Plugging device and plugging system

Abstract

The present invention relates to a plugging device and a plugging system. The plugging device includes a plugging part, a fixing part and a first clamping part. The plugging part includes a self-expanding body. The fixing part is located at one end of the plugging part, and the first clamping part is fixed to the plugging part through the fixing part. For the plugging device provided by the present invention, on the one hand, the plugging effect is not affected by the shape of the left and right atrial walls, so the plugging effect is better and there will be no residual shunt. On the other hand, the plugging device has no double-disk structure, and the instrument can be made smaller, reducing the metal content of the implanted instrument, reducing the risk of human nickel ion allergy, and not affecting the possibility of re-puncturing the atrial septum. On the third hand, due to the cancellation of the double-plugging disk structure, for a longer patent foramen ovale channel, it can avoid the extrusion of the atrial septum tissue caused by the pulling of the plugging disks into the patent foramen ovale channel due to the longer patent foramen ovale channel in the two-disk plugging device, thereby reducing the damage to the myocardial membrane.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a occluding device and an occluding system. Background Art

[0002] The information provided in this section is only background information related to the present disclosure, and it is not necessarily prior art.

[0003] Patent foramen ovale (PFO) is a common congenital heart disease, which is an abnormal passage in the interatrial septum between the left atrium and the right atrium. The specific reason is that the primary septum and the secondary septum do not adhere and fuse with each other, resulting in an oblique passage where the myocardial membranes of the left and right atria overlap. This passage allows thrombi in the venous system to flow into the left heart with the blood flow, which can subsequently cause cerebral infarction and migraine. Generally, it is considered that the degree of overlap between the primary septum and the secondary septum of each person's interatrial septum is different, and the non-fused distance is also different, resulting in different shapes and sizes of the PFO passage.

[0004] In recent years, the potential hazards of patent foramen ovale have attracted increasing attention in the academic community, and the treatment has become more and more active. Currently, the mainstream treatment method for PFO is to perform percutaneous (femoral vein) occlusion using an occluder.

[0005] The occluders used in the prior art are generally "I"-shaped occluders 60 woven from nitinol alloy wires, which have two occluding disks and a waist. The occluder 60 includes an occluding disk 61 and a flow-blocking membrane layer 62 disposed within the occluding disk, as Figures 1-3 shown. On the one hand, in the existing "I"-shaped occluders, the occluding disks 61 are all metal skeletons with dense grids woven from nitinol alloy. The metal skeletons have strong rigidity, and the waist is integrally woven with the occluding disks, resulting in poor compliance of the waist and mutual influence between the shape of the occluding disks and the waist. Since the PFO passage is inclined relative to the interatrial septum tissue 90, the occluding disks of the integrated "I"-shaped occluder have poor morphological adaptability to the tissue, and it is easy to squeeze the septum tissue to cause tissue deformation, resulting in certain tissue damage. On the other hand, after the occluder is released into the patent foramen ovale, an angle α is formed between the disk surface of the occluding disk and the interatrial septum tissue, as Figure 3 shown. As a result, the fitting of the occluding disk surface to the interatrial septum tissue is not tight. When dealing with a long PFO passage (the wall of the interatrial septum tissue is thicker), part of the two occluding disk surfaces is pulled into the PFO passage, causing the deformation of the occluding disk surface, increasing the extrusion of the tissue and resulting in serious tissue damage. At the same time, it causes the disk surface to warp, increasing the α angle, affecting the fitting of the occluding disk to the interatrial septum, resulting in residual shunt (flowing from the right atrium RA into the left atrium LA), and affecting the occluding effect, as Figure 3 shown.

[0006] Therefore, there is an urgent need for an occluding device that can not only adapt to the morphology of the interatrial septum tissue to reduce tissue damage, but also prevent residual shunt and thus have a better occluding effect. Summary of the Invention

[0007] One technical problem solved by the present invention is how to provide a plugging device that can not only adapt to the tissue morphology of the atrial septum to reduce tissue damage, but also prevent residual shunting, thus having a better plugging effect.

[0008] On the one hand, the present invention provides a plugging device, which includes a plugging part, a fixing part and a first clamping part. The plugging part expands self - adaptively to adapt to and support in the oval foramen channel. The plugging part includes a self - expanding body, a first end part and a second end part. The self - expanding body includes a main body part and a first constricting part. The first constricting part constricts at one of the first end parts, and the fixing part is located at one of the first end parts. The first clamping part includes a connecting part, an extending part, a bending part and a clamping piece. The connecting part connects the fixing part. The extending part obliquely extends from the connecting part and gradually moves away from the fixing part. The bending part bends from the end of the extending part away from the fixing part and extends in the direction of the second end part, and connects the clamping piece. The clamping piece extends from the end of the bending part away from the extending part in a direction parallel to the axis where the main body part is located or slightly inclines towards the side of the self - expanding body, so as to be in a clamping state where it contacts or nearly contacts or slightly presses the main body part.

