CN112568955A - Improve left auricle of heart plugging device of structure - Google Patents

Abstract

The invention provides a left auricle occluder which comprises an anchoring part, a waist part and a sealing part which are sequentially connected. The anchoring portion includes a plurality of anchoring repeating units arranged around the central axis for one turn. The waist includes a plurality of waist repeating units arranged around the central axis for one revolution. The lumbar repeating unit comprises at least one lumbar support bar and/or at least one support ring. The sealing portion includes a plurality of sealing repeating units arranged around the central axis for one turn. When the left auricle plugging device plugs the left auricle, the anchoring part is positioned in the left auricle and fixed on the inner wall of the left auricle, and the sealing part deforms, so that the sealing part can be attached to the wall surface of the orifice of the left auricle, and the orifice of the left auricle is plugged. The left atrial appendage occluder provided by the invention has the advantages of excellent toughness performance, strong adherence and high sealing degree in each area.

Description

Improve left auricle of heart plugging device of structure

Technical Field

The invention relates to the technical field of medical instruments, in particular to a left atrial appendage occluder with an improved structure.

Background

Atrial fibrillation (atrial fibrillation for short) is the most common persistent arrhythmia. The incidence of atrial fibrillation increases with age, reaching 10% in people over 75 years of age. The frequency of atrial activation in atrial fibrillation reaches 300-. The contraction force of the left auricle is reduced during atrial fibrillation, and the morphological characteristics of the left auricle and the unevenness of the trabecula muscularis in the left auricle make the blood flow in the left auricle generate vortex and slow down the flow velocity, so as to promote the formation of thrombus. More than 90% of left atrial thrombus exists in left auricle of patients with non-valvular ward fibrillation. After the thrombus falls off, the thrombus enters arterial vessels of the brain through aortic vessels to form cerebral embolism, namely stroke.

Aiming at the risk of stroke of patients with atrial fibrillation, three methods are mainly adopted for prevention and treatment clinically, namely anticoagulant drug treatment, surgical operation treatment and percutaneous left atrial appendage occlusion treatment. Anticoagulant therapy refers to the administration of anticoagulant drugs to inhibit blood clotting, thereby reducing the risk of thrombosis in the left atrial appendage and thus reducing the incidence of stroke. However, anticoagulant medication is a lengthy process and there are significant complications, mainly manifested as bleeding complications, and more serious cases may occur. Surgical treatment includes surgical excision or suture of the left atrial appendage, but the surgical trauma is large, and the surgical trauma is generally completed when performing other operations such as valve replacement or coronary artery bypass, and patients generally have difficulty in simple left atrial appendage surgery, especially for elderly patients. The percutaneous left atrial appendage occlusion treatment is that a left atrial appendage occluder is delivered to a left atrial appendage positioned in the left atrium of a heart and released by a percutaneous puncture mode and a delivery sheath with a smaller diameter. The left auricle occluder can occlude the opening position of the left auricle, and the blood flow in the atrium can not enter the left auricle, thus the thrombus can not be formed, and the aim of preventing the atrial fibrillation thromboembolism is achieved. Since the clinical application of Left Atrial Appendage Closure (LAAC) via catheter in 2002, research data (PROTECT-AF and PREVAIL5 follow-up) show that the curative effect of the left atrial appendage closure is superior to that of anticoagulant therapy, and the post-operation bleeding rate, disability rate, mortality rate and other adverse reaction event rates are lower than those of the anticoagulant therapy. The technology has obtained enough evidence in the aspect of preventing cardiogenic embolism caused by atrial fibrillation, and the left atrial appendage occlusion can effectively reduce the occurrence probability of stroke of patients with atrial fibrillation.

The current left atrial appendage occluder causes the reposition of redundant personnel of postoperative to omit easily, and adherence is relatively poor, and the leakproofness is not high, or current left atrial appendage occluder passes through welded mode to be connected, and the toughness of the wire of left atrial appendage occluder can change under high temperature, brings the postoperative hidden danger easily.

Therefore, how to design a left atrial appendage occluder with excellent toughness performance, strong adherence and high sealing degree in each region becomes a technical problem to be solved urgently.

Disclosure of Invention

The left atrial appendage occluder provided by the invention has the advantages of excellent toughness performance, strong adherence and high sealing degree in each area.

The invention provides a left auricle occluder, which comprises a framework formed by cutting, wherein the framework is provided with a central axis and comprises an anchoring part, a waist part and a sealing part which are sequentially connected; the anchoring part comprises a plurality of anchoring repeating units which are arranged around the central axis for a circle, and each anchoring repeating unit comprises at least one anchoring supporting rod; the waist comprises a plurality of waist repeating units which are arranged around the central axis for one circle, and each waist repeating unit comprises at least one waist supporting rod and/or at least one supporting ring; the sealing part comprises a plurality of sealing repeating units which are arranged around the central axis for one circle, and each sealing repeating unit comprises at least one sealing support rod; when the left auricle occluder blocks the left auricle, the anchoring part is positioned in the left auricle and fixed on the inner wall of the left auricle, and the sealing part deforms so that the sealing part can be attached to the wall surface of the orifice of the left auricle to block the orifice of the left auricle.

The anchoring part, the waist part, the sealing part and the connector of the left auricle occluder are naturally formed by only one-time cutting without any welding or bonding process, so that unnecessary axial length and risk of fracture caused by welding or bonding between the anchoring part and the waist part, between the sealing part and the waist part and between the sealing part and the connector are effectively avoided; and the toughness in each region of left atrial appendage occluder is good, and the anchor portion of being convenient for, waist, sealing part have good deformability to make the inner wall of left atrial appendage fixed effectively in anchor portion, and make the sealing part seal the drill way department of left atrial appendage effectively, improve left atrial appendage occluder's leakproofness, adherence, in order to avoid the shunt to omit after the art.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a perspective view of a left atrial appendage occluder according to a first embodiment of the present invention.

Figure 2 is a front view of a left atrial appendage occluder in accordance with a first embodiment of the present invention.

Figure 3 is a schematic diagram of the anchoring repeating unit, the lumbar repeating unit and the sealing repeating unit of the left atrial appendage occluder provided by the first embodiment of the invention.

Figure 4 is a top view of a left atrial appendage occluder in accordance with a first embodiment of the present invention.

Figure 5 is a partial view of the anchoring portion of a left atrial appendage occluder in accordance with a first embodiment of the present invention.

Figure 6 is a partial view of the waist and sealing portion of a left atrial appendage occluder in accordance with a first embodiment of the present invention.

Figure 7 is a front view of a left atrial appendage occluder in accordance with a second embodiment of the present invention.

Figure 8 is a front view of the waist of a left atrial appendage occluder in accordance with a second embodiment of the present invention.

Figure 9 is a front view of a left atrial appendage occluder in accordance with a third embodiment of the present invention.

Figure 10 is a front view of the waist and sealing portion of a left atrial appendage occluder in accordance with a third embodiment of the present invention.

Figure 11 is a front view of a left atrial appendage occluder in accordance with a fourth embodiment of the present invention.

Figure 12 is a front view of a left atrial appendage occluder in accordance with a fifth embodiment of the present invention.

Figure 13 is a front view of a left atrial appendage occluder in accordance with a sixth embodiment of the present invention.

Figure 14 is a front view of a left atrial appendage occluder in accordance with a seventh embodiment of the present invention.

Detailed Description

The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

Referring to fig. 1, fig. 1 is a leftatrial appendage occluder 100 according to an embodiment of the present invention. For convenience of description, proximal end a refers to the end near the left atrial location, and distal end B refers to the end away from the left atrial location.

Referring to fig. 1 and 2 together, the leftatrial appendage occluder 100 includes a framework formed by cutting. The framework has a central axis L. The skeleton includesanchor portion 1,waist 2, sealing 3 and theconnector 4 that connects gradually. When the leftatrial appendage occluder 100 occludes the left atrial appendage, theanchoring portion 1 is located at the distal end B, and thesealing portion 3 is located at the proximal end a.

