Tissue defect occlusion device and tissue defect occlusion device

Abstract

The present application relates to a kind of tissue defect plugging device and tissue defect plugging device.Tissue defect plugging device includes plugging device body, plugging device body is memory material.When plugging device body is in natural relaxed state, all clamping ring is in the same plane, or, adjacent two clamping ring is provided with gap in the direction of straight line perpendicular to its plane, can produce original shape restoring torque, so that the first atrial septum and the second atrial septum produce mutual close tendency, and then make the first atrial septum and the second atrial septum mutually close and close, finally reach the purpose of closing foramen ovale, plugging effect is better, while operation is relatively simple.In addition, because the caliber of clamping ring is different, so as to cancel the flow blocking film, simple structure, also obtain the effect of plugging foramen ovale;In addition, using the above structure design form, the metal material implanted in body is less, can avoid the complication of thrombosis, i.e. not easy to cause adverse reaction.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical suturing instruments, in particular to a tissue defect plugging device and a tissue defect plugging device. BACKGROUND

[0002] The oval foramen is a physiological channel of the embryonic period of the atrial septum of the heart. The fetus has no pulmonary circulation, and the oxygen-containing blood from the umbilical cord flows into the left atrium through the oval foramen from the right atrium of the fetus. After birth, with the establishment of pulmonary circulation, the secondary septum and the primary septum approach and adhere to each other and fuse, gradually forming a permanent atrial septum. However, a part of the population is not fused, which forms patent foramen ovale (PFO for short). In most cases, the pressure of the left atrium of the human heart is greater than that of the right atrium, and the PFO channel is in a closed state. In some specific cases, the PFO channel can be pushed open, forming a passage between the left and right atria. Emboli from the venous system can enter the systemic circulation system through the PFO channel, and if embolism occurs in the cerebral arterial system, it will manifest as cerebral stroke or transient ischemic attack (TIA for short).

[0003] The common transcatheter interventional plugging method for patent foramen ovale is to implant a PFO plugging device to make the secondary septum and the primary septum approach and fuse with each other. After the device is implanted, the endothelium will gradually grow, and eventually wrap the entire PFO plugging device to form complete plugging. The PFO plugging device usually comprises two plugging discs and a waist connecting the two plugging discs. The PFO plugging device is usually made of a super-elastic metal material, specifically, for example, a nickel-titanium alloy, which can be compressed into an elongated strip shape, and is delivered to the atrial septum position along the blood vessel path from the outside of the body through a delivery catheter. After being delivered to the specified position, the PFO plugging device is released from the delivery catheter and restores its original two-disc-one-waist shape. The waist is placed in the PFO tunnel, and the two plugging discs are respectively attached to the left and right atrial sides and are respectively clamped at the two end openings of the tunnel. Among them, the plugging disc is formed by weaving a nickel-titanium alloy wire into two sides, the two sides are connected to each other and form a certain internal space in the middle, and the internal space between the two sides needs to be sutured with a flow-blocking film. The flow-blocking film plays a role in plugging the oval foramen tunnel, and the operation of suturing the flow-blocking film is complex, and the manufacturing process is complex. SUMMARY

[0004] The present application provides a tissue defect plugging device and a tissue defect plugging device to solve one or more technical problems in the prior art.

[0005] The technical scheme is as follows: a tissue defect plugging device, the tissue defect plugging device comprises a plugging device body, the plugging device body is a memory material;

[0006] The occlusion device body comprises a wire body, which is spirally arranged and formed with at least two clamping rings, at least one of which is used for abutting against the side of the first atrial septum away from the second atrial septum, and at least another one of which is used for abutting against the side of the second atrial septum away from the first atrial septum; when the occlusion device body is in a natural relaxed state, all the clamping rings are arranged on the same plane, or two adjacent clamping rings are arranged with a spacing in a straight line direction perpendicular to the plane.

[0007] In one of the embodiments, the occlusion device body comprises a first clamping disc for abutting against the first atrial septum and a second clamping disc for abutting against the second atrial septum, the first clamping disc is connected with the second clamping disc; the first clamping disc comprises at least two clamping rings with different diameters and sequentially connected, and the second clamping disc comprises at least two clamping rings with different diameters and sequentially connected.

