An occlusion device

Abstract

The application belongs to the technical field of medical devices, and discloses a plugging device, which comprises a loading assembly, a first plugging assembly, a second plugging assembly, a pushing tube, a pushing rod and a positioning piece. The loading assembly is provided with a lumen, the first plugging assembly and the second plugging assembly are both arranged in the lumen, the distal end of the pushing tube is arranged in the lumen, and the pushing tube is located on the side of the first plugging assembly away from the second plugging assembly. The distal end of the pushing rod is sequentially arranged in the pushing tube, the first plugging assembly and is threadedly connected with the second plugging assembly. The positioning piece is detachably arranged at the proximal end of the pushing tube, and the distal end of the positioning piece can abut against the loading assembly. The plugging device provided by the application can quickly and accurately move the first plugging assembly and the second plugging assembly out of the lumen of the loading assembly during the operation, is convenient to operate, effectively reduces the operation time and accelerates the operation progress.

Description

Technical Field

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

[0002] The foramen ovale is a passageway between the left and right ventricles of the heart during fetal development. Blood from the mother's umbilical vein enters the left ventral chamber of the fetus through this passage and is then distributed throughout the body, providing the fetus with the oxygen and nutrients necessary for development. Without the foramen ovale, the fetus cannot develop normally, demonstrating its essential and normal physiological structure. After birth, the baby establishes normal pulmonary circulation, fulfilling the foramen ovale's function. With the first cry, the pressure in the left atrium increases, causing the valve of the left primary septum to partially adhere to the edge of the right secondary septum, resulting in functional closure. Anatomical closure typically occurs 5-7 months after birth. Approximately 77.6% of newborns have their foramen ovale closed within one year. However, in some individuals, the foramen ovale remains open. A true patent foramen ovale is defined as a foramen ovale that has not closed by age 3.

[0003] In most people, the pressure in the left atrium is greater than in the right atrium. Therefore, even if a patent foramen ovale (PFO) exists, the shunting from left to right through the PFO is minimal and does not cause noticeable symptoms. During fetal development, the flow of blood from the PFO to the left atrium and then to the rest of the body is for normal fetal development. However, as the baby grows, this blood flow pattern can potentially cause problems.

[0004] Atrial septal defect (ASD) is similar to patent foramen ovale (PFO), but it is a congenital heart defect. ASD is caused by abnormalities during embryonic development and usually presents with symptoms such as shortness of breath, palpitations, and fatigue. Both PFO and ASD involve a residual, unclosed opening between the left and right atria, allowing blood to flow between them.

[0005] However, the size of the patent foramen ovale is generally smaller than that of an atrial septal defect (approximately 4 mm for the patent foramen ovale and approximately 8 mm for the atrial septal defect). Moreover, the valvular defect foramen does not extend vertically to the valve wall, meaning that the foramen ovale foramen ovale of the left and right hearts are not concentric. A patent foramen ovale with a diameter of 4 mm or more poses a significant risk to health.

[0006] In current techniques, atrial septal defects and patent foramen ovale are typically treated with occluders. These occluders are usually disc-shaped and are delivered to a specific location on the patient's heart via catheter or lead. However, in current cardiac surgery procedures, pushing the occluder to the specific location is inconvenient, requires a long operation time, and affects the progress of the surgery. Summary of the Invention

[0007] The purpose of this invention is to provide a sealing device that effectively reduces operation time and speeds up the surgical process.

[0008] To achieve this objective, the present invention adopts the following technical solution:

[0009] A sealing device is provided, comprising:

[0010] The loading assembly is equipped with a cavity;

[0011] The first sealing component is inserted into the cavity;

[0012] The second sealing component is connected to the first sealing component. The second sealing component is inserted into the lumen, and the first sealing component and the second sealing component are arranged alternately from the proximal end to the distal end of the lumen.

[0013] A push tube, the distal end of which is movably inserted into the lumen, and the push tube is located on the side of the first blocking assembly facing away from the second blocking assembly, and the push tube can abut against the first blocking assembly;

[0014] A push rod, the distal end of which is sequentially movably inserted through the push tube, the first sealing component, and threadedly connected to the second sealing component;

[0015] A positioning element is detachably disposed at the proximal end of the push tube, and the distal end of the positioning element can abut against the loading assembly.

[0016] Optionally, a valve is provided at the proximal end of the push tube, and the push rod passes through the valve and the push tube in sequence, with the valve having two states: clamping or releasing the push rod.

[0017] Optionally, the positioning element has a positioning cavity at its center, and the outer wall of the positioning element has an opening that extends longitudinally along the positioning element and communicates with the positioning cavity.

[0018] Optionally, the opening angle α of the opening is 75°-100°.

[0019] Optionally, the outer wall of the positioning member is provided with a protrusion, which extends along the axial direction of the positioning member.

[0020] Optionally, the loading component includes:

[0021] A loader, the proximal end of which can abut against the distal end of the positioning member;

[0022] A delivery conduit, the proximal end of which is detachably connected to the distal end of the loader; wherein,

[0023] The lumen includes a loading lumen disposed on the loader and a conduit lumen disposed on the delivery conduit, wherein the first sealing component and the second sealing component are disposed within the loading lumen.

[0024] Optionally, the proximal diameter of the loading cavity is larger than the distal diameter of the loading cavity.

