when the number of central occlusion units 215 and waist sections 217 is large, resulting in a significant axial length of the occluder 20, improving the stability of the occlusion frame 210 becomes particularly important. The waist section 217 is fitted with a fixing element 218, effectively dividing the occlusion frame 210 into multiple smaller axial sections. This improves the overall stability of the occlusion frame 210, allowing the occluder 20 to stably maintain its preset shape at the lesion site, thus enhancing the occlusion effect.

[0123] The aforementioned plugging device 20 has a fixing member 218 fitted on its waist 217. The fixing member 218 helps to fix the displacement path of the pusher 430 in the plugging frame 210, so that the pusher 430 is displaced along the fixed path until its distal end abuts against the first end cap 220 of the plugging device 20, thereby achieving axial tension of the plugging device 20 for easy loading. Furthermore, during loading, due to the restriction of the fixing member 218, the distal end of the pusher 430 is prevented from slipping or improper operation from disengaging from the first end cap 220, so that the pusher 430 can remain in contact with the first end cap 220 without shifting, thus ensuring that the loading of the plugging device 20 can be carried out smoothly.

[0124] Furthermore, after the occluder 20 is delivered to the lesion site through the delivery sheath 490, before confirming whether the occluder 20 is in the correct position, the pusher 430 can remain in contact with the first end cap 220 without shifting due to the restraint of the fixing member 218. This allows the occluder 20 to be reliably kept in an axially stretched state, so that the operator can adjust the position of the occluder 20.

[0125] Meanwhile, the fastener 218 helps to fix the relative position of the pusher 430 and the first end cap 220, and helps to avoid unnecessary friction between the pusher 430 and the first end cap 220 and / or the sealing frame 210, thereby avoiding damage to the first end cap 220 and / or the sealing frame 210.

[0126] Therefore, the locking element can be omitted from the plugging device 20. The plugging device 20 of the plugging system 100 cooperates with the conveying device 40, making the loading and forming of the plugging device 20 more convenient and reliable.

[0127] In one embodiment, when there is one central occlusion unit 215 and two waist sections 217, and the fixing member 218 is a ring structure formed by winding polymer threads around the outer periphery of the waist section 217, the tightness of the polymer threads wound around the two fixing members 218 is different, and the width D6 of the channel of the two fixing members 218 is not equal. The fixing member 218 located at the distal end has a smaller tightness and a larger value of D6. This arrangement ensures convenient loading and shaping while making it easier to adjust the axial length of the occluder 20, thus facilitating the smooth operation.

[0128] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0129] 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. An occluder comprising an occlusion frame, a first occlusion head and a second occlusion head, characterized in that, The occlusion frame has an inner cavity, and the occlusion frame has opposite first and second openings, the first and second heads are respectively located at the distal and proximal ends of the occlusion frame, and the inner cavity, the first opening and the second opening are communicated to form a path; The first head is provided with a first through hole, and the second head is provided with a second through hole, the first through hole is communicated with the first opening, the second through hole is communicated with the second opening, the second head is used for detachable connection with an external conveying device, the aperture of the first through hole is smaller than the aperture of the second through hole, so that the pushing member of the external conveying device passes through the second through hole and abuts against the first head; The first through hole is a stepped hole, one end of the stepped hole with a larger size is located at the proximal end, and one end of the stepped hole with a smaller size is located at the distal end, the stepped hole has a step, and the step of the stepped hole is used for abutting against the step on the pushing member.

2. The occluder of claim 1, wherein, The occlusion frame comprises a first occlusion unit, a middle occlusion unit, a second occlusion unit and a waist, two ends of the middle occlusion unit are connected with the first and second occlusion units through the waist respectively, a fixing member is sleeved on the waist, a channel is formed in the middle of the fixing member, the first opening, the channel, the inner cavity and the second opening are communicated to form the path, the first head is arranged on the first occlusion unit, and the second head is arranged on the second occlusion unit.

3. The occluder of claim 2, wherein, The fixing member is a sleeve formed by a high molecular material or a ring structure formed by winding a high molecular wire on the outer periphery of the waist.

4. The occluder of claim 2, wherein, The number of the middle occlusion units is at least one, the number of the waists is at least two, when the number of the middle occlusion units is greater than one, the number of the waists is greater than two, and the multiple middle occlusion units with a number greater than one and the multiple waists with a number greater than two are arranged alternately in the axial direction.

5. The occluder of claim 2, wherein, The axial length of the middle occlusion unit is greater than the axial length of the first and second occlusion units.

6. An occlusion system, characterized by The occlusion frame comprises a first occlusion unit, a middle occlusion unit, a second occlusion unit and a waist, the conveying device comprises an adjusting member, the adjusting member is slidably arranged along the path, the distal end of the adjusting member extends out of the inner cavity, and the distal end of the adjusting member is abuttable against the first occlusion unit.

7. The occlusion system of claim 6, wherein, In a natural state, one end of the adjusting member has a pre-bent part, when the adjusting member is slidably arranged along the path and the pre-bent part is located outside the occlusion frame, the pre-bent part restores the bent state and is abuttable against the first occlusion unit.

8. The occlusion system of claim 7, wherein, The pre-bent part is an arc-shaped rod or an arc-shaped wire, and the angle of the arc-shaped rod or the arc-shaped wire is 40°-90°.

9. The occlusion system of claim 6, wherein, The conveying device further comprises a pushing member, the pushing member has an inner cavity, the pushing member is slidably arranged along the path, the distal end of the pushing member is abuttable against the first head, and the adjusting member is slidably arranged through the pushing member.

10. The occlusion system of claim 9, wherein, The blocking frame comprises a first blocking unit, a middle blocking unit, a second blocking unit and a waist, two ends of the middle blocking unit are connected with the first blocking unit and the second blocking unit through the waist, a fixing member is sleeved on the waist, and a channel is formed in the middle of the fixing member; The outer diameter of the pushing member is 0.1-4mm smaller than the radial width of the channel.

Citation Information

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