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. The occluder includes a fixing portion, a sealing portion, and a connecting portion connected between the fixing portion and the sealing portion. The occluder also includes a plurality of hollow ablation parts, which are arranged on the fixing portion. The occlusion system includes a medium conveying device that can be detachably connected to the connecting portion. By arranging the ablation part on the fixing portion, while the occluder blocks the mouth of the left atrial appendage, the ablation part cooperates with the 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. In addition, the ablation part located at the fixing portion can also cooperate with the embolic agent to increase the anchoring ability of the fixing portion. After the embolic agent is injected and expanded, the ablation part presses against the inner wall of the left atrial appendage, further reducing the possibility of the occluder falling off from the anchoring position.

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 plurality of hollow ablation members, wherein the ablation members are arranged on the fixing portion, and the distance between at least part of the outer surface of the ablation member and the axis of the occluder is greater than or equal to the distance between any point on the fixing portion and the axis. An accommodating cavity is provided inside the connecting portion, and the accommodating cavity is connected to the interior of the ablation member.

[0008] In one embodiment, the invention 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 element.

[0009] In one embodiment, the ablation element is connected to the accommodating cavity via a tube, the fixing portion includes a rod, and the tube extends along a surface of the rod.

[0010] In one embodiment, the connecting portion further includes a circulation cavity, which is connected to the accommodating cavity through a connecting hole. One end of the pipe is connected to the interior of the ablation component, and the other end is connected to the circulation cavity.

[0011] In one embodiment, the conduit is located inside the rod.

[0012] In one embodiment, the delivery channel is provided with a control component, and the control component controls the connection and / or disconnection between the accommodating cavity and the ablation element.

[0013] 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 presses the sealing cover to seal the exchange channel in the absence of external force.

[0014] In one embodiment, the control component comprises a fixed part and a movable part that can move relative to the fixed part, the movable part comprises 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 that is 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.

[0015] 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.

[0016] 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.

[0017] The occluder and occlusion system provided by the present invention have an ablation element at the fixed position. While the occluder is blocking the opening of the left atrial appendage, the ablation element 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 achieving 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, and reducing the operational difficulty and risk of active left atrial appendage electrical isolation. At the same time, the occlusion of the left atrial appendage is achieved. Under the dual effects of electrical isolation and occlusion, the occurrence of stroke can be better prevented, and the postoperative treatment effect is better. In addition, the ablation element at the fixed position can also cooperate with an embolic agent to increase the anchoring ability of the fixed part. After the embolic agent is injected, the ablation element expands and presses against the inner wall of the left atrial appendage, further reducing the possibility of the occluder falling off from the anchoring position. 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 fixing member in Example 1 of the present invention;

[0020] Figure 3 Schematic diagram of the working of the flow-blocking membrane in Example 1 of the present invention;

[0021] Figure 4 Schematic cross-sectional view of the left atrial appendage occluder in Example 1 of the present invention;

[0022] Figure 5 for Figure 4 A magnified schematic diagram of area A in the middle;

[0023] Figure 6 Schematic diagram of the structure of the left atrial appendage occluder in Example 2 of the present invention;

[0024] Figure 7 Schematic diagram of the structure of the control component in Example 2 of the present invention;

[0025] Figure 8 for Figure 7 Sectional view of the middle BB plane;

[0026] Figure 9 This is a schematic diagram of the operation of the control component in Example 2 of the present invention;

[0027] Figure 10 Schematic diagram of the structure of the control component in Example 3 of the present invention;

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

[0029] Figure 12 Schematic diagram of the structure of the fixing portion in Example 5 of the present invention;

[0030] Figure 13 This is a schematic diagram of the first stage of release of the left atrial appendage occluder in Example 6 of the present invention;

[0031] Figure 14 Schematic diagram of the second stage of release of the left atrial appendage occluder in Example 6 of the present invention;

[0032] Figure 15 Schematic diagram of the structure of the left atrial appendage occluder in Example 7 of the present invention;

