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WO2022166403A1 - 一种宫腔负压止血装置及使用方法 - Google Patents

一种宫腔负压止血装置及使用方法 Download PDF

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Publication number
WO2022166403A1
WO2022166403A1 PCT/CN2021/137384 CN2021137384W WO2022166403A1 WO 2022166403 A1 WO2022166403 A1 WO 2022166403A1 CN 2021137384 W CN2021137384 W CN 2021137384W WO 2022166403 A1 WO2022166403 A1 WO 2022166403A1
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negative pressure
uterine cavity
water
vaginal
sac
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郑明明
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Nanjing Drum Tower Hospital
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Nanjing Drum Tower Hospital
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium

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  • the invention belongs to the technical field of auxiliary medical devices, and in particular relates to a uterine cavity negative pressure hemostasis device and a using method.
  • Postpartum hemorrhage is a serious obstetric complication and one of the leading causes of maternal mortality.
  • the most common cause of postpartum hemorrhage is uterine atony.
  • emergency hysterectomy is required, resulting in the regret of organ loss and lifelong infertility.
  • intrauterine balloon compression has gradually become an alternative for treating postpartum hemorrhage. By injecting water into the balloon to make the balloon expand continuously, it can compress the blood vessels at the bleeding site, thereby achieving hemostasis.
  • the clinical treatment of postpartum hemorrhage due to uterine atony mostly adopts intrauterine packing hemostasis with water balloon or uterine gauze to stop the bleeding.
  • the hemostatic water bag When heavy bleeding occurs, put the hemostatic water bag into the uterus through the vagina to avoid contact with the vaginal wall. After the uterine water bag reaches the fundus, inject 400-800ml of water into the uterine water bag with a syringe to fill the water bag to play a hemostatic effect. .
  • the existing uterine cavity compression balloon device has the following disadvantages: (1) Due to the uncertain volume of the uterus and the irregular shape of the uterine cavity after delivery, it is difficult to accurately quantify the amount of water injected into the water balloon to achieve the best fit with the uterine wound, so it is difficult to play the best role.
  • the purpose of the present invention is to provide a uterine cavity negative pressure hemostasis device and a using method for the deficiencies of the prior art.
  • a uterine cavity negative pressure hemostasis device comprising a water bag conveyor, a uterine cavity water bag, a uterine cavity water bag input tube, a negative pressure device and a negative pressure tube;
  • the water bag conveyor is hollow inside, and one end of the water bag conveyor is The input end, the other end is the remote end;
  • the end of the input end of the water bladder conveyor is provided with a negative pressure suction port;
  • the negative pressure pipe is arranged inside the water bladder conveyor, one end of the negative pressure pipe is connected with the negative pressure suction port, and the other end is connected to the negative pressure suction port.
  • the uterine cavity water bag is arranged at the input end of the water bag conveyor, and is fixed on the water bag conveyor; the uterine cavity water bag input tube is arranged inside the water bag conveyor One end of the uterine cavity water bag input tube is connected to the uterine cavity water bag, and the other end is connected to the first interface, and the physiological saline is input into the uterine cavity water bag through the first interface and the uterine cavity water bag input tube.
  • the device is also provided with a vaginal water bag and a vaginal water bag input tube
  • the vaginal water bag is fixed on the water bag conveyor
  • the vaginal water bag input tube is arranged inside the water bag conveyor
  • the vaginal water bag input tube is provided.
  • One end of the tube is connected to the vaginal water bag, and the other end is connected to the second interface, and the physiological saline is input into the vaginal water bag through the second interface and the vaginal water bag input tube.
  • both the uterine cavity water bladder input tube and the negative pressure tube are latex tubes.
  • volume of the uterine cavity water bladder is 400-800 ml.
  • vaginal water bladder input tube adopts a latex tube.
  • volume of the vaginal water bladder is 100-200ml.
