Catheter closure device

Abstract

The utility model provides a kind of cavity plugging device, cavity plugging device includes plugging device body, specifically including disc portion and tubular portion, at least one surface on the inner side disc surface of disc portion and tubular portion is equipped with telescopic area, telescopic area is arranged around with the axis of tubular portion as center;The structure of telescopic area is set to: it can be more easily deformed and have greater elastic force relative to other areas of plugging device body. If the size of cavity plugging device is too large, when being placed to the size smaller cavity defect, the inward force applied to tubular portion by cavity defect can make telescopic area release the force by the way of extension deformation, to avoid the outer edge portion of disc portion inward deformation and cause the inner side disc surface of cavity plugging device to bulge.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a cavity occlusion device. Background Technology

[0002] Occluders, as implants used in interventional therapy, are used to treat various conditions caused by cavity defects, such as atrial septal defects, ventricular septal defects, and patent ductus arteriosus, and have been widely used in clinical practice.

[0003] This method of treating various cavity defects through minimally invasive interventional procedures has developed rapidly and is now very mature. Compared with traditional surgery, minimally invasive interventional therapy is a modern, high-tech, minimally invasive treatment. Through femoral vein puncture, guided by medical imaging equipment, a guide wire is inserted along the femoral vein and inferior vena cava to the area to be occluded. Subsequently, a delivery sheath is placed along the guide wire at the site of the cavity defect, and finally, the cavity occluder is pushed into the delivery sheath to perform the occlusion treatment. This minimally invasive interventional therapy has advantages such as no incision, minimal trauma, fewer complications, rapid recovery, good efficacy, a wide range of indications, and relatively low surgical costs.

[0004] In the actual clinical application of cavity occluders, it is necessary to select the appropriate size of cavity occluder based on the size of the apex to be occluded as shown in the image. If a relatively large cavity occluder is placed at a relatively small apex due to factors such as the imaging angle of the imaging equipment or the operator's misjudgment, the occluder disc will bulge and occupy a large cavity space. This will also result in incomplete occlusion at the apex and a slower process of endothelialization on the disc surface, thus prolonging postoperative recovery time and causing postoperative complications, and even endangering life. Utility Model Content

[0005] The technical problem to be solved by this utility model is to overcome the defects of the prior art in cavity occlusion devices. If the size of the cavity occlusion device is too large, when it is placed at a cavity defect of relatively small size, the disc of the cavity occlusion device will bulge and occupy a large cavity space. It will also cause incomplete sealing at the gap and slow endothelialization process of the disc surface, thereby prolonging the postoperative recovery time and postoperative complications. The present invention provides a cavity occlusion device.

[0006] The present invention solves the above-mentioned technical problems through the following technical solution:

[0007] A cavity occluder includes an occluder body, the occluder body including a disc-shaped portion and a tubular portion, the disc-shaped portion and the tubular portion being connected sequentially along the axial direction of the cavity occluder, the tubular portion being connected to the inner disc surface of the disc-shaped portion, and at least one surface of the inner disc surface of the disc-shaped portion and the tubular portion having a telescopic region, the telescopic region being arranged around the axis of the tubular portion as the center;

[0008] The structure of the expansion region is configured to allow it to deform more easily and have greater elastic force compared to other regions of the plug body.

[0009] If the cavity plug is selected to be too large, when it is placed at a cavity defect of relatively small size, the inward force exerted by the cavity defect on the tubular part can release the force by extending and deforming the inner disc surface of the disc part and / or the expansion and contraction area of ​​the tubular part, so as to avoid the outer edge of the disc part deforming inward and causing the outer disc surface of the cavity plug to bulge.

[0010] Therefore, this structural design can improve the applicability of the cavity occluder, while avoiding the bulging of the outer disc of the cavity occluder due to factors such as the imaging angle of the imaging equipment or the operator's judgment error, which may cause the cavity occluder to be too large. This solves the problem of postoperative complications and prolonged postoperative recovery time caused by the cavity occluder being too large at its root.

[0011] By designing a structure for the expansion region that allows it to deform more easily and have relatively greater elastic force compared to other areas of the occluder body, this approach is more conducive to manufacturing and the self-expansion recovery of the occluder's pre-set shape.

[0012] Preferably, the telescopic region provided on the disc-shaped portion is formed by surface folding along the radial direction of the inner disc surface of the disc-shaped portion;

[0013] And / or, the telescopic region provided on the tubular portion is formed by surface folding along the axial direction of the tubular portion.

[0014] By folding the surface of the occluder body, the resulting expansion area is more prone to deformation and has greater elasticity than other areas of the occluder body. This method is more conducive to manufacturing and the self-expansion recovery of the occluder's pre-set shape.

[0015] Meanwhile, the folding of the surface of the occluder body does not change the material properties of the expansion area, allowing the cavity occluder to be smoothly released from the delivery sheath and self-expand to restore to the preset occluder shape.

[0016] Preferably, the surface folding shape of the telescopic region is wavy.

[0017] By folding the surface of the occluder body in a wavy shape to form a telescopic region, the telescopic region is more easily deformed and has greater elastic force along the radial direction of the inner disc surface of the disc portion and / or the axial direction of the tubular portion. At the same time, the folding shape along the radial direction of the inner disc surface of the disc portion and / or the axial direction of the tubular portion is arranged in a concentric circle to maintain the disc shape of the disc portion or the tubular shape of the tubular portion, thereby improving the occlusion effect.

[0018] Preferably, the surface folding shape of the telescopic region is a continuous wave shape or a discontinuous wave shape.

[0019] With this scheme, the wave pattern can be set continuously or discontinuously, meaning the wave pattern can be broken and segmented in the middle.

[0020] Preferably, the surface folding shape of the telescopic region is a wave shape of the same size or a wave shape of different sizes.

[0021] With this scheme, the wave pattern can be set to the same size, meaning the wave pattern has the same dimensions, or it can be set to different sizes, meaning the wave pattern has different dimensions.

[0022] Preferably, the surface folding shape of the telescopic region is either a wave shape with the same shape or a wave shape with different shapes.

