CN107126240A - A kind of occluder for left auricle and its application method - Google Patents
A kind of occluder for left auricle and its application method Download PDFInfo
- Publication number
- CN107126240A CN107126240A CN201710426556.0A CN201710426556A CN107126240A CN 107126240 A CN107126240 A CN 107126240A CN 201710426556 A CN201710426556 A CN 201710426556A CN 107126240 A CN107126240 A CN 107126240A
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- Prior art keywords
- closure disk
- left auricle
- umbrella
- occluder
- closure
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- 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
- 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
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires 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
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Surgical Instruments (AREA)
Abstract
A kind of occluder for left auricle and its application method, it includes closure disk and fixed umbrella；Connected between the closure disk and fixed umbrella by bindiny mechanism；The closure disk is circular, water-drop-shaped or ellipse；The fixation umbrella is in petal-shaped, and has barb structure in end；The bindiny mechanism is a rotary shaft so that the closure disk can be rotated by axle of the rotary shaft.First according to left auricle of heart form, the thermal finalization mould of closure disk is printed using 3D printing technique, closure disk of the columned close net memory alloy wire thermal finalization into suitable closure left auricle of heart opening will be compiled into；Secondly, the fixed umbrella of release so that the barb structure of fixed umbrella is pierced into left auricle of heart inwall；Finally, closure disk is released after release from conveying device, the rotation conveying device in atrium sinistrum, and then causes closure disk to occur the relative rotation with fixed umbrella so that closure disk is blocked to left auricle of heart opening.The present invention can reduce the generation of residual leakage.
Description
Technical field
The invention belongs to medical instruments field, the occluder for left auricle of more particularly to a kind of personalized designs and its user
Method.
Background technology
Auricular fibrillation (atrial fibrillation) is most common arrhythmia cordis, and its incidence is 0.4~1% or so, and the current whole nation is at least
There are 10,000,000 patients with atrial fibrillation, and with Chinese population aging steady growth, patients with atrial fibrillation is also increasing year by year.Patients with atrial fibrillation is most
Main complication is cerebral apoplexy, and the Hazard ratio general population of cerebral apoplexy will be higher by 5~10 times.More than 87% in patients with cerebral apoplexy
Patient be thromboembolism, the thrombosis more than 90% originate from left auricle of heart (LAA).Left auricle of heart is the embryonic stage original left heart
The remnants in room, are presented the tube-like condition of bending, during sinus rhythm, left auricle of heart because normal contraction ability is hardly formed thrombus.When
When atrial fibrillation occurs, left auricle of heart mouthful is broadening, loses effective rule and shrinks, the introversive movement of auricle wall can not cause enough left hearts
Emptied in ear, cause blood to be deposited in left auricle of heart, easily produced blood and be vortexed and flows decrease, be thrombus shape in left auricle of heart
Into pathologic basis.Therefore, it is significant to prevention patients with atrial fibrillation cerebral apoplexy for the intervention study of left auricle of heart.
Previously the key agents of prevention thromboembolism are neodicoumarins, but warfarin has that compliance is poor, and monitoring is bothered, medicine
The problems such as side effect is more.Furthermore, it is possible to carry out surgical operation and thoracic cavity Minimally Invasive Surgery are treated, but surgical operation is created
Wound is larger, is typically employed in the patients with atrial fibrillation that cardiac operation is carried out because of other reasonses.Though thoracic cavity Minimally Invasive Surgery wound compared with
It is small, but because chamber structures can cause left auricle of heart residual cavity to be formed extremely, therefore still have thrombotic possibility.
Occluder for left auricle as treatment patients with atrial fibrillation a new technology, with wound it is small, chest need not be opened and follow in vitro
The characteristics of ring, it is considered to have good potential applicability in clinical practice.At present, existing multiple international clinical researches demonstrate its validity
And security.Occluder for left auricle can make apoplexy/embolism/cardiovascular mortality reduction by 40%, cardiovascular mortality reduction
60%, All-cause death rate reduction by 34%.
