CN105520758A - Closure apparatus for patent foramen ovale or small atrial septal defect - Google Patents

Abstract

Translated fromChinese

本发明属于植入人体的医疗器械领域，具体涉及一种新型卵圆孔未闭或小房间隔缺损闭合装置及一种新型卵圆孔未闭或小房间隔缺损闭合装置的输送装置。所述新型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 into human bodies, and in particular relates to a novel patent foramen ovale or small atrial septal defect closing device and a delivery device for the novel patent foramen ovale or small atrial septal defect closing device. The novel patent foramen ovale or small atrial septal defect closing device includes a closing unit, the closing unit includes two closers, and the two closers are arranged oppositely; the end of the closer is an embedded part, and the The embedding part is curled and can be embedded in the periphery of the patent foramen ovale or atrial septal defect; the delivery device includes a push sheath and a occluder accommodating device, and the occluder accommodating device is placed in the push sheath, The first and second closers are within the closer receiver. The beneficial effect of the present invention is that the implanted device is small, easy to locate, and can be released and recovered repeatedly, so as to ensure that the horizontal shunt of the room is blocked on the basis of accurately setting the closer.

Description

The closing device of a kind of patent foramen ovale or Small Atrial Septal Defect

Technical field

The invention belongs to the medical instruments field of implant into body, be specifically related to a kind of novel patent foramen ovale or Small Atrial Septal Defect closing device.

Background technology

Oval foramen (Patentforamenoval, PFO) is the normal channel of the blood of fetal period, is an one-way cock structure, its role is to fetal period and makes room blood flow to left atrium by oval foramen from right atrium, to ensure normal fetal circulation.After breathing appears in fetal birth, along with pulmonary vascular resistance reduces, oval foramen one-way cock is closed, and room horizontal traffic disappears.But in normal adult crowd, about there is the Adult Groups oval foramen of 1/3 not close, still retain a little room horizontal flow (be less than 5mm, be greater than 5mm and be namely called atrial septal defect).Generally, this type of crowd due to oval foramen shunt volume few, both asymptomatic, also without long term complication.But evidence show at present, in this part crowd, there is the risk of cerebral infarction higher than normal population in generation infective endocarditis and person in middle and old age's phase.

Atrial septal defect (Atrialseptaldefect, ASD) is a kind of common congenital heart disease, is that interatrial septum occurs abnormal in embryo development procedure, causes between left and right atrium and leave over hole.Atrial septal defect can occur separately, also can deposit with the cardiovascular malformation of other types.Most atrial septal defect diameter is greater than 5mm, the larger atrial septal defect being at present greater than 5mm for diameter is applicable to by surgical operation or Wicresoft's transcatheter operative treatment, but surgery operating wound is large, operation risk is high, post-operative recovery time is long, and transcatheter operation then needs to place in vivo a larger metal atrial septal defect plugging device.Because internal cardiac structures is complicated, get involved postoperative short-term and all may increase the occurrence risk of complication long term, and larger stopper is placed in heart, a lot of patient not easily accepts, and transcatheter is difficult to accomplish repeatedly to discharge recovery in addition.

Summary of the invention

For the deficiency existed in background technology, the object of the present invention is to provide a kind of novel patent foramen ovale or Small Atrial Septal Defect closing device, be used for the treatment of patent foramen ovale or the atrial septal defect of 1-5mm.

Technical scheme of the present invention is as follows: a kind of novel patent foramen ovale or Small Atrial Septal Defect closing device, described patent foramen ovale or Small Atrial Septal Defect closing device comprise a closed cell, described closed cell end is Embedded Division, described Embedded Division is curling shape, can embed patent foramen ovale or week side, Small Atrial Septal Defect place.

Further, described closed cell comprises two closers, and described two closers are oppositely arranged;

Described closer comprises an extension and an Embedded Division, described two closers are connected by extension, and the junction of two extensions connects a delivery guidewire jointly, described Embedded Division embeds patent foramen ovale or week side, Small Atrial Septal Defect place, and the position embedded by described two Embedded Divisions is relative.

Further, described extension is elastic metallic material; Described Embedded Division is memory metal material.

Further, described elastic metallic material is beryllium-bronze or spring steel; Described memory metal material is Ni-Ti alloy.

The conveyer device of a kind of novel patent foramen ovale or Small Atrial Septal Defect closing device, for carrying above-mentioned novel patent foramen ovale or Small Atrial Septal Defect closing device, described conveyer device comprises pushing sheath tube and a closer storing apparatus, described closer storing apparatus is placed in described pushing sheath tube, and described closed cell is contained in described closer storing apparatus.