[0025] Optionally, a handle may be detachably connected to the proximal end of the push rod.

[0026] Optionally, it also includes a suture thread, which passes through the first occlusion assembly and the second occlusion assembly, and the suture thread connects the first occlusion assembly and the second occlusion assembly.

[0027] Optionally, the push tube has a first cavity and a second cavity, the push rod is inserted into the first cavity, and the suture is inserted into the second cavity.

[0028] Beneficial effects:

[0029] The occlusion device provided by this invention first moves the push tube and push rod towards the distal end of the lumen of the loading component until the distal end of the positioning element abuts against the loading component. The second occlusion component then detaches from the lumen under the push of the push tube and is positioned on the distal side of the membrane wall. Next, the positioning element is removed from the push rod, and the loading component is moved towards the proximal end of the push tube, i.e., the position of the push rod relative to the push tube remains unchanged. The first occlusion component detaches from the lumen under the limitation of the push rod and is positioned on the proximal side of the membrane wall. Finally, the second occlusion component and push rod are disassembled, and the loading component, push tube, and push rod are withdrawn from the body. By sealing the membrane wall defect with the first and second occlusion components, the first and second occlusion components can be quickly and accurately removed from the lumen of the loading component during surgery. The operation is convenient, effectively reducing operation time and accelerating the surgical progress. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of a blocking device provided by the present invention;

[0031] Figure 2 This is another schematic diagram of the sealing device provided by the present invention;

[0032] Figure 3 This is another schematic diagram of the blocking device provided by the present invention;

[0033] Figure 4 This is a schematic diagram of the structure when the suture is tightened according to the present invention;

[0034] Figure 5 This is a schematic diagram of the distal structure of the push tube provided by the present invention;

[0035] Figure 6This is a schematic diagram of the proximal structure of the push tube provided by the present invention;

[0036] Figure 7 This is a schematic diagram of the proximal structure of the push rod provided by the present invention;

[0037] Figure 8 This is a schematic diagram of the loading component provided by the present invention;

[0038] Figure 9 This is a schematic diagram of the positioning component provided by the present invention from one perspective;

[0039] Figure 10 This is a schematic diagram of the positioning component provided by the present invention from another perspective.

[0040] Figure 11 This is a schematic diagram of the connection structure between the first and second sealing components provided by the present invention;

[0041] In the picture:

[0042] 100. Loading assembly; 101. Lumen; 110. Loader; 111. Pipe body; 112. Loading seat; 120. Delivery conduit; 130. Second Luer connector;

[0043] 200, First sealing component; 210, First support member; 211, First sleeve portion; 2111, First threading hole; 212, First support rod; 213, First protrusion; 2131, First fixing hole; 220, First buckle; 221, First main body portion; 2211, First positioning end face; 222, First snap-fit ​​portion;

[0044] 300. Second sealing assembly; 310. Second support member; 311. Second sleeve portion; 3111. Second wire hole; 312. Second support rod; 313. Second protrusion; 3131. Second fixing hole; 320. Second buckle; 321. Second main body portion; 3211. Second positioning end face; 322. Second snap-fit ​​portion;

[0045] 400, Push tube; 401, First cavity; 402, Second cavity; 410, Valve; 411, Valve body; 4111, Main pipe; 4112, First branch pipe; 4113, Second branch pipe; 412, Fastener; 420, First Luer connector;

[0046] 500. Push rod; 510. Handle; 520. Clamping component;

[0047] 600, Positioning element; 601, Positioning cavity; 602, Opening; 610, Raised strip;

[0048] 700, suture thread; 710, loop section; 720, locking section. Detailed Implementation

[0049] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, and not all of the structures.

[0050] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0051] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0052] In the description of this embodiment, the terms "upper," "lower," "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. In addition, the terms "first" and "second" are used only for distinction in description and have no special meaning.

[0053] Reference Figures 1 to 3 As shown, this embodiment provides a blocking device, which includes a loading component 100, a first blocking component 200, a second blocking component 300, a push tube 400, a push rod 500, and a positioning component 600.

[0054] Specifically, the loading assembly 100 is provided with a lumen 101, and the first sealing assembly 200 and the second sealing assembly 300 are both disposed within the lumen 101, with the first sealing assembly 200 and the second sealing assembly 300 arranged alternately from the proximal end to the distal end of the lumen 101. In this embodiment, the first sealing assembly 200 and the second sealing assembly 300 are connected together, and the first sealing assembly 200 and the second sealing assembly 300 are used to be disposed on both sides of the membrane wall to seal defects in the membrane wall. The distal end of the lumen 101 refers to the end of the first sealing assembly 200 and the second sealing assembly 300 that moves towards the membrane wall within the lumen 101 during the surgical procedure, and the proximal end of the lumen 101 refers to the opposite end of the distal end. Furthermore, the definitions of the proximal and distal ends of other components in this embodiment are the same as those of the proximal and distal ends of the lumen 101, and will not be elaborated further in this application. For example, the membrane wall includes, but is not limited to, the interatrial septum, which is blocked by the first occlusion component 200 and the second occlusion component 300 to prevent the generation of blood shunting in the atria.

