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CN110448364A - Puncturing hole auxiliary expanding equipment and puncturing operation system - Google Patents

Puncturing hole auxiliary expanding equipment and puncturing operation system
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Publication number
CN110448364A
CN110448364ACN201910858448.XACN201910858448ACN110448364ACN 110448364 ACN110448364 ACN 110448364ACN 201910858448 ACN201910858448 ACN 201910858448ACN 110448364 ACN110448364 ACN 110448364A
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puncture hole
puncture
wall
airbag
catheter
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李博宁
肖建华
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GUANGZHOU QIJUN BIOTECHNOLOGY Co Ltd
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GUANGZHOU QIJUN BIOTECHNOLOGY Co Ltd
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Abstract

Translated fromChinese

本发明涉及一种穿刺孔辅助扩张装置及穿刺手术系统,包括:接头,所述接头接通有导管,所述导管远离所述接头的一端设有穿孔头;气囊,所述气囊接通于所述导管上,且所述气囊具有小体积的收缩状态和大体积的膨胀状态;及切割件,所述切割件设置于所述气囊上并能够紧贴所述气囊的外壁。气囊逐渐膨胀并体积增大而进入扩张状态,气囊的外壁上设置有切割件,切割件能够借助气囊壁的挤推力对穿刺孔孔壁处的房间隔组织进行切割,使穿刺孔被逐渐撑大,即最终得到满足需要的孔径的穿刺孔。后续手术中使用到的一些具有较大体积的治疗器械便能够从扩张后的穿刺孔穿过进入相邻心房,保证手术正常进行,提高手术操作效率,降低手术实施难度。

The invention relates to a puncture hole auxiliary expansion device and a puncture operation system, comprising: a joint, the joint is connected with a catheter, and the end of the catheter away from the joint is provided with a perforation head; an air bag, the air bag is connected to the on the catheter, and the air bag has a small-volume contracted state and a large-volume expanded state; and a cutting element, the cutting element is arranged on the air bag and can be close to the outer wall of the air bag. The airbag gradually inflates and increases in volume and enters an expanded state. The outer wall of the airbag is provided with a cutting piece, which can cut the atrial septal tissue at the wall of the puncture hole by means of the pushing force of the airbag wall, so that the puncture hole is gradually expanded. , that is, a puncture hole with a pore diameter that meets the requirements is finally obtained. Some large-volume therapeutic instruments used in subsequent operations can pass through the expanded puncture hole and enter the adjacent atrium to ensure normal operation, improve the efficiency of operation, and reduce the difficulty of operation.

Description

Translated fromChinese
穿刺孔辅助扩张装置及穿刺手术系统Puncture hole auxiliary expansion device and puncture operation system

技术领域technical field

本发明涉及医疗机械技术领域,特别是涉及一种穿刺孔辅助扩张装置及穿刺手术系统。The invention relates to the technical field of medical machinery, in particular to a puncture hole auxiliary expansion device and a puncture operation system.

背景技术Background technique

目前,在一些微创手术,例如房间隔造瘘手术中,需要借助穿刺针对房间隔进行穿刺成孔,通过该逆行穿刺房间隔方式达到输送手术器械的目的。At present, in some minimally invasive operations, such as atrial septostomy, it is necessary to puncture the atrial septum by means of puncture to form a hole, and the purpose of delivering surgical instruments is achieved through the retrograde puncture of the atrial septum.

然而,由于现有的穿刺针穿刺形成的穿刺孔的孔径很小,一般仅有0.3mm左右,因而仅能够允许导丝穿过,对于某些具有较大体积的后续治疗器械,则无法穿过穿刺孔而进入相邻的心房内,导致手术无法正常开展,增加手术操作难度,影响手术完成效率。However, because the puncture hole formed by the existing puncture needle has a small diameter, generally only about 0.3 mm, it can only allow the guide wire to pass through, and for some follow-up treatment instruments with larger volumes, it cannot pass through. If the puncture hole enters the adjacent atrium, the operation cannot be carried out normally, which increases the difficulty of the operation and affects the efficiency of the operation.

发明内容Contents of the invention

基于此,有必要提供一种穿刺孔辅助扩张装置及穿刺手术系统,旨在解决现有技术治疗器械无法穿过穿刺孔,导致手术难度增加,手术难以正常高效进行的问题。Based on this, it is necessary to provide a puncture hole auxiliary expansion device and a puncture surgery system, aiming at solving the problem that the prior art treatment instruments cannot pass through the puncture hole, which increases the difficulty of the operation and makes the operation difficult to perform normally and efficiently.

其技术方案如下:Its technical scheme is as follows:

一方面,本申请提供一种穿刺孔辅助扩张装置,其包括:In one aspect, the present application provides a puncture hole auxiliary expansion device, which includes:

接头,所述接头接通有导管,所述导管远离所述接头的一端设有穿孔头;a joint, the joint is connected with a conduit, and the end of the conduit away from the joint is provided with a perforating head;

气囊,所述气囊接通于所述导管上,且所述气囊具有小体积的收缩状态和大体积的膨胀状态;及a balloon connected to the catheter, and the balloon has a small volume in a deflated state and a large volume inflated state; and

切割件,所述切割件设置于所述气囊上并能够紧贴所述气囊的外壁。A cutting piece, the cutting piece is arranged on the airbag and can be in close contact with the outer wall of the airbag.