At present, the occluder for left auricle of in the market is hemispherical or disc-shaped structure, and left auricle of heart opening is usually from oval
Other irregular shapes such as shape, water-drop-shaped.Left atrial appendage is fixed in hemispherical stopper is overall, so that in anatomical structure
There is a situation where occur residual leakage.Serious residual leakage may may proceed to cause thrombus to flow out left auricle of heart, and then trigger cerebral apoplexy.
In order to prevent serious residual leakage, it can continue to be implanted into small-sized hemispherical closure between hemispherical stopper and left auricle of heart space
Device, but the risk that plugging device comes off may be increased.Disc-shaped stopper mainly includes closure disk and the position of fixed disk two, still
It blocks disk and fixed disk connecting portion and lacks axial direction modulability, is difficult during the left atrial appendage occlusion bent for internal structure
Alignment is formed, and then causes different degrees of residual leakage.In addition, the circular closure disk of disc-shaped stopper is long and narrow for opening
Left atrial appendage occlusion when, the excessive plugging device of diameter easily causes to close on the closure of pulmonary vein opening by mistake.
The content of the invention
It is an object of the invention to provide a kind of occluder for left auricle and its application method, it can realize of closure disk
Propertyization is designed, and regulation closure disk and fixed umbrella axial direction angle and (or) the distance between axles of regulation closure disk and fixed umbrella,
To strengthen the seal-off effect of plugging device, the generation of residual leakage is reduced.
To achieve the above object, the present invention takes following technical scheme：
A kind of occluder for left auricle, it includes closure disk and fixed umbrella；By bindiny mechanism between the closure disk and fixed umbrella
Connection；The closure disk is the irregular shapes such as circular, water-drop-shaped or ellipse；The fixation umbrella is in petal-shaped, and is had in end
Barb structure；The bindiny mechanism is a rotary shaft so that the closure disk can be rotated by axle of the rotary shaft.
Further, sleeve is provided with the middle part of the fixed umbrella, described rotary shaft one end is located in the sleeve, and positioned at the set
Part in cylinder is arranged with spring, and the spring causes the closure disk to have to the close trend of the fixation umbrella.
Further, there is rotation section on the inside of the closure disk, the rotation section has spherical rotation space；It is described to rotate
Axle close to the rotation section one end in spherical, in the rotation space so that the rotary shaft can be in axially with the fixed umbrella
0 °~60 ° changes.
Further, the rotary shaft is bourdon tube.
Further, the closure disk is that memory alloy wire braiding is formed, and the fixed umbrella is that NiTi pipe cuts thermal finalization
Shaping.
Further, there are one or more developing marks on the closure disk, the closure disk hinders provided with macromolecule
Flow film.
Further, the petal quantity of the fixed umbrella is 6~12, and the barb structure is integrated knot with the fixation umbrella
Structure, hangnail also is provided with macromolecule choked flow film towards the closure disk, the surface of the fixation umbrella.
Further, provided with raised conveying device connecting pole on the outside of the closure disk.
A kind of application method of described occluder for left auricle, first according to left auricle of heart form, is beaten using 3D printing technique
The thermal finalization mould of closure disk is printed off, columned close net memory alloy wire thermal finalization will be compiled into and opened into suitable closure left auricle of heart
The closure disk of mouth；Secondly, the fixed umbrella of release so that the barb structure of fixed umbrella is pierced into left auricle of heart inwall；Finally, will closure disk from
Conveying device is released after release, the rotation conveying device in atrium sinistrum, and then causes closure disk to occur turn relative with fixed umbrella
It is dynamic so that closure disk is blocked to left auricle of heart opening.
The beneficial effects of the invention are as follows：Compared to prior art, the closure disk of the occluder for left auricle of the invention provided is
Personalized designs so that closure disk is adapted with left auricle of heart opening shape, and the generation of residual leakage can be reduced or avoided.In the present invention
Occluder for left auricle, the axle of closure disk and fixed umbrella axial direction angle and (or) regulation closure disk and fixed umbrella can be adjusted
Spacing, can preferably adapt to the various structures and sizes of left auricle of heart cavity.
Brief description of the drawings
Fig. 1 is the overall schematic of occluder for left auricle embodiment 1 of the present invention.
Fig. 2 is the implantation of occluder for left auricle embodiment 1 left auricle of heart schematic diagram of the present invention.
