CN116831675A - Left auricle plugging device - Google Patents

Abstract

The invention relates to the technical field of left auricle plugging through interventional operation, and discloses a left auricle plugging device which comprises an elastically deformable plugging part and a fixing part connected with the plugging part, wherein the fixing part comprises an elastically deformable frame structure formed by a plurality of supporting rods or braided wires, the frame structure is provided with a concave distal end face at one side far away from the plugging part, a membrane piece is attached to the frame structure, the membrane piece at least covers the concave of the distal end face, and the membrane piece is connected and limited at the position corresponding to the concave of the membrane piece by a traction piece which is led to one side direction of the plugging part so as to enhance the safety and stability of the left auricle plugging device.

Description

Left auricle plugging device

Technical Field

The invention relates to the technical field of left auricle plugging through interventional operation, in particular to an implantable medical device for left auricle plugging.

Background

The left atrial appendage occlusion can be used for treating patients with non-valve atrial fibrillation, and researches show that more than 90% of thrombus in the left atrium comes from the left atrial appendage, when atrial fibrillation occurs, the normal rhythm of the left atrium is disturbed, so that the blood flow velocity in the left atrium is reduced, the blood flow velocity in the left atrial appendage is slower, blood components are retained in the left atrial appendage and solidify to form thrombus, and the probability of atrial fibrillation embolism can be greatly reduced after the left atrial appendage occlusion.

The left auricle occluder can be implanted through an interventional operation, can be elastically compressed in a sheath tube, is released after being conveyed to the auricle through an interventional passage, and can be fixed and occlude the left auricle after deformation recovery. Left atrial appendage occluders typically have an interconnecting but relatively independent securing member disposed in the atrial appendage lumen for securing the occluder to the left atrial appendage and an occluding member positioned by the former at the atrial appendage ostium for occlusion. Typical left atrial appendage occlusion devices of this type are described in the prior art in, for example, chinese patents CN101795628A (AGA), CN202143640U (qian), CN204814031U (denox), CN104856741a (pulse), CN206120393U (puli), CN108472031a (keyi ton). Wherein, the fixing component and the plugging component can be respectively selected into various shapes of frames such as disk, dish, column, umbrella, trapezoid and the like according to the requirement, and the two frames can be of an integrated structure (for example, the plugging device disclosed in CN101795628A is integrally woven by weaving wires) or a split type two-component connecting structure.

The fixing part can be selected to be a net-shaped body frame structure woven by braided wires or a frame structure formed by arranging a plurality of support rods through laser cutting and shaping. Some fixing elements have a recess at the distal end of their frame structure, for example CN202143640U, CN104856741a and CN108472031a disclose central recess umbrella-shaped fixing disc structures obtained by cutting a tube to shape a support rod, and CN204814031U and CN206120393U disclose fixing members formed by braiding braided wires having distal end surface structures with a distal end recess. The fixing component can be provided with a membrane, for example, the capacity of sealing the auricle is improved, the shape stability of the frame is maintained, the friction requirement is reduced, and the like, and part of the membrane can be beneficial to endothelial cell growth and quicken endothelialization coverage of the sealing device.

The portion of the recess where the distal end of the fixation element is disposed is typically covered directly over the recess, however, the potential risk associated therewith may not be considered.

Disclosure of Invention

The present invention aims to provide an improved left atrial appendage occlusion device with enhanced safety and stability.

The embodiment of the left auricle plugging device comprises an elastically deformable plugging part and a fixing part connected with the plugging part, wherein the fixing part comprises an elastically deformable frame structure formed by a plurality of supporting rods or braided wires, the frame structure is provided with a concave distal end face at one side far away from the plugging part, a membrane is attached to the frame structure, the membrane at least covers the concave of the distal end face, and the membrane is connected and limited at the position corresponding to the concave through a traction part which is led to one side direction of the plugging part.

When the fixing part is placed in the working state of the auricle, the fixing part is usually pressed by the auricle to have compression deformation with a certain amplitude, and the diameter is reduced. The inventors have found that when the left atrial appendage occlusion device is in an operational state, the portion of the membrane covering the distal concave surface of the fixation member is prone to prolapse, and that during contraction and relaxation of the left atrial appendage, this prolapsed portion of the membrane is oscillated in response to reciprocal punching by blood flow in the atrial appendage lumen, which may be disadvantageous, for example, the prolapse may form repeated friction in contact with other portions or frames of the membrane, which may lead to a reduced fatigue life of the membrane, as well as early rupture failure of the membrane. Furthermore, the uncontrolled swinging of the prolapsed portion of the membrane may also provide additional undesirable traction to the frame of the fixation means, which may reduce the positioning ability of the frame within the auricular cavity.

