A left atrial appendage occluder with a bionic micro-spine attachment structure

Abstract

The present invention relates to a left atrial appendage occluder with a bionic micro-spine attachment structure, which at least includes an attachment frame. The attachment frame includes multiple elastic skeletons and multiple bionic micro-spine attachment structures. In the natural unconstrained state, the multiple skeletons diverge outward from the center and enclose a three-dimensional structure. The attachment frame has anatomical morphological self-adaptability. The bionic micro-spine attachment structures are arranged on the outer surface of the skeletons. The morphology of the bionic micro-spine attachment structures is similar to the sparse micro-spines on the surface of plants. The bionic micro-spine attachment structure includes a spine root and a micro-spine. The micro-spine consists of a spine body and a spine tip. The micro-spine is linear or J-shaped or a combination of both. The spine body and / or the spine tip can touch the inner cavity tissue of the left atrial appendage to achieve the attachment and anchoring function. The present invention has a wide range of adaptability, firm and non-damaging anchoring, high safety, excellent occlusion effectiveness, and is also convenient for realizing personalized customization according to the clinical needs of patients.

Description

Technical Field

[0001] The present invention relates to a medical device, and more particularly to a left atrial appendage occluder with a bionic micro-needle attachment structure. Background Art

[0002] Atrial fibrillation (AF for short) is one of the most common arrhythmias clinically, with an incidence rate of 1% - 2% in the population. At the same time, with the increase of age, the incidence rate of AF is also increasing continuously. Some research reports point out that the incidence rate of AF in people over 80 years old reaches 10% - 17%. In addition to the discomfort caused by symptoms such as palpitation, dizziness, and shortness of breath, the most important harm of AF is the formation of thrombus in the heart. After the thrombus detaches, it can lead to complications such as stroke, organ embolism, and peripheral vascular embolism. At present, there are more than 10 million AF patients in China, and about 70% of them are at high risk of stroke. Moreover, the stroke risk of AF patients is 5 times that of ordinary people. Clinical studies have shown that in AF patients, more than 90% of the thrombi in non-valvular AF patients originate from the left atrial appendage, and 15% of the thrombi in valvular AF patients originate from the left atrial appendage. Under normal sinus rhythm in normal people, the left atrial appendage rarely forms thrombus due to its normal contraction ability. However, during AF, the left atrial appendage significantly enlarges and loses effective regular contraction, resulting in blood stasis in the left atrial appendage and making it extremely easy to form thrombus. The morphological characteristics of the left atrial appendage itself are likely to cause blood flow to generate vortices and slow down the flow velocity, which is also a condition that promotes thrombus formation.

[0003] Left atrial appendage occlusion is a new method for non-pharmacological prevention of thromboembolism in AF patients. Its principle of action is to use an occluder to block the blood flow between the left atrial appendage and the left atrium, and at the same time prevent the thrombus generated in the left atrial appendage from entering the atrium. After a period of time, the surface of the occluder is endothelialized, thus solving the problem of the left atrial appendage thrombus entering the left atrium and reducing the risk of stroke.

[0004] Currently, the commercially available left atrial appendage occluder products mainly include the American Boston Scientific WATCHMAN TM Occluder, the American St. Jude Medical ACP TM Occluder, the Shenzhen A&A LAmbre TM Occluder, and the Shanghai Push Medical LA cbes TM Occluder. The WATCHMAN TM Occluder (Patent CN103917169B) has been on the market for a long time, with a long clinical research time and a large implantation volume. However, it cannot be inserted into the left atrial appendage with a shallow mouth. At the same time, since this occluder cannot be bent, it also cannot adapt to the left atrial appendage with a large angle. In addition, under certain special conditions, the WATCHMAN TM Occluder has a risk of insufficient anchoring strength, and there have been reports of the occluder falling off and entering the abdominal aorta of the human body after surgery.

[0005] LAmbre TMThe occluder (patent CN102805654B) is a "disc + plug" structure, which is easy to bend and deflect, and can be applied to most left atrial appendage structures. However, the design of its anchoring stent also determines that this type of occluder has insufficient adaptability. In most cases, it relies on the strong radial support force of the fixing frame to open the left atrial appendage cavity to achieve fixed support, and it is difficult for itself to change adaptively with the different shapes of the left atrial appendage; secondly, the barbs of this type of occluder are rigid, straight, and thick, and there are precedents of puncturing the left atrial appendage in clinical reports. At the same time, due to the limited number of anchoring studs, there is also a risk of insufficient anchoring strength; in addition, the anchoring frame of this type of occluder (especially in the distal area) has a large number of (close to) straight line segments, which cannot completely fit the inner cavity of the left atrial appendage, and is prone to forming a suspended area in a local area. The barbs in this area cannot effectively anchor the left atrial appendage.

[0006] ACP TM Occluder and the latest WATCHMAN FLEXⅡ from Boco TM The occluders (patent CN104918559A) are all of distal closed structure. This closed structure determines that this type of occluder can only be applied to the left atrial appendage with an approximately circular opening and a single-leaf structure, but not to the left atrial appendage with a multi-leaf structure or a shallow and flat opening.

[0007] Most of the left atrial appendage occluders made of nickel-titanium tube carving or nickel-titanium wire weaving use a rigid, straight, thick and long barb structure (such as Figure 10 a and Figure 10 b) design to achieve anchoring. Barbs can penetrate the inner wall of the left atrial appendage, provided that radial support is provided by the support net inside the barbs, and the support net is usually a regular rotating body structure, which cannot adapt to the anatomical forms of various left atrial appendages. Most of the left atrial appendages in reality are flat, shallow, and multi-lobed, so they are even more unable to adapt. Even if they can be put in, the self-centering ability is insufficient, the blocking performance is poor, and residual shunts are formed; at the same time, there are also design defects in the barb structure itself: first, the inner wall of the left atrial appendage is very thin, and the barb structure is easy to pierce the left atrial appendage, which is easy to cause risks such as pericardial effusion; in addition, the inner wall of the left atrial appendage is attached with abundant pectinate muscles and trabeculae, and the inner wall is thinner, and the left atrial appendages of different populations are different in depth, and the left atrial appendage mouth is mostly non-circular flat structure, and the left atrial appendage mouth is at a certain bending angle with its inner cavity. Just because the left atrial appendage structure of each person is different in shape, there is no left atrial appendage occluder on the market that can fully adapt to the anatomical structural characteristics of all left atrial appendages.

[0008] Therefore, there is an urgent need in the market for a left atrial appendage occluder with a wider range of applications and higher safety. Summary of the invention

[0009] The object of the present invention is to overcome the deficiencies of the prior art and provide a left atrial appendage occluder with a bionic micro-spine attachment structure, which can adapt to various morphological structures of the left atrial appendage, has a good occlusion effect, and ensures firm fixation.

[0010] The object of the present invention is achieved by the following technical solutions:

[0011] A left atrial appendage occluder with a bionic micro-spine attachment structure, at least including an attachment frame, the attachment frame includes a plurality of elastic skeletons and a plurality of bionic micro-spine attachment structures. In the natural unconstrained state, the plurality of skeletons diverge outward from the center and enclose a three-dimensional structure. The attachment frame has anatomical morphological self-adaptability. The bionic micro-spine attachment structures are arranged on the outer surface of the skeletons. The morphology of the bionic micro-spine attachment structures is sparse micro-spines on the surface of a plant. The bionic micro-spine attachment structures include a spine root and micro-spines. The micro-spines are composed of a spine body and a spine tip. The micro-spines are linear or J-shaped or a combination of both. The spine body and / or the spine can touch the inner cavity tissue of the left atrial appendage to achieve the function of attachment and anchoring.

[0012] The object of the present application can also be further achieved by the following technical solutions:

[0013] In one embodiment, when the micro-spines contact the inner cavity tissue of the left atrial appendage, they can undergo adaptive bending deformation, which is beneficial for the micro-spines to attach to the inner cavity tissue of the left atrial appendage without damage and enhance their attachment and anchoring function.

[0014] In one embodiment, the plants include but are not limited to Xanthium sibiricum, Humulus scandens, Caesalpinia decapetala, Polygonum perfoliatum, Euryale ferox, Prickly amaranth, Rubus corchorifolius, Cirsium japonicum, Polygonum senticosum, Acantopanax trifoliatus.

[0015] In one embodiment, it is defined that: the length of the spine body is L1, the curve length of the spine tip is L2, and the included angle between the extension line direction of the spine body facing outward and the extension line direction of the distal end of the spine tip facing outward is β. The spine body length L1, the spine tip curve length L2, and the included angle β satisfy the following mathematical relationship: 0.2 mm ≤ L1 ≤ 3 mm, 0 ≤ L2 ≤ 1.5 mm, 0 ≤ β ≤ 150°, so that the micro-spines have the characteristics of being shallow and short, and the length of the linear micro-spines is less than the length of the J-shaped micro-spines.

[0016] In a preferred embodiment, the total number of the bionic micro-spine attachment structures is between 6 and 600. By adjusting the parameters L1, L2, and β, it is convenient for the spine tips to touch the left atrial appendage wall and increase the effectiveness of attachment and anchoring.

[0017] In a preferred embodiment, the sashimi length L1, the spire curve length L2, and the included angle β satisfy the following mathematical relationships: 0.5 ≤ L1 ≤ 1.5 mm, 0 ≤ L2 ≤ 1 mm, 90° ≤ β ≤ 150°.

[0018] In a preferred embodiment, the number of the bionic micro-spine attachment structures provided on each of the skeletons is between 2 and 20.

[0019] In a preferred embodiment, the distance between the tip point of the spire and the sashimi ≤ 0.5 mm, such that the J-shaped spire is in a micron-level folded hook shape or an arc-shaped hook shape.

[0020] In a preferred embodiment, when the shape of the micro-spine is linear, the sashimi of the micro-spine is the spire.

[0021] In a preferred embodiment, the sashimi length L1 of the linear micro-spine ≤ 1 mm.

[0022] In a preferred embodiment, among all the micro-spines, the proportion of the linear micro-spines is between 50% and 99%.

[0023] In a preferred embodiment, among all the micro-spines, multiple groups of linear micro-spines and J-shaped micro-spines adopt an intermittent repetition design. When the J-shaped micro-spines and the linear micro-spines in each group adaptively contact the left atrial appendage lumen tissue, they cooperate with each other and form a "self-locking" structure, so that each of the skeletons cannot move distally or proximally along the skeleton axis, increasing the restraint and strengthening the firmness of the attachment to the left atrial appendage lumen tissue.

[0024] In an embodiment, the bionic micro-spine attachment structure further includes a limiting mechanism, and the root of the spine and the limiting mechanism cooperate with each other to limit the relative position of the micro-spine on the skeleton.

[0025] In an embodiment, the limiting mechanism is a hole groove provided on the skeleton. The bionic micro-spine attachment structure corresponds to the hole groove in position. At least a partial area of the root of the spine is located in the hole groove, and the root of the spine and the hole groove cooperate with each other to limit the relative position of the micro-spine on the skeleton.

[0026] In one embodiment, each of the bionic micro-spine attachment structures includes at least 1 spine root and 2 micro-spines. The micro-spines and the hole grooves correspond to each other in position and quantity. At least a partial area of the spine root is attached to the framework. The spine root has a U-shaped or loop-shaped structure and penetrates through two of the hole grooves. Each of the bionic micro-spine attachment structures is formed by a wire material with elasticity and shape memory passing through the corresponding two hole grooves in sequence. The cross-sectional area of the wire material ≤ 0.04mm 2 , such that the micro-spines are slender and soft.

[0027] In a preferred embodiment, each of the micro-spines is coplanar.

[0028] In a preferred embodiment, the spine root penetrates through two adjacent hole grooves.

[0029] In a preferred embodiment, the cross-sectional area of the wire material is between 0.002mm 2 and 0.015mm 2 .

[0030] In a preferred embodiment, the bionic micro-spine attachment structure has both flexibility and elasticity and has a villus-like property, and is used to achieve attachment and anchoring to the left atrial appendage tissue. When the micro-spines are under an external force, they can rotate and deform freely in the direction of the outer surface of each framework with the spine root as the center. When implanted into the left atrial appendage of the human body, since there are many local protrusions on the inner wall of the left atrial appendage, when the micro-spines contact the local protrusions, the orientations of some of the micro-spines can adaptively change, enhancing the attachment and anchoring property of the micro-spines, and they will not rigidly and straightly penetrate into the tissue without damaging the left atrial appendage. Therefore, the entire bionic micro-spine attachment structure has self-adaptability and enhances the attachment and anchoring function to the left atrial appendage.

[0031] In one embodiment, the limiting mechanism is one or more of a local necking structure, a local protrusion structure, and a keyway structure provided on the framework, or the limiting mechanism realizes the fixed connection between the framework and the spine root through glue bonding, welding, or mechanical cooperation.

[0032] In one embodiment, the attachment frame includes a surrounding body that winds around the skeleton and at least wraps the thorn roots that fit the skeleton, for enhancing the connection strength between the skeleton and the bionic micro-thorn attachment structure, avoiding partial or all of the skeleton from directly contacting the cavity tissue, reducing the precipitation amount of metal ions, and improving biocompatibility; reducing the friction coefficient and reducing the resistance of the attachment frame to be received and released in the delivery sheath tube; increasing smoothness and providing a better tactile experience; enhancing the anti-fatigue durability of the attachment frame, playing a role of "secondary protection" for the attachment frame, and avoiding the risk of fracture of the attachment frame caused by long-term corrosion or fatigue failure in the left atrial appendage cavity.

