Closure device and closure system

Abstract

The application is suitable for the technical field of interventional medical instruments, and provides a closure device and a closure system with the same, which comprises a braided main body formed by a braided mesh tube formed by braiding of braided wires with shape memory function and shaped, and a contraction deformation drag reduction structure provided on the braided main body and reducing the resistance of the braided main body entering a pipeline. The contraction deformation drag reduction structure reduces the contact area between the braided main body and the inner wall of the pipeline when the braided main body is radially contracted and deformed when entering the pipeline, thereby reducing the pipeline entering resistance of the braided main body, so that the closure device can enter the pipeline of a delivery sheath more smoothly and smoothly, and the difficulty and risk of surgery caused by the unsmooth entry of the closure device into the sheath can be greatly reduced.

Description

Technical Field

[0001] This invention belongs to the field of interventional medical device technology, and particularly relates to an occluder and an occlusion system having the occluder. Background Technology

[0002] Atrial septal defect (ASD) is a common congenital heart defect that occurs when the primitive atrial septum develops abnormally during embryonic development, leaving a gap between the left and right atria. Clinically, it is often treated with an atrial septal defect occluder. Figure 1 As shown, existing plugs 100' are often made of braided wires. Braided plugs have a tight weave, resulting in greater constraint between the braided wires. This increases the force required for the plug 100' to deform, thus increasing the sheath insertion resistance and making it difficult to adapt to smaller sheaths. When it is necessary to deliver the plug 100' through a smaller sheath, for example... Figure 2 As shown, when performing interventional surgery on children, the delivery sheath is usually smaller (e.g., a delivery sheath with an inner diameter of 6F or less). If the resistance to insertion into the sheath is too great, it will increase the difficulty and risk of the surgery, and in severe cases, it may even endanger the patient's life. Summary of the Invention

[0003] The purpose of this invention is to provide an occluder that addresses the problem of high resistance during insertion of existing occluders, which increases the difficulty and risk of surgery.

[0004] The present invention is implemented as follows: a occluder, comprising:

[0005] The braided body is formed by shaping a braided mesh tube made of braided yarns with shape memory function.

[0006] The braided body is provided with a shrinkage deformation drag reduction structure to reduce the resistance of the braided body entering the pipe; the shrinkage deformation drag reduction structure reduces the contact area between the braided body and the inner wall of the pipe when the braided body undergoes radial shrinkage deformation upon entering the pipe, thereby reducing the resistance of the braided body entering the pipe.

[0007] Specifically, the shrinkage deformation drag reduction structure includes a recess on the knitted body, the recess being recessed inward toward the inside of the knitted body.

[0008] In some embodiments, at least one recess is provided, and the recess extends through the proximal and distal ends of the knitted body.

[0009] In some embodiments, the knitting body includes a distal disc and a shrinkage portion connected to the distal disc, wherein the radial cross-sectional dimension of the shrinkage portion is smaller than the radial cross-sectional dimension of the distal disc; the recess is located near the transition connection between the distal disc and the shrinkage portion;

[0010] or,

[0011] The recess is located at the transition connection between the distal disc and the contraction section.

[0012] In some embodiments, the recesses are distributed along the sidewall of the braided mesh in a spiral pattern.

[0013] In some embodiments, the knitting body includes a distal disc, a proximal disc, and a waist portion connecting the proximal disc and the distal disc. The disc surface dimensions of both the distal and proximal discs are larger than the radial cross-sectional dimensions of the waist portion. Multiple recesses are provided, spaced apart on the knitting body, and each recess has a different depth. The depth of the recesses on the proximal disc near its longitudinal central axis is less than the depth of the recesses away from its longitudinal central axis. Similarly, the depth of the recesses on the distal disc near its longitudinal central axis is less than the depth of the recesses away from its longitudinal central axis.

[0014] In some embodiments, the occluder includes a proximal plug located at the proximal end of the braided body, and the recess is located at the proximal end of the braided body, with the recess opposite to the proximal plug.

