An apparatus with an adaptive cavity

Abstract

The present invention provides a device with an adaptive cavity, including a central end portion and an anchoring bracket. The anchoring bracket is surrounded by a plurality of elastic support rods diverging from the central end portion. An adaptive structure is provided in a partial or all area of the support rods of the anchoring bracket. When the anchoring bracket is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation response, so that the anchoring bracket fits the inner wall of the cavity adaptively. The device provided by the present invention can adapt to left atrial appendages of various different forms, with a wider adaptability, and greatly reduces the incidence of intraoperative and postoperative complications.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly relates to a device with an adaptive cavity. Background Art

[0002] Atrial fibrillation (hereinafter referred to as "AF") is the most common tachyarrhythmia. During AF, the effective atrial contraction is lost, causing blood to stagnate in the left atrial appendage. In addition, the unique anatomical structure of the left atrial appendage and the unevenness of the internal trabeculae cause the stagnant blood to generate eddy currents, promoting thrombus formation. The thrombus detaches from the left atrial appendage and enters the arterial system, which may cause pulmonary embolism, cerebral infarction, myocardial infarction, etc. The most serious outcome of thrombus detachment is cerebral infarction. Since the thrombus remains in the blood vessels of the brain, restricting blood flow, it causes stroke. Once a stroke occurs, it can cause disability or even death.

[0003] Currently, the prevention strategies for high-risk AF patients mainly include anticoagulant therapy, surgical left atrial appendage ligation, and left atrial appendage occlusion. The application of left atrial appendage occlusion to reduce embolism events caused by atrial fibrillation has become a current research hotspot. The left atrial appendage occlusion is different from other treatment options and is an innovative surgical procedure for preventing stroke in patients with non-valvular AF. It prevents embolism caused by thrombus detachment from the left atrial appendage by occluding the left atrial appendage, thereby avoiding the occurrence of ischemic stroke and systemic embolism. The left atrial appendage occlusion can reduce the risks and traumas brought by surgery, eliminate the patient's dependence on long-term anticoagulant therapy, avoid problems such as patient intolerance, bleeding events, and compliance caused by anticoagulant drugs, and also bring new hope to patients with contraindications to anticoagulant drugs.

[0004] The key device for left atrial appendage occlusion is the occluder. Currently, the structures of the anchor frames of occluders on the market are diverse. However, in terms of product form, they are nothing more than the following two types: The first type is that the distal ends of multiple rods forming the anchor frame are in a freely open state, and the anchor frame forms an umbrella-shaped or bowl-shaped structure, represented by the LAmbre product (patent number: CN201480073126.X) and the WATCHMAN product (patent number: CN201280054920.0); The second type is that the distal end is closed and fixedly connected to form a cage-like structure, represented by the LACbes product of Shanghai Pushi (patent number: CN201610565731.X).

[0005] The disadvantages of the first type of occluder anchor frame are as follows:

[0006] 1. The distal end is in an open state. The distal end of the rod will come into contact with the inner wall of the delivery sheath. Since the distal end of the rod is relatively sharp, it is likely to cause damage to the sheath and the risk of being unable to be released from the sheath. Therefore, the conventional surgical method for installing and releasing the occluder (after the occluder is loaded into the short sheath, the short sheath is connected to the long sheath, and then the occluder is pushed into the long sheath and released) cannot be adopted. This structure requires the occluder to be pre-installed in the long sheath, so the required delivery sheath diameter is relatively large, and the indication range is limited.

[0007] 2. The current measure is to form a ball head at the distal end, but there are still disadvantages such as relatively large resistance to being released from the sheath and poor tactile experience for the operator. Moreover, the ball head is connected to the distal end of the rod by welding or other methods, resulting in problems such as poor corrosion resistance.

[0008] 3. Particularly importantly, the distal end is in an open state, the distal end of the rod is relatively sharp, and the rod is particularly rigid. The inner wall of the left atrial appendage is extremely thin. Even if the ball head measure is adopted at the distal end of the rod, during the process of the operator pushing the occluder out of the sheath and after it is released to the target position, the left atrial appendage will still be stabbed.

[0009] 4. The distal end of the rod is open and completely unconstrained, and the shape of the anchoring frame in the left atrial appendage varies greatly, making it difficult to effectively ensure the anchoring effect.

[0010] The disadvantages of the second type of occluder anchoring frame are as follows:

[0011] 1. The distal end is in a closed state. For manufacturers, the manufacturing process of the closed connection is cumbersome, including the need for additional designed sleeves and fixed connection processes, resulting in increased manufacturing costs. The currently commonly used fixed connection process is welding, and the occurrence of connection failure faults is relatively frequent. The phenomenon of the anchoring frame losing wires or falling apart often occurs clinically.

[0012] 2. Due to the need for additional designed connection structures such as sleeves, the sheath diameter for compression into the delivery sheath is relatively large, restricting the applicable range.

[0013] 3. Particularly importantly, the distal rod is particularly rigid, and the inner wall of the left atrial appendage is extremely thin. Even if the closed distal end (and the sleeve) adopts measures such as a ball head, during the process of the operator pushing the occluder out of the sheath and after it is released to the target position, the inner wall of the left atrial appendage will still be punctured, causing risks such as cardiac tamponade, perforation, and pericardial effusion.

[0014] 4. The anchoring frame is a closed grid-like structure with a large radial supporting force. Therefore, its anatomical shape adaptability in the left atrial appendage is not good, and it is easy to over-correct the shape of the left atrial appendage. The waist of the anchoring frame is likely to cause local irritation and inflammatory reactions to the contact area of the left atrial appendage.

