Special occluder and treatment components for ventricular septal perforation

Abstract

The present invention relates to a special occluder for ventricular septal perforation and a treatment component. The special occluder for ventricular septal perforation includes a first occluding disc and a second occluding disc, and a waist connecting the first occluding disc and the second occluding disc; the special occluder for ventricular septal perforation is configured as follows: the waist is used to penetrate into the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation; the first occluding disc and the second occluding disc are respectively arranged on both axial sides of the ventricular septal perforation to block the ventricular septal perforation while clamping the normal myocardium. There is no interaction force between the waist of the occluder of the present invention and the diseased myocardium, so as to avoid residual shunt caused by the diseased myocardium being crushed by force. In the preferred treatment component, the occluder and its operating rod also have an inner cavity for the guide wire to penetrate, and there is no need to withdraw the guide wire before delivering the occluder, which is easy to operate, shortens the operation time and achieves precise release.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a special occluder and a treatment component for ventricular septal perforation. Background Art

[0002] Ventricular septal rupture (VSR) is one of the serious complications after acute myocardial infarction (AMI), accounting for about 1% to 2% of patients with AMI.

[0003] Treatments for ventricular septal perforation include medical medication, interventional closure and surgical treatment. Medical medication aims to improve symptoms and cardiac function, creating opportunities for the next surgery or interventional treatment. At present, there is no specially designed occluder for ventricular septal perforation in interventional closure treatment. The occluder used clinically is a congenital ventricular septal defect occluder, which is prone to complications such as residual shunt. Summary of the invention

[0004] The purpose of the present invention is to provide a special occluder and treatment component for ventricular septal perforation, which can be adapted to ventricular septal perforation caused by myocardial infarction and reduce the probability of complications such as residual shunt.

[0005] To achieve the above-mentioned purpose, the present invention provides a dedicated occluder for ventricular septal perforation, comprising a first occluding disc and a second occluding disc arranged opposite to each other, and a waist connecting the first occluding disc and the second occluding disc;

[0006] The dedicated occluder for ventricular septal perforation is configured as follows: the waist is used to be penetrated into the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation; the first occluding disk and the second occluding disk are respectively arranged on both axial sides of the ventricular septal perforation to block the ventricular septal perforation while clamping the normal myocardium.

[0007] Optionally, the ratio of the maximum diameter of the waist to the diameter of the first occluding disk is 1:(8-10); and / or the ratio of the maximum diameter of the waist to the diameter of the second occluding disk is 1:(7-9).

[0008] Optionally, the maximum diameter of the waist is 3mm-4mm.

[0009] Optionally, the axial length of the waist is 5mm-6mm.

[0010] Optionally, the first sealing disk includes a first clamping surface and a first sealing surface that are oppositely arranged, wherein the first clamping surface is connected to the waist, the first sealing surface is a curved surface, and the concave side of the first sealing surface is arranged toward the first clamping surface.

[0011] Optionally, the second sealing disk includes a second clamping surface and a second sealing surface that are oppositely arranged, wherein the second clamping surface is arranged opposite to the first clamping surface, the second sealing surface is an arc surface, and the concave side of the second sealing surface is arranged toward the second clamping surface.

[0012] Optionally, the first occluding disk and the second occluding disk are both woven from braided wires, and the braiding density of the first occluding disk is greater than the braiding density of the second occluding disk.

[0013] Optionally, the dedicated occluder for ventricular septal perforation is provided with a first inner cavity which axially penetrates the first occluding disk, the waist and the second occluding disk.

[0014] Optionally, a valve is provided in the first inner cavity.

[0015] To achieve the above-mentioned purpose, the present invention also provides a ventricular septal perforation treatment component, comprising a delivery sheath, an operating rod and the special ventricular septal perforation occluder as described above; the operating rod has a proximal end and a distal end, and the distal end is detachably connected to the special ventricular septal perforation occluder; the delivery sheath has an axially through-going second inner cavity, and the second inner cavity is used to accommodate the special ventricular septal perforation occluder in a compressed state and the distal end of the operating rod.