[0033] Figure 16 Schematic diagram of the structure of the left atrial appendage occluder in Example 8 of the present invention;

[0034] Figure 17 This is a schematic structural diagram of the ablation component in Example 8 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] Reference Figure 1 , 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] Reference Figure 2 , Figure 2 The structural diagram of the fixing member 12 in the embodiment 1 of the present invention is shown. Figure 2 The structure of the fixing part 12 shown in the figure, the fixing part 12 includes a plurality of cantilever rods, the cantilever rods include a first cantilever rod 121 and a second cantilever rod 222, wherein the first cantilever rod 121 is provided with an ablation part 13, and the second cantilever rod 122 is provided with a barb 1211, and the cantilever rod 321 is provided with a hook assembly 1211, and the hook assembly 1211 plays an anchoring role after the fixing part 12 is released, anchoring the fixing part 12 to the inner wall of the left atrial appendage.

[0042] In this embodiment, 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 achieving electrical isolation between the left atrial appendage and the left atrium, achieving the effect of electrical isolation, and enabling the patient to maintain normal sinus rhythm for a long time after electrical isolation of the left atrial appendage.

[0043] 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 comprises a balloon made of a compliant material, such as a polyamide and 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.

[0044] Because the ablating element 13 has excellent compliance, it will not significantly affect the size selection of the delivery device during delivery. Furthermore, the ablating element 13 can rapidly expand after being injected with refrigerant, and when filled to a certain degree, can fully abut the inner wall of the left atrial appendage. Thus, the ablating element 13 forms an isolation area on the inner wall of the left atrial appendage with the help of the refrigerant, and multiple ablating elements form an isolation zone on the inner wall of the left atrial appendage, thereby achieving electrical isolation between the left atrial appendage and the left atrium. Thus, the shape of the ablating element 13 can be changed accordingly according to the degree of filling of the ablating element 13 to cooperate with the traction of the fixing portion 12 on the sealing portion 11, strengthen the fit between the sealing portion 11 and the opening of the left atrial appendage, and thus improve the stability and occlusion performance of the left atrial appendage occluder 11. Furthermore, because 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 obstruction caused by the detachment of thrombus in the left atrial appendage.

[0045] 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.

[0046] 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.

[0047] In this embodiment, the ablation element 13 is disposed in the fixing portion 12 , and the final cryoablation position is also located at the location of the fixing portion 12 .

[0048] Preferably, adjacent first cantilever rods 121 are spaced apart by equal numbers of second cantilever rods 122 , which can ensure both a good anchoring effect and a uniform state of cryoablation.

[0049] When the left atrial appendage occluder of this embodiment is released, the fixing portion 12 expands, the outer side of the cantilever rod of the fixing portion 12 presses against the inner wall of the left atrial appendage, and the barb assembly 1211 further clamps the fixing portion 12 on the inner wall of the left atrial appendage. At this time, refrigerant is injected into the ablation component 13 along the pipeline 131, and the ablation component 13 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.

[0050] In another embodiment, after cryoablation is completed, an embolic agent is injected into the ablation component 13, so that the ablation component 13 expands and presses against the inner wall of the left atrial appendage, thereby making the ablation component 13 have a good fixing effect, further improving the anchoring ability of the fixing part 12, and effectively reducing the risk of the left atrial appendage occluder falling off in this embodiment.

[0051] 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.

[0052] 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).

[0053] 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.

[0054] In this embodiment, the ablation component 13 is a balloon structure and is arranged on the fixing part 12 (at least part of the side surface of the ablation component 13 is located on the outside of the fixing part 12). The sealing part 11 and the fixing part 12 are connected by a connecting part 14. The connecting part 14 is a hollow tube and is provided with a through hole 1411 to connect to the interior of the ablation component 13.

[0055] 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.

