CN108926368A - It is a kind of to use the occluder for left auricle and its assembly method for being cross-linked structure - Google Patents
It is a kind of to use the occluder for left auricle and its assembly method for being cross-linked structure Download PDFInfo
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- CN108926368A CN108926368A CN201810480128.0A CN201810480128A CN108926368A CN 108926368 A CN108926368 A CN 108926368A CN 201810480128 A CN201810480128 A CN 201810480128A CN 108926368 A CN108926368 A CN 108926368A
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- occluder
- left auricle
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
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- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A—HUMAN NECESSITIES
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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Abstract
The invention discloses a kind of using the occluder for left auricle and its assembly method that are cross-linked structure, occluder for left auricle includes sealing interconnected and anchor portion, the sealing and anchor portion are respectively provided with the interconnecting piece being made up of shape convergence, and the interconnecting piece of both sealing and anchor portion extends towards and the fixation that misplaces;Wherein the anchor portion is that cutting is formed, and the distal side of anchor portion before releasing is closed loop configuration.Occluder for left auricle of the present invention improves the connection type of sealing and anchor portion, can avoid and delays occluder for left auricle axial elongated on the whole, is further ensured that sealing attaches and block left auricle of heart mouth.
Description
Technical field
The present invention 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, clinical test shows that anticoagulant treatment can significantly reduce the probability of happening of cerebral apoplexy, but anticoagulation
Object treatment is a very long process, while there is also apparent complication.Surgical operation therapy include surgical resection or
Person sutures left auricle of heart, but surgery operating wound is big, other operations such as valve replacement or coronary bypass of being usually expert at
When complete, patient is generally difficult to receive simple left auricle of heart surgical operation, especially elderly patient.Percutaneous left atrial appendage occlusion treatment
Refer to by way of percutaneous puncture, using the lesser delivery sheath of a diameter, an occluder for left auricle is transported to positioned at the heart
The left auricle of heart of dirty atrium dextrum and release, to achieve the purpose that prevent auricular fibrillation thromboembolism.It is percutaneous left since 2001
Atrial appendage occlusion treatment starts to come into operation, and has successively carried out zoopery and clinical test.Divide from structure, it is left currently on the market
Atrial appendage occlusion device mainly divides two types:Plug structure and double disk structure.
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, i.e.,: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.
The structure of the occluder for left auricle of existing double disk structure, anchor portion is generally knitted to form reticular structure, cuts
Formed it is rod-shaped, for the anchor portion of woven mesh structure, since wire rod can have partial intersection overlapping used in the process of braiding, so
Delivery sheath size required for the anchor portion of woven mesh structure is often greater than the cutting structure under the same terms;And it cuts
Rod-shaped anchor portion, because of rod-like structure end opposing spaced apart and hanging feature releases sheath after takeing in sheath once more
During pipe, there are the risks that supporter end easily tangles, and then anchor portion is caused not to be unfolded normally, in the prior art often
It is constrained by the way that overlay film is arranged in supporter end, and increasing overlay film can make sheath pipe diameter used increase.
Summary of the invention
The present invention provides a kind of occluder for left auricle, to end (far from one end of sealing before release) shape of anchor portion
It improves, prevents end from tangling and being easier to repeatedly to discharge.Further also improve the connection of sealing and anchor portion
Mode can avoid and delay occluder for left auricle axial elongated on the whole, is further ensured that sealing attaches and block left auricle of heart
Mouthful.
A kind of use is cross-linked the occluder for left auricle of structure, including sealing interconnected and anchor portion, described
Sealing and anchor portion are respectively provided with the interconnecting piece being made up of shape convergence, and the interconnecting piece of both sealing and anchor portion is opposite
Extend and the fixation that misplaces;Wherein the anchor portion is that cutting is formed, and the distal side of anchor portion before releasing is closed loop configuration.
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
Directly offset, naturally it is also possible to using the connector of transition, this structure will lead to plugging device, and axial length is too long on the whole,
It is unfavorable for sealing.
Sealing and the dislocation of the interconnecting piece of anchor portion are arranged in the present invention, space can be avoided dry during opposite move close to
It relates to, significantly reduces sealing and anchor portion spacing, improve sealing effect.
Anchor portion uses more support bars, by it is multiple mutually cross, Y-shaped reticulates structure, either there is rule
The cell for restraining distribution, is also possible to random cell, its periphery is surrounded by support bar for each cell.
The distal side of anchor portion before releasing is the endpoint that isolated, single support bar is not present using closed loop configuration, generally
The adjacent two support bar end that can be mutually cross connection, form V-arrangement or U structure.
The present invention can eliminate the risk that anchor portion end easily tangles by closed loop configuration, guarantee that anchor portion is smoothly unfolded.
The distal side of anchor portion of the present invention before releasing uses the support bar of closed loop configuration, relative to the more dense of cutting
Anchoring web frame, be more easier to discharge.
More dense its end of anchoring web frame, which interconnects, to cross, and forms mutually constraint, during release, due to
Cutting net end, which mutually pulls, forms a very big restraining force, so the end can show one forward when release
The horn mouth stretched cannot achieve the turnup of anchoring net, cause successfully discharge anchor portion.
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.
Sealing is process by way of weaving or cutting, and sealing can be using rule or irregular netted knot
Structure, using can be as needed in suitable position setting skeleton to improve intensity when reticular structure, and skeleton is relative to other parts
It can be the increase of sectional area, or at least there is higher intensity, reticular structure can have rule or irregular cell,
It is preferred that the cell of diamond shape or near-rhombic, can at least be compressed radially, and in order to recycle and discharge, reticular structure
With apparent longitude and latitude structure, longitude and latitude intersection can be stationary nodes, can also use revocable mode, i.e., between longitude and latitude
Can misplace sliding, 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 converges to global convergence or local convergence.
Sealing and anchor portion have certain diameter range due to left auricle of heart to be blocked, and interconnecting piece diameter compared with
Carefully, diameter change therebetween can be gradual change or mutation, for example, by using global convergence mode when diameter change position present
Pyramidal structure, and local convergence can be considered as the mutation of diameter, such as be mutated into thinner bar or beam by biggish sectional area.
