Occluders and occlusion systems

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to an occluder and an occlusion system, wherein the occluder includes a fixing portion and a sealing portion, wherein the fixing portion and the sealing portion are connected via a connecting portion, and the occluder further includes an ablation component, wherein the ablation component is provided on the connecting portion, and a channel is provided inside the connecting portion, wherein the channel is connected to the interior of the ablation component. The occlusion system includes a medium conveying device that can be detachably connected to the connecting portion. By providing an ablation component, while the occluder blocks the mouth of the left atrial appendage, the ablation component cooperates with a refrigerant to freeze the left atrial appendage, so that an isolation zone is formed on the inner wall of the left atrial appendage, thereby blocking the conduction of electrical signals between the left atrial appendage and the left atrium, and realizing electrical isolation between the left atrial appendage and the left atrium.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to an occluder and an occluding system. Background Art

[0002] Atrial fibrillation is the most common clinical arrhythmia, with an incidence of 1.0%-1.5%, and its incidence increases with age. Atrial fibrillation can impair cardiac function and may induce thrombosis, severely impacting quality of life. Atrial fibrillation is the strongest risk factor for stroke and heart failure, accounting for 20% of strokes, posing a significant threat to patients' lives.

[0003] Atrial fibrillation is primarily caused by dysregulated electrical signals within the heart. Pulmonary (caval) vein muscle sleeves and specialized atrial structures, such as the crista terminalis, coronary sinus, and ligament of Marshall, can spontaneously generate electrical activity, potentially driving or triggering atrial electrical activity, leading to atrial fibrillation. In 1997, Haissaguerre discovered that electrical activity within the pulmonary vein muscle sleeves could drive / trigger atrial electrical activity, inducing atrial fibrillation. He therefore proposed that catheter radiofrequency ablation (RFA) could terminate atrial fibrillation by isolating the electrical connection between the pulmonary veins and the left atrium. Catheter ablation for atrial fibrillation has undergone a difficult process of optimizing the procedure. Currently, circumferential pulmonary vein ablation remains the cornerstone of the procedure, with the consensus that additional ablation diameters, fractionated potentials, and plexus ablation can be added as needed. However, conventional ablation often has the disadvantages of prolonged procedure time, large ablation areas, and incomplete ablation. This inability to completely prevent current reentry can lead to recurrence of atrial fibrillation.

[0004] Due to its unique morphology and structure, the left atrial appendage (LAA) is not only the primary site for thrombosis in atrial fibrillation (AF), but also a key area for its development and maintenance. Some patients with AF can benefit from active left atrial appendage isolation (LAAI). Furthermore, non-paroxysmal AF often requires aggressive left atrial ablation to achieve the ablation endpoint, which can easily lead to passive LAAI. Ablation-related iatrogenic LAAI can theoretically significantly increase the risk of thromboembolic events, necessitating high vigilance among electrophysiologists.

[0005] Catheter ablation of the pulmonary veins is a widely accepted treatment for atrial fibrillation. However, catheter ablation is difficult and time-consuming, and can easily lead to recurrence of atrial fibrillation. Passive left atrial appendage electrical isolation can lead to cerebral embolism and other diseases, often requiring repeat ablation or long-term oral anticoagulation to prevent these conditions. Left atrial electrical isolation is effective in maintaining sinus rhythm in patients over the long term, but it can also predispose to left atrial appendage thrombosis, which can cause cerebral embolic events. Summary of the Invention

[0006] The present invention provides an occluder and an occlusion system to solve the problems of high operational difficulty and high risk in implementing active left atrial appendage electrical isolation.

[0007] An occluder is provided, comprising a fixing portion, a sealing portion, and a connecting portion connected between the fixing portion and the sealing portion. The occluder also comprises a hollow ablation component, which is arranged on the connecting portion. A accommodating cavity is provided inside the connecting portion, and the accommodating cavity is connected to the interior of the ablation component.

[0008] In one embodiment, the ablation element comprises an expandable balloon structure, and the number of the balloons of the ablation element is one or more.

[0009] In one embodiment, an annular flow-blocking membrane is provided on the sealing portion, and the annular flow-blocking membrane has a through hole. A plurality of flow-blocking parts are provided on the edge of the through hole of the flow-blocking membrane, one end of the flow-blocking part is connected to the annular flow-blocking membrane, and the other end is a free end, and the flow-blocking parts gather together when not under force.

[0010] In one embodiment, the occluder is provided with a control component, and the control component controls the connection and / or disconnection between the accommodating cavity and the ablation element.

