Background technique
Auricular fibrillation (atrial fibrillation) is the clinically most common perpetual arrhythmia, and atrial fibrillation disease incidence is in general population
0.5%~1.3%.The most important harm of atrial fibrillation is to promote thrombosis, is easy to cause cerebral apoplexy, peripheral blood vessel after thrombus breaks loose
The complication such as embolism, dramatically increase disability rate and lethality.Cerebral apoplexy is that atrial fibrillation is most common, endangers maximum complication, the world
There are about 15,000,000 people to suffer from cerebral apoplexy every year in range, wherein 20%~25% is attributed to atrial fibrillation.The rheumatism of studies have shown that 60%
Property the cardiogenic thrombus of heart disease patients with atrial fibrillation come from left auricle of heart, 90% or more thrombosis Yu Zuoxin in Non-valvular disease patients with atrial fibrillation
Ear.Therefore, intervene left auricle of heart and prevent patients with atrial fibrillation thromboembolism, especially stroke, with important theoretical foundation and clinical meaning
Justice.
Anticoagulant therapy is currently the standard method for preventing atrial fibrillation stroke complication, but anticoagulant therapy has certain limitation.
Therefore it is of great significance using more efficient safe measure prevention atrial fibrillation stroke.It mostly uses at present and utilizes interventional therapy
The method for occluding left auricle of heart.Common occluder for left auricle have using WATCHMAN as plunger type plugging device in the monomer of representative and with
AMPLATZER Cardiac Plug (ACP) is the plug disc type occluder for left auricle of representative.
1, the defect and deficiency of interior plunger type occluder for left auricle
Interior plunger type occluder for left auricle is the frame using Nitinol as self-expanding structure, around there is fixed barb, the heart
Room face is covered by polytetrafluoroethylstephanoporate stephanoporate permeable membrane, and blood flow can pass in and out left auricle of heart.
When the instrument fills in left auricle of heart, due to left auricle of heart oral area shape very irregular, and the deformability of the instrument has
Limit, cannot block left auricle of heart oral area completely, it is difficult to which elimination causes left auricle of heart portion to form thrombus due to atrial fibrillation.The structure of left auricle of heart
Different, varying depth, there are also multi-cavity structure, interior plunger type occluder for left auricle cannot adapt to the solution of all left auricle of hearts completely
Structure is cutd open, while cannot achieve stable fixation.
2, the defect and deficiency of dish-type occluder for left auricle are filled in
Filling in dish-type plugging device is a kind of double dish sample left atrial appendage occlusion devices, by the butterfly blade and butterfly cap that are placed in left auricle of heart
It forms, is connected among the two by the waist being recessed, butterfly blade, which is placed in left auricle of heart, prevents plugging device from shifting, and butterfly cap seals the left heart
Ear oral area.
Filling in disc type occluder for left auricle is to block disk and fixed disk one, cannot completely independent be deformed, when plug is filled in
After left auricle of heart, when disc part is buckled in the oral area of left auricle of heart, the drawing of plug portion will receive, prevent disc part is from abundant
It is fitted in the oral area of left auricle of heart, is extremely difficult to optimal plugging effect.Since the length adjustment of plug portion and disc part has
Limit is difficult to realize best fixation and bloodstream blocking, while dish structure and being not suitable with different left auricle of heart cavity shapes.
In short, plunger type or plug dish-type occluder for left auricle in either, for different, varying depth the left heart
Ear has certain defect and deficiency, existing in the prior art to solve it is therefore necessary to further investigate in plugging device configuration aspects
Defect and shortcoming.
Summary of the invention
The purpose of the present invention is to provide a kind of occluder for left auricle, to solve existing occluder for left auricle for shape
The not strong problem of the adaptability of different, varying depth left auricle of heart.
