A kind of occluder for left auricle for improving shape
Technical field
The utility model relates to medical instruments, and in particular to a kind of for blocking the intervention therapeutic apparatus of left auricle of heart.
Background technique
Auricular fibrillation (abbreviation atrial fibrillation) is the most common perpetual arrhythmia.The incidence of atrial fibrillation is not with age
Disconnected to increase, crowd is up to 10% within 75 years old or more.The frequency of atrial impulses reaches 300-600 beats/min when atrial fibrillation, and palmic rate is often fast
And it is irregular, atrium loses effective contractile function.Left auricle of heart convergent force declines when atrial fibrillation, along with the shape of left auricle of heart itself
State feature and its interior trabecular muscles are rough and uneven in surface, so that blood flow generates whirlpool and flows decrease in left auricle of heart, promote thrombosis.
90% or more Non-valvular disease patients with atrial fibrillation left atrial thrombus is present in left auricle of heart.Brain can be entered by aorta vessel after thrombus breaks loose
Portion's arteries forms cerebral embolism, that is, cerebral apoplexy.
It is clinically main at present to carry out prophylactic treatment using three kinds of methods for the risk of patients with atrial fibrillation cerebral apoplexy, i.e., it is anti-
Solidifying drug therapy, surgical operation therapy and the treatment of percutaneous left atrial appendage occlusion.Anticoagulant treatment refers to by taking anticoagulant
Inhibit blood clotting, to reduce the risk of thrombosis in left auricle of heart, and then reduces the probability of happening of cerebral apoplexy.Clinical test
Show that anticoagulant treatment can significantly reduce the probability of happening of cerebral apoplexy, but anticoagulant treatment is a very long process,
There is also apparent complication simultaneously, are mainly shown as hemorrhage complication, and be likely to occur more serious situation.Surgical operation
Treatment includes surgical resection or suture left auricle of heart, but surgery operating wound is big, be usually expert at valve replacement or
It is completed when other operations such as coronary bypass, patient is generally difficult to receive simple left auricle of heart surgical operation, especially advanced age
Patient.Percutaneous left atrial appendage occlusion treatment refers to by way of percutaneous puncture, using the lesser delivery sheath of a diameter, by a left side
Atrial appendage occlusion device is transported to the left auricle of heart positioned at heart atrium dextrum and release.Occluder for left auricle can be by the aperture position of left auricle of heart
It blocks, blood flow not can enter left auricle of heart in atrium, therefore cannot form thrombus, to reach prevention auricular fibrillation thromboembolism
Purpose.Since 2001, percutaneous left atrial appendage occlusion treatment started to come into operation, and had successively carried out zoopery and clinical examination
It tests.Clinical test shows that left atrial appendage occlusion art can effectively reduce the probability of happening of patients with atrial fibrillation cerebral apoplexy.
Divide from structure, occluder for left auricle mainly divides two types currently on the market: plug structure and double disk structure.
Because the application time of occluder for left auricle is relatively short, technology is relatively immature, postoperative to will appear some complication
Influence the quality of life of patient;Wherein instrument residual shunt is one of the major complications of left atrial appendage occlusion art, wherein with regard to plug
Structure, in terms of its 6 months Follow-up results, there are residual shunt complication, the Follow-up results from 12 months are shown 8% patient,
There are the residual shunt complication of certain degree by the patient at different centers 32%~34.5%;And the left atrial appendage occlusion of double disk structure
Device, the 6 months clinical follow up results in different centers see that there are moderate residual shunt complication by 2%~16.2% patient;It is residual
Remaining shunting complication rate is higher, this will affect the quality of life of patient, therefore reduce occluder for left auricle postoperative residue point
Stream is one of the main target for improving occluder for left auricle clinical value.
The occluder for left auricle of double disk structure is usually made of a sealing and an anchor portion, seals after release
Portion blocks left auricle of heart aperture position, and anchor portion release is in left atrial appendage and has hangnail, plays the role of fixing seal portion.It releases
The sealing for putting rear occluder for left auricle will be fitted tightly over left auricle of heart aperture position, and left auricle of heart oral area is blocked.If sealing
Portion cannot be fitted closely with left auricle of heart mouth, be may cause sealing and be suspended in atrium sinistrum, and left auricle of heart oral area cannot be effectively played
The effect of closure, thereby increases and it is possible to further increase the risk of thrombosis.And cause sealing that cannot effectively be attached to left auricle of heart
One connection type between principal element and sealing and anchor portion of mouth position is related, it may be assumed that between anchor portion and sealing
Cannot be compact link together, the entire length of product is longer, and anchor portion is radially compressed after release, further increases product
Entire length after release, while sealing and anchor portion axial distance can be caused to increase, it cannot be effective after sealing release
It is attached to left auricle of heart oral area, causes residual shunt.
Utility model content
The utility model proposes a kind of occluder for left auricle, improve the shape of sealing, are conducive to sealing and anchor
Determine mutually approaching for portion, can avoid and delay occluder for left auricle axial elongated on the whole, be further ensured that sealing attach and
Block left auricle of heart mouth.
A kind of occluder for left auricle for improving shape, including sealing interconnected and anchor portion, which is characterized in that institute
Stating sealing includes the disk backwards to anchor portion, the waist for trying to get to the heart of a matter and connecting disk and try to get to the heart of a matter towards anchor portion, the waist
At least a part of in portion is converging portion, which collapses along the direction shape towards anchor portion.
Optionally, the waist is converging portion on the whole.
Waist can be on the whole to attenuate in gathering always, be also possible to part it is isometrical extend it is even thicker, but
At least a part of is converging portion, heavy convenient for guidance sealing Relative anchor subordinate by converging portion, i.e., during assembly
Gradually close to anchor portion is even pushed against, both guarantees that can be adaptive are aligned.
Moreover, converging portion is set in waist, also plays certain precommpression effect, discharges use process in vivo
In, axial deformation can be delayed to elongate, to maintain sealing effect.
Optionally, the waist is tubular wire frame structure.
Sealing can be process by way of weaving or cutting respectively with anchor portion, and sealing (anchor portion) can be adopted
With rule or irregular wire frame structure, using can be strong to improve in suitable position setting skeleton as needed when wire frame structure
Degree, skeleton can be the increase of sectional area relative to other parts, or at least have higher intensity, and reticular structure can be rule
Then or irregular cell, the preferred cell of diamond shape or near-rhombic, can at least be compressed radially, in order to
Recycling and release, reticular structure have apparent longitude and latitude structure, longitude and latitude intersection can be stationary nodes more preferably use it is non-solid
Fixed mode, i.e., can misplace sliding between longitude and latitude, to provide compliance and deformability.
It can be structure as a whole after cutting or braiding between sealing and anchor portion and respective interconnecting piece, Huo Zhelian
Socket part is fixed as independent component by the assembly of the means such as welding.It is preferable that integral structure, easy to process to also ensure
Integral strength.
Optionally, the shape of the converging portion gradually collapses or ladder-like gathering.
For the trend of gathering, it can be continuously, or interval, wherein also can wrap the mutation containing trend.
For example, optional, the bus of converging portion is one or more snippets, and every section of shape is straight line or camber line.
Same reason, on waist, converging portion can have many places, and the converging portion not existed together is independent to have shape
Variation.
Optionally, described at least part tried to get to the heart of a matter is plane, and the converging portion is only located at waist, or is extended to by waist
The outer rim of the plane.
