WO2010069215A1 - 妇科手术和检查用阴道内超声探头 - Google Patents

妇科手术和检查用阴道内超声探头 Download PDF

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Publication number
WO2010069215A1
WO2010069215A1 PCT/CN2009/074990 CN2009074990W WO2010069215A1 WO 2010069215 A1 WO2010069215 A1 WO 2010069215A1 CN 2009074990 W CN2009074990 W CN 2009074990W WO 2010069215 A1 WO2010069215 A1 WO 2010069215A1
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Prior art keywords
arm
probe
ultrasonic transducer
speculum
connecting rod
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PCT/CN2009/074990
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English (en)
French (fr)
Inventor
王敏岐
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无锡科美达医疗科技有限公司
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Publication of WO2010069215A1 publication Critical patent/WO2010069215A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction

Definitions

  • the present invention relates to a medical device for gynecological surgery and gynecological examination, in particular, an intravaginal sputum ultrasonic detecting device including intrauterine, cervical and fallopian tube assisted operation operations.
  • the device described in WO 99/03 399 is placed in the vagina during use and is secured to the cervical tissue by a cervical clamp. This may result in loss of contact between the ultrasound transmitter and the cervical tissue region. Losing this contact can make the ultrasound description inferior and significantly reduce the resolution.
  • movement of the ultrasonic probe in the direction of the tissue zone creates pressure on the fixed points described above, which can cause tissue damage.
  • the combination of cervical forceps, grippers, and vaginal probes is already very large relative to the vagina, and even exceeds the usual speculum size. Obviously, this will affect some operations.
  • Intravaginal ultrasound examination for intrauterine treatment is a system for guiding and monitoring intrauterine, cervical and fallopian tube treatment.
  • the system includes (a) an assembly that can be operated by a weaker hand of the surgeon.
  • the assembly comprises: (i) an intravaginal ultrasound transducer adapted to be inserted into a portion of a patient's vagina, the intravaginal ultrasound transducer for generating an ultrasound beam; (ii) a cervical clamp for clamping the patient's cervix And (iii) a connector for connecting the ultrasonic transducer to the cervical holder; (b) a medical device for performing a treatment procedure, the medical device being a medical device Strong hand operation; and (c) a device for monitoring the alignment of the medical device with the intravaginal ultrasound transducer and thus with the ultrasound beam.
  • a device (10) for surgical operation of the cervix and the fallopian tube comprising an assembly having There is: an intravaginal ultrasonic transmitter (12) that can be placed in the vagina of the patient to be positioned against the patient's cervix; a cervical gripper (14) for holding the cervix; and one for a connector (20) interconnecting the ultrasonic sounder (12) and the cervical clamp (14), the connector (20) being configured to reversely prevent the ultrasonic transmitter (12) from being clamped relative to the cervix
  • the movement of the device (14), the reversely blocked movement is a movement in a direction away from the cervix.
  • a system for directing and monitoring medical devices used in intrauterine, cervical, and fallopian tube surgery operations having: (a) an intravaginal ultrasound transmitter that can be placed into the vagina of the patient; (b) a cervical gripper for gripping a patient's cervix; (c) a connector for interconnecting the ultrasonic transmitter with the cervical gripper, the connector being configured to reversely prevent the ultrasonic transmitter from being opposed to the cervical clip The movement of the holder in a direction away from the patient's cervix; and (d) a means of monitoring the positioning of the medical device relative to the ultrasound beam emitted by the intravaginal ultrasound transmitter.
  • US Patent US6960166 is an ultrasonic display diagnostic device that uses ultrasound to monitor the transfer of test tube embryos through the cervix to provide a better image of the vagina display.
  • the ultrasound probe can be attached to the front or rear blades of the detector. This requires custom-made speculum and clamping devices, as well as ultrasound probes.
  • the two pages of the speculum are mainly used to expand the vaginal wall, most of the ultrasound probes placed along the page described in the patent are the rectum or the bladder, and the uterus is not well imaged.
  • the uterus cannot be scanned in a comprehensive manner, the two groups of products are alternately used during the operation, which is very troublesome in practical use.
  • the B-mode ultrasound monitor provides a B-mode ultrasonic monitor that is attached to the probe and the speculum.