[0009] In one embodiment, the self - expanding body further includes a second constricting part disposed opposite to the first constricting part. The second constricting part constricts at the second end part. At least two fixing parts are provided. The plugging device further includes a second clamping part, and the other fixing part is located at the second end part so that the second clamping part is fixed to the plugging part through the other fixing part.

[0010] In one embodiment, the self - expanding body includes a main body part, a first constricting part and a second constricting part. The first constricting part is located at the proximal end of the main body part, and the second constricting part is located at the distal end of the main body part. The first constricting part constricts at the first end part, the second constricting part constricts at the second end part, and the fixing part is located at the second end part.

[0011] In one embodiment, one side of the first end part close to the self - expanding body includes a first opening groove for constricting the first constricting part of the self - expanding body. The side of the first end part away from the self - expanding body includes a second opening groove, and a threaded connecting piece is arranged in the second opening groove.

[0012] In one embodiment, an acute angle is formed between the clamping piece and the extending part.

[0013] In one embodiment, the extending part extends from the connecting part towards the side away from the self - expanding body.

[0014] On the other hand, the present invention also provides a plugging system, including the plugging device as described above, characterized in that the plugging system includes a delivery sheath and a delivery steel cable, and the delivery steel cable is sleeved inside the delivery sheath.

[0015] In one embodiment, the plugging system further includes a delivery handle and a traction wire. The traction wire is used to connect to a first clamping part at the proximal end of the plugging device. The delivery handle includes a first control member. The traction wire is connected to the first control member, and the first control member is connected to the traction wire inside the delivery handle to control the retraction and release of the traction wire.

[0016] The technical effect of an embodiment of the present invention is as follows: The plugging device provided by the present invention is composed of a plugging part including a self-expanding body and a first clamping part located at one end of the plugging part. The plugging part self-expands to adapt to and support in the foramen ovale channel, thereby achieving the plugging effect of cutting off blood flow. On the one hand, since the plugging effect of the plugging part does not need to conform to the shape of the left and right atrial walls, its plugging or conforming performance is not affected by the shape of the left and right atrial walls. Therefore, its plugging effect is better and there will be no residual shunt. On the other hand, since the plugging device provided by the present invention does not have a double-disk structure, the instrument can be made smaller, and only needs to adapt to the size of the foramen ovale channel to achieve plugging, which can reduce the metal content of the implanted instrument and reduce the risk of human nickel ion allergy. Moreover, when the patient needs to use atrial septal puncture again due to other causes such as atrial fibrillation or mitral regurgitation, there will be no situation where the plugging disk surface of the occluder blocks the entire atrial septum, that is, it does not affect the possibility of re-puncturing the atrial septum. On the one hand, since the structure of the double plugging disks is cancelled, for the relatively long foramen ovale channel, the plugging device provided by the present invention can avoid the extrusion of the atrial septal tissue caused by the part of the plugging disk near the waist being pulled into the foramen ovale channel due to the relatively long foramen ovale channel in the two-disk plugging device, thereby reducing the damage to the myocardial membrane caused by the implantation of the plugging device. Description of the Drawings

[0017] Figure 1 It is a three-dimensional structure diagram of an integrated "I"-shaped occluder in the prior art;

[0018] Figure 2 It is the morphological pattern of the atrial septal tissue when the foramen ovale is not closed;

[0019] Figure 3 It is a schematic diagram of residual shunt caused by an occluder in the prior art;

[0020] Figure 4 It is a schematic structural diagram of the plugging device provided in Embodiment 1 of the present invention in the natural state;

[0021] Figure 5 It is a three-dimensional structure diagram of the plugging device provided in Embodiment 1 of the present invention in the natural state;

[0022] Figure 6 A schematic structural diagram of the first end portion provided in Example 1 of the present invention;

[0023] Figure 7 for Figure 6 Cross-sectional view in the AA direction;

[0024] Figure 8 A schematic structural diagram of the second end portion provided in Example 1 of the present invention;

[0025] Figure 9 A schematic diagram of the structure of the assembly of the first clamping portion and the second end portion provided in Example 1 of the present invention;

[0026] Figure 10 A schematic structural diagram of the first clamping portion provided in Example 1 of the present invention;

[0027] Figure 11 This is a schematic structural diagram of the plugging system after loading provided in Example 1 of the present invention;

[0028] Figure 12 A schematic structural diagram of the occlusion system provided in Example 1 of the present invention, wherein the delivery sheath is withdrawn to the bend of the first clamping portion;

[0029] Figure 13 This is a schematic structural diagram of the first clamping portion of the occlusion system provided in Example 1 of the present invention clamping the septal tissue on the left side of the heart between the occlusion portion and the first clamping portion;

[0030] Figure 14 A schematic structural diagram of the occlusion device of the occlusion system provided in Example 1 of the present invention, which is freed from the restraint of the delivery sheath and self-expands;