[0023] With this scheme, the wave shape can be a single shape, meaning the wave shape can take one form, or it can be a combination of different shapes.

[0024] Preferably, the telescopic region located on the inner side of the disc-shaped portion is disposed close to the tubular portion.

[0025] By placing the telescopic region on the inner side of the disc-shaped portion close to the tubular portion, and extending the telescopic region to the required position, the inward force exerted on the tubular portion by the cavity defect can be quickly transmitted to the telescopic region. The force is released by the force-induced extension deformation of the telescopic region, preventing the force from being transmitted to the outer edge of the disc-shaped portion and causing the outer disc surface of the cavity blocker to bulge. After the cavity blocker is released from the delivery sheath, it can self-expand and return to the preset shape of the blocker, that is, keep the outer disc surface of the disc-shaped portion in the preset shape.

[0026] Preferably, the telescopic region on the tubular portion is located close to the inner surface of the disc-shaped portion.

[0027] By positioning the telescopic region of the tubular portion close to the inner surface of the disc-shaped portion, and extending the telescopic region to the required position, the inward force exerted on the tubular portion by the cavity defect can be quickly transmitted to the telescopic region. This force is released through the force-induced extension and deformation of the telescopic region, preventing the force from being transmitted to the outer edge of the disc-shaped portion and causing the outer surface of the cavity blocker to bulge. Furthermore, after the cavity blocker is released from the delivery sheath, it can self-expand and return to the preset shape of the blocker, i.e., maintaining the preset shape of the outer surface of the disc-shaped portion.

[0028] Preferably, the plugging device body has a mesh structure;

[0029] The proximal end of the cavity occluder is closed by means of wire closure to close the proximal mesh structure disk surface; or, by means of wire piercing to close the proximal mesh structure disk surface; or, by means of ...

[0030] This method involves closing the proximal mesh structure of the cavity occluder by using a wire closure method. This means gathering the proximal mesh structure together with a wire, including sutures or mesh wires, and tying it in place to fix the structure, thereby closing the proximal mesh structure.

[0031] Closing the proximal surface of the mesh structure by interlacing the mesh wires refers to closing the proximal surface of the mesh structure by having the mesh wires interlaced.

[0032] Closing the proximal end of the mesh structure by setting a connecting part on the disc surface means that the mesh structure gathers and fixes the mesh wires together at the proximal end of the disc surface using the connecting part, so that the proximal end face is closed. This connecting part can also be connected to a conveying device for conveying the plug.

[0033] Preferably, the distal end of the cavity occluder closes the disk surface of the distal mesh structure by means of wire closure; or, the distal end of the mesh structure is closed by means of wire piercing; or, the distal end of the mesh structure is closed by means of a fixing part provided on the disk surface.

[0034] This method involves closing the distal end of the cavity occluder by using a wire closure method to gather the distal mesh structure together and tie it in place, thereby closing the distal mesh structure.

[0035] Closing the disk surface of the distal mesh structure by interlacing mesh wires refers to closing the disk surface of the distal mesh structure by interlacing mesh wires.

[0036] Closing the disk surface of the distal mesh structure by setting a fixing part on the disk surface means that the mesh structure uses the fixing part to gather and fix the distal mesh wires together on the distal disk surface, so as to close the distal end face.

[0037] Preferably, the disc-shaped portion includes a first disc-shaped portion and a second disc-shaped portion, and the first disc-shaped portion, the tubular portion and the second disc-shaped portion are connected sequentially along the direction from the distal end to the proximal end of the cavity occluder.

[0038] A method for manufacturing a cavity occluder, the method comprising:

[0039] The tubular mesh of the cavity occluder is placed in a mold, and the occluder body is formed by applying a clamping force to the tubular mesh through the mold and heating to shape it. The occluder body includes a disc-shaped part and a tubular part, and a telescopic region is formed on the inner disc surface of the disc-shaped part facing the tubular part and on at least one surface of the tubular part by surface folding. The telescopic region is more prone to deformation and has greater elastic force than other areas of the occluder body.

[0040] The method for manufacturing this cavity occluder involves applying a mold to the surface of a tubular mesh body and forming the occluder body by hot pressing and shaping the surface of the tubular mesh body through folding to create a stretching area. This allows the cavity occluder body, made from the tubular mesh body, to be placed at a relatively small cavity defect. The inward force exerted by the cavity defect on the tubular portion allows the stretching area on the inner disc surface of the disc portion and / or the tubular portion to release this force through extension deformation at the folded position. This prevents the outer edge of the disc portion of the cavity occluder from deforming inward and causing the outer disc surface of the cavity occluder to bulge.

[0041] Therefore, the cavity occluder manufactured by this method has high applicability and can avoid the bulging of the outer disc surface of the cavity occluder due to factors such as the imaging angle of the imaging equipment or the operator's judgment error, which may cause the cavity occluder to be too large. This solves the problem of postoperative complications and prolonged postoperative recovery time caused by the cavity occluder being too large at the root.

[0042] Meanwhile, by folding the surface to form a relatively easier-to-deform stretchable area, and by using a mold to heat-press and shape it, the structure is simple and easy to process in batches.

[0043] Preferably, in the manufacturing method, the surface folding shape of the formed telescopic region is wavy along the radial direction of the inner disk surface of the disc-shaped portion; and / or, the surface folding shape of the formed telescopic region is wavy along the axial direction of the tubular portion.

[0044] By forming a wavy folded shape along the radial direction of the inner disc surface of the disc-shaped portion and / or along the axial direction of the tubular portion, the expansion and contraction area is more easily deformed and has greater elastic force along the radial direction of the inner disc surface of the disc-shaped portion and / or along the axial direction of the tubular portion. At the same time, the folded shape along the radial direction of the inner disc surface of the disc-shaped portion and / or along the axial direction of the tubular portion is arranged in a concentric circle to maintain the disc-shaped shape of the disc-shaped portion or the tubular shape of the tubular portion, thereby improving the sealing effect.

