技术领域technical field
本发明涉及介入医疗器械技术领域，尤其涉及一种介入治疗先天性心脏病的封堵器、输送器及封堵系统。The invention relates to the technical field of interventional medical devices, in particular to an occluder, a conveyer and an occlusion system for interventional treatment of congenital heart disease.
背景技术Background technique
经导管介入封堵器是经导管介入治疗方法中常用的器械，可用于微创治疗房间隔缺损、室间隔缺损、动脉导管未闭和卵圆孔未闭等先天性心脏病。现有技术中的封堵器一般包括具有两个封堵单元和连接该两个封堵单元的腰部的封堵本体，其中两个封堵单元用来盖住缺损部位两侧壁的组织，腰部用来填充缺损。Transcatheter interventional occluder is a commonly used device in transcatheter interventional therapy, which can be used for minimally invasive treatment of congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus and patent foramen ovale. The occluder in the prior art generally includes an occluding body with two occluding units and a waist connecting the two occluding units, wherein the two occluding units are used to cover the tissue on both side walls of the defect site, and the waist Used to fill gaps.
当前多采用记忆金属或高分子材料制备封堵器。然而，记忆金属会在使用中因疲劳而失效，高分子材料有低弹性或无弹性的特点，这均将导致两个封堵单元之间的收缩力不足。收缩力不足的两个封堵单元不能贴紧缺损部位的两侧而影响封堵效果。因此这些封堵器均需要有效的约束结构来保持两个封堵单元之间的距离(即封堵器的腰高)稳定，以确保封堵的可靠性。At present, most memory metal or polymer materials are used to prepare occluders. However, the memory metal will fail due to fatigue during use, and the polymer material has the characteristics of low elasticity or no elasticity, which will lead to insufficient contraction force between the two plugging units. The two occlusion units with insufficient contraction force cannot be tightly attached to both sides of the defect site, which affects the occlusion effect. Therefore, these occluders all need an effective restraint structure to keep the distance between the two occlusion units (that is, the waist height of the occluder) stable, so as to ensure the reliability of occlusion.
现有技术中常采用锁定机构锁定设置于封堵本体两端的近端封头和/或远端封头来约束两个封堵单元之间的距离。然而，锁定机构对封头进行锁定时，因锁定力仅施加于封堵单元靠近封头的部位上，难以到达封堵单元远离封头的部位，直接导致封堵单元远离封头的部位不能贴紧缺损部位，从而影响封堵的可靠性。In the prior art, a locking mechanism is often used to lock the proximal head and/or the distal head arranged at both ends of the occlusion body to constrain the distance between the two occlusion units. However, when the locking mechanism locks the head, because the locking force is only applied to the part of the plugging unit close to the head, it is difficult to reach the part of the plugging unit far away from the head, which directly causes the part of the plugging unit far away from the head to be unable to be attached. Tight defect parts, thus affecting the reliability of plugging.
发明内容Contents of the invention
基于此，有必要提供一种使封堵单元贴紧缺损部位的封堵器，及与所述封堵器配套使用的输送器，以及封堵系统。Based on this, it is necessary to provide an occluder for making the occluder close to the defect, a conveyor used in conjunction with the occluder, and an occluder system.
本发明提供一种封堵器，包括网状带空腔的封堵本体、近端封头和穿设于所述空腔的锁定机构，所述近端封头具有与所述空腔贯通的限定孔，所述锁定机构包括至少一个锁定件，所述锁定件包括一端与所述封堵器远端相连的连接段和与所述连接段另一端相连的至少一个弹性段；所述弹性段包括与所述连接段相连的弯曲部和与所述弯曲部相连的抵压部，在无外力施加时，所述弯曲部朝向所述封堵器的近端方向弯曲，所述抵压部大致沿垂直所述封堵器的纵向中心线且远离所述锁定机构的中心的方向延伸；当所述锁定机构对所述封堵本体锁定时，所述抵压部远离相应的所述弯曲部的端部穿过所述近端封头的限定孔，所述抵压部抵压所述封堵本体的表面。The present invention provides an occluder, which comprises a mesh-shaped occluding body with a cavity, a proximal head and a locking mechanism pierced through the cavity, and the proximal head has a hole penetrating the cavity. A hole is defined, and the locking mechanism includes at least one locking member, and the locking member includes a connecting segment connected at one end to the distal end of the occluder and at least one elastic segment connected to the other end of the connecting segment; the elastic segment It includes a bending portion connected to the connecting section and a pressing portion connected to the bending portion. When no external force is applied, the bending portion bends toward the proximal end of the occluder, and the pressing portion is approximately extending in a direction perpendicular to the longitudinal centerline of the occluder and away from the center of the locking mechanism; when the locking mechanism locks the occluding body, the pressing portion is far away from the corresponding bending portion The end portion passes through the defined hole of the proximal head, and the pressing portion presses against the surface of the blocking body.
在其中一个实施例中，当所述锁定机构对所述封堵本体锁定时，所述弯曲部抵压所述近端封头的近端端面。In one of the embodiments, when the locking mechanism locks the occluding body, the curved portion presses against the proximal end surface of the proximal head.
在其中一个实施例中，所述锁定件的数量为至少两个，每个所述锁定件均为杆状，每个所述锁定件均包括一个所述连接段和一个所述弹性段。In one embodiment, there are at least two locking pieces, each of the locking pieces is rod-shaped, and each of the locking pieces includes one connecting segment and one elastic segment.
