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CN105520758B - A closure device for patent foramen ovale or small atrial septal defect - Google Patents

A closure device for patent foramen ovale or small atrial septal defect Download PDF

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Publication number
CN105520758B
CN105520758B CN201610035276.2A CN201610035276A CN105520758B CN 105520758 B CN105520758 B CN 105520758B CN 201610035276 A CN201610035276 A CN 201610035276A CN 105520758 B CN105520758 B CN 105520758B
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septal defect
closure
atrial septal
foramen ovale
patent foramen
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CN105520758A (en
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高伟
于存涛
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Fuwai Hospital of CAMS and PUMC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00601Implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623Introducing or retrieving devices therefor

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

本发明属于植入人体的医疗器械领域,具体涉及一种卵圆孔未闭或小房间隔缺损闭合装置及一种卵圆孔未闭或小房间隔缺损闭合装置的输送装置。所述卵圆孔未闭或小房间隔缺损闭合装置包括闭合单元,所述闭合单元包括两个闭合器,所述两个闭合器相对设置;所述闭合器端部为嵌入部,所述嵌入部为卷曲状,可嵌入卵圆孔未闭或房间隔缺损处周侧;所述输送装置包括推送鞘管及一闭合器容纳装置,所述闭合器容纳装置置于所述推送鞘管内,所述第一闭合器及第二闭合器在所述闭合器容纳装置内。本发明的有益效果:具有置入装置小,易定位,可反复释放回收,进而实现确保在准确设置闭合器的基础上,阻断房水平分流。

The invention belongs to the field of medical devices implanted in the human body, in particular to a patent foramen ovale or small atrial septal defect closing device and a delivery device for a patent foramen ovale or small atrial septal defect closing device. The patent foramen ovale or small atrial septal defect closing device includes a closing unit, and the closing unit includes two closing devices, and the two closing devices are arranged oppositely; the end of the closing device is an embedded part, and the embedded part is The portion is curled and can be embedded in the peripheral side of the patent foramen ovale or atrial septal defect; the delivery device includes a pusher sheath and a occluder accommodating device, and the occluder accommodating device is placed in the pusher sheath, so The first closer and the second closer are in the closer accommodating device. The beneficial effects of the invention are as follows: the implantation device is small, easy to locate, and can be repeatedly released and recovered, thereby ensuring that the horizontal shunt of the room can be blocked on the basis of accurately setting the closure device.