[0031] Figure 15 This is a morphological diagram of the occlusion device provided in Example 1 of the present invention implanted in the foramen ovale channel;

[0032] Figure 16 This is a schematic structural diagram of the blocking device provided in Example 2 of the present invention in its natural state;

[0033] Figure 17 This is a structural schematic diagram of the blocking device provided by Example 2 of the present invention in a natural state from another angle;

[0034] Figure 18 This is a schematic structural diagram of the assembly of the delivery sheath, delivery cable, and delivery handle provided in Example 2 of the present invention;

[0035] Figure 19 for Figure 18 Cross-sectional view in the middle BB direction;

[0036] Figure 20 Structural schematic diagram and partial internal structure diagram of the delivery handle provided in Embodiment 2 of the present invention;

[0037] Figure 21 Structural schematic diagram of the occlusion device provided in Embodiment 2 of the present invention loaded in the delivery sheath;

[0038] Figure 22 Structural schematic diagram of the delivery sheath retracted to expose the first folded clip portion at the distal end face of the delivery sheath in Embodiment 2 of the present invention;

[0039] Figure 23 Structural schematic diagram of adjusting the first knob to release the traction wire provided in Embodiment 2 of the present invention;

[0040] Figure 24 Structural schematic diagram of the traction wire released to make the first clip portion in a natural clamping state provided in Embodiment 2 of the present invention;

[0041] Figure 25 Morphological diagram of the occlusion device implanted in the oval foramen channel provided in Embodiment 2 of the present invention;

[0042] Figure 26 Structural schematic diagram of the occlusion device in another embodiment provided by the present invention;

[0043] Figure 27 Structural schematic diagram of the occlusion device in still another embodiment provided by the present invention. Detailed implementation manners

[0044] For ease of understanding the present invention, the present invention will be described more comprehensively below with reference to the relevant drawings. Preferred embodiments of the present invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided so that the disclosure of the present invention can be understood more thoroughly and comprehensively.

[0045] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "inner", "outer", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only embodiments.

[0046] For convenience of description, the terms "distal end" and "proximal end" are defined herein. These terms are commonly used in the field of interventional medical devices. Specifically, the "distal end" refers to the end far from the operator during the surgical procedure, and the "proximal end" refers to the end close to the operator during the surgical procedure. The general method of atrial septum puncture is to puncture from the right atrium to the left atrium. The "axial direction" generally refers to the length direction of the medical device during delivery, the "circumferential direction" generally refers to the direction around the "axial direction", and the "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction" and passing through the central axis. Based on this principle, the "axial direction" and "radial direction" of any component of the medical device are defined.

[0047] Embodiment 1

[0048] The present invention provides a occluding device 10 and an occluding system, as Figures 4-15 shown. The occluding device 10 includes an occluding portion 11, a fixing portion 1131 and a first clamping portion 12. The first clamping portion 12 is fixedly connected to the occluding portion 11 through the fixing portion 1131, so as to clamp the atrial septum tissue by using the first clamping portion 12, thereby fixing the occluding portion 11 in the foramen ovale 91 channel, as Figure 15 shown.

[0049] In this embodiment, as Figures 4-7 shown, the occluding portion 11 includes a self-expanding body 111 and end portions. The self-expanding body 111 includes a main body portion 1111, a first constriction portion 1112 and a second constriction portion 1114. Among them, the first constriction portion 1112 is arranged at the proximal end of the self-expanding body 111, and the second constriction portion 1114 is arranged at the distal end of the self-expanding body 111, so that the first constriction portion 1112 and the second constriction portion 1114 are oppositely arranged at both ends of the self-expanding body. Both the first constriction portion 1112 and the second constriction portion 1114 include a connection end connected to the main body portion 1111 and a tail end opposite to the connection end. The radial width dimension of the tail end is smaller than that of the connection end, so that both ends of the self-expanding body 111 are in a constricted shape. Whether the constriction degrees of the first constriction portion 1112 and the second constriction portion 1114 (i.e., the length along the axial direction from the connection end to the tail end) are the same is not limited. The tail end of the first constriction portion 1112 of the self-expanding body 111 is constricted into the first end portion 112, and the tail end of the second constriction portion 1114 is constricted into the second end portion 113. The tail end of the first constriction portion 1112 can be directly constricted into the first end portion 112, or the tail end of the first constriction portion 1112 can be constricted into an embedded portion first, and then embedded into the first end portion 112 through the embedded portion, so as to fixedly connect the occluding portion 11 with the first end portion 112; similarly, the tail end of the second constriction portion 1114 can be directly constricted into the second end portion 113, or the tail end of the second constriction portion 1114 can be constricted into an embedded portion first, and then embedded into the second end portion 113 through the embedded portion, so as to fixedly connect the occluding portion 11 with the second end portion 113. The embedded portion can be a head with a smaller size than the first end portion and the second end portion, and is used to constrict the end of the braided wire.