[0033] In a preferred embodiment, the surrounding body is a flexible medical wire / filament / tape, and the cross-sectional shape of the surrounding body includes one or a combination of a circle, an ellipse, and a rectangle.

[0034] In a preferred embodiment, the surrounding body is wound by a suture, and the material of the suture includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxanone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide-lactide (PGLA), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or a medical metal and / or medical polymer material with a visualization effect.

[0035] In a preferred embodiment, one or more local protrusions are provided on the outer surface of the surrounding body itself, and the local protrusions form barbed structures by themselves, and the barbed structures face the left atrial appendage wall or the left atrial appendage opening side, further enhancing the anchoring.

[0036] In a preferred embodiment, the surrounding body is wrapped with a functional agent that has an endothelialization-promoting effect. The functional agent includes but is not limited to growth factors. In addition, the functional agent is a visualization point, a visualization wire, and a visualization ring to facilitate enhancing the visualization of the operation. The surrounding body can selectively use a material with a microporous structure, and the material with the microporous structure is convenient for cells or tissues to grow into and promotes endothelialization inside the surrounding body.

[0037] In one embodiment, on any cross-section in the major axis direction of the framework, the thickness of the framework is defined as P1, the length of the hole groove itself is P2, the spacing between any two adjacent hole grooves is P3, and the angle between the extension direction of the sashimi facing outward and the direction of the axis m of the framework away from the attachment frame is ω. The parameters P1, P2, P3, and ω respectively satisfy the following mathematical relationships: 0.05 mm ≤ P1 ≤ 0.5 mm, 0.05 mm ≤ P2 ≤ 1 mm, 0.5 mm ≤ P3 ≤ 10 mm, 30° ≤ ω < 180°. Adjusting the specific parameters of P1 and P2 can achieve the adjustment of the angle ω, ensuring that each thorn tip faces the left atrial appendage opening side in the natural state, enhancing the effectiveness of attachment-type anchoring. At the same time, adjusting the parameter P3 can adjust the total number of the micro-thorns.

[0038] In a preferred embodiment, the thickness P1 of the framework, the outer diameter P2 of the hole groove, the hole groove spacing P3, and the angle ω respectively satisfy the following mathematical relationships: 0.1 mm ≤ P1 ≤ 0.3 mm, 0.1 mm ≤ P2 ≤ 0.3 mm, 0.5 mm ≤ P3 ≤ 2 mm, 60° ≤ ω ≤ 150°.

[0039] In one embodiment, the three-dimensional structure formed by multiple frameworks is in a "mushroom shape", "kettle shape", "cage shape", "gourd shape", or "bowl shape" in the natural unconstrained state. The three-dimensional structure has flexibility and resilience and can adapt to the left atrial appendage lumen with different anatomical shapes. The attachment frame further includes a central member. Multiple frameworks diverge outward from the central member and enclose the three-dimensional structure. In the natural unconstrained state, the central member of the attachment frame is located inside the three-dimensional structure. The height K1 of the three-dimensional structure and the maximum outer diameter D1 of the three-dimensional structure satisfy the following mathematical relationships: 3 mm ≤ K1 ≤ 20 mm, 10 mm ≤ D1 ≤ 50 mm, and K1 ≤ D1.

[0040] In a preferred embodiment, the "mushroom shape" includes, but is not limited to, shiitake mushroom shape, straw mushroom shape, flower mushroom shape, tea tree mushroom shape, Agaricus bisporus shape, Tricholoma matsutake shape, Pluteus citrinopileatus shape, and Pleurotus nebrodensis shape.

[0041] In a preferred embodiment, the height K1 of the three-dimensional structure satisfies the following mathematical relationship: 5 mm ≤ K1 ≤ 10 mm.

[0042] In a preferred embodiment, when the three-dimensional structure is in the shape of a "mushroom" or a "bowl", the central axis of the attachment frame is defined as m. In the natural unconstrained state, the outermost end of the attachment frame forms a plane, which is defined as α1, the innermost end of the attachment frame forms a plane, which is defined as α2, and the proximal end of the central member of the attachment frame forms a plane, which is defined as α3. The planes α1, α2, and α3 are all perpendicular to the central axis m. The distance between the plane α1 and the plane α3 is defined as K2, and the distance between the plane α2 and the plane α3 is defined as K3. Then, the following mathematical relationship exists: K1 = K2 + K3, 0 < K2 / K3 ≤ 1.

[0043] In one embodiment, when the three-dimensional structure formed by multiple skeletons is in the shape of a "mushroom" or a "bowl" in the natural unconstrained state, the skeletons sequentially include a proximal independent rod, an intermediate connecting rod, and a distal ring-shaped body in the direction of the central member facing outward. The flexibility of the proximal independent rod is greater than or equal to the flexibility of the intermediate connecting rod, and the flexibility of the intermediate connecting rod is greater than or equal to the flexibility of the distal ring-shaped body. When the attachment frame is subjected to a radial squeezing force from the outside, the order of the adaptive deformation of each part of the skeleton is: the proximal independent rod, the intermediate connecting rod, and the distal ring-shaped body, so that the attachment frame has high flexibility.

[0044] In a preferred embodiment, the number of the skeletons is between 3 and 20, and each skeleton includes at least one distal ring-shaped body.

[0045] In a preferred embodiment, a plurality of bionic micro-spine attachment structures are provided on the intermediate connecting rod and the distal ring-shaped body.

[0046] In one embodiment, some of the distal ring-shaped bodies are located in the peripheral contour area of the "mushroom" or "bowl". A plurality of J-shaped micro-spines are provided on the outer surface of the distal ring-shaped bodies in this area. The tips of the J-shaped micro-spines are in the shape of a micron-level folded hook or an arc-shaped hook, and the angle ω of the micro-spines in this area gradually decreases in the direction away from the central axis m of the attachment frame.

[0047] In one embodiment, the distal loop-like body is a curled structure formed by the outer peripheral region of the framework, or a curled structure formed by further extending the end of the framework towards the end direction. The curled structure is one or more of an elliptical shape, a circular shape, or a two-dimensional spiral structure. And the plane where each curled structure is located is coplanar with the central axis m of the attachment frame. The curled structure has elasticity and shape memory, so that when the distal loop-like body is gradually pushed out and released from the delivery sheath, the distal loop-like body gradually unfolds from the straight state compressed and loaded in the delivery sheath into a curled shape. During the unfolding process, once two or more distal loop-like bodies touch the inner wall of the left atrial appendage cavity, the distal loop-like body spontaneously drives the entire attachment frame to swim towards the deep part of the left atrial appendage lumen distally, further enhancing the anchoring effectiveness of the attachment frame. At the same time, the occlusion disc is pulled, so that the occlusion disc fills the left atrial appendage opening area more tightly, maximizing the spontaneous "inner suction filling" effect and enhancing the occlusion effectiveness of the occlusion disc.

[0048] In a preferred embodiment, the curling direction of the curled structure is inwards, and the included angle σ between the extension direction of the end of the curled structure and the direction of the central axis m of the attachment frame towards the distal end satisfies: 0° ≤ σ ≤ 90°, and the number of turns n of the curled structure satisfies: 0.5 ≤ n ≤ 1.5.

[0049] In one embodiment, a protective member is provided at the end of the framework. The protective member is fixedly connected to the framework. The form of the protective member can be one or more combined structures of a ring body or a sphere with a diameter slightly larger than the width of the framework, and a flexible member with a higher flexibility than the end region of the framework. When the attachment frame is released from the delivery sheath, the protective member can contact the inner wall tissue of the left atrial appendage without damage.

[0050] In a preferred embodiment, the flexible member includes but is not limited to a flexible spring, a flexible tube, a flexible rod, and a flexible wire.

[0051] In a preferred embodiment, one or more fixing structures are provided on each framework, and the proximal end and / or the distal end of the surrounding body are effectively connected or position-limited to the framework through the fixing structures.

[0052] In a preferred embodiment, the fixing structures are respectively provided on the proximal region of the proximal independent rod of each framework and the distal region of the protective member. The fixing structure is a through hole penetrating the framework. After the surrounding body passes through the through hole on the proximal independent rod to achieve connection, it tightly winds and wraps the framework and all thorn roots between the through holes, and finally passes through the through hole on the protective member and achieves connection.

[0053] In a preferred embodiment, the surrounding body is wound and wrapped by a single flexible round wire or flat wire around most or all of the framework, all the thorn roots, and passes through all the through holes, and finally forms a closed loop.

[0054] In one embodiment, the intermediate connecting rods of the attachment frame are interconnected to form a three-dimensional wave-like and / or reticular structure.

[0055] In one embodiment, the frameworks of the attachment frame are independent of each other and not connected, and each framework has a circumferential rotational symmetry structure centered on the central axis m of the attachment frame.

[0056] In one embodiment, the attachment frame is formed by integrally laser cutting a medical metal pipe with elasticity and shape memory and shaping it through heat treatment, or the attachment frame is formed by integrally weaving a medical metal or polymer wire with elasticity and shape memory and shaping it through heat treatment, or the attachment frame is directly formed by integrally hot processing a medical polymer material with elasticity and shape memory.

[0057] In one embodiment, the attachment frame is provided with a flexible second flow-blocking membrane, which adheres to and is connected to the framework or the surrounding body, and can prevent the detachment of existing and potentially generated thrombi in the left atrial appendage lumen.

[0058] In a preferred embodiment, the second flow-blocking membrane is located in the peripheral area of the attachment frame, and the micro thorns can expose the second flow-blocking membrane.

[0059] In a preferred embodiment, when the three-dimensional structure is in a "mushroom shape" or "bowl shape", the maximum coverage range of the second flow-blocking membrane does not exceed the intersection area of the intermediate connecting rod and the distal ring-shaped body.

[0060] In one embodiment, the left atrial appendage occluder with a bionic micro-thorn attachment structure further includes a occluding disc and a connecting member. The occluding disc and the attachment frame are connected by the connecting member. The occluding disc is made of a material with elasticity and shape memory. The occluding disc has a three-dimensional cage-like structure, and a three-dimensional first flow-blocking membrane is provided on the occluding disc.

[0061] Compared with the prior art, this patent has the following outstanding advantages:

[0062] 1. The bionic micro - thorn attachment structure provided by the present invention has the morphology of sparse micro - thorns on the surface of plants. The bionic micro - thorn attachment structure includes thorn roots and micro - thorns. The micro - thorns can face the left atrial appendage wall or the side of the left atrial appendage opening, enabling the attachment frame to easily grasp the inner wall tissue of the left atrial appendage and form an effective anchor. The micro - thorns are slender, shallow, short, and soft, endowing the micro - thorns with villus - like characteristics, realizing the attachment - type non - invasive anchoring function, and avoiding the trauma caused by deeply and directly piercing into the left atrial appendage tissue. When the micro - thorns come into contact with the inner cavity tissue of the left atrial appendage, they can undergo adaptive bending deformation, which is conducive to the non - damaging attachment of the micro - thorns to the inner cavity tissue of the left atrial appendage and enhances their attachment - type anchoring function.

[0063] 2. The micro - thorns provided by the present invention are in a linear shape, J - shape, or a combination of the two. The micro - thorns are composed of thorn bodies and thorn tips and have the following advantages: a) The J - shaped micro - thorns have micron - sized thorn tips that can hook onto the inner wall tissue of the left atrial appendage, avoiding the trauma caused by deeply and directly piercing into the left atrial appendage tissue; b) Many micro - thorns are like the uneven patterns on the outer surface of a tire, so they also play a role in increasing roughness. Particularly for linear micro - thorns, on the one hand, it significantly increases the static friction between the micro - thorns and the left atrial appendage wall, enhancing the adhesion force to the left atrial appendage wall. On the other hand, it plays a special anchoring role in certain specific left atrial appendage structures. For example, when encountering a multi - lobed left atrial appendage with well - developed pectinate muscles, when one or two skeletons of the occluder touch the multi - lobed structure in the inner cavity of the left atrial appendage, the linear micro - thorns can directly anchor the pectinate muscles, enabling the entire skeleton to hang on the inner wall of the multi - lobed structure and realizing effective anchoring; c) Particularly, the J - shaped micro - thorns and the linear micro - thorns cooperate with each other to form a "self - locking" structure, making each skeleton unable to move distally or proximally along the skeleton axis, increasing the restraint and strengthening the firmness of the attachment to the inner cavity tissue of the left atrial appendage.

[0064] 3. The bionic micro-spine attachment structure provided by the present invention includes a spine root and a spine tip, and adopts a combined structure with the framework of the attachment frame. The limiting mechanisms on the spine root and the framework cooperate with each other to limit the relative position of the micro-spines on the framework. This design enables: a) The lengths of the micro-spine bodies and the spine tips are adjustable, which can effectively ensure that the bodies and the spine tips of the linear micro-spines and J-shaped micro-spines contact the left atrial appendage wall without damage, thereby avoiding risks such as piercing the left atrial appendage and causing pericardial effusion; b) The bionic micro-spine attachment structure has both high flexibility and high elasticity, enabling the micro-spines to rotate and deform freely on the outer surface direction of each framework with the spine root as the center when subjected to external forces. When implanted into the left atrial appendage of the human body, due to the presence of many local protrusions on the left atrial appendage wall, when the micro-spines contact these local protrusions, the orientations and the included angle ω of some micro-spines can adaptively change, enhancing the attachment-type anchoring of the micro-spines without rigidly and straightly penetrating deeply into the tissue and causing no damage to the left atrial appendage. Therefore, the entire bionic micro-spine attachment structure has self-adaptability and enhances the attachment-type anchoring function to the left atrial appendage; c) The framework of the attachment frame and the micro-spines are connected through the cooperation of the spine root and the limiting mechanism, and the spine root can effectively prevent the micro-spines from breaking due to fatigue failure.