Further, described pushing sheath tube front end is through hole, and a closer release portion is extended in described through hole front end, and described closer release portion is cylindric, and in described closer release portion cylindrical shape, diameter of section is identical with described through-hole diameter size;

Described pushing sheath tube front end outer side is provided with spacing block set;

Described closer release portion outside is provided with the guide portion of surface smoothing.

Further, described through hole is provided with closer storing apparatus slideway, for closer storing apparatus is guided to through hole in contrast to the side of closer release portion.

Further, have a spatial accommodation in described closer storing apparatus, described spatial accommodation is cylindric, and the interior diameter of described spatial accommodation 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 both sides relative in closer spatial accommodation.

The method of closing at patent foramen ovale or Small Atrial Septal Defect place, apply above-mentioned novel patent foramen ovale or the conveyer device of Small Atrial Septal Defect closing device, described method is:

A) application guides seal wire, through upper limb/veins of lower extremity, to right atrium, arrives oval foramen or atrial septal defect place, and protrudes out through oval foramen or atrial septal defect place;

B) along guiding seal wire, the pushing sheath tube of closing device is delivered to oval foramen or atrial septal defect place, after portion to be guided enters defect, extracts out and guide seal wire, push delivery guidewire, make extension and Embedded Division enter side, left room;

C) push delivery guidewire further again, described extension is launched, described Embedded Division is conflicted in patent foramen ovale or week side, atrial septal defect place;

D) in 6-10 minute, radiography observes the conflict position of Embedded Division, adjust conflict position and tractive delivery guidewire, Embedded Division is made to be embedded in defect week side, after 10-15 minute, memory metal completes curling, the curling embedding patent foramen ovale of described Embedded Division or week side, atrial septal defect place, complete closed, release closing device.

Beneficial effect of the present invention: by technical scheme of the present invention, can realize carrying out Wicresoft to the patent foramen ovale or atrial septal defect that are less than 5mm and close, embedded device is little, easy location, repeatedly can discharge recovery, and then realize guaranteeing to arrange closer on position accurately, and resistance flowing effect is strong.

Accompanying drawing explanation

Fig. 1 is the structural representation of the embodiment of the present invention;

Fig. 2 is the closing device installation procedure figure that the embodiment of the present invention proposes.

Detailed description of the invention

In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with drawings and Examples, the present invention is explained in further detail.Should be appreciated that specific embodiment described herein only for explaining the present invention, being not intended to limit the present invention.

On the contrary, the present invention is contained any by the substituting of making on marrow of the present invention and scope of defining of claim, amendment, equivalent method and scheme.Further, in order to make the public have a better understanding to the present invention, in hereafter details of the present invention being described, detailedly describe some specific detail sections.

As shown in Figure 1, for the structural representation of one embodiment of the invention, this structural representation illustrates the overall structure of described a kind of novel patent foramen ovale or atrial septal defect closing device, and described patent foramen ovale or Small Atrial Septal Defect closing device are arranged on defect place.

Described novel patent foramen ovale or atrial septal defect are closed comprises the first closer 1 and the second closer 2, and atrial septal defect place hooks and closes by described first closer 1 and described second closer 2 jointly, described first closer 1 and the second closer 2 structure identical.

Described first closer 1 comprises the first extension 11 and the first Embedded Division 12, described first extension 11 is connected with described first Embedded Division 12, described second closer 2 comprises the second extension 21 and the second Embedded Division 22, described second extension 21 is connected with described second Embedded Division 22, and described first extension 11 is connected by central connection point 3 with the second extension 21, and this central connection point 3 described connects delivery guidewire 6, by delivery guidewire 6, can realize controlling while first, second closer 1,2.

Described first extension 11 and the second extension 21 are connected in delivery guidewire 6 by screw joining manner.

Described first Embedded Division 12 and the second Embedded Division 22 are the curling shape extended inside central connection point 3, under the state that the first closer 1 and the second closer 2 are thoroughly opened, described first Embedded Division 12 and the second Embedded Division 22 embed described patent foramen ovale or week side, atrial septal defect place, being specially the first Embedded Division 12 with the place embedded by the second Embedded Division 22 is position relative on all sides in patent foramen ovale or atrial septal defect place, and is closed by complete for atrial septal defect place hook in conjunction with the first extension 11 and the second extension 21.