In order to solve the above technical problems, the present invention provides a kind of occluder for left auricle, the occluder for left auricle includes: envelope
Stifled disk, fixed disk and attachment device, wherein
The closure disk is to block left auricle of heart;
The fixed disk has the occluder for left auricle to be fixed on the left auricle of heart in the fixed disk
Hook;
The attachment device connects the closure disk and the fixed disk, and the attachment device includes detachable adjusting knot
Structure, the detachable adjustment structure include the first component and the second component that separates or close with the first component, institute
Stating the first component and the second component can do relative motion, and the first component is connect with the closure disk, and described second
Component is connect with the fixed disk.
Optionally, in the occluder for left auricle, the diameter of the fixed disk is less than the diameter for blocking disk.
Optionally, in the occluder for left auricle, the barb is flexible barb.
Optionally, in the occluder for left auricle, the quantity of the barb be it is multiple, multiple barbs are uniformly distributed in
The periphery of the fixed disk.
Optionally, in the occluder for left auricle, the closure disk includes the first frame and is covered on described first
The first permeable membrane on frame;The fixed disk includes the second frame and the second permeable membrane for being covered on second frame.
Optionally, in the occluder for left auricle, the material of first frame and the second frame is that NiTi closes
Gold;The material of first permeable membrane and the second permeable membrane is high molecular material.
Optionally, in the occluder for left auricle, the attachment device further includes an at least flexible connector, described
The first component is connect by the flexible connector with the closure disk.
Optionally, in the occluder for left auricle, the attachment device further includes connection fixture, and the connection is solid
The one end for determining part is connect with one end of the flexible connector, the other end of the connection fixture and the detachable adjusting
Structure connection.
Optionally, in the occluder for left auricle, the flexible connector includes multiple helical springs, the multiple
The both ends of helical spring are separately connected one first plate and the second plate.
Optionally, in the occluder for left auricle, the detachable adjustment structure is screw nut structure, outer flower
Key internal spline structure or buckle structure.
In occluder for left auricle provided by the invention, pass through the first component and second component in detachable adjustment structure
Between relative motion depth/length adjusting for occluder for left auricle may be implemented, to adapt to a left side for varying depth
Auricle;Further, it can be split between the detachable adjustment structure and fixed disk, to face shape, different sizes
Left auricle of heart, the detachable adjustment structure can choose the various sizes of fixed disk of connection, to adapt to a different left side
Auricle;It further, include a flexible connector between the detachable adjustment structure and fixed disk, for adapting to difference
Left auricle of heart cavity shape, allow to block when disk and fixed disk are implanted left atrial appendage and completely independent deform, reach most
Good plugging effect.
Specific embodiment
Occluder for left auricle proposed by the present invention is described in further detail below in conjunction with the drawings and specific embodiments.Root
According to following explanation and claims, advantages and features of the invention will be become apparent from.It should be noted that attached drawing be all made of it is very simple
The form of change and use non-accurate ratio, only for the purpose of facilitating and clarifying the purpose of the embodiments of the invention.Especially
, since each attached drawing wants content outstanding different, often use different ratios.
" proximal end " and " distal end " is from using doctor's angle of the medical instrument to carry out read fortune for mutual element herein
Or movement relative bearing, relative position, direction, although " proximal end " and " distal end " be not be it is restrictive, " proximal end " lead to
Often refer to one end of the Medical Devices close doctor in course of normal operation, and " distal end " typically refers to initially enter patient's body
One end.
As used in the specification and the appended claims, singular "a", "an" and "the" includes
Plural reference, in addition in addition non-content explicitly points out.As used in the specification and the appended claims, term "or"
Usually carried out with including the meaning of "and/or" using, in addition in addition non-content explicitly points out.
[embodiment one]
Please refer to Fig. 1 and Fig. 2, wherein Fig. 1 is the structural schematic diagram of the occluder for left auricle of the embodiment of the present invention one;Fig. 2
For the enlarged diagram of part-structure in occluder for left auricle shown in FIG. 1.As depicted in figs. 1 and 2, the occluder for left auricle
1 includes: to block disk 10, fixed disk 11 and attachment device 12, wherein the closure disk 10 is to block left auricle of heart;It is described solid
Price fixing 11 has barb 110 occluder for left auricle 1 to be fixed on the left auricle of heart in the fixed disk 11;Institute
It states attachment device 12 and connects the closure disk 10 and the fixed disk 11, the attachment device 12 includes detachable adjustment structure
120, the detachable adjustment structure 120 includes the first component 1200 and can separate or close with the first component 1200
The second component 1201 risen, the first component 1200 and the second component 1201 can do relative motion, and described first
Part 1200 is connect with the closure disk 10, and the second component 1201 is connect with the fixed disk 11.