上述穿刺孔辅助扩张装置应用于房间隔造瘘手术中,用于对穿刺针在房间隔上形成的穿刺孔进行扩张(扩孔)作业。具体而言,首先将接头与气源装置连接良好;紧接着,当使用穿刺针在房间隔上穿刺形成穿刺孔后,取离穿刺针,将导管远离接头一端的穿孔头对准穿刺孔并慢慢插入穿刺孔内,直至气囊穿设在穿刺孔内后停止推进装置,因为此时气囊处于收缩状态,体积小并接近穿孔头的外径,因而可顺利穿入穿刺孔内。之后,开启气源装置,气体流经接头、导管并逐渐充入气囊内,气囊逐渐膨胀并体积增大而进入扩张状态,在此过程中,气囊体积增大对穿刺孔具有扩张作用,且由于气囊的外壁上设置有切割件,切割件能够借助气囊壁的挤推力对穿刺孔孔壁处的房间隔组织进行切割,使穿刺孔被逐渐撑大,即最终得到满足需要的孔径的穿刺孔。基于此,后续手术中使用到的一些具有较大体积的治疗器械便能够从扩张后的穿刺孔穿过进入相邻心房,保证手术正常进行,提高手术操作效率,降低手术实施难度。The above-mentioned auxiliary puncture hole expansion device is used in atrial septostomy operation, and is used for dilating (reaming) the puncture hole formed by the puncture needle on the atrial septum. Specifically, first connect the connector to the air source device well; then, after using the puncture needle to puncture the atrial septum to form a puncture hole, remove the puncture needle, align the puncture head at the end of the catheter away from the connector to the puncture hole and slowly Slowly insert into the puncture hole until the airbag is inserted into the puncture hole and then stop the propulsion device, because the airbag is in a contracted state at this time, and its volume is small and close to the outer diameter of the puncture head, so it can smoothly penetrate into the puncture hole. Afterwards, the gas source device is turned on, the gas flows through the connector and the catheter, and is gradually filled into the airbag, and the airbag gradually inflates and increases in volume and enters an expanded state. The outer wall of the airbag is provided with a cutting part, which can cut the interatrial septal tissue at the wall of the puncture hole by means of the pushing force of the airbag wall, so that the puncture hole is gradually expanded, that is, a puncture hole with a diameter that meets the requirements is finally obtained. Based on this, some large-volume therapeutic instruments used in follow-up operations can pass through the expanded puncture hole and enter the adjacent atrium to ensure the normal operation of the operation, improve the efficiency of the operation, and reduce the difficulty of the operation.

下面对本申请的技术方案作进一步的说明:The technical scheme of the present application is described further below:

在其中一个实施例中,所述切割件为丝线状,且所述切割件的两端分别固定于所述导管上,所述切割件的中部紧贴所述气囊的外壁。In one embodiment, the cutting member is in the shape of a wire, and the two ends of the cutting member are respectively fixed on the catheter, and the middle part of the cutting member is close to the outer wall of the airbag.

在其中一个实施例中,所述切割件为至少两根,至少两根所述切割件相互交错布置并盘绕于所述气囊的外壁上。In one embodiment, there are at least two cutting elements, and at least two cutting elements are arranged alternately and coiled on the outer wall of the airbag.

在其中一个实施例中,所述切割件的两端分别固定于所述导管上,所述切割件的中部包括压接在所述气囊的外壁上的基体、及设置于所述基体上的割刃。In one of the embodiments, the two ends of the cutting member are respectively fixed on the catheter, and the middle part of the cutting member includes a base body which is crimped on the outer wall of the airbag, and a cutting body arranged on the base body. blade.

在其中一个实施例中,所述切割件采用镍钛记忆合金制成。In one of the embodiments, the cutting part is made of nickel-titanium memory alloy.

在其中一个实施例中,所述接头开设有穿入通道和充气通道,所述穿入通道和所述充气通道均与所述导管的管腔连通;所述导管的管壁开设有过气孔,所述过气孔被包覆于所述气囊内。In one of the embodiments, the joint is provided with a penetration channel and an inflation channel, and both the penetration channel and the inflation channel communicate with the lumen of the catheter; the tube wall of the catheter is provided with an air hole, The air holes are covered in the airbag.