[0008] In one of the embodiments, at least one of the clamping rings in the first clamping disc and / or the second clamping disc is arranged in the foramen ovale tunnel.

[0009] In one of the embodiments, all the clamping rings of the first clamping disc are coaxially arranged, and the diameters of all the clamping rings of the first clamping disc gradually increase or gradually decrease according to the arrangement order; all the clamping rings of the second clamping disc are coaxially arranged, and the diameters of all the clamping rings of the second clamping disc gradually increase or gradually decrease according to the arrangement order.

[0010] In one of the embodiments, when the occlusion device body is in a natural relaxed state, the clamping rings of the first clamping disc and the clamping rings of the second clamping disc are alternately arranged.

[0011] In one of the embodiments, all the clamping rings of the occlusion device body are coaxially arranged, and the diameters of all the clamping rings of the occlusion device body gradually increase or gradually decrease according to the arrangement order.

[0012] In one of the embodiments, one end of the first clamping disc is one free end of the tissue defect occlusion device, one end of the second clamping disc is another free end of the tissue defect occlusion device, and the other end of the first clamping disc is connected with the other end of the second clamping disc.

[0013] In one of the embodiments, when the occlusion device body is in a natural relaxed state, the first clamping disc and the second clamping disc are arranged on the same plane, or the first clamping disc and the second clamping disc are arranged with a spacing in a straight line direction perpendicular to the plane.

[0014] In one of the embodiments, the first clamping disc and the second clamping disc are connected to form an integrated structure; the first clamping disc and the second clamping disc are made of the same memory material.

[0015] In one of the embodiments, the clamping ring is in a shape of circle, ellipse, star, petal, triangle or polygon.

[0016] In one of the embodiments, the wire body is arranged as a spring in a helical extension arrangement.

[0017] In one of the embodiments, the wire body is at least two; one of the wire bodies is arranged as a spring in a helical extension arrangement around a first direction, another of the wire bodies is arranged as a spring in a helical extension arrangement around a second direction opposite to the first direction, and the helical turns of the two springs abut one by one.

[0018] In one of the embodiments, when the occluder body is in a fully stretched state, the occluder body is stretched into an elongated strip shape.

[0019] In one of the embodiments, the occluder body is made of memory alloy or memory metal.

[0020] A tissue defect occlusion device, comprising the tissue defect occluder.

[0021] In one of the embodiments, the tissue defect occlusion device further comprises a sheath and a pushing assembly, the occluder body is connected to the pushing assembly and arranged inside the sheath.

[0022] The tissue defect plugging device and the tissue defect plugging device described above are used to close the foramen ovale, the plugging device body is compressed and placed in the delivery device, the plugging device is sent into the right atrium through the blood vessel, the delivery device is passed through the foramen ovale tunnel, the delivery device is gradually released to make at least one clamping ring outside the first atrial septum of the left atrium, the delivery device is withdrawn from the foramen ovale tunnel, and the clamping ring abutting the first atrial septum remains stationary, and then at least another clamping ring is released and placed in the foramen ovale tunnel, the delivery device is further withdrawn to release the remaining clamping ring to make the remaining clamping ring abut the second atrial septum of the right atrium. Since the plugging device body is made of a memory material, when the plugging device body is in a natural relaxed state, all the clamping rings are in the same plane, or there is a spacing between two adjacent clamping rings in the direction of a straight line perpendicular to the plane of the clamping rings, a restoring original shape torque is generated to make the first atrial septum and the second atrial septum approach each other, thereby making the first atrial septum and the second atrial septum approach and abut each other, and finally achieving the purpose of closing the foramen ovale, and the plugging effect is good, and the operation is relatively simple. In addition, since the diameters of the clamping rings are different, the flow blocking film can be cancelled, the structure is simple, and the effect of plugging the foramen ovale is also achieved. In addition, the structure design described above uses less metal material implanted in the body, and can avoid the complication of thrombosis, that is, is not easy to cause adverse reactions. BRIEF DESCRIPTION OF DRAWINGS

[0023] The accompanying drawings, which form a part of this application, are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification. The drawings illustrate one exemplary embodiment of the present application and, together with the description, serve to explain the principles of the present application.

