技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及一种输卵管诊断疏通装置。The invention relates to the technical field of medical devices, in particular to a device for diagnosing and dredging fallopian tubes.
背景技术Background technique
输卵管通液是利用美蓝液或生理盐水自宫颈注入宫腔,再从宫腔流入输卵管,根据推注药液时阻力的大小及液体返流的情况,判断输卵管是否通畅。目前,临床输卵管通液器在使用时,通常将子宫通液导管按探针检测方向插入颈管,固定于事先选择的深度,然后将溶液缓推注入液体;若液体顺利注入,则无阻力,宫颈外无漏液,病人也无明显不适,表示输卵管通畅;若遇阻力,稍加压力,病人稍有腹部不适即可顺利注入,表示输卵管通而不畅;当感阻力大,液体自宫颈外口溢出,腹部胀难忍,多为输卵管完全不通。并且,通液时,听诊器在下腹两侧可听到液体自输卵管伞端冒出之声音。Tubal fluid is injected from the cervix into the uterine cavity with methylene blue solution or normal saline, and then flows into the fallopian tube from the uterine cavity. According to the resistance and fluid reflux when the drug is injected, it is judged whether the fallopian tube is unobstructed. At present, when the clinical tubal infusion device is used, the uterine infusion catheter is usually inserted into the cervical canal according to the detection direction of the probe, fixed at the depth selected in advance, and then the solution is slowly pushed into the liquid; if the liquid is injected smoothly, there is no resistance. If there is no leakage outside the cervix and the patient has no obvious discomfort, it means that the fallopian tube is unobstructed; if there is resistance, a little pressure is applied, and the patient can inject smoothly with slight abdominal discomfort, which means that the fallopian tube is not smooth; when the resistance is large, the liquid flows from the outside of the cervix The mouth overflows, the abdomen is unbearably bloated, and most of them are completely obstructed fallopian tubes. Moreover, when the fluid is passed, the stethoscope can hear the sound of the fluid coming out of the umbrella end of the fallopian tube on both sides of the lower abdomen.
综上可知,通液时前方压力多少完全是通过操作人员的自我经验进行判断,该方式对操作人员要求极高,易出现误诊,还有可能出现输卵管破裂的危险。并且,近年来随着通液器材料和技术的进步,通液管可以在导丝的导引下直接到达一侧输卵管近宫腔端,除了可以检查输卵管是否通畅,对于黏连较轻的,同时也可以进行输卵管通液治疗。但这样就更增加了输卵管是否通畅的判断难度,降低输卵管诊断的准确度,单纯凭医生经验和手感,容易发生医疗事故。To sum up, it can be seen that the amount of frontal pressure during fluid passage is completely judged by the operator's self-experience. This method has extremely high requirements on the operator, is prone to misdiagnosis, and may cause the risk of tubal rupture. Moreover, in recent years, with the advancement of the material and technology of the fluid-through device, the fluid-through tube can directly reach the end of the fallopian tube near the uterine cavity under the guidance of the guide wire. In addition to checking whether the fallopian tube is unobstructed, for those with mild adhesions, Tubal fluid therapy can also be performed at the same time. But this increases the difficulty of judging whether the fallopian tube is unobstructed, reduces the accuracy of fallopian tube diagnosis, and medical accidents are prone to occur simply by doctor's experience and feel.
发明内容Contents of the invention
鉴于以上所述现有技术的缺点,本发明的目的在于提供一种输卵管诊断疏通装置,有效提高输卵管诊断的准确度,同时还能有效防止损伤输卵管。In view of the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a fallopian tube diagnosis and dredging device, which can effectively improve the accuracy of fallopian tube diagnosis and effectively prevent fallopian tube damage.
为实现上述目的,本发明提供一种输卵管诊断疏通装置,包括外鞘、可移动地穿设在外鞘中的内导管、可移动地穿设在内导管中的压力传感导丝、固定在压力传感导丝远端的压力传感器、用于引入药液的通液管、安装在通液管上的流量泵、状态指示面板、以及控制器,所述外鞘的远端具有可缩胀的密封固定段、以及开设在外鞘远端端面上的远端通孔,所述内导管具有与通液管连通的通液腔、以及开设在内导管远端端面上且与通液腔连通的第一通液孔,所述压力传感导丝具有一段分布在压力传感器远端侧的导丝头端;所述压力传感器、流量泵和状态指示面板都与控制器通讯连接;In order to achieve the above object, the present invention provides a device for diagnosis and dredging of fallopian tubes, comprising an outer sheath, an inner catheter movably threaded in the outer sheath, a pressure sensing guide wire movably threaded in the inner catheter, The pressure sensor at the distal end of the sensing guide wire, the liquid tube for introducing the liquid medicine, the flow pump installed on the liquid tube, the status indication panel, and the controller, the distal end of the outer sheath has an expandable The sealing and fixing section, and the distal through hole provided on the distal end surface of the outer sheath, the inner catheter has a liquid passage cavity communicated with the liquid passage tube, and a second fluid passage provided on the distal end surface of the inner catheter and communicated with the liquid passage chamber. A liquid hole, the pressure sensing guide wire has a guide wire tip distributed on the far side of the pressure sensor; the pressure sensor, the flow pump and the status indicating panel are all communicated with the controller;
当所述内导管的远端和导丝头端都位于外鞘中时,所述第一通液孔和远端通孔连通。When the distal end of the inner catheter and the tip end of the guide wire are located in the outer sheath, the first liquid hole communicates with the distal through hole.
进一步地,所述内导管的远端还开设有数个分布在通液腔外周侧的第二通液孔,所述通液腔和内导管的外界通过第二通液孔连通。Further, the distal end of the inner catheter is provided with several second liquid holes distributed on the outer periphery of the liquid cavity, and the liquid cavity communicates with the outside of the inner catheter through the second liquid holes.