在其中一个实施例中,所述导管包括相互套接的第一管体和第二管体,所述第二管体的内管径大于所述第一管体的外管径,所述第二管体位于所述第一管体的外部并间隔形成环形过气通道;所述接头开设有穿入通道和充气通道,所述穿入通道与所述第一管体的管腔连通,所述充气通道与所述环形过气通道连通;所述第一管体远离所述接头的一端伸出于所述第二管体并形成有所述穿孔头,所述气囊的一端密封设置于所述第一管体上,所述气囊的另一端密封设置于所述第二管体上,所述第二管体远离所述接头的出气管口被包覆于所述气囊内。In one of the embodiments, the catheter includes a first tube body and a second tube body that are nested in each other, the inner diameter of the second tube body is larger than the outer diameter of the first tube body, and the first tube body The two pipe bodies are located outside the first pipe body and form an annular air passing channel at intervals; the joint is provided with a penetration channel and an inflation channel, and the penetration channel communicates with the lumen of the first tube body, so The inflation channel communicates with the annular air passage; the end of the first tube body away from the joint protrudes from the second tube body and forms the perforation head, and one end of the air bag is sealed and arranged on the The other end of the airbag is sealed on the second pipe body, and the air outlet of the second pipe body away from the joint is covered in the airbag.

在其中一个实施例中,所述穿孔头的外壁设有导入部;和/或所述穿孔头采用柔性材料制成。In one of the embodiments, the outer wall of the piercing head is provided with an introduction part; and/or the piercing head is made of flexible material.

在其中一个实施例中,所述穿刺孔辅助扩张装置还包括显影环,所述显影环设置于所述气囊的内部。In one of the embodiments, the puncture hole auxiliary expansion device further includes a developing ring, and the developing ring is arranged inside the air bag.

此外,本申请还提供一种穿刺手术系统,其包括如上所述的穿刺孔辅助扩张装置。如此,该穿刺手术系统能够根据需要对房间隔上穿刺形成的穿刺孔进行扩孔到所需孔径,从而方便后续手术中的治疗器械由穿刺孔穿过,降低手术难度,提高手术实施效率,确保手术正常开展。In addition, the present application also provides a puncture operation system, which includes the above-mentioned auxiliary puncture hole expansion device. In this way, the puncture surgery system can ream the puncture hole formed by the puncture on the atrial septum to the required aperture according to the need, so that the treatment instruments in the subsequent operation can pass through the puncture hole, reduce the difficulty of the operation, improve the efficiency of the operation, and ensure The operation proceeded normally.

附图说明Description of drawings

图1为本发明一实施例所述的穿刺孔辅助扩张装置处于收缩状态(非工作状态)的结构示意图;Fig. 1 is a schematic structural view of a puncture hole auxiliary expansion device in a contracted state (non-working state) according to an embodiment of the present invention;

图2为本发明另一实施例所述的穿刺孔辅助扩张装置处于膨胀状态(工作状态)的结构示意图。Fig. 2 is a schematic structural view of the puncture hole auxiliary expansion device in an expanded state (working state) according to another embodiment of the present invention.

附图标记说明:Explanation of reference signs:

10、接头;11、穿入通道;12、充气通道;20、导管;21、穿孔头;30、气囊;40、切割件;50、显影环。10. Joint; 11. Penetrating channel; 12. Inflatable channel; 20. Catheter; 21. Piercing head; 30. Airbag; 40. Cutting piece; 50. Developing ring.

具体实施方式Detailed ways

为使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及具体实施方式,对本发明进行进一步的详细说明。应当理解的是,此处所描述的具体实施方式仅用以解释本发明,并不限定本发明的保护范围。In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific implementation methods. It should be understood that the specific embodiments described here are only used to explain the present invention, and do not limit the protection scope of the present invention.

需要说明的是,当元件被称为“固设于”、“设置于”或“安设于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件;一个元件与另一个元件固定连接的具体方式可以通过现有技术实现,在此不再赘述,优选采用螺纹连接的固定方式。It should be noted that when an element is referred to as being “fixed on”, “disposed on” or “installed on” another element, it may be directly on the other element or there may be an intervening element. When an element is considered to be "connected" to another element, it may be directly connected to the other element or there may be an intervening element at the same time; the specific way that one element is fixedly connected to another element can be realized through existing technologies, and will not be discussed here. To repeat it again, it is preferable to adopt a fixing method of threaded connection.

除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terminology used herein in the description of the present invention is only for the purpose of describing specific embodiments, and is not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

本发明中所述“第一”、“第二”不代表具体的数量及顺序,仅仅是用于名称的区分。The "first" and "second" mentioned in the present invention do not represent specific numbers and sequences, but are only used to distinguish names.

本申请要求保护一种穿刺手术系统,其应用在房间隔造瘘手术中(当然还可以应用于其它类型治疗手术中),对左心房和右心房之间的房间隔进行穿刺作业。该穿刺手术系统主要由穿刺执行装置、X光定位装置和穿刺孔辅助扩张装置。穿刺执行装置实现对房间隔的穿刺作业,X光定位装置对穿刺针的移动进行定位和导引。穿刺孔辅助扩张装置实现对穿刺后的穿刺孔进行扩孔作业,X光定位装置对穿刺孔辅助扩张装置的移动进行定位和导引。如此,该穿刺手术系统能够根据需要对房间隔上穿刺形成的穿刺孔进行扩孔到所需孔径,从而方便后续手术中的治疗器械由穿刺孔穿过,降低手术难度,提高手术实施效率,确保手术正常开展。The present application claims to protect a puncture operation system, which is used in atrial septostomy operation (certainly can also be applied in other types of treatment operations), and performs puncture operation on the atrial septum between the left atrium and the right atrium. The puncture operation system mainly consists of a puncture executing device, an X-ray positioning device and a puncture hole auxiliary expansion device. The puncture execution device realizes the puncture operation of the interatrial septum, and the X-ray positioning device positions and guides the movement of the puncture needle. The puncture hole auxiliary expansion device realizes the operation of reaming the puncture hole after puncture, and the X-ray positioning device positions and guides the movement of the puncture hole auxiliary expansion device. In this way, the puncture surgery system can ream the puncture hole formed by the puncture on the atrial septum to the required aperture according to the need, so that the treatment instruments in the subsequent operation can pass through the puncture hole, reduce the difficulty of the operation, improve the efficiency of the operation, and ensure The operation proceeded normally.

