WO2021212863A1 - 单体式宫腔电切器 - Google Patents

单体式宫腔电切器 Download PDF

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Publication number
WO2021212863A1
WO2021212863A1 PCT/CN2020/134858 CN2020134858W WO2021212863A1 WO 2021212863 A1 WO2021212863 A1 WO 2021212863A1 CN 2020134858 W CN2020134858 W CN 2020134858W WO 2021212863 A1 WO2021212863 A1 WO 2021212863A1
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WO
WIPO (PCT)
Prior art keywords
fixed rod
electrode
uterine cavity
support body
piece
Prior art date
Application number
PCT/CN2020/134858
Other languages
English (en)
French (fr)
Inventor
张重医
Original Assignee
张重医
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202021302233.4U external-priority patent/CN212307898U/zh
Priority claimed from CN202010642586.7A external-priority patent/CN111904472B/zh
Application filed by 张重医 filed Critical 张重医
Priority to JP2022563183A priority Critical patent/JP2023522077A/ja
Priority to US17/919,634 priority patent/US20240000503A1/en
Publication of WO2021212863A1 publication Critical patent/WO2021212863A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1485—Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • 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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00559—Female reproductive organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle

Definitions

  • the invention relates to an electric cutting instrument of a hysteroscope surgical treatment system, in particular to a single uterine cavity electric cutting ring and an electric cutting needle that can be separated from the hysteroscope.
  • the resection instruments such as the resection ring and the resection needle are usually packaged as a whole with the endoscope, and the cutting electrodes of the resection ring and the resection needle and the operating rod are fixed perpendicularly to each other, and the treatment is performed in the uterine cavity.
  • the electrosurgical ring and the electrosurgical needle are fixed perpendicularly to each other, and the treatment is performed in the uterine cavity.
  • the electrosurgical ring and the electrosurgical needle into the resectoscope. Therefore, the resectoscope itself is thicker, and the uterus needs to be expanded to 8-11mm when used.
  • Chinese patent CN208426206U discloses a foldable electrode resectoscope, in which the resectoscope uses a spring to connect the cutting electrode and the metal sleeve, so that the cutting electrode can be rotated at a certain angle, and the cutting is completed by pushing and pulling, which improves the reduction of kidney cysts.
  • the surgical efficiency of compression surgery is still an integrated structure, and the size of the resection scope is large.
  • the spring part is a conductive body, which is connected to the cutting electrode as a whole, and also has a cutting effect. Therefore, the electrode resection scope is in When used for intrauterine surgery, a larger dilation size is required, and it is easy to accidentally damage the normal tissue next to the lesion during the operation, which increases the risk of complications.
  • the object of the present invention is to provide a single-piece uterine cavity electrocutter.
  • the electric cutter includes a fixed rod, a traction wire, a cutting electrode, and an operating handle.
  • the fixed rod is provided with a guide sliding sleeve and a support that can swing to any end of the fixed rod (for example, the front and rear ends).
  • One end of the rod (for example, the rear end) and the two ends of the traction wire respectively extend along the turn-back channel formed by the guide sliding sleeve on the outer side of the other end (for example, the front end) of the fixed rod and are connected to the operating handle and the support body, inside the fixed rod
  • a tension wire with one end extending outward and connected to the support is provided, the cutting electrode is arranged on the support, and the cutting electrode is connected with a cable extending along the fixed rod.
  • the guide sliding sleeve includes a bent tube body and a straight tube body connected to each other, the concave side of the bent tube body covers one end (for example, the front end) of the fixed rod, and the straight tube body extends to the fixed rod The other end (for example, the rear end) of the operating handle is provided.
  • the support body is in the shape of a curved shell, one end of the support body is pin-connected to the fixed rod, the other end of the support body is connected to the ring electrode, and one end of the cable is connected to the lead electrode arranged inside or on the outside of the fixed rod. Connected, the main body of the cable is arranged inside the fixed rod, and the other end of the cable extends to the connection position of the ring electrode and the support body.
  • the support body is in the shape of a hollow cylinder, one end of the support body is pin-connected to the fixed rod, the other end of the support body is connected to a needle electrode, and one end of the cable is connected to a lead electrode arranged inside or on the outside of the fixed rod,
  • the main body of the cable is arranged inside the fixing rod, and the other end of the cable extends to the support body.
  • the operating handle includes a pair of mutually hinged handle bodies, the tension wire is connected with the handle body clamped on the corresponding end (for example, the rear end) of the fixed rod, and the other handle body is connected with the traction wire.
  • the cross-sectional size of the fixing rod gradually decreases along the direction from one end (for example, the rear end) of the self-fixing rod with the operating handle to the other end (for example, the front end).
  • the swing angle of the support body is 30-120 degrees.
  • the diameter of the cutting electrode is 0.5-1.5 mm.
  • the electric cutter of the present invention can move the traction wire along the guide sliding sleeve on the fixed rod by opening and closing the operating handle, thereby controlling the support body connected with the traction wire, and restricting the pulling back or pulling of the tension wire
  • drive the cutting electrode for example, needle electrode, ring electrode
  • the cutting electrode can be folded when entering and exiting the uterine cavity, and the electrocutter can still be easily moved in and out of the uterine cavity without the need for dilation or the size of the dilation is reduced, and the cutting electrode is not easily damaged.
