Left atrial appendage ablation plugging system

Abstract

The utility model provides a left auricle ablation plugging system which comprises a left auricle ablation plugging device, a sealing part of the left auricle ablation plugging device comprises a net-shaped area and a bunchy area, the bunchy area comprises a plurality of bunchy pieces, the first ends of the bunchy pieces converge and are connected with a connecting part, and the second ends of the bunchy pieces converge and are connected with the connecting part. The second ends of the multiple bundle-shaped pieces are connected with the net-shaped area, and each bundle-shaped piece is formed by winding at least two weaving wires according to the preset direction, so that the mutual slippage among the weaving wires can be reduced, and the probability of damaging the insulation structure on the surface of the bundle-shaped piece can be reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field especially relates to a left auricle ablation plugging system. BACKGROUND

[0002] In recent years, in non-valvular atrial fibrillation patients, 90% of the brain stroke caused by atrial fibrillation is from left auricle. Clinical data shows that when atrial fibrillation, resection left auricle in cardiac surgery can reduce the incidence of brain stroke, which indicates that left auricle is harmful in thromboembolism. Since left auricle is the nidus of thrombus, plugging the opening of left auricle can eliminate the basis of thrombosis in left auricle. Left auricle ablation plugging device is an effective way to prevent brain stroke caused by atrial fibrillation.

[0003] Some left auricle ablation plugging devices include fixed parts and sealing parts, wherein at least part of the surface of the sealing part is insulated, and the sealing part is woven by interlaced wires, and the interlaced wires can slide relative to each other at the intersection, and the insulation layer on the surface is easily damaged during relative sliding. UTILITY MODEL CONTENT

[0004] In view of the above-mentioned technical deficiencies, the utility model provides a left auricle ablation plugging system, which comprises: a left auricle ablation plugging device and a conveyor for conveying the left auricle ablation plugging device to a target position, the left auricle ablation plugging device comprises: a fixed part for fixing the left auricle ablation plugging device at a predetermined position, a sealing part for sealing, and a connecting part connecting the fixed part and the sealing part, the sealing part comprises a distal disc surface, the distal disc surface comprises a mesh area and a bundle area, the bundle area comprises a plurality of bundle parts, the first end of the plurality of bundle parts converges and is connected with the connecting part, the second end of the plurality of bundle parts is connected with the mesh area, at least one bundle part is wound by at least two interlaced wires according to a first direction, the conveyor comprises a pusher, the proximal end of the sealing part further comprises a peg head, the distal end of the pusher is detachably connected with the peg head, the pusher can be rotated relative to the peg head towards a second direction and locked with each other, and the pusher can be rotated relative to the peg head towards a first direction and unlocked with each other.

[0005] The utility model discloses still provide a left auricle ablation plugging system, include: left auricle ablation plugging ware, left auricle ablation plugging ware includes: for the left auricle ablation plugging ware fixed in predetermined position's fixed part, the sealing part of sealing effect and the connecting part of connecting fixed part with sealing part, sealing part includes distal end disc, distal end disc includes net area and bundle area, bundle area includes a plurality of bundle, the first end of a plurality of bundle converges and is connected with connecting part, the second end of a plurality of bundle is connected with net area, every bundle is by at least two braided silk and is wound according to first direction or according to second direction opposite with first direction, and the bundle that is wound according to first direction is recorded as first bundle, and the bundle that is wound according to second direction is recorded as second bundle, in bundle area, the number of first bundle is more than the number of second bundle, and the number of second bundle is greater than or equal to zero.

[0006] In one embodiment, the left auricle ablation plugging system further comprises a delivery device for delivering the left auricle ablation plugging device to a target position, the delivery device comprising a pusher, the proximal end of the sealing part further comprising a peg, the distal end of the pusher being detachably connected to the peg, the pusher being rotatable relative to the peg in a second direction and being locked to each other, the pusher being rotatable relative to the peg in a first direction and being unlocked from each other.

[0007] In one embodiment, the bundle in the bundle area is wound by at least two braided wires in a first direction.

[0008] In one embodiment, the bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire intersecting at the second end of the first bundle to form a first overlapping point, at the first overlapping point, the first braided wire of the first bundle is closer to the distal end of the left auricle ablation plugging device than the second braided wire.

[0009] In one embodiment, the bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire intersecting at the second end of the second bundle to form a second overlapping point, at the second overlapping point, the second braided wire of the second bundle is closer to the distal end of the left auricle ablation plugging device than the first braided wire.

[0010] In one of the embodiments, the mesh region comprises a plurality of support wires, the bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire of the bundle are connected to corresponding support wires respectively, the support wires connected to the first braided wire are referred to as first support wires, the support wires connected to the second braided wire are referred to as second support wires, the first support wires and the second support wires are arranged in sequence along the first direction.

[0011] In one of the embodiments, the first direction is counterclockwise or clockwise.