[0055] Furthermore, the distal end of the push tube 400 is movably inserted into the cavity 101, and the push tube 400 is located on the side of the first sealing assembly 200 facing away from the second sealing assembly 300. The push tube 400 can abut against the first sealing assembly 200, so that the push tube 400 can push the first sealing assembly 200 out of the distal end of the cavity 101. The distal end of the push rod 500 is movably inserted through the push tube 400 and the first sealing assembly 200 in sequence and is threadedly connected to the second sealing assembly 300. The push rod 500 can push the second sealing assembly 300 out of the distal end of the cavity 101. Positioning member 60 The positioning member 600 is detachably disposed at the proximal end of the push tube 400. The distal end of the positioning member 600 can abut against the loading component 100 to prevent the first blocking component 200 from being pushed out at the distal end of the lumen 101. It can be understood that when the positioning member 600 is disposed at the proximal end of the push tube 400, the first blocking component 200 is always located inside the lumen 101; when the distal end of the positioning member 600 abuts against the loading component 100, the second blocking component 300 is located outside the distal end of the lumen 101; when the positioning member 600 is disengaged from the push tube 400, the first blocking component 200 can be located outside the distal end of the lumen 101.

[0056] In this embodiment, the push tube 400 and push rod 500 are first moved toward the distal end of the lumen 101 of the loading assembly 100 until the distal end of the positioning member 600 abuts against the loading assembly 100. The second sealing assembly 300 is disengaged from the lumen 101 and placed on the distal side of the membrane wall under the push of the push tube 400. Then, the positioning member 600 is removed from the push rod 500, the positioning member 600 is removed, and the loading assembly 100 is moved toward the proximal end of the push tube 400, that is, the position of the push rod 500 relative to the push tube 400 remains unchanged. The first sealing assembly 200 is disengaged from the lumen 101 and placed on the proximal side of the membrane wall under the limitation of the push rod 500. Finally, the second sealing assembly 300 and push rod 500 are disassembled, and the loading assembly 100, push tube 400 and push rod 500 are withdrawn from the body. By sealing the defects in the membrane wall with the first sealing component 200 and the second sealing component 300, the first sealing component 200 and the second sealing component 300 can be quickly and accurately removed from the lumen 101 of the loading component 100 during the operation. The operation is convenient, effectively reducing the operation time and speeding up the operation.

[0057] In this embodiment, reference is made to Figure 4 As shown, the occlusion device also includes a suture 700, which passes through the first occlusion component 200 and the second occlusion component 300, connecting the first occlusion component 200 and the second occlusion component 300. During the operation, after the first occlusion component 200 is detached from the lumen 101 and placed on the proximal side of the membrane wall, the suture 700 connects the first occlusion component 200 and the second occlusion component 300, giving them the effect of clamping the membrane wall, thereby enabling the first occlusion component 200 and the second occlusion component 300 to have a good sealing effect on the defects in the membrane wall.

[0058] For example, the material of the suture 700 can be PP material.

[0059] Specifically, the suture 700 has a loop portion 710 and a locking portion 720. The loop portion 710 has an adjustment margin, meaning its length is adjustable. In this embodiment, the loop portion 710 has an adjustment margin so that the first sealing assembly 200 and the second sealing assembly 300, placed in the lumen 101 of the loading assembly 100, are spaced apart. After the first sealing assembly 200 and the second sealing assembly 300 are respectively placed on both sides of the membrane wall and adjusted to their positions, the loop portion 710 is tightened to fix the first sealing assembly 200 and the second sealing assembly 300.

[0060] Specifically, after the first end of the loop portion 710 passes through the first sealing component 200 and the second sealing component 300, it is woven with the second end of the loop portion 710 to form a locking knot portion 720. The loop portion 710 is tightened by pulling back either the first or second end. For example, the locking knot portion 720 can be a fisherman's knot. The weaving structure of the locking knot portion 720 is prior art and is not the focus of this application, so it will not be described further.

[0061] In this embodiment, reference is made to Figure 5 As shown, the push tube 400 has a first cavity 401 and a second cavity 402. A push rod 500 passes through the first cavity 401, and a suture 700 passes through the second cavity 402 to prevent the push rod 500 from becoming entangled with the suture 700 and affecting the surgical procedure. The diameter of the first cavity 401 is larger than the diameter of the push rod 500, meaning the push rod 500 can slide freely within the first cavity 401. In this embodiment, the locking portion 720 is larger than the second cavity 402 to prevent the locking portion 720 from being placed inside the second cavity 402. When the first or second end of the suture loop 710 is pulled back, the end of the second cavity 402 pushes against the locking portion 720, thereby tightening the suture loop 710 and facilitating operation.

[0062] For example, the material of the push tube 400 can be nylon.

[0063] Specifically, the distal end of the push tube 400 is chamfered to facilitate the push tube 400 passing through the cavity 101 of the loading assembly 100.