[0015] 5. As the heart beats, the anchoring frame in the left atrial appendage will cause stress concentration and fatigue at its fixed connection points. Since the rod of the anchoring frame adopts a rigid and hard structural design, the rod of the anchoring frame, especially the distal end of the anchoring frame, will wear the inner cavity tissue of the left atrial appendage and even stab the inner wall of the left atrial appendage, resulting in risks such as cardiac tamponade, perforation, and pericardial effusion.

[0016] 6. The anchoring frame is a closed cage-like structure, and the rod of the anchoring frame adopts a rigid and hard structural design. Therefore, the position of the distal fixed connection point is relatively fixed compared to the proximal end of the anchoring frame. In the anatomical morphology of the left atrial appendage, about 80% are bilobed or multilobed left atrial appendages, that is, the left atrial appendage has different depths. When the distance between the opening of the left atrial appendage and the ridge of the lobes inside the left atrial appendage (i.e., the depth of the anchoring area) is too small, especially when it is less than the height of the waist of the anchoring frame, it is very difficult for the anchoring frame to be completely inserted into the left atrial appendage. Therefore, this type of occluder is not suitable for placement in such cases.

[0017] In summary, there is an urgent need to design a device that can adapt to the cavity, which is convenient for safe and smooth release during the operation and can adapt to various anatomical morphologies of the left atrial appendage. Summary of the Invention

[0018] The purpose of the present invention is to provide a device that can adapt to the cavity to solve the problem that the anchoring device of the occluder in the prior art cannot adapt to various anatomical morphologies of the left atrial appendage.

[0019] To achieve the above technical objectives, the present invention adopts the following technical means:

[0020] A device that can adapt to the cavity includes a central end and an anchoring bracket. The anchoring bracket is formed by a plurality of elastic support rods diverging from the central end. An adaptive structure is provided in a partial or all area of the support rods of the anchoring bracket. When the anchoring bracket is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation reaction, so that the anchoring bracket fits the inner wall of the cavity adaptively.

[0021] Preferably, the anchoring bracket extends inwards and concavely from the central end towards the distal end to form a first bending part, extends outwards and convexly from the end of the first bending part away from the central end towards the proximal end to form a second bending part, and extends towards the distal end from the end of the second bending part away from the first bending part to form a transition part; a plurality of the support rods are rotationally symmetric around the central axis of the central end to form the bowl-shaped anchoring bracket; in the transition part, the heads and / or tails of a plurality of support rods are connected to form a wavy structure; an anchoring structure is provided on the anchoring bracket.

[0022] Preferably, it further includes a converging portion extending from the distal end of the anchoring bracket along the direction of the central axis close to the central end and converging at a converging point, so that the device forms a cage shape, and an adaptive structure is arranged on the converging portion.

[0023] Preferably, the bending modulus of the adaptive structure does not exceed 1 / 10 of the bending modulus of the non-adaptive structure.

[0024] Preferably, the adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05-0.2 mm, and the overall diameter of the spring is 0.2-1 mm; or the adaptive structure is a two-dimensional S-shaped structure, and the width of the solid rod of the two-dimensional S-shaped structure ≤ 1 / 2 of the overall width; or the adaptive structure is a linear structure, and the minimum cross-sectional area in the linear structure ≤ 1 / 2 of the cross-sectional area of the non-adaptive structure.

[0025] Preferably, the adaptive structure of the converging portion is a three-dimensional spiral structure, and the three-dimensional spiral structure is a spring; the support rods and the springs correspond to each other in number and position, one end of multiple support rods is connected to multiple springs, and the other ends of multiple springs converge to form the converging point; or the number of support rods is even, the number of springs is half of the number of support rods, one end and the other end of multiple support rods are connected to multiple springs, and multiple springs are intertwined and wound with each other in the middle area of each spring to achieve connection and form the converging point.

[0026] Preferably, the adaptive structure of the converging portion is a two-dimensional S-shaped structure.

[0027] Preferably, a transition connection structure is arranged on the support rod, and part of the spring is wound on the transition connection structure, so that a buffer connection area is formed between the transition connection structure and the spring; or an enhanced connection structure is arranged on the support rod, and the spring forms a limit connection or a fixed connection at the enhanced connection structure.

[0028] Preferably, after one end of the adaptive structure is connected to the support rod, it extends out of the anchoring bracket and forms an anchoring structure.

[0029] Preferably, it further includes a first flow blocking film, the first flow blocking film is composed of multiple layers of coated films, and the multiple layers of coated films cover the support rods of the anchoring bracket; a film connection structure is arranged on the anchoring bracket, and the film connection structure includes at least one coil and / or a limiting structure, and through the cooperation of the coil and the limiting structure, the coated film is fixedly connected to the anchoring bracket.

[0030] The present invention adopts the above technical solutions, and compared with the prior art, has the following technical effects:

[0031] (1) Different from the occluders of existing cage-shaped or bowl-shaped anchoring frames, when the adaptive cavity device provided by the present invention is subjected to a certain pressure, due to the excellent pressure transmission performance of the adaptive structure, it endows the device with good introducibility during the process of being pushed from the proximal end to the distal end in the sheath tube, facilitating smooth arrival at the biological cavity, such as the target position of the left atrial appendage, etc., and also avoiding problems such as scraping the inner wall of the sheath tube that are very likely to occur during the introduction process of traditional occluders in the sheath tube.