进一步地,所述密封固定段包括褶皱部、分布在褶皱部近端侧的气囊部、以及分隔在褶皱部和气囊部之间的封堵部,所述褶皱部的远端延伸至外鞘的远端;Further, the sealing and fixing section includes a folded part, a balloon part distributed on the proximal side of the folded part, and a blocking part separated between the folded part and the balloon part, and the distal end of the folded part extends to the outer sheath remote;
当所述内导管的远端被收拢在外鞘中时,所述褶皱部分布在内导管远端的外周侧,所述褶皱部的内周空腔与第二通液孔连通,所述褶皱部的远端与内导管的远端密封配合。When the distal end of the inner catheter is folded into the outer sheath, the folded portion is distributed on the outer peripheral side of the distal end of the inner catheter, and the inner peripheral cavity of the folded portion communicates with the second liquid hole, and the folded portion The distal end of the inner catheter is sealingly matched with the distal end of the inner catheter.
进一步地,所述输卵管诊断疏通装置还包括用于引入气体的通气管、以及串接安装在通气管上的电磁阀、调压阀和压力计,所述外鞘中开设有通气腔,所述通气腔的近端和远端分别与通气管和气囊部连通,所述电磁阀和压力计都与控制器通讯连接。Further, the fallopian tube diagnosis and dredging device also includes a ventilation tube for introducing gas, and a solenoid valve, a pressure regulating valve and a pressure gauge mounted on the ventilation tube in series, a ventilation cavity is opened in the outer sheath, and the The near end and the far end of the ventilation cavity communicate with the ventilation tube and the air bag respectively, and the electromagnetic valve and the pressure gauge are both communicated with the controller.
进一步地,所述褶皱部呈锥形,所述褶皱部的外径沿近端朝向远端的方向逐渐减小。Further, the folded portion is tapered, and the outer diameter of the folded portion gradually decreases along the direction from the proximal end to the distal end.
进一步地,所述褶皱部的远端端面上开设有十字槽,所述十字槽与远端通孔相通。Further, a cross groove is formed on the distal end surface of the folded part, and the cross groove communicates with the distal through hole.
进一步地,所述褶皱部远端的内周面上设有第一密封锥面,所述内导管远端的外周面上设有第二密封锥面;当所述内导管的远端被收拢在外鞘中时,所述第一密封锥面和第二密封锥面面接触配合。Further, a first tapered sealing surface is provided on the inner peripheral surface of the distal end of the folded portion, and a second tapered sealing surface is provided on the outer peripheral surface of the distal end of the inner catheter; when the distal end of the inner catheter is folded When in the outer sheath, the first sealing cone surface and the second sealing cone surface contact and fit.
进一步地,所述内导管为内外双层结构,包括内层管体和环绕在内层管体外部的外层管体,所述内层管体的近端和外层管体的近端相固定,所述内层管体和外层管体之间的环形腔构成所述通液腔,所述第一通液孔开设在内层管体的远端端面和外层管体的远端端面上,所述第二通液孔开设在外层管体的远端管壁上,所述压力传感导丝可移动地穿设在内层管体内。Further, the inner catheter has an inner and outer double-layer structure, including an inner tube body and an outer tube body surrounding the inner tube body, and the proximal end of the inner tube body is connected to the proximal end of the outer tube body. fixed, the annular cavity between the inner tube body and the outer tube body constitutes the liquid cavity, and the first liquid hole is set on the distal end surface of the inner tube body and the distal end of the outer tube body On the end face, the second liquid hole is opened on the distal tube wall of the outer tube body, and the pressure sensing guide wire is movably installed in the inner tube body.
进一步地,所述内层管体和外层管体都为可弯曲的弯曲管。Further, both the inner tube body and the outer tube body are bendable curved tubes.
进一步地,所述内层管体和外层管体都为金属管,所述金属管的内周面和外周面上都包覆有密封绝缘层;所述压力传感导丝为金属丝。Further, both the inner tube body and the outer tube body are metal tubes, and the inner and outer peripheral surfaces of the metal tubes are coated with a sealing insulating layer; the pressure sensing guide wire is a metal wire.
进一步地,所述导丝头端的远端端面为光滑圆面。Further, the distal end surface of the guide wire tip is a smooth round surface.
进一步地,所述输卵管诊断疏通装置还包括设有若干操作按钮的操作手柄,所述操作手柄与控制器通讯连接。Further, the fallopian tube diagnosis and dredging device also includes an operating handle provided with several operating buttons, and the operating handle is connected to the controller in communication.
进一步地,所述输卵管诊断疏通装置还包括与内导管近端传动连接的第一驱动单元、以及与压力传感导丝近端传动连接的第二驱动单元,所述第一驱动单元驱动内导管转动和轴向移动,所述第二驱动单元驱动压力传感导丝转动和轴向移动,所述第一驱动单元中的驱动源和第二驱动单元中的驱动源都与控制器通讯连接。Further, the fallopian tube diagnosis and dredging device also includes a first driving unit that is drivingly connected to the proximal end of the inner catheter, and a second driving unit that is drivingly connected to the proximal end of the pressure sensing guide wire, and the first driving unit drives the inner catheter rotation and axial movement, the second drive unit drives the pressure sensing guide wire to rotate and move axially, and the drive source in the first drive unit and the drive source in the second drive unit are both communicated with the controller.
