A heart occluder

Abstract

The present application relates to the field of cardiac occlusion therapy technology, and in particular to a cardiac occluder, including an occluder body woven from alloy wires, the occluder body having two disc-shaped bodies arranged opposite to each other and a connecting portion connected between the two disc-shaped bodies, and also including a first fixing sleeve and a second fixing sleeve for fixing the alloy wires, the first fixing sleeve and the second fixing sleeve being respectively located on the two disc-shaped bodies and being connected to each other closely through a height adjustment component. With such a configuration, during the process of interventional therapy, the cardiac occluder can adjust its own height to adapt to the actual thickness of the tissue surrounding the defect, thereby making the cardiac occluder more adaptable and controllable, and at the same time being able to improve the effect of the occlusion therapy and reduce the risk of surgery.

Description

Technical Field

[0001] The present application relates to the technical field of cardiac occlusion treatment, and more specifically, to a cardiac occluder. Background Art

[0002] Congenital heart disease refers to anatomical abnormalities caused by formation disorders or abnormal development of the heart and large blood vessels during embryonic development, or failure to close the channels that should close automatically after birth. It is the most common type of congenital malformation, with an incidence of about 0.4% to 1% of newborns. Abnormal hemodynamics in congenital heart disease will increase the burden on the heart, leading to heart failure and inducing arrhythmias; abnormal blood shunt in congenital heart disease will increase abnormal blood flow in the lungs, leading to respiratory infections in children; children with congenital heart disease are significantly slower in development than normal children, and because of the impact of congenital heart disease on the nervous system, they are likely to have intellectual and cognitive impairments. Therefore, the treatment of congenital heart disease has become an important issue of social concern.

[0003] Congenital heart diseases mainly include atrial septal defect, ventricular septal defect, patent foramen ovale, patent ductus arteriosus, etc. Most of them can be treated by interventional surgery. The occluders on the market are mostly composed of three parts: a stainless steel sleeve, an occluder stent woven from nickel-titanium alloy wire with shape memory function, and a flow barrier. The structural design of the occluder is different for different diseases, and occluders of different specifications can be selected for defects of different sizes. However, in actual use, the shape of heart defects varies, and the specifications of occluder production are generally fixed. The size of the occluder that doctors can choose is usually different from the actual defect. Among them, the height of the occluder corresponds to the thickness of the actual defect, which is also one of the key parameters of the occluder. The smaller the height, the greater the clamping force of the occluder on the surrounding tissue, which may cause tissue wear, ECG block, and other complications; the larger the height, the smaller the clamping force of the occluder on the surrounding tissue, which may cause slow endothelialization, residual shunt, and even cause the occluder to fall off, bringing potential risks to patients.

[0004] Therefore, how to solve the problem of deviation between the existing occluder size and the actual defect, high surgical risk and potential risks is a key technical problem that technicians in this field need to solve. Summary of the invention

[0005] In order to overcome the problems existing in the related art to at least a certain extent, the purpose of the present application is to provide a cardiac occluder that can solve the problems of deviation between the existing occluder size and the actual defect, high surgical risk, and potential risks.

[0006] The present application provides a cardiac occluder, comprising an occluder main body woven from alloy wires, the occluder main body having two disc-shaped bodies arranged opposite to each other and a connecting portion connected between the two disc-shaped bodies, and also comprising a first fixing sleeve and a second fixing sleeve for fixing the alloy wires, the first fixing sleeve and the second fixing sleeve are respectively located on the two disc-shaped bodies and can be connected to each other closely through a height adjustment component.

[0007] Preferably, the height adjustment assembly includes an adjustment rod located inside the occluder body, the first end of the adjustment rod can be axially rotatably fixed in the first fixing sleeve, the second end passes through the second fixing sleeve and can be connected to the push rod, and the adjustment rod is matched with the inner wall of the second fixing sleeve through a first thread.