  • the hysteroscope and the electrocutter of the present invention can be held separately and cooperate with each other to complete the operation.
  • the doctor can continuously complete different angles and depths in a certain field of view (the operation range is larger and flexible)
  • the surgical operation for resection of the lesions makes the treatment process simple and achieves better treatment results, and the operation process is safer.
  • the popularization and application of the present invention can also reduce the cost of the equipment (the price of the existing integrated resectoscope is far greater than the price of the single resectoscope), treatment cost and time, and reduce the pain of treatment, which can be used in outpatient clinics. Complete the corresponding surgical operation.
  • different cutting electrode opening angles can be formed by operating the swing angle of the support body, which can not only align the uterus Intracavitary polyps, intrauterine adhesions, submucosal fibroids, etc. can be treated with electrical resection, and can effectively stop bleeding from small blood vessels in the uterine cavity.
  • the present invention can maximize the cutting of tissue by using a cutting electrode with a larger diameter, thereby shortening the operation time and reducing the risk of complications such as water intoxication.
  • the operating handle of the electrosurgical device is located at the thicker rear end of the fixed rod, and the fixed rod gradually becomes thinner toward the front end thereof, so that the front end of the electrosurgical device is easier to enter during treatment (for example, along the uterus).
  • the arc-shaped shell-shaped or hollow cylindrical support used in the present invention with flexible angle adjustment, effectively reduces the non-cutting electrode's electrocutting of the tissue, and avoids the damage to the normal tissues caused by the wrong operation during the electrocutting. And damage.
  • Figure 1 is a front view of the single-piece electric cutting ring in Example 1 (when the ring electrode is folded, 30 degrees);
  • Embodiment 2 is a schematic diagram of the connection between the support body and the ring electrode in Embodiment 1 (the side view of the fixed rod);
  • Figure 3 is a schematic diagram of cable connection in Embodiment 1;
  • Figure 4 is a front view of the single-piece electric cutting ring in Example 1 (when the ring electrode is opened at 90 degrees);
  • Embodiment 5 is a schematic diagram of the connection between the support body and the ring electrode in Embodiment 1 (the perspective of the end face of the fixed rod);
  • Figure 6a is a front view of the single-piece electric cutting ring in Example 1 (when the ring electrode is opened at 120 degrees), the tension wire part in the fixed rod is not shown;
  • Figure 6b is a front view of the single-piece electric cutting ring in Example 1 (when the ring electrode is opened at 120 degrees), which shows the tension wire part in the fixed rod;
  • Figure 7 is a front view of the single-piece electric cutting needle in Example 2 (when the needle electrode is folded, 30 degrees);
  • Figure 8 is a front view of the single-piece electric cutting needle in Example 2 (when the needle electrode is opened at 90 degrees);
  • FIG. 10 is the second schematic diagram of the connection between the support body and the needle electrode in Embodiment 2;
  • Figure 11 is a schematic diagram of cable connection in Embodiment 2.
  • Figure 12 is a front view of the single-piece electric cutting needle in Example 2 (when the needle electrode is opened at 120 degrees);
  • 1-1 is the first handle body
  • 1-2 is the second handle body
  • 1-3 handle connection part 1-4 is the traction wire
  • 1-5 is the fixed rod
  • 1-6 is the tension wire
  • 2 is a guide sliding sleeve
  • 3 is a support body
  • 3-1 is a movable connection point
  • 3-2 is a fixed connection point
  • 4 is a ring electrode
  • 5 is a cable
  • 6 is a lead electrode
  • 7 is a needle electrode.
  • the current hysterectomy mirrors are all cylindrical, with a diameter of more than 8mm. They are developed from the male prostate resection mirrors, but the structure of the male urethral system is quite different from that of the female vagina and uterine reproductive system.
  • the present invention separates the uterine cavity inspection system of the resectoscope from the electrosurgical system, and improves the structure of the electrosurgical system, thereby forming a single-cell electrosurgical system ,
  • the cutting electrode can effectively avoid rubbing with the tissue when entering and leaving the uterine cavity.
  • it can play a therapeutic effect in a larger range, so as to better utilize the female's own physiological structure for treatment. It can reduce the difficulty and cost of treatment, and also reduce the pain of the patient.
  • the single-piece electric cutting ring provided in this embodiment includes a handle, a fixed rod 1-5, and multiple sections of flexible wires with a certain strength and can be bent freely (for example, synthetic nylon, etc.) Fiber, PE and other high molecular polymers, titanium steel and other metal alloy materials) and a circuit loop system.
  • flexible wires with a certain strength and can be bent freely (for example, synthetic nylon, etc.) Fiber, PE and other high molecular polymers, titanium steel and other metal alloy materials) and a circuit loop system.
  • the handle includes a first handle body 1-1 and a second handle body 1-2 connected (articulated) by a handle connecting portion 1-3, and the first handle body 1-1 is engaged with the rear end of the fixed rod 1-5 Fixed, the second handle body 1-2 is connected with a section of the above-mentioned flexible wire as the traction wire 1-4, the traction wire 1-4 runs through the guide sliding sleeve 2 which is located on the upper part of the fixed rod 1-5 as a whole, and the traction wire 1- 4 Horizontally lead out from the second handle body 1-2 and extend towards the front end of the fixed rod 1-5, the front end of the traction wire 1-4 passes through the guide sliding sleeve 2 close to the outer side of the front end of the fixed rod 1-5.