如上所述,本发明涉及的输卵管诊断疏通装置,具有以下有益效果:As mentioned above, the fallopian tube diagnosis and dredging device related to the present invention has the following beneficial effects:
本申请涉及的输卵管诊断疏通装置用于诊断输卵管是否通畅、以及在诊断输卵管不通畅时疏通输卵管,在输卵管诊断疏通装置插入输卵管时,导丝头端始终位于外鞘和内导管的外部,能将反作用力传递给压力传感器,操作者根据状态指示面板上所显示的压力传感器反馈的压力值来找出最佳的插入角度,防止操作者经验不足暴力插入输卵管而导致损伤输卵管;并且,在诊断过程中,控制流量泵的运转,依次通过通液管、内导管的通液腔和第一通液孔、以及外鞘的远端通孔向输卵管中通液,控制器获取流量泵反馈的通液流量和压力传感器反馈的液体压力,根据这两个数据能够精确地判断出输卵管的通畅状态,有效提高输卵管诊断的准确度。The fallopian tube diagnosis and dredging device involved in this application is used to diagnose whether the fallopian tube is unobstructed, and to dredge the fallopian tube when the fallopian tube is not smooth. The reaction force is transmitted to the pressure sensor, and the operator finds the best insertion angle according to the pressure value fed back by the pressure sensor displayed on the status indication panel, so as to prevent the operator from inexperienced violently inserting the fallopian tube and causing damage to the fallopian tube; and, during the diagnosis process In the middle, the operation of the flow pump is controlled, and the liquid is passed through the fallopian tube through the liquid passage tube, the liquid passage chamber of the inner catheter, the first liquid passage hole, and the distal through hole of the outer sheath in sequence, and the controller obtains the liquid passage fed back by the flow pump. The fluid pressure fed back by the flow and pressure sensors can accurately determine the patency of the fallopian tubes based on these two data, effectively improving the accuracy of fallopian tube diagnosis.
附图说明Description of drawings
图1为本申请中输卵管诊断疏通装置的结构示意图。Fig. 1 is a structural schematic diagram of the fallopian tube diagnosis and dredging device in the present application.
图2为本申请中外鞘、内导管和压力传感导丝之间的连接示意图。Fig. 2 is a schematic diagram of the connection among the outer sheath, the inner catheter and the pressure sensing guide wire in the present application.
图3为图2的A圈放大图。FIG. 3 is an enlarged view of circle A in FIG. 2 .
图4为本申请中外鞘的结构示意图。Fig. 4 is a schematic structural diagram of the outer sheath in the present application.
图5为图4的B圈放大图。FIG. 5 is an enlarged view of circle B in FIG. 4 .
图6为图4的半剖图。FIG. 6 is a half-sectional view of FIG. 4 .
图7为图6的C圈放大图。FIG. 7 is an enlarged view of circle C in FIG. 6 .
图8为本申请中内导管的结构示意图。Fig. 8 is a schematic structural view of the inner catheter in the present application.
图9为图8的D圈放大图。FIG. 9 is an enlarged view of circle D in FIG. 8 .
图10为图8的主视图。Fig. 10 is a front view of Fig. 8 .
图11为图8的半剖图。FIG. 11 is a half-sectional view of FIG. 8 .
图12为图11的E圈放大图。FIG. 12 is an enlarged view of circle E in FIG. 11 .
图13为本申请中压力传感导丝的结构示意图。Fig. 13 is a schematic diagram of the structure of the pressure sensing guide wire in the present application.
图14为图13的F圈放大图。FIG. 14 is an enlarged view of circle F in FIG. 13 .
图15至图17为本申请中输卵管诊断疏通装置用于诊断输卵管通畅状态的操作过程图。15 to 17 are diagrams of the operation process of the fallopian tube diagnosis and dredging device in the present application for diagnosing the patency of fallopian tubes.
图18a至图18d为通液流量n和液体压力P的关系曲线图。18a to 18d are graphs showing the relationship between the liquid flow rate n and the liquid pressure P.
图19为本申请中输卵管诊断疏通装置用于疏通输卵管时的状态一示意图。Fig. 19 is a schematic diagram of
图20为疏通输卵管时判断内导管和压力传感导丝通过阻碍物所对应的移动距离L和液体压力P的关系曲线图。Fig. 20 is a graph showing the relationship between the moving distance L and the liquid pressure P when the inner catheter and the pressure-sensing guide wire pass through the obstacle when the fallopian tube is unblocked.
图21为本申请中输卵管诊断疏通装置用于疏通输卵管时的状态二示意图。Fig. 21 is a schematic diagram of state 2 when the fallopian tube diagnosis and dredging device in this application is used to dredge the fallopian tubes.
图22为疏通输卵管过程中移动距离L和液体压力P的关系曲线图。Fig. 22 is a graph showing the relationship between the moving distance L and the fluid pressure P during the process of dredging the fallopian tubes.
图23为疏通输卵管过程中内导管和压力传感导丝与输卵管之间的关系示意图。Fig. 23 is a schematic diagram of the relationship between the inner catheter, the pressure-sensing guide wire and the fallopian tube in the process of dredging the fallopian tube.
元件标号说明Component designation description
10 控制器10 controllers
20 外鞘20 outer sheath
21 密封固定段21 Sealing section
211 褶皱部211 folds
212 气囊部212 Airbag Department
213 封堵部213 Blocking Department
22 远端通孔22 Distal through hole
23 通气腔23 Vent cavity
24 十字槽24 Cross recessed
25 第一密封锥面25 First sealing cone
26 通气接管段26 Vent connection section
30 内导管30 inner catheter
31 通液腔31 Liquid chamber
32 第一通液孔32 The first liquid hole
33 第二通液孔33 Second liquid hole
34 第一密封锥面34 First sealing cone
35 内层管体35 Inner tube body
36 外层管体36 outer tube body
37 通液接管段37 Liquid connection section
40 压力传感导丝40 Pressure Sensing Guidewire
41 导丝头端41 Guide wire tip
42 光滑圆面42 smooth round
50 压力传感器50 pressure sensor
60 通液管60 liquid pipe
70 流量泵70 flow pump
80 状态指示面板80 status indicator panel
90 通气管90 snorkel
110 电磁阀110 solenoid valve
120 调压阀120 pressure regulating valve
130 压力计130 pressure gauge
140 操作手柄140 Operating handle
150 第一驱动单元150 First drive unit
160 第二驱动单元160 Second drive unit
170 外部气源170 External air supply
180 药液源180 Liquid Medicine Source
190 数据接口190 data interface
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。The implementation of the present invention will be illustrated by specific specific examples below, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.