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the accompanying drawings needed to be used in the embodiment description will be briefly introduced. Obviously, the accompanying drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort.

[0025] Figure 1 The structure schematic diagram of the tissue defect plugging device of an embodiment of the present application is shown in the figure.

[0026] Figure 2 The working state structure schematic diagram of the tissue defect plugging device shown in the figure is installed in the foramen ovale. Figure 1

[0027] Figure 3 The structure schematic diagram of the tissue defect plugging device of another embodiment of the present application is shown in the figure.

[0028] Figure 4 The working state structure schematic diagram of the tissue defect plugging device shown in the figure is installed in the foramen ovale. Figure 3 ​The diagram shows the working state of the tissue defect occluder installed in the orifice oval.

[0029] Figure 5 This is a schematic diagram of the structure of a tissue defect occluder according to another embodiment of the present invention;

[0030] Figure 6 for Figure 5 The diagram shows the working state of the tissue defect occluder installed in the orifice oval.

[0031] Figure 7 This is a schematic diagram of the structure of a tissue defect occluder according to an embodiment of the present invention in its naturally extended state;

[0032] Figure 8 This is a schematic diagram of the tissue defect occlusion device according to another embodiment of the present invention from one perspective.

[0033] Figure 9 This is a schematic diagram of another embodiment of the tissue defect occluder of the present invention from another perspective.

[0034] Figure 10 This is a schematic diagram of the tissue defect occlusion device according to another embodiment of the present invention from one perspective.

[0035] Figure 11 This is a schematic diagram of another embodiment of the tissue defect occluder of the present invention from another perspective.

[0036] 10. Occluder body; 11. Wire; 111. Clamping ring; 112. First clamping disc; 113. Second clamping disc; 114. Waist section; 20. First chamber; 30. Second chamber septum; 40. Oval tunnel. Detailed Implementation

[0037] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0038] See Figure 1 , Figure 1 A schematic diagram of a tissue defect occluder according to an embodiment of the present invention is shown. The tissue defect occlusion device provided by this embodiment of the present invention is suitable for suturing patent foramen ovale, vascular suturing, atrial septal defect suturing, ventricular septal defect suturing, etc. The tissue defect occlusion device includes a tissue defect occluder.

[0039] See Figure 1With Figure 2 , Figure 2 As Figure 1 shown in the working state structure schematic diagram of the tissue defect occluder installed in the oval foramen; in one embodiment, the tissue defect occluder comprises an occluder body 10, which is a memory material. The occluder body 10 comprises a wire body 11, which is spirally arranged and formed with at least two clamping rings 111, at least one clamping ring 111 is used to abut against the side of the first atrial septum 20 away from the second atrial septum 30, and at least another clamping ring 111 is used to abut against the side of the second atrial septum 30 away from the first atrial septum 20. When the occluder body 10 is in a natural relaxed state, all the clamping rings 111 are in the same plane, or adjacent two clamping rings 111 are provided with a spacing in the direction of a straight line perpendicular to the plane where they are located.

[0040] It should be noted that the clamping ring 111 refers to the structure formed by one turn of the spiral arrangement of the wire body 11, for example, as Figure 1 shown, the occluder body 10 comprises nine clamping rings 111 with increasing diameters, when the occluder body 10 is installed at the oval foramen, the clamping rings 111 abut against the wall of the atrial septum to play a clamping and fixing role on the atrial septum.

