CN104352260B - Left atrial appendage occlusion system - Google Patents
Left atrial appendage occlusion system Download PDFInfo
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- CN104352260B CN104352260B CN201410537620.9A CN201410537620A CN104352260B CN 104352260 B CN104352260 B CN 104352260B CN 201410537620 A CN201410537620 A CN 201410537620A CN 104352260 B CN104352260 B CN 104352260B
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- atrial appendage
- appendage occlusion
- occlusion system
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- 210000005248 left atrial appendage Anatomy 0.000 title claims abstract description 59
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims abstract description 51
- 229910000831 Steel Inorganic materials 0.000 claims abstract description 18
- 229910001000 nickel titanium Inorganic materials 0.000 claims abstract description 18
- 239000010959 steel Substances 0.000 claims abstract description 18
- 230000000694 effects Effects 0.000 claims abstract description 17
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229910045601 alloy Inorganic materials 0.000 claims abstract description 10
- 239000000956 alloy Substances 0.000 claims abstract description 10
- 238000009954 braiding Methods 0.000 claims description 10
- 238000007493 shaping process Methods 0.000 claims description 7
- 230000000903 blocking effect Effects 0.000 claims description 4
- 229910052751 metal Inorganic materials 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- 238000011084 recovery Methods 0.000 claims description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims 1
- 239000010931 gold Substances 0.000 claims 1
- 229910052737 gold Inorganic materials 0.000 claims 1
- 150000002739 metals Chemical class 0.000 claims 1
- 208000007536 Thrombosis Diseases 0.000 abstract description 8
- 238000000034 method Methods 0.000 description 14
- 206010003658 Atrial Fibrillation Diseases 0.000 description 9
- 238000013461 design Methods 0.000 description 9
- 210000002837 heart atrium Anatomy 0.000 description 7
- 238000010438 heat treatment Methods 0.000 description 6
- 238000002513 implantation Methods 0.000 description 6
- 238000009941 weaving Methods 0.000 description 6
- 206010008190 Cerebrovascular accident Diseases 0.000 description 5
- 208000006011 Stroke Diseases 0.000 description 5
- 230000008901 benefit Effects 0.000 description 5
- 230000002490 cerebral effect Effects 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 5
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 4
- 230000006378 damage Effects 0.000 description 4
- 238000011161 development Methods 0.000 description 4
- 230000018109 developmental process Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 230000006835 compression Effects 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 230000006698 induction Effects 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 208000033999 Device damage Diseases 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 2
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 238000004873 anchoring Methods 0.000 description 2
- 230000010100 anticoagulation Effects 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- ZZUFCTLCJUWOSV-UHFFFAOYSA-N furosemide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(O)=O)=C1NCC1=CC=CO1 ZZUFCTLCJUWOSV-UHFFFAOYSA-N 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 229910052759 nickel Inorganic materials 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
- 229910052719 titanium Inorganic materials 0.000 description 2
- 235000017060 Arachis glabrata Nutrition 0.000 description 1
- 241001553178 Arachis glabrata Species 0.000 description 1
- 235000010777 Arachis hypogaea Nutrition 0.000 description 1
- 235000018262 Arachis monticola Nutrition 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 230000001746 atrial effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 206010061592 cardiac fibrillation Diseases 0.000 description 1
- 238000013194 cardioversion Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
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- 238000002651 drug therapy Methods 0.000 description 1
- 238000010041 electrostatic spinning Methods 0.000 description 1
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- 230000002349 favourable effect Effects 0.000 description 1
- 230000002600 fibrillogenic effect Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
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- 239000000463 material Substances 0.000 description 1
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- 235000020232 peanut Nutrition 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
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- 208000024891 symptom Diseases 0.000 description 1
- 230000001732 thrombotic effect Effects 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 238000009966 trimming Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
- A61B17/1214—Coils or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Vascular Medicine (AREA)
- Reproductive Health (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Cardiology (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
The invention discloses a kind of left atrial appendage occlusion system, including closure disk and anchor disk, described closure disk is woven using nitinol alloy wire, it is thermally treated to be shaped as disk-like structure, described anchor disk is also woven using nitinol alloy wire, it is thermally treated to be shaped as column structure, the anchor disk comprises at least a crin, the crin by the more nitinol alloy wires it is close around into, when the anchor disk is in appropriate location, nitinol alloy wire described in wherein at least one stretches out from the anchor disk to tiltedly outer direction, pierced as anchor, point to the closure disk, an other titanium-nickel wire also exists as a silk in mesh grid, play a part of connection two steel bushings up and down.The present invention is a kind of inaccessible left auricle of heart, blocks thrombus outflow effect in left auricle of heart good, repeatable positioning, fixing-stable, fatigue proof left atrial appendage occlusion system.