[0050] The main body 1111 of the self-expanding body 111 is a self-expanding network tube structure to adapt to the size of the foramen ovale. A flow-blocking membrane 1113 can be arranged in the main body 1111, or the converging part of the network tube structure can be woven into a dense network to play a flow-blocking role. The flow-blocking membrane 1113 can be fixed in the network tube structure by means such as suturing. A layer of flow-blocking membrane 1113 can be arranged in the middle area of the occluding waist, or two layers of flow-blocking membranes can be arranged at intervals in the main body 1111 to increase the flow-blocking reliability.

[0051] The end part includes a first end part 112 and a second end part 113. The first end part 112 is located at the proximal end of the occluding part 11, and the second end part 113 is located at the distal end of the occluding part 11. The first end part 112 includes a first opening groove 1121 and a second opening groove 1122 arranged opposite to the first opening groove 1121, so that the first end part 112 has a groove structure with openings at both ends. The side of the first end part 112 close to the self-expanding body 111 is the first opening groove 1121, and the first opening groove 1121 is used to converge the first converging part 1112 of the self-expanding body 111. The side of the first end part 112 away from the self-expanding body 111 is the second opening groove 1122, and the second opening groove 1122 is used to set an internal thread or a threaded connector (an internal thread is arranged in the threaded connector). Among them, the threaded connector can be integrally connected with the first end part 112 or welded together in a split manner. The internal thread is flush with the end face of the second opening groove 1122 away from the self-expanding body 111, or the internal thread is close to the end face of the second opening groove 1122 away from the self-expanding body 111, so as to be connected with the external thread at the distal end of the conveying cable 60 of the conveyor, thereby realizing the conveying and release of the occluding device 10 through the internal and external threads.

[0052] As Figures 8-10 Combined Figures 4-5 shown, the second end part 113 includes a fixing part 1131. The first clamping part 12 is fixed to the occluding part 11 through the fixing part 1131. In this embodiment, the fixing part 1131 is provided with an embedding groove 1131a along the circumferential direction. There can be two embedding grooves 1131a arranged opposite to each other. The first clamping part 12 is clamped and fixed to the fixing part 1131 of the second end part 113 through the embedding groove 1131a.

[0053] In this embodiment, as Figure 4As shown, the first clamping part 12 is arranged on the second end part 113 at the distal end of the plugging part 11 to form a clamping structure with the plugging part 11, or the first clamping part itself forms a clamping structure, so that the clamping structure can be used to clamp the atrial septum tissue at the foramen ovale. Whether the first clamping part itself forms a clamping structure or forms a clamping structure with the plugging part is not limited herein, as long as it can achieve fixing the plugging part in the foramen ovale channel by clamping the tissue with the first clamping part. In other embodiments, the first clamping part can also be arranged on the first end part at the proximal end of the plugging part, or the first clamping part is arranged on the first end part respectively, and the second clamping part is arranged on the second end part.

[0054] The occlusion device 10 for patent foramen ovale provided by the present invention is composed of a radially compressible occlusion part 11 and a first clamping part 12 for clamping tissue. The size of the occlusion part 11 is generally slightly larger than the radial size of the foramen ovale, so that the occlusion part 11 expands self-adaptively to adapt to and support in the foramen ovale channel, thereby achieving the occlusion effect of cutting off blood flow. On the one hand, since the occlusion effect of the occlusion part 11 does not need to conform to the shape of the left and right atrial walls, its occlusion or fitting performance is not affected by the shape of the left and right atrial walls, so its occlusion effect is better and there will be no residual shunt. On the other hand, since the occlusion device 10 provided by the present invention has no double-disk structure, the instrument can be made smaller, and only needs to adapt to the size of the foramen ovale channel to achieve occlusion, which can reduce the metal content of the implanted instrument and reduce the risk of human nickel ion allergy. Moreover, when the patient needs to use atrial septal puncture again due to other causes such as atrial fibrillation or mitral regurgitation, there will be no situation where the occlusion disk surface of the occluder blocks the entire atrial septum, that is, it does not affect the possibility of re-puncturing the atrial septum. On the other hand, since the structure of the double occlusion disks is cancelled, for the relatively long foramen ovale channel, the occlusion device 10 provided by the present invention can avoid the extrusion of the atrial septum tissue caused by the occlusion disk near the waist part of the two-disk occlusion device 10 being pulled into the foramen ovale channel due to the relatively long foramen ovale channel, thereby reducing the damage to the myocardial membrane caused by the implantation of the occlusion device 10.