[0016] Optionally, the dedicated occluder for ventricular septal perforation has a first inner cavity axially passing through the first occluding disk, the waist and the second occluding disk; the operating rod has an axially connected third inner cavity, and the third inner cavity is used to communicate with the first inner cavity; the ventricular septal perforation treatment component also includes a guide wire, and the guide wire is used to be movably arranged in the third inner cavity and the first inner cavity to guide the delivery sheath to deliver the dedicated occluder for ventricular septal perforation to the ventricular septal perforation.

[0017] Optionally, a valve is provided in the first inner cavity. When the guide guide wire is inserted into the first inner cavity, the valve opens to form a through hole for the guide guide wire to pass through. When the guide guide wire withdraws from the first inner cavity, the valve closes to separate the first inner cavity into two parts that are not connected to each other.

[0018] Optionally, the delivery sheath has a second proximal end and a second distal end opposite to each other, the second distal end is formed into a frustoconical structure, and a cross section of the frustoconical structure tapers from the second proximal end to the second distal end.

[0019] Optionally, the delivery sheath has a second proximal end and a second distal end opposite to each other; the ventricular septal perforation treatment assembly further comprises a locking mechanism, the locking mechanism is arranged on the second proximal end of the delivery sheath, and the first proximal end of the operating rod is used to selectively connect or disconnect with the locking mechanism;

[0020] The ventricular septal perforation treatment component is configured as follows: when the first proximal end of the operating rod is connected to the locking mechanism, the operating rod remains relatively stationary relative to the delivery sheath; when the first proximal end of the operating rod is disconnected from the locking mechanism, the operating rod can move axially relative to the delivery sheath.

[0021] Optionally, the locking mechanism includes a locking body, which is detachably connected to the delivery sheath; the locking body has an axially penetrating fourth inner cavity, and the cavity wall of the fourth inner cavity is provided with an internal thread; the first proximal end of the operating rod is provided with an external thread, and the first proximal end is used to penetrate the fourth inner cavity and be connected to the internal thread on the cavity wall of the fourth inner cavity.

[0022] Optionally, the locking mechanism further comprises a flying wing, and the flying wing is arranged on the outer surface of the locking body.

[0023] Compared with the prior art, the dedicated occluder and treatment assembly for ventricular septal perforation of the present invention has the following advantages:

[0024] First, the aforementioned dedicated occluder for ventricular septal perforation includes a first occluding disc and a second occluding disc arranged relatively to each other, and a waist connecting the first occluding disc and the second occluding disc. The dedicated occluder for ventricular septal perforation is configured as follows: the waist is used to penetrate into the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation; at the same time, the first occluding disc and the second occluding disc are respectively arranged on both axial sides of the ventricular septal perforation to clamp the normal myocardium and block the ventricular septal perforation. Since there is a gap between the waist and the diseased myocardium at the ventricular septal perforation, it is avoided that the diseased myocardium is crushed by the radial force of the waist, causing complications such as residual shunt.

[0025] Second, the ratio of the maximum diameter of the waist to the diameter of the first occluding disk is 1:(8-10), and / or the ratio of the maximum diameter of the waist to the diameter of the second occluding disk is 1:(7-9). By designing a special occluding device for ventricular septal perforation according to this size, it can be ensured that the first occluding disk and the second occluding disk are clamped on the normal myocardium when there is a gap between the waist and the diseased myocardium, thereby effectively blocking the ventricular septal perforation.

[0026] Third, the axial length of the waist is 5mm-6mm, which is smaller than the thickness of the ventricular septum. Therefore, when the waist is inserted into the perforation of the ventricular septum, it is stretched and deformed to generate elastic force. Under the action of the elastic force, the clamping force of the first occluding disk and the second occluding disk is enhanced, thereby improving the sealing effect of the perforation of the ventricular septum.

[0027] Fourth, the occluder for ventricular septal perforation also has a first inner cavity that axially penetrates the first occluding disk, the waist and the second occluding disk, and the first inner cavity is used to pass a guide wire for positioning, so as to facilitate the delivery of the occluder for ventricular septal perforation. Furthermore, a valve is also provided in the first inner cavity. When the guide wire is passed through the first inner cavity, the valve opens to form a through hole for the guide wire to pass through. When the guide wire is withdrawn from the first inner cavity, the valve automatically closes to separate the first inner cavity into two parts that are not connected to each other, so as to prevent blood from flowing from the left ventricle into the right ventricle through the first inner cavity, thereby improving the blocking effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is an anatomical diagram of the human heart, showing a ventricular septal perforation.