Description
Technical field
The present invention relates to a kind of inaccessible left auricle of heart, blocks thrombus outflow effect in left auricle of heart good, repeatable positioning is fixed stably
Fixed, fatigue proof left atrial appendage occlusion system.
Background technology
At present, with the development of intervention apparatus, what many surgical operations can not treat, which cure the disease, is cured.These are cured the disease
Treatment relative to the treatment method of surgical operation, the wound of intervenient cure is small, recovers fast, curative effect is good.By nearly half
The development in century, intervenient cure have obtained swift and violent development, also generate various interventional medical device products.So that
Increasing cure the disease obtains medical treatment with patient.
Auricular fibrillation (atrial fibrillation) is one of most common arrhythmia cordis, except the discomfort that palpitaition symptom is brought, thromboembolism
It is the most important harm of atrial fibrillation etc. complication.In non-valvular and non-nonrheumatic atrial fibrillation patient, about 90% thrombus source
From left auricle of heart.Thromboembolic events and cerebral apoplexy occur for annual 5% patients with atrial fibrillation that there are about.And fatal rate is up to caused by cerebral apoplexy
50%.Therefore, how to prevent and treat atrial fibrillation thrombus caused by cerebral apoplexy there is important clinical meaning.Prevention and treatment at present
The method of atrial fibrillation thrombus has surgical operation, drug therapy and interventional therapy method.Wherein surgical method occlusion left auricle of heart, due to
The reasons such as its wound is big, risk is high are not widely used.At present, the method some of fibrillation patient prevention headstroke is most universal
Method be Long-term Oral anticoagulation medicine, but anticoagulation medicine has the risk for causing bleeding, there are about 14%~44% patient
It can not receive long-term agents anticoagulant therapy because contraindication be present.Recent domestic has developed a kind of state-of-the-art PCI
Method, special occluder for left auricle is implanted in left auricle of heart by tiny conduit, inaccessible left auricle of heart, prevents and treats atrial fibrillation
Cardioversion and cerebral apoplexy occur for patient.This treatment method wound is small, and risk is low, recovers fast, and curative effect is good, so as to as prevention
With the treatment method for treating cerebral apoplexy first choice caused by atrial fibrillation.
Such apparatus can be broadly divided into Weaving type, cutting-type and mixed type from the point of view of structure at present.The left heart of these types
Plugging device can be sent into left auricle of heart by ear plugging device by the method for intubation intervention, realize left atrial appendage occlusion.But all deposit
In suitable limitation.Everyone left auricle of heart anatomical structure is complicated, different, there is ellipticity, peanut shape etc..Left auricle of heart
Inwall is uneven, in irregular shape, and left auricle of heart wall is thin.So being difficult to neither piercing through heart wall, and can is firmly anchored on the left heart
Do not fallen off in ear, be finally reached preferable plugging effect.
Such as the Weaving type occluder for left auricle designed by patent of invention CN200610037789 and CN200580002183.He
Using the rough structure of the fixation panel surface of plugging device come grappling plugging device, closure disk blocks in left auricle of heart mouth, reaches
To the effect of occlusion.The design advantage of this structure is simple in construction, and difficulty of processing is small, and cost is low.But the fixation of braiding
The grappling dynamics of disk is relatively low, it is difficult to adapt to different left auricle of heart form.Grappling hook is sutured on fixed disk, in fixation
Disk is difficult still to be pierced into left auricle of heart wall in the case of being squeezed deformation, realizes stable fix.And fixed disk is in left auricle of heart
It can influence to block the shape of disk after being inside squeezed deformation, cause plugging effect bad.