  • This type of structure requires the same probe and speculum to be customized, and since the probe is snapped onto a page of the speculum, the probes and speculums of the front and rear uterus need to be scanned differently, especially Generally, the position of the anterior iliac crest is shallow, and the anterior uterus scans the anterior uterus. The probe of the anterior humerus compresses the cervical canal, which hinders the entry of surgical instruments.
  • the object of the present invention is: to propose a B-type ultrasonic monitor probe for surgery and gynecological examination, especially an intravaginal real-time ultrasonic detecting device for intrauterine, cervical and fallopian tube assisted operation, which can adapt to various The need for gynecological surgery.
  • the device can be fixed without using a special holder, a special speculum or other devices.
  • the position of the proposed B-mode ultrasonic monitor probe enters a better position (such as a posterior iliac crest), and can be used for various positions of the uterus. Scanning is performed without any interference with traditional surgical procedures.
  • a device for intravaginal real-time ultrasonography guidance and monitoring that can be used for intrauterine, cervical and fallopian tube surgery and non-surgical procedures (including physical examination, etc.) without the above disadvantages.
  • the object of the present invention is to achieve an intravaginal ultrasound probe for gynecological surgery and examination, including a B-ultrasonic transducer placed in the vaginal posterior iliac crest of the patient during intrauterine, cervical and fallopian tube surgery operations; A probe arm and a cable take-up arm for connecting the B-ultrasonic transducer are provided, and the probe arm and the cable take-up arm are transitioned through an arc-shaped connecting rod, and the probe is mounted on the top of the probe arm.
  • the transducer When used with a speculum, the transducer is at least beyond the top of the lower page of the speculum, but not higher than the edge of the lower page of the speculum; its scanning angle is at least greater than 120°, typically about 135°; the scanning angle begins The angle between the position and the vaginal wall is about 50°; the probe arm and the cable take-up arm
  • the extension line has an angle of 78-87°, especially the same angle as the upper or lower page of the speculum and the curved handle, typically 85. .
  • the probe arm and the curved connecting rod and even the cable take-up arm are flat and wide cable-shells enveloping the flexible circuit board.
  • the cross section of the probe arm and the curved connecting rod coincides with the shape of the lower page of the speculum, and the cable take-up arm passes The connecting cable is connected to the host.
  • the probe arm of the present invention and the curved connecting rod and even the outer casing of the cable bow are the upper and lower closed casings for mounting the B-ultrasonic transducer and the flexible lead-out wire.
  • a B-ultrasonic transducer sheath is provided at the end of the lower shell, and the sides of the sheath have the same shape as the two sides of the B-ultrasonic transducer; the longitudinal section is semi-circular or semi-elliptical, from a semicircle Or a semi-elliptical extended straight line segment.
  • the invention uses ⁇ :
  • the probe arm connecting the B-ultrasonic transducer is a rigid structure which is placed into the body of the operator through the vagina for monitoring the operation of the uterus, the cervix or the fallopian tube.
  • Guide the medical device put the B-ultrasonic transducer into the patient's vagina, especially when placed through the speculum, the contour of the curved connecting rod fits the outer shape of the lower corner of the speculum, and the B-ultrasonic transducer can be placed In the neck or posterior iliac crest (the shape of the probe and the posterior condyle are relatively consistent), located at the front end of the lower page of the speculum, the height is not higher than the edge of the speculum, and will not affect the operation and examination of the uterus, such as intrauterine birth control.
  • the B-ultrasonic transducer and the curved connecting rod are partially placed in the vagina of the patient, and are placed close to the vaginal wall to prevent medical (surgical) instruments from being placed.
  • Typical medical devices include the use of a uterine sampler, a uterine probe or a stainless steel uterus detector, a double-ended or single-ended uterine dilator, a sparkmann cannula, a cervical endoscope, a probe arm and a curved connecting rod with the entry of the above surgical instruments.
  • the front end of the speculum is attached, the probe arm and the curved connecting rod of the invention do not affect the entry and use of the surgical instrument, and all the surgical instruments are operated under the monitoring of the ultrasound apparatus of the invention, that is, the whole process of the cervical or fallopian tube operation And the position of the surgical instrument is under visual monitoring of the present invention.
  • the curved connecting rod is bent downward along the natural curve of the human body. The use of ⁇ does not affect the convenience of the human
  • the invention is characterized in that: the disadvantages of the prior device are overcome, and the position of the B-ultrasonic transducer is put into a more ideal position for surgery. In particular, it can be effectively combined with a speculum, and can be used for intrauterine, cervical and fallopian tube surgery and non-surgical operations (including physical examination, etc.) for intravaginal real-time ultrasonography guidance and monitoring devices.