[0012] In one of the embodiments, the surface of the mesh region is conductive, and the surface of the bundle region is insulating.

[0013] In one of the embodiments, the bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire are spirally wound with each other; or the first braided wire extends along a straight line, and the second braided wire spirally winds on the first braided wire; or the second braided wire extends along a straight line, and the first braided wire spirally winds on the second braided wire.

[0014] In one of the embodiments, the mesh region comprises a plurality of support wires, each support wire of the mesh region is connected to and integrated with a corresponding braided wire in a one-to-one correspondence.

[0015] In one of the embodiments, the sealing portion has an accommodating cavity inside, at least one film body is arranged in the accommodating cavity, and the edge of the film body is fixed to the circumferential inner wall of the accommodating cavity; the film body comprises a film main body and a through portion arranged on the film main body, the through portion comprises a petal and a through hole, the through hole penetrates the film main body along the axial direction of the sealing portion, the petal comprises a fixed end and a movable end, the fixed end is fixedly connected to the film main body, and the movable end is movable relative to the film main body; when the petal covers the through hole, the through portion is in a closed state, and when the movable end moves relative to the film main body to make the through portion in an open state, the through hole provides a passage penetrating the film main body.

[0016] In one of the embodiments, the petal is one or more of a trapezoid, a trapezoid-like shape, a rectangle, a square, and a hexagon.

[0017] In one of the embodiments, the petal comprises two edges and two waists connecting the two edges, the two edges are spaced apart and arranged opposite to each other along the height direction of the petal, and the two waists are spaced apart and arranged opposite to each other along the width direction of the petal, one of the edges serves as the fixed end, and the other edge serves as the movable end.

[0018] In one of the embodiments, the two edges are a long edge and a short edge respectively, the long edge is a fixed end, and the short edge is a movable end.

[0019] In one of the embodiments, the edge as the free end is linear or arc-shaped.

[0020] The utility model provides a left auricle ablation plugging system, including left auricle ablation plugging ware, the sealing part of this left auricle ablation plugging ware includes netted area and bundle area, and the bundle area includes a plurality of bundle pieces, the first end of a plurality of bundle pieces converges and is connected with the connecting part, and the second end of a plurality of bundle pieces is connected with the netted area, and the bundle piece is formed by at least two braided wires according to the predetermined direction, so as to reduce the mutual slip between the braided wires, so as to reduce the probability of damaging the insulating structure on the surface. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 It is the structure schematic diagram of left auricle ablation plugging ware of an embodiment of the utility model;

[0022] Figure 2 It is the top view of the distal end disc of the sealing part of an embodiment of the utility model;

[0023] Figure 3 It is Figure 2 It is the local enlarged schematic view of area A;

[0024] Figure 4 It is the connection schematic view of the second bundle piece and the first support wire and the second support wire of an embodiment of the utility model;

[0025] Figure 5 It is the structure schematic diagram of the film body of left auricle ablation plugging ware in an embodiment of the utility model;

[0026] Figure 6 It is the structure schematic diagram of the film body of left auricle ablation plugging ware in another embodiment of the utility model;

[0027] Figure 7 It is Figure 6 It is the local enlarged view of area B;

[0028] Figure 8 It is the structure schematic diagram of the film body of left auricle ablation plugging ware in still another embodiment of the utility model;

[0029] Figure 9 It is Figure 8 It is the local enlarged view of area C;

[0030] Figure 10 It is the schematic view of the tubular piece through Figure 8 The film body. DETAILED DESCRIPTION

[0031] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.

[0032] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0033] The technical solution of this utility model will be further described in detail below with reference to specific embodiments.

[0034] Example 1

[0035] The left atrial appendage ablation occlusion system of this embodiment includes a left atrial appendage ablation occluder 1 and a delivery device for delivering the left atrial appendage ablation occluder 1 to the target location. The left atrial appendage ablation occluder 1 provided by this invention is implanted into the left atrial appendage and blocks the opening of the left atrial appendage. It can also release ablation energy to the target tissue to substantially alter the electrical shape, mechanical properties, chemical properties, or other properties of the target tissue. This ablation energy includes, but is not limited to, thermal energy, cold energy, electrical energy, acoustic energy, radio frequency energy, pulsed high-voltage energy, mechanical energy, ionizing radiation, optical energy, and combinations thereof, as well as other types of energy suitable for treating tissue. The delivery device includes a sheath and a pusher movably inserted within the sheath. The sheath establishes a delivery channel, and the distal end of the pusher is detachably connected to the proximal end of the left atrial appendage ablation occluder 1 for pushing the left atrial appendage ablation occluder 1 during delivery.