Such as the cutting-type occluder for left auricle involved by patent of invention CN200410059976 and CN99815453.They will
Nickel-titanium metal pipe is cut, heat-treating profiled into designed shape.It is designed with the position contacted with left auricle of heart inwall and outwards sticks up
The grappling thorn risen, is pierced into left auricle of heart inwall, realizes stable fix.Choked flow film is generally sewed with the grid framework of cutting-type,
Realize the effect of left atrial appendage occlusion.The advantage of this structure design is that whole plugging device is integrally formed, and rigidity is stronger, easily
Fixed in left auricle of heart inwall, designed grappling thorn is easily pierced into left auricle of heart inwall, stable to fix, and prevents plugging device from coming off.
But deformability is limited in shape for cutting-type occluder for left auricle, different left auricle of heart form can not be adapted to so that
Its use is very restricted.For cutting-type occluder for left auricle after filling in such as left auricle of heart, the part in atrium sinistrum is usual
Depression can be formed with atrial wall ratio, form new " left auricle of heart " region, increase new thrombotic risk.Cutting-type left auricle of heart
The grappling thorn of plugging device is typically to stab atrium sinistrum, plays stable plugging device, prevents plugging device from coming off.But stab atrium sinistrum
Grappling thorn can be stuck in sheath tube wall edge in resetting, recovery plugging device so that plugging device can not reclaim, and carry out repeating to determine
Position.
Such as the mixed type occluder for left auricle involved by patent of invention CN201110146287 and CN103099652A.At this
Pattern of the disk using braiding is blocked in a little designs, generally choked flow film is sewed with closure disk, for inaccessible left auricle of heart.And fix
Disk has the cutting of nickel-titanium metal pipe, heat-treating profiled into designed shape.It is oriented in the position design contacted with left auricle of heart inwall
The grappling thorn of outer tilting, is pierced into left auricle of heart inwall, realizes stable fix.Mixed type occluder for left auricle effectively solves cutting
Most of problem of type occluder for left auricle.But the grappling thorn of fixed disk is typically to stab such as in CN103099652A
Atrium sinistrum, stable plugging device is played, prevents plugging device from coming off.But the grappling thorn of atrium sinistrum is stabbed in resetting, recovery envelope
Sheath tube wall edge can be stuck in during stifled device so that plugging device can not reclaim, and carry out resetting.And this mixed type left atrial appendage occlusion
The usual deformation of fixed disk of device is larger, and to overturn the direction of grappling thorn, the tension force and deformation quantity for causing fixed disk reach material
Limiting value.Fatigue strength of this apparatus in Permanent implantation is poor, is easily broken, and punctures its hetero-organization such as heart, jeopardizes
Life.
Therefore, advantage and disadvantage of comprehensive various occluder for left auricle, development it is a kind of can effectively inaccessible left auricle of heart, repeat calmly
Position, it is stable fixed, can Permanent implantation occluder for left auricle.
Therefore, a kind of inaccessible left auricle of heart, block thrombus outflow effect in left auricle of heart good, repeatable positioning, fixing-stable,
Fatigue proof left atrial appendage occlusion system.
The content of the invention
It is an object of the invention to provide a kind of inaccessible left auricle of heart, blocks thrombus outflow effect in left auricle of heart good, repeatable fixed
Position, fixing-stable, fatigue proof left atrial appendage occlusion system.
To achieve these goals, technical scheme provided by the invention is：A kind of left atrial appendage occlusion system, including envelope are provided
Stifled disk and anchor disk, described closure disk is woven using nitinol alloy wire, thermally treated to be shaped as disk-like structure, described grappling
Disk is also woven using nitinol alloy wire, and thermally treated to be shaped as column structure, both ends are fixed with steel bushing, and the anchor disk is at least wrapped
Include a crin, the crin by the more nitinol alloy wires it is close around into, when the anchor disk is in appropriate location, wherein
An at least nitinol alloy wire stretches out from the anchor disk to tiltedly outer direction, is pierced as anchor, points to the closure disk, separately
An outer titanium-nickel wire also exists as a silk in mesh grid, plays a part of connection two steel bushings up and down.