In the embodiment of the present application, pass through the first component 1200 and second component 1201 in detachable adjustment structure 120
Between relative motion depth/length adjusting for occluder for left auricle 1 may be implemented, to adapt to a left side for varying depth
Auricle;Further, it can be split between the detachable adjustment structure 120 and fixed disk 11, to face shape, size
Different left auricle of heart, the detachable adjustment structure 120 can choose the various sizes of fixed disk 11 of connection, to adapt to shape
Different left auricle of heart.
Preferably, the closure disk 10 and fixed disk 11 are dish structure, the attachment device 12 with the closure
The connection of the center of disk and fixed disk 11.Dish structure has preferable stability;Meanwhile the attachment device 12 is and institute
The center connection for stating closure disk and fixed disk 11 can guarantee that the occluder for left auricle 1 has splendid symmetrical configuration
Property, consequently facilitating the release and recycling of the occluder for left auricle 1.
Fig. 3 a to Fig. 3 c is please referred to, is the structural schematic diagram of the various sizes of fixed disk of the embodiment of the present invention one.Such as
Shown in Fig. 3 a to Fig. 3 c, here it is shown that the fixed disk 11 that three diameters are different, for example, the diameter of fixed disk 11 shown in Fig. 3 a
For 10mm, the diameter of fixed disk 11 shown in Fig. 3 b is 12mm, and the diameter of fixed disk 11 shown in Fig. 3 c is 15mm.Thus it faces
The left auricle of heart of different shapes and sizes can select a adaptable fixed disk 11, to well adapt to shape, size not
Same left auricle of heart, reaches optimal fixed effect.Further, in the specific use process, consolidating for various diameters can be equipped with
Price fixing 11, for example including the isodiametric fixed disk 11 of diameter 8mm, 9mm, 10mm ... 16mm, thus, it is possible to preferably adapt to shape
Shape, left auricle of heart of different sizes.
With continued reference to FIG. 1, here, the diameter of the fixed disk 11 be less than it is described block disk 10 diameter, thus can be just
In the release and recycling of the occluder for left auricle 1.
Further, the barb 110 is flexible barb.Flexible barb had not only had firm structure, but also had bigger
Rebound space, that is, guarantee suitable extending space, thus both can guarantee that occluder for left auricle 1 was secured, stable is fixed on a left side
On auricle, and it can guarantee with good recycling ability.Preferably, the quantity of the barb 110 is multiple, multiple barbs 110
It is uniformly distributed in the periphery of the fixed disk 11.The extension angle of multiple barbs 110 can be different, than if any barb towards proximal end
Extend, some barbs can extend towards distal end.Thus, it is possible to further increase fixed stability and fastness.In the application reality
It applies in example, the barb 110 can be not only integrally formed with the fixed disk 11, but also can be by being fixedly welded on the fixed disk 11
On.
In the embodiment of the present application, first for blocking disk 10 and including the first frame and being covered on first frame
Permeable membrane;The fixed disk 11 includes the second frame and the second permeable membrane being covered on second frame.Preferably, described
The material of first frame and the second frame is Nitinol;The material of first permeable membrane and the second permeable membrane is high score
Sub- material.Further, first frame and the second frame can also both be formed by being knitted to form by cutting.
Specifically, referring to FIG. 4, it is the structural schematic diagram of the first frame of the embodiment of the present invention one.As shown in figure 4,
First frame 101 provides the frame structure for blocking disk 10, and high molecular material is covered on first frame 101 and is made
Permeable membrane can be obtained block disk 10.Likewise, the frame structure of fixed disk 11 is provided by the second frame, described second
Permeable membrane made of high molecular material is covered on frame can be obtained fixed disk 11.