[0036] like Figure 1 As shown, Figure 1 This is a schematic diagram of the structure of the left atrial appendage ablation occlusion device 1 in Embodiment 1 of this utility model. The left atrial appendage ablation occlusion device 1 includes a fixing part 10 and a sealing part 20 connected to the fixing part 10. The fixing part 10 and the sealing part 20 are connected by a connecting part 30. The fixing part 10 is used to fix the left atrial appendage ablation occlusion device 1 in a predetermined position, and the sealing part 20 is used to block the opening of the left atrial appendage. Furthermore, in this embodiment, the fixing part 10 and the sealing part 20 can also release ablation energy to the target tissue. In other embodiments, either the fixing part 10 or the sealing part 20 can release ablation energy to the target tissue.

[0037] In the embodiment, the sealing part 20 and the fixing part 10 are arranged along the axial direction of the left atrial appendage ablation plug 1. The sealing part 20 is located at the proximal end of the left atrial appendage ablation plug 1, and the fixing part 10 is located at the distal end of the left atrial appendage ablation plug 1. The left atrial appendage ablation plug 1 has a compressed state accommodated in the sheath tube of the delivery device for facilitating delivery, and an expanded state as shown in the drawing after being stretched out of the distal end of the sheath tube and self-expanding and unfolding. The utility model is not particularly limited, and the shape and structural features of the left atrial appendage ablation plug 1 in the expanded state are described. Figure 1 The shape of the left atrial appendage ablation plug 1 after being released in the left atrial appendage cavity is completely the same or basically consistent with Figure 1 .

[0038] The fixing part 10 can be formed by cutting a nickel-titanium tube or braiding a nickel-titanium wire. In the embodiment, the fixing part 10 is formed by cutting a nickel-titanium tube and then heat setting. The shape of the fixing part 10 is not limited, and can be columnar or umbrella-shaped, etc.

[0039] In the embodiment, the sealing part 20 is formed by braiding a plurality of wires (for example, nickel-titanium wires or the like having shape memory capability) into a mesh tube, and the two ends of the mesh tube are respectively gathered. Then, the mesh tube is heat set into a disc shape, a disc plug shape, a columnar shape or a plug shape, etc., so as to obtain the sealing part 20 for plugging the left atrial appendage opening. In other embodiments, the sealing part 20 can be formed by cutting or partially formed by cutting and partially formed by braiding. The sealing part 20 has an accommodation cavity in the inside, and at least one film body 23 is arranged in the accommodation cavity, and the edge of the film body 23 is fixed to the inner wall of the accommodation cavity of the sealing part 20. The film body 23 is used to block the blood flow from one side of the sealing part 20 to the other side, so as to block the blood flow between the left atrial appendage and the left atrium.

[0040] The sealing part 20 in the embodiment is in a disc plug shape, and includes a proximal disc face 20a, a distal disc face 20b and a plug head 24. The distal disc face 20b is a disc face facing the fixing part 10, and the inner side end of the distal disc face 20b (the inner side end of the disc face refers to the end closer to the center of the disc face) is connected (for example, fixedly connected or movably connected) to the connecting part 30. The proximal disc face 20a is a disc face away from the fixing part 10, and the inner side end of the proximal disc face 20a is connected to the plug head 24. The outer side end of the distal disc face 20b (the outer side end of the disc face refers to the end farther away from the center of the disc face, that is, the end closer to the radial edge of the disc face) is connected to the outer side end of the proximal disc face 20a. In the embodiment, the proximal disc face 20a and the distal disc face 20b are integrally braided, so that the outer side end of the proximal disc face 20a and the outer side end of the distal disc face 20b jointly form the outer edge of the sealing part 20. In other embodiments, the outer side end of the proximal disc face 20a and the outer side end of the distal disc face 20b can also be connected by other components.

[0041] Referring to Figure 2 , Figure 3, Figure 4 The distal disc surface 20b comprises a mesh region 21 and a bundle region 22. The surface of the mesh region 21 is conductive, so that ablation energy can be transmitted to the target tissue through the mesh region 21. The surface of the bundle region 22 is insulated, so that the conductive region in the sealing part 20 is concentrated in the region that is in contact with the target tissue, which can avoid damaging the tissue structure outside the target tissue and reduce unnecessary loss of ablation energy.

[0042] The bundle region 22 comprises a plurality of bundle members 220. The first ends (i.e. the inner side ends) of the plurality of bundle members 220 converge and are connected to the connecting part 30. The second ends (i.e. the outer side ends) of the plurality of bundle members 220 each extend radially outward and are connected to the mesh region 21. The inner side end of the mesh region 21 is connected to the outer side end of the bundle member 220, and the outer side end of the mesh region 21 is connected to the outer side end of the proximal disc surface 20a. The surface of the bundle member 220 can be insulated by sleeving an insulating sleeve or providing an insulating coating.