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 are there is no stringent limitation, when only at one, generally lie in sealing or
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 regarded as sealing and sealing is at least a part of contacts with each other, and
Due to pushing against power, so that sealing has deformation.
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.
At least one of choked flow film is equipped in the sealing, sealing is that the wire frame structure that cutting is formed or establishment are formed
Reticular structure.
The present invention is provided with one or more choked flow film in sealing;Overlay film can also be carried out in the periphery of anchor portion,
Such as all or part of overlay film on anchor portion outer surface.
Anchor portion end mentioned in the present invention, refers to anchor portion before release, that is, is in compressive state or the left heart
When ear plugging device is compressed in conveying device, one end far from sealing, state before which is known as compressive state or discharges;
Occluder for left auricle discharges the state after expansion in vivo, can also claim to discharge (rear) state or swelling state.
In no specified otherwise, the sealing of description of the present invention and the shape of anchor portion can be regarded as discharging
Under state.
One end far from operator when distal end of the present invention refers to operation, and distal end and proximal end are relative concept.By this
Invention release operation and left auricle of heart physiological structure feature are limited, and anchor portion is in the distal end of sealing, corresponding orientation relationship with
This analogizes.
Optionally, the sealing is seal disc or sealing-plug.
" disk ", " plug " herein is interpreted as rough features of shape, for example, disk be it is flat, outer rim shape substantially conforms to
Physiological make-up feature at left auricle of heart, such as round or other shapes according to actual needs.
Such as plug is with certain thickness column, such as approximate cylinder, rotary table etc., but no matter its periphery or bus
Shape does not limit strictly, on the one hand can refer to the prior art, on the other hand can also according to actual needs, with regard to sealing itself
For shape and non-present invention improves emphasis, and certainly, present invention provides preferred or improved plans.
Preferably, the sealing is seal disc, have the pre-setting state that is not contacted with anchor portion and with anchoring
The abutting state that portion contacts with each other, relative to pre-setting state, the seal disc bottom surface for pushing against state has towards anchor portion side
Deformation.
Preferably, the sealing is seal disc, and there is the pre-setting state not contacted with anchor portion and and anchor
Determine the abutting state that portion contacts with each other;Relative to pre-setting state, the middle part for pushing against the seal disc of state has axially towards anchoring
The deformation of portion's protrusion.
Preferably, the sealing includes trying to get to the heart of a matter and connecting disk backwards to the disk of anchor portion, towards anchor portion
With the waist tried to get to the heart of a matter, wherein described try to get to the heart of a matter as flat or middle part of trying to get to the heart of a matter towards anchor portion side protrusion or middle part of trying to get to the heart of a matter backwards to anchor portion
Side protrusion.
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 present invention.The diameter of cage structure be mainly waist diameter and anchor portion it is straight
Diameter is substantially suitable, and disk diameter improves the plugging effect of end slightly larger than the diameter of waist.
Preferably, the diameter of waist and anchor portion diameter are basic quite or to be slightly larger than anchor portion diameter, and in disk and
Choked flow film is respectively provided in waist.
Waist has enough outer diameters, and when use can cooperate with left auricle of heart lumen contact with disk, forms dual-seal and imitates
Fruit.
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, the diameter under pre-setting state of trying 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.
Disk described herein 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 be section
The relativeness of long-pending or whole thickness, since the diameter of disk is greater than the diameter tried to get to the heart of a matter, is on the whole circle by taking circle as an example
The top surface of platform shape, upper part is bigger, more down more restrains, the bottom surface of lower part is smaller, in this way when offseting with anchor portion, can comply with
Be bonded with anchor portion.
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 pushes against the sealing of state in waist and/or tries to get to the heart of a matter with deformation relative to pre-setting state.
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, the anchor portion is cut by tubing forms.
Optionally, the tubing is Nitinol material.
Optionally, sealing is bottom towards anchor portion side, and described tubing one end is the interconnecting piece equipped with annular, and should
Interconnecting piece is connected with the bottom of sealing.
Optionally, the seperated knot that the interconnecting piece of anchor portion is structure as a whole or is fixed to each other with the rest part of anchor portion
Structure;The bottom of the sealing collects and passes through the interconnecting piece of anchor portion, and the company for being limited to anchor portion is equipped on being pierced by part
The axial limiting portion of socket part.The bottom of the i.e. described sealing collects interconnecting piece of the position as sealing.
The interconnecting piece of anchor portion is ring structure, and central area extends through convenient for the part of sealing bottom, is anchored
When the interconnecting piece in portion and the rest part of anchor portion are structure as a whole, the rest part of anchor portion implements cutting, and in end head
The reserved one end in position is not cut, the interconnecting piece of the end position as anchor portion, and furthermore the interconnecting piece of anchor portion is also possible to point
Body structure is fixedly connected using forms such as welding, hook or bindings with the rest part of anchor portion.
Optionally, the anchor portion is by constituting extended segment backwards to sealing extension at itself interconnecting piece, and extended segment is far from close
The side in envelope portion, which turns up to turn back, constitutes back-turning section to the bottom of sealing, which folds in the bottom position of sealing
The bottom of mouth formation closing in section, the closing in section and sealing offsets.
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.
Closing in section substantially radially extends inwardly, contacts with the bottom of sealing, is more advantageous to application pretightning force.
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.
Since closing in section is suspended in the periphery of extended segment, it is single layer structure that anchor portion can smooth out with the fingers directly before releasing, in order to fill
It is loaded into sheath and recycling, after anchor portion distal end is detached from sheath when release, has and proximally facing turn over the trend stuck up;With discharging
The progress of journey, distally further towards proximal end turnup;After release, the edge of distal end turnup to proximal end and distal end keeps opening
State.
Optionally, the extended segment is taper, and major part side (i.e. cone bottom side) is far from interconnecting piece and opening setting.
Extended segment is horn-like convenient for recycling, and can also be improved the stability of intensity and structure at flaring.