[0008] Preferably, a limiting structure for limiting the rotation of the adjusting rod along a first direction is provided between the first end of the adjusting rod and the inner wall of the first fixing sleeve; when the adjusting rod rotates along a second direction, the second fixing sleeve is displaced along the adjusting rod toward the first fixing sleeve under the action of the first thread; the first direction is opposite to the second direction, and both are the rotation directions of the adjusting rod.

[0009] Preferably, the limiting structure includes a plurality of limiting members and a plurality of buckles corresponding to the positions of the limiting members one by one, the plurality of limiting members are sequentially arranged around the inner wall of the first fixing sleeve, the plurality of buckles are sequentially arranged around the outer wall of the adjusting rod through elastic members, and cooperate with the limiting members under the action of the elastic members, when the adjusting rod rotates along the first direction, the limiting member restricts the buckles from passing along the limiting member, and when the adjusting rod rotates along the second direction, the buckles pass through the limiting member in sequence.

[0010] Preferably, the limiting member is arranged to gradually move away from a block of the adjusting rod along the first direction, and the buckle is against the block under the action of the elastic member; the outer wall of the adjusting rod is provided with a plurality of support rods extending toward the first fixing sleeve, and the buckle is hinged to the end of the support rod; one end of the elastic member is connected to the adjusting rod, and the other end is connected to the buckle and is away from the position of the adjusting rod.

[0011] Preferably, the limiting member is configured as a slot gradually approaching the adjusting rod along the first direction, the buckle is embedded in the slot and abuts against the opening of the slot under the action of the elastic member, and adjacent slots are connected and can allow the buckle to pass through.

[0012] Preferably, a protrusion is arranged around the first end of the adjusting rod, and a groove for the protrusion to be embedded in the inner wall of the first fixing sleeve is arranged, and the opening of the groove faces the adjusting rod.

[0013] Preferably, the second end of the adjusting rod is connected to the pushing rod via a second thread, and the first thread is opposite to the second thread.

[0014] Preferably, an interlayer is provided between the inner wall and the outer wall of the first fixing sleeve and the second fixing sleeve, and the closing end of the alloy wire is fixed in the interlayer.

[0015] Preferably, the inner or outer surfaces of the two disc-shaped bodies are provided with flow-blocking films.

[0016] The technical solution provided by this application may have the following beneficial effects:

[0017] The cardiac occluder comprises a first fixing sleeve and a second fixing sleeve for fixing the alloy wire, wherein the first fixing sleeve and the second fixing sleeve are respectively arranged on two disc-shaped bodies and connected by a height adjustment component. By adjusting the height adjustment component, the distance between the first fixing sleeve and the second fixing sleeve can be adjusted so that the first fixing sleeve and the second fixing sleeve can be brought closer to each other. When the first fixing sleeve and the second fixing sleeve are brought closer to each other, the connecting part in the middle is compressed, thereby driving the two disc-shaped bodies to be brought closer to each other, thereby achieving the size of the cardiac occluder corresponding to the size of the actual defect. Moreover, the distance between the two disc-shaped bodies is adjustable, so that the clamping force on the surrounding tissues can be moderately controlled to avoid safety hazards caused by excessive or insufficient clamping force.

[0018] During interventional therapy, the heart occluder can adjust its height to adapt to the actual thickness of the tissue surrounding the defect, thereby making the heart occluder more adaptable and controllable, while improving the effect of occlusion therapy and reducing surgical risks.

[0019] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 is a front view of a cardiac occluder according to some exemplary embodiments;

[0023] Figure 2 is a schematic structural diagram of a cardiac occluder according to some exemplary embodiments;

[0024] Figure 3 is a front view of a first fixing sleeve according to some exemplary embodiments;

[0025] Figure 4 is a top view of a first fixing sleeve according to some exemplary embodiments;

[0026] Figure 5 is a front view of a first fixing sleeve according to some other exemplary embodiments;

[0027] Figure 6 is a top view of a first fixing sleeve according to some other exemplary embodiments;

[0028] Figure 7 is a schematic structural diagram of a second fixing sleeve according to some exemplary embodiments;

[0029] Figure 8 is a schematic structural diagram of a cardiac occluder according to some other exemplary embodiments.