如图1和图2所示,为本申请一实施例展示的穿刺孔辅助扩张装置,其包括:接头10、气囊30及切割件40。接头10用于承载和固定气囊30及切割件40,并用于传输气体给气囊30,使气囊30结构形态发生变化。气囊30根据通入气体能够体积膨胀而对穿刺孔进行扩张,切割件40实现对穿刺孔孔壁的组织进行切割,使穿刺孔更易于发生扩张。As shown in FIG. 1 and FIG. 2 , it is an auxiliary puncture hole expansion device shown in an embodiment of the present application, which includes: a joint 10 , a balloon 30 and a cutting member 40 . The joint 10 is used to carry and fix the airbag 30 and the cutting part 40 , and is used to transmit gas to the airbag 30 to change the structure of the airbag 30 . The airbag 30 can expand the puncture hole according to the volume expansion of the gas, and the cutting member 40 can cut the tissue of the puncture hole wall, so that the puncture hole is easier to expand.

具体地,所述接头10接通有导管20,所述导管20远离所述接头10的一端设有穿孔头21;所述气囊30接通于所述导管20上,且所述气囊30具有小体积的收缩状态和大体积的膨胀状态;所述切割件40设置于所述气囊30上并能够紧贴所述气囊30的外壁。Specifically, the joint 10 is connected with a catheter 20, and the end of the catheter 20 away from the joint 10 is provided with a perforation head 21; the air bag 30 is connected to the catheter 20, and the air bag 30 has a small The contracted state of the volume and the expanded state of the large volume; the cutting member 40 is disposed on the airbag 30 and can cling to the outer wall of the airbag 30 .

实施上述技术方案至少能够获得如下技术效果:上述穿刺孔辅助扩张装置应用于房间隔造瘘手术中,用于对穿刺针在房间隔上形成的穿刺孔进行扩张(扩孔)作业。具体而言,首先将接头10与气源装置连接良好;紧接着,当使用穿刺针在房间隔上穿刺形成穿刺孔后,取离穿刺针,将导管20远离接头10一端的穿孔头21对准穿刺孔并慢慢插入穿刺孔内,直至气囊30穿设在穿刺孔内后停止推进装置,因为此时气囊30处于收缩状态,体积小并接近穿孔头21的外径,因而可顺利穿入穿刺孔内。之后,开启气源装置,气体流经接头10、导管20并逐渐充入气囊30内,气囊30逐渐膨胀并体积增大而进入扩张状态,在此过程中,气囊30体积增大对穿刺孔具有扩张作用,且由于气囊30的外壁上设置有切割件40,切割件40能够借助气囊30壁的挤推力对穿刺孔孔壁处的房间隔组织进行切割,使穿刺孔被逐渐撑大,即最终得到满足需要的孔径的穿刺孔。基于此,后续手术中使用到的一些具有较大体积的治疗器械便能够从扩张后的穿刺孔穿过进入相邻心房,保证手术正常进行,提高手术操作效率,降低手术实施难度。Implementing the above technical solution can at least obtain the following technical effects: the above-mentioned puncture hole auxiliary expansion device is used in atrial septostomy surgery, and is used to expand (ream) the puncture hole formed by the puncture needle on the atrial septum. Specifically, first connect the connector 10 to the air source device well; then, after using the puncture needle to puncture the interatrial septum to form a puncture hole, remove the puncture needle, and align the puncture head 21 at the end of the catheter 20 away from the connector 10 Puncture the hole and slowly insert it into the puncture hole until the airbag 30 is pierced in the puncture hole and then stop the propulsion device, because the airbag 30 is in a contracted state at this time, and its volume is small and close to the outer diameter of the puncture head 21, so it can be smoothly inserted into the puncture hole. inside the hole. Afterwards, the gas source device is turned on, the gas flows through the joint 10 and the catheter 20 and is gradually filled into the airbag 30, and the airbag 30 gradually inflates and increases in volume and enters an expanded state. expansion, and because the outer wall of the balloon 30 is provided with a cutting member 40, the cutting member 40 can cut the interatrial septal tissue at the wall of the puncture hole by means of the pushing force of the wall of the balloon 30, so that the puncture hole is gradually expanded, that is, finally Obtain a puncture hole of the required pore size. Based on this, some large-volume therapeutic instruments used in follow-up operations can pass through the expanded puncture hole and enter the adjacent atrium to ensure the normal operation of the operation, improve the efficiency of the operation, and reduce the difficulty of the operation.