[0065] 4. The number of the bionic micro-spine attachment structures provided by the present invention is adjustable and can be densely distributed on the outer surface of the framework of the attachment frame according to the actual clinical needs, increasing the contact probability between the attachment frame and the cavity tissue, ensuring that effective attachment-type anchoring can be achieved on each surface where the attachment frame contacts the inner wall of the left atrial appendage during implantation, further increasing the anchoring strength, and avoiding the risk of the occluder falling off caused by insufficient anchoring strength; the bodies and the spine tips of the micro-spines face the outer surface, avoiding direct contact between the micro-spines and the inner wall of the sheath tube, and eliminating the problems of unsmooth pushing or other safety hazards caused by the micro-spines scraping the sheath. Therefore, the present invention has the characteristics of complete recovery and repeated release.

[0066] 5. At least part of the area of the barbs provided in the present invention is attached to the framework. The barbs are in a U-shaped or loop-shaped structure and penetrate through the holes and grooves on the framework, so that: a) The length, thickness and fineness of the microbarbs can be adjusted. For most occluders on the market, the barbs and the attachment frame are integrally carved from the same tube. Limited by the design of the raw materials, such barbs are often hard and thick and cannot be freely deformed, increasing the risk of barb breakage and piercing the left atrial appendage wall. At the same time, the length of the barbs is also limited by the design space of the raw materials. The bionic microbarb attachment structure of the present invention can be independently designed and is no longer limited by the raw materials in design. While avoiding broken barbs, it can adaptively deform inside the left atrial appendage, greatly increasing the anchoring safety and meeting the personalized customization requirements at the same time: b) During the manufacturing process, once the manufacturer finds that the length of one or some microbarbs is too long or too short, or the size is too thick or too thin, the microbarbs with better length or thickness can be temporarily replaced to realize the personalized customization "barb planting" function for the clinical needs of patients, ensuring that each microbarb can maximize the attachment-type anchoring function. Of course, it is also possible to perform non-destructive rework for defective microbarbs, avoiding the increase in the production cost of the manufacturer caused by the scrapping of the entire left atrial appendage occluder due to defective barbs in the prior art; c) The cross-sectional area of the wire material selected for the microbarbs ≤ 0.04mm 2 , making the microbarbs slender and soft. On this premise, once the surgeon finds that the length of one or some linear microbarbs is too long and there is a high risk of piercing the left atrial appendage wall during the operation, the microbarbs can be flexibly cut into a more appropriate length to realize the "barb adjustment" (adjusting the barb length) function for the personalized clinical needs of patients, thus ensuring the non-damaging advantages and characteristics of attachment-type anchoring and avoiding the trauma caused by deeply and directly piercing the left atrial appendage tissue.

[0067] 6. The left atrial appendage occluder with the bionic microbarb attachment structure provided by the present invention can make corresponding adjustments to the design of the bionic microbarb attachment structure according to the different anatomical shapes of the left atrial appendage, that is, by reasonably setting the thickness of the framework, the spacing of the holes and grooves, the length of the holes and grooves themselves, the microbarb inclination angle and the number, ensuring that most of the microbarbs can adaptively anchor the internal tissue of the cavity and giving full play to the maximum advantage of the microbarb attachment-type anchoring function.

[0068] 7. The attachment frame provided by the present invention is in a "mushroom shape" or "bowl shape" in the natural unconstrained state. When subjected to external radial extrusion, the order of adaptive deformation of each part of the skeleton in the attachment frame is as follows: the proximal independent rod, the intermediate connecting rod, and the distal ring-shaped body. The advantages of this design are as follows: a) It can make the entire attachment frame have both high flexibility and high resilience, adapt to the left atrial appendage lumen with different anatomical shapes, and have morphological self-adaptability. Different from traditional occluders that simply rely on the radial supporting force of the attachment frame to expand the left atrial appendage lumen and make the left atrial appendage cooperate with the shape of the attachment frame of the traditional occluder to achieve fixation, it does not cause damage to the left atrial appendage, and thus realizes non-invasive anchoring; b) The flattened "mushroom shape" or "bowl shape" attachment frame can be easily compressed and expanded radially, and has excellent adaptability to the left atrial appendage with a shallow and flat anatomical shape; c) By virtue of the elasticity and shape memory of the proximal independent rod and the intermediate connecting rod with a curved shape, the central member can further provide the power for the entire attachment frame to swim deep into the distal end of the left atrial appendage lumen after implantation inside the "mushroom shape" or "bowl shape", and at the same time drive the occluding disc to "fill" into the left atrial appendage, generating a spontaneous "inner suction filling" effect, improving the anchoring safety and sealing effectiveness of the occluder.

[0069] 8. The distal ring-shaped body provided by the present invention has the following advantages: a) The distal ring-shaped body is in a curled structure, which improves the fitting degree between the attachment frame and the inner wall of the left atrial appendage, and at the same time increases the number of bionic micro-spine attachment structures in contact with the left atrial appendage wall, which is beneficial to further enhance the firmness of the occluder anchoring. Most of the parts of competing products in contact with the cavity are straight-section designs, which are insufficient in terms of the fitting degree and adaptability to the inner wall of the cavity; b) The distal ring-shaped body has elasticity and shape memory. When the distal ring-shaped body is gradually pushed out and released from the delivery sheath, the distal ring-shaped body gradually unfolds from the straight state compressed and loaded in the delivery sheath into a curled shape. This unfolding process is like an "engine" providing a power source to move deep into the left atrial appendage. During the release process, along with the pushing of the delivery cable and the retraction of the delivery sheath, the entire movement process of the distal ring-shaped body is like a "wheel", its curled shape is like a circular tire, and the micro-spines are like the uneven textures on the outer surface of the tire. Once the distal ring-shaped body touches the inner wall of the left atrial appendage like a "lane", it "rolls" on the inner wall of the left atrial appendage, showing a movement trend of "spontaneously" driving the entire attachment frame like a "body" to swim deep into the inner cavity of the left atrial appendage, further enhancing the anchoring effectiveness of the attachment frame. At the same time, it pulls the occluding disc connected to the attachment frame like "cargo on the vehicle", making the occluding disc more tightly packed in the opening area of the left atrial appendage, maximizing the "inner suction filling" effect of spontaneity, and enhancing the anchoring safety of the attachment frame and the occluding effectiveness of the occluding disc; c) Each distal ring-shaped body is independent of each other, and the deformations do not interfere with each other, having its own morphological self-adaptability, and can make adaptive changes according to the specific anatomical morphology of the release position. For example, if a certain distal ring-shaped body is in an unfully unfolded straight state, its distal end can easily hook the uneven pectinate muscles or trabeculae in the inner cavity of the left atrial appendage, so that each ring-shaped body contributes to the anchoring function. Of course, it also enhances the self-adaptability to various anatomical morphologies, so it has a wide range of adaptation.

[0070] 9. The present invention is provided with a surrounding body which is wound around the framework and at least wraps the thorn roots in contact with the framework. The advantages of this design are as follows: a) The surrounding body prevents the direct contact between the framework and the cavity tissue, reduces the precipitation amount of metal ions, and improves biocompatibility; b) It reduces the friction coefficient and decreases the resistance of the attachment frame during the release and retraction in the delivery sheath; c) It increases smoothness and provides a better tactile experience; d) It enhances the anti-fatigue durability of the attachment frame, plays a role of "secondary protection" for the attachment frame, and avoids the risk of fracture of the attachment frame caused by long-term corrosion or fatigue failure in the left atrial appendage cavity; e) It increases the force transmission, ensures that each framework is uniformly stressed and there is no obvious jamming feeling when the occluder is sheathed; f) It enhances the fitting degree and position limitation between the thorn roots and the framework; g) It finely adjusts the micro-thorn angle to ensure that the damage to the left atrial appendage wall by the micro-thorns is minimized; h) In the embodiment where the second flow-blocking membrane is provided on the attachment frame, the surrounding body can pre-bury or hide the suture connecting the second flow-blocking membrane and the attachment frame, avoiding the wear and fracture of the suture directly contacting the inner surface of the delivery system sheath during the repeated release and retraction of the conventional occluder; i) By changing the single-layer thickness and the number of winding turns of the surrounding body, the overall thickness of the surrounding body in the radial direction is adjusted, and further the adjustability of the length of the micro-thorns exposed outside the framework is realized, avoiding the deep penetration or even piercing of the left atrial appendage cavity tissue.

[0071] 10. The end of the framework provided by the present invention is provided with a protective member, and its advantages are as follows: a) When the attachment frame is released from the delivery sheath, the protective member can contact the inner wall tissue of the left atrial appendage without damage; b) When the operator initially releases the attachment frame inside the left atrial appendage, the protective member can play an effective buffering and protecting role, avoiding the hidden danger of the framework end piercing the left atrial appendage wall due to poor release position; c) The protective member increases the imaging effect, which is beneficial for the operator to grasp the release position of the attachment frame in the left atrial appendage and facilitate timely adjustment.

[0072] 11. The attachment frame provided by the present invention is provided with a second flow-blocking membrane, and the second flow-blocking membrane is attached to and connected to the framework or the surrounding body. The design has the following advantages: a) It can achieve a secondary occlusion effect, prevent the detachment of existing and possibly generated thrombi in the left atrial appendage lumen, and further improve the occlusion effectiveness and safety; b) It has a step-by-step flow-blocking function. Especially when the attachment frame is just released during the operation (at this time the occlusion disc has not been deployed), it can push the existing thrombi inside the left atrial appendage back into the left atrial appendage lumen to prevent the thrombi from falling out from the open atrial appendage orifice.

[0073] 12. The left atrial appendage occluder with a bionic micro-thorn attachment structure of the present invention is further provided with an occlusion disc. The occlusion disc is in a three-dimensional cage-like structure, which has good self-centering property, ensures the self-centering effect of the left atrial appendage occluder, avoids the deflection and displacement of the attachment frame under the action of external forces during and after the operation, resulting in the weakening or loss of the anchoring effectiveness of the bionic micro-thorn attachment structure, and thus enhances the occlusion effectiveness and safety of the left atrial appendage occluder. Brief Description of the Drawings

[0074] Figure 1 3D view of a left atrial appendage occluder with a bionic micro - spine attachment structure in the present invention;

[0075] Figure 2 is Figure 1 front view of, showing the outer contour;

[0076] Figure 3 Partial schematic diagram of the bionic micro - spine attachment structure provided by the present invention;

[0077] Figure 4 Schematic diagram of the cooperation between the bionic micro - spine attachment structure and the skeleton provided by the present invention;

[0078] Figure 5 Schematic diagram of a partial skeleton with holes and grooves in the present invention;

[0079] Figure 6a U - shaped fixing form of the bionic micro - spine attachment structure in the skeleton in the present invention;

[0080] Figure 6b Square - shaped fixing form of the bionic micro - spine attachment structure in the skeleton in the present invention;

[0081] Figure 7 Dimension marking diagram related to the morphology control of the bionic micro - spine attachment structure in the present invention;

[0082] Figure 8 is Figure 2 partial view Figure Ⅰ magnified view of, showing the micro - spine morphology in the waist area of the outermost contour of the skeleton;

[0083] Figure 9a Schematic diagram of the micro - spines in the left atrial appendage occluder with a bionic micro - spine attachment structure provided by the present invention realizing a certain degree of free rotation and deformation around the spine root under external force;

[0084] Figure 9b Schematic diagram of the J - shaped micro - spines and straight - shaped micro - spines in the left atrial appendage occluder with a bionic micro - spine attachment structure provided by the present invention cooperating with each other to form a "self - locking" structure when the J - shaped micro - spines undergo adaptive bending deformation;

[0085] Figure 10 a is a schematic diagram showing only the rigid, straight, thick and long straight barbs structure in a conventional occluder;

[0086] Figure 10 b is a schematic diagram showing only the rigid, thick and long large hook barbs structure in a conventional occluder;

[0087] Figure 10Figure c shows only the J-shaped microspines of the present invention, which have soft, slender, short and shallow barbs and tips, and the tips are tiny and arc-shaped hooked;

[0088] Figure 10 Figure d shows only the J-shaped microspines of the present invention, which have soft, slender, short and shallow barbs and tips, and the tips are tiny and zigzag-shaped hooked;

[0089] Figure 10 Figure e shows only the straight microspines of the present invention, which are soft, slender, short and shallow;

[0090] Figure 11 Figure shows the left atrial appendage occluder with a bionic microspine attachment structure provided by the present invention in a "mushroom shape", and the relevant dimensions are marked;

[0091] Figure 12a Figure shows the movement trend of the left atrial appendage occluder provided by the present invention when it is radially extruded externally by the atrial appendage;

[0092] Figure 12b Figure shows the movement trend of a conventional occluder on the market when it is radially extruded externally by the left atrial appendage;