[0041] The above-mentioned tissue defect occluder, when closing the oval foramen for example, the occluder body 10 is compressed and placed in the delivery device, the occlusion device is sent into the right atrium through the blood vessel, the delivery device passes through the oval foramen tunnel 40, the delivery device gradually releases the clamping ring 111, so that at least one clamping ring 111 is outside the first atrial septum 20 of the left atrium; the delivery device is withdrawn from the oval foramen tunnel 40, and the clamping ring 111 abutting against the outside of the first atrial septum 20 remains unchanged, and then at least another clamping ring 111 is released and placed in the oval foramen tunnel 40; the delivery device further exits, and the remaining clamping rings 111 are released to tightly adhere to the outside of the second atrial septum 30 of the right atrium. Among them, since the occluder body 10 is a memory material, when the occluder body 10 is in a natural relaxed state, all the clamping rings 111 are in the same plane, or adjacent two clamping rings 111 are provided with a spacing in the direction of a straight line perpendicular to the plane where they are located, a restoring original shape torque is generated, so that the first atrial septum 20 and the second atrial septum 30 tend to approach each other, and then the first atrial septum 20 and the second atrial septum 30 between them approach and tightly adhere to each other, finally achieve the purpose of closing the oval foramen, and the occlusion effect is good, and the operation is relatively simple. In addition, since the diameters of the clamping rings 111 are different, the flow-blocking membrane can be cancelled, the structure is simple, and the effect of occluding the oval foramen is also obtained; in addition, by using the above-mentioned structure design form, the amount of metal material implanted in the body is less, and the complication of thrombosis can be avoided, that is, adverse reactions are not easy to cause.

[0042] Further, the plurality of closing rings 111 is at least three, and at least one of the plurality of closing rings 111 is arranged in the oval foramen tunnel 40.

[0043] It should be noted that the number of the closing rings 111 arranged in the oval foramen tunnel 40 can be one, two, three or other numbers, which is not limited herein, as long as the specific oval foramen structure can be adapted, the closing ring 111 for abutting against the first atrial septum 20 and the closing ring 111 for abutting against the second atrial septum 30 can be connected to achieve better occlusion of the defect site. Specifically, the depth, length and other parameters of the oval foramen tunnel 40 can be automatically adjusted to one or more layers of the closing ring 111.

[0044] Referring to Figure 1 and Figure 2 In one embodiment, the occluder body 10 includes a first clamping disc 112 for abutting against the first atrial septum 20, and a second clamping disc 113 for abutting against the second atrial septum 30. The first clamping disc 112 is connected with the second clamping disc 113. The first clamping disc 112 includes at least two closing rings 111 with different diameters and sequentially connected, and the second clamping disc 113 includes at least two closing rings 111 with different diameters and sequentially connected. In this way, after the oval foramen is occluded by the tissue defect occluder, the first clamping disc 112 abuts against the first atrial septum 20, and the second clamping disc 113 abuts against the second atrial septum 30, that is, the first clamping disc 112 and the second clamping disc 113 can realize the mutual close contact of the first atrial septum 20 and the second atrial septum 30, and finally achieve the purpose of closing the oval foramen, and the occlusion effect is better. In addition, the first clamping disc 112 includes at least two closing rings 111 with different diameters and sequentially arranged, and the second clamping disc 113 includes at least two closing rings 111 with different diameters and sequentially arranged, which can achieve better occlusion effect and cancel the flow resistance film, and the structure is simple.

[0045] Referring to Figure 1 and Figure 2 or referring to Figure 5 and Figure 6 Further, at least one of the closing rings 111 in the first clamping disc 112 and / or the second clamping disc 113 is arranged in the oval foramen tunnel 40. At least one of the closing rings 111 in the first clamping disc 112 and / or the second clamping disc 113 is arranged in the oval foramen tunnel 40 and is equivalent to the waist portion 114.

[0046] It should be noted that in the process of using the tissue defect plugging device to plug the foramen ovale, in order to adapt to the specific structure of the foramen ovale and achieve better plugging of the defect site, at least one clamping ring 111 in the first clamping disc 112 can be placed in the foramen ovale tunnel 40 as the waist portion 114 according to the specific circumstances, or at least one clamping ring 111 of the second clamping disc 113 can be placed in the foramen ovale tunnel 40 as the waist portion 114, or at least one clamping ring 111 of the first clamping disc 112 and at least one clamping ring 111 of the second clamping disc 113 can be placed in the foramen ovale tunnel 40 as the waist portion 114.