[0029] Figure 2 It is a schematic diagram of using a congenital ventricular septal defect occluder to occlude ventricular septal perforation in the prior art;

[0030] Figure 3 2 is a schematic structural diagram of a dedicated occluder for ventricular septal perforation provided by the present invention according to an embodiment;

[0031] Figure 4 is a schematic diagram of a dedicated occluder for ventricular septal perforation provided by the present invention according to an embodiment when occluding ventricular septal perforation;

[0032] Figure 5 is a cross-sectional view of a dedicated occluder for ventricular septal perforation provided by the present invention according to one embodiment;

[0033] Figure 6 It is a schematic diagram of the structure of a valve of a dedicated occluder for ventricular septal perforation provided by the present invention according to one embodiment;

[0034] Figure 7 It is a schematic structural diagram of a special treatment component for ventricular septal perforation provided by the present invention according to one embodiment.

[0035] [Description of reference numerals is as follows]:

[0036] 1-left atrium, 2-left ventricle, 3-right ventricle, 4-right atrium, 5-ventricular septum, 6-ventricular septum perforation;

[0037] 10-Special occluder for ventricular septal perforation;

[0038] 100, 100'- first blocking plate;

[0039] 110-first clamping surface, 120-first blocking surface;

[0040] 200, 200'- second blocking plate;

[0041] 210-second clamping surface, 220-second blocking surface;

[0042] 300, 300' - waist;

[0043] 400-first inner cavity;

[0044] 500-valve;

[0045] 20-delivery sheath, 30-operating rod, 40-guide wire. DETAILED DESCRIPTION

[0046] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0047] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0048] As used in this specification, the singular forms "a", "an", and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The same or similar figure marks in the drawings represent the same or similar parts.

[0049] Figure 1 The anatomy of the human heart is shown in FIG. Figure 1 The heart shown includes a left atrium 1, a left ventricle 2, a right ventricle 3 and a right atrium 4, wherein the left ventricle 2 and the right ventricle 3 are separated by a ventricular septum 5, and a ventricular septal perforation 6 occurs on the ventricular septum 5. As described in the background art, currently, most clinical methods use congenital ventricular septal defect occluders to occlude ventricular septal perforations. Figure 2 The figure shows a schematic diagram of using a congenital ventricular septal defect occluder to occlude a ventricular septal perforation. Figure 2 As shown, the occluder for congenital ventricular septal defect includes a first occluding disc 100', a second occluding disc 200' and a waist 300', wherein the waist 300' connects the first occluding disc 100' and the second occluding disc 200'. Currently, this type of occluder has multiple specifications and is suitable for different defects, but basically all are designed so that when the maximum diameter of the waist 300' is D1, the diameter of the first occluding disc 100' is (D1+8mm), and the diameter of the second occluding disc 200' is (D1+4mm). The diameter of the first occluding disc 100', the diameter of the second occluding disc 200' and the diameter of the waist 300' are not much different.

[0050] In actual operation, when performing occlusion of the ventricular septal perforation 6, the operator selects an occluder with a suitable diameter of the waist 300' according to the size of the ventricular septal perforation 6, and uses the waist 300' to fill the defect to completely close the ventricular septal perforation 6, while using the first occluding disc 100' and the second occluding disc 200' to clamp the ventricular septum 5 to achieve the positioning of the occluder. However, a large number of patients develop complications such as residual shunts after surgery. The applicant found that this is because the myocardium around the ventricular septal perforation 6 is a fragile diseased myocardium, which is significantly different from the healthy congenital myocardial defect part. When using a congenital ventricular septal defect occluder for occlusion, the waist 300' completely fills the perforation and squeezes the diseased myocardium in the radial direction, which can easily cause the diseased myocardium to break and cause residual shunts. However, if an occluder with a smaller waist 300' is selected, since the diameters of the first occluding disk 100' and the second occluding disk 200' are not much different from the diameter of the waist 300', the ventricular septal perforation 6 cannot be completely occluded, and the treatment effect cannot be achieved.

