一种新型超声波容器的密封装置在临床实用和采用先进的止血方式对腹腔镜子宫切除术中封闭大血管的应用

一种新型超声波容器的密封装置在临床实用和采用先进的止血方式对腹腔镜子宫切除术中封闭大血管的应用
Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode

Abstract
摘要
OBJECTIVE(S):
目的（s）：
The ultrasonic advanced energy study device (AH device) is the first surgical device indicated to seal vessels up to and including 7mm using ultrasonic technology alone. This study assesses clinical experience during total laparoscopic hysterectomy (TLH) using advanced hemostasis mode (AHM).
超声先进能源研究装置（AH设备）是第一个密封血管的手术器械及包括7mm单独使用超声波技术。本研究评估了在腹腔镜全子宫切除术的临床经验（TLH）采用先进的止血方式（AHM）。

STUDY DESIGN:
研究设计：
This was a prospective, non-randomized, single arm, multicenter, observational study which did not modify or influence current surgeon technique for elective TLH for benign disease. Each surgeon assessed hemostasis, defined as the hemostatic transection of the uterine vasculature (left/right) with at least one use of the AH device in AHM without the use of additional hemostatic measures other than the AH device. Patients were followed for 4-6 weeks after surgery. Vessel sealing performance was quantitatively assessed for transection and sealing of the uterine artery (UA), the uterine pedicle (UP; defined as cases where the UA could not be 'isolated') and the ovarian pedicle (OP) (when indicated). Adverse events (AEs) related to the AH device or procedures were collected.
这是一项前瞻性、非随机、多中心、单臂、观察性研究，并没有改变或影响当前的外科医生的技术择期TLH良性疾病。每一个外科医生评估止血，定义为子宫血管的止血切断术（左/右）至少有一个使用在AHM，AH装置的使用无需额外的止血措施。随访术后4-6周，容器的密封性能进行定量评估子宫动脉的切断与封闭（UA），子宫蒂（UP; 定义为在UA不能被'孤立'）和卵巢蒂（OP）（在显示时）。有关对AH设备或程序副反应（AE）收集。

RESULTS:
结果:
Forty patients underwent the procedure. Mean age was 49 years and mean body mass index was 28kg/m(2). Mean surgical duration was 88min. None required conversion to open procedure. Using only the AH device, hemostasis was achieved and maintained in 119 (94.4%) transections (both left and right sides of the UA/UP and OP). Additional hemostasis was achieved in 5 patients using conventional bipolar (4) or monopolar (1) energy. No patient required a blood transfusion postoperatively. Only one adverse event of pain was considered to be related to the use of the ultrasonic AH device during this study.
四十例患者行手术治疗。平均年龄为49岁，平均体重指数为28公斤/米（2）。平均手术时间为88min无需中转开放手术。仅使用AH设备，止血达到并维持在119（94.4%）横切（在UA/UP 和 OP左、右两侧）。使用传统的双极性的5例患者实现了额外的止血（4）或单极的（1）能量。无病人术后需要输血。在研究的过程中只有一个副反应的疼痛被认为是相关的超声波AH设备引起。

CONCLUSION:
结论：
These results support that the AH device with its AHM has clinical utility in sealing named vessels in TLH. The new algorithm to deliver energy in the AHM has the potential to reduce the need for additional hemostatic devices or products as well as the potential to reduce the need for multiple instrument changes during surgery.
这些结果支持AH装置和AHM在TLH密封性命名的容器中有临床应用。在AHM提供能源的新算法以减少额外的止血设备或产品的需求以及潜在的减少术中的多个仪器的变化需要的可能。

原文：
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一种新型超声波容器的密封装置在临床实用和采用先进的止血方式对腹腔镜子宫切除术中封闭大血管的应用