须知,本说明书附图所绘的结构、比例、大小等,均仅用以配合说明书所揭示的内容,以供熟悉此技术的人士了解与阅读,并非用以限定本发明可实施的限定条件,故不具技术上的实质意义,任何结构的修饰、比例关系的改变或大小的调整,在不影响本发明所能产生的功效及所能达成的目的下,均应仍落在本发明所揭示的技术内容能涵盖的范围内。同时,本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语,亦仅为便于叙述明了,而非用以限定本发明可实施的范围,其相对关系的改变或调整,在无实质变更技术内容下,当亦视为本发明可实施的范畴。It should be noted that the structures, proportions, sizes, etc. drawn in the drawings of this specification are only used to match the content disclosed in the specification, for those who are familiar with this technology to understand and read, and are not used to limit the conditions for the implementation of the present invention. Therefore, there is no technical substantive meaning, and any modification of structure, change of proportional relationship or adjustment of size shall still fall within the scope of the disclosure of the present invention without affecting the functions and objectives of the present invention. within the scope of technical content. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for convenience of description and are not used to limit the present invention. The practicable scope, the change or adjustment of its relative relationship, without any substantial change in the technical content, shall also be regarded as the practicable scope of the present invention.
本申请提供一种输卵管诊断疏通装置,用于诊断输卵管的通畅状态、以及在诊断输卵管不通畅时疏通输卵管。为便于叙述,下述实施例中,将输卵管诊断疏通装置靠近操作者的一端定义为近端,将输卵管诊断疏通装置远离操作者的一端定义为远端;操作者通常为医生。The application provides a device for diagnosing and dredging the fallopian tubes, which is used for diagnosing the patency of the fallopian tubes and dredging the fallopian tubes when the fallopian tubes are diagnosed to be blocked. For ease of description, in the following embodiments, the end of the fallopian tube diagnosis and dredging device close to the operator is defined as the proximal end, and the end of the fallopian tube diagnosis and dredge device away from the operator is defined as the distal end; the operator is usually a doctor.
如图1至图3所示,本申请涉及的输卵管诊断疏通装置包括外鞘20、内导管30、压力传感导丝40、固定在压力传感导丝40远端的压力传感器50、用于引入药液的通液管60、安装在通液管60上的流量泵70、状态指示面板80、以及控制器10;其中,外鞘20、内导管30和压力传感导丝40都沿近端朝向远端的方向轴向延伸,内导管30可轴向移动地穿设在外鞘20中,压力传感导丝40可轴向移动地穿设在内导管30中;外鞘20的远端具有可缩胀的密封固定段21、以及开设在外鞘20远端端面上的远端通孔22,通过密封固定段21的膨胀可使外鞘20固定在输卵管口部、并与输卵管口部之间密封;内导管30具有与通液管60连通的通液腔31、以及开设在内导管30远端端面上且与通液腔31连通的第一通液孔32;压力传感导丝40具有一段分布在压力传感器50远端侧的导丝头端41;压力传感器50、流量泵70和状态指示面板80都与控制器10通讯连接。As shown in Figures 1 to 3, the fallopian tube diagnosis and dredging device involved in the present application includes an outer sheath 20, an inner catheter 30, a pressure sensing guide wire 40, a pressure sensor 50 fixed on the distal end of the pressure sensing guide wire 40, The liquid tube 60 for introducing the liquid medicine, the flow pump 70 installed on the liquid tube 60, the status indicating panel 80, and the controller 10; wherein, the outer sheath 20, the inner catheter 30 and the pressure sensing guide wire 40 are all along the proximal The end extends axially toward the direction of the distal end, the inner catheter 30 is threaded in the outer sheath 20 in an axially movable manner, and the pressure sensing guide wire 40 is threaded in the inner catheter 30 in an axially movable manner; the distal end of the outer sheath 20 It has an expandable sealing and fixing section 21, and a distal through hole 22 opened on the distal end surface of the outer sheath 20, through the expansion of the sealing and fixing section 21, the outer sheath 20 can be fixed on and between the ostium of the fallopian tube The inner catheter 30 has a liquid passage cavity 31 communicated with the liquid passage tube 60, and a first liquid passage hole 32 opened on the distal end surface of the inner catheter 30 and communicated with the liquid passage chamber 31; the pressure sensing guidewire 40 There is a guide wire tip 41 distributed on the distal side of the pressure sensor 50 ; the pressure sensor 50 , the flow pump 70 and the status indicating panel 80 are all in communication connection with the controller 10 .
上述输卵管诊断疏通装置中,通过控制内导管30在外鞘20中的轴向移动,能够使内导管30的远端能被收拢在外鞘20中、或从外鞘20的远端通孔22中伸出至外鞘20外;通过控制压力传感导丝40在内导管30中的轴向移动,能够使压力传感导丝40远端的导丝头端41能被收拢在内导管30中、或依次从内导管30的第一通液孔32和外鞘20的远端通孔22中伸出至外鞘20外。当内导管30的远端被收拢在外鞘20中、且导丝头端41被收拢在内导管30中时,即内导管30的远端和导丝头端41都位于外鞘20中,此时,如图17所示,内导管30远端的第一通液孔32和外鞘20远端的远端通孔22对准并连通。In the above fallopian tube diagnosis and dredging device, by controlling the axial movement of the
本申请涉及的输卵管诊断疏通装置用于诊断输卵管的通畅状态、以及疏通输卵管时都借助宫腔镜,在宫腔镜下使用,此过程中外鞘20穿设在宫腔镜的机械通道中。The device for diagnosing and dredging fallopian tubes involved in this application is used for diagnosing the patency of fallopian tubes and dredging fallopian tubes with the aid of a hysteroscope.