Referring to fig. 2 and 3, theanchoring portion 1 includes a plurality of anchoring repeatingunits 11 arranged around the central axis L. The anchoring repeatingunit 11 includes at least oneanchoring support rod 111.

Referring to fig. 2 and 3, thewaist portion 2 includes a plurality ofwaist repeating units 21 arranged around the central axis L, and thewaist repeating units 21 include at least onewaist support bar 211 and/or at least one support ring.

Referring to fig. 2 and 3, the sealingportion 3 includes a plurality of sealing repeatingunits 31 arranged around the central axis L. The sealing repeatingunit 31 includes at least onesealing support rod 311. When the left auricle occluder 100 occludes the left auricle, theanchoring portion 1 is located in the left auricle and fixed on the inner wall of the left auricle, and thesealing portion 3 deforms under the pulling force of theanchoring portion 1, so that thesealing portion 3 can be attached to the wall surface of the orifice of the left auricle, and the orifice of the left auricle is occluded.

Specifically, the leftatrial appendage occluder 100 is constrained within a delivery device, and the leftatrial appendage occluder 100 is able to reach a target location with the delivery device, which may be within the left atrial appendage of the heart to be occluded. The delivery device releases the left atrial appendage occluder 100 and the left atrial appendage occluder 100 expands to return to its original shape after being unbound. The leftatrial appendage occluder 100 is generally in the shape of a cage. The anchoringportion 1 is distant from the orifice of the left atrial appendage with respect to thewaist portion 2. The anchoringpart 1 abuts against and is fixed on the inner wall of the left auricle after being expanded, thewaist part 2 is positioned in the left auricle after being expanded, and thesealing part 3 is positioned at the orifice of the left auricle after being expanded; theanchoring part 1 pulls the sealingpart 3 through thewaist part 2, and the area of the sealing surface of the sealingpart 3 is larger than or equal to the area of the orifice of the left auricle, so that the sealingpart 3 is just blocked in the orifice of the left auricle, or thesealing part 3 is positioned outside the orifice of the left auricle and sealed in the orifice of the left auricle.

Further, the deformation of sealing 3 that produces under the pulling force ofanchor portion 1 includes the compression deformation of sealing 3 along axis L direction, still includes because the compliance of sealing 3 self makes the shape of sealing 3 can be along with the shape of the drill way of left atrial appendage is out of shape. The surface of the sealingpart 3 for sealing the orifice of the left atrial appendage deforms along with the shape of the wall surface of the orifice of the left atrial appendage, so that the surface of the sealingpart 3 is sealed and attached to the wall surface of the orifice of the left atrial appendage. Specifically, when the drill way rule of left auricle is flat, the wall in the drill way of left auricle is level and smooth, and at this moment, sealing 3 is the form of keeping flat, and sealing 3 only takes place along the deformation of axis L direction, can make sealing 3's surface with the wall in the drill way of left auricle is laminated mutually. When the surface of the orifice of the left auricle is irregular, the wall surface of the orifice of the left auricle is irregular, and thesealing part 3 has flexibility, so that thesealing part 3 can be irregularly deformed according to the shape of the wall surface of the orifice of the left auricle, for example, the sealingpart 3 is folded, so that the surface of the sealingpart 3 is attached to the wall surface of the orifice of the left auricle.

Furthermore, one or more layers of flow-blocking films are arranged on the inner wall or the outer surface of the sealingpart 3, so that when the sealingpart 3 is used for blocking the orifice of the left atrial appendage, the sealingpart 3 and the flow-blocking films can effectively block the orifice of the left atrial appendage.

The leftatrial appendage occluder 100 is formed into an integral structure by cutting from a piece of alloy tubing or sheet, preferably a shape memory alloy, including but not limited to nitinol, other nickel alloys. Anchoringportion 1,waist 2 and sealingportion 3 structure as an organic whole, need not to add connection structure and part in addition and just can reducesealing portion 3 and anchoringportion 1 interval by a wide margin, leftatrial appendage occluder 100 is fixed in the inner wall of left atrial appendage throughanchoring portion 1, in order to be fixed in the left atrial appendage, whenanchoring portion 1 is fixed in the inner wall of left atrial appendage, 1tractive sealing portion 3 of anchoring portion, so thatsealing portion 3 is extruded and the shutoff in the drill way department of left atrial appendage under the tractive force with the irregular form in left atrial appendage drill way, and then make left atrial appendage occluder 100 block in the left atrial appendage, improve leftatrial appendage occluder 100's sealed effect.

In the process of fixing the left atrial appendage occluder 100 to the left atrial appendage, if theanchoring portion 1 is located at a deeper position of the left atrial appendage, at this time, the pulling force of theanchoring portion 1 to thesealing portion 3 is large, which may cause thesealing portion 3 to excessively press the orifice of the left atrial appendage or theanchoring portion 1 to slide relative to the left atrial appendage under the action of thesealing portion 3 to scratch the inner wall of the left atrial appendage; if theanchoring part 1 is located at a shallow position of the left auricle, the pulling force of the anchoringpart 1 on the sealingpart 3 is small, which may cause the sealingpart 3 not to be tightly attached to the orifice of the left auricle; through setting up sealing 3 can take place to deform in axis L direction and make sealing 3's shape along with the shape in the drill way of left auricle and deformation because sealing 3 self compliance, whenanchor portion 1 is located the degree of depth of difference,anchor portion 1 is different to sealing 3's pulling force, sealing 3 can produce the deformation of different degrees to this different pulling force adaptively, so that sealing 3 all can seal up in the drill way of left auricle.

It should be noted that the leftatrial appendage occluder 100 provided by the present invention may be a skeleton formed by cutting a nitinol tube. In other words, theanchor portion 1, thewaist portion 2, theseal portion 3, and theconnector 4 are integrally formed. The method comprises the steps of processing meshes required by an anchoringpart 1, awaist part 2 and a sealingpart 3 from a nickel-titanium alloy pipe through a cutting process, pressing the pipe into the anchoringpart 1, thewaist part 2 and the sealingpart 3 with specific shapes through heat treatment, wherein the connectinghead 4 can be formed by not performing mesh treatment on one end of the nickel-titanium alloy pipe.

Compared with a left auricle occluder woven by metal wires, the anchoringpart 1, thewaist part 2, the sealingpart 3 and theconnector 4 of theleft auricle occluder 100 provided by the invention are naturally formed only by cutting once without any welding or bonding process, so that the fracture between the anchoringpart 1 and thewaist part 2, between the sealingpart 3 and thewaist part 2 and between the sealingpart 3 and theconnector 4 due to welding or bonding is effectively avoided, the sealingpart 3 of theleft auricle occluder 100 provided by the invention is more stable, the problem of degeneration of the framework of theleft auricle occluder 100 at high temperature is avoided, and the service life and the reliability of theleft auricle occluder 100 are improved; and the toughness in each region of leftatrial appendage occluder 100 is good, and theportion 1,waist 2, the sealing 3 of being convenient for anchor have good deformability to make the inner wall of the fixed left atrial appendage ofanchor portion 1 effectively, and make the sealing 3 seal the orifice department of left atrial appendage effectively, improve leftatrial appendage occluder 100's leakproofness, adherence, in order to avoid the shunt to omit after the art.

Compared with theleft auricle occluder 100 connected by other modes such as traditional threaded connection, insertion connection and the like, the integrally formed leftauricle occluder 100 provided by the invention has the advantages of simple structure, smooth lines, reduced possibility of blood retention and reduced risk of loosening and falling of parts after operation.

Referring to fig. 2 and 3, the anchoringportion 1 may be formed by arranging a plurality of anchoring repeatingunits 11 around the central axis L. Wherein theanchoring repeating unit 11 includes at least one anchoringsupport rod 111. The anchoringsupport rod 111 may be a piece of nitinol rod that is laser cut. The nickel-titanium alloy rod has certain bending deformation capacity. The plurality of anchor struts 111 may be parallel to each other or cross-linked to each other in a polygonal ring shape to form theanchor strut net 112. The shape of theanchor strut 111 includes, but is not limited to, linear, arcuate, wavy, and helical. The anchoringsupport network 112 includes, but is not limited to, one or more diamond, rhomboid, hexagonal structures. At least one anchoringsupport net 112 and at least one anchoringsupport bar 111 are connected to form ananchoring repeating unit 11.