  • FIG. 1 is a schematic view showing the structure of an upper casing of an upper and lower closed casing of a B-superconductor and a flexible lead wire according to the present invention
  • FIG. 2 is a schematic view showing the structure of the lower case of the upper and lower closed casings of the B-superconductor and the flexible lead wire of the present invention.
  • FIG. 3 is a schematic view showing the other side structure of the upper and lower casings of the upper and lower closed casings of the B superconductor and the flexible lead wires of the present invention
  • FIG. 4 is a schematic view showing the other side structure of the lower case of the upper and lower closed casings of the B-superconductor and the flexible lead wire of the present invention
  • the B-ultrasonic transducer 1, the probe arm 2, the curved connecting rod 3, the cable take-up arm 4, the upper casing 5, the lower casing 6, the upper casing 5 and the lower casing 6 integrally include or cover the probe arm 2.
  • the embodiments are described below in conjunction with the drawings.
  • the device of each of the embodiments enables the surgeon to easily align the medical device used with the ultrasound transmitter, the B-ultrasonic transducer 1, the probe arm 2 covering the flexible lead wire, the cable take-up arm 5 and the curved connection The outer shell of the rod).
  • the probe arm and the cable take-up arm pass through an arcuate connecting rod, and in view of the length of the probe arm, according to the embodiment, when the medical device is placed through the patient's cervix, the surgeon can ensure that the medical device is positioned parallel to the extension, thereby The medical device can be "placed" or "placed” into the ultrasound beam.
  • the other end of the present invention is further provided with a cable connector that is connected to the host through a cable.
  • the cross section of the probe arm 2 or the curved connecting rod 3 is provided with a circular arc curvature, which is a flat arc shape with both ends upturned, and the upper edge of the cross section (section) cooperates with the outer side of the lower page of the universal speculum.
  • Cross section (section) The radius of curvature of the upper edge is the same as the outer cross section of the lower page of the speculum.
  • the cross section of the probe arm 2 or the curved connecting rod 3 is provided with a circular arc curvature, which is a flat arc shape with both ends upturned; the upper surface of the probe is attached to the lower surface of the lower page of the speculum (having the same shape).
  • the transducer extends beyond the top of the lower page of the speculum and is no higher than the edge of the lower page of the speculum.
  • the size of the lens surface of the ultrasound probe in the vagina is ⁇ 15mm.
  • the probe passes through the vagina, placed in the cervix or the posterior malleolus (the shape of the probe is relatively consistent with the shape of the posterior condyle), and does not affect the operation and examination of the uterus. .
  • the upper and lower closed outer casings are provided with a tongue-and-groove or concave-convex fitting structure. Closed up and down The cavity between the shells is for accommodating flexible wires, and the entire casing has a thickness of about 3 mm and a width of 12-14 mm.
  • the angle between the element normal of one end of the B-ultrasonic transducer and the extension of the probe arm and the cable take-up arm is less than 50°, and the angle between the normal of the array element at the other end and the extension of the probe arm and the cable take-up arm is greater than 180°.