[0064] In this embodiment, reference is made to Figure 6As shown, a valve 410 is provided at the proximal end of the push tube 400, and the push rod 500 passes through the valve 410 and the push tube 400 in sequence. The valve 410 has two states: clamping or releasing the push rod 500. In this embodiment, during the operation, the push rod 500 is first clamped by the valve 410 to fix the push rod 500 and the push tube 400 together, and the push tube 400 is moved toward the distal end of the lumen 101 of the loading assembly 100. The push tube 400 drives the push rod 500 to move toward the distal end of the lumen 101 until the distal end of the positioning member 600 abuts against the loading assembly 100. The second sealing assembly 300 is disengaged from the lumen 101 and placed on the distal side of the membrane wall. The position of the second sealing assembly 300 is adjusted so that the second sealing assembly 300 abuts against the membrane wall. Then, the positioning member 600 is removed from the push rod 500, and the loading assembly 100 is removed. The push tube 400 moves towards the proximal end of the push tube 400, and the first sealing component 200 disengages from the lumen 101 and is placed on the proximal side of the membrane wall. Finally, the push rod 500 is released by the valve 410, and the push tube 400 is moved towards the first sealing component 200. During this process, the push rod 500 remains stationary, and the push tube 400 moves relative to the push rod 500. The push tube 400 pushes against the first sealing component 200 to adjust the position of the first sealing component 200 so that the first sealing component 200 is against the membrane wall, and the loop portion 710 is tightened to complete the fixation of the first sealing component 200 and the second sealing component 300, thereby achieving the sealing of the membrane wall defect.

[0065] Specifically, a first Luer connector 420 is provided at the proximal end of the push tube 400. The proximal end of the push tube 400 is detachably connected to the distal end of the valve component 410 through the first Luer connector 420. In this embodiment, when the positioning component 600 is removed from the push rod 500 and the loading component 100 abuts against the first Luer connector 420, the first sealing component 200 moves outside the cavity 101. The first Luer connector 420 can be connected to the proximal end of the push tube 400 by means of bonding or injection molding.

[0066] Specifically, the valve component 410 includes a valve body 411, an elastic pad (not shown), and a fastener 412. The valve body 411 has a first hole through which the push rod 500 passes. The first hole is a stepped hole, with the larger end of the first hole located near its proximal end. An elastic pad is disposed within the larger end of the first hole and is fitted onto the push rod 500. The fastener 412 is threadedly connected to the larger end of the first hole. In this embodiment, in its natural state, the inner diameter of the elastic pad is larger than the outer diameter of the push rod, allowing the push rod 500 to move relative to the push tube 400. Tightening the fastener 412 compresses the elastic pad, causing it to elastically deform and clamp the push rod 500, thus fixing the push rod 500 to the push tube 400.

[0067] Specifically, the valve body 411 includes a main pipe 4111, which has a first hole. The first Luer connector 420 is detachably connected to the main pipe 4111.

[0068] Specifically, the valve body 411 also includes a first branch pipe 4112 and a second branch pipe 4113. The first branch pipe 4112 has a second hole, and the second branch pipe has a third hole. The end of the suture 700 passes through the first cavity 401 of the push tube 400 and exits through one of the second and third holes. The first, second, and third holes can be connected, and the other of the second and third holes serves as a flushing hole to inject medication or flushing fluid into the push tube 400.

[0069] For example, valve 410 can be a Y-type valve.

[0070] In this embodiment, reference is made to Figure 7 As shown, a handle 510 is detachably connected to the proximal end of the push rod 500. By rotating the push rod 500 through the handle 510, the push rod 500 can be separated from the second sealing assembly 300 for easy operation. To facilitate gripping and rotating the handle 510, wavy protrusions can be evenly provided on the outer surface of the handle 510.

[0071] Specifically, the handle 510 has a fixing hole, into which the push rod 500 is inserted. A clamping member 520 is provided around the periphery of the handle 510. The clamping member 520 passes through the handle 510 and presses against the push rod 500 in the fixing hole to fix the push rod 500 to the handle 510. The clamping member 520 can be threadedly connected to the handle 510. The clamping member 520 includes a rod portion and a grip portion. The rod portion passes through the periphery of the handle 510 and is threadedly connected to the handle 510. The outer surface of the grip portion is also uniformly provided with wavy protrusions to facilitate gripping and rotating the clamping member 520.

[0072] In this embodiment, reference is made to Figure 1 and Figure 8As shown, the loading assembly 100 includes a loader 110 and a delivery conduit 120. The proximal end of the loader 110 can abut against the distal end of the positioning member 600 to prevent the first occlusion assembly 200 from being pushed out of the distal end of the lumen 101. The proximal end of the delivery conduit 120 is detachably connected to the distal end of the loader 110. The lumen 101 includes a loading lumen disposed on the loader 110 and a conduit lumen disposed on the delivery conduit 120. The first occlusion assembly 200 and the second occlusion assembly 300 are disposed within the loading lumen. The loading assembly 100 has a split design, facilitating the insertion of the delivery conduit 120 into the human body. After the distal end of the delivery conduit 120 passes through the membrane wall via a defect, the loader 110, containing the first occlusion assembly 200 and the second occlusion assembly 300, is then connected to the delivery conduit 120 to continue subsequent surgical procedures. This design is convenient and effectively shortens the surgical time.

[0073] Specifically, the proximal end of the delivery conduit 120 is provided with a second Luer connector 130, and the proximal end of the delivery conduit 120 is detachably connected to the distal end of the loader 110 through the second Luer connector 130. The second Luer connector 130 can be connected to the proximal end of the delivery conduit 120 by means of bonding or injection molding.