[0015] In some other embodiments, an even number of recesses are provided, and the even number of recesses are provided in pairs on the sidewall of the braided mesh tube, with each pair of recesses being symmetrically arranged about the central axis of the braided mesh tube.

[0016] In some embodiments, a plurality of recesses are provided, each recess penetrating the braided mesh tube in the axial direction, and the plurality of recesses are asymmetrically arranged on the sidewall of the braided mesh tube.

[0017] In other embodiments, multiple recesses are provided, and the multiple recesses are distributed in a dotted pattern on the braided mesh tube.

[0018] In other embodiments, the present invention also provides a plugging system including any of the plugs described above.

[0019] The occluder provided by this invention features a shrinkage deformation drag-reducing structure on its braided body. This structure reduces the contact area between the braided body and the inner wall of the delivery sheath when the braided body undergoes radial shrinkage deformation upon entering the pipe, thereby reducing the resistance of the braided body entering the pipe. This allows the braided body of the occluder to smoothly enter the delivery sheath or other pipes, reducing or preventing obstruction or jamming when the occluder enters the sheath or other pipes, thus lowering the difficulty and risk of the procedure. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the prior art occluder provided by the present invention in its natural state;

[0021] Figure 2 This is a schematic diagram of the prior art plugging device provided by the present invention entering the sheath;

[0022] Figure 3 This is a schematic diagram of a double-disc occluder provided in an embodiment of the present invention;

[0023] Figure 3a yes Figure 3 Enlarged view of point A;

[0024] Figure 4 This is a schematic diagram of a plugging device without a distal end cap provided in an embodiment of the present invention;

[0025] Figure 5 This is a schematic diagram of a single-disc occluder provided in an embodiment of the present invention;

[0026] Figure 6 This is a schematic diagram of an occluder without a proximal plug and a distal end cap provided in an embodiment of the present invention;

[0027] Figure 7 This is a schematic diagram of the occluder in a stretched state according to Embodiment 1 of the present invention;

[0028] Figure 8 This is a schematic diagram of the braided mesh tube provided in Embodiment 1 of the present invention;

[0029] Figure 9 yes Figure 8 A schematic diagram of the AA-direction cross-section of the braided mesh tube;

[0030] Figure 10 This is a schematic diagram of the occluder provided in Embodiment 2 of the present invention in its natural state;

[0031] Figure 11 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 2 of the present invention;

[0032] Figure 12 This is a schematic diagram of the occluder provided in Embodiment 3 of the present invention in its natural state;

[0033] Figure 13 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 3 of the present invention;

[0034] Figure 14 This is a schematic diagram of the plug provided in Embodiment 4 of the present invention when it is stretched;

[0035] Figure 15 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 4 of the present invention;

[0036] Figure 16 This is a schematic diagram of the plug provided in Embodiment 5 of the present invention when it is stretched;

[0037] Figure 17 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 5 of the present invention;

[0038] Figure 18 This is a schematic diagram of the plug provided in Embodiment 7 of the present invention when it is stretched;

[0039] Figure 19 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 7 of the present invention;

[0040] Figure 20 This is a cross-sectional schematic diagram of another braided mesh tube before shaping, provided in Embodiment 7 of the present invention;

[0041] Figure 21 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 8 of the present invention;

[0042] Figure 22 This is a cross-sectional schematic diagram of the braided mesh tube before it is shaped, provided in Embodiment 9 of the present invention;

[0043] Figure 23 These are related images of the prior art plugging device without a shrinkage deformation drag reduction structure provided by this invention inside a transparent pipe;

[0044] Figure 24 These are related images of the plug with a shrinkage deformation drag reduction structure provided in the embodiments of the present invention inside a transparent pipe;

[0045] Figure 25 These are images of quantitative measurements taken under a laser confocal microscope of the waist of a prior art plug without a shrinkage deformation drag reduction structure when it is stretched, as provided by this invention.

[0046] Figure 26 This invention provides Figure 25The measurement results of the occluder under a laser co-concentration microscope;

[0047] Figure 27 These are related images of quantitative measurements taken under a laser confocal microscope of the waist section of the plug with a shrinkage deformation drag reduction structure provided in the embodiments of the present invention when it is stretched.