In the embodiment of the invention, the traction piece pulls the membrane piece at the fixing part towards one side of the plugging part, the membrane piece swing is limited by traction, compared with the condition that the traction piece is not arranged, the swing amplitude and the swing direction of the part of the membrane piece, which covers the far-end concave surface, in the left auricle cavity during the systole or diastole along with the auricle are reduced, and the method is beneficial in various aspects, such as improving the stability of the membrane piece, avoiding early rupture failure of the membrane piece caused by frequent and severe fluctuation swing and improving the fatigue life of the membrane piece; for another example, the swing amplitude and direction of the membrane subjected to the blood flow impact are limited, so that the traction on the fixed frame is reduced, the influence on the positioning of the fixed frame in the left auricle cavity is reduced, and the displacement or falling-off phenomenon of the fixed frame in the left auricle cavity is reduced.

In certain embodiments of the invention, the distal end face of the frame structure has a central recess and the membrane covers the distal end face of the frame structure.

In other embodiments, the membrane covers a distal end face of the frame structure and surrounds at least a portion of an outer perimeter of the frame structure adjacent the distal end face.

In some embodiments of the invention, the membrane may be secured at its edges to support rods or woven wires of the frame structure in order to attach the membrane to the frame structure.

Alternatively, the membrane may be bound by binding wires, adhesive bonding, welding, or clamping support rods or braided wires secured to the frame structure.

Without being limited to the above, the person skilled in the art may alternatively implement the attachment fixation of the membrane to the frame structure in other ways.

In the embodiment of the invention, the membrane is limited by the traction piece, so that the membrane is limited in deflection or deformation towards one side far away from the plugging part.

In a preferred embodiment, the membrane is restrained by the traction member without substantially bulging deformation to a side away from the occluding component.

In a preferred embodiment, the membrane is restrained by the traction element in a substantially tensioned state when the left atrial appendage occlusion device is in an unconstrained state.

In one embodiment of the invention, one end of the traction element is fixed to the blocking element.

In some embodiments, the plugging member is a mesh structure woven by braided wires, and the plugging member further comprises a fixing member for fixing the free ends of the braided wires, and a choke film fixed to the mesh structure, wherein one end of the traction member, which is directed to one side of the plugging member, is fixed to the braided wires of the mesh structure of the plugging member, or the fixing member, or the choke film.

In another embodiment of the present invention, one end of the traction member directed to one side of the blocking member is fixed to the proximal end of the fixing member.

In some embodiments, the fixing component comprises a frame structure formed by braiding a plurality of braiding wires, a proximal end of the frame structure is provided with a proximal end component for converging and fixing each braiding wire, and one end of the traction component, which is led to one side direction of the plugging component, is fixed on the proximal end component.

In some embodiments, the fixing part comprises a frame structure formed by a plurality of support rods, each support rod is converged at one end part at the proximal end of the fixing part, and one end of the traction part, which is directed to one side of the plugging part, is fixed to the end part.

In some embodiments, the fixing component comprises a frame structure formed by intersecting a plurality of support rods, each support rod is converged at an end component at the proximal end of the fixing component, the intersecting arrangement of the support rods forms an intersecting overlapping position adjacent to the end component, and one end of the traction component, which is directed to one side of the plugging component, is fixed at the intersecting overlapping position.

In still another embodiment of the present invention, the blocking member and the fixing member are connected by a connecting body having a smaller diameter than the blocking member and the fixing member, and one end of the traction member directed to one side of the blocking member is fixed to the connecting body.

The traction member may be a single strand or at least two strands formed after at least two opposite passes of a single strand through the membrane.

In certain embodiments, the wire of the traction element has a diameter greater than the thickness of the membrane element.

In some embodiments, the traction element is a surgical suture, and the membrane element is a spun-laced nonwoven fabric of PET or PTFE.

According to the left auricle occluder, the prolapsed part of the membrane is limited by the traction piece, so that the safety and stability of the left auricle occluder after implantation can be enhanced.

Drawings

The present invention will be described in further detail with reference to the accompanying drawings.