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Description

说明书
Title of Invention:妇科手术和检査用阴道内超声探头 技术领域
技术领域
[1] 本发明涉及用于妇科手术和妇科检査用医疗器械， 尤其是包括子宫内、 宫颈和 输卵管辅助手术作业的阴道内实吋超声检测装置。
背景技术
背景技术
[2] 妇科的检査和子宫内、 宫颈和输卵管外科手术作业传统上仅仅依靠通过手工操 作的器械传导的"感觉"和外科医师是的经验来进行作业。 但是， 若医师对子宫的 位置和尺寸判断不准的话， 很可能刺穿子宫或导致对身体的其它伤害， 如在有 宫颈狭窄或子宫肿瘤 (子宫内膜瘤或肉瘤)的情况下刺穿子宫的危险性更大。 上述 的刺穿子宫的主要危险包括出血、 对腹部内脏的创伤以及对内部器官例如肠、 网膜、 肠系膜、 输尿管和输卵管的损伤。 因此， 常常由于偶然的刺穿子宫而需 要釆用腹腔镜检査术或剖腹术来检査腹部内腔。 盲目手术的其他不良后果还包 括例如无法完全摘除诸如胎盘或者说胎儿组织之类的子宫组织， 这就必需在一 般麻醉或置入外物或胚胎镜的情况下进行第二次刮除术。
[3] 经腹壁的超声波通常不能用来实吋监控和指导上述的外科手术， 因为它的分辨 率较低， 需要患者在手术过程中保持膀胱充满尿液， 并且还需要额外的手术材 料， 以及手术操作者以外的另一个人来握持超声波探头。
[4] 在现有技术中， 用于诊断和监控产科和妇科疾病的阴道内超声装置是众所熟知 的。 美国专利 US4497 325、 4671292公开了用于实吋监控和指引外科手术作业的 阴道内超声装置， 用来实吋监控子宫内的、 宫颈的和输卵管的手术作业。 上述 这些专利的大部分提出了一些超声探头， 它们包括用来将针和 Z或导管导入到 要治疗的组织上的针和 Z或与其连接的导管指引件。 但是， 釆用上述的阴道内 超声探头所进行的外科手术通常是十分有限的。 这种手术包括脓肿的刺穿和引 流、 局部组织取样和流体的收集。 [5] 上述用于指引和监控子宫内的、 宫颈的和输卵管的手术作业的装置的不足之外 是由于该装置的非顺从特性造成的。 传统的阴道探头为普通手持式诊察而设计 ， 具有一个较粗长的连接杆与手柄相连， 以及通常在连接杆延长线上的适宜抓 握的手柄。 在妇科手术过程中， 1) 这种结构的探头需要占用外科医生的一只手 来握持， 2) 连接杆占据了阴道内， 尤其是阴道口有限的截面积， 3) 探头手柄 妨碍了手术器械的操作， 4) 探头固定以后可能不能扫査全部子宫体。 这些不利 因素使得直接使用传统的阴道探头来用于指引和监控子宫内的、 宫颈的和输卵 管的手术作业变得非常困难。
[6] —些专利已经用来解决上述问题。 WO 99/03 399， 中国专利 CN1264280A， 中国专利 （00813840.0) ， WO2006/123345A2等专利都描述了利用宫颈钳或窥 器来绑定传统超声探头的方法。 所有这些专利都只解决了上述不利中的第一项
[7] WO 99/03 399所述的装置在使用吋是安置在阴道内的， 并通过宫颈夹持器固 定到宫颈组织上。 这可能导致超声发射器与宫颈组织区之间失去接触。 而失去 这种接触便会使超声描述大为逊色， 并显著降低分辨率。 另外， 超声探头沿组 织区方向的移动会对上述的固定点产生压力， 这会造成组织损伤。 再则， 宫颈 钳， 夹持器， 阴道探头三者组合在一起吋相对于阴道来讲已经是非常大了， 甚 至已经超过通常的窥器尺寸， 显然， 这会影响部分手术。
[8] 中国专利 CN1264280A与 WO 99/03 399相仿， 子宫内处置的阴道内超声检査 引导是用于引导和监测子宫内， 宫颈及输卵管处置的系统。 该系统包括 （a) — 个可由外科医生一只较弱的手操作的组件。 该组件包括： （i) 一个适于插入患 者阴道的一部分内的阴道内超声换能器， 该阴道内超声换能器用于产生超声波 束； （ii) 一个用于夹持患者宫颈的宫颈夹持器； 以及 （iii) 一个用于将超声换 能器与子宫颈夹持器连接在一起的连接器； （b) —个用于进行处置过程的医疗 器械， 该医疗器械可由外科医生的一只较强壮的手操作； 以及 （c) 一个用于监 测将医疗器械与阴道内超声换能器对准并因而也就是与超声波束对准的装置。