[0074] Specifically, the proximal diameter of the loading cavity is larger than the distal diameter of the loading cavity. In this embodiment, both the first sealing component 200 and the second sealing component 300 have an expanded state and a compressed state. In their natural state, both the first sealing component 200 and the second sealing component 300 are in an expanded state and have the effect of sealing membrane wall defects. However, when the first sealing component 200 and the second sealing component 300 are placed in the loading cavity, they are in a compressed state. It can be understood that the proximal diameter of the loading cavity is larger than the distal diameter of the loading cavity, which facilitates the insertion of the first sealing component 200 and the second sealing component 300.

[0075] Specifically, the loader 110 is stepped, comprising a tube body 111 and a loading seat 112 connected together. The tube body 111 is the distal end of the loader 110, and the loading section is the proximal end. The diameter of the loading cavity in the loading section gradually increases from the distal end to the proximal end to facilitate the insertion of the first sealing assembly 200 and the second sealing assembly 300 into the loading cavity of the tube body 111. The placement of the first sealing assembly 200 and the second sealing assembly 300 within the loading cavity of the tube body 111 ensures their stable placement. The distal end of the tube body 111 is detachably connected to the second Luer connector 130.

[0076] In this embodiment, reference is made to Figure 9 and Figure 10As shown, the positioning member 600 has a centrally located positioning cavity 601, and an opening 602 extending longitudinally along the positioning member 600 and communicating with the positioning cavity 601. The push tube 400 can pass through the opening 602 to enter or exit the positioning cavity 601, facilitating the assembly and disassembly of the positioning member 600 relative to the push tube 400. For example, the positioning member 600 is columnar, the positioning cavity 601 is opened along the axial direction of the positioning member 600, and the opening 602 is located on the periphery of the positioning member 600.

[0077] For example, the positioning element 600 can be made of resin. In this embodiment, the positioning element 600 can be 3D printed, which facilitates molding and manufacturing.

[0078] In one feasible implementation, the opening angle α of the opening 602 is 75°-100°, effectively ensuring the stability of the connection between the positioning member 600 and the push tube 400, and facilitating the assembly and disassembly of the positioning member 600. For example, the opening angle α of the opening 602 is 80°, 85°, or 90°. Exemplarily, the positioning cavity 601 is a circular hole, and the opening angle α refers to the included angle between the two opposing surfaces of the opening 602, and the two opposing surfaces of the opening 602 extend to coincide with the centerline of the positioning cavity 601.

[0079] In one feasible embodiment, the outer wall of the positioning member 600 is provided with a protrusion 610, which extends axially along the positioning member 600, facilitating the assembly and disassembly of the positioning member 600. Further, the protrusion 610 is provided at the distal end of the positioning member 600, allowing the positioning member 600 to abut against the proximal end of the loader 110, thereby stably defining the position of the loader 110. Exemplarily, at least one protrusion 610 is provided; for example, two protrusions 610 are spaced apart circumferentially along the positioning member 600. This application does not specifically limit the number of protrusions 610.

[0080] In this embodiment, reference is made to Figure 11 As shown, the first sealing assembly 200 includes a first support member 210 and a first latch 220. The first support member 210 includes a first sleeve portion 211 and a plurality of first support rods 212 spaced circumferentially along the first sleeve portion 211. Each first support rod 212 has a first connecting end and a first free end opposite to the first connecting end, and the first connecting end is connected to the first sleeve portion 211. The first latch 220 engages with the first sleeve portion 211. In this embodiment, the design of the first support member 210 effectively reduces the amount of implanted metal, thereby reducing the risk of complications. Furthermore, the push tube 400 pushes against the first latch 220, which provides better stability compared to directly pushing against the first sleeve portion 211, and facilitates adjustment of the position of the first sealing assembly 200.

[0081] For example, the first support member 210 can be made of nickel-titanium alloy. Nickel-titanium alloy has excellent biocompatibility and can be implanted into the human body. After detachment from the delivery catheter 120, the first support member 210 can recover from a compressed state to an expanded state due to its own elasticity, and it also has good support force. In this embodiment, the first support member 210 is integrally formed by laser cutting and then heat-setting a nickel-titanium tube. The manufacturing process is simple, and the amount of metal implanted in the first support member 210 is less than that of a traditional occlusion disc, reducing the risk of complications and facilitating the puncture of the atrial septum. Of course, the first support member 210 can also be made of other materials, and this application does not impose further limitations.

[0082] For example, a plurality of first support rods 212 are distributed at equal intervals along the circumference of the first sleeve portion 211.

[0083] For example, when the first support member 210 is in the cavity 101 of the loading device, such as in the loading cavity of the loader 110, the first free end of the first support rod 212 bends toward the distal end of the first sleeve portion 211, so that the first sealing assembly 200 is in a compressed state, which facilitates the insertion of the first sealing assembly 200 into the loading cavity, and there is no radial overlap between the first support rod 212 and the first sleeve portion 211, which effectively reduces the diameter of the loader 110 and the delivery conduit 120, and facilitates the delivery of the loader 110 and the delivery conduit 120.

[0084] For example, when the first blocking assembly 200 is in the extended state, the first free end of the first support rod 212 bends toward the proximal end of the first sleeve portion 211, which facilitates the delivery, retrieval and release of the first support member 210 relative to the delivery conduit 120.