[0093] Figure 13 is Figure 1 a partial skeleton schematic diagram showing only a partial area;

[0094] Figure 14 Figure a shows a schematic diagram of the distal loop with an elliptical structure in the present invention;

[0095] Figure 14 Figure b shows a schematic diagram of the distal loop with a circular structure in the present invention;

[0096] Figure 14 Figure c shows a schematic diagram of the distal loop with a two-dimensional spiral structure in the present invention;

[0097] Figure 15 a to Figure 15 Figure a~e shows a schematic diagram of the process of the left atrial appendage occluder with a bionic microspine attachment structure provided by the present invention gradually unfolding from a straight state to a fully expanded state in a compression delivery sheath tube. Among them Figure 15 Figure a shows the just-released state, Figure 15 Figure b shows the state when the distal loop just unfolds, Figure 15 Figure c shows the state when the distal loop gradually unfolds when the delivery sheath tube is retracted, Figure 15 Figure d shows the state after the attachment frame is released when the delivery sheath tube is further retracted, Figure 15 Figure e shows the state when the attachment frame is fully unfolded and drives the occluding disc to "suction filling";

[0098] Figure 16 Figure a isFigure 14 Partial view of a Figure Ⅱ Enlarged view, showing a ring body structure protector;

[0099] Figure 16 b is Figure 14 Partial view of a Figure Ⅱ Enlarged view, showing a sphere structure protector;

[0100] Figure 16 c is Figure 14 Partial view of a Figure Ⅱ Enlarged view, showing a protector with a flexible spring structure;

[0101] Figure 17 a to Figure 17 c are three forms of the three-dimensional wave-shaped and / or reticular structure composed of the proximal independent rod and the intermediate connecting rod in the present invention;

[0102] Figure 18 a to Figure 18 d is a schematic diagram of the process of gradually deploying the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention from the delivery sheath;

[0103] Figure 19 a is the possible release form of the left atrial appendage occluder of the present invention in the conventional left atrial appendage lumen;

[0104] Figure 19 b is the possible release form of the left atrial appendage occluder of the present invention in the left atrial appendage lumen with a local protrusion structure;

[0105] Figure 19 c is the possible release form of the left atrial appendage occluder of the present invention in the left atrial appendage lumen with a flat mouth structure;

[0106] Figure 19 d is the possible release form of the left atrial appendage occluder of the present invention in the left atrial appendage lumen with a multi-lobe structure;

[0107] Figure 19 e is the possible release form of the left atrial appendage occluder of the present invention in the left atrial appendage lumen with another multi-lobe structure;

[0108] Figure 20 a is a schematic diagram of the bionic micro-spine attachment structure in the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention before being wound around the surrounding body;

[0109] Figure 20 b is a schematic diagram of the bionic micro-spine attachment structure in the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention after being wound around the surrounding body;

[0110] Figure 21Schematic diagram of the fixing structure of the surrounding body provided on the local skeleton in the present invention;

[0111] Figure 22 a is a schematic diagram of the straight-wound surrounding body in the present invention;

[0112] Figure 22 b is a schematic diagram of the obliquely-wound surrounding body in the present invention;

[0113] Figure 22 c is a schematic diagram of the cross-wound surrounding body in the present invention;

[0114] Figure 23 Schematic diagram of the surrounding body with a local barbed structure in the present invention;

[0115] Figure 24 Schematic diagram of the attachment frame provided with a second flow-blocking membrane in the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention;

[0116] Figure 25 Schematic diagram of the second flow-blocking membrane of the attachment frame in the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention blocking the thrombus inside the atrial appendage;

[0117] Figure 26a Schematic diagram of the suture in the present invention adopting a pre-buried winding method;

[0118] Figure 26b Schematic diagram of the suture in the present invention adopting a hidden winding method;

[0119] Figure 27 Schematic diagram of the suture of a conventional occluder on the current market after adopting an exposed winding method and then suturing;

[0120] Figure 28 a is a schematic diagram of the "cover type" second flow-blocking membrane in the present invention;

[0121] Figure 28 b is a schematic diagram of the "fitting type" second flow-blocking membrane in the present invention;

[0122] Figure 29 Schematic diagram of the local skeleton after film covering in the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention;

[0123] Figure 30a Local necking structure on the skeleton in the fourth embodiment of the present invention;

[0124] Figure 30b Local convex structure on the skeleton in the fourth embodiment of the present invention;

[0125] Figure 30c Keyway structure on the skeleton in the fourth embodiment of the present invention;

[0126] Figure 31 Schematic diagram of the integral bionic micro - thorn attachment structure in the fourth embodiment of the present invention;

[0127] Figure 32 Schematic diagram of the welding - type fixing method of the framework and the bionic micro - thorn attachment structure in the fourth embodiment of the present invention;

[0128] Figure 33a Schematic diagram of the integral embedding fixing method of the framework and the bionic micro - thorn attachment structure in the fourth embodiment of the present invention;

[0129] Figure 33b Schematic diagram of the independent embedding fixing method of the framework and the bionic micro - thorn attachment structure in the fourth embodiment of the present invention;

[0130] Figures 34a to 34c Schematic diagram of the outer contour of the left atrial appendage occluder in three different forms in the natural unconstrained state in the fifth embodiment of the present invention, where Figure 34a is "kettle - shaped", Figure 34b is "cage - shaped", Figure 34c is "gourd - shaped";

[0131] Figure 34d Three - dimensional view of the left atrial appendage occluder in the shape of a "bowl" in the natural unconstrained state in the fifth embodiment of the present invention, where the outer peripheral edge of the "bowl" has a distal ring - like structure;

[0132] Figures 35a to 35c respectively in Figures 34a to 34c on the basis of which, schematic diagram of the outer contour of the left atrial appendage occluder connected with a occluding disc;

[0133] Figure 35d is in Figure 34d on the basis of which, three - dimensional view of the left atrial appendage occluder connected with a occluding disc.

[0134] Among them, 1 is the left atrial appendage occluder, 2 is the delivery sheath, 3 is the thrombus, 10 is the occluding disc, 11 is the connecting piece, 12 is the attachment frame, 120 is the central part, 121 is the framework, 122 is the bionic micro - thorn attachment structure, 123 is the surrounding body, 124 is the second flow - blocking membrane, 125 is the first flow - blocking membrane, 1210 is the proximal independent rod, 1211 is the intermediate connecting rod, 1212 is the distal ring - like body, 1213 is the hole groove, 1220 is the thorn root, 1221 is the micro - thorn, 1222 is the limiting mechanism, 1223 is the limiting hole, 1231 is the fixing structure, 1241 is the suture, 12120 is the protective part, 12210 is the thorn body, 12211 is the thorn tip. Detailed implementation manners

[0135] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0136] In order to more clearly describe the left atrial appendage occluder with a bionic micro-spine attachment structure provided by the present invention, the terms "distal end" and "proximal end" are defined herein. The above terms are common terms in the field of interventional medical devices. Specifically, the "proximal end" refers to the end close to the operator during the operation, and the "distal end" refers to the end far from the operator during the operation.

[0137] The present invention will be further described in detail below with reference to the accompanying drawings and a plurality of specific embodiments.

[0138] Embodiment 1:

[0139] As Figure 1 and Figure 2 shown, the left atrial appendage occluder 1 with a bionic micro-spine attachment structure provided by the present invention includes an attachment frame 12. The attachment frame 12 includes a plurality of elastic skeletons 121 and a plurality of bionic micro-spine attachment structures 122. In the natural unconstrained state, the plurality of skeletons 121 diverge outward from the center and enclose a three-dimensional structure. The attachment frame 12 has anatomical morphological self-adaptability. The bionic micro-spine attachment structures 122 are arranged on the outer surface of the skeletons 121. The morphology of the bionic micro-spine attachment structures 122 is similar to the sparse micro-spines on the surface of plants. The bionic micro-spine attachment structures 122 include thorn roots 1220 and micro-spines 1221. The micro-spines 1221 are composed of thorn bodies 12210 and thorn tips 12211. The micro-spines 1221 are linear or J-shaped or a combination of both. The thorn bodies 12210 and / or the thorn tips 12211 can touch the inner cavity tissue of the left atrial appendage to achieve the attachment and anchoring function.

[0140] Figure 3It is a partial schematic diagram of the bionic micro-spine attachment structure 122. The micro-spines 1221 in the bionic micro-spine attachment structure 122 are imitated from the micro-spines sparsely growing on the outer surfaces of fruits, leaves or stems of some plants in nature, and have the characteristics of being shallow, short and slender. Such plants include but are not limited to Xanthium sibiricum, Humulus scandens, Caesalpinia decapetala, Polygonum perfoliatum, Euryale ferox, Acanthopanax trifoliatus var. setosus, Rubus corchorifolius, Cirsium japonicum, Polygonum senticosum, Acanthopanax trifoliatus, making the bionic micro-spine attachment structure 122 have villous characteristics and be used to achieve attachment-type anchoring with the left atrial appendage tissue. In the present invention, each micro-spine 1221 is linearly shaped or J-shaped in morphology. When it is J-shaped, the body 12210 of the micro-spine 1221 is equivalent to the vertical segment of the "letter J", and the tip 12211 is equivalent to the hooked segment of the "letter J". The tip 12211 of the J-shaped micro-spine 1221 can hook the inner wall tissue of the left atrial appendage, making the J-shaped micro-spine 1221 have good attachment-type anchoring property and avoiding the trauma caused by deep and direct penetration into the left atrial appendage tissue; when the micro-spine 1221 is linearly shaped, the linearly shaped micro-spine 1221 can play a role in increasing roughness. On the one hand, it significantly increases the static friction between the micro-spine 1221 and the left atrial appendage wall and enhances the attachment force to the left atrial appendage wall. On the other hand, the linearly shaped micro-spine 1221 can play a special anchoring role in some specific left atrial appendage structures. For example, when encountering a multi-lobed left atrial appendage with well-developed pectinate muscles, when one or two skeletons 121 of the occluder touch the multi-lobed structure in the atrial appendage lumen, the linearly shaped micro-spine 1221 can directly anchor the pectinate muscles, making the entire skeleton 121 hang on the inner wall of the multi-lobed structure to achieve effective anchoring; preferably, when the tip 12211 of the micro-spine 1221 is extremely small, for example, the distance between the tip point of the tip 12211 and the body 12210 ≤ 0.5 mm, the tip 12211 of the J-shaped micro-spine 1221 is in a micron-level folded hook shape (as shown in Figure 10 as shown in Figure 10As shown in c), this not only endows the micro-spines 1221 with the advantages of both J-shaped and linear shapes, but also enables the micro-spines 1221 to perform the function of attachment and anchoring to the inner wall of the left atrial appendage. Moreover, it avoids the situation where multiple J-shaped micro-spines 1221 on multiple frameworks 121 may hook each other when the attachment framework 12 enters the delivery sheath 2 or is pushed in the delivery sheath 2, resulting in partial or complete inability of some or all of the frameworks 121 to fully expand into the optimal shape in the left atrial appendage cavity, which affects the anchoring effectiveness. Therefore, finally, the attachment framework 12 provided by the present invention has the characteristics of complete recovery and repeated release. In one embodiment, it is defined that: the length of the spine body 12210 is L1, the curve length of the spine tip 12211 is L2, and the angle between the extension direction of the spine body 12210 facing outward and the extension direction of the distal end of the spine tip 12211 facing outward is β. The length L1 of the spine body 12210, the curve length L2 of the spine tip 12211, and the angle β satisfy the following mathematical relationships: 0.2 mm ≤ L1 ≤ 3 mm, 0 ≤ L2 ≤ 1.5 mm, 0 ≤ β ≤ 150°, so that the micro-spines 1221 have the characteristics of being shallow and short like the sparse micro-spines on the plant surface. The length of the linear micro-spines 1221 is less than that of the J-shaped micro-spines 1221. The preferred relationships are as follows: 0.5 ≤ L1 ≤ 2 mm, 0 ≤ L2 ≤ 1 mm, 90° ≤ β ≤ 150°. As Figure 4 shown, by adjusting the parameters L1, L2, and β, it is convenient for the spine tip 12211 to touch the left atrial appendage wall, increasing the effectiveness of attachment and anchoring. At the same time, it can effectively ensure contact with the atrial appendage wall without damage, avoiding the risk of traditional occluder anchoring devices piercing too deeply, which may lead to risks such as piercing the left atrial appendage and causing pericardial effusion. In one embodiment, the total number of the bionic micro-spine attachment structures 122 is between 6 and 600. To fully exert the respective advantages of the linear and J-shaped micro-spines 1221 mentioned above and hereinafter, the proportion of the linear ones should be between 50% and 99%. Preferably, the number of the bionic micro-spine attachment structures 122 provided on each framework 121 is between 1 and 20. Such a design makes the bionic micro-spine attachment structures 122 densely distributed on the outer surface of the framework 121 of the attachment framework 12, increasing the contact probability between the attachment framework 12 and the cavity tissue, ensuring that effective attachment and anchoring can be achieved on each surface where the attachment framework contacts the inner wall of the left atrial appendage during implantation, further increasing the anchoring strength, and avoiding the risk of occluder detachment caused by insufficient anchoring strength. In a preferred embodiment, when the shape of the micro-spine 1221 is linear, the spine body 12210 of the micro-spine 1221 is the spine tip 12211. Preferably, the length L1 of the spine body 12210 of the linear micro-spine 1221 ≤ 1 mm, which can fully exert the attachment and anchoring property of the micro-spine 1221 and avoid the trauma caused by deep and direct penetration into the left atrial appendage tissue.