[9] 中国专利 （00813840.0) 妇科手术的阴道内实吋超声描记指引和监控子宫内的
、 宫颈的和输卵管的手术作业的装置 (10)， 该装置 (10)包括一个组件， 该组件具 有： 一个可置入患者的阴道内的一部分以便靠着患者的宫颈来定位的阴道内超 声波发射器 (12); —个用于夹持宫颈的宫颈夹持器 (14); 和一个用于使超声发声 器 (12)与宫颈夹持器 (14)互相连接的连接器 (20)， 该连接器 (20)的结构做成可以反 向地阻止超声发射器 (12)相对于宫颈夹持器 (14)的移动， 所述的被反向阻止的移 动是沿离开宫颈的方向的移动。 指引和监控子宫内、 宫颈和输卵管手术作业中 所用的医疗器械的系统， 该系统具有： （a)—个可置入患者的阴道内的一部分的 阴道内超声发射器； （b)—个用于夹持患者宫颈的宫颈夹持器； （c)一个用于将超 声发射器与宫颈夹持器互相连接的连接器， 该连接器的结构做成可以反向阻止 超声发射器相对于宫颈夹持器沿离开患者宫颈的方向的移动； 和 (d)—个监控医 疗器械相对于由阴道内超声发射器发出的超声波束的定位的装置。
[10] 另外一些专利如 US6960166, 中国专利公开 （公告号 CN2717390) ， WO2005/0 58128等通过在窥器的一个上、 下页面上放置或卡接一个超声探头来解决上述难 题。 但是这些专利或是存在扫描盲区， 或是实际缺少必要的超声孔径， 以及同 吋需要配套专门的窥器， 给实际使用带来了不便， 甚至不可能。
[11] 美国专利 US6960166是超声波显示的诊断器， 利用超声波监视通过子宫颈进行 试管胚胎的移植， 提供一种较好的阴道显示超声图像， 超声探头可以固定在探 测器的前面或后面叶片上。 这需要定做专门的窥器和夹持装置， 和超声探头。 且由于窥器的两个页面主要是用来扩张阴道壁， 专利所述的沿页面放置的超声 探头扫査的大部分是直肠或膀胱， 不能很好的对子宫进行成像。 且由于不能全 景扫査子宫， 对应于手术过程中会发生交替使用两组产品进行， 在实际应用中 是非常麻烦的。
[12] 中国专利公开 （公告号 CN2717390) 女性计划生育手术 B型超声监测仪提供了 一种探头与窥器卡接的 B型超声监测仪。 这种结构方式需要同吋定做探头和窥器 ， 并且由于探头是卡接在窥器的一个页面上， 对前位和后位子宫需要用不同夹 持的探头和窥器才能进行扫査， 特别是一般前穹隆位置较浅， 前位子宫扫査吋 ， 前穹隆的探头会压迫宫颈管， 使手术器械的进入造成阻碍。
[13] 子宫体相对于阴道的位置有较多的变化， 如前屈， 后屈等等， 且妇科的手术种 类极多， 包括各种子宫内、 宫颈或输卵管手术作业， 如子宫输卵管造影、 子宫 机械手、 Hulka控制持钩或夹钳、 快速真空抽吸刮宫器、 子宫深度探针、 取样器 、 塑料子宫探测器或不锈钢子宫探测器、 双端或单端的子宫扩张器、 刮宫器、 子宫切除钳、 宫内装置取出器、 活组织检査钻孔器、 宫颈内窥器、 抽吸器、 抽 吸管、 凝固器、 胚胎转移器、 授精器、 子宫导管、 输卵管导管等。
[14] 适应上述各种妇科手术的女性的置入式 B型超声监测仪是有需求的， 但现有技 术的 B型超声监测仪还是有所局限。 或者其 B型超声监测仪探头的体积较大， 或 者说需要专用夹持器或固定器进行固定， 或者说 B型超声监测仪探头的位置难以 到达比较理想的地方， 或者说 B型超声监测仪探头在某个固定位置不能扫査完整 子宫等， 从而不能够适应多种子宫位置及多种妇科手术。
对发明的公开
技术问题
[15] 本发明的目的是： 提出一种手术和妇科检査用 B型超声监测仪探头， 尤其是子 宫内、 官颈和输卵管辅助手术作业的阴道内实吋超声检测装置， 能够适应多种 妇科手术的需求。 该装置可以不需要釆用专用夹持器、 特制窥器或其它器件进 行固定， 提出的 B型超声监测仪探头的位置进入较理想的位置 （如后穹窿） ， 对 各种位置的子宫都能进行扫査， 对传统手术操作没有任何干扰。 提出没有上述 缺点的可用于子宫内、 宫颈和输卵管外科手术和非外科手术作业 （包括身体检 査等使用） 的阴道内实吋超声描记指引和监控的装置。
技术解决方案