需要说明的是,在另一种操作方式中,也可以随着气囊30不断穿入穿刺孔的同时同步向气囊30内充入气体,形成气囊30穿孔伴随气囊30体积膨胀变大的方案,也可以达到通过气囊30对穿刺孔的孔径进行扩张的目的。It should be noted that, in another mode of operation, the airbag 30 can also be filled with gas synchronously as the airbag 30 continuously penetrates the puncture hole to form a scheme in which the airbag 30 is perforated and the volume of the airbag 30 expands. The purpose of expanding the diameter of the puncture hole through the balloon 30 can be achieved.

可以理解的,气囊30具有类似于气球的特性。初始状态时,气囊30收缩而紧贴在导管20外壁上,此时体积小而便于穿入穿刺孔内;当对气囊30充入气体时,随着充入气体的增加,气囊30可逐渐膨胀使得自身变大,对穿刺孔形成顶撑扩张作用;当放出气体后,气囊30又可再次回复初始形状,以便于下次手术对穿刺孔进行扩张操作。可选地,气囊30可以采用但不限于橡胶、硅胶等。It can be understood that the airbag 30 has characteristics similar to a balloon. In the initial state, the airbag 30 shrinks and clings to the outer wall of the catheter 20. At this time, the volume is small and easy to penetrate into the puncture hole; when the airbag 30 is inflated with gas, the airbag 30 can gradually expand with the increase of the inflated gas. It makes itself bigger, and forms a supporting and expanding effect on the puncture hole; when the gas is released, the airbag 30 can return to the original shape again, so as to facilitate the expansion operation on the puncture hole in the next operation. Optionally, the airbag 30 can use but not limited to rubber, silicone and the like.

请继续参阅图1和图2,一实施例中,为使切割件40具备较佳的切割能力,所述切割件40为丝线状,且所述切割件40的两端分别固定于所述导管20上,所述切割件40的中部紧贴所述气囊30的外壁。本实施例中,切割件40为一根;根据需要,切割件40可平行与导管20的管长方向布置并紧贴气囊30外壁布置,或与导管20呈一定倾斜角度紧贴气囊30外壁设置。气囊30膨胀变大时,可更好的挤推切割件40向穿刺孔的孔壁处的房间隔组织挤压,而实现有效切割,当切割件40对孔壁切割形成割口时,孔壁组织溃缩,更易于穿刺孔孔径扩大。Please continue to refer to FIG. 1 and FIG. 2 , in one embodiment, in order to enable the cutting member 40 to have a better cutting ability, the cutting member 40 is in the shape of a wire, and the two ends of the cutting member 40 are respectively fixed on the catheter 20 , the middle part of the cutting member 40 is in close contact with the outer wall of the airbag 30 . In this embodiment, the cutting part 40 is one piece; as required, the cutting part 40 can be arranged parallel to the tube length direction of the catheter 20 and arranged close to the outer wall of the airbag 30, or arranged close to the outer wall of the airbag 30 at a certain inclined angle with the catheter 20 . When the balloon 30 expands and becomes larger, it can better push the cutting part 40 to squeeze the atrial septal tissue at the hole wall of the puncture hole, so as to realize effective cutting. When the cutting part 40 cuts the hole wall to form an incision, the hole wall Tissue collapses, making it easier for the puncture hole to expand in size.

较优选地,所述切割件40为至少两根,至少两根所述切割件40相互交错布置并盘绕于所述气囊30的外壁上。此时,所有丝线状切割件40构成网络片状结构满布于气囊30的整个外周壁上,随着气囊30体积膨胀变大,各个切割件40可同时对穿刺孔的整个周向孔壁进行切割,可进一步提升扩孔效率。More preferably, there are at least two cutting elements 40 , and at least two cutting elements 40 are arranged alternately and coiled on the outer wall of the airbag 30 . At this moment, all the thread-shaped cutting parts 40 form a network sheet structure and are all over the entire peripheral wall of the air bag 30. As the volume of the air bag 30 expands, each cutting part 40 can simultaneously perform a puncture on the entire peripheral wall of the puncture hole. Cutting can further improve the efficiency of reaming.

可以理解的,由于切割件40为丝线状,当丝线的直径足够小时,例如线径达到零点几毫米至几毫米之间,随着气囊30膨胀施加丝线挤推力,丝线逐渐对穿刺孔的组织挤压,丝线便能够形成菜刀的刀刃切割食物的效果,使孔径扩张变大。It can be understood that, since the cutting member 40 is in the shape of a wire, when the diameter of the wire is small enough, for example, the wire diameter reaches between a few tenths of a millimeter and several millimeters, as the balloon 30 expands and the pushing force of the wire is applied, the wire gradually squeezes against the tissue of the puncture hole. When pressed, the silk thread can form the effect of cutting food with the blade of a kitchen knife, making the aperture expand and become larger.