In the embodiment of the present application, when the first component 1200 is separated with the second component 1201, the fixed disk
11 can separate with the second component 1201;It is described when the first component 1200 is closed with the second component 1201
Fixed disk 11 can be connect with the second component 1201.The detachable adjustment structure 120 is screw nut structure,
This, the first component 1200 is helicitic texture, and the second component 1201 is nut structure, and the second component 1201 can
The moving in rotation on the first component 1200, i.e., the described first component 1200 can do opposite fortune with the second component 1201
It is dynamic.
Further, there is through-hole, the first component 1200 passes through in the fixed disk 11 in the fixed disk 11
Through-hole, the second component 1201 is screwed on the first component 1200, to can easily consolidate the fixed disk 11
It lives calmly.Here, since the fixed disk 11 uses dish structure, with biggish bearing area, therefore, even if opening up thereon
There is through-hole, can also guarantee that the fixed disk 11 has splendid stability, to guarantee the quality of the occluder for left auricle 1
With reliability.
Here, depth/length that occluder for left auricle 1 is adjusted by screwing the second component 1201, so that
The occluder for left auricle 1 adapts to different left auricle of heart depth.Meanwhile the detachable adjustment structure 120 can connect not
With the fixed disk 11 of size, so as to adapt to different left auricle of heart.
In the embodiment of the present application, the attachment device 12 further includes a flexible connector 121, the first component 1200
It is connect by the flexible connector 121 with the closure disk 10.Preferably, the depth of the flexible connector 121 is adjustable.Please
It is the structural schematic diagram of the flexible connector of the embodiment of the present invention with reference to Fig. 5.As shown in figure 5, the flexible connector 121
For an elastomeric element, can be made of metal or plastics.The both ends of the flexible connector 121 are that structure is fixedly mounted,
Centre is helical spring structure.For example, the both ends of the flexible connector 121 are screw nut structure, pass through the screw thread spiral shell
Parent structure, the flexible connector 121 can be fixedly connected with the structures such as disk 10 or the first component 1200 are blocked.
It please also refer to Fig. 1, here, the flexible connector 14 is connect with the closure disk 10, by for the envelope
Stifled disk 10 presses, thus it is possible to vary depth/length of the flexible connector 14, so that the occluder for left auricle 1 can be with
Preferably adapt to the left auricle of heart of varying depth.In addition, certain radial deflection can also occur for the flexible connector 14, thus
It may be implemented to block when disk 10 and fixed disk 11 are implanted left atrial appendage and completely independent deform, reach optimal closures and imitate
Fruit.Further, gasket can be set between the flexible connector 14 and the closure disk 10, to guarantee the elasticity even
The intensity and reliability connected between fitting 14 and the closure disk 10.
Further, the occluder for left auricle 1 further includes connection fixture 122, one end of the connection fixture 122
It is connect with one end of the flexible connector 121, the other end of the connection fixture 122 and the detachable adjustment structure
120 connections.
Please continue to refer to Fig. 1 and Fig. 2, in the embodiment of the present application, the connection fixture 122 is through-hole structure, wherein
The both ends of the through-hole structure are provided with screw nut structure.The flexible connector 121 and the first component 1200
It is fixedly connected by the screw nut structure with the connection fixture 122.Specifically, the one of the connection fixture 122
End is connect with the flexible connector 121, and the other end is connected with the detachable adjustment structure 1200.Here, institute
Connection fixture 122 is stated to be connected by screwing with the flexible connector 121 and detachable adjustment structure 120, it is possible thereby to
Depth/length of the occluder for left auricle 1 is further adjusted, so that the occluder for left auricle 1 preferably be made to adapt to not
Same left auricle of heart depth.
In the other embodiments of the application, the connection fixture 122 can also pass through buckle structure and the elasticity
Connector 121 is fixedly connected.It is connected in the detachable adjustment structure 120 in addition, the connection locating piece 122 is also solderable.
The usage mode of the occluder for left auricle 1 is as follows:
The channel established using occluder for left auricle conveying device by conduit is 1 guiding catheter of occluder for left auricle
End, end discharge.When release, the fixed disk 11 with barb comes out from sheath first, guarantees suitable stretching, extension;?