[16] 相当数量的手术需要在阴道扩张吋操作。 因此新提出的探头特别适用于与窥器 的贴合和符合人体工程学， 使用吋使医生得心应手， 便于检査和手术操作的裕 如。
[17] 本发明的目的是这样实现的， 妇科手术和检査用阴道内超声探头， 包括在子宫 内、 官颈和输卵管手术作业中置入患者阴道内后穹窿部位的 B超换能器； 设有一 个用于连接 B超换能器的探头臂和电缆引出臂构成， 探头臂和电缆引出臂通过一 弧形连接杆过渡， 探头安装在探头臂顶端。 当和窥器共同使用吋， 换能器至少 超出窥器下页的顶部， 但不高于窥器下页的边沿； 其扫査角度至少大于 120°， 一 般约为 135°; 扫査角开始的位置与阴道壁的夹角约为 50°; 探头臂和电缆引出臂 的延长线的夹角为 78-87° , 尤其是与窥器的上页或下页与弯柄的夹角相同， 一般 为 85。。
[18] 探头臂和弧形连接杆甚至电缆引出臂均为扁宽的包裹柔性电路板的电缆壳， 探 头臂和弧形连接杆的截面与窥器的下页形状相吻合， 电缆引出臂通过连接电缆 与主机相连接。
[19] 考虑到 B超换能器和柔性引出线的安装， 本发明探头臂和弧形连接杆甚至电缆 弓 I出臂的外壳为安装 B超换能器和柔性引出线的上下闭合的外壳， 下壳端部设有 B超换能器护套， 护套的两侧部形状与 B超换能器的两侧部相同； 其纵截面是半 圆形或半椭圆形， 从半圆形或半椭圆形延伸的直线段弓 I出。
[20] 本发明使用吋： 连接 B超换能器的探头臂弧形连接杆本身是刚性结构， 通过阴 道置入被手术者体内， 用于监控子宫内的、 宫颈的或输卵管的手术作业吋指引 医疗器械， 将 B超换能器置入患者阴道内， 尤其是当通过窥器置放吋， 弧形连接 杆的轮廓与窥器下叶外侧形状贴合， 可以将 B超换能器置于宫颈部位或后穹窿部 位 （探头与后穹窿的形状相对吻合） ， 位于窥器下页的前端， 高度不高于窥器 的边沿， 不至于影响对子宫的手术和检査， 如宫内节育器的探査、 放置和取出 手术， 也包括人流术等。 B超换能器及弧形连接杆部分置入患者阴道内， 紧贴阴 道壁， 不妨害置入医疗 （手术） 器械。 典型的医疗器械包括使用子宫取样器、 子宫探测器或不锈钢子宫探测器、 双端或单端的子宫扩张器、 sparkmann套管、 宫颈内窥器， 探头臂和弧形连接杆与上述手术器械的进入窥器前端贴合， 本发 明探头臂和弧形连接杆不影响手术器械的进入和使用， 并使各种手术器械均在 本发明超声仪的监测下工作， 即宫颈或输卵管手术作业的全过程以及手术器械 的位置均在本发明可视监测下。 弧形连接杆使用吋沿人体自然曲线向下弯曲的 ， 使用吋不影响医生手术的方便性， 几乎感觉不到它的存在。
有益效果
[21] 本发明的特点是： 克服了现有装置的缺点， 使 B超换能器位置进入较理想的位 置便于手术。 特别是与窥器能有效结合使用， 可用于子宫内、 宫颈和输卵管外 科手术和非外科手术作业 （包括身体检査等使用） 的阴道内实吋超声描记指引 和监控的装置。 附图说明
[22] 图 1是本发明安装 B超换能器和柔性引出线的上下闭合的外壳之上壳结构示意图
(即包括 B超换能器的探头臂和电缆引出臂及弧形连接杆的外壳） ；
[23] 图 2是本发明安装 B超换能器和柔性引出线的上下闭合的外壳之下壳结构示意图
[24] 图 3是本发明安装 B超换能器和柔性引出线的上下闭合的外壳之上壳另侧结构示 意图；
[25] 图 4是本发明安装 B超换能器和柔性引出线的上下闭合的外壳之下壳另侧结构示 意图；
[26] 其中， B超换能器 1、 探头臂 2、 弧形连接杆 3， 电缆引出臂 4、 上壳 5、 下壳 6， 上壳 5和下壳 6在整体上包括或覆盖探头臂 2、 弧形连接杆 3， 电缆引出臂 4。
本发明的最佳实施方式
[27] 以下结合附图说明实施例。 其中每个实施例的该装置都能使外科医生容易将所 用的医疗器械与超声发射器对准， B超换能器 1、 覆盖柔性引出线的探头臂 2、 电 缆引出臂 5及弧形连接杆的外壳） 。 探头臂和电缆引出臂通过一弧形连接杆， 考 虑到探头臂的长度， 按照本实施例， 当通过患者的宫颈置入医疗器械吋， 外科 医生可保证医疗器械平行于延伸段而定位， 从而可将医疗器械 "置于 "或"置入" 超声波束中。