[0032] (2) The three-dimensional helical structure as the adaptive structure has very strong bending compliance characteristics, making the overall converging part able to be as soft as a silk thread. At the moment when the device is just about to be pushed from the sheath tube to the target position, the converging point of the converging part is first pushed out of the sheath tube and is in an ellipsoidal or spherical shape, as Figure 2a shown. This shape ensures that during the process of the device exiting the sheath and from being completely pushed out of the sheath tube until released to the target position and the transition part fits to the inner wall of the left atrial appendage, the distal part of the anchoring frame, including the converging part, will never damage the cavity tissue, so there is no risk of puncturing the inner wall of the left atrial appendage at all, which also reduces the psychological pressure of the operator during the intraoperative release of the device.

[0033] (3) When the three-dimensional helical structure is subjected to a force within the allowable tensile force range, it will have good elasticity. That is to say, the total length of the three-dimensional helical structure can be elongated by a certain length within a certain range. When the distance between the opening of the left atrial appendage and the ridge of the lobes inside the left atrial appendage (i.e., the depth of the anchoring area) is too small, especially when it is less than the height of the waist of the device, the device can still be completely inserted into the left atrial appendage, as Figure 2b shown, without the problem that the position of the device placed in the left atrial appendage is too shallow, resulting in reduced anchoring effectiveness, etc. Therefore, this enables the converging part to adapt to the multi-lobed anatomical structure of the left atrial appendage, and thus has a wide range of adaptability, almost covering all patient populations.

[0034] (4) The overall cross-sectional area of the three-dimensional helical structure is much larger than the cross-section of the support rod of the conventional occluder, making the present invention have excellent intraoperative imaging effects, facilitating the operator to observe and identify in time during the operation to ensure the safety and smoothness of the operation process. Of course, it is also convenient for postoperative follow-up of the patient.

[0035] (5) The three-dimensional helical structure and linear structure as the adaptive structure have very strong bending compliance characteristics. After the device is placed in a biological cavity such as the left atrial appendage, the radial support force provided by the device is weakened to a certain extent. The device as a whole can be compressed at will and can adapt to the morphology of the left atrial appendage cavity, thus avoiding the irreconcilable contradiction between the radial support force of the traditional cage occluder and various left atrial appendage anatomical structures. On the basis of ensuring a certain anchoring force, the device can better adapt to the internal morphology of the left atrial appendage itself.

[0036] (6) In terms of the manufacturing method, when a spring is used for the adaptive structure of the converging part, the distal converging point does not need to be welded. Only several springs need to be simply interwoven and strung together to complete. The process of interweaving and strung together is firmly connected, avoiding the occurrence of wire shedding, and further avoiding fatal problems such as fatigue fracture and poor corrosion resistance caused by processes such as welding required for traditional cage occluders.

[0037] (7) The two-dimensional S-shaped structure or linear structure as the adaptive structure enables the device to have a certain radial support force. This radial support force will not overly expand the left atrial appendage cavity, nor will it overly correct the morphology of the left atrial appendage, and further improves the anchoring force of the device; in addition, the two-dimensional S-shaped structure design facilitates adding coils to shape the first blocking membrane without the need to additionally set a limiting structure, and fixing the first blocking membrane on the device will not cause random sliding or falling off. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1a is a schematic structural view of the device with an adaptive cavity in Embodiment 1 of the present invention;

[0039] Figure 1b is Figure 1a an enlarged view of the partial view Ⅰ;

[0040] Figure 1c is a top view of the device with an adaptive cavity in Embodiment 1 of the present invention;

[0041] Figure 1d When a transition connection structure is provided on the support rod in Embodiment 1 of the present invention, Figure 1c is an enlarged view of the partial view Ⅱ;

[0042] Figure 1e When a strengthening connection structure is provided on the support rod in Embodiment 1 of the present invention, Figure 1c is an enlarged view of the partial view Ⅱ;

[0043] Figure 1f is a schematic view of the way of forming a converging point by a spring in Embodiment 1 of the present invention;

[0044] Figure 2a is a schematic view of the morphology of the device with an adaptive cavity of the present invention during the release process in the left atrial appendage;

[0045] Figure 2b Schematic diagram of the morphology of the device with an adaptive cavity of the present invention after being released in the multi-lobed left atrial appendage;

[0046] Figure 3a Schematic diagram of another implementation manner in Embodiment 1 of the present invention;

[0047] Figure 3b is Figure 3a Enlarged view of partial view Ⅲ;

[0048] Figure 4a Schematic diagram of the structure of the device with an adaptive cavity in Embodiment 2 of the present invention;

[0049] Figure 4b Schematic diagram of the structure of the membrane connection structure in Embodiment 2 of the present invention;

[0050] Figure 5a Schematic diagram of the structure of the device with an adaptive cavity in Embodiment 3 of the present invention;

[0051] Figure 5b is Figure 5a Enlarged view of partial view Ⅳ;

[0052] Figure 5c Top view of the device with an adaptive cavity in Embodiment 3 of the present invention;

[0053] Figure 5d Schematic diagram of the two-dimensional S-shaped structure of the present invention performing the function of the limiting structure in the membrane connection structure;

[0054] Figure 6a Schematic diagram of the structure of the device with an adaptive cavity in Embodiment 4 of the present invention;

[0055] Figure 6b Top view of the device with an adaptive cavity in Embodiment 4 of the present invention;