输卵管诊断疏通装置用于诊断输卵管的通畅状态时的操作如下:首先,初始状态下,如图1和图2所示,压力传感导丝40预装在内导管30中,压力传感导丝40的远端被收拢在内导管30中;内导管30预装在外鞘20中,内导管30的远端被收拢在外鞘20中。其次,内导管30和压力传感导丝40随外鞘20穿在宫腔镜的机械通道中进入子宫,并在宫腔镜下找到输卵管口部。之后,使压力传感导丝40朝向远端前移,则导丝头端41依次穿过内导管30远端的第一通液孔32和外鞘20远端的远端通孔22后伸出至外鞘20外,如图15所示,导丝头端41在宫腔镜下插入输卵管间质部,导丝头端41受输卵管间质部的反作用,将反作用力传递给压力传感器50,控制器10将压力传感器50实时反馈的压力值显示在状态指示面板80上,医生根据压力值大小找出导丝头端41插入输卵管间质部的最佳插入角度,防止医生经验不足暴力插入而导致损伤输卵管。再后,外鞘20和内导管30一起随导丝头端41向远端移动、置入输卵管口部,如图15所示。然后,外鞘20远端的密封固定段21膨胀,如图16所示,将外鞘20远端固定于输卵管间质部,同时也使外鞘20远端和输卵管间质部之间密封,也就密封输卵管口部并隔绝宫腔与输卵管之间的压力传递。最后,使压力传感导丝40朝向近端退移至内导管30中,则内导管30的远端和导丝头端41都位于外鞘20中,如图17所示;控制器10驱动流量泵70运转,通液管60引入药液,药液依次经内导管30的通液腔31、内导管30的第一通液孔32和外鞘20的远端通孔22流入输卵管,控制器10获取流量泵70反馈的通液流量n和压力传感器50反馈的液体压力P,并将通液流量n和液体压力P的关系曲线图实时显示在状态指示面板80上,医生根据通液流量n和液体压力P的关系曲线图判断输卵管的通畅、通而不畅、阻塞、积液等状态。The operation of the fallopian tube diagnosis and dredging device for diagnosing the patency of the fallopian tubes is as follows: first, in the initial state, as shown in Figure 1 and Figure 2, the pressure
输卵管诊断疏通装置用于疏通输卵管的操作如下:首先,如图19所示,使压力传感导丝40朝向远端前移,使内导管30朝向远端前移,则内导管30顶开外鞘20的远端通孔22后伸出至外鞘20外,导丝头端41通过内导管30的第一通液孔32后伸出至内导管30外。控制器10将压力传感器50实时反馈的压力值与内导管30和压力传感导丝40前移距离L之间的关系曲线图显示在状态指示面板80上,显示输卵管的疏通状态信息,如图20所示,医生由此判断内导管30和导丝头端41通过了输卵管内的阻塞物。之后,使压力传感导丝40朝向近端退移至内导管30中,如图21所示。最后,控制器10驱动流量泵70运转,重新进行通液,由此疏通输卵管。The operation of the fallopian tube diagnosis and dredging device for dredging the fallopian tubes is as follows: first, as shown in Figure 19, the pressure
因此,本申请涉及的输卵管诊断疏通装置既能用于诊断输卵管是否通畅,又能用于疏通输卵管;在输卵管诊断疏通装置插入输卵管时,医生根据状态指示面板80上所显示的压力传感器50反馈的压力值来找出最佳的插入角度,防止操作者经验不足暴力插入输卵管而导致损伤输卵管,不易损伤输卵管口部;在诊断过程中,医生根据状态指示面板80上显示的通液流量n和液体压力P的关系曲线图判断输卵管的通畅、通而不畅、阻塞、积液等状态,有效提高输卵管诊断的准确度,也可以得到更具体的诊疗结果。Therefore, the device for diagnosing and dredging the fallopian tubes involved in the present application can be used for diagnosing whether the fallopian tubes are unobstructed, and can be used for dredging the fallopian tubes; Pressure value to find out the best insertion angle, prevent the operator from inexperienced violently inserting the fallopian tube and cause damage to the fallopian tube, and not easy to damage the fallopian tube mouth; The relationship curve of pressure P can judge the patency, patency, blockage, fluid accumulation and other states of the fallopian tube, which can effectively improve the accuracy of fallopian tube diagnosis and obtain more specific diagnosis and treatment results.
进一步地,如图3所示,内导管30的远端还开设有数个分布在通液腔31外周侧的第二通液孔33,通液腔31和内导管30的外界通过第二通液孔33连通。如此,在疏通输卵管的过程中,如图23所示,内导管30通过第二通液孔33输出均匀的液体压力,使得内导管30可以随着输卵管内部结构前移或后腿,且内导管30在前后移动的过程中,经第二通液孔33输出的药液会在内导管30和输卵管之间形成液体保护层,保护输卵管不被穿破。Further, as shown in FIG. 3 , the distal end of the
进一步地,外鞘20的优选结构为:如图4至图7所示,外鞘20远端的密封固定段21包括褶皱部211、分布在褶皱部211近端侧的气囊部212、以及分隔在褶皱部211和气囊部212之间的封堵部213,封堵部213为气囊部212的部分薄壁;本实施例中,褶皱部211有两个、轴向排布,远端侧的褶皱部211的远端延伸至外鞘20的远端;或者说,褶皱部211的远端端面构成了外鞘20的远端端面。当内导管30的远端被收拢在外鞘20中时,如图3所示,褶皱部211分布在内导管30远端的外周侧,褶皱部211的内周空腔与第二通液孔33连通,褶皱部211的远端还与内导管30的远端密封配合。在外鞘20插入输卵管的过程中,褶皱部211处于缩起的状态,故褶皱部211能够被折叠,便于褶皱部211的插入,同时还减少对输卵管的损伤。之后,在宫腔镜下观察到褶皱部211均置入输卵管口部后再通液,通液腔31中的药液会通过第二通液孔33流入至褶皱部211的内周空腔中,驱使褶皱部211胀起,进而将外鞘20的远端固定于输卵管间质部;之后,再向气囊部212中通气,驱使气囊部212胀起,用以密封输卵管口部并隔绝宫腔与输卵管之间的压力传递,则在后续诊断和疏通过程中能够确保压力传感导丝40更加精准的传导力,排除外界干扰。Further, the preferred structure of the