[0030] In the figure: 1- occluder body, 11- disc-shaped body, 12- connecting part, 13- alloy wire, 2- first fixing sleeve, 3- second fixing sleeve, 4- adjusting rod, 5- pushing rod, 6- limiting member, 7- buckle, 8- elastic member, 9- supporting rod. DETAILED DESCRIPTION

[0031] Here, exemplary embodiments will be described in detail, and examples thereof are shown in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present application. Instead, they are only examples of devices or methods consistent with some aspects of the present application.

[0032] This specific embodiment provides a cardiac occluder that can adjust its own height according to the actual thickness of the tissue around the defect and the expected occlusion target during the interventional treatment operation, thereby making the cardiac occluder more adaptable and controllable, while improving the effect of the occlusion treatment and reducing the surgical risk, effectively solving the problem of deviation between the existing occluder size and the actual defect, high surgical risk, and potential risks.

[0033] To make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described in detail below. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other implementation methods obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention.

[0034] The following is an explanation of the embodiments with reference to the accompanying drawings. In addition, the embodiments shown below do not limit the invention described in the claims. In addition, the entire contents of the configurations shown in the following embodiments are not limited to the solutions required as the invention described in the claims.

[0035] refer to Figure 1-Figure 8 This specific embodiment provides a cardiac occluder, including an occluder body 1, wherein the occluder body 1 is woven from alloy wires 13, wherein the alloy wires 13 are preferably nickel-titanium alloy wires with shape memory function, so as to facilitate the occlusion of the defect, and the occluder body 1 has two relatively arranged disc-shaped bodies 11 and a connecting portion 12, wherein the connecting portion 12 is located between the two disc-shaped bodies 11 and connects the two disc-shaped bodies 11, and in order to facilitate clamping of the surrounding tissues of the defect, the diameter of the connecting portion 12 is smaller than the diameter of the two disc-shaped bodies 11.

[0036] The cardiac occluder also includes a first fixing sleeve 2 and a second fixing sleeve 3 for fixing the alloy wire 13, wherein the first fixing sleeve 2 and the second fixing sleeve 3 are respectively arranged on two disc-shaped bodies 11 and connected by a height adjustment component. By adjusting the height adjustment component, the distance between the first fixing sleeve 2 and the second fixing sleeve 3 can be adjusted so that they can be close to each other. When the first fixing sleeve 2 and the second fixing sleeve 3 are close to each other, the connecting portion 12 in the middle is compressed, thereby driving the two disc-shaped bodies 11 to be close to each other, thereby achieving the size of the cardiac occluder corresponding to the size of the actual defect. Moreover, the distance between the two disc-shaped bodies 11 is adjustable, and the clamping force on the surrounding tissues can be moderately controlled to avoid safety hazards caused by excessive or insufficient clamping force.

[0037] With such a configuration, during the interventional treatment operation, the cardiac occluder can adjust its own height to adapt to the actual thickness of the tissue surrounding the defect, thereby making the cardiac occluder more adaptable and controllable, while also being able to improve the effect of the occlusion treatment and reduce surgical risks.