Fig. 3 is the closure disk irregular shape design diagram of occluder for left auricle of the present invention.
Fig. 4 is that the circular closure disk seal of occluder for left auricle of the present invention blocks up water-drop-shaped left auricle of heart generation residual leakage schematic diagram.
Fig. 5 is that the water-drop-shaped closure disk seal of occluder for left auricle of the present invention blocks up water-drop-shaped left auricle of heart schematic diagram.
Fig. 6 is the overall schematic of occluder for left auricle embodiment 2 of the present invention.
Fig. 7 is the implantation of occluder for left auricle embodiment 2 left auricle of heart schematic diagram of the present invention.
Fig. 8 is the overall schematic of occluder for left auricle embodiment 3 of the present invention.
Fig. 9 is the implantation of occluder for left auricle embodiment 3 left auricle of heart schematic diagram of the present invention.
Embodiment
In order to be better understood from the present invention, the preferred embodiments of the present invention are described further with reference to the accompanying drawings.
As Figure 1-Figure 5, the present invention provides a kind of occluder for left auricle, and it includes closure disk 1 and fixed umbrella 2, the envelope
Connected between stifled disk 1 and fixed umbrella 2 by bindiny mechanism.The closure disk 1 is the irregular shapes such as circular, water-drop-shaped or ellipse,
To adapt to the different opening shapes of left auricle of heart 3, the generation of residual leakage is reduced or avoided.As shown in figure 3, preferential design structure is circle
Shape.For the left auricle of heart of water-drop-shaped (or irregular shape), circular closure disk 1, which exists, to block left auricle of heart 3 completely
Phenomenon, as shown in figure 4, and then occurring different degrees of residual leakage.When the shape and the hatch frame shape of left auricle of heart 3 of closure disk 1
When shape is adapted, as shown in figure 5, closure disk 1 and fixed umbrella 2 can be caused by conveying device rotation conveying device connecting pole 4
Relatively rotate, the regulation closure block-up position of disk 1 so that closure disk 1 is corresponding with the open cross sectional shape of left auricle of heart 3, reduces
Or avoid the generation of residual leakage.
The fixation umbrella 2 has in end barb structure 5 in petal-shaped.The petal quantity of the fixation umbrella 2 is 6~12,
The barb structure 5 is structure as a whole with the fixation umbrella 2, and hangnail is provided with macromolecule towards the closure disk 1, the surface of the fixation umbrella 2
Choked flow film.The closure disk 1 is that memory alloy wire braiding is formed, and the fixation umbrella 2 is the cutting thermal finalization shaping of NiTi pipe.The closure disk
Have on 1 on one or more developing marks 6, the closure disk 1 and also be provided with macromolecule choked flow film.The bindiny mechanism is a rotary shaft
7 so that the closure disk 1 can be rotated with the rotary shaft 7 for axle.The conveying device connecting pole 4 of the outside of closure disk 1 provided with projection,
To connect conveying device.
In addition, as Figure 1-Figure 2, the middle part of fixation umbrella 2 is provided with sleeve 8, and the one end of rotary shaft 7 is located in the sleeve 8,
And the part in the sleeve 8 is arranged with spring 9, the spring 9 causes the closure disk 1 to have to become to the fixation umbrella 2 is close
Gesture, can so adjust the distance between closure disk 1 and fixed umbrella 2.The inner side of closure disk 1 has rotation section 10, the rotation section
10 have spherical rotation space.The rotary shaft 7 is in spherical close to one end of the rotation section 10, in the rotation space, is made
Obtaining the rotary shaft 7 can be with the fixation umbrella 2 axially in 0 °~60 ° changes, and then the personalized shape of regulation blocks disk 1 in left auricle of heart 3
The block-up position of opening.
As shown in fig. 6, the attachment structure of the present invention can also be not provided with built-in spring 9, closure disk 1 and fixed umbrella are only realized
2 axial direction angular adjustments.As shown in fig. 7, when plugging device discharges, operator can adjust closure disk 1 and fixed umbrella 2 in time
Axial angle.