[0056] A accommodating cavity 141 is provided in the connecting portion 14, and the accommodating cavity 141 is connected to the pipeline 131 through the through hole 1411, thereby connecting to the interior of the ablation part 13. At the same time, a convergence portion 142 is provided on the side of the accommodating cavity 141 close to the sealing portion 11. The outer side of the convergence portion 142 converges and fixes the nickel-titanium wire at the distal end of the sealing portion 11, and the inner side of the convergence portion 142 is connected to the accommodating cavity 141.

[0057] In this embodiment, a circulation cavity 143 is further provided in the connecting portion 14. Since there are multiple ablation components 13, multiple pipes 131 are correspondingly provided. The entrances of the pipes 131 are all located inside the circulation cavity 143. The circulation cavity 143 and the accommodating cavity 141 are connected through the through hole 1411.

[0058] In another embodiment, multiple pipes 131 are converged into a single pipe directly connected to the through hole 1411 .

[0059] In another embodiment, a plurality of through holes 1411 are provided in the accommodating cavity 141 , and the through holes 1411 correspond to the pipes 131 one by one and are connected to each other.

[0060] In this embodiment, the ablation element 13 is arranged on the first cantilever rod 121. The ablation element 13 is a balloon structure. The tube 131 of the ablation element 13 extends along the surface of the first cantilever rod 121 at the position of the fixing portion 12 and extends into the circulation cavity 143 to connect with the accommodating cavity 141.

[0061] Preferably, the pipe 131 is arranged along the inner side of the first cantilever rod 112 to prevent the pipe 131 from contacting the inner wall of the left atrial appendage. Furthermore, in order to achieve a better ablation effect, that is, to ensure that the ablation element 13 can contact the inner wall of the left atrial appendage, at least part of the surface of the ablation element 13 is preferably located on the outside of the first cantilever rod 121 or coplanar with the outer surface of the first cantilever rod 121, that is, the distance from at least part of the surface of the ablation element 13 to the axis of the left atrial appendage occluder 1 is greater than or equal to the distance from any point on the fixing part 12 to the axis of the left atrial appendage occluder 1.

[0062] Preferably, the cantilever rod 131 and the cantilever rod 112 are spaced apart, which can ensure both a good anchoring effect and a uniform state of cryoablation.

[0063] In another embodiment, one ablation element 13 spans across a plurality of cantilever rods on the fixing portion 12 along a ring shape, that is, the ablation element 13 may be an annular element provided on the fixing portion 12 .

[0064] In this embodiment, a channel 1111 is provided inside the proximal connector 111, and the channel 1111 is directly opposite the constriction portion 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 refrigerant from the freezing device to the interior of the ablative element 13. Therefore, the catheter passes through the channel 1111 and is inserted into the interior of the constriction portion 142 to communicate with the accommodating cavity 141, thereby achieving injection of liquid into the ablative element 13.

[0065] 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.

[0066] 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:

[0067] First, when injecting liquid into the ablative element 13, the sealing effect of the sealing portion 11 is maintained;

[0068] Secondly, after the delivery device is withdrawn from the body, the sealing effect of the sealing portion 11 is maintained.

[0069] 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.

[0070] The known flow blocking film is located between the proximal connector 111 and the connecting portion 14. Figure 3 , Figure 3 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.

[0071] 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.

[0072] Reference Figure 4-5 , Figure 4 FIG1 shows a cross-sectional schematic diagram of the left atrial appendage occluder 1 in Example 1 of the present invention, Figure 5 yes Figure 4In the enlarged schematic diagram of area A, further control of the injection of the ablating element 13 can be achieved by disposing a control assembly 15 at a predetermined position between the ablating element 13 and the connecting portion 14. This position is the through-hole connecting the accommodating cavity 141 and the circulation cavity 143 (or the ablating element 13). In this embodiment, the control assembly 15 includes a sealing cover 151 and an exchange channel 152, wherein the sealing cover 151 is located on the side close to the ablating element 13, and the exchange channel 152 connects the accommodating cavity 141 and the interior of the ablating element 13. The sealing cover 151 covers the end surface of the exchange channel 152 close to the ablating element 13, and to ensure a good sealing effect, the sealing cover 151 is provided with a protrusion that snaps into the exchange channel 152.