[0011] In one embodiment, the control component includes a sealing cover and an exchange channel, wherein the exchange channel connects the accommodating cavity and the interior of the ablation component, and the sealing cover is provided with an elastic structure, which drives the sealing cover to press and seal the exchange channel in the absence of external force.

[0012] In one embodiment, the control component includes a fixed part and a movable part that can move relative to the fixed part, the movable part includes a first part and a second part, the second part is provided with a first cavity inside, the fixed part is provided with a second cavity inside, the fixed part is provided with a connecting hole connected to the interior of the ablation part, the second part moves along the inner wall of the second cavity, and when the second part moves to a predetermined position, the first cavity is connected to the connecting hole.

[0013] In one embodiment, the control component includes a valve body and a spring structure, the valve body is provided with an opening, one end of the spring structure is connected to the valve body, and the other end is freely snapped on the opening surface to seal the opening in a natural state.

[0014] In one embodiment, there are multiple ablation elements, each of which is disposed on the fixing element. The ablation elements are connected to the connecting portion through a passage, and the passage is located inside the fixing portion.

[0015] In one embodiment, there are multiple ablation elements, some of which are disposed inside the fixing portion, and other portions of which are disposed between the fixing portion and the sealing portion.

[0016] A closure system is also provided, comprising the closure device described above, and a medium conveying device detachably connected to the connecting portion, wherein the medium conveying device is in communication with the accommodating cavity to convey the medium to the ablation element.

[0017] The occluder and occlusion system provided by the present invention are equipped with an ablation component. While the occluder occludes the opening of the left atrial appendage, the ablation component cooperates with a refrigerant to freeze the left atrial appendage, so that an isolation zone is formed on the inner wall of the left atrial appendage, thereby blocking the conduction of electrical signals between the left atrial appendage and the left atrium, and realizing electrical isolation between the left atrial appendage and the left atrium, so that the patient can enjoy the benefits of long-term maintenance of sinus rhythm after the electrical isolation of the left atrial appendage and the left atrium, reducing the probability of thrombus formation in the left atrial appendage, reducing the operational difficulty and risk of active left atrial appendage electrical isolation, and at the same time realizing the occlusion of the left atrial appendage. Under the dual effects of electrical isolation and occlusion, the occurrence of stroke can be better prevented, and the postoperative treatment effect is better. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Schematic diagram of the structure of the left atrial appendage occluder in Example 1 of the present invention;

[0019] Figure 2 This is a schematic structural diagram of a connecting member in Example 1 of the present invention;

[0020] Figure 3 is a cross-sectional schematic diagram of the left atrial appendage occluder in Example 1 of the present invention;

[0021] Figure 4 for Figure 3 A magnified schematic diagram of area A in the middle;

[0022] Figure 5 Schematic diagram of the structure of the left atrial appendage occluder in Example 2 of the present invention;

[0023] Figure 6 Schematic diagram of the structure of the control component in Example 2 of the present invention;

[0024] Figure 7 for Figure 6 Sectional view of the middle BB plane;

[0025] Figure 8 This is a schematic diagram of the operation of the control component in Example 2 of the present invention;

[0026] Figure 9 Schematic diagram of the structure of the control component in Example 3 of the present invention;

[0027] Figure 10 Schematic diagram of the structure of the left atrial appendage occluder in Example 4 of the present invention;

[0028] Figure 11 Schematic diagram of the structure of the ablation component in Example 4 of the present invention;

[0029] Figure 12 This is a three-dimensional schematic diagram of the fixing portion in Example 5 of the present invention;

[0030] Figure 13 Schematic diagram of the structure of the left atrial appendage occluder in Example 5 of the present invention;

[0031] Figure 14 This is a schematic structural diagram of a cantilever rod in another embodiment of embodiment 5 of the present invention;

[0032] Figure 15 Schematic diagram of the structure of the fixing portion in another embodiment of embodiment 5 of the present invention;

[0033] Figure 16 This is a schematic diagram of the first stage of release of the left atrial appendage occluder in Example 6 of the present invention;

[0034] Figure 17 Schematic diagram of the second stage of release of the left atrial appendage occluder in Example 6 of the present invention. DETAILED DESCRIPTION

[0035] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The accompanying drawings illustrate preferred embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0036] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0038] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This principle is used to define the "proximal end" and "distal end" of any component of a medical device. The location where the left atrium enters the left atrial appendage is defined as the left atrial appendage's orifice, and the location within the left atrial appendage adjacent to the left atrial appendage's orifice is defined as the left atrial appendage's neck. "Axial" generally refers to the length of a medical device during delivery, and "radial" generally refers to the direction perpendicular to the "axial" direction of the medical device. This principle is used to define the "axial" and "radial" ends of any component of a medical device.