[0048] Figure 28 This is provided by the embodiments of the present invention. Figure 27 The image shows the measurement results of the plug under a laser co-concentration microscope. Detailed Implementation

[0049] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0050] It should be noted that when a component is referred to as "fixed to" or "set on" another component, it can be directly on the other component or may have an intervening component present. When a component is referred to as "connected to" another component, it can be directly connected to the other component or may have an intervening component present.

[0051] It should also be noted that the directional terms such as left, right, up, and down in this embodiment are only relative concepts or are based on the normal use of the product, and should not be considered as restrictive.

[0052] 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.

[0053] like Figure 3The diagram shown is a schematic of a double-disc occluder 100 provided in an embodiment of the present invention. It includes a braided body 10, a proximal plug head 20, and a distal end cap 30. The braided body 10 is formed by shaping a braided mesh tube using shape-memory braided wire, such as nickel-titanium alloy wire. The braided body 10 has a proximal free end and a distal free end. The proximal plug head 20 is located at the proximal end of the braided body 10 and is used to collect and fix the proximal free end of the braided body 10. The distal end cap 30 is located at the distal end of the braided body 10 and is used to collect and fix the braided mesh. At the distal free end of the main body 10, a shrinkage deformation drag reduction structure 40 is provided on the braided main body 10 to reduce the resistance of the braided main body 10 entering the pipe, for example, to reduce the resistance of the braided main body 10 entering the delivery sheath pipe, or to reduce the resistance when the free end of the braided main body 10 enters the proximal plug head 20 and the distal end cap 30; the shrinkage deformation drag reduction structure 40 reduces the contact area between the braided main body 10 and the inner wall of the pipe when the braided main body 10 undergoes radial shrinkage deformation upon entering the pipe, thereby reducing the resistance of the braided main body entering the pipe.

[0054] See also Figure 3 , Figure 3a The shrinkage deformation drag reduction structure 40 provided in this embodiment includes a recess 401 on the braided body 10. The recess 401 is concave towards the inner side of the braided body 10. The recess 401 can be any shape such as an arc-shaped recess, a V-shaped recess, or a rectangular recess, or an irregularly shaped recess, as long as it is concave towards the inner side of the braided body 10 relative to the outer wall of the braided body 10. When the braided body 10 enters a narrow pipe space such as a delivery sheath, it needs to shrink, resulting in a large radial pressure. At this time, It will come into contact with the inner wall of the delivery sheath. If the stress is too great, the delivery of the occluder will be stuck. The recess 401 allows the braided body 10 to distribute some of the stress towards the inner side of the braided body 10 when it shrinks and deforms. This reduces the contact with the inner wall of the delivery sheath, that is, reduces the radial stress of contact with the inner wall of the pipe. This allows the braided body 10 to enter the delivery sheath and other pipes more smoothly, avoiding the situation of jamming or obstruction when entering the sheath, and reducing the risk and difficulty of the surgical operation.

[0055] like Figure 4As shown, in some other embodiments, the occluder 100 may only have a braided body 10 and a proximal plug 20, with the shrinkage deformation drag reduction structure 40 disposed on the braided body 10. That is, in this embodiment, the distal end of the braided body 10 of the occluder 100 can be bound and fixed by the braiding and winding of the braided threads of the braided body 10 itself, which can also achieve the function of fixing the distal end. That is, the occluder in this embodiment does not have a distal plug; or, the braided threads at the distal end of the occluder 100 can also be bundled and fixed by welding, which can also achieve the function of fixing the distal end.

[0056] like Figure 5 As shown, in some other embodiments, unlike the double-disc occluder of the aforementioned embodiments, the braided body 10 of the occluder 100 is single-disc, that is, the braided body 10 only includes a distal disc 11, a waist 12 and a proximal plug head 20. The shrinkage deformation drag reduction structure 40 is provided on the distal disc 11. By providing the shrinkage deformation drag reduction structure 40 on the distal disc 11, the contact area between the single-disc occluder 100 and the inner wall of the pipe is reduced when it enters the sheath pipe and undergoes radial compression deformation, thereby reducing the sheath entry resistance.