在其中一个实施例中，所述锁定件的数量为一个，所述锁定件包括一个所述连接段和至少两个所述弹性段，所述连接段为管状结构，每个所述弹性段均为片状结构。In one of the embodiments, the number of the locking member is one, and the locking member includes one connecting segment and at least two elastic segments, the connecting segment is a tubular structure, and each elastic segment is For the sheet structure.
在其中一个实施例中，所述弹性段采用具有形状记忆功能的材料制备。In one of the embodiments, the elastic segment is made of a material having a shape memory function.
在其中一个实施例中，所述弹性段的材料选自弹性不锈钢、镍钛铜合金、镍钛钴合金、镍钛合金、聚乳酸和尼龙中的一种或者几种。In one embodiment, the material of the elastic section is selected from one or more of elastic stainless steel, nickel-titanium-copper alloy, nickel-titanium-cobalt alloy, nickel-titanium alloy, polylactic acid and nylon.
在其中一个实施例中，所述抵压部远离相应的所述弯曲部的端部为悬空端，所述悬空端的端面与所述悬空端的周面平滑过渡。In one of the embodiments, the end of the pressing portion away from the corresponding bending portion is a suspended end, and the end surface of the suspended end is smoothly transitioned to the peripheral surface of the suspended end.
在其中一个实施例中，所述锁定机构还包括连接座，所述至少一个锁定件设置于所述连接座的一端，所述连接座的另一端与所述封堵器的远端相连，所述连接座的侧面上设置有外螺纹。In one of the embodiments, the locking mechanism further includes a connecting seat, the at least one locking member is arranged at one end of the connecting seat, and the other end of the connecting seat is connected to the distal end of the occluder, so External threads are provided on the side of the connecting seat.
在其中一个实施例中，所述封堵器还包括远端封头，所述锁定机构与所述远端封头相连。In one of the embodiments, the occluder further includes a distal head, and the locking mechanism is connected with the distal head.
本发明还提供一种输送器，用于输送上述任一项所述的封堵器，所述输送器包括中空的锁定管，所述锁定管的远端用于收容所述锁定机构并进入所述封堵本体的空腔中与所述封堵器的远端可拆卸连接。The present invention also provides a transporter for transporting the occluder described in any one of the above items, the transporter includes a hollow locking tube, the distal end of the locking tube is used to accommodate the locking mechanism and enter the The cavity of the occluder body is detachably connected with the distal end of the occluder.
在其中一个实施例中，所述锁定管的远端设有用于与所述锁定机构的远端可拆卸相连的内螺纹。In one of the embodiments, the distal end of the locking tube is provided with an internal thread for detachable connection with the distal end of the locking mechanism.
在其中一个实施例中，所述输送器还包括中空鞘管、穿设于所述鞘管内的推管、固设于所述推管远端的锁头和连接丝，所述锁定管穿设于所述推管和所述锁头内，所述连接丝的一端固定在所述锁头上。In one of the embodiments, the transporter further includes a hollow sheath, a push tube pierced in the sheath, a lock head and a connecting wire fixed at the distal end of the push tube, and the lock tube pierces In the push tube and the lock head, one end of the connecting wire is fixed on the lock head.
本发明还提供一种封堵系统，包括上述任一项所述的封堵器和上述的输送器，所述输送器还包括中空鞘管、穿设于所述鞘管内的推管、固设于所述推管远端的锁头和连接丝，所述锁定管穿设于所述推管和所述锁头内，所述锁定管的远端进入所述封堵本体的空腔内并与所述封堵器的远端可拆卸连接，所述封堵器的锁定机构收容于所述锁定管的管腔中，所述连接丝的一端固定在所述锁头上，另一端穿过所述封堵器后套在所述锁定管上。The present invention also provides an occlusion system, including the occluder described in any one of the above and the above-mentioned delivery device, and the delivery device also includes a hollow sheath tube, a push tube inserted in the sheath tube, a fixed The locking head and the connecting wire at the distal end of the push tube, the locking tube is passed through the pushing tube and the locking head, the distal end of the locking tube enters the cavity of the blocking body and It is detachably connected to the distal end of the occluder, the locking mechanism of the occluder is accommodated in the lumen of the locking tube, one end of the connecting wire is fixed on the lock head, and the other end passes through The occluder is then sleeved on the locking tube.
在其中一个实施例中，所述锁定管的远端设有内螺纹，所述锁定机构的远端设有与所述内螺纹配合的外螺纹。In one of the embodiments, the distal end of the locking tube is provided with an internal thread, and the distal end of the locking mechanism is provided with an external thread that cooperates with the internal thread.
采用本发明的锁定机构对封堵本体进行锁定时，锁定件的抵压部抵压封堵本体的表面，由于该抵持力施加在封堵本体上而不是限于近端封头端面，抵持力的施加范围较大，从而使封堵本体的封堵单元能够贴紧缺损部位，提高了封堵的可靠性。When the locking mechanism of the present invention is used to lock the blocking body, the pressing part of the locking piece presses against the surface of the blocking body, and since the resisting force is applied to the blocking body instead of being limited to the end surface of the proximal head, the resistance The application range of the force is relatively large, so that the sealing unit of the sealing body can be tightly attached to the defective part, and the reliability of sealing is improved.
附图说明Description of drawings
图1为本发明一实施例的封堵器的锁定状态的结构示意图。Fig. 1 is a structural schematic diagram of a locked state of an occluder according to an embodiment of the present invention.
图2为图1中封堵器的另一方向示意图。Fig. 2 is a schematic diagram of another direction of the occluder in Fig. 1 .