Referring to fig. 2 and 3, thewaist portion 2 may be formed by a plurality ofwaist repeating units 21 arranged around the central axis L. Wherein thelumbar repeating unit 21 comprises at least onelumbar support bar 211 and/or at least one support ring. Thelumbar support rod 211 may be a nickel-titanium alloy rod formed by laser cutting. The nickel-titanium alloy rod has certain bending deformation capacity. Thelumbar support rod 211 may be connected to theanchor support rod 111 of theanchor unit 1. The plurality oflumbar support rods 211 may be parallel to each other or cross-linked to each other in a polygonal ring shape to form thelumbar repeating unit 21. The shape of thelumbar support rod 211 includes, but is not limited to, linear, arcuate, wavy, and spiral. Theanchor strut 111 may be linear or curved.

Referring to fig. 2 and 3, the sealingportion 3 may be formed by a plurality of sealing repeatingunits 31 arranged around the central axis L. Wherein thesealing repeating unit 31 includes at least one sealingsupport rod 311. The sealingsupport rod 311 may be a piece of nitinol rod formed by laser cutting. The nickel-titanium alloy rod has certain bending deformation capacity. Wherein the sealingsupport bar 311 is connected to thelumbar support bar 211 or the support ring. The shape of theseal support bar 311 includes, but is not limited to, linear, arcuate, wavy, and spiral. The plurality of sealing support bars 311 may be parallel to each other or cross-linked to each other in a polygonal ring shape to form at least one sealingsupport net 312. The sealingsupport mesh 312 includes, but is not limited to, one or more diamond, diamond-like, hexagonal structures. At least oneseal support net 312 and at least oneseal support rod 311 are connected to form aseal repeating unit 31.

Referring to fig. 2 and 3, the sealingportion 3 is constricted at a side facing away from the anchoringportion 1 to form aconnector 4, and theconnector 4 is formed by an unprocessed portion of the nitinol tube. Theconnector 4 is used to connect to a delivery device of the leftatrial appendage occluder 100 so that the leftatrial appendage occluder 100 can be delivered to a target site by the delivery device.

Referring to fig. 2 and 3, the anchoringsupport rod 111 of the anchoringportion 1, thelumbar support rod 211 of thelumbar portion 2, and the sealingsupport rod 311 of the sealingportion 3 are connected in sequence and integrally interconnected, and no joint exists between each two, and the two support rods are formed by cutting a nitinol tube by means of laser and the like, so that the connection strength and the smoothness of the leftatrial appendage occluder 100 are improved.

It can be understood that the leftatrial appendage occluder 100 can also be made of cobalt-chromium alloy, stainless steel and other metal materials. The leftatrial appendage occluder 100 can also be made of degradable materials, such as degradable metal materials, or degradable polymer materials, such as polylactic acid, polycaprolactone, polydioxanone, and the like.

It will be appreciated that the inner wall of theseal 3 is provided with one or more layers of a fluid barrier film. Although the sealingpart 3 is in a net shape, when the sealingpart 3 is sealed in the orifice of the left atrial appendage, the sealingpart 3 and the flow blocking membrane can be tightly sealed in the orifice of the left atrial appendage, so as to effectively prevent shunt leakage after operation.

In a possible embodiment, with reference to fig. 2 and 4, the radial dimension of the anchoringportion 1 is greater than the radial dimension of thewaist portion 2 and less than the radial dimension of the sealingportion 3. It is understood that the radial directions of the anchoringportion 1 and thewaist portion 2 are perpendicular to the central axis L in the present invention. For example, the H direction in fig. 2 is a radial direction of theanchor portion 1.

The radial dimension of thewaist part 2 is smaller than that of the anchoringpart 1 and that of the sealingpart 3, so that thewaist part 2 is easier to bend compared with the anchoringpart 1 and the sealingpart 3, the leftatrial appendage occluder 100 can enter left atrial appendages with different bending shapes, and the use environment of the leftatrial appendage occluder 100 is increased; radial dimension through setting upanchor portion 1 is less than the radial dimension of sealing 3, adapts to left auricle anatomical structure to when makinganchor portion 1 be fixed in the inner wall of left auricle, sealing 3 butt outside the drill way of left auricle, and then realize the effect in the drill way of sealed left auricle.

In a possible embodiment, with reference to fig. 2, the axial dimension of the anchoringportion 1 is greater than the axial dimension of the sealingportion 3.

Because left auricle duct is darker, through setting up the axial dimension of anchoringportion 1 is great relatively to make anchoringportion 1 can get into in the left auricle, and anchoringportion 1's outer peripheral face has sufficient area and laminates in the inner wall of left auricle, improve the fixed acting force between the outer peripheral face of anchoringportion 1 and the inner wall of left auricle, and sealingportion 3 only need radial surface can seal the drill way of left auricle, through setting up sealingportion 3's axial dimension is less relatively, can reduce sealingportion 3's axial dimension, and then the size of the sealingportion 3 who reduces.

In a possible embodiment, theanchoring repeating unit 11 comprises the anchoringsupport bar 111 or the anchoring support net 112 or a combination of the anchoringsupport bar 111 and anchoringsupport net 112.

Referring to fig. 3, 5 and 6, theanchoring repeating unit 11 includes the anchoringsupport rod 111 and the anchoringsupport net 112 extending from thewaist repeating unit 21 in sequence. Thesealing repeating unit 31 includes the sealingsupport rod 311 and the sealing support net 312 sequentially extended from the connectinghead 4.

In one embodiment, referring to fig. 3, the anchoringsupport network 112 may be different from the sealingsupport network 312. For example, the anchoringsupport mesh 112 is hexagonal and the sealingsupport mesh 312 is quadrilateral. The sealingsupport net 312 is easier to deform in the direction of the central axis L relative to the anchoringsupport net 112, so that the deformation capacity of thesealing repeating unit 31 in the direction of the central axis L is greater than that of theanchoring repeating unit 11 in the direction of the central axis L, and the sealingpart 3 can better block the orifice of the left atrial appendage. Of course, in other embodiments, the anchoringsupport network 112 may be identical to the sealingsupport network 312, e.g., both theanchoring support network 112 and the sealingsupport network 312 are quadrilateral.

In a possible embodiment, the deformation capability of the sealingportion 3 in the direction of the central axis L is greater than that of the anchoringportion 1 in the direction of the central axis L, so that the sealingportion 3 can be transformed from the strip shape in the contracted state to the flat shape in which the two ends in the expanded state are close to each other and the middle is convex, so that the sealingportion 3 can seal the orifice of the left atrial appendage. The deformability of sealingportion 3 in the radial direction is greater than the deformability of anchoringportion 1 in the radial direction to make sealingportion 3 can be from the cage structure of contraction state expansion that radial dimension is greater than the radial dimension of anchoringportion 1, and then can seal the drill way of left atrial appendage.

The following examples are specific structural examples of thewaist repeating unit 21, theanchoring repeating unit 11, and thesealing repeating unit 31, respectively, and it is understood that the examples of the present application include, but are not limited to, the following embodiments. By specifically illustrating thewaist repeating unit 21, theanchoring repeating unit 11, and thesealing repeating unit 31, one skilled in the art can form thewaist portion 2 by making a plurality ofwaist repeating units 21 surround the central axis L, form the anchoringportion 1 by making a plurality of anchoring repeatingunits 11 surround the central axis L, and form the sealingportion 3 by making a plurality of sealing repeatingunits 31 surround the central axis L. Further, thewaist repeating unit 21, theanchoring repeating unit 11, and thesealing repeating unit 31 exemplified in the following different embodiments may be combined with each other to form different leftatrial appendage occluders 100.