[0085] Furthermore, the first blocking assembly 200 also includes a first flow-blocking membrane (not shown), which covers the space between the plurality of first support rods 212. The first flow-blocking membrane can effectively prevent blood shunting. In this embodiment, when the first blocking assembly 200 is in the extended state, the first support rods 212 of the first support member 210 expand the first flow-blocking membrane.

[0086] For example, the material of the first flow-blocking membrane can be a polymer material, such as PET. Of course, the material of the first flow-blocking membrane can also be other materials, and this application does not impose any restrictions.

[0087] Specifically, the first connecting end of the first support rod 212 is connected to the distal end of the first sleeve portion 211. In its natural state, the first support rod 212 bends towards the proximal end of the first sleeve portion 211, with a bending angle β less than or equal to 90°. This ensures the expansion area of ​​the first flow-blocking membrane while effectively ensuring that the first support rod 212 stably abuts against the membrane wall, making the first flow-blocking membrane sufficient to seal any defects in the membrane wall. For example, the bending angle β can be 45°, 60°, 75°, 80°, 85°, etc.

[0088] In one feasible implementation, the first free end of the first support rod 212 is provided with a first protrusion 213, which effectively increases the connection strength between the first flow-blocking membrane and the first support rod 212, and effectively increases the contact area between the first free end of the first support rod 212 and the membrane wall, thus avoiding force concentration and damage to the membrane wall. For example, the shape of the first protrusion 213 can be disc-shaped.

[0089] Specifically, the first protrusion 213 is provided with a first fixing hole 2131. The first flow-blocking membrane can be sewn onto the first support rod by threading through the first fixing hole 2131, effectively blocking blood flow. Of course, the first flow-blocking membrane can also be wrapped onto the first support rod 212 by heat fusion or other methods, which is not limited in this application.

[0090] In this embodiment, reference continues to be made to... Figure 11 As shown, the first buckle 220 includes a first main body 221 and at least two first engaging portions 222. The first main body 221 has a first through hole through which the distal end of the push rod 500 passes and connects to the second sealing assembly 300. The first engaging portions 222 are spaced apart circumferentially along the first main body 221 and engage with the first sleeve portion 211. The first engaging portions 222 can be evenly spaced along the circumferential direction of the first main body 221. In this embodiment, the first buckle 220 and the first support member 210 are connected by engaging the first engaging portions 222, which is simple, quick, and provides a stable and reliable connection.

[0091] For example, the first snap-fit ​​portion 222 is provided with 2 to 6, such as 3 or 4.

[0092] For example, the first perforation may be formed at the center of the first body.

[0093] Specifically, the first main body 221 has a first positioning end face 2211, on which a first snap-fit ​​part 222 is provided. The first snap-fit ​​part 222 is hook-shaped. The first snap-fit ​​part 222 passes through the proximal end of the first sleeve part 211 and hangs on the distal end of the first sleeve part 211. The first positioning end face 2211 abuts against the proximal end of the first sleeve part 211 to realize the connection between the first buckle 220 and the first support member 210.

[0094] In this embodiment, reference continues to be made to... Figure 11 As shown, the second occlusion assembly 300 includes a second support member 310 and a second latch 320. The second support member 310 includes a second sleeve portion 311 and a plurality of second support rods 312 spaced circumferentially along the second sleeve portion 311. Each second support rod 312 has a second connecting end and a second free end opposite to the second connecting end, and the second connecting end is connected to the second sleeve portion 311. The second latch 320 engages with the second sleeve portion 311. In this embodiment, the design of the second support member 310 effectively reduces the amount of implanted metal, thereby reducing the risk of complications. Furthermore, the design of the second latch 320 facilitates the connection of the second support member 310 to the distal end of the push rod 500.

[0095] For example, the second support member 310 can be made of nickel-titanium alloy, and its forming method is the same as that of the first support member 210, which will not be described in detail here. Of course, the second support member 310 can also be made of other materials, which are not limited here.

[0096] For example, a plurality of second support rods 312 are distributed at equal intervals along the circumference of the second sleeve portion 311.

[0097] For example, when the second support member 310 is in the cavity 101 of the loading device, such as in the loading cavity of the loader 110, the second free end of the second support rod 312 bends toward the distal end of the first sleeve portion 211, so that the second sealing assembly 300 is in a compressed state, which facilitates the placement of the second sealing assembly 300 into the loading cavity, and there is no radial overlap between the second support rod 312 and the second sleeve portion 311, which effectively reduces the diameter of the loader 110 and the delivery conduit 120, and facilitates the delivery of the loader 110 and the delivery conduit 120.

[0098] For example, when the second sealing assembly 300 is in the extended state, the second free end of the second support rod 312 bends toward the proximal end of the second sleeve portion 311, which facilitates the delivery, retrieval and release of the second support member 310 relative to the delivery conduit 120.

[0099] Furthermore, the second occlusion assembly 300 also includes a second flow-blocking membrane (not shown), which covers the space between the plurality of second support rods 312 and can effectively prevent blood shunting.

[0100] For example, the material of the second flow-blocking membrane can be a polymer material, such as PET. Of course, the material of the second flow-blocking membrane can also be other materials, and this application does not impose any restrictions.