[0047] Please refer to Figure 3 With Figure 4 Of course, as an optional solution, the waist portion 114 can also be arranged between the first clamping disc 112 and the second clamping disc 113, and the first clamping disc 112 is connected to the second clamping disc 113 through the waist portion 114. The shape of the waist portion 114 is not limited, for example, it can be one or a combination of a clamping ring 111, a straight line segment, an arc line segment, and a broken line segment. In this way, after the foramen ovale is plugged by the tissue defect plugging device, the first clamping disc 112 abuts against the first atrial septum 20, and the second clamping disc 113 abuts against the second atrial septum 30, so that the waist portion 114 is in the foramen ovale tunnel 40, and the clamping rings 111 of the first clamping disc 112 and the second clamping disc 113 do not need to be arranged in the foramen ovale tunnel 40, and thus the first clamping disc 112 and the second clamping disc 113 can achieve the purpose of bringing the first atrial septum 20 and the second atrial septum 30 close to each other, and ultimately achieve the purpose of closing the foramen ovale, and the plugging effect is good.

[0048] Specifically, the more the number of clamping rings 111 of the first clamping disc 112, the better, and at least two clamping rings 111 of different diameters of the first clamping disc 112 abut against the first atrial septum 20 from inside to outside in turn, and the fixing effect on the first atrial septum 20 is good. Similarly, the more the number of clamping rings 111 of the second clamping disc 113, the better, and at least two clamping rings 111 of different diameters of the second clamping disc 113 abut against the second atrial septum 30 from inside to outside in turn, and the fixing effect on the second atrial septum 30 is good, so that the flow blocking film can be cancelled, and the structure is simple.

[0049] Please refer to Figures 1 to 6 In an embodiment, all clamping rings 111 of the first clamping disc 112 are arranged coaxially, and the diameters of all clamping rings 111 of the first clamping disc 112 gradually increase or gradually decrease according to their arrangement order. In this way, all clamping rings 111 of the first clamping disc 112 are arranged in turn from inside to outside or from outside to inside, and abut against at least two different positions of the first atrial septum 20, so that a better plugging effect can be achieved, the flow blocking film can be cancelled, and the structure is simple.

[0050] It should be noted that the arrangement order of all the clamping rings 111 of the first clamping disc 112 is the connection order of all the clamping rings 111 of the first clamping disc 112. Of course, in the present embodiment, the diameters of all the clamping rings 111 of the first clamping disc 112 do not necessarily change in the arrangement order. For example, as an alternative, at least two clamping rings 111 with the same diameter can be allowed to exist in all the clamping rings 111 of the first clamping disc 112.

[0051] Referring to Figures 1 to 6 In one embodiment, all the clamping rings 111 of the second clamping disc 113 are coaxially arranged, and the diameters of all the clamping rings 111 of the second clamping disc 113 gradually increase or gradually decrease in the arrangement order. Similarly, all the clamping rings 111 of the second clamping disc 113 are arranged from inside to outside or from outside to inside, abutting against at least two different positions of the second atrial septum 30, so that a better occlusion effect can be achieved, and the flow-blocking film can be cancelled, while the structure is simple.

[0052] It should be noted that the arrangement order of all the clamping rings 111 of the second clamping disc 113 is the connection order of all the clamping rings 111 of the second clamping disc 113. Of course, in the present embodiment, the diameters of all the clamping rings 111 of the second clamping disc 113 do not necessarily change in the arrangement order. Similarly, as an alternative, at least two clamping rings 111 with the same diameter can be allowed to exist in all the clamping rings 111 of the second clamping disc 113.

[0053] As an example, when the occluder body 10 is in a natural relaxed state, all the clamping rings 111 of the first clamping disc 112 are arranged at equal intervals from inside to outside, and when abutting against the first atrial septum 20, the compression effect on the first atrial septum 20 is more stable; when the occluder body 10 is in a natural relaxed state, all the clamping rings 111 of the second clamping disc 113 are arranged at equal intervals from inside to outside, and when abutting against the second atrial septum 30, the compression effect on the second atrial septum 30 is more stable. Of course, when the occluder body 10 is in a natural relaxed state, all the clamping rings 111 of the first clamping disc 112 are not limited to be arranged at equal intervals from inside to outside, but can also be arranged at intervals in other manners; similarly, all the clamping rings 111 of the second clamping disc 113 are not limited to be arranged at equal intervals from inside to outside, but can also be arranged at intervals in other manners, which are not limited herein.