[0141] In one embodiment, the bionic micro-spine attachment structure 122 further includes a limiting mechanism 1222. The spine root 1220 cooperates with the limiting mechanism 1222 to limit the relative position of the micro-spines 1221 on the framework 121, which can effectively prevent the micro-spines 1221 from breaking due to fatigue failure. As Figure 5 shown, in this embodiment, the limiting mechanism 1222 is a hole groove 1213 provided on the framework 121 for fixing the bionic micro-spine attachment structure 122 on the framework 121. The bionic micro-spine attachment structure 122 corresponds to the hole groove 1213 in position. At the same time, at least a part of the spine root 1220 is located in the hole groove 1213, and the spine root 1220 cooperates with the hole groove 1213 to limit the relative position of the micro-spines 1221 on the framework 121. As Figure 6a and Figure 6b shown, in one embodiment, each bionic micro-spine attachment structure 122 includes at least 1 spine root 1220 and 2 micro-spines 1221. The micro-spines 1221 correspond to the hole grooves 1213 in position and quantity. At least a part of the spine root 1220 is attached to the framework 121. The spine root 1220 has a U-shaped or loop-shaped structure and penetrates through two hole grooves 1213. In this embodiment, the bionic micro-spine attachment structure 122 and the framework 121 of the attachment frame 12 adopt a combined structure. The advantages of this design are as follows: a) The length, thickness and width of the micro-spines 1221 can be adjusted. For most occluders on the market, the barbs and the attachment frame 12 are integrally formed by laser engraving on the same tube. Limited by the design of raw materials, such barbs are often hard and thick, increasing the risk of barb breakage; b) During the manufacturing process, once the manufacturer finds that the length of one or some micro-spines 1221 is too long or too short, or the size is too thick or too thin, the micro-spines 1221 with better length or thickness can be temporarily replaced to achieve the personalized customization "seeding spines" (sowing micro-spines) function according to the clinical needs of patients, ensuring that each micro-spine 1221 can maximize the attachment and anchoring function. Of course, it is also possible to perform non-destructive rework on the performance due to defective micro-spines 1221, avoiding the increase in the production cost of the manufacturer caused by the scrapping of the entire left atrial appendage occluder due to defective barbs in the prior art. As a preferred embodiment, each micro-spine 1221 is coplanar. On this basis, the spine root 1220 penetrates through two adjacent hole grooves 1213, thus avoiding the increase in the sheath diameter of the delivery sheath 2 caused by the possible overlap of multiple spine roots 1220. As a more preferred embodiment, each bionic micro-spine attachment structure 122 is formed by a wire with elasticity and shape memory passing through two adjacent hole grooves 1213 in sequence. The cross-sectional area of the selected wire is ≤0.04mm 2, making the micro-spines 1221 slender and flexible. On this premise, during the operation, once the surgeon finds that the length of a certain or certain linear micro-spines 1221 is too long and there is a high risk of piercing the left atrial appendage wall, the micro-spines 1221 can be flexibly cut into a more appropriate length to achieve the function of "adjusting the spines" (adjusting the spine length) according to the individual clinical needs of the patient, thus ensuring the non-invasive advantages and characteristics of the attached anchoring and avoiding the trauma caused by deeply and directly piercing into the left atrial appendage tissue; further, the material of the wire includes but is not limited to cobalt-chromium alloy, nickel-titanium alloy, 316L stainless steel, pure tantalum, titanium alloy, gold, platinum-iridium alloy, and its cross-sectional area is between 0.002mm 2 and 0.015mm 2 , which can maximize the villus-like characteristics of the aforementioned bionic micro-spine attachment structure 122 and effectively realize the attached anchoring function with the left atrial appendage tissue.

[0142] As Figure 7 shown, in one embodiment, on the cross-section in the long diameter direction of any one of the skeletons 121, the thickness of the skeleton 121 is defined as P1, the self-length of the hole groove 1213 is defined as P2, the distance between any two adjacent hole grooves 1213 is defined as P3, the central axis of the attachment frame 12 is m, and the included angle ω between the outward extension direction of the sashimi 12210 and the direction of the skeleton 121 away from the central axis m satisfies the following mathematical relationships: 0.05mm ≤ P1 ≤ 0.5mm, 0.05mm ≤ P2 ≤ 1mm, 0.5mm ≤ P3 ≤ 10mm, 30° ≤ ω < 180°. Adjusting the specific parameters of P1 and P2 can realize the adjustment of the included angle ω and the total number of micro-spines 1221, ensuring that each tip 12211 in contact with the left atrial appendage lumen tissue can face the left atrial appendage wall or the left atrial appendage opening side, as Figure 8 and Figure 9b shown, enhancing the effectiveness of the attached anchoring, and at the same time, the total number of micro-spines can be adjusted by adjusting the parameter P3. In a preferred embodiment, the above mathematical relationships are as follows: 0.1mm ≤ P1 ≤ 0.3mm, 0.1mm ≤ P2 ≤ 0.3mm, 0.5mm ≤ P3 ≤ 2mm, 60° ≤ ω ≤ 150°. In another embodiment, on the outer surface of a part of the distal ring body 1212 in the peripheral contour area of the "mushroom shape" mentioned below, a plurality of J-shaped micro-spines 1221 are provided. The tips 12211 of the J-shaped micro-spines 1221 are in a micron-level folded hook shape or arc hook shape, and the included angle ω of the micro-spines 1221 in this area gradually decreases in the direction away from the central axis m, as Figure 8As shown, the advantage of this design is that, on the one hand, by adjusting the inclination angles of the micro-spines 1221 at different positions in the waist region of the attachment frame 12, the micro-spines 1221 can better adapt to the anatomical structure characteristics of the left atrial appendage, increasing the effective attachment and anchoring probability of the micro-spines 1221 and reducing the situation where some micro-spines 1221 fail to anchor effectively due to local extrusion deformation when contacting the atrial appendage wall. On the other hand, the micro-spines 1221 far from the central axis m first contact the inner wall of the left atrial appendage when the attachment frame 12 is released. If the length of the shaft body 12210 of the micro-spines 1221 here is relatively long, the micro-spines 1221 are very likely to deflect and thus fail to effectively anchor. Therefore, the length of the shaft body 12210 of the micro-spines 1221 in the waist region of the attachment frame 12 can preferably adopt a gradient design that gradually decreases in the direction away from the central axis m. In yet another embodiment, the quantity ratios of the bionic micro-spine attachment structures 122 on the intermediate connecting rod 1211 and the distal ring-shaped body 1212 described below can be set to 10% - 30% and 60% - 90% respectively.

[0143] In the present invention, the bionic micro-spine attachment structure 122 has both flexibility and elasticity and has a villus-like characteristic, which is used to achieve attachment and anchoring to the left atrial appendage tissue. When the micro-spines 1221 contact the left atrial appendage lumen tissue, they can undergo adaptive bending deformation, which is beneficial for the micro-spines 1221 to attach to the left atrial appendage lumen tissue without damage and enhance their attachment and anchoring function. Further, when the micro-spines 1221 are subjected to an external force, they can rotate and deform freely in the direction of the outer surface of each framework 12 with the thorn root 1220 as the center, as Figure 9a shown. When implanted into the left atrial appendage of the human body, since there are many local protrusions on the inner wall of the left atrial appendage, when the micro-spines 1221 contact these local protrusions, the orientations and included angles ω of some micro-spines 1221 can undergo adaptive changes, enhancing the attachment and anchoring property of the micro-spines 1221 without rigidly and straightly deeply penetrating into the tissue and causing no damage to the left atrial appendage. At the same time, when the J-shaped micro-spines adaptively contact the left atrial appendage lumen tissue, they can cooperate with the linear micro-spines to form a "self-locking" structure, as Figure 9b shown, such that each framework cannot move distally or proximally along the framework axis, increasing the restraint and strengthening the firmness of the attachment to the left atrial appendage lumen tissue. Therefore, the entire bionic micro-spine attachment structure 122 has self-adaptability and enhances the attachment and anchoring function to the left atrial appendage. It is particularly noted here that, in order to achieve this functional purpose, the length of the shaft body 12210 of the linear micro-spines 1221 should be less than the length of the shaft body 12210 of the J-shaped micro-spines 1221 so that the tips 12211 of both can contact the left atrial appendage lumen tissue. In addition, in order to maximize the enhanced attachment firmness function brought by the "self-locking" structure, a multi-group alternating repetitive design of the linear micro-spines 1221 and the J-shaped micro-spines 1221 should be adopted, as Figure 9b shown. Figure 10 a toFigure 10 Figures e respectively show the comparison diagrams of a single barbed structure of a conventional occluder and a single micro barb 1221 structure in the present invention. The barbs of the conventional occluder are usually straight barbs or large hook barbs with a completely fixed shape and skeleton, and are overall rigid, straight, thick and long, and cannot deform adaptively at all. They can only penetrate too deeply into the left atrial appendage tissue at a fixed angle in the left atrial appendage, which easily leads to the risk of piercing the left atrial appendage wall. However, the barb body 12210 and barb tip 12211 of the micro barb 1221 of the present invention have morphological and performance characteristics such as being slender, shallow, short and soft, and the barb tip 12211 is tiny and hook-shaped at the micron level. Therefore, in terms of both morphological structure and function, it has advantages that cannot be compared with the traditional barbed structure.

[0144] As Figure 11 shown, in one embodiment, multiple skeletons 121 diverge outward from the center and enclose a "mushroom-shaped" three-dimensional structure. This "mushroom-shaped" three-dimensional structure has flexibility and resilience, and can adapt to the inner cavities of left atrial appendages with different shapes. On this basis, the bionic micro barb attachment structure 122 is arranged on the outer surface of the skeleton 121, so that during the whole process of the left atrial appendage occluder 1 with the bionic micro barb attachment structure provided by the present invention entering and exiting the delivery sheath 2, all the micro barbs 1221 on the attachment frame 12 are inside the delivery sheath 2, as Figure 18 a to Figure 18As shown in c, the micro spines 1221 are thus prevented from directly contacting the delivery sheath 2, eliminating the problems of poor pushing caused by the scraping of the delivery sheath 2 by the micro spines 1221 or other safety hazards, and further ensuring that the left atrial appendage occluder 1 with a bionic micro spine attachment structure provided by the present invention has complete retrievability and repeatable release. In a preferred embodiment, the "mushroom shape" includes, but is not limited to, the shapes of shiitake mushrooms, straw mushrooms, flower mushrooms, tea tree mushrooms, Agaricus bisporus, matsutake mushrooms, golden top mushrooms, and fragrant apricot mushrooms. The attachment frame 12 further includes a central member 120, and the skeleton 121 and the connecting member 11 are connected through the central member 120. In the natural unconstrained state, the central member 120 of the attachment frame 12 is located inside the "mushroom shape", and the height K1 of the "mushroom shape" and the maximum outer diameter D1 of the "mushroom shape" satisfy the following mathematical relationship: 3 mm ≤ K1 ≤ 20 mm, 10 mm ≤ D1 ≤ 50 mm, K1 ≤ D1, preferably 5 mm ≤ K1 ≤ 10 mm. The advantages of this design are as follows: a) Under normal circumstances, the depth of the human left atrial appendage generally does not exceed 30 mm, and its shape is mostly flat-mouthed, and the effective area suitable for the occluder to be anchored is even smaller. If the height of the occluder is too high, it cannot be generally applicable to the conventional left atrial appendage anatomical structure. If the height is too low, the effective anchoring conditions are insufficient. Therefore, the overall height of the attachment frame 12 in the present invention is controlled within the above range; b) The flattened "mushroom-shaped" attachment frame 12 can be easily compressed and expanded in the radial direction, and has excellent adaptability to the left atrial appendage with a shallow and flat anatomical shape. In a preferred embodiment, in the natural unconstrained state, the outermost end of the attachment frame 12 forms a plane, which is defined as α1, the innermost end of the attachment frame 12 forms a plane, which is defined as α2, and the proximal end of the central member 120 of the attachment frame 12 forms a plane, which is defined as α3. Among them, the planes α1, α2, and α3 are all perpendicular to the central axis m. The distance between the plane α1 and the plane α3 is defined as K2, and the distance between the plane α2 and the plane α3 is defined as K3. Then, the following mathematical relationship exists: K1 = K2 + K3, 0 < K2 / K3 ≤ 1. The advantages of this design are as follows: By virtue of the elasticity and shape memory of the proximal independent rod 1210 and the intermediate connecting rod 1211 with a curved shape, the central member 120 provides the power for the entire attachment frame 12 to swim deep into the distal end of the left atrial appendage lumen after implantation inside the "mushroom shape", driving the occluding disc 10 to "stuff" into the atrial appendage, generating a spontaneous "inner suction stuffing" effect, and improving the anchoring safety and sealing effectiveness of the occluder. Figure 12a and Figure 12bThe movement trends of the occluder of the present invention and the conventional occluders on the market when being externally squeezed by the left atrial appendage are respectively shown. It can be seen from the figure that since the central member 120 of most of the occluders on the market is located outside the attachment frame 12, when the left atrial appendage is externally squeezed, its structure determines that the attachment frame 12 will inevitably have a movement trend of moving towards the left atrial appendage orifice, and at the same time, it will push the occluding disc 10 connected to the attachment frame 12, causing the occluding disc 10 to bulge outwards, thus resulting in incomplete occlusion and even the risk of the detachment of the attachment frame 12; while the central member 120 of the present invention is located inside the attachment frame 12. When being externally squeezed, the attachment frame 12 has a tendency to move inwards, and at the same time, it "drags" the occluding disc 10 into the atrial appendage interior, improving the occlusion effectiveness of the occluding disc 10.