[0056] Figure 7 Schematic diagram of another implementation manner in Embodiment 4 of the present invention;

[0057] Figure 8a Schematic diagram of the structure of the device with an adaptive cavity in Embodiment 5 of the present invention;

[0058] Figure 8b Top view of the device with an adaptive cavity in Embodiment 5 of the present invention;

[0059] Figure 8c is Figure 8b Enlarged view of partial view Ⅴ;

[0060] Figure 8d is Figure 8bEnlarged view of the partial view VI;

[0061] Figure 9a Schematic structural view of the device with an adaptive cavity in Embodiment 6 of the present invention;

[0062] Figure 9b Top view of the device with an adaptive cavity in Embodiment 6 of the present invention;

[0063] Figure 9c is Figure 9b partial view of Figure Ⅶ enlarged view;

[0064] Figure 9d is Figure 9b enlarged view of the partial view VIII;

[0065] Figure 10a Schematic structural view of the device with an adaptive cavity in Embodiment 7 of the present invention;

[0066] Figure 10b Top view of the device with an adaptive cavity in Embodiment 7 of the present invention;

[0067] Figure 11 Schematic structural view of the device with an adaptive cavity in Embodiment 8 of the present invention;

[0068] Explanation of the markings in the figure:

[0069] 10 - Anchoring bracket, 11 - First bending part, 12 - Second bending part, 13 - Transition part, 14 - Anchoring structure, 141 - J-shaped hook, 142 - Zigzag barb, 15 - Coil, 16 - Limiting structure, 20 - Central end part, 30 - Converging part, 40 - First flow-blocking membrane, 50 - Second flow-blocking membrane, 60 - Sealing plate. Detailed implementation mode

[0070] In this application document, "proximal" and "distal" are the relative orientations, relative positions, and directions of elements or actions with respect to each other from the perspective of the operator using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device closer to the doctor during normal operation, while "distal" generally represents the end away from the doctor during the surgical procedure.

[0071] The adaptive structure has excellent pressure transmission performance, which can endow the device with good introducibility during the process of being pushed from the proximal end to the distal end in the sheath tube, facilitating smooth arrival at the biological cavity, such as the target position like the left atrial appendage, and can also avoid problems such as scraping the inner wall of the sheath tube that are very likely to occur during the introduction process of traditional occluders in the sheath tube.

[0072] Therefore, the present invention provides a device with an adaptive cavity, such as Figure 1a - 1cIt includes a central end portion and an anchoring bracket. The anchoring bracket is surrounded by multiple elastic support rods that diverge from the central end portion. An adaptive structure is provided in a partial or all area of the support rods of the anchoring bracket. When the anchoring bracket is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation response, so that the anchoring bracket fits adaptively to the inner wall of the cavity.

[0073] In a specific embodiment, as Figure 1a In it, the anchoring bracket extends inwards concavely from the central end portion towards the distal end to form a first bending portion, extends outwards convexly from one end of the first bending portion away from the central end portion towards the proximal end to form a second bending portion, and extends towards the distal end direction from one end of the second bending portion away from the first bending portion to form a transition portion; multiple support rods are rotationally symmetric around the central axis of the central end portion to form a bowl-shaped anchoring bracket; within the transition portion, the heads and / or tails of multiple support rods are joined to form a wavy structure; an anchoring structure is provided on the anchoring bracket.

[0074] Furthermore, as Figure 1a In it, it further includes a converging portion that extends from the distal end of the anchoring bracket along the direction of the central axis close to the central end portion and converges at a converging point, so that the device forms a cage shape, and an adaptive structure is provided in the converging portion.

[0075] For the above-mentioned adaptive structure, in a specific embodiment, the bending modulus of the adaptive structure does not exceed 1 / 10 of the bending modulus of the non-adaptive structure. Further, the adaptive structure is a three-dimensional spiral structure. The three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05 - 0.2 mm, and the overall diameter of the spring is 0.2 - 1 mm; or the adaptive structure is a two-dimensional S-shaped structure, as Figure 5d In it, the width of the solid rod of the two-dimensional S-shaped structure ≤ 1 / 2 of the overall width; or the adaptive structure is a linear structure, as Figure 1b In it, and the minimum cross-sectional area in the linear structure ≤ 1 / 2 of the cross-sectional area of the non-adaptive structure. Among them, in a preferred embodiment, the material of the spring is a medical implant-grade metal material, such as nitinol, tantalum, 316L, etc.

[0076] The two-dimensional S-shaped structure or the linear structure as the adaptive structure enables the device to have a certain radial supporting force. This radial supporting force will not overly expand the left atrial appendage cavity nor overly correct the morphology of the left atrial appendage, and further improves the anchoring force of the device; in addition, the two-dimensional S-shaped structure design is convenient for adding coils to shape the first occlusive membrane without the need to additionally set a limiting structure, and fixes the occlusive membrane on the device so that it will not slide or fall off randomly.

[0077] As adaptive structures, the three-dimensional spiral structure and linear structure have very strong bending compliance characteristics, so that after the device is placed in a biological cavity such as the left atrial appendage, the radial support force provided by the device is weakened to a certain extent. The device as a whole can be compressed at will and can make adaptive changes according to the shape of the left atrial appendage cavity. Therefore, it avoids the irreconcilable contradiction between the radial support force of the traditional cage occluder and various anatomical structures of the left atrial appendage. On the basis of ensuring a certain anchoring force, the device can better adapt to the internal shape of the left atrial appendage itself.