Anchor portion is proximal end close to the side of sealing, and the side far from sealing is distal end, the connecting portion of anchor portion
In anchor portion proximally and distally between, the axial distance of the interconnecting piece of anchor portion and anchor portion proximal end is L1, the company of anchor portion
The axial distance of socket part and anchor portion distal end is L2;And L1 is greater than L2.
On the one hand the interconnecting piece of anchor portion can save material far from sealing, in addition extend relative to the axis of anchor portion
The suitable tilt angle of Duan Caiyong is conducive to improve the radial stability after release.Can will anchor portion interconnecting piece axial direction in
Point is used as reference point, measures the distance of anchor portion axial sides respectively.
Preferably, L1:L2=1.2~2:1.
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, in anchor portion axial direction, the interconnecting piece of anchor portion is than closing in section further from sealing;Relatively
Under pre-setting state, abutting state, in anchor portion axial direction, the interconnecting piece of anchor portion is with respect to closing in section further towards sealing
Portion.
When i.e. sealing and anchor portion are relatively close, closing in section is first contacted with the bottom of sealing, due to the company of anchor portion
Socket part and sealing still have a distance farther out, this section of distance is also that further drawing forms pretightning force there are spaces and can
Energy.
The closing in section inner edge after the corresponding release in distal end before anchor portion release, closing in section include that be spaced apart multiple support
Pawl respectively supports pawl around the axis distribution of anchor portion and offsets with sealing.
For abutting metastable between anchor portion and sealing, there should be enough quantity and circumferentially distributed to pawl.
Preferably, the pawl that supports is engraved structure only with frame.Lesser radial ruler can be obtained before releasing
Very little, i.e., in the preferred scheme, the pawl that supports other than itself frame, there is no support construction be more convenient for compressing by inside.
Optionally, the pawl that supports is at least four, and respectively supporting pawl towards closing in section inner edge side is closed loop configuration, and direction closes up
Section outer rim side is connect with the back-turning section.
Here closed loop configuration, that is, above-mentioned " distal side of anchor portion before releasing be closed loop configuration ", to avoid spine or
Isolated endpoint.
Preferably, the pawl that supports is at least six.As further preferred, the pawl that supports is seven~nine.
Each supporting pawl includes two first support bars, this two first support bar one end are intersected in closing in section inner edge, intersection
Position is V-shaped or U-shaped, the other end of two first support bars extend to closing in section outer rim and intersect with back-turning section.
V-arrangement or U-shaped are only the general shape to pawl end, illustrate the trend to cross, excellent when intersection area is V-arrangement
Being selected in the end polishing that crosses is rounded structure.
Respectively support pawl towards closing in section inner edge side relative to towards closing in section outer rim side farther away from sealing.
I.e. the extending direction to pawl is radial not along anchor portion, but slightly inclination angle, more closes on anchor portion axis, further away from
Sealing.Due to supporting pawl end far from sealing, pawl is respectively supported with what sealing offseted and is positioned adjacent to closing in section outer rim.
In order to preferably guide anchor portion to discharge and avoid stabbing body cavity walls, preferably, respectively supporting pawl and the folding
The position for returning section connection is arc transition.
Adjacent supporting is mutually indepedent at closing in section position between pawl.
Adjacent supports pawl independently of one another there is no cross-linked structure is formed, so that there is certain activity in anchor portion end when overturning
Space is recovered to the structure bent to interconnecting piece when can discharge from sheath, smoothly complete release.
The back-turning section has unit grid structure, under release conditions the first vertex of each unit grid towards sealing,
In pairs, same group of two first support bars extension is crossed to form wherein the first support bar extended by each first vertex
One supports pawl.
It constitutes the first support bar to pawl to extend from the unit grid vertex of back-turning section, regular unit grid structure
It circumferentially arranges, so that the mechanical property at each position is roughly the same, for each unit grid, shape is not done strictly
Limitation.
Preferably, the unit grid be hexagonal mesh structure or network structure or hexagonal mesh structure with
The combination of network structure.
Preferably, extended segment is made of the second support bar of more radiation profiles, each second support bar one end and anchoring
The interconnecting piece in portion intersects, and the other end extends to back-turning section.
The back-turning section has unit grid structure, and the second vertex of back-turning section each unit grid is backwards to close under release conditions
Envelope portion, each second support bar extend and intersect at corresponding second vertex.
First support bar of the present invention, the second support bar, the first vertex, in the second vertex, " first ", " second " are only
Only for distinguishing locating different parts, additional qualification is not made to the design feature on support bar or vertex itself.
Second support bar to the second vertex during extension, it is mutually indepedent between the second adjacent support bar.Due to simultaneously
There is no cross-linked structure and use mutually indepedent setting, it is easier to radial compression and overturning release.
Optionally, in anchor portion axial direction, the unit grid of back-turning section is a row, two rows or three rows.
Preferably, the unit grid of back-turning section is a row, the intersection area of adjacent cells grid in anchor portion axial direction
It is in the middle part of back-turning section, as cross-shaped portion, is crossed for the first time between the adjacent pawl that balances each other in cross-shaped portion.
Similarly, it is handed over for the first time after being extended outwardly between adjacent two second support bar by the interconnecting piece of anchor portion in cross-shaped portion
It converges.
Cross-shaped portion is in the middle part of back-turning section, can make the first adjacent support bar and the second adjacent support bar it
Between be all independent from each other before extending to cross-shaped portion, can have the characteristics that bigger freedom degree to adapt to the left heart of different configuration
Ear inner wall.
Cross-shaped portion is preferably straightway, for example, by using hexagonal mesh structure, the position of adjacent two unit grids intersection
An as straightway.
Optionally, the outside of the cross-shaped portion is equipped with hangnail.
Optionally, in the unit grid structure, two support bars are 20 ° -70 ° in the intersecting angle of intersection part.
Before release, it is radially in compressive state, each support bar is gathered to center, therefore two support bars are in intersection
The intersecting angle of position refers generally in the released state.
Optionally, the width for forming the support bar of anchor portion reticular structure is 0.18~0.3mm.