[28] 本发明另一端还设有一个电缆连接器， 通过电缆与主机连接。
[29] 探头臂 2或弧形连接杆 3的横断面设有圆弧曲率， 是两端上翘的扁平的弧状， 横 断面 （截面） 上缘与通用窥器的下页外侧配合。 横断面 （截面） 上缘曲率半径 与窥器下页的外侧横断面相同。 探头臂 2或弧形连接杆 3的横断面设有圆弧曲率 ， 是两端上翘的扁平的弧状； 探头的上表面与窥器下页的下表面贴合 （有相同 形状） 。 换能器伸出窥器下页的顶端， 且不高于窥器下页的边沿。
[30] 阴道内的超声波探头的透镜面尺寸范围为 <15mm， 探头通过阴道、 置于宫颈部 位或后穹窿部位 （探头与后穹窿的形状相对吻合） ， 不至于影响对子宫的手术 和检査。
[31] 如图 4所示， 上下闭合的外壳贴合处设有榫槽或凹凸配合结构。 上下闭合的外 壳之间的腔用于容纳柔性导线， 整个壳体的厚度在 3mm左右， 宽度在 12-14mm。 B超换能器的一端的阵元法线与探头臂和电缆引出臂的延长线的夹角小于 50°， 另一端的阵元法线与探头臂和电缆引出臂的延长线的夹角大于 180°。

Claims

权利要求书
妇科手术和检査用阴道内超声探头， 包括在子宫内、 宫颈和输卵 管手术作业中置入患者阴道内的 B超换能器； 其特征是设有一个用 于连接 B超换能器的探头臂和电缆引出臂构成， 探头臂和电缆引出 臂通过一弧形连接杆过渡， 探头安装在探头臂顶端， 探头臂和电 缆引出臂的延长线的夹角为 78-87°。
根据权利要求 1所述的妇科手术和检査用阴道内超声探头， 其特征 是探头臂和弧形连接杆甚至电缆引出臂均为扁宽的包裹柔性电路 板的电缆壳， 探头臂和弧形连接杆的截面与窥器的下页相吻合， 电缆引出臂通过连接电缆与主机相连接。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是探头臂和弧形连接杆甚至电缆引出臂的外壳为安装 B超换能 器和柔性引出线的上下闭合的外壳， 下壳端部设有 B超换能器护套 ， 护套的两侧部形状与 B超换能器的两侧部相同； 其纵截面是半圆 形或半椭圆形， 从半圆形或半椭圆形延伸的直线段弓 I出。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是探头臂和电缆引出臂的延长线的夹角与窥器的上页或下页 与弯柄的夹角相同的 85±1°。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是探头臂 （2) 或弧形连接杆 3的横断面设有圆弧曲率， 是两 端上翘的扁平的弧状， 横断面上缘曲率半径与窥器下页的外侧横 断面相同。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是探头的上表面与窥器下页的下表面贴合； 换能器伸出窥器 下页的顶端， 且不高于窥器下页的边沿。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是考虑到 B超换能器和柔性引出线的安装， 上下闭合的外壳 的外壳在靠近换能器端贴合处设有至少两个方向凹凸配合结构以 防止上下壳的移位。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是 B超换能器釆用柔性引出线， 上下闭合的外壳电缆引出端 有一个刚性圆柱结构， 可以用来固定 B超换能器； B超换能器的曲 率半径≤15mm。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是整个 B超换能器中截面积最小的部位是弧形连接杆 3， 且截 面厚度小于 5mm。
根据权利要求 1或 2所述的妇科手术和检査用阴道内超声探头， 其 特征是 B超换能器的一端的阵元法线与探头臂和电缆引出臂的延长 线的夹角小于 50°， 另一端的阵元法线与探头臂和电缆引出臂的延 长线的夹角大于 180°。
PCT/CN2009/074990 2008-12-15 2009-11-17 妇科手术和检查用阴道内超声探头 WO2010069215A1 (zh)

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