When trying to get to the heart of a matter as flat-bottom structure, axial length can almost be ignored, and converging portion be axially extend and change it is outer
Diameter, therefore alternatively converging portion exists only in waist, when extend to waist with try to get to the heart of a matter junction after, with can not be along axis
Line continues to extend to flat.
Same reason can still continue to extend, illustrate disk if converging portion extends to waist with after the junction tried to get to the heart of a matter
Bottom be no longer it is flat, similarly there is contraction shape, waist and the boundary between trying to get to the heart of a matter have not been apparent at this time, it is also difficult to
It clearly divides, but this is not the utility model emphasis, what is be more concerned about in the utility model is sealing towards the one of anchor portion
There is the convergent feature of shape on side.It is separate in order to further indicate that the trend of change in shape or as a result, on the bus of converging portion
One end of anchor portion is starting point, is terminal close to one end of anchor portion, line and occluder for left auricle between beginning and end
The angle of axis is 0~60 degree.
Preferably, the angle of line and occluder for left auricle axis between the beginning and end is 15~45 degree.
When trying to get to the heart of a matter as flat-bottom structure, after converging portion reaches bus terminal, it is meant that it no longer restrains, can be isometrical extension,
It even extends out, is also possible to the junction for reaching waist just Yu trying to get to the heart of a matter.
It tries to get to the heart of a matter when not being flat-bottom structure, after converging portion reaches bus terminal, it is meant that no longer restrain, can be isometrical prolong
It stretches, or even extends out, be also possible to reach the axis position of sealing just.
Optionally, at least a part of in the bus of converging portion is straight line, the folder of the straight line and occluder for left auricle axis
Angle is 0~60 degree.
Preferably, at least a part of in the bus of converging portion is straight line, the straight line and occluder for left auricle axis
Angle is 2~45 degree.
Preferably, trying to get to the heart of a matter as flat-bottom structure, waist is collectively as converging portion, and the bus of converging portion is straight line.This
When, sealing can be considered the round table-like of standard other than disk position.
Optionally, the sealing and anchor portion are respectively provided with interconnecting piece, the interconnecting piece phase of both sealing and anchor portion
It is fixed to each other to extension and by connector.
It is fixed preferably, the interconnecting piece of both sealing and anchor portion misplaces.
In the prior art, the interconnecting piece of both sealing and anchor portion is usually and aligns, the end face if being directly connected to
It directly offsets, naturally it is also possible to which using the connector of transition, will lead to plugging device, axial length is too long on the whole, is unfavorable for close
Envelope.
Interconnecting piece both in the utility model, which misplaces, to be arranged, can avoid space interference during opposite move close to, greatly
The reduction sealing and anchor portion spacing of amplitude improve sealing effect.
Optionally, it is structure as a whole between the sealing and anchor portion and respective interconnecting piece, or point being fixed to each other
Body structure.
Optionally, the interconnecting piece on both the sealing and anchor portion is at one, and is connected with each other;Or the sealing
Interconnecting piece in both portion and anchor portion is many places, and is connected with each other correspondingly.
The quantity of interconnecting piece and position when only at one, generally lie in sealing or anchor portion there is no stringent limitation
Middle part.
Optionally, the sealing is connected directly with the interconnecting piece of both anchor portions or is connected by connector.
It being connected directly, i.e. the interconnecting piece of the two contacts with each other, it is fixed to each other by welding, anchor ear, the mutually modes such as winding,
And may be not contact with each other, but be respectively relative to connector and fix by the interconnecting piece of the connected then the two of connector, even
Fitting can be the component that a separate part or multiple components are constituted.
Optionally, the interconnecting piece of both the sealing and anchor portion is along linear extension;Or
The connection of one of them extends along linear extension, the extension of another one along curve;Or
The interconnecting piece of the two extends along curve.
Both sealing and anchor portion are positioned opposite, and the interconnecting piece of the two mutually extends closer and connects, in the mistake of extension
Its path is not limited in journey strictly, in order to simplify structure, preferably the interconnecting piece of both sealing and anchor portion is equal
Along linear extension.
The shape of interconnecting piece itself both may be that simple straight-bar is also likely to be more complicated three-dimensional structure, therefore here
Linear extension be interpreted as overall trend, i.e., there is no detours or bending on the whole for extension process.
As a further preference, the interconnecting piece of both sealing and anchor portion prolongs along occluder for left auricle axis direction
It stretches.
Optionally, the interconnecting piece of both the sealing and anchor portion is at mutually matched position, mutually nested or phase
Mutually deviate.
The interconnecting piece of both sealing and anchor portion is and mutually nested or deviate from each other can be real due to being dislocation arrangement
Continue to extend under the premise of dislocation now, without space interference, deviating from each other herein is not answered for nesting
It is interpreted as being located remotely from each other, such as on the section of vertical occluder for left auricle axis, the interconnecting piece of both sealing and anchor portion
It can be and mutually recline or with certain interval.
Optionally, the end that the interconnecting piece of both the sealing and anchor portion is extended towards and gone past the opponent.
Behind the end that wherein an interconnecting piece is gone past the opponent, also imply that the end of party B is crossed in the end of another interconnecting piece,
Interconnecting piece both in this way at mutually matched position, the projection along vertical occluder for left auricle axis direction be arranged side by side or
It is least partially overlapped.
When sealing is mutually nested with the interconnecting piece of both anchor portions, projection also must be overlapping, deviate from each other
When, projection of shape is related with visual angle, therefore side by side or the equal possibility that partly overlaps, if sealing and anchor portion although dislocation, simultaneously
Other side end is not continued to extend across, then still has and further lifts close to the space of sealing and anchor portion, product structure
It is not compact enough.
Optionally, both sealing and anchor portion mutually recline in the peripheral region of respective interconnecting piece.
The gap of both sealing and anchor portion can be blocked by mutually reclining, and improve sealing effect.
As a further preference, both sealing and anchor portion are mutually pushed against in the peripheral region of respective interconnecting piece.
The mutual abutting of sealing and anchor portion can be realized by way of applying pretightning force, it can be more after plugging device release
Good attaching and block left auricle of heart mouth, even if anchor portion or sealing are radially compressed and lengthen, can still keep sealing with
Anchor portion reclines, and guarantees sealing effect.
In conjunction with the prior art, one or more choked flow film is provided in sealing;The periphery of anchor portion can also be into
Row overlay film, such as all or part of overlay film on anchor disk outer surface.Under the premise of non-specified otherwise, institute in the utility model
The shape and positional relationship of description are that occluder for left auricle discharges the state after expansion in vivo, can also abbreviation release conditions
Or swelling state, occluder for left auricle is compressed in conveying device before release, shape before can be described as compressive state or discharging
State.
Optionally, the sealing and anchor portion are independent for wire frame structure or reticular structure.
Disk is tried to get to the heart of a matter and waist constitutes cage structure on the whole, and one or more choked flow film can be set in cage type knot
Inside structure, cage structure can be closing or fractional open form in addition to necessary hollow out position, process sealing in braiding
When, there can be a collecting end with disk trying to get to the heart of a matter.
Cage structure is since inside has certain space, even if having certain deformation it is also ensured that sealing effect, especially
For this feature is pushed against with anchor portion suitable for the utility model.