[0055] Such as Figures 8-10As shown, the first clamping part 12 includes a connecting part 121, an extending part 122, a bending part 123 and a clamping piece 124. The connecting part 121 of the first clamping part 12 is partially disposed in the slot 1131a of the fixing part 1131. The connecting part 121 includes two clamping parts 1211. Each clamping part 1211 includes a connecting end connected to the extending part 122 and a free end opposite to the connecting end. The free ends of the two clamping parts 1211 approach each other on the side away from the extending part 122 so that the two clamping parts 1211 are in a surrounding shape relative to the fixing part 1131, thus making the clamping parts 1211 more firmly clamped to the fixing part 1131. And there is a little gap between the free ends of the two clamping parts 1211 to facilitate the connecting part 121 to be clamped onto the fixing part 1131 along the slot 1131a of the fixing part 1131. In other embodiments, the connecting part 121 can also be fixedly welded or integrally formed with the second end part 113.

[0056] The extending part 122 extends from the connecting part 121 toward the side away from the self-expanding body 111 and gradually moves away from the fixing part 1131. The bending part 123 bends from the end of the extending part 122 away from the fixing part 1131 and extends toward the direction of the first end part 112, so that an acute angle is formed between the clamping piece 124 and the extending part 122, thereby maintaining the clamping force of the first clamping part 12. The clamping piece 124 extends from the end of the bending part 123 away from the extending part 122 toward the axis parallel to the main body part 1111 or inclines slightly toward the side of the self-expanding body 111, so as to be in a clamping state of contacting or nearly contacting or slightly pressing against the main body part 1111. The first clamping part 12 is made of an elastic material, so that the first clamping part 12 has an elastic clip structure, thereby forming a clamping structure with the self-expanding body 111, so as to clamp the spacer tissue between the first clamping part 12 and the plugging part 11, as Figure 4 and Figure 15 shown.

[0057] As Figures 11-14 shown in Figures 4-10 combination, the elasticity of the first clamping part 12 can cause the clamping piece 124 to flip away from the main body part 1111 under the action of an external force, while maintaining a tendency to flip back. As Figure 11 shown, when the clamping piece 124 is flipped to the form on the side of the second end part 113 away from the self-expanding body 111 with the bending part 123 as the flipping fulcrum and loaded into the delivery sheath 50 (the plugging part 11 is loaded into the delivery sheath 50 in a radially compressed form), the clamping piece 124 has a tendency to flip back to the clamping state. During the release process of the plugging device 10, when the restraint of the delivery sheath 50 on the clamping piece 124 is released by withdrawing the delivery sheath 50, due to the elasticity of the first clamping part 12 itself, the clamping piece 124 can return to the clamping state after the restraint is released, so as to clamp the tissue during the release process of the plugging device 10 in the body, as Figure 13 shown.

[0058] Since the degree of folding of the clip 124 within the delivery sheath 50 is nearly 180° compared to its natural state, the stress at the folding fulcrum is excessive, which easily leads to fatigue fracture. The extension portion 122 extends in the opposite direction relative to the main body portion 1111 and cooperates with the bending portion 123. When the clip 124 is folded, the reversely extending extension portion 122 can conform to the folding trend of the clip 124. At the same time, combined with the bending of the bending portion 123, while maintaining the clamping force of the first clamping portion 12, the risk of fatigue fracture during the folding of the clip 124 is reduced, that is, the failure risk of the first clamping portion 12 is reduced, and the reliability of the first clamping portion 12 to achieve clamping during in-vivo release is increased.

[0059] As Figure 10 Combined with Figures 4-5 As shown, the clip 124 includes an inner side surface 1241 and an outer side surface 1242. In the natural state of the occlusion device 10, the surface of the clip 124 close to the main body portion 1111 is the inner side surface 1241, and the surface of the clip 124 away from the main body portion 1111 is the outer side surface 1242. A plurality of anchors 1243 are arranged at intervals on the inner side surface 1241. The anchors 1243 are inclined in the direction towards the fixing portion 1131 connected to the clip 124 to increase the friction force on the tissue when the first clamping portion 12 clamps the tissue.

[0060] When the occlusion device 10 is retracted into the delivery sheath 50 and the clip 124 has a tendency to return to the clamping state, the inner side surface 1241 of the folded clip 124 is close to the inner wall of the sheath tube of the delivery sheath 50. An arc chamfer is provided at the end of the anchor 1243 close to the main body portion 1111, which can prevent thrombus caused by debris generated when the anchor 1243 moves relative to the delivery sheath 50 and scratches the inner wall of the delivery sheath 50 during the process of the delivery sheath 50 being retracted to release the occlusion device 10.

[0061] As Figures 11-14 As shown, the present embodiment also provides an occlusion system including the above-mentioned occlusion device 10. The occlusion system further includes a delivery steel cable 6, a delivery sheath 50, and a loader (not shown in the figure). Based on the puncture direction of the transseptal puncture operation being from the right atrium RA to the left atrium LA, when the occlusion device in the present embodiment is implanted in the body, the first end portion 112 is located on the right heart side, and the second end portion 113 is located on the left heart side, so as to facilitate the threaded connection between the internal thread in the second opening groove 1122 of the first end portion 112 and the external thread at the distal end of the delivery steel cable 60.