[0057] like Figure 6 As shown, in some other embodiments, the occluder 100 may only include a braided body 10, which includes a distal disc 11 and a waist 12. The shrinkage deformation drag reduction structure 40 is provided on the distal disc 11 of the braided body 10. That is, in this embodiment, the occluder 100 does not have a proximal plug and a distal end cap. Its proximal and distal ends can be gathered by braiding and winding the braided wires, or by welding.

[0058] The following example illustrates the specific arrangement of the shrinkage deformation drag reduction structure 40 on the plugger 100:

[0059] First Embodiment

[0060] See Figures 7 to 9 In this embodiment, as Figure 7 As shown, only one recess 401a is provided, and the recess 401a penetrates the proximal and distal ends of the knitting body 10a, that is, the recess 401a is groove-shaped on the side wall of the knitting body 10a, extending from the proximal end to the distal end of the knitting body 10a. Figure 8 The diagram shown is a schematic of the braided mesh tube before the braided main body 10a is set. Figure 7 Before the braided body 10a shown, it is generally cylindrical. At this point, an auxiliary clamp can be used to create a recess 401a on the side wall of the braided mesh tube, resulting in a cross-section of the braided mesh tube as shown below. Figure 9As shown, the concave shape can be provided. Of course, in this embodiment, the concave 401a can also be provided in multiple ways. All of the multiple concave 401a can penetrate the proximal and distal ends of the braided body 10a, that is, the multiple concave 401a can be arranged in parallel.

[0061] In some specific embodiments, the specific manufacturing method of the recess 401a can be carried out as follows: using a fine copper wire to... Figure 8 The cylindrical braided mesh tube shown is bound and secured as a whole, so that... Figure 8 The cylindrical braided mesh shown has an internally recessed sidewall, forming a groove that runs through the proximal and distal ends of the braided mesh. Its cross-section is as follows: Figure 9 As shown, the braided mesh tube is compressed due to binding, resulting in a reduction in the area of ​​the internal cavity. The braided mesh tube is then shaped to form the braided body 10a. After the braided body 10a is shaped, the binding of the fine copper wires is released. The sealing device 100 then enters... Figure 7 When the sealing system 200 is formed inside the delivery sheath 50, the braided body 10a is compressed and deformed due to its overall concavity. Because of the recess 401a on the braided body 10a, the recess 401a is squeezed inwards, thus relatively reducing the contact area between the braided body 10a and the inner wall of the delivery sheath 50, reducing the positive pressure between them. Therefore, the resistance to entering the delivery sheath 50 is reduced, allowing the sealer 100 to smoothly enter the smaller delivery sheath 50 and be pushed within it, making the pushing process smoother and more efficient. Furthermore, the reduced resistance makes sheath removal easier, preventing sudden increases in sheath removal force that could lead to poor force control and sudden shaking or vibration of the sealer. This avoids excessive stimulation or damage to other tissues, improving the controllability and safety of the procedure. Furthermore, due to the recess 401a on the braided body 10a, a recess is formed on the disc surface facing the blood flow, which can reduce the impact of blood flow on the disc surface, making the occluder more stably implanted at the defect site and accelerating the endothelialization speed.

[0062] Second Embodiment

[0063] like Figure 10 and Figure 11 As shown, in this embodiment, the knitting body 10b has a distal disc 11b and a shrinkage portion 12b connected to the distal disc 11b. The radial cross-sectional dimension of the shrinkage portion 12b is smaller than the radial cross-sectional dimension of the distal disc 11b. The recess 401b is provided near the transition connection between the distal disc 11b and the shrinkage portion 12b; or, the recess 401b may be provided exactly at the transition connection between the distal disc 11b and the shrinkage portion 12b.