[0145] In one embodiment, as Figure 13 shown, the framework 121 successively includes a proximal independent rod 1210, an intermediate connecting rod 1211 and a distal ring-shaped body 1212 in the direction in which the central member 120 diverges outwards. In a preferred embodiment, the number of the frameworks 121 is between 3 and 20, and each framework 121 includes at least one distal ring-shaped body 1212. In another preferred embodiment, a plurality of bionic micro-spine attachment structures 122 are arranged on the intermediate connecting rod 1211 and the distal ring-shaped body 1212. The flexibility of the proximal independent rod 1210 is greater than or equal to that of the intermediate connecting rod 1211, and the flexibility of the intermediate connecting rod 1211 is greater than or equal to that of the distal ring-shaped body 1212. When the attachment frame 12 is subjected to an external radial squeezing force, the sequence of the adaptive deformation of each part of the framework 121 is: the proximal independent rod 1210, the intermediate connecting rod 1211, the distal ring-shaped body 1212. The advantages of this design are as follows: a) enabling the entire attachment frame 12 to have both high flexibility and high resilience, adapting to the left atrial appendage inner cavities of different anatomical forms, having morphological self-adaptability, different from the traditional occluders that simply rely on the radial supporting force of the attachment frame 12 to expand the left atrial appendage inner cavity, enabling the left atrial appendage to cooperate with the form of the traditional occluder attachment frame 12 to achieve fixation, not causing damage to the left atrial appendage, and thus realizing non-invasive anchoring; b) when being externally radially squeezed, further providing power for the attachment frame 12 to swim deep into the left atrial appendage inner cavity, and at the same time driving the occluding disc 10 to "fill" towards the atrial appendage interior, further enhancing the anchoring safety and sealing effectiveness of the occluder.

[0146] As Figure 14 a~ Figure 14As shown in Fig. c, the distal loop 1212 of the framework 121 is a coiled structure formed by the outer peripheral region of the framework 121, or a coiled structure formed by further extending the end of the framework 121 in the end direction. The coiled structure can be one or more of an oval shape, a circular shape or a two-dimensional helix structure, and the plane where each coiled structure is located is coplanar with the central axis m. This design has the following advantages: a) The coiled structure has good compliance and smoothness, which can ensure the smoothness of the distal loop 1212 when the sheath is retracted and released; b) It further increases the degree of fit between the attachment frame 12 and the inner wall of the auricle, and at the same time, the number of bionic micro-spine attachment structures 122 in contact with the auricle wall also increases, thus further enhancing the firmness of the attachment type anchoring. Most of the parts of competing products in contact with the cavity are straight section designs, which are poor in terms of the degree of fit and adaptability with the inner wall of the cavity; c) Each distal loop 1212 is coplanar with the central axis m, which can ensure that the distal loop 1212 always moves along the major axis direction of the sheath tube 2 in the delivery sheath tube 2, avoiding abnormal unfolding caused by torsion and entanglement of different distal loops 1212. In addition, the distal loop 1212 also has the following two advantages in function: a) The distal loop 1212 has elasticity and shape memory, so that when the distal loop 1212 is gradually pushed out and released from the delivery sheath tube 2, the distal loop 1212 gradually unfolds from the straight state compressed and loaded in the delivery sheath tube 2 into a coiled shape. This unfolding process is like a "motor" providing a power source to move deep into the left auricle. The process is as shown in Figure 15 a~ Figure 15As shown in e), first, the ends of one or more distal coiled bodies 1212 touch the inner wall of the left atrial appendage. Further pushing the delivery cable, the distal coiled bodies 1212 move towards the inside of the left atrial appendage, and some microspines 1221 begin to contact the atrial appendage wall. When in the appropriate position, while continuing to push the delivery cable, the delivery sheath 2 is retracted. The distal coiled bodies 1212 gradually unfold inside the left atrial appendage. The microspines 1221 that first contacted the inner wall of the left atrial appendage may become detached from the anchoring and be in a "floating" state, but more microspines 1221 that unfold with the distal coiled bodies 1212 gradually contact the left atrial appendage wall and achieve anchoring. Therefore, during the release process, along with the pushing of the delivery cable and the retraction of the delivery sheath 2, the entire movement process of the distal coiled bodies 1212 is like a "wheel". Its coiled shape is like a circular tire, and the microspines 1221 are like the uneven textures on the outer surface of the tire. Once the distal coiled bodies 1212 touch the inner wall of the left atrial appendage like a "lane", they "roll" on the inner wall of the left atrial appendage, showing a movement trend of "spontaneously" driving the entire attachment frame 12 like a "vehicle body" into the deep lumen of the left atrial appendage, further enhancing the anchoring effectiveness of the attachment frame 12. At the same time, it pulls the occlusion disc 10 connected to the attachment frame 12 like "cargo on the vehicle", making the occlusion disc 10 more tightly packed in the opening area of the left atrial appendage, maximizing the "inner suction packing" effect of spontaneity and enhancing the occlusion effectiveness of the occlusion disc 10; b) Each distal coiled body 1212 is independent of each other, and the deformations do not interfere with each other. It has its own morphological self - adaptability and can make adaptive changes according to the specific anatomical morphology of the release position. For example, if a certain distal coiled body 1212 is in an unfully expanded straight state, its distal end can also easily hook the uneven pectinate muscles or trabeculae in the atrial appendage lumen, thereby enabling each coiled body to contribute to the anchoring function. Of course, it also enhances the self - adaptability to various anatomical morphologies, so it has a wide range of adaptability. In addition, in one embodiment, the coiling direction of the coiled structure is inward coiling, and the included angle σ between the extension line direction of the end of the coiled structure and the direction of the middle axis m towards the distal end satisfies: 0° ≤ σ ≤ 90°, and the number of turns n of the coiled structure satisfies: 0.5 ≤ n ≤ 1.5. If the number of turns is too small, the function of the distal coiled bodies 1212 cannot be exerted; if the number of turns is too large, the designed length of the entire attachment frame 12 will be too long and the practicality will be reduced. In a preferred embodiment, the proximal independent rod 1210 is provided with microspines 1221, which is convenient for improving the interception efficiency of thrombus 3 existing during the operation and possibly generated after the operation in the left atrial appendage cavity. Further, microspines 1221 can also be provided on the inner surface of the framework 121 of the distal coiled bodies 1212, which can also bring this benefit. Therefore, this design is effective enough in preventing the detachment of thrombus 3.

[0147] In one embodiment, a protective member 12120 is provided at the end of the framework 121 of the attachment frame 12. The design of the protective member 12120 has the following advantages: a) When the attachment frame 12 is released from the delivery sheath 2, the protective member 12120 can contact the inner wall tissue of the left atrial appendage without damage; b) When the operator initially releases the attachment frame 12 inside the left atrial appendage, the protective member 12120 can play an effective buffering and protective role, avoiding the hidden danger of the end of the framework 121 piercing the atrial wall due to poor release position; c) The protective member 12120 increases the imaging effect, which is conducive to the operator's grasp of the release position of the attachment frame 12 in the atrial appendage and facilitates timely adjustment. The protective member 12120 is fixedly connected to the framework 121, and its shape can be one or more combined structures of a ring body or a sphere with a diameter slightly larger than the width of the framework 121, or a flexible member with a higher flexibility than the end region of the framework 121, as shown respectively in Figure 16 a to Figure 16 c. The advantage of the ring body structure is that the processing technology is simple, and it can be integrally processed with the distal ring 1212. At the same time, the ring body structure can also be used as the fixing structure 1231 of the surrounding body 123 in the second embodiment of the present invention; the advantage of the sphere structure is that the size of the sphere can be adjusted according to the design, and it has a wide contact area with the atrial wall and does not damage the atrial wall; the advantage of the flexible member is that it has extremely high flexibility, excellent buffering effect with the atrial wall, and minimal damage to the atrial wall. In a preferred embodiment, the flexible member includes but is not limited to a flexible spring, a flexible tube, a flexible rod, and a flexible wire.

[0148] As Figure 17 a to Figure 17 c shown, the intermediate connecting rods 1211 of the attachment frame 12 are interconnected to form a three-dimensional wavy and / or reticular structure, or the frameworks 121 of the attachment frame 12 are independent of each other and not connected. And the plane where each framework 121 is located is coplanar with the central axis m. The advantage of this design is that it can greatly improve the morphological self-adaptability of the entire attachment frame 12, and at the same time provide appropriate radial support force for the distal ring 1212 to enhance the anchoring firmness. When the frameworks 121 of the attachment frame 12 adopt an independent and non-connected design, the above intermediate connecting rods 1211, the proximal independent rods 1210, and the distal ring 1212 are of an integral structure. To ensure the morphological self-adaptability of the entire attachment frame 12, the intermediate connecting rods 1211 can selectively adopt a compensation design, such as a variable diameter design, local thickening or thinning, and use the second blocking film 124 in the third embodiment of the present invention to achieve its flexible compensation.

[0149] The attachment frame 12 of the present invention is formed by integrally laser cutting a medical metal pipe with elasticity and shape memory and shaping it through heat treatment, or by integrally braiding a medical metal or polymer wire with elasticity and shape memory and shaping it through heat treatment, or directly formed by integrally hot processing a medical polymer material with elasticity and shape memory. The medical metals mentioned here include but are not limited to cobalt-chromium alloy and nickel-titanium alloy.

[0150] In one embodiment, the left atrial appendage occluder 1 with a bionic micro-spike attachment structure further includes a occluding disk 10 and a connecting member 11. The occluding disk 10 and the attachment frame 12 are connected through the connecting member 11. The occluding disk 10 is made of a material with elasticity and shape memory and has a three-dimensional cage-like structure. It has good self-centering property, ensuring the self-centering effect of the left atrial appendage occluder 1, and avoiding deflection and displacement of the attachment frame 12 under external force during and after the operation, resulting in weakening or loss of the anchoring effectiveness of the bionic micro-spike attachment structure 122. Therefore, the occlusion effectiveness and safety of the left atrial appendage occluder 1 are enhanced, and it has excellent morphological self-adaptability. A three-dimensional first flow-blocking membrane 125 is provided on the occluding disk 10, which can block the thrombus 3 inside the atrial appendage in all directions, minimizing residual shunt to the greatest extent and greatly improving the occlusion completeness, safety and effectiveness.

[0151] Figure 18 a~ Figure 18Figure d is a schematic diagram of the gradual deployment process of the left atrial appendage occluder 1 with the bionic micro-spine attachment structure 122 provided by the present invention. When the occluder is loaded in the delivery sheath 2, the attachment frame 12 and the occluding disc 10 are in a compressed state. Each of the skeletons 121 of the attachment frame 12 is independent of each other without entanglement. The point on the attachment frame 12 farthest from the operator is the protective member 12120. At the same time, the proximal end of the occluding disc 10 is connected to the delivery cable through a detachable connection structure such as a thread, a buckle, or a spring piece, for the pushing and releasing of the occluder in the delivery sheath 2. During the operation, when the distal end of the delivery sheath 2 reaches the predetermined position, the delivery cable is pushed. Under the thrust of the delivery cable, the entire occluder gradually moves in the delivery sheath 2. During the release process, the protective member 12120 of the attachment frame 12 reaches the distal end of the delivery sheath 2 first. By further pushing the delivery cable, the protective member 12120 contacts the inner wall tissue of the left atrial appendage without damage and can play an effective buffering and protecting role. Continuing to push the delivery cable, the distal circular body 1212 of the attachment frame 12 gradually unfolds. At the same time, the bionic micro-spine attachment structure 122 on the skeleton 121 is gradually released from the delivery sheath 2. When it reaches the appropriate position, the bionic micro-spine attachment structure 122 on one or more skeletons 121 can contact the pectinate muscles or other inner wall tissues of the left atrial appendage. With the further pushing of the delivery cable, the attachment frame 12 is completely released. Due to the excellent adaptability of the attachment frame 12 to the shape of the left atrial appendage, most of the bionic micro-spine attachment structures 122 on the skeleton 121 have achieved effective attachment and anchoring to the left atrial appendage. After the occluding disc 10 is completely released, the release process of the entire occluder ends. During the operation, the operator can recover the occluder at any time according to the actual situation, and the recovery process is similar to the release process. Figure 19 a~ Figure 19 Figure e is a possible release form of the left atrial appendage occluder 1 with the bionic micro-spine attachment structure 122 of the present invention in the left atrial appendage lumen. Compared with the same type of left atrial appendage occluder on the market, it has the characteristics of a wider application range, better anchoring firmness and safety, and better occlusion effectiveness.