[0062] During the operation, a puncture is made from one femoral artery, and then a guide wire is sent to the position of the left atrium to establish an in-vivo delivery track; the delivery sheath 50 is delivered along the guide wire to extend beyond the septal tissue 92 on the left heart side by a certain length (in the surgical procedure corresponding to the occlusion device provided in the present embodiment, the initial position of the delivery sheath to start the release process of the occlusion device needs to extend beyond about the length of one clip 124, refer toFigure 11 As shown); the loader is sleeved from the distal end of the conveying steel cable 60. Subsequently, after the internal thread of the second opening groove 1122 of the first end portion 112 is threadedly connected to the external thread of the distal end of the conveying steel cable 60, the plugging device 10 is constricted by means of the loader, and the loader is communicated with the proximal end of the conveying sheath 50, so that the plugging device 10 is loaded into the proximal end of the conveying sheath 50 in a constricted state (the plugging portion 11 is radially compressed, and the first clamping portion 12 is folded away from the main body portion, as Figure 11 shown); then, the conveying steel cable 60 is pushed towards the distal end, and the plugging device 10 is conveyed to the distal end of the conveying sheath 50.

[0063] Next, the release process of the plugging device 10 is as follows:

[0064] First, the conveying steel cable 60 is fixed. At the same time, the distal end face of the conveying sheath 50 is retracted to the spacer tissue 92 on the left heart side so that the bending portion (bending portion 123) of the first clamping portion 12 is exposed at the distal end of the conveying sheath 50. Refer to Figure 12 and Figure 13 the intermediate state of. At this time, the folded state of the first clamping portion 12 loses the restraint of the conveying sheath 50. Due to the self-elasticity of the first clamping portion 12, the clamping piece 124 will rebound towards the natural state, so as to clamp the spacer tissue 92 on the left heart side between the plugging portion 11 and the first clamping portion 12, as Figure 13 shown;

[0065] Subsequently, the conveying sheath 50 is continuously retracted, so that the plugging device is released from the restraint of the conveying sheath and self-expands, as Figure 14 shown, so that the self-expanding body 111 self-expands in the patent foramen ovale and supports and fits in the patent foramen ovale channel, so that the main body portion 1111 of the plugging portion 11 is supported in the channel of the patent foramen ovale;

[0066] And whether there is blood shunt is checked by ultrasound to judge the plugging effect of the plugging device 10. If the plugging effect is not good, the conveying sheath 50 can be pushed forward to make the plugging device 10 constricted in the conveying sheath 50 again, so as to realize the adjustment and re-release of the plugging device 10;

[0067] After the plugging effect is confirmed, the threaded connection between the conveying steel cable 60 and the plugging device 10 is disengaged and then withdrawn from the human body, thus completing the operation.

[0068] Embodiment 2

[0069] Embodiment 2 proposes another plugging device 20 and plugging system. As Figures 16-25 shown, the same or reusable characteristic parts in the plugging device 20 of Embodiment 2 and the plugging device 10 of Embodiment 1 will not be described in detail here. The main difference is that in the plugging device 20 of Embodiment 2, as Figures 16-17 combined with Figure 18As shown, the fixing part 2121 is arranged at the first end part 212, and the first clamping part 22 is fixed to the first end part 212 through the fixing part 2121. A perforation 2243 is further arranged at one end of the clamping piece 224 away from the bending part 223. The perforation 2243 penetrates through the inner side surface 2241 and the outer side surface 2242, so as to be connected to a traction wire 71 arranged in the conveying device when the plugging device 20 is retracted into the conveying sheath 50.

[0070] This embodiment also provides a plugging system including the above-mentioned plugging device 20. The features of the plugging system that are the same as or can be borrowed from those in Embodiment 1 will not be described in detail here. The main difference is that, as Figures 18-20 Combined Figures 16-17 As shown, the plugging system of Embodiment 2 further includes a conveying handle 70. The conveying handle 70 includes a first control member 72, an opening 73 and a second control member 74. The first control member 72 includes a first knob and is arranged at the proximal end of the conveying handle 70. The second control member 74 includes a second knob and is arranged at the distal end of the conveying handle 70. The opening 73 is arranged at the proximal end of the second control member 74 and on the distal side of the first control member 72. Among them, the first control member 72 is connected to the traction wire 71 inside the conveying handle 70, the second control member 74 is connected to the conveying steel cable 60 inside the conveying handle 70, and a spacing device 75 is arranged in the opening 73, so that the two wires formed by the folding back of the traction wire 71 can be separated on both sides of the spacing device 75 at a certain position in the conveying handle 70, which is convenient for cutting one of the wires to disconnect the connection between the perforation 2243 and the traction wire 71, so as to recover the traction wire 71 into the conveying handle 70. The setting of the spacing device can prevent the wrong cutting of the two wires, resulting in the failure of the traction wire recovery. The spacing device can be set as a spacer plate or a guide plate or other structures that play a spacing role, as long as the folded-back traction wires can be spaced apart to prevent the wrong cutting of the two wires.