[0045] The positive and progressive effects of this utility model are as follows:

[0046] (1) When the cavity plug is placed at a cavity defect of relatively small size, the inward force exerted by the cavity defect on the tubular part can release the force by extending and deforming the inner disc surface of the disc part and / or the expansion and contraction area of ​​the tubular part, effectively avoiding the outer edge of the disc part from deforming inward and causing the outer disc surface of the cavity plug to bulge.

[0047] (2) The cavity occluder has high applicability and can avoid the bulging of the outer plate of the cavity occluder caused by factors such as the shooting angle of the imaging equipment or the operator's judgment error. It solves the problem of postoperative complications and prolonged postoperative recovery time caused by the cavity occluder being too large. Attached Figure Description

[0048] Figure 1 This is a schematic diagram of the current room partition defect sealing device.

[0049] Figure 2 This is a schematic diagram showing the current usage status of the room partition defect sealing device.

[0050] Figure 3 A schematic diagram (I) of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0051] Figure 4 This is a schematic diagram showing the usage status of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0052] Figure 5 A schematic diagram (II) of the structure of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0053] Figure 6 This is a schematic diagram of an alternative embodiment 1 of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0054] Figure 7 This is a schematic diagram of an alternative embodiment 2 of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0055] Figure 8 This is a schematic diagram of an alternative embodiment 3 of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0056] Figure 9 This is a schematic diagram of an alternative embodiment 4 of the atrial septal defect occluder provided in Embodiment 1 of this utility model.

[0057] Figure 10a This is a schematic diagram (I) of the folded telescopic region of Embodiment 1 of this utility model.

[0058] Figure 10b This is a schematic diagram (II) of the structure of the folded telescopic region in Embodiment 1 of this utility model.

[0059] Figure 10c This is a schematic diagram (III) of the folded telescopic region of Embodiment 1 of this utility model.

[0060] Figure 10d This is a schematic diagram (IV) of the folded telescopic region of Embodiment 1 of this utility model.

[0061] Figure 11 This is a schematic diagram of the atrial septal defect occluder provided in Embodiment 2 of this utility model.

[0062] Figure 12 This is a schematic diagram of the atrial septal defect occluder provided in Embodiment 3 of this utility model.

[0063] Figure 13 This is a schematic diagram of the patent ductus arteriosus occluder provided in Embodiment 4 of this utility model.

[0064] Figure 14 This is a schematic diagram of the ventricular septal defect occluder provided in Embodiment 5 of this utility model.

[0065] Figure 15 This is a schematic diagram of the structure of the unclosed orifice plug provided in Embodiment 6 of this utility model.

[0066] Figure 16 This is a schematic diagram of the structure of the left atrial appendage occluder provided in Embodiment 7 of this utility model.

[0067] Figure 17 This is a schematic diagram of the vascular plug provided in Embodiment 8 of this utility model.

[0068] Explanation of reference numerals in the attached figures:

[0069] Atrial septal defect occluder 100

[0070] Patent ductus arteriosus occluder 200

[0071] Ventricular septal defect occluder 300

[0072] Patent foramen ovale occluder 400

[0073] Left atrial appendage occluder 500

[0074] 600 vascular plugs

[0075] First disc-shaped portion 10, inner disc surface 11

[0076] Tubular portion 20

[0077] The second disc-shaped portion 30, the inner disc surface 12

[0078] Scalable area 111

[0079] Fixing part 40

[0080] Connecting part 50 Detailed Implementation

[0081] The following preferred embodiment, in conjunction with the accompanying drawings, will provide a clearer and more complete description of the present invention, but this does not limit the present invention to the scope of the described embodiment. The terms "proximal," "distal," "anterior," and "posterior" are used relative to the operator (e.g., a clinician) manipulating the atrial septal defect occluder. The terms "proximal" and "posterior" refer to the portion relatively closer to the operator (e.g., the clinician), while the terms "distal" and "anterior" refer to the portion relatively farther from the operator (e.g., the clinician). For example, the portion of the atrial septal defect occluder relatively closer to the operator (e.g., the clinician) is the proximal end (or posterior end), and the portion relatively farther from the operator (e.g., the clinician) is the distal end (or anterior end).

[0082] Example 1

[0083] The types of cavity occluders correspond to the objects they are occluded, including atrial septal defect occluders, patent ductus arteriosus occluders, ventricular septal defect occluders, patent foramen ovale occluders, left atrial appendage occluders, vascular plugs, and various other cavity occluders used to close other cavity defects where no blood can pass through.

[0084] Specifically, in this embodiment, taking a cavity occluder for sealing defects through which blood flows as an example, the provided cavity occluder is an atrial septal defect occluder, and the cavity defect it addresses is an atrial septal defect. The atrial septal defect occluder is used to seal an atrial septal defect between the left and right atria. Under the guidance of medical imaging equipment, the guide wire is inserted along the femoral vein and inferior vena cava until it enters the right atrium, passes through the atrial septal defect, and enters the left atrium. Subsequently, the delivery sheath is placed along the guide wire at the atrial septal defect site, and finally, the atrial septal defect occluder is pushed into the delivery sheath to the atrial septal defect site for occlusion treatment.

[0085] Specifically, such as Figure 1 As shown, in this embodiment, the occluder body of the atrial septal defect occluder 100 is a mesh structure. The mesh structure can be made of shape memory material, metal material, or polymer material. Of course, in other embodiments, other structures existing in the prior art besides the mesh structure can also be used to construct the occluder body.

[0086] Specifically, the mesh structure in this embodiment typically includes a first disc-shaped portion 10, a tubular portion 20, and a second disc-shaped portion 30. The first disc-shaped portion 10, the tubular portion 20, and the second disc-shaped portion 30 are connected sequentially from the distal end to the proximal end of the atrial septal defect occluder 100. The side of the first disc-shaped portion 10 facing the tubular portion 20 is called the inner disc surface 11, and the side of the second disc-shaped portion 30 facing the tubular portion 20 is called the inner disc surface 12. The two ends of the tubular portion 20 are respectively connected to the inner disc surface 11 of the first disc-shaped portion 10 and the inner disc surface 12 of the second disc-shaped portion 30. The first disc-shaped portion 10, the tubular portion 20, and the second disc-shaped portion 30 are typically woven from threads. Therefore, in this embodiment, a connecting portion 50 is provided at the center of the disc surface of the second disc-shaped portion 30 for gathering and fixing the ends of the woven threads and connecting to a conveying device to transport the atrial septal defect occluder 100 to the atrial septal defect site.