[0043] Each bundle member 220 is formed by winding at least two braided wires in a first direction or a second direction. In the embodiment, the method for determining the winding direction of the braided wires in the bundle member 220 comprises: fixing the inner side end of the bundle member 220, and rotating at the outer side end of the bundle member 220 in the first direction (which is a circumferential direction). If the bundle member 220 becomes tighter as it is rotated, and becomes looser (i.e. unwinds) as it is rotated in the second direction opposite to the first direction, it is determined that the winding direction of the bundle member 220 is the first direction. If the bundle member 220 becomes looser as it is rotated, and becomes tighter as it is rotated in the second direction opposite to the first direction, it is determined that the winding direction of the bundle member 220 is the second direction.

[0044] The bundle member 220 wound in the first direction is referred to as a first bundle member 220a, and the bundle member 220 wound in the second direction is referred to as a second bundle member 220b.

[0045] The bundle-shaped region 22 at least comprises a first bundle-shaped piece 220a, when the sealing part 20 is subjected to an external force in the first direction, the first bundle-shaped piece 220a can avoid the tendency of disentangling, and the relative displacement of the first braided wire 221 and the second braided wire 222 at the outer side end, and further can reduce the risk of damaging the insulating layer or displacing the insulating sleeve during the relative displacement. Further, the number of the first bundle-shaped pieces 220a is greater than the number of the second bundle-shaped pieces 220b, and the number of the second bundle-shaped pieces 220b is greater than or equal to zero. Since the number of the first bundle-shaped pieces 220a is greater than the number of the second bundle-shaped pieces 220b, the risk of damaging the insulating layer or displacing the insulating sleeve when the sealing part 20 is subjected to an external force in the first direction can be further reduced. Exemplarily, in the embodiment, all the bundle-shaped pieces 220 in the bundle-shaped region 22 are the first bundle-shaped pieces 220a. Since all the bundle-shaped pieces 220 are the first bundle-shaped pieces 220a, the risk of damaging the insulating layer or displacing the insulating sleeve when the sealing part 20 is subjected to an external force in the first direction can be maximally reduced.

[0046] The bundle-shaped piece 220 comprises the first braided wire 221 and the second braided wire 222, and the outer side end of the bundle-shaped piece 220 is overlapped to form an overlapping point. The outer side end of the first bundle-shaped piece 220a is overlapped to form a first overlapping point 223, and at the first overlapping point 223, the first braided wire 221 of the first bundle-shaped piece 220a is closer to the distal end of the left atrial appendage ablation plug 1 than the second braided wire 222, that is, at the first overlapping point 223, the second braided wire 222 of the first bundle-shaped piece 220a is closer to the accommodating cavity of the sealing part 20 than the first braided wire 221. The outer side end of the second bundle-shaped piece 220b is overlapped to form a second overlapping point 224, and at the second overlapping point 224, the first braided wire 221 of the second bundle-shaped piece 220b is farther away from the distal end of the left atrial appendage ablation plug 1 than the second braided wire 222, that is, at the second overlapping point 224, the second braided wire 222 of the second bundle-shaped piece 220b is farther away from the accommodating cavity of the sealing part 20 than the first braided wire 221.

[0047] The first braided wire 221 and the second braided wire 222 can be wound in various ways, for example, the first braided wire 221 and the second braided wire 222 are spirally wound with each other, or the first braided wire 221 extends in a straight line, and the second braided wire 222 is spirally wound on the first braided wire 221; or the second braided wire 222 extends in a straight line, and the first braided wire 221 is spirally wound on the second braided wire 222. In the embodiment, by adopting the way of spirally winding the first braided wire 221 and the second braided wire 222 with each other, it is beneficial to reduce the possibility of relative sliding of the first braided wire 221 and the second braided wire 222.

[0048] The mesh region 21 comprises a plurality of interlaced units and a plurality of deformable meshes 213 formed by a plurality of first support wires 211 and a plurality of second support wires 212 arranged at intervals, each of the interlaced units comprises a plurality of interlaced units arranged in a circumferential direction, and each of the deformable meshes 213 comprises a plurality of deformable meshes 213 arranged in a circumferential direction. The first support wires 211 extend in the third direction, and the second support wires 212 extend in the fourth direction. The first support wires 211 and the second support wires 212 are interlaced to form a plurality of deformable meshes 213 and a plurality of interlaced units. The deformable mesh 213 is substantially in the shape of a rhombus, and can also be in the shape of a square, a rectangle or other shapes. The four corners of the deformable mesh 213 are provided with four interlaced units. Each of the interlaced units comprises an intersection 214 formed by the first support wire 211 and the second support wire 212, and the first support wire 211 and the second support wire 212 can move relative to each other to a certain extent at the intersection 214.

[0049] The two adjacent support wires at the inner end of the mesh region 21 are interlaced to form an intersection and are connected to a corresponding bundle 220. One of the support wires is connected to the first braided wire 221 of the bundle 220, and the support wire connected to the first braided wire 221 is referred to as the first support wire 211. The other support wire is connected to the second braided wire 222, and the support wire connected to the second braided wire 222 is referred to as the second support wire 212. In this embodiment, the first support wire 211 and the first braided wire 221 are in an integrated structure and belong to one wire, and the second support wire 212 and the second braided wire 222 are in an integrated structure and belong to one wire. In other embodiments, the first support wire 211 and the first braided wire 221 can be separately manufactured and spliced together, and / or the second support wire 212 and the second braided wire 222 can be separately manufactured and spliced together. The intersection formed by the first support wire 211 and the second support wire 212 at the inner end of the mesh region 21 is the intersection formed by the first braided wire 221 and the second braided wire 222 at the outer end of the bundle 220.