During the anchor disk expansion, the anchor disk props up left auricle of heart inwall, and the anchor thorn is pierced into left auricle of heart inwall, with steady
Fixed fixation of the anchor disk in left auricle of heart.The occluder for left auricle can be straightened and pull in sheath, and wherein anchor thorn also may be used
Deform upon and be incorporated into sheath so that the plugging device realizes repeatable positioning function.Due to the occluder for left auricle be by
Metal wire knitted forms, and deformation is smaller, and fatigue durability is high, can be implanted as Permanent implantation body.
PTFE or PET choked flow films are sutured on the closure disk.To reduce choked flow film surface thrombus originality, accelerate closure dish cart
Face endothelialization.Such choked flow film can use electrostatic spinning to spin, and be formed through low-temperature plasma surface active.
The length of each anchor thorn is 0.5-10 millimeters.
It is described closure disk and the anchor disk can integral weaving, it is thermally treated to form.
One end of the closure disk is connected equipped with screw thread coupling with conveying push rod.
Also include pusher, the threaded one end of the closure disk connects the pusher, and one end of the closure disk is equipped with
Multiple wires, the wire have the larger end of volume, and the end can be stuck between the connector of pusher, the envelope
Stifled disk and the pusher are flexible connection.
Compared with prior art, the present invention has the following advantages：
The anchor disk structural deformation of the left atrial appendage occlusion system of the present invention is soft, stable.The fatigue performance of Permanent implantation
It is splendid.It is suitable for the left auricle of heart cavity of various forms and size.
The two-piece design of the left atrial appendage occlusion system of the present invention so that the plugging device is suitable for various forms and size
Left auricle of heart cavity.
The left atrial appendage occlusion system of the present invention can be provided simultaneously with grappling and consolidate, and effectively inaccessible left auricle of heart.
The repeatable positioning of the left atrial appendage occlusion system of the present invention.In some cases if placement is ineffective, do not having
The situation of conveying push rod is freed, plugging device can be withdrawn in sheath, resetting and placement, until reaching satisfied grappling and closing
The effect of plug, substantially reduces operation risk.
Less induction system can be used in the left atrial appendage occlusion system of the present invention, further reduces surgical procedure conveying device
Damage to blood vessel.
The left atrial appendage occlusion system of the present invention and the flexible connection of pusher, greatly reduce in surgical procedure pusher to this
The tension force that plugging device applies so that the position that plugging device is placed is more accurate.
It will be become more fully apparent by following description and with reference to accompanying drawing, the present invention, these accompanying drawings are used to explain the present invention
Embodiment.
Brief description of the drawings
Fig. 1 is the front view of the first embodiment of left atrial appendage occlusion system of the present invention.
Fig. 2 is the close partial enlarged drawing pierced around wire and anchor of left atrial appendage occlusion system as shown in Figure 1.
Fig. 3 is the anchor disk upward view of left atrial appendage occlusion system as shown in Figure 1.
Fig. 4 is the anchor disk top view of left atrial appendage occlusion system as shown in Figure 1.
Fig. 5 is the front view of the second embodiment of left atrial appendage occlusion system of the present invention.
Fig. 6 is the anchor disk upward view of the second embodiment of left atrial appendage occlusion system as shown in Figure 5.
Fig. 7 is the anchor disk top view of the second embodiment of left atrial appendage occlusion system as shown in Figure 5.
Fig. 8 a are a form of enlarged drawing of the grappling thorn of the 3rd embodiment of left atrial appendage occlusion system of the present invention.
Fig. 8 b are the another form of enlarged drawing of the grappling thorn of the 3rd embodiment of left atrial appendage occlusion system of the present invention.
Fig. 8 c are the enlarged drawing of another form of the grappling thorn of the 3rd embodiment of left atrial appendage occlusion system of the present invention.