The diameter of cage structure be mainly waist diameter and anchor portion diameter it is substantially suitable, and disk diameter be slightly larger than waist
The diameter in portion is to improve the plugging effect of end.
Optionally, the sealing has the pre-setting state that does not contact with anchor portion and contacts with each other with anchor portion
Abutting state;Relative to pre-setting state, the sealing for pushing against state has deformation.
Optionally, the sealing has the pre-setting state that does not contact with anchor portion and contacts with each other with anchor portion
Abutting state, described try to get to the heart of a matter are greater than the diameter tried to get to the heart of a matter under abutting state in the diameter under pre-setting state.Disk described herein
Face or the diameter tried to get to the heart of a matter, the two can be approximately circle, if other shapes, it will be appreciated that for sectional area or the opposite pass of whole thickness
System is truncated cone-shaped since the diameter of disk is greater than the diameter tried to get to the heart of a matter, the top surface of upper part is omited by taking circle as an example on the whole
Greatly, it more down more restrains, the bottom surface of lower part is smaller, adaptable to be bonded with anchor portion in this way when offseting with anchor portion.
Optionally, relative to pre-setting state, the sealing of state is pushed against in waist and/or is tried to get to the heart of a matter with deformation.
Pre-setting state refers to that sealing itself is fixed by heat under no assembling or not by external force after processing is completed
The shape that type obtains, due to being pushed against with anchor portion after assembling, and in order to improve or keep this pretightning force, therefore with anchor portion
Deformation is generated after abutting.
Optionally, relative to pre-setting state, the sealing for pushing against state has the deformation radially collapsed in waist.
When sealing and anchor portion are located remotely from each other or when by radial compression, the deformation radially collapsed can offset or delay
Axially extending trend, to guarantee the leakproofness at left auricle of heart opening position.The deformation radially collapsed can be such that waist generates centainly
Taper is also preferably bonded with left auricle of heart to improve sealing effect.
Optionally, relative to pre-setting state, the sealing for pushing against state is being tried to get to the heart of a matter with axially towards anchor portion protrusion
Deformation.
The deformation of similar principle, the axial direction towards anchor portion protrusion can also offset or delay occluder for left auricle whole
On in axial extension.Reclining for sealing and anchor portion is kept as far as possible, guarantees sealing effect.
Optionally, the sealing at least offsets at the outer rim position tried to get to the heart of a matter with anchor portion.The outer rim position tried to get to the heart of a matter and anchor
Determine to can get bigger sealing deformation in the case that portion is mutually against identical pretightning force, more conducively compensates and offset axial prolong
It stretches.
Optionally, sealing respectively collects with anchor portion and is connected by connector.
If reticular structure, then the silk for being used to weave sealing or anchor portion respectively collects and is connected by connector.It should
It collects and is presented as structure feature, also contain corresponding steps when processing, i.e., multi-filament is pooled into a bundle.
If wire frame structure, sealing or anchor portion are generally by the way of tubing cutting, then the end of tubing can manage
Solution is to collect position.
Optionally, trying to get to the heart of a matter for sealing collects with first, and the middle part radially of anchor portion has second to collect, described
Connector tool connects respectively there are two channel and fixes first and collect to be collected with second.
First collect with second collect relative to connector it is reversed traction may make sealing and anchor portion main part
It is close to each other until push against.The interference that channel independent is constructed when can avoid traction, is also convenient for assembling.
Optionally, two channels on connector are arranged side by side or inside and outside nested arrangement.Two channels are those in general
This dislocation arrangement, interference when traction is further avoided, is also convenient for assembling.
Optionally, the anchor portion is by constituting extended segment backwards to sealing extension at connector, and extended segment is far from linkage section
Side turn up and turn back to the peripheral region of the converging portion and constitute back-turning section.
Back-turning section is spatially cylindrical in shape structure, and the utility model uses the first purpose of converging portion, is also easy for filling
Timing guidance sealing is sunk in the tubular structure.
Anchor portion generally Eversible structure, the periphery that back-turning section is looped around extended segment forms double-layer structure, in double-layer structure
Portion has certain space, and deformation occurs after can be absorbed and anchor portion being allowed to push against sealing, but does not weaken its anchoring effect
Fruit.
Optionally, the apical margin infolding of the back-turning section closes up to form closing in section, the closing in section and sealing try to get to the heart of a matter and
The peripheral region of converging portion bottom offsets.
Closing in section substantially radially extends inwardly, forms face contact with the bottom of sealing, is more advantageous to application pretightning force,
Although anchor portion and sealing are engraved structure, so-called face contact can be regarded as reclining between wire side herein, not
It is required that face contact physically.
Optionally, first the bottom center positioned at sealing is collected.And closing in section upwards against sealing bottom it is outer
Edge position, may make the bottom of sealing in back taper by the drawing of pretightning force in this way.
Optionally, the closing in section is suspended in the periphery of extended segment or connect with extended segment.
" suspension " there is no connection relationship or is only to be contacted with the periphery of extended segment, each other can be free when deformation
Relative movement, if there is connection, may be a fixed connection or slide, be rotatably assorted, and both constraints are opposite to a certain extent transports
Flowing mode.
Optionally, the extended segment is taper, and major part side (i.e. cone bottom side) is far from connector and opening setting.
Extended segment is horn-like convenient for recycling, and can also be improved the stability of intensity and structure at flaring.
Optionally, the anchor portion contacts with each other with the pre-setting state not pushed against with sealing and with sealing
Abutting state, under pre-setting state, anchor portion axially the upper connector than closing in section further from sealing.
I.e. sealing and anchor portion it is relatively close when, closing in section is first contacted with the bottom of sealing, due to connector with it is close
Still there is a distance in envelope portion farther out, this section of distance is also that further drawing forms pretightning force there are spaces and may.
Optionally, under abutting state, in the upper connector of anchor portion axial direction and closing in section flush or more than closing in section
Far from sealing.
Optionally, the connector includes mutually nested inner ring and outer rings, and described first collects and collect with second,
Middle one is penetrated and is fixed in inner ring, and another one is penetrated and is fixed in the gap of inner ring and outer ring.
Optionally, the connector includes mutually nested inner ring and outer rings, and described first collects and collect with second,
Middle one is penetrated and is fixed in the gap of inner ring and outer ring, and wherein another one through inner ring and is fixed with and connects in traversing through end
The anti-drop head that part offsets.
Optionally, the connector includes the ontology with two channels side by side, and described first collects and collect point with second
Not Guan Chuan corresponding channel, and the anti-drop head to offset with the ontology is respectively fixed in traversing through end.
The connector and anti-drop head can for stainless steel, Nitinol or other meet the gold of biocompatibility requirement
Belong to material.
Preferably, anchor portion has the abutting position to offset with sealing, anchor portion is tubular under compression
Structure, and the inner wall side for pushing against position and being in tubular structure.
Preferably, anchor portion is tubular structure under compression, under release conditions the inner wall side of tubular structure against
Sealing.
Upon discharge, due to the outside turnup of anchor portion, the inner wall side being in originally pushes against position and is in after turnup
It outside and offsets towards sealing, and with sealing.
Under compressive state, need if the outer wall side that abutting position is in tubular structure using increasingly complex turnup side
Otherwise formula is difficult to take into account and obtains big outer diameter in anchor portion to support and be anchored left auricle of heart inner wall.