图3为图1中封堵器的锁定机构的结构示意图。Fig. 3 is a structural schematic diagram of the locking mechanism of the occluder in Fig. 1 .
图4为本发明另一实施例的锁定机构的结构示意图。Fig. 4 is a schematic structural diagram of a locking mechanism according to another embodiment of the present invention.
图5为图4中锁定机构锁定封堵器的示意图。Fig. 5 is a schematic diagram of locking the occluder by the locking mechanism in Fig. 4 .
图6为本发明一实施例的输送器的局部结构示意图。Fig. 6 is a schematic diagram of a partial structure of a conveyor according to an embodiment of the present invention.
图7为图1中封堵器位于鞘管中的封堵系统示意图。Fig. 7 is a schematic diagram of the occlusion system in Fig. 1 in which the occluder is located in the sheath.
图8为图7中封堵器推出鞘管的示意图。Fig. 8 is a schematic diagram of pushing out the sheath tube of the occluder in Fig. 7 .
图9为图8中封堵器到达缺损部位释放但未锁定的示意图。Fig. 9 is a schematic diagram showing that the occluder in Fig. 8 reaches the defect site and is released but not locked.
图10为图9中封堵器继续释放但未锁定的示意图。Fig. 10 is a schematic diagram of the occluder in Fig. 9 continuing to be released but not locked.
图11为图10中封堵器已锁定的示意图。Fig. 11 is a schematic diagram of the locked occluder in Fig. 10 .
图12为图11中封堵器与输送器分离的示意图。Fig. 12 is a schematic diagram of separation of the occluder from the conveyor in Fig. 11 .
具体实施方式Detailed ways
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.
为了更加清楚地描述本发明的结构，此处限定术语“远端”和“近端”，这些术语为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。In order to describe the structure of the present invention more clearly, the terms "distal end" and "proximal end" are defined here. These terms are commonly used terms in the field of interventional medical devices, wherein "distal end" means the end away from the operator during the operation, " "Proximal" means the end that is closest to the operator during the procedure.
请参阅图1和图2，本发明一实施例的封堵器100处于锁定状态，封堵器100包括网状带空腔201的封堵本体20、近端封头40和锁定机构50。近端封头40设于封堵本体20的近端(即封堵本体20靠近操作者的一端)且与其相连。近端封头40具有与空腔201贯通的限定孔401。锁定机构50穿设于封堵本体20的空腔201内，且锁定机构50的远端(即锁定机构50远离操作者的一端)与封堵本体20的远端(即封堵本体20远离操作者的一端)连接。锁定机构50的近端(即锁定机构50靠近操作者的一端)穿过近端封头40的限定孔401且抵压封堵本体20以锁定封堵本体20的两个封堵单元之间的距离。Referring to FIG. 1 and FIG. 2 , an occluder 100 according to an embodiment of the present invention is in a locked state. The occluder 100 includes a mesh-shaped occluder body 20 with a cavity 201 , a proximal head 40 and a locking mechanism 50 . The proximal head 40 is disposed on the proximal end of the sealing body 20 (ie, the end of the sealing body 20 close to the operator) and connected thereto. The proximal end cap 40 has a defined hole 401 that communicates with the cavity 201 . The locking mechanism 50 is installed in the cavity 201 of the blocking body 20, and the distal end of the locking mechanism 50 (that is, the end of the locking mechanism 50 away from the operator) is connected to the distal end of the blocking body 20 (that is, the blocking body 20 is away from the operator). end of the receiver) connection. The proximal end of the locking mechanism 50 (that is, the end of the locking mechanism 50 close to the operator) passes through the defined hole 401 of the proximal head 40 and presses against the blocking body 20 to lock the gap between the two blocking units of the blocking body 20 distance.
本实施例中，封堵本体20包括盘状结构的第一封堵单元202和盘状结构的第二封堵单元203。第一封堵单元202和第二封堵单元203连通形成“工”字形结构。在封堵心脏缺损时，第一封堵单元202和第二封堵单元203分别用于与缺损处房间隔的两侧壁相抵持，以起到封堵心脏缺损的作用。可以理解，封堵本体20还可以为其他任意形状，如封堵本体为单盘结构。本实施例中封堵本体20的结构仅用作举例，并不是对本发明的限制，本领域的普通技术人员可在本发明的启示下选择任意适合的封堵本体20的结构。In this embodiment, the blocking body 20 includes a first blocking unit 202 in a disk shape and a second blocking unit 203 in a disk shape. The first blocking unit 202 and the second blocking unit 203 communicate to form an "I"-shaped structure. When occluding a heart defect, the first occluding unit 202 and the second occluding unit 203 are respectively used to resist against the two side walls of the atrial septum at the defect, so as to seal the heart defect. It can be understood that the blocking body 20 can also be in any other shape, for example, the blocking body has a single disc structure. The structure of the blocking body 20 in this embodiment is only used as an example, and is not a limitation to the present invention. Those skilled in the art can choose any suitable structure of the blocking body 20 under the enlightenment of the present invention.