[0050] The first support wire 211 and the second support wire 212 are arranged in the first direction circumferentially along the sealing part 20 in sequence. The two support wires connected with the first bundle-like part 220a are recorded as the first support wire 211 group, and the two support wires connected with the second bundle-like part 220b are recorded as the second support wire 212 group. In the first support wire 211 group, the first support wire 211 and the second support wire 212 form an overlapping point (i.e. the first overlapping point 223) at the inner side end of the mesh area 21, and the first support wire 211 is closer to the distal end of the left atrial appendage ablation plug 1 than the second support wire 212, i.e. at the overlapping point, the second support wire 212 is closer to the accommodation cavity of the sealing part 20 than the first support wire 211. While in the second support wire 212 group, the first support wire 211 and the second support wire 212 form an overlapping point (i.e. the second overlapping point 224) at the inner side end of the mesh area 21, and the second support wire 212 is closer to the distal end of the left atrial appendage ablation plug 1 than the first support wire 211, i.e. at the overlapping point, the first support wire 211 is closer to the accommodation cavity of the sealing part 20 than the second support wire 212.

[0051] In the embodiment, the pusher can rotate relative to the plug head 24 towards the second direction and be locked, and the pusher can rotate relative to the plug head 24 towards the first direction and be unlocked. After the left atrial appendage ablation plug 1 is implanted, the pusher is inevitably applied with a force towards the first direction when rotating relative to the plug head 24 towards the first direction and being unlocked. Since the bundle-like area 22 includes at least one first bundle-like part 220a, when the sealing part 20 is subjected to an external force in the first direction, the first bundle-like part 220a can be prevented from being untwisted to cause the relative displacement of the first braided wire 221 and the second braided wire 222 at the outer side end, and thus the risk of damaging the insulation layer or causing the displacement of the insulation sleeve during the relative displacement can be reduced.

[0052] In the embodiment, the first direction is counterclockwise, and the second direction is clockwise. In other embodiments, the first direction is clockwise, and the second direction is counterclockwise.

[0053] Embodiment Two

[0054] The left atrial appendage ablation and occlusion system of the embodiment comprises a left atrial appendage ablation and occlusion device 1 and a delivery device for delivering the left atrial appendage ablation and occlusion device 1 to a target position. The left atrial appendage ablation and occlusion device 1 is used for implanting into the left atrial appendage and occluding the mouth of the left atrial appendage, and can also release ablation energy to the target tissue to substantially change the electrical shape, mechanical properties, chemical properties or other properties of the target tissue. The ablation energy includes but is not limited to thermal energy, cold energy, electrical energy, acoustic energy, radio frequency energy, pulsed high voltage energy, mechanical energy, ionizing radiation, optical energy and combinations thereof, and other types of energy suitable for treating tissue. The delivery device comprises a sheath tube for establishing a delivery channel and a pusher movably arranged in the sheath tube, and the distal end of the pusher is detachably connected to the proximal end of the left atrial appendage ablation and occlusion device 1 for pushing the left atrial appendage ablation and occlusion device 1 during delivery.

[0055] As shown in Figure 1 , the left atrial appendage ablation and occlusion device 1 comprises a fixed part 10 and a sealing part 20 connected to the fixed part 10, and the fixed part 10 and the sealing part 20 are connected through a connecting part 30. Among them, the fixed part 10 is used for fixing the left atrial appendage ablation and occlusion device 1 at a predetermined position, and the sealing part 20 is used for occluding the mouth of the left atrial appendage. In addition, the fixed part 10 and the sealing part 20 of the embodiment can also release ablation energy to the target tissue, and in other embodiments, any one of the fixed part 10 and the sealing part 20 can release ablation energy to the target tissue.

[0056] In the embodiment, the sealing part 20 and the fixed part 10 are arranged in the axial direction of the left atrial appendage ablation and occlusion device 1. The sealing part 20 is located at the proximal end of the left atrial appendage ablation and occlusion device 1, and the fixed part 10 is located at the distal end of the left atrial appendage ablation and occlusion device 1. The left atrial appendage ablation and occlusion device 1 has a compressed state accommodated in the sheath tube of the delivery device to facilitate delivery, and an expanded state as shown in Figure 1 after extending out of the distal end of the sheath tube and self-expanding and unfolding. The utility model does not particularly state, and the shape and structural features of the left atrial appendage ablation and occlusion device 1 in the expanded state are described. The shape of the left atrial appendage ablation and occlusion device 1 after being released in the left atrial appendage cavity is Figure 1 completely the same or basically consistent.