[0038] In this embodiment, the height adjustment assembly includes an adjustment rod 4, such as Figure 2As shown, the adjusting rod 4 is located inside the occluder body 1 and is connected to the first fixing sleeve 2 and the second fixing sleeve 3 respectively, wherein the first end of the adjusting rod 4 is rotatably fixed in the first fixing sleeve 2 along its own axial direction, and the second end of the adjusting rod 4 passes through the second fixing sleeve 3 and can be connected to the pushing rod 5; moreover, the adjusting rod 4 is matched with the inner wall of the second fixing sleeve 3 through the first thread, so that under the rotation of the pushing rod 5, the adjusting rod 4 can be driven to rotate. Since the adjusting rod 4 is threadedly matched with the second fixing sleeve 3, when the adjusting rod 4 rotates, the second fixing sleeve 3 will be displaced relative to the adjusting rod 4 along the first thread, and then can be close to the first fixing sleeve 2 along the axial direction of the adjusting rod 4 to achieve the approach of the first fixing sleeve 2 and the second fixing sleeve 3. It is easy to operate through adjustment and control by the pushing rod 5, and the structure is simple and easy to control.

[0039] Furthermore, a limiting structure is provided between the first end of the adjusting rod 4 and the inner wall of the first fixing sleeve 2, and the limiting structure is used to limit the adjusting rod 4 from rotating in the first direction, and when the adjusting rod 4 rotates in the second direction, the second fixing sleeve 3 is displaced along the adjusting rod 4 toward the first fixing sleeve 2 under the action of the first thread, wherein the first direction is opposite to the second direction and both are the rotation direction of the adjusting rod 4, that is, one of the first direction and the second direction is counterclockwise and the other is clockwise. In this way, when the adjusting rod 4 rotates in the second direction, the first fixing sleeve 2 and the second fixing sleeve 3 can approach each other so that the two disc-shaped bodies 11 clamp the tissue around the defect; when the adjusting rod 4 rotates in the first direction, due to the action of the limiting structure, the first fixing sleeve 2 and the second fixing sleeve 3 cannot move away from each other, thereby preventing the two disc-shaped bodies 11 from loosening during the clamping process, causing the heart occluder to fall off, and effectively avoiding potential risks.

[0040] The limiting structure includes a plurality of limiting members 6 and a plurality of buckles 7, wherein the plurality of limiting members 6 are sequentially arranged around the inner wall of the first fixing sleeve 2, and the plurality of buckles 7 are sequentially arranged around the outer wall of the adjusting rod 4, and are fixedly connected to the adjusting rod 4 through the elastic member 8; moreover, the positions of the limiting members 6 and the buckles 7 correspond one to one, and are matched under the action of the elastic member 8. When the adjusting rod 4 rotates along the first direction, the limiting member 6 limits the buckles 7 from passing along the limiting member 6 to limit the first fixing sleeve 2 and the second fixing sleeve 3 from moving away; when the adjusting rod 4 rotates along the second direction, the buckles 7 sequentially pass through the limiting member 6 to achieve the first fixing sleeve 2 and the second fixing sleeve 3 approaching. In this way, the one-way rotation of the adjusting rod 4 is achieved through the matching of the limiting member 6 and the buckle 7, which has a simple structure, convenient operation, and is stable and reliable, and easy to achieve.

[0041] like Figure 3-4As shown, in some embodiments, the limit member 6 is configured as a block, and the buckle 7 is abutted against the block under the action of the elastic member 8, and the surface of the block in contact with the buckle 7 gradually moves away from the adjusting rod 4 along the first direction. In this way, a boss that can limit the movement of the buckle 7 along the first direction is formed between adjacent blocks. When the buckle 7 moves along the second direction, under the action of the elastic member 8, the buckle 7 will move from the top of the boss to the bottom of the boss in sequence.

[0042] A plurality of support rods 9 extending toward the first fixing sleeve 2 are arranged on the outer wall of the adjusting rod 4, and the support rods 9 correspond to the buckles 7 one by one, wherein the buckles 7 are hinged to the ends of the support rods 9, and one end of the elastic member 8 is connected to the adjusting rod 4, and the other end is connected to the buckle 7 and is away from the adjusting rod 4. In this way, the connection between the buckle 7 and the adjusting rod 4 is more stable through the support structure of the support rod 9, and under the action of the elastic member 8, the buckle 7 always abuts against the block, which is conducive to preventing the connection between the adjusting rod 4 and the first fixing sleeve 2 from loosening, so as to prolong the service life. Here, the elastic member 8 is preferably a pressure spring.