  • the tube body can be bent (along the bent tube body) to a certain distance toward the rear end of the fixed rod 1-5, and finally connected to the movable support 3 ( Arc-shaped shell) connection.
  • Another section of the above-mentioned flexible wire is extended from the inside of the fixed rod 1-5 in the direction toward the front end of the fixed rod 1-5, and is connected to the support body 3.
  • the specific connection position can be selected to connect the traction wire 1-4 to the support body 3
  • this piece of flexible wire penetrates into one end of the fixed rod 1-5, can go along the inside of the fixed rod 1-5 to the rear end of the fixed rod 1-5, and is pre-set inside the fixed rod 1-5
  • the springs are connected to form a tension wire 1-6.
  • the wire winding mechanism (for example, a fixed knob) arranged on the fixed rod 1-5 or the first handle body 1-1 can be used to retract the flexible wire, thereby forming a tension wire .
  • the circuit loop system includes a ring-shaped electrode 4 installed on a support 3 (curved shell shape), a cable 5 whose main body is embedded in the fixed rod 1-5, and a positive and negative lead electrode 6 through which the lead electrode 6 passes.
  • the connection hole on the fixed rod 1-5 is connected to an external control circuit, one end of the cable 5 is connected to the positive and negative lead electrodes 6 respectively, and the other end is led out of the fixed rod 1-5 and connected to both ends of the ring electrode 4.
  • the supporting body 3 is processed by a curved shell cut from the side of the truncated cone.
  • the pin is connected to the fixed rod 1-5, the fixed rod 1-5 gradually widens in the radial section from the front end to the rear end, and turns around the pin on the concave side of the arc surface housing (active connection point 3-1)
  • the ring electrode 4 can be folded.
  • the inner concave surface of the support body 3 (curved shell shape) is close to the fixed rod 1-5, so that the radial size of the electrosurgical ring (especially the part that needs to be extended into the uterine cavity) is minimized and easy to pass
  • the external cervical orifice and the intrauterine cavity solve the problem that the electrosurgical ring is prone to damage when passing through the cervical canal and the internal orifice of the cervical canal.
  • the lower part of the arcuate shell has mounting holes (fixed connection points 3-2), and the end of the ring electrode 4 can be fastened by screws, which facilitates the installation of ring electrodes 4 of different sizes (used in the case of intrauterine resection.
  • the cable 5 can pass through the fixed rod 1-5 from the movable connection point 3-1 (for example, inside the pin).
  • the second handle body 1-2 pulls the traction wire 1-4, so that the support body 3 (curved shell shape) drives the ring electrode 4 toward the front end of the fixed rod 1-5 Rotate while pulling back the tension wire 1-6 to be pulled apart.
  • the rotation angle of the ring electrode 4 (relative to the fixed rod) is 120 degrees at this time.
  • the support 3 (curved shell shape) together with the ring electrode 4 is subjected to the reverse traction of the traction wire 1-4 and the tension wire 1-6.
  • the fixed position not only can use 90 degrees, but also can choose other different angles (for example, any angle between 45-120 degrees) for treatment.
  • the tension wire 1-6 is pulled back so that the support body 3 drives the ring electrode 4 to rotate toward the rear end of the fixed rod 1-5 until the support body 3 is in close contact with the fixed rod 1-5. Due to the adoption of the fixed rod 1-5 with gradually changing radial dimensions, the tension wire 1-6 can be installed obliquely, which effectively reduces the extension length of the tension wire 1-6 and minimizes the amount of the extension. Kink corners to reduce interference with operation.
  • vaginal speculum As an independent electrocutter, you can use hysteroscopy for inspection first.
  • electrosurgical treatment is needed, one method is to use a vaginal speculum to perform proper dilation according to the tightness of the uterine orifice. Generally, the uterine orifice is required to be about 6mm. According to the position of the uterus examined by the hysteroscopy, the uterus should be delivered first. Put the asana resection ring into the uterine cavity, then fix the single-piece resection ring with one hand, and hold the hysteroscope in the other hand and enter the uterine cavity from one side of the single-piece resection ring. Another method is not to use the vaginal speculum.
  • the single-piece electrosurgical ring is first introduced into the cervical canal near the mouth of the uterine cavity, and the hysteroscope is withdrawn into the cervical canal. Under the direct vision of the hysteroscope, the single-piece electrosurgical ring is sent into the uterus. Then the hysteroscope is sent into the uterine cavity from one side; if the uterine mouth is loose, the single-piece electrosurgical ring can also be sent directly into the uterine cavity along the hysteroscope.
  • the single-piece electric resection ring is operated under hysteroscope for treatment. Hold the handle tightly to open the ring electrode 4, and choose different opening angles of the handle according to the required incision position and depth.
  • the angle of the ring electrode 4, that is, the resection of polyps, fibroids and other lesions by the rotation of the ring electrode 4 is more in line with the principle of hoe weeding, so that the lesions are completely removed and better treatment effects are achieved.