[0057] The fixed part 10 can be formed by cutting a nickel-titanium tube or braiding a nickel-titanium wire. In the embodiment, the fixed part 10 is formed by cutting a nickel-titanium tube and then heat setting. The shape of the fixed part 10 is not limited and can be columnar or umbrella-shaped, etc.

[0058] In this embodiment, the sealing portion 20 is formed by weaving a plurality of wires (e.g., nickel-titanium wires or the like having shape memory capability) into a mesh tube, and then heat setting the mesh tube into a disc shape, a disc plug shape, a column shape, or a plug shape, etc., thereby obtaining the sealing portion 20 for occluding the opening of the left atrial appendage. In other embodiments, the sealing portion 20 can be formed by cutting, or partially formed by cutting and partially formed by weaving. The sealing portion 20 has an accommodation cavity inside, and at least one film body 23 is arranged in the accommodation cavity, and the edge of the film body 23 is fixed to the circumferential inner wall of the accommodation cavity of the sealing portion 20. The film body 23 is used to block the blood flow from one side of the sealing portion 20 to the other side, so as to block the blood flow between the left atrial appendage and the left atrium.

[0059] The sealing portion 20 of this embodiment is in a disc plug shape, and includes a proximal disc face 20a, a distal disc face 20b, and a plug head 24. The distal disc face 20b is the disc face facing the fixing portion 10, and the inner side end of the distal disc face 20b (the inner side end of the disc face refers to the end closer to the center of the disc face) is connected (e.g., fixedly connected or movably connected) to the connecting portion 30. The proximal disc face 20a is the disc face away from the fixing portion 10, and the inner side end of the proximal disc face 20a is connected to the plug head 24. The outer side end of the distal disc face 20b (the outer side end of the disc face refers to the end farther away from the center of the disc face, i.e., the end closer to the radial edge of the disc face) is connected to the outer side end of the proximal disc face 20a. In this embodiment, the proximal disc face 20a and the distal disc face 20b are integrally woven, so the outer side end of the proximal disc face 20a and the outer side end of the distal disc face 20b together form the outer edge of the sealing portion 20. In other embodiments, the outer side end of the proximal disc face 20a and the outer side end of the distal disc face 20b can also be connected by other components.

[0060] The film body 23 in the sealing portion 20 includes a film main body 231 and a through portion 232 arranged on the film main body 231, and the through portion 232 can provide a passage for the tubular member 40 (e.g., a catheter or an inner sheath tube for transmitting ablation energy to the fixing portion 10) to pass through the film main body 231.

[0061] Referring to Figure 5 In some embodiments, the above-mentioned through portion 232 includes a slit or a through hole. For example, a slit is arranged in the middle of the film main body 231. Since the film main body 231 has a certain flexibility, the tubular member 40 can pass through the slit and move distally, and can also be withdrawn from the slit. After the tubular member 40 is withdrawn, the slit can substantially restore to its original shape, so as not to excessively reduce the flow blocking capability of the film body 23.

[0062] Referring to Figure 6 , Figure 7In some embodiments, the penetrating portion 232 comprises a plurality of first petals 2322 and a first through hole penetrating the film body 231 in the axial direction of the sealing portion 20, and the plurality of first petals 2322 are arranged in the through hole in the circumferential direction. Each of the first petals 2322 is substantially triangular or leaf-shaped, and comprises a fixed end 2325 and a movable end 2326. The fixed end 2325 is fixedly connected to the film body 231, for example, the first petals 2322 are connected to the edge of the through hole and are integrated with the film body 231. For example, the complete sheet film is cut in the middle region in a cross shape or a rice-shaped, and a plurality of first petals 2322 are obtained. The movable end 2326 is pointed and movable relative to the film body 231 in the axial direction of the sealing portion 20. When the tubular member 40 is not inserted between the first petals 2322, the movable ends 2326 of the plurality of first petals 2322 are close to each other and converge together, so that the plurality of first petals 2322 cover the first through hole, thereby achieving the closure of the penetrating portion 232. When the tubular member 40 is inserted between the first petals 2322, the movable ends 2326 of the plurality of first petals 2322 are movable relative to the film body 231 in the axial direction, and the tubular member 40 can pass through the through hole. After the tubular member 40 is withdrawn, the first petals 2322 can substantially restore the closed state, and a cross-shaped gap or a rice-shaped gap is formed between the plurality of first petals 2322. Since the gap is very small, the flow resistance of the film body 23 is not greatly reduced.