封堵本体20为易于变形的网状结构，因此在输送过程中封堵器100可以容易地压缩收容于鞘管中，而且当封堵器100推出鞘管到达缺损部位时，封堵器100可以容易地变形成包括用于封堵缺损的盘状结构的器械。封堵本体20的网状结构可采用具有形状记忆功能的材料或高分子材料通过编织、管材切割、注塑成型等方式制成。所述具有形状记忆功能的材料可选自弹性不锈钢、镍钛铜合金、镍钛钴合金和镍钛合金中的一种或者几种。所述高分子材料可选自聚苯二甲酸乙二醇酯(PET：Polyethylene Terephthalate)、聚乳酸(PLA：Poly-L-lactide Acid)、聚乙醇酸(PGA：Poly-glycolide)、聚羟基脂肪酸脂(PHA：Poly-hydroxyalkanoate)、聚二氧环己酮(PDO：Poly-dioxanone)和聚己内酯(PCL：Poly-caprolactone)中的一种或者几种。The occluder body 20 is an easily deformable mesh structure, so the occluder 100 can be easily compressed and accommodated in the sheath during delivery, and when the occluder 100 is pushed out of the sheath to reach the defect site, the occluder 100 can An instrument that is easily deformed to include a disc-like structure for closing a defect. The mesh structure of the blocking body 20 can be made by weaving, pipe cutting, injection molding, etc. using materials with shape memory function or polymer materials. The material with shape memory function can be selected from one or more of elastic stainless steel, nickel-titanium-copper alloy, nickel-titanium-cobalt alloy and nickel-titanium alloy. The polymer material may be selected from polyethylene terephthalate (PET: Polyethylene Terephthalate), polylactic acid (PLA: Poly-L-lactide Acid), polyglycolic acid (PGA: Poly-glycolide), polyhydroxy fatty acid One or more of lipids (PHA: Poly-hydroxyalkanoate), polydioxanone (PDO: Poly-dioxanone) and polycaprolactone (PCL: Poly-caprolactone).
封堵器100还可以包括设置于封堵本体20的远端且与其相连的远端封头30。锁定机构50的远端在空腔201内与远端封头30连接。可以理解，锁定机构50可以与远端封头30固定连接，也可以为可拆卸连接。还可以理解，封堵器100也可以不包括远端封头30，此时锁定机构50可以直接与封堵本体20的远端直接相连。当封堵本体20采用可降解高分子丝编织而成时，远端封头30设置于封堵本体20的远端并收容所述高分子丝的一端，近端封头40设置于封堵本体20的近端并收容所述高分子丝的另一端。本发明中对远端封头30和近端封头40的形状和结构不作特别限定，本实施例中，远端封头30为半球形结构，近端封头40为中空柱状结构。The occluder 100 may further include a distal end cap 30 disposed at the distal end of the occlusion body 20 and connected thereto. The distal end of the locking mechanism 50 is connected to the distal end cap 30 in the cavity 201 . It can be understood that the locking mechanism 50 can be fixedly connected to the distal end cap 30 or can be detachably connected. It can also be understood that the occluder 100 may not include the distal end cap 30 , at this time, the locking mechanism 50 may be directly connected to the distal end of the occlusion body 20 . When the plugging body 20 is braided with degradable polymer filaments, the distal end cap 30 is arranged on the far end of the plugging body 20 and accommodates one end of the polymer filaments, and the proximal cap 40 is arranged on the plugging body The proximal end of 20 accommodates the other end of the polymer filament. The shape and structure of the distal head 30 and the proximal head 40 are not particularly limited in the present invention. In this embodiment, the distal head 30 is a hemispherical structure, and the proximal head 40 is a hollow columnar structure.
请参阅图3，锁定机构50包括连接座501和设置于连接座501上的多个锁定件503。本实施例中，连接座501为圆柱状；锁定件503为杆状卡勾；连接座501的一个端面上设置多个锁定件503；连接座501的远离多个锁定件503的另一端与远端封头30固定连接。连接座501的侧面上设置有外螺纹(图未标)，用于与输送器配合连接。Referring to FIG. 3 , the locking mechanism 50 includes a connecting base 501 and a plurality of locking pieces 503 disposed on the connecting base 501 . In this embodiment, the connecting seat 501 is cylindrical; the locking member 503 is a rod-shaped hook; one end surface of the connecting seat 501 is provided with a plurality of locking members 503; The end seal head 30 is fixedly connected. An external thread (not shown) is provided on the side of the connection seat 501 for mating connection with the conveyor.
锁定件503在无外力施加时的自然形状如图3所示，本实施例中，每个锁定件503均为杆状，每个锁定件503包括连接段5031和弹性段5033。连接段5031的一端与连接座501连接，连接段5031的另一端与弹性段5033连接。弹性段5033为一端悬空的弯曲结构。弹性段5033包括与连接段5031相连的弯曲部5034和与弯曲部5034连接的抵压部5035。弯曲部5034朝向封堵器100的近端方向弯曲。抵压部5035的一端与弯曲部5034连接，抵压部5035的另一端为悬空端且该悬空端大致沿垂直封堵器100的纵向中心线且远离锁定件503中心的方向延伸。The natural shape of the locking pieces 503 when no external force is applied is shown in FIG. 3 . In this embodiment, each locking piece 503 is rod-shaped, and each locking piece 503 includes a connecting section 5031 and an elastic section 5033 . One end of the connection section 5031 is connected to the connection seat 501 , and the other end of the connection section 5031 is connected to the elastic section 5033 . The elastic section 5033 is a curved structure with one end hanging in the air. The elastic section 5033 includes a bending portion 5034 connected to the connecting section 5031 and a pressing portion 5035 connected to the bending portion 5034 . The bent portion 5034 is bent toward the proximal direction of the occluder 100 . One end of the pressing portion 5035 is connected to the bending portion 5034 , and the other end of the pressing portion 5035 is a dangling end extending substantially along the longitudinal centerline of the occluder 100 and away from the center of the locking member 503 .
本实施例中，当锁定机构50对封堵本体20进行锁定时，锁定件503的弹性段5033的悬空端穿过近端封头40的限定孔401，弹性段5033的弯曲部5034抵压近端封头40的近端端面，且抵压部5035抵压封堵本体20的第二封堵单元203的表面，从而实现对封堵本体20锁定，此时弯曲部5034近端的弯曲顶端至抵压部5035的距离大致等于近端封头40沿封堵器100的纵向中心线的长度。可以理解，弯曲部5034近端的弯曲顶端至抵压部5035的距离也可以大于近端封头40沿封堵器100的纵向中心线的长度，此时，弯曲部5034与近端封头40的近端端面分离，仅由弹性段5033的抵压部5035抵压第二封堵单元203的表面以实现锁定。In this embodiment, when the locking mechanism 50 locks the blocking body 20, the suspended end of the elastic section 5033 of the locking member 503 passes through the defined hole 401 of the proximal head 40, and the curved portion 5034 of the elastic section 5033 presses the proximal end. The proximal end face of the end seal head 40, and the pressing part 5035 presses against the surface of the second blocking unit 203 of the blocking body 20, so as to lock the blocking body 20. At this time, the curved top end of the bending part 5034 near the The distance of the pressing portion 5035 is approximately equal to the length of the proximal head 40 along the longitudinal centerline of the occluder 100 . It can be understood that the distance from the curved top of the proximal end of the curved portion 5034 to the pressing portion 5035 may also be greater than the length of the proximal end cap 40 along the longitudinal centerline of the occluder 100 . The proximal end faces of the second blocking unit 203 are separated, and only the pressing portion 5035 of the elastic section 5033 is pressed against the surface of the second blocking unit 203 to achieve locking.
本实施例中，抵压部5035的悬空端的端面与该悬空端的周面平滑过渡，从而防止抵压部5035的悬空端对第二封堵单元203或者心脏其他部位产生损伤。In this embodiment, the end surface of the suspended end of the pressing portion 5035 transitions smoothly with the surrounding surface of the suspended end, thereby preventing the suspended end of the pressing portion 5035 from causing damage to the second blocking unit 203 or other parts of the heart.
本实施例中，锁定件503的连接段5031和弹性段5033一体成型且采用具有弹性或形状记忆功能的材料制备。连接段5031和弹性段5033的材料可以选自弹性不锈钢、镍钛铜合金、镍钛钴合金、镍钛合金、聚乳酸和尼龙中的一种或者几种。如此，弹性段5033可以在外力作用下产生变形，并且通过外力牵引弹性段5033穿过近端封头40的限定孔401；当撤销外力时，由于弹性段5033采用具有弹性或形状记忆功能的材料制成，故弹性段5033恢复至图3所示的自然状态，实现对封堵本体20的锁定。可以理解的是，锁定件503的连接段5031也可以不采用具有弹性或形状记忆功能的材料制备，只需要弹性段5033采用具有弹性或形状记忆功能的材料制备即可。In this embodiment, the connecting section 5031 and the elastic section 5033 of the locking member 503 are integrally formed and made of materials with elasticity or shape memory function. The materials of the connecting section 5031 and the elastic section 5033 can be selected from one or more of elastic stainless steel, nickel-titanium-copper alloy, nickel-titanium-cobalt alloy, nickel-titanium alloy, polylactic acid and nylon. In this way, the elastic section 5033 can be deformed under the action of an external force, and the elastic section 5033 can be pulled through the defined hole 401 of the proximal head 40 by the external force; Therefore, the elastic section 5033 returns to the natural state shown in FIG. 3 , realizing the locking of the blocking body 20 . It can be understood that the connecting section 5031 of the locking member 503 may not be made of materials with elasticity or shape memory function, only the elastic section 5033 is made of materials with elasticity or shape memory function.
本实施例中，锁定件503的数量为三个，弹性段5033的数量也为三个。可以理解，锁定件的数量还可以均为一个、二个、四个、五个等其他数量，只需所述锁定件可以实现锁定封堵本体即可。还可以理解的是，锁定机构还可以仅包括一个锁定件，所述一个锁定件包括一个连接段和多个弹性段。同时可以理解的是，锁定机构也可以包括多个锁定件，其中至少一个所述锁定件包括多个弹性段。In this embodiment, the number of locking pieces 503 is three, and the number of elastic segments 5033 is also three. It can be understood that the number of locking pieces can also be one, two, four, five, etc., as long as the locking pieces can realize locking and blocking the main body. It can also be understood that the locking mechanism may only include one locking piece, and the one locking piece includes one connecting segment and multiple elastic segments. At the same time, it can be understood that the locking mechanism may also include multiple locking pieces, wherein at least one of the locking pieces includes multiple elastic segments.
可以理解的是，锁定件的连接段的形状不限制于杆状，还可以为其他形状，如丝状、片状、管状或其他不规则形状。锁定件的弹性段的形状也不限制于杆状，也可以为其他形状，如丝状、片状或其他不规则形状。It can be understood that the shape of the connecting section of the locking member is not limited to a rod shape, and can also be in other shapes, such as wire shape, sheet shape, tube shape or other irregular shapes. The shape of the elastic section of the locking member is not limited to the rod shape, and can also be other shapes, such as wire shape, sheet shape or other irregular shapes.
请参阅图4和图5，本发明另一实施例的锁定机构50a的结构与上述实施例的锁定机构50大致相同，包括连接座501a和设置于连接座501a上的一个锁定件503a，区别之处在于锁定件503a的形状与上述实施例的锁定件503不同。Please refer to Fig. 4 and Fig. 5, the structure of the locking mechanism 50a of another embodiment of the present invention is substantially the same as the locking mechanism 50 of the above-mentioned embodiment, including a connecting base 501a and a locking piece 503a arranged on the connecting base 501a, the difference The difference is that the shape of the locking piece 503a is different from that of the locking piece 503 in the above embodiment.
锁定件503a包括一个连接段5031a和多个与连接段5031a连接的弹性段5033a。本实施例中，在无外力施加时，连接段5031a为管状结构，每个弹性段5033a均为片状弯曲结构。每个弹性段5033a均包括与连接段5031a相连的弯曲部5034a和与弯曲部5034a连接的抵压部5035a。The locking member 503a includes a connecting section 5031a and a plurality of elastic sections 5033a connected to the connecting section 5031a. In this embodiment, when no external force is applied, the connecting section 5031a is a tubular structure, and each elastic section 5033a is a sheet-shaped curved structure. Each elastic segment 5033a includes a bent portion 5034a connected to the connecting segment 5031a and a pressing portion 5035a connected to the bent portion 5034a.
当锁定机构50a对封堵本体20a进行锁定时，锁定件503a的弹性段5033a的悬空端穿过近端封头40a的限定孔401a，弹性段5033a的弯曲部5034a抵压近端封头40a的近端端面，且抵压部5035a抵压封堵本体20a的第二封堵单元203a的表面。本实施例中，由于弹性段5033a为片状结构，弯曲部5034a与近端封头40a的近端端面的接触面积较大，且抵压部5035a与第二封堵单元203a的接触面较较大，从而，锁定机构50a可以更好的使封堵本体20a的封堵单元贴紧缺损部位。When the locking mechanism 50a locks the blocking body 20a, the free end of the elastic section 5033a of the locking member 503a passes through the defined hole 401a of the proximal end cap 40a, and the curved portion 5034a of the elastic section 5033a presses against the proximal end cap 40a. The proximal end surface, and the pressing portion 5035a presses against the surface of the second blocking unit 203a of the blocking body 20a. In this embodiment, since the elastic section 5033a has a sheet-like structure, the contact area between the curved portion 5034a and the proximal end surface of the proximal head 40a is relatively large, and the contact area between the pressing portion 5035a and the second blocking unit 203a is relatively large. Therefore, the locking mechanism 50a can better make the occlusion unit of the occlusion body 20a close to the defect site.
同样可以理解，弹性段5033a的弯曲部5034a也可以不与近端封头40a的近端端面接触，即弯曲部5034a可以不对近端封头40a施加压力，仅由抵压部5035a抵压封堵本体20a即可。It can also be understood that the curved portion 5034a of the elastic section 5033a may not be in contact with the proximal end surface of the proximal end cap 40a, that is, the curved portion 5034a may not exert pressure on the proximal end cap 40a, and only be blocked by the pressing portion 5035a The main body 20a is sufficient.
请参阅图6，本发明一实施例的输送器200包括推管60、锁头70和锁定管80。推管60为具有一管腔的中空结构，锁头70也为具有一孔腔的中空结构，锁头70固定设置于推管60的远端，且锁头70的孔腔与推管60的管腔连通。锁定管80穿设于推管60的管腔和锁头70的孔腔内，且锁定管80可相对推管60和锁头70沿推管60的纵向中心线方向移动。Referring to FIG. 6 , the conveyor 200 according to an embodiment of the present invention includes a push tube 60 , a locking head 70 and a locking tube 80 . The push tube 60 is a hollow structure with a lumen, and the lock head 70 is also a hollow structure with a cavity. The lumen communicates. The locking tube 80 passes through the lumen of the push tube 60 and the bore of the lock head 70 , and the lock tube 80 can move relative to the push tube 60 and the lock head 70 along the longitudinal centerline of the push tube 60 .
本实施例中，锁定管80为中空管状，且锁定管80的远端的内侧表面设置有内螺纹(图未示)。所述内螺纹用于与封堵器100的锁定机构50的连接座501的外螺纹配合，使锁定管80与锁定机构50可拆卸连接，锁定机构50的锁定件503可以产生弹性变形且容纳于锁定管80的内腔中。In this embodiment, the locking tube 80 is a hollow tube, and the inner surface of the distal end of the locking tube 80 is provided with an internal thread (not shown in the figure). The internal thread is used to cooperate with the external thread of the connecting seat 501 of the locking mechanism 50 of the occluder 100, so that the locking tube 80 is detachably connected to the locking mechanism 50, and the locking member 503 of the locking mechanism 50 can be elastically deformed and accommodated in the Locking tube 80 lumen.
本实施例中，锁头70大致为“工”字形中空管状结构，包括推送部701、套管部702以及连接推送部701和套管部702的连接部703。套管部702套设于推管60的远端侧面上，并与推管60的远端固定连接；推管60可以带动锁头70沿推管60的纵向中心线方向移动，且锁头70的推送部701可以对封堵器100施加压力，使封堵器100的封堵本体20变形形成封堵单元。In this embodiment, the lock head 70 is roughly an "I"-shaped hollow tubular structure, including a pushing part 701 , a sleeve part 702 and a connecting part 703 connecting the pushing part 701 and the sleeve part 702 . The sleeve part 702 is sleeved on the side of the distal end of the push tube 60, and is fixedly connected with the distal end of the push tube 60; the push tube 60 can drive the lock 70 to move along the longitudinal centerline of the push tube 60, and the lock 70 The pushing part 701 of the occluder can apply pressure to the occluder 100 to deform the occluder body 20 of the occluder 100 to form an occluder unit.
输送器200还包括连接丝90，锁头70的连接部703上开设有连接孔7031。连接丝90为具有两个自由端的丝状体，连接丝90折叠后，连接丝90的两个自由端均固定设置于锁头70的套管部702上，连接丝90的剩余部分可以从锁头70的推送部701的远端绕过，并同时穿过封堵器100的封堵本体20，最后可以穿过连接部703的连接孔7031并套设于锁定管80上。The conveyor 200 also includes a connecting wire 90 , and a connecting hole 7031 is opened on the connecting portion 703 of the locking head 70 . The connecting wire 90 is a filament with two free ends. After the connecting wire 90 is folded, the two free ends of the connecting wire 90 are all fixedly arranged on the sleeve part 702 of the lock head 70, and the remaining part of the connecting wire 90 can be removed from the lock. The distal end of the pushing part 701 of the head 70 bypasses and passes through the occluding body 20 of the occluder 100 at the same time, and finally passes through the connecting hole 7031 of the connecting part 703 and is sleeved on the locking tube 80 .
输送器200还包括鞘管91，鞘管91套设于推管60和锁头70外且用于收容封堵器100。The transporter 200 also includes a sheath tube 91 , which is sheathed on the outside of the push tube 60 and the lock head 70 and is used to accommodate the occluder 100 .
本实施例中，锁定管80的外径小于封堵器100的近端封头40的限定孔401的内径，从而锁定管80可以穿过限定孔401与锁定机构50连接。同时可以理解，锁头70的推送部701的内径小于近端封头40的外径，从而防止近端封头40进入推送部701的管腔内。In this embodiment, the outer diameter of the locking tube 80 is smaller than the inner diameter of the limiting hole 401 of the proximal head 40 of the occluder 100 , so that the locking tube 80 can pass through the limiting hole 401 and be connected with the locking mechanism 50 . At the same time, it can be understood that the inner diameter of the pushing portion 701 of the locking head 70 is smaller than the outer diameter of the proximal head 40 , thereby preventing the proximal head 40 from entering the lumen of the pushing portion 701 .
本发明的封堵系统300包括封堵器100和用于输送封堵器100的输送器200。以下结合附图对本发明的封堵系统300的工作过程作进一步的阐述。The occlusion system 300 of the present invention includes an occluder 100 and a conveyor 200 for delivering the occluder 100 . The working process of the blocking system 300 of the present invention will be further described below in conjunction with the accompanying drawings.
请参阅图7，首先，将封堵器100径向压缩后置入输送器200的鞘管91的内腔中。具体地，首先，连接丝90穿过封堵本体20的近端，并继续穿过锁头70的连接孔7031并套设于锁定管80上；其次，将锁定管80的远端与封堵器100的锁定机构50的连接座501通过螺纹进行连接，锁定件503产生弹性变形且容纳于锁定管80的内腔中；然后，推动锁定管80，使锁定管80带动封堵本体20的远端朝向远端移动，同时，由于连接丝90穿过封堵本体20的近端，所以封堵本体20在锁定管80和连接丝90的共同作用下产生拉伸变形；接着，向近端拉动推管60，使推管60带动锁头70向近端移动，进而通过连接丝90带动封堵器100和锁定管80一起收容进鞘管91的内腔中。利用股静脉穿刺，导入导丝(未示出)并将导丝的远端输送到病变位置，建立输送轨道。沿导丝将输送器200的远端以及位于其内的封堵器100一起推送到病变位置。Referring to FIG. 7 , firstly, the occluder 100 is radially compressed and put into the lumen of the sheath tube 91 of the delivery device 200 . Specifically, first, the connecting wire 90 passes through the proximal end of the blocking body 20, and continues to pass through the connecting hole 7031 of the lock head 70 and is sleeved on the locking tube 80; secondly, connect the distal end of the locking tube 80 to the blocking The connecting seat 501 of the locking mechanism 50 of the device 100 is connected by threads, and the locking member 503 is elastically deformed and accommodated in the inner cavity of the locking tube 80; then, the locking tube 80 is pushed to make the locking tube 80 drive the far side of the blocking body 20 At the same time, since the connecting wire 90 passes through the proximal end of the blocking body 20, the blocking body 20 is stretched and deformed under the joint action of the locking tube 80 and the connecting wire 90; then, it is pulled toward the proximal end. Push the tube 60 to make the push tube 60 drive the locking head 70 to move proximally, and then drive the occluder 100 and the locking tube 80 through the connecting wire 90 to be accommodated in the inner cavity of the sheath tube 91 together. Using femoral venipuncture, a guide wire (not shown) is introduced and the distal end of the guide wire is delivered to the lesion site, establishing a delivery track. The distal end of the conveyor 200 and the occluder 100 inside are pushed together to the lesion along the guide wire.
请参阅图8，当封堵系统300到达病变位置时，向近端拉动鞘管91，使封堵器100露出鞘管91外。由于锁定管80和连接丝90的共同作用，封堵本体20仍然处于拉伸变形状态。Referring to FIG. 8 , when the occlusion system 300 reaches the lesion, the sheath 91 is pulled proximally, so that the occluder 100 is exposed from the sheath 91 . Due to the joint action of the locking tube 80 and the connecting wire 90, the blocking body 20 is still in a stretched deformation state.