  • resection It is also possible to perform blood coagulation using the energized ring electrode 4.
  • the single-piece electrical cutting needle provided in this embodiment includes a handle, a fixed rod 1-5, and multiple sections of flexible wires with a certain strength and can be bent freely (for example, synthetic fibers such as nylon, PE And other high molecular polymers, titanium steel and other metal alloy materials) and a circuit loop system.
  • the circuit loop system adopts the needle electrode 7 as the cutting electrode, and the support body 3 for installing the needle electrode 7 is in the form of a cylindrical seat, which is convenient for installing the needle electrode 7 and convenient for extraction. Connect the cables 5 from the fixed poles 1-5.
  • the support 3 (cylinder base) and the needle electrode 7 are close to the fixed rod 1-5, and the support 3 (cylinder base) and the needle electrode 7 are relative to the fixed rod 1-5 It has a small radial size, so that the overall radial size of the electrosurgical needle (except the handle) is minimized, and it is easy to pass through the external cervix and the intrauterine cavity, and the needle electrode 7 can be prevented from being touched and damaged.
  • the supporting body 3 in the form of a barrel seat
  • the fixed rod 1-5 are connected by pins.
  • the supporting body 3 in the form of a barrel seat
  • the supporting body 3 includes a Cylinder
  • the bottom of the cylinder is connected to the end of the needle electrode 7 through a screw thread
  • the top of the cylinder the cable connected to one lead electrode is connected to the top of the cylinder
  • the cable connected to the other lead electrode is connected to the cylinder
  • Two inverted L-shaped pins are installed on the side wall of the device.
  • the angle of the needle electrode 7 relative to the fixed rod 1-5 Adjust accordingly. According to the degree of intrauterine adhesion and the size of the submucosal fibroids protruding into the uterine cavity, different angles can be selected for electrical resection treatment between 60-120 degrees.
  • the method of using the above-mentioned single-type electric cutting needle is basically the same as that of the single-type electric cutting ring in Example 1. That is, the angle of the needle-shaped electrode 7 is adjusted by opening or closing the handle, and the needle-shaped electrode 7 is used to pair under the power state. Resection treatment of uterine adhesions, submucosal fibroids and other lesions is more in line with the principle of resection treatment from shallow to deep, so as to achieve better treatment results. If necessary, the energized needle electrode 7 can be used for blood coagulation. .
  • a 5mm diameter inspection mirror has a cross-sectional area of 6.25 ⁇ , plus a 4mm diameter, cross-sectional area of 4 ⁇ , the combined cross-sectional area of the two instruments is 10.25 ⁇ , and the diameter of the uterine mouth is 6mm.
  • the cross-sectional area is 9 ⁇ , and the cross-sectional area of the uterine orifice with a diameter of 7mm is 12.25 ⁇ .
  • the uterine orifice is about 6mm, so there is basically no need to expand the uterus. The damage to the patient’s cervix is minimized.
  • the hysteroscope and the electric cutter in the above embodiments are operated without the restriction of the speculum and the cylindrical metal package, and the field of view is wider and the range of movement is larger.
  • the single-piece electric cutting ring and electric cutting needle of the present invention are more in line with the physiological structure of the human uterine cavity.
  • the single-piece electric cutting ring and electric cutting needle are closed
  • the front end is small, with a diameter of about 4mm, and can be fed separately. Therefore, the dilation size is reduced, the damage to the cervix is less, and the complications caused by it are less.
  • the single-piece electrosurgical ring and electrosurgical needle of the present invention have a larger range of motion in the uterine cavity, and by replacing the cutting electrode (for example, a larger diameter), the effect of the electrosurgical operation is improved, and the operation process is correspondingly accelerated , Which reduces the risk of complications.
  • the angle of the cutting electrode can be adjusted within a relatively large range, which solves the limitation of the position of the uterus, the size of the internal opening and the observation in the existing electrosurgical endoscopy.
  • the tissue for each resection can be increased at any time as needed, thereby significantly shortening the resection operation time and reducing surgical complications.
  • the single-piece electrosurgical loop and electrosurgical needle of the present invention basically do not require uterine expansion and have little damage, so the treatment process can be completed in the outpatient operating room, which not only reduces the treatment cost, but also achieves a good treatment effect.