But under the form using complicated turnup, thus it is possible to vary anchor portion end (distal end of compressive state) extends out when discharging
Trend, can be opposite to improve safety to avoid stabbing left auricle of heart inner wall.
Preferably, the anchor portion and sealing have the use state for directly contacting and pushing against.
Under normal operating condition, anchor portion may be directly to contact and push against, but directly contact and push against simultaneously with sealing
Not exclusive use state, under the action of special physiological construction, or after a period of use, between anchor portion and sealing
It may be located remotely from each other and even generate gap.
Preferably, the sealing is bottom towards anchor portion side, it is top, the anchor backwards to the side of anchor portion
Determine portion to be connected with the bottom of sealing.
Opposite situation is that anchor portion is connected locally through sealing and with the top of sealing, the present invention in anchor portion with
The bottom of sealing, which is mutually connected in, to be easier to obtain the pre- deformation of sealing when anchor portion is mutually pushed against with sealing system, is had in other words
There is higher deformation to obtain efficiency.
Preferably, the sealing is double-layer structure.
As further preferred, the inside of the double-layer structure is equipped with one or more layers choked flow film.
It is elongated due to being easier to burst in axially generation pine when sealing uses double-layer structure, the present invention is it is also preferred that applicable
In the sealing of double-layer structure.Either dish type or column can be considered double-layer structure, and built-in choked flow film.Preferably,
The anchor portion and sealing are separate structure.
As further preferred, the anchor portion and sealing mutually push against in assembling process.
Using separate structure, heat treatment shaping respectively, then assembled, and after being pushed against in assembling process
Pre- deformation effects.Although abutting effect can also be obtained according to integral structure, since there is no assembling process therefore to need
It is just obtained after thermal finalization and pushes against effect, therefore requirements at the higher level are proposed to heat setting process, generally required to anchor portion and sealing
Portion is heat-treated respectively, improves processing difficulty.
It is continuously distributed in the circumferential in order to obtain preferable support and anchoring effect, the anchor portion.
Although net or rod-like structure have gap in the axial direction, should continuously divide in the axial direction in overall structure and distribution
Cloth avoids only providing support by circumferential part to strive for distribution of force more evenly and stablize support.
Preferably, anchor portion seals against the outer edge of the position adjacent to anchor portion in portion.
Preferably, sealing is against the position of anchor portion adjacent to the outer edge of sealing.
Outer edge position, which offsets, more easily obtains the convergence of axial deformation or radial direction, improves deformation under same stress
Amount.
Preferably, the sealing and anchor portion are assembled after completing thermal finalization, sealing and anchor portion when assembly
First state with initial contact;
Connecting portion between sealing and anchor portion also has the second state after being axially towards one another movement preset distance.
First state sealing portion and is just contacted with anchor portion, since sealing and anchor portion have all completed heat
Sizing, so if the two moves toward one another one of them axially further can generate deformation and keep tangible in the second condition
Become bring stress.
Preferably, the connecting portion between the sealing and anchor portion both is located at radial middle part, first
Peripheral region under state between the sealing and anchor portion in connecting portion is in contact.
Above-mentioned stress is also the source of the pretightning force, if before without thermal finalization, but thermal finalization again after assembling, that
Stress can disappear when heat treatment, can not generate required pretightning force.
Therefore it is emphasized that under the second state, the sealing and the relative position that anchor portion is after being assembled
Relationship is no longer heat-treated after the second state.
Since anchor portion has better rigidity, the generation of general stress is mainly derived from the deformation of sealing.
Preferably, relative to first state, the position that is connect on sealing with anchor portion in the second state more towards
It moves close to anchor portion side.
When being transferred to the second state, connecting portion of the sealing between anchor portion is axially towards one another at a distance from movement, is influenced
The size of stress, therefore need to be expressed in a manner of adapting to and accordingly controlled in assembly.
Preferably, the expression way of the preset distance are as follows:
Between connecting portion axial force;Or
The pressure of contact site between sealing and sealing and the anchor portion of anchor portion;Or
The deformation quantity at the position being connect on sealing with anchor portion.
The deformation quantity is the Axial changes amount or sealing predetermined position and sealing axis of sealing predetermined position
Angle.
The sealing predetermined position is the position that deformation occurs when first state changes to the second state, for the ease of table
It reaches and measures, can choose the relatively large position of deformation quantity.Such as the sealing predetermined position is to seal under first state
The position that portion is contacted with anchor portion.
By detecting the variable quantity of the expression way of preset distance when assembly, stress intensity obtained can be corresponded to.
If without the presence of the stress, even if sealing and anchor portion have localized contact when assembly, but in use process
It is when the axial whole elongation of occluder for left auricle, i.e., inherent between sealing and anchor portion when sealing and anchor portion are located remotely from each other
Restoring force it is smaller, axial whole elongate only is overcome by the elasticity of respective material.
In the present invention, by way of passing through first thermal finalization, rear assembly and retaining axial stress when assembling, it can make subsequent
With preferably overcoming the axial entirety of occluder for left auricle to elongate in the process, pass through the elasticity of sealing and anchor portion material and preload
The superposition of power improves restoring force, ensure that the plugging effect of long-time service.
Corresponding the utility model also provides a kind of assembly method of occluder for left auricle, and sealing and anchor portion complete heat
It is assembled after sizing, sealing and anchor portion are closer and when initially contacting mutually first state when assembly;In first state
On the basis of, the connecting portion between sealing and anchor portion reaches the second state after being axially towards one another movement preset distance;
Connecting portion between sealing and anchor portion is fixed to each other, so that connecting portion is maintained at the second state and completes dress
Match.
Since mutual localized contact, first state to the second state turn for first state sealing portion and anchor portion
When change, sealing as a whole may be with the axial position between anchor portion there is no changing, and only local deformation generates
Stress.
Occluder for left auricle described in the utility model is conveyed by way of percutaneous puncture by delivery sheath
To the position of heart left auricle of heart, by left atrial appendage occlusion, thrombus is formed to prevent patients with atrial fibrillation in left auricle of heart and then leads to apoplexy
Risk.
The utility model by improving sealing shape, be more convenient for sealing and anchor portion it is mutual close to even pushing against,
The even closer and closure left auricle of heart that sealing and left auricle of heart can be allowed to attach is open, with the generation of leakage and residual shunt in reduction
Rate.