  • the use method of the above-mentioned uterine cavity negative pressure hemostatic device includes the following steps:
  • S3 connect the negative pressure device to the third interface, start the negative pressure device, form a negative pressure environment (60-100mmHg), the negative pressure suction port is adsorbed on the surface of the myometrium, and the adsorption time is adjusted as appropriate according to the hemostasis situation;
  • step S4 Turn off the negative pressure device, connect the third interface to the drainage bag, and observe for 20 minutes. If the blood accumulation in the drainage bag does not increase significantly, continue to place the hemostatic bag and take it out after 12-18 hours; if the blood accumulation in the drainage bag continues to increase, Then repeat step S3, and observe the hemostatic effect every 60 minutes of suction.
  • the volume of the physiological saline injected into the uterine cavity water sac is 400-500 ml, and the volume of the physiological saline injected into the vaginal water sac is 100-200 ml.
  • the negative pressure is set to 60-100mmHg.
  • duration of continuous negative pressure suction should not exceed 4 hours.
  • the invention designs a negative pressure suction port on the basis of the previous water sac compressing the uterus to stop bleeding, and on the basis of the vaginal water sac sealing the uterine cavity, the suction of the negative pressure device keeps the uterine cavity in a continuous negative pressure state, so that the uterus and the uterus are in a continuous negative pressure state.
  • the lower segment of the uterus fits more closely with the water sac and squeezes the surface of the water sac, so as to achieve the purpose of effective and rapid hemostasis.
  • the continuous negative pressure state in the uterine cavity avoids the displacement of the uterine cavity water bladder;
  • the top negative pressure suction port of the present invention has dense air holes, which on the one hand helps the uterine cavity to form negative pressure, and on the other hand, it can also be connected after the negative pressure is over. Drainage bag to drain hemorrhage in the uterine cavity helps to observe the effect of hemostasis.
  • FIG. 1 is a schematic structural diagram of an embodiment of the present invention
  • FIGS. 2 and 3 are schematic views of the structure of the negative pressure suction port according to the embodiment of the present invention.
  • Negative pressure suction port 2. Stoma; 3. Uterine water sac; 4. Vaginal water sac; 5. Uterine water sac input tube; 6. The first interface; Second interface; 9. Water bladder conveyor; 10. Negative pressure tube; 11. Third interface.
  • an embodiment of the present invention provides a uterine cavity negative pressure hemostasis device, including a water bladder conveyor 9, a uterine cavity water bladder 3, a uterine cavity water bladder input tube 5, a vaginal water bladder 4, and a vaginal water bladder input Pipe 7, negative pressure device and negative pressure pipe 10;
  • the inside of the water bladder conveyor 9 is hollow, one end of the water bladder conveyor 9 is the input end, and the other end is the remote end;
  • the end of the input end of the water bladder conveyor 9 is provided with a negative Pressure suction port 1, a number of air holes 2 are densely distributed on the negative pressure suction port 1;
  • the negative pressure pipe 10 is arranged inside the water bladder conveyor 9, one end of the negative pressure pipe 10 is connected with the negative pressure suction port 1, and the other end passes through
  • the third interface 11 is connected to the negative pressure device;
  • the uterine cavity water bladder 3 is arranged at the input end of the water bladder transporter 9 and is fixed on the water bladder transporter 9;
  • the vaginal water bag 4 is fixed on the water bag conveyor 9, the vaginal water bag input pipe 7 is arranged inside the water bag conveyor 9, one end of the vaginal water bag input pipe 7 is connected to the vaginal water bag 4, and the other end
  • the second interface 8 is connected, and the physiological saline is input into the vaginal water bag 4 through the second interface 8 and the vaginal water bag input tube 7 .
  • the uterine cavity water sac input tube 5, the vaginal water sac input tube 7, and the negative pressure tube 10 are all latex tubes; the volume of the uterine cavity water sac 3 is set to 400-800ml; the vagina The volume of the water bladder 4 is set to 100-200ml.