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Abstract

一种单体式宫腔电切器：包括固定杆（1-5）、牵引丝（1-4）、切割电极、张紧丝（1-6）及手柄，通过张合手柄使牵引丝（1-4）沿着固定杆（1-5）上的导向滑套（2）移动，从而控制与牵引丝（1-4）连接的支撑体（3），并在张紧丝（1-6）的回拉约束下，带动切割电极完成打开、收拢及改变打开角度。在进出宫腔时，可以在手柄的操作下收拢切割电极，使得电切器容易进出宫腔，不易损坏切割电极；在治疗中切割电极的角度可以在较大范围内灵活、精确的调整，治疗效果更好，操作过程更为安全。该单体式宫腔电切器不仅可以降低治疗费用和时间，而且可以减轻治疗痛苦程度，为在门诊完成相应的手术操作提供了便利条件。

Description

单体式宫腔电切器 技术领域
本发明涉及宫腔镜手术治疗系统的电切器械，具体涉及可以与宫腔镜分离的单体式宫腔电切环、电切针。
 背景技术
在电切镜中，电切环、电切针等电切器械通常是与内窥镜包裹为一体的，而且电切环、电切针的切割电极与操作杆相互垂直固定，在宫腔治疗过程中，为了避免切割电极等部分损坏（例如，在进出宫颈外口、颈管及内口时），需要将电切环、电切针缩回到电切镜内部。因此，导致电切镜本身较粗，在使用时需要扩宫到8-11mm，而扩宫越大，对宫颈损伤越大，术后引起宫颈机能不全的可能性越大。同时，电切镜结构精细、价格较高、在操作中容易损坏，使得在门诊广泛开展宫腔镜手术面临诸多限制因素。
由于电切镜中的电切环、电切针与操作杆固定，无法在电切治疗中单独调整角度，导致在宫腔镜检查过程中发现宫腔内存在息肉、宫腔粘连、粘膜下肌瘤时，不仅电切操作复杂，而且所需要的电切时间也随着病灶（例如，较大的粘膜下肌瘤）的增大而增长，使得并发低钠血症、水中毒的概率明显增大，增加了在门诊开展宫腔镜手术的难度。
中国专利CN208426206U公开了一种折叠式电极电切镜，其中，电切器械利用弹簧连接切割电极和金属套管，使切割电极可以转动一定角度，并通过推拉完成切割，提高了肾囊肿去顶减压术的手术效率。但是，其电切器械与内窥镜仍为一体结构，电切镜尺寸较大，同时，弹簧部分属于导电体，与切割电极连接为一体，也具有切割作用，因此，该电极电切镜在用于宫腔内手术时，需要较大的扩宫尺寸，且操作中容易误伤病灶旁边的正常组织，增加并发症风险。
目前国内及国外还没有见到用于与独立的宫腔镜配合使用的单体式宫腔电切器的报道。
 技术问题
本发明的目的在于提供一种单体式宫腔电切器。
 技术解决方案
该电切器包括固定杆、牵引丝、切割电极及操作手柄，所述固定杆上设置有导向滑套及可向固定杆任意端（例如，前后端）摆动的支撑体，操作手柄设置在固定杆的一端（例如，后端），牵引丝的两端沿着由导向滑套在固定杆另一端（例如，前端）外侧形成的折返通道分别延伸并连接至操作手柄和支撑体，固定杆内设置有一端向外延伸并连接至支撑体的张紧丝，切割电极设置在支撑体上，切割电极与沿固定杆延伸的电缆相连。
优选的，所述导向滑套包括相互连接的弯折管体和平直管体，弯折管体的内凹侧覆盖在固定杆的一端（例如，前端）上，平直管体延伸至固定杆设置有操作手柄的另一端（例如，后端）。
优选的，所述支撑体为弧面壳体状，支撑体的一端与固定杆销接，支撑体的另一端与环状电极相连，电缆的一端与设置在固定杆内部或外表上的引出电极相连，电缆的主体设置于固定杆内部，电缆的另一端延伸至环状电极与支撑体的连接位置。
优选的，所述支撑体为空心圆柱状，支撑体的一端与固定杆销接，支撑体的另一端与针状电极相连，电缆的一端与设置在固定杆内部或外表上的引出电极相连，电缆的主体设置于固定杆内部，电缆的另一端延伸至支撑体上。
优选的，所述操作手柄包括一对相互铰接的柄体，张紧丝与其中卡合在固定杆的对应端（例如，后端）上的柄体相连，另一个柄体与牵引丝相连。
优选的，所述固定杆的截面尺寸沿着自固定杆设置有操作手柄的一端（例如，后端）向另一端（例如，前端）的方向逐渐减小。
优选的，所述支撑体的摆动角度为30-120度。
优选的，所述切割电极的直径为0.5-1.5mm。
 有益效果
本发明所述电切器可通过张合操作手柄，使牵引丝沿着固定杆上的导向滑套移动，从而控制与牵引丝连接的支撑体，并在张紧丝的回拉或牵拉约束下，带动切割电极（例如，针状电极、环状电极）完成打开、收拢及改变打开角度。在进出宫腔时可以收拢切割电极，在不需要扩宫或扩宫尺寸减小的情况下，仍可以使得电切器容易进出宫腔，且切割电极不易损坏。在宫腔镜治疗中，可分别持宫腔检查镜及本发明所述电切器，并相互配合完成操作，不仅可以由医生连续完成一定视野内不同角度和深浅位置（操作范围更大、灵活性更强）的病灶（宫腔内存在的息肉、宫腔粘连、粘膜下肌瘤）切除手术操作，使得治疗过程操作简单，并达到更好的治疗效果，而且操作过程更为安全。同时，本发明的推广应用还可以降低器械的成本费用（现有一体式电切镜的价格远远大于单体式电切器的价格）、治疗费用和时间，减轻治疗痛苦程度，可以在门诊完成相应的手术操作。