Position view of the left atrial appendage occlusion system of Fig. 9 present invention in left auricle of heart anatomical structure.
Figure 10 is the view that left atrial appendage occlusion system as shown in Figure 1 is fully drawn into sheath.
Figure 11 is that the anchoring portions disk of left atrial appendage occlusion system as shown in Figure 1 is drawn into the view of sheath.
Figure 12 is that the closure disk of left atrial appendage occlusion system as shown in Figure 1 is drawn into the view of sheath.
Figure 13 is the view that left atrial appendage occlusion system as shown in Figure 1 goes out sheath completely.
Figure 14 is the front view of the 3rd embodiment of left atrial appendage occlusion system of the present invention.
Embodiment
Embodiments of the invention are described with reference now to accompanying drawing, similar element numbers represent similar element in accompanying drawing.
Embodiment 1
As shown in Fig. 1, Fig. 2 and Fig. 3, left atrial appendage occlusion system 100 involved in the present invention, include closure disk 1, with closure
Disk 1 connect anchor disk 2, wherein as shown in figure 3, closure disk 1 be woven into mesh grid with titanium-nickel wire, it is thermally treated discoid, two
End is fixed with steel bushing, and the one end and anchor disk 2 for blocking disk 1 are connected with steel bushing 4.The other end sets threaded nut 3 and conveying
The pusher connection of device.Likewise, anchor disk 2 is also to be woven into mesh grid (as shown in Figure 2) with titanium-nickel wire 8, it is thermally treated
Discoid, both ends steel bushing 4 is fixed, and is blocked and is sewed with PFTE or PET choked flow films respectively inside disk 1 and anchor disk 2, wherein, use
Have 6 in the titanium-nickel wire of braiding anchor disk 2, titanium-nickel wire 6 be by two titanium-nickel wires it is close around into.Weave weave when, it is close around
Titanium-nickel wire 6 and other single titanium-nickel wires using the braiding of identical weaving manner.In heat treatment shaping by it is close around NiTi
Silk 6 in a titanium-nickel wire from it is close around titanium-nickel wire 6 in branch away, and trim be shaped into it is hook-shaped, formed anchor thorn 7, positioned at grappling
The side of disk 2, in addition a titanium-nickel wire 10 also exist as a silk in mesh grid, play connection up and down two steel bushings 4
Effect.Wherein anchor thorn 7 is in approximate half-circular, is opened to outside anchor disk 2, its end direction closure disk 1 direction.Anchor thorn 7 not by
It is flared out, and can be pierced into the tissue of left auricle of heart inwall automatically in the case of pressure.The anchor pierces 7 force-applied deformations during compression,
It is recyclable enter sheath in.
As shown in Figure 10, Figure 11, Figure 12 and Figure 13, left atrial appendage occlusion system enters sheath in the pulling force effect by pusher 15
Pipe 14 (B directions) and the process for being come out (A directions) in sheath 14 by the thrust of pusher 15 have following features：Left auricle of heart seals
The closure disk 1 and anchor disk 2 of stifled system are straightened and are compressed in sheath 14, and wherein anchor thorn 7 is stretched deformation, is squeezed in narrow
In sheath 14.Under the thrust of pusher 15, anchor disk 2 is initially pushed out sheath 14.Because Nitinol has shape
Memory and hyperelastic superior function, anchor disk 2 and anchor thorn 7 reply rapidly reset condition.It is close to left auricle of heart in the side of anchor disk 2
Inwall, its anchor thorn are pierced into left auricle of heart interior wall tissue, securely fix the position of anchor disk 2.Pusher 15 continues to push power,
Closure disk 1 is released into sheath.Block disk 1 and also reply reset condition rapidly.The one side that disk 1 is blocked close to anchor disk 2 will be bonded a left side
The outer of auricle, isolate the path of atrium sinistrum and left auricle of heart, play the purpose of closure left auricle of heart.Apply pulling force in pusher 15 to make
With the B processes and the A processes of the application thrust release left atrial appendage occlusion system of pusher 15 of recovery left atrial appendage occlusion system
Each stage is opposite.Left atrial appendage occlusion system is pushed device 15 along direction B and pulls in sheath 14, and outstanding feature is that anchor thorn 7 is by opening up
Oblique lateral direction of the oblique lateral direction deformation of direction closure disk towards steel bushing 4 when opening.This process ensures that anchor thorn 7 will not scratch
Left auricle of heart wall, and can smoothly enter sheath 14.The left atrial appendage occlusion system of the present embodiment not only can ensure that anchor disk 2 in left auricle of heart
Interior repeatable positioning function, also greatly reduce damage of the apparatus to left auricle of heart wall, reduce the risk and complication of operation.