Waistrepetitive unit 21 connects between anchoringrepetitive unit 11 and sealedrepetitive unit 31, waistrepetitive unit 21 can take place deformation in radial and central axis L's direction, andwaist 2 can take place to buckle to make leftatrial appendage occluder 100 can take place to stretch out and draw back and take place to buckle in central axis L's direction, with the left atrial appendage that adapts to the different degree of depth or different degree of curvature, so that leftatrial appendage occluder 100 can be applied to in the left atrial appendage environment of more complicacy. The structure of thewaist repeating unit 21 is not particularly limited in the present application, and the non-repeating units provided in the examples of the present application include, but are not limited to, the following embodiments.

In a first possible embodiment, referring to fig. 6, thewaist 2 is formed by a plurality ofwaist repeating units 21 arranged axially around a central axis L of thewaist 2. Thelumbar repeating unit 21 includes 1 or morelumbar support rods 211 extending axially parallel or intersecting each other. The shape of thelumbar support rod 211 includes a straight rod shape, a wave shape, or a spiral shape, so that thelumbar portion 2 can be deformed in the radial and axial directions.

Specifically, referring to fig. 6, thelumbar repeating unit 21 may include a plurality oflumbar support rods 211 parallel to each other, so that thelumbar region 2 is formed by a plurality oflumbar support rods 211 parallel to each other around the central axis L. Whenwaist bracing piece 211 is straight rod-shaped,waist 2 can radially take place expansion or shrink deformation and bending deformation to make leftatrial appendage occluder 100 buckle, adapt to more complicated left atrial appendage environment. The support rods of thewaist repeating unit 21 extend along the central axis L. Both ends of the support rod of thewaist repeating unit 21 are connected to the support rod of the anchoringportion 1 and the support rod of the sealingportion 3, respectively. Thewaist 2 is a cylindrical structure formed by a plurality of parallelwaist support rods 211 arranged around the axial direction of the central axis L at equal intervals. The plurality of parallelwaist support rods 211 can be radially drawn together or scattered by taking the central axis L as the center and can also be bent, so that thewaist 2 has good radial deformation force, axial support force and bending capacity, and therefore, the waist support rods can adapt to irregular left auricles.

Specifically, thewaist repeating unit 21 may further include a plurality of wavywaist supporting bars 211 cross-linked with each other. Thelumbar support rod 211 may be annularly disposed around the central axis L, so that thelumbar region 2 is a mesh tube formed by a plurality of mutually cross-linkedlumbar support rods 211. Thewaist 2 can be along the axial deformation of stretching out and drawing back and buckle deformation to make leftatrial appendage occluder 100 can extend, shorten and buckle, adapt to more complicated left atrial appendage environment.

Specifically, thelumbar repeating unit 21 may further include a plurality of helicallumbar support rods 211 parallel to each other. Thewaist support rod 211 can be arranged around the central axis L, so that thewaist 2 is in a mesh shape formed by a plurality of mutually parallelwaist support rods 211, and further thewaist 2 can be subjected to telescopic deformation along the axial direction, torsional deformation and bending deformation along the axial direction, so that the leftatrial appendage occluder 100 can be extended, shortened, twisted and bent to adapt to a more complex left atrial appendage environment.

Of course, in other embodiments, the plurality oflumbar support rods 211 may have a wave shape parallel to each other, a straight rod shape cross-linked to each other, a spiral shape cross-linked to each other, or the like.

In a second possible embodiment, referring to fig. 7 and 8, when thelumbar repeating unit 21 includes a plurality of mutually parallel support rings 212, a plurality oflumbar support rods 211 are connected between two adjacent parallel support rings 212. The shape of thelumbar support rod 211 includes a straight rod shape, a wave shape or a spiral shape.

Specifically, referring to fig. 7 and 8, thelumbar region 2 further includes afirst connection ring 213, asecond connection ring 214, and a plurality oflumbar support rods 211 connected between thefirst connection ring 213 and thesecond connection ring 214. Thefirst connection ring 213 and thesecond connection ring 214 are connected to opposite ends of a support rod of thewaist repeating unit 21, respectively, to increase a supporting force of thewaist portion 2 to theanchor portion 1 and the sealingportion 3 on the central axis L. The plurality oflumbar support rods 211 are arranged in parallel and connected between thefirst connection ring 213 and thesecond connection ring 214 to increase the axial expansion and contraction deformation and bending deformation capability of the lumbar 2. Thewaist 2 structure has elasticity in the radial direction and the axial direction, and the direction and the distance between the anchoringpart 1 and the sealingpart 3 can be adjusted according to different forms of the left auricle in the process of implanting the left auricle, so that the waist can adapt to more left auricles with different forms, and the stable sealing effect can be achieved in the left auricle with a special form.

In this embodiment, the spring-like spiral cutting pattern capable of moving in all directions is formed between the two adjacent support rings 212 of thewaist portion 2, and this structure has the function of adjusting the orientation and distance between theanchor portion 1 and theseal portion 3 without using an additional connecting member, and can change the axial distance and the connection angle between theanchor portion 1 and theseal portion 3, and the integral structure of theanchor portion 1 and theseal portion 3 also improves the sealing effect.

Whenwaist 2 is the spiral cutting decorative pattern form, during a plurality of heliciformwaist bracing pieces 211 arrange around the axis and form cylinder appearance both ends parallel and level and insert thesupport ring 212, this structure all has elasticity in radial and axial, can adjust the direction and the interval ofanchor portion 1 and sealingportion 3 according to the different forms of left auricle at the in-process of implanting the left auricle, can adapt to the left auricle of more different forms, also can reach firm sealed effect in the more special left auricle of form.

Of course, in other embodiments, at least one third connection ring may be disposed between thefirst connection ring 213 and thesecond connection ring 214, and two adjacent connection rings may be connected by a plurality oflumbar support rods 211.

In a third possible embodiment, thelumbar repeating unit 21 comprises 1 or more axially extending arrangements of mutually parallel or intersecting support rings 212, such that thelumbar region 2 is a cylindrical nitinol tube. The shape of thesupport ring 212 may include a circle, an ellipse, a wave or a spiral to allow the deformation of thewaist 2 in the radial and axial directions.

Specifically, referring to fig. 9 to 11, thewaist repeating unit 21 may be a supportingring 212, and the supportingring 212 may extend along the axial direction and have a trapezoid shape. Thesupport ring 212 is formed by laser cutting a nitinol tube. Thesupport ring 212 may provide thelumbar repeating unit 21 with a good supporting force in the axial direction to enable a firm and strong connection between theanchor portion 1 and the sealingportion 3. Thesupport ring 212 keeps thewaist 2 radially unchanged, and the surface of the hollow cylinder which is not subjected to cutting treatment does not generate axial deformation and radial deformation, so that the support ring has good radial and axial supporting force and is suitable for being implanted into the shallow left atrial appendage.

In this embodiment, thewaist 2 may be a section of uncut nitinol tube, with both ends extending radially outward to form the sealingportion 3 and the anchoringportion 1.Sealing portion 3 in this embodiment is trapezoidal cage structure, compares first embodiment and can provide better sealing power, andwaist 2 is radial to keep unchangeable, and the surface does not do the hollow circular cylinder of cutting processing, does not produce axial deformation and radial deformation, has fine radial and axial holding power, is fit for implanting in the left atrial appendage of less shallow form.

It will be appreciated that the overall shape of thewaist 2 may be selected from irregular shapes such as cylindrical, diamond, spherical, or combinations thereof. The cut texture of thewaist 2 includes, but is not limited to, spiral, web, vertical stripe, cylindrical, etc. Wherein, thewaist 2 with the spiral texture ensures good bending flexibility and is suitable for the left atrial appendage with irregular shape. Thecylindrical waist 2 ensures that the axial supporting force is suitable for the regular left atrial appendage.

Anchoringportion 1 is fixed in the inner wall of left atrial appendage, anchoringportion 1 produces the pulling force to sealingportion 3 to make sealingportion 3 seal in the orifice department of left atrial appendage, in order to improve the degree of tightness of leftatrial appendage occluder 100. The structure of theanchor 1 is not particularly limited in the present application, and theanchor 1 provided in the examples of the present application includes, but is not limited to, the following embodiments.