[0087] Regarding the issue that the mesh structure of the relatively large room partition defect sealer 100 tends to bulge at the distal end of the first disc-shaped portion 10 when installed in a relatively small room partition defect area, the technicians, after research, understood the principle behind this bulging: (e.g.) Figure 2As shown, when the size of the atrial septal defect is relatively small, after the relatively large atrial septal defect occluder 100 is deployed at that location, the relatively small atrial septal defect will exert a force toward the center A on the tubular portion 20, causing the periphery of the tubular portion 20 to move toward the center A, thereby driving the inner disc surface 11 of the first disc portion 10 to move along its radial direction B, making the size of the inner disc surface 11 of the first disc portion 10 smaller, while at the same time pulling the outer edge of the first disc portion 10 to flip and deform inward along direction C, ultimately causing the outer disc surface of the first disc portion 10 to bulge along direction D.

[0088] To address the issue of bulging at the distal end of the atrial septal defect occluder 100, such as... Figure 3 As shown, the atrial septal defect occluder 100 of this embodiment has a telescopic region 111 on the inner disc surface 11 of the first disc-shaped portion 10. This telescopic region 111 is arranged around the axis of the tubular portion 20. Specifically, the telescopic region 111 is formed by folding its surface along the radial direction B of the inner disc surface 11. By folding the surface at this point in the mesh structure, the telescopic region 111 can deform more easily than other areas of the mesh structure. "More easily deformable" means that the telescopic region 111 deforms first and to a greater extent when subjected to a force along the radial direction B compared to other areas. Furthermore, the telescopic region 111 has relatively large elastic force after deformation, like a spring, and easily returns to its original shape after being stretched. Moreover, the surface folding method of the mesh structure facilitates manufacturing and does not change the material properties of the telescopic region 111, allowing the atrial septal defect occluder 100 to be smoothly released from the delivery sheath and self-expand to return to the preset shape of the occluder.

[0089] Specifically, such as Figure 4 As shown, when the relatively large atrial septal defect occluder 100 is placed at a relatively small atrial septal defect, the force exerted by the atrial septal defect on the tubular portion 20 in the central direction A can be released by the telescopic region 111 located on the inner surface 11 of the first disc-shaped portion 10 through radial deformation. That is, due to the action and reaction forces, the telescopic region 111, after extension and deformation (see details...), releases the force. Figure 4 The dashed line represents the stretchable area 111, which will automatically restore its original shape (see details). Figure 4The solid line represents the expansion region 111. Therefore, the size of the inner disc surface 11 of the first disc-shaped portion 10 will not decrease, and the outer edge of the first disc-shaped portion 10 will not be rotated or deformed inward. This keeps the outer disc surface of the first disc-shaped portion 10 flat and prevents bulging, reducing the release length of the atrial septal defect occluder 100 and the space it occupies in the atrium during the operation. This reduces the probability of residual shunt at the atrial septal defect, increases the endothelialization rate of the outer disc surface, makes the operation more effective and safer, shortens the postoperative recovery time, and reduces the occurrence of postoperative complications.

[0090] In other words, the atrial septal defect occluder 100, by providing a telescopic region 111 on the inner disc surface 11 of the first disc-shaped portion 10, makes the telescopic region 111 more easily deformable than other regions and also has greater elasticity. This telescopic region 111, through its extension and deformation, alleviates and releases the inward force exerted on the tubular portion 20 by a relatively small atrial septal defect, thereby preventing the outer edge of the first disc-shaped portion 10 from deforming inward and causing the outer disc surface of the first disc-shaped portion 10 to bulge. This allows the atrial septal defect occluder 100 to be suitable for relatively small atrial septal defects, improving its applicability. Simultaneously, it avoids the outer disc surface of the first disc-shaped portion 10 from bulging due to factors such as the imaging angle of the imaging device or operator errors, which could lead to an oversized atrial septal defect occluder 100. This fundamentally solves the problem of postoperative complications and prolonged postoperative recovery time caused by an oversized atrial septal defect occluder 100.

[0091] The telescopic region 111 can be selectively positioned relatively close to the tubular portion 20 on the inner surface 11 of the first disc-shaped portion 10, and can extend to the desired location. For example, in this embodiment, the telescopic region 111 is directly positioned adjacent to the tubular portion 20. By positioning the telescopic region 111 close to the tubular portion 20, the inward force exerted by the atrial septal defect on the tubular portion 20 can be quickly transmitted to the telescopic region 111. This force is then released through the force-induced extension and deformation of the telescopic region 111, preventing the force from being transmitted to the outer edge of the first disc-shaped portion 10 and causing the outer surface of the first disc-shaped portion 10 to bulge. Furthermore, after the atrial septal defect occluder 100 is released from the delivery sheath, it can self-expand and return to the preset shape of the occluder, i.e., maintaining the outer surface of the first disc-shaped portion 10 as a flat, preset shape.

[0092] Of course, this embodiment takes the atrial septal defect occluder 100 as an example to illustrate how a telescopic region is provided on the inner disc surface of the disc-shaped portion of the cavity occluder to solve the problems of postoperative complications and prolonged postoperative recovery time caused by the selection of an excessively large cavity occluder size. By applying this structural design scheme of the telescopic region 111 to the disc-shaped portion of other cavity occluders besides the atrial septal defect occluder 100, the corresponding problems can also be solved.