[0071] The traction wire 71 includes a first end and a second end. The first end of the traction wire 71 is wound and connected to the first control member 72. And when the clamping piece 224 is in the folded state, there is a release margin between the traction wire 71 and the first knob, so that when the first knob is rotated, the clamping piece 224 can be released to the natural clamping state through the traction wire 71; after the end of the second end of the traction wire 71 penetrates into the perforation 2243, the second end is folded back to the first knob and then connected to the first knob or connected to the inner wall of the conveying handle 70 in the inner cavity of the conveying handle 70, so that the traction wire 71 forms two folded lines and is connected to the clamping piece 224 through the perforation 2243, so that by rotating the first knob, the traction wire 71 can be retracted and released, and further, after the plugging part 21 is self-expanded, the release of the first clamping part 22 can be realized, so that the first clamping part 22 clamps the septal tissue 93 on the right heart side between the main body part and the first clamping part 22.

[0072] As Figure 19As shown, an axial channel 61 for the traction wire 71 to pass through is provided inside the delivery sheath 50, enabling the traction wire 71 to move relative to the axial channel, facilitating the winding and unwinding of the traction wire by the first control member 72 and the recovery of the traction wire 71 after wire cutting.

[0073] As Figure 20 shown, the first control member includes a first knob 721, a transmission shaft 722, and a worm and worm gear structure. The first knob 721 is connected to the worm of the worm and worm gear structure 723 through the transmission shaft 722, so that the worm can rotate self - axially around a direction perpendicular to the transmission shaft 722, enabling the first knob 721 to drive the worm to wind and unwind the traction wire 71 by circumferentially rotating around the central axis of the delivery handle 70. Both ends of the worm are supported inside the delivery handle by fixing rods 724, and the worm can rotate self - axially around the central axis of the worm on the fixed shaft. The worm also includes two oppositely arranged wire winding shafts 725. The first end and the second end of the traction wire 71 are respectively fixed to the two wire winding shafts 725, and the first end and the second end of the traction wire 71 are wound around their respective wire winding shafts 725 or released from their respective wire winding shafts 725 as the first knob 721 rotates.

[0074] In this embodiment, except for the difference in the order of first threading the traction wire 71 and folding the first clamping portion 22 during the loading of the occlusion device 20 provided, the other loading processes are basically the same as those in Embodiment 1 and will not be elaborated here. Due to the different positions of the first clamping portion 22 of the occlusion device 20 in this embodiment, the pre - delivery position of the delivery sheath 50 is different from that in Embodiment 1. The delivery sheath 50 does not need to extend beyond the septal tissue on the left - heart side, and the distal end face of the delivery sheath 50 is located within the oval foramen. After the loading of the delivery device is completed, it can be adjusted to the position to be released according to the positions of the occlusion device 20 and the first clamping portion 22 relative to the septal tissue 93 on the right - heart side. As Figures 21-24 shown, the release process of the occlusion device 20 provided in this embodiment is as follows:

[0075] First, referring to Figures 21-22 shown, fix the delivery steel cable 60. At the same time, retract the distal end face of the delivery sheath 50 to the atrial septal tissue on the right - heart side, so that the self - expanding body self - expands and fits within the oval foramen in the oval foramen, thereby enabling the main body of the occlusion portion 21 to be supported within the channel of the oval foramen.

[0076] Subsequently, continue to retract the delivery sheath 50 to expose the folded first clamping portion 22 at the distal end of the delivery sheath 50. As Figure 22 Combined with Figures 18-20As shown, then rotate the first knob 721 to control the release of the traction wire 71. Due to the elasticity of the first clamping part 22 itself, the folded first clamping part 22 loses the restraint of the traction wire 71, and the clamping piece 224 rebounds towards the natural state. By controlling the first knob, the first clamping part can also be slowly released, so as to clamp the atrial septal tissue on the right heart side between the occlusion part 21 and the first clamping part 22. The adjustment of the first control part can realize the slow release of the first clamping part, preventing the elasticity of the sudden release of the first clamping part from damaging the myocardial membrane;

[0077] And check whether there is blood shunt through ultrasound to judge the occlusion effect of the occlusion device 20. If the occlusion effect is not good, the traction wire 71 can be pulled back by adjusting the first control part 72, so that the first clamping part 22 is folded to the state where the outer side of the clamping piece adheres to the delivery steel cable (such as Figure 22 the state shown), and then the delivery sheath 50 is pushed forward to constrict the occlusion part 21, so that the whole occlusion device 20 is constricted back into the delivery sheath 50 again, thus realizing the adjustment and re - release of the occlusion device 20;

[0078] After confirming the occlusion effect, cut one of the separated lines at the opening 73 of the delivery handle 70 or cut the line that is not directly connected to the first control part 72, and then rotate the first knob 721 to recover the traction wire 71. After detaching the thread - connected delivery steel cable 60 from the occlusion device 20, withdraw it from the human body, thus completing the operation.