进一步地,如图1所示,输卵管诊断疏通装置还包括用于引入气体的通气管90、以及串接安装在通气管90上的电磁阀110、调压阀120和压力计130,外鞘20中开设有轴向延伸的通气腔23,通气腔23的近端和远端分别与通气管90的和气囊部212的近端连通,电磁阀110和压力计130都与控制器10通讯连接。电磁阀110受控制器10控制,电磁阀110作用于调压阀120,控制调压阀120的开度,用于对气囊部212充气、保压和泄气;压力计130向控制器10反馈外鞘20的通气腔23中的实时压力,便于控制器10控制流量泵70的运转、以及通过电磁阀110控制调压阀120的压力,从而精确控制褶皱部211和气囊部212的胀起程度。具体说,在流量泵70运转通液驱使褶皱部211胀起时,封堵部213可以传导压力,压力计130此时获得褶皱部211的内周空腔中的液体压力,当该液体压力达到设定值后,控制器10控制流量泵70自动停止,防止患者过度不适;之后,控制器10向电磁阀110发送指令,使得调压阀120升高压力值,驱使气囊部212胀起,压力计130此时获得通气腔23和气囊部212内的气体压力,当该气体压力达到设定值后,控制器10控制电磁阀110切换为保压状态,停止向气囊部212中充气。另外,输卵管诊断疏通装置通电后,控制器10会预先打开电磁阀110,将调压阀120设置为较低的压力,使得外鞘20的通气腔23和气囊部212中有一定压力,从而使得外鞘20能保持适度刚度,更加容易且顺利地置入宫腔镜的机械通道中。Further, as shown in FIG. 1 , the fallopian tube diagnosis and dredging device also includes a
优选地,通气管90引入气体的结构为:如图1所示,将通气管90的一端与一外部气源170相连;另外,如图4和图6所示,外鞘20的近端设有一段径向平直延伸的通气接管段26,该通气接管段26与外鞘20的通气腔23相通,通气管90的另一端与通气接管段26相连。如此,外部气源170供给的气体依次经通气管90和通气腔23流入外鞘20远端的气囊部212中,使气囊部212充气膨胀。Preferably, the gas introduction structure of the
优选地,如图5和图7所示,褶皱部211呈锥形,褶皱部211的外径沿近端朝向远端的方向逐渐减小,便于褶皱部211插入输卵管。褶皱部211的远端端面上开设有十字槽24,十字槽24与远端通孔22相通,十字槽24能降低褶皱部211的远端端面的强度,便于内导管30能够从外鞘20的远端通孔22中顶出。如图3、图7和图9所示,褶皱部211远端的内周面上设有第一密封锥面25,内导管30远端的外周面上设有第二密封锥面34;当内导管30的远端被收拢在外鞘20中时,第一密封锥面25和第二密封锥面34面接触配合,实现此时褶皱部211的远端与内导管30的远端之间的密封配合,避免在褶皱部211通液胀起的过程中药液从外鞘20中流出。外鞘20整体由一定硬度的弹性体支撑,比如外鞘20由橡胶或硅胶等制成。Preferably, as shown in FIG. 5 and FIG. 7 , the folded
进一步地,内导管30的优选结构为:如图8至图12所示,内导管30为内外双层结构,包括内层管体35和环绕在内层管体35外部的外层管体36,内层管体35的近端和外层管体36的近端相固定,内层管体35和外层管体36之间的环形腔构成通液腔31,通液腔31沿内导管30的长度方向轴向延伸,第一通液孔32开设在内层管体35的远端端面和外层管体36的远端端面上,第二通液孔33开设在外层管体36的远端管壁上,压力传感导丝40可移动地穿设在内层管体35内。第一通液孔32为轴向开设的通孔,第二通液孔33为径向开设的通孔,数个第二通液孔33均匀分布在外层管体36的远端。Further, the preferred structure of the
进一步地,内层管体35和外层管体36都为可弯曲的弯曲管,故内导管30可以任意角度弯曲,利于输卵管的疏通。内层管体35和外层管体36都为金属管,金属管的内周面和外周面上都包覆有密封绝缘层,密封绝缘层为弹性材料,起到密封和绝缘的效果;压力传感导丝40为金属丝。如此,内导管30和压力传感导丝40都为金属材质,可在X光下呈现,使得本装置亦可通造影剂,兼顾其他术式的使用特征。Further, both the
优选地,通液管60引入药液的结构为:如图1所示,将通液管60的一端与一药液源180相连,药液源180可以为盛放药液的药液袋或药液瓶,药液组成由医师根据需求配置,可以为造影剂或抗生素生理盐水或亚甲蓝染色剂等。另外,如图9至图11所示,内导管30在外层管体36的近端设有一端径向平直延伸的通液接管段37,该通液接管段37与内导管30的通液腔31相通,通液管60的另一端与通液接管段37相连。如此,药液源180供给的药液经通液接管段37流入通液腔31中。Preferably, the structure for introducing the liquid medicine through the
进一步地,如图13和图14所示,导丝头端41的远端端面为光滑圆面42,使得压力传感导丝40的远端圆润,避免损伤输卵管。压力传感器50与压力传感导丝40连接为一体。Further, as shown in FIG. 13 and FIG. 14 , the distal end surface of the
进一步地,如图1所示,输卵管诊断疏通装置还包括设有若干操作按钮的操作手柄140,操作手柄140和状态指示面板80都通过数据接口190与控制器10通讯连接;若干操作按钮包括导丝探测按钮、通液探测按钮、自动疏通按钮、结束按钮、紧急停止按钮等。Further, as shown in FIG. 1 , the fallopian tube diagnosis and dredging device also includes an
进一步地,如图1所示,输卵管诊断疏通装置还包括与内导管30近端传动连接的第一驱动单元150、以及与压力传感导丝40近端传动连接的第二驱动单元160,第一驱动单元150驱动内导管30转动和轴向移动,第二驱动单元160驱动压力传感导丝40转动和轴向移动,第一驱动单元150中的驱动源和第二驱动单元160中的驱动源都与控制器10通讯连接,受控制器10的信号控制。因此,本申请中的内导管30在外鞘20中即可轴向移动、又可转动,压力传感导丝40在内导管30中即可轴向移动、又可转动,在疏通过程中,当阻塞物较大时,通过内导管30和压力传感导丝40转动的方式,使其更加容易地通过阻塞物。Further, as shown in FIG. 1 , the fallopian tube diagnosis and dredging device also includes a
综上所述,具有上述结构的输卵管诊断疏通装置用于诊断输卵管的通畅状态的使用方法,包括以下步骤:In summary, the method for diagnosing the patency of the fallopian tube with the fallopian tube diagnosis and dredging device having the above structure includes the following steps:
A1、将输卵管诊断疏通装置通电,控制器10预先打开电磁阀110,将调压阀120设置为较低的压力,使得外鞘20的通气腔23和气囊部212中有一定压力,外鞘20保持适度刚性置入宫腔镜的器械通道。A1. Power on the fallopian tube diagnosis and dredging device, the
A2、将压力传感导丝40预装在内导管30中,将内导管30预装在外鞘20中,且压力传感导丝40的远端和内导管30的远端都位于外鞘20中。内导管30和压力传感导丝40随外鞘20穿在宫腔镜的机械通道中进入子宫,并在宫腔镜下找到输卵管口部。医生按下操作手柄140上的导丝探测按钮,控制器10控制第二驱动单元160动作,将压力传感导丝40的导丝头端41向前推出至外鞘20外,如图15所示;导丝头端41在宫腔镜下插入输卵管间质部,状态指示面板80显示压力传感器50实时反馈的压力值,医生根据压力值大小找出导丝头端41插入输卵管间质部的最佳插入角度,防止医生经验不足暴力插入而导致损伤输卵管。A2, the