[0093] Specifically, by providing a telescopic region on the inner side of the disc-shaped portion of the cavity blocker, or on the tubular portion, this region is made more easily deformable than other regions and also has greater elasticity. The extension deformation of this region can alleviate and release the relatively small inward force exerted on the tubular portion of the cavity blocker by other cavity defects, thereby preventing the outer edge of the disc-shaped portion of the cavity blocker from deforming inward and causing the outer disc surface of the cavity blocker to bulge.

[0094] Specifically, a telescopic region 111 can be formed on the inner surface 11 of the first disc-shaped portion 10 in various ways, such as in this embodiment, for example... Figures 3-5 As shown, the expansion region 111 is formed by folding the surface of the mesh structure in a wavy pattern within the expansion region 111. This wavy folding shape of the expansion region 111 makes it easier to deform in the radial direction of the inner disc surface 11 and gives it greater elasticity. At the same time, the concentric circle arrangement of the folding shape in the radial direction of the inner disc surface 11 can also increase the support force and shape self-expansion recovery of the atrial septal defect occluder 100 on the disc surface at this location, so as to maintain the disc shape of the first disc portion 10 and improve the occlusion effect.

[0095] In alternative implementation method 1, such as Figure 6As shown, the telescopic region 111 can be simultaneously disposed on the inner disk surface 11 of the first disc-shaped portion 10 and the surface of the tubular portion 20. Specifically, the telescopic region 111 is formed by surface folding along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10 and the axial direction of the tubular portion 20, and the folding shapes along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10 and the axial direction of the tubular portion 20 are arranged in a concentric circle layout. More preferably, the telescopic region 111 on the inner disk surface 11 of the first disc-shaped portion 10 is disposed close to the tubular portion 20, and at the same time, the telescopic region 111 on the tubular portion 20 is close to the inner side of the first disc-shaped portion 10. The disc surface 11 is provided, and the telescopic region 111 can be extended to the required position, so that the inward force exerted by the atrial septal defect on the tubular part 20 can be transmitted to the telescopic region 111 as soon as possible. The force is released by the force extension deformation of the telescopic region 111, avoiding the force from being transmitted to the outer edge of the first disc part 10 and causing the outer disc surface of the first disc part 10 to bulge. After the atrial septal defect occluder 100 is released from the delivery sheath, it can self-expand and recover to the preset shape of the occluder. It can simultaneously maintain the disc shape of the first disc part 10 and the second disc part 30, or maintain the tubular shape of the tubular part 20, thereby improving the occlusion effect.

[0096] In alternative implementation method 2, such as Figure 7 As shown, the telescopic region 111 can be provided only on the tubular portion 20. Specifically, the telescopic region 111 is formed by folding the surface along the axial direction of the tubular portion 20, and the folding shape along the axial direction of the tubular portion 20 is arranged in a concentric circle pattern. More preferably, the telescopic region 111 on the tubular portion 20 is located close to the inner disc surface 11 of the first disc-shaped portion 10 and / or the inner disc surface 12 of the second disc-shaped portion 30, and the telescopic region 111 can extend to the required position so that the inward force exerted by the atrial septal defect on the tubular portion 20 can be reduced. The force is quickly transmitted to the telescopic region 111, and released through the force extension and deformation of the telescopic region 111. This prevents the force from being transmitted to the outer edge of the first disc-shaped portion 10 and / or the second disc-shaped portion 30, which would cause the outer disc surface of the first disc-shaped portion 10 and / or the second disc-shaped portion 30 to bulge. After the atrial septal defect occluder 100 is released from the delivery sheath, it can self-expand and return to the preset shape of the occluder. It can also maintain the disc-shaped shape of the first disc-shaped portion 10 and the second disc-shaped portion 30, or maintain the tubular shape of the tubular portion 20, thereby improving the occlusion effect.

[0097] In alternative implementation method 3, such as Figure 8As shown, the telescopic region 111 can be simultaneously disposed on the inner disk surface 11 of the first disc-shaped portion 10 and the inner disk surface 12 of the tubular portion 20 and the second disc-shaped portion 30. Specifically, the telescopic region 111 is formed by surface folding along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10, the axial direction of the tubular portion 20, and the radial direction of the inner disk surface 12 of the second disc-shaped portion 30. The folded shapes along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10, the axial direction of the tubular portion 20, and the radial direction of the inner disk surface 12 of the second disc-shaped portion 30 are arranged in a concentric circle. More preferably, the telescopic regions 111 located on the inner disk surface 11 of the first disc-shaped portion 10 and the inner disk surface 12 of the second disc-shaped portion 30 are disposed close to the tubular portion 20. At the same time, the telescopic regions 111 located on the inner disk surface 11 of the first disc-shaped portion 10 and the inner disk surface 12 of the second disc-shaped portion 30 are also disposed close to the tubular portion 20. The telescopic region 111 is located close to the inner disc surface 11 of the first disc-shaped portion 10 and the inner disc surface 12 of the second disc-shaped portion 30. The telescopic region 111 can extend to the required position, so that the inward force exerted by the atrial septal defect on the tubular portion 20 can be transmitted to the telescopic region 111 as soon as possible. The force is released by the force extension deformation of the telescopic region 111, avoiding the force from being transmitted to the outer edge of the first disc-shaped portion 10 and the second disc-shaped portion 30, which would cause the outer disc surface of the first disc-shaped portion 10 and the second disc-shaped portion 30 to bulge. After the atrial septal defect occluder 100 is released from the delivery sheath, it can self-expand and return to the preset shape of the occluder. It can simultaneously maintain the disc-shaped shape of the first disc-shaped portion 10 and the second disc-shaped portion 30, or maintain the tubular shape of the tubular portion 20, thereby improving the occlusion effect.