[0051] In view of this, an embodiment of the present invention proposes a special occluder for ventricular septal perforation, which includes a first occluding disc and a second occluding disc, and a waist connecting the first occluding disc and the second occluding disc. The special occluder for ventricular septal perforation is configured as follows: the waist is used to penetrate the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation; the first occluding disc and the second occluding disc are respectively arranged on both sides of the axial direction of the ventricular septal perforation, and the first occluding disc and the second occluding disc both extend to the normal myocardial part around the ventricular septal perforation. That is, the special occluder for ventricular septal perforation uses the first occluding disc and the second occluding disc to clamp the normal myocardium to achieve positioning, and also uses the first occluding disc and the second occluding disc to block the ventricular septal perforation. In this way, the waist only serves the purpose of connecting the two occluding discs, and will not generate radial force on the diseased myocardium to cause the diseased myocardium to break, effectively reducing the probability of residual shunt.

[0052] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0053] Figure 3 The structure diagram of the dedicated occluder for ventricular septal perforation provided in the embodiment of the present invention is shown. Figure 4 A schematic diagram is shown of a ventricular septal perforation occluder provided in an embodiment of the present invention being implanted into a patient's heart to occlude the ventricular septal perforation.

[0054] Please refer to Figure 3 The ventricular septal perforation occluder 10 comprises a first occluding disc 100 and a second occluding disc 200, and a waist 300 connecting the first occluding disc 100 and the second occluding disc 200. Figure 4 When the ventricular septum perforation special occluder 10 is used to block the ventricular septum perforation, the waist 300 is inserted into the ventricular septum perforation, and the maximum diameter of the waist 300 is smaller than the minimum diameter of the ventricular septum perforation, so that there is a gap between the waist 300 and the diseased myocardium of the ventricular septum perforation. At the same time, the first occluding disc 100 and the second occluding disc 200 are respectively arranged on both sides of the axial direction of the ventricular septum perforation, and the first occluding disc 100 and the second occluding disc 200 are extended to the normal myocardial area around the ventricular septum perforation to block the ventricular septum perforation. That is to say, in this embodiment, the first occluding disc 100 and the second occluding disc 200 not only play a positioning role, but also play a role in blocking the ventricular septum perforation, so that the waist 300 is only used to connect the first occluding disc 100 and the second occluding disc 200, which does not need to completely fill the ventricular septum perforation, and will not produce radial force on the fragile diseased myocardium around the ventricular septum perforation, avoiding the complications such as residual shunt caused by the fragmentation of the diseased myocardium, and improving the treatment effect.

[0055] In this embodiment, the larger the gap between the waist 300 and the myocardium around the ventricular septal perforation, the better. At the same time, the first occluding disc 100 and the second occluding disc 200 also need to completely cover the ventricular septal perforation and extend to the healthy myocardial area around the ventricular septal perforation. Therefore, the radial dimensions of the first occluding disc 100 and the second occluding disc 200 are quite different from the radial dimensions of the waist 300. Specifically, the ratio of the maximum diameter of the waist 300 to the diameter of the first occluding disc 100 can be 1: (8-10), for example, 1: 8, 1: 9, 1: 9.5, 1: 10, etc. The ratio of the maximum diameter of the waist 300 to the diameter of the second occluding disc 200 can be 1: (7-9), for example, 1: 7, 1: 7.5, 1: 9, 1: 10, etc. In this way, the first occluding disc 100 and the second occluding disc 200 can achieve the purpose of blocking the ventricular septal perforation while the diameter of the waist 300 is as small as possible. When the ventricular septal perforation occluder 10 is actually manufactured, the maximum diameter of the waist is less than or equal to 4 mm, which is much smaller than the size of the ventricular septal perforation (the diameter of the ventricular septal perforation is generally more than ten millimeters). In addition, due to the limitations of materials and processes, the maximum diameter of the waist 300 is generally greater than or equal to 3 mm.

[0056] The thickness of the interventricular septum 5 is generally 7mm-8mm, so in this embodiment, the axial length of the waist 300 is preferably 5mm-6mm, which is smaller than the thickness of the interventricular septum 5. The reason for this arrangement is that the first occluding disc 100, the second occluding disc 200 and the waist 300 of the special occluding device for interventricular septal perforation 10 are all woven with braided silk and have a certain elasticity. Therefore, when the special occluding device for interventricular septal perforation 10 is used to block the interventricular septum, the waist 300 is inserted into the interventricular septal perforation and stretched under the action of the interventricular septum 5 to generate elastic force, which can enhance the clamping force of the first occluding disc 100 and the second occluding disc 200 on the interventricular septum 5 and improve the blocking effect.