[0152] Embodiment 2:

[0153] Reference Figure 20 a and Figure 20b. Based on the first embodiment, in the second embodiment, the attachment frame 12 includes a surrounding body 123. The surrounding body 123 is wound around the framework 121 and at least wraps the root thorns 1220 that are in contact with the framework 121, so as to enhance the connection strength between the framework 121 and the bionic micro-thorn attachment structure 122. The design of the surrounding body 123 also has the following advantages: a) The surrounding body 123 prevents part or all of the framework 121 from directly contacting the cavity tissue, reduces the precipitation amount of metal ions, and improves biocompatibility; b) Reduces the friction coefficient and decreases the resistance of the attachment frame 12 during the retraction and release in the delivery sheath 2; c) Increases smoothness and provides a better tactile experience; d) Enhances the anti-fatigue durability of the attachment frame 12, playing a role of "secondary protection" for the attachment frame 12 and avoiding the risk of fracture of the attachment frame 12 caused by long-term corrosion or fatigue failure in the left atrial appendage cavity; e) Increases the force transmissibility, ensuring that each framework 121 is evenly stressed and there is no obvious jamming feeling when the occluder is sheathed; f) Enhances the fitting degree and position limitation of the root thorns 1220 and the framework. As shown in Figure 20 and Figure 20 , by adjusting the winding and wrapping force of the surrounding body 123, it is beneficial to ensure that the root thorns 1220 fit the framework 121 to the greatest extent, minimize the sheath diameter of the required delivery sheath 2, expand the range of suitable populations, especially suitable for populations with small vascular accesses such as infants and women; g) Can finely adjust the angle of the micro-thorns 1221 to ensure that the damage to the left atrial appendage wall by the micro-thorns 1221 is minimized; h) In the third embodiment where the second flow-blocking membrane 124 is provided on the attachment frame 12, the surrounding body 123 can pre-bury or hide the suture 1241 that sutures the second flow-blocking membrane 124 to the attachment frame 12, avoiding the wear and fracture of the suture 1241 directly contacting the inner surface of the delivery system sheath during the repeated retraction and release of the occluder; i) By changing the single-layer thickness and the number of winding turns of the surrounding body 123, the overall thickness of the surrounding body 123 in the radial direction is adjusted, and further the length adjustability of the micro-thorns 1221 exposed outside the framework 121 is realized. For example, when the operator discovers according to clinical needs that the left atrial appendage wall of some patients is very thin and the length of the micro-thorns 1221 exposed outside the framework 121 needs to be minimized, the operator can flexibly and immediately increase the number of winding turns of the surrounding body 123 to realize the "thorn adjustment" function for the personalized clinical needs of patients, ensure the non-invasive advantages and characteristics of attachment anchoring, and avoid the trauma caused by deeply and directly piercing the left atrial appendage tissue. Therefore, to a certain extent, personalized customization of clinical needs is realized. Figure 20 a and Figure 20 As shown in Figure 20 and Figure 20 , by adjusting the winding and wrapping force of the surrounding body 123, it is beneficial to ensure that the root thorns 1220 fit the framework 121 to the greatest extent, minimize the sheath diameter of the required delivery sheath 2, expand the range of suitable populations, especially suitable for populations with small vascular accesses such as infants and women; g) Can finely adjust the angle of the micro-thorns 1221 to ensure that the damage to the left atrial appendage wall by the micro-thorns 1221 is minimized; h) In the third embodiment where the second flow-blocking membrane 124 is provided on the attachment frame 12, the surrounding body 123 can pre-bury or hide the suture 1241 that sutures the second flow-blocking membrane 124 to the attachment frame 12, avoiding the wear and fracture of the suture 1241 directly contacting the inner surface of the delivery system sheath during the repeated retraction and release of the occluder; i) By changing the single-layer thickness and the number of winding turns of the surrounding body 123, the overall thickness of the surrounding body 123 in the radial direction is adjusted, and further the length adjustability of the micro-thorns 1221 exposed outside the framework 121 is realized. For example, when the operator discovers according to clinical needs that the left atrial appendage wall of some patients is very thin and the length of the micro-thorns 1221 exposed outside the framework 121 needs to be minimized, the operator can flexibly and immediately increase the number of winding turns of the surrounding body 123 to realize the "thorn adjustment" function for the personalized clinical needs of patients, ensure the non-invasive advantages and characteristics of attachment anchoring, and avoid the trauma caused by deeply and directly piercing the left atrial appendage tissue. Therefore, to a certain extent, personalized customization of clinical needs is realized.

[0154] In one embodiment, one or more fixing structures 1231 are provided on each framework 121, and the proximal end and / or the distal end of the surrounding body 123 are effectively connected or position-limited to the framework 121 through the fixing structures 1231. As shown in Figure 21 Figure 21As shown. In a preferred embodiment, fixing structures 1231 are respectively provided on the proximal independent rod 1210 and the protection member 12120 of each skeleton 121. The fixing structure 1231 is a through hole penetrating the skeleton 121. After the surrounding body 123 passes through the through hole on the proximal independent rod 1210 to achieve connection, it tightly winds and wraps the skeleton 121 and all thorn roots 1220 between the through holes, and finally passes through the through hole on the protection member 12120 and achieves connection. By tying knots or other forms to connect the proximal end and / or the distal end of the surrounding body 123 to the fixing structure 1231, the position of the surrounding body 123 on the skeleton 121 can be further restricted, the strength of the surrounding body 123 on the skeleton 121 can be strengthened, and loosening can be avoided. In another preferred embodiment, the surrounding body 123 is wound and wrapped around most or all of the skeleton 121 and all thorn roots 1220 by a single flexible round wire or flat wire, and passes through all through holes, and finally forms a closed loop. The advantage of winding with a single surrounding body 123 is that the number of knots between the surrounding body 123 and the fixing structure 1231 is minimized, the number of knot heads is reduced, the resistance of the entire attachment frame 12 for receiving and releasing is increased due to too many knot heads is avoided, and at the same time, the manufacturing process is simplified, the production efficiency of the product is improved, and at the same time, through the mutual cooperation with the through holes, the effectiveness and firmness of the connection are enhanced, ensuring that the following surrounding body 123 maintains a predetermined winding shape on the skeleton 121, and avoiding the surrounding body 123 sliding relative to the skeleton 121 along the skeleton 121 during the process of entering and exiting the delivery sheath 2, resulting in weakening or inability to exert the above-mentioned functions of the surrounding body 123.

[0155] Figure 22 a~ Figure 22 Figures a - c are schematic diagrams of different winding methods of the surrounding body 123 on the local skeleton 121. The winding methods of the surrounding body 123 include one or more combinations of straight winding, oblique winding, and cross winding. Among them, the straight winding is simple in operation and high in efficiency; the oblique winding has better smoothness of receiving and releasing the sheath of the skeleton 121; the cross winding is stronger in firmness. The manufacturer can select the best winding method according to different needs. The number of winding layers of the surrounding body 123 is between 1 layer and 5 layers. If the number of layers is too many, although the winding firmness will be increased, the overall volume will increase, the resistance of the attachment frame 12 for receiving and releasing in the delivery sheath 2 will increase, and the experience of the operator will be reduced.

[0156] In a preferred embodiment, the surrounding body 123 is a flexible medical wire / filament / tape, and its cross-sectional shape includes one or a combination of a circle, an ellipse, and a rectangle. In another preferred embodiment, the surrounding body is formed by winding a suture 1241, and the material of the suture 1241 includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxanone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide-lactide (PGLA), polycaprolactone (PCL), silk, catgut, animal tendon tissue, or a medical metal and / or medical polymer material with a developing effect.

[0157] As Figure 23 shown, in one embodiment, one or more local protrusions may be provided on the outer surface of the surrounding body 123 itself. The local protrusions form barbed structures by themselves, and the barbed structures face the left atrial appendage wall or the left atrial appendage opening side, which can further enhance the anchoring effect.

[0158] In one embodiment, the surrounding body 123 is wrapped with a functional agent, and the functional agent has an endothelialization-promoting effect. The functional agent includes but is not limited to growth factors, such as vascular endothelial growth factor (VEGF), stromal cell-derived factor-1 (SDF-1α), platelet-derived growth factor β-chain (PDGF-β), and transforming growth factor β1 protein (TGF-β1), etc.; in addition, the above functional agent can be a developing point, a developing wire, a developing ring, etc., so as to enhance the visualization of the operation. The surrounding body 123 can also selectively use a material with a microporous structure, which is convenient for cells or tissues to grow into, promotes endothelialization inside the surrounding body 123, enables the attachment frame 12 to be connected to the inner wall of the left atrial appendage through tissue growth to become an integrated body, and enhances the biocompatibility and long-term anchoring safety of the attachment frame 12.

[0159] Example Three:

[0160] Refer to Figure 24 , compared with Example One and Example Two, the difference between Example Three and Example One and Example Two is that the attachment frame 12 is further provided with a flexible second blocking film 124. The second blocking film 124 adheres to and is connected to the framework 121, and its design has the following advantages: a) It can achieve the effect of secondary occlusion, can prevent the detachment of existing and possible thrombi 3 in the left atrial appendage lumen, and further improve the occlusion effectiveness and safety. As Figure 25As shown in the figure; b) It has the function of gradually blocking the flow, especially when the attachment frame 12 is just released during the operation (at this time, the occlusion disc 10 has not been deployed), it can push the existing thrombus 3 inside the left atrial appendage back into the lumen of the left atrial appendage, preventing the thrombus 3 from falling out from the open atrial appendage orifice. In a preferred embodiment, the second blocking membrane 124 is located in the peripheral area of the attachment frame 12, and its maximum coverage does not exceed the intersection area of the middle connecting rod 1211 and the distal ring 1212, and the microspines 1221 can expose the second blocking membrane 124. This design is based on the following two considerations: a) The presence of the second blocking membrane 124 does not weaken the anchoring effect of the microspines 1221, avoiding the risk of partial microspines 1221 losing their anchoring effect; b) The covered area of the second blocking membrane 124 does not involve the distal ring 1212, so it avoids the distal ring 1212 being affected by the second blocking membrane 124 during the release process, which affects its free deployment and morphological self - adaptability.

[0161] In one embodiment, a suture 1241 can be used to suture - connect the second blocking membrane 124 to the distal end face of the attachment frame 12 (abbreviated as suture - membrane). The suture 1241 fixes the second blocking membrane 124 to the framework 121 of the attachment frame 12 through winding, tying, and knotting, etc. Multiple reserved holes can be designed on the framework 121 to facilitate threading and suturing. Figure 26a and Figure 26b are two winding forms of the suture 1241 on the framework 121. Figure 26a The pre - embedding type, that is, by passing the suture 1241 through the surrounding body 123 on the distal end face of the framework 121, part of the suture 1241 is buried inside the surrounding body 123 to achieve the effect of pre - embedding, or the suture 1241 is wound around the framework 121 in advance, and then the surrounding body 123 is wound, so that the suture 1241 is buried between the surrounding body 123 and the proximal end face of the framework 121; Figure 26b The hidden type, the suture 1241 is wound inside the groove between the surrounding bodies 123, so that the suture 1241 does not protrude. The advantages of these two winding forms are that the suture 1241 is pre - embedded or hidden inside the surrounding body 123, so that when the attachment frame 12 is withdrawn from the delivery sheath, the suture 1241 will not directly contact the inner wall of the delivery sheath 2, avoiding the suture 1241 being worn and broken during multiple withdrawal and release operations. Figure 27 is the winding method of the conventional suture 1241 of the occluder on the market at present. At this time, the suture 1241 is directly exposed on the outer surface of the occluder. The suture 1241 in this area is bound to contact the inner wall of the delivery sheath 2. When the occluder is repeatedly withdrawn and released, it will cause the risk of the suture 1241 being worn and broken, resulting in the second blocking membrane 124 not being firmly fixed to the attachment frame 12, and even causing the second blocking membrane 124 to fall off, ultimately affecting the blocking function of the second blocking membrane 124. In the suture - membrane method, the covering method of the second blocking membrane 124 on the attachment frame 12 can be divided into the "covering type" and the "fitting type", as shown in Figure 28a and Figure 28 As shown in b, the advantage of the "cover type" is that the process is simple and the production efficiency is high; the advantage of the "fitting type" is that the second blocking film 124 has a higher degree of fitting with the surface of the attachment frame 12, which can avoid the wrinkles and loosening of the film body, and also avoid the irregular aggregation of the second blocking film 124 in the proximal independent rod 1210 area of the left atrial appendage occluder after being compressed and entering the delivery sheath 2, resulting in a larger size of the required delivery sheath 2. Therefore, to a certain extent, the requirement for the size of the access such as blood vessels is reduced. The flexible materials suitable for making the second blocking film 124 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomer, polyamide, silica gel, polyolefin, degradable materials such as polylactic acid, polyvinyl alcohol, and animal tissues, etc. The suture 1241 can be made of non-absorbable materials such as polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene, etc., or can be made of absorbable materials such as sheep intestine tissue, polylactic acid, and polyglycolic acid, etc.