[0098] In alternative implementation method 4, such as Figure 9As shown, the telescopic region 111 can be simultaneously disposed on the inner disk surface 11 of the first disk-shaped portion 10 and the inner disk surface 12 of the second disk-shaped portion 30. Specifically, the telescopic region 111 is formed by folding the surfaces along the radial direction of the inner disk surface 11 of the first disk-shaped portion 10 and the radial direction of the inner disk surface 12 of the second disk-shaped portion 30. The folded shapes along the radial direction of the inner disk surface 11 of the first disk-shaped portion 10 and the radial direction of the inner disk surface 12 of the second disk-shaped portion 30 are arranged in a concentric circle pattern. More preferably, the telescopic regions 111 located on the inner disk surface 11 of the first disk-shaped portion 10 and the inner disk surface 12 of the second disk-shaped portion 30 are disposed close to the tubular portion 20. Furthermore, the telescopic region 111 can extend to the required position, allowing the inward force exerted by the atrial septal defect on the tubular portion 20 to be transmitted to the telescopic region 111 as quickly as possible. This force is released through the force-induced extension and deformation of the telescopic region 111, preventing the force from being transmitted to the outer edges of the first disc portion 10 and the second disc portion 30, which would cause the outer disc surfaces of the first disc portion 10 and the second disc portion 30 to bulge. After the atrial septal defect occluder 100 is released from the delivery sheath, it can self-expand and return to the preset shape of the occluder. It can simultaneously maintain the disc-shaped shape of the first disc portion 10 and the second disc portion 30, or maintain the tubular shape of the tubular portion 20, thereby improving the occlusion effect.

[0099] Specifically, the location of the telescopic region 111 is set according to actual needs. It is selected to be set on at least one surface of the inner disc surface 11 of the first disc-shaped part 10, the inner disc surface 12 of the second disc-shaped part 30, and the tubular part 20, so as to maintain the disc-shaped shape of the first disc-shaped part 10 and / or the second disc-shaped part 30, or to maintain the tubular shape of the tubular part 20, thereby improving the sealing effect. However, it is not limited to the specific location provided in the above embodiments.

[0100] Of course, in other alternative embodiments, folding can also be performed according to other structural forms to achieve the same purpose of making the folded telescopic region 111 more easily deformable and having greater elastic force compared to other regions of the mesh structure. Specifically, such as Figures 10a-10d The diagram shows a schematic representation of the surface folding shape of the telescopic region 111. The surface folding shape of the telescopic region 111 can be a continuous wavy structure, as shown in this embodiment (see [reference]). Figure 10a It can also be a discontinuous wavy structure (i.e., a segmented structure where the wavy part can be broken in the middle and connected by straight segments, see [reference]). Figure 10b Alternatively, it could be a wave-like structure with small waves in the middle and large waves at both ends (see...). Figure 10c Alternatively, it could be a wave-like structure with a large wave in the middle and small waves at both ends (see...). Figure 10dIt can also be a wave with the same shape (i.e., each wave has a different shape) or a wave with different shapes (i.e., each wave can have a different shape, and multiple wave forms can be combined to achieve this). The specific wave structure is set according to actual needs and is not limited to the above settings, so that the expansion area 111 formed by surface folding can be more easily deformed and have relatively large elastic force compared to other areas of the mesh structure, forming a structure similar to a spring.

[0101] Furthermore, this embodiment also provides a method for manufacturing an atrial septal defect occluder 100, for use in manufacturing such an occluder. Figure 5 The atrial septal defect occluder 100 shown is manufactured in the following manner: a manufacturing step of placing a tubular mesh in a mold, i.e., placing the tubular mesh in the mold, and setting a structure on the surface of the mold corresponding to the shape of the expansion region 111. By contacting the tubular mesh with the mold surface, applying a pressing force, and heating to shape it, the mold surface acts on the tubular mesh to form the mesh structure of the occluder (including the first disc-shaped portion 10, the tubular portion 20, and the second disc-shaped portion 30) while folding its surface, thereby forming a wavy expansion region 111 on the surface of the mesh structure. The formed expansion region 111 can be located on at least one of the inner disc surface of the first disc-shaped portion facing the tubular portion, the surface of the tubular portion, and the inner disc surface of the second disc-shaped portion facing the tubular portion, making the expansion region 111 more easily deformable and having greater elastic force than other areas of the mesh structure. More preferably, the expansion region 111 is formed in a wavy folding shape along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10 and / or along the radial direction of the inner disk surface 12 of the second disc-shaped portion 30 and / or along the axial direction of the tubular portion 20. This makes the expansion region 11 more easily deformable and have greater elastic force along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10 and / or the radial direction of the inner disk surface 12 of the second disc-shaped portion 30 and / or the axial direction of the tubular portion 20. At the same time, the folding shape along the radial direction of the inner disk surface 11 of the first disc-shaped portion 10 and / or the radial direction of the inner disk surface 12 of the second disc-shaped portion 30 and / or the axial direction of the tubular portion 20 is arranged in a concentric circle to maintain the disc-shaped shape of the first disc-shaped portion 10 and / or the second disc-shaped portion 30, or to maintain the tubular shape of the tubular portion 20, thereby improving the sealing effect. Of course, in other embodiments, the surface of the atrial septal defect occluder 100 can be folded to form the expansion region 111 by other processing methods (such as 3D printing or cutting).

[0102] In this embodiment, the atrial septal defect occluder 100 has two disc-shaped portions, namely a first disc-shaped portion 10 and a second disc-shaped portion 30, distributed on the distal and proximal sides of the atrial septal defect occluder 100. Of course, in other embodiments, various cavity occluders, including the atrial septal defect occluder 100, may have only one disc-shaped portion, for example, only located on the distal or proximal side of the cavity occluder. In this case, by setting the telescopic region on the inner disc surface of the disc-shaped portion or the surface of the tubular portion, the bulging of the outer disc surface of the cavity occluder can be prevented, thus improving the sealing effect of the cavity occluder on the cavity defect.

[0103] It should be noted that in this embodiment, the tubular mesh and the mesh structure formed after processing are woven from wires. However, the tubular mesh or mesh structure actually used to form the atrial septal defect occluder is not limited to being formed by wire weaving. In fact, any processing method that appears in the prior art (such as 3D printing or cutting) can be used to form the tubular mesh or mesh structure.