Here support bar refers to anchor portion, certainly also includes the first support bar and the second support bar.
Optionally, the outside of the anchor portion is equipped with hangnail.
Hangnail can stablize the position for keeping occluder for left auricle in left auricle of heart, and in the case where there is overlay film, hangnail is pierced by
Overlay film extends to outside.
Optionally, the hangnail and anchor portion are structure as a whole.
I.e. hangnail is also to cut, and can cut through overdraw at the position for forming hangnail as a part of support bar
Stay, such as cut with "-" type notch in support bar side, or cut with V-notch at the middle part of support bar transverse direction.
The hangnail has many places around anchor portion is circumferentially distributed.
In anchor portion axial direction, each hangnail is located at the middle part of anchor portion.
Optionally, the bottom of the sealing collects and passes through the interconnecting piece of anchor portion, is equipped on being pierced by part limited
In the axial limiting portion of the interconnecting piece of anchor portion.
Sealing then mutually gathers receipts in the bottom of sealing for weaving the silk of sealing if the reticular structure of braiding
Beam, this, which is collected, is presented as structure feature, also contains corresponding steps when processing, i.e., multi-filament is pooled a bundle.
Sealing cuts the wire frame structure to be formed if tubing, and the end of sealing tubing, which can be used as, collects position.
Optionally, the axial limiting portion is that banding is fixed on the anti-drop head that sealing collects periphery.
Anti-drop head outer diameter is greater than the internal diameter of the interconnecting piece of anchor portion, and sealing is limited to the state being affixed with anchor portion,
And necessary pretightning force can be maintained.
Anti-drop head can for stainless steel, Nitinol or other meet the metal material of biocompatibility requirement.The present invention
The occluder for left auricle is transported to the position of heart left auricle of heart by delivery sheath by way of percutaneous puncture,
By left atrial appendage occlusion, thrombus is formed to prevent patients with atrial fibrillation in left auricle of heart and then leads to the risk of apoplexy.
Preferably, the back-turning section includes the multiple unit grids being circumferentially arranged, unit grid is in anchor portion axial direction
Both ends all have endpoint, support bar is connected at endpoint, each support bar is respectively formed extended segment towards corresponding direction bending
With closing in section.
As further preferred, the back-turning section includes at least a complete unit grid in the axial direction.
The present invention uses unit grid structure, and an at least complete row in axial direction in back-turning section, can provide stronger
Radial support power, distribution of force is more uniform.
If not forming complete row cell structure in back-turning section is likely to result in proximally and distally having for back-turning section
Biggish intensity difference, the possibility used under the special environment being not precluded certainly.
Preferably, each mutually independent extension of support bar crosses to the interconnecting piece of anchor portion in the extended segment.
Preferably, each support bar is mutually crossed in pairs for the closed loop configuration in the closing in section.
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 double-layer structure, it is bottom towards anchor portion, is top layer backwards to anchor portion,
Sealing is connected by bottom with anchor portion.
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 is connected, and is easier to obtain the pre- deformation of sealing when anchor portion and sealing system mutually push against, in other words
Efficiency is obtained with higher deformation.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 is:
The axial force of connecting portion between sealing and anchor portion;Or
The pressure of contact site between sealing and 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.
It is close accordingly the present invention also provides a kind of assembly method using the occluder for left auricle for being cross-linked structure
Envelope portion and anchor portion are assembled after completing thermal finalization, and sealing and anchor portion are mutually the closer and when initially contacting when assembly
One state;On the basis of first state, after the connecting portion between sealing and anchor portion is axially towards one another movement preset distance
Reach the second state;
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 with the axial position between anchor portion there is no changing, only local deformation or
Stress.
The present invention realizes sealing and the compact connection of anchor portion by improving connection type, and keeps certain pretightning force energy
The even closer and closure left auricle of heart for enough allowing sealing and left auricle of heart 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 in occluder for left auricle of the present invention before sealing assembling;
Fig. 2 a is the schematic diagram in occluder for left auricle of the present invention before anchor portion assembling;
Fig. 2 b is the schematic diagram of another angle of anchor portion in Fig. 2 a;
Fig. 3 is the schematic diagram of sealing and anchor portion connection procedure;
Fig. 4 is the schematic diagram after occluder for left auricle of the present invention assembling;
Fig. 5 is the schematic diagram of occluder for left auricle in embodiment 2;
Fig. 6 is the schematic diagram of occluder for left auricle in embodiment 3;
Fig. 7 a~Fig. 7 c is the schematic diagram that occluder for left auricle of the present invention discharges process;
Fig. 7 d is part A enlarged drawing in Fig. 7 c;
Fig. 8 a~Fig. 8 d is the schematic diagram of anchor portion release conditions process in occluder for left auricle of the present invention;
Fig. 9~Figure 11 is that anchor portion discharges process schematic in embodiment 4, and sealing is illustrated with state after discharging in figure;
Figure 12~Figure 14 is the schematic diagram of the sealing of different shapes of trying to get to the heart of a matter in embodiment 4;
Figure 15~Figure 19 is the control schematic diagram of 4 mid-game bottom of embodiment deformation front and back;
Figure 20~Figure 22 tries to get to the heart of a matter for another shape in embodiment 4 deforms the control schematic diagram of front and back;
Figure 23~Figure 24 is the control schematic diagram of 5 mid-game bottom of embodiment deformation front and back;
Figure 25~Figure 34 is the assembly front and back schematic diagram of different connection types in embodiment 6.
Specific embodiment
Embodiment 1
As shown in Figure 1, the sealing 1 of occluder for left auricle of the present invention is woven using titanium-nickel wire, sealing 1 includes disk
It face 11, waist 12 and tries to get to the heart of a matter 14, has bolt head 13 for connecting conveying device in disk end.Sealing 1 is on the whole for one
The cage structure for determining inner space, under pre-setting state, waist 12 is generally cylindrical, the axial middle part of disk 11, waist 12
It region and tries to get to the heart of a matter and is sewed with 1 layer of choked flow film (omitting in figure) respectively in 14.