In a first possible embodiment, referring to fig. 2 and 5, the anchoringportion 1 is formed by a plurality of anchoring repeatingunits 11 arranged around the axis L of thewaist portion 2. Theanchoring repeating unit 11 includes a plurality of the anchoringsupport rods 111 cross-linked with each other. The plurality of anchor struts 111 may be parallel to each other or cross-linked to each other in a polygonal ring shape to form theanchor strut net 112. Theanchoring repeating unit 11 includes at least an anchoringsupport rod 111 and an anchoringsupport net 112 extending from thewaist portion 2.

In particular, the anchoringsupport network 112 includes, but is not limited to, one or more diamond-shaped, diamond-like, hexagonal structures. So that anchoringportion 1 includes that at least one circle is by a plurality of rhombuses or similar rhombuses or hexagon be the support ring that the annular was arranged and is formed, so that anchoringportion 1 is difficult for taking place deformation in radial and axial, and then anchoringportion 1's outer peripheral face has certain support strength. When the support ring of the anchoringpart 1 abuts against the inner wall of the left auricle, radial deformation is not easy to occur, so that a larger abutting force can be provided, the support ring of the anchoringpart 1 is tightly attached to the inner wall of the left auricle, and the fixing stability of the anchoringpart 1 on the inner wall of the left auricle is further improved.

Further, the complexity of the polygonal structure of theanchor portion 1 may be greater than that of the sealingportion 3. For example, the polygonal structure of theanchor portion 1 is hexagonal, and the polygonal structure of the sealingportion 3 is rhombic or rhomboid, so that the support ring of theanchor portion 1 is not easy to deform radially relative to the support ring of the sealingportion 3, and thus theanchor portion 1 can provide a larger abutting force, and the polygonal structure of the sealingportion 3 has a stronger deformation capability, so that theanchor portion 1 has a better sealing performance at different depths.

Specifically, a circumferential radial dimension formed by the position where theanchoring repeating unit 11 abuts against the inner wall of the left atrial appendage around the central axis L is larger than radial dimensions of other positions of the anchoringportion 1. The region of theanchoring repeating unit 11 for abutting the inner wall of the left atrial appendage comprises at least the anchoringsupport net 112. The peripheral wall of the anchoringsupport net 112 is provided with at least one circle of anchoringthorns 117 for positioning. One end of theanchor spike 117 is fixed to theanchoring repeating unit 11. The other end of theanchor 117 gradually deviates from the central axis L and extends toward the sealingportion 3. When the leftatrial appendage occluder 100 occludes the left atrial appendage, the anchoring spikes 117 penetrate the inner wall of the left atrial appendage to stably fix the anchoringportion 1 to the inner wall of the left atrial appendage, thereby enabling the leftatrial appendage occluder 100 to be well fixed in the left atrial appendage. Furthermore, the outer periphery of theanchor 1, i.e. around eachanchor support rod 111, is provided with a coating, increasing the tightness against the left atrial appendage.

Specifically, the radial dimension of the support ring formed by the first anchoring support net around the central axis L is larger than the radial dimension of the structure formed by the other regions of the anchoringportion 1 around one circle, so that the support ring formed by the anchoringsupport net 112 around the central axis L can be tightly abutted against the inner wall of the left atrial appendage. The peripheral wall of the first anchoring and supporting net is circumferentially provided with at least one circle of anchoringthorns 117. Specifically, the anchoringsupport net 112 is provided with at least one circle of anchoringbarbs 117 along the circumferential direction around the support ring formed by the central axis L. When the supporting ring formed by the anchoring supporting net 112 around the central axis L can be tightly abutted to the inner wall of the left atrial appendage, at least one circle of anchoringthorns 117 can penetrate into the inner wall of the left atrial appendage, so that the anchoringportion 1 is stably fixed on the inner wall of the left atrial appendage, and further, a pulling force towards the inside of the left atrial appendage is generated for the sealingportion 3, so that the sealingportion 3 is tightly sealed in the orifice of the left atrial appendage.

Specifically, referring to fig. 2, 7 and 9, theanchoring repeating units 11 are arranged around the central axis L to form the anchoringportion 1 extending from one end of thewaist portion 2 away from the sealingportion 3 to form an inverted structure, an open structure or a closed structure.

In a first embodiment, referring to fig. 2 and 5, theanchoring repeating unit 11 is an inverted structure. Specifically, the anchoringportion 1 forms an inverted hemispherical structure, and the opening faces the proximal end a. Theanchoring repeating unit 11 includes a plurality of waist support bars 211 which are cut from the side of thewaist 2 remote from the sealingportion 3 and then radially reversely curled to form a cross-linked structure. Theanchoring repeating unit 11 gradually deviates from thewaist portion 2 and extends away from the sealingportion 3 first, and then is reversely close to the sealingportion 3 to form an overturned hemispherical structure. The extending end of theanchoring repeating unit 11 of the turning structure after forming the turned hemispherical structure extends reversely, and approaches to the sealingpart 3 towards thewaist part 2 to form a curled section with smaller curvature radius, and the curled section is used for preventing the leftatrial appendage occluder 100 from damaging the inner wall of the body cavity in the releasing process.

Specifically, referring to fig. 2 and 5, theanchor repeat unit 11 includes astart segment 114, amiddle segment 115, and anend segment 116.Anchor portion 1 extends towards the side of keeping away from sealing 3, and deviates fromanchor portion 1's axis gradually when extending, finally presents the appearance structure of the hemisphere of similar upset. This structure makes and has the guide effect when getting into left auricle at leftauricle plugging device 100, makes the entering leftauricle plugging device 100 that can be more smooth. The end of thestart segment 114 is bent toward theseal portion 3, extends in the axial direction gradually closer to theseal portion 3, and reaches themiddle segment 115, and themiddle segment 115 of theanchor repeating unit 11 is preferably formed in a rhombic or approximately rhombic, hexagonal, or other unit structure. The width of the anchoringsupport bar 111 in themiddle section 115 of theanchoring repeating unit 11 is in the range of 0.2-0.4 mm. The part of themiddle section 115 of theanchoring repeating unit 11, which is abutted against the inner wall of the left atrial appendage, is provided with an anchoringthorn 117 for positioning. Themiddle portion 115 of the intermediate segment of theanchoring repeating unit 11 is provided with a curled segment bent toward the axial direction and the distal end B direction up to the end. The crimped segment is theend segment 116 of the anchoringrepeat unit 11. The ends of the crimped segments of two adjacentanchoring repeating units 11 merge. This structure makes the plugging device can be fine fix in the left atrial appendage. The turning structure of the anchoringpart 1 enables the occluder to be more smoothly retracted out of the sheath, the tail end of the anchoringsupport rod 111 is provided with a curled section with smaller curvature radius, and the curled section can prevent the inner wall of the body cavity from being damaged in the releasing process to a certain extent.

By setting the anchoringportion 1 to be of a flip structure, the anchoringbarbs 117 do not scratch the inner wall of the left atrial appendage in the process of releasing the leftatrial appendage occluder 100 in the left atrial appendage. The leftatrial appendage occluder 100 of the embodiment can not only ensure the positioning function of the anchoringpart 1 in the left atrial appendage, but also greatly reduce the damage of the apparatus to the wall of the left atrial appendage and reduce the risk and complications of the operation.

In a second embodiment, referring to fig. 9, 10 and 11, theanchor portion 1 is an open structure. The anchoringportion 1 is formed by extending a plurality of anchoring repeatingunits 11 in a direction away from thewaist portion 2, and is axially arranged around the central axis L to form a cup-shaped structure with an opening facing the distal end B. Theanchoring repeating unit 11 is gradually deviated from the central axis L from thewaist portion 2 and away from the sealingportion 3 until a tip of the anchoringportion 1 is formed. The top end of the anchoringpart 1 of the open structure can be provided with a curled section to prevent the inner wall of the body cavity from being damaged in the releasing process.