Description

A kind of closing device of acleistocardia or Small Atrial Septal Defect
Technical field
The invention belongs to be implanted into the medical instruments field of human body, and in particular to a kind of acleistocardia or Small Atrial Septal Defect Closing device.
Background technique
Oval foramen (Patent foramen oval, PFO) is the normal channel of the blood of fetal period, is a check valve Door, its role is to fetal periods, and room blood to be made to flow to atrium sinistrum from atrium dextrum by oval foramen, normal to guarantee Fetal circulation.After breathing occurs in fetal birth, as pulmonary vascular resistance reduces, oval foramen one-way cock is closed, room horizontal traffic It disappears.But in normal adult crowd, there are about 1/3 Adult Groups oval foramens to be not off, and still retains a small aqueous humor and divides equally Stream (is less than 5mm, be greater than 5mm and be known as atrial septal defect).Under normal circumstances, such crowd due to oval foramen shunt volume it is few, both It is asymptomatic, also without long term complication.But at present evidence show, in this part population, occur infectious endocarditis and in it is old The risk that cerebral infarction occurs for the term is higher than normal population.
Atrial septal defect (Atrial septal defect, ASD) is a kind of common congenital heart disease, is atrial septum Occur exception in embryo development procedure, causes to leave hole between left and right atrium.Atrial septal defect can individually occur, can also be with Other kinds of cardiovascular malformation is simultaneously deposited.Most atrial septal defect diameters are greater than 5mm, larger greater than 5mm for diameter at present Atrial septal defect fit through surgical operation or minimally invasive transcatheter operative treatment, but surgery operating wound is big, operation risk Height, post-operative recovery time is long, and transcatheter operation then needs to place a biggish metal atrial septal defect plugging device in vivo. Due to internal cardiac structures complexity, postoperative short-term and the occurrence risk at a specified future date that may all will increase complication, and biggish envelope are intervened Stifled device is placed in heart, and many patients are not easily accepted by, and furthermore transcatheter is difficult to release recycling repeatedly.
Summary of the invention
For deficiency present in background technique, the purpose of the present invention is to provide a kind of acleistocardia or cubicle every Defect closing device, for treating the acleistocardia or atrial septal defect of 1-5mm.
Technical scheme is as follows: a kind of acleistocardia or Small Atrial Septal Defect closing device, the oval foramen Patent or Small Atrial Septal Defect closing device include a closed cell, and the closed cell end is embedded division, the embedded division To be curly, side at embeddable acleistocardia or Small Atrial Septal Defect.
Further, the closed cell includes two closers, and described two closers are oppositely arranged;
The closer includes an extension and an embedded division, and described two closers are connected by extension, and two prolong The junction of extending portion connects a delivery guidewire jointly, and the embedded division is embedded in side at acleistocardia or Small Atrial Septal Defect, Position embedded by described two embedded divisions is opposite.
Further, the extension is elastic metallic material;The embedded division is memory metal material.
Further, the elastic metallic material is beryllium-bronze or spring steel;The memory metal material is Ni-Ti conjunction Gold.
The conveying device of a kind of acleistocardia or Small Atrial Septal Defect closing device, for conveying above-mentioned oval foramen not It closes or Small Atrial Septal Defect closing device, the conveying device includes pushing sheath tube and a closer storing apparatus, the closure Device storing apparatus is placed in the pushing sheath tube, and the closed cell is accommodated in the closer storing apparatus.
Further, the pushing sheath tube front end is through-hole, and the front end of the through hole extends a closer release portion, described Closer release portion is cylindrical shape, and closer release portion cylindrical shape inner section diameter is identical as the through-hole diameter size;
The pushing sheath tube front end outer side is provided with spacing block set;
The guide portion of smooth surface is equipped with outside closer release portion.