[0039] Example 1

[0040] Figure 1 The structural diagram of the left atrial appendage occluder 1 in Example 1 of the present invention is shown. The left atrial appendage occluder 1 includes a sealing portion 11 and a fixing portion 12 connected to the sealing portion 11. The sealing portion 11 is used to block the opening of the left atrial appendage, and the fixing portion 12 contacts the inner wall of the left atrial appendage to achieve the overall anchoring of the left atrial appendage occluder 1. The sealing portion 11 and the fixing portion 12 are connected by a connecting portion 14. The sealing portion 11 can be a disc-shaped or columnar, plug-shaped or other structure, which is not limited here. The sealing portion 11 is hollow inside and has an opening at the proximal end. The shape of the fixing portion 12 is not limited and can be columnar or umbrella-shaped or the like. The fixing portion 12 can be formed by cutting a nickel-titanium tube or braiding nickel-titanium wire. In the present embodiment, the fixing portion 12 is formed by cutting a nickel-titanium tube.

[0041] In the left atrial appendage occluder 1 provided by the present invention, an ablation element 13 is also provided on the left atrial appendage occluder 1. The ablation element 13 is used to cryoablate the left atrial appendage 11 to form an isolation zone to block the conduction of electrical signals between the left atrial appendage and the left atrium, thereby realizing electrical isolation between the left atrial appendage and the left atrium, achieving the effect of electrical isolation, and enabling the patient to enjoy long-term maintenance of normal sinus rhythm after electrical isolation of the left atrial appendage.

[0042] The ablating element 13 is connected to a cryostat (not shown) that provides a refrigerant (e.g., N2O) to the ablating element 13. In this embodiment, the ablating element 13 is located between the sealing portion 11 and the fixing portion 12. The ablating element 13 comprises a balloon made of a compliant material, such as a polyamide and a polyether block copolymer. Polyamides are aliphatic, such as nylon 12, nylon 11, nylon 9, nylon 6, nylon 6 / 12, nylon 6 / 11, nylon 6 / 9, and nylon 6 / 6. The polyether block can be selected from polyoxytetramethylene glycol, tetramethylene ether, polyethylene glycol, or polypropylene glycol.

[0043] Because the ablation element 13 has good compliance, it will not significantly affect the size selection of the delivery device during transportation. The ablation element 13 can expand rapidly after being injected with refrigerant, and when filled to a certain extent, it can fully abut the inner wall of the left atrial appendage. Therefore, the ablation element 13 forms an annular isolation zone on the inner wall of the left atrial appendage with the help of the refrigerant, thereby achieving electrical isolation between the left atrial appendage and the left atrium. Therefore, the shape of the ablation element 13 can be changed accordingly according to the filling degree of the ablation element 13 to cooperate with the traction of the fixing part 12 on the sealing part 11, strengthen the fit between the sealing part 11 and the mouth of the left atrial appendage, thereby improving the stability and occlusion performance of the left atrial appendage occluder 11. In addition, since the electrical isolation between the left atrial appendage and the left atrium can be achieved while occluding the left atrial appendage, the patient can maintain sinus rhythm for a long time without the risk of cerebral vascular blockage caused by the detachment of thrombus in the left atrial appendage.

[0044] It should be noted that when the refrigerant is injected into the ablation element 13, the liquid refrigerant output from the freezing device is sprayed into the channel entrance of the ablation element 13 and rapidly vaporizes, and the vaporized refrigerant quickly fills the ablation element 13. When the liquid refrigerant N2O is sprayed into the ablation element 13 and vaporizes, the vaporized liquid refrigerant N2O absorbs heat from the surrounding tissue, causing the temperature of the myocardial tissue in contact with the ablation element 13 to rapidly drop to a lower temperature, for example, to below -30°C. In this way, the temperature of the myocardial cells at the mouth or neck of the left atrial appendage is rapidly reduced due to the freezing of the refrigerant N2O vaporization (hereinafter referred to as the "freezing stage"). After the freezing is completed, the temperature of the frozen area at the mouth or neck of the left atrial appendage gradually rises (hereinafter referred to as the "warming stage"). During the freezing stage, ice crystals form in the myocardial tissue, causing myocardial cell dehydration and necrosis, and destroying the cell structure. During the warming stage, the ice crystals melt, resulting in obstruction of microcirculation, secondary damage, and ultimately irreversible damage to the myocardial tissue, thereby forming an isolation zone on the inner wall of the left atrial appendage, preventing the transmission of electrical signals between the left atrial appendage and the left atrium, and achieving an electrical isolation effect.