当然了,根据本领域技术人员的实际需要,其它实施例中切割件40也可以是其它的结构设计。例如,所述切割件40的两端分别固定于所述导管20上,所述切割件40的中部包括压接在所述气囊30的外壁上的基体、及设置于所述基体上的割刃。基体与气囊30外壁压接,可保证切割件40与气囊30配合紧凑、稳固,并保证割刃具有较高的安装强度。当气体不断通入,气囊30不断膨胀变大时,提供给割刃向穿刺孔孔壁的挤压力,割刃便能够切割孔壁组织,使孔壁形成割口而使穿刺孔的孔径更易于被气囊30扩张变大。Of course, according to the actual needs of those skilled in the art, the cutting member 40 in other embodiments may also have other structural designs. For example, the two ends of the cutting member 40 are respectively fixed on the catheter 20, and the middle part of the cutting member 40 includes a base body crimped on the outer wall of the airbag 30, and a cutting edge arranged on the base body . The base body is crimped with the outer wall of the airbag 30 to ensure a compact and stable fit between the cutting part 40 and the airbag 30, and to ensure that the cutting edge has high installation strength. When the gas continues to flow in and the airbag 30 continues to expand and become larger, the cutting edge is provided with a pressing force to the wall of the puncture hole, and the cutting edge can cut the tissue of the hole wall, so that the hole wall forms an incision and the aperture of the puncture hole becomes larger. It is easy to be enlarged by the airbag 30 .

需要说明的是,由于气囊30具备小体积的收缩状态和大体积的膨胀状态,在两种状态间切换时,气囊30的外形尺寸时刻发生这改变,为保证切割件40不干涉气囊30发生结构形态变化,且可靠发挥切割作用,切割件40也需要具备收缩形变能力。在本方案中,所述切割件40采用镍钛记忆合金制成。镍钛记忆合金具备能将自身的塑性变形在某一特定温度下自动恢复为原始形状的能力,具有良好的可塑性。如此,气囊30收缩状态下,切割件40便能够之中适配和跟随气囊30发生形状变化而满足正常工作。It should be noted that since the airbag 30 has a contracted state with a small volume and an expanded state with a large volume, when switching between the two states, the external dimensions of the airbag 30 will change all the time. In order to ensure that the cutting member 40 does not interfere with the structure of the airbag 30 In order to change the shape and perform the cutting function reliably, the cutting member 40 also needs to have shrinkage deformation ability. In this solution, the cutting member 40 is made of nickel-titanium memory alloy. Nickel-titanium memory alloy has the ability to automatically restore its own plastic deformation to its original shape at a certain temperature, and has good plasticity. In this way, when the airbag 30 is contracted, the cutting member 40 can be adapted and follow the shape change of the airbag 30 to satisfy normal operation.

请继续参阅图1和图2,本方案中,穿刺孔辅助扩张装置可完成穿刺和扩孔两道工序。一实施例中所述接头10开设有穿入通道11和充气通道12,所述穿入通道11和所述充气通道12均与所述导管20的管腔连通;穿刺针可由穿入通道11穿入到导管20内,并从穿孔头21伸出而刺穿房间隔,得到穿刺孔。之后,抽离穿刺孔,再将穿孔头21插入穿刺孔内;紧接着开启气源装置,气体由充气通道12进入导管20,由于所述导管20的管壁开设有过气孔,且所述过气孔被包覆于所述气囊30内。因而气体便能够被充入气囊30内,促使气囊30膨胀变大,实现对穿刺孔扩张作业。在本实施例中,穿刺针、导丝和气流公用导管20的管腔作为工作通道。Please continue to refer to Fig. 1 and Fig. 2. In this solution, the puncture hole auxiliary expansion device can complete two processes of puncture and hole reaming. In one embodiment, the joint 10 is provided with a penetration channel 11 and an inflation channel 12, and both the penetration channel 11 and the inflation channel 12 communicate with the lumen of the catheter 20; into the catheter 20, and protrude from the piercing head 21 to puncture the interatrial septum to obtain a puncture hole. Afterwards, withdraw the puncture hole, and then insert the puncture head 21 in the puncture hole; then open the gas source device, and the gas enters the catheter 20 from the inflation channel 12. Air holes are covered in the airbag 30 . Therefore, the gas can be filled into the air bag 30, which causes the air bag 30 to expand and become larger, so as to realize the operation of expanding the puncture hole. In this embodiment, the lumen of the puncture needle, the guide wire and the common airflow conduit 20 serves as the working channel.

需要说明的是,气囊30为两端开口的袋状结构,为避免出现漏气,影响气囊30正常工作,两个开口端通过焊接、粘接等方式固定在导管20上,从而保证密封性。It should be noted that the airbag 30 is a bag-shaped structure with two ends open. In order to avoid air leakage and affect the normal operation of the airbag 30, the two open ends are fixed on the catheter 20 by welding or bonding to ensure airtightness.

需要说明的是,根据实际需要,过气孔的数量可以是一个、两个或多个,在此不作具体限定。It should be noted that, according to actual needs, the number of air holes may be one, two or more, which is not specifically limited here.