Further, the through-hole is equipped with closer storing apparatus slideway in contrast to the side in closer release portion, is used for Closer storing apparatus is guided to through hole.
Further, there is an accommodation space, the accommodation space is cylindrical shape, described in the closer storing apparatus The interior diameter of accommodation space is less than the diameter of through-hole, and the overall diameter of storing apparatus is greater than the diameter of through-hole.
Further, the first closer and the second closer are placed in two sides opposite in closer accommodation space.
Method of closing at a kind of acleistocardia or Small Atrial Septal Defect, using above-mentioned acleistocardia or cubicle Every the conveying device of defect closing device, the method are as follows:
A) application guidance seal wire, through upper limb/veins of lower extremity, until atrium dextrum, reaches at oval foramen or atrial septal defect, and convex It extends through at oval foramen or atrial septal defect;
B) pushing sheath tube of closing device is delivered at oval foramen or atrial septal defect along guidance seal wire, portion to be guided Into after defect, extraction guidance seal wire pushes delivery guidewire, extension and embedded division is made to enter left room side;
C) further push delivery guidewire, the extension be unfolded, the embedded division contradict in acleistocardia or Side at atrial septal defect;
D) in 6-10 minutes, radiography observes the conflict position of embedded division, and adjustment contradicts position and pulls delivery guidewire, makes Embedded division is embedded in defect side, and after 10-15 minutes, memory metal completes curling, the embedded division curling insertion oval foramen Closure is completed in side at patent or atrial septal defect, discharges closing device.
Beneficial effects of the present invention: according to the technical solution of the present invention, it can be achieved that the acleistocardia or room for being less than 5mm Septal defect carries out minimally invasive closure, and embedded device is small, easily positions, and can discharge recycling repeatedly, and then realization ensures in accurate position Setting closer is set, and resistance flowing effect is strong.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of the embodiment of the present invention;
Fig. 2 is the closing device installation procedure figure that the embodiment of the present invention proposes.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to the accompanying drawings and embodiments, right The present invention is explained in further detail.It should be appreciated that described herein, the specific embodiments are only for explaining the present invention, not For limiting the present invention.
On the contrary, the present invention covers any substitution done on the essence and scope of the present invention being defined by the claims, repairs Change, equivalent method and scheme.Further, in order to make the public have a better understanding the present invention, below to of the invention thin It is detailed to describe some specific detail sections in section description.
As shown in Figure 1, being the structural schematic diagram of one embodiment of the invention, which shows a kind of oval The overall structure of hole patent or atrial septal defect closing device, the acleistocardia or Small Atrial Septal Defect closing device are set It sets in defect point.
The acleistocardia or atrial septal defect closure include the first closer 1 and the second closer 2, and described first closes Clutch 1 and second closer 2 will hook at atrial septal defect jointly to be closed, 2 structure of first closer 1 and the second closer It is identical.
First closer 1 include the first extension 11 and the first embedded division 12, first extension 11 with it is described The connection of first embedded division 12, second closer 2 include the second extension 21 and the second embedded division 22, second extension 21 connect with second embedded division 22, and first extension 11 is connect with the second extension 21 by central connection point 3, And the described central connection point 3 connects delivery guidewire 6, by delivery guidewire 6, it can be achieved that the same of the first, second closer 1,2 When control.
First extension 11 and the second extension 21 are connected in delivery guidewire 6 by screw joining manner.