Sealing 1 and anchor portion 2 before proceeding, are formed by mold high-temperature heat treatment, close after heat treatment shaping
Envelope portion 1 has a distal end to collect the titanium-nickel wire 15 of processing, is equivalent to the interconnecting piece of sealing 1.
As shown in Fig. 2 a~Fig. 2 b, anchor portion 2 cuts to be formed using tubing, reserved when centre is cutting not cut
Part, interconnecting piece 21 of the part as anchor portion, the cut portion of anchor portion by interconnecting piece 21 its extend radially outward and
Simultaneously far from sealing, the extended segment 22 of netted taper is formed, the outer sealing Zhou Dynasty side of extended segment 22, which turns down to be formed, turns back
Section 23, which extends proximate to trying to get to the heart of a matter for sealing, passes through arc transition part 24 between extended segment 22 and back-turning section 23
It is mutually linked.
Back-turning section 23 bends inwards at neighbouring sealing and extends to form closing in section 25, back-turning section 23 towards anchor portion axis
It is mutually linked between closing in section 25 by arc transition part 26.
Extended segment 22 constitutes internal layer web frame, and back-turning section 23 constitutes outer layer web frame, and closing in section 25 is suspended in interconnecting piece 21
Periphery.
Such as:Extended segment is several rod-like structures radially scattered;Back-turning section 23 includes generally axially being distributed
Longitudinal bracing item (i.e. longitudinal bracing item is arranged along anchor portion axis direction), longitudinal bracing item has more circumferentially successively to arrange,
It is connected with each other between each longitudinal bracing item by circumferential connecting rod.
Under release conditions, in anchor portion axial direction, circumferential connecting rod can be set it is a row or multi-row, when circumferential connecting rod only
When having a row, multiple units of open loop structure are constituted between circumferential connecting rod and each longitudinal bracing item.
When circumferential connecting rod has multiple rows of, closed loop configuration is constituted between adjacent row circumferential direction connecting rod and each longitudinal bracing item
Have multiple unit grids.Unit grid is hexagon or quadrangle.Can be regarded as back-turning section 23 at this time is by longitudinal bracing item
The reticular structure constituted with circumferential connecting rod.
Left auricle of heart wall is punctured to avoid the tip at circumferential connecting rod turnover position from forming spine, it can be in the turning point of connecting rod
Position is drawn support bar and is mutually connected with closing in section or extended segment accordingly, specifically as shown in figs. 3-4.
In conjunction with Fig. 3 and Fig. 4, anchor portion 2 is reticular structure on the whole, in the released state, in 21 axial direction of interconnecting piece
Point is used as reference point, and the axial distance with anchor portion proximal end is L1, and the axial distance with anchor portion distal end is L2;And L1 is greater than
L2。
Back-turning section 23 has the unit grid of a line hexagon along axial arranging, such as unit grid 30 adjacent in figure, list
First grid 31 and unit grid 32 are the cross-shaped portion 39 (longitudinal bracing item) of straightway shape between two unit grids.
Extended segment 22 includes the more support bars extended from the radiation of interconnecting piece 21, such as adjacent support bar 36 and support bar
37, by the orientation Fig. 3, each support bar is folded upward at again after from interconnecting piece radial radiation and slightly sinking, until support bar 36 and unit
The connection of 31 bottom apex of grid, support bar 37 are connect with 32 bottom apex of unit grid.Support bar 36 and 37 one end of support bar are logical
It crosses interconnecting piece 21 to be connected, the other end is via unit grid 31 and unit grid 32 until reaching unit grid 31 and unit grid 32
Between cross-shaped portion just mutually cross, before this independently of each other, have biggish freedom degree.Closing in section 25 can be directly connected to
The support bar of extended segment can also connect the support bar of extended segment by circumferential connecting rod.As shown in figures 3 and 4, closing in section 25 includes
Circumferentially it is multiple support pawl (to avoid view from interfering, in Fig. 3 omit rear side respectively support pawl, other relevant drawings are similarly),
Respectively supporting pawl is that border structure is surrounded by two support bars, such as support bar 33 and support bar 34 intersect at endpoint in anchor portion end
35, it is v-shaped structure at endpoint 35, that is, forms closed loop configuration.
The other end of support bar 33 and support bar 34 each extends over until with 32 top of unit grid 31 and unit grid
Vertex is connected.On the left of support bar 33 be it is adjacent it is another support pawl 38, support pawl and to receiving between pawl 38 where support bar 33
Mouth section position is independently of each other i.e. without forming crosslinking, and the support bar for the pawl that balances each other is up to extending to unit grid 30, unit grid 31
Between cross-shaped portion 39 just cross for the first time.
Position of the hangnail 4 to stablize anchor portion, the intersection of each hangnail 4 and place are additionally provided on the outside of each cross-shaped portion
Portion's (a part that cross-shaped portion itself also can be considered one of support bar or support bar) is structure as a whole.
The support bar width of anchor portion everywhere is 0.18~0.3mm, and support bar crosses and the angle of bifurcation is
20°-70°.Such as the top and bottom of cross-shaped portion 39 cross and the angle of bifurcation is 20 ° -70 °.
It is 8 that pawl is supported in the present embodiment, respectively supports pawl towards 25 inner edge side of closing in section relative to towards 25 outer rim of closing in section
The outer rim for being positioned adjacent to closing in section 25 that pawl and sealing offset respectively is supported in side after sealing, assembling.
The interconnecting piece 21 that the titanium-nickel wire 15 of sealing 1 is passed through to annular when installation, applies certain pulling force for 1 He of sealing
The compact connection of anchor portion 2, trying to get to the heart of a matter 14 mutually pushes against with closing in section 25 and forms certain pretightning force, and is made by this pretightning force
Sealing generates certain deformation, while can reduce the whole height of occluder for left auricle.The deformation of sealing can be:
Try to get to the heart of a matter 14 part by titanium-nickel wire 15 traction towards anchor portion protrusion;
Try to get to the heart of a matter 14 part is compressed and deformation while the side diameter for drawing waist 12 adjacent to anchor portion 2 by anchor portion 2
It collapses.