[0045] In this embodiment, after the ablation piece 13 completes ablation, an embolic agent can be injected into the interior thereof, so that the ablation piece 13 expands and presses against the inner wall of the left atrial appendage, thereby further strengthening the fixation and occlusion. In other words, the ablation piece 13 can play a fixing role, further improving the anchoring effect of the left atrial appendage occluder 1.

[0046] In this embodiment, the ablation element 13 is located between the sealing portion 11 and the fixing portion 12 , and the final cryoablation position is also located between the sealing portion 11 and the fixing portion 12 .

[0047] In another embodiment, the ablation element 13 is located at the distal end of the fixing portion 12 , that is, the side away from the sealing portion 11 , and the final cryoablation position is also located at the distal end of the fixing portion 12 .

[0048] In another embodiment, the left atrial appendage occluder 1 includes a plurality of ablation elements 13, which are distributed between the sealing portion 11 and the fixing portion 12 and / or on the distal side of the fixing portion 12, to further enhance the ablation effect and the fixing effect after the ablation element 13 is injected with the embolic agent.

[0049] In this embodiment, at least one layer of flow-blocking membrane is provided inside the sealing portion 11 to prevent blood from flowing from the left atrium to the left atrial appendage, thereby ensuring a tight seal on the opening of the left atrial appendage.

[0050] In this embodiment, the size of the flow-blocking membrane on sealing portion 11 is comparable to the size of the disk surface of sealing portion 11, allowing the membrane to completely cover the disk surface of sealing portion 11 to achieve a tight seal. The flow-blocking membrane is made of a polymer material, preferably PTFE (Polytetrafluoroethylene) or PET (Polyethylene terephthalate).

[0051] In another embodiment, at least one layer of flow-blocking membrane (not shown in the figure) may be provided inside or outside the fixing portion 12, thereby cooperating with the sealing portion 11 to achieve multiple occlusions and improve the occlusion performance of the left atrial appendage.

[0052] In this embodiment, the ablation element 13 is a balloon structure, which is sleeved on the connecting portion 14 connecting the sealing portion 11 and the fixing portion 12 . The connecting portion 14 is hollow and tubular, and a through hole 1411 is provided on the connecting portion 14 to connect to the interior of the ablation element 13 .

[0053] In this embodiment, the connecting portion 14 is located between the sealing portion 11 and the fixing portion 12, and a proximal connecting piece 111 is provided on the sealing portion 11. The proximal connecting piece 111 serves as both a gathering portion for the nickel-titanium wire on the proximal surface of the sealing portion 11 and a connecting portion between the left atrial appendage occluder 1 and the conveying device. A thread is provided at the proximal end of the proximal connecting piece 111, which is detachably connected to the conveying device for conveying the left atrial appendage occluder 1 through the thread. After the conveying device completes conveying the left atrial appendage occluder 1, the proximal connecting piece 111 and the conveying device are detached from the proximal connecting piece 111.

[0054] A accommodating cavity 141 is provided in the connecting portion 14, and the accommodating cavity 141 is connected to the interior of the ablation part 13 through a through hole 1411. At the same time, a gathering portion 142 is provided on the side of the accommodating cavity 141 close to the sealing portion 11. The outer side of the gathering portion 142 gathers and fixes the nickel-titanium wire at the distal end of the sealing portion 11, and the inner side of the gathering portion 142 is connected to the accommodating cavity 141.

[0055] The proximal connector 111 is provided with a channel 1111, which is opposite to the constriction 142. The delivery device (generally a steel cable) of the left atrial appendage occluder 1 is threadedly connected to the proximal connector 111. A catheter is provided inside the delivery device to transfer the refrigerant from the freezing device to the ablative element 13. Therefore, the catheter passes through the channel 1111 and is inserted into the constriction 142 to communicate with the accommodating cavity 141, thereby achieving the injection of liquid into the ablative element 13.

[0056] Specifically, the delivery device is fixed on the proximal connector 111, and a catheter is provided inside the delivery device. The catheter passes through the channel 1111 of the proximal connector 111 and passes through the interior of the contraction portion 142 to connect the accommodating cavity 141 and the interior of the ablation component 13. After the delivery device delivers the left atrial appendage occluder 1 to a predetermined position, the catheter injects a refrigerant into the ablation component 13 so that the ablation component 13 can exert an ablation effect, or in a subsequent step, an embolic agent is injected into the ablation component 13 so that the ablation component 13 can play a supporting role. After the entire injection process is completed, the delivery device and the proximal connector 111 are kept connected, the catheter is withdrawn, and then the delivery device is rotated to separate the delivery device from the proximal connector 111, thereby achieving the complete release of the left atrial appendage occluder.