[0054] Referring to Figure 7In one embodiment, when the occluder body 10 is in the natural relaxed state, the clamping rings 111 of the first clamping disc 112 are arranged alternately with the clamping rings 111 of the second clamping disc 113. In this way, when the occluder body 10 is in the natural relaxed state, the clamping rings 111 of the first clamping disc 112 are arranged alternately with the clamping rings 111 of the second clamping disc 113, so as to avoid overlapping together, so as to be arranged in the same plane as far as possible on the one hand, and to make the occluder body 10 have a better flow blocking effect on the other hand.

[0055] It should be noted that the clamping rings 111 of the first clamping disc 112 are arranged alternately with the clamping rings 111 of the second clamping disc 113, which means that the clamping rings 111 of the first clamping disc 112 are located between the adjacent two clamping rings 111 of the second clamping disc 113, and the clamping rings 111 of the second clamping disc 113 are located between the adjacent two clamping rings 111 of the first clamping disc 112.

[0056] Of course, as an optional solution, when the occluder body 10 is in the natural relaxed state, the clamping rings 111 of the first clamping disc 112 are not limited to the above-mentioned alternative arrangement with the clamping rings 111 of the second clamping disc 113, for example, the clamping rings 111 of the first clamping disc 112 and the clamping rings 111 of the second clamping disc 113 can be in contact with each other when the diameters of the clamping rings 111 are the same, and in addition, other arrangement modes can also be used, as long as the elastic force provided by the deformation is sufficient to make the first atrial septum 20 and the second atrial septum 30 close to each other when the foramen ovale is closed, and the specific structure form is not limited here.

[0057] Referring to Figure 5 and Figure 6 In one embodiment, all the clamping rings 111 of the occluder body 10 are coaxially arranged, and the diameters of all the clamping rings 111 of the occluder body 10 gradually increase or gradually decrease according to the arrangement order. In this way, according to the specific characteristics of the foramen ovale, the clamping ring 111 with a relatively small diameter can be sent to and abut against the first atrial septum 20, and the clamping ring 111 with a relatively large diameter can be abutted against the second atrial septum 30, so as to have a better occlusion effect on the foramen ovale. Of course, the clamping ring 111 with a relatively large diameter can also be sent to and abut against the first atrial septum 20, and the clamping ring 111 with a relatively small diameter can be abutted against the second atrial septum 30, so as to have a better occlusion effect on the foramen ovale.

[0058] Referring to Figures 1 to 6 In one embodiment, one end of the first clamping disc 112 is one free end of the tissue defect occluder, one end of the second clamping disc 113 is the other free end of the tissue defect occluder, and the other end of the first clamping disc 112 is connected to the other end of the second clamping disc 113.

[0059] In one embodiment, when the occluder body 10 is in its naturally extended state, the first clamping disc 112 and the second clamping disc 113 are on the same plane. This generates a torque that restores the original shape, causing the first atrial septum 20 and the second atrial septum 30 to tend to approach each other, thereby bringing them closer together and ultimately closing the foramen ovale. This results in a good occlusion effect and a relatively simple surgical procedure.

[0060] In another embodiment, the first clamping disc 112 and the second clamping disc 113 are spaced apart in a straight line perpendicular to their respective planes. The distance is defined as d, and d is set to, for example, less than 1 mm. Thus, due to the small distance d, a torque is generated to restore the original shape, causing the first atrial septum 20 and the second atrial septum 30 to tend to approach each other, thereby bringing them closer together and ultimately achieving the purpose of closing the foramen ovale. The sealing effect is good, and the surgical procedure is relatively simple.

[0061] In one embodiment, the first clamping disc 112 and the second clamping disc 113 are connected to form an integrated structure. The first clamping disc 112 and the second clamping disc 113 are made of the same memory material. In this way, the first clamping disc 112 and the second clamping disc 113 can be formed by processing the same memory filament separately, which results in faster processing speed, higher production efficiency, less material usage, and minimal damage to the body.