FIG. 1 is a schematic view of a prior art left atrial appendage occlusion device disposed in a left atrial appendage;

FIG. 2 is a schematic view of the left atrial appendage occlusion device of FIG. 1;

FIG. 3 shows a membrane attached to a stationary member;

FIG. 4 is a partial schematic view of a fixation element of another prior art left atrial appendage occlusion device showing a distal end of the fixation element;

FIG. 5 is a partial schematic view of the securing member of the left atrial appendage occlusion device of FIG. 4 secured within the left atrial appendage lumen;

FIG. 6 is a schematic view of a left atrial appendage occlusion device embodiment of the present invention;

FIG. 7 is a schematic view of another embodiment of a left atrial appendage occlusion device of the present invention;

FIG. 8 is a schematic view of a still further embodiment of a left atrial appendage occlusion device of the present invention;

FIG. 9 is a schematic view of a still further embodiment of a left atrial appendage occlusion device of the present invention;

FIG. 10 is a partial schematic view of a left atrial appendage closure of an embodiment of the present invention with a securing member secured within a left atrial appendage lumen;

fig. 11 is a partial schematic view of a securing member of another embodiment of a left atrial appendage occlusion device of the present invention secured within a left atrial appendage lumen.

In the above figures, the reference numerals are as follows:

1, a fixing part; 11, concave; 12, a film member; 121, a portion of the membrane covering the recess; 13, supporting a rod; 131, anchoring;

2, plugging parts; 21, a choke film; 3, a connector; 4, auricle wall; 5, a traction piece;

61, a first fixed point; 62, a second fixed point.

Detailed Description

The invention will be described in further detail with reference to the drawings and the detailed description, but the invention is not limited thereto.

Referring to fig. 1, there is shown a schematic diagram of a prior art left atrial appendage occlusion device for occluding a left atrial appendage after being implanted in the left atrial appendage, wherein a fixing member 1 is positioned in the atrial appendage cavity adjacent to the atrial appendage opening, a blocking member 2 connected to the fixing member 1 is provided on one side of a proximal end of the fixing member 1, and the blocking member 2 is positioned at the atrial appendage opening to isolate the left atrial appendage cavity from the left atrial appendage cavity, thereby realizing occlusion of the left atrial appendage. Referring to fig. 2, a plurality of support rods 13 are arranged to cross each other to form a frame structure of the fixing member 1, the membrane 12 is located at the distal end of the fixing member and covers each support rod 13 forming the frame of the fixing member 2, and is fixed by a plurality of fixing points, and the distal end of the frame structure is recessed toward the crossing position of the support rods, and corresponds to the recessed-covered portion 121 of the membrane. For a more specific construction and preparation of the left atrial appendage occlusion device shown in fig. 1-2, reference is made to chinese patent CN108472031a, which is incorporated herein in its entirety by reference.

Referring to the embodiment shown in fig. 3, which shows the membrane 12 covered at the distal end of the fixation member 1, wherein the fixation points may comprise two turns, a plurality of first fixation points 61 arranged circumferentially around the frame of the ring fixation member 1, and a plurality of second fixation points 62 arranged on the distal surface of the frame of the fixation member 2. The first fixing point 61 is located at or near the edge of the membrane. The second fixing point is not necessary but is generally recommended to further reduce the relative sliding of the membrane to the frame, allowing the membrane to be compactly attached to the frame. Thus, the above-described attachment of the membrane to the frame of the fixed component is a substantially non-movable connection, for example, the membrane 12 may be lashed by lashing lines, adhesively bonded, welded, or clamped to a support bar of the frame structure. Without being limited thereto, the person skilled in the art may alternatively implement the attachment fixation of the membrane to the frame structure in other ways.

Anchor 131 may optionally be provided on the frame of the fixing element 1, and the membrane 12 may optionally be sized so as not to extend to the anchor 131, as shown in fig. 2. In another embodiment, the anchoring barbs 131 may penetrate the membrane 12, as shown in FIG. 3.

Not limited to the example of the fixing element 1 of the left atrial appendage occlusion device shown in fig. 1-3, which is formed of a support rod, a frame of the fixing element 1 which may be formed by braiding wires in a disc, cylinder or other shape is also a well known technical means in the art.

Referring to fig. 4, there is shown a fixing member 1 of a braid structure, the frame of which may be braided from nitinol wires and heat-set, the distal center of the frame having a recess 11 therein, the distal end face of the frame being covered with a membrane 12, the membrane 12 being fixable to the nitinol wires in contact with the membrane by a loop of fixing points as described above.