[0057] That is, the catheter actually passes through the sealing portion 11 and reaches the position of the convergent portion 142. The sealing portion 11 is provided with a flow-blocking membrane. Therefore, the catheter needs to pass through the flow-blocking membrane, so the following two points must be met:

[0058] First, when injecting liquid into the ablative element 13, the sealing effect of the sealing portion 11 is maintained;

[0059] Secondly, after the delivery device is withdrawn from the body, the sealing effect of the sealing portion 11 is maintained.

[0060] In order to simultaneously meet the above two points, that is, it is necessary to meet the following requirements: when the catheter passes through the sealing part 11, the catheter passes through the flow-blocking membrane inside the sealing part 11. At this time, the channel 1111 and the accommodating cavity 141 are connected, but this does not affect the sealing effect of the sealing part 11; when the catheter is withdrawn from the body, the sealing part 11 can still play a blocking role.

[0061] The known flow blocking film is located between the proximal connector 111 and the connecting portion 14. Figure 2 , Figure 2 This is a working schematic diagram of the flow-blocking membrane 20 in Example 1 of the present invention. At this time, the catheter 20 passes through the flow-blocking membrane 112, and a part of the center position of the flow-blocking membrane 112 is sewn and covered with multiple nickel-titanium wires 113 that are closed together. The free ends of the nickel-titanium wires 113 have a tendency to close. When the proximal connector 111 enters the sealing portion 11, the free ends of the nickel-titanium wires 113 separate from each other and cling to the surface of the proximal connector 111 under the rebound tendency. At this time, the channel 1111 and the connecting portion 141 are connected; after the catheter 20 is withdrawn, the nickel-titanium wires 113 recover by themselves through their own elastic force, that is, the free ends of the nickel-titanium wires 113 gather together, the opening of the flow-blocking membrane 112 is sealed, and the sealing portion 11 as a whole has a sealing effect.

[0062] In another embodiment, the nickel-titanium wire can be replaced with multiple elastic leaflet structures with through holes in the middle of the multiple leaflet structures. The leaflet structures squeeze each other and seal the through holes under the action of elasticity. The material of the leaflet structure can be made of PET film, PTFE film, silicone and other materials.

[0063] Reference Figure 3-4 , Figure 3 FIG1 shows a cross-sectional schematic diagram of the left atrial appendage occluder 1 in Example 1 of the present invention, Figure 4 yes Figure 3 In the enlarged schematic diagram of the middle A area, further control of the injection of the ablation component 13 can be achieved by setting a control component 15 between the ablation component 13 and the connecting part 14 (that is, at the position where the accommodating cavity 141 is connected to the ablation component 13). The control component 15 in this embodiment includes a sealing cover 131 and an exchange channel 132, wherein the sealing cover 131 is located on the side close to the ablation component 13, and the exchange channel 132 connects the accommodating cavity 141 and the interior of the ablation component 13, and the sealing cover 131 covers the end face of the exchange channel 132 on one side close to the ablation component 13, and in order to ensure a good sealing effect, a protrusion is provided on the sealing cover 131 to be inserted into the exchange channel 132.

[0064] When unstressed, a spring in tension is provided on the side of the sealing cover 131 proximal to the exchange channel 132. The spring pulls the sealing cover 131 tight against the surface of the exchange channel 132. When unstressed, the sealing cover 131 tends to seal the exchange channel 132. When the internal fluid pressure of the accommodating chamber 141 reaches a set value, the sealing cover 131 is pressed radially away from the axis of the connecting portion 141 (i.e., the sealing cover 131 is separated from the surface of the exchange channel 132). At this point, the exchange channel 132 is opened, allowing fluid to enter the ablation element 13. When the internal fluid pressure of the accommodating chamber 141 falls below the set value, the sealing cover 131 returns to its original position, sealing the exchange channel 132. Liquid exchange between the ablation element 13 and the accommodating chamber 141 ceases.

[0065] It can be understood that in other embodiments, if the fixing part is formed by cutting the nickel-titanium tube, the proximal end of the fixing part can also accommodate the proximal end of the sealing part 11. At this time, the tubular structure of the fixing part close to the sealing part can also be equivalent to the connecting part supporting the ablation part between the fixing part and the sealing part.

[0066] Example 2

[0067] The same parts as those in Example 1 will not be described here. The difference lies in that Example 2 uses a different control component from that in Example 1. Figure 5-8 , Figure 5 is a schematic structural diagram of the left atrial appendage occluder 2 in Example 2, Figure 6 is a schematic structural diagram of the control component 25 in Example 2, Figure 7 yes Figure 6 The cross-section of the BB plane, Figure 8 This is a working diagram of the control component 25 in Example 2. The control component 25 is located in the accommodating cavity 241 , and the through hole 253 on the control component 25 is used to connect the inner cavity of the control component 25 with the ablation component 23 .