进一步的，本发明在应用于宫腔镜阴道内镜技术中时，根据病灶的大小，通过操作支撑体的摆动角度形成不同的切割电极打开角度（例如，45-120度），不仅可以对宫腔内息肉、宫腔粘连、粘膜下肌瘤等进行电切治疗，而且可以对宫腔内小血管的出血，给予有效的电凝止血。
进一步的，本发明可以通过采用直径较大的切割电极，实现切割组织的最大化，从而缩短手术时间，降低发生水中毒等并发症的风险。
进一步的，本发明中，电切器的操作手柄位于固定杆较粗的后端，固定杆朝着其前端的方向逐渐变细，治疗中电切器的前端更容易进入（例如，沿着宫腔检查镜镜体）并穿过宫腔内较为狭窄的部位（例如，宫颈内口），提高手术操作效率。
进一步的，本发明中采用的弧面壳体状或空心圆柱状支撑体，配合灵活的角度调整，有效的减少了非切割电极对组织的电切，避免了电切中误操作对正常组织的破坏和损伤。
 附图说明
图1为实施例1中的单体式电切环的主视图（环状电极收拢时，30度）；
图2为实施例1中支撑体与环状电极的连接示意图（固定杆侧面视角）；
图3为实施例1中电缆连接示意图；
图4为实施例1中的单体式电切环的主视图（环状电极打开为90度时）；
图5为实施例1中支撑体与环状电极的连接示意图（固定杆端面视角）；
图6a为实施例1中的单体式电切环的主视图（环状电极打开为120度时），其中未显示固定杆内的张紧丝部分；
图6b为实施例1中的单体式电切环的主视图（环状电极打开为120度时），其中显示固定杆内的张紧丝部分；
图7为实施例2中的单体式电切针的主视图（针状电极收拢时，30度）；
图8为实施例2中的单体式电切针的主视图（针状电极打开为90度时）；
图9为实施例2中支撑体与针状电极的连接示意图之一；
图10为实施例2中支撑体与针状电极的连接示意图之二；
图11为实施例2中电缆连接示意图；
图12为实施例2中的单体式电切针的主视图（针状电极打开为120度时）；
图中：1-1为第一柄体，1-2为第二柄体，1-3手柄连接部，1-4为牵引丝，1-5为固定杆，1-6为张紧丝，2为导向滑套，3为支撑体，3-1为活动连接点，3-2为固定连接点，4为环状电极，5为电缆，6为引出电极，7为针状电极。
 本发明的最佳实施方式
下面结合附图和实施例对本发明作进一步详细说明。
目前所用的宫腔电切镜都是圆柱形，直径在8mm以上，其从男性前列腺电切镜发展而来，但男性的尿道系统与女性的阴道、子宫生殖系统的结构有较大差别。本发明为了很好的利用女性自身的生理结构，将电切镜的宫腔检查系统与电切系统分开，并对电切系统的结构作了改进，从而形成了一种单体式电切系统，其切割电极在进出宫腔中可以有效避免与组织碰擦，同时在检查镜的配合下，能在更大的范围内发挥治疗作用，从而更好的利用女性自身的生理结构而进行治疗，可以降低治疗的难度和成本，也减轻了病人的痛苦程度。
实施例1
参见图1、图3及图6b，本实施例提供的单体式电切环，包括一个手柄、一个固定杆1-5、多段具有一定强度、可自由弯曲的柔性线材（例如，尼龙等合成纤维、PE等高分子聚合物、钛钢等金属合金材料）及一个电路回路系统。所述手柄包括通过手柄连接部1-3相连（铰接）的第一柄体1-1和第二柄体1-2，第一柄体1-1与固定杆1-5的后端卡合固定，第二柄体1-2上连接有一段上述柔性线材并作为牵引丝1-4，牵引丝1-4穿行在整体位于固定杆1-5上部的导向滑套2内，牵引丝1-4自第二柄体1-2水平引出并朝向固定杆1-5的前端延伸，牵引丝1-4的前端穿过紧贴固定杆1-5前端外侧的导向滑套2弯曲段（一段弯折管体），从而可以通过弯曲（沿着弯折管体）向固定杆1-5后端方向折返一定距离，并最终与连接在固定杆1-5前端附近的可以活动的支撑体3（弧面壳体状）连接。以另一段上述柔性线材沿着朝向固定杆1-5前端的方向从固定杆1-5内部伸出，并与支撑体3连接，具体连接位置可以选择在牵引丝1-4与支撑体3连接位置的背侧，该段柔性线材穿入固定杆1-5的一端，可以沿着固定杆1-5内部到达固定杆1-5的后端，并与一个预置在固定杆1-5内部的弹簧相连，从而形成回拉张紧丝1-6。若无预置的弹簧，则可以利用布置在固定杆1-5或第一柄体1-1上的卷丝机构（例如，可以固定的旋钮）收放柔性线材，从而形成牵拉张紧丝。所述电路回路系统包括安装在支撑体3（弧面壳体状）上的环状电极4、主体埋置于固定杆1-5内部的电缆5以及正、负引出电极6，引出电极6通过固定杆1-5上的接线孔与外部控制电路相连，电缆5的一端分别连接正、负引出电极6，另一端引出固定杆1-5并与环状电极4的两端连接。