请参阅图9和图10，拉动锁定管80朝近端移动，锁定管80带动封堵器100朝近端移动直至封堵器100的近端封头40的近端端面抵持锁头70的推送部701的远端端面。继续向近端拉动锁定管80，同时推送部701的远端端面抵住近端封头40，使封堵本体20开始松弛形成第一封堵单元202和第二封堵单元203，并且第一封堵单元202和第二封堵单元203分别抵持于缺损处房间隔的两侧壁。Please refer to FIG. 9 and FIG. 10 , the locking tube 80 is pulled to move proximally, and the locking tube 80 drives the occluder 100 to move proximally until the proximal end surface of the proximal head 40 of the occluder 100 is against the lock head 70 The distal end surface of the pushing part 701. Continue to pull the locking tube 80 to the proximal end, and at the same time, the distal end surface of the pushing part 701 is against the proximal end cap 40, so that the blocking body 20 begins to loosen to form the first blocking unit 202 and the second blocking unit 203, and the first The occlusion unit 202 and the second occlusion unit 203 respectively abut against the two side walls of the interatrial septum at the defect.
请参阅图11，旋转锁定管80，使锁定管80与锁定机构50的连接座501分离。拉动锁定管80向近端移动，因为锁定管80此时已经与连接座501分离，所以封堵器100保持不动，直至容纳于锁定管80管腔中的锁定件503完全释放。因为锁定件503采用具有形状记忆功能的材料制备，当锁定件503从锁定管80释放时，锁定件503恢复至如图3所示的无外力施加时的自然形状，抵压部5035抵压第二封堵单元230的表面，实现对封堵本体20的锁定。Referring to FIG. 11 , the locking tube 80 is rotated to separate the locking tube 80 from the connecting base 501 of the locking mechanism 50 . Pull the locking tube 80 to move proximally, because the locking tube 80 has been separated from the connecting seat 501 at this time, so the occluder 100 remains still until the locking member 503 accommodated in the lumen of the locking tube 80 is completely released. Because the locking member 503 is made of a material with shape memory function, when the locking member 503 is released from the locking tube 80, the locking member 503 returns to its natural shape when no external force is applied as shown in FIG. The surface of the second blocking unit 230 realizes the locking of the blocking body 20 .
请参阅图12，继续拉动锁定管80相对推管60向近端移动，直至锁定管80不再覆盖锁头70的连接孔7031，连接丝90自动与锁定管80脱离。此时输送器200完全与封堵器100分离，从而可以从体内单独撤回输送器200。至此，封堵系统300的工作过程结束。Referring to FIG. 12 , continue to pull the locking tube 80 to move proximally relative to the push tube 60 until the locking tube 80 no longer covers the connecting hole 7031 of the lock head 70 , and the connecting wire 90 is automatically separated from the locking tube 80 . At this point, the transporter 200 is completely separated from the occluder 100, so that the transporter 200 can be withdrawn from the body alone. So far, the working process of the sealing system 300 ends.
本发明中锁定机构50的连接座501与锁定管80之间通过螺纹实现可拆卸连接，可以理解的是，连接座与锁定管还可以采用卡合等其他可拆卸连接方式。In the present invention, the connecting seat 501 of the locking mechanism 50 and the locking tube 80 are detachably connected by threads. It can be understood that the connecting seat and the locking tube may also adopt other detachable connection methods such as snap-fitting.
还可以理解的是，锁定机构50还可以不包括连接座501，锁定机构50的锁定件503的远端与远端封头30或者封堵本体20的远端固定连接，锁定管80可以直接与远端封头30或者封堵本体20的远端进行可拆卸连接，锁定件503收容于锁定管80的管腔中。It can also be understood that the locking mechanism 50 may not include the connecting seat 501, the distal end of the locking member 503 of the locking mechanism 50 is fixedly connected to the distal end of the distal end head 30 or the blocking body 20, and the locking tube 80 can be directly connected to the The distal end of the distal head 30 or the closure body 20 is detachably connected, and the locking member 503 is accommodated in the lumen of the locking tube 80 .
采用本发明的锁定机构50对封堵本体20进行锁定时，锁定件503的抵压部5035抵压封堵本体20的第二封堵单元203的表面，由于该抵持力施加在封堵本体上而不是限于近端封头端面，抵持力的施加范围较大，从而使封堵本体20的第二封堵单元203能够贴紧缺损部位，提高了封堵可靠性。When the locking mechanism 50 of the present invention is used to lock the blocking body 20, the pressing portion 5035 of the locking member 503 presses against the surface of the second blocking unit 203 of the blocking body 20, since the resisting force is applied to the blocking body It is not limited to the end surface of the proximal head, and the application range of the resisting force is relatively large, so that the second blocking unit 203 of the blocking body 20 can be tightly attached to the defect, and the sealing reliability is improved.
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511033594.7ACN106923872B (en) | 2015-12-31 | 2015-12-31 | Plugging device, conveyer and plugging system |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511033594.7ACN106923872B (en) | 2015-12-31 | 2015-12-31 | Plugging device, conveyer and plugging system |
| Publication Number | Publication Date |
|---|---|
| CN106923872A CN106923872A (en) | 2017-07-07 |
| CN106923872Btrue CN106923872B (en) | 2019-10-29 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201511033594.7AActiveCN106923872B (en) | 2015-12-31 | 2015-12-31 | Plugging device, conveyer and plugging system |
| Country | Link |
|---|---|
| CN (1) | CN106923872B (en) |
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