[0064] In practical applications, due to the significant difference in cross-sectional dimensions between the distal disc 11b and the contraction section 12b, the sheath insertion resistance generated at the transition connection between the two is also correspondingly large, making it a difficult position for the occluder to be sheathed. By placing the recess 401b at or near the transition connection between the distal disc 11b and the contraction section 12b, the sheath insertion resistance of the braided body 10b can be greatly reduced, making its sheath insertion and withdrawal smoother. This avoids the difficulty in sheath withdrawal caused by difficulty in sheath insertion in the prior art, and further prevents the occluder 100 from suddenly shaking or vibrating due to a sudden increase in sheath withdrawal force, which could lead to poor force control. This avoids excessive stimulation to the human body or damage to other human tissues, and improves the controllability and safety of the surgery.

[0065] Third Embodiment

[0066] See Figure 12 and Figure 13 In this embodiment, the braided body 10c includes a proximal disc 13c located at the proximal end and a proximal plug 20 located at the proximal end of the proximal disc 13c. In this embodiment, a recess 401c is provided between the proximal plug 20 and the disc surface of the proximal disc 13c. Here, the disc surface of the proximal disc 13c refers to the surface with the largest radial cross-sectional dimension of the proximal disc 13c. During interventional surgery, due to the significant difference in radial dimensions between the proximal end of the occluder 100 and the surface of the proximal disc 13c, the cross-sectional diameter of the braided body 10c gradually increases or suddenly increases from the proximal end of the occluder 100 to the surface of the proximal disc 13c. Therefore, the section from the proximal thimble 20 to the surface of the proximal disc 13c is also a difficult position to insert into the sheath. By placing the recess 401c between the proximal thimble 20 and the surface of the proximal disc 13c, the contact area between the braided body 10c and the inner wall of the sheath can be reduced, thereby reducing the resistance to insertion into the sheath, allowing the occluder 100 to enter the sheath smoothly, improving the safety and operability of the surgery, and reducing the difficulty and risk of the surgery.

[0067] Similarly, in this embodiment, the recess 401c can also be formed by using fine copper wire to bind and position the braided mesh tube at the location where the recess needs to be set, thus forming a braided mesh tube with an inward concavity, the cross-section of which is as follows: Figure 13 As shown, the braided mesh tube is then shaped. After shaping, a depression is formed at the corresponding position of the braided body 10c. Even if the fine copper wire is removed, it can still maintain the state of having the corresponding depression.

[0068] Fourth embodiment

[0069] See Figure 14 , Figure 15The difference between this embodiment and the above embodiment lies in the different positions of the recesses 401d. The recesses 401d are distributed in a spiral trajectory along the side wall of the knitting body 10d. The knitting body 10d includes a distal disc 11d, a proximal disc 13d, and a waist portion 12d located between the distal disc 11d and the proximal disc 13d. Figure 15 The depression 401d corresponds to... Figure 14 The diagram shows cross-sectional views at positions A, B, and C. In this embodiment, the recesses 401d are spirally distributed around the central axis of the braided body 10d. The spiral distribution of the recesses 401d along the central axis disperses the impact force of blood flow, avoids stress concentration, and thus reduces the occurrence of fatigue fracture of the metal mesh tube's threads. In actual manufacturing, recesses distributed in a spiral trajectory along the side wall of the cylindrical braided mesh tube before processing and shaping can be first processed using auxiliary tooling such as fine copper wire on the side wall of the cylindrical braided mesh tube, and then shaped to form the braided body.