[0078] When the adaptive structure of the collection part adopts a three-dimensional spiral structure, the collection part as a whole can be as soft as a silk thread. At the moment when the device is just about to be pushed from the sheath to the target position, the collection point of the collection part is first pushed out of the sheath and becomes an ellipsoid or sphere, such as Figure 2a As shown, this shape ensures that during the process of unsheathing and completely pushing the device out of the sheath tube until it is released to the target position so that the transition portion fits the inner wall of the left atrial appendage, the distal part of the anchoring frame, including the gathering part, will never damage the cavity tissue. Therefore, there is no risk of puncturing the inner wall of the left atrial appendage, which reduces the psychological pressure on the operator to release the device during the operation.

[0079] In addition, the three-dimensional spiral structure will have good elasticity when subjected to a force within the allowable tensile force range. In other words, the total length of the three-dimensional spiral structure can be stretched to a certain length within a certain range. When the distance between the left atrial appendage opening and the ridge of the inner lobes of the left atrial appendage (i.e., the depth of the anchoring area) is too small, especially when it is less than the height of the waist of the device, the device can still be completely inserted into the left atrial appendage. Figure 2b As shown, the device is not placed too shallowly in the left atrial appendage, resulting in problems such as reduced anchoring effectiveness. Therefore, this allows the collection portion to adapt to the multi-lobed left atrial appendage anatomical structure, thereby having a wide range of adaptability, covering almost all patient populations.

[0080] On the basis of the above contents, in a specific implementation manner of the present invention, as Figure 1a In the embodiment, the adaptive structure of the collecting part is a three-dimensional spiral structure, and the three-dimensional spiral structure is a spring; Figure 5c In the embodiment, the support rods and the springs correspond one to one in number and position, multiple support rods are connected to one end of multiple springs, and the other ends of multiple springs are gathered to form a gathering point; or the number of support rods is an even number, such as Figure 1c In the embodiment, the number of springs is half the number of support rods, the multiple support rods are connected to both ends of the multiple springs, and the multiple springs are interlaced and entangled with each other in the middle area of ​​each spring to form a convergence point; further, as Figure 1fAmong them, a straight line segment with a certain length is set in the middle area of the spring, so that each spring can be wound and connected to each other at this position, thereby forming a gathering point of the gathering part, which is convenient for the manufacturer to wind and connect, making it more convenient and firm; furthermore, the present invention can be based on clinical personalized needs. For example, the left atrial appendage anatomical structures of different patients vary greatly. The gathering part needs to have strong shape retention ability in some areas, while in some areas, such as near the gathering point, the shape retention ability is weak and small deformations can occur. Therefore, the spring can be set as a variable-diameter spring with a small diameter in the gathering point area and a large diameter in the outer peripheral area of the gathering part. In addition, in some embodiments, the spring gathering methods also include glue connection, mechanical clamping, laser welding, etc.

[0081] In a preferred embodiment, each three-dimensional helical structure of the gathering part emanates from its center point and is radially divergent or helically divergent with respect to the central axis of the central end; among them, when the three-dimensional helical structure is helically divergent, as Figure 5c Among them, it has more prominent bending compliance and tensile elasticity. Because the spring has more prominent bending compliance characteristics, after the stent is placed in biological cavities such as the left atrial appendage, the radial support force provided by the stent is further weakened, and the anchor frame as a whole can be compressed at will and can make more prominent adaptive changes with the shape of the left atrial appendage cavity. Therefore, it avoids the contradiction that the radial support force of the traditional cage occluder cannot be reconciled with various left atrial appendage anatomical structures. On the basis of ensuring a certain anchoring force, the device can better adapt to the internal shape of the left atrial appendage itself.

[0082] In a specific embodiment, a transition connection structure is provided on the support rod, and part of the spring is wound around the transition connection structure, so that the transition connection structure and the spring form a buffer connection area, such as a buckle structure, as Figure 1d Among them; or an enhanced connection structure is provided on the support rod, and the spring forms a limit connection or a fixed connection at the enhanced connection structure, such as one or more connection holes, as Figure 1e Among them; in addition, in some embodiments, the fixed connection methods between the support rod and the spring also include glue connection, mechanical clamping, laser welding, etc.

[0083] In a specific embodiment, after one end of the adaptive structure is connected to the support rod, it extends out of the anchor stent and forms an anchor structure, as Figure 6a - 6b Among them, the anchor structure shown in the figure is a J-shaped hook. Compared with the J-shaped hook made by cutting, the J-shaped hook made of the spring tail end wire has a certain stress buffer and will not undergo fatigue fracture.

[0084] In a specific embodiment, an anchor structure is provided on the anchor stent to enhance the anchoring effectiveness of the anchor stent in the left atrial appendage cavity and prevent it from falling off, as Figure 5aIn it, the anchoring structure can be a zigzag barb provided at the intersection of the first bending portion and the second bending portion, or as Figure 1a In it, the anchoring structure can be a J-shaped hook provided on the transition section. Further, the free end of the barb or the hook is blunt-treated, such as a ball head, a hemispherical head, an elliptical head, etc. The advantage of the J-shaped hook is that the J-shaped hook can improve the anchoring force, and the blunt-treated J-shaped hook will hook on the pectinate muscle during the release process to further improve the anchoring force. After the occluder is implanted, it will not wear the inner wall tissue of the left atrial appendage with the beating of the heart, nor will it damage or pierce the left atrial appendage. In addition, in some embodiments, the anchoring stent is provided with one row or multiple rows of anchoring structures, and the shape of the anchoring structure is one or more of a zigzag shape, a hook shape, a J-shaped shape, a flat body shape, and a curved shape.

