WO2019206042A1 - 一种多功能高频电切开刀 - Google Patents

一种多功能高频电切开刀 Download PDF

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Publication number
WO2019206042A1
WO2019206042A1 PCT/CN2019/083463 CN2019083463W WO2019206042A1 WO 2019206042 A1 WO2019206042 A1 WO 2019206042A1 CN 2019083463 W CN2019083463 W CN 2019083463W WO 2019206042 A1 WO2019206042 A1 WO 2019206042A1
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Prior art keywords
electrode
frequency electric
caliper arm
hollow
distal end
Prior art date
Application number
PCT/CN2019/083463
Other languages
English (en)
French (fr)
Inventor
胡晓
唐志
范茗侨
解欢
李常青
冷德嵘
Original Assignee
南京微创医学科技股份有限公司
四川省人民医院
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.)
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Application filed by 南京微创医学科技股份有限公司, 四川省人民医院 filed Critical 南京微创医学科技股份有限公司
Priority to KR1020207029757A priority Critical patent/KR20210011910A/ko
Priority to US17/048,240 priority patent/US20210077179A1/en
Priority to CA3097932A priority patent/CA3097932C/en
Priority to EP19791969.9A priority patent/EP3785654B1/en
Priority to JP2020570623A priority patent/JP7064024B2/ja
Priority to BR112020021605-4A priority patent/BR112020021605A2/pt
Priority to AU2019260152A priority patent/AU2019260152B2/en
Publication of WO2019206042A1 publication Critical patent/WO2019206042A1/zh

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • A61B2218/002—Irrigation

Definitions

  • the invention relates to an electric incision knife for performing high-frequency cutting of diseased tissue under the guidance of an endoscope in the field of medical instruments, in particular to a high-frequency electric incision knife with integrated cutting, injecting and hemostasis functions.
  • the endoscopic technique has been in existence for more than 50 years, from the diagnosis of diseases to the treatment of diseases. It has been very effective and reliable for the treatment of some digestive diseases, and has even become the treatment of choice for treatment.
  • endoscopic techniques endoscopic biopsy, endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD) have been widely used.
  • EMR endoscopic mucosal resection
  • ESD endoscopic submucosal dissection
  • Endoscopic submucosal dissection is an endoscopic minimally invasive technique that uses a high-frequency instrument to perform submucosal dissection of lesions larger than 2 cm. This technique achieves a large resection of large lesions, providing an accurate pathological diagnosis staging for the lesion. Compared with traditional surgery, ESD better preserves the physiological functions of the digestive tract on the basis of radical tumors, and significantly improves the quality of life of patients after surgery. It has become an early stage of cancer and precancerous lesions including the esophagus. The preferred treatment.
  • ESD surgery is complicated and usually takes a long time and requires surgery under endoscopy.
  • the endoscope first enters the human body to find the diseased tissue.
  • the instrument enters the human body with the endoscopic forceps.
  • the lesion is marked, the instrument is withdrawn after the marker, and the injection needle is used for submucosal injection.
  • the appropriate electric cutting knife is used for the operation.
  • About 1 to 2 hours or so can successfully remove a 3cm early cancer lesion and remove the specimen for pathological analysis.
  • the need to change instruments during surgery makes the procedure more cumbersome and prolongs the operation time, causing pain to the patient. Therefore, it is necessary to develop a high-frequency electric cutting knife that integrates cutting, injection and coagulation functions.
  • the object of the present invention is to provide a multifunctional high-frequency electric cutting knife device, which can cut human diseased tissue, high-frequency coagulation, high-temperature cauterization, liquid injection, realize integrated cutting, infusion and coagulation, and can be positioned. Multi-function high-frequency electric cutting knife.
  • one end of the treatment portion is defined as a distal end
  • one end of the operation portion is defined as a proximal end.