[0101] Specifically, the second connecting end of the second support rod 312 is connected to the distal end of the second sleeve portion 311. In its natural state, the second support rod 312 bends towards the proximal end of the second sleeve portion 311, with a bending angle γ greater than or equal to 90° and less than 180°. This ensures the expansion area of ​​the second flow-blocking membrane while effectively ensuring that the second support rod 312 stably abuts against the membrane wall, making the second flow-blocking membrane sufficient to seal any defects in the membrane wall. For example, the bending angle γ can be 100°, 120°, 145°, 150°, 160°, etc.

[0102] In one feasible implementation, the second free end of the second support rod 312 is provided with a second protrusion 313, which effectively increases the connection strength between the second flow-blocking membrane and the second support rod 312, and effectively increases the contact area between the second free end of the second support rod 312 and the membrane wall, thus avoiding force concentration and damage to the membrane wall. For example, the shape of the second protrusion 313 can be disc-shaped.

[0103] Specifically, the second protrusion 313 is provided with a second fixing hole 3131. The second flow-blocking membrane can be sewn onto the second support rod by threading through the second fixing hole 3131, effectively blocking blood flow. Of course, the second flow-blocking membrane can also be wrapped onto the second support rod 312 by heat fusion or other methods, which is not limited in this application.

[0104] In this embodiment, reference continues to be made to... Figure 11 As shown, the second snap fastener 320 includes a second main body 321 and at least two second engaging portions 322. The second main body 321 has a second through hole, and the distal end of the push rod 500 is threadedly connected to the second through hole. The second engaging portions 322 are spaced apart circumferentially along the second main body 321 and engage with the second sleeve portion 311. The second engaging portions 322 can be evenly spaced along the circumference of the second main body 321. In this embodiment, the second snap fastener 320 and the second support member 310 are connected by snap-fit ​​using the second engaging portions 322, which is simple, quick, and provides a stable and reliable connection. Furthermore, the threaded connection between the distal end of the push rod 500 and the second through hole of the second main body 321 facilitates assembly and disassembly, effectively improving surgical efficiency.

[0105] For example, the second latching portion 322 is provided with 2 to 6, such as 3 or 4.

[0106] For example, the second perforation may be opened at the center of the second body.

[0107] Specifically, the second main body 321 has a second positioning end face 3211, on which a second snap-fit ​​portion 322 is provided. The second snap-fit ​​portion 322 is hook-shaped and passes through the proximal end of the second sleeve portion 311 and abuts against the distal end of the second sleeve portion 311. The second positioning end face 3211 abuts against the proximal end of the second sleeve portion 311 to achieve the connection between the second buckle 320 and the second support member 310. In this embodiment, the distal end of the push rod 500 slides sequentially through the first cavity 401 of the push tube 400, the cavity 101 of the loading component 100, the first through hole of the first buckle 220, and the first sleeve portion 211 before being threadedly connected to the second through hole of the second buckle 320. The structure is compact and effectively reduces the diameter of the delivery conduit 120.

[0108] In this embodiment, the first sleeve portion 211 has a first threading hole 2111 radially, and the second sleeve portion 311 has a second threading hole 3111 radially. The loop portion 710 of the suture 700 passes through the first threading hole 2111 and the second threading hole 3111 to connect the first support member 210 and the second support member 310 together. A locking portion 720 is located at the first sleeve to facilitate tightening of the loop portion 710.

[0109] For example, taking an unclosed room opening in a room partition as an example, the specific steps of the sealing structure provided in this embodiment are as follows:

[0110] S100, the delivery catheter 120 is advanced along the femoral vein and inferior vena cava to the right atrium and then through the foramen ovale to the left atrium.

[0111] Specifically, during the procedure, the skin around the right femoral vein is first anesthetized. A cannula (not shown in the figure) is then inserted into the right femoral vein. A guidewire is then inserted into the cannula and ascends along the femoral vein and inferior vena cava to the right atrium, then passes through the interatrial foramen on the interatrial septum to the left atrium (the guidewire is not shown in the figure, and the entire process must be completed under the guidance of an X-ray imaging device). A delivery catheter 120 is then inserted along the guidewire. After the delivery catheter 120 reaches the right atrium, contrast agent is injected to confirm the location of the foramen ovale. The guidewire is then withdrawn after the delivery catheter 120 passes through the interatrial foramen.

[0112] S200, Install the loader 110 on the delivery conduit 120.

[0113] Specifically, the loader 110 is connected to the second Luer connector 130 of the delivery conduit 120.

[0114] Before step S200, the following steps are also included:

[0115] S210, The first sealing assembly 200 and the second sealing assembly 300 are connected together by passing through the suture 700.

[0116] Specifically, the suture 700 passes through the first thread hole 2111 and the second thread hole 3111 and is tied with a lock knot, thus forming the loop portion 710 and the lock knot portion 720 of the suture 700.

[0117] S220. Pass the suture 700 through the second cavity 402 of the push tube 400, and make the suture 700 extend out through the second or third hole of the valve 410.

[0118] S230, the push rod 500 is sequentially passed through the first hole of the valve 410, the first cavity 401 of the push tube 400 and the first sealing assembly 200 and threadedly connected to the second buckle 320 of the second sealing assembly 300.

[0119] S240. Adjust the position of the push rod 500 relative to the push tube 400 so that the first sealing component 200 and the second sealing component 300 maintain a certain distance, and fix the push rod 500 by the valve 410.