[0085] In a preferred embodiment, the device with an adaptive cavity further includes a first flow-blocking membrane, and the first flow-blocking membrane is composed of multiple layers of coated films, and the multiple layers of coated films cover the support rods on the anchoring stent, as Figure 4a shown. The advantage of setting the flow-blocking membrane is that effective occlusion can be achieved without an additional occlusion disc. Specifically, the material of the coated film is polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or a degradable material such as polylactic acid, polyvinyl alcohol, etc., or the coated film is selected from animal tissues.

[0086] Furthermore, the anchoring stent is provided with a membrane connection structure, and the membrane connection structure includes one or more coils and a limiting structure, as Figure 4b In it, through the mutual cooperation of the coil and the limiting structure, the coated film is connected to the anchoring stent, so that the first flow-blocking membrane does not fall off or break during the process of entering and exiting the sheath. In addition, in some embodiments, the connection method between the anchoring stent and the coated film is hot pressing, suture fixation, etc. More preferably, the connection method between the anchoring stent and the coated film is hot pressing, and this method is more firm than the traditional suture fixation. Since there are no suture holes, the first flow-blocking membrane is not easy to fall off and is less likely to break when the device enters and exits the delivery sheath.

[0087] In a specific embodiment, a detachable connection structure is provided at the central end for facilitating connection with the delivery cable.

[0088] In a specific embodiment, the device further includes an occlusion disc connected to the central end, and a detachable connection structure is provided at the proximal end of the occlusion disc for facilitating connection with the delivery cable.

[0089] In order to make the purpose, features and advantages of the present invention clearer, the following will be further described in detail with reference to the attached Figures 1a to 11 drawings and specific embodiments. It should be noted that the specific embodiments described here all use simplified forms and non-precise proportions to explain the present invention, and are not used to limit the present invention.

[0090] Example 1

[0091] As Figures 1a - 1f In, this embodiment provides a device with an adaptive cavity, including a central end portion 20 and an anchoring bracket 10, and the anchoring bracket 10 is surrounded by a plurality of elastic support rods diverging from the central end portion 20. As Figure 1a and 1c In, the support rods extend inwards concavely from the central end portion 20 towards the distal end to form a first bending portion 11, extend outwards convexly from one end of the first bending portion 11 away from the central end portion 20 towards the proximal end to form a second bending portion 12, and extend towards the distal end direction from one end of the second bending portion 12 away from the first bending portion 11 to form a transition portion 13; a plurality of support rods are rotationally symmetric around the central axis of the central end portion 20 to form a bowl-shaped anchoring bracket 10; within the transition portion 13, the heads and / or tails of a plurality of support rods are joined together to form a wavy structure; the transition portion 13 is provided with an anchoring structure, and the first bending portion 11 and / or the second bending portion 12 are provided with an adaptive structure. When the anchoring bracket 10 is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation response, so that the transition portion 13 of the anchoring bracket 10 fits adaptively to the inner wall of the cavity.

[0092] In this embodiment, as Figure 1b In, the adaptive structure provided on the first bending portion 11 and / or the second bending portion 12 is a linear structure, and the minimum cross-sectional area in the linear structure ≤ 1 / 2 of the cross-sectional area of the non-adaptive structure, and the bending modulus of the adaptive structure does not exceed 1 / 10 of the bending modulus of the non-adaptive structure.

[0093] In this embodiment, as Figure 1a and 1c In, it further includes a converging portion 30 that extends from the distal end of the anchoring bracket 10 along the direction of the central axis close to the central end portion 20 and converges at a converging point, so that the device forms a cage shape. An adaptive structure is provided on the converging portion 30, and the bending modulus of the adaptive structure does not exceed 1 / 10 of the bending modulus of the non-adaptive structure. As Figure 1c In, the adaptive structure is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05 - 0.2 mm, and the diameter of the spring is preferably 0.2 - 1 mm. The material of the spring is a medical implant-grade metal material, such as nitinol, tantalum, 316L, etc.

[0094] In this embodiment, as Figure 1a and 1c In, the number of support rods at the distal end of the anchoring bracket 10 is 6, and the number of springs is 3. As Figure 1f In, the 3 springs are intertwined and wound around each other in the middle region of each spring to achieve connection and form a converging point, and the 3 springs constitute the converging portion 30.

[0095] In this embodiment, in one implementation, a transition connection structure is provided on the support rod, and the spring is wound around the transition connection structure, so that a buffer connection area is formed between the transition connection structure and the spring, as Figure 1d shown, the transition connection structure is a buckle, and both ends of each spring are respectively and limit-connected to the buckles on the support rod. In another implementation, a reinforcement connection structure is provided on the support rod, as Figure 1e shown, the reinforcement connection structure is one or more connection holes. For this kind of perforation connection, one or more connection holes should be set in advance in the distal region of the anchoring bracket 10 to facilitate the two ends of the spring wire to pass through the connection holes.

[0096] In another embodiment, the difference from Embodiment 1 is that there is no distal support rod of the anchoring bracket 10 in this structure, as Figure 3a and Figure 3b shown, both ends of the spring are directly connected to the end of the transition section 13 of the anchoring bracket 10, as Figure 3b shown.

[0097] In this embodiment, the anchoring structure 14 provided on the transition part 13 is a J-shaped hook 142.