[0063] Referring to Figure 8 , Figure 9 , Figure 10The through portion 232 of the present embodiment comprises a second petal 2323 and a second through hole 2324, the second through hole 2324 penetrates the film body 231 along the axial direction of the sealing portion 20, and the second petal 2323 is arranged in the second through hole 2324. The second petal 2323 comprises a fixed end 2325 and a movable end 2326, wherein the fixed end 2325 is fixedly connected with the film body 231, for example, the second petal 2323 can be connected with the edge of the second through hole 2324 and integrated with the film body 231, and the second petal 2323 is obtained by cutting the middle region of the complete sheet film. The movable end 2326 can move relative to the film body 231 along the axial direction of the sealing portion 20. The shape of the second through hole 2324 matches the shape of the second petal 2323. When the tubular member 40 is not inserted between the second petal 2323, the second petal 2323 substantially covers the second through hole 2324, thereby realizing the closure of the through portion 232. When the tubular member 40 is inserted between the second petal 2323, the movable end 2326 of the second petal 2323 can move relative to the film body 231 along the axial direction, and the tubular member 40 can penetrate the film body 231 through the second through hole 2324. After the tubular member 40 is withdrawn, the second petal 2323 can restore the closed state, thereby not excessively reducing the flow resistance of the film body 23. The above-mentioned second petal 2323 comprises two edges 2327 and waists 2328 connecting the two edges 2327, wherein the two edges 2327 are spaced and oppositely arranged along the height direction of the second petal 2323 (i.e. the direction in which the fixed end 2325 points to the movable end 2326), and the two waists 2328 are spaced and oppositely arranged along the width direction of the second petal 2323 (i.e. the direction perpendicular to the height direction), wherein one edge 2327 serves as the fixed end 2325, and the other edge 2327 serves as the movable end 2326. As shown in FIG. 2, the second petal 2323 is substantially trapezoidal or trapezoidal-like structure, wherein one edge 2327 is a long edge 2327a serving as the fixed end 2325, and the other edge 2327 is a short edge 2327b serving as the movable end 2326. The edge serving as the movable end 2326 can be linear, arc-shaped or any other suitable shape. In other embodiments, the short edge 2327b can serve as the fixed end 2325, and the long edge 2327a can serve as the movable end 2326. Figure 9 As shown in FIG. 2, the second petal 2323 is substantially trapezoidal or trapezoidal-like structure, wherein one edge 2327 is a long edge 2327a serving as the fixed end 2325, and the other edge 2327 is a short edge 2327b serving as the movable end 2326. The edge serving as the movable end 2326 can be linear, arc-shaped or any other suitable shape. In other embodiments, the short edge 2327b can serve as the fixed end 2325, and the long edge 2327a can serve as the movable end 2326. Figure 9 As shown in FIG. 2, the second petal 2323 is substantially trapezoidal or trapezoidal-like structure, wherein one edge 2327 is a long edge 2327a serving as the fixed end 2325, and the other edge 2327 is a short edge 2327b serving as the movable end 2326. The edge serving as the movable end 2326 can be linear, arc-shaped or any other suitable shape. In other embodiments, the short edge 2327b can serve as the fixed end 2325, and the long edge 2327a can serve as the movable end 2326. Figure 9Since the short side 2327b is a free end and the long side 2327a is a fixed end 2325, the longer fixed end 2325 can better support the second flap 2323, so that the second flap 2323 can better maintain the shape to better cover the second through hole 2324. In other embodiments, the two waist lines 2328 and the edge of the movable end 2326 together form an arc-shaped edge. In other embodiments, the second flap 2323 described above can be a rectangle, a square, a hexagon, or other polygons. In other embodiments, Figure 9 The second flap 2323 in the above embodiment can also be multiple.

[0064] The film body 23 described above can be made of one or more of PET, FEP, PU, ETFE, PFA, PTFE, PEEK, and silicone. In other embodiments, the film body 23 described above can also be made of any suitable material.

[0065] Further, the fixed part 10 described above can also be covered with a film that can also play a role in blocking flow. The film can be made of one or more of PET, FEP, PU, ETFE, PFA, PTFE, PEEK, and silicone.

[0066] The specific embodiments described above are only part of the embodiments of the present application, and are not a limitation of the present application. The present specification cannot exhaust all embodiments of the present application, and part of the features of the above different embodiments can be replaced or combined with each other. The person skilled in the art can also make simple replacements according to the actual needs. The concept of the present application is subject to the scope of protection required.