Specifically, theanchor repeating unit 11 includes a plurality of anchor support bars 111 radially curled from one end of thewaist portion 2 away from the sealingportion 3 toward a direction away from the sealingportion 3 to be cross-linked with each other. Anchoringrepeat unit 11 includes abeginning segment 114, amiddle segment 115, and anend segment 116. Thestarting section 114 extends from thewaist 2 to the side far away from the sealingpart 3, and gradually deviates from the axis of the anchoringpart 1 while extending, the extending direction and the axis form an included angle of approximately 90 degrees, the extending direction of the middle section of theanchoring repeating unit 11 is parallel to the axis, the tail ends of theanchoring repeating unit 11 are gathered in pairs, and the intersection is smoothly processed. The middle section of theanchoring repeating unit 11 is preferably in a rhombic or approximately rhombic or hexagonal unit structure, and the width of the anchoringsupport bar 111 at themiddle section 115 of theanchoring repeating unit 11 is in the range of 0.2-0.4 mm. The part of themiddle section 115 of theanchoring repeating unit 11, which is attached to the inner wall of the left atrial appendage, is provided with an anchoringspike 117 for positioning, so that the leftatrial appendage occluder 100 can be well fixed in the left atrial appendage. This structure makes and has the guide effect when getting into left auricle at leftauricle plugging device 100, makes the entering leftauricle plugging device 100 that can be more smooth. The cup-like structure of the anchoringportion 1 enables the leftatrial appendage occluder 100 to be more smoothly withdrawn from the sheath.

In a third embodiment, referring to fig. 7 and 8, theanchor portion 1 is a closed structure. Theanchor portion 1 is of a closed type without an opening. Theanchor portion 1 may be formed integrally with theseal portion 3 and thewaist portion 2 into a double-disk structure. Theanchoring repeating unit 11 gradually extends away from the sealingportion 3 from thewaist portion 2, gradually deviates from the central axis L and then gradually approaches the central axis L until the top end of the anchoringportion 1 is formed.

Specifically, the anchoringportion 1 is formed by a plurality of anchoring repeatingunits 11 extending from the distal end of thewaist portion 2 to a direction away from the sealingportion 3 and including at least one rhomboid structure, and the anchoring repeating units are axially arranged around the central axis L of thewaist portion 2 for one circle. The distal end of the anchoringportion 1 converges to a cage-like structure formed by a closed loop. The first support of theanchoring repeating unit 11 has a rod width in the range of 0.2 to 0.4 mm. The part that anchorportion 1 and left auricle inner wall pasted is equipped with theanchor thorn 117 that is used for the location, and this structure makes the plugging device can be fine fix in the left auricle.

In a fourth embodiment, please refer to fig. 12, theanchor portion 1 is a closed structure. Anchoringrepetitive unit 11 certainlywaist 2 is kept away from gradually sealingportion 3 extends, deviates gradually earlier axis L is close to gradually again axis L keeps away from sealingportion 3 extends the secondary and deviates axis L is close to gradually again axis L keeps away from again until forming the top of anchoringportion 1. The ends of all the anchoringsupport rods 111 of theanchoring repeating unit 11 are folded at the top end to form a bundling head, forming a cage-shaped closed structure or a dumbbell-shaped closed structure.

Specifically, the present embodiment is substantially the same in structure as theanchor 1 of the third embodiment, and differs mainly in that theanchor repeating unit 11 of theanchor 1 has two radians, and the radian at the proximal end a is not smaller than the radian at the distal end B. Around 2 axis L axial arrangement in waist backanchor portion 1 presents calabash form appearance, is equipped withround anchor thorn 117 in great radian periphery. Compared with the third embodiment, the structure has the gourd-shapedanchoring part 1, can enter the left atrial appendage more deeply, is more stable in anchoring, and is suitable for the left atrial appendage structure with longer depth.

It is understood that theanchor portion 1 is smoothly processed at the tissue contact portion in the present invention to prevent secondary damage to the body tissue.

In the invention, the sealingpart 3 is plugged at the orifice of the left auricle to improve the sealing degree of the leftauricle plugging device 100 and reduce the problems of shunt omission and the like after the operation. The structure of the sealingportion 3 is not particularly limited in the present application, and the sealingportion 3 provided in the examples of the present application includes, but is not limited to, the following embodiments.

In a possible embodiment, referring to fig. 2, 3 and 6, the sealingportion 3 is a double-layer mesh tube structure in the axial direction. The inner wall of the sealingpart 3 is provided with one or more layers of flow-blocking films, so that when the sealingpart 3 blocks the orifice of the left auricle, the sealingpart 3 and the flow-blocking films can effectively block the orifice of the left auricle. The sealingportion 3 includes aconnection head 4. Theconnector 4 is located and keeps away from the axis L position on the top ofanchor portion 1.

Specifically, the sealingportion 3 is formed by a plurality of sealing repeatingunits 31 extending from thewaist portion 2 in a direction away from theanchor portion 1 and arranged around the central axis L in an axial direction for a circle, and the proximal end a of the sealingportion 3 converges to the cage-shaped structure formed by theconnector 4. Thesealing repeating unit 31 includes a plurality of the sealing support bars 311 cross-linked with each other. The plurality of mutually cross-linked support bars form at least a sealingsupport bar 311 and a sealingsupport net 312 extending from the connectinghead 4. It is understood that thesealing repeating unit 31 may include a plurality of the sealingsupport rods 311; alternatively, thesealing repeating unit 31 may include a plurality of the sealingsupport nets 312; alternatively, thesealing repeating unit 31 may further include a combination of a plurality of the sealing support bars 311 and a sealingsupport net 312.

Further, the sealingsupport mesh 312 includes one or more diamond-shaped, diamond-like, hexagonal structures. When the sealingportion 3 is elastically deformed, the sealingsupport net 312 is bent, and the sealingportion 3 can be ensured to have good bending toughness by the structure of the sealing support net with a plurality of rhombuses and similar rhombuses, so that the sealingportion 3 has strong elastic deformation capability, and the sealingportion 3 also has good elastic recovery capability.

Specifically, theseal repeating unit 31 gradually deviates from thewaist portion 2 to the central axis L and is away from the anchoringportion 1, and deviates to a point that the radial length of the sealingportion 3 is greater than that of the anchoringportion 1, and then gradually approaches to the central axis L and continues to be away from the anchoringportion 1 until the ends of all theseal support rods 311 are folded to form the top end of the sealingportion 3. One end of aconnector 4 of the sealingpart 3 is connected with the top end of the sealingpart 3, and the other end of theconnector 4 is used for being connected with a conveying appliance to form a cage-shaped double-layer net pipe structure.

For example, referring to fig. 7, the sealingportion 3 includes a plurality of sealingsupport rods 311 that are cut from a side of thewaist portion 2 away from the anchoringportion 1 and then curled toward the direction of the central axis L by radiation to form a cross-linked structure. The plurality ofseal support rods 311 radially extend from thewaist portion 2 toward a side away from theanchor portion 1. The radial length of the radial extension of the plurality of sealingsupport rods 311 is greater than the radial length of the anchoringpart 1, and then the radial length and the axial direction are extended and symmetrically folded, finally the sealing support rods are in a flat cage-shaped appearance structure, and the tail end of the sealingpart 3 is curled towards the proximal end A by 90 degrees and extends to form aconnector 4. In the extending process, the sealingsupport rods 311 extend to theend connectors 4 in a hexagonal adjacent manner, and the width of the sealingsupport rods 311 is in the range of 0.1-0.2 mm. The sealing support bars 311 are thinner in width than the anchoring support bars 111 of theanchoring repeating unit 11, and the number of the sealing support bars 311 is greater than the number of the anchoring support bars 111 of theanchoring repeating unit 11. Therefore, theseal support net 312 of theseal repeating unit 31 is finer, higher in softness, and higher in deformability than theanchor support net 112 of theanchor repeating unit 11, and improves the sealing performance of theseal portion 3.