As shown in Figure 8, Figure 9, attachment structure of the invention can also be bourdon tube 11, bourdon tube 11 and described fixation umbrella
2 be an entirety, is formed by the cutting of NiTi pipe, and described bourdon tube 11 can adjust closure disk 1 by itself flexural deformation
With the axial angle of fixed umbrella 2, and then ensure that the closure being open to left auricle of heart 3 can easily, successfully be realized by blocking disk 1.
The present invention also provides a kind of application method of above-mentioned occluder for left auricle, first according to the form of left auricle of heart 3, utilizes 3D
Printing technique print closure disk 1 thermal finalization mould, will be compiled into columned close net memory alloy wire thermal finalization into be adapted to
Block the closure disk 1 that left auricle of heart 3 is open.Secondly, the fixed umbrella 2 of release so that the barb structure 5 of fixed umbrella 2 is pierced into left auricle of heart 3
Wall.Finally, closure disk 1 is released after release from conveying device, the rotation conveying device in atrium sinistrum, and then causes closure disk 1
Occurs the relative rotation with fixed umbrella 2 so that closure disk 1 is blocked to the opening of left auricle of heart 3.
The bindiny mechanism of the present invention can adjust connected closure disk and fixed umbrella axial direction angle and (or) regulation
The distance between axles of disk and fixed umbrella is blocked, the various structures and sizes of left auricle of heart cavity can be preferably adapted to.Institute of the present invention
The closure disk stated is released after release from intervention sheath, and now conveying device is not separated also with occluder for left auricle, can be on a left side
Rotation conveying device in atrium, and then cause closure disk to occur the relative rotation with fixed umbrella, adjust the closure of per-sonalization structures
Disk block-up position.The occluder for left auricle positioning of the present invention and plugging effect are good, and easily resetting, defeated completely disengaging from
Send also recyclable before device.
Described above is better embodiment of the present invention, can not to show the present invention, all spirit in the present invention with
Any modification, equivalent conversion and improvement for being made between principle etc., all should be included within protection scope of the present invention.
Claims (9)
1. a kind of occluder for left auricle, it is characterised in that it includes closure disk and fixed umbrella；Between the closure disk and fixed umbrella by
Bindiny mechanism connects；The closure disk is circular, water-drop-shaped or ellipse；The fixation umbrella is in petal-shaped, and has hangnail in end
Structure；The bindiny mechanism is a rotary shaft so that the closure disk can be rotated by axle of the rotary shaft.
2. occluder for left auricle according to claim 1, it is characterised in that sleeve is provided with the middle part of the fixed umbrella, described
Rotary shaft one end is located in the sleeve, and the part in the sleeve is arranged with spring, and the spring causes the closure disk to have
The close trend of the oriented fixation umbrella.
3. occluder for left auricle according to claim 2, it is characterised in that have rotation section on the inside of the closure disk, should
Rotation section has spherical rotation space；The rotary shaft is in spherical close to one end of the rotation section, in the rotation space,
Enable the rotary shaft with the fixed umbrella axially in 0 °~60 ° changes.
4. occluder for left auricle according to claim 1, it is characterised in that the rotary shaft is bourdon tube.
5. occluder for left auricle according to claim 1, it is characterised in that the closure disk is memory alloy wire braiding
Into the fixed umbrella is the cutting thermal finalization shaping of NiTi pipe.
6. occluder for left auricle according to claim 1, it is characterised in that have on the closure disk one or more aobvious
Shadow is marked, and the closure disk is provided with macromolecule choked flow film.
7. occluder for left auricle according to claim 6, it is characterised in that the petal quantity of the fixed umbrella is 6~12
Individual, the barb structure is structure as a whole with the fixation umbrella, and hangnail also is provided with height towards the closure disk, the surface of the fixation umbrella
Molecule choked flow film.
8. occluder for left auricle according to claim 1, it is characterised in that provided with raised conveying on the outside of the closure disk
Device connecting pole.