  • the present invention also provides a method for using the uterine cavity negative pressure hemostasis device, comprising the following steps:
  • the medical staff passes the unfilled uterine cavity water sac 3 through the vagina, avoiding contact with the vaginal wall, and gently sends it to the uterine cavity, making sure that the negative pressure suction port 1 with dense stomata 2 reaches or is close to The fundus of the uterus, the vaginal sac 4 is located in the vagina below the cervix;
  • S3 connect the negative pressure device to the third interface 11, start the negative pressure device (negative pressure is set at 60-100mmHg), form a negative pressure environment, and the negative pressure suction port 1 is adsorbed on the surface of the myometrium for 60min;
  • step S4 Turn off the negative pressure device, connect the third interface 11 to the drainage bag, and observe for 20 minutes. If the blood accumulation in the drainage bag does not increase significantly, continue to place the hemostatic bag and take it out after 12-18 hours; if the blood accumulation in the drainage bag continues to increase , step S3 is repeated, and the hemostatic effect is observed every 60 minutes of suction. The duration of continuous negative pressure suction should not exceed 4 hours.
  • the uterine cavity negative pressure hemostatic sac of the invention mainly designs a continuous negative pressure suction port on the basis of the existing uterine cavity hemostatic sac, which is opened at the top of the uterine cavity water sac, and the uterine cavity water sac is filled with water to initially compress the uterine wall and vaginal water. After the sac seals the opening of the uterine cavity, the negative pressure suction device is used to continuously suck through the negative pressure suction port, so that the uterine cavity outside the water sac forms a negative pressure, changing the positive pressure in the uterine cavity to negative pressure, and the negative pressure in the uterus and the uterine cavity.