[0057] For further information, please refer to Figure 3 , the first occluding disc 100 includes a first clamping surface 110 and a first blocking surface 120 which are arranged opposite to each other. The first clamping surface 110 is used to attach to the ventricular septum, the first blocking surface 120 is an arc surface, and the concave side of the arc surface is arranged toward the first clamping surface 110. Similarly, the second occluding disc 200 includes a second clamping surface 210 and a second blocking surface 220 which are arranged opposite to each other, wherein the second clamping surface 210 is arranged opposite to the first clamping surface 110 and is connected to the waist 300 for attaching to the ventricular septum, the second blocking surface 220 is an arc surface, and the concave side of the arc surface is arranged toward the second clamping surface 210. The centers of the first blocking surface 110 and the second blocking surface 210 are both located on the axis of the waist 300. The advantage of such an arrangement is that the clamping force of the first occluding disc 100 and the second occluding disc 200 on the normal myocardium gradually increases in the direction away from the ventricular septal perforation, which enhances the clamping force on the normal myocardium and further avoids the fragmentation of the diseased myocardium.

[0058] In addition, when the dedicated occluder 10 for ventricular septal perforation is used to block ventricular septal perforation, the first occluding disc 100 is used to be attached to the surface of the ventricular septum 5 facing the left ventricle, so the first occluding disc 100 is also called the left occluding disc. Correspondingly, the second occluding disc 200 is attached to the surface of the ventricular septum 5 facing the right ventricle, so the second occluding disc 200 is also called the right occluding disc. In this way, the blood flow impact force received by the first occluding disc 100 is greater than the blood flow impact force received by the second occluding disc 200. Based on this, the weaving density of the first occluding disc 100 is preferably greater than the weaving density of the second occluding disc 200, so as to improve the blocking effect and further avoid the generation of residual shunt.

[0059] Figure 5 A cross-sectional view of the dedicated occluder for ventricular septal perforation is shown. Figure 5As shown, the dedicated occluder 10 for ventricular septal perforation also has a first inner cavity 400, and the first inner cavity 400 axially penetrates the first occluding disk 100, the waist 300 and the second occluding disk 200, and the first inner cavity 400 is used to pass a guide wire for easy delivery. Furthermore, a valve 500 is also provided in the first inner cavity 400, and when a guide wire is passed through the first inner cavity 400, the valve 500 is opened to form a through hole for the guide wire to pass through. When the guide wire is withdrawn from the first inner cavity 400, the valve 500 is closed to separate the first inner cavity 400 into two parts that are not connected to each other, so that blood cannot circulate along the first inner cavity 400. In a feasible manner, the valve 500 can be made of a multi-petal biomaterial (such as Figure 6 shown).

[0060] In addition, it should be known that the dedicated occluder 10 for ventricular septal perforation is provided with a connecting portion (not shown in the figure), and the connecting portion is used for detachably connecting an operating rod to facilitate delivery in the human body.

[0061] Furthermore, another object of the present invention is to provide a special treatment component for ventricular septal perforation, such as Figure 7 As shown, the dedicated treatment assembly for ventricular septal perforation includes a delivery sheath 20, an operating rod 30 and the dedicated occluder 10 for ventricular septal perforation. The operating rod 30 has a first proximal end and a first distal end relative to each other, and the first distal end is used to be detachably connected to the dedicated occluder 10 for ventricular septal perforation. The delivery sheath 20 has a second inner cavity that is axially connected, and the second inner cavity is used to accommodate the dedicated occluder 10 for ventricular septal perforation in a compressed state and the first distal end of the operating rod 30. The operator uses the delivery sheath 20 and the operating rod 30 to deliver the dedicated occluder 10 for ventricular septal perforation to the ventricular septal perforation and release it to block the ventricular septal perforation. It can be understood that the "proximal end" and "distal end" mentioned here are the relative orientation, relative position, and direction of the elements or actions relative to each other from the perspective of the doctor using the medical device. Although the "proximal end" and "distal end" are not restrictive, the "proximal end" usually refers to the end of the medical device that is close to the doctor during normal operation, and the "distal end" usually refers to the end that first enters the patient's body.