Wherein said first extension 11 and the second extension 21 are elastic metallic material, specifically can be in prior art, have elastic metal material, such as beryllium-bronze, spring steel etc.; Described first Embedded Division 12 and the second Embedded Division 22 are memory metal material, specifically can be the Ni-Ti alloys such as ambrose alloy, titanium ferronickel, titanium nickel chromium triangle of admiring.

The present invention also provides one for the conveyer device of novel patent foramen ovale or atrial septal defect closing device, described conveyer device comprises pushing sheath tube 4 and a closer storing apparatus 5, described closer storing apparatus 5 is placed in described pushing sheath tube 4, described pushing sheath tube 4 front end is through hole 41, a closer release portion 42 is extended in all sides, described through hole 41 front end, described closer release portion 42 is cylindric, and described cylindrical inner is smooth, in cylindric, diameter of section is identical with described through hole 41 diameter, described closer release portion 42 weeks sides are provided with the guide portion 45 of surface smoothing, described guide portion 45 entirety is smooth surface, after arrival patent foramen ovale or atrial septal defect place, closer release portion 42 is made to be placed in patent foramen ovale or centre, atrial septal defect place by the guiding of smooth surface, described through hole 41 is provided with closer storing apparatus slideway 43 in contrast to the side of closer release portion 42, for closer storing apparatus 5 is guided to through hole 41 place, also may arrange restraint device 44 outside described pushing sheath tube 4, described restraint device 44 is projection, for being stuck in outside atrial septal defect place, avoids closer release portion 42 to protrude out too much.

In described closer storing apparatus 5, there is a spatial accommodation, described first closer 1 and the second closer 2 are all placed in this spatial accommodation, and described spatial accommodation is cylindric, the interior diameter of described spatial accommodation is slightly less than the diameter of through hole 41, and 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 for drawing close state, the first closer 1 and the second closer 2 are placed in relative both sides.

As shown in Figure 2, the present invention also provides a kind of application above-mentioned conveyer device, and to the operational approach of the placement of patent foramen ovale or atrial septal defect closing device, the operational approach of described placement specifically comprises the steps:

A) application guides seal wire, through upper limb/veins of lower extremity, to right atrium, arrives oval foramen or atrial septal defect place, and protrudes out through oval foramen or atrial septal defect place;

B) along guiding seal wire, the pushing sheath tube of closing device is delivered to oval foramen or atrial septal defect place, after portion to be guided enters defect, extracts out and guide seal wire, push delivery guidewire, make extension and Embedded Division enter side, left room;

C) push delivery guidewire further again, described extension is launched, described Embedded Division is conflicted in patent foramen ovale or week side, atrial septal defect place;

D) in 6-10 minute, radiography observes the conflict position of Embedded Division, adjust conflict position and tractive delivery guidewire, Embedded Division is made to be embedded in defect week side, after 10-15 minute, memory metal completes curling, the curling embedding patent foramen ovale of described Embedded Division or week side, atrial septal defect place, complete closed, release closing device; Realize hooking completely closing patent foramen ovale or atrial septal defect, complete placement, if when placing inaccurate, by tractive seal wire in effective time before memory metal distortion, draw, under the position limitation effect of storing apparatus front end, first closer and the second closer are recovered in closer storing apparatus, again adjust position, release closer, until accurately install.

Claims (10)