[0068] The control assembly 25 includes a movable part 251 and a fixed part 252. The movable part 251 and the fixed part 252 are connected by a spring. When no force is applied, the spring presses the movable part 251 against the proximal end surface of the second cavity 2521 of the fixed part 252. The movable part 251 can be separated from the surface of the fixed part 252 when force is applied. Specifically, the first part 2511 of the movable part 251 is connected to the fixed part 252 by a spring, and the spring is in a stretched state, that is, the first part 2511 and the fixed part 251 tend to approach each other when no external force is applied. The second part 2512 of the movable part 251 is located at the proximal end of the first part, and includes a first cavity 25111 and a side channel 25112 connected to the first cavity 25111. The second part 2512 is located in the second cavity 2521 inside the fixed part 252 and can move along the inner wall of the second cavity 2521. The fixed part 252 includes the second cavity 2521, and the first cavity 25111 can be connected to the through hole 253 on the side wall of the fixed part 252. In a natural state, the second part 2512 is located at the proximal end of the fixed part. When the second part 2512 moves toward the distal end, the side channel 25112 gradually connects to the through hole 253. The through hole 253 is an internal channel between the ablation part 23 and the first cavity 25111.

[0069] Therefore, when the catheter 20 is inserted into the interior of the first lumen 25111, and the side channel 25112 is connected to the through-hole 251, the interior of the ablative element 23 can be injected with liquid. To achieve a sealing effect, the bottom opening 2522 of the fixed portion 252 is sealed with the catheter 20, and the injection port of the catheter 20 is located on the side wall of the end of the catheter 20. Specifically, in the initial state, the first portion 2511 maintains contact with the fixed portion 251, and the catheter 20 extends axially into the first lumen 25111, with the top of the straight catheter 20 abutting the distal end surface of the first lumen 25111. At this time, if the catheter 20 is further pushed, the catheter 20 drives the second portion 2512 to move axially. On the one hand, the catheter 20 overcomes the spring pressure and drives the first portion 2511 away from the fixed portion 252. On the other hand, the movement of the second portion 2512 along the second lumen 2521 causes the side channel 25112 to gradually connect with the through-hole 253, thereby achieving communication between the catheter 20 and the ablative element 23. When the catheter 20 is withdrawn, the spring is reset due to the presence of the spring, and the first portion 2511 continues to be pressed against the fixed member 252 , and the through hole 253 is sealed by the side wall of the movable member 251 .

[0070] In another embodiment, the movable member 251 is threadedly connected to the outer side of the fixed portion 252, while the remaining structure remains unchanged. The catheter 20 is inserted into the interior of the first lumen 25111. When the side channel 25112 is connected to the through-hole 251, the interior of the ablative element 23 can be injected with liquid. The catheter 20 is also threadedly connected to the opening of the second portion 2512 (i.e., the opening of the first lumen 25111). The locking direction of the threaded engagement between the catheter 20 and the second portion 2512 is the same as the locking direction between the first portion 2511 and the fixed portion 252. However, the locking force between the catheter 20 and the second portion 2512 (i.e., the friction force when the catheter 20 and the second portion 2512 rotate relative to each other along the thread groove) is greater than the locking force between the first portion 251 and the fixed portion 252 (i.e., the friction force when the first portion 251 and the fixed portion 252 rotate relative to each other along the thread groove).

[0071] In the initial state, the first part 2511 and the fixing part 251 are locked with each other, the catheter 20 is extended into the first cavity 25111, rotates along the first direction and gradually extends into the first cavity 25111, and the top of the straight catheter 20 is against the distal end face of the first cavity 25111; at this time, the catheter 20 continues to rotate, and the catheter 20 drives the second part 2512 to rotate along the first direction, driving the first part 2511 to separate from the fixing part 252, thereby driving the second part 2512 to move along the second cavity 2521 until the side channel 251112 gradually connects with the through hole 253, thereby realizing the connection between the catheter 20 and the ablation component 23. When withdrawing catheter 20, it rotates in the second direction. Because the locking force between catheter 20 and second portion 2512 is greater than the locking force between first portion 251 and fixed portion 252, catheter 20 first drives second portion 2512 to rotate together, gradually tightening first portion 251 and fixed portion 252 until side channel 25112 is no longer connected to through-hole 253, thereby eliminating communication between catheter 20 and ablation element 23. Once second portion 2512 contacts the proximal inner wall of second lumen 2521, catheter 20 continues to rotate in the second direction, disengaging from second portion 2512 and sealing through-hole 253 with the side wall of movable member 251.