  • a multifunctional high-frequency electric cutting knife comprises: a processing part, a sheath part, an operation part; a processing part, located at a distal end of the multifunctional high-frequency electric cutting knife, comprising an electrode for tissue cutting and injecting liquid, The electrode can be pushed out or withdrawn relative to the distal end of the sheath portion, the electrode having a hollow tubular portion extending axially; the clip assembly for tissue hemostasis, the clip assembly being pushable relative to the distal end of the sheath portion Or retracting, the clip assembly includes a first collet and a second collet, a first pin, the first collet and the second collet are connected by a first pin, and the first pin is driven to implement the clip assembly Opening and closing; a sheath portion at a proximal end of the treatment portion, including a hollow rod, the proximal end of the electrode extending distally through the interior of the proximal hollow rod, the hollow rod passing the first pin
  • the shaft is coupled to
  • a card member is disposed on an outer surface of the hollow tubular portion of the electrode, and a limiting block is disposed on an outer wall of the hollow tubular portion of the electrode, and the limiting block is matched with the first pin shaft to control the electrode to be far The maximum distance at which the end protrudes.
  • An operation portion located at a proximal end of the sheath portion, including a high frequency joint that connects the electrodes by a wire; a component that drives the electrode to move by an operation wire; a member that drives the movement of the hollow rod; and a liquid circulation a liquid inlet to the hollow tubular portion of the electrode.
  • the member is a slider and the slider slides back and forth along the core to extend or retract the clip assembly.
  • the component that drives the movement of the electrode is a thumb ring disposed at the proximal end of the operating portion, and the thumb ring sliding back and forth along the core rod to extend or retract the electrode.
  • the jacket portion also includes a spring tube that is externally embedded in the outer layer of the hollow tie rod.
  • the distal outer surface of the hollow rod is covered with a fixing seat, and the fixing seat is connected to the distal end of the spring tube.
  • the operating portion further includes a core rod extending along the axial direction of the high frequency electric cutting blade, and the distal end of the core rod is connected to the insulating outer tube.
  • the sheath portion has flexibility, including a fixing seat, a hollow rod, a spring tube, and an insulating outer tube.
  • a treatment portion disposed at a distal end side of the sheath portion, comprising: a clip assembly and an electrode; and an operation portion disposed at a proximal end of the sheath portion for operating the processing portion , including high frequency joints, sliders, liquid inlets, thumb rings, and core rods.
  • the treatment portion has a clip assembly and an electrode.
  • the clip assembly comprises: a first collet and a second collet, a first pin, a second pin, a third pin and a fourth pin, a first caliper arm, a second caliper arm, and a third caliper arm, a fourth caliper arm for tissue hemostasis, the clip assembly being pushable or retractable relative to a distal end of the sheath portion, the clip assembly including a first collet and a second collet, a first collet and a second collet
  • the head is connected by a first pin shaft, and driving the first pin shaft enables opening and closing of the clip assembly.
  • the hollow rod is also movably connected to the third caliper arm and the fourth caliper arm through the first pin shaft, the third caliper arm and the first caliper arm are movably connected by the third pin shaft, and the fourth caliper arm and the second caliper arm pass
  • the fourth pin is movably connected, and the first caliper arm and the second caliper arm are movably connected to the hollow rod through the second pin.
  • the first collet and the second collet are cross-staggered and their staggered positions are movably connected by the first pin to form a clip portion of the clip assembly.
  • the first collet and the second collet are symmetrical in shape, and after the first collet and the second collet are combined, the ends thereof are formed into any one of a T shape, an L shape, a cylindrical shape, or a spherical shape.
  • the first chuck and the second chuck are closed.
  • the first chuck and the second chuck are coated with a coating or ceramic to provide insulation.
  • the first caliper arm and the second caliper arm may also be hook-shaped at the end, and the first collet and the second collet are movably connected through the third pin and the fourth pin respectively; the electrode includes: extending along the axial direction The hollow tubular portion and the projection at the distal end.
  • the distal end of the electrode extends outwardly from the axis of the hollow tubular portion in a direction perpendicular to the radius of the cross section of the hollow tubular portion of the electrode, and the outwardly extending portion forms a projection at the distal end of the electrode.
  • the cross-sectional profile of the protrusion is a divergent distribution, such as a circumferential distribution, a triangular distribution, a Y-shaped distribution.
  • the protrusions may be a hemisphere, a sphere, a cylinder, a triangular prism, a Y font, etc., the electrodes are powered, and the convex portion can cut the target lesion tissue as the cutter head portion of the entire high frequency electric cutting knife.