The support rod or the braided wire forms a fixed part of the frame, and when the frame is placed in the working state in the auricle, the frame is usually compressed and deformed to a certain extent by the auricle and beats along with the auricle. Referring to fig. 4 and 5, fig. 5 shows the fixation member 1 being placed in the atrial appendage lumen and being compressed by the inner wall of the atrial appendage to remain positioned in the atrial appendage lumen, the compressed diameter of the fixation member 1 shown in fig. 5 being significantly reduced relative to the unconstrained state shown in fig. 4. The diameter variation may generally be about 5% -40% according to the left atrial appendage occlusion device structure, the preparation process, the shape selection size, etc., and may be referred to, for example, as the fixing component of some woven frame structures, the diameter variation may be about 10% -30%, and the diameter variation may be about 5% -25%, but it should be understood that the fixing component of the woven frame structure is not always more easily compressed relative to the support frame structure to change the diameter. The distal indent portion of the membrane covering the securing member tends to prolapse due to the reduced diameter of the securing member when the left atrial appendage occlusion device is in an operative state, and with reference to fig. 5, the indent-covering portion 121 of the membrane is shown bulging toward the distal end of the atrial appendage lumen, however, it should be appreciated that the shape of the prolapsed portion of the membrane may be random, such as by bulging into or random folding of the distal indent of the frame, as the prolapsed portion of the membrane is not constrained.

Although occlusion of the auricle can be achieved after implantation of the left auricle occluder, blood occluded in the auricle cavity can flow in the auricle during the initial period of occlusion, for example, 1-3 months or more, as the left auricle contracts and expands. This prolapsed portion of the membrane is then oscillated by the reciprocating ram of blood flow in the auricular cavity, which is uncontrolled, random, e.g., the prolapse may form repeated friction with other portions or frames of the membrane, which may lead to reduced fatigue life of the membrane, as well as early rupture failure of the membrane. Furthermore, the uncontrolled oscillation of the prolapsed portion of the membrane increases the instability of the left atrial appendage occlusion device, which counteracts the frame of the fixation component, creating an undesirable additional pulling of the frame of the fixation component, which may reduce the positioning ability of the frame within the atrial appendage lumen.

Based on the above, in the left atrial appendage occlusion device of the embodiment of the present invention, the distal membrane of the fixing member is connected and limited in its corresponding distal recess of the fixing frame by a traction member directed to one side of the occlusion member. Referring to fig. 10 and 11, the distal end of the pulling member 5 is attached to the portion 121 of the membrane 12 covering the recess 11, and the proximal end of the pulling member 5 is directed in the direction of the side of the occluding component. When the left auricle occluder is in an operating state, the concave-covered part 121 of the membrane is limited by the traction of the traction part 5 and cannot bulge out freely towards the distal end of the auricle inner cavity. Referring to fig. 10, the concave covered portion 121 of the membrane forms a slight fold due to the spacing, which is substantially at the distal end face of the frame of the fixation member 1, such that it does not form a large bulge towards the distal end of the ear lumen, and thus the concave covered portion 121 of the membrane does not substantially form a wobble outside the frame of the fixation member 1, significantly reducing the influence of the wobble of the membrane on the positioning of the fixation member. Referring to fig. 11, a further embodiment of the invention is shown in which the portion 121 of the membrane covering the recess forms a bulge in the recess of the frame as a result of being pulled by the pulling element 5 to a limited extent.

The traction limit of the traction element 5 on the membrane 12 may be based on the traction of the own weight of the traction element 5 on the membrane, for example, the other end of the traction element 5 may be unfixed but arranged to be directed to the side of the occluding component 2.

In a preferred embodiment, however, the other end of the pulling element 5 is fixed such that the concave-covered portion 121 of the membrane is restrained against movement or deformation away from the occluding component.

In some embodiments, the distance between the two ends of the traction element 5 in the axial direction of the left atrial appendage occlusion device may be variable, for example, when the left atrial appendage occlusion device is changed from an unconstrained state to an operating state, the axial length of the fixing element 1 and/or the occlusion element 2 may be increased while the diameter is reduced, for example, the proximal end and the distal end of the frame of the fixing element 1 may be moved in different directions, respectively, when the other end of the traction element 5 is fixed to the proximal end of the frame of the fixing element 1, the concave-covered portion 121 of the traction element 5 may be moved or deformed in the proximal direction of the fixing element to form a bulge-like concave condition, for example, as shown in fig. 11. It is obvious that the other end of the pulling element 5 is not limited to the proximal end of the frame fixed to the fixing element 1, but may be fixed to the blocking element 2, or may be fixed to the connecting body 3 when the connecting body 3 is present between the fixing element 1 and the blocking element 2.