  • the pressure difference between the normal pressure outside the abdominal cavity makes the myometrium including the lower uterine segment continue to press on the surface of the balloon. On the one hand, it can quickly stop bleeding. , The problem of fully compressing the uterus, avoiding the problems of insufficient compression of the lower segment of the uterus, overfilling of the uterine cavity and balloon fall off.

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Abstract

一种宫腔负压止血装置，包括水囊输送器（9）、宫腔水囊（3）、宫腔水囊输入管（5）、阴道水囊（4）、阴道水囊输入管（7）、负压装置和负压管（10）；水囊输送器（9）的端部设置负压吸引口（1），负压吸引口（1）上密集分布气孔（2）；负压管（10）设置在水囊输送器（9）内部，一端与负压吸引口（1）连接，另一端与负压装置连接；宫腔水囊（3）固定在水囊输送器（9）上；宫腔水囊输入管（5）一端连通宫腔水囊（3），另一端连接第一接口（6）；阴道水囊（4）固定在水囊输送器（9）上，阴道水囊输入管（7）一端连通阴道水囊（4），另一端连接第二接口（8）。上述装置的使用方法可使子宫及子宫下段紧密挤压水囊表面，从而达到快速止血的目的，同时宫腔内持续负压状态避免宫腔水囊（3）的移位或脱落。

Description

一种宫腔负压止血装置及使用方法 技术领域：
本发明属于辅助医疗器械技术领域，具体涉及一种宫腔负压止血装置及使用方法。
背景技术：
产后出血是产科严重的并发症，是孕产妇死亡的主要原因之一。产后出血最常见的原因为子宫收缩乏力，常规保守止血无效的情况下需紧急手术切除子宫，造成患者器官缺失以及终生不孕的遗憾。近年来，宫腔球囊压迫逐渐成为一种处理产后出血的备选方案，通过向球囊内注水使得球囊不断膨胀从而对出血部位的血管形成压迫作用，进而实现止血功能。
目前临床上对于宫缩乏力的产后出血救治多采用宫腔内填塞止血用水囊或子宫纱条压迫止血。发生大出血时，将止血用水囊通过阴道放入子宫内，避免接触阴道壁，在宫腔水囊达到宫底后，用注射器向宫腔水囊内注水400-800ml，使水囊充盈发挥止血作用。但是现有宫腔压迫球囊装置存在着如下弊端：(1)因产后子宫体积不定、宫腔形态不规则，水囊注水量难以准确量化以与子宫创面达到最佳贴合，从而难以发挥最佳止血作用；(2)产后子宫收缩乏力常表现为子宫下段收缩不佳，目前的止血囊由于不能针对子宫下段局部收缩不佳形成局部压迫，对子宫下段的压迫止血效果欠佳；(3)对于严重宫缩不良，宫腔体积较大的病例，需要注入大量液体(可达到1000ml左右)至球囊才能起到压迫子宫壁的作用，但较大体积的球囊会妨碍子宫有效收缩和复旧，引起临床质疑；(4)常规水囊放置后由于子宫收缩常出现水囊受压后位置下移，甚至脱落于宫腔外。基于此，本发明提出一种宫腔负压止血装置以解决上述问题。
发明内容：
本发明的目的是针对现有技术的不足，提供一种宫腔负压止血装置及使用方法。
为实现上述技术目的，本发明采取的技术方案为
一种宫腔负压止血装置，包括水囊输送器、宫腔水囊、宫腔水囊输入管、负压装置和负压管；所述水囊输送器内部中空，水囊输送器一端为输入端，另一端为远离端；水囊输送器输入端的端部设置有负压吸引口；所述负压管设置在水囊输送器内部，负压管一端与负压吸引口连接，另一端通过第三接口与负压装置连接；所述宫腔水囊设置在水囊输送器的输入端，并固定在水囊输送器上；所述宫腔水囊输入管设置在水囊输送器内部，宫腔水囊输入管一端连通宫腔水囊，另一端连接第一接口，生理盐水通过第一接口和宫腔水囊输入管输入至宫腔水囊内。