然而,上述在导管20侧壁上开孔来对气囊30充气的实施方式并非唯一,作为可替代的,在另一实施例中,所述导管20包括相互套接的第一管体和第二管体,所述第二管体的内管径大于所述第一管体的外管径,所述第二管体位于所述第一管体的外部并间隔形成环形过气通道;所述接头10开设有穿入通道11和充气通道12,所述穿入通道11与所述第一管体的管腔连通,所述充气通道12与所述环形过气通道连通;所述第一管体远离所述接头10的一端伸出于所述第二管体并形成有所述穿孔头21,所述气囊30的一端密封设置于所述第一管体上,所述气囊30的另一端密封设置于所述第二管体上,所述第二管体远离所述接头10的出气管口被包覆于所述气囊30内。如此,穿刺针和导丝使用第一管体的管腔作为工作通道,而气流则使用第一管体与第二管体套接后形成的过气通道(环形空腔)作为工作通道,彼此互不干涉。气体从过气通道的出口端通入气囊30内,也能够实现气囊30通气膨胀变大的目的,进而能够对穿刺孔完成扩孔作业。However, the above-mentioned implementation of opening holes on the side wall of the catheter 20 to inflate the airbag 30 is not the only implementation. As an alternative, in another embodiment, the catheter 20 includes a first tube body and a second A pipe body, the inner diameter of the second pipe body is larger than the outer diameter of the first pipe body, the second pipe body is located outside the first pipe body and forms an annular air passage at intervals; the The joint 10 is provided with a penetration channel 11 and an inflation channel 12, the penetration channel 11 communicates with the lumen of the first pipe body, and the inflation channel 12 communicates with the annular air passage; the first tube One end of the body away from the joint 10 protrudes from the second pipe body and forms the perforation head 21, one end of the air bag 30 is sealed on the first pipe body, and the other end of the air bag 30 The seal is arranged on the second tube body, and the air outlet of the second tube body away from the joint 10 is covered in the air bag 30 . In this way, the puncture needle and the guide wire use the lumen of the first tube as the working channel, while the air flow uses the air passage (annular cavity) formed after the first tube and the second tube are sleeved as the working channel. non-interference. Gas is passed into the airbag 30 from the outlet end of the air passage, and the purpose of expanding the airbag 30 can also be realized, and then the hole reaming operation can be completed on the puncture hole.

或者,在其它实施例中,还可以采用现有技术中的其它成熟技术手段实现对气囊30通入气流,也都在本申请的保护范围内,在此不再赘述。Alternatively, in other embodiments, other mature technical means in the prior art can also be used to realize the air flow to the airbag 30, which are also within the protection scope of the present application, and will not be repeated here.

在上述任一实施例的基础上,为便于穿孔头21插入穿刺孔内,所述穿孔头21的外壁设有导入部。可选地,导入部为制作在穿孔头21的外壁上的斜面或弧面,使得穿孔头21朝向穿刺孔的至少一部分形成为横截尺寸渐变的尖端结构,保证穿孔头21可易于插入穿刺孔内。和/或,为了避免穿孔头21插入深度过深,从而戳伤心房壁,所述穿孔头21采用柔性材料制成。所使用的材料可以是但不限于硅胶。On the basis of any of the above embodiments, in order to facilitate the insertion of the piercing head 21 into the puncture hole, the outer wall of the piercing head 21 is provided with an introduction portion. Optionally, the introduction part is a slope or an arc made on the outer wall of the piercing head 21, so that at least a part of the piercing head 21 facing the puncture hole is formed as a tip structure with a gradual change in cross-sectional size, ensuring that the piercing head 21 can be easily inserted into the puncture hole Inside. And/or, in order to prevent the piercing head 21 from being inserted too deeply, thereby poking the atrial wall, the piercing head 21 is made of flexible material. The material used can be, but is not limited to, silica gel.

请继续参阅图2,而为了保证穿孔头21能够快速、准确找到穿刺孔的位置,所述穿刺孔辅助扩张装置还包括显影环50,所述显影环50设置于所述气囊30的内部。如此,显影环50能够在X光定位装置下实现影响定位,从而引导穿孔头21快速对准穿刺孔,利于提升手术操作效率与可靠性。Please continue to refer to FIG. 2 , and in order to ensure that the puncture head 21 can quickly and accurately find the position of the puncture hole, the puncture hole auxiliary expansion device further includes a developing ring 50 , and the developing ring 50 is arranged inside the air bag 30 . In this way, the developing ring 50 can achieve impact positioning under the X-ray positioning device, so as to guide the piercing head 21 to quickly align with the puncture hole, which is beneficial to improve the efficiency and reliability of the operation operation.

较优选地,显影环50的数量为两个,且间隔设置于气囊30内部,从而提升定位可靠性。当某一个显影环50被阻挡而无法准确定位时,另一个显影环50仍能精准定位。More preferably, the number of developing rings 50 is two, and they are arranged at intervals inside the airbag 30, so as to improve positioning reliability. When a certain developing ring 50 is blocked and cannot be positioned accurately, another developing ring 50 can still be accurately positioned.