The traction piece pulls the membrane piece at the fixing part towards one side of the plugging part, the swing of the membrane piece is limited by traction, compared with the condition that the traction piece is not arranged, the swing amplitude and the direction of the part of the membrane piece, which covers the concave surface of the far end, in the left auricle cavity during the contraction or the diastole along with the auricle are reduced, and the method is beneficial in various aspects, such as improving the stability of the membrane piece, avoiding the early rupture failure of the membrane piece caused by frequent and severe fluctuation swing and improving the fatigue life of the membrane piece; for another example, the swing amplitude and direction of the membrane subjected to the blood flow impact are limited, so that the traction on the fixed frame is reduced, the influence on the positioning of the fixed frame in the left auricle cavity is reduced, and the displacement or falling-off phenomenon of the fixed frame in the left auricle cavity is reduced.

Some specific embodiments of the left atrial appendage occlusion device of the present invention are described in detail below.

Example 1

Referring to fig. 6, there is shown a left atrial appendage occlusion device comprising a fixing member 1 and an occlusion member 2, the fixing member 1 comprising a plurality of support rods 13, which may be a plurality of support rods 13 cut out of a nickel titanium tube and then spread out with a die, and shaped into a disk shape having a distal end face diameter and an outer circumference as shown in fig. 6 by means of heat treatment. The plugging member 2 is made into a woven mesh by using nickel titanium wires in a weaving mode, is made into a disc shape by using a heat treatment mode, is fixed at two ends by using sleeves to form a sealing disc, then is welded on the sleeve at the proximal end to be provided with a threaded connecting piece connected with a conveyor, the other end of the sealing disc is a fixed end, the sleeve at the fixed end is connected to a joint of the fixing member 1 to form a connecting body 3 so as to realize the connection of the fixing member 1 and the plugging member 2, and a choke film (PTFE or PET film) is sewn in the sealing disc by using medical suture, and is not shown in the figure.

Nine support rods 13 may be used for the fixing element 1, but other numbers may be selected, such as six, eight, twelve, sixteen, etc., depending on mechanical properties and dimensional specifications. The nine support rods 13 are radially and symmetrically arranged, are unfolded in an umbrella shape from the center in the direction of the oblique axis, and then the ends of the support rods 13 are made to be substantially parallel to the central axis of the fixing member 1 by U-shaped bending. The support rods 13 finally converge into the joints of the fixed part 1. The joint is at the uncut end of the nitinol tube and is centered on the stationary part 1 to constitute the central end connected to the closure disc.

The distal end of the fixing element 1 is provided with a membrane 12 covering the distal end face of the fixing element 1 having a central recess 11 and surrounding a portion of the frame structure of the fixing element 1 adjacent to the outer periphery of said distal end face. Referring to fig. 3, the membrane 12 may be bound to the support bar 13 at a first fixing point 61, a second fixing point 62 on the outer circumference. One surgical suture is used as a traction piece 5, one end of the surgical suture is bound and fixed on a concave-covered part 121 of the membrane, and the other end of the surgical suture is bound and fixed on a knitting wire on the surface of the far-end disc of the sealing disc.

Example 2

Referring to fig. 7, there is shown a left atrial appendage occlusion device in which the support rods of the fixing element 1 are formed in a cross arrangement, and the cross arrangement between the support rods forms a staggered overlapping portion adjacent to the joint of the fixing element 1, unlike in embodiment 1, referring to the left atrial appendage occlusion device structure of fig. 1-3 as well as the foregoing.

Wherein the distal end of the fixing element 1 is provided with a membrane 12 covering the distal end face of the fixing element 1 having a central recess 11 and surrounding a portion of the frame structure of the fixing element 1 adjacent to the outer periphery of said distal end face. Referring to fig. 7, a surgical suture is threaded around the crossing portion of the support rod to cover the concave portion 121 of the membrane penetrating member 12, and the two ends of the suture are tied together to form a coil as a traction member. Compared with the embodiment 1, the traction piece 5 formed by the coils is more compact in arrangement mode, the axial length of the traction piece 5 is shorter, and interference is avoided.