参见图1、图2及图5，所述支撑体3由截取自圆台侧面的一个弧面壳体加工而成，该弧面壳体的上部仅保留了位于两侧的部分，该部分分别通过销钉与固定杆1-5相连，固定杆1-5沿从前端到后端的方向径向截面逐渐变宽，在弧面壳体的内凹侧以销钉为轴（活动连接点3-1）转向固定杆1-5时，可以使环状电极4收拢。收拢状态下，支撑体3（弧面壳体状）的内凹面紧贴着固定杆1-5，使得电切环（特别是前端需要伸入宫腔的部分）径向尺寸达到最小，容易通过宫颈外口及宫腔内口，解决了电切环在通过宫腔颈管及颈管内口时容易发生损坏的问题。上述弧面壳体的下部具有安装孔（固定连接点3-2），可以通过螺丝紧固环形电极4的端部，既方便安装不同尺寸的环状电极4（在电切宫腔粘连时采用较细的环状电极；在电切肌瘤时采用较粗的环状电极），也可以在环状电极4因切割消耗后进行方便的更换。电缆5可以由活动连接点3-1（例如，销钉内部）穿出固定杆1-5。
参见图4及图6a，随着手柄张开，第二柄体1-2拉动牵引丝1-4，使支撑体3（弧面壳体状）带动环状电极4朝向固定杆1-5前端转动，同时回拉张紧丝1-6被拉开，当手柄完全张开时，此时环状电极4的转动角度（相对于固定杆）为120度。在以上转动过程中，一旦手柄停止张开动作，则支撑体3（弧面壳体状）连同环状电极4受到牵引丝1-4及回拉张紧丝1-6的反向牵引的作用而固定位置，根据宫腔内治疗目标的不同，不仅可以采用90度，还可以选择其他不同的角度（例如，45-120度之间任意一个角度）进行治疗。随着手柄合拢，回拉张紧丝1-6使支撑体3带动环状电极4朝向固定杆1-5后端转动，直至支撑体3与固定杆1-5紧贴。由于采用了径向尺寸渐变的固定杆1-5，回拉张紧丝1-6可以倾斜安装，从而有效减少回拉张紧丝1-6的伸出长度，并尽可能减少伸出部分的折角，从而减少对操作的干扰。
上述单体式电切环的使用方法：
作为独立的电切器，可以先使用宫腔镜进行检查。需要进行电切治疗时，一种方法是上阴道窥器，根据宫口的松紧度进行适当的扩宫，一般要求宫口在6mm左右，根据宫腔镜检查的子宫的位置，先送入单体式电切环到宫腔里，然后一手固定单体式电切环，另一手持宫腔镜并从单体式电切环一侧进入宫腔。另一种方法是不上阴道窥器，在阴道内镜技术下，先使用宫腔镜进行检查，需要进行电切治疗时，一手操作宫腔镜，一手持单体式电切环，并沿着宫腔镜将单体式电切环先送入颈管近宫腔内口处，回撤宫腔镜到颈管内，在宫腔镜直视下，将单体式电切环送入宫腔，再将宫腔镜从一侧送入宫腔；如果宫口较松，也可以将单体式电切环沿着宫腔镜直接送入宫腔内。
在检查到宫腔息肉、宫腔粘连，粘膜下肌瘤等需要进行电切的病灶时，在宫腔镜下操作单体式电切环进行治疗。握紧手柄，使环状电极4打开，根据需要的切开部位及深浅程度选择手柄不同的张开角度，需要进行通电治疗时，脚踩电极板，使电流经引出电极6、电缆5通入环状电极4，对于单体式电切环（使用回拉张紧丝1-6），除了可以利用固定杆1-5进行回拉或者前推外，还可以通过手柄的张开或者收拢调节环状电极4角度，即通过环状电极4的转动对息肉、肌瘤等病灶进行切除，更符合锄头锄草的原理，从而将病灶彻底清除干净，达到更好的治疗效果，切除中必要时还可以利用通电的环状电极4进行凝血。
实施例2
参见图7及图11，本实施例提供的单体式电切针，包括一个手柄、一个固定杆1-5、多段具有一定强度、可自由弯曲的柔性线材（例如，尼龙等合成纤维、PE等高分子聚合物、钛钢等金属合金材料）及一个电路回路系统。与实施例1不同的是，所述电路回路系统采用针状电极7作为切割电极，用于安装针状电极7的支撑体3为筒座形式，既方便安装针状电极7，又方便与引出自固定杆1-5的电缆5连接。在手柄合拢时，支撑体3（筒座形式）及针状电极7紧挨在固定杆1-5上，支撑体3（筒座形式）及针状电极7相对于固定杆1-5而言具有较小的径向尺寸，因此，使得电切针（除手柄外）总体径向尺寸达到最小，容易通过宫颈外口及宫腔内口，可以避免针状电极7碰触损坏。
参见图9及图10，所述支撑体3（筒座形式）与固定杆1-5采用销接，与实施例1不同的是，支撑体3（筒座形式）包括一个带有内螺纹的圆筒，圆筒下部通过螺纹与针状电极7尾端连接固定，圆筒顶部（与一个引出电极连接的电缆，连接在圆筒顶部上，与另一个引出电极连接的电缆，连接在圆筒的侧壁上）安装有两个倒L字型销钉。当圆筒以销钉为轴（活动连接点3-1）转向固定杆1-5时，可以使针状电极7收拢。
参见图8及图12，随着手柄张开或合拢，牵引丝1-4移动，并在回拉张紧丝1-6作用力约束下，针状电极7相对于固定杆1-5的角度随之调整。根据宫腔粘连的程度及粘膜下肌瘤凸向宫腔的大小，可以在60-120度之间选用不同的角度进行电切治疗。