[0062] Furthermore, when the dedicated occluder 10 for ventricular septal perforation has the first inner cavity ( Figure 7 The operating rod 30 has an axially through third lumen, and when the third lumen is used to communicate with the first lumen, the dedicated treatment component for ventricular septal perforation further includes a guide wire 40, and the guide wire 40 is used to be movably passed through the third lumen and the first lumen to guide the delivery sheath 20 to deliver the dedicated ventricular septal perforation occluder 10 to the ventricular septal perforation.

[0063] The occluder 10 and the operating rod 30 of the special treatment assembly for ventricular septal perforation can be passed through by the guide wire 40. There is no need to withdraw the guide wire 40 before delivering the occluder 10, which is easy to operate and further shortens the operation time. The occluder 10 is limited by the guide wire 40 to achieve accurate release.

[0064] Furthermore, the delivery sheath 20 has a second proximal end and a second distal end relative to each other. The dedicated treatment assembly for ventricular septal perforation also includes a locking mechanism 50, which is disposed on the second proximal end of the delivery sheath 20, and the locking mechanism 50 is used to selectively connect or disconnect with the first proximal end of the operating rod 30. When the first proximal end of the operating rod 30 is connected to the locking mechanism 50, the operating rod 30 and the delivery sheath 20 remain relatively stationary, which can prevent the dedicated occluder 10 for ventricular septal perforation from extending out of the delivery sheath 20 in advance during the delivery process, thereby causing damage to human tissue. When the first proximal end of the operating rod 30 is disconnected from the locking mechanism 50, the operating rod 30 can move axially relative to the delivery sheath 20 to release the dedicated occluder 10 for ventricular septal perforation.

[0065] In an optional implementation, the locking mechanism 50 includes a locking body 51, and the locking body 51 can be threadedly connected to the proximal end of the delivery sheath 20. The locking body 51 has an axially through fourth inner cavity, and the cavity wall of the fourth inner cavity is provided with an internal thread. The first proximal end of the operating rod 30 is provided with an external thread, and the first proximal end of the operating rod 30 can pass through the fourth inner cavity and be threadedly connected to the cavity wall of the fourth inner cavity. In this way, during the delivery of the dedicated occluder 10 for ventricular septal perforation, the locking body 51 is connected to the delivery sheath 20, and the first proximal end of the operating rod 30 is connected to the cavity wall of the fourth inner cavity, so as to achieve the purpose of fixing the operating rod 30. When the ventricular septal perforation occluder 10 is delivered to the target position, the locking body 51 is removed from the proximal end of the delivery sheath 20, and the connection between the wall of the fourth inner cavity and the first proximal end of the operating rod 30 is released. The operating rod 30 can then move axially relative to the delivery sheath 20 to release the ventricular septal perforation occluder 10.

[0066] Furthermore, the locking mechanism 50 also includes at least one wing 52, and at least one wing 52 is arranged on the outer surface of the locking body 51 for easy holding.

[0067] Furthermore, the distal end of the delivery sheath 20 is designed as a frustum-shaped structure, and the cross-section of the frustum-shaped structure tapers from the proximal end to the distal end to improve the passability of the delivery sheath 20 in the human body.

[0068] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A special occluder for ventricular septal perforation, characterized in that: It comprises a first occluding disc and a second occluding disc arranged opposite to each other, and a waist connecting the first occluding disc and the second occluding disc; The dedicated occluder for ventricular septal perforation is configured as follows: the waist is used to penetrate the ventricular septal perforation, and the maximum diameter of the waist is smaller than the minimum diameter of the ventricular septal perforation, so that there is a gap between the waist and the diseased myocardium around the ventricular septal perforation; the first occluding disc and the second occluding disc are respectively used to be arranged on both axial sides of the ventricular septal perforation, so as to block the ventricular septal perforation while clamping the normal myocardium; The dedicated occluder for ventricular septal perforation is provided with a first inner cavity which axially penetrates the first occluding disk, the waist and the second occluding disk, and a valve is provided in the first inner cavity.