Detailed description of the invention
Fig. 1 is the schematic diagram of the occluder for left auricle in embodiment one;
Fig. 2 a is the schematic diagram in embodiment one after sealing thermal finalization;
Fig. 2 b is the structural schematic diagram of sealing in embodiment one;
Fig. 2 c is the structural schematic diagram relative to sealing converging portion difference trend in Fig. 2 b;
Fig. 2 d is the angle calculation schematic diagram of sealing converging portion in Fig. 2 c;
Fig. 2 e is the angle calculation schematic diagram of converging portion under different trend;
Fig. 2 f is the angle calculation schematic diagram of converging portion under another trend;
Fig. 3 is the schematic diagram in embodiment one after anchor portion thermal finalization;
Fig. 4 a is the schematic diagram of anchor portion and sealing connection procedure (anchor portion side) in embodiment one;
Fig. 4 b is part A enlarged drawing in Fig. 4 a;
Fig. 5 is the schematic diagram of anchor portion and sealing connection procedure (sealing side) in embodiment one;
Fig. 6 starts the schematic diagram docked with sealing for anchor portion in embodiment one;
Fig. 7 a is that anchor portion connect the schematic diagram completed with sealing in embodiment one;
Fig. 7 b is the connection schematic diagram of sealing and anchor portion in the prior art;
Omit schematic diagram in the part that Fig. 7 c is Fig. 7 a;
Fig. 8 is that occluder for left auricle is put into the schematic diagram blocked in left auricle of heart in embodiment one;
Fig. 9 a is the schematic diagram of the occluder for left auricle in embodiment two;
Fig. 9 b is part A enlarged drawing in Fig. 9 a;
Figure 10 is the schematic diagram of anchor portion and sealing connection procedure in embodiment two;
Figure 11 a is the schematic diagram of the occluder for left auricle in embodiment three;
Figure 11 b is part A enlarged drawing in Figure 11 a;
Figure 12 a is the schematic diagram of anchor portion and sealing connection procedure in embodiment three;
Figure 12 b is part A enlarged drawing in Figure 12 a;
Figure 13 is the schematic diagram of anchor portion and sealing connection procedure in embodiment three;
Figure 14 is the schematic diagram (only illustrating sealing) of the occluder for left auricle in example IV;
Figure 15 is the schematic diagram (only illustrating sealing) of the occluder for left auricle in embodiment five;
Figure 16 is the schematic diagram (only illustrating sealing) of the occluder for left auricle in embodiment six;
Figure 17 a~Figure 17 c is that anchor portion discharges process schematic in embodiment seven, and sealing is shown with state after discharging in figure
Meaning;Figure 18~Figure 20 is the schematic diagram of the sealing of different shapes of trying to get to the heart of a matter in embodiment seven;
Figure 21~Figure 25 is the control schematic diagram of seven mid-game bottom of embodiment deformation front and back;
Figure 26~Figure 28 tries to get to the heart of a matter for another shape in embodiment seven deforms the control schematic diagram of front and back;
Figure 29~Figure 30 is the control schematic diagram of eight mid-game bottom of embodiment deformation front and back;
Figure 31~Figure 40 is the assembly front and back schematic diagram of different connection types in embodiment nine.
Specific embodiment
Embodiment one:
As shown in Figure 1, one occluder for left auricle 1000 of the utility model embodiment includes sealing 1100 interconnected
With anchor portion 1200.Sealing 1100 is all made of titanium-nickel wire with anchor portion 1200 and weaves.
Sealing 1100 includes disk 1110, waist 1120 and 1170 compositions of trying to get to the heart of a matter, and has bolt head 1130, disk in disk end
Be sewed with 1 layer of PET choked flow film 1140 in face, in the middle part of waist in be sewed with 1 layer of choked flow film 1150, try to get to the heart of a matter in be sewed with 1 layer of choked flow film 1160.
Anchor portion netted cylindrical 1220, outer layer end bending part 1230, internal layer by the netted taper 1210 of internal layer, outer layer
Netted taper 1210 and the arc transition part 1240 of outer layer netted cylindrical 1220 and outer layer netted cylindrical 1220 and end
The arc transition part 1250 of portion's bending part 1230 forms, and is circumferentially uniformly distributed in netted cylindrical 1220 outer surface of outer layer
Hangnail 1270.
Wherein the netted taper 1210 of internal layer is equivalent to extended segment;Outer layer netted cylindrical 1220 is equivalent to back-turning section;Outer layer
End bending part 1230 is equivalent to closing in section.
Sealing, which is tried to get to the heart of a matter, distally to link together with anchor portion inner layer net tapered proximal end, which can be by just covering
The mode of fastening or laser welding links together.
Sealing and anchor portion are to cross mold high-temperature heat treatment using cylindrical braiding NiTi Netcom respectively before proceeding
It is formed.Fig. 2 a, Fig. 3 are the sealing in the utility model embodiment one after 1000 heat treatment shaping of occluder for left auricle respectively
Portion 1100 and anchor portion 1200, wherein sealing 1100 has a distal end titanium-nickel wire to collect, the netted taper of 1200 internal layer of anchor portion
1210 have a proximal end titanium-nickel wire to collect.
B referring to fig. 2, shape gradually restrains the waist of sealing on the direction towards anchor portion on the whole, as receipts
Section 1121 is held back, contrasts Fig. 2 c, the gathering trend of converging portion becomes apparent in Fig. 2 c, or means the receipts of converging portion 1121 in Fig. 2 c
Hold back speed faster.
D referring to fig. 2, it is eventually close to one end of anchor portion that on the bus of converging portion, one end far from anchor portion, which is starting point A,
Point B, the angle α of line Y and occluder for left auricle axis X between starting point A and terminal B are 0~60 degree.It is about 45 degree in figure.
The bus of converging portion can be camber line or straight line, extend trend according to it, can be one or more snippets, female in Fig. 2 d
Line is S-shaped, can be considered the rounding off connection of multistage.
In Fig. 2 e, the bus of converging portion is waveform, i.e. convergence has stair-stepping variation tendency, but in general, waist
The diameter in portion is from the coarse to fine.
Similarly f, the bus of converging portion are the camber line of a standard referring to fig. 2, naturally it is also possible to be straight lines.
In conjunction with Fig. 1, turn after matching, the bending part 1230 of anchor portion is equivalent to closing in section, and closing in section and sealing are tried to get to the heart of a matter
And the periphery of converging portion bottom offsets.
Fig. 4 a~Fig. 7 a, Fig. 7 c are the sealing 1100 and anchor of occluder for left auricle 1000 in the utility model embodiment one
Determine a kind of connection type in portion 1200.
The proximal end titanium-nickel wire 1261 of anchor portion is convergent on an outer layer steel bushing 1262 (being equivalent to outer ring) and an internal layer steel bushing
It is visible in figure to be collected for weaving the titanium-nickel wire of anchor portion in the proximal end of extended segment between 1263 (being equivalent to inner ring), and with
Ectonexine steel bushing as connector is connected.It can be seen that the ectonexine steel bushing as connector in Fig. 4 a, it is more farther than closing in section
From sealing, the anchor portion of turnup structure substantially bowl (or nest) shape, connector, which is located in bowl, to be sunk to below the rim of a bowl.
Then ectonexine steel bushing and the proximal end titanium-nickel wire 1261 between it are fixed on one by welding or compressing mode
It rises, internal layer steel bushing 1263 is a hollow structure, then by cutting or laser treatment mode will be other than 1262 proximal end of outer layer steel bushing
Titanium-nickel wire remove.
Such as Fig. 5 and Fig. 6, the distal end titanium-nickel wire 1171 of sealing passes through internal layer steel bushing 1263 after the middle part tried to get to the heart of a matter collects,
Certain pulling force can be applied by sealing 1100 and the compact connection of anchor portion 1200, form certain pretightning force, and pass through this
Pretightning force makes the stretching waist of sealing at the structure of a taper, while can reduce the whole height of occluder for left auricle.
Sealing structural form as shown in Figure 7a;The distal end titanium-nickel wire 1171 of sealing (is equivalent to by steel bushing 1172
Anti-drop head) it is fixed together, steel bushing 1172 should slide and consolidate after pushing against the distal end of internal layer steel bushing 1263 with distal end titanium-nickel wire 1171
It is fixed.This 1172 outer diameter of steel bushing is greater than the internal diameter of internal layer steel bushing 1263, prevents distal end titanium-nickel wire 1171 from deviating from internal layer steel bushing 1263.