For another example, referring to fig. 9, the sealingportion 3 includes a plurality of sealingsupport rods 311 that are cut from a side of thewaist portion 2 away from the anchoringportion 1 and then radially curled toward the direction of the central axis L to form a cross-linked structure. Many sealed bracingpieces 311 begin to extend towards one side radiation of keeping away fromanchor portion 1 fromwaist 2, extending direction and axis L contained angle are close to 90, extend a section distance after change direction, be less than 45 with the axis contained angle and continue to extend more than 0, demonstrate trapezoidal appearance after, sealed bracingpiece 311 extends with axis L vertically direction towards well axis L and assembles, finally present for trapezoidal cage-shaped structure, turn over after end towards far away heart B invagination and be close to 90 curls and extend towards heart A andform connector 4. The supporting rods extend to theend connectors 4 in a hexagonal adjacent mode in the extending process, the width range of the supporting rods is 0.1-0.2 mm, and the supporting rods are thinner than the supporting rods of theanchoring repeating units 11 and are more in number. Therefore, the diamond-like structure of thesealing repeating unit 31 is finer, more flexible and stronger in deformation capability than theanchoring repeating unit 11. The sealing performance of theseal portion 3 is improved.

Compared with theanchoring repeating unit 11 of the anchoringpart 1, thesealing repeating unit 31 of the sealingpart 3 in the embodiment has the advantages that the thickness and thickness of the supporting rods and the size and number of the supporting grids are designed, so that the sealingpart 3 has stronger deformation capacity in the axial direction and the radial direction than the anchoringpart 1, and the sealing effect of the anchoringpart 1 and the sealingpart 3 which are matched with each other in the left auricle after theleft auricle occluder 100 is implanted is facilitated to be better. Because, fix the back in the left auricle at the release of anchoringportion 1, anchoringportion 1 can produce the pulling force effect to sealing 3, and sealing 3 needs to deal with the pulling force and produces elastic deformation and become the laminating left auricle drill way of flat form, and then realizes the purpose in sealed left auricle drill way.

In the prior art, the connecting portions of the sealingportion 3 and the anchoringportion 1 are generally aligned with each other, and then directly abut against and are fixed or are aligned and fixed through a connecting piece, so that the structure can cause the plugging device to be overlong in axial length on the whole, and sealing is not facilitated. Therefore, theintegrated waist part 2 provided by the invention is simplified in process and structure, only oneconnector 4 for connecting a conveyer is arranged at the proximal end A of the instrument, and the risks of loosening and falling off of parts are not easy to occur after operation.

It will be appreciated that the overall shape of theseal portion 3 includes, but is not limited to, a cage, a trapezoid, a disc, a sphere, etc.

Referring to fig. 13, an embodiment of the present invention further provides a leftatrial appendage occluder 100, which is different from the leftatrial appendage occluder 100 provided in fig. 7 in that the radial dimension of thewaist portion 2 is similar to the radial dimension of the anchoringportion 1, and is suitable for plugging a shallower left atrial appendage.

Referring to fig. 14, the embodiment of the present invention further provides a leftatrial appendage occluder 100, in which the radial dimension of thewaist portion 2 is similar to the radial dimension of the anchoringportion 1, and the radial dimension of the sealingportion 3 is slightly larger than the radial dimension of the anchoringportion 1, as compared to the leftatrial appendage occluder 100 provided in fig. 7. The sealingpart 3 is trapezoidal, the small-size end of the sealingpart 3 is connected with thewaist part 2, and the large-size end of the sealingpart 3 is close to the connectinghead 4. The small dimension end of the sealingportion 3 is at least partially located in the left atrial appendage and the large dimension end of the sealingportion 3 seals off the orifice located in the left atrial appendage. Theanchor 117 is provided on the outer peripheral wall of the small-sized end of theseal portion 3. When the small-size end of the sealingpart 3 is at least partially positioned in the left atrial appendage, theanchor 117 is fixed on the inner wall of the left atrial appendage, and the large-size end of the sealingpart 3 tightly seals the orifice of the left atrial appendage, so that the sealing part is suitable for sealing the shallower left atrial appendage. The inner wall of the sealingpart 3 is provided with one or more layers of flow-blocking films, so that when the sealingpart 3 blocks the orifice of the left auricle, the sealingpart 3 and the flow-blocking films can effectively block the orifice of the left auricle.

While the foregoing is directed to embodiments of the present invention, it will be appreciated by those skilled in the art that various changes may be made in the embodiments without departing from the principles of the invention, and that such changes and modifications are intended to be included within the scope of the invention.

Claims (17)