进一步的，本装置还设置有阴道水囊和阴道水囊输入管，所述阴道水囊固定在水囊输送器上，所述阴道水囊输入管设置在水囊输送器内部，阴道水囊输入管一端连通阴道水囊，另一端连接第二接口，生理盐水通过第二接口和阴道水囊输入管输入至阴道水囊内部。
进一步的，所述负压吸引口上分布有若干个气孔。
进一步的，所述宫腔水囊输入管和负压管均采用乳胶管。
进一步的，所述宫腔水囊的体积为400～800ml。
进一步的，所述阴道水囊输入管采用乳胶管。
进一步的，所述阴道水囊的体积为100～200ml。
以上所述的宫腔负压止血装置的使用方法，包括以下步骤：
S1、使用时，将未充液的宫腔水囊通过阴道，避免接触阴道壁，轻轻送至子宫腔，明确带有密集气孔的负压吸引口到达或接近子宫底部，阴道水囊位于宫口下方的阴道内；
S2、通过第一接口经宫腔水囊输入管向宫腔水囊内注射生理盐水，通过第二接口经阴道水囊输入管向阴道水囊注射生理盐水；
S3、将负压装置连接第三接口，启动负压装置，形成负压环境(60-100mmHg)，负压吸引口吸附在子宫肌层表面，根据止血情况酌情调整吸附时间；
S4、关闭负压装置，将第三接口连接引流袋，观察20min，若引流袋内积血未见明显增多，则继续放置止血囊，12-18h后取出；若引流袋内积血持续增多，则重复步骤S3，每吸引60min观察止血效果。
进一步的，S2中，宫腔水囊内注射生理盐水体积为400-500ml，阴道水囊内注射生理盐水体积为100～200ml。
进一步的，负压设定60-100mmHg。
进一步的，持续负压吸引的时间不超过4小时。
本发明的有益效果：
本发明在既往水囊压迫子宫止血的基础上设计负压吸引口，在阴道水囊封闭宫腔的基础上，通过负压装置的抽吸保持宫腔内呈持续负压状态，从而使子宫及子宫下段与水囊贴合更紧密并挤压水囊表面，从而达到有效快速止血的目的。同时宫腔内持续负压状态避免宫腔水囊的移位；本发明的顶端负压吸引口带有密集气孔，一方面帮助宫腔形成负压，另一方面也可在负压结束后连接引流袋引流宫腔积血，有助于观察止血效果。
附图说明
图1为本发明实施例结构示意图；
图2、3为本发明实施例负压吸引口结构示意图；
附图中的标记为：
1、负压吸引口；2、气孔；3、宫腔水囊；4、阴道水囊；5、宫腔水囊输入管；6、第一接口；7、阴道水囊输入管；8、第二接口；9、水囊输送器；10、负压管；11、第三接口。
具体实施方式：
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。实施例中未注明的实施条件通常为常规实验中的条件。
参照图1～3，本发明实施例提供一种宫腔负压止血装置，包括水囊输送器9、宫腔水囊3、宫腔水囊输入管5、阴道水囊4、阴道水囊输入管7、负压装置和负压管10；所述水囊输送器9内部中空，水囊输送器9一端为输入端，另一端为远离端；水囊输送器9输入端的端部设置有负压吸引口1，负压吸引口1上密集分布有若干个气孔2；所述负压管10设置在水囊输送器9内部，负压管10一端与负压吸引口1连接，另一端通过第三接口11与负压装置连接；所述宫腔水囊3设置在水囊输送器9的输入端，并固定在水囊输送器9上；所述宫腔水囊输入管5设置在水囊输送器9内部，宫腔水囊输入管5一端连通宫腔水囊3，另一端连接第一接口6，生理盐水通过第一接口6和宫腔水囊输入管5输入至宫腔水囊3内；所述阴道水囊4固定在水囊输送器9上，所述阴道水囊输入管7设置在水囊输送器9内部，阴道水囊输入管7一端连通阴道水囊4，另一端连接第二接口8，生理盐水通过第二接口8和阴道水囊输入管7输入至阴道水囊4内部。
本发明实施例中，所述宫腔水囊输入管5、阴道水囊输入管7、负压管10均采用乳胶管；所述宫腔水囊3的体积设置为400～800ml；所述阴道水囊4的体积设置为100～200ml。
本发明还提供一种宫腔负压止血装置的使用方法，包括以下步骤：
S1、当发生子宫出血时，医护人员将未充液的宫腔水囊3通过阴道，避免接触阴道壁，轻轻送至子宫腔，明确带有密集气孔2的负压吸引口1到达或接近子宫底部，阴道水囊4位于宫口下方的阴道内；
S2、用注射器通过第一接口6经宫腔水囊输入管5向宫腔水囊3内注射400-800ml生理盐水，通过第二接口8经阴道水囊输入管7向阴道水囊4注射100～200ml生理盐水；
S3、将负压装置连接第三接口11，启动负压装置(负压设定60-100mmHg)，形成负压环境，负压吸引口1吸附在子宫肌层表面，持续60min；