The extra distal end titanium-nickel wire 1171 in sealing distal end is cut later or laser mode is disposed.The utility model institute
The steel bushing material stated can for stainless steel, Nitinol or other meet the metal material of biocompatibility requirement, the present embodiment
Select stainless steel material.
In assembling process, when sealing 1100 and anchor portion 1200 are mutually moved close to, first state can be considered when just contacting,
With the axial further drawing of distal end titanium-nickel wire 1171, side meeting and anchor portion of the sealing 1100 towards anchor portion 1200
1200 gradually push against generation stress, that is, pretightning force, reach the second state after the axial drawing preset distance of distal end titanium-nickel wire 1171, this
When pass through steel bushing 1172 again sealing 1100 and anchor portion 1200 be maintained at the second state, that is, keep the presence of stress.
Axial drawing preset distance can be measured directly, can also be according to sealing 1100 towards the one of anchor portion 1200
Side be try to get to the heart of a matter 1170 change in shape expression obtain, can also directly measure the pulling force or sealing 1100 of distal end titanium-nickel wire 1171
Pulling force between anchor portion 1200.
The shape that 1170 change in shape of trying to get to the heart of a matter both had been referred to oneself in first state, can also be referring under different conditions
With the angle of 1100 axis of waist 1120 or sealing.
Comparison diagram 6 and Fig. 7 a can obviously learn, (on the basis of Fig. 6 sealing 1100 and anchor portion 1200 under first state
It further closer contacts, but due to being just to have contacted, the shape of sealing 1100 is not changed, therefore can refer to Fig. 6
Shape.) try to get to the heart of a matter it is 1170 substantially vertical with waist 1120, and under the second state of Fig. 7 a, try to get to the heart of a matter 1170 with the angle of waist 1120
Increase, 1170 radial middle parts of trying to get to the heart of a matter can also further be expressed towards 1200 side of anchor portion protrusion, therefore by variable angle
The preset distance axially pulled with control distal end titanium-nickel wire 1171.
The utility model uses converging portion, on the one hand heavy convenient for guidance sealing Relative anchor subordinate, i.e., in the mistake of assembly
Gradually close to anchor portion is even pushed against in journey, in addition aligning for both guarantees that can be adaptive also plays certain
Precommpression effect, discharges in use process in vivo, axial deformation can be delayed to elongate, to maintain sealing effect.
After sealing 1100 is connect with anchor portion 1200, by way of suture, in occluder for left auricle sealing disk
Inseam unifies layer PET choked flow film 1140, sealing waist centre and 1 layer of suture, 1150,1 layers of PET choked flow film PET resistance respectively of trying to get to the heart of a matter
Film 1160 is flowed, as shown in Figure 1.
Meanwhile can also be as needed, decide whether to stitch overlay film in the periphery of anchor portion.
Sealing 1100 is on the whole the cage structure with certain inner space, and under pre-setting state, waist is substantially
To be cylindric, comparison diagram 2 and Fig. 7 can be seen that pan bottom position after assembling and mutually push against with closing in section, and waist distal side is radially received
Hold together deformation and have certain taper, form substantially inverted round stage structure, moreover under the action of pretightning force, try to get to the heart of a matter middle part also court
Anchor portion side protrusion.
Referring to Fig. 7 b, sealing 1100 has interconnecting piece 1180 in the prior art, and anchor portion 1200 has interconnecting piece 1280,
The interconnecting piece of 1200 the two of sealing 1100 and anchor portion is extended towards and is aligned, and is extended to after contacting with each other and is passed through welding
Or the modes such as circumferential band are fixed.
There is larger gap between visible sealing 1100 and anchor portion 1200 in figure, sealing effect has much room for improvement.
In the present embodiment, sealing 1100 and the respective position that collects of anchor portion 1200 are used as interconnecting piece, can in conjunction with Fig. 5
See, the interconnecting piece of sealing 1100, that is, the distal end titanium-nickel wire 1171 after collecting is formed by 1170 convergences of trying to get to the heart of a matter, by larger area
1170 mutation of trying to get to the heart of a matter convergence, forms thinner collect.
In conjunction with Fig. 3 as it can be seen that the interconnecting piece of anchor portion 1200, that is, the proximal end titanium-nickel wire 1261 after collecting is by the netted taper of internal layer
1210 gradually convergence form thinner collect.
Referring to Fig. 7 c, after completing assembly, the interconnecting piece of anchor portion 1200 is fixed on outer layer steel bushing 1262 and internal layer steel bushing
Between 1263, and the interconnecting piece of sealing 1100 is fixed after passing through internal layer steel bushing 1263 by steel bushing 1172, and steel bushing 1172 pushes against interior
The distal end side of layer steel bushing 1263, the interconnecting piece that can be seen that sealing 1100 from the connection type are in middle section, are anchored
The interconnecting piece in portion 1200 is in its peripheral region, and the interconnecting piece of the two is inside and outside staggeredly, and crosses mutual end position.
Along occluder for left auricle axial direction, i.e. A direction projection is seen in Fig. 7 c, the interconnecting piece and sealing 1100 of anchor portion 1200
Interconnecting piece it is mutually nested, respective extension path is straight line, i.e., axially extending along occluder for left auricle, due to being dislocation cloth
It sets, there is no the interference on space in respective extend, the distance of further as far as possible sealing 1100 and anchor portion 1200, until
Mutually mutually pushed against in the interconnecting piece peripheral region of the two.
B direction projection is seen along vertical occluder for left auricle axis direction, i.e. Fig. 7 c, the interconnecting piece of anchor portion 1200 with it is close
The interconnecting piece in envelope portion 1100 is overlapped, and the interconnecting piece of sealing 1100 is in the view field of the interconnecting piece of anchor portion 1200
It is interior.
In the present embodiment, sealing 1100 and anchor portion 1200 and respective interconnecting piece are all integral structures, moreover,
Separate form can also be used, i.e., what is do not extended towards collects, but the two is in an opposite middle side part all companies of being fixed with
The connecting rod of extension bar, one of them is hollow structure, and the connecting rod of another one extends there through, and inside and outside interlock also may be implemented in this way
Be fixedly connected.
As shown in figure 8, the present embodiment left auricle of heart envelope device 1000 is transported in left auricle of heart by percutaneous catheter transportation system
Afterwards, which is anchored in left auricle of heart, and the connection type of anchor portion and sealing to form one between two parts
The structure of pretightning force, 1120 taper of occluder for left auricle waist can be attached preferably with the aperture position of left auricle of heart, be pre-tightened
It is even closer that power can allow sealing disk 1110 to attach with left auricle of heart, so that 3 layers of overlay film effectively stop blood flow to flow into a left side
In auricle, to reduce the interior incidence leaked.
Embodiment two:
Two occluder for left auricle 2000 of the utility model embodiment is made of sealing 2100 and anchor portion 2200, sealing
It is the same as example 1 with the planform after anchor portion thermal finalization.It is anchor portion and sealing with the difference of embodiment one
Connection type is different.As shown in figures 9 a and 9b.
Sealing 2100 and anchor portion in the utility model embodiment two after 2000 heat treatment shaping of occluder for left auricle
2200, wherein sealing 2100 has a distal end titanium-nickel wire to collect, and anchor portion 2200 has a proximal end titanium-nickel wire to collect.