Translated fromChinese

1.一种新型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，可嵌入卵圆孔未闭或小房间隔缺损处周侧。1. A novel patent foramen ovale or small atrial septal defect closing device is characterized in that the patent foramen ovale or small atrial septal defect closing device comprises a closing unit, and the closing unit end is an embedded part , the embedding part is curled and can be embedded in the periphery of the patent foramen ovale or small atrial septal defect.2.根据权利要求1所述的一种新型卵圆孔未闭或小房间隔缺损闭合装置，其特征在于，所述闭合单元包括两个闭合器，所述两个闭合器相对设置；2. A novel patent foramen ovale or small atrial septal defect closing device according to claim 1, wherein the closing unit includes two closers, and the two closers are arranged opposite to each other;所述闭合器包括一延伸部及一嵌入部，所述两个闭合器通过延伸部连接，并两延伸部的连接处共同连接一输送导丝，所述嵌入部嵌入卵圆孔未闭或小房间隔缺损处周侧，所述两个嵌入部所嵌入的位置相对。The occluder includes an extension part and an embedding part, the two occluders are connected through the extension part, and a delivery guide wire is connected to the junction of the two extension parts, and the embedding part is embedded in the patent foramen ovale or small On the peripheral side of the atrial septal defect, the embedded positions of the two embedding parts are opposite.3.根据权利要求2所述的一种新型卵圆孔未闭或小房间隔缺损闭合装置，其特征在于，所述延伸部为弹性金属材质；所述嵌入部为记忆金属材质。3. A new device for closing patent foramen ovale or small atrial septal defect according to claim 2, characterized in that, the extension part is made of elastic metal material; the embedded part is made of memory metal material.4.根据权利要求3所述的一种新型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。4. A novel patent foramen ovale or small atrial septal defect closing device according to claim 3, wherein the elastic metal material is beryllium bronze or spring steel; the memory metal material is nickel-titanium alloy.5.一种新型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1-4之一所述的新型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。5. A delivery device for a novel patent foramen ovale or small atrial septal defect closing device, used to deliver the novel patent foramen ovale or small atrial septal defect closing device described in any one of claims 1-4 above, which It is characterized in that the delivery device includes a pushing sheath and a occluder accommodating device, the occluder accommodating device is placed in the pushing sheath, and the closure unit is accommodated in the occluder accommodating device.6.根据权利要求5所述的一种新型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；6. A new type of delivery device for a patent foramen ovale or a small atrial septal defect closure device according to claim 5, wherein the front end of the pushing sheath is a through hole, and a front end of the through hole extends a A closer release part, the closer release part is cylindrical, and the cylindrical inner cross-sectional diameter of the closer 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；A limiting protrusion is arranged on the outside of the front end of the pushing sheath;所述闭合器释放部外部设有表面平滑的引导部。A guide portion with a smooth surface is provided on the exterior of the closer release portion.7.根据权利要求6所述的一种新型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。7. A delivery device for a novel patent foramen ovale or small atrial septal defect closure device according to claim 6, characterized in that the side of the through hole opposite to the release part of the occluder is provided with a occluder accommodating device. Device slides for guiding the closer holder to the through hole.8.根据权利要求6所述的一种新型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，容纳装置的外直径大于通孔的直径。8. The delivery device for a novel patent foramen ovale or small atrial septal defect closure device according to claim 6, characterized in that there is an accommodation space inside the closer accommodation device, and the accommodation space is a circle The inner diameter of the accommodating space is smaller than the diameter of the through hole, and the outer diameter of the accommodating device is larger than the diameter of the through hole.9.根据权利要求8所述的一种新型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闭合器容纳空间内相对的两侧。9. The delivery device for a novel patent foramen ovale or small atrial septal defect closure device according to claim 8, characterized in that the first occluder and the second occluder are placed opposite to each other in the occluder accommodating space sides.10.一种卵圆孔未闭或小房间隔缺损处的闭合方法，应用上述权利要求5-9之一所述的新型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，所述方法为：10. A method for closing a patent foramen ovale or a small atrial septal defect, using the delivery device of the novel patent foramen ovale or a small atrial septal defect closing device according to any one of claims 5-9, characterized in In that, the method is:A）应用引导导丝，经上肢/下肢静脉，至右心房，到达卵圆孔或房间隔缺损处，并凸伸穿过卵圆孔或房间隔缺损处；A) The guide wire is used to go through the upper/lower limb veins to the right atrium, reach the foramen ovale or atrial septal defect, and protrude through the foramen ovale or atrial septal defect;B）沿着引导导丝将闭合装置的推送鞘管输送至卵圆孔或房间隔缺损处，待引导部进入缺损后，抽出引导导丝，推送输送导丝，使延伸部及嵌入部进入左房侧；B) Deliver the pushing sheath of the closure device to the foramen ovale or atrial septal defect along the guide wire, after the guide part enters the defect, pull out the guide wire, push and deliver the guide wire, so that the extension part and the embedded part enter the left house side;C）再进一步推送输送导丝，使所述延伸部展开，所述嵌入部抵触在卵圆孔未闭或房间隔缺损处周侧；C) Further push the delivery guide wire to expand the extension part, and the embedding part is in contact with the periphery of the patent foramen ovale or atrial septal defect;D）在6-10分钟内，造影观察嵌入部的抵触位置，调整抵触位置并牵拉输送导丝，使嵌入部嵌入在缺损周侧，在10-15分钟后，记忆金属完成卷曲，所述嵌入部卷曲嵌入卵圆孔未闭或房间隔缺损处周侧，完成闭合，释放闭合装置。D) Within 6-10 minutes, observe the interference position of the embedding part by angiography, adjust the interference position and pull the delivery guide wire, so that the embedding part is embedded on the side of the defect. After 10-15 minutes, the memory metal is completely curled, and the The embedding part is curled and embedded in the periphery of the patent foramen ovale or atrial septal defect to complete the closure and release the closure device.