[0073] When unstressed, a spring in tension is provided on the side of the sealing cover 151 proximal to the exchange channel 152. The spring pulls the sealing cover 151 tight against the surface of the exchange channel 152. When unstressed, the sealing cover 151 tends to seal the exchange channel 152. When the internal fluid pressure of the accommodating chamber 141 reaches a set value, the sealing cover 151 is pressed radially away from the axis of the connecting portion 141 (i.e., the sealing cover 151 is separated from the surface of the exchange channel 152). At this point, the exchange channel 152 is opened, allowing fluid to enter the ablation element 15. When the internal fluid pressure of the accommodating chamber 141 falls below the set value, the sealing cover 151 returns to its original position, sealing the exchange channel 152. Liquid exchange between the ablation element 15 and the accommodating chamber 141 ceases.

[0074] 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.

[0075] Example 2

[0076] 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 6-9 , Figure 6 is a schematic structural diagram of the left atrial appendage occluder 2 in Example 2, Figure 7 is a schematic structural diagram of the control component 25 in Example 2, Figure 8 yes Figure 7 The cross-section of the BB plane, Figure 9 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 .

[0077] 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.

[0078] 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 .

[0079] 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).

[0080] 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.

[0081] Example 3

[0082] 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 10 , Figure 10Figure 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.

[0083] 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.

[0084] Example 4

[0085] The same parts as those in Example 1 will not be described here. The difference lies in that Example 4 uses a cantilever rod structure different from that in Example 1. Figure 11 As shown, Figure 11 This is a schematic diagram of the cantilever rod structure in Example 4 of the present invention. The cantilever rod can be a single rod, or it can be configured with a bifurcated rod 3221, a diamond rod 3222, a diamond rod 3223, a round rod 3224, and a round rod 3225 at the tail end. This configuration of the cantilever rod can adapt to a variety of environments, and in combination with an ablation device, multiple ablation devices can be installed on a single cantilever rod.

[0086] Example 5

[0087] The same parts as those in Example 1 will not be described here. The difference lies in that Example 5 uses a cantilever rod structure different from that in Example 1. Figure 12 As shown, Figure 12 It is a structural diagram of the fixing portion 42 in Example 5 of the present invention. The fixing portion 52 is disc-shaped, and the ablation component 43 can be simultaneously arranged at the proximal and distal ends of the hook position of the fixing portion 42 to further enhance the freezing and blocking effects.

[0088] In another embodiment, the ablation elements 43 may be evenly distributed on adjacent cantilever rods, that is, all cantilever rods are first cantilever rods, thereby ensuring that the isolation zone ultimately formed on the inner wall of the left atrial appendage is as continuous as possible.

[0089] Example 6

[0090] 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 13-14 As shown, Figure 13 Schematic diagram of the first stage of release of the left atrial appendage occluder 5 in Example 6 of the present invention, Figure 14 This is a schematic diagram of the second stage of release of the left atrial appendage occluder 5 in Example 6 of the present invention. The fixing portion 52 of the left atrial appendage occluder 5 is a columnar structure, and the ablation component 53 is a balloon structure and is arranged inside the fixing portion 52. The connecting portion 54 extends into the interior of the fixing portion 52. After the fixing portion 52 is released, the refrigerant is injected into the ablation component 53, and the ablation component 53 expands and contacts the inner wall of the fixing portion 52, and partially protrudes from the grid of the fixing portion 52 to contact the inner wall of the left atrial appendage, thereby realizing cryoablation of the inner wall of the left atrial appendage, and then realizing electrical isolation between the left atrial appendage and the left atrium.

[0091] 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.

[0092] It is understandable that the occluder can also have at least two ablation parts, and the multiple ablation parts can be arranged in the fixed part and between the fixed part and the sealing part, so that the diameter of the outer surface of the ablation part after expansion is greater than or equal to the diameter of the fixed part, so as to achieve the effect of multiple ablations.