  • the electrode may also have only a hollow tubular portion extending in the axial direction, at which time the hollow tubular portion serves as the tip portion of the entire high frequency electric cutting knife.
  • the outer wall of the hollow tubular portion of the electrode is provided with a card member, which is block-shaped, annular or tubular, wherein the block-shaped card member can be a set of mutually spaced blocks.
  • the electrode is composed of a metal material, and the metal material is not limited to a conductive material such as stainless steel, titanium or tungsten, and the electrode can be pushed out or retracted, and the target diseased tissue is cut when pushed out.
  • a part of the hollow tubular portion of the electrode is located in the core rod, and another portion protrudes from the core rod, and a portion of the hollow tubular portion of the electrode protruding from the core rod is provided with an insulating outer tube, and the insulating outer tube is fixed in position.
  • the hollow tubular portion of the electrode extends from the distal end side of the sheath portion to the operating portion in the axial direction of the sheath portion, and is connected to the operating portion through the operating wire.
  • the sheath portion is disposed at the proximal end of the processing portion, and includes: a fixing seat, a hollow rod, a spring tube, an insulating outer tube, and a card member.
  • the outer tube of the insulation is covered with an insulating coating to serve as an insulation.
  • the insulating outer tube has a lumen extending along the axis of the sheath portion, and the outer wall of the hollow tubular portion of the electrode in the insulating outer tube is provided with a card member, and the first collet and the second collet are moved when the card member moves to the closed state. At the end of the end, the clip is caught by the collet to achieve positioning, and the electrode has the smallest extension length.
  • a limiting block on the outer wall of the hollow tubular portion of the electrode according to requirements, and the limiting block is moved to the distal end of the electric cutting knife by the first pin shaft, and is controlled by the cooperation of the limiting block and the first pin shaft. The maximum distance the cutter head extends.
  • the limit block is block or ring.
  • the clips and the stop blocks can be insulated or insulated.
  • the limiting block can be disposed at a certain distance on the outer wall of the hollow tubular portion of the electrode, and the length of the cutting head is reserved, so that the hollow tubular portion and the protrusion of the electrode can completely absorb the insulating outer tube.
  • the cutter head only partially collects the outer tube of the insulation.
  • the spring tube adopts a spiral coated with an insulating coating or a hollow hose with a conductive layer, so that the sheath portion can be freely bent in the endoscope, and can better pass the endoscope curve.
  • a hollow tie rod is externally embedded on the proximal outer layer of the hollow tubular portion of the electrode.
  • the outer layer of the hollow tie rod is embedded with a spring tube.
  • the spring tube and the hollow tubular portion of the electrode serve as a driving portion, which is a torque transmitting component, and a double drive is formed inside the sheath portion, and the proximal end of the spring tube and the hollow tubular portion of the electrode are in communication to realize conduction of the circuit.
  • At the distal end of the spring tube there is a fixed seat for connecting the pull rod and the distal end of the spring tube.
  • the operation part has a high frequency joint, a slider, a liquid inlet, a core rod, and a thumb ring.
  • the core rod extends along the axial direction of the high-frequency electric cutting knife, and the distal end of the core rod is connected to the outer insulating tube, and the end of the core rod is provided with a thumb ring for controlling the movement of the hollow tubular portion of the electrode, and the protruding ring may be Round, square, oval and other shapes.
  • the thumb ring is connected to the proximal end of the hollow tubular portion of the electrode, and the inner diameter of the hollow tubular structure of the electrode is smaller than the inner diameter of the core rod, so that the thumb ring can be pulled, and the hollow tubular shape of the electrode can be pulled back and forth along the inside of the core rod to withdraw or retract the electrode.
  • the limiting block of the outer wall of the hollow tubular portion is in contact with the first pin shaft, so as to achieve precise limit on the amount of protrusion of the cutter head. In the specific operation, if there is a curve or the like, the electrode has sufficient length between the core rods to ensure the surplus of the cutter head.
  • a slider is provided to push the slider, and the hollow rod can reciprocate in the cavity along the core rod to push out or retract the clip assembly.
  • the diameter of the inner cavity of the core rod is larger than the diameter of the inner cavity of the spring tube, and the diameter of the inner diameter of the spring tube is larger than the diameter of the inner diameter of the hollow rod.