[0070] Fifth embodiment

[0071] See Figure 16 , Figure 17In this embodiment, the knitting body 10e includes a distal disc 11e, a waist portion 12e, and a proximal disc 13e. The waist portion 12e is located between the distal disc 11e and the proximal disc 13e. The disc surface dimensions of both the distal disc 11e and the proximal disc 13e are larger than the radial cross-sectional dimension of the waist portion 12e. In this embodiment, multiple recesses 401e can be provided, and each recess 401e is distributed at intervals on the knitting body 10e. Each recess 401e has a different depth. The recesses on the distal disc 11e that are closer to the disc surface of the distal disc 11e are deeper, that is, the recesses on the distal disc 11e that are closer to the longitudinal central axis of the distal disc 11e are deeper. The depth of the depression is less than the depth of the depression away from the longitudinal central axis of the distal disk 11e. For example, the depth of the depression 401e at position A near the disk surface of the distal disk 11e is 1 mm, while the depth of the depression 401e at position B far from the disk surface of the distal disk 11e is 0.5 mm. The depth of the depression at position A is greater than the depth of the depression at position B. Similarly, the depth of the depression on the proximal disk 13e increases as it approaches the disk surface. That is, the depth of the depression near the longitudinal central axis of the proximal disk 13e is less than the depth of the depression away from the longitudinal central axis of the proximal disk 13e. For example, the depth of the depression 401e at position C near the disk surface of the proximal disk 13e is 1 mm, while the depth of the depression 401e at position D far from the disk surface of the proximal disk 13e is 0.5 mm. The depth of the depression at position C is greater than the depth of the depression at position D. Because the cross-sectional dimensions of the distal disc 11e and proximal disc 13e of the braided body 10e are larger than those of other parts when it enters the sheath, the closer the position is to the distal disc 11e and proximal disc 13e, the more likely it is to be blocked or stuck when entering the sheath. In this embodiment, the depth of the recess 401e on the disc surface near the distal disc 11e and proximal disc 13e is greater than the depth of the recess 401e on the disc surface far from the distal disc 11e and proximal disc 13e. This targeted setting allows most of the stress of the braided body 10e near the disc surface of the proximal disc 13e and distal disc 11e to move towards the center of the braided body 10e when entering the sheath, reducing the normal pressure between the side wall of the braided body 10e and the inner wall of the sheath, thereby reducing the resistance to entering the sheath.

[0072] The specific manufacturing method of the recess 401e in this embodiment can be referred to the above embodiment: first, use tools such as fine copper wire to position the braided mesh tube to form a recess 401e, and then perform shaping processing. After removing the tools such as fine copper wire, the braided body 10e with the recess 401e can be formed.

[0073] Seventh Embodiment

[0074] See Figure 18 , Figure 19 , Figure 20In this embodiment, as Figure 18 As shown, an even number of recesses 401g are provided, and the even number of recesses 401g are paired on the side wall of the braided body 10g. That is, any pair of recesses 401g are symmetrically arranged about the central axis of the braided body 10g. This structural arrangement allows for a more balanced stress distribution when the braided body 10g of the occluder 100 is inserted into the sheath, thereby effectively reducing the resistance during insertion and lowering the difficulty and risk of the surgery. When the paired recesses 401g are axially symmetrically arranged, they can... Figure 19 As shown, the paired recesses 401g are symmetrical about the central axis of the knitting body 10g, meaning the paired recesses 401g are directly opposite the center of the knitting body 10g. Alternatively, they can be arranged as follows: Figure 22 As shown, the paired recesses 401g are offset from the center of the braided body 10g and are mirror-symmetrically arranged, that is, the recesses 401g are offset from the center of the braided body 10g and are not directly opposite it.

[0075] Eighth embodiment

[0076] In some other embodiments, such as Figure 21 As shown, multiple recesses 401h can be provided, each recess 401h penetrating the braided mesh tube 10h along the axial direction, and multiple recesses 401h are asymmetrically arranged on the side wall of the braided mesh tube 10h. This structural arrangement can also reduce the radial stress that the occluder experiences when it enters the delivery sheath and abuts against the inner wall of the sheath, thereby allowing the occluder to enter the sheath more smoothly and reducing the difficulty and risk of the operation.

[0077] Ninth Embodiment

[0078] like Figure 22 As shown, in some other embodiments, multiple recesses 401i can also be provided, with each recess 401i distributed in a dotted pattern on the side wall of the braided tube 10i. In this case, when the shaped braided body is inserted into the sheath, the dotted recesses 401i can disperse and buffer the stress that abuts against the inner wall of the sheath, thereby reducing the resistance of the occluder entering the sheath and making the occluder enter the sheath more smoothly and easily, so as to reduce the difficulty and risk of the operation.