Embodiment 2
As shown in Fig. 5, Fig. 6 and Fig. 7, left atrial appendage occlusion system involved in the present invention includes closure disk 1, with blocking disk 1
The anchor disk 2 of connection.Closure disk 1 uses unitary design with anchor disk 2.Mesh grid, both ends steel are woven into using titanium-nickel wire
Set 4 is fixed, thermally treated into double disk structure, has relatively fine waist 11 between closure disk 1 and anchor disk 2.Block the another of disk 1
One end is provided with screw thread 3, is connected with the pusher 15 of conveying device.Closure disk 1 and anchor disk 2 inside be sewed with respectively PFTE or
PET choked flow films.Wherein, for have in the titanium-nickel wire of braiding 8 titanium-nickel wires 6 be by two titanium-nickel wires it is close around into.In braiding,
It is close around titanium-nickel wire 6 and other single titanium-nickel wires using the braiding of identical weaving manner.In heat treatment shaping by it is close around
A titanium-nickel wire in titanium-nickel wire 6 from it is close around titanium-nickel wire 6 in branch away, and trim and be shaped into hook-shaped, form anchor thorn 7, be located at
The side of anchor disk, in addition a titanium-nickel wire 10 also as in mesh grid a silk exist, play connection up and down two steel bushings 4
Effect.Wherein anchor thorn 7 is in approximate half-circular, is opened to outside anchor disk 2, its end direction closure disk 1 direction.Anchor thorn 7 is not
It is flared out, and can be pierced into the tissue of left auricle of heart inwall automatically in the case of being stressed.The anchor pierces 7 force-applied changes during compression
Shape, it is recyclable enter sheath in.
Embodiment 3
As shown in figure 14, left atrial appendage occlusion system involved in the present invention includes closure disk 1, the anchor being connected with closure disk 1
Price fixing 2.Closure disk 1 and the anchor disk 2 being connected with blocking disk 1 use unitary design.Mesh grid is woven into using titanium-nickel wire, two
End steel bushing 4 is fixed, thermally treated into double disk structure.The other end of closure disk 1 is provided with screw thread 3, the push with conveying device
Device 15 connects.PFTE or PET choked flow films are sewed with respectively inside closure disk 1 and anchor disk 2.Wherein, the titanium-nickel wire for braiding
In have 8 titanium-nickel wires 6 be by two titanium-nickel wires it is close around into.In braiding, it is close around titanium-nickel wire 6 and other single titanium-nickel wires
Woven using identical weaving manner.In heat treatment shaping by it is close around titanium-nickel wire 6 in a titanium-nickel wire from it is close around nickel
Branched away in titanium silk 6, and trim and be shaped into hook-shaped, form anchor thorn 7, positioned at the side of anchor disk, a titanium-nickel wire 10 is also in addition
Exist as a silk in mesh grid, play a part of connection two steel bushings 4 up and down.Wherein anchor thorn 7 is in approximate half-circular, to
Opened outside anchor disk 2, its end direction closure disk 1 direction.Anchor thorn 7 is flared out automatically in the case where not being stressed, and can
It is pierced into the tissue of left auricle of heart inwall.During compression the anchor pierce 7 force-applied deformations, it is recyclable enter sheath in.