以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (10)

Translated fromChinese
1.一种穿刺孔辅助扩张装置,其特征在于,包括:1. A puncture hole auxiliary expansion device, characterized in that it comprises:接头,所述接头接通有导管,所述导管远离所述接头的一端设有穿孔头;a joint, the joint is connected with a conduit, and the end of the conduit away from the joint is provided with a perforating head;气囊,所述气囊接通于所述导管上,且所述气囊具有小体积的收缩状态和大体积的膨胀状态;及a balloon connected to the catheter, and the balloon has a small volume in a deflated state and a large volume inflated state; and切割件,所述切割件设置于所述气囊上并能够紧贴所述气囊的外壁。A cutting piece, the cutting piece is arranged on the airbag and can be in close contact with the outer wall of the airbag.2.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述切割件为丝线状,且所述切割件的两端分别固定于所述导管上,所述切割件的中部紧贴所述气囊的外壁。2. The puncture hole auxiliary expansion device according to claim 1, wherein the cutting member is in the shape of a thread, and the two ends of the cutting member are respectively fixed on the catheter, and the middle part of the cutting member is tightly closed. Paste the outer wall of the air bag.3.根据权利要求2所述的穿刺孔辅助扩张装置,其特征在于,所述切割件为至少两根,至少两根所述切割件相互交错布置并盘绕于所述气囊的外壁上。3 . The auxiliary puncture hole expansion device according to claim 2 , wherein there are at least two cutting members, and the at least two cutting members are arranged alternately and coiled on the outer wall of the balloon. 4 .4.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述切割件的两端分别固定于所述导管上,所述切割件的中部包括压接在所述气囊的外壁上的基体、及设置于所述基体上的割刃。4. The puncture hole auxiliary expansion device according to claim 1, characterized in that, the two ends of the cutting member are respectively fixed on the catheter, and the middle part of the cutting member is crimped on the outer wall of the balloon. The base body and the cutting edge arranged on the base body.5.根据权利要求2至4任一项所述的穿刺孔辅助扩张装置,其特征在于,所述切割件采用镍钛记忆合金制成。5. The puncture hole auxiliary expansion device according to any one of claims 2 to 4, characterized in that, the cutting part is made of nickel-titanium memory alloy.6.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述接头开设有穿入通道和充气通道,所述穿入通道和所述充气通道均与所述导管的管腔连通;所述导管的管壁开设有过气孔,所述过气孔被包覆于所述气囊内。6. The puncture hole auxiliary expansion device according to claim 1, wherein the joint is provided with a penetration channel and an inflation channel, and both the penetration channel and the inflation channel communicate with the lumen of the catheter ; The tube wall of the catheter is provided with an air hole, and the air hole is covered in the air bag.7.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述导管包括相互套接的第一管体和第二管体,所述第二管体的内管径大于所述第一管体的外管径,所述第二管体位于所述第一管体的外部并间隔形成环形过气通道;所述接头开设有穿入通道和充气通道,所述穿入通道与所述第一管体的管腔连通,所述充气通道与所述环形过气通道连通;所述第一管体远离所述接头的一端伸出于所述第二管体并形成有所述穿孔头,所述气囊的一端密封设置于所述第一管体上,所述气囊的另一端密封设置于所述第二管体上,所述第二管体远离所述接头的出气管口被包覆于所述气囊内。7. The puncture hole auxiliary dilating device according to claim 1, characterized in that, the catheter comprises a first tube body and a second tube body socketed in each other, and the inner diameter of the second tube body is larger than that of the The outer pipe diameter of the first pipe body, the second pipe body is located outside the first pipe body and forms an annular air passing channel at intervals; the joint is provided with a penetration channel and an inflation channel, and the penetration channel is connected to the air passage. The lumen of the first pipe body communicates, and the inflation channel communicates with the annular air passage; the end of the first pipe body away from the joint protrudes from the second pipe body and forms the A piercing head, one end of the air bag is sealed on the first tube body, the other end of the air bag is sealed on the second tube body, and the second tube body is away from the air outlet of the joint Wrapped in the air bag.8.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述穿孔头的外壁设有导入部;和/或所述穿孔头采用柔性材料制成。8. The puncture hole auxiliary expansion device according to claim 1, characterized in that, the outer wall of the piercing head is provided with an introduction part; and/or the piercing head is made of flexible material.9.根据权利要求1所述的穿刺孔辅助扩张装置,其特征在于,所述穿刺孔辅助扩张装置还包括显影环,所述显影环设置于所述气囊的内部。9 . The auxiliary puncture hole expansion device according to claim 1 , wherein the auxiliary puncture hole expansion device further comprises a developing ring, and the developing ring is arranged inside the air bag. 10 .10.一种穿刺手术系统,其特征在于,包括如上述权利要求1至9任一项所述的穿刺孔辅助扩张装置。10. A puncture operation system, characterized by comprising the puncture hole auxiliary expansion device according to any one of claims 1 to 9.
CN201910858448.XA2019-09-112019-09-11Puncturing hole auxiliary expanding equipment and puncturing operation systemPendingCN110448364A (en)

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