First embedded division 12 and the second embedded division 22 be extend on the inside of central connection point 3 it is curly, In the state that one closer 1 and the second closer 2 are thoroughly opened, first embedded division 12 and the second embedded division 22 are embedded in institute Side at acleistocardia or atrial septal defect is stated, specially the first embedded division 12 is with place embedded by the second embedded division 22 At acleistocardia or atrial septal defect at position opposite on side, and combine the first extension 11 and the second extension 21 will Conjunction is completely hooked at atrial septal defect.
Wherein first extension 11 and the second extension 21 are elastic metallic material, concretely in the prior art, With elastic metal material, such as beryllium-bronze, spring steel etc.;First embedded division 12 and the second embedded division 22 For memory metal material, concretely Ni-Ti alloys such as ambrose alloy, titanium ferronickel, titanium nickel chromium triangle by the emperor himself.
The present invention also provides one for acleistocardia or the conveying device of atrial septal defect closing device, the conveying dress It sets including pushing sheath tube 4 and a closer storing apparatus 5, the closer storing apparatus 5 is placed in the pushing sheath tube 4, institute Stating 4 front end of pushing sheath tube is through-hole 41, and a closer release portion 42 is extended in the 41 front end side of through-hole, and the closer is released Portion 42 is put as cylindrical shape, and the cylindrical inner is smooth, cylindric inner section diameter is identical as 41 diameter of through-hole, 42 side of closer release portion is provided with the guide portion 45 of smooth surface, the guide portion 45 generally smooth surface, After reaching at acleistocardia or atrial septal defect, by the guidance of smooth surface so that closer release portion 42 is placed in oval foramen Centre at patent or atrial septal defect, the through-hole 41 are accommodated in contrast to the side in closer release portion 42 equipped with closer Device slideway 43, for guiding closer storing apparatus 5 to through-hole 41;Setting limit is also possible on the outside of the pushing sheath tube 4 Device 44 processed, the limits device 44 are convex block, for being stuck in outside at atrial septal defect, closer release portion 42 are avoided to protrude out Excessively.
There is an accommodation space in the closer storing apparatus 5, first closer 1 and the second closer 2 are set In in the accommodation space, and the accommodation space is cylindrical shape, and the interior diameter of the accommodation space is slightly less than the diameter of through-hole 41, The overall diameter of storing apparatus 5 is slightly larger than the diameter of through-hole 51.
When the first closer 1 and the second closer 2 are to draw close state, the first closer 1 and the second closer 2 are placed in Opposite two sides.
As shown in Fig. 2, being closed the present invention also provides a kind of above-mentioned conveying device of application to acleistocardia or atrial septal defect The operating method for the placement set is attached together, the operating method of the placement specifically comprises the following steps:
A) application guidance seal wire, through upper limb/veins of lower extremity, until atrium dextrum, reaches at oval foramen or atrial septal defect, and convex It extends through at oval foramen or atrial septal defect;
B) pushing sheath tube of closing device is delivered at oval foramen or atrial septal defect along guidance seal wire, portion to be guided Into after defect, extraction guidance seal wire pushes delivery guidewire, extension and embedded division is made to enter left room side;
C) further push delivery guidewire, the extension be unfolded, the embedded division contradict in acleistocardia or Side at atrial septal defect;
D) in 6-10 minutes, radiography observes the conflict position of embedded division, and adjustment contradicts position and pulls delivery guidewire, makes Embedded division is embedded in defect side, and after 10-15 minutes, memory metal completes curling, the embedded division curling insertion oval foramen Closure is completed in side at patent or atrial septal defect, discharges closing device;Realize that hooking conjunction acleistocardia or atrial septum completely lacks Damage is completed to place, if place inaccuracy, by drawing seal wire within the effective time before memory metal deformation, is led Draw, under the position restriction effect of storing apparatus front end, the first closer and the second closer is recovered to closer and accommodate dress In setting, position is adjusted again, discharges closer, until accurate installation.