Claims

1. A left atrial appendage ablation and occlusion system, characterized by, The left atrial appendage ablation occluder comprises a fixing part for fixing the left atrial appendage ablation occluder at a predetermined position, a sealing part for sealing, and a connecting part connecting the fixing part and the sealing part, the sealing part comprises a distal disc surface, the distal disc surface comprises a mesh region and a bundle region, the bundle region comprises a plurality of bundle-shaped pieces, the first ends of the plurality of bundle-shaped pieces converge and are connected with the connecting part, the second ends of the plurality of bundle-shaped pieces are connected with the mesh region, at least one of the bundle-shaped pieces is wound by at least two braided wires in a first direction, and the delivery device comprises a pusher, the proximal end of the sealing part further comprises a peg head, the distal end of the pusher is detachably connected with the peg head, the pusher can be rotated relative to the peg head in a second direction and locked, and the pusher can be rotated relative to the peg head in a first direction and unlocked. The left atrial appendage ablation occluder comprises a fixing part for fixing the left atrial appendage ablation occluder at a predetermined position, a sealing part for sealing, and a connecting part connecting the fixing part and the sealing part, the sealing part comprises a distal disc surface, the distal disc surface comprises a mesh region and a bundle region, the bundle region comprises a plurality of bundle-shaped pieces, the first ends of the plurality of bundle-shaped pieces converge and are connected with the connecting part, the second ends of the plurality of bundle-shaped pieces are connected with the mesh region, each of the bundle-shaped pieces is wound by at least two braided wires in a first direction or in a second direction opposite to the first direction, the bundle-shaped piece wound in the first direction is referred to as a first bundle-shaped piece, and the bundle-shaped piece wound in the second direction is referred to as a second bundle-shaped piece, the number of the first bundle-shaped pieces is greater than the number of the second bundle-shaped pieces in the bundle region, and the number of the second bundle-shaped pieces is greater than or equal to zero.

2. A left atrial appendage ablation and occlusion system, characterized by, The left atrial appendage ablation occluder further comprises a delivery device for delivering the left atrial appendage ablation occluder to a target position, the delivery device comprises a pusher, the proximal end of the sealing part further comprises a peg head, the distal end of the pusher is detachably connected with the peg head, the pusher can be rotated relative to the peg head in a second direction and locked, and the pusher can be rotated relative to the peg head in a first direction and unlocked. The bundle-shaped pieces in the bundle region are all wound by at least two braided wires in a first direction.

3. The left atrial appendage ablation and occlusion system of claim 2, wherein, The bundle-shaped piece comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire cross at the second end of the first bundle-shaped piece to form a first overlapping point, and at the first overlapping point, the first braided wire of the first bundle-shaped piece is closer to the distal end of the left atrial appendage ablation occluder than the second braided wire.

4. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The bundle-shaped piece comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire cross at the second end of the second bundle-shaped piece to form a second overlapping point, and at the second overlapping point, the second braided wire of the second bundle-shaped piece is closer to the distal end of the left atrial appendage ablation occluder than the first braided wire.

5. The left atrial appendage ablation and occlusion system of claim 2, wherein, ​ 6. The left atrial appendage ablation and occlusion system of claim 2, wherein, ​ 7. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The mesh region comprises a plurality of support wires, the bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire of the bundle are connected to corresponding support wires respectively, the support wire connected to the first braided wire is referred to as a first support wire, and the support wire connected to the second braided wire is referred to as a second support wire, the first support wire and the second support wire are arranged in sequence along the first direction.

8. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The first direction is counterclockwise or clockwise.

9. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The surface of the mesh region is conductive, and the surface of the bundle region is insulating.

10. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The bundle comprises a first braided wire and a second braided wire, the first braided wire and the second braided wire are spirally wound with each other; or the first braided wire extends along a straight line, and the second braided wire spirally winds on the first braided wire; or the second braided wire extends along a straight line, and the first braided wire spirally winds on the second braided wire.

11. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The mesh region comprises a plurality of support wires, each support wire of the mesh region is connected to and integrated with a corresponding braided wire in a one-to-one correspondence.

12. The left atrial appendage ablation and occlusion system of claim 1 or 2, wherein, The sealing portion has an accommodation cavity in the interior, at least one film body is arranged in the accommodation cavity, and the edge of the film body is fixed to the circumferential inner wall of the accommodation cavity; the film body comprises a film main body and a through portion arranged on the film main body, the through portion comprises a petal and a through hole, the through hole penetrates the film main body along the axial direction of the sealing portion, the petal comprises a fixed end and a movable end, the fixed end is fixedly connected to the film main body, and the movable end is movable relative to the film main body; when the petal covers the through hole, the through portion is in a closed state, and when the movable end moves relative to the film main body to make the through portion in an open state, the through hole provides a channel penetrating the film main body.

13. The left atrial appendage ablation and occlusion system of claim 12, wherein, The petal is one or more of a trapezoid, a trapezoid-like shape, a rectangle, a square, and a hexagon.

14. The left atrial appendage ablation and occlusion system of claim 12, wherein, The petal comprises two edges and two waists connecting the two edges, the two edges are spaced apart and arranged opposite to each other along the height direction of the petal, and the two waists are spaced apart and arranged opposite to each other along the width direction of the petal, one of the edges serves as the fixed end, and the other of the edges serves as the movable end.

15. The left atrial appendage ablation and occlusion system of claim 14, wherein, The two edges are a long edge and a short edge respectively, the long edge serves as the fixed end, and the short edge serves as the movable end.

16. The left atrial appendage ablation and occlusion system of claim 14, wherein, The edge serving as the free end is linear or arc-shaped.

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