As shown in Fig. 8 a, 8b, 8c, it is close around titanium-nickel wire and anchor thorn the form of expression.Wherein shown in Fig. 8 a it is close around NiTi
Silk by two titanium-nickel wires it is close around into heat treatment shaping by it is close around titanium-nickel wire 6 in a titanium-nickel wire from it is close around NiTi
Branched away in silk 6, and trim and be shaped into hook-shaped, form anchor thorn 7, positioned at the side of anchor disk, a titanium-nickel wire 10 is also made in addition
Exist for a silk in mesh grid, play a part of connection two steel bushings 4 up and down.Wherein shown in Fig. 8 b it is close around titanium-nickel wire by
Three titanium-nickel wires it is close around into heat treatment shaping by it is close around titanium-nickel wire 6 in a titanium-nickel wire from it is close around titanium-nickel wire 6
In branch away, and trim be shaped into it is hook-shaped, formed anchor thorn 7, positioned at the side of anchor disk, two titanium-nickel wires are close in addition is coiled into NiTi
Silk 12 also exists as a silk in mesh grid, plays a part of connection two steel bushings 4 up and down.Wherein shown in Fig. 8 c it is close around
Titanium-nickel wire by three titanium-nickel wires it is close around into heat treatment shaping by it is close around titanium-nickel wire 6 in two titanium-nickel wires from it is close around
Being branched away in titanium-nickel wire 6, trimming respectively is shaped into hook-shaped, forms two anchors thorn 13, positioned at the side of anchor disk, a nickel in addition
The close titanium-nickel wire 10 that is coiled into of titanium silk also exists as a silk in mesh grid, plays a part of connection two steel bushings 4 up and down.
As shown in figure 9, placement schematic diagram of the left atrial appendage occlusion system of the present invention in atrium sinistrum LA left auricle of heart LAA.
The present invention left atrial appendage occlusion system is flexible and the anchor disk of retractility 2 so that anchor disk 2 can need to place according to clinic
In deeper or shallower position.
In summary, left atrial appendage occlusion system of the invention includes closure disk and anchor disk, have good elasticity and
Inaccessible performance.The plugging device overall structure stability is good, repeats positioning, and grappling consolidates, is suitable for various left auricle of heart forms, subtracts
Few operating difficulty and the damage to tissue.The plugging device includes having favorable elasticity and the interior closure disk for being sewed with choked flow film, its
Block disk has good deformability by one or segmentation one flexible anchor disk of connection, the anchor disk so that
The left atrial appendage occlusion system adapts to various left auricle of heart forms.There is anchor thorn in the anchor disk, left auricle of heart can be stabbed with stretching, extension naturally
Inwall, the anchoring ability of anchor thorn is greatly enhanced, reduce damage of the anchor thorn to tissue so that the plugging device has the work(of resetting
Energy.The Integral design of this anchor thorn, overall deformation is small, and stress is small, reduces the risk that Permanent implantation is broken, also causes this
The left atrial appendage occlusion system of invention uses less induction system.
Therefore, the present invention has advantages below：
The anchor disk structural deformation of the left atrial appendage occlusion system of the present invention is soft, stable, the fatigue performance of Permanent implantation
It is splendid, it is suitable for the left auricle of heart cavity of various forms and size.
The two-piece design of the left atrial appendage occlusion system of the present invention so that the plugging device is suitable for various forms and size
Left auricle of heart cavity, occlusive effect are splendid.
The left atrial appendage occlusion system of the present invention can be provided simultaneously with grappling and consolidate, and effectively inaccessible left auricle of heart.
The repeatable positioning of the left atrial appendage occlusion system of the present invention, in some cases if placement is ineffective, is not having
The situation of conveying push rod is freed, plugging device can be withdrawn in sheath, resetting and placement, until reaching satisfied grappling and closing
The effect of plug, surgical procedure is greatly simplified, reduce operating difficulty and risk.
Less induction system can be used in the left atrial appendage occlusion system of the present invention, further reduces surgical procedure conveying device
Damage to blood vessel.