  • the diameter of the inner diameter of the hollow rod is larger than the diameter of the hollow tubular portion of the electrode, ensuring the hollow tubular portion of the electrode. Insert the shaft into the inside of the spring tube. At the end of the mandrel, there is also a liquid inlet, such as a 6% Luer fitting.
  • the syringe or infusion pump can be connected to a 6% Luer connector for infusion, such as injection of physiological saline.
  • the high frequency connector is located at the distal end of the operating portion, the high frequency connector is connected to the spring tube inside the electric cutting blade, and the high frequency connector is externally connected with the high frequency power generator, wherein the high frequency generator includes 60- not only limited to CONMED. 8200-230, ERBE VIO300S, 300D, etc.
  • the outer tube of the insulation can be moved to the proximal end first, and the slider is pushed to move to the distal end of the high-frequency electric cutting knife, and the hollow rod drives the movement of the first chuck and the second chuck, the first chuck and The second chuck can be opened and closed under the driving of the spring tube and the hollow tubular portion of the electrode, so that the first chuck and the second chuck are opened, and can be used as a hemostat for electrocoagulation to stop bleeding, and the clip assembly can be freely rotated, which is convenient. Accurately remove blood spots.
  • the slider is pushed to the proximal end of the high-frequency electric cutting knife, and the first chuck and the second chuck are closed.
  • the thumb loop is pushed to the distal end of the high-frequency electric cutting knife to extend the electrode, and the electrode protrusion is used as a cutting knife to cut the diseased tissue.
  • the electrode may also have only a hollow tubular portion extending in the axial direction, and the hollow tubular portion is used for cutting the diseased tissue.
  • the "water pad” forms an effective isolation between the muscle layer and the diseased tissue, and also effectively prevents heat conduction, makes the surgical field clearer, and the blood vessel is squeezed and closed by the water pad. The risk of bleeding is significantly reduced. This fluid channel also cleans the bleeding site. In the operation of the operation, it is not necessary to frequently replace the accessories, which greatly reduces the time for surgery and improves the safety of the operation.
  • the multifunctional high-frequency electric cutting knife provided by the invention comprises the metal material having a hollow tubular portion, thereby forming a liquid passage, and the liquid can pass through the hollow tubular portion of the electrode, and the submucosal layer is injected to bulge the mucosal tissue, or Wash the bleeding site.
  • the multifunctional high-frequency electric cutting knife provided by the invention has a spiral tube with an outer insulating coating or a hollow hose with a conductive layer, so that the electric cutting knife can freely bend in the endoscope. .
  • the multi-function high-frequency electric cutting knife provided by the invention can freely close and open the first collet and the second collet, and the clip assembly can be freely rotated when closed, so as to conveniently and accurately grasp the blood spot.
  • the multifunctional high-frequency electric cutting knife provided by the invention has a card member and a limiting block on the outer surface of the hollow tubular portion of the electrode, can realize free positioning, and select different cutting lengths according to actual conditions.
  • Figure 1 is a schematic diagram of a multi-function high-frequency electric cutting knife
  • Figure 2 is a schematic view of a partially enlarged multi-function high-frequency electric cutting knife with the collet closed
  • 3A-3B are schematic views of a partially enlarged multi-function high-frequency electric cutting knife in a state in which the chuck is opened.
  • 4A-4B are schematic diagrams of the multifunctional high-frequency electric cutting knife under different knife length states.
  • 5A-5F are schematic views of the distal end of the electrode
  • 6A-6D are schematic diagrams showing the use process of the multi-function high-frequency electric cutting knife
  • Figure 7 is a schematic view of the thumb ring
  • Processing unit 11, electrode, 111, hollow tubular portion, 112, projection, 12a, first collet, 12b, second collet, 13a, first pin, 13b, second pin, 13c, Third pin shaft, 13d, fourth pin shaft, 14a, first caliper arm, 14b, second caliper arm, 14c, third caliper arm, 14d, fourth caliper arm, 15, card member, 16a, hook structure , 16b, hook structure, 17, limit block, 20, sheath, 21, fixed seat, 22, hollow tie rod, 23, