WO2022052975A1 - Interventional punching device and punching method - Google Patents

Abstract

Provided is an interventional punching device (100, 200), comprising a push tube assembly (20) and a punching assembly (40), the push tube assembly (20) comprises an inner push tube (21) and an outer push tube (23) that is movably sleeved outside of the inner push tube (21), the punching assembly (40) comprises an inner punching head (41) fixed to the distal end of the inner push tube (21) and an outer punching head (43) that is fixed to the distal end of the outer push tube (23), the inner punching head (41) is provided with a sampling groove (412); the outer push tube (23) moves in the axial direction relative to the inner push tube (21), so as to drive the outer punching head (43) to move in the axial direction relative to the inner punching head (41), so that the outer punching head (43) punches the tissue sleeved on the periphery of the sampling groove (412); and after punching, the removed tissue remains within the sampling groove (412). The interventional punching device (100, 200) can punch holes as well as take samples, is less traumatic for patients, is convenient and efficient to operate, and has low surgical risk. Also provided is a punching method for interventional punching devices.

Description

Translated fromChinese

介入性冲切器及冲切方法Interventional punching device and punching method

本申请主张申请日为2020年9月9日、申请号为202010944119.X、名称为“介入性冲切器”的发明专利申请，以及申请日为2020年9月9日、申请号为202021961494.7、名称为“介入性冲切器”的实用新型专利申请的优先权。This application claims an invention patent application with an application date of September 9, 2020, an application number of 202010944119.X, and the title of "Interventional Punching Device", as well as an application date of September 9, 2020, application number of 202021961494.7, Priority for utility model patent application entitled "Interventional Die Cutter".

技术领域technical field

本申请涉及医疗器械技术领域，尤其涉及一种介入性冲切器及所述介入性冲切器的冲切方法。The present application relates to the technical field of medical devices, and in particular, to an interventional punching device and a punching method for the interventional punching device.

背景技术Background technique

随着外科手术的复杂性、外科医疗设备的深度介入性的提高，实施手术时不可避免地需要对患处或者其他器官、组织进行打孔、取样等操作，而且不管是在手术前还是手术中，这些操作都十分必要。With the complexity of surgical operations and the improvement of in-depth intervention of surgical medical equipment, it is inevitable to perform operations such as drilling and sampling on the affected area or other organs and tissues, and whether it is before or during surgery, These operations are all necessary.

然而，现有技术中，实现打孔、取样等操作的传统器械由于手术视野的问题，往往需要外科医生预先切割较大创口再深入目标位置实现打孔或取样，对病患的创伤大；再者，在实现打孔、取样等操作的过程中，各种器械频繁进出病患器官病变部位或血管内，操作步骤繁琐、时间长，可能会损伤到不必要的组织，而且容易将空气、异物等带入其内，在鞘管内部则很容易形成血栓，往往还需要做开胸手术，由此，极易带来二次伤害和污染，从而引起并发症等不良后果，手术风险高。However, in the prior art, traditional instruments for performing operations such as punching and sampling often require the surgeon to cut a large wound in advance and then go deep into the target position to achieve punching or sampling due to the problem of the surgical field, which causes great trauma to the patient; However, in the process of perforating, sampling and other operations, various instruments frequently enter and exit the diseased parts of the patient's organs or blood vessels. The operation steps are cumbersome and time-consuming, which may damage unnecessary tissues, and it is easy to cause air and foreign objects to be damaged. If it is brought into the sheath, it is easy to form a thrombus inside the sheath, and a thoracotomy is often required. As a result, it is very easy to cause secondary injury and pollution, resulting in adverse consequences such as complications, and the operation risk is high.

发明内容SUMMARY OF THE INVENTION

本申请旨在至少解决现有技术中存在的技术问题之一。为此，本申请提供一种既能实现打孔又能取样的介入性冲切器及冲切方法，对病患的创伤小，操作方便效率高，手术风险低。The present application aims to solve at least one of the technical problems existing in the prior art. Therefore, the present application provides an interventional punching device and punching method that can realize both punching and sampling, with less trauma to the patient, convenient operation, high efficiency, and low surgical risk.

为解决上述技术问题，本申请提供一种介入性冲切器，包括推管组件及冲切组件，所述推管组件包括内推管及活动地套设于所述内推管外的外推管，所述冲切组件包括固定于所述内推管远端的内冲切头及固定于所述外推管远端的外冲切头，所述内冲切头开设取样槽；所述外推管相对所述内推管沿轴向移动以带动所述外冲切头相对所述内冲切头沿轴向移动，以使所述外冲切头对套于所述内冲切头的取样槽外周的组织进行冲切，冲切后被切除组织保留在所述取样槽内。In order to solve the above technical problems, the present application provides an interventional punching device, which includes a push tube assembly and a punching assembly, wherein the push tube assembly includes an inner push tube and an outer pusher movably sleeved outside the inner push tube. The punching assembly includes an inner punching head fixed at the distal end of the inner push tube and an outer punching head fixed at the distal end of the outer push tube, and the inner punching head is provided with a sampling groove; the The outer push tube moves axially relative to the inner push tube to drive the outer punching head to move axially relative to the inner punching head, so that the outer punching head is sleeved on the inner punching head The tissue around the sampling groove is punched, and the excised tissue remains in the sampling groove after punching.

本申请还提供一种冲切方法，所述冲切方法包括：The present application also provides a punching method, the punching method comprising:

提供介入性冲切器，所述介入性冲切器包括冲切组件及推管组件，所述推管组件包括内推管及活动地套设于所述内推管外的外推管；所述冲切组件包括固定于所述内推管的远端的内冲切头及固定于所述外推管的远端的外冲切头，所述内冲切头开设取样槽；An interventional punching device is provided, the interventional punching device includes a punching component and a push tube assembly, the push tube component includes an inner push tube and an outer push tube movably sleeved outside the inner push tube; The punching assembly includes an inner punching head fixed to the distal end of the inner push pipe and an outer punching head fixed to the distal end of the outer push pipe, and the inner punching head is provided with a sampling groove;

将所述外推管相对所述内推管沿轴向移动以带动所述外冲切头相对所述内冲切头沿轴向移动，以使所述外冲切头对套于所述内冲切头的取样槽外周的组织进行冲切；Move the outer push tube relative to the inner push tube in the axial direction to drive the outer punching head to move axially relative to the inner punching head, so that the outer punching head is sleeved on the inner punching head. The tissue around the sampling groove of the punching head is punched;

将被切除组织保留在所述取样槽内。The resected tissue is retained in the sampling well.

本申请提供的所述介入性冲切器及冲切方法，所述推管组件的内推管和外推管套装在一起，所述冲切组件的内冲切头和外冲切头分别固定于内推管和外推管的远端，使得所述介入性冲切器的远端部分的直径较小，可通过小口径鞘管建立介入通道进入病患体内，对病患的创伤小；再者，通过控制所述外推管相对所述内推管沿轴向移动，使所述外冲切头相对所述内冲切头做冲切运动，即可在目标位置的组织 上实现打孔和取样，操作方便效率高；此外，所述外冲切头能够封闭所述内冲切头的取样槽，被切除组织保留在所述取样槽内，使得血管内或者鞘管内没有组织碎屑的残留，防止血栓的形成，不需要做开胸手术，避免带来二次伤害和污染，手术风险低。In the interventional punching device and punching method provided by the present application, the inner push tube and the outer push tube of the push tube assembly are sleeved together, and the inner punching head and the outer punching head of the punching assembly are respectively fixed At the distal ends of the inner push tube and the outer push tube, the diameter of the distal part of the interventional punching device is small, and an intervention channel can be established through a small-diameter sheath tube to enter the patient's body, and the trauma to the patient is small; Furthermore, by controlling the outer push tube to move in the axial direction relative to the inner push tube, so that the outer punching head performs punching movement relative to the inner punching head, the punching can be achieved on the tissue at the target position. hole and sampling, easy to operate and efficient; in addition, the outer punching head can close the sampling groove of the inner punching head, and the resected tissue remains in the sampling groove, so that there is no tissue debris in the blood vessel or sheath It can prevent the formation of thrombus, does not require thoracotomy, avoids secondary injury and pollution, and has low surgical risk.

附图说明Description of drawings

为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，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，还可以根据这些附图获得其他的附图。In order to explain the technical solutions of the embodiments of the present application more clearly, the following briefly introduces the accompanying drawings that need to be used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

图1是本申请第一实施例提供的介入性冲切器的结构示意图。FIG. 1 is a schematic structural diagram of an interventional punch provided by a first embodiment of the present application.

图2是图1中的介入性冲切器的轴向剖视图。FIG. 2 is an axial cross-sectional view of the interventional punch of FIG. 1 .

图3是图1中的介入性冲切器的分解结构示意图。FIG. 3 is an exploded schematic diagram of the interventional punch in FIG. 1 .

图4是图1中的介入性冲切器在取样槽被暴露时的远端部分的结构示意图。FIG. 4 is a schematic structural view of the distal portion of the interventional punch of FIG. 1 when the sampling slot is exposed.

图5是图4中的介入性冲切器在取样槽被封闭时的远端部分的结构示意图。FIG. 5 is a schematic structural diagram of the distal end portion of the interventional punch in FIG. 4 when the sampling slot is closed.

图6是图2中VI部分的放大示意图。FIG. 6 is an enlarged schematic view of part VI in FIG. 2 .

图7是图6中的内冲切头去除第一连接部的结构示意图。FIG. 7 is a schematic structural diagram of the inner punching head in FIG. 6 with the first connecting portion removed.

图8是图6中的外冲切头去除第二连接部的结构示意图。FIG. 8 is a schematic structural diagram of the outer punching head in FIG. 6 with the second connecting portion removed.

图9是图7中的内冲切头去除第一连接部的另一实施方式的结构示意图。FIG. 9 is a schematic structural diagram of another embodiment in which the first connecting portion is removed from the inner punching head in FIG. 7 .

图10是图8中的外冲切头去除第二连接部的另一实施方式的结构示意图。FIG. 10 is a schematic structural diagram of another embodiment in which the second connecting portion is removed from the outer punching head in FIG. 8 .

图11至图14是本申请的介入性冲切器的使用过程示意图。11 to 14 are schematic diagrams of the use process of the interventional punch of the present application.

图15是本申请第二实施例提供的介入性冲切器的结构示意图。FIG. 15 is a schematic structural diagram of an interventional punch provided by the second embodiment of the present application.

图16是图15中的介入性冲切器的轴向剖视图。FIG. 16 is an axial cross-sectional view of the interventional punch of FIG. 15 .

图17至图20是图16中的介入性冲切器的锁定机构的使用过程示意图。17-20 are schematic diagrams of the use of the locking mechanism of the interventional punch of FIG. 16 .

图21是本申请第三实施例提供的介入性冲切器的轴向剖视图。FIG. 21 is an axial cross-sectional view of the interventional punch provided by the third embodiment of the present application.

图22是本申请第四实施例提供的介入性冲切器的冲切组件的结构示意图。FIG. 22 is a schematic structural diagram of the punching assembly of the interventional punching device provided in the fourth embodiment of the present application.

图23至图25是图22中的冲切组件的使用过程示意图。23 to 25 are schematic diagrams of the use process of the punching assembly in FIG. 22 .

图26是第四实施例中的介入性冲切器的锁定机构的结构示意图。FIG. 26 is a schematic structural diagram of the locking mechanism of the interventional punch in the fourth embodiment.

图27是本申请的介入性冲切器的冲切方法流程图。FIG. 27 is a flow chart of the punching method of the interventional punch of the present application.

具体实施方式detailed description

下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present application.

在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或者暗示所指的装置或者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”等仅用于描述目的，而不能理解为指示或暗示相对重要性。In the description of the present application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings, only for the purpose of It is for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as a limitation of the present application. Furthermore, the terms "first," "second," etc. are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”等应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或者一体地连接；可以是直接相连，也可以是通过中间媒介间接相连。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, it should be noted that, unless otherwise expressly specified and limited, the terms "installed", "connected", "connected", etc. should be understood in a broad sense, for example, it may be a fixed connection or a Detachable connection, or integral connection; it can be directly connected or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood in specific situations.

在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于医疗器械远端中心和近端中心连线的方向，而径向是指垂直于医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。In the description of this application, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther away from the operator; the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the device, and the radial direction refers to the direction perpendicular to the line connecting the center of the distal end and the center of the proximal end of the medical device. The above definitions are only for the convenience of expression, and should not be construed as limitations on the present application.

请一并参阅图1至图5，本申请提供一种介入性冲切器100，其包括推管组件20及冲切组件40，推管组件20包括内推管21及活动地套设于内推管21外的外推管23，冲切组件40包括固定于内推管21的远端的内冲切头41及固定于外推管23的远端的外冲切头43。其中，内冲切头41的远端还连接有呈锥体结构的导引头45。依次连接的内推管21、内冲切头41及导引头45可穿装导丝，通过相应的鞘管建立介入通道后，导丝可经介入通道进入病患体内并靠近目标位置，在导丝的引导下，推管组件20的远端部分及固定于推管组件20的远端的冲切组件40能够被推送至目标位置附近，朝远端进一步推送导引头45时，导引头45可带动内冲切头41部分穿过目标位置的组织。可以理解的是，内推管21及外推管23套装在一起，内冲切头41和外冲切头43分别固定于内推管21和外推管23的远端，使得介入性冲切器100的远端部分的直径较小，可通过小口径的鞘管建立介入通道以进入病患体内，对病患的创伤小。Please refer to FIG. 1 to FIG. 5 together. The present application provides aninterventional punching device 100, which includes apush tube assembly 20 and apunching assembly 40. Thepush tube assembly 20 includes aninner push tube 21 and is movably sleeved inside For theouter push tube 23 outside thepush tube 21 , thepunching assembly 40 includes aninner punching head 41 fixed to the distal end of theinner push tube 21 and anouter punching head 43 fixed to the distal end of theouter push tube 23 . Wherein, the distal end of theinner punching head 41 is also connected with a guidinghead 45 having a pyramid structure. Theinner push tube 21, theinner punching head 41 and theguide head 45 connected in sequence can be fitted with a guide wire. After the intervention channel is established through the corresponding sheath tube, the guide wire can enter the patient through the intervention channel and approach the target position. Under the guidance of the guide wire, the distal part of thepush tube assembly 20 and thepunching assembly 40 fixed to the distal end of thepush tube assembly 20 can be pushed to the vicinity of the target position, and when theguide head 45 is further pushed toward the distal end, the guide Thehead 45 can drive theinner punching head 41 partially through the tissue at the target site. It can be understood that theinner push tube 21 and theouter push tube 23 are assembled together, and theinner punching head 41 and theouter punching head 43 are respectively fixed to the distal ends of theinner push tube 21 and theouter push tube 23, so that the interventional punching can be performed. The diameter of the distal part of thedevice 100 is small, and an intervention channel can be established through a small-diameter sheath to enter the patient's body, and the trauma to the patient is small.

需要重点说明的是，本申请中，内冲切头41开设取样槽412，外推管23相对内推管21沿轴向移动以带动外冲切头43相对内冲切头41沿轴向移动，以使外冲切头43对套于内冲切头41的取样槽412外周的组织进行冲切，冲切后被切除组织保留在取样槽412内。具体地，当冲切组件40接近目标位置时，外推管23相对内推管21沿轴向朝近端移动以带动外冲切头43相对内冲切头41沿轴向朝近端移动，使取样槽412暴露(见图4)，操作者同时推动整个介入性冲切器100向前，使导引头45穿过组织，内冲切头41在导引头45的带动下部分穿过目标位置的组织，待切割组织卡在内冲切头41的取样槽412外周。当然，在其他实施例中，使待切割组织卡在内冲切头41的取样槽412外周的过程也可以是冲切组件40的远端部分穿过目标位置组织之后，再将外推管23相对内推管21沿轴向朝近端移动以带动外冲切头43相对内冲切头41沿轴向朝近端移动，使取样槽412暴露(见图4)，待切割组织卡在内冲切头41的取样槽412外周。然后外推管23相对内推管21沿轴向朝远端移动以带动外冲切头43相对内冲切头41沿轴向朝远端移动，使取样槽412封闭(见图5)，在外冲切头43封闭取样槽412的过程中，由于内冲切头41与外冲切头43的相互剪切，即可切取与冲切组件40的口径相当的组织保留在取样槽412内。可以理解的是，取样槽412内的组织在外冲切头43的封闭下随介入性冲切器100撤出至病患体外后，目标位置的组织上即可留下与外冲切头43的形状相当的孔(外冲切头43可包括但不限于为圆筒状，内冲切头41可包括但不限于为中空的哑铃型)，而保留在取样槽412内的被切除组织可以作为活检样材，从而实现打孔和取样的目的，整个过程中，操作方便效率高；再者，被切除组织保留在封闭的取样槽412内，使得血管内或者鞘管内没有组织碎屑的残留，可减少血栓的形成，不需要做开胸手术，能够避免带来二次伤害和污染，手术风险低。It should be noted that in this application, theinner punching head 41 is provided with asampling groove 412, and theouter push tube 23 moves relative to theinner push tube 21 in the axial direction to drive theouter punching head 43 to move relative to theinner punching head 41 in the axial direction , so that theouter punching head 43 punches the tissue around thesampling groove 412 sleeved on theinner punching head 41 , and the excised tissue remains in thesampling groove 412 after punching. Specifically, when the punchingassembly 40 approaches the target position, theouter push tube 23 moves towards the proximal end in the axial direction relative to theinner push tube 21 to drive theouter punching head 43 to move towards the proximal end in the axial direction relative to theinner punching head 41, With thesampling slot 412 exposed (see FIG. 4 ), the operator pushes the entireinterventional punch 100 forward at the same time, allowing theintroducer head 45 to pass through the tissue, and theinner punch head 41 partially passes under the lead of theintroducer head 45 For the tissue at the target position, the tissue to be cut is stuck to the periphery of thesampling groove 412 of theinner punching head 41 . Of course, in other embodiments, the process of making the tissue to be cut stuck to the outer periphery of thesampling groove 412 of theinner punching head 41 may also be that after the distal end portion of the punchingassembly 40 passes through the tissue at the target position, theouter push tube 23 Theinner push tube 21 is moved toward the proximal end in the axial direction to drive theouter punching head 43 to move toward the proximal end relative to theinner punching head 41 in the axial direction, so that thesampling groove 412 is exposed (see FIG. 4 ), and the tissue to be cut is stuck inside The outer periphery of thesampling groove 412 of the punchinghead 41 . Then, theouter push tube 23 moves axially distally relative to theinner push tube 21 to drive theouter punching head 43 to move axially towards the distal end relative to theinner punching head 41 to close the sampling groove 412 (see FIG. 5 ). During the process of closing thesampling groove 412 by the punchinghead 43, due to mutual shearing between theinner punching head 41 and theouter punching head 43, the tissue corresponding to the diameter of the punchingassembly 40 can be cut and retained in thesampling groove 412. It can be understood that, after the tissue in thesampling groove 412 is withdrawn from the patient's body with theinterventional punch 100 under the sealing of theouter punching head 43, the tissue at the target position can be left with theouter punching head 43. A hole with a similar shape (theouter punching head 43 may include, but is not limited to, a cylindrical shape, and theinner punching head 41 may include, but is not limited to, a hollow dumbbell shape), and the resected tissue retained in thesampling groove 412 may be used as Biopsy sample material, so as to achieve the purpose of punching and sampling, in the whole process, the operation is convenient and efficient; in addition, the resected tissue is retained in theclosed sampling groove 412, so that no tissue debris remains in the blood vessel or sheath, It can reduce the formation of thrombus, does not require thoracotomy, can avoid secondary injury and pollution, and has low surgical risk.

其中，为了保证安全性，推管组件20、冲切组件40及导引头45均由具有生物相容性的金属材料或者高分子材料制成，金属材料包括但不限于不锈钢、镍钛合金，高分子材料包括但不限于Pebax(聚醚嵌段聚酰胺)、Peek(聚醚醚酮)、PA(Polyamide，聚酰胺)。本实施例中，推管组件20及导引头45选用Pebax制成，冲切组件40选用不锈钢制成。Among them, in order to ensure safety, thepush tube assembly 20, the punchingassembly 40 and theguide head 45 are all made of biocompatible metal materials or polymer materials, and metal materials include but are not limited to stainless steel, nickel-titanium alloy, Polymer materials include but are not limited to Pebax (polyether block polyamide), Peek (polyether ether ketone), PA (Polyamide, polyamide). In this embodiment, thepush tube assembly 20 and theguide head 45 are made of Pebax, and the punchingassembly 40 is made of stainless steel.

请一并参阅图2及图6，内推管21及外推管23均为细长的中空管体，二者同轴套装在一起。具体地，如图6所示，本实施例中，内推管21包括芯管212及套管214，芯管212、套管214及外推管23自内而外同轴套装在一起。Please refer to FIG. 2 and FIG. 6 together, theinner push tube 21 and theouter push tube 23 are both elongated hollow tube bodies, and the two are coaxially sleeved together. Specifically, as shown in FIG. 6 , in this embodiment, theinner push tube 21 includes acore tube 212 and asleeve 214 , and thecore tube 212 , thesleeve 214 and theouter push tube 23 are coaxially sleeved together from the inside to the outside.

其中，外推管23活动地套装于套管214外，套管214固定套装于芯管212外。本实施例中，套管214通过注塑成型的方式固定套装于芯管212外。Thepush tube 23 is movably sheathed outside thesleeve 214 , and thesleeve 214 is fixedly sheathed outside thecore tube 212 . In this embodiment, thesleeve 214 is fixed and sheathed outside thecore tube 212 by means of injection molding.

其中，芯管212的远端部分位于套管214的远端外，并且芯管212的远端管口外扩成喇叭状，以用于固定内冲切头41的远端。具体而言，如图6所示，内冲切头41沿轴向开设有贯通两端的轴向通道415，轴向通道415的远端具有扩口416，扩口416的形状与芯管212的远端管口的形状匹配。芯管212的远端部分穿装于内冲切头41的轴向通道415内，且芯管212的远端管口收容并抵顶于轴向通道415的远端扩口416处，芯管212的远端管口外扩成喇叭状可以起到固定内冲切头41的远端的作用。The distal end portion of thecore tube 212 is located outside the distal end of thesleeve 214 , and the distal mouth of thecore tube 212 is expanded into a trumpet shape for fixing the distal end of theinner punching head 41 . Specifically, as shown in FIG. 6 , theinner punching head 41 is provided with anaxial channel 415 penetrating both ends in the axial direction, and the distal end of theaxial channel 415 has aflare 416 , and the shape of theflare 416 is the same as that of thecore tube 212 . The shape of the distal nozzle matches. The distal end portion of thecore tube 212 is inserted into theaxial channel 415 of theinner punching head 41 , and the distal mouth of thecore tube 212 is accommodated and abuts against thedistal flare 416 of theaxial channel 415 . The distal end nozzle of 212 can be expanded into a trumpet shape to fix the distal end of theinner punching head 41 .

其中，内冲切头41固定套接于芯管212的远端。具体地，请一并参阅图6及图7，本实施例中，内冲切头41的形状大致呈哑铃状，其包括位于远端的切台411、位于近端的导台413以及开设于切台411与导台413之间的环状取样槽412，切台411的远端设置有用于连接导引头45的第一连接部414；内冲切头41沿轴向开设有贯通两端的轴向通道415，轴向通道415的远端具有扩口416，扩口416的形状与芯管212的远端管口的形状匹配。如图6所示，芯管212的远端部分穿装于内冲切头41的轴向通道415内，且芯管212的远端管口收容并抵顶于轴向通道415的远端扩口416处，套管214包括但不限于通过注塑成型或热压方式固定套装于芯管212外，套管214的远端抵顶于内冲切头41的近端，由此，内冲切头41的两端分别被芯管212的远端和套管214的远端固定，使得内冲切头41牢固地固定于内推管21的远端。Theinner punching head 41 is fixedly sleeved on the distal end of thecore tube 212 . Specifically, please refer to FIG. 6 and FIG. 7 together. In this embodiment, theinner punching head 41 is roughly in the shape of a dumbbell, and includes a cutting table 411 at the distal end, a guide table 413 at the proximal end, and a cutting table 413 located at the proximal end. Theannular sampling groove 412 between the cutting table 411 and the guiding table 413, the distal end of the cutting table 411 is provided with a first connectingpart 414 for connecting the guidinghead 45;Axial channel 415, the distal end ofaxial channel 415 has aflare 416, the shape of theflare 416 matches the shape of the distal orifice of thecore tube 212. As shown in FIG. 6 , the distal end portion of thecore tube 212 is inserted into theaxial channel 415 of theinner punching head 41 , and the distal mouth of thecore tube 212 is accommodated and abuts against the distal end of theaxial channel 415 to expand. At theport 416, thesleeve 214 includes but is not limited to being fixed and sleeved outside thecore tube 212 by injection molding or hot pressing, and the distal end of thesleeve 214 abuts the proximal end of theinner punching head 41, thereby, the inner punching Both ends of thehead 41 are respectively fixed by the distal end of thecore tube 212 and the distal end of thesleeve 214 , so that theinner punching head 41 is firmly fixed to the distal end of theinner push tube 21 .

如图6所示，本实施例中，导引头45的近端开设有连接孔451，第一连接部414及切台411的远端部分卡接于导引头45近端的连接孔451内，以实现导引头45与内冲切头41的固定连接。显然，在其他实施例中，导引头45也可以通过注塑成型的方式直接固定连接于切台411的第一连接部414。As shown in FIG. 6 , in this embodiment, a connectinghole 451 is formed at the proximal end of theguide head 45 , and the distal end of the first connectingportion 414 and the cutting table 411 are clamped to the connectinghole 451 at the proximal end of theguide head 45 . inside, so as to realize the fixed connection between theguide head 45 and theinner punching head 41 . Obviously, in other embodiments, theguide head 45 can also be directly and fixedly connected to the first connectingportion 414 of the cutting table 411 by means of injection molding.

其中，第一连接部414与切台411可以为一体结构，也可以为非一体结构并通过粘接等方式固定连接。本实施例中，第一连接部414与切台411为一体的。Wherein, the first connectingportion 414 and the cutting table 411 may be of an integral structure, or may be a non-integrated structure and fixedly connected by means of bonding or the like. In this embodiment, the first connectingportion 414 is integrated with the cutting table 411 .

在其他实施例中，切台411的远端可以不设置第一连接部414，切台411直接与导引头45通过粘接等方式固定连接。In other embodiments, the distal end of the cutting table 411 may not be provided with the first connectingportion 414, and the cutting table 411 is directly and fixedly connected to theguide head 45 by means of bonding or the like.

在其他实施列中，第一连接部414与导引头45的连接孔451之间也可以通过螺接等方式固定连接。In other embodiments, thefirst connection portion 414 and theconnection hole 451 of theguide head 45 may also be fixedly connected by means of screwing or the like.

此外，如图2所示，导引头45还沿轴向开设有贯通其近端与远端的通孔452，导引头45与内冲切头41固定连接，导引头45的通孔452与穿装于内冲切头41的轴向通道415内的芯管212的内腔连通，从而形成用于穿设导丝的导丝通道。In addition, as shown in FIG. 2 , theguide head 45 is also provided with a throughhole 452 penetrating the proximal end and the distal end of theguide head 45 in the axial direction. Theguide head 45 is fixedly connected with theinner punching head 41 , and the through hole of theguide head 45 452 communicates with the inner cavity of thecore tube 212 which is inserted into theaxial channel 415 of theinner punching head 41, thereby forming a guide wire channel for threading the guide wire.

外冲切头43固定于外推管23的远端。具体地，请一并参阅图6及图8，本实施例中，外冲切头43为中空的筒状刀片，其包括筒状的刀片本体431及设置于刀片本体431的远端的刃口432，刀片本体431 的近端设置有用于连接外推管23的第二连接部433。本实施例中，第二连接部433卡接于外推管23的远端内腔中，以使外冲切头43固定于外推管23的远端。显然，在其他实施例中，外推管23也可以通过注塑成型或胶接等的方式固定连接于第二连接部433。Theouter punching head 43 is fixed to the distal end of theouter push tube 23 . Specifically, please refer to FIG. 6 and FIG. 8 together. In this embodiment, theouter punching head 43 is a hollow cylindrical blade, which includes acylindrical blade body 431 and a cutting edge disposed at the distal end of theblade body 431 432 , the proximal end of theblade body 431 is provided with a second connectingportion 433 for connecting thepusher tube 23 . In this embodiment, the second connectingportion 433 is clamped in the inner cavity of the distal end of thepusher tube 23 , so that theouter punching head 43 is fixed to the distal end of thepusher tube 23 . Obviously, in other embodiments, the push-outtube 23 can also be fixedly connected to the second connectingportion 433 by means of injection molding or gluing.

同样的，第二连接部433与刀片本体431可以为一体结构，也可以为非一体结构并通过粘接等方式固定连接。本实施例中，第二连接部433与刀片本体431为一体的。Likewise, thesecond connection portion 433 and theblade body 431 may be of an integral structure, or may be of a non-integrated structure and fixedly connected by means of bonding or the like. In this embodiment, the second connectingportion 433 is integrated with theblade body 431 .

在其他实施例中，刀片本体431的近端可以不设置第二连接部414，刀片本体431直接与外推管23固定连接，例如，刀片本体431与外推管23粘接，或者，刀片本体414设置内螺纹，外推管23的远端对应设置外螺纹，刀片本体431与外推管23螺纹连接。In other embodiments, the proximal end of theblade body 431 may not be provided with the second connectingportion 414, and theblade body 431 is directly and fixedly connected to the push-outtube 23, for example, theblade body 431 is bonded to the push-outtube 23, or theblade body 414 is provided with internal threads, the distal end of the push-outtube 23 is provided with external threads correspondingly, and theblade body 431 is threadedly connected with the push-outtube 23 .

需要说明的是，在套管214与第二连接部433之间设有间隙，从而不会阻碍外推管23与内推管21沿轴向的相对移动。本实施例中，第二连接部433沿轴向开设有贯通近端与远端的轴向通道，以供内推管21轴向活动穿过，从而不会阻碍外推管23相对内推管21沿轴向移动。It should be noted that a gap is provided between thesleeve 214 and the second connectingportion 433 so as not to hinder the relative movement of theouter push tube 23 and theinner push tube 21 in the axial direction. In this embodiment, the second connectingportion 433 is provided with an axial channel extending through the proximal end and the distal end in the axial direction, so as to allow theinner push tube 21 to move through the inner push tube axially, so as not to hinder theouter push tube 23 relative to theinner push tube 21 moves in the axial direction.

请一并参阅图5及图6，初始状态下，内冲切头41大部分收容于外冲切头43的内腔中，取样槽412被封闭。具体地，如图6所示，内冲切头41的整个导台413、整个取样槽412以及切台411的近端部分收容于外冲切头43的刀片主体431的内腔，外冲切头43的刃口432覆盖于切台411外周。可以理解的是，当需要暴露取样槽412，以使待切割组织进入取样槽412时，可通过控制外推管23相对内推管21沿轴向朝近端移动以带动外冲切头43相对内冲切头41沿轴向朝近端移动，使取样槽412处于被暴露的状态，如图4所示，此时，刀片主体43的刃口432套于导台413的外周；当需要再次封闭取样槽412，以使刃口432冲切套于内冲切头41的取样槽412的外周的组织，并使被切除组织保留在取样槽412内时，可通过控制外推管23相对内推管21沿轴向朝远端移动以带动外冲切头43相对内冲切头41沿轴向朝远端移动至封闭取样槽412。当然，在其他实施例中，也可以是控制内推管21相对外推管23沿轴向朝近端或远端移动，以带动内冲切头41相对外冲切头43沿轴向朝近端或朝远端移动；或，同时控制内推管21与外推管23的移动以实现内冲切头41与外冲切头43的相对移动。Please refer to FIG. 5 and FIG. 6 together. In the initial state, most of theinner punching head 41 is accommodated in the inner cavity of theouter punching head 43 , and thesampling groove 412 is closed. Specifically, as shown in FIG. 6 , the entire guide table 413 of theinner punching head 41 , theentire sampling groove 412 and the proximal end portion of the cutting table 411 are accommodated in the inner cavity of theblade body 431 of theouter punching head 43 , and the outer punching Thecutting edge 432 of thehead 43 covers the outer periphery of the cutting table 411 . It can be understood that, when thesampling slot 412 needs to be exposed, so that the tissue to be cut enters thesampling slot 412, theouter punching head 43 can be driven to move toward the proximal end in the axial direction relative to the inner pushingtube 21 by controlling thepusher tube 23. Theinner punching head 41 moves toward the proximal end in the axial direction, so that thesampling groove 412 is exposed, as shown in FIG. When thesampling groove 412 is closed, so that thecutting edge 432 punches the tissue surrounding thesampling groove 412 of theinner punching head 41, and the excised tissue is kept in thesampling groove 412, the push-outtube 23 can be controlled relatively inwardly. Thepush tube 21 moves toward the distal end in the axial direction to drive theouter punching head 43 to move toward the distal end relative to theinner punching head 41 in the axial direction to close thesampling groove 412 . Of course, in other embodiments, theinner push tube 21 can also be controlled to move toward the proximal end or the distal end relative to theouter push tube 23 in the axial direction, so as to drive theinner punching head 41 to move closer to theouter punching head 43 in the axial direction. or, control the movement of theinner push tube 21 and theouter push tube 23 at the same time to realize the relative movement of theinner punching head 41 and theouter punching head 43 .

其中，切台411具有与外冲切头43的刃口432的直径相匹配的冲切直径，用于实现外冲切头43相对内冲切头41沿轴向移动时的冲切运动。具体地，如图7所示，本实施例中，切台411的直径自近端向远端保持不变，且切台411的直径等于或略小于刀片主体431的内径，由此，刃口432覆盖于切台411外周时，刀片主体431的内壁贴合于切台411的外壁，从而实现刃口432对套于内冲切头41的取样槽412的外周的组织的冲切，且使被切除组织保留在取样槽412内。Wherein, the cutting table 411 has a punching diameter matching the diameter of thecutting edge 432 of theouter punching head 43 for realizing punching motion when theouter punching head 43 moves relative to theinner punching head 41 in the axial direction. Specifically, as shown in FIG. 7 , in this embodiment, the diameter of the cutting table 411 remains unchanged from the proximal end to the distal end, and the diameter of the cutting table 411 is equal to or slightly smaller than the inner diameter of theblade body 431 . When the 432 covers the outer periphery of the cutting table 411, the inner wall of theblade body 431 is attached to the outer wall of the cutting table 411, so that thecutting edge 432 can punch the tissue on the outer periphery of thesampling groove 412 of theinner punching head 41, and make The resected tissue remains within sampling well 412 .

如图9所示，在其他实施例中，内冲切头41b的结构与第一实施例中的内冲切头41的结构相似，不同之处在于：内冲切头41b的切台411的直径自近端向远端逐渐增大，即切台411呈锥台状，如图8所示，刃口432的远端末端的内径小于切台411的远端直径且大于切台411的近端直径，由此，刃口432覆盖于切台411外周时，刃口432的远端末端抵顶于切台411位于近端与远端之间的某个位置，便于刃口432的远端末端实现对套于内冲切头41b的取样槽412的外周的组织的冲切，并使被切除组织保留在取样槽412内。As shown in FIG. 9 , in other embodiments, the structure of theinner punching head 41b is similar to that of theinner punching head 41 in the first embodiment, the difference is that the cutting table 411 of theinner punching head 41b has a The diameter gradually increases from the proximal end to the distal end, that is, the cutting table 411 is in the shape of a truncated cone, as shown in FIG. Therefore, when thecutting edge 432 covers the outer circumference of the cutting table 411, the distal end of thecutting edge 432 abuts against the cutting table 411 at a position between the proximal end and the distal end, which is convenient for the distal end of thecutting edge 432. The distal end realizes punching of the tissue around the outer periphery of thesampling groove 412 of theinner punching head 41 b , and keeps the resected tissue in thesampling groove 412 .

可以理解的是，冲切之后，导台413收容于刀片主体431内，因此，导台413的直径可以等于或者略小于刀片主体431的内径。优选地，在其中一个实施例中，导台413的直径等于刀片主体431的内径，且内冲切头41的切台411与导台413的直径相等，使刀片主体43的内壁可贴合于切台411与导台413 的外壁。其中，导台413的直径等于刀片主体431的内径，以便于外冲切头43相对内冲切头41的轴向移动实现冲切，导台413可以起到导滑的作用。内冲切头41的切台411与导台413的直径相等，使刀片主体43的内壁可贴合于切台411与导台413的外壁，便于冲切，以及在冲切之后，将被切除组织封闭保留在所样槽412内。内冲切头41的切台411与导台413的直径相等，还有利于内冲切头41的加工制造。It can be understood that after punching, the guide table 413 is accommodated in theblade body 431 , so the diameter of the guide table 413 may be equal to or slightly smaller than the inner diameter of theblade body 431 . Preferably, in one of the embodiments, the diameter of the guide table 413 is equal to the inner diameter of theblade body 431, and the diameter of the cutting table 411 of theinner punching head 41 and the guide table 413 are the same, so that the inner wall of theblade body 43 can fit on the The outer walls of the cutting table 411 and the guide table 413 . The diameter of the guide table 413 is equal to the inner diameter of theblade body 431 , so that the axial movement of theouter punching head 43 relative to theinner punching head 41 can realize punching, and the guide table 413 can play the role of guiding and sliding. The diameters of the cutting table 411 and the guide table 413 of theinner punching head 41 are equal, so that the inner wall of theblade body 43 can fit the outer wall of the cutting table 411 and the guide table 413, which is convenient for punching, and after punching, it will be cut off. The tissue seal remains within the sampledwells 412. The diameters of the cutting table 411 and the guide table 413 of theinner punching head 41 are equal, which is also beneficial to the processing and manufacture of theinner punching head 41 .

此外，如图6所示，本实施例中，外冲切头43的轴向长度与内冲切头41的轴向长度大致相等，外冲切头43的刃口432覆盖于切台411外周时，外冲切头43的第二连接部433的远端抵顶于内冲切头41的导台413的近端，此时，外冲切头43相对内冲切头41沿轴向朝远端的移动被限制，可以防止外冲切头43相对内冲切头41朝远端移动过多的距离导致刃口432切割在导引头45上，以避免损伤导引头45。在没有导引头45的情况下，避免损伤人体组织。In addition, as shown in FIG. 6 , in this embodiment, the axial length of theouter punching head 43 is substantially equal to the axial length of theinner punching head 41 , and thecutting edge 432 of theouter punching head 43 covers the outer periphery of the cutting table 411 , the distal end of the second connectingportion 433 of theouter punching head 43 abuts against the proximal end of the guide table 413 of theinner punching head 41 , at this time, theouter punching head 43 faces theinner punching head 41 in the axial direction relative to theinner punching head 41 The movement of the distal end is limited, which can prevent theouter punching head 43 from moving too far distally relative to theinner punching head 41 to cause thecutting edge 432 to cut on theguide head 45 to avoid damage to theguide head 45 . Without theseeker 45, damage to human tissue is avoided.

请一并参阅图6及图8，外冲切头43的刃口432包括切割刃面434，切割刃面434自近端向远端逐渐靠近外推管23的轴线m。可以理解的是，为保证切割刃面434的锋利度，切割刃面434的切线n与外推管23的轴线m之间的夹角α不宜过大。在其中一个实施例中，切割刃面434的切线n与外推管23的轴线m之间的夹角α可以为10度。显然，在其他实施例中，切割刃面434的切线n与外推管23的轴线m之间的夹角还可以为8度、9度或者其他合理的角度。Please refer to FIG. 6 and FIG. 8 together, thecutting edge 432 of theouter punching head 43 includes acutting edge surface 434 , and thecutting edge surface 434 gradually approaches the axis m of thepusher tube 23 from the proximal end to the distal end. It can be understood that, in order to ensure the sharpness of the cuttingedge surface 434, the angle α between the tangent line n of the cuttingedge surface 434 and the axis m of theextrapolation tube 23 should not be too large. In one of the embodiments, the included angle α between the tangent line n of the cuttingedge surface 434 and the axis m of the push-outtube 23 may be 10 degrees. Obviously, in other embodiments, the included angle between the tangent line n of the cuttingedge surface 434 and the axis m of theextrapolation tube 23 may also be 8 degrees, 9 degrees or other reasonable angles.

请参阅图7至图10，刃口432可以为平滑刃口或者齿状刃口或者为二者的结合。刃口432可以为平直的刃口或斜切的刃口，即刃口432所形成的切面与外冲切头43的轴向的夹角为大于0度且小于180度。Referring to FIGS. 7 to 10 , thecutting edge 432 may be a smooth cutting edge or a toothed cutting edge or a combination of the two. Thecutting edge 432 may be a straight cutting edge or a chamfered cutting edge, that is, the included angle between the cutting plane formed by thecutting edge 432 and the axial direction of theouter punching head 43 is greater than 0 degrees and less than 180 degrees.

如图8所示，本实施例中，刃口432包括平滑刃口，且刃口432为平口，即刃口432所形成的切面与外冲切头43的轴向的夹角为90度。As shown in FIG. 8 , in this embodiment, thecutting edge 432 includes a smooth cutting edge, and thecutting edge 432 is a flat cutting edge, that is, the included angle between the cutting surface formed by thecutting edge 432 and the axial direction of theouter punching head 43 is 90 degrees.

如图10所示，在其他实施例中，外冲切头43b的结构与第一实施例中的外冲切头43的结构相似，不同之处在于：外冲切头43b的刃口432包括齿状刃口，且刃口为斜切的刃口，即刃口432所形成的切面的远端与外冲切头43b的轴向的远端的夹角为锐角。相比于平滑刃口，齿状刃口在冲切组织时，通过多个锋利的齿尖对组织进行冲切，能够使刃口432更容易地切除组织。相比于平直的刃口，斜切的刃口在冲切组织时，切割刃面的远端与组织的接触面积较小，在相同的冲切动力下，更小的接触面积能够使刃口432更容易地切除组织。As shown in FIG. 10 , in other embodiments, the structure of theouter punching head 43b is similar to that of theouter punching head 43 in the first embodiment, except that thecutting edge 432 of theouter punching head 43b includes The tooth-shaped cutting edge is a chamfered cutting edge, that is, the included angle between the distal end of the cutting surface formed by thecutting edge 432 and the axial distal end of theouter punching head 43b is an acute angle. Compared with the smooth cutting edge, the tooth-shaped cutting edge uses a plurality of sharp tooth tips to punch the tissue when punching the tissue, so that thecutting edge 432 can cut the tissue more easily. Compared with the straight cutting edge, the beveled cutting edge has a smaller contact area between the distal end of the cutting edge surface and the tissue when punching tissue. Under the same punching power, the smaller contact area can make the cutting edge.Port 432 makes it easier to resect tissue.

请一并参阅图1至图3，为了便于控制外推管23相对内推管21沿轴向的移动，介入性冲切器100还设置有手柄组件60，手柄组件60套设于内推管21的近端。手柄组件60包括壳体及活动地穿装于壳体内的滑轴65，壳体的近端相对于内推管21的近端固定。滑轴65套设于内推管21的近端外，并且滑轴65与外推管23的近端固定连接，由此，滑轴65在壳体内沿轴向滑动时，滑轴65带动外推管23相对内推管21沿轴向移动。其中，滑轴65沿轴向开设有供内推管21穿过的轴向通道。Please refer to FIGS. 1 to 3 together. In order to facilitate the control of the axial movement of theouter push tube 23 relative to theinner push tube 21, theinterventional punch 100 is further provided with ahandle assembly 60, and thehandle assembly 60 is sleeved on theinner push tube 21 proximal end. Thehandle assembly 60 includes a housing and a slidingshaft 65 movably inserted into the housing. The proximal end of the housing is fixed relative to the proximal end of theinner push tube 21 . The slidingshaft 65 is sleeved outside the proximal end of theinner push tube 21, and the slidingshaft 65 is fixedly connected with the proximal end of the outer pushingtube 23. Therefore, when the slidingshaft 65 slides in the axial direction in the housing, the slidingshaft 65 drives the outer Thepush tube 23 moves relative to theinner push tube 21 in the axial direction. Wherein, the slidingshaft 65 is provided with an axial channel along the axial direction for theinner push tube 21 to pass through.

具体地，如图3所示，壳体包括第一壳体61及与第一壳体61盖合的第二壳体62，二者通过螺接、卡合等方式可拆卸连接。本实施例中，第一壳体61上开设有卡合孔，第二壳体62对应凸设有卡合柱，第一壳体61与第二壳体62卡合连接。进一步地，壳体还包括分别可拆卸连接于盖合在一起的第一壳体61及第二壳体62的相对两端的第一卡箍63及第二卡箍64。如图2所示，本实施例中，第一卡箍63套接于第一壳体61及第二壳体62的远端，第二卡箍64螺接于第一壳体61及第二壳体62的近端。Specifically, as shown in FIG. 3 , the casing includes afirst casing 61 and asecond casing 62 that is covered with thefirst casing 61 , and the two are detachably connected by means of screwing, snapping or the like. In this embodiment, thefirst casing 61 is provided with an engaging hole, thesecond casing 62 is correspondingly provided with an engaging post, and thefirst casing 61 and thesecond casing 62 are engaged with each other. Further, the housing further includes afirst clamp 63 and asecond clamp 64 respectively detachably connected to opposite ends of thefirst case 61 and thesecond case 62 which are covered together. As shown in FIG. 2 , in this embodiment, thefirst clamp 63 is sleeved on the distal ends of thefirst casing 61 and thesecond casing 62 , and thesecond clamp 64 is screwed on thefirst casing 61 and thesecond casing 62 . Proximal end ofhousing 62 .

第一壳体61的内腔自远端向近端依次开设有相互连通且呈半圆槽状的第一腔体611、第二腔体612及第三腔体613。具体地，如图3所示，第一腔体611的远端贯穿第一壳体61的远端，第一腔体611的近端与第二腔体612直接连通，且第一腔体611的直径大于第二腔体612的直径，二者的连接处形成有半环状的止挡台阶；第二腔体612的近端与第三腔体613的远端之间设有半圆环状的间隔板；第三腔体613的近端连通第一壳体61的近端。Afirst cavity 611 , asecond cavity 612 and athird cavity 613 that communicate with each other and are in the shape of a semicircular groove are sequentially opened in the inner cavity of thefirst housing 61 from the distal end to the proximal end. Specifically, as shown in FIG. 3 , the distal end of thefirst cavity 611 penetrates the distal end of thefirst housing 61 , the proximal end of thefirst cavity 611 is in direct communication with thesecond cavity 612 , and thefirst cavity 611 The diameter of thesecond cavity 612 is larger than that of thesecond cavity 612 , and a semi-annular stop step is formed at the connection between the two; The proximal end of thethird cavity 613 communicates with the proximal end of thefirst housing 61 .

第二壳体62的内腔自远端向近端依次开设有与第一壳体61的第一腔体611、第二腔体612及第三腔体613一一对应的三个腔体(图未示)，其内腔结构与第一壳体61的内腔结构相同，此处不再赘述。The inner cavity of thesecond housing 62 is sequentially opened with three cavities ( Not shown), the inner cavity structure is the same as the inner cavity structure of thefirst housing 61 , which will not be repeated here.

可以理解的是，第一壳体61与第二壳体62盖合在一起后，第一壳体61与第二壳体62可围拢构成三个圆槽状的容置腔，具体为自远端向近端依次排列的第一容置腔、第二容置腔及第三容置腔。其中，第一容置腔的远端贯通壳体的远端，第一容置腔与第二容置腔的连接处具有环状的止挡台阶614(见图3)；第二容置腔与第三容置腔之间具有环状的间隔板616(见图3)，二者通过环状的间隔板616中间的圆孔连通，间隔板616中间的圆孔还用于供内推管21的近端穿过；第三容置腔连通于壳体的近端。It can be understood that, after thefirst casing 61 and thesecond casing 62 are covered together, thefirst casing 61 and thesecond casing 62 can be surrounded to form three circular groove-shaped accommodating cavities, specifically, the self-distance The first accommodating cavity, the second accommodating cavity and the third accommodating cavity are arranged in sequence from the end to the proximal end. The distal end of the first accommodating cavity penetrates the distal end of the housing, and the connection between the first accommodating cavity and the second accommodating cavity has an annular stop step 614 (see FIG. 3 ); the second accommodating cavity There is an annular spacer plate 616 (see FIG. 3 ) between it and the third accommodating cavity, and the two are communicated through the circular hole in the middle of theannular spacer plate 616, and the circular hole in the middle of thespacer plate 616 is also used for the inner push tube. The proximal end of 21 passes through; the third accommodating cavity is communicated with the proximal end of the housing.

如图2所示，手柄组件60还包括阀体66，阀体66滑动安装于第一容置腔内而位于壳体的远端，且阀体66的远端伸出于壳体的远端外。阀体66的远端固定连接于外推管23的近端，阀体66的近端固定连接于滑轴65的远端。本实施例中，阀体66与外推管23通过一连接管(未标号)固定连接，连接管的相对两端分别插接于阀体66的远端及外推管23的近端；滑轴65的远端插接于阀体66的近端，并且通过一对固定销(未标号)固定，以使滑轴65与阀体66直接固定连接。As shown in FIG. 2 , thehandle assembly 60 further includes avalve body 66 . Thevalve body 66 is slidably installed in the first accommodating cavity and is located at the distal end of the housing, and the distal end of thevalve body 66 protrudes from the distal end of the housing. outside. The distal end of thevalve body 66 is fixedly connected to the proximal end of the push-outtube 23 , and the proximal end of thevalve body 66 is fixedly connected to the distal end of the slidingshaft 65 . In this embodiment, thevalve body 66 and thepush tube 23 are fixedly connected by a connecting tube (not numbered), and the opposite ends of the connecting tube are respectively inserted into the distal end of thevalve body 66 and the proximal end of thepush tube 23; The distal end of theshaft 65 is inserted into the proximal end of thevalve body 66 and fixed by a pair of fixing pins (not numbered), so that the slidingshaft 65 is directly and fixedly connected with thevalve body 66 .

需要说明的是，阀体66开设有贯通两端的内腔，连接管及滑轴65分别插接于阀体66的内腔的相对两端。阀体66的内腔连通于连接管及外推管23的内腔，以及连通于滑轴65的轴向通道。It should be noted that thevalve body 66 is provided with an inner cavity penetrating both ends, and the connecting pipe and the slidingshaft 65 are respectively inserted into the opposite ends of the inner cavity of thevalve body 66 . The inner cavity of thevalve body 66 is communicated with the inner cavity of the connecting pipe and theouter push pipe 23 , and is communicated with the axial passage of the slidingshaft 65 .

如图2所示，阀体66的远端还开设有连通其内腔的阀口665，阀口665也即连通于外推管23的内腔，外推管23的远端对应开设有至少一个出液孔235，阀口665用于注入生理盐水或者造影剂等液体，液体经外推管23与内推管21之间的间隙并从出液孔235流出。本实施例中，外推管23的远端靠近外冲切头43的位置对称开设有一对出液孔235。可以理解的是，通过阀口665注入生理盐水后，生理盐水经外推管23与内推管21之间的间隙并从出液孔235流出，能够排除外推管23与内推管21之间的空气及杂质；而通过阀口665注入造影剂，造影剂经外推管23与内推管21之间的间隙并从出液孔235流出，能够实现手术过程中的影像观察，有利于辅助手术操作，提高手术效率和安全性。As shown in FIG. 2 , the distal end of thevalve body 66 is also provided with avalve port 665 which communicates with its inner cavity. Thevalve port 665 is also communicated with the inner cavity of theextrapolation tube 23 , and the distal end of theextrapolation tube 23 is correspondingly provided with at least There is aliquid outlet hole 235, and thevalve port 665 is used for injecting liquid such as physiological saline or contrast agent. In this embodiment, a pair of liquid outlet holes 235 are symmetrically opened at the position of the distal end of thepush tube 23 close to theouter punching head 43 . It can be understood that, after injecting the physiological saline through thevalve port 665, the physiological saline flows out from theliquid outlet hole 235 through the gap between theouter push tube 23 and theinner push tube 21, which can eliminate the relationship between theouter push tube 23 and theinner push tube 21. The contrast agent is injected through thevalve port 665, and the contrast agent flows out from theliquid outlet hole 235 through the gap between theouter push tube 23 and theinner push tube 21, which can realize image observation during the operation, which is beneficial to Assist surgical operations to improve surgical efficiency and safety.

优选地，本实施例中，手柄组件60还包括设置于阀口665的近端的密封塞67，用于防止液体从手柄组件60外漏。在其中一个实施例中，密封塞67设置于阀体66与内推管21之间且位于阀口665的近端、滑轴65的远端，用于防止阀口665注入的液体流入滑轴65与内推管21之间的间隙，从而保证液体只能从外推管23的出液孔235流出，提高液体的利用率。Preferably, in this embodiment, thehandle assembly 60 further includes a sealingplug 67 disposed at the proximal end of thevalve port 665 for preventing liquid from leaking from thehandle assembly 60 . In one embodiment, the sealingplug 67 is disposed between thevalve body 66 and theinner push tube 21 and is located at the proximal end of thevalve port 665 and the distal end of the slidingshaft 65, so as to prevent the liquid injected into thevalve port 665 from flowing into the slidingshaft 65 and theinner push pipe 21, so as to ensure that the liquid can only flow out from theliquid outlet hole 235 of theouter push pipe 23, and improve the utilization rate of the liquid.

如图2所示，第三容置腔用于固定一鲁尔接头68。具体地，鲁尔接头68的远端部分卡合安装于第三容置腔内，鲁尔接头68的近端自第三容置腔伸出于壳体的近端外。内推管21的近端依次穿过外推管23、连接管、阀体66的内腔及滑轴65的轴向通道，并且穿过第二容置腔与第三容置腔之间的间隔板中部的圆孔而固定连接于鲁尔接头68的远端，从而实现内推管21的近端相对壳体的近端固定。As shown in FIG. 2 , the third accommodating cavity is used for fixing aluer connector 68 . Specifically, the distal end portion of theluer connector 68 is snap-fitted into the third accommodating cavity, and the proximal end of theluer connector 68 protrudes out of the proximal end of the housing from the third accommodating cavity. The proximal end of theinner push tube 21 passes through theouter push tube 23, the connecting tube, the inner cavity of thevalve body 66 and the axial passage of the slidingshaft 65 in sequence, and passes through the space between the second accommodating cavity and the third accommodating cavity. The round hole in the middle of the spacer plate is fixedly connected to the distal end of theluer connector 68, so that the proximal end of theinner push tube 21 is fixed relative to the proximal end of the housing.

请再次参阅图2，滑轴65的主体部分滑动安装于壳体的第二容置腔内，滑轴65的远端部分伸入第一容置腔内而与阀体66的近端固定连接，滑轴65的近端设置有驱动件，驱动件用于驱动滑轴65在第 一容置腔与第二容置腔内沿轴向滑动。Please refer to FIG. 2 again, the main part of the slidingshaft 65 is slidably installed in the second accommodating cavity of the housing, and the distal part of the slidingshaft 65 extends into the first accommodating cavity and is fixedly connected with the proximal end of thevalve body 66 The proximal end of the slidingshaft 65 is provided with a driving member, and the driving member is used to drive the slidingshaft 65 to slide axially in the first accommodating cavity and the second accommodating cavity.

具体地，驱动件可通过旋转方式或推拉滑动等方式驱动滑轴65沿轴向滑动，如图2及图3所示，本实施例中，驱动件通过旋转方式驱动滑轴65沿轴向滑动。第一壳体61的近端部分与对应第二腔体612的近端的区域内开设有连通其内腔且沿其轴向延伸的导滑槽615，第二壳体62对应开设有导滑槽625，第一壳体61与第二壳体62盖合在一起后，第一壳体61的导滑槽615与第二壳体62的导滑槽625关于滑轴65轴对称。本实施例中，驱动件为开设有外螺纹的一对凸块655，一对凸块655轴对称地凸设于滑轴65的近端，滑轴65安装于壳体内时，每一凸块655位于一对应的导滑槽内并延伸出导滑槽外露；进一步地，盖合在一起的第一壳体61及第二壳体62的近端部分还套设有转套69，转套69的内周面设置有与凸块655上的外螺纹配合的内螺纹，转套69与一对凸块655螺纹连接。其中，需要说明的是，如图2及图3所示，盖合在一起的第一壳体61及第二壳体62靠近中部的位置设有一圈止挡环617，转套69套接于盖合在一起的第一壳体61及第二壳体62的近端部分上时，转套69的远端抵顶于止挡环617上，第二卡箍64螺接于第一壳体61及第二壳体62的近端后，第二卡箍64的远端抵顶于转套69的近端，使得转套69相对壳体的轴向位置被固定，转套69只能相对壳体转动。由于转套69不能相对壳体沿轴向移动，因此，当转套69相对凸块655转动时，转套69可驱动凸块655在对应的导滑槽内沿壳体的轴向移动，进而驱动滑轴65在第一容置腔与第二容置腔内沿轴向滑动，滑轴65带动与其连接的阀体66及与阀体66连接的外推管23沿轴向移动，使得外推管23相对内推管21沿轴向移动以带动外冲切头43相对内冲切头41沿轴向移动。Specifically, the driving member can drive the slidingshaft 65 to slide in the axial direction by means of rotation or push-pull sliding. As shown in FIG. 2 and FIG. 3 , in this embodiment, the driving member drives the slidingshaft 65 to slide in the axial direction by means of rotation. . The proximal end portion of thefirst housing 61 and the region corresponding to the proximal end of thesecond cavity 612 are provided with aguide chute 615 communicating with the inner cavity and extending along the axial direction thereof, and thesecond housing 62 is correspondingly provided with aguide chute 615Slot 625 , after thefirst casing 61 and thesecond casing 62 are covered together, theguide groove 615 of thefirst casing 61 and theguide groove 625 of thesecond casing 62 are axially symmetrical with respect to the slidingshaft 65 . In this embodiment, the driving member is a pair ofprotrusions 655 with external threads. The pair ofprotrusions 655 are axially symmetrically protruded on the proximal end of the slidingshaft 65. When the slidingshaft 65 is installed in the housing, eachprotrusion 655 is located in a corresponding guide chute and extends out of the guide chute to be exposed; further, the proximal end portion of thefirst shell 61 and thesecond shell 62 that are covered together is also sleeved with arotating sleeve 69, and the rotating sleeve The inner peripheral surface of 69 is provided with an inner thread which is matched with the outer thread on theconvex block 655 , and therotating sleeve 69 is threadedly connected with a pair ofconvex blocks 655 . Among them, it should be noted that, as shown in FIG. 2 and FIG. 3 , astop ring 617 is provided near the middle of thefirst housing 61 and thesecond housing 62 that are covered together, and therotating sleeve 69 is sleeved on the When the proximal end portion of thefirst shell 61 and thesecond shell 62 are closed together, the distal end of therotating sleeve 69 abuts against thestop ring 617, and thesecond clamp 64 is screwed to thefirst shell 61 and the proximal end of thesecond casing 62, the distal end of thesecond clamp 64 abuts against the proximal end of therotating sleeve 69, so that the axial position of therotating sleeve 69 relative to the casing is fixed, and therotating sleeve 69 can only be opposite The casing rotates. Since therotating sleeve 69 cannot move relative to the housing in the axial direction, when therotating sleeve 69 rotates relative to theconvex block 655, the rotatingsleeve 69 can drive theconvex block 655 to move along the axial direction of the casing in the corresponding guide chute, and further The slidingshaft 65 is driven to slide axially in the first accommodating cavity and the second accommodating cavity, and the slidingshaft 65 drives thevalve body 66 connected to it and thepush tube 23 connected to thevalve body 66 to move in the axial direction, so that the external Thepush tube 23 moves relative to theinner push tube 21 in the axial direction to drive theouter punching head 43 to move relative to theinner punching head 41 in the axial direction.

本实施例中，一对凸块655轴对称设置，转套69相对凸块655转动而提供给滑轴65的驱动力对称，使得滑轴65的滑动平稳性较好。In this embodiment, a pair ofprojections 655 are axially symmetrical, and therotating sleeve 69 rotates relative to theprojections 655 to provide a symmetrical driving force to the slidingshaft 65 , so that the sliding stability of the slidingshaft 65 is better.

在其他实施例中，一对凸块655可以非轴对称设置，其对应的两个导滑槽非轴对称开设于第一壳体61和/或第二壳体62上。In other embodiments, a pair ofprotrusions 655 may be disposed axisymmetrically, and the corresponding two guide grooves are axisymmetrically provided on thefirst casing 61 and/or thesecond casing 62 .

在其他实施例中，凸块655的数量可以设置为一个或者多个，导滑槽的数量对应设置一个或者多个；多个凸块655可以轴对称设置或者非轴对称设置，相应的，多个导滑槽轴对称开设或者非轴对称开设于第一壳体61和/或第二壳体62上。In other embodiments, the number of thebumps 655 can be set to one or more, and the number of guide grooves can be set to one or more correspondingly; the plurality ofbumps 655 can be arranged axisymmetrically or axisymmetrically. Axisymmetrically or non-axisymmetrically open each guide chute on thefirst casing 61 and/or thesecond casing 62 .

可以理解的是，凸块655在对应的导滑槽内沿轴向朝远端滑动至抵顶于导滑槽的远端时，凸块655朝远端的移动被限制，滑轴65带动外推管23相对内推管21沿轴向朝远端的移动也被限制；而凸块655在对应的导滑槽内沿轴向朝近端滑动至抵顶于导滑槽的近端时，凸块655朝近端的移动被限制，滑轴65带动外推管23相对内推管21沿轴向朝近端的移动也被限制。换句话说，导滑槽的轴向长度用于限制凸块655沿轴向的滑动距离，进而限制滑轴65带动外推管23相对内推管21沿轴向移动的距离。为了保证外推管23相对于内推管21沿轴向移动的距离足够长，以使外冲切头41相对内冲切头43沿轴向移动后能够完全暴露或者完全封闭取样槽412，导滑槽的轴向长度应大于或者等于完全暴露或者封闭取样槽412时外冲切头41相对内冲切头43沿轴向移动的距离。优选地，本实施例中，导滑槽的轴向长度等于完全暴露或者封闭取样槽412时外冲切头41相对内冲切头43沿轴向移动的距离。It can be understood that, when theprotrusion 655 slides axially toward the distal end in the corresponding guide chute until it abuts against the distal end of the guide chute, the movement of theprotrusion 655 toward the distal end is restricted, and the slidingshaft 65 drives the outside. The distal movement of thepush tube 23 relative to theinner push tube 21 in the axial direction is also restricted; and when theprojection 655 slides axially toward the proximal end in the corresponding guide chute until it abuts against the proximal end of the guide chute, The movement of theprotrusion 655 toward the proximal end is restricted, and the movement of theouter push tube 23 driven by the slidingshaft 65 toward the proximal end relative to theinner push tube 21 in the axial direction is also restricted. In other words, the axial length of the guide chute is used to limit the axial sliding distance of theprojection 655 , thereby limiting the axial movement distance of theouter push tube 23 relative to theinner push tube 21 driven by the slidingshaft 65 . In order to ensure that the distance that theouter push tube 23 moves in the axial direction relative to theinner push tube 21 is long enough so that theouter punching head 41 can completely expose or completely close thesampling groove 412 after theouter punching head 41 moves relative to theinner punching head 43 in the axial direction, the guide The axial length of the chute should be greater than or equal to the distance that theouter punching head 41 moves relative to theinner punching head 43 in the axial direction when thesampling groove 412 is completely exposed or closed. Preferably, in this embodiment, the axial length of the guide chute is equal to the distance that theouter punching head 41 moves relative to theinner punching head 43 in the axial direction when thesampling groove 412 is completely exposed or closed.

如图2所示，第一容置腔与第二容置腔的连接处形成有环状的止挡台阶，当滑轴65带动阀体66沿轴向朝近端移动至阀体66的近端抵顶于止挡台阶时，同样可以限制滑轴65朝近端的移动，从而限制外推管23相对内推管21沿轴向朝近端的移动；此外，如前，当第二连接部433的远端抵顶于导台413的 近端时(见图6)，同样可以限制外冲切头43相对内冲切头41沿轴向朝远端的移动，从而限制外推管23相对内推管21沿轴向朝远端的移动。可见，限制外推管23相对内推管21沿轴向朝任一端的移动可以通过一种或多种不同的方式来实现，有利于提高限制外推管23相对于内推管21沿轴向移动的可靠性。As shown in FIG. 2 , an annular stop step is formed at the connection between the first accommodating cavity and the second accommodating cavity. When the slidingshaft 65 drives thevalve body 66 to move toward the proximal end in the axial direction to the proximal end of thevalve body 66 When the end abuts the stop step, the movement of the slidingshaft 65 towards the proximal end can also be restricted, thereby restricting the movement of theouter push tube 23 relative to theinner push tube 21 toward the proximal end in the axial direction; in addition, as before, when the second connection When the distal end of theportion 433 abuts against the proximal end of the guide table 413 (see FIG. 6 ), the movement of theouter punching head 43 relative to theinner punching head 41 toward the distal end in the axial direction can also be restricted, thereby restricting thepusher tube 23 The movement of theinner pusher tube 21 toward the distal end in the axial direction. It can be seen that restricting the movement of theouter push tube 23 relative to theinner push tube 21 toward either end in the axial direction can be achieved in one or more different ways, which is beneficial to improve the restriction of the axial movement of theouter push tube 23 relative to theinner push tube 21 in the axial direction. Mobile reliability.

本实施例中，转套69与凸块655之间为螺纹连接，当撤掉用于旋转转套69的外力时，螺纹结构会实现转套69与凸块665之间的自锁，由于此时转套69相对壳体不转动，因此凸块665及滑轴65与壳体之间的轴向相对位置不变，从而使外推管23相对内推管21的轴向位置也不变，由此，外冲切头43封闭内冲切头41的取样槽412后保持转套69不动，外冲切头43就能够始终封闭取样槽412。In this embodiment, the rotatingsleeve 69 and theconvex block 655 are connected by a thread. When the external force for rotating therotating sleeve 69 is removed, the threaded structure will realize the self-locking between therotating sleeve 69 and theconvex block 665. When therotating sleeve 69 does not rotate relative to the housing, the axial relative position between theprojection 665 and the slidingshaft 65 and the housing remains unchanged, so that the axial position of theouter push tube 23 relative to theinner push tube 21 also remains unchanged. Therefore, theouter punching head 43 can keep therotating sleeve 69 still after closing thesampling groove 412 of theinner punching head 41, and theouter punching head 43 can always close thesampling groove 412.

请一并参阅图11至图14，以下以房间隔为目标位置，说明本申请提供的介入性冲切器100的冲切方法包括冲切前处理、冲切处理及冲切后处理，具体使用过程：Please refer to FIG. 11 to FIG. 14 together. The following describes the punching method of theinterventional punching device 100 provided by the present application, taking the interatrial septum as the target position, including pre-punching treatment, punching treatment and post-punching treatment. Process:

所述冲切前处理包括：The pre-cutting treatment includes:

第一步：提供如上所述的介入性冲切器100，其包括冲切组件40及推管组件20，推管组件20包括内推管21及活动地套设于内推管21外的外推管23；冲切组件40包括固定于内推管21的远端的内冲切头41及固定于外推管23的远端的外冲切头43，内冲切头41开设取样槽412，取样槽412用于将被切除组织保留在其内。具体的，选择经股静脉-右心房-房间隔的途径，利用鞘管(图未示)建立从患者体外到体内的介入通道，沿介入通道送入导丝直至右心房，再穿刺房间隔的卵圆窝位置，将导丝由右心房送至左心房；然后将介入性冲切器100的推管组件20及冲切组件40穿装在鞘管中，并在导丝的引导下推送至左心房，使导引头45及冲切组件40靠近房间隔，如图11所示。当然，还可根据手术实际情况选择其他可靠近房间隔的途径。Step 1: Provide theinterventional punching device 100 as described above, which includes a punchingassembly 40 and apush tube assembly 20 , and thepush tube assembly 20 includes aninner push tube 21 and an outer push tube movably sleeved outside theinner push tube 21Push tube 23; the punchingassembly 40 includes aninner punching head 41 fixed to the distal end of theinner push tube 21 and anouter punching head 43 fixed to the distal end of theouter push tube 23, and theinner punching head 41 is provided with asampling groove 412 , thesampling slot 412 is used to retain the resected tissue therein. Specifically, the route through the femoral vein-right atrium-atrial septum is selected, an interventional channel from the outside of the patient's body to the body is established by using a sheath (not shown in the figure), a guide wire is sent along the interventional channel to the right atrium, and then the atrial septum is punctured. At the position of the fossa ovalis, the guide wire is sent from the right atrium to the left atrium; then thepush tube assembly 20 and the punchingassembly 40 of theinterventional punching device 100 are inserted into the sheath, and pushed to the In the left atrium, theintroducer head 45 and thedie cutting assembly 40 are brought close to the atrial septum, as shown in FIG. 11 . Of course, other approaches that can be close to the atrial septum can also be selected according to the actual situation of the operation.

第二步：操作者通过旋转转套69，以驱动滑轴65在壳体内沿轴向朝近端移动，使外冲切头43相对内冲切头41沿轴向朝近端移动，使得内冲切头41的取样槽412完全暴露出来；操作者同时朝远端推动整个手柄组件60，使导引头45穿过房间隔，以带动内冲切头41穿过房间隔，此时，需保证外冲切头43的刃口432不穿过房间隔，且部分房间隔组织进入取样槽412内，如图12所示。当然，在其他实施例中，使待切割组织进入取样槽412内的过程也可以是冲切组件40的远端部分穿过目标位置组织之后，再将外推管23相对内推管21沿轴向朝近端移动以带动外冲切头43相对内冲切头41沿轴向朝近端移动，使取样槽412暴露(见图4)，部分房间隔组织进入取样槽412内。Step 2: The operator rotates therotary sleeve 69 to drive the slidingshaft 65 to move toward the proximal end in the axial direction in the housing, so that theouter punching head 43 moves toward the proximal end in the axial direction relative to theinner punching head 41, so that theinner punching head 43 moves toward the proximal end in the axial direction relative to theinner punching head 41 Thesampling groove 412 of the punchinghead 41 is completely exposed; the operator pushes theentire handle assembly 60 toward the distal end at the same time, so that theguide head 45 passes through the interatrial septum, so as to drive theinner punching head 41 to pass through the interatrial septum. It is ensured that thecutting edge 432 of theouter punching head 43 does not pass through the atrial septum, and part of the atrial septum tissue enters thesampling groove 412, as shown in FIG. 12 . Of course, in other embodiments, the process of entering the tissue to be cut into thesampling groove 412 may also be that after the distal end portion of the punchingassembly 40 passes through the tissue at the target position, theouter push tube 23 is moved relative to theinner push tube 21 along the axis Move toward the proximal end to drive theouter punching head 43 to move proximally relative to theinner punching head 41 in the axial direction to expose the sampling groove 412 (see FIG. 4 ), and part of the interatrial septum tissue enters thesampling groove 412 .

第三步：冲切处理：操作者反向旋转转套69，以驱动滑轴65在壳体内沿轴向朝远端移动，使外冲切头43相对内冲切头41沿轴向朝远端移动，促使外冲切头43的刃口432冲切套于内冲切头41的取样槽412的外周的组织，直至外冲切头43完全封闭取样槽412且刃口432覆盖于内冲切头41的切台411外周，如图13所示。The third step: punching processing: the operator reversely rotates therotary sleeve 69 to drive the slidingshaft 65 to move axially to the distal end in the housing, so that theouter punching head 43 is axially farther than theinner punching head 41 The end moves, so that thecutting edge 432 of theouter punching head 43 punches the tissue around thesampling groove 412 of theinner punching head 41 until theouter punching head 43 completely closes thesampling groove 412 and thecutting edge 432 covers theinner punching head 41. The outer periphery of the cutting table 411 of the cuttinghead 41 is shown in FIG. 13 .

第四步：冲切后处理：保持转套69不动，使外冲切头43相对内冲切头41的轴向位置不变，外冲切头43始终封闭取样槽412，被切除组织保留在取样槽412内，再将整个介入性冲切器100撤出体外，此时房间隔上留下与外冲切头43的形状相当的孔，如图14所示。最后取出保留在取样槽412内的被切除组织，以作为活检样本进行检验分析，手术过程完毕。从而实现打孔和取样的目的，整个过程中，操作方便效率高；再者，被切除组织保留在封闭的取样槽412内，使得血管内或者鞘管内没有组织碎屑的残留，可减少血栓的形成，不需要做开胸手术，能够避免带来二次伤害和污染，手术风险低。The fourth step: post-punching treatment: keep therotating sleeve 69 still, so that the axial position of theouter punching head 43 relative to theinner punching head 41 remains unchanged, theouter punching head 43 always closes thesampling groove 412, and the excised tissue is retained In thesampling groove 412, the entireinterventional punch 100 is withdrawn from the body, and at this time, a hole corresponding to the shape of theouter punching head 43 is left in the interatrial septum, as shown in FIG. 14 . Finally, the resected tissue remaining in thesampling groove 412 is taken out to be used as a biopsy sample for inspection and analysis, and the operation process is completed. In this way, the purpose of punching and sampling is achieved. In the whole process, the operation is convenient and efficient; in addition, the resected tissue is retained in theclosed sampling groove 412, so that no tissue debris remains in the blood vessel or sheath, which can reduce the risk of thrombosis. It does not require thoracotomy, can avoid secondary injury and pollution, and has low surgical risk.

上述实施例提供的介入性冲切器100针对患者体内组织通过旋转前进的方式，可实现稳定可控的切 割与抓捕。Theinterventional punch 100 provided by the above embodiments can achieve stable and controllable cutting and capturing by rotating and advancing the tissue in the patient's body.

在其中一个实施例中，如图1所示，内推管21和/或外推管23可以为预塑形鞘管或可调弯鞘管，便于通过弯曲的血管，从而将导引头45及冲切组件40推送至目标位置。In one of the embodiments, as shown in FIG. 1 , theinner pusher tube 21 and/or theouter pusher tube 23 may be a pre-shaped sheath tube or an adjustable sheath tube, which is convenient for passing through a curved blood vessel, so as to insert theintroducer 45 And the punchingassembly 40 is pushed to the target position.

请一并参阅图15及图16，本申请第二实施例提供的介入性冲切器200与第一实施例的介入性冲切器100的结构基本相似，不同之处在于：在第二实施例中，驱动件通过推拉方式驱动滑轴65滑动。具体地，驱动件为凸设于滑轴65近端的至少一个推拉环655b，推拉环655b通过对应的导滑槽外露且可在导滑槽内移动，通过推动和拉动推拉环655b控制滑轴65及与滑轴65连接的外推管23沿壳体的轴向移动，操作同样方便简单。Please refer to FIG. 15 and FIG. 16 together. The structure of theinterventional punch 200 provided by the second embodiment of the present application is basically similar to that of theinterventional punch 100 of the first embodiment. The difference is that in the second embodiment In an example, the driving member drives the slidingshaft 65 to slide in a push-pull manner. Specifically, the driving member is at least one push-pull ring 655b protruding from the proximal end of the slidingshaft 65, the push-pull ring 655b is exposed through the corresponding guide groove and can move in the guide groove, and the sliding shaft is controlled by pushing and pulling the push-pull ring 655b 65 and the push-outtube 23 connected with the slidingshaft 65 move along the axial direction of the housing, and the operation is also convenient and simple.

本实施例中，驱动件优选为两个推拉环655b，且两个推拉环655b对称设置于滑轴65的两侧，从而能够通过两个推拉环655b向滑轴65提供对称的驱动力，使滑轴65平稳滑动。In this embodiment, the driving member is preferably two push-pull rings 655b, and the two push-pull rings 655b are symmetrically arranged on both sides of the slidingshaft 65, so that the two push-pull rings 655b can provide a symmetrical driving force to the slidingshaft 65, so that theThe sliding shaft 65 slides smoothly.

此外，与介入性冲切器100的不同之处还在于，介入性冲切器200中，手柄组件60的近端还设置有锁定机构，用于防止外冲切头43封闭取样槽412后弹开，避免取样槽412被暴露。In addition, the difference from theinterventional punch 100 is that in theinterventional punch 200, the proximal end of thehandle assembly 60 is further provided with a locking mechanism for preventing theouter punching head 43 from closing thesampling groove 412 and rebounding open to prevent thesampling slot 412 from being exposed.

具体地，请一并参阅图17至图20，锁定机构包括设置于壳体近端的卡凸91和位于驱动件(即推拉环655b)远端的弹片93，卡凸91和弹片93可形成卡扣结构，以锁定驱动件的沿轴向滑动。弹片93包括位于远端的凸起932及位于凸起932的近端一侧的凹槽931，推动推拉环655b时，凸起932大致朝远端方向移动，滑动地抵推卡凸91，以使弹片93逐渐进行弹性形变，当卡凸91正对凹槽931时，弹片93弹性复位使卡凸91卡入凹槽931内，使驱动件沿轴向朝近端的移动被锁定。在没有受到外力作用时，卡凸91和弹片93形成的卡扣结构能够防止推拉环655b朝近端移动，避免外冲切头43朝近端移动而暴露取样槽412。可以理解的是，当需要暴露取样槽412时，操作者只需朝近端拉动推拉环655b，即可解除锁定机构对推拉环655b的锁定，使推拉环655b带动滑轴65沿轴向朝近端滑动，最终带动外冲切头43朝近端移动而暴露取样槽412，解锁过程简单。Specifically, please refer to FIG. 17 to FIG. 20 together, the locking mechanism includes a latchingprotrusion 91 disposed at the proximal end of the housing and anelastic piece 93 located at the distal end of the driving member (ie, the push-pull ring 655b). The latchingprotrusion 91 and theelastic piece 93 can form a The snap structure is used to lock the axial sliding of the driving member. Theelastic piece 93 includes aprotrusion 932 located at the distal end and agroove 931 located at the proximal end of theprotrusion 932. When the push-pull ring 655b is pushed, theprotrusion 932 moves approximately toward the distal end, and slidably pushes against the latchingprotrusion 91, so that Theelastic piece 93 is gradually elastically deformed. When the latchingprotrusion 91 is facing thegroove 931, theelastic piece 93 is elastically reset so that the latchingprotrusion 91 is inserted into thegroove 931, so that the proximal movement of the driving member in the axial direction is locked. When no external force is applied, the snap structure formed by thesnap protrusions 91 and theelastic pieces 93 can prevent the push-pull ring 655b from moving toward the proximal end and prevent theouter punching head 43 from moving toward the proximal end and exposing thesampling groove 412 . It can be understood that, when thesampling groove 412 needs to be exposed, the operator only needs to pull the push-pull ring 655b toward the proximal end, and then the locking mechanism of the push-pull ring 655b can be released, so that the push-pull ring 655b drives the slidingshaft 65 toward the axial direction. The end slides, and finally drives theouter punching head 43 to move toward the proximal end to expose thesampling groove 412 , and the unlocking process is simple.

请参阅图21，本申请第三实施例提供的介入性冲切器300与第二实施例的介入性冲切器200的结构基本相似，不同之处在于：在第三实施例中，介入性冲切器300还包括导电线81，导电线81的远端自手柄组件的近端穿入至电连接于外冲切头43和/或电连接于内冲切头41，导电线81的近端外接能源装置以向冲切组件40提供消融能量，消融能量能够对组织细胞进行消融，有利于外冲切头43快速在目标位置的组织上进行消融打孔，而且在打孔完成后，外冲切头43的外壁仍可以继续对组织上的穿孔进行消融，能够降低组织上的穿孔愈合的风险。Referring to FIG. 21 , theinterventional punch 300 provided by the third embodiment of the present application is basically similar in structure to theinterventional punch 200 of the second embodiment, except that in the third embodiment, theinterventional punch 200 Thepunch 300 also includes aconductive wire 81, the distal end of theconductive wire 81 penetrates from the proximal end of the handle assembly to the electrical connection to theouter punching head 43 and/or to theinner punching head 41, and the proximal end of theconductive wire 81 is connected. An external energy device is connected to the end to provide ablation energy to thepunching component 40. The ablation energy can ablate tissue cells, which is beneficial for theouter punching head 43 to quickly ablate and perforate the tissue at the target position. The outer wall of the punchinghead 43 can still continue to ablate the perforation in the tissue, which can reduce the risk of healing of the perforation in the tissue.

具体地，本实施例中，导电线81的远端自鲁尔接头68的内腔中穿入，经内推管21与滑轴65之间的间隙、内推管21与阀体66之间的间隙、内推管21与外推管23之间的间隙电连接于外冲切头43，导电线81的近端电连接一能量接头83，通过能量接头83外接能源装置，从而向外冲切头43提供消融能量。Specifically, in this embodiment, the distal end of theconductive wire 81 penetrates through the lumen of theluer connector 68 , passes through the gap between theinner push tube 21 and the slidingshaft 65 , and between theinner push tube 21 and thevalve body 66 . The gap between theinner push tube 21 and theouter push tube 23 is electrically connected to theouter punching head 43, the proximal end of theconductive wire 81 is electrically connected to anenergy connector 83, and an external energy device is connected through theenergy connector 83, thereby punching outward. The cuttinghead 43 provides ablation energy.

其中，消融能量可以包括但不限于为射频能源、微波能源、脉冲能源中的任意一种。相应的，能源装置为射频能源装置、微波能源装置、脉冲能源装置。The ablation energy may include, but is not limited to, any one of radio frequency energy, microwave energy, and pulse energy. Correspondingly, the energy device is a radio frequency energy device, a microwave energy device, and a pulse energy device.

请一并参阅图22至图25，本申请第四实施例提供的介入性冲切器与第三实施例的介入性冲切器300的结构基本相似，不同之处在于：第四实施例中，外冲切头43选用弹性金属材料制成用于进行弹性形变，外冲切头43可沿轴向被压缩且沿径向被扩张，以用于对套于外冲切头43外周的组织的穿孔进行扩 张，使穿孔附近的组织紧贴于外冲切头43的外壁，有利于促进外冲切头43传递消融能量以对穿孔附近的组织进行消融，从而有效防止穿孔愈合。Please refer to FIG. 22 to FIG. 25 together. The structure of the interventional punch provided by the fourth embodiment of the present application is basically similar to that of theinterventional punch 300 of the third embodiment. The difference is that in the fourth embodiment , theouter punching head 43 is made of elastic metal material for elastic deformation, and theouter punching head 43 can be compressed in the axial direction and expanded in the radial direction, so as to be used to cover the tissue on the outer periphery of theouter punching head 43 The perforation is expanded, so that the tissue near the perforation is close to the outer wall of theouter punching head 43, which is conducive to promoting theouter punching head 43 to transmit ablation energy to ablate the tissue near the perforation, thereby effectively preventing the perforation from healing.

具体地，本实施例中，外冲切头43设有腰部4312，外冲切头43靠近腰部4312的远端的部分435(见图22)和外冲切头43靠近腰部4312的近端的部分436(见图22)的直径大于腰部4312的直径。内冲切头41的切台411的直径自近端向远端逐渐增大，当外冲切头43对套于内冲切头41的取样槽412的外周的组织进行冲切后，外冲切头43的刃口432抵顶于切台411上，之后可调整介入性冲切器，使打孔后的组织包裹腰部4312，继续朝远端挤压外冲切头43时，由于刃口432抵顶于切台411上，外冲切头43沿轴向被压缩且沿径向被扩张，此时，腰部4312外周的组织随外冲切头43一起扩张，可以促进腰部4312紧贴打孔附近的组织以对其进行消融，从而有效防止组织上的穿孔愈合。Specifically, in this embodiment, theouter punching head 43 is provided with awaist portion 4312 , a portion 435 (see FIG. 22 ) of theouter punching head 43 near the distal end of thewaist portion 4312 and aportion 435 of theouter punching head 43 near the proximal end of thewaist portion 4312 The diameter of the portion 436 (see FIG. 22 ) is greater than the diameter of thewaist 4312 . The diameter of the cutting table 411 of theinner punching head 41 gradually increases from the proximal end to the distal end. When theouter punching head 43 punches the tissue surrounding thesampling groove 412 of theinner punching head 41, the outer punching Thecutting edge 432 of the cuttinghead 43 abuts on the cutting table 411, and then the interventional punching device can be adjusted so that the punched tissue wraps thewaist 4312. 432 abuts on the cutting table 411, and theouter punching head 43 is compressed in the axial direction and expanded in the radial direction. At this time, the tissue around thewaist 4312 expands together with theouter punching head 43, which can promote thewaist 4312 to stick to the punching head. The tissue near the hole is ablated to effectively prevent the perforation in the tissue from healing.

进一步地，请参阅图26，第四实施例提供的介入性冲切器中，弹片93的凹槽931b具有轴向长度，轴向长度用于限定外冲切头43的最大轴向形变长度。具体地，刃口432抵顶于切台411上时，卡凸91卡入凹槽931b且位于凹槽931b的远端，朝远端推动推拉环655b以使外冲切头43朝远端移动时，外冲切头43逐渐发生弹性形变，外冲切头43开始沿轴向被压缩且沿径向被扩张，卡凸91在凹槽931b内朝近端滑动。可以理解的是，当卡凸91在凹槽931b内朝近端滑动至卡凸91抵顶于凹槽931b的近端槽壁时，推拉环655b朝远端的移动被限制，从而外冲切头43朝远端的移动也被限制，外冲切头43的轴向形变长度达到最大值，相应的，外冲切头43的径向扩张量也即达到最大值。因此，通过控制凹槽931b的轴向长度，可以控制外冲切头的轴向形变长度，也即可以控制外冲切头43的径向扩张量，以使外冲切头43在安全范围内沿径向扩张。Further, referring to FIG. 26 , in the interventional punching device provided by the fourth embodiment, thegroove 931b of theelastic piece 93 has an axial length, and the axial length is used to limit the maximum axial deformation length of theouter punching head 43 . Specifically, when thecutting edge 432 abuts on the cutting table 411, thesnap protrusion 91 snaps into thegroove 931b and is located at the distal end of thegroove 931b, and pushes the push-pull ring 655b toward the distal end to move theouter punching head 43 toward the distal end At the time, theouter punching head 43 gradually undergoes elastic deformation, theouter punching head 43 begins to be compressed in the axial direction and expands in the radial direction, and thesnap protrusion 91 slides toward the proximal end in thegroove 931b. It can be understood that when the snap-onprotrusion 91 slides toward the proximal end in thegroove 931b until the snap-onprotrusion 91 abuts against the proximal end groove wall of thegroove 931b, the movement of the push-pull ring 655b toward the distal end is limited, so that the outer punch is cut. The movement of thehead 43 towards the distal end is also restricted, the axial deformation length of theouter punching head 43 reaches the maximum value, and correspondingly, the radial expansion amount of theouter punching head 43 also reaches the maximum value. Therefore, by controlling the axial length of thegroove 931b, the axial deformation length of theouter punching head 43 can be controlled, that is, the radial expansion amount of theouter punching head 43 can be controlled, so that theouter punching head 43 is within a safe range Expand radially.

需要说明的是，在其他实施例中，内冲切头41的切台411的直径可以等于刃口432的直径，切台411的外周设置止挡结构，通过止挡结构抵顶刃口432，持续朝远端移动外冲切头43时同样可以实现外冲切头43的弹性变形。其中，止挡结构可以是止挡环、止挡块等任意结构。It should be noted that, in other embodiments, the diameter of the cutting table 411 of theinner punching head 41 may be equal to the diameter of thecutting edge 432, and a stopper structure is provided on the outer periphery of the cutting table 411, and thecutting edge 432 is pushed against the stopper structure by the stopper structure. The elastic deformation of theouter punching head 43 can also be achieved by continuously moving theouter punching head 43 towards the distal end. Wherein, the stop structure can be any structure such as stop ring and stop block.

请参阅图27，图27是本申请的介入性冲切器的冲切方法流程图。所述介入性冲切器的冲切方法，包括：Please refer to FIG. 27 , which is a flowchart of the punching method of the interventional punching device of the present application. The punching method of the interventional punching device includes:

提供介入性冲切器，所述介入性冲切器包括冲切组件40及推管组件20，所述推管组件20包括内推管21及活动地套设于所述内推管21外的外推管23；所述冲切组件40包括固定于所述内推管21的远端的内冲切头41及固定于所述外推管23的远端的外冲切头43，所述内冲切头41开设取样槽412；An interventional punching device is provided, the interventional punching device includes a punchingassembly 40 and apush tube assembly 20, thepush tube assembly 20 includes aninner push tube 21 and a movably sleeved outside theinner push tube 21. Theouter push tube 23 ; the punchingassembly 40 includes aninner punching head 41 fixed to the distal end of theinner push tube 21 and anouter punching head 43 fixed to the distal end of theouter push tube 23 . Theinner punching head 41 is provided with asampling groove 412;

将所述外推管23相对所述内推管21沿轴向移动以带动所述外冲切头43相对所述内冲切头41沿轴向移动，以使所述外冲切头43对套于所述内冲切头41的取样槽412外周的组织进行冲切；Move theouter push tube 23 relative to theinner push tube 21 in the axial direction to drive theouter punching head 43 to move relative to theinner punching head 41 in the axial direction, so that theouter punching head 43 The tissue on the periphery of thesampling groove 412 of theinner punching head 41 is punched;

将被切除组织保留在所述取样槽412内。The resected tissue is retained in thesampling slot 412 .

以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present application, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of this application.

Claims (21)

Translated fromChinese

一种介入性冲切器，其特征在于，包括：An interventional punching device, characterized in that it comprises:推管组件，所述推管组件包括内推管及活动地套设于所述内推管外的外推管；a push tube assembly, the push tube assembly includes an inner push tube and an outer push tube movably sleeved outside the inner push tube;冲切组件，所述冲切组件包括固定于所述内推管的远端的内冲切头及固定于所述外推管的远端的外冲切头，所述内冲切头开设取样槽；A punching assembly, the punching assembly includes an inner punching head fixed at the distal end of the inner push tube and an outer punching head fixed at the distal end of the outer push tube, the inner punching head is provided with sampling groove;所述外推管相对所述内推管沿轴向移动以带动所述外冲切头相对所述内冲切头沿轴向移动，以使所述外冲切头对套于所述内冲切头的取样槽外周的组织进行冲切，冲切后被切除组织保留在所述取样槽内。The outer push tube moves axially relative to the inner push tube to drive the outer punching head to move axially relative to the inner punching head, so that the outer punching head is sleeved on the inner punching head The tissue around the sampling groove of the cutting head is punched, and the excised tissue remains in the sampling groove after punching.如权利要求1所述的介入性冲切器，其特征在于，所述介入性冲切器还包括手柄组件，所述手柄组件套设于所述内推管的近端；所述手柄组件包括壳体及活动地穿装于所述壳体内的滑轴，所述壳体的近端相对于所述内推管的近端固定；The interventional punching device according to claim 1, wherein the interventional punching device further comprises a handle assembly, the handle assembly is sleeved on the proximal end of the inner push tube; the handle assembly includes a casing and a sliding shaft movably inserted into the casing, the proximal end of the casing is fixed relative to the proximal end of the inner push tube;所述滑轴套设于所述内推管的近端外，并且所述滑轴与所述外推管的近端固定连接，所述滑轴在所述壳体内沿轴向滑动时，所述滑轴带动所述外推管相对所述内推管沿轴向移动。The sliding shaft is sleeved outside the proximal end of the inner push tube, and the sliding shaft is fixedly connected with the proximal end of the outer pushing tube. When the sliding shaft slides in the axial direction in the housing, the The sliding shaft drives the outer push tube to move relative to the inner push tube in the axial direction.如权利要求2所述的介入性冲切器，其特征在于，所述滑轴的近端设置有驱动件，所述驱动件用于驱动所述滑轴滑动。The interventional punch according to claim 2, wherein a driving member is provided at the proximal end of the sliding shaft, and the driving member is used to drive the sliding shaft to slide.如权利要求3所述的介入性冲切器，其特征在于，所述驱动件通过旋转方式驱动所述滑轴滑动，所述壳体的近端部分开设有连通其内腔且沿所述壳体的轴向延伸的导滑槽，所述驱动件为开设有外螺纹的凸块，所述凸块位于所述导滑槽内并通过所述导滑槽外露；The interventional punching device according to claim 3, wherein the driving member drives the sliding shaft to slide in a rotational manner, and the proximal end portion of the housing is provided with a cavity communicating with the inner cavity and extending along the housing. an axially extending guide chute of the body, the driving member is a convex block with an external thread, the convex block is located in the guide chute and is exposed through the guide chute;所述壳体的近端部分套设有转套，所述转套的内周面设置有与所述外螺纹配合的内螺纹，所述转套与所述凸块螺纹连接，所述转套相对所述凸块转动以带动所述凸块在所述导滑槽内沿所述壳体的轴向移动。The proximal part of the casing is sleeved with a rotating sleeve, the inner peripheral surface of the rotating sleeve is provided with an inner thread matched with the external thread, the rotating sleeve is threadedly connected with the convex block, and the rotating sleeve is Rotating relative to the protruding block drives the protruding block to move in the guide chute along the axial direction of the housing.如权利要求3所述的介入性冲切器，其特征在于，所述驱动件通过推拉方式驱动所述滑轴滑动，所述壳体的近端部分开设有连通其内腔且沿所述壳体的轴向延伸的导滑槽，所述驱动件为至少一个推拉环，所述推拉环通过所述导滑槽外露且可在所述导滑槽内移动；The interventional punching device according to claim 3, wherein the driving member drives the sliding shaft to slide in a push-pull manner, and the proximal end portion of the housing is provided with a cavity that communicates with the inner cavity and extends along the housing. an axially extending guide chute of the body, the driving member is at least one push-pull ring, and the push-pull ring is exposed through the guide chute and can move in the guide chute;通过推动或拉动所述推拉环控制所述滑轴及与所述滑轴连接的所述外推管沿所述壳体的轴向移动。By pushing or pulling the push-pull ring, the sliding shaft and the push-out tube connected with the sliding shaft are controlled to move in the axial direction of the housing.如权利要求5所述的介入性冲切器，其特征在于，所述手柄组件的近端设置有锁定机构，用于防止所述外冲切头封闭所述取样槽后弹开；The interventional punching device according to claim 5, wherein a locking mechanism is provided at the proximal end of the handle assembly to prevent the outer punching head from popping open after closing the sampling groove;所述锁定机构包括所述壳体近端的卡凸和位于所述驱动件的弹片，所述卡凸和所述弹片形成卡扣结构，从而锁定所述驱动件的单向滑动。The locking mechanism includes a latching protrusion at the proximal end of the housing and an elastic piece located on the driving member, and the latching protrusion and the elastic sheet form a latching structure, thereby locking the one-way sliding of the driving member.如权利要求6所述的介入性冲切器，其特征在于，所述弹片包括位于远端的凸起及位于所述凸起的近端一侧的凹槽，推动所述推拉环时，所述凸起抵推所述卡凸，以使所述弹片进行弹性形变至所述卡凸卡入所述凹槽内，所述驱动件朝近端的移动被锁定。The interventional punch according to claim 6, wherein the elastic piece comprises a protrusion at the distal end and a groove at the proximal side of the protrusion, and when the push-pull ring is pushed, the The protrusion pushes against the locking protrusion, so that the elastic piece is elastically deformed until the locking protrusion is locked into the groove, and the proximal movement of the driving member is locked.如权利要求7所述的介入性冲切器，其特征在于，所述凹槽具有轴向长度，所述轴向长度用于限定所述外冲切头的最大轴向形变长度。8. The interventional punch of claim 7, wherein the groove has an axial length that defines a maximum axial deformation length of the outer punch.如权利要求2所述的介入性冲切器，其特征在于，所述介入性冲切器还包括导电线，所述导电线的远端自所述手柄组件的近端穿入至电连接于所述外冲切头和/或电连接于所述内冲切头，所述导电线的近端外接能源装置以向所述冲切组件提供消融能量。The interventional punch of claim 2, wherein the interventional punch further comprises a conductive wire, the distal end of the conductive wire is threaded from the proximal end of the handle assembly to electrically connected to the The outer punching head is and/or electrically connected to the inner punching head, and the proximal end of the conductive wire is connected to an external energy source device to provide ablation energy to the punching assembly.如权利要求9所述的介入性冲切器，其特征在于，所述消融能量包括射频能源、微波能源、脉冲能源中的任意一种。The interventional punching device according to claim 9, wherein the ablation energy comprises any one of radio frequency energy, microwave energy, and pulse energy.如权利要求1所述的介入性冲切器，其特征在于，所述外冲切头选用弹性金属材料制成，用于进行弹性形变，所述外冲切头可沿轴向被压缩且沿径向被扩张。The interventional punching device according to claim 1, wherein the outer punching head is made of elastic metal material for elastic deformation, and the outer punching head can be compressed in the axial direction and can be compressed along the axial direction. radially expanded.如权利要求11所述的介入性冲切器，其特征在于，所述外冲切头设有腰部，所述外冲切头靠近所述腰部的远端的部分和所述外冲切头靠近所述腰部的近端的部分的直径大于所述腰部的直径。12. The interventional punch of claim 11, wherein the outer punch is provided with a waist, and the portion of the outer punch adjacent to the distal end of the waist and the outer punch adjacent to the waist The proximal portion of the waist has a diameter greater than the diameter of the waist.如权利要求1所述的介入性冲切器，其特征在于，所述外冲切头的远端包括刃口，所述内冲切头的远端包括切台，所述切台具有与所述刃口的直径相匹配的冲切直径，用于所述外冲切头相对所述内冲切头沿轴向移动时实现冲切。The interventional punch of claim 1, wherein the distal end of the outer punching head includes a cutting edge, and the distal end of the inner punching head includes a cutting table, the cutting station having the same The punching diameter matching the diameter of the cutting edge is used to realize punching when the outer punching head moves relative to the inner punching head in the axial direction.如权利要求13所述的介入性冲切器，其特征在于，所述切台的直径自近端向远端逐渐增大或者保持不变。14. The interventional punch of claim 13, wherein the diameter of the cutting table gradually increases or remains constant from the proximal end to the distal end.如权利要求13所述的介入性冲切器，其特征在于，所述刃口为平直的刃口或斜切的刃口。14. The interventional punch of claim 13, wherein the cutting edge is a straight cutting edge or a chamfered cutting edge.如权利要求13所述的介入性冲切器，其特征在于，所述刃口包括平滑刃口或者齿状刃口或者为二者的结合。14. The interventional punch of claim 13, wherein the cutting edge comprises a smooth cutting edge or a toothed cutting edge or a combination thereof.如权利要求13所述的介入性冲切器，其特征在于，所述刃口包括切割刃面，所述切割刃面自近端向远端逐渐靠近所述外推管的轴线。14. The interventional punch of claim 13, wherein the cutting edge includes a cutting edge surface that gradually approaches the axis of the pusher tube from a proximal end to a distal end.如权利要求1所述的介入性冲切器，其特征在于，所述外推管和/或所述内推管为预塑形鞘管或可调弯鞘管。The interventional punch according to claim 1, wherein the outer push tube and/or the inner push tube is a pre-shaped sheath tube or a bendable sheath tube.如权利要求2所述的介入性冲切器，其特征在于，所述手柄组件还包括设置于所述壳体的远端的阀体，所述阀体的远端固定连接于所述外推管的近端，所述阀体的近端固定连接于所述滑轴的远端；The interventional punch of claim 2, wherein the handle assembly further comprises a valve body disposed at the distal end of the housing, the distal end of the valve body being fixedly connected to the pusher The proximal end of the tube, the proximal end of the valve body is fixedly connected to the distal end of the sliding shaft;所述阀体开设有连通所述外推管的内腔的阀口，所述外推管的远端对应开设有至少一个出液孔，所述阀口用于注入液体，所述液体经所述外推管与所述内推管之间的间隙并从所述出液孔流出。The valve body is provided with a valve port that communicates with the inner cavity of the extrapolation tube, and at least one liquid outlet hole is correspondingly provided at the distal end of the extrapolation tube, and the valve port is used for injecting liquid, and the liquid passes through the The gap between the outer push pipe and the inner push pipe flows out from the liquid outlet hole.如权利要求19所述的介入性冲切器，其特征在于，所述手柄组件还包括设置于所述阀口的近端一侧的密封塞，用于防止所述液体从所述手柄组件外漏。20. The interventional punch of claim 19, wherein the handle assembly further comprises a sealing plug disposed on the proximal side of the valve port for preventing the liquid from passing from outside the handle assembly leak.一种介入性冲切器的冲切方法，其特征在于，包括：A punching method for an interventional punching device, comprising:提供介入性冲切器，所述介入性冲切器包括冲切组件及推管组件，所述推管组件包括内推管及活动地套设于所述内推管外的外推管；所述冲切组件包括固定于所述内推管的远端的内冲切头及固定于所述外推管的远端的外冲切头，所述内冲切头开设取样槽；An interventional punching device is provided, the interventional punching device includes a punching component and a push tube assembly, and the push tube component includes an inner push tube and an outer push tube movably sleeved outside the inner push tube; The punching assembly includes an inner punching head fixed at the distal end of the inner push pipe and an outer punching head fixed at the distal end of the outer push pipe, and the inner punching head is provided with a sampling groove;将所述外推管相对所述内推管沿轴向移动以带动所述外冲切头相对所述内冲切头沿轴向移动，以使所述外冲切头对套于所述内冲切头的取样槽外周的组织进行冲切；Move the outer push tube relative to the inner push tube in the axial direction to drive the outer punching head to move axially relative to the inner punching head, so that the outer punching head is sleeved on the inner punching head. The tissue around the sampling groove of the punching head is punched;将被切除组织保留在所述取样槽内。The resected tissue is retained in the sampling well.

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