[0093] Example 7

[0094] The same parts as those in Example 1 will not be described here. The difference lies in that Example 7 uses a different ablation element structure from that in Example 1. Figure 15 As shown, Figure 15 It is a structural schematic diagram of the left atrial appendage occluder 6 in Example 7 of the present invention. The sealing part 61 and the fixing part 62 are connected by a connecting part 64. The connecting part 64 is provided with an ablation part 63, wherein the ablation part 63 is a balloon structure, and the diameter of the ablation part 63 after expansion is greater than or equal to the diameter of the fixing part 62.

[0095] The connecting portion 64 is a hollow tube with an accommodating cavity 641 inside. The distal end of the accommodating cavity 641 is sealed and the proximal end is open. The accommodating cavity 641 is connected to the interior of the ablation component 63 through an opening located on the side wall of the connecting portion 64 .

[0096] Since the ablation element 61 is located between the sealing portion 61 and the fixing portion 62 , the final cryoablation position is also located between the sealing portion 61 and the fixing portion 62 .

[0097] In another embodiment, the ablation element 63 is located at the distal end of the fixing portion 62 , ie, the side away from the sealing portion 11 , and the final cryoablation position is also located at the distal end of the fixing portion 62 .

[0098] In another embodiment, the left atrial appendage occluder includes multiple ablation elements 63, which are distributed between the sealing portion 61 and the fixing portion 62 and / or on the distal side of the fixing portion 62, further enhancing the ablation effect and the fixing effect after the ablation element 63 is injected with the embolic agent.

[0099] Example 8

[0100] The same parts as those in Example 7 will not be described here. The difference lies in that Example 8 uses a different ablation element structure from that in Example 7. Figure 16-17 , Figure 16 is a schematic structural diagram of the left atrial appendage occluder 7 in Example 8 of the present invention, Figure 17 Schematic diagram of the structure of the ablation element 73 in Example 8 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 731, the second ablation sub-element 732, and the third ablation sub-element 733 being evenly spaced. After expansion, the ablation element 43 arranged in this way has better flexibility and is in 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.

[0101] It is understandable that the three intermediate components can be controlled separately by three control components.

[0102] 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 number of hollow ablation parts for cryoablation, which are arranged on the fixed part. The distance between at least part of the outer surface of at least one of the ablation parts and the axis of the occluder is greater than or equal to the distance between any point on the fixed part and the axis. A accommodating cavity is provided inside the connecting part, and the accommodating cavity is connected to the interior of the ablation part. The occluder includes a control component, which controls the connection and / or disconnection between the accommodating cavity and the ablation part.

2. The occluder according to claim 1, characterized in that: The ablation element is connected to the accommodating cavity through a pipeline. The fixing portion includes a rod, and the pipeline extends along the surface of the rod.

3. The occluder according to claim 2, characterized in that: The connecting portion further includes a circulation cavity, which is communicated with the accommodating cavity through a connecting hole. One end of the pipeline is communicated with the interior of the ablation component, and the other end is communicated with the circulation cavity.

4. The occluder according to claim 2, characterized in that: The conduit is located inside the rod.

5. The occluder according to claim 1, characterized in that: The occluder includes a flow-blocking membrane located at a sealing portion, wherein a plurality of nickel-titanium wires that are closed together are sewn to the center of the flow-blocking membrane. When the free ends of the nickel-titanium wires are gathered together, the flow-blocking membrane is sealed.

6. The occluder according to claim 5, 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 presses the sealing cover to seal the exchange channel in the absence of external force.

7. The occluder according to claim 5, characterized in that: The control component comprises a fixed part and a movable part that can move relative to the fixed part, wherein the movable part includes a first part and a second part, a first cavity is provided inside the second part, a second cavity is provided inside the fixed part, a connecting hole connected to the interior of the ablation part is provided on the fixed 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.

8. The occluder according to claim 5, 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.

9. 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.

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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