[0079] It is worth noting that the processing and manufacturing of the depressions 401g, 40h, and 40i in Examples 7, 8, and 9 can all be carried out by referring to the manufacturing method of the depressions in other examples. That is, the braided mesh tube is first bound and positioned by using tools such as fine copper wire to form the corresponding depression structure on the braided mesh tube, and then the shaping process is carried out to form the braided body. The specific manufacturing method will not be described in detail here.

[0080] For smaller occluders, due to their small size and the even smaller size of the shrinkage deformation drag-reducing structure (recess), the shrinkage deformation drag-reducing structure (recess) is usually not noticeable to the naked eye. In such cases, it can be observed through modeling and measurement using a confocal microscope. The difference is relatively more obvious compared to an occluder of the same size without a shrinkage deformation drag-reducing structure (recess). The following is a comparison of measurements taken under a confocal microscope between a prior art occluder of the same size without a shrinkage deformation drag-reducing structure and the occluder provided in this embodiment of the invention with a shrinkage deformation drag-reducing structure:

[0081] like Figure 23 The images shown are related to the prior art occluder without a shrinkage deformation drag reduction structure provided by this invention, inside a transparent tube. For ease of experimental observation, the prior art occluder was pushed into a transparent tube with an inner diameter equal to that of the delivery sheath used to transport the occluder, simulating the environment in which the occluder enters the delivery sheath during interventional surgery. The images were then observed under a standard optical microscope at 20 to 100 times magnification. In this embodiment, the images were obtained at 20 times magnification. Figure 23 The image shown.

[0082] An occluder with a concave deformation-reducing structure at the waist is pushed into a transparent tube. The inner diameter of this transparent tube is equal to the inner diameter of the delivery sheath used to deliver the occluder, simulating the environment in which the occluder enters the delivery sheath during interventional surgery. The occluder is then observed under a standard optical microscope at 20 to 100 times magnification. In this embodiment, observation at 20 times magnification yields... Figure 24 The image shown; comparison Figure 23 and Figure 24 It can be seen that the occluder with the shrinkage deformation drag reduction structure (concave) has a clear concave waist when observed under a regular optical microscope, while the occluder without the shrinkage deformation drag reduction structure (concave) has little change in waist, and no obvious concavity or depression can be seen.

[0083] like Figure 25 The image shown is a quantitative measurement of the indentation depth of the waist of the prior art occluder without a shrinkage deformation drag reduction structure under a laser confocal microscope in its natural state (i.e., without external force). In this image, no obvious indentation is observed in the waist of the occluder; while... Figure 27 These are related images of the occluder with a shrinkage deformation drag reduction structure (recess) provided in the embodiments of the present invention, showing the depth of the recess at the waist under a laser confocal microscope in its natural state. Figure 27 In the middle, a noticeable indentation is visible at the waist.

[0084] Figure 26 This invention provides Figure 25The image shows the measurement results of the occluder under 20x magnification using a laser confocal microscope. The horizontal axis represents the local length of the occluder, and the vertical axis represents the vertical depth of the corresponding position. Since the waist of the occluder in this image does not have a recess (i.e., a shrinkage deformation drag-reducing structure), its depth difference is only 0.0483 mm. In this embodiment, during measurement, the longitudinal central axis of the occluder is parallel to the stage plane of the microscope. The horizontal axis represents the axial length of the waist of the occluder in its natural state, and the vertical axis represents the radial depth of the corresponding position of the waist. It can be understood that if the shrinkage deformation drag-reducing structure is provided on the outer end face of the disk, and the longitudinal central axis of the occluder is perpendicular to the stage plane of the microscope during measurement, then the horizontal axis represents the radial length of the disk in its natural state, and the vertical axis represents the axial depth of the disk at the corresponding position. Figure 28 This is provided by the embodiments of the present invention. Figure 27 The image shows the results of measuring the occluder under a laser confocal microscope at 20x magnification. The horizontal axis represents the local length of the occluder, and the vertical axis represents the radial width at the corresponding location. Because the occluder's waist section has a recess (i.e., a shrinkage deformation drag-reducing structure), the depth difference is 0.5051 mm. It should be noted that if any measurement depth exceeds 0.1 mm within the 5 to 50x magnification range of the laser confocal microscope, it proves that a shrinkage deformation drag-reducing structure was intentionally incorporated.