S4、关闭负压装置，将第三接口11连接引流袋，观察20min，若引流袋内积血未见明显 增多，则继续放置止血囊，12-18h后取出；若引流袋内积血持续增多，则重复步骤S3，每吸引60min观察止血效果。持续负压吸引的时间不超过4小时。
本发明宫腔负压止血囊，主要是在现有的宫腔止血囊的基础上设计持续负压吸引口，开口于宫腔水囊顶端，在宫腔水囊注水初步压迫子宫壁和阴道水囊封闭宫腔开口后，利用负压吸引装置通过负压吸引口持续抽吸，使水囊外的宫腔形成负压，改变宫腔内正压压迫为负压压迫，子宫内负压和子宫外位于腹腔的常压之间的压力差使得子宫肌层包括子宫下段持续压迫于球囊表面，一方面可快速止血，另一方面可解决宫腔水囊与宫腔贴合不佳导致无法全面、充分压迫子宫的问题，避免子宫下段压迫不足、宫腔过度充盈和球囊脱落的问题。
以上仅是本发明的优选实施方式，本发明的保护范围并不仅局限于上述实施例，凡属于本发明思路下的技术方案均属于本发明的保护范围，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理前提下的若干改进和润饰，应视为本发明的保护范围。

Claims (10)

  1. 一种宫腔负压止血装置，其特征在于，包括水囊输送器(9)、宫腔水囊(3)、宫腔水囊输入管(5)、负压装置和负压管(10)；
    所述水囊输送器(9)内部中空，水囊输送器(9)一端为输入端，另一端为远离端；水囊输送器(9)输入端的端部设置有负压吸引口(1)；
    所述负压管(10)设置在水囊输送器(9)内部，负压管(10)一端与负压吸引口(1)连接，另一端通过第三接口(11)与负压装置连接；
    所述宫腔水囊(3)设置在水囊输送器(9)的输入端，并固定在水囊输送器(9)上；
    所述宫腔水囊输入管(5)设置在水囊输送器(9)内部，宫腔水囊输入管(5)一端连通宫腔水囊(3)，另一端连接第一接口(6)，生理盐水通过第一接口(6)和宫腔水囊输入管(5)输入至宫腔水囊(3)内。
  2. 根据权利要求1所述的宫腔负压止血装置，其特征在于，还设置有阴道水囊(4)和阴道水囊输入管(7)，所述阴道水囊(4)固定在水囊输送器(9)上，所述阴道水囊输入管(7)设置在水囊输送器(9)内部，阴道水囊输入管(7)一端连通阴道水囊(4)，另一端连接第二接口(8)，生理盐水通过第二接口(8)和阴道水囊输入管(7)输入至阴道水囊(4)内部。
  3. 根据权利要求1所述的宫腔负压止血装置，其特征在于，所述负压吸引口(1)上分布有若干个气孔(2)。
  4. 根据权利要求1所述的宫腔负压止血装置，其特征在于，所述宫腔水囊输入管(5)和负压管(10)均采用乳胶管。
  5. 根据权利要求1所述的宫腔负压止血装置，其特征在于，所述宫腔水囊(3)的体积为400～800ml。
  6. 根据权利要求2所述的宫腔负压止血装置，其特征在于，所述阴道水囊输入管(7)采用乳胶管。
  7. 根据权利要求2所述的宫腔负压止血装置，其特征在于，所述阴道水囊(4)的体积为100～200ml。
  8. 权利要求1～7任意一项所述的宫腔负压止血装置的使用方法，其特征在于，包括以下步骤：
    S1、使用时，将未充液的宫腔水囊(3)通过阴道，避免接触阴道壁，轻轻送至子宫腔，明确带有密集气孔(2)的负压吸引口(1)到达或接近子宫底部，阴道水囊(4)位于宫口下方的阴道内；
    S2、通过第一接口(6)经宫腔水囊输入管(5)向宫腔水囊(3)内注射生理盐水，通过第二 接口(8)经阴道水囊输入管(7)向阴道水囊(4)注射生理盐水；
    S3、将负压装置连接第三接口(11)，启动负压装置，形成负压环境，负压吸引口(1)吸附在子宫肌层表面，根据止血情况酌情调整吸附时间；
    S4、关闭负压装置，将第三接口(11)连接引流袋，观察20min，若引流袋内积血未见明显增多，则继续放置止血囊，12-18h后取出；若引流袋内积血持续增多，则重复步骤S3，每吸引60min观察止血效果。
  9. 根据权利要求8所述的宫腔负压止血装置的使用方法，其特征在于，S2中，宫腔水囊(3)内注射生理盐水体积为400-800ml，阴道水囊(4)内注射生理盐水体积为100～200ml。
  10. 根据权利要求8所述的宫腔负压止血装置的使用方法，其特征在于，负压设定60-100mmHg；持续负压吸引的时间不超过4小时。
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