As shown in Figure 10, in the present embodiment the proximal end of the distal end titanium-nickel wire 2171 and anchor portion of sealing titanium-nickel wire
2261 respectively collect after it is (opposite) across a steel bushing 2272 (being equivalent to connector ontology) from opposite direction.
Direction shown in arrow applies pulling force to two beam titanium-nickel wires respectively along Figure 10, makes seal disc 2100 and anchor portion 2200
Compact connection forms certain pretightning force, and makes the waist 2120 of sealing be drawn into a taper by this pretightning force
Structure;Then such as Fig. 9 b, the titanium-nickel wire 2261 of the proximal end of anchor portion can be passed through compression or welding manner through steel bushing 2172
It is fixed together, the distal end titanium-nickel wire 2171 of sealing is fixed together through steel bushing 2263 by compression or welding manner
Afterwards, then 2272 two sides of steel bushing are stuck in, and extra titanium-nickel wire is cut or is disposed by way of laser treatment.
Referring to Fig. 9 b, in the present embodiment sealing 2100 and anchor portion 2200 also using with embodiment it is a kind of as mode,
With integral structure and the interconnecting piece that extends towards, the interconnecting pieces that both difference is are that the mode deviated from each other is interlocked, to scheme
For middle orientation, one keeps left, and another one is kept right.
Equally can be to avoid space interference when extending towards, the phase that sealing 2100 and anchor portion 2200 can be crossed to the greatest extent
Mutually further.
Embodiment three:
Occluder for left auricle 3000 is made of sealing 3100 and anchor portion 3200 in the utility model embodiment three, sealing
Portion 3100 and the planform after 3200 thermal finalization of anchor portion are identical as embodiment one, embodiment two.With embodiment one, implementation
The difference of example two is that anchor portion is different from the connection type of sealing.As shown in Figure 11 a and Figure 11 b.
Sealing 3100 and anchor portion in the utility model embodiment three after 3000 heat treatment shaping of occluder for left auricle
3200, wherein sealing 3100 has a distal end titanium-nickel wire to collect, and anchor portion 3200 has a proximal end titanium-nickel wire to collect.Figure 12 a~figure
13 be sealing 3100 and another connection of anchor portion 3200 of occluder for left auricle 3000 in the utility model embodiment three
Mode.
In the present embodiment in occluder for left auricle 3000, the distal end titanium-nickel wire 3171 of sealing 3100 collects and passes through outer layer
Between steel bushing 3172 and internal layer steel bushing 3173, then by welding or compressing mode for outer layer steel bushing 3172 and internal layer steel bushing
3173 titanium-nickel wire is fixed together, internal layer steel bushing 3173 be a hollow structure, then by cut or laser treatment mode will
Titanium-nickel wire other than distal end removes.
The proximal end titanium-nickel wire 3261 of anchor portion collects and passes through the internal layer steel bushing 3173 of sealing distal end, penetrates sealing
Net is intermediate, can apply certain pulling force and sealing and the compact connection of anchor portion are formed certain pretightning force, and is pre- by this
Clamp force makes the stretching waist of sealing at the structure of a taper;Then the proximal end NiTi tow of anchor portion is passed through into steel bushing
3162 are fixed together, this 3162 outer diameter of steel bushing is greater than the internal diameter of sealing internal layer steel bushing 3173, and anchor portion proximal end is extra
Titanium-nickel wire cut or laser treatment is fallen.
Example IV:
Relative to embodiment one, it is the shape of waist on sealing in place of the difference of the present embodiment, as it can be seen that empty in Figure 14
Pan bottom in coil is divided into flat-bottom structure, and waist is collectively as converging portion, and the bus of converging portion is straight line, and sealing removes
Other than disk position, the round table-like of standard can be considered.
On the bus of converging portion, one end far from anchor portion is starting point A, is terminal B, starting point A close to one end of anchor portion
The angle α of line Y and occluder for left auricle axis X between terminal B are about 45 degree.
Embodiment five:
Relative to embodiment one, the shape for being waist on sealing in place of the difference of the present embodiment and trying to get to the heart of a matter, Figure 15
In as it can be seen that the trying to get to the heart of a matter part in virtual coil is not flat-bottom structure, and slightly restrain, waist and between trying to get to the heart of a matter in the present embodiment
Boundary be not it is obvious that be only it is artificial divide, but this is not the utility model emphasis.
When Figure 15 mid-game bottom is not flat-bottom structure, on the bus of converging portion, one end far from anchor portion is starting point A, terminal B
Just the axis position of sealing is reached.The angle α of line Y and occluder for left auricle axis X between starting point A and terminal B are about
It is 55 degree.
Embodiment six:
Relative to embodiment one, it is the shape of waist on sealing in place of the difference of the present embodiment, as it can be seen that receiving in Figure 16
Hold back section bus wherein one section be straight line, straight line both ends are respectively endpoint C and endpoint D, the line between endpoint C and endpoint D with
The angle α of occluder for left auricle axis X is about 30 degree.
Embodiment seven:
The present embodiment emphasis illustrate anchor portion release and in assembling process sealing shape variation, anchor portion with
And sealing specific structure can combine unless otherwise specified at least one of other embodiments.
Referring to Figure 17 a~Figure 17 c, occluder for left auricle includes sealing 5100 and anchor interconnected in the present embodiment
Determine portion 5200, anchor portion 5200 is compressed in sheath to be walked in vivo into lesions position, compressive state before releasing
Lower anchor portion 5200 is tubular, and position A is in cylindrical inner wall, as (turnup direction can be found in arrow to the release of 5200 turnup of anchor portion
Head instruction direction), position A is gradually turned up by cylindrical inner wall, is finally offseted with the position of trying to get to the heart of a matter of sealing 5100.
Referring to Figure 18~Figure 20, sealing 1100 includes disk, waist and tries to get to the heart of a matter 5110, and 5110 central area of trying to get to the heart of a matter is received
Beam forms distal end titanium-nickel wire 5120, and distal end titanium-nickel wire 5120 passes through the connecting portion 5210 of anchor portion (for example, by using shapes such as steel bushings
Formula).
In various embodiments, try to get to the heart of a matter 5110 central region can backwards to anchor portion protrusion, such as Figure 18;It tries to get to the heart of a matter
5110 central region can be flat, such as Figure 19;Try to get to the heart of a matter 5110 central region can also towards anchor portion protrusion, such as Figure 20.
Above it is to try to get to the heart of a matter 5110 not assembling completion, i.e., not yet applies features of shape when pretightning force, apply pretightning force
Afterwards, 5110 central region of trying to get to the heart of a matter has different degrees of deformation, generally further draws close towards anchor portion.
1~Figure 25 referring to fig. 2, by taking one of which tries to get to the heart of a matter shape as an example, sealing is respectively processed and is heat-treated with anchor portion
Start to assemble after sizing, the connecting portion 5210 that distal end titanium-nickel wire 5120 passes through anchor portion is first made into sealing and anchor portion edge
It is axial close to each other.