[0072] Example 3

[0073] The same parts as those in Example 1 are not described here. The difference lies in that Example 3 uses a different control component from that in Example 1. Figure 9 , Figure 9Figure 3 is a schematic diagram of the control assembly in Example 3 of the present invention. The control assembly in this embodiment includes a hollow valve body 351 and a spring structure 352 disposed on the exterior of the valve body 351. The valve body 351 is generally U-shaped, with its opening facing the interior of the connecting portion and communicating with the interior of the connecting portion. A through hole 3511 is provided at the bottom of the valve body 351, which communicates with the ablative element. One end of the spring structure 352 is fixed to the outer wall of the valve body 351, while the other end engages and covers the through hole 3511. When unstressed, the spring structure 352 remains engaged. The free end of the spring structure 352 is provided with a protrusion 3521, which is inserted into the through hole 3511 of the valve body 351 to seal the through hole 3511. When the liquid pressure inside the valve body 351 reaches a predetermined value, the free end of the spring structure 352 is pressurized, and the protrusion 3521 leaves the through hole 3511, so that the interior of the valve body 351 is connected with the ablation component.

[0074] It is understandable that in other embodiments, the through hole 3511 may also be provided on other side walls of the valve body 351 as long as communication between the interior of the connecting portion and the interior of the ablation component can be achieved.

[0075] Example 4

[0076] The same parts as those in Example 1 will not be described here. The difference lies in that Example 4 uses a different ablation element structure from that in Example 1. Figure 10-11 , Figure 10 is a schematic structural diagram of a left atrial appendage occluder 4 in Example 4 of the present invention, Figure 11 Schematic diagram of the structure of the ablation element 43 in Example 4 of the present invention. In this embodiment, the ablation element 43 is a split structure, that is, multiple ablation sub-elements are distributed circumferentially at the same axial position. In this embodiment, there are preferably three ablation sub-elements, with the first ablation sub-element 431, the second ablation sub-element 432, and the third ablation sub-element 433 being evenly spaced. After expansion, the ablation element 43 thus arranged has better flexibility and closer contact with the inner wall of the left atrial appendage, thereby achieving a better contact effect. In this embodiment, the ablation sub-elements are all balloon structures.

[0077] It is understandable that the three intermediate components can be controlled separately by three control components.

[0078] Example 5

[0079] The same parts as those in Example 1 will not be described here. The difference lies in that Example 5 uses a different ablation element structure from that in Example 1. Figure 12-13 As shown, Figure 12 is a three-dimensional schematic diagram of the fixing portion 32 in Example 5 of the present invention, Figure 133 is a schematic structural diagram of the left atrial appendage occluder 3 in Example 5 of the present invention. A plurality of cantilever rods are provided on the fixing portion 32 , including a cantilever rod 321 and a cantilever rod 322 .

[0080] A barb assembly 3211 is provided on the cantilever rod 322. The barb assembly 3211 plays an anchoring role after the fixing portion 32 is released, anchoring the fixing portion 32 to the inner wall of the left atrial appendage.

[0081] In this embodiment, the ablation element 33 is arranged on the cantilever rod 321. The ablation element 33 is a balloon structure. The passage 331 of the ablation element 33 is arranged along the cantilever rod 321 and extends into the accommodating cavity 341. The accommodating cavity 341 is also connected to the ablation element 33 through the passage 331.

[0082] When the left atrial appendage occluder of this embodiment is released, the fixing portion 32 expands, the outer side of the cantilever rod of the fixing portion 32 presses against the inner wall of the left atrial appendage, and the hook assembly 3211 further clamps the fixing portion 32 on the inner wall of the left atrial appendage. At this time, the refrigerant is injected into the ablation component 33 along the passage 331, and the ablation component 33 collides with and adheres to the inner wall of the left atrial appendage, thereby achieving cryoablation of the inner wall of the left atrial appendage.

[0083] Preferably, the passage 331 is arranged along the inner side of the cantilever rod 331 to prevent the passage 331 from contacting the inner wall of the left atrial appendage.

[0084] Preferably, the cantilever rod 331 and the cantilever rod 332 are spaced apart, which can ensure both a good anchoring effect and a uniform state of cryoablation.

[0085] In another embodiment, after cryoablation is completed, an embolic agent is injected into the ablation component 33, so that the ablation component 33 expands and presses against the inner wall of the left atrial appendage, thereby making the ablation component 33 have a good fixing effect, further improving the anchoring ability of the fixing part 32, and effectively reducing the risk of the left atrial appendage occluder in this embodiment falling off.