2. The ventricular septal perforation occluder according to claim 1, characterized in that: The ratio of the maximum diameter of the waist to the diameter of the first occluding disk is 1:(8-10); and / or the ratio of the maximum diameter of the waist to the diameter of the second occluding disk is 1:(7-9).

3. The dedicated occluder for ventricular septal perforation according to claim 2, characterized in that: The maximum diameter of the waist is 3mm-4mm.

4. The dedicated occluder for ventricular septal perforation according to any one of claims 1 to 3, characterized in that: The axial length of the waist is 5mm-6mm.

5. The dedicated occluder for ventricular septal perforation according to claim 1, characterized in that: The first sealing disk includes a first clamping surface and a first sealing surface which are arranged opposite to each other, wherein the first clamping surface is connected to the waist, the first sealing surface is a curved surface, and the concave side of the first sealing surface is arranged toward the first clamping surface.

6. The dedicated occluder for ventricular septal perforation according to claim 5, characterized in that: The second sealing disk includes a second clamping surface and a second sealing surface that are oppositely arranged, wherein the second clamping surface is arranged opposite to the first clamping surface, the second sealing surface is an arc surface, and the concave side of the second sealing surface is arranged toward the second clamping surface.

7. The dedicated occluder for ventricular septal perforation according to claim 1, characterized in that: The first occluding disk and the second occluding disk are both woven from braided wires, and the braiding density of the first occluding disk is greater than that of the second occluding disk.

8. A ventricular septal perforation treatment assembly, characterized in that: It comprises a delivery sheath, an operating rod and a dedicated occluder for ventricular septal perforation as described in any one of claims 1 to 7; the operating rod has a first proximal end and a first distal end opposite to each other, the first distal end being detachably connected to the dedicated occluder for ventricular septal perforation; the delivery sheath has an axially through-going second inner cavity, the second inner cavity being used to accommodate the dedicated occluder for ventricular septal perforation in a compressed state and the first distal end of the operating rod; the operating rod has an axially connected third inner cavity, the third inner cavity being used to communicate with the first inner cavity.

9. The ventricular septal perforation treatment assembly according to claim 8, characterized in that: The ventricular septal perforation treatment component also includes a guide wire, which is used to be movably arranged in the third inner cavity and the first inner cavity to guide the delivery sheath to deliver the ventricular septal perforation dedicated occluder to the ventricular septal perforation.

10. The ventricular septal perforation treatment assembly according to claim 9, characterized in that: A valve is provided in the first inner cavity. When the guide wire is inserted into the first inner cavity, the valve is opened to form a through hole for the guide wire to pass through. When the guide wire is withdrawn from the first inner cavity, the valve is closed to separate the first inner cavity into two parts that are not connected to each other.

11. The ventricular septal perforation treatment assembly according to claim 8, characterized in that: The delivery sheath has a second proximal end and a second distal end opposite to each other. The second distal end is formed into a truncated cone-shaped structure, and a cross section of the truncated cone-shaped structure tapers from the second proximal end to the second distal end.

12. The ventricular septal perforation treatment assembly according to claim 8, characterized in that: The delivery sheath has a second proximal end and a second distal end opposite to each other; the ventricular septal perforation treatment assembly further includes a locking mechanism, which is disposed on the second proximal end of the delivery sheath, and the first proximal end of the operating rod is used to selectively connect or disconnect with the locking mechanism; The ventricular septal perforation treatment component is configured as follows: when the first proximal end of the operating rod is connected to the locking mechanism, the operating rod remains relatively stationary relative to the delivery sheath; when the first proximal end of the operating rod is disconnected from the locking mechanism, the operating rod can move axially relative to the delivery sheath.

13. The ventricular septal perforation treatment assembly according to claim 12, characterized in that: The locking mechanism includes a locking body, which is detachably connected to the delivery sheath; the locking body has an axially through-going fourth inner cavity, and the cavity wall of the fourth inner cavity is provided with an internal thread; the first proximal end of the operating rod is provided with an external thread, and the first proximal end is used to penetrate the fourth inner cavity and be connected with the internal thread on the cavity wall of the fourth inner cavity.

14. The ventricular septal perforation treatment assembly according to claim 13, characterized in that: The locking mechanism further includes a flying wing, which is disposed on an outer surface of the locking body.

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