[0062] Of course, as an optional solution, the first clamping plate 112 and the second clamping plate 113 are not limited to being formed by processing a single wire 11 in the above embodiment. They can also be manufactured by other methods. For example, the first clamping plate 112 and the second clamping plate 113 can be processed independently and then combined to form an integrated structure by means of, for example, fusion bonding.

[0063] In one embodiment, the clamping ring 111 is circular (e.g., Figures 1 to 6 (As shown), the shape can be elliptical, star-shaped, petal-shaped, triangular, or polygonal. Thus, when the outline of the clamping ring 111 is designed as a regular shape, it facilitates the processing and forming of the first clamping plate 112 and the second clamping plate 113, resulting in higher production efficiency.

[0064] It should be noted that the outline of the clamping ring 111 can be flexibly set and adjusted according to the size and shape of the foramen ovale. It can be a regular shape or an irregular shape, as long as it can compress the interatrial septum when it abuts against the outer wall of the interatrial septum.

[0065] See Figures 8 to 11In one embodiment, the wire body 11 is arranged as a spring in a helical extension arrangement. In this way, the wire body 11 is arranged as a spring in a helical extension arrangement, which can be stretched and compressed accordingly when subjected to local force, so that the occluder body 10 can be well adapted to oval orifices of different sizes and shapes, thereby being stably installed at the oval orifice and less likely to fall off, and the occlusion effect on the oval orifice is better, while the tissue damage caused is less.

[0066] Referring to Figure 10 and Figure 11 In one embodiment, the wire body 11 is at least two. One of the wire bodies 11 is arranged as a spring in a helical extension arrangement around a first direction, and the other wire body 11 is arranged as a spring in a helical extension arrangement around a second direction opposite to the first direction, and the helical turns of the two springs abut one by one. In this way, since the helical extension directions of the two wire bodies 11 are opposite, i.e., the uncoiling forces of the two wire bodies 11 are opposite and cancel each other out, so as to prevent any one of the wire bodies 11 from uncoiling, and the fixing effect is better. Of course, as Figure 8 and Figure 9 As shown, the wire body 11 can also be arranged as one, and the specific number is not limited here, which can be arranged according to actual needs.

[0067] In one embodiment, when the occluder body 10 is in a fully stretched state, the occluder body 10 is stretched into an elongated strip shape. In this way, during the process of transporting the occluder body 10 to the surgical site, the occluder body 10 can be stretched into an elongated strip shape and placed in a sheath with a smaller size, and then transported to the right atrium through the sheath and to the tissue defect site.

[0068] It should be noted that the occluder body 10 is in a fully stretched state, i.e., the occluder body 10 is stretched to the limit position.

[0069] In one embodiment, the occluder body 10 is a memory alloy or a memory metal. In this way, the use of memory alloy or memory metal causes less damage to human tissue, and the memory alloy or memory metal is durable, has a long service life, and has a lower cost. The memory alloy includes but is not limited to titanium-nickel alloy, aluminum alloy, titanium alloy, and nickel alloy, which can be selected according to actual needs.

[0070] In one embodiment, the tissue defect plugging device further comprises a sheath and a pushing assembly, the plugging body 10 is connected with the pushing assembly and arranged inside the sheath. In this way, the pushing assembly and the plugging body 10 are delivered to the vicinity of the foramen ovale through the sheath which is arranged in the blood vessel to establish a surgical channel. The pushing assembly is, for example, a steel cable, the plugging body 10 is further provided with a threaded connection part connected with the wire body 11, the steel cable is provided with a threaded hole matched with the threaded connection part, the wire body 11 is gradually released to the outside of the sheath by rotating the steel cable to unlock the threaded connection part, and since the wire body 11 is a memory material, when each clamping ring 111 is gradually released, a torque to restore the original shape is generated, so that the first atrial septum 20 and the second atrial septum 30 have a mutual approaching trend, thereby making the first atrial septum 20 and the second atrial septum 30 approach and tightly contact each other, and finally achieving the purpose of closing the foramen ovale, and the plugging effect is good.

[0071] The technical features of the above embodiments can be combined in any manner. In order to make the description simple, all possible combinations of the technical features in the above embodiments are not described, however, as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the description.