The redundance of titanium-nickel wire 15 is cut off after tension, and (is equivalent to anticreep by welding or installing steel bushing 16 in end
Head), realization is mutually axially limited with interconnecting piece 21.
When using 16 mode of steel bushing, steel bushing 16 is slided and the distal end back ferrule for pushing against interconnecting piece 21 fastens, steel bushing 16 can
For stainless steel, Nitinol or other meet the metal material of biocompatibility requirement, the present embodiment selects stainless steel material.
Since titanium-nickel wire 15 passes through inside the interconnecting piece 21 of annular, the two is inside and outside staggeredly, i.e., mutually interts staggeredly
Connection, and cross mutual end position.It is axially seen along occluder for left auricle, the 15 (phase of titanium-nickel wire of interconnecting piece 21 and sealing 1
When in the interconnecting piece of sealing) it is mutually nested, respective extension path is straight line, i.e., and it is axially extending along occluder for left auricle,
Due to being dislocation arrangement, there is no the interference on space in respective extend, can further as far as possible sealing 1 and anchor portion 2 away from
From until the two is mutually pushed against in the peripheral region of plugging device axis.
In assembling process, when sealing 1 and anchor portion 2 are mutually moved close to, first state can be considered when just contacting, with nickel
The axial further drawing of titanium silk 15, sealing 1 can gradually push against generation stress towards the side of anchor portion 2 with anchor portion 2 and be
Pretightning force, titanium-nickel wire 15 reach the second state after axially pulling preset distance, by sealing 1 and are anchored by steel bushing 16 again at this time
Portion 2 is maintained at the second state, that is, keeps the presence of stress.
Axial drawing preset distance can be measured directly, can also be according to sealing 1 towards side, that is, disk of anchor portion 2
The change in shape at bottom 14, which is expressed, to be obtained, and the drawing between the pulling force or sealing 1 and anchor portion 2 of titanium-nickel wire 15 can also be directly measured
Power.
14 change in shape of trying to get to the heart of a matter both had been referred to from the shape in first state, can also referring under different conditions with
The angle of 1 axis of waist 12 or sealing.
In other embodiments, the titanium-nickel wire 15 of sealing passes through interconnecting piece 21 after the middle part tried to get to the heart of a matter collects, due to
Titanium-nickel wire 15 and the interlaced arrangement of interconnecting piece 21 spatially, therefore can be by sealing 1 and anchor portion 2 as close as possible to reduce
Occluder for left auricle axial dimension, not stringent limitation need to push against.
In other embodiments, sealing 1 and anchor portion 2 are as close as possible to until contact to reduce occluder for left auricle axis
To size, sealing 1 and anchor portion 2 contact with each other but do not limit strictly and do not need to push against.
Embodiment 2
Referring to Fig. 5, the difference of the present embodiment and embodiment 1 is only that the shape of sealing 1, and sealing is back taper, interior
One or two layers choked flow film is arranged in portion, and sealing passes through cone towards the middle part of the side of anchor portion towards anchor portion side protrusion
Facial position offsets with anchor portion.
Embodiment 3
Referring to Fig. 6, the difference of the present embodiment and embodiment 1 is only that the shape of sealing 1, and sealing 1 is flat disk
Shape, i.e. seal disc, seal disc are double-layer structure, and inside setting choked flow film, under the action of pretightning force, sealing is towards anchor portion
Side offset with anchor portion.
Discharge procedure declaration
Referring to Fig. 7 a~Fig. 7 d and Fig. 8 a~Fig. 8 d, by taking the occluder for left auricle of embodiment 3 as an example, process is discharged
For occluder for left auricle is connected by wirerope 5 with operation handle, is arranged with sheath 6, left auricle of heart envelope in the slide outside of wirerope 5
It is also accommodated in sheath 6 after stifled device compression.
Occluder for left auricle along the direction arrow B successively pass through inferior caval vein 70, atrium dextrum 71, atrium sinistrum 72 enter left auricle of heart
73, sheath 6 is then withdrawn, the occluder for left auricle of compressive state is made gradually to expose release, the end of anchor portion 2 discharges at first,
In release outward, turnup backward, until anchor portion 2 is fully exposed to outside sheath 6, and turnup restores to its shape setting heat treatments
Shape obtained.
Extended segment is in distal end after release, and back-turning section and left auricle of heart inner wall are affixed and are anchored by hangnail, and closing in section is most
Pipe discharges at first, but due to being in the proximal end of anchoring, i.e. one adjacent to sealing after release instead to sealing turnup
Side.
After anchor portion 2 discharges, sheath 6, the gradually exposure release of sealing 1, until sealing 1 is released completely are further withdrawn
It puts, then wirerope 5 and occluder for left auricle is detached from, i.e., disengaged with the bolt head 13 of 1 disk end of sealing.
Pretightning force in the present invention between sealing 1 and anchor portion 2 can allow sealing more to step up with what left auricle of heart attached
It is close, so that the choked flow film in sealing effectively stops blood flow to flow into left auricle of heart, to reduce the interior incidence leaked.
Embodiment 4
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 Fig. 9~Figure 11, occluder for left auricle includes sealing 5100 interconnected and anchoring in the present embodiment
Portion 5200, anchor portion 5200 is compressed in sheath before releasing in order to be walked in vivo into lesions position, under compressive state
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
Indicate 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 12~Figure 14, 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 12;It tries to get to the heart of a matter
5110 central region can be flat, such as Figure 13;Try to get to the heart of a matter 5110 central region can also towards anchor portion protrusion, such as Figure 14.
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.
Referring to Figure 15~Figure 19, 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 19 comparison, and dotted line expresses middle part under first state
The position of region C.
0~Figure 22 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 21 arrow direction, is on the whole in the second condition inverted cone shape together with pan bottom, is passed through
Figure 22 comparison can more obviously embody, and dotted line expresses the position of waist and central region C under first state.