A3、外鞘20和内导管30一起随导丝头端41前移置入输卵管口部,在宫腔镜下观察褶皱部211都置入输卵管口部后,医生按下操作手柄140上的通液探测按钮。控制器10控制流量泵70运转,流量泵70将药液源180中的药液经通液管60流入内导管30的通液腔31中,药液经内导管30的第二通液孔33流入至褶皱部211的内周空腔中,如图16所示,褶皱部211胀起,将外鞘20的远端固定于输卵管间质部;此过程中,褶皱部211和气囊部212之间较薄的封堵部213传导压力,压力计130获得褶皱部211的内周空腔中的液体压力,当该液体压力达到设定值后,控制器10控制流量泵70自动停止,防止患者过度不适;并且,第一密封锥面25和第二密封锥面34始终面接触配合,导丝头端41与第一通液孔32的孔壁之间也密封,故药液不会流出至外鞘20的外部。流量泵70停止后,控制器10向电磁阀110发送指令,使得调压阀120升高压力值,向气囊部212中充气,气囊部212胀起;此过程中,压力计130获得通气腔23和气囊部212中的气体压力,当该气体压力达到设定值后,控制器10控制电磁阀110切换为保压状态,则胀起的气囊部212封堵在输卵管口部处,隔绝宫腔与输卵管之间的压力传递。A3. The
A4、控制器10控制第二驱动单元160再动作,将压力传感导丝40的导丝头端41向后回退至内导管30中,如图17所示;之后,控制器10控制流量泵70运转,流量泵70按设定值泵入药液,药液通过内导管30的第一通液孔32和外鞘20的远端通孔22流入输卵管,进行输卵管的状态诊断。A4. The
A5、控制器10中预存有液体压力阈值Px;控制器10获取流量泵70反馈的通液流量n和压力传感器50反馈的液体压力P,并将通液流量n和液体压力P的关系曲线图实时显示在状态指示面板80上,医生根据通液流量n和液体压力P的关系曲线图判断输卵管的通畅、通而不畅、阻塞、积液等状态。A5. The liquid pressure threshold Px is pre-stored in the
当状态指示面板80上显示的n-P关系曲线图如图18a所示时,表明压力传感器50反馈的液体压力P恒定且始终小于液体压力阈值Px,则说明输卵管畅通,在通液流量n达到设定值后停止泵入药液。When the n-P relationship graph displayed on the
当状态指示面板80上显示的n-P关系曲线图如图18b所示时,表明压力传感器50反馈的液体压力P先逐渐增加、后逐渐减小至恒定值,但压力传感器50反馈的液体压力P始终小于液体压力阈值Px,则说明输卵管通而不畅,需要后续内导管30的疏通。When the n-P relationship graph displayed on the
当状态指示面板80上显示的n-P关系曲线图如图18c所示时,表明压力传感器50反馈的液体压力P一直在逐渐增加、并大于液体压力阈值Px,则说明输卵管堵塞,此时,控制器10控制流量泵70自动停止,需要后续内导管30的疏通。When the n-P relationship graph displayed on the
当状态指示面板80上显示的n-P关系曲线图如图18d所示时,表明压力传感器50反馈的液体压力P先逐渐增加、后逐渐减小至恒定值、但突然急剧增加至大于液体压力阈值Px,则说明输卵管存在积液等病变,此时,控制器10控制流量泵70自动停止,需要后续结合腹腔镜进行手术诊断。When the n-P relationship graph displayed on the
针对图18b和图18c所示的情况,医生按下操作手柄140上的自动疏通按钮,则具有上述结构的输卵管诊断疏通装置用于疏通输卵管的使用方法,包括以下步骤:For the situation shown in Figure 18b and Figure 18c, the doctor presses the automatic dredging button on the
B1、控制器10控制第一驱动单元150和第二驱动单元160动作,使压力传感导丝40朝向远端前移,使内导管30朝向远端前移,如图19所示,内导管30顶开外鞘20的远端通孔22后伸出至外鞘20外,导丝头端41通过内导管30的第一通液孔32后伸出至内导管30外。B1. The
B2、控制器10将内导管30和压力传感导丝40的前移距离L和压力传感器50反馈的液体压力P的关系曲线图显示在状态指示面板80上。当状态指示面板80上显示的L-P关系曲线图如图20所示时,表明压力传感器50反馈的液体压力P先从恒定值逐渐增加至第一压力记忆点P1、再从第一压力记忆点P1逐渐减小至恒定值,也就表明内导管30的远端和导丝头端41通过了阻塞物。同时,控制器10自动获取第一距离记忆点L1和第二距离记忆点L2,第一距离记忆点L1对应液体压力P从恒定值开始增加的前移距离,第二距离记忆点L2对应液体压力P减小至恒定值的前移距离。B2. The
B3、控制器10控制第二驱动单元160再动作,将压力传感导丝40的导丝头端41向后回退至内导管30中,如图21所示;控制器10控制流量泵70运转,重新进行通液,药液经内导管30的通液腔31、第一通液孔32和第二通液孔33流至输卵管中。若状态指示面板80上显示的n-P关系曲线图如图18a所示,则疏通成功,表明阻塞物被内导管30和压力传感导丝40成功分离,如图21所示。若状态指示面板80上显示的n-P关系曲线图如图18b所示,则执行下述步骤B4。B3. The
B4、控制器10向第一驱动单元150和第二驱动单元160发送指令,使内导管30和压力传感导丝40各自回退至第一距离记忆点L1,之后,第一驱动单元150驱动内导管30转动、以及在第一距离记忆点L1和第二距离记忆点L2之间往复移动,第一驱动单元150驱动压力传感导丝40转动、以及在第一距离记忆点L1和第二距离记忆点L2之间往复移动,获取到第二次操作时的第二压力记忆点P2、以及第三次操作时的第三压力记忆点P3,如图22所示,压力记忆点对应的液体压力随着操作次数的增加会下降,当第N次操作时的压力记忆点对应的液体压力相较于第一压力记忆点P1下降超过50%后,再进行通液测试;如此反复操作,直至状态指示面板80上显示如图18a所示的n-P关系曲线图。疏通过程中,如图23所示,经内导管30的第二通液孔33输出的药液会在内导管30和输卵管之间形成液体保护层,保护输卵管不被穿破。B4. The
B5、在疏通成功或其他已显示的不再适宜进行介入疏通的情况下,医生按下操作手柄140上的结束按钮,第一驱动单元150驱动内导管30回退,第二驱动单元160驱动压力传感导丝40回退。回退至输卵管口部时,控制器10控制流量泵70反转,对通液腔31进行泄压,随即褶皱部211泄压,取消外鞘20在输卵管给口部的固定;同时,电磁阀110泄压,取消气囊部212的胀起,当压力计130度数值降到预设值后,状态指示面板80提示泄压完成,医生在宫腔镜下进行另一侧输卵管的疏通或取出装置结束手术。B5. In the case of successful dredging or other displayed situations where it is no longer suitable to perform interventional dredging, the doctor presses the end button on the