The membrane 12 may be substantially tensioned or loose when the left atrial appendage occlusion device is in its unconstrained state, as defined by the traction element.

Example 3

Referring to fig. 8, there is shown a left atrial appendage occlusion device comprising a fixation member 1 and an occlusion member 2, and a connector 3 connecting the fixation member 1 and the occlusion member 2. The fixing part 1 and the plugging part 2 are respectively made into a woven net by a nickel titanium wire in a weaving mode, are made into a disc shape by a heat treatment mode, and the two ends of the disc of the plugging part 2 are fixed by sleeves to form a closed disc, and the two ends of the disc of the fixing part 1 are fixed by sleeves to form an anchoring disc. The sleeve at the proximal end of the sealing disk is welded with a threaded connecting piece connected with the conveyor, and the sleeve at the other end of the sealing disk is fixed with the sleeve at the proximal end of the anchoring disk to form a connecting body 3. A choke film 21 is sewn on the inside of the sealing disk by a medical suture, and the choke film can be made of PTFE or PET film. The other end of the anchor disc, i.e. the center of the distal end, is shaped in a concave shape, and the sleeve of the anchor disc, to which the braided wire is secured at the distal end, may be positioned in the concave shape, part of the sleeve of the disc not being shown for simplicity.

The distal end of the anchor disc is provided with a membrane 12 covering the distal end face of the fixation member 1 with a central recess 11. The ginseng film 12 may have one or two loops of fixation points near its edge bound by a wire to a braided wire on the distal face of the anchor disc. One surgical suture is used as a traction piece 5, one end of the surgical suture is bound and fixed on a concave-covered part 121 of the membrane piece, and the other end of the surgical suture is bound and fixed on a flow blocking membrane 21 in the sealing disc.

Example 4

Referring to fig. 9, there is shown a left atrial appendage occlusion device similar to that of example 3, the distal end of the anchor disc being provided with a membrane 12 covering the distal end face of the fixation element 1 having a central recess 11. The ginseng film 12 may have one or two loops of fixation points near its edge bound by a wire to a braided wire on the distal face of the anchor disc. One surgical suture is used as a traction piece 5, one end of the surgical suture is bound and fixed on a concave-covered part 121 of the membrane, and the other end of the surgical suture is bound and fixed on a braiding wire of a proximal disc surface of the sealing disc.

Without limitation, the fixation and occlusion members may be woven in various ways or structures known in the art other than the embodiments described above, such as the fixation and occlusion members being integrally woven, having a woven mesh portion without a connector that transitions between the two members, the connector 3 not being necessary, and in some implementations the fixation member 1 and occlusion member 2 being an integral woven structure, the fixation member 1 being directly connected to the occlusion member 2 without a transitional connector portion. Still alternatively, the braided filaments of the fixation members in some embodiments may be secured by a steel sleeve at one end only. In some embodiments, one end of the traction element may be fixed to the connecting body 3 or to the steel sheath to which the braided filaments are fixed.

In the embodiment of the invention, the traction element 5 may be flexible, for example with respect to the support rods or the woven wires, but may be at the same time more rigid with respect to the membrane 12, i.e. the traction element 5 may be less deformable than the membrane, for example by choosing the diameter of the traction element to be larger than the thickness of the membrane, whereby the load-fixing of the traction element 5 to the membrane 12 forms a limitation of the membrane 12, which may reduce the free swing amplitude of the membrane's concave covered portion 121. The traction elements 5 may also be in non-wire form, such as cylindrical, block or ribbon form.

In some embodiments, the traction element may be selected as a surgical suture, the membrane element may be selected from PET or PTFE, preferably a spun-laced nonwoven, and the membrane element may be generally partially permeable to blood but impermeable to larger emboli. The membrane may be chemically or physically surface modified, for example to increase hydrophilicity, lubricity, etc.

In certain embodiments, the distal recess 11 of the fixation component 1 of the left atrial appendage closure has a distal face that is at least one quarter, or one third, or one half, or even a greater proportion of the radial cross-sectional area.