[0120] S250, the first sealing component 200 and the second sealing component 300 are sequentially installed in the loader 110, and the positioning component 600 is fitted onto the delivery pipe.

[0121] Specifically, the first sealing assembly 200 and the second sealing assembly 300 are both inserted into the loading seat 112 of the loader 110 and adjusted into the tube body 111 of the loader 110.

[0122] Specifically, the positioning element 600 abuts against the first Luer joint 420.

[0123] S300, the first sealing component 200 and the second sealing component 300 are placed on both sides of the interatrial partition.

[0124] Step S300 includes the following steps:

[0125] S310, push push rod 500 and push tube 400 until positioning member 600 abuts against loader 110.

[0126] At this time, the second occlusion assembly 300 is disengaged from the delivery catheter 120 and is placed in the left atrium after being deployed.

[0127] S320. The position of the second sealing component 300 is adjusted by the push rod 500 and push tube 400 fixed together so that the second sealing component 300 abuts against the interatrial partition.

[0128] S320. Remove the positioning element 600 from the push tube 400 and retract the delivery catheter 120 so that the delivery catheter 120 returns to the right atrium.

[0129] At this time, the first occlusion component 200 is detached from the delivery catheter 120, and the first occlusion component 200 is deployed and placed in the right atrium.

[0130] S330, after the adjusting valve 410 releases the push rod 500, tightens the suture 700 and pushes the push tube 400 toward the atrial septum until the first sealing assembly 200 and the second sealing assembly 300 close the atrial septum.

[0131] S400, rotate handle 510 to disengage push rod 500 from second latch 320 of second sealing assembly 300.

[0132] S500, by pushing the locking part 720 through the push tube 400, the loop part 710 is tightened, thereby fixing the first sealing component 200 and the second sealing component 300.

[0133] S600, withdraw the push tube 400 and push rod 500, and the suture cutter is sent along the delivery catheter 120 into the right atrium to cut the suture 700.

[0134] S700, remove the suture cutter and delivery catheter 120 to the outside of the body, and complete the surgery.

[0135] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art will be able to make various obvious changes, readjustments, and substitutions without departing from the scope of protection of the present invention. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A sealing device, characterized in that, include: The loading assembly (100) is provided with a lumen (101); The first sealing assembly (200) is inserted into the cavity (101); The second sealing component (300) is connected to the first sealing component (200). The second sealing component (300) is inserted into the lumen (101), and the first sealing component (200) and the second sealing component (300) are arranged alternately from the proximal end to the distal end of the lumen (101). A push tube (400) is provided, the distal end of which is movably inserted into the lumen (101), and the push tube (400) is located on the side of the first blocking component (200) facing away from the second blocking component (300), and the push tube (400) can abut against the first blocking component (200); A push rod (500) is provided, the distal end of which is sequentially movably inserted through the push tube (400), the first sealing assembly (200), and threadedly connected to the second sealing assembly (300); A positioning element (600) is detachably disposed at the proximal end of the push tube (400), and the distal end of the positioning element (600) can abut against the loading assembly (100); When the positioning element (600) is positioned at the proximal end of the push tube (400), the first blocking component (200) is located inside the cavity (101); when the distal end of the positioning element (600) abuts against the loading component (100), the second blocking component (300) is located outside the distal end of the cavity (101); when the positioning element (600) disengages from the push tube (400), the first blocking component (200) may be located outside the distal end of the cavity (101).

2. The sealing device according to claim 1, characterized in that, A valve (410) is provided at the proximal end of the push tube (400), and the push rod (500) passes through the valve (410) and the push tube (400) in sequence. The valve (410) has two states: clamping or releasing the push rod (500).

3. The sealing device according to claim 1, characterized in that, The positioning member (600) has a positioning cavity (601) at its center, and the outer wall of the positioning member (600) has an opening (602) that extends longitudinally along the positioning member (600) and communicates with the positioning cavity (601).

4. The sealing device according to claim 3, characterized in that, The opening angle α of the opening (602) is 75°-100°.

5. The sealing device according to claim 1, characterized in that, The outer wall of the positioning member (600) is provided with a protrusion (610), which extends axially along the positioning member (600).

6. The sealing device according to claim 1, characterized in that, The loading assembly (100) includes: The loader (110) has a proximal end that can abut against the distal end of the positioning member (600); A delivery conduit (120), the proximal end of which is detachably connected to the distal end of the loader (110); wherein, The lumen (101) includes a loading lumen disposed on the loader (110) and a conduit lumen disposed on the delivery conduit (120), wherein the first sealing component (200) and the second sealing component (300) are disposed in the loading lumen.

7. The sealing device according to claim 6, characterized in that, The proximal diameter of the loading cavity is larger than the distal diameter of the loading cavity.

8. The sealing device according to claim 1, characterized in that, The push rod (500) has a handle (510) detachably connected to its proximal end.

9. The sealing device according to any one of claims 1-8, characterized in that, It also includes a suture (700) that passes through the first occlusion assembly (200) and the second occlusion assembly (300) and connects the first occlusion assembly (200) and the second occlusion assembly (300).

10. The sealing device according to claim 9, characterized in that, The push tube (400) has a first cavity (401) and a second cavity (402). The push rod (500) is inserted into the first cavity (401), and the suture (700) is inserted into the second cavity (402).

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