本申请涉及的输卵管诊断疏通装置具有的自动疏通功能,大大降低了医生的手术操作复杂性,也更精确的针对病灶点进行疏通。The automatic dredging function of the fallopian tube diagnosis and dredging device involved in the present application greatly reduces the complexity of the doctor's operation and can more accurately dredge the lesion.
综上所述,本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。To sum up, the present invention effectively overcomes various shortcomings in the prior art and has high industrial application value.
上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。The above-mentioned embodiments only illustrate the principles and effects of the present invention, but are not intended to limit the present invention. Anyone skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical ideas disclosed in the present invention shall still be covered by the claims of the present invention.
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CN202210881965.0ACN115251843B (en) | 2022-07-26 | 2022-07-26 | A fallopian tube diagnosis and dredging device |
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CN202210881965.0ACN115251843B (en) | 2022-07-26 | 2022-07-26 | A fallopian tube diagnosis and dredging device |
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CN115251843Atrue CN115251843A (en) | 2022-11-01 |
CN115251843B CN115251843B (en) | 2025-02-18 |
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CN202210881965.0AActiveCN115251843B (en) | 2022-07-26 | 2022-07-26 | A fallopian tube diagnosis and dredging device |
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CN108294727A (en)* | 2017-01-11 | 2018-07-20 | 宁波智光机电科技有限公司 | Fine electronics fallopian tubal diagnoses dredger |
CN208319191U (en)* | 2017-04-25 | 2019-01-04 | 深圳市人民医院 | Fallopian tube fluid-passing device |
CN110898317A (en)* | 2019-12-10 | 2020-03-24 | 复旦大学附属妇产科医院 | Uterine neck sheath tube for oviduct interventional embolization |
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US20110087109A1 (en)* | 2009-10-09 | 2011-04-14 | Betsy Swann | Methods and apparatus for determining fallopian tube occlusion |
CN101744600A (en)* | 2009-12-15 | 2010-06-23 | 夏萍 | Combined type falloposcopy with guide wire |
CN102370514A (en)* | 2011-09-29 | 2012-03-14 | 杨帆 | Oviduct injection dredging device with pressure gauge |
US20130090572A1 (en)* | 2011-10-07 | 2013-04-11 | Robert Bilgor Peliks | Integrity Testing Method and Apparatus for Delivering Vapor to the Uterus |
CN103239794A (en)* | 2013-04-25 | 2013-08-14 | 江门市富美尔环保电子科技有限公司 | Oviduct recanalization therapeutic catheter with air bag and capable of automatically being fixed |
CN103989510A (en)* | 2014-05-30 | 2014-08-20 | 河南科技大学第一附属医院 | Multifunctional fallopian tube dredging device for laparoscopic surgery |
CN106388784A (en)* | 2016-10-27 | 2017-02-15 | 钱良 | Hydrotubation device |
CN108294727A (en)* | 2017-01-11 | 2018-07-20 | 宁波智光机电科技有限公司 | Fine electronics fallopian tubal diagnoses dredger |
CN207412146U (en)* | 2017-03-02 | 2018-05-29 | 王俊兰 | A kind of fallopian tube fluid-passing device |
CN208319191U (en)* | 2017-04-25 | 2019-01-04 | 深圳市人民医院 | Fallopian tube fluid-passing device |
CN107837081A (en)* | 2017-12-07 | 2018-03-27 | 上海英诺伟医疗器械有限公司 | A kind of Pressure wire |
CN110898317A (en)* | 2019-12-10 | 2020-03-24 | 复旦大学附属妇产科医院 | Uterine neck sheath tube for oviduct interventional embolization |
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