[0162] In another embodiment, the two end faces of the attachment frame 12, the near and far ones, can be formed into one body by suture, heat connection, glue bonding, coupling agent connection, etc. for film covering. The materials used can be polytetrafluoroethylene (PTFE), polypropylene (PP), polyethylene terephthalate (PET), etc. with a microporous structure. Figure 29 FIG. is a partial view of the attachment frame 12 after film covering. At this time, both the near and far end faces of the attachment frame 12 are covered by the second blocking film 124, and a part of the skeleton 121 of the attachment frame 12 is wrapped inside the second blocking film 124. The advantage of the film covering method is that the second blocking film 124 has an excellent degree of fitting and flatness with the attachment frame 12. At the same time, the second blocking film 124 deforms in the same way as the attachment frame 12. During the process of receiving and releasing the attachment frame 12, the second blocking film 124 after film covering will not form local wrinkles or depressions. During the blocking process, there will be no local leakage at the film. Further, the second blocking film 124 covered with polytetrafluoroethylene material has a very small and dense microporous structure, and hardly allows blood to pass through in the atrial appendage, and the blocking effect is excellent, greatly improving the blocking function of the second blocking film 124. In a preferred embodiment, when the material of the surrounding body 123 on the attachment frame 12 is also polytetrafluoroethylene, the second blocking film 124 can be integrally formed by film covering with the surrounding body 123.

[0163] Example 4:

[0164] As shown in FIGS. 30 to 33, referring to Example 1, the difference between Example 4 and Example 1 is that the limiting mechanism 1222 is one or more of a local necking structure, a local convex structure, and a keyway structure provided on the skeleton 121 (such as Figures 30a to 30cAs shown, or the limiting mechanism 1222 realizes the fixed connection between the skeleton 121 and the thorn root 1220 by means of glue bonding, welding, mechanical fitting, etc. In this embodiment, two structures of welding type and mechanical fitting are mainly described. When the welding type structure is adopted, at this time, several bionic micro-thorn attachment structures 122 are integrally processed from thin-walled pipes with elasticity and shape memory, and form a whole, such as Figure 31 As shown, at this time, the bionic micro-thorn attachment structure 122 is fixed on the skeleton 121 by welding. Further, limiting holes 1223 can be provided on the bionic micro-thorn attachment structure 122 and the skeleton 121, and the bionic micro-thorn attachment structure 122 is fixed on the hole groove 1213 of the skeleton 121 by using the surrounding body 123 to realize secondary strengthening and fixation, such as Figure 32 As shown, the advantages of this design are: a) The bionic micro-thorn attachment structure 122 is integrally processed, with simple manufacturing process and convenient assembly; b) By using the limiting holes of the bionic micro-thorn attachment structure 122, the fixed position of the bionic micro-thorn attachment structure 122 on the skeleton 121 can be adjusted at any time, and then the distribution of the micro-thorns 1221 on the skeleton 121 can be finely adjusted, so the personalized customization of the product can be realized. When the mechanical fitting type structure is adopted, at this time, the limiting mechanism 1222 on the skeleton 121 is a keyway structure, and the thorn root 1220 of the bionic micro-thorn attachment structure 122 is embedded inside the hole groove 1213 through mechanical fitting, and the secondary fixation is realized by winding with the surrounding body 123. The design of the mechanical fitting type structure can be divided into two types. One is the overall embedding type. At this time, the bionic micro-thorn attachment structure 122 is similar to the aforementioned welding type combination method, and is integrally processed from thin-walled pipes with elasticity and shape memory, and can realize overall embedding, such as Figure 33a As shown, the other is the independent embedding type. At this time, the bionic micro-thorn attachment structure 122 is made of wire materials with elasticity and shape memory, and is independently embedded in the hole groove 1213, such as Figure 33b As shown. The mechanical fitting type design has the following advantages: a) The thorn root 1220 of the bionic micro-thorn attachment structure 122 is not exposed outside the skeleton 121, and the resistance is the smallest when being received and released in the delivery sheath 2; b) The compressed volume of the entire attachment frame 12 is the smallest. Compared with the same type of products, a smaller sheath diameter of the delivery sheath 2 can be selected, so the trauma to the human blood vessels during the operation is smaller.

[0165] Embodiment Five:

[0166] Referring to Embodiment One, the difference between Embodiment Five and Embodiment One is that the three-dimensional structure surrounded by multiple skeletons 121 of the attachment frame 12 is in the shape of a "kettle", "cage", "gourd" or "bowl" in the natural unconstrained state, respectively, as Figures 34a to 34dAs shown, the attachment frame 12 is provided with a flexible second flow-blocking film 124. In particular, when the three-dimensional structure is in a "bowl shape", the maximum coverage range of the second flow-blocking film 124 should not exceed the intersection area of the middle connecting rod 1211 and the distal ring-shaped body 1212. At this time, the second flow-blocking film 124 can play a role in blocking thrombus inside the auricle. Further, the left atrial appendage occluder 1 of the attachment frame 12 with a three-dimensional structure in a "kettle shape", "cage shape", "gourd shape" or "bowl shape" in the natural unconstrained state may further include a blocking disc 10 and a connecting member 11. The attachment frame 12 is connected to the blocking disc 10 through the connecting member 11. As Figures 35a to 35d shown, the blocking disc 10 further enhances the left atrial appendage occlusion effect.

[0167] Finally, it should be noted that the above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A left atrial appendage occluder (1) with a bionic micro-spine attachment structure, at least including an attachment frame (12), characterized in that, The attachment frame (12) includes multiple elastic skeletons (121) and multiple bionic micro-spine attachment structures (122). In a natural unconstrained state, the multiple skeletons (121) diverge outward from the center and enclose a three-dimensional structure. The attachment frame (12) has anatomical morphological self-adaptability. The bionic micro-spine attachment structures (122) are arranged on the outer surface of the skeletons (121). The morphology of the bionic micro-spine attachment structures (122) is sparse micro-spines on the surface of a plant. The bionic micro-spine attachment structures (122) include spine roots (1220) and micro-spines (1221). The micro-spines (1221) are composed of spine bodies (12210) and spine tips (12211). The micro-spines (1221) are linear micro-spines or J-shaped micro-spines or a combination of both. The spine body (12210) and / or the spine tip (12211) can touch the inner cavity tissue of the left atrial appendage to achieve the attachment and anchoring function. When the micro-spines (1221) contact the inner cavity tissue of the left atrial appendage, they can undergo adaptive bending deformation, which is beneficial for the micro-spines (1221) to attach to the inner cavity tissue of the left atrial appendage without damage and enhance their attachment and anchoring function. Each bionic micro-spine attachment structure (122) is formed by a wire, and the cross-sectional area of the wire ≤ 0.04 mm 2 , so that the micro-spines (1221) are slender and soft.

2. The left atrial appendage occluder (1) with a bionic micro - thorn attachment structure according to claim 1, wherein it is defined that: the length of the thorn body (12210) is L1, the curved length of the thorn tip (12211) is L2, and the included angle between the outward extension direction of the thorn body (12210) and the outward extension direction of the distal end of the thorn tip (12211) is β. The length L1 of the thorn body (12210), the curved length L2 of the thorn tip (12211), and the included angle β satisfy the following mathematical relationships: 0.2 mm ≤ L1 ≤ 3 mm, 0 ≤ L2 ≤ 1.5 mm, 0 ≤ β ≤ 150°, such that the micro - thorns (1221) have the characteristics of being shallow and short, and the length of the linear micro - thorns (1221) is less than the length of the J - shaped micro - thorns (1221).

3. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 2, wherein The bionic micro - thorn attachment structure (122) further includes a limiting mechanism (1222), and the limiting mechanism (1222) is a hole - groove (1213) provided on the framework (121). The bionic micro - thorn attachment structure (122) corresponds to the hole - groove (1213) in position. At least a part of the thorn root (1220) is located within the hole - groove (1213), and the thorn root (1220) cooperates with the hole - groove (1213) to define the relative position of the micro - thorns (1221) on the framework (121).

4. The left atrial appendage occluder (1) with a bionic micro - thorn attachment structure according to claim 3, characterized in that, Each bionic micro - thorn attachment structure (122) includes at least 1 thorn root (1220) and 2 micro - thorns (1221). The micro - thorns (1221) correspond to the hole - grooves (1213) in position and quantity. At least a part of the thorn root (1220) is in contact with the framework (121). The thorn root (1220) has a U - shaped or loop - shaped structure, and the thorn root (1220) penetrates through two hole - grooves (1213). Each bionic micro - thorn attachment structure (122) is formed by a wire material with elasticity and shape memory passing through the corresponding two hole - grooves (1213) in sequence.

5. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 2, characterized in that, The bionic micro - thorn attachment structure (122) further includes a limiting mechanism (1222). The limiting mechanism (1222) is one or a combination of a local necking structure, a local protrusion structure, and a key - groove structure provided on the framework (121), or the limiting mechanism (1222) realizes the fixed connection between the framework (121) and the thorn root (1220) through glue bonding, welding, or mechanical fitting.

6. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 1, characterized in that, The attachment frame (12) includes a surrounding body (123). The surrounding body (123) is wound around the framework (121) and at least wraps the thorn root (1220) in contact with the framework (121) to enhance the connection strength between the framework (121) and the bionic micro - thorn attachment structure (122). One or more fixing structures (1231) are provided on each framework (121), and the proximal end and / or the distal end of the surrounding body (123) are effectively connected or position - defined with the framework (121) through the fixing structures (1231).

7. The left atrial appendage occluder (1) with a bionic micro-needle attachment structure according to claim 3, characterized in that, On any cross-section in the major axis direction of the said framework (121), the thickness of the said framework (121) is defined as P1, the length of the said hole groove (1213) itself is P2, the distance between any two adjacent said hole grooves (1213) is P3, and the included angle between the outward extension direction of the said sashimi (12210) and the direction of the framework (121) away from the central axis m of the attachment frame (12) is ω. Among them, the parameters P1, P2, P3 and the parameter ω respectively satisfy the following mathematical relationships: 0.05 mm ≤ P1 ≤ 0.5 mm, 0.05 mm ≤ P2 ≤ 1 mm, 0.5 mm ≤ P3 ≤ 10 mm, 30° ≤ ω < 180°.

8. The left atrial appendage occluder (1) with a bionic micro - thorn attachment structure according to claim 6, characterized in that, The three-dimensional structure formed by multiple said frameworks (121) is in a "mushroom shape", "kettle shape", "cage shape", "gourd shape" or "bowl shape" in the natural unconstrained state. The three-dimensional structure has flexibility and resilience and can adapt to the left atrial appendage lumen of different anatomical forms. The attachment frame (12) further includes a central member (120). Multiple said frameworks (121) diverge outward from the central member (120) and enclose the three-dimensional structure. In the natural unconstrained state, the central member (120) of the attachment frame (12) is located inside the three-dimensional structure. The height K1 of the three-dimensional structure and the maximum outer diameter D1 of the three-dimensional structure satisfy the following mathematical relationships: 3 mm ≤ K1 ≤ 20 mm, 10 mm ≤ D1 ≤ 50 mm, K1 ≤ D1.

9. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 8, characterized in that, When the three-dimensional structure formed by multiple said frameworks (121) is in a "mushroom shape" or "bowl shape" in the natural unconstrained state, the framework (121) successively includes a proximal independent rod (1210), an intermediate connecting rod (1211) and a distal ring-shaped body (1212) in the direction of diverging outward from the central member (120). The flexibility of the proximal independent rod (1210) is greater than or equal to the flexibility of the intermediate connecting rod (1211), and the flexibility of the intermediate connecting rod (1211) is greater than or equal to the flexibility of the distal ring-shaped body (1212). When the attachment frame (12) is subjected to an external radial extrusion force, the sequence of adaptive deformation of each part of the framework (121) is: the proximal independent rod (1210), the intermediate connecting rod (1211), the distal ring-shaped body (1212), so that the attachment frame (12) has high flexibility.

10. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 9, characterized in that, Part of the distal ring-shaped body (1212) is located in the peripheral contour area of the "mushroom shape" or "bowl shape". A plurality of said J-shaped micro-spines (1221) are provided on the outer surface of the distal ring-shaped body (1212) in this area. The tip (12211) of the J-shaped micro-spine (1221) is in a micron-level folded hook shape or arc hook shape, and the included angle ω of the micro-spines (1221) in this area gradually decreases in the direction away from the central axis m of the attachment frame (12).

11. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 9, characterized in that, The distal coiled structure (1212) is a coiled structure formed by the peripheral region of the framework (121), or a coiled structure formed by further extending the end of the framework (121) towards the end direction. The coiled structure is one or more of an oval shape, a circular shape or a two-dimensional helix structure, and the plane where each coiled structure is located is coplanar with the central axis m of the attachment frame (12). The coiled structure has elasticity and shape memory.

12. The left atrial appendage occluder (1) with a bionic micro-needle attachment structure according to claim 11, characterized in that, The coiling direction of the coiled structure is inward coiling, and the included angle σ between the extension line direction of the end of the coiled structure and the direction of the central axis m of the attachment frame (12) towards the distal end satisfies: 0° ≤ σ ≤ 90°, and the number of turns n of the coiled structure satisfies: 0.5 ≤ n ≤ 1.

5.

13. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to claim 6, wherein the attachment frame (12) is provided with a flexible second blocking membrane (124), and the second blocking membrane (124) is attached to and connected to the framework (121) or the surrounding body (123).

14. The left atrial appendage occluder (1) with a bionic micro-spine attachment structure according to any one of claims 7-13, wherein the left atrial appendage occluder (1) further comprises an occluding disc (10) and a connecting member (11), and the occluding disc (10) and the attachment frame (12) are connected by the connecting member (11), characterized in that, The occluding disc (10) is made of a material with elasticity and shape memory. The occluding disc (10) has a three-dimensional cage-like structure, and a three-dimensional first blocking membrane (125) is provided on the occluding disc.

Images