[0085] Modeling is performed using confocal microscopy. The principle is to measure and identify the depth of the recessed areas on the braided body of the occluder. Figure 27 The measured difference between the highest and lowest points of the indentation on the braided body of the occluder was 0.5051 mm, meaning the depth of the indentation was 0.5051 mm. (See...) Figure 28 ;and Figure 26 The braided body of the control group's prior art occluder, lacking a shrinkage deformation drag reduction structure (recess), has a depth of only 0.0483 mm at the waist of the occluder, with almost no height difference, which is within the range of process error. The two groups show a significant difference.

[0086] It should be noted that the occluder with the shrinkage deformation drag reduction structure of the present invention is a single-layer occluder (that is, both the proximal and distal disc surfaces of the occluder are single-layer braided structures). It can be used without a flow-blocking membrane according to actual needs (for example, by using more than or equal to 72 braided filaments to form an occluder that can accommodate a delivery sheath with an inner diameter of less than 6F). This further reduces the inner diameter of the delivery sheath, resulting in less trauma for young patients.

[0087] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A sealing device, characterized in that: include: The braided body is formed by shaping a braided mesh tube made of braided yarns with shape memory function. The braided body is provided with a shrinkage deformation drag-reducing structure to reduce the resistance of the braided body entering the sheath tube; the shrinkage deformation drag-reducing structure reduces the contact area between the braided body and the inner wall of the sheath tube when the braided body undergoes radial shrinkage deformation upon entering the sheath tube, thereby reducing the entry resistance of the braided body. The shrinkage deformation drag reduction structure includes a recess on the knitted body, the recess being recessed inward toward the inside of the knitted body. The knitting body includes a distal disc, a proximal disc, and a waist section connecting the proximal disc and the distal disc. The disc surface dimensions of the distal disc and the proximal disc are both larger than the radial cross-sectional dimensions of the waist section. Multiple recesses are provided, spaced apart on the knitting body, and each recess has a different depth. The depth of the recesses on the proximal disc near its longitudinal central axis is less than the depth of the recesses away from its longitudinal central axis. Similarly, the depth of the recesses on the distal disc near its longitudinal central axis is less than the depth of the recesses away from its longitudinal central axis.

2. The occluder as described in claim 1, characterized in that: The plurality of the aforementioned recesses extend through the proximal and distal ends of the woven body.

3. The occluder as described in claim 1, characterized in that: The braided body includes a shrinkage portion connected to the distal disc, the radial cross-sectional dimension of the shrinkage portion being smaller than the radial cross-sectional dimension of the distal disc; the recess is located near the transition connection between the distal disc and the shrinkage portion; or, The recess is located at the transition connection between the distal disc and the contraction section.

4. The occluder as described in claim 1, characterized in that: The braided body includes a proximal plug head located at the proximal end of the proximal disc; the recess is located between the proximal plug head and the disc surface of the proximal disc.

5. The plugging device as described in claim 2, characterized in that: The multiple recesses are distributed along the sidewall of the braided mesh tube in a spiral trajectory.

6. The occluder as described in claim 1, characterized in that: The recesses are provided in an even number, and the even number of recesses are provided in pairs on the side wall of the braided mesh tube. Each pair of recesses is symmetrical about the central axis of the braided mesh tube.

7. The plugging device as described in claim 2, characterized in that: Each of the aforementioned recesses extends through the braided mesh tube along the axial direction, and the plurality of recesses are asymmetrically arranged on the sidewall of the braided mesh tube.

8. The occluder as described in claim 1, characterized in that: Multiple indentations are distributed in a dotted pattern on the braided mesh tube.

9. The occlusion device as described in claim 1, characterized in that: The plug is a single-layer structure without a flow-blocking membrane.

10. The occluder as described in claim 9, characterized in that: The plug is delivered via a sheath with an inner diameter of less than 6F.

11. A plugging system comprising a plugging device as described in any one of claims 1 to 10 and a delivery sheath for delivering the plugging device.

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