[0104] Example 2

[0105] like Figure 11 As shown, this embodiment also provides an atrial septal defect occluder 100, whose structure is roughly the same as that of the atrial septal defect occluder 100 in Embodiment 1. The difference is that the first disc-shaped portion 10 of the atrial septal defect occluder 100 in this embodiment is provided with a fixing portion 40 to achieve the purpose of gathering and fixing the mesh wires at the distal end of the atrial septal defect occluder 100 together and closing the distal end face. At the same time, a connecting portion 50 is provided in the second disc-shaped portion 30 to achieve the purpose of gathering and fixing the mesh wires at the proximal end of the atrial septal defect occluder 100 together and closing the proximal end face. Meanwhile, the connecting portion 50 located at the proximal end also has the function of connecting with an external delivery device. By connecting the atrial septal defect occluder 100 to the delivery device via the connecting portion 50, the delivery device can deliver the atrial septal defect occluder 100 to the atrial septal defect site in the heart. The specific delivery method is prior art and will not be described in detail here.

[0106] In this embodiment, a telescopic region 111 is also provided on the inner disc surface 11 of the first disc-shaped portion 10 to prevent the outer disc surface of the first disc-shaped portion 10 from bulging due to the force exerted at the atrial septal defect when the atrial septal defect occluder 100 is placed at a relatively small atrial septal defect. Of course, in other embodiments, the telescopic region 111 can also be provided on the inner disc surface of the tubular portion and / or the second disc-shaped portion 30 to similarly prevent the corresponding disc surface from bulging, thereby improving the occlusion effect.

[0107] Example 3

[0108] like Figure 12 As shown, this embodiment also provides an atrial septal defect occluder 100, whose structure is roughly the same as that of the atrial septal defect occluder 100 in Embodiment 1. The difference is that the distal end of the first disc-shaped portion 10 of the atrial septal defect occluder 100 in this embodiment is not provided with a fixing portion, and the proximal end of the second disc-shaped portion 30 is not provided with a connecting portion. This is because the manufacturing process of the atrial septal defect occluder 100 in this embodiment has been adjusted. The disc surfaces of the mesh structure at both ends of the atrial septal defect occluder 100 are closed by means of wire closure (i.e., the mesh structure at both ends is gathered together and knotted to fix the structure with wire including sewing thread or mesh wire, thereby closing the disc surfaces of the mesh structure at both ends) or the disc surfaces of the mesh structure at both ends are closed by means of mesh wire interlacing (i.e., the disc surfaces of the mesh structure at both ends are closed by means of mesh wire interlacing). Therefore, it is not necessary to provide a fixing portion and a connecting portion to gather and fix the mesh wire at both ends.

[0109] In this embodiment, a telescopic region 111 is also provided on the inner disc surface 11 of the first disc-shaped portion 10 to prevent the outer disc surface of the first disc-shaped portion 10 from bulging due to the force exerted at the atrial septal defect when the atrial septal defect occluder 100 is placed at a relatively small atrial septal defect. Of course, in other embodiments, the telescopic region 111 can also be provided on the inner disc surface of the tubular portion and / or the second disc-shaped portion 30 to similarly prevent the corresponding disc surface from bulging, thereby improving the occlusion effect.

[0110] Example 4

[0111] This embodiment provides a cavity occluder, which differs from the atrial septal defect occluders provided in embodiments 1-3 in that the cavity occluder in this embodiment is specifically a patent ductus arteriosus occluder, and is used to address the cavity defect of patent ductus arteriosus.

[0112] The specific structure is as follows: Figure 13 As shown, the first disc-shaped portion 10 of the patent ductus arteriosus occluder 200 is located at the distal end of the tubular portion 20, and the second disc-shaped portion 30 is located at the proximal end of the tubular portion 20. The connecting portion 50 is located on the proximal end face of the second disc-shaped portion 30.

[0113] In this embodiment, the telescopic region 111 is disposed on the surface of the tubular portion 20 to prevent the outer disc surface of the patent ductus arteriosus occluder 200 from bulging due to the force exerted at the cavity defect when the patent ductus arteriosus occluder 200 is placed at a relatively small cavity defect. Of course, in other embodiments, the telescopic region 111 may also be disposed on the inner disc surface of the first disc portion 10 to similarly prevent the outer disc surface of the patent ductus arteriosus occluder 200 from bulging, thereby improving the occlusion effect.

[0114] Example 5

[0115] This embodiment provides a cavity occluder, which differs from the atrial septal defect occluders provided in embodiments 1-3 in that the cavity occluder in this embodiment is specifically a ventricular septal defect occluder, and is used to address ventricular septal defects.

[0116] The specific structure is as follows: Figure 14 As shown, the ventricular septal defect occluder 300 is provided with a first disc-shaped portion 10, a tubular portion 20 and a second disc-shaped portion 30 in sequence, and the connecting portion 50 is provided on the outer disc surface of the second disc-shaped portion 30.

[0117] In this embodiment, the telescopic region 111 is continuously disposed on the inner disc surface 11 of the first disc-shaped portion 10 and the surface of the tubular portion 20 to prevent the outer disc surface of the ventricular septal defect occluder 300 from bulging due to the force at the cavity defect when the ventricular septal defect occluder 300 is placed at a relatively small cavity defect. Of course, in other embodiments, the telescopic region 111 can also be disposed at other locations on the ventricular septal defect occluder 300, such as on the inner disc surface 12 of the second disc-shaped portion 30, to similarly prevent the outer disc surface of the ventricular septal defect occluder 300 from bulging, thereby improving the occlusion effect.

[0118] Example 6

[0119] This embodiment provides a cavity occluder, which differs from the atrial septal defect occluders provided in embodiments 1-3 in that the cavity occluder in this embodiment is specifically a patent foramen ovale occluder, and is used to address a patent foramen ovale defect.

[0120] The specific structure is as follows: Figure 15 As shown, the patent foramen ovale plug 400 is provided with a first disc-shaped part 10, a tubular part 20 and a second disc-shaped part 30 in sequence, and the connecting part 50 is provided on the outer disc surface of the second disc-shaped part 30.