[0043] like Figure 5-6 As shown, in other embodiments, the limiting member 6 is provided with a slot for the buckle 7 to be embedded. In order to facilitate the elastic member 8 to extend into the connection buckle 7, the slot is provided with an opening, and the opening faces the adjustment rod 4. The buckle 7 is embedded in the slot and abuts against the opening of the slot under the action of the elastic member 8, so that the buckle 7 has a tendency to move toward the adjustment rod 4. Among them, the inner surface of each slot abutting against the buckle 7 gradually approaches the adjustment rod 4 along the first direction, and the adjacent slots are connected and can allow the buckle 7 to pass through. In this way, multiple slots are connected to form a channel for the buckle 7 to slide, and a notch that can limit the displacement of the buckle 7 along the first direction is formed between the adjacent slots. When the buckle 7 is displaced along the second direction, under the action of the elastic member 8, the buckle 7 will move from the top of the notch to the inside of the notch in sequence. The structure is stable and simple, and the operation is convenient, which ensures that the connection between the buckle 7 and the adjustment rod 4 is more stable, and under the action of the elastic member 8, the buckle 7 always abuts against the slot, which is conducive to preventing the connection between the adjustment rod 4 and the first fixing sleeve 2 from loosening, so as to extend the service life. Here, the elastic member 8 is preferably a tension spring.

[0044] In order to enhance the connection stability between the adjusting rod 4 and the first fixed sleeve 2, a protrusion is arranged around the first end of the adjusting rod 4, and a groove is arranged around the inner wall of the first fixed sleeve 2. The protrusion is embedded in the groove, and the opening of the groove faces the adjusting rod 4. In this way, the two side walls of the groove can limit the axial displacement of the protrusion along the first fixed sleeve 2, thereby avoiding the displacement of the adjusting rod 4 relative to the first fixed sleeve 2, and effectively improving the connection stability between the adjusting rod 4 and the first fixed sleeve 2.

[0045] In this embodiment, Figure 7As shown, the second end of the adjusting rod 4 is connected with the pushing rod 5 through the second thread, and the first thread is opposite to the second thread, so that when the pushing rod 5 rotates in the first direction, the limiting structure limits the rotation of the adjusting rod 4 relative to the first fixing sleeve 2, so that the pushing rod 5 rotates relative to the adjusting rod 4 to disengage; when the pushing rod 5 rotates in the second direction, the adjusting rod 4 is driven to rotate in the second direction to adjust the first fixing sleeve 2 and the second fixing sleeve 3 to be close. In this way, it is conducive to the disengagement of the pushing rod 5 and the rotation adjustment of the adjusting rod 4, and it is convenient to control the height of the present cardiac occluder.

[0046] It should be noted that in order to avoid interference between the push rod 5 and the thread of the second fixing sleeve 3 , the diameter of the first thread is greater than the diameter of the second thread.

[0047] Among them, an interlayer is arranged between the inner wall and the outer wall of the first fixing sleeve 2 and the second fixing sleeve 3, and the closing end of the alloy wire 13 is fixed in the interlayer. In this way, the alloy wire 13 can be prevented from being pulled out by fixing the first fixing sleeve 2 and the second fixing sleeve 3, thereby effectively ensuring the structural stability of the occluder body 1.

[0048] A flow-blocking membrane is arranged on the inner or outer surface of the two disc-shaped bodies 11 to enhance the blocking effect of the heart occluder.

[0049] It should be noted that the words “first”, “second”, etc. described in this article do not limit the specific order, but are merely used to distinguish between various components or functions.

[0050] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

[0051] It can be understood that the same or similar parts of the above embodiments can be referenced to each other, and the contents not described in detail in some embodiments can refer to the same or similar contents in other embodiments.