The left atrial appendage occlusion system of the present invention and the flexible connection of pusher, greatly reduce in surgical procedure pusher to this
The tension force that plugging device applies so that the position that plugging device is placed is more accurate.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
Any modification, equivalent substitute and improvement made within refreshing and principle etc., should be included in the scope of the protection.
Claims (6)
- A kind of 1. left atrial appendage occlusion system, it is characterised in that：Including closure disk and anchor disk, described closure disk is closed using NiTi Spun gold is woven, thermally treated to be shaped as disk-like structure, and described anchor disk is also woven using nitinol alloy wire, thermally treated shaping Into column structure, both ends are fixed with steel bushing, and the anchor disk comprises at least a crin, and the crin is by the more Nitinols Silk is close around into when the anchor disk is in appropriate location, nitinol alloy wire described in wherein at least one is from the anchor disk It is middle to be stretched out to tiltedly outer direction, pierced as anchor, the length of each anchor thorn is 0.5-10 millimeters, points to the closure disk, in addition A piece titanium-nickel wire also exists as a silk in mesh grid, plays a part of connection two steel bushings, in addition to pusher up and down, The threaded one end of the closure disk connects the pusher, wherein, pusher applies pulling force effect recovery left atrial appendage occlusion system When, towards the oblique lateral direction of steel bushing when being changed into shrinking towards the oblique lateral direction shape for blocking disk when the anchor thorn can be from deploying.
- 2. left atrial appendage occlusion system as claimed in claim 1, it is characterised in that：During the anchor disk expansion, the anchor disk Left auricle of heart inwall is propped up, the anchor thorn is pierced into left auricle of heart inwall, to stablize fixation of the anchor disk in left auricle of heart.
- 3. left atrial appendage occlusion system as claimed in claim 1, it is characterised in that：PTFE or PET resistances are sutured on the closure disk Flow film.
- 4. left atrial appendage occlusion system as claimed in claim 1, it is characterised in that：The closure disk and the anchor disk can be overall Braiding, it is thermally treated to form.
- 5. left atrial appendage occlusion system as claimed in claim 1, it is characterised in that：One end of the closure disk is equipped with threaded connection Device is connected with conveying push rod.
- 6. left atrial appendage occlusion system as claimed in claim 1, it is characterised in that：One end of the closure disk is equipped with multiple metals Silk, the wire have the larger end of volume, and the end can be stuck between the connector of pusher, the closure disk and institute Pusher is stated as flexible connection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410537620.9A CN104352260B (en) | 2014-10-13 | 2014-10-13 | Left atrial appendage occlusion system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410537620.9A CN104352260B (en) | 2014-10-13 | 2014-10-13 | Left atrial appendage occlusion system |
Publications (2)
| Publication Number | Publication Date |
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| CN104352260A CN104352260A (en) | 2015-02-18 |
| CN104352260B true CN104352260B (en) | 2017-11-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410537620.9A Active CN104352260B (en) | 2014-10-13 | 2014-10-13 | Left atrial appendage occlusion system |
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| US11213297B2 (en) | 2016-03-14 | 2022-01-04 | Beijing Med Zenith Medical Scientific Co., Ltd. | Atrial appendage occluder capable of entering half-released state by means of pushing head-end fiber |
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| WO2017011170A1 (en) * | 2015-07-13 | 2017-01-19 | Marvel Medical Technologies LLC | Method and device for left atrial appendage closure |
| CN108992120B (en) | 2015-07-28 | 2022-01-07 | 杭州德诺电生理医疗科技有限公司 | Improved left auricle occluder |
| CN104958087B (en) * | 2015-07-28 | 2018-09-25 | 杭州诺茂医疗科技有限公司 | A kind of occluder for left auricle |
| MX2018008000A (en) * | 2015-12-29 | 2019-01-10 | Shenzhen Kyd Biomedical Tech Co Ltd | Left atrial appendage closure device. |
| CN106923884B (en) * | 2015-12-31 | 2018-12-21 | 先健科技(深圳)有限公司 | Occluder for left auricle |
| CN106923886B (en) * | 2015-12-31 | 2022-04-22 | 先健科技(深圳)有限公司 | Left atrial appendage occluder |
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