9. a kind of application method of occluder for left auricle as claimed in any one of claims 1-9 wherein, it is characterised in that root first
According to left auricle of heart form, the thermal finalization mould of closure disk is printed using 3D printing technique, columned close net memory will be compiled into
Closure disk of the B alloy wire thermal finalization into suitable closure left auricle of heart opening；Secondly, the fixed umbrella of release so that the barb structure of fixed umbrella
It is pierced into left auricle of heart inwall；Finally, closure disk is released after release from conveying device, the rotation conveying device in atrium sinistrum, and then
So that the relative rotation with fixed umbrella occurs for closure disk so that closure disk is blocked to left auricle of heart opening.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710426556.0A CN107126240A (en) | 2017-06-08 | 2017-06-08 | A kind of occluder for left auricle and its application method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710426556.0A CN107126240A (en) | 2017-06-08 | 2017-06-08 | A kind of occluder for left auricle and its application method |
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| CN107126240A true CN107126240A (en) | 2017-09-05 |
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| CN201710426556.0A Pending CN107126240A (en) | 2017-06-08 | 2017-06-08 | A kind of occluder for left auricle and its application method |
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Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109662745A (en) * | 2017-10-17 | 2019-04-23 | 上海微创医疗器械（集团）有限公司 | Occluder for left auricle and left atrial appendage occlusion system |
| WO2019075640A1 (en) * | 2017-10-17 | 2019-04-25 | 上海微创医疗器械（集团）有限公司 | Left atrial appendage occlusion device and left atrial appendage occlusion system |
| WO2019165966A1 (en) * | 2018-03-02 | 2019-09-06 | 上海微创医疗器械（集团）有限公司 | Occluder, and medical device |
| CN110680443A (en) * | 2019-11-21 | 2020-01-14 | 陕西省核工业二一五医院 | Heart plugging device |
| CN110974315A (en) * | 2019-11-19 | 2020-04-10 | 先健科技(深圳)有限公司 | Plugging device |
| CN111000598A (en) * | 2019-11-19 | 2020-04-14 | 先健科技(深圳)有限公司 | Plugging device |
| CN111000600A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN111000601A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN112137675A (en) * | 2020-08-28 | 2020-12-29 | 河南科技大学第一附属医院 | Left ventricle plugging device and using method |
| CN112401948A (en) * | 2020-11-24 | 2021-02-26 | 李建朝 | Semi-spherical structure plugging device for extracardiac operation |
| CN112472197A (en) * | 2020-12-30 | 2021-03-12 | 东南大学泰州生物医药与医疗器械研究院 | Left auricle plugging device |
| CN112932567A (en) * | 2021-03-15 | 2021-06-11 | 上海捍宇医疗科技股份有限公司 | Plugging device |
| WO2021128938A1 (en) * | 2019-12-24 | 2021-07-01 | 上海微创心脉医疗科技(集团)股份有限公司 | Occluder and system |
| CN113873957A (en) * | 2019-03-25 | 2021-12-31 | 拉米纳公司 | Device and system for treating left atrial appendage |
| CN114027912A (en) * | 2021-12-03 | 2022-02-11 | 上海心玮医疗科技股份有限公司 | Left auricle occluder capable of adjusting angle in multiple directions |
| CN114340516A (en) * | 2019-08-30 | 2022-04-12 | 波士顿科学医学有限公司 | Left atrial appendage implant with sealing disk |
| CN116763384A (en) * | 2023-05-23 | 2023-09-19 | 上海玮启医疗器械有限公司 | An anticoagulant-coated left atrial appendage occlusion device and its preparation method |
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| CN109662745A (en) * | 2017-10-17 | 2019-04-23 | 上海微创医疗器械（集团）有限公司 | Occluder for left auricle and left atrial appendage occlusion system |
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| CN110680443A (en) * | 2019-11-21 | 2020-01-14 | 陕西省核工业二一五医院 | Heart plugging device |
| CN111000601B (en) * | 2019-12-17 | 2021-11-16 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN111000601A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN111000600A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN111000600B (en) * | 2019-12-17 | 2022-03-22 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| WO2021128938A1 (en) * | 2019-12-24 | 2021-07-01 | 上海微创心脉医疗科技(集团)股份有限公司 | Occluder and system |
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| CN112401948A (en) * | 2020-11-24 | 2021-02-26 | 李建朝 | Semi-spherical structure plugging device for extracardiac operation |
| CN112401948B (en) * | 2020-11-24 | 2023-09-05 | 李建朝 | Hemispherical structure plugging device for extracardiac operation |
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