Claims (6)

1.一种卵圆孔未闭或小房间隔缺损闭合装置,其特征在于,所述卵圆孔未闭或小房间隔缺损闭合装置包括一闭合单元,所述闭合单元端部为嵌入部,所述嵌入部为卷曲状,能够嵌入卵圆孔未闭或小房间隔缺损处周侧,所述闭合单元包括两个闭合器,所述两个闭合器相对设置;1. a patent foramen ovale or small atrial septal defect closing device, it is characterized in that, described patent foramen ovale or small atrial septal defect closing device comprises a closing unit, and described closing unit end is embedded part, The embedding part is curled and can be inserted into the peripheral side of the patent foramen ovale or the small atrial septal defect, and the closing unit includes two closure devices, and the two closure devices are arranged oppositely; 每个闭合器均包括一延伸部及所述嵌入部,所述两个闭合器通过延伸部连接,并两个延伸部的连接处共同连接一输送导丝,所述嵌入部通过输送导丝嵌入卵圆孔未闭或小房间隔缺损处周侧,在10-15分钟后,嵌入部完成卷曲,两个嵌入部所嵌入的位置相对,所述延伸部为弹性金属材质;所述嵌入部为记忆金属材质。Each closure includes an extension portion and the embedded portion, the two closures are connected by the extension portion, and a delivery guide wire is commonly connected to the connection of the two extension portions, and the embedded portion is inserted through the delivery guide wire On the peripheral side of the patent foramen ovale or small atrial septal defect, after 10-15 minutes, the embedded part is curled, the positions of the two embedded parts are opposite to each other, and the extension part is made of elastic metal; the embedded part is Memory metal material. 2.根据权利要求1所述的一种卵圆孔未闭或小房间隔缺损闭合装置,其特征在于,所述弹性金属材质为铍青铜或弹簧钢;所述记忆金属材质为镍-钛合金。2. a kind of patent foramen ovale or small atrial septal defect closure device according to claim 1, is characterized in that, described elastic metal material is beryllium bronze or spring steel; Described memory metal material is nickel-titanium alloy . 3.一种卵圆孔未闭或小房间隔缺损闭合装置的输送装置,用于输送上述权利要求1-2之一所述的卵圆孔未闭或小房间隔缺损闭合装置,其特征在于,所述输送装置包括推送鞘管、及一闭合器容纳装置,所述闭合器容纳装置置于所述推送鞘管内,所述闭合单元容置在所述闭合器容纳装置内,所述推送鞘管前端为通孔,所述通孔前端延伸出一闭合器释放部,所述闭合器释放部为圆筒状,所述闭合器释放部圆筒状内截面直径与所述通孔直径大小相同;3. A delivery device for a patent foramen ovale or a small atrial septal defect closing device, for delivering the patent foramen ovale or a small atrial septal defect closing device according to one of the above claims 1-2, characterized in that , the delivery device comprises a push sheath tube and a closure accommodating device, the closure accommodating device is placed in the push sheath tube, the closing unit is accommodated in the closer accommodating device, the push sheath The front end of the tube is a through hole, a closure release part extends from the front end of the through hole, the closure release part is cylindrical, and the cylindrical inner cross-sectional diameter of the closure release part is the same as the diameter of the through hole ; 所述推送鞘管前端外侧设置有限位凸块;The outer side of the front end of the push sheath is provided with a limit bump; 所述闭合器释放部外部设有表面平滑的引导部。The outside of the closer release portion is provided with a guide portion with a smooth surface. 4.根据权利要求3所述的一种卵圆孔未闭或小房间隔缺损闭合装置的输送装置,其特征在于,所述通孔相反于闭合器释放部的一侧设有闭合器容纳装置滑道,用于将闭合器容纳装置引导至通孔处。4 . The delivery device for a patent foramen ovale or a small atrial septal defect closure device according to claim 3 , wherein a closure accommodating device is provided on the side of the through hole opposite to the closure release portion. 5 . The slideway is used to guide the closer accommodating device to the through hole. 5.根据权利要求3所述的一种卵圆孔未闭或小房间隔缺损闭合装置的输送装置,其特征在于,所述闭合器容纳装置内具有一容纳空间,所述容纳空间为圆筒状,所述容纳空间的内直径小于通孔的直径,所述闭合器容纳装置的外直径大于通孔的直径。5 . The delivery device for a patent foramen ovale or a small atrial septal defect closure device according to claim 3 , wherein the closure accommodating device has an accommodating space, and the accommodating space is a cylinder. 6 . The inner diameter of the accommodating space is smaller than the diameter of the through hole, and the outer diameter of the closure accommodating device is larger than the diameter of the through hole. 6.根据权利要求5所述的一种卵圆孔未闭或小房间隔缺损闭合装置的输送装置,其特征在于,第一闭合器及第二闭合器置于所述容纳空间内相对的两侧。6. The delivery device for a patent foramen ovale or a small atrial septal defect closure device according to claim 5, wherein the first closure device and the second closure device are placed on two opposite sides in the accommodating space. side.
CN201610035276.2A 2016-01-19 2016-01-19 A closure device for patent foramen ovale or small atrial septal defect Active CN105520758B (en)

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US7338514B2 (en) * 2001-06-01 2008-03-04 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods and tools, and related methods of use
US20050192627A1 (en) * 2003-10-10 2005-09-01 Whisenant Brian K. Patent foramen ovale closure devices, delivery apparatus and related methods and systems
US20070198057A1 (en) * 2006-02-21 2007-08-23 Daniel Gelbart Method and device for closing holes in tissue
US20080039743A1 (en) * 2006-08-09 2008-02-14 Coherex Medical, Inc. Methods for determining characteristics of an internal tissue opening
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CN205458820U (en) * 2016-01-19 2016-08-17 高伟 Acleistocardia or little atrial septal defect's closing device and conveyor thereof

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Address after: 100037 Beijing City, Xicheng District No. 167 North

Patentee after: FUWAI HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES

Address before: No. 167 Beilishi Road, Xicheng District, Beijing, 100035

Patentee before: Gao Wei