After left auricle of heart cavity wall stationary positioned is good, attachment device 12 comes out therewith;Finally, blocking the oral area that disk 10 is buckled in left auricle of heart, fill
Divide fitting, reaches optimal plugging effect.
Contrary in recycling, fixed disk 11 drives barb to recycle naturally from the cavity wall of left auricle of heart.Concrete operations
When, the attachment device 12 in the present embodiment can replace different size/size fixed disk, to adapt to different left auricle of heart
Structure is realized and is fixed;By adjusting the position between fixed disk 11 and attachment device 12 or the depth of attachment device 12 itself
And then length/depth of adjustable occluder for left auricle 1, adapt to different left auricle of heart depth.
[embodiment two]
Referring to FIG. 6, its use schematic diagram for the occluder for left auricle of the embodiment of the present invention two.As shown in fig. 6, described
Occluder for left auricle 2 includes: to block disk 20, fixed disk 21 and attachment device 22, wherein the closure disk 20 is to block a left side
Auricle;The fixed disk 21 has in the fixed disk 21 occluder for left auricle 2 to be fixed on the left auricle of heart
Barb 210;The attachment device 22 connects the closure disk 20 and the fixed disk 21, and the attachment device 22 includes detachable
Formula adjustment structure 220, the detachable adjustment structure 220 include the first component (in Fig. 6 for mark) and can be with described the
The second component (marking in Fig. 6) that one component is separated or closed, the first component and the second component can do phase
To movement, the first component is connect with the closure disk 20, and the second component is connect with the fixed disk 21.
The embodiment of the present application two and embodiment one the difference is that, the quantity of the flexible connector in embodiment one is one
It is a, and the quantity of the flexible connector in the present embodiment two is multiple.
Specifically, referring to FIG. 7, it is the use schematic diagram of multiple flexible connectors of the embodiment of the present invention.Such as Fig. 7 institute
Show, in the embodiment of the present application, multiple flexible connectors 221 are multiple helical springs, and the connection fixture 222 is two pieces flat
Row plate, multiple flexible connectors 221, which are held in two pieces of parallel flats, (to be distinguished at the both ends of i.e. the multiple helical spring
One end/proximal end of one first plate and the second plate namely the multiple helical spring/distally connect with the first plate is connected,
The other end/distal end/proximal end is connect with the second plate).Preferably, multiple flexible connectors 221 are uniformly distributed in two pieces and put down in parallel
In plate.
In the embodiment of the present application, each flexible connector 221 can be fixed in two pieces of parallel flats by fixed cell,
For example, each flexible connector 221 is fixed in two pieces of parallel flats by screw nut.Specifically, the flexible connector
221 both ends are that structure is fixedly mounted, and centre is helical spring structure.Here, the fixed peace at 221 both ends of elastic connection year
Assembling structure can be fixation hole, pass through the fixation hole and a parallel flat by screw, and nut screws the screw,
Flexible connector 221 is fixed on connection fixture 222 by realization.
With continued reference to FIG. 6, in the embodiment of the present application, a parallel flat is fixed in detachable adjustment structure 220,
Preferably, the center of a parallel flat is connected with the detachable adjustment structure 220;Another parallel flat and closure
Disk 20 connects, it is preferred that the center of another parallel flat is connected with the closure disk 20.
In the embodiment of the present application, the detachable adjustment structure 220 is the same as example 1, the detachable tune
Section structure 220 and the connection type of fixed disk 21 are also the same as example 1, and the application repeats no more this.
Outside, in the other embodiments of the application, the detachable adjustment structure can also be external splines internal spline
Structure or buckle structure etc..When the detachable adjustment structure is external splines internal spline structure or buckle structure,
The insertion between the insertion depth or card and portion and buckling parts between external splines structure and internal spline structure can equally be passed through
Length/depth of the adjustable occluder for left auricle of depth, to adapt to different left auricle of heart depth.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair
Any change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims
Range.