[0121] In this embodiment, the telescopic region 111 is disposed on the surface of the inner disc surface 11 of the first disc-shaped portion 10 to prevent the outer disc surface of the patent foramen ovale occluder 400 from bulging due to the force exerted at the cavity defect when the patent foramen ovale occluder 400 is placed at a relatively small cavity defect. Of course, in other embodiments, the telescopic region 111 can also be disposed at other locations on the patent foramen ovale occluder 400, such as on the surface of the tubular portion 20 or on the inner disc surface 12 of the second disc-shaped portion 30, to similarly prevent the outer disc surface of the patent foramen ovale occluder 400 from bulging, thereby improving the occlusion effect.

[0122] Example 7

[0123] This embodiment provides a cavity occluder, which differs from the atrial septal defect occluders provided in embodiments 1-3 in that the cavity occluder in this embodiment is specifically a left atrial appendage occluder.

[0124] The specific structure is as follows: Figure 16 As shown, the left atrial appendage occluder 500 is provided with a first disc-shaped portion 10, a tubular portion 20 and a second disc-shaped portion 30 in sequence, and the connecting portion 50 is provided on the outer disc surface of the second disc-shaped portion 30.

[0125] In this embodiment, the telescopic region 111 is continuously disposed on the surfaces of the inner disc surface 11 of the first disc-shaped portion 10, the tubular portion 20, and the inner disc surface 12 of the second disc-shaped portion 30. This prevents the outer disc surface of the left atrial appendage occluder 500 from bulging due to the force exerted at the cavity defect when the left atrial appendage occluder 500 is placed at a relatively small cavity defect. Of course, in other embodiments, the telescopic region 111 can also be disposed at other locations on the left atrial appendage occluder 500, for example, separately on the surface of the tubular portion 20, or separately on the inner disc surface 11 of the first disc-shaped portion 10 or the inner disc surface 12 of the second disc-shaped portion 30, to similarly prevent the outer disc surface of the left atrial appendage occluder 500 from bulging, thereby improving the occlusion effect.

[0126] Example 8

[0127] This embodiment provides a cavity occluder, which differs from the atrial septal defect occluders provided in embodiments 1-3 in that the cavity occluder in this embodiment is specifically a vascular plug.

[0128] The specific structure is as follows: Figure 17 As shown, the first disc-shaped portion 10 and the second disc-shaped portion 30 on the vascular plug 600 are located at the distal and proximal ends of the vascular plug, respectively, and their outer edges do not protrude from the side surface of the tubular portion 20. In this embodiment, the connecting portion 50 is disposed on the proximal surface of the second disc-shaped portion 30, that is, on the outer disc surface of the second disc-shaped portion 30.

[0129] In this embodiment, the telescopic region 111 is disposed on the entire surface of the tubular portion 20 to prevent the outer surface of the vascular plug 600 from bulging due to the force exerted at the cavity defect when the vascular plug 600 is placed at a relatively small cavity defect. Of course, in other embodiments, the telescopic region 111 may also be disposed at other locations on the vascular plug 600, for example, only on a partial surface of the tubular portion 20, to similarly prevent the outer surface of the vascular plug 600 from bulging, thereby improving the sealing effect.

[0130] While specific embodiments of this utility model have been described above, those skilled in the art should understand that these are merely illustrative examples, and the scope of protection of this utility model is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of this utility model, but all such changes and modifications fall within the scope of protection of this utility model.

Claims

1. A cavity occlusion device, comprising an occlusion device body, the occlusion device body comprising a disc-shaped portion and a tubular portion, the disc-shaped portion and the tubular portion being sequentially connected along the axial direction of the cavity occlusion device, the tubular portion being connected to the inner surface of the disc-shaped portion, characterized in that, A telescopic region is provided on the inner disc surface of the disc-shaped portion and at least one surface of the tubular portion, and the telescopic region is arranged around the axis of the tubular portion. The structure of the expansion region is configured to allow it to deform more easily and have greater elastic force compared to other regions of the plug body.

2. The cavity occlusion device as described in claim 1, characterized in that, The telescopic region provided on the disc-shaped portion is formed by folding the surface along the radial direction of the inner disc surface of the disc-shaped portion; And / or, the telescopic region provided on the tubular portion is formed by surface folding along the axial direction of the tubular portion.

3. The cavity occlusion device as described in claim 2, characterized in that, The surface folding shape of the expansion and contraction area is wavy.

4. The cavity occlusion device as described in claim 3, characterized in that, The surface folding shape of the telescopic region is either a continuous wave shape or a discontinuous wave shape; And / or, the surface folding shape of the telescopic region is a wave shape of the same size or a wave shape of different sizes; And / or, the surface folding shape of the telescopic region is either a wave shape of the same type or a wave shape of different types.

5. The cavity occlusion device according to any one of claims 1-4, characterized in that, The telescopic area located on the inner side of the disc-shaped portion is disposed close to the tubular portion; And / or, the telescopic region located on the tubular portion is disposed close to the inner disk surface of the disk-shaped portion.

6. The cavity occlusion device according to any one of claims 1-4, characterized in that, The plugging device body has a mesh structure; The proximal end of the cavity occluder is closed by a wire-sealing method to seal the mesh structure disc at the proximal end; Alternatively, the disk surface of the near-end mesh structure can be closed by interlacing the mesh wires; Alternatively, the mesh structure on the near end of the disk can be closed by setting connecting parts on the disk surface.

7. The cavity occlusion device according to any one of claims 1-4, characterized in that, The distal end of the cavity occluder is closed by a wire-sealing method to seal the distal mesh structure disc. Alternatively, the disk surface of the mesh structure at the far end can be closed by interlacing the mesh wires; Alternatively, the disk surface of the mesh structure at the far end can be closed by setting a fixing part on the disk surface.

8. The cavity occlusion device according to any one of claims 1-4, characterized in that, The disc-shaped portion includes a first disc-shaped portion and a second disc-shaped portion, which are connected sequentially along the direction from the distal end to the proximal end of the cavity occluder.

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