Embodiment 5
3 and Figure 24 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 6
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 25, Tu26Zhong, 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, 7, Figure 28 referring to fig. 2, the 7110 central area shape of trying to get to the heart of a matter restrain 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, 9, Figure 30 referring to fig. 2, the 7110 central area shape of trying to get to the heart of a matter restrain 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 31, Figure 32, 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 33, Figure 34,7110 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 embodiments of the present invention, but the present invention is not limited to this, the technology of this field
Various changes and modifications can be made to the invention by personnel without departing from the spirit and scope of the present invention.Obviously these changes and change
Type should belong to the present invention claims protection scope protection in.In addition, although being used some specific terms in this specification,
These terms are merely for convenience of description, does not constitute to the present invention any specifically limited.
Claims (32)
1. a kind of using the occluder for left auricle for being cross-linked structure, including sealing interconnected and anchor portion, feature
It is, the sealing and anchor portion are respectively provided with the interconnecting piece being made up of shape convergence, both sealing and anchor portion
Interconnecting piece extends towards and the fixation that misplaces;Wherein the anchor portion is that cutting is formed, and the distal side of anchor portion before releasing is
Closed loop configuration.
2. as described in claim 1 using the occluder for left auricle for being cross-linked structure, which is characterized in that the sealing and anchor
The interconnecting piece for determining both portions is connected directly or is connected by connector.
3. as described in claim 1 using the occluder for left auricle for being cross-linked structure, which is characterized in that the sealing and anchor
The interconnecting piece in both portions is determined at mutually matched position, it is mutually nested or deviate from each other.
4. as described in claim 1 using the occluder for left auricle for being cross-linked structure, which is characterized in that the sealing and anchor
The end that the interconnecting piece for determining both portions is extended towards and gone past the opponent.
5. as described in claim 1 using the occluder for left auricle for being cross-linked structure, which is characterized in that sealing and anchor portion
The two mutually reclines or pushes against in the peripheral region of respective interconnecting piece.
6. as described in claim 1 using being cross-linked the occluder for left auricle of structure, which is characterized in that the sealing includes
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, wherein described try to get to the heart of a matter is flat
Or middle part of trying to get to the heart of a matter is raised backwards to anchor portion side towards anchor portion side protrusion or middle part of trying to get to the heart of a matter.
7. as claimed in claim 6 using the occluder for left auricle for being cross-linked structure, which is characterized in that the sealing has
The pre-setting state not contacted with anchor portion and the abutting state to contact with each other with anchor portion are supported relative to pre-setting state
The sealing of tight state in waist and/or is tried to get to the heart of a matter with deformation.
8. the occluder for left auricle of closed loop configuration as described in claim 1, which is characterized in that the sealing is seal disc, and
With the pre-setting state not contacted with anchor portion and the abutting state to contact with each other with anchor portion;Relative to pre-setting shape
State, the middle part for pushing against the seal disc of state have the axial deformation towards anchor portion protrusion.
9. as described in claim 1 using the occluder for left auricle for being cross-linked structure, which is characterized in that the anchor portion is by pipe
Material cuts to be formed;Sealing is bottom towards anchor portion side, and described tubing one end is equipped with annular interconnecting piece, and the connection
Portion is connected with the bottom of sealing.
10. as claimed in claim 9 using the occluder for left auricle for being cross-linked structure, which is characterized in that the connection of anchor portion
The separate structure that the rest part of portion and anchor portion is structure as a whole or is fixed to each other;The bottom of the sealing collects and passes through
The interconnecting piece of anchor portion is equipped with the axial limiting portion for being limited to the interconnecting piece of anchor portion on being pierced by part.
11. as claimed in claim 10 using being cross-linked the occluder for left auricle of structure, which is characterized in that the anchor portion by
Extend at itself interconnecting piece backwards to sealing and constitute extended segment, extended segment is turned up far from the side of sealing turns back to sealing
Bottom constitutes back-turning section, which closes up to form closing in section in the bottom position infolding of sealing, the closing in Duan Yumi
The bottom in envelope portion offsets.
12. as claimed in claim 11 using the occluder for left auricle for being cross-linked structure, which is characterized in that the extended segment is
Taper, major part side is far from interconnecting piece and opening setting.
13. as claimed in claim 11 using the occluder for left auricle for being cross-linked structure, which is characterized in that anchor portion is close to close
The side in envelope portion be proximal end, far from sealing side be distal end, the connecting portion of anchor portion in anchor portion proximally and distally
Between, the interconnecting piece of anchor portion and the axial distance of anchor portion proximal end are L1, the interconnecting piece of anchor portion and the axis of anchor portion distal end
It is L2 to distance;And L1 is greater than L2.
14. as claimed in claim 11 using the occluder for left auricle for being cross-linked structure, which is characterized in that the anchor portion tool
There are not the pre-setting state pushed against and the abutting state that contacts with each other with sealing with sealing, under pre-setting state, in anchor
Determine in portion's axial direction, the interconnecting piece of anchor portion is than closing in section further from sealing;Relative to pre-setting state, under abutting state,
In anchor portion axial direction, the interconnecting piece of anchor portion is with respect to closing in section further towards sealing.
15. as claimed in claim 5 using the occluder for left auricle for being cross-linked structure, which is characterized in that anchor portion is being compressed
It is tubular structure under state, the inner wall side of tubular structure seals against portion under release conditions.
16. as claimed in claim 11 using the occluder for left auricle for being cross-linked structure, which is characterized in that before anchor portion release
The corresponding release in distal end after closing in section inner edge, closing in section includes that be spaced apart multiple support pawl, respectively supports pawl around the axis of anchor portion
Line is distributed and offsets with sealing.
17. as claimed in claim 16 using the occluder for left auricle for being cross-linked structure, which is characterized in that the pawl that supports is only
Engraved structure with frame.
18. as claimed in claim 16 using the occluder for left auricle for being cross-linked structure, which is characterized in that described to support pawl at least
It is four, respectively supporting pawl towards closing in section inner edge side is closed loop configuration, is connect towards closing in section outer rim side with the back-turning section.