[0086] In another embodiment, the cantilever rod can be a single rod, or a forked rod or a diamond rod can be provided at the tail end. Figure 14 As shown, Figure 14 It is a structural diagram of a cantilever rod in another embodiment of embodiment 5 of the present invention. The cantilever rod can be set to a forked rod 3221, a diamond rod 3222, a diamond rod 3223, a round rod 3224 and a round rod 3225, etc.

[0087] In another embodiment, if Figure 13 As shown, Figure 15 This is a structural diagram of the fixing portion 52 in another embodiment of Example 5 of the present invention. The fixing portion 52 is disc-shaped, and the ablation component 53 can be simultaneously arranged at the proximal and distal ends of the hook position of the fixing portion 52 to further enhance the freezing and blocking effects.

[0088] Example 6

[0089] The same parts as those in Example 1 will not be described here. The difference lies in that the ablation element in Example 6 is located at a different position than that in Example 1. Figure 16-17 As shown, Figure 16 Schematic diagram of the first stage of release of the left atrial appendage occluder 6 in Example 6 of the present invention, Figure 17 This is a schematic diagram of the second stage of release of the left atrial appendage occluder 6 in Example 6 of the present invention. The fixing portion 62 of the left atrial appendage occluder 6 is a columnar structure, the ablation component 63 is located inside the fixing portion 62, and the connecting portion 64 extends into the inside of the fixing portion 62. After the fixing portion 62 is released, a refrigerant is injected into the ablation component 63 to achieve cryoablation of the inner wall of the left atrial appendage, thereby achieving electrical isolation between the left atrial appendage and the left atrium.

[0090] In addition, the expansion of the ablation element 63 increases the radial support force of the fixing portion 62 and also helps the fixing portion 62 to be better anchored on the inner wall of the left atrial appendage.

[0091] It is understandable that the occluder may also have at least two ablation components, and the multiple ablation components may be respectively arranged in the fixing portion and between the fixing portion and the sealing portion to achieve a multiple ablation effect.

[0092] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

Claims

1. An occluder, comprising a fixing portion, a sealing portion, and a connecting portion connected between the fixing portion and the sealing portion, characterized in that: The occluder also includes a hollow ablation component for cryoablation, which is arranged on the connecting part. A accommodating cavity is provided inside the connecting part, and the accommodating cavity is connected to the interior of the ablation component. The ablation component includes an expandable balloon structure, and the ablation component is always located on the distal side of the sealing part.

2. The occluder according to claim 1, characterized in that: The number of the balloons of the ablation component is one or more.

3. The occluder according to claim 1, characterized in that: An annular flow-blocking membrane is provided on the sealing portion, and the annular flow-blocking membrane has a through hole. A plurality of flow-blocking parts are provided on the edge of the through hole of the flow-blocking membrane, one end of the flow-blocking part is connected to the annular flow-blocking membrane, and the other end is a free end. The flow-blocking parts gather together when not under force.

4. The occluder according to claim 1, characterized in that The occluder is provided with a control component, and the control component controls the connection and / or disconnection between the accommodating cavity and the ablation component.

5. The occluder according to claim 4, characterized in that: The control component includes a sealing cover and an exchange channel, wherein the exchange channel communicates with the accommodating cavity and the interior of the ablation component. The sealing cover is provided with an elastic structure, which drives the sealing cover to press and seal the exchange channel in the absence of external force.

6. The occluder according to claim 4, characterized in that: The control component includes a fixed part and a movable part that can move relative to the fixed part. The movable part includes a first part and a second part. The second part is provided with a first cavity inside, and the fixed part is provided with a second cavity inside. The fixed part is provided with a connecting hole that is connected to the interior of the ablation part. The second part moves along the inner wall of the second cavity. When the second part moves to a predetermined position, the first cavity is connected to the connecting hole.

7. The occluder according to claim 4, characterized in that: The control assembly includes a valve body and a spring structure. The valve body is provided with an opening. One end of the spring structure is connected to the valve body, and the other end is freely buckled on the opening surface to seal the opening in a natural state.

8. The occluder according to claim 6, characterized in that: It also includes sub-ablation parts, and there are multiple sub-ablation parts. The sub-ablation parts are arranged on the fixing part. The sub-ablation parts are connected to the connecting part through a passage, and the passage is located inside the fixing part.

9. The occluder according to claim 1, characterized in that: It also includes a plurality of sub-ablation parts, some of which are arranged inside the fixing part, and the other sub-ablation parts are arranged between the fixing part and the sealing part.

10. A blocking system, characterized in that: The occluder according to any one of claims 1 to 9 further comprises a medium conveying device detachably connected to the connecting portion, wherein the medium conveying device is communicated with the accommodating cavity to transmit the medium to the ablation component.

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