WO2023116205A1 - Atrial septostomy device - Google Patents

Abstract

An atrial septostomy device, comprising a first tube body (1), a second tube body (2) and an auxiliary assembly (5), wherein a distal end of the second tube body (2) is connected to a cutter (4); the cutter (4) is provided with a cavity (41) in communication with a tube cavity of the second tube body (2); and the first tube body (1) is slidably arranged in the second tube body (2) and the cutting knife (4) in a penetrating manner. The auxiliary assembly (5) comprises a push-pull rod (51) and a cutting auxiliary member (52), wherein the push-pull rod (51) is slidably arranged in the first tube body (1) in a penetrating manner; a proximal end of the cutting auxiliary member (52) is connected to a distal end of the first tube body (1); a distal end of the cutting auxiliary member (52) is connected to a distal end of the push-pull rod (51); and the push-pull rod (51) can slide relative to the first tube body (1), such that the cutting auxiliary member (52) is switched between an unfolded state and a stretched state. When the cutting auxiliary member (52) is in the stretched state, the cutting auxiliary member can be accommodated inside the cavity (41). When the cutting auxiliary member (52) is in the unfolded state, the cutting auxiliary member has a mesh surface facing the cutter (4) for collecting atrial septum tissues which are cut off by the cutter (4) and pulling the atrial septum tissues into the cavity (41).

Description

房间隔造口装置atrial septostomy device

本申请要求2021年12月21日申请的、申请号为202111574517.8、名称为“一种房间隔造口装置”的中国专利申请、2021年12月21日申请的、申请号为202111572477.3、名称为“一种房间隔造口装置”的中国专利申请，以及2022年4月7日申请的、申请号为202210362009.1、名称为“一种房间隔造口装置”的中国专利申请的优先权，在此将其全文引入作为参考。This application requires a Chinese patent application filed on December 21, 2021, with application number 202111574517.8, titled "An atrial septostomy device", and filed on December 21, 2021, with application number 202111572477.3, named " A Chinese patent application for an atrial septostomy device” and the priority of a Chinese patent application with application number 202210362009.1 and titled “A kind of atrial septostomy device” filed on April 7, 2022. It is incorporated by reference in its entirety.

技术领域technical field

本申请涉及医疗器械技术领域，尤其涉及一种房间隔造口装置。The present application relates to the technical field of medical devices, in particular to an atrial septostomy device.

背景技术Background technique

心力衰竭作为各种心脏疾病的严重和终末阶段，发病率高，是当今最严重的心血管病之一。根据心衰发生的部位可分为左心、右心和全心衰竭。临床上通常用房间隔造口术治疗肺动脉高压(右向左分流)或左心衰(左向右分流)，房间隔造口术是在患者房间隔处造口，从而形成左右心房间的分流。As the severe and terminal stage of various heart diseases, heart failure has a high incidence rate and is one of the most serious cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart failure, right heart failure and whole heart failure. Clinically, atrial septostomy is usually used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt). .

传统的房间隔造口术通常先在房间隔上开设预开孔，在预开孔处留有导丝，再将器械沿导丝移动至预开孔处，随后使用器械在房间隔的预开孔处造口。在使用器械对组织进行造口时，抓取装置先对所需要切割的部分组织进行定位并抓取，然后由切割装置对抓取装置所抓取的部分组织进行切割，切割下来的部分组织被抓取装置带出体外，从而形成造口。然而，现有的房间隔造口术仍存在较高的风险，因此，房间隔造口装置仍需要进一步改进，以降低房间隔造口术的风险。In traditional atrial septostomy, a pre-opening hole is usually made on the atrial septum, and a guide wire is left at the pre-opening hole, and then the instrument is moved along the guide wire to the pre-opening hole, and then the instrument is used to close the pre-opening hole in the atrial septum. Stoma at the hole. When using an instrument to stoma the tissue, the grasping device first positions and grasps the part of the tissue to be cut, and then the cutting device cuts the part of the tissue grasped by the grasping device, and the cut part of the tissue is The grasping device is brought out of the body, creating the stoma. However, the existing atrial septostomy still has a high risk, therefore, the atrial septostomy device still needs to be further improved to reduce the risk of atrial septostomy.

发明内容Contents of the invention

本申请部分实施例提供一种房间隔造口装置，包括第一管体、第二管体和辅助组件。第二管体的远端连接有切割刀，所述切割刀设置有与所述第二管体的管腔连通的空腔，所述第一管体滑动穿设于所述第二管体和所述切割刀内。辅助组件包括推拉杆和切割辅助件，所述推拉杆滑动穿设于所述第一管体内，所述切割辅助件的近端连接所述第一管体的远端，所述切割辅助件的远端连接所述推拉杆的远端，所述推拉杆能够相对所述第一管体滑动，以使所述切割辅助件在展开状态和拉伸状态之间切换；所述切割辅助件处于所述拉伸状态时，能够被收容于所述空腔内；所述切割辅助件处于所述展开状态时，具有朝向所述切割刀的网状面，所述网状面用于收集所述切割刀切除的房间隔组织并将其拉入所述空腔内。Some embodiments of the present application provide an atrial septostomy device, including a first tube body, a second tube body and an auxiliary component. The distal end of the second tube body is connected with a cutting knife, and the cutting knife is provided with a cavity communicating with the lumen of the second tube body, and the first tube body slides through the second tube body and inside the cutting knife. The auxiliary assembly includes a push-pull rod and a cutting aid, the push-pull rod slides through the first tubular body, the proximal end of the cutting aid is connected to the distal end of the first tubular body, and the cutting aid The distal end is connected to the distal end of the push-pull rod, and the push-pull rod can slide relative to the first tube body, so that the cutting aid can be switched between the unfolded state and the stretched state; the cutting aid is in the In the stretched state, it can be accommodated in the cavity; when the cutting aid is in the expanded state, it has a mesh surface facing the cutting knife, and the mesh surface is used to collect the cut The knife excises the interatrial septal tissue and pulls it into the cavity.

在一些实施例中，所述空腔内设置有限位台，所述切割辅助件能够抵接于所述限位台。In some embodiments, a limiting platform is provided in the cavity, and the cutting aid can abut against the limiting platform.

在一些实施例中，所述房间隔造口装置还包括第一驱动组件，所述第一驱动组件能够驱动所述第二管体沿轴向移动。所述房间隔造口装置还包括第二驱动组件，所述第二驱动组件包括第二壳体，所述第二壳体滑动连接于所述第一驱动组件，所述第一管体穿设于所述第一驱动组件并固定连接于所述第二壳体的内部。所述房间隔造口装置还包括第三驱动组件，所述第三驱动组件包括第二驱动件，所述第二驱动件连接于所述第二壳体的近端，所述第二壳体的近端开设有第二穿孔，所述推拉杆的近端穿过所述第二穿孔连接于所述第二驱动件，所述第二驱动件能够驱动所述推拉杆沿轴向移动。In some embodiments, the atrial septostomy device further includes a first driving assembly capable of driving the second tubular body to move axially. The atrial septostomy device further includes a second drive assembly, the second drive assembly includes a second housing, the second housing is slidably connected to the first drive assembly, and the first tube passes through It is connected to the first drive assembly and fixedly connected to the inside of the second casing. The atrial septostomy device further includes a third driving assembly, the third driving assembly includes a second driving member, the second driving member is connected to the proximal end of the second housing, and the second housing The proximal end of the push-pull rod is provided with a second through hole, and the proximal end of the push-pull rod passes through the second through-hole to be connected to the second driving member, and the second drive member can drive the push-pull rod to move in the axial direction.

在一些实施例中，所述切割辅助件处于所述展开状态时，所述网状面的外径等于或大于所述空腔的内径；所述切割辅助件处于所述展开状态时，所述网状面与所述推拉杆之间的夹角为80-90度。In some embodiments, when the cutting aid is in the unfolded state, the outer diameter of the mesh surface is equal to or greater than the inner diameter of the cavity; when the cutting aid is in the unfolded state, the The angle between the mesh surface and the push-pull rod is 80-90 degrees.

在一些实施例中，所述房间隔造口装置还包括第三管体，所述第二管体滑动穿设于所述第三管体。In some embodiments, the atrial septostomy device further includes a third tube, and the second tube slides through the third tube.

在一些实施例中，所述第一驱动组件包括第一壳体和第一驱动件，所述第二管体的近端伸入所述第一壳体，所述第二管体的近端连接有第一导向件，所述第一壳体的内壁上开设有第一导向槽，所述第一导向槽沿所述第二管体的轴向延伸，所述第一导向件滑动设置于所述第一导向槽内，所述第一驱动件能够驱动所述第二管体沿轴向移动。所述第一驱动组件还包括第一螺杆，所述第一驱动件设置于所述第一壳体内，且所述第一驱动件上开设有第一螺纹孔，所述第一螺杆螺纹连接于所述第一螺纹孔内，所述第一螺杆的一端连接所述第二管体的近端，所述第一螺杆的另一端穿出所述第一驱动件，且所述第一导向件连接所述第一螺杆的侧壁。所述第一壳体的近端沿所述第一管体的轴向延伸有连接部，所述连接部上同轴开设有第一穿孔，所述第一穿孔与所述第一壳体的内腔连通，所述连接部伸入所述第二壳体内，且所述第二壳体能够沿所述连接部滑动，所述第一管体的端部穿过所述第一穿孔并固定连接于所述第二壳体的内部。In some embodiments, the first driving assembly includes a first housing and a first driving member, the proximal end of the second tube protrudes into the first housing, and the proximal end of the second tube A first guide piece is connected, and a first guide groove is opened on the inner wall of the first housing, and the first guide groove extends along the axial direction of the second pipe body, and the first guide piece is slidably arranged on the In the first guide groove, the first driving member can drive the second pipe body to move in the axial direction. The first driving assembly also includes a first screw, the first driving member is disposed in the first housing, and a first threaded hole is opened on the first driving member, and the first screw is threadedly connected to In the first threaded hole, one end of the first screw rod is connected to the proximal end of the second tubular body, the other end of the first screw rod passes through the first driving member, and the first guide member Connect the side wall of the first screw. The proximal end of the first casing extends along the axial direction of the first tubular body with a connecting portion, and a first through hole is formed coaxially on the connecting portion, and the first through hole is connected with the first casing. The inner cavity communicates, the connecting part protrudes into the second casing, and the second casing can slide along the connecting part, and the end of the first tube passes through the first through hole and is fixed connected to the inside of the second casing.

在一些实施例中，所述第三驱动组件还包括连接杆和第二螺杆，所述连接杆同轴连接于所述推拉杆的近端，所述连接杆至少部分置于所述第二穿孔内，所述连接杆远离所述推拉杆的一端穿出所述第二穿孔并与所述第二螺杆同轴连接，所述第二驱动件上开设有第二螺纹孔，所述第二螺杆与所述第二螺纹孔螺接，所述第二驱动件转动连接于所述第二壳体远离所述第一壳体的一端。In some embodiments, the third driving assembly further includes a connecting rod and a second screw rod, the connecting rod is coaxially connected to the proximal end of the push-pull rod, and the connecting rod is at least partially placed in the second through hole Inside, the end of the connecting rod away from the push-pull rod passes through the second through hole and is coaxially connected with the second screw rod, and a second threaded hole is opened on the second driving member, and the second screw rod Screwed with the second threaded hole, the second driving member is rotatably connected to an end of the second housing away from the first housing.

在一些实施例中，所述切割辅助件包括沿近端到远端方向依次设置的第一延伸部和第二延伸部；所述第一延伸部呈管状；所述第二延伸部包括固定件和伸缩件，所述固定件连接所述第一延伸部，且所述固定件具有环形网面；所述伸缩件使得所述切割辅助件能够在展开状态和拉伸状态之间切换。In some embodiments, the cutting aid comprises a first extension and a second extension arranged sequentially in a proximal-to-distal direction; the first extension is tubular; the second extension comprises a fixation member and a telescopic part, the fixing part is connected to the first extension part, and the fixing part has an annular mesh surface; the telescoping part enables the cutting aid to be switched between an unfolded state and a stretched state.

在一些实施例中，所述伸缩件包括沿近端到远端方向依次设置的过渡段和远端段，所述切割辅助件处于展开状态时，所述过渡段呈锥台形。In some embodiments, the telescoping member includes a transition section and a distal section arranged in sequence along the direction from the proximal end to the distal end, and when the cutting aid is in an unfolded state, the transition section is in the shape of a truncated cone.

在一些实施例中，所述切割辅助件为弹性编织网，所述第一延伸部套接于所述第一管体的远端，所述推拉杆穿过所述第一延伸部并连接于所述第二延伸部。In some embodiments, the cutting aid is an elastic braided mesh, the first extension part is sleeved on the distal end of the first tube body, and the push-pull rod passes through the first extension part and is connected to the second extension.

在一些实施例中，所述环形网面的外径大于所述第一延伸部的外径；所述房间隔造口装置还包括环形的切割刀，所述切割刀的内径与所述环形网面的外径之差不大于1mm。In some embodiments, the outer diameter of the annular mesh surface is larger than the outer diameter of the first extension; the atrial septostomy device further includes an annular cutting knife, and the inner diameter of the cutting knife is the same as that of the annular mesh. The difference between the outer diameters of the surfaces shall not be greater than 1mm.

在一些实施例中，所述房间隔造口装置还包括第一卡接组件和第二卡接组件，所述第一卡接组件包括第一外环和套装于所述第一外环内的第一内环，所述第一内环的一端卡接所述推拉杆，所述伸缩件的远端卡接于所述第一外环和第一内环之间；所述第二卡接组件包括第二外环和套装于所述第二外环内的第二内环，所述第二内环的一端卡接所述第一管体，所述第一延伸部的近端卡接于所述第二外环和第二内环之间。In some embodiments, the atrial septostomy device further includes a first clamping assembly and a second clamping assembly, the first clamping assembly includes a first outer ring and a ring sleeved in the first outer ring The first inner ring, one end of the first inner ring is clamped to the push-pull rod, and the distal end of the telescopic member is clamped between the first outer ring and the first inner ring; the second clamping The assembly includes a second outer ring and a second inner ring sleeved in the second outer ring, one end of the second inner ring is clipped to the first tube body, and the proximal end of the first extension part is clipped to between the second outer ring and the second inner ring.

在一些实施例中，所述环形网面与所述推拉杆轴向的夹角为80°-100°。In some embodiments, the included angle between the annular mesh surface and the axial direction of the push-pull rod is 80°-100°.

在一些实施例中，所述切割刀包括切割刀体和载药结构，所述切割刀体沿轴线方向设置有贯穿的通孔，所述切割刀体的一端为切割端，另一端为连接端；所述载药结构设置在所述切割刀体的外壁上，所述载药结构用于承载药物。In some embodiments, the cutting knife includes a cutting knife body and a drug-loaded structure, the cutting knife body is provided with a through hole along the axis direction, one end of the cutting knife body is a cutting end, and the other end is a connecting end ; The drug-loading structure is arranged on the outer wall of the cutting knife body, and the drug-loading structure is used to carry drugs.

在一些实施例中，所述载药结构为开设在所述切割刀体外壁上的载药槽。In some embodiments, the drug-loading structure is a drug-loading groove opened on the outer wall of the cutting knife.

在一些实施例中，所述载药槽为沿所述切割刀体的周向设置的环形槽。In some embodiments, the drug-loading groove is an annular groove arranged along the circumference of the cutting blade body.

在一些实施例中，所述载药槽的槽底面为倾斜面，沿切割方向，所述载药槽的载药深度逐渐减小。In some embodiments, the bottom surface of the drug-loading groove is an inclined surface, and along the cutting direction, the drug-loading depth of the drug-loading groove gradually decreases.

在一些实施例中，所述载药槽包括多个载药子槽，多个所述载药子槽沿所述切割刀体的周向或切割方向间隔设置。In some embodiments, the drug-loaded groove includes a plurality of drug-loaded sub-grooves, and the plurality of drug-loaded sub-grooves are arranged at intervals along the circumferential direction or the cutting direction of the cutting blade body.

在一些实施例中，所述载药槽的内壁上设置有吸附结构，所述吸附结构用于吸附所述药物；所述吸附结构为吸附膜，所述吸附膜贴附在所述载药槽的内壁上；或者，所述吸附结构为吸附粗糙面，所述载药槽的内壁被配置为形成所述吸附粗糙面。In some embodiments, an adsorption structure is provided on the inner wall of the drug-loading tank, and the adsorption structure is used to adsorb the drug; the adsorption structure is an adsorption film, and the adsorption film is attached to the drug-loading tank or, the adsorption structure is an adsorption rough surface, and the inner wall of the drug-loading tank is configured to form the adsorption rough surface.

在一些实施例中，所述切割刀体包括呈阶梯状连接的第一部和第二部，所述第一部和所述 第二部均呈圆柱状，所述第一部的外径大于所述第二部的外径，所述第一部远离所述第二部的一端为所述切割端，所述第二部远离所述第一部的一端为所述连接端，所述载药结构设置于所述第一部的外壁。所述通孔包括呈阶梯状连接的第一孔和第二孔，所述第一孔位于所述第一部内部，所述第二孔的至少部分位于所述第二部内，所述第一孔的内径大于所述第二孔的内径。In some embodiments, the cutting body includes a first part and a second part connected in a stepped shape, both of the first part and the second part are cylindrical, and the outer diameter of the first part is larger than The outer diameter of the second part, the end of the first part far away from the second part is the cutting end, the end of the second part far away from the first part is the connecting end, and the loading The medicine structure is arranged on the outer wall of the first part. The through hole includes a first hole connected in a stepped shape and a second hole, the first hole is located inside the first part, at least part of the second hole is located in the second part, and the first hole is located inside the first part. The inner diameter of the hole is larger than the inner diameter of the second hole.

本发明的各个实施例的细节将在下面的附图和描述中进行说明。根据说明书、附图以及权利要求书的记载，本领域技术人员将容易理解本发明的其它特征、解决的问题以及有益效果。The details of various embodiments of the invention are set forth in the accompanying drawings and the description below. From the description, drawings and claims, those skilled in the art will easily understand other features, problems to be solved and beneficial effects of the present invention.

附图说明Description of drawings

为了更清楚地说明本申请实施例中的技术方案，下面将对本申请实施例描述中所需要使用的附图作简单的介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据本申请实施例的内容和这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the description of the embodiments of the present application. Obviously, the accompanying drawings in the following description are only some embodiments of the present application , those skilled in the art can also obtain other drawings according to the content of the embodiment of the present application and these drawings without any creative work.

图1是本申请实施例提供的房间隔造口装置中切割辅助件呈拉伸状态的结构示意图；Fig. 1 is a schematic structural view of a cutting aid in a stretched state in an atrial septostomy device provided by an embodiment of the present application;

图2是本申请实施例提供的房间隔造口装置中切割辅助件呈展开状态的结构示意图；Fig. 2 is a schematic structural view of the cutting aid in the unfolded state of the atrial septostomy device provided by the embodiment of the present application;

图3是本申请实施例提供的切割刀的第一种结构示意图；Fig. 3 is a schematic diagram of the first structure of the cutting knife provided by the embodiment of the present application;

图4是本申请实施例提供的切割刀的第二种结构示意图；Fig. 4 is a second structural schematic diagram of the cutting knife provided by the embodiment of the present application;

图5是本申请实施例提供的切割刀的第三种结构示意图；Fig. 5 is a schematic diagram of the third structure of the cutting knife provided by the embodiment of the present application;

图6是本申请实施例提供的切割辅助件的结构示意图；Fig. 6 is a schematic structural diagram of a cutting aid provided by an embodiment of the present application;

图7是本申请实施例提供的房间隔造口装置的结构示意图；Fig. 7 is a schematic structural view of an atrial septostomy device provided in an embodiment of the present application;

图8是本申请实施例提供的房间隔造口装置的第一视角的剖视图；Fig. 8 is a cross-sectional view of a first viewing angle of the atrial septostomy device provided by the embodiment of the present application;

图9是本申请实施例提供的房间隔造口装置的第二视角的剖视图；Fig. 9 is a cross-sectional view of the atrial septostomy device provided by the embodiment of the present application at a second viewing angle;

图10是本申请实施例提供的第一驱动组件的结构示意图；Fig. 10 is a schematic structural diagram of the first drive assembly provided by the embodiment of the present application;

图11是本申请实施例提供的第二驱动组件的结构示意图；Fig. 11 is a schematic structural diagram of a second driving assembly provided by an embodiment of the present application;

图12是本申请实施例提供的第三驱动组件的结构示意图；Fig. 12 is a schematic structural diagram of a third drive assembly provided by an embodiment of the present application;

图13是本申请另一实施例提供的房间隔造口装置的结构示意图；Fig. 13 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application;

图14是本申请另一实施例提供的弹性编织网的结构示意图；Fig. 14 is a schematic structural view of an elastic braided net provided by another embodiment of the present application;

图15是本申请另一实施例所提供的房间隔造口装置的结构示意图；Fig. 15 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application;

图16是本申请另一实施例所提供的房间隔造口装置的结构示意图；Fig. 16 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application;

图17是本申请实施例所提供的房间隔造口装置进行造口操作时的示意图；Fig. 17 is a schematic diagram of the atrial septostomy device provided in the embodiment of the present application during stoma operation;

图18是本申请实施例所提供的房间隔造口装置进行上药操作时的示意图。Fig. 18 is a schematic diagram of the atrial septostomy device provided in the embodiment of the present application during the operation of applying medicine.

具体实施方式Detailed ways

下面结合附图和实施例对本申请作进一步的详细说明。可以理解的是，此处所描述的具体实施例仅仅用于解释本申请，而非对本申请的限定。另外还需要说明的是，为了便于描述，附图中仅示出了与本申请相关的部分而非全部结构。The application 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 application, but not to limit the present application. In addition, it should be noted that, for the convenience of description, only some structures related to the present application are shown in the drawings but not all structures.

在本申请的描述中，除非另有明确的规定和限定，术语“相连”、“连接”、“固定”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。In the description of this application, unless otherwise clearly specified and limited, the terms "connected", "connected" and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.

在本申请中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之 下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。In this application, unless otherwise expressly specified and limited, a first feature being "on" or "under" a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them. Moreover, "above", "above" and "above" the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. "Below", "under" and "under" the first feature include the first feature directly below and obliquely below the second feature, or simply mean that the first feature is less horizontally than the second feature.

在本实施例的描述中，术语“上”、“下”、“左”、“右”等方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化操作，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”仅仅用于在描述上加以区分，并没有特殊的含义。In the description of this embodiment, the terms "up", "down", "left", "right" and other orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operations. It is not intended to indicate or imply that the device or element referred to must have a particular orientation, be constructed, or operate in a particular orientation, and thus should not be construed as limiting the application. In addition, the terms "first" and "second" are only used to distinguish in description, and have no special meaning.

首先，需要说明的是，在本实施例的描述中，“远端”指的是在使用时该零部件远离操作者一端，即靠近心脏一端，“近端”指的是在使用时该零部件靠近操作者一端，即远离心脏一端。First of all, it should be noted that in the description of this embodiment, "distal end" refers to the end of the component that is away from the operator when in use, that is, the end near the heart, and "proximal end" refers to the end of the part that is close to the heart when in use. The part is close to the end of the operator, that is, away from the heart.

申请人注意到，现有的房间隔造口术存在较高的风险，如在手术中抓取装置发生松动或在术后回收时，可能导致所切割的组织脱落并形成栓塞。此外，如果在切割过程中，抓取装置的松动极易导致其它心肌组织受损，且该方法的装置结构复杂，操作不便。The applicant noticed that the existing atrial septostomy has a high risk, such as loosening of the grasping device during the operation or recovery after the operation, which may cause the cut tissue to fall off and form an embolism. In addition, if the grasping device loosens during the cutting process, other myocardial tissues are easily damaged, and the device of this method has a complex structure and is inconvenient to operate.

基于此，本申请的目的之一在于提供一种房间隔造口装置，能避免手术过程中或在术后回收时切割的房间隔组织脱落，防止形成栓塞或者心肌组织受损。Based on this, one of the objectives of the present application is to provide an atrial septostomy device, which can prevent the cut atrial septal tissue from falling off during the operation or during postoperative recovery, and prevent the formation of embolism or damage to myocardial tissue.

本申请的部分实施例提供房间隔造口装置，包括第一管体、第二管体和辅助组件。第二管体的远端连接有切割刀，切割刀设置有与第二管体的管腔连通的空腔，第一管体滑动穿设于第二管体和切割刀内。辅助组件包括推拉杆和切割辅助件，推拉杆滑动穿设于第一管体内，切割辅助件的近端连接第一管体的远端，切割辅助件的远端连接推拉杆的远端，推拉杆能够相对第一管体滑动，以使切割辅助件在展开状态和拉伸状态之间切换。切割辅助件处于拉伸状态时，能够被收容于空腔内。切割辅助件处于展开状态时，具有朝向切割刀的网状面，网状面用于收集切割刀切除的房间隔组织并将其拉入空腔内。Some embodiments of the present application provide an atrial septostomy device, including a first tubular body, a second tubular body and an auxiliary component. The distal end of the second tube body is connected with a cutting knife, and the cutting knife is provided with a cavity communicating with the lumen of the second tube body, and the first tube body slides through the second tube body and the cutting knife. The auxiliary assembly includes a push-pull rod and a cutting auxiliary piece. The push-pull rod slides through the first tube body. The proximal end of the cutting auxiliary piece is connected to the distal end of the first tube body. The pull rod is slidable relative to the first tubular body to switch the cutting aid between a deployed state and a stretched state. When the cutting aid is in a stretched state, it can be accommodated in the cavity. In the deployed state, the cutting aid has a meshed surface facing the cutter for collecting atrial septal tissue resected by the cutter and drawing it into the cavity.

如图1和图2所示，本实施例提供一种房间隔造口装置，该房间隔造口装置包括第一管体1、第二管体2和辅助组件5。As shown in FIGS. 1 and 2 , this embodiment provides an atrial septostomy device, which includes a first tube body 1 , a second tube body 2 and an auxiliary component 5 .

具体地，第二管体2远端连接切割刀4，切割刀4设置有与第二管体2的管腔连通的空腔41，第一管体1滑动穿设于第二管体2和切割刀4内。辅助组件5包括推拉杆51和切割辅助件52，推拉杆51滑动穿设于第一管体1内，并能够从第一管体1内伸出，切割辅助件52的近端连接第一管体1的远端，切割辅助件52的远端连接推拉杆51的远端，推拉杆51能够相对第一管体1滑动。Specifically, the distal end of the second tube body 2 is connected to the cutting knife 4, and the cutting knife 4 is provided with a cavity 41 communicating with the lumen of the second tube body 2, and the first tube body 1 slides through the second tube body 2 and Inside the cutting knife 4. The auxiliary assembly 5 includes a push-pull rod 51 and a cutting aid 52. The push-pull rod 51 slides through the first tube body 1 and can protrude from the first tube body 1. The proximal end of the cutting aid 52 is connected to the first tube The distal end of the body 1 and the distal end of the cutting aid 52 are connected to the distal end of the push-pull rod 51 , and the push-pull rod 51 can slide relative to the first tubular body 1 .

切割辅助件52具有展开状态和拉伸状态。切割辅助件52处于拉伸状态时，切割辅助件52能够包覆于推拉杆51的外表面，此时切割辅助件52具有较小的外径，能够被收容于切割刀4的空腔41内，且能够穿过房间隔100上的预开孔。切割辅助件52从切割刀4的空腔41内伸出并处于展开状态时，具有朝向切割刀4的网状面，该网状面的外径等于或大于或略小于空腔41的内径，使其能够用于收集切割刀4切除的房间隔组织并将其拉入空腔41内。Cutting aid 52 has a deployed state and a stretched state. When the cutting aid 52 is in a stretched state, the cutting aid 52 can cover the outer surface of the push-pull rod 51. At this time, the cutting aid 52 has a smaller outer diameter and can be accommodated in the cavity 41 of the cutting knife 4 , and can pass through the pre-opened hole on the interatrial septum 100 . When the cutting aid 52 protrudes from the cavity 41 of the cutting knife 4 and is in an unfolded state, it has a mesh surface facing the cutting knife 4, the outer diameter of the mesh surface is equal to or greater than or slightly smaller than the inner diameter of the cavity 41, It can be used to collect interatrial septal tissue excised by cutting knife 4 and pull it into cavity 41 .

推拉杆51能够相对于第一管体1移动，以使切割辅助件52在展开状态和拉伸状态之间切换。当推拉杆51相对于第一管体1沿远端到近端方向移动时，切割辅助件52在轴向上收缩，同时在径向上扩展，使得切割辅助件52由拉伸状态切换至展开状态。当推拉杆51相对于第一管体1沿近端到远端方向移动时，切割辅助件52在轴向上拉伸，同时在径向上收缩，使得切割辅助件52由展开状态切换至拉伸状态。The push-pull rod 51 can move relative to the first tubular body 1 to switch the cutting aid 52 between the expanded state and the stretched state. When the push-pull rod 51 moves relative to the first tubular body 1 along the direction from the distal end to the proximal end, the cutting aid 52 contracts in the axial direction and simultaneously expands in the radial direction, so that the cutting aid 52 is switched from the stretched state to the expanded state . When the push-pull rod 51 moves in the proximal-to-distal direction relative to the first tubular body 1, the cutting aid 52 is stretched in the axial direction and contracted in the radial direction at the same time, so that the cutting aid 52 is switched from the expanded state to the stretched state. state.

本实施例的切割辅助件52能够在拉伸状态下被收容于切割刀4的空腔41内，使得切割刀4和辅助组件5可同时被递送至房间隔100处，而无需将切割刀4和辅助组件5先后单独递送至房间隔100处，简化了手术操作步骤，节约了手术时间。The cutting aid 52 of this embodiment can be accommodated in the cavity 41 of the cutting knife 4 in a stretched state, so that the cutting knife 4 and the auxiliary assembly 5 can be delivered to the interatrial septum 100 at the same time without moving the cutting knife 4 and the auxiliary component 5 are delivered separately to the interatrial septum 100 successively, which simplifies the operation steps and saves operation time.

使用本实施例的房间隔造口装置进行房间隔造口术时，切割刀4和切割辅助件52被同时递送至房间隔100处，此时，切割辅助件52呈拉伸状态并收容于切割刀4的空腔41内。驱动第一管体1，使第一管体1相对于第二管体2由近端到远端方向移动，使切割辅助件52从切割刀4的空腔41内伸出，并穿过房间隔100处的预开孔。当切割辅助件52穿过预开孔后，驱动推 拉杆51，使推拉杆51相对于第一管体1沿远端到近端方向移动，使切割辅助件52由拉伸状态切换为展开状态。在展开状态下，切割辅助件52具有朝向切割刀4的网状面，能够抵接于房间隔100的背离切割刀4的一侧，从而和切割刀4从房间隔100的两侧固定住需要切除的组织。然后驱动第二管体2，使第二管体2相对于第一管体1由近端到远端方向移动，第二管体2带动切割刀4朝向房间隔100移动，并在切割辅助件52的固定下对房间隔组织进行切割。切割辅助件52能够定位及固定待切割房间隔组织，使得切割刀4的切除操作更为快速、精准。待切除完毕后，被切除的房间隔组织在切割辅助件52的固定下能够进入切割刀4的空腔41内，避免房间隔组织脱落引起的栓塞心肌组织受损。When using the atrial septostomy device of this embodiment to perform atrial septostomy, the cutting knife 4 and the cutting aid 52 are delivered to the atrial septum 100 at the same time. At this time, the cutting aid 52 is in a stretched state and accommodated in the cutting In the cavity 41 of the knife 4. Drive the first tubular body 1 to move the first tubular body 1 relative to the second tubular body 2 from the proximal end to the distal end, so that the cutting aid 52 protrudes from the cavity 41 of the cutting knife 4 and passes through the room. Pre-drilled holes at intervals of 100. When the cutting aid 52 passes through the pre-opening hole, the push-pull rod 51 is driven to move the push-pull rod 51 relative to the first tube body 1 along the direction from the distal end to the proximal end, so that the cutting aid 52 is switched from the stretched state to the unfolded state . In the unfolded state, the cutting aid 52 has a mesh surface facing the cutting knife 4, and can abut against the side of the interatrial septum 100 away from the cutting knife 4, so as to be fixed with the cutting knife 4 from both sides of the interatrial septum 100 as needed. resected tissue. Then the second tubular body 2 is driven to move the second tubular body 2 from the proximal end to the distal end relative to the first tubular body 1, and the second tubular body 2 drives the cutting knife 4 to move toward the interatrial septum 100, and the cutting aid The atrial septal tissue was cut under the fixation of 52. The cutting aid 52 can locate and fix the atrial septal tissue to be cut, so that the cutting operation of the cutting knife 4 is faster and more accurate. After the resection is completed, the resected atrial septal tissue can enter the cavity 41 of the cutting knife 4 under the fixing of the cutting aid 52, so as to avoid damage to the embolized myocardial tissue caused by atrial septal tissue shedding.

切割辅助件52可以为弹性编织网，并具有预定型结构。具体为，当切割辅助件52处于展开状态时，具有朝向所述切割刀4的网状面，该网状面为预定型结构。通过推拉杆51相对于第一管体1的移动，能够控制切割辅助件52的弹性变形程度，进而控制切割辅助件52对房间隔100的抵靠力，对切割刀4的配合度更高，提高了手术的安全性。Cutting aid 52 may be an elastic woven mesh and have a pre-shaped structure. Specifically, when the cutting aid 52 is in an unfolded state, it has a mesh surface facing the cutting knife 4, and the mesh surface is a predetermined structure. Through the movement of the push-pull rod 51 relative to the first tubular body 1, the degree of elastic deformation of the cutting aid 52 can be controlled, and further the abutting force of the cutting aid 52 against the interatrial septum 100 can be controlled, and the degree of cooperation with the cutting knife 4 is higher. The safety of the operation is improved.

需要说明的是，切割辅助件52处于展开状态时，网状面的外径可以大于、等于或略小于空腔41的内径。当网状面的外径等于或略小于空腔41的内径时，切割刀4将房间隔组织切下后，该网状面可以将切除的房间隔组织拉入空腔41内，同时该网状面的至少部分也可被拉入空腔41内。当网状面的外径大于空腔41的内径时，切割刀4将房间隔组织切下后，拉动推拉杆51，该网状面将切除的房间隔组织拉入空腔41内并抵靠于切割刀4的远端处。在其他实施例中，当网状面的外径大于空腔41的内径时，可通过推拉杆51控制网状面的形态，切割刀4切除房间隔组织后，控制推拉杆51由近端到远端方向轻微移动，使网状面的外径减小至等于或小于空腔41的内径。It should be noted that when the cutting aid 52 is in the expanded state, the outer diameter of the mesh surface may be greater than, equal to or slightly smaller than the inner diameter of the cavity 41 . When the outer diameter of the mesh surface is equal to or slightly smaller than the inner diameter of the cavity 41, after the cutting knife 4 cuts off the atrial septal tissue, the mesh surface can pull the resected atrial septal tissue into the cavity 41, while the mesh At least part of the surface can also be drawn into the cavity 41 . When the outer diameter of the mesh surface is greater than the inner diameter of the cavity 41, the cutting knife 4 cuts off the atrial septal tissue and then pulls the push-pull rod 51, and the mesh surface pulls the excised atrial septal tissue into the cavity 41 and leans against it. at the distal end of the cutting knife 4. In other embodiments, when the outer diameter of the mesh surface is greater than the inner diameter of the cavity 41, the shape of the mesh surface can be controlled by the push-pull rod 51. After the cutting knife 4 excises the atrial septal tissue, the push-pull rod 51 is controlled from the proximal end to the The slight movement in the distal direction reduces the outer diameter of the mesh surface to be equal to or smaller than the inner diameter of cavity 41 .

在切割刀4对房间隔组织进行切除时，为了防止第二管体2和切割刀4沿近端到远端方向移动的距离过大，空腔41内可以设置限位台42。第二管体2和切割刀4切除房间隔组织后，若继续沿近端到远端移动，切割辅助件52将抵接于限位台42，此时第二管体2和切割刀4停止移动，完成造口。When the cutting knife 4 excises the interatrial septal tissue, in order to prevent the second tube body 2 and the cutting knife 4 from moving too far along the direction from the proximal end to the distal end, a limiting platform 42 may be provided in the cavity 41 . After the second tubular body 2 and the cutting knife 4 cut off the interatrial septal tissue, if they continue to move from the proximal end to the distal end, the cutting auxiliary member 52 will abut against the limit platform 42, and at this time the second tubular body 2 and the cutting knife 4 stop Move and complete the stoma.

切割刀4与第二管体2的连接方式包括但不限于如图3-图5所示的方式。如图3所示，切割刀4的近端设置有沿其周向延伸的容置腔43，切割刀4在开设容置腔43处的内径与第二管体2的外径可以相同。第二管体2的远端伸入容置腔43中，第二管体2的外壁与容置腔43的槽壁贴合。切割刀4与第二管体2的连接处通过胶水粘接，或者在切割刀4与第二管体2的连接处套设热缩管，加热热缩管以实现切割刀4与第二管体2之间的连接。The connection manner between the cutting knife 4 and the second pipe body 2 includes but not limited to the manner shown in Fig. 3-Fig. 5 . As shown in FIG. 3 , the proximal end of the cutting knife 4 is provided with an accommodating cavity 43 extending along its circumference, and the inner diameter of the cutting knife 4 at the opening of the accommodating cavity 43 may be the same as the outer diameter of the second tube body 2 . The distal end of the second tube body 2 extends into the accommodating cavity 43 , and the outer wall of the second tube body 2 is attached to the groove wall of the accommodating cavity 43 . The connection between the cutting knife 4 and the second tube body 2 is bonded by glue, or a heat-shrinkable tube is sleeved at the joint between the cutting knife 4 and the second tube body 2, and the heat-shrinkable tube is heated to realize the connection between the cutting knife 4 and the second tube body. Connection between body 2.

如图4所示，切割刀4朝向第二管体2的一端伸入第二管体2的远端内并与第二管体2固定连接。切割刀4近端的外径与第二管体2远端的内径可以相同。切割刀4朝向第二管体2的一端伸入第二管体2中，且第二管体2的内壁与切割刀4的外壁贴合并通过胶水粘接，或者在切割刀4与第二管体2的连接处套设热缩管，加热热缩管以实现切割刀4与第二管体2之间的连接。As shown in FIG. 4 , the cutting knife 4 protrudes into the distal end of the second tubular body 2 toward the end of the second tubular body 2 and is fixedly connected with the second tubular body 2 . The outer diameter of the proximal end of the cutting knife 4 may be the same as the inner diameter of the distal end of the second tubular body 2 . The cutting knife 4 extends into the second pipe body 2 toward one end of the second pipe body 2, and the inner wall of the second pipe body 2 is attached to the outer wall of the cutting knife 4 and bonded by glue, or the cutting knife 4 and the second pipe body A heat-shrinkable tube is sheathed at the junction of the body 2 , and the heat-shrinkable tube is heated to realize the connection between the cutting knife 4 and the second tube body 2 .

如图5所示，切割刀4与第二管体2朝向彼此的端面相对并贴合。切割刀4的外壁沿周向开设储胶槽44，储胶槽44不贯通切割刀4的端面。切割刀4与第二管体2的端面贴合后，在第二管体2与切割刀4的连接处沿周向涂覆胶水，并将胶水延伸至储胶槽44内，增加连接面积，保证了粘接的牢固程度。还可在切割刀4与第二管体2的连接处套设热缩管，加热热缩管以实现切割刀4与第二管体2之间的连接。As shown in FIG. 5 , the end faces of the cutting knife 4 and the second pipe body 2 facing each other are opposed to and attached to each other. The outer wall of the cutting knife 4 is provided with a glue storage tank 44 along the circumference, and the glue storage tank 44 does not pass through the end face of the cutting knife 4 . After the cutting knife 4 is attached to the end face of the second pipe body 2, glue is coated on the joint of the second pipe body 2 and the cutting knife 4 along the circumferential direction, and the glue is extended into the glue storage tank 44 to increase the connection area. Ensure the firmness of the bonding. A heat-shrinkable tube can also be sleeved at the connection between the cutting knife 4 and the second tube body 2 , and the heat-shrinkable tube can be heated to realize the connection between the cutting knife 4 and the second tube body 2 .

本实施例中，切割刀4的远端可设置有刀刃45，刀刃45的形状为环形、矩形或椭圆形等任意形状，这均是在本申请的保护范围之内，本实施例在此不做限制。具体地，通过对切割刀4侧壁进行倒角形成刀刃45，倒角的方式可以为内壁倒角、外壁倒角或内壁外壁同时倒角形成刀刃45。切割刀4的材料可以是不锈钢或钛合金等，一方面，结构强度满足使用需求，另一方面，具有显影性，手术时，便于了解切割刀4的位置。切割刀4的轴向长度可以为10-20mm， 内径可以为4-10mm，外径可以为6-12mm，刀刃45处的倒角的角度可以为15°-30°。In this embodiment, the far end of cutting knife 4 can be provided with blade 45, and the shape of blade 45 is any shape such as ring, rectangle or ellipse, and this all is within the scope of protection of the present application, and the present embodiment does not refer to it here. Do limit. Specifically, the edge 45 is formed by chamfering the side wall of the cutting knife 4 . The chamfering method can be chamfering the inner wall, chamfering the outer wall, or chamfering the inner and outer walls simultaneously to form the edge 45 . The material of the cutting knife 4 can be stainless steel or titanium alloy, etc. On the one hand, the structural strength meets the requirements of use; The axial length of the cutting knife 4 can be 10-20mm, the inner diameter can be 4-10mm, the outer diameter can be 6-12mm, and the angle of the chamfer at the blade 45 can be 15°-30°.

进一步地，如图6所示，切割辅助件52为弹性编织网，弹性编织网包括沿近端到远端方向依次设置的第一延伸部521和第二延伸部522；第一延伸部521套接于第一管体1的远端，推拉杆51穿过第一延伸部521并连接于第二延伸部522；切割辅助件52处于展开状态时，第二延伸部522的近端具有朝向切割刀4的网状面。其中，第一延伸部521可以为呈圆柱形，第一延伸部521的近端具有开口，通过开口套接于第一管体1的远端，第一延伸部521能够穿过房间隔100的预开孔。推拉杆51从第一管体1内通过开口进入切割辅助件52内。第一延伸部521可以对切割辅助件52的位置进行准确限定，且不损伤预开孔。第二延伸部522的一端固定连接第一延伸部521远离第一管体1的另一端，推拉杆51穿过第一延伸部521并连接于第二延伸部522的底部，推拉杆51相对切割辅助件52抽拉的过程中，第二延伸部522能够展开和/或拉伸。Further, as shown in FIG. 6 , the cutting aid 52 is an elastic braided mesh, and the elastic braided mesh includes a first extension portion 521 and a second extension portion 522 arranged in sequence along the direction from the proximal end to the distal end; the first extension portion 521 covers Connected to the distal end of the first tubular body 1, the push-pull rod 51 passes through the first extension part 521 and is connected to the second extension part 522; when the cutting aid 52 is in the unfolded state, the proximal end of the second extension part 522 has a direction toward the cutting Mesh side of knife 4. Wherein, the first extension part 521 may be cylindrical, the proximal end of the first extension part 521 has an opening, and is sleeved on the distal end of the first tube body 1 through the opening, and the first extension part 521 can pass through the interatrial septum 100 Pre-drilled. The push-pull rod 51 enters the cutting aid 52 from the first tube body 1 through the opening. The first extension portion 521 can accurately define the position of the cutting aid 52 without damaging the pre-opening hole. One end of the second extension part 522 is fixedly connected to the other end of the first extension part 521 away from the first tube body 1, the push-pull rod 51 passes through the first extension part 521 and is connected to the bottom of the second extension part 522, and the push-pull rod 51 is oppositely cut During the pulling process of the auxiliary part 52, the second extension part 522 can expand and/or stretch.

在一些实施例中，切割辅助件52处于展开状态时，网状面与推拉杆51之间的夹角为80-90度，提高了网状面对房间隔100固定的稳定性。In some embodiments, when the cutting aid 52 is in the unfolded state, the angle between the mesh surface and the push-pull rod 51 is 80-90 degrees, which improves the stability of the mesh surface and the fixation of the interatrial septum 100 .

在一些实施例中，推拉杆51连接于第二延伸部522的远端。通过第一延伸部521和第二延伸部522，切割辅助件52形成袋状编织网，能够容纳推拉杆51穿过其中，且在径向和轴向都能有较好的弹性伸缩能力，易于穿过房间隔100的预开孔，且能有效固定切割组织。推拉杆51位于切割辅助件52内，在切割辅助件52弹性变形过程中能提供轴向引导，避免轴向压缩时倾斜或者径向压缩时断裂。In some embodiments, the push-pull rod 51 is connected to the distal end of the second extension part 522 . Through the first extension part 521 and the second extension part 522, the cutting aid 52 forms a bag-shaped braided net, which can accommodate the push-pull rod 51 passing through it, and has better elastic expansion and contraction in the radial and axial directions, and is easy to It passes through the pre-opening hole of the interatrial septum 100, and can effectively fix the cut tissue. The push-pull rod 51 is located in the cutting aid 52, and can provide axial guidance during the elastic deformation of the cutting aid 52, so as to avoid tilting during axial compression or fracture during radial compression.

在一些实施例中，推拉杆51采用金属材质，与切割辅助件52焊接连接，提高了连接可靠性，降低了切割辅助件52脱落的风险。进一步地，推拉杆51包括沿轴向设置的直杆部和弹性部，直杆部位于推拉杆51的近端，弹性部位于推拉杆51的远端，直杆部与弹性部焊接连接，设置弹性部，使得推拉杆51在弹性部处能够弯曲，更利于准确到达预开孔的位置。其中，弹性部可以为弹簧。In some embodiments, the push-pull rod 51 is made of metal, and is welded to the cutting auxiliary part 52, which improves connection reliability and reduces the risk of the cutting auxiliary part 52 falling off. Further, the push-pull rod 51 includes a straight rod part and an elastic part arranged in the axial direction, the straight rod part is located at the proximal end of the push-pull rod 51, and the elastic part is located at the far end of the push-pull rod 51, and the straight rod part and the elastic part are welded and connected. The elastic part enables the push-pull rod 51 to bend at the elastic part, which is more conducive to accurately reaching the position of the pre-drilled hole. Wherein, the elastic part may be a spring.

在一些实施例中，第二延伸部522的截面形状可为三角形、矩形、菱形、星形等规则或不规则的多边形，也可为圆形、椭圆形等具有弧形边的形状，这均是在本申请的保护范围之内，本实施例在此不做限制。In some embodiments, the cross-sectional shape of the second extension part 522 can be a regular or irregular polygon such as a triangle, rectangle, rhombus, star, or a shape with arc-shaped sides such as a circle or an ellipse. It is within the protection scope of this application, and this embodiment is not limited here.

进一步地，第二延伸部522包括固定件5221和伸缩件5222，固定件5221的一侧连接第一延伸部521，另一侧连接伸缩件5222。固定件5221可以为预定型的网状面，网状面的形状可以为圆形，当然在本申请的其他实施例中，网状面还可以为椭圆形、菱形等规则或不规则的形状。固定件5221呈网状面形态时能够贴合房间隔100背离切割刀4的一侧，使得与切割刀4对房间隔100的夹持更为牢固。在推拉杆51沿远端到近端方向滑动时，切割辅助件52产生轴向压缩、径向扩张，此时固定件5221呈网状面形态，切割辅助件52以固定件5221为基准面，对房间隔100进行准确夹持。Further, the second extension part 522 includes a fixing part 5221 and a telescopic part 5222 , one side of the fixing part 5221 is connected to the first extension part 521 , and the other side is connected to the telescopic part 5222 . The fixing member 5221 can be a pre-shaped mesh surface, and the shape of the mesh surface can be circular. Of course, in other embodiments of the present application, the mesh surface can also be regular or irregular shapes such as ellipse and rhombus. When the fixing member 5221 is in the form of a mesh surface, it can fit the side of the interatrial septum 100 away from the cutting knife 4, so that the clamping of the interatrial septum 100 with the cutting knife 4 is more firm. When the push-pull rod 51 slides along the direction from the distal end to the proximal end, the cutting auxiliary part 52 produces axial compression and radial expansion. At this time, the fixing part 5221 is in the form of a mesh surface, and the cutting auxiliary part 52 takes the fixing part 5221 as a reference plane. Accurate clamping of interatrial septum 100 is performed.

进一步地，伸缩件5222包括沿近端到远端方向依次设置的过渡段52221和远端段。过渡段52221具有预定型结构，切割辅助件52处于展开状态时，过渡段52221可以为呈锥台形，过渡段52221的直径自近端到远端的方向逐渐减小，锥台形的过渡段52221对固定件5221起支撑作用，能够进一步增加了固定件5221的抗变形能力，防止切割过程中固定件5221向远离切割刀4的方向翻折，增加了手术成功率。推拉杆51的远端可拆卸连接于伸缩件5222的远端段，远端段具有较小的直径，能够较好地引导切割辅助件52穿过房间隔100的预开孔。过渡段52221在展开状态下具有较大的直径，能够对房间隔组织有更大的接触面积，固定效果更好。Further, the telescoping member 5222 includes a transition section 52221 and a distal section arranged in sequence along the direction from the proximal end to the distal end. The transition section 52221 has a predetermined structure. When the cutting aid 52 is in the unfolded state, the transition section 52221 can be in the shape of a truncated cone. The diameter of the transition section 52221 gradually decreases from the proximal end to the distal end. The fixing part 5221 plays a supporting role, which can further increase the anti-deformation ability of the fixing part 5221, prevent the fixing part 5221 from turning away from the cutting knife 4 during the cutting process, and increase the success rate of the operation. The distal end of the push-pull rod 51 is detachably connected to the distal section of the telescoping member 5222 , and the distal section has a smaller diameter, which can better guide the cutting aid 52 through the pre-opening hole of the interatrial septum 100 . The transition section 52221 has a larger diameter in the unfolded state, which can have a larger contact area with the interatrial septal tissue and better fixation effect.

进一步地，切割辅助件52可以由多根合金丝线编织组成，合金丝线的材料可以为镍合金，也可以为其他具有记忆能力的合金材料，编织方法可以为本领域内的任何现有编织技术，本实施例在此不做限制。更进一步地，合金丝线的丝径范围可以为0.05mm-0.15mm，切割辅助件52的孔隙密度可以为每英寸交叉数30-80，既能保持良好的弹性变形性，且具有足够的固定支撑强度。切割辅助件52的网孔形状可为圆形或者多边形等，这均是在本申请的保护范围之内。Further, the cutting aid 52 can be composed of a plurality of alloy wires braided, and the material of the alloy wires can be nickel alloy, or other alloy materials with memory ability, and the weaving method can be any existing weaving technology in the art, This embodiment is not limited here. Furthermore, the wire diameter range of the alloy wire can be 0.05mm-0.15mm, and the pore density of the cutting aid 52 can be 30-80 intersections per inch, which can maintain good elastic deformability and have sufficient fixed support strength. The mesh shape of the cutting aid 52 can be circular or polygonal, etc., which are all within the protection scope of the present application.

更进一步地，第一管体1包括多个卡扣，卡扣设置于第一管体1的远端端部，卡扣能够卡接切割辅助件52。例如，卡扣卡接在第一延伸部521的开口，通过卡扣，能够对第一管体1和切割辅助件52进行快速拆装，作业效率更高。Furthermore, the first tube body 1 includes a plurality of buckles, the buckles are arranged at the distal end of the first tube body 1 , and the buckles can be engaged with the cutting aid 52 . For example, the buckle is engaged with the opening of the first extension part 521 , through the buckle, the first pipe body 1 and the cutting auxiliary part 52 can be quickly disassembled, and the work efficiency is higher.

在一些实施例中，如图8所示，第一管体1可以为双腔管，该双腔管包括沿其轴向贯通的推拉杆腔12和导丝腔11，推拉杆腔12用于穿设推拉杆51，导丝腔11用于穿设导丝。在一个实施例中，推拉杆腔12与第一管体1同轴设置。在其他实施例中，第一管体1可以为单腔管，推拉杆51能够滑动穿设于该单腔管中，推拉杆51上开设有导丝腔11，导引导丝能够滑动穿设于该导丝腔11中。切割辅助件52上设置有与导丝腔11正对的导丝通孔，导丝能够穿过导丝通孔伸入导丝腔11，或者切割辅助件52上的网眼与导丝腔11正对设置，在此不作限定。In some embodiments, as shown in FIG. 8 , the first tube body 1 can be a double-lumen tube, which includes a push-pull rod lumen 12 and a guide wire lumen 11 penetrating along its axial direction. The push-pull rod lumen 12 is used for The push-pull rod 51 is threaded, and the guide wire cavity 11 is used for threading the guide wire. In one embodiment, the push-pull rod cavity 12 is arranged coaxially with the first tube body 1 . In other embodiments, the first tube body 1 can be a single-lumen tube, and the push-pull rod 51 can slide through the single-lumen tube. The guidewire lumen 11. The cutting aid 52 is provided with a guide wire through hole facing the guide wire chamber 11, and the guide wire can pass through the guide wire through hole and stretch into the guide wire chamber 11, or the mesh on the cutting aid 52 is aligned with the guide wire chamber 11. The settings are not limited here.

进一步地，如图7-图9所示，本申请的房间隔造口装置还包括第三管体3，第二管体2滑动穿设于第三管体3。在房间隔造口装置递送过程中，第三管体3包覆第一管体1、第二管体2、切割刀4和辅助组件5，防止切割刀4触碰血管部位，对第一管体1、第二管体2、切割刀4和辅助组件5起防护作用，提高作业安全性。Further, as shown in FIGS. 7-9 , the atrial septostomy device of the present application further includes a third tube body 3 , and the second tube body 2 is slidably passed through the third tube body 3 . During the delivery process of the atrial septostomy device, the third tube body 3 covers the first tube body 1, the second tube body 2, the cutting knife 4 and the auxiliary assembly 5, so as to prevent the cutting knife 4 from touching the blood vessel, and the first tube body The body 1, the second pipe body 2, the cutting knife 4 and the auxiliary component 5 play a protective role and improve the operation safety.

需要特别说明的是，房间隔造口装置还包括第一驱动组件6、第二驱动组件7和第三驱动组件8，第一驱动组件6能够驱动第二管体2沿轴向移动，第二驱动组件7能够驱动第一管体1沿轴向移动，第三驱动组件8能够驱动推拉杆51沿轴向移动，以使切割辅助件52在展开状态和拉伸状态之间切换。It should be noted that the atrial septostomy device also includes a first drive assembly 6, a second drive assembly 7 and a third drive assembly 8, the first drive assembly 6 can drive the second tubular body 2 to move axially, the second The driving assembly 7 can drive the first tubular body 1 to move in the axial direction, and the third driving assembly 8 can drive the push-pull rod 51 to move in the axial direction, so that the cutting aid 52 can switch between the expanded state and the stretched state.

具体地，如图10所示，第一驱动组件6包括第一壳体61和第一驱动件62，第二管体2的近端伸入第一壳体61，第二管体2的近端连接有第一导向件631，第一壳体61的内壁上开设有第一导向槽611，第一导向槽611沿第二管体2的轴向延伸，第一导向件631滑动置于第一导向槽611内，第一驱动件62能够驱动第二管体2沿轴向移动。通过设置第一导向槽611和第一导向件631，提高了第二管体2沿轴向移动的可靠性，保证了能够准确的到达预开孔的位置处，保证了造口位置的准确性，保证了手术的安全性，降低了手术风险，第一壳体61能够保护第一导向件631，保证了耐用性。Specifically, as shown in FIG. 10 , the first driving assembly 6 includes a first housing 61 and a first driving member 62, the proximal end of the second tube body 2 extends into the first housing 61, and the proximal end of the second tube body 2 The end is connected with a first guide piece 631, and a first guide groove 611 is opened on the inner wall of the first housing 61. The first guide groove 611 extends along the axial direction of the second pipe body 2, and the first guide piece 631 is slidably placed in the second pipe body. In a guide groove 611 , the first driving member 62 can drive the second pipe body 2 to move in the axial direction. By setting the first guide groove 611 and the first guide piece 631, the reliability of the axial movement of the second tubular body 2 is improved, ensuring that the position of the pre-opening hole can be accurately reached, and the accuracy of the stoma position is ensured , ensuring the safety of the operation and reducing the risk of the operation, and the first housing 61 can protect the first guide 631 to ensure durability.

进一步地，第一壳体61的远端连接于第三管体3，第三管体3的近端同轴连接有连接管体31，连接管体31连接于第一壳体61上。第三管体3的近端伸入连接管体31内，且第三管体3的外壁与连接管体31的内壁粘接。连接管体31远离第三管体3的端面连接于第一壳体61，第一壳体61上开设有连通孔，使第一壳体61的腔体与连接管体31连通，第二管体2能够通过连通孔穿出第一壳体61至第三管体3内。Further, the distal end of the first shell 61 is connected to the third tube body 3 , and the proximal end of the third tube body 3 is coaxially connected with the connecting tube body 31 , and the connecting tube body 31 is connected to the first shell body 61 . The proximal end of the third tube body 3 extends into the connecting tube body 31 , and the outer wall of the third tube body 3 is glued to the inner wall of the connecting tube body 31 . The end face of the connecting pipe body 31 away from the third pipe body 3 is connected to the first housing 61, and a communication hole is opened on the first housing 61, so that the cavity of the first housing 61 communicates with the connecting pipe body 31, and the second pipe The body 2 can pass through the first casing 61 into the third pipe body 3 through the communication hole.

进一步地，第一驱动组件6还包括第一螺杆63，第一驱动件62设置于第一壳体61内，且第一驱动件62上开设有第一螺纹孔，第一螺杆63螺纹连接于第一螺纹孔内，第一螺杆63的一端连接于第二管体2的近端，第一螺杆63的另一端穿出第一驱动件62，且第一导向件631连接第一螺杆63的侧壁。上述结构设置，通过转动第一驱动件62实现第二管体2的直线移动，结构简单，加工方便。Further, the first driving assembly 6 also includes a first screw rod 63, the first driving member 62 is arranged in the first casing 61, and a first threaded hole is opened on the first driving member 62, and the first screw rod 63 is screwed to the In the first threaded hole, one end of the first screw rod 63 is connected to the proximal end of the second tubular body 2, the other end of the first screw rod 63 passes through the first driving member 62, and the first guide member 631 is connected to the end of the first screw rod 63. side wall. With the above-mentioned structural arrangement, the linear movement of the second pipe body 2 can be realized by rotating the first driving member 62 , and the structure is simple and the processing is convenient.

具体地，第一螺杆63同轴连接第二管体2的近端，第一螺杆63上同轴开设有通孔，通孔贯穿第一螺杆63的轴向两端，便于第一管体1穿设。第二管体2的近端伸入第一螺杆63的通孔内，且第一螺杆63朝向第二管体2的一端的侧壁上开设有点胶孔632，点胶孔632贯通于第一螺杆63的通孔，能够通过点胶孔632将胶水滴至第二管体2的侧壁上，实现第二管体2与第一螺杆63的粘接。在其他实施例中，还可通过其他方式实现第二管体2与第一螺杆63的连接，在此不作限定。Specifically, the first screw rod 63 is coaxially connected to the proximal end of the second tubular body 2, and a through hole is coaxially opened on the first screw rod 63, and the through hole runs through both axial ends of the first screw rod 63, so that the first tubular body 1 wear. The proximal end of the second tube body 2 extends into the through hole of the first screw rod 63, and the side wall of the first screw rod 63 towards the end of the second tube body 2 offers a dispensing hole 632, and the dispensing hole 632 runs through the second tube body 2. A through hole of the screw 63 can drop glue onto the side wall of the second tube body 2 through the glue dispensing hole 632 to realize the bonding of the second tube body 2 and the first screw rod 63 . In other embodiments, the connection between the second pipe body 2 and the first screw rod 63 can also be realized in other ways, which is not limited here.

在本实施例中，第一壳体61的侧壁上开设有调节开口，第一驱动件62能够通过调节开口外露于第一壳体61，操作人员能够通过调节开口拨动第一驱动件62转动，便于调节第二管体2沿轴向的移动，提高了实用性。In this embodiment, an adjustment opening is provided on the side wall of the first housing 61, and the first driving member 62 can be exposed to the first housing 61 through the adjustment opening, and the operator can move the first driving member 62 through the adjustment opening. Rotation is convenient for adjusting the movement of the second pipe body 2 in the axial direction, which improves the practicability.

进一步地，第一驱动件62的外侧壁上可沿周向设置有多个长槽，长槽沿第二管体2的轴向 设置，增大摩擦力，便于手动转动第一驱动件62，实现第二管体2的移动。Further, the outer wall of the first driving member 62 can be provided with a plurality of long grooves along the circumferential direction, and the long grooves are arranged along the axial direction of the second pipe body 2 to increase the friction force and facilitate the manual rotation of the first driving member 62. The movement of the second pipe body 2 is realized.

在本实施例中，第一壳体61远离第二管体2的一端设置有连接部612，连接部612沿第一管体1的轴向延伸，设置连接部612用于连接第二驱动组件7。具体地，连接部612上同轴开设有第一穿孔，第一穿孔与第一壳体61的内腔连通，便于第一管体1穿过第一穿孔到达第二管体2内。In this embodiment, the end of the first shell 61 away from the second pipe body 2 is provided with a connecting portion 612, the connecting portion 612 extends along the axial direction of the first pipe body 1, and the connecting portion 612 is provided for connecting the second driving assembly 7. Specifically, the connecting portion 612 is coaxially provided with a first through hole, and the first through hole communicates with the inner cavity of the first housing 61 , so that the first tube body 1 can pass through the first through hole to reach the second tube body 2 .

在一些实施例中，如图11所示，第二驱动组件7包括第二壳体71，连接部612伸入第二壳体71内，且第二壳体71能够沿连接部612滑动，第一管体1的端部穿过第一穿孔并固定连接于第二壳体71的内部，通过第二壳体71与第一壳体61之间的相对滑动，实现第一管体1沿轴向的移动，结构较为简单，便于生产加工。In some embodiments, as shown in FIG. 11 , the second drive assembly 7 includes a second housing 71, the connecting portion 612 protrudes into the second housing 71, and the second housing 71 can slide along the connecting portion 612, and the second housing 71 can slide along the connecting portion 612. The end of a pipe body 1 passes through the first through hole and is fixedly connected to the inside of the second housing 71. Through the relative sliding between the second housing 71 and the first housing 61, the first pipe body 1 can move along the shaft. The movement in the direction, the structure is relatively simple, and it is convenient for production and processing.

进一步地，第二驱动组件7还包括第二导向件72，第二壳体71的内壁上开设有第二导向槽711，第二导向件72连接于连接部612远离第二管体2的一端，第二导向件72置于第二导向槽711内并能够沿第二导向槽711滑动。通过设置第二导向件72以及第二导向槽711，对第一管体1起到了导向作用，提高了第一管体1沿轴向移动的稳定性，保证了能够准确的到达预开孔的位置处，保证了造口位置的准确性，保证了手术的安全性。具体地，连接部612呈圆柱状，第二导向件72凸出于连接部612的侧壁设置，第二导向件72凸出的部分置于第二导向槽711内。Further, the second drive assembly 7 also includes a second guide 72, a second guide groove 711 is formed on the inner wall of the second casing 71, and the second guide 72 is connected to the end of the connecting portion 612 away from the second pipe body 2 , the second guide member 72 is placed in the second guide slot 711 and can slide along the second guide slot 711 . By setting the second guide piece 72 and the second guide groove 711, it plays a guiding role for the first pipe body 1, improves the stability of the first pipe body 1 moving in the axial direction, and ensures that it can accurately reach the pre-drilled hole. position, which ensures the accuracy of the stoma position and the safety of the operation. Specifically, the connecting portion 612 is cylindrical, the second guiding member 72 protrudes from the side wall of the connecting portion 612 , and the protruding part of the second guiding member 72 is placed in the second guiding groove 711 .

再进一步地，第二驱动组件7还包括锁紧螺钉73，第二壳体71的侧壁开设有螺纹通孔，锁紧螺钉73螺接于螺纹通孔并能够抵接于连接部612。当第一管体1到达预设位置时，拧紧锁紧螺钉73，使锁紧螺钉73与连接部612抵接，限定第二壳体71与连接部612之间的相对位置，达到限制第二壳体71的位置的作用，避免了第一管体1活动，避免影响切割刀4和推拉杆51的位置，降低了切割位置偏移的可能性。Furthermore, the second driving assembly 7 further includes a locking screw 73 , a threaded through hole is opened on the side wall of the second housing 71 , the locking screw 73 is screwed into the threaded through hole and can abut against the connecting portion 612 . When the first pipe body 1 reaches the preset position, tighten the locking screw 73 so that the locking screw 73 abuts against the connecting portion 612 to limit the relative position between the second housing 71 and the connecting portion 612 to limit the second The role of the position of the housing 71 prevents the movement of the first pipe body 1, avoids affecting the positions of the cutting knife 4 and the push-pull rod 51, and reduces the possibility of deviation of the cutting position.

在一些实施例中，如图12所示，第三驱动组件8包括第二驱动件81，第二驱动件81连接于第二壳体71远离第一壳体61的一端，第二壳体71远离第一壳体61的一端开设有第二穿孔，推拉杆51的近端穿过第二穿孔连接于第二驱动件81，第二驱动件81能够驱动推拉杆51沿轴向移动。将第二驱动件81连接于第二壳体71，由于第一管体1与第二壳体71固定连接，当驱动第一管体1和推拉杆51朝向预开孔位置移动时，仅需推动第二壳体71，即能够带动推拉杆51与第一管体1同时移动，简化了操作过程，提高了实用性。In some embodiments, as shown in FIG. 12 , the third drive assembly 8 includes a second drive member 81, the second drive member 81 is connected to an end of the second housing 71 away from the first housing 61, and the second housing 71 A second through hole is defined at an end away from the first housing 61 , and a proximal end of the push-pull rod 51 passes through the second through-hole to be connected to a second driving member 81 , and the second driving member 81 can drive the push-pull rod 51 to move axially. The second driving member 81 is connected to the second housing 71. Since the first pipe body 1 is fixedly connected to the second housing 71, when the first pipe body 1 and the push-pull rod 51 are driven to move toward the pre-opening position, only Pushing the second casing 71 can drive the push-pull rod 51 and the first pipe body 1 to move simultaneously, which simplifies the operation process and improves the practicality.

进一步地，第三驱动组件8还包括连接杆83和第三导向件84，连接杆83同轴连接于推拉杆51的近端，连接杆83至少部分置于第二穿孔内，第二穿孔的孔壁上开设有第三导向槽712，第三导向槽712沿推拉杆51的轴向延伸，连接杆83的侧壁连接于第三导向件84，第三导向件84凸出于连接杆83设置，第三导向件84置于第三导向槽712内并能够沿第三导向槽712滑动。通过设置第三导向槽712和第三导向件84，提高了推拉杆51沿轴向移动的可靠性，保证了能够准确的到达预开孔的位置处，使得切割辅助件52能够穿过预开孔并切换为展开状态，保证了造口过程的顺利进行。可以理解的是，为了避免第三导向件84滑脱第三导向槽712，第三导向槽712与第二穿孔的两端端面均不贯通。Further, the third drive assembly 8 also includes a connecting rod 83 and a third guide 84, the connecting rod 83 is coaxially connected to the proximal end of the push-pull rod 51, the connecting rod 83 is at least partially placed in the second through hole, and the second through hole A third guide groove 712 is provided on the hole wall, and the third guide groove 712 extends along the axial direction of the push-pull rod 51. The side wall of the connecting rod 83 is connected to the third guide member 84, and the third guide member 84 protrudes from the connecting rod 83. It is provided that the third guide member 84 is placed in the third guide groove 712 and can slide along the third guide groove 712 . By setting the third guide groove 712 and the third guide member 84, the reliability of the axial movement of the push-pull rod 51 is improved, and it is ensured that the position of the pre-opened hole can be accurately reached, so that the cutting auxiliary member 52 can pass through the pre-opened hole. The hole is switched to the unfolded state, which ensures the smooth progress of the stoma process. It can be understood that, in order to prevent the third guide member 84 from slipping off the third guide groove 712 , the third guide groove 712 does not communicate with both ends of the second through hole.

在一些实施例中，第三驱动组件8还包括第二螺杆82，连接杆83远离推拉杆51的一端穿出第二穿孔并与第二螺杆82同轴连接，第二驱动件81上开设有第二螺纹孔，第二螺杆82与第二螺纹孔螺接，第二驱动件81转动连接于第二壳体71远离第一壳体61的一端。上述结构设置，结构简单，便于生产加工。In some embodiments, the third drive assembly 8 further includes a second screw 82, the end of the connecting rod 83 away from the push-pull rod 51 passes through the second hole and is coaxially connected with the second screw 82, and the second drive member 81 is provided with The second threaded hole, the second screw rod 82 is screwed into the second threaded hole, and the second driving member 81 is rotatably connected to the end of the second housing 71 away from the first housing 61 . The above-mentioned structural arrangement has a simple structure and is convenient for production and processing.

在一些实施例中，切割刀4呈圆环状，切割刀4采用金属材质，可采用不锈钢等材质。切割刀4的一端设置环状切割刃，另一端连接于第二管体2，第一管体1和辅助组件5穿设于切割刀4内。第二管体2为采用Pebax(聚醚嵌段聚酰胺)材质包覆在不锈钢编织层上的结构。In some embodiments, the cutting knife 4 is annular, and the cutting knife 4 is made of metal, such as stainless steel. One end of the cutting knife 4 is provided with an annular cutting edge, and the other end is connected to the second pipe body 2 , and the first pipe body 1 and the auxiliary assembly 5 are passed through the cutting knife 4 . The second pipe body 2 is a structure in which the material of Pebax (polyether block polyamide) is coated on the braided layer of stainless steel.

本实施例中，第一驱动组件6、第二驱动组件7和第三驱动组件8为相互连接的结构，结构简单，减少体积。且推拉杆51不仅能够通过第二驱动组件7随第一管体1同时移动，使辅助 组件5穿过预开孔到达指定位置，推拉杆51还能够通过第二驱动件81单独驱动，实现辅助组件5在拉伸状态与展开状态中切换。In this embodiment, the first drive assembly 6 , the second drive assembly 7 and the third drive assembly 8 are interconnected structures with a simple structure and reduced volume. Moreover, the push-pull rod 51 can not only move simultaneously with the first pipe body 1 through the second drive assembly 7, so that the auxiliary assembly 5 can pass through the pre-opened hole to reach the designated position, but the push-pull rod 51 can also be driven independently by the second drive member 81 to realize auxiliary Component 5 switches between stretched state and unfolded state.

为了便于理解，本实施例提供的房间隔造口装置的操作步骤如下：For ease of understanding, the operating steps of the atrial septostomy device provided in this embodiment are as follows:

首先，第三管体3包覆第一管体1、第二管体2、切割刀4和辅助组件5，且切割辅助件52呈拉伸状态，将导丝穿入导丝腔11，第三管体3、第二管体2、第一管体1以及辅助组件5能够沿导丝到达预开孔位置。推动第二驱动组件7的第二壳体71，使得第一管体1与辅助组件5进一步朝向预开孔位置移动，使辅助组件5穿过预开孔到达指定位置。然后，使用第三驱动组件8拉回推拉杆51，使切割辅助件52呈展开状态，切割辅助件52抵靠在预开孔的一侧。使用第一驱动组件6驱动第二管体2前进，切割刀4对房间隔组织进行切割，切除的组织在切割辅助件52的固定下进入空腔41内，完成造口。最后，第一驱动组件6和第二驱动组件7调整第一管体1、第二管体2、切割刀4和辅助组件5退回至第三管体3内，将房间隔造口装置整体撤出。First, the third tube body 3 covers the first tube body 1, the second tube body 2, the cutting knife 4 and the auxiliary component 5, and the cutting aid 52 is stretched, and the guide wire is inserted into the guide wire lumen 11. The three tube bodies 3, the second tube body 2, the first tube body 1 and the auxiliary component 5 can reach the pre-opening position along the guide wire. Pushing the second casing 71 of the second drive assembly 7 makes the first pipe body 1 and the auxiliary assembly 5 move further towards the pre-opening position, so that the auxiliary assembly 5 passes through the pre-opening hole to reach the designated position. Then, use the third driving assembly 8 to pull back the push-pull rod 51, so that the cutting auxiliary part 52 is in an unfolded state, and the cutting auxiliary part 52 abuts against one side of the pre-opened hole. The first driving assembly 6 is used to drive the second tubular body 2 forward, the cutting knife 4 cuts the atrial septal tissue, and the resected tissue enters the cavity 41 under the fixing of the cutting aid 52 to complete the stoma. Finally, the first driving assembly 6 and the second driving assembly 7 adjust the first tubular body 1, the second tubular body 2, the cutting knife 4 and the auxiliary assembly 5 to retreat into the third tubular body 3, and withdraw the atrial septostomy device as a whole. out.

由此可见，上述实施例的房间隔造口装置在使用时，由于处于拉伸状态的切割辅助件包覆于推拉杆的外表面，此时切割辅助件具有较小的外径，能够被收容于切割刀的空腔内，所以切割刀和辅助组件可同时在血管内移动，简化输送流程；房间隔造口装置整体向左心房滑动并带动切割组件穿过房间隔的预开孔时，此时，切割辅助件呈拉伸状态，即径向压缩且轴向扩张，能够轻松穿过预开孔；当切割辅助件穿过预开孔后，推拉杆反向滑动时，切割辅助件呈展开状态，即产生轴向压缩且径向扩张，被压缩的切割辅助件能够抵接房间隔背离切割刀的一侧，从而和切割刀从房间隔的两侧固定住需要切除的组织。然后驱动第二管体和切割刀相对第一管体向远端移动，切割刀切割房间隔，在切割辅助件的固定下，切割辅助件能够提供辅助控制，对房间隔进行固定、定位，使得切割刀的切除动作更为快速、精准，防止切除的组织脱落；待切除完毕后，被切除的房间隔组织在切割辅助件的固定下进入切割刀的空腔内，避免组织脱落引起的栓塞心肌组织受损。切割辅助件的弹性伸缩动作由推拉杆控制，结构简单，不会发生松动或者固定失效，更为安全高效；通过推拉杆的滑动位置，能够控制切割辅助件的弹性变形程度，进而控制切割辅助件对房间隔的抵压力，对切割刀的配合度更高，提高了手术的安全性。It can be seen that when the atrial septostomy device in the above embodiment is in use, since the cutting aid in the stretched state is covered on the outer surface of the push-pull rod, the cutting aid has a smaller outer diameter and can be accommodated In the cavity of the cutting knife, the cutting knife and auxiliary components can move in the blood vessel at the same time, which simplifies the delivery process; When the cutting aid is stretched, that is, radially compressed and axially expanded, it can easily pass through the pre-opened hole; when the cutting aid passes through the pre-opened hole, when the push-pull rod slides in the opposite direction, the cutting aid is unfolded state, that is, produces axial compression and radial expansion, and the compressed cutting aid can abut against the side of the atrial septum away from the cutting knife, thereby fixing the tissue to be resected with the cutting knife from both sides of the atrial septum. Then drive the second tube body and the cutting knife to move distally relative to the first tube body, the cutting knife cuts the interatrial septum, and under the fixing of the cutting aid, the cutting aid can provide auxiliary control to fix and position the interatrial septum, so that The cutting action of the cutting knife is faster and more precise, preventing the removed tissue from falling off; after the cutting is completed, the removed atrial septal tissue enters the cavity of the cutting knife under the fixing of the cutting auxiliary parts, so as to avoid the embolism of the myocardium caused by the tissue falling off Tissue damage. The elastic expansion and contraction of the cutting aid is controlled by the push-pull rod, which has a simple structure and will not loosen or fail to fix, making it safer and more efficient; through the sliding position of the push-pull rod, the degree of elastic deformation of the cutting aid can be controlled, and then the cutting aid can be controlled. The resistance to the atrial septum and the degree of cooperation with the cutting knife are higher, which improves the safety of the operation.

如图13-图14所示，本申请实施例还提供一种房间隔造口装置，用于对房间隔100进行造口操作，本实施例的房间隔造口装置在进行造口之前，已经使用穿刺设备在房间隔100上形成穿刺孔。房间隔造口装置包括弹性编织网1a，弹性编织网1a包括沿近端到远端方向依次设置的第一延伸部11a和第二延伸部12a，第一延伸部11a呈管状，第二延伸部12a包括固定件121和伸缩件122，固定件121连接第一延伸部11a，且固定件121具有环形网面。本申请实施例的房间隔造口装置，管状的第一延伸部11a能够穿过房间隔100上的穿刺孔，环形网面能够贴合穿刺孔；因其具有环形网面，固定件121能够较好地贴合在房间隔100上，对弹性编织网1a的位置进行准确限定，且不损伤穿刺孔。第二延伸部12a能够从房间隔100的远端侧覆盖造口周围需要切除的组织，并对房间隔100进行固定、定位，便于对造口周围组织的切割过程中提供辅助控制，使得切除动作更为快速、精准，防止切除的组织脱落；待组织切除完毕后，弹性编织网1a能从房间隔100的远端侧辅助夹持切割下的组织并将组织带到体外，避免组织脱落引起的栓塞或心肌组织受损。As shown in Fig. 13-Fig. 14, the embodiment of the present application also provides an atrial septostomy device for stoma operation on the atrial septum 100. The atrial septostomy device in this embodiment has been A puncture hole is made in the interatrial septum 100 using a puncture device. The atrial septostomy device includes an elastic braided mesh 1a, the elastic braided mesh 1a includes a first extension 11a and a second extension 12a arranged in sequence along the direction from the proximal end to the distal end, the first extension 11a is tubular, and the second extension 12a is 12a includes a fixing part 121 and a telescoping part 122, the fixing part 121 is connected to the first extension part 11a, and the fixing part 121 has an annular mesh surface. In the atrial septostomy device of the embodiment of the present application, the tubular first extension part 11a can pass through the puncture hole on the interatrial septum 100, and the annular mesh surface can fit the puncture hole; because of its annular mesh surface, the fixing member 121 can be more It fits well on the interatrial septum 100, accurately limits the position of the elastic braided net 1a, and does not damage the puncture hole. The second extension part 12a can cover the tissue that needs to be removed around the stoma from the distal side of the atrial septum 100, and fix and position the atrial septum 100, so as to provide auxiliary control during the cutting process of the tissue around the stoma, so that the cutting action Faster and more accurate, preventing the resected tissue from falling off; after the tissue is resected, the elastic braided mesh 1a can assist in clamping the cut tissue from the distal side of the interatrial septum 100 and bring the tissue out of the body to avoid tissue loss caused by Embolism or damage to heart muscle tissue.

在一些实施例中，弹性编织网1a由多根合金丝线编织组成，合金丝线的材料包括镍合金，也可为其他具有记忆能力的合金材料，编制方法为本领域内的现有技术，本实施例在此不做限制。更进一步地，合金丝线的丝径范围为0.05mm-0.15mm，弹性编织网1a的孔隙密度为每英寸交叉数30-80，弹性编织网1a的网孔形状可为圆形或者多边形，既能保持良好的弹性变形性，又具有足够的固定支撑强度。具体地，伸缩件122的截面形状可为三角形、矩形、菱形、星形等规则或不规则的多边形，也可为圆形、椭圆形等具有弧形边的形状，这均是在本申请的保护范围之内，本实施例在此不做限制。In some embodiments, the elastic braided net 1a is composed of a plurality of alloy wires. The material of the alloy wires includes nickel alloy, or other alloy materials with memory capacity. The weaving method is the prior art in this field. Examples are not limited here. Furthermore, the wire diameter range of the alloy wire is 0.05mm-0.15mm, the pore density of the elastic braided net 1a is 30-80 crossings per inch, and the mesh shape of the elastic braided net 1a can be circular or polygonal, which can It maintains good elastic deformation and has sufficient fixed support strength. Specifically, the cross-sectional shape of the telescopic member 122 can be regular or irregular polygons such as triangles, rectangles, rhombuses, and stars, and can also be circular, elliptical, etc. with arc-shaped sides, which are defined in this application. Within the scope of protection, this embodiment is not limited here.

进一步地，房间隔造口装置还包括第一管体1和推拉杆3a，第一管体1可以为输送鞘管，第一管体1内部中空，推拉杆3a穿设于第一管体1内，第一延伸部11a的近端连接于第一管体1的远端，推拉杆3a穿过第一延伸部11a并连接于第二延伸部12a的远端。可以理解的是，第一延伸部11a的一端具有开口，用于连接第一管体1，推拉杆3a从第一管体1内通过第一延伸部11a的开口进入弹性编织网1a内，并连接第二延伸部12a的远端。推拉杆3a在弹性编织网1a内进行支撑，能够引导弹性编织网1a穿过房间隔100的穿刺孔。Further, the atrial septostomy device also includes a first tubular body 1 and a push-pull rod 3a, the first tubular body 1 may be a delivery sheath, the first tubular body 1 is hollow inside, and the push-pull rod 3a is passed through the first tubular body 1 Inside, the proximal end of the first extension part 11a is connected to the distal end of the first tube body 1, and the push-pull rod 3a passes through the first extension part 11a and is connected to the distal end of the second extension part 12a. It can be understood that one end of the first extension part 11a has an opening for connecting the first pipe body 1, the push-pull rod 3a enters the elastic braided net 1a from the first pipe body 1 through the opening of the first extension part 11a, and The distal end of the second extension 12a is connected. The push-pull rod 3 a is supported in the elastic braided net 1 a, and can guide the elastic braided net 1 a through the puncture hole of the interatrial septum 100 .

更进一步地，推拉杆3a能够相对于第一管体1沿轴向移动，以使第二延伸部12a在径向和/或轴向上伸缩。可以理解的是，弹性编织网1a的弹性伸缩包括径向伸缩和轴向伸缩：当推拉杆3a向左心房滑动并带动弹性编织网1a穿过房间隔100的穿刺孔时，弹性编织网1a产生径向压缩且轴向扩张，能够轻松穿过孔径较小的穿刺孔；当推拉杆3a反向滑动时，弹性编织网1a产生轴向压缩且径向扩张，被压缩的弹性编织网1a能够贴合在环形网状的固定件121上，轴向压缩后的弹性编织网1a具有更大的径向面积，能够以固定件121的环形网面为基准面，对房间隔100进行准确抵接固定，对于造口周围组织的夹持更为有效。弹性编织网a1的弹性伸缩动作由推拉杆3a控制，结构简单，不会发生松动或者固定失效，更为安全高效；通过推拉杆3a的滑动位置，能够控制弹性编织网1a的弹性变形程度，进而控制弹性编织网1a对房间隔100的抵压力，对切割动作的配合度更高。Furthermore, the push-pull rod 3a can move axially relative to the first tube body 1, so that the second extension portion 12a can expand and contract radially and/or axially. It can be understood that the elastic expansion and contraction of the elastic braided net 1a includes radial expansion and axial expansion and contraction: when the push-pull rod 3a slides to the left atrium and drives the elastic braided net 1a to pass through the puncture hole of the interatrial septum 100, the elastic braided net 1a produces Radial compression and axial expansion can easily pass through puncture holes with small apertures; when the push-pull rod 3a slides in reverse, the elastic braided net 1a produces axial compression and radial expansion, and the compressed elastic braided net 1a can stick to the Fitted on the annular mesh-shaped fixing member 121, the elastic braided mesh 1a after axial compression has a larger radial area, and can accurately abut and fix the atrial septum 100 with the annular mesh surface of the fixing member 121 as the reference plane , it is more effective for clamping the tissue around the stoma. The elastic expansion and contraction of the elastic braided net a1 is controlled by the push-pull rod 3a, which has a simple structure and will not loosen or fail to fix, making it safer and more efficient; through the sliding position of the push-pull rod 3a, the degree of elastic deformation of the elastic braided net 1a can be controlled, and then Controlling the pressing force of the elastic braided net 1a against the interatrial septum 100 has a higher degree of cooperation with the cutting action.

进一步地，环形网面的外径大于第一延伸部11a的外径，如此，可使得环形网面具有较大的接触面积，一方面能够贴合更多的房间隔100面积，对组织的夹持更为稳固，另一方面，能够避免在推拉杆3a反向滑动时弹性编织网1a脱离左心房，防止房间隔100受损或者装置损坏。Further, the outer diameter of the annular mesh surface is larger than the outer diameter of the first extension part 11a, so that the annular mesh surface can have a larger contact area, on the one hand, it can fit more interatrial septum 100 areas, and the tissue clamping On the other hand, it can prevent the elastic braided mesh 1a from leaving the left atrium when the push-pull rod 3a slides in reverse, preventing the interatrial septum 100 from being damaged or the device from being damaged.

进一步地，房间隔造口装置还包括环形的切割刀4a，环形网面的外径等于或略小于切割刀4a的内径。优选的，切割刀4a的内径与环形网面的外径之差可以不大于1mm。优选地，切割刀4a滑动连接于第一管体1外，第一管体1对准穿刺孔，切割刀4a在第一管体1上滑动，并能沿第一管体1的轴向滑动，从而从右心房侧抵接房间隔100，与第二延伸部12a分别位于房间隔100的两侧。在本实施例中，弹性编织网1a与切割刀4a同轴心设置，当固定件121的环形网面外径略小于切割刀4a的内径时，弹性编织网1a能对切割的组织进行有效固定，同时当组织切割下来之后，弹性编织网1a能将切割下来的组织拉入切割刀4a的内腔中，避免组织脱落。Further, the atrial septostomy device further includes an annular cutting knife 4a, and the outer diameter of the annular mesh surface is equal to or slightly smaller than the inner diameter of the cutting knife 4a. Preferably, the difference between the inner diameter of the cutting knife 4a and the outer diameter of the annular mesh surface may not be greater than 1mm. Preferably, the cutting knife 4a is slidably connected to the outside of the first tube body 1, the first tube body 1 is aligned with the puncture hole, the cutting knife 4a slides on the first tube body 1, and can slide along the axial direction of the first tube body 1 , so as to abut against the interatrial septum 100 from the right atrium side, and the second extension part 12a is respectively located on both sides of the interatrial septum 100 . In this embodiment, the elastic braided net 1a is coaxially arranged with the cutting knife 4a, and when the outer diameter of the annular mesh surface of the fixing member 121 is slightly smaller than the inner diameter of the cutting knife 4a, the elastic braided net 1a can effectively fix the cut tissue At the same time, when the tissue is cut, the elastic braided mesh 1a can pull the cut tissue into the inner cavity of the cutting knife 4a to prevent the tissue from falling off.

进一步地，推拉杆3a可拆卸连接于伸缩件122的远端。推拉杆3a位于弹性编织网1a内，在弹性编织网1a弹性变形过程中能提供轴向引导，避免轴向压缩时倾斜或者径向压缩时断裂；推拉杆3a连接于伸缩件122的远端，能够控制整个弹性编织网1a进行伸缩，易于引导带动整个弹性编织网1a穿过房间隔100的穿刺孔，且在手术过程中或在术后对切割的房间隔组织具有更好的固定和回收能力。Further, the push-pull rod 3 a is detachably connected to the distal end of the telescoping member 122 . The push-pull rod 3a is located in the elastic braided net 1a, and can provide axial guidance during the elastic deformation of the elastic braided net 1a, so as to avoid inclination during axial compression or fracture during radial compression; the push-pull rod 3a is connected to the distal end of the telescopic member 122, It can control the expansion and contraction of the entire elastic braided net 1a, and it is easy to guide and drive the entire elastic braided net 1a to pass through the puncture hole of the atrial septum 100, and it has better fixation and recovery capabilities for the cut atrial septal tissue during the operation or after the operation .

进一步地，房间隔造口装置还包括第一卡接组件(图中未示出)，第一卡接组件包括第一外环和套装于第一外环内的第一内环，第一内环的一端卡接推拉杆3a，伸缩件122的远端卡接于第一外环和第一内环之间。可以理解的是，第一外环和第一内环之间具有间隙，可以容纳并固定伸缩件122的远端，在一个例子中，也可将第一外环和第一内环之间进行焊接，并将第一内环与推拉杆3a之间进行焊接，增加推拉杆3a、伸缩件122的连接可靠性。Further, the atrial septostomy device also includes a first clamping assembly (not shown in the figure), the first clamping assembly includes a first outer ring and a first inner ring sleeved in the first outer ring, the first inner ring One end of the ring is engaged with the push-pull rod 3a, and the distal end of the telescopic member 122 is engaged between the first outer ring and the first inner ring. It can be understood that there is a gap between the first outer ring and the first inner ring, which can accommodate and fix the distal end of the telescopic member 122. In one example, the gap between the first outer ring and the first inner ring can also be Welding, and welding between the first inner ring and the push-pull rod 3a increases the connection reliability of the push-pull rod 3a and the telescopic member 122.

进一步地，房间隔造口装置还包括第二卡接组件(图中未示出)，第二卡接组件包括第二外环和套装于第二外环内的第二内环，第二内环的一端卡接第一管体1，第一延伸部11a的近端卡接于第二外环和第二内环之间。也即，第二卡接组件具有和第一卡接组件相同的结构，结构简单，易于实现第一管体1与弹性编织网1a之间的拆装，且固定可靠。Further, the atrial septostomy device also includes a second clamping assembly (not shown in the figure), the second clamping assembly includes a second outer ring and a second inner ring sleeved in the second outer ring, the second inner ring One end of the ring is engaged with the first tube body 1 , and the proximal end of the first extension part 11a is engaged between the second outer ring and the second inner ring. That is to say, the second clamping assembly has the same structure as the first clamping assembly, which is simple in structure, easy to realize disassembly and assembly between the first pipe body 1 and the elastic braided net 1a, and is reliable in fixing.

进一步地，环形网面与推拉杆3a轴向的夹角优选为80°-100°。在该角度范围内，第二延伸部12a既能够较为轻松地穿过房间隔的穿刺孔，且不易从穿刺孔内脱落滑入右心房一侧。具体地，例如环形网面与推拉杆3a轴向的夹角可以为80°、85°、87°、90°、91°、95°、 100°等。在其它实施例中，环形网面与推拉杆3a轴向的夹角也可以选用其它角度，不以本实施例为限。Further, the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a is preferably 80°-100°. Within this angle range, the second extension part 12a can easily pass through the puncture hole of the interatrial septum, and is not easy to fall off from the puncture hole and slide into the right atrium side. Specifically, for example, the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a may be 80°, 85°, 87°, 90°, 91°, 95°, 100° and so on. In other embodiments, the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a can also be selected from other angles, which is not limited to this embodiment.

进一步地，伸缩件122包括伸缩过渡段1221，伸缩过渡段1221的两端分别为大径端和小径端，大径端连接环形网面。通过过渡段1221，将伸缩件122分为两部分，直径较小的小径端位于伸缩件122的远端，易于通过第一卡接组件连接推拉杆3a，能够较好地引导弹性编织网1a穿过房间隔100的穿刺孔；直径较大的大径端能够在径向扩张时对房间隔100有更大的覆盖面积，固定夹持效果更好。在大径端和小径端之间，伸缩过渡段1221的截面形状可为圆形、椭圆形、多边形等多种形状，本实施例在此不做限制。Further, the telescopic member 122 includes a telescopic transition section 1221, the two ends of the telescopic transition section 1221 are respectively a large-diameter end and a small-diameter end, and the large-diameter end is connected to the annular mesh surface. Through the transition section 1221, the telescopic member 122 is divided into two parts, and the small-diameter end with a smaller diameter is located at the far end of the telescopic member 122. It is easy to connect the push-pull rod 3a through the first clamping assembly, and can better guide the elastic braided net 1a to wear. Through the puncture hole of the interatrial septum 100; the large diameter end with a larger diameter can have a larger coverage area on the atrial septum 100 during radial expansion, and the fixing and clamping effect is better. Between the large-diameter end and the small-diameter end, the cross-sectional shape of the telescopic transition section 1221 can be various shapes such as a circle, an ellipse, and a polygon, which are not limited in this embodiment.

申请人还注意到，在房间隔造口术过程中，医生需要借助手术切割刀在心脏上形成分流口，待分流口形成后，还需要借助其他器具往分流口处输送药物。现有技术中一般是在气囊导管上涂抗增生或免疫抑制药物后然后输送到分流口处，使分流口附近的组织吸收药物，从而保持分流口的长期畅通。不过，由于造口和上药使用不同的设备进行操作，导致了手术操作过程较为繁杂，且步骤较多，手术时间较长。The applicant also noticed that during the atrial septostomy, the doctor needs to form a shunt opening on the heart with the help of a surgical knife, and after the shunt opening is formed, it is necessary to use other instruments to deliver medicine to the shunt opening. In the prior art, anti-proliferative or immunosuppressive drugs are generally coated on the balloon catheter and then delivered to the shunt port, so that the tissues near the shunt port can absorb the drug, thereby maintaining the long-term unblocked flow of the shunt port. However, since the stoma and medicine are operated with different equipment, the operation process is more complicated, and there are many steps, and the operation time is longer.

基于此，本申请实施例还提供房间隔造口装置，该房间隔造口装置能够执行切割操作和上药操作，简化了手术操作步骤，缩短了手术时间，提高了手术效果。可以理解，以下实施例的房间隔造口装置可以是基于上述任一实施例的进一步改进，也可以是对现有房间隔造口装置的进一步改进，均是在本申请的保护范围之内。Based on this, the embodiment of the present application also provides an atrial septostomy device, the atrial septostomy device can perform cutting operations and drug application operations, which simplifies the operation steps, shortens the operation time, and improves the operation effect. It can be understood that the atrial septostomy device in the following embodiments may be a further improvement based on any of the above embodiments, or may be a further improvement on an existing atrial septostomy device, all of which are within the protection scope of the present application.

本申请部分实施例还提供了一种房间隔造口装置，该房间隔造口装置用于在房间隔造口术中进行造口操作和上药操作。当然除了用于房间隔造口术以外，根据需求该房间隔造口装置还可以用于其他手术中，具体的使用场景不做限制，只要是同时需要进行切割操作和上药操作的手术，本实施例所提供的房间隔造口装置均适用。Some embodiments of the present application also provide an atrial septostomy device, and the atrial septostomy device is used for stoma operation and drug application operation in atrial septostomy. Of course, in addition to being used for atrial septostomy, the atrial septostomy device can also be used in other operations according to the needs. All the atrial septostomy devices provided in the embodiments are applicable.

如图15所示，该房间隔造口装置的切割刀可包括切割刀体10和载药结构。其中，切割刀体10为柱状结构，沿轴线方向切割刀体10上设置有通孔110，切割刀体10的一端为切割端，切割端上设置有用于造口的切割刀刃120，切割刀体10的另一端为连接端，通过连接端切割刀体10可以与输送工具连接，医生通过输送工具能够将切割刀体10输送至目标位置从而进行造口操作和上药操作。载药结构设置在切割刀体10的外壁上，从而保证在房间隔造口装置完成造口操作后可以顺次进行上药操作。载药结构用于承载药物，当切割刀刃120完成造口操作后，房间隔造口装置继续移动直至载药结构移动至切口处，药物在切口处释放从而发挥作用。As shown in FIG. 15 , the cutting knife of the atrial septostomy device may include a cutting knife body 10 and a drug-loaded structure. Wherein, the cutting knife body 10 is a columnar structure, and a through hole 110 is arranged on the cutting knife body 10 along the axial direction. The other end of 10 is a connection end, through which the cutting knife body 10 can be connected with the delivery tool, and the doctor can transport the cutting knife body 10 to the target position through the delivery tool to perform stoma operation and medicine application. The drug-loading structure is arranged on the outer wall of the cutting knife body 10, so as to ensure that the drug feeding operation can be performed sequentially after the stoma operation of the atrial septostomy device is completed. The drug-loaded structure is used to carry drugs. After the cutting blade 120 completes the stoma operation, the atrial septostomy device continues to move until the drug-loaded structure moves to the incision, and the drug is released at the incision to play a role.

相较于利用两个完全独立的工具分别去执行造口操作和上药操作造成的手术过程繁琐以及手术效率低下的问题，本实施例通过将载药结构直接设置在房间隔造口装置的切割刀体10上，从而使切割刀刃120完成造口操作后可以顺次进行上药操作(如图17和图18所示)，由于在造口操作和上药操作之间不需要更换工具，因此能够简化手术步骤，缩短手术时长，提高手术效率，手术效率的提高利于患者术后恢复。Compared with the cumbersome operation process and low operation efficiency caused by using two completely independent tools to perform the stoma operation and the drug application operation respectively, this embodiment directly arranges the drug-loaded structure on the incision of the atrial septostomy device. on the knife body 10, so that the cutting blade 120 can perform the medicine application operation in sequence after the stoma operation is completed (as shown in Figure 17 and Figure 18), since there is no need to change the tool between the stoma operation and the medicine application operation, so It can simplify the operation steps, shorten the operation time, improve the operation efficiency, and the improvement of the operation efficiency is beneficial to the postoperative recovery of patients.

需要注意的是，在本实施例中，载药结构承载的药物包括抗增生药物或者免疫抑制药物，对切口进行上药操作能够减缓切口愈合的速度，从而保持形成的分流口的长期畅通。当然在其他实施例中，如果该房间隔造口装置用于进行其他手术，那么根据需求载药结构内承载的药物也可以进行更换，并不局限于抗增生药物和免疫抑制药物。It should be noted that in this embodiment, the drugs carried by the drug-loaded structure include anti-proliferative drugs or immunosuppressive drugs, and the operation of applying drugs to the incision can slow down the speed of incision healing, so as to keep the formed shunt open for a long time. Of course, in other embodiments, if the atrial septostomy device is used for other operations, the drugs carried in the drug-loading structure can also be replaced according to requirements, not limited to anti-proliferative drugs and immunosuppressive drugs.

继续参照图15所示，在本实施例中，切割刀体10包括呈阶梯状连接的第一部130和第二部140。第一部130和第二部140均呈圆柱状，第一部130的外径大于第二部140的外径，第一部130远离第二部140的一端为切割端，第二部140远离第一部130的一端为连接端。且通过将切割刀体10设置为阶梯柱状，使输送工具能够套设在第二部140上，并定位抵在阶梯面上，从而能够提高该房间隔造口装置与输送工具的连接稳定性。Continuing to refer to FIG. 15 , in this embodiment, the cutter body 10 includes a first portion 130 and a second portion 140 connected in a stepped shape. Both the first part 130 and the second part 140 are cylindrical, the outer diameter of the first part 130 is larger than the outer diameter of the second part 140, the end of the first part 130 away from the second part 140 is a cutting end, and the second part 140 is away from One end of the first part 130 is a connection end. Moreover, by setting the cutter body 10 in a stepped column shape, the delivery tool can be sleeved on the second part 140 and positioned against the stepped surface, thereby improving the connection stability between the atrial septostomy device and the delivery tool.

进一步地，设置在切割刀体10内的通孔110呈阶梯状连接的第一孔111和第二孔112，其中，第一孔111位于第一部130内部，第二孔112的至少部分位于第二部140内，第一孔111 的内径大于第二孔112的内径。在本实施例中，第一孔111的长度小于切割刀体10的第一部130的长度，第二孔112的长度大于切割刀体10的第二部140的长度，如此设置可将分别形成在切割刀体10内外两侧的内台阶面和外台阶面错位设置，从而不仅使切割刀体10的厚度均匀，且保证了第一部130和第二部140的连接处结构强度较大，避免了房间隔造口装置在操作时变形或者断裂。Further, the through hole 110 provided in the cutter body 10 is a first hole 111 and a second hole 112 connected in a step shape, wherein the first hole 111 is located inside the first part 130, and at least part of the second hole 112 is located In the second part 140 , the inner diameter of the first hole 111 is larger than the inner diameter of the second hole 112 . In this embodiment, the length of the first hole 111 is shorter than the length of the first portion 130 of the cutting body 10, and the length of the second hole 112 is greater than the length of the second portion 140 of the cutting body 10, so that the length of the first hole 111 can be formed respectively The inner and outer stepped surfaces of the inner and outer sides of the cutter body 10 are misaligned, so that not only the thickness of the cutter body 10 is uniform, but also the structural strength of the joint between the first part 130 and the second part 140 is ensured. The deformation or breakage of the atrial septostomy device during operation is avoided.

在一些实施例中，沿切割方向，第一部130的至少部分的厚度逐渐减小从而在切割端形成切割刀刃120，切割刀刃120为宽度极小的圆环面，当医生将切割端对准待切割组织300并施力时，切割刀刃120能够快速地在待切割组织300上形成一个孔状结构，如此即完成了造口操作并形成一个分流口。In some embodiments, along the cutting direction, the thickness of at least part of the first portion 130 gradually decreases to form a cutting edge 120 at the cutting end. The cutting edge 120 is a torus with a very small width. When the tissue to be cut 300 is applied and a force is applied, the cutting edge 120 can quickly form a hole-like structure on the tissue to be cut 300, thus completing the stoma operation and forming a shunt.

为了形成切割刀刃120，继续参照图17和图18所示，通孔110还包括第三孔113，第三孔113设置在第一部130内，且第三孔113和第二孔112位于第一孔111的两侧，在本实施例中，第三孔113为锥状孔，第三孔113的小尺寸端与第一孔111连接。当然在其他实施例中，切割刀刃120也可以根据需求设置为其他形状，并不局限于本实施例中的圆环面。In order to form the cutting edge 120, continue to refer to shown in Figure 17 and Figure 18, the through hole 110 also includes a third hole 113, the third hole 113 is arranged in the first part 130, and the third hole 113 and the second hole 112 are located in the second hole 113 On both sides of the first hole 111 , in this embodiment, the third hole 113 is a tapered hole, and the small-sized end of the third hole 113 is connected with the first hole 111 . Of course, in other embodiments, the cutting blade 120 can also be set in other shapes according to requirements, and is not limited to the torus in this embodiment.

在一些实施例中，载药结构为开设在切割刀体10外壁面上的载药槽200，具体地，载药槽200开设在第一部130对应的外壁面上，载药槽200内用于承载药品。通过在切割刀体10上直接开槽形成载药结构，不仅加工方式简单，不会导致房间隔造口装置的结构复杂化，且由于载药槽200在切割刀体10上的位置固定，不会发生移动，因此将载药结构设置为载药槽200利于提高其内药品的稳定性。In some embodiments, the drug-loading structure is a drug-loading groove 200 provided on the outer wall of the cutting blade body 10, specifically, the drug-loading groove 200 is provided on the corresponding outer wall of the first part 130, and the drug-loading groove 200 is used for for carrying medicines. The drug-loading structure is formed by directly slotting on the cutter body 10, not only the processing method is simple, the structure of the atrial septostomy device will not be complicated, and because the position of the drug-loading groove 200 on the cutter body 10 is fixed, no Movement will occur, so setting the drug-loading structure as the drug-loading groove 200 is beneficial to improve the stability of the drug inside.

在一些实施例中，继续参照图15所示，载药槽200为沿切割刀体10的周向设置的环形槽。环形槽的载药容量大，制造方式简单。In some embodiments, as shown in FIG. 15 , the drug-loading groove 200 is an annular groove arranged along the circumference of the cutting blade body 10 . The drug-carrying capacity of the annular groove is large, and the manufacturing method is simple.

进一步地，由于在切口处需要使用的药品的种类可能为多种，可以根据需求在切割刀体10的外壁面上沿切割方向设置多个载药槽200，每个载药槽200均为环形槽。多个载药槽200内承载的药物可以相同，也可以不同。每个载药槽200的载药深度可以相同，也可以不同。每个载药槽200的容量可以相同，也可以不同。在本实施例中，根据需要承载的药品种类选择在载药槽200的数量，每一个载药槽200用于承载一种药品，每个载药槽200均为环形槽，每个环形槽的宽度相同、载药深度不同，从而使每个载药槽200的容量也不同，载药槽200的容量跟其内药品的用量相匹配。Further, since there may be many kinds of medicines to be used at the incision, a plurality of drug-loading grooves 200 can be arranged on the outer wall surface of the cutter body 10 along the cutting direction according to requirements, and each drug-loading groove 200 is annular. groove. The medicines carried in the multiple medicine-loading grooves 200 can be the same or different. The drug loading depth of each drug loading groove 200 can be the same or different. The capacity of each drug-loading tank 200 can be the same or different. In this embodiment, the number of drug-loading grooves 200 is selected according to the type of medicine to be carried. Each drug-loading groove 200 is used to carry a kind of medicine. Each drug-loading groove 200 is an annular groove. The width is the same, but the drug-loading depth is different, so that the capacity of each drug-loading groove 200 is also different, and the capacity of the drug-loading groove 200 matches the amount of medicine in it.

进一步地，载药槽200包括三个内壁面，三个内壁面分别为两个相对设置的侧壁面和一个槽底面，为了避免载药槽200内的药品掉落至非切口位置，载药槽200的内壁面设置有吸附结构，吸附结构用于吸附药物，从而达到避免药物从载药槽200内掉落的目的。吸附结构可以为实体结构，例如涂覆或者设置在内壁面上的吸附膜，当然，除了实体结构外，吸附结构也可以为吸附粗糙面，吸附粗糙面为通过增大内壁面的表面粗糙度形成具有吸附作用的粗糙表面。或者，也可以将药物与聚合物进行混合然后喷涂到载药槽内，通过聚合物能够增大药物的粘性，从而使药物能够稳定地置于载药槽200内，达到避免药物从载药槽200内掉落的目的。Further, the drug-loading tank 200 includes three inner wall surfaces, which are respectively two opposite side wall surfaces and a tank bottom surface. In order to prevent the medicine in the drug-loading tank 200 from falling to a non-cut position, The inner wall of the 200 is provided with an adsorption structure, and the adsorption structure is used for absorbing drugs, thereby achieving the purpose of preventing the drugs from falling from the drug-loading tank 200 . The adsorption structure can be a solid structure, such as an adsorption film coated or arranged on the inner wall surface. Of course, in addition to the solid structure, the adsorption structure can also be an adsorption rough surface. The adsorption rough surface is formed by increasing the surface roughness of the inner wall surface. Rough surface with adsorption. Alternatively, the drug can be mixed with the polymer and then sprayed into the drug-loading tank, the polymer can increase the viscosity of the drug, so that the drug can be stably placed in the drug-loading tank 200, so as to prevent the drug from being released from the drug-loading tank. Objects that drop within 200.

载药槽200内各处的深度可以相同，也可以不同，在本实施例中，通过将槽底面设置为倾斜面，从而使载药槽200内的各处的深度不同，以便于载药槽200内的药品能够尽可能多的附着在切口处。具体地，在本实施例中，沿切割方向，槽底面朝背离轴线方向的方向倾斜，从而使载药槽200的载药深度逐渐减小，在涂药过程中，切口处进入载药内的组织300能够在与药品接触的过程将药品向后上方推动，从而使尽可能多的药品粘粘在切口处的组织300上。The depth of each place in the drug-loading groove 200 can be the same or different. In this embodiment, the depth of each place in the drug-loading groove 200 is different by setting the bottom surface of the groove as an inclined surface, so that the drug-loading groove can Medicines within 200 can be attached to the incision as much as possible. Specifically, in this embodiment, along the cutting direction, the bottom surface of the groove is inclined in a direction away from the axial direction, so that the drug-loading depth of the drug-loading groove 200 gradually decreases. The tissue 300 can push the medicine backward and upward during the process of being in contact with the medicine, so that as much medicine as possible can stick to the tissue 300 at the incision.

本申请部分实施例还提供了一种房间隔造口装置，该房间隔造口装置用于在房间隔造口术中进行造口操作和上药操作。当然除了用于房间隔造口术以外，根据需求该房间隔造口装置还可以用于其他手术中，具体的使用场景不做限制，只要是需要进行切割操作和上药操作的手术，本实施例所提供的房间隔造口装置均适用。Some embodiments of the present application also provide an atrial septostomy device, and the atrial septostomy device is used for stoma operation and drug application operation in atrial septostomy. Of course, in addition to being used for atrial septostomy, the atrial septostomy device can also be used in other operations according to requirements. The atrial septostomy devices provided in the example are applicable.

具体地，如图16所示，该房间隔造口装置包括切割刀体10和载药结构。其中，切割刀体 10为柱状结构，沿轴线方向切割刀体10上设置有通孔110，切割刀体10的一端为切割端，切割端上设置有用于造口的切割刀刃120，切割刀体10的另一端为连接端，通过连接端切割刀体10可以与输送工具连接，医生通过输送工具能够将房间隔造口装置输送至目标位置从而进行造口作业和上药作业。载药结构设置在切割刀体10的外壁面上，并且沿切割方向载药结构设置在切割刀刃120的后方，从而保证在房间隔造口装置完成造口操作后可以顺次进行上药操作。载药结构用于承载药物，当切割刀刃120完成造口作业后，房间隔造口装置继续移动直至载药结构移动至切口处，药物在切口处释放从而发挥作用。Specifically, as shown in FIG. 16 , the atrial septostomy device includes a cutter body 10 and a drug-loaded structure. Wherein, the cutting knife body 10 is a columnar structure, and a through hole 110 is arranged on the cutting knife body 10 along the axial direction. The other end of 10 is the connection end, through which the cutting knife body 10 can be connected with the delivery tool, and the doctor can transport the atrial septostomy device to the target position through the delivery tool to perform stoma operation and medicine application. The drug-loading structure is arranged on the outer wall of the cutter body 10, and the drug-loading structure is arranged behind the cutting edge 120 along the cutting direction, so as to ensure that the drug feeding operation can be performed sequentially after the stoma operation of the atrial septostomy device is completed. The drug-loaded structure is used to carry drugs. After the cutting blade 120 completes the stoma operation, the atrial septostomy device continues to move until the drug-loaded structure moves to the incision, and the drug is released at the incision to play a role.

相较于利用两个完全独立的工具分别去执行造口作业和上药作业造成的手术过程繁琐以及手术效率低下的问题，本实施例通过将载药结构直接设置在房间隔造口装置的切割刀体10上，从而使房间隔造口装置完成造口操作后可以顺次进行上药操作(如图17和图18所示)，由于在造口操作和上药操作之间不需要更换工具，因此能够简化手术步骤，缩短手术时长，提高手术效率，手术效率的提高利于患者术后恢复。Compared with the cumbersome operation process and low operation efficiency caused by using two completely independent tools to perform stoma operation and drug application operation respectively, this embodiment directly arranges the drug-loading structure on the cutting part of the atrial septostomy device. on the knife body 10, so that the atrial septostomy device can perform the medicine application operation in sequence after the stoma operation (as shown in Figure 17 and Figure 18), because there is no need to change the tool between the stoma operation and the medicine application operation , so the operation steps can be simplified, the operation time can be shortened, and the operation efficiency can be improved. The improvement of operation efficiency is beneficial to the postoperative recovery of patients.

需要注意的是，在本实施例中，载药结构承载的药物包括抗增生药物或者免疫抑制药物，对切口进行上药作业能够减缓切口愈合的速度，从而保持形成的分流口的长期畅通。当然在其他实施例中，如果该房间隔造口装置用于进行其他手术，那么根据需求载药结构内承载的药物也可以进行更换，并不局限于抗增生药物和免疫抑制药物。It should be noted that in this embodiment, the drugs carried by the drug-loading structure include anti-proliferative drugs or immunosuppressive drugs, and applying drugs to the incision can slow down the speed of incision healing, so as to keep the formed shunt open for a long time. Of course, in other embodiments, if the atrial septostomy device is used for other operations, the drugs carried in the drug-loading structure can also be replaced according to requirements, not limited to anti-proliferative drugs and immunosuppressive drugs.

具体地，继续参照图16所示，在本实施例中，切割刀体10包括呈阶梯状连接的第一部130和第二部140。第一部130和第二部140均呈圆柱状，第一部130的直径大于第二部140的直径，第一部130远离第二部140的一端为切割端，第二部140远离第一部130的一端为连接端，载药结构设置于第一部130的外壁。且通过将切割刀体10设置为阶梯柱状，使输送工具能够套设在第二部140上，并定位抵在阶梯面上，从而能够提高该房间隔造口装置与输送工具的连接稳定性。Specifically, referring to FIG. 16 , in this embodiment, the cutter body 10 includes a first portion 130 and a second portion 140 connected in a stepped shape. Both the first part 130 and the second part 140 are cylindrical, the diameter of the first part 130 is greater than the diameter of the second part 140, the end of the first part 130 away from the second part 140 is a cutting end, and the second part 140 is far away from the first part. One end of the part 130 is a connection end, and the drug-loading structure is arranged on the outer wall of the first part 130 . Moreover, by setting the cutter body 10 in a stepped column shape, the delivery tool can be sleeved on the second part 140 and positioned against the stepped surface, thereby improving the connection stability between the atrial septostomy device and the delivery tool.

进一步地，设置在切割刀体10内的通孔110呈阶梯状连接的第一孔111和第二孔112，其中，第一孔111位于第一部130内部，第二孔112的至少部分位于第二部140内，第一孔111的内径大于第二孔112的内径。在本实施例中，第一孔111的长度小于切割刀体10的第一部130的长度，第二孔112的长度大于切割刀体10的第二部140的长度，如此设置可将分别形成在切割刀体10内外两侧的内台阶面和外台阶面错位设置，从而不仅使切割刀体10的厚度均匀，且保证了第一部130和第二部140的连接处结构强度较大，避免了房间隔造口装置在作业时变形或者断裂。Further, the through hole 110 provided in the cutter body 10 is a first hole 111 and a second hole 112 connected in a step shape, wherein the first hole 111 is located inside the first part 130, and at least part of the second hole 112 is located In the second portion 140 , the inner diameter of the first hole 111 is larger than the inner diameter of the second hole 112 . In this embodiment, the length of the first hole 111 is shorter than the length of the first portion 130 of the cutting body 10, and the length of the second hole 112 is greater than the length of the second portion 140 of the cutting body 10, so that the length of the first hole 111 can be formed respectively The inner and outer stepped surfaces of the inner and outer sides of the cutter body 10 are misaligned, so that not only the thickness of the cutter body 10 is uniform, but also the structural strength of the joint between the first part 130 and the second part 140 is ensured. The deformation or breakage of the atrial septostomy device during operation is avoided.

在一些实施例中，沿切割方向，第一部130的至少部分的厚度逐渐减小从而在切割端形成切割刀刃120，切割刀刃120为宽度极小的圆环面，当医生将切割端对准待切割组织300并施力时，切割刀刃120能够快速地在人体组织300上形成一个孔状结构，如此即完成了造口作业并形成一个分流口。In some embodiments, along the cutting direction, the thickness of at least part of the first portion 130 gradually decreases to form a cutting edge 120 at the cutting end. The cutting edge 120 is a torus with a very small width. When the tissue 300 is to be cut and force is applied, the cutting blade 120 can quickly form a hole-like structure on the human tissue 300, thus completing the stoma operation and forming a shunt opening.

为了形成切割刀刃120，继续参照图17和图18所示，通孔110还包括第三孔113，第三孔113设置在第一部130内，且第三孔113和第二孔112位于第一孔111的两侧，在本实施例中，第三孔113为锥状孔，第三孔113的小尺寸端与第一孔111连接。当然在其他实施例中，切割刀刃120也可以根据需求设置为其他形状，并不局限于本实施例中的圆环面。In order to form the cutting edge 120, continue to refer to shown in Figure 17 and Figure 18, the through hole 110 also includes a third hole 113, the third hole 113 is arranged in the first part 130, and the third hole 113 and the second hole 112 are located in the second hole 113 On both sides of the first hole 111 , in this embodiment, the third hole 113 is a tapered hole, and the small-sized end of the third hole 113 is connected with the first hole 111 . Of course, in other embodiments, the cutting blade 120 can also be set in other shapes according to requirements, and is not limited to the torus in this embodiment.

在一些实施例中，载药结构为开设在切割刀体10外壁面上的载药槽200，具体地，载药槽200开设在第一部130对应的外壁面上，载药槽200内用于承载药品。通过在切割刀体10上直接开槽形成载药结构，不仅加工方式简单，不会导致房间隔造口装置的结构复杂化，且由于载药槽200在切割刀体10上的位置固定，不会发生移动，因此将载药结构设置为载药槽200利于提高其内药品的稳定性。In some embodiments, the drug-loading structure is a drug-loading groove 200 provided on the outer wall of the cutting blade body 10, specifically, the drug-loading groove 200 is provided on the corresponding outer wall of the first part 130, and the drug-loading groove 200 is used for for carrying medicines. The drug-loading structure is formed by directly slotting on the cutter body 10, not only the processing method is simple, the structure of the atrial septostomy device will not be complicated, and because the position of the drug-loading groove 200 on the cutter body 10 is fixed, no Movement will occur, so setting the drug-loading structure as the drug-loading groove 200 is beneficial to improve the stability of the drug inside.

在一些实施例中，继续参照图16所示，载药槽200包括多个载药子槽210，多个载药子槽210沿切割刀体10的周向间隔设置。载药槽200具体可以为方形槽、圆形槽、腰形槽等规则槽， 也可以为花朵型、波纹型等异型槽。多个载药子槽210的设置能够保证切割刀体10的结构强度，避免连续开槽造成开槽处切割刀体10结构强度的急剧下降，从而避免切割刀体10断裂现象的出现。In some embodiments, as shown in FIG. 16 , the drug-loaded groove 200 includes a plurality of drug-loaded sub-grooves 210 , and the drug-loaded sub-grooves 210 are arranged at intervals along the circumference of the cutting blade body 10 . Specifically, the drug-loading groove 200 may be a regular groove such as a square groove, a circular groove, or a waist-shaped groove, or may be a special-shaped groove such as a flower shape or a corrugated shape. The arrangement of multiple drug-loaded sub-grooves 210 can ensure the structural strength of the cutting blade body 10, and avoid the sharp decline in the structural strength of the cutting blade body 10 caused by continuous slotting, thereby avoiding the occurrence of breakage of the cutting blade body 10.

进一步地，由于在切口处需要使用的药品的种类可能为多种，根据需求在切割刀体10的外壁面上沿切割方向可以设置多个载药槽200，每一个载药槽200均包括多个载药子槽210，沿平行于轴线方向的方向，相邻两个载药子槽210可以错位设置，也可以共线设置。不同载药子槽210内承载的药物可以相同，也可以不同。每个载药子槽210的载药深度可以相同，也可以不同。每个载药子槽210的容量可以相同，也可以不同。在本实施例中，根据需要承载的药品种类选择载药槽200的数量，每一个载药槽200包括的多个载药子槽210用于承载同一种药品。Further, since there may be various types of medicines to be used at the incision, a plurality of drug-loaded grooves 200 may be arranged on the outer wall surface of the cutter body 10 along the cutting direction according to requirements, and each drug-loaded groove 200 includes multiple drug-loaded grooves. For each drug-carrying sub-groove 210, along the direction parallel to the axial direction, two adjacent drug-carrying sub-grooves 210 can be arranged in dislocation, or can be arranged in line. The drugs loaded in different drug-loaded sub-tanks 210 may be the same or different. The drug-loading depth of each drug-loading sub-groove 210 may be the same or different. The capacity of each drug-carrying sub-tank 210 can be the same or different. In this embodiment, the number of drug-loading tanks 200 is selected according to the type of drug to be loaded, and each drug-loading tank 200 includes a plurality of drug-loading sub-channels 210 for loading the same drug.

进一步地，载药子槽210包括三个内壁面，三个内壁面分别为两个相对设置的侧壁面和一个槽底面，为了避免载药子槽210内的药品掉落至非切口位置，载药子槽210的内壁面设置有吸附结构，吸附结构用于吸附药物，从而达到避免药物从载药子槽210内掉落的目的。可选地，吸附结构可以为实体结构，例如涂覆或者设置在内壁面上的吸附膜，当然，除了实体结构外，吸附结构也可以为吸附粗糙面，吸附粗糙面为通过增大内壁面的表面粗糙度形成的具有吸附作用的粗糙表面。或者，也可以将药物与聚合物进行混合然后喷涂到载药槽内，通过聚合物能够增大药物的粘性，从而使药物能够稳定地置于载药子槽210内，达到避免药物从载药子槽210内掉落的目的。Further, the drug-carrying sub-groove 210 includes three inner wall surfaces, the three inner wall surfaces are respectively two opposite side wall surfaces and a groove bottom surface. The inner wall of the drug sub-tank 210 is provided with an adsorption structure, and the adsorption structure is used for adsorbing the drug, so as to prevent the drug from falling from the drug-carrying sub-tank 210 . Optionally, the adsorption structure can be a solid structure, such as an adsorption film coated or arranged on the inner wall surface. Of course, in addition to the solid structure, the adsorption structure can also be an adsorption rough surface. The adsorption rough surface is obtained by increasing the thickness of the inner wall surface Surface roughness forms a rough surface with adsorption. Alternatively, the drug can be mixed with the polymer and then sprayed into the drug-loaded tank, the polymer can increase the viscosity of the drug, so that the drug can be stably placed in the drug-loaded sub-groove 210 to prevent the drug from The purpose of dropping in the sub-slot 210.

载药子槽210内各处的深度可以相同，也可以不同，在本实施例中，通过将槽底面设置为倾斜面，从而使载药子槽210内的各处的深度不同，以便于载药子槽210内的药品能够尽可能多的附着在切口处。具体地，在本实施例中，沿切割方向，槽底面朝背离轴线方向的方向倾斜，从而使载药子槽210的载药深度逐渐减小，在涂药过程中，切口处进入载药内的组织300能够在与药品接触的过程将药品向后上方推动，从而使尽可能多的药品粘粘在切口处的组织300上。The depth of each place in the drug-loading sub-groove 210 can be the same or different. In this embodiment, the depth of each place in the drug-loading sub-groove 210 is different by setting the bottom surface of the groove as an inclined surface, so as to facilitate loading. The medicine in the medicine sub-groove 210 can be attached to the incision as much as possible. Specifically, in this embodiment, along the cutting direction, the bottom surface of the groove is inclined in a direction away from the axial direction, so that the drug-loading depth of the drug-carrying sub-groove 210 gradually decreases. The tissue 300 can push the medicine backward and upward during the process of contacting with the medicine, so that as much medicine as possible can stick to the tissue 300 at the incision.

基于此，本申请的上述实施例提供了一种房间隔造口装置，该房间隔造口装置包括切割刀体和载药结构，切割刀体沿轴线方向设置有贯穿的通孔，切割刀体的一端为切割端，另一端为连接端，载药结构设置在切割刀体的外壁上，载药结构用于承载药物。该房间隔造口装置上设置有载药结构，不仅能够执行切割操作，且能够在切割操作后进行上药操作，上药操作不必更换工具，在极大程度上简化了手术步骤，提高了手术效率，缩短了手术时间，利于患者恢复。Based on this, the above embodiments of the present application provide an atrial septostomy device, the atrial septostomy device includes a cutting knife body and a drug-loading structure, the cutting knife body is provided with a through hole along the axial direction, the cutting knife body One end of the blade is a cutting end, and the other end is a connecting end. The drug-loading structure is arranged on the outer wall of the cutting knife body, and the drug-loading structure is used for carrying drugs. The atrial septostomy device is provided with a drug-loading structure, which can not only perform the cutting operation, but also perform the drug application operation after the cutting operation. The drug application operation does not need to change tools, which greatly simplifies the operation steps and improves the operation efficiency. Efficiency shortens the operation time and facilitates the recovery of patients.

可以理解，本申请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。It can be understood that the various technical features of the embodiments of the present application can be combined arbitrarily. For the sake of concise description, all possible combinations of the various technical features in the above embodiments are not described. However, as long as there is no combination of these technical features Any contradiction should be regarded as within the scope of the description in this specification.

注意，上述仅为本申请的较佳实施例及所运用技术原理。本领域技术人员会理解，本申请不限于这里所述的特定实施例，对本领域技术人员来说能够进行各种明显的变化、重新调整和替代而不会脱离本申请的保护范围。因此，虽然通过以上实施例对本申请进行了较为详细的说明，但是本申请不仅仅限于以上实施例，在不脱离本发明构思的情况下，还可以包括更多其他等效实施例，而本申请的范围由所附的权利要求范围决定。Note that the above are only preferred embodiments and technical principles used in this application. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the protection scope of the present application. Therefore, although the present application has been described in detail through the above embodiments, the present application is not limited to the above embodiments, and can also include more other equivalent embodiments without departing from the concept of the present invention, and the present application The scope is determined by the scope of the appended claims.

Claims (20)

1. 一种房间隔造口装置，包括：An atrial septostomy device comprising:

   第一管体；first body;

   第二管体，其远端连接有切割刀，所述切割刀设置有与所述第二管体的管腔连通的空腔，所述第一管体滑动穿设于所述第二管体和所述切割刀内；其中：The second tubular body has a cutting knife connected to its distal end, the cutting knife is provided with a cavity communicating with the lumen of the second tubular body, and the first tubular body slides through the second tubular body and within said cutting knife; wherein:

   辅助组件，其包括推拉杆和切割辅助件，所述推拉杆滑动穿设于所述第一管体内，所述切割辅助件的近端连接所述第一管体的远端，所述切割辅助件的远端连接所述推拉杆的远端，所述推拉杆能够相对所述第一管体滑动，以使所述切割辅助件在展开状态和拉伸状态之间切换；The auxiliary assembly includes a push-pull rod and a cutting aid, the push-pull rod slides through the first tube body, the proximal end of the cutting aid is connected to the distal end of the first tube body, and the cutting aid The distal end of the member is connected to the distal end of the push-pull rod, and the push-pull rod can slide relative to the first tubular body, so that the cutting aid can be switched between a deployed state and a stretched state;

   所述切割辅助件处于所述拉伸状态时，能够被收容于所述空腔内；所述切割辅助件处于所述展开状态时，具有朝向所述切割刀的网状面，所述网状面用于收集所述切割刀切除的房间隔组织并将其拉入所述空腔内。When the cutting aid is in the stretched state, it can be accommodated in the cavity; when the cutting aid is in the unfolded state, it has a mesh surface facing the cutting knife, and the mesh The surface is used to collect the atrial septal tissue resected by the cutting knife and pull it into the cavity.
2. 根据权利要求1所述的房间隔造口装置，其中，所述空腔内设置有限位台，所述切割辅助件能够抵接于所述限位台。The atrial septostomy device according to claim 1, wherein a limiting platform is arranged in the cavity, and the cutting aid can abut against the limiting platform.
3. 根据权利要求1所述的房间隔造口装置，还包括：The atrial septostomy device according to claim 1, further comprising:

   第一驱动组件，所述第一驱动组件能够驱动所述第二管体沿轴向移动；a first drive assembly capable of driving the second tubular body to move axially;

   第二驱动组件，所述第二驱动组件包括第二壳体，所述第二壳体滑动连接于所述第一驱动组件，所述第一管体穿设于所述第一驱动组件并固定连接于所述第二壳体的内部；The second drive assembly, the second drive assembly includes a second housing, the second housing is slidably connected to the first drive assembly, the first tube passes through the first drive assembly and is fixed connected to the inside of the second casing;

   第三驱动组件，所述第三驱动组件包括第二驱动件，所述第二驱动件连接于所述第二壳体的近端，所述第二壳体的近端开设有第二穿孔，所述推拉杆的近端穿过所述第二穿孔连接于所述第二驱动件，所述第二驱动件能够驱动所述推拉杆沿轴向移动。The third driving assembly, the third driving assembly includes a second driving member, the second driving member is connected to the proximal end of the second housing, and the proximal end of the second housing is provided with a second through hole, The proximal end of the push-pull rod is connected to the second driving member through the second through hole, and the second driving member can drive the push-pull rod to move axially.
4. 根据权利要求1所述的房间隔造口装置，其中，所述切割辅助件处于所述展开状态时，所述网状面的外径等于或大于所述空腔的内径；所述切割辅助件处于所述展开状态时，所述网状面与所述推拉杆之间的夹角为80-90度。The atrial septostomy device according to claim 1, wherein when the cutting aid is in the deployed state, the outer diameter of the mesh surface is equal to or greater than the inner diameter of the cavity; the cutting aid When in the unfolded state, the angle between the mesh surface and the push-pull rod is 80-90 degrees.
5. 根据权利要求1所述的房间隔造口装置，其中，还包括第三管体，所述第二管体滑动穿设于所述第三管体。The atrial septostomy device according to claim 1, further comprising a third tube body, and the second tube body slides through the third tube body.
6. 根据权利要求3所述的房间隔造口装置，其中，所述第一驱动组件包括第一壳体和第一驱动件，所述第二管体的近端伸入所述第一壳体，所述第二管体的近端连接有第一导向件，所述第一壳体的内壁上开设有第一导向槽，所述第一导向槽沿所述第二管体的轴向延伸，所述第一导向件滑动设置于所述第一导向槽内，所述第一驱动件能够驱动所述第二管体沿轴向移动；The atrial septostomy device according to claim 3, wherein the first driving assembly comprises a first housing and a first driving member, and the proximal end of the second tube extends into the first housing, The proximal end of the second tube body is connected with a first guide piece, the inner wall of the first housing is provided with a first guide groove, and the first guide groove extends along the axial direction of the second tube body, The first guide member is slidably disposed in the first guide groove, and the first drive member can drive the second pipe body to move axially;

   所述第一驱动组件还包括第一螺杆，所述第一驱动件设置于所述第一壳体内，且所述第一驱动件上开设有第一螺纹孔，所述第一螺杆螺纹连接于所述第一螺纹孔内，所述第一螺杆的一端连接所述第二管体的近端，所述第一螺杆的另一端穿出所述第一驱动件，且所述第一导向件连接所述第一螺杆的侧壁；The first driving assembly also includes a first screw, the first driving member is disposed in the first housing, and a first threaded hole is opened on the first driving member, and the first screw is threadedly connected to In the first threaded hole, one end of the first screw rod is connected to the proximal end of the second tubular body, the other end of the first screw rod passes through the first driving member, and the first guide member connecting the side walls of the first screw;

   所述第一壳体的近端沿所述第一管体的轴向延伸有连接部，所述连接部上同轴开设有第一穿孔，所述第一穿孔与所述第一壳体的内腔连通，所述连接部伸入所述第二壳体内，且所述第二壳体能够沿所述连接部滑动，所述第一管体的端部穿过所述第一穿孔并固定连接于所述第二壳体的内部。The proximal end of the first casing extends along the axial direction of the first tubular body with a connecting portion, and a first through hole is formed coaxially on the connecting portion, and the first through hole is connected with the first casing. The inner cavity communicates, the connecting part protrudes into the second casing, and the second casing can slide along the connecting part, and the end of the first tube passes through the first through hole and is fixed connected to the inside of the second casing.
7. 根据权利要求3所述的房间隔造口装置，其中，所述第三驱动组件还包括连接杆和第二螺杆，所述连接杆同轴连接于所述推拉杆的近端，所述连接杆至少部分置于所述第二穿孔内，所述连接杆远离所述推拉杆的一端穿出所述第二穿孔并与所述第二螺杆同轴连接，所述第二驱动件上开设有第二螺纹孔，所述第二螺杆与所述第二螺纹孔螺接，所述第二驱动件转动连接于所述第二壳体远离所述第一壳体的一端。The atrial septostomy device according to claim 3, wherein the third driving assembly further comprises a connecting rod and a second screw rod, the connecting rod is coaxially connected to the proximal end of the push-pull rod, and the connecting rod At least partially placed in the second through hole, the end of the connecting rod away from the push-pull rod passes through the second through hole and is coaxially connected with the second screw rod, and the second driving member is provided with a first Two threaded holes, the second screw rod is screwed into the second threaded hole, and the second driving member is rotatably connected to an end of the second housing away from the first housing.
8. 根据权利要求1所述的房间隔造口装置，其中，所述切割辅助件包括沿近端到远端方向依次设置的第一延伸部和第二延伸部；The atrial septostomy device according to claim 1, wherein the cutting aid comprises a first extension and a second extension arranged sequentially in a proximal-to-distal direction;

   所述第一延伸部呈管状；The first extension part is tubular;

   所述第二延伸部包括固定件和伸缩件，所述固定件连接所述第一延伸部，且所述固定件具有环形网面；The second extension part includes a fixing part and a telescopic part, the fixing part is connected to the first extension part, and the fixing part has an annular mesh surface;

   所述伸缩件使得所述切割辅助件能够在展开状态和拉伸状态之间切换。The telescoping member enables the cutting aid to be switched between a deployed state and a stretched state.
9. 根据权利要求8所述的房间隔造口装置，其中，所述伸缩件包括沿近端到远端方向依次设置的过渡段和远端段，所述切割辅助件处于展开状态时，所述过渡段呈锥台形。The atrial septostomy device according to claim 8, wherein the telescopic element comprises a transition section and a distal section sequentially arranged along the direction from the proximal end to the distal end, and when the cutting aid is in a deployed state, the transition section Segments are conical.
10. 根据权利要求8所述的房间隔造口装置，其中，所述切割辅助件为弹性编织网，所述第一延伸部套接于所述第一管体的远端，所述推拉杆穿过所述第一延伸部并连接于所述第二延伸部。The atrial septostomy device according to claim 8, wherein the cutting aid is an elastic braided mesh, the first extension part is sleeved on the distal end of the first tubular body, and the push-pull rod passes through The first extension part is connected to the second extension part.
11. 根据权利要求8所述的房间隔造口装置，其中，所述环形网面的外径大于所述第一延伸部的外径；所述房间隔造口装置还包括环形的切割刀，所述切割刀的内径与所述环形网面的外径之差不大于1mm。The atrial septostomy device according to claim 8, wherein the outer diameter of the annular mesh surface is larger than the outer diameter of the first extension; the atrial septostomy device further comprises an annular cutting knife, the The difference between the inner diameter of the cutting knife and the outer diameter of the annular mesh surface is not more than 1mm.
12. 根据权利要求8所述的房间隔造口装置，其中，所述房间隔造口装置还包括第一卡接组件和第二卡接组件，所述第一卡接组件包括第一外环和套装于所述第一外环内的第一内环，所述第一内环的一端卡接所述推拉杆，所述伸缩件的远端卡接于所述第一外环和第一内环之间；The atrial septostomy device according to claim 8, wherein the atrial septostomy device further comprises a first clamping component and a second clamping component, and the first clamping component comprises a first outer ring and a casing The first inner ring in the first outer ring, one end of the first inner ring is clamped to the push-pull rod, and the distal end of the telescopic member is clamped to the first outer ring and the first inner ring between;

    所述第二卡接组件包括第二外环和套装于所述第二外环内的第二内环，所述第二内环的一端卡接所述第一管体，所述第一延伸部的近端卡接于所述第二外环和第二内环之间。The second clamping assembly includes a second outer ring and a second inner ring sleeved in the second outer ring, one end of the second inner ring is clamped to the first pipe body, and the first extension The proximal end of the part is clamped between the second outer ring and the second inner ring.
13. 根据权利要求8所述的房间隔造口装置，其中，所述环形网面与所述推拉杆轴向的夹角为80°-100°。The atrial septostomy device according to claim 8, wherein the included angle between the annular mesh surface and the axial direction of the push-pull rod is 80°-100°.
14. 根据权利要求1所述的房间隔造口装置，所述切割刀包括：The atrial septostomy device according to claim 1, said cutting knife comprising:

    切割刀体，所述切割刀体沿轴线方向设置有贯穿的通孔，所述切割刀体的一端为切割端，另一端为连接端；A cutting knife body, the cutting knife body is provided with a through hole along the axis direction, one end of the cutting knife body is a cutting end, and the other end is a connecting end;

    载药结构，所述载药结构设置在所述切割刀体的外壁上，所述载药结构用于承载药物。A drug-loading structure, the drug-loading structure is arranged on the outer wall of the cutting knife body, and the drug-loading structure is used for carrying drugs.
15. 根据权利要求14所述的房间隔造口装置，其中，所述载药结构为开设在所述切割刀体外壁上的载药槽。The atrial septostomy device according to claim 14, wherein the drug-loading structure is a drug-loading groove opened on the outer wall of the cutting knife.
16. 根据权利要求15所述的房间隔造口装置，其中，所述载药槽为沿所述切割刀体的周向设置的环形槽。The atrial septostomy device according to claim 15, wherein the drug-loading groove is an annular groove arranged along the circumference of the cutting blade body.
17. 根据权利要求15所述的房间隔造口装置，其中，所述载药槽的槽底面为倾斜面，沿切割方向，所述载药槽的载药深度逐渐减小。The atrial septostomy device according to claim 15, wherein the bottom surface of the drug-loading groove is an inclined surface, and the drug-loading depth of the drug-loading groove gradually decreases along the cutting direction.
18. 根据权利要求15所述的房间隔造口装置，其中，所述载药槽包括多个载药子槽，多个所述载药子槽沿所述切割刀体的周向或切割方向间隔设置。The atrial septostomy device according to claim 15, wherein the drug-loading groove comprises a plurality of drug-loading sub-grooves, and the plurality of drug-loading sub-grooves are arranged at intervals along the circumferential direction or cutting direction of the cutting blade body .
19. 根据权利要求15所述的房间隔造口装置，其中，所述载药槽的内壁上设置有吸附结构，所述吸附结构用于吸附所述药物；所述吸附结构为吸附膜，所述吸附膜贴附在所述载药槽的内壁上；或者，所述吸附结构为吸附粗糙面，所述载药槽的内壁被配置为形成所述吸附粗糙面。The atrial septostomy device according to claim 15, wherein an adsorption structure is provided on the inner wall of the drug-loading tank, and the adsorption structure is used to absorb the drug; the adsorption structure is an adsorption film, and the adsorption A film is attached to the inner wall of the drug-loading groove; or, the adsorption structure is an adsorption rough surface, and the inner wall of the drug-loading groove is configured to form the adsorption rough surface.
20. 根据权利要求14-19中任一项所述的房间隔造口装置，其中，The atrial septostomy device according to any one of claims 14-19, wherein,

    所述切割刀体包括呈阶梯状连接的第一部和第二部，所述第一部和所述第二部均呈圆柱状，所述第一部的外径大于所述第二部的外径，所述第一部远离所述第二部的一端为所述切割端，所述第二部远离所述第一部的一端为所述连接端，所述载药结构设置于所述第一部的外壁；The cutter body includes a first part and a second part connected in a stepped shape, both of the first part and the second part are cylindrical, and the outer diameter of the first part is larger than that of the second part Outer diameter, the end of the first part away from the second part is the cutting end, the end of the second part away from the first part is the connecting end, and the drug-loading structure is arranged on the the outer wall of the first part;

    所述通孔包括呈阶梯状连接的第一孔和第二孔，所述第一孔位于所述第一部内部，所述第二孔的至少部分位于所述第二部内，所述第一孔的内径大于所述第二孔的内径。The through hole includes a first hole connected in a stepped shape and a second hole, the first hole is located inside the first part, at least part of the second hole is located in the second part, and the first hole is located inside the first part. The inner diameter of the hole is larger than the inner diameter of the second hole.

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