[0072] The above embodiments only express several implementation manners of the present application, the description is relatively specific and detailed, however, it should not be understood as the limitation to the patent scope of the present application. It should be pointed out that, for the ordinary skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

[0073] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements indicated must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0074] In addition, the terms "first", "second" are only for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0075] In the present application, unless specifically defined otherwise, the terms "mounting", "connected", "connecting", "fixed", and "fixing" should be construed as broad terms, for example, can be fixed connection, can also be detachable connection, or integral; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be the internal communication of two elements or the interaction relationship of two elements, unless specifically defined otherwise. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0076] In the present application, unless specifically defined otherwise, the first feature is "on" or "under" the second feature can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0077] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there can be a middle element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there can be a middle element. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are for illustrative purposes only and are not the only implementation.

Claims

1. A tissue defect occluder, characterized by, The tissue defect plugging device comprises a plugging body, which is made of a memory material; The plugging body comprises a wire body, which is spirally arranged and formed with at least two clamping rings, at least one of which is used for abutting against the first atrial septum away from the second atrial septum, and at least another one of which is used for abutting against the second atrial septum away from the first atrial septum; The plugging body comprises a first clamping disc for abutting against the first atrial septum and a second clamping disc for abutting against the second atrial septum, the first clamping disc is connected with the second clamping disc; the first clamping disc comprises at least two clamping rings with different diameters and sequentially connected, and the second clamping disc comprises at least two clamping rings with different diameters and sequentially connected. When the plugging body is in a natural relaxed state, the first clamping disc and the second clamping disc are in the same plane.

2. The tissue defect occluder of claim 1, wherein, At least one of the clamping rings in the first clamping disc and / or the second clamping disc is arranged in the foramen ovale tunnel.

3. The tissue defect occluder of claim 1, wherein, All the clamping rings of the first clamping disc are coaxially arranged, and the diameters of all the clamping rings of the first clamping disc gradually increase or gradually decrease according to their arrangement order; all the clamping rings of the second clamping disc are coaxially arranged, and the diameters of all the clamping rings of the second clamping disc gradually increase or gradually decrease according to their arrangement order.

4. The tissue defect occluder of claim 3, wherein, When the plugging body is in a natural relaxed state, the clamping rings of the first clamping disc and the clamping rings of the second clamping disc are alternately arranged.

5. The tissue defect occluder of claim 1, wherein, All the clamping rings of the plugging body are coaxially arranged, and the diameters of all the clamping rings of the plugging body gradually increase or gradually decrease according to their arrangement order.

6. The tissue defect occluder of claim 1, wherein, One end of the first clamping disc is one free end of the tissue defect plugging device, one end of the second clamping disc is another free end of the tissue defect plugging device, and the other end of the first clamping disc is connected with the other end of the second clamping disc.

7. The tissue defect occluder of claim 1, wherein, The first clamping disc and the second clamping disc are connected to form an integrated structure; the first clamping disc and the second clamping disc are made of the same memory material.

8. The tissue defect occluder of claim 1, wherein, The clamping ring is circular, elliptical, star-shaped, petal-shaped or polygonal.

9. The tissue defect occluder of claim 1, wherein, The wire body is arranged as a spring spirally extending.

10. The tissue defect occluder of claim 9, wherein, The wire body is at least two; one of the wire bodies is arranged as a spring spirally extending around a first direction, and another one of the wire bodies is arranged as a spring spirally extending around a second direction opposite to the first direction, and the spirally extending turns of the two springs abut one by one.

11. The tissue defect occluder of claim 1, wherein, When the plugging body is in a fully stretched state, the plugging body is stretched into an elongated strip shape.

12. The tissue defect occluder of claim 1, wherein, The plugging body is made of a memory metal.

13. A tissue defect occlusion device, comprising: The tissue defect plugging device comprises the tissue defect plugging device as claimed in any one of claims 1 to 12.

14. The tissue defect occlusion device of claim 13, wherein, The tissue defect plugging device further comprises a sheath tube and a pushing assembly, the plugging body is connected with the pushing assembly and arranged inside the sheath tube.

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