[0079] When the occlusion device 20 is constricted in the delivery sheath 50, the proximal end of the folded clamping piece 224 is connected to the traction wire 71, so that when the delivery sheath 50 is withdrawn until the folded clamping piece 224 is completely exposed from the delivery sheath 50, the clamping piece 224 can still keep the outer side 2242 of the clamping piece attached to the delivery steel cable 60 under the traction of the traction wire 71, while the inner side 2241 faces outward. Then, release the traction wire 71 by adjusting the first knob 721, so that the first clamping part 22 returns to the natural state to realize clamping the atrial septal tissue between the first clamping part 22 and the occlusion part 21.

[0080] In another embodiment, as Figure 26 shown, the self - expanding body 211 includes a main body part 2111 and a constriction part. The constriction part is the first constriction part 2112 constricted at the proximal end of the self - expanding body. The tail end of the first constriction part 2112 is constricted in the first end part 212, and the side opposite to the first constriction part 2112 is in an unconstricted open shape. The non - constricted open end can reduce the circumferential restraint on the main body part due to the existence of the constriction part, thereby increasing the contact area between the occlusion part 21 and the foramen ovale channel. Since the size of the occlusion part is slightly larger than the foramen ovale channel, increasing the contact area can increase the stability between the occlusion part and the foramen ovale channel, and together with the clamping action of the first clamping part, further increase the implantation stability of the occlusion device.

[0081] In yet another embodiment, as Figure 27 shown, the fixing portions 2121 can be respectively arranged at the first end portion 212 and the second end portion 213, so that clamping portions are arranged at both ends of the blocking portion 21. Among them, the first clamping portion 22 is arranged on the first end portion 212 at the proximal end of the blocking portion 11, and the second clamping portion 23 is arranged on the second end portion 213 at the distal end of the blocking portion 11, further increasing the clamping reliability of the blocking device 20. The blocking system and the surgical procedure thereof can refer to the blocking system and the surgical procedure of the blocking device with only one clamping portion arranged at one of the end portions in combination with the above. That is, whether the blocking device is provided with one clamping portion at the first end portion or the second end portion respectively, or with clamping portions at both end portions, is not limited herein.

[0082] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0083] The above-described embodiments only represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent shall be subject to the appended claims.

Claims

1. A plugging device, characterized in that, The occluding device includes an occluding part, a fixing part and a first clamping part. The occluding part expands self - adaptively to adapt to and support in the oval foramen passage. The occluding part includes a self - expanding body, a first end part and a second end part. The self - expanding body includes a main body part and a first constricting part. The first constricting part constricts at one of the first end parts. The fixing part is located at one of the first end parts. The first clamping part includes a connecting part, an extending part, a bending part and a clamping piece. The connecting part connects the fixing part. The extending part obliquely extends from the connecting part and gradually moves away from the fixing part. The bending part bends from the end of the extending part away from the fixing part and extends in the direction towards the second end part, and connects the clamping piece. The clamping piece extends from the end of the bending part away from the extending part towards parallel to the axis where the main body part is located or slightly inclines towards the side of the self - expanding body, so as to be in a clamping state of contacting or nearly contacting or slightly pressing against the main body part.

2. The plugging device according to claim 1, wherein, The self - expanding body further includes a second constricting part disposed opposite to the first constricting part. The second constricting part constricts at the second end part. At least two fixing parts are provided. The occluding device further includes a second clamping part. Another fixing part is located at the second end part so that the second clamping part is fixed to the occluding part through another fixing part.

3. The plugging device according to claim 1, wherein, The self - expanding body includes a main body part, a first constricting part and a second constricting part. The first constricting part is located at the proximal end of the main body part. The second constricting part is located at the distal end of the main body part. The first constricting part constricts at the first end part. The second constricting part constricts at the second end part. The fixing part is located at the second end part.

4. The plugging device according to claim 1, characterized in that One side of the first end part close to the self - expanding body includes a first opening groove for constricting the first constricting part of the self - expanding body. The side of the first end part away from the self - expanding body includes a second opening groove, and a threaded connecting piece is arranged in the second opening groove.

5. The plugging device according to claim 1, wherein An acute angle is formed between the clamping piece and the extending part.

6. The plugging device according to claim 1, characterized in that, The extending part extends from the connecting part towards the side away from the self - expanding body.

7. A plugging system, comprising the plugging device according to any one of claims 1-6, characterized in that, The occluding system includes a delivery sheath and a delivery steel cable. The delivery steel cable is sleeved inside the delivery sheath.

8. The plugging system according to claim 7, characterized in that, The occluding system further includes a delivery handle and a traction wire. The traction wire is used to connect to the first clamping part at the proximal end of the occluding device. The delivery handle includes a first control member. The traction wire is connected to the first control member, and the first control member is connected to the traction wire inside the delivery handle to control the retraction and release of the traction wire.

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