上述单体式电切针的使用方法与实施例1中的单体式电切环基本相同，即通过手柄的张开或者合拢调节针状电极7角度，在通电状态下利用针状电极7对宫腔粘连、粘膜下肌瘤等病灶进行电切治疗，更符合从浅入深的电切治疗原理，从而达到更好的治疗效果，切除中必要时还可以利用通电的针状电极7进行凝血。
以上实施例中的电切器（电切环或电切针），在与宫腔检查镜配合治疗时，宫口被拉扯成一个椭圆形。一个直径5mm的检查镜横截面积为6.25π，再加上一个直径4mm、横截面积为4π的电切器，两个器械合起来的横截面积为10.25π，而直径6mm的宫口横截面积为9π，直径7mm的宫口横截面积为12.25π，对于大部分患者，其宫口在6mm左右，因而基本不需要扩宫，扩宫越小甚至不扩宫，就可以相应地将对患者宫颈的损伤降到最小。而且，宫腔检查镜及以上实施例中的电切器是在没有窥器及圆柱形金属包裹的限制下完成操作的，视野更广、活动范围更大。
本发明提出的单体式电切环、电切针的特点如下：
1）本发明的单体式电切环、电切针，更符合人体宫腔生理结构，在与宫腔镜（检查镜）配合治疗中，单体式电切环、电切针在收拢时前端较小，直径在4mm左右，可以单独送入。因此，扩宫尺寸减小，对宫颈的损伤更小，所引起的并发症更少。
2）本发明的单体式电切环、电切针在宫腔内治疗的活动范围更大，并通过更换切割电极（例如更粗的直径），提高电切效果，相应的加快了手术进程，降低了并发症的风险。
3）本发明的单体式电切环、电切针，切割电极角度可以在较大范围内调整，解决了现有宫腔电切镜操作中受限于子宫位置、内口的大小及窥器的问题，根据需要可以随时增加每次电切的组织，从而显著缩短电切手术时间，降低手术并发症。
4）本发明的单体式电切环、电切针，基本无需扩宫，损伤小，所以在门诊手术室即可完成治疗过程，不仅降低治疗成本，而且可以达到良好的治疗效果。

Claims (10)

  1. 一种单体式宫腔电切器，其特征在于：包括固定杆（1-5）、牵引丝（1-4）、切割电极及操作手柄，所述固定杆（1-5）上设置有导向滑套（2）及可向固定杆（1-5）任意端摆动的支撑体（3），操作手柄设置在固定杆（1-5）的一端，牵引丝（1-4）沿着由导向滑套（2）在固定杆（1-5）另一端形成的折返通道分别延伸并连接至操作手柄和支撑体（3），固定杆（1-5）内设置有向外延伸并连接至支撑体（3）的张紧丝（1-6），切割电极设置在支撑体（3）上，切割电极与沿固定杆（1-5）延伸的电缆（5）相连。
  2. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述导向滑套（2）包括相互连接的弯折管体和平直管体，弯折管体的内凹侧覆盖在固定杆（1-5）的一端上，平直管体延伸至固定杆（1-5）设置有操作手柄的另一端。
  3. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述支撑体（3）为弧面壳体状，支撑体（3）的一端与固定杆（1-5）销接，支撑体（3）的另一端与切割电极相连。
  4. 根据权利要求3所述一种单体式宫腔电切器，其特征在于：所述切割电极采用环状电极（4），电缆（5）的一端与设置在固定杆（1-5）内部或外表上的引出电极（6）相连，电缆（5）的主体设置于固定杆（1-5）内部，电缆（5）的另一端延伸至环状电极（4）与支撑体（3）的连接位置。
  5. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述支撑体（3）为空心圆柱状，支撑体（3）的一端与固定杆（1-5）销接，支撑体（3）的另一端与切割电极相连。
  6. 根据权利要求5所述一种单体式宫腔电切器，其特征在于：所述切割电极采用针状电极（7），电缆（5）的一端与设置在固定杆（1-5）内部或外表上的引出电极（6）相连，电缆（5）的主体设置于固定杆（1-5）内部，电缆（5）的另一端延伸至支撑体（5）上。
  7. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述操作手柄包括一对相互铰接的柄体，张紧丝（1-6）与其中卡合在固定杆（1-5）的对应端上的柄体相连，另一个柄体与牵引丝（1-4）相连。
  8. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述固定杆（1-5）的截面尺寸自固定杆（1-5）设置有操作手柄的一端向另一端逐渐减小。
  9. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述支撑体（3）的摆动角度为30-120度。
  10. 根据权利要求1所述一种单体式宫腔电切器，其特征在于：所述切割电极的直径为0.5-1.5mm。
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