[0052] Although the embodiments of the present application have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limitations on the present application. Ordinary technicians in this field can change, modify, replace and modify the above embodiments within the scope of the present application.

Claims

1. A cardiac occluder, comprising an occluder body (1) woven from alloy wires (13), the occluder body (1) having two disc-shaped bodies (11) arranged opposite to each other and a connecting portion (12) connected between the two disc-shaped bodies (11), characterized in that: It also includes a first fixing sleeve (2) and a second fixing sleeve (3) for fixing the alloy wire (13), wherein the first fixing sleeve (2) and the second fixing sleeve (3) are respectively located on the two disc-shaped bodies (11) and can be connected to each other by a height adjustment component; The height adjustment assembly comprises an adjustment rod (4) located inside the occluder body (1); a first end of the adjustment rod (4) is axially rotatably fixed inside the first fixing sleeve (2); a second end of the adjustment rod (4) passes through the second fixing sleeve (3) and is connectable to a push rod (5); the adjustment rod (4) is engaged with an inner wall of the second fixing sleeve (3) via a first thread; A limiting structure for limiting the rotation of the adjusting rod (4) in a first direction is provided between the first end of the adjusting rod (4) and the inner wall of the first fixing sleeve (2); when the adjusting rod (4) rotates in a second direction, the second fixing sleeve (3) is displaced along the adjusting rod (4) towards the first fixing sleeve (2) under the action of the first thread; the first direction is opposite to the second direction, and both are the rotation directions of the adjusting rod (4); The limiting structure comprises a plurality of limiting members (6) and a plurality of buckles (7) corresponding to the positions of the limiting members (6) in a one-to-one manner. The plurality of limiting members (6) are sequentially arranged around the inner wall of the first fixing sleeve (2). The plurality of buckles (7) are sequentially arranged around the outer wall of the adjusting rod (4) through an elastic member (8) and cooperate with the limiting members (6) under the action of the elastic member (8). When the adjusting rod (4) rotates along the first direction, the limiting member (6) restricts the buckles (7) from passing along the limiting member (6). When the adjusting rod (4) rotates along the second direction, the buckles (7) sequentially pass through the limiting member (6). The inner or outer surfaces of the two disc-shaped bodies (11) are provided with flow-blocking films.

2. The cardiac occluder according to claim 1, characterized in that: The limiting member (6) is arranged as a block gradually moving away from the adjusting rod (4) along the first direction, and the buckle (7) abuts against the block under the action of the elastic member (8); the outer wall of the adjusting rod (4) is provided with a plurality of support rods (9) extending toward the first fixing sleeve (2), the buckle (7) is hinged to the end of the support rod (9), and one end of the elastic member (8) is connected to the adjusting rod (4), and the other end is connected to the buckle (7) and is away from the adjusting rod (4).

3. The cardiac occluder according to claim 1, characterized in that: The limiting member (6) is arranged to gradually approach a slot of the adjusting rod (4) along the first direction, the buckle (7) is embedded in the slot and abuts against an opening of the slot under the action of the elastic member (8), and adjacent slots are connected and can allow the buckle (7) to pass through.

4. The cardiac occluder according to claim 1, characterized in that: A protrusion is arranged around the first end of the adjusting rod (4), and the inner wall of the first fixing sleeve (2) is provided with a groove for the protrusion to be embedded in, and the opening of the groove faces the adjusting rod (4).

5. The cardiac occluder according to claim 1, characterized in that: The second end of the adjusting rod (4) is connected to the pushing rod (5) via a second thread, and the first thread is opposite to the second thread.

6. The cardiac occluder according to claim 1, characterized in that: An interlayer is provided between the inner wall and the outer wall of the first fixing sleeve (2) and the second fixing sleeve (3), and the closing end of the alloy wire (13) is fixed in the interlayer.

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