Such as Figure 22, just contact still without applying pretightning force when be first state, the 5110 central region C of trying to get to the heart of a matter at this time has
Backwards to the trend of anchor portion protrusion, then distal end titanium-nickel wire 5120 is pulled downward on along Figure 23 arrow direction, and the connection of anchor portion
Position 5210 then moves upwards in the direction of the arrow relatively, and central region C stress and deformation is until reach scheduled deformation or pretightning force
It is required that recycle 5130 stationary remote titanium-nickel wire 5120 of anti-drop head, as the second state, such as Figure 24 at this time, central region C stress
Deformation is in flat state substantially.
In order to control assembling process, the variation of angle B or the axial direction of central region C can be monitored when applying pretightning force
Variable quantity H, central region C stress and deformation can more obviously be embodied by Figure 25 comparison, and dotted line expresses middle part under first state
The position of region C.
6~Figure 28 referring to fig. 2, in another embodiment, sealing have just been contacted still with anchor portion without applying pretightning force
When be first state, the 5110 central region C of trying to get to the heart of a matter at this time has trend backwards to anchor portion protrusion, distal end titanium-nickel wire when assembly
It pulls downward on, and the connecting portion of anchor portion then relative upward movement, central region C stress and deformation is until reach scheduled deformation
Or force request is pre-tightened, recycle anti-drop head stationary remote titanium-nickel wire, as the second state at this time, when central region C stress and deformation
The waist of sealing is radially converged along Figure 27 arrow direction, is on the whole in the second condition inverted cone shape together with pan bottom, is passed through
Figure 28 comparison can more obviously embody, and dotted line expresses the position of waist and central region C under first state.
Embodiment eight:
9 and Figure 30 referring to fig. 2, occluder for left auricle includes sealing 6100 and anchor portion 6200, sealing in the present embodiment
Portion 6100 is in the first state that inverted cone shape tries to get to the heart of a matter 6110 towards the side in anchor portion, and 6110 central areas of trying to get to the heart of a matter collect to be formed
Distal end titanium-nickel wire 6120, distal end titanium-nickel wire 6120 pass through the connecting portion 6210 of anchor portion 6200 (for example, by using shapes such as steel bushings
Formula).
Under the second state after assembly, try to get to the heart of a matter 6110 middle part further move close to 6210 taper of connecting portion increase, distal end
Titanium-nickel wire 6120 locks axial position by anti-drop head 6130.
Embodiment nine:
The present embodiment emphasis illustrates anchor portion and the different connection type of sealing, and anchor portion and sealing are specific
Structure can combine unless otherwise specified at least one of other embodiments.
In the present embodiment attached drawing, occluder for left auricle includes sealing 7100 interconnected and anchor portion 7200, close
Envelope portion 7100 includes disk, waist and tries to get to the heart of a matter 7110.
Figure 31, Tu32Zhong, the 7110 central area shape of trying to get to the heart of a matter restrain to form interconnecting piece, i.e., central area collect to be formed it is remote
Titanium-nickel wire 7120 is held, shape restrains to form interconnecting piece on the whole at the middle part of anchor portion, and end (such as is adopted by connector 7210
With steel bushing) it is fixed, distal end titanium-nickel wire 7120 passes through the hollow part of the connector 7210 of anchor portion and opposite tenses shape when assembly
At pretightning force, anchor portion and sealing mutually push against the central region deformation at hub disk bottom further towards anchor portion protrusion, finally
Using (for example, by using the stirrup) stationary remote of anti-drop head 7130 titanium-nickel wire 7120, then cut off the redundance of distal end titanium-nickel wire 7120
Complete assembly.
In other embodiment, referring to Figure 33, Figure 34, the 7110 central area shape of trying to get to the heart of a matter restrains to form interconnecting piece,
I.e. central area collects to form distal end titanium-nickel wire 7120, and shape restrains on the whole at the middle part of anchor portion, that is, collects to form proximal end nickel
Titanium silk 7220, using band, there are two the connectors 7210 in the channel being arranged side by side, so that distal end titanium-nickel wire 7120 and proximal end NiTi
Silk 7220 is in opposite directions through corresponding channel and opposite tense forms pretightning force, after anchor portion and sealing mutually push against
The central region deformation tried to get to the heart of a matter further towards anchor portion protrusion, finally utilizes anti-drop head 7130 (for example, by using stirrup) stationary remote
Titanium-nickel wire 7120, then cut off the redundance of distal end titanium-nickel wire 7120;It is fixed close using anti-drop head 7230 (for example, by using stirrup)
Titanium-nickel wire 7220 is held, then cuts off the redundance completion assembly of proximal end titanium-nickel wire 7220.
In other embodiment, referring to Figure 35, Figure 36, the 7110 central area shape of trying to get to the heart of a matter restrains to form interconnecting piece,
Its end is fixed by connector 7140 (for example, by using steel bushing), and shape restrains on the whole at the middle part of anchor portion, that is, collects to be formed
Proximal end titanium-nickel wire 7220, proximal end titanium-nickel wire 7220 passes through the hollow region of connector 7140 and opposite tense forms pretightning force, anchor
Determine portion and sealing and mutually push against the central region deformation at hub disk bottom further towards anchor portion protrusion, utilizes anti-drop head 7230
(for example, by using stirrup) fixed proximal end titanium-nickel wire 7220, then cut off the redundance completion assembly of proximal end titanium-nickel wire 7220.
In other embodiment, referring to Figure 37, Figure 38, the 7110 central area shape of trying to get to the heart of a matter restrains to form interconnecting piece,
I.e. central area collects to form distal end titanium-nickel wire 7120, and shape restrains on the whole at the middle part of anchor portion, that is, collects to form proximal end nickel
Titanium silk 7220.
Between distal end titanium-nickel wire 7120 and proximal end titanium-nickel wire 7220 by the way of being directly connected to, that is, connector is eliminated,
Visible 7220 bolt of proximal end titanium-nickel wire is wrapped in 7120 periphery of distal end titanium-nickel wire in figure, and in distal end, 7120 end of titanium-nickel wire is settable
The end of anti-drop head 7130 (for example, by using stirrup), proximal end titanium-nickel wire 7220 can be fixed on sealing by the way of welding
It tries to get to the heart of a matter position, can also be its spiral-shaped preparatory thermal finalization processing, when winding overcomes its elasticity expansion and again around the home remote
7120 periphery of titanium-nickel wire is held, moreover, distal end titanium-nickel wire 7120 can also use spiral way, mutual with proximal end titanium-nickel wire 7220
Around.
In other embodiment, referring to Figure 39, Figure 40,7110 global shapes of trying to get to the heart of a matter restrain to form interconnecting piece, i.e., integrally
It collects to form distal end titanium-nickel wire 7120, shape restrains to form interconnecting piece on the whole at the middle part of anchor portion, and end passes through connector
7210 is fixed (for example, by using steel bushings), and distal end titanium-nickel wire 7120 passes through the hollow part of the connector 7210 of anchor portion simultaneously when assembly
Opposite tense forms pretightning force, finally utilizes (for example, by using the stirrup) stationary remote of anti-drop head 7130 titanium-nickel wire 7120, then cut off
The redundance of distal end titanium-nickel wire 7120 completes assembly.
Disclosed above is only specific embodiment of the utility model, but the utility model is not limited to this, ability
The technical staff in domain can carry out various modification and variations without departing from the spirit and scope of the utility model to the utility model.
These obvious modification and variations should belong in the protection scope protection of the requires of the utility model.In addition, although in this specification
It uses some specific terms, these terms are merely for convenience of description, and it is any special not constitute to the utility model
Limitation.