Translated fromChinese

1.一种左心耳封堵器，其特征在于，包括一个通过切割形成的骨架，所述骨架具有中轴线，所述骨架包括依次连接的锚定部、腰部及密封部；1. A left atrial appendage occluder, characterized in that it comprises a skeleton formed by cutting, the skeleton has a central axis, and the skeleton comprises an anchor portion, a waist portion and a sealing portion connected in sequence;所述锚定部包括围绕所述中轴线排布一周的多个锚定重复单元，所述锚定重复单元包括至少一个锚定支撑杆；The anchoring portion includes a plurality of anchoring repeating units arranged around the central axis, the anchoring repeating units including at least one anchoring support rod;所述腰部包括围绕所述中轴线排布一周的多个腰部重复单元，所述腰部重复单元包括至少一个腰部支撑杆和/或至少一个支撑环；The waist includes a plurality of waist repeating units arranged around the central axis, the waist repeating units including at least one waist support rod and/or at least one support ring;所述密封部包括围绕所述中轴线排布一周的多个密封重复单元，所述密封重复单元包括至少一个密封支撑杆；The sealing portion includes a plurality of sealing repeating units arranged around the central axis, the sealing repeating units including at least one sealing support rod;当所述左心耳封堵器封堵左心耳时，所述锚定部位于所述左心耳内且固定于所述左心耳内壁，所述密封部产生形变，以使所述密封部能够与所述左心耳的孔口的壁面相贴合，进而封堵所述左心耳的孔口。When the left atrial appendage occluder occludes the left atrial appendage, the anchoring portion is located in the left atrial appendage and is fixed to the inner wall of the left atrial appendage, and the sealing portion is deformed, so that the sealing portion can be connected with the left atrial appendage. The wall surfaces of the orifice of the left atrial appendage are in contact with each other, thereby blocking the orifice of the left atrial appendage.2.如权利要求1所述的左心耳封堵器，其特征在于，所述锚定部的径向尺寸大于所述腰部的径向尺寸且小于所述密封部的径向尺寸。2 . The left atrial appendage occluder according to claim 1 , wherein the radial dimension of the anchor portion is larger than the radial dimension of the waist portion and smaller than the radial dimension of the sealing portion. 3 .3.如权利要求1所述的左心耳封堵器，其特征在于，所述锚定部的轴向尺寸大于所述密封部的轴向尺寸。3 . The left atrial appendage occluder according to claim 1 , wherein the axial dimension of the anchoring portion is larger than the axial dimension of the sealing portion. 4 .4.如权利要求1所述的左心耳封堵器，其特征在于，所述锚定重复单元包括多个相互交联的所述锚定支撑杆，以形成至少一个锚定支撑网，所述锚定支撑网包括一个或多个菱形、类菱形、六边形结构；所述密封重复单元包括多个相互交联的所述密封支撑杆，以形成至少一个密封支撑网，所述密封支撑网包括一个或多个菱形、类菱形、六边形结构。4. The left atrial appendage occluder of claim 1, wherein the anchor repeating unit comprises a plurality of the anchor support rods cross-linked to each other to form at least one anchor support mesh, the anchor support The anchoring support mesh includes one or more rhombus, rhombus-like, hexagonal structures; the seal repeating unit includes a plurality of the seal support rods cross-linked to each other to form at least one seal support mesh, the seal support mesh Including one or more rhombus, rhombus-like, hexagonal structures.5.如权利要求1所述的左心耳封堵器，其特征在于，所述密封部在所述中轴线方向上的形变能力大于所述锚定部在所述中轴线方向上的形变能力；所述密封部在径向方向上的形变能力大于所述锚定部在径向方向上的形变能力。5. The left atrial appendage occluder according to claim 1, wherein the deformation capacity of the sealing portion in the direction of the central axis is greater than the deformation capacity of the anchor portion in the direction of the central axis; The deformation capacity of the sealing portion in the radial direction is greater than the deformation capacity of the anchor portion in the radial direction.6.如权利要求1所述的左心耳封堵器，其特征在于，所述腰部重复单元包括一个或多个相互平行或相交的腰部支撑杆轴向延伸排列，所述腰部支撑杆的形状包括直杆状、波浪状或螺旋状，以使所述腰部能够在径向和轴向发生形变。6 . The left atrial appendage occluder according to claim 1 , wherein the lumbar repeating unit comprises one or more lumbar support rods that are parallel or intersecting with each other in an axially extending arrangement, and the shape of the lumbar support rods includes: 7 . Straight rod, wavy or helical shape, so that the waist can be deformed radially and axially.7.如权利要求1所述的左心耳封堵器，其特征在于，所述腰部重复单元包括一个或多个相互平行或相交的支撑环轴向延伸排列，所述支撑环的形状包括圆形、椭圆形、波浪状或螺旋状，以使所述腰部能够在径向和轴向发生形变。7 . The left atrial appendage occluder according to claim 1 , wherein the waist repeating unit comprises one or more mutually parallel or intersecting support rings arranged in an axially extending manner, and the shape of the support rings includes a circular shape. 8 . , elliptical, wavy or helical, so that the waist can be deformed radially and axially.8.如权利要求7所述的左心耳封堵器，其特征在于，当所述腰部重复单元包括多个相互平行的支撑环时，相邻的两个平行的支撑环之间连接有一个或多个腰部支撑杆，所述腰部支撑杆的形状包括直杆状、波浪状或螺旋状。8 . The left atrial appendage occluder according to claim 7 , wherein when the waist repeating unit includes a plurality of mutually parallel support rings, one or two adjacent parallel support rings are connected between them. 9 . A plurality of lumbar support rods, the shapes of the lumbar support rods include straight rod shape, wave shape or spiral shape.9.如权利要求1所述的左心耳封堵器，其特征在于，所述锚定重复单元包括所述锚定支撑杆；或者，所述锚定重复单元包括所述锚定支撑网；或者，所述锚定重复单元包括所述锚定支撑杆和锚定支撑网的组合。9. The left atrial appendage occluder of claim 1, wherein the anchoring repeating unit comprises the anchoring support rod; or the anchoring repeating unit comprises the anchoring support mesh; or , the anchoring repeating unit includes the combination of the anchoring support rod and the anchoring support mesh.10.如权利要求9所述的左心耳封堵器，其特征在于，所述锚定重复单元围绕所述中轴线排布一周从所述腰部的远离密封部的一端延伸形成翻转结构、开放结构或封闭结构的锚定部。10 . The left atrial appendage occluder according to claim 9 , wherein the anchor repeating units are arranged around the central axis and extend from the end of the waist away from the sealing portion to form an inverted structure and an open structure. 11 . or the anchoring part of the closed structure.11.如权利要求9所述的左心耳封堵器，其特征在于，所述锚定重复单元与左心耳内壁抵接的位置围绕中轴线所形成的一周径向尺寸大于所述锚定部的其他位置的径向尺寸，所述锚定重复单元用于抵接所述左心耳内壁的区域至少包括所述锚定支撑网；所述锚定支撑网的外周壁周向设置至少一圈锚刺；所述锚刺的一端固定于所述锚定重复单元，所述锚刺的另一端逐渐偏离所述中轴线且朝向所述密封部延伸。11 . The left atrial appendage occluder according to claim 9 , wherein the circumferential radial dimension formed by the position where the anchor repeating unit abuts against the inner wall of the left atrial appendage around the central axis is larger than the diameter of the anchoring portion. 12 . The radial dimension of other positions, the area where the anchor repeating unit is used to abut the inner wall of the left atrial appendage at least includes the anchor support mesh; the outer peripheral wall of the anchor support mesh is circumferentially provided with at least one ring of anchoring spines ; One end of the anchor thorn is fixed on the anchor repeating unit, and the other end of the anchor thorn gradually deviates from the central axis and extends toward the sealing portion.12.如权利要求10所述的左心耳封堵器，其特征在于，所述翻转结构的锚定重复单元自所述腰部逐渐偏离所述中轴线延伸先远离所述密封部，再反向靠近所述密封部形成翻转的半球状结构。12 . The left atrial appendage occluder according to claim 10 , wherein the anchor repeating unit of the inverted structure gradually deviates from the central axis from the waist and extends away from the sealing part first, and then approaches in the opposite direction. 13 . The sealing portion forms an inverted hemispherical structure.13.如权利要求12所述的左心耳封堵器，其特征在于，所述翻转结构的锚定重复单元在形成翻转的半球状结构后的延伸末端反向延伸，朝向所述腰部向所述密封部靠近，形成卷曲段，所述卷曲段用于防止所述左心耳封堵器在释放过程中损伤体腔内壁。13 . The left atrial appendage occluder according to claim 12 , wherein the extension end of the anchor repeating unit of the inversion structure after forming the inversion hemispherical structure is reversely extended, toward the waist toward the waist. 14 . The sealing parts are close to form a crimped section, and the crimped section is used to prevent the left atrial appendage occluder from damaging the inner wall of the body cavity during the release process.14.如权利要求10所述的左心耳封堵器，其特征在于，所述开放结构的锚定重复单元自所述腰部逐渐偏离所述中轴线并远离所述密封部，直至形成所述锚定部的顶端。14 . The left atrial appendage occluder according to claim 10 , wherein the anchor repeating unit of the open structure is gradually deviated from the central axis and away from the sealing portion from the waist until the anchor is formed. 15 . the top of the fixed part.15.如权利要求10所述的左心耳封堵器，其特征在于，所述封闭结构的锚定重复单元自所述腰部逐渐远离所述密封部延伸，先逐渐偏离所述中轴线再逐渐靠近所述中轴线，直至形成所述锚定部的顶端；或者继续远离所述密封部延伸二次偏离所述中轴线再二次逐渐靠近所述中轴线，直至形成所述锚定部的顶端；所述锚定重复单元的所有锚定支撑杆的末端在所述顶端收拢并形成收束头，形成笼状的封闭结构或者哑铃状的封闭结构。15 . The left atrial appendage occluder according to claim 10 , wherein the anchoring repeating unit of the closed structure gradually extends away from the sealing portion from the waist, first gradually deviates from the central axis, and then gradually approaches. 16 . the central axis until the top end of the anchoring portion is formed; or continue to extend away from the sealing portion twice to deviate from the central axis and then gradually approach the central axis for a second time until the top end of the anchoring portion is formed; The ends of all anchoring support rods of the anchoring repeating unit are gathered at the top end to form a cinch head, forming a cage-like closed structure or a dumbbell-like closed structure.16.如权利要求1所述的左心耳封堵器，其特征在于，所述密封重复单元包括所述密封支撑杆；或者，所述密封重复单元包括所述密封支撑网；或者，所述密封重复单元包括所述密封支撑杆和密封支撑网的组合。16. The left atrial appendage occluder according to claim 1, wherein the sealing repeating unit comprises the sealing support rod; or, the sealing repeating unit comprises the sealing support net; or, the sealing The repeating unit includes the combination of the seal support rod and seal support mesh.17.如权利要求15所述的左心耳封堵器，其特征在于，所述密封重复单元自所述腰部逐渐偏离所述中轴线并远离所述锚定部，偏离至所述密封部的径向长度大于所述锚定部的径向长度再逐渐靠近中轴线并继续远离所述锚定部，直至所有所述密封支撑杆的末端收拢形成所述密封部的顶端；所述密封部的连接头一端连接所述密封部的顶端，所述连接头的另一端用于与输送器械连接，形成笼状的双层网管结构。17 . The left atrial appendage occluder according to claim 15 , wherein the sealing repeating unit gradually deviates from the central axis from the waist and away from the anchoring part, and deviates to the diameter of the sealing part. 18 . The length is greater than the radial length of the anchoring portion, and then gradually approach the central axis and continue to be away from the anchoring portion, until the ends of all the sealing support rods are gathered together to form the top end of the sealing portion; the connection of the sealing portion One end of the head is connected to the top end of the sealing part, and the other end of the connecting head is used for connecting with the conveying device to form a cage-like double-layer network tube structure.

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