In the embodiment of the invention, the traction element pulls the membrane element at the fixing part towards the direction of one side where the plugging part is located, the membrane element swing is limited by traction, compared with the condition that the traction element is not arranged, the swing amplitude and the swing direction of the part of the membrane element, which covers the far-end concave surface, in the left auricle cavity during the systole or diastole along with the auricle are at least reduced, and the invention is beneficial in various aspects, such as improving the stability of the membrane element, avoiding the early rupture failure of the membrane element caused by frequent and severe fluctuation swing and improving the fatigue life of the membrane element; for another example, the swing amplitude and direction of the membrane are firstly controlled, so that the traction on the fixed frame is reduced, the influence on the positioning of the fixed frame in the left auricle cavity is reduced, and the displacement or falling-off phenomenon of the fixed frame in the left auricle cavity is reduced.

Claims (16)

1. The utility model provides a left auricle plugging device, includes but elastic deformation's shutoff part and with the fixed part that the shutoff part is connected, but fixed part includes the elastic deformation's that a plurality of bracing pieces or braided wire constitute frame construction, frame construction is keeping away from the one side of shutoff part is for having the distal end terminal surface of indent, attaches the membrane on it, the membrane covers at least the indent of distal end terminal surface, the membrane is at its correspondence the indent is passed through a guide to the traction element of shutoff part one side direction is connected spacingly.

2. The left atrial appendage occlusion device of claim 1, wherein: the membrane covers a distal end face of the frame structure that includes a central recess.

3. The left atrial appendage occlusion device of claim 1, wherein: the membrane covers a distal end face of the frame structure and surrounds at least a portion of an outer periphery of the frame structure adjacent the distal end face.

4. A left atrial appendage occlusion device as in any one of claims 1-3, wherein: the membrane is fixed at its edges to support rods or woven wires of the frame structure.

5. The left atrial appendage occlusion device of claim 4, wherein: the membrane is bound by binding wires, bonded by adhesive, welded or clamped and fixed on the support rods or the braided wires of the frame structure.

6. The left atrial appendage occlusion device of claim 1, wherein: the membrane is limited by the traction piece and does not bulge out to one side far away from the plugging part.

7. The left atrial appendage occlusion device of claim 1, wherein: when the left auricle occluder is in an unbound state, the membrane is limited by the traction piece and is in a basically tensioned state.

8. The left atrial appendage occlusion device of claim 1, wherein: one end of the traction piece is fixed on the plugging part.

9. The left atrial appendage occlusion device of claim 8, wherein: the plugging part is a net-shaped body structure woven by braided wires, and further comprises a fixing member used for fixing the free ends of the braided wires of the plugging part and a choke film fixed on the net-shaped body structure, wherein one end of the traction part, which is directed to one side of the plugging part, is fixed on the braided wires of the net-shaped body structure of the plugging part, or the fixing member, or the choke film.

10. The left atrial appendage occlusion device of claim 1, wherein: one end of the traction piece, which is led to one side direction of the plugging part, is fixed to the proximal end of the fixing part.

11. The left atrial appendage occlusion device of claim 10, wherein: the fixing part comprises a frame structure formed by braiding a plurality of braiding wires, the proximal end of the frame structure is provided with a proximal component which is used for converging and fixing each braiding wire, and one end of the traction part which is led to one side direction of the plugging part is fixed on the proximal component.

12. The left atrial appendage occlusion device of claim 10, wherein: the fixing part comprises a frame structure formed by a plurality of supporting rods, each supporting rod is converged at one end part component at the proximal end of the fixing part, and one end of the traction part, which is led to one side direction of the plugging part, is fixed to the end part component.

13. The left atrial appendage occlusion device of claim 10, wherein: the fixing component comprises a frame structure formed by a plurality of support rods in a crossed arrangement, the support rods are converged at one end component at the proximal end of the fixing component, the support rods are crossed and arranged to form a staggered overlapping part adjacent to the end component, and one end of the traction component, which is led to one side of the blocking component, is fixed at the staggered overlapping part.

14. The left atrial appendage occlusion device of claim 1, wherein: the plugging part and the fixing part are connected through a connecting body, the connecting body is smaller than the diameters of the plugging part and the fixing part, and one end of the traction part, which is led to one side direction of the plugging part, is fixed on the connecting body.

15. The left atrial appendage occlusion device of claim 1, wherein: the traction piece is a single-stranded wire or at least two-stranded wires formed after one wire passes through the membrane piece at least twice, and the diameter of the wire of the traction piece is larger than the thickness of the membrane piece.

16. The left atrial appendage occlusion device of claim 1, wherein: the traction piece is a surgical suture, and the membrane piece is a spun-laced non-woven fabric made of PET or PTFE.