19. as claimed in claim 16 using the occluder for left auricle for being cross-linked structure, which is characterized in that each include to pawl
Two first support bars, this two first support bar one end are intersected in closing in section inner edge, and intersection area is V-shaped or U-shaped, and two pieces the
The other end of one support bar extends to closing in section outer rim and intersects with back-turning section.
20. as claimed in claim 16 using the occluder for left auricle for being cross-linked structure, which is characterized in that respectively support pawl towards receipts
Mouthful section inner edge side relative to towards closing in section outer rim side farther away from sealing.
21. as claimed in claim 16 using being cross-linked the occluder for left auricle of structure, which is characterized in that it is adjacent support pawl it
Between it is mutually indepedent at closing in section position.
22. as claimed in claim 19 using the occluder for left auricle for being cross-linked structure, which is characterized in that the back-turning section tool
There is unit grid structure, the first vertex of each unit grid is extended towards sealing by each first vertex under release conditions
In pairs, same group of two first support bars extension is crossed to form wherein one supports pawl to first support bar.
23. as claimed in claim 22 using the occluder for left auricle for being cross-linked structure, which is characterized in that the unit grid
For the combination of hexagonal mesh structure or network structure or hexagonal mesh structure and network structure.
24. as claimed in claim 11 using the occluder for left auricle for being cross-linked structure, which is characterized in that extended segment is by more
Second support bar of radiation profiles forms, and each second support bar one end is intersected with the interconnecting piece of anchor portion, and the other end extends to folding
Return section.
25. as claimed in claim 24 using the occluder for left auricle for being cross-linked structure, which is characterized in that the back-turning section tool
There is unit grid structure, the second vertex of back-turning section each unit grid is prolonged backwards to sealing, each second support bar under release conditions
It stretches and intersects at corresponding second vertex.
26. the occluder for left auricle of closed loop configuration as described in claim 1, which is characterized in that the anchor portion and sealing are
Separate structure;The anchor portion and sealing mutually push against in assembling process.
27. as claimed in claim 26 using being cross-linked the occluder for left auricle of structure, which is characterized in that the sealing with
Anchor portion is assembled after completing thermal finalization, and sealing and anchor portion have the first state of initial contact when assembly;
Connecting portion between sealing and anchor portion also has the second state after being axially towards one another movement preset distance.
28. as claimed in claim 27 using being cross-linked the occluder for left auricle of structure, which is characterized in that the sealing with
Connecting portion between anchor portion both is located at radial middle part, under first state between the sealing and anchor portion
The peripheral region of connecting portion is in contact.
29. improving the occluder for left auricle of sealing effect as claimed in claim 28, which is characterized in that relative to the first shape
State, the position connecting on sealing with anchor portion in the second state are moved close to more towards anchor portion side.
30. as claimed in claim 29 using the occluder for left auricle for being cross-linked structure, which is characterized in that the preset distance
Expression way be:
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.
31. as claimed in claim 30 using being cross-linked the occluder for left auricle of structure, which is characterized in that the deformation quantity is
The Axial changes amount of sealing predetermined position or the angle of sealing predetermined position and sealing axis.
32. a kind of as described in claim 1 using the assembly method for the occluder for left auricle for being cross-linked structure, feature exists
It is assembled after, sealing and anchor portion complete thermal finalization, sealing and anchor portion mutually closer and initially contact when assembly
When be first state;On the basis of first state, it is predetermined that the connecting portion between sealing and anchor portion is axially towards one another movement
Reach the second state after 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 assembly.
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CN2017205816509 | 2017-05-23 | ||
CN201720581650 | 2017-05-23 |
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CN201810481172.3A Active CN108926370B (en) | 2017-05-23 | 2018-05-18 | Left auricle plugging device capable of improving sealing effect and assembling method thereof |
CN201810480320.XA Pending CN108926369A (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle and its assembly method being cross-linked |
CN201820749521.0U Active CN209074752U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle being cross-linked |
CN201820749240.5U Active CN208958225U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle for improving shape |
CN201810480128.0A Pending CN108926368A (en) | 2017-05-23 | 2018-05-18 | It is a kind of to use the occluder for left auricle and its assembly method for being cross-linked structure |
CN201820749196.8U Active CN208958224U (en) | 2017-05-23 | 2018-05-18 | It is a kind of to use the occluder for left auricle for being cross-linked structure |
CN201820749254.7U Active CN208958226U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle of closed loop configuration |
CN201820749252.8U Active CN209074751U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle improving sealing effect |
CN201810482033.2A Active CN108926371B (en) | 2017-05-23 | 2018-05-18 | Left auricle plugging device with closed-loop structure and assembly method thereof |
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CN201810481172.3A Active CN108926370B (en) | 2017-05-23 | 2018-05-18 | Left auricle plugging device capable of improving sealing effect and assembling method thereof |
CN201810480320.XA Pending CN108926369A (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle and its assembly method being cross-linked |
CN201820749521.0U Active CN209074752U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle being cross-linked |
CN201820749240.5U Active CN208958225U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle for improving shape |
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CN201820749196.8U Active CN208958224U (en) | 2017-05-23 | 2018-05-18 | It is a kind of to use the occluder for left auricle for being cross-linked structure |
CN201820749254.7U Active CN208958226U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle of closed loop configuration |
CN201820749252.8U Active CN209074751U (en) | 2017-05-23 | 2018-05-18 | A kind of occluder for left auricle improving sealing effect |
CN201810482033.2A Active CN108926371B (en) | 2017-05-23 | 2018-05-18 | Left auricle plugging device with closed-loop structure and assembly method thereof |
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Also Published As
Publication number | Publication date |
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CN108926369A (en) | 2018-12-04 |
CN108926371A (en) | 2018-12-04 |
CN209074752U (en) | 2019-07-09 |
CN108926370A (en) | 2018-12-04 |
CN208958225U (en) | 2019-06-11 |
CN209074751U (en) | 2019-07-09 |
CN208958226U (en) | 2019-06-11 |
CN108926370B (en) | 2024-04-16 |
CN108926371B (en) | 2024-04-16 |
CN208958224U (en) | 2019-06-11 |
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