[0098] Embodiment 2

[0099] As Figures 4a - 4b shown, the device with an adaptive cavity provided in this embodiment is based on the device provided in Embodiment 1, and further includes a first flow-blocking film 40. The first flow-blocking film 40 is composed of multiple layers of coated films, and the multiple layers of coated films wrap the support rod of the anchoring bracket 10 therein, as Figure 4a shown. A film connection structure is provided on the anchoring bracket 10, which is one or more coils 15 and a limiting structure 16. As Figure 4b shown, through the mutual cooperation of the coil 15 and the limiting structure 16, the coated film is connected to the anchoring bracket 10, so that the first flow-blocking film 40 does not fall off or break during the process of entering and exiting the sheath.

[0100] In this embodiment, a detachable connection structure is provided at the central end 20 to facilitate connection with the transmission cable.

[0101] In this embodiment, the connection method between the anchoring bracket 10 and the coated film is hot press lamination.

[0102] Embodiment 3

[0103] As Figures 5a - 5d shown, the device with an adaptive cavity provided in this embodiment is based on the device provided in Embodiment 1. The first difference between Embodiment 3 and Embodiment 1 is that each three-dimensional spiral structure of the converging part 30, that is, the spring, emits from its center point and is spirally divergent relative to the central axis of the central end 20, rather than radially divergent, as Figure 5cAmong them, the support rods and the springs correspond to each other in number and position. One end of 6 support rods is connected to 6 springs, and the other ends of the 6 springs converge to form a convergence point.

[0104] The second difference is that: the first bending part 11, the second bending part 12 and the transition section 13 of the anchoring bracket 10 are provided with an adaptive structure, such as Figure 5b In [reference], it is a two-dimensional S-shaped structure. The width of the solid rod of the two-dimensional S-shaped structure ≤ 1 / 2 of the overall width, so that the two-dimensional S-shaped structure realizes three-dimensional bending. And a zigzag barb 142 is provided at the intersection of the first bending part 11 and the second bending part 12, and there is no J-shaped hook 141 in the transition section 13, as shown in Figure 5a In [reference].

[0105] Embodiment 4

[0106] Such as Figures 6a - 6b In [reference], the device with an adaptive cavity provided in this embodiment is based on the device provided in Embodiment 1. The first difference between Embodiment 4 and Embodiment 1 is that: a three-dimensional spiral structure, that is, a spring, extends and winds around all or part of the transition part 13 to realize its fixation with the anchoring bracket 10.

[0107] The second difference is that: as an adaptive structure, the three-dimensional spiral structure, that is, a spring, after being connected to the support rod at both ends, further extends outside the anchoring bracket 10 and forms an anchoring structure 14, that is, a J-shaped hook 141.

[0108] In another embodiment, the first bending part 11 and the second bending part 12 of the anchoring bracket 10 of the device provided in Embodiment 4 are provided with a two-dimensional S-shaped structure, such as Figure 7 In [reference].

[0109] Embodiment 5

[0110] The central end 20 and the anchoring bracket 10 (including the first bending part 11, the second bending part 12 and the transition section 13) of the device with an adaptive cavity provided in Embodiments 1-4 are formed by cutting and shaping a medical metal tube. However, in this embodiment, as shown in Figures 8a - 8d In [reference], only the transition part 13 of the anchoring bracket 10 is formed by cutting and shaping a medical metal tube. The central end 20, the first bending part 11 and the second bending part 12 are formed by the three-dimensional spiral structure (that is, a spring) in the adaptive structure, and these springs are wound around the transition part 13 of the anchoring bracket 10.

[0111] In this embodiment, one end of the spring of the first bending part 11 forms the central end part 20 of the device, and the other end is connected to one end of the second bending part 12, while the other end of the second bending part 12 is wound around the wave band on one side of the transition part 13; the connection between the spring of the converging part 30 and the anchoring bracket 10 is the same as that in Embodiment 4, and both ends are wound around the wave bands on the other side of the transition part 13, and the end wires at both ends of the spring of the converging part 30 are made into J-shaped hooks 141.

[0112] The technical means in this embodiment have the following advantages: ① The spring has shrinkage and ductility, so that it can adapt to complex left atrial appendages, such as left atrial appendages with multiple lobes or well-developed pectinate muscles; ② The spring has good softness, and the inner wall of the left atrial appendage is extremely thin, so the risk of left atrial appendage injury is greatly reduced; ③ The three-dimensional spiral structure design of the first bending part 11 or the second bending part 12 facilitates adding coils to shape the first blocking membrane 40, and the first blocking membrane 40 can be fixed to the device without additionally arranging a limiting structure 16, so that the first blocking membrane 40 does not slide or fall off randomly.

[0113] Embodiment 6

[0114] As Figures 9a - 9d In, based on the device provided in Embodiment 5, the difference between this embodiment and Embodiment 5 is that the device with an adaptive cavity provided in this embodiment only has a three-dimensional spiral structure, that is, a spring structure.

[0115] In this embodiment, as Figure 9b In, the converging part 30 is composed of 3 independent springs, and each spring is wound together by three medical metal wires. The way the 3 springs form a converging point can be seen in Figure 1f . One spring at the proximal end of the converging part 30 is divided into two to form the wave-like structure of the transition section 13. One wave band on one side is a spring wound by 2 wires, and the wave band on the other side is a spring wound by 1 wire. At the proximal end of the transition section 13, the end of one of the 2 wires is made into a J-shaped hook 141, and the spring wound by the other wire converges with the spring on the other side of the adjacent wave band structure to form the second bending part 12, the first bending part 11 and the central end part 20 of the anchoring bracket 10.

[0116] In this embodiment, the device with an adaptive cavity only has one structure. This design not only has the advantages of Embodiments 1-5, but also because the whole is a spring structure, the device is softer and can adapt to left atrial appendages with various shaped openings without correcting the morphology of the left atrial appendage, which also reduces the risk of postoperative complications such as pericardial effusion, cardiac tamponade, and pericardial perforation.

[0117] Embodiment 7

[0118] As Figure 10a And 10bIn this case, based on the device provided in Embodiment 1, the difference between this embodiment and Embodiment 1 is that: the adaptive structures of the first bending portion 11, the second bending portion 12, and the converging portion 30 are two-dimensional S-shaped structures, and the device with an adaptive cavity provided in this embodiment is formed by cutting and shaping a medical metal pipe.

[0119] In this embodiment, the advantages of the two-dimensional S-shaped structure design are as follows: ① Compared with the three-dimensional spiral structure, this device is integrally cut and is relatively simple to manufacture; ② It has a certain radial support force, that is, a shape retention force; ③ The two-dimensional S-shaped structure in the first bending portion 11 is convenient for adding coils and shaping the first blocking film without the need to additionally set a limiting structure; ④ Compared with the three-dimensional spiral structure, its sheath insertion and extraction resistance is smaller.

[0120] Embodiment 8

[0121] As Figure 11 In this case, Embodiment 8 is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that: the device with an adaptive cavity further includes a blocking disk 60, and the blocking disk 60 is fixedly connected to the central end portion 20.

[0122] The blocking disk 60 is made of an elastic and / or shape memory material and can be placed at the mouth or inside of a biological cavity. A second blocking film 50 is provided on the proximal disk surface of the blocking disk 60, which further improves the blocking effect of the device with an adaptive cavity. A detachable connection structure is provided at the proximal end of the blocking disk 60, which is convenient for connecting to a delivery cable.

[0123] The specific embodiments of the present invention have been described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions made to the present invention are also within the scope of the present invention. Therefore, equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

1. An apparatus with an adaptive cavity, comprising a central end portion and an anchoring bracket (10). The anchoring bracket (10) is formed by a plurality of elastic support rods diverging from the central end portion. Characterized in that, An adaptive structure is provided in a partial or all area of the support rods of the anchoring bracket (10). When the anchoring bracket (10) is squeezed by the inner wall of the cavity, the adaptive structure immediately makes a bending deformation response, so that the anchoring bracket (10) fits adaptively to the inner wall of the cavity. Wherein, it further comprises a converging portion (30) extending from the distal end of the anchoring bracket (10) along the central axis direction close to the central end portion (20) and converging at a converging point, so that the apparatus forms a cage shape, and an adaptive structure is provided in the converging portion (30). Wherein, the adaptive structure of the converging portion (30) is a three-dimensional spiral structure, the three-dimensional spiral structure is a spring, the wire diameter of the spring is 0.05 - 0.2 mm, and the overall diameter of the spring is 0.2 - 1 mm; the support rods and the springs correspond to each other in number and position, one end of a plurality of the support rods is connected to one end of a plurality of the springs, and the other ends of a plurality of the springs converge to form the converging point; or the number of the support rods is an even number, the number of the springs is half of the number of the support rods, one end of a plurality of the support rods is connected to both ends of a plurality of the springs, and a plurality of the springs are intertwined and wound around each other in the middle area of each spring to achieve connection and form the converging point.

2. The apparatus with an adaptive cavity according to claim 1, Characterized in that, The anchoring bracket (10) extends inwards and concavely from the central end portion towards the distal end to form a first bending portion (11), extends outwards and convexly from one end of the first bending portion (11) away from the central end portion (20) towards the proximal end to form a second bending portion (12), and extends towards the distal end direction from one end of the second bending portion (12) away from the first bending portion (11) to form a transition portion (13); a plurality of the support rods are rotationally symmetric around the central axis of the central end portion (20) to form the bowl-shaped anchoring bracket (10); within the transition portion (13), the heads and / or tails of a plurality of the support rods are connected to form a wave-shaped structure; an anchoring structure (14) is provided on the anchoring bracket (10).

3. The apparatus with an adaptive cavity according to claim 1, Characterized in that, The bending modulus of the adaptive structure does not exceed 1 / 10 of the bending modulus of the non-adaptive structure.

4. The apparatus with an adaptive cavity according to claim 1, Characterized in that, A transition connection structure is provided on the support rod, and a part of the adaptive structure is wound around the transition connection structure, so that the transition connection structure and the adaptive structure form a buffer connection area; or a reinforcement connection structure is provided on the support rod, and the adaptive structure forms a limit connection or a fixed connection at the reinforcement connection structure.

5. The apparatus with an adaptive cavity according to claim 4, Characterized in that, After one end of the adaptive structure is connected to the support rod, it extends out of the anchoring bracket (10) and forms an anchoring structure (14).

6. The device with an adaptive cavity according to claim 1, wherein, it further includes a first flow-blocking film (40), and the first flow-blocking film (40) is composed of multiple layers of coating films which coat the support rod of the anchoring bracket (10); a film connection structure is provided on the anchoring bracket (10), and the film connection structure includes at least one coil (15) and / or a limiting structure (16). Through the mutual cooperation of the coil (15) and the limiting structure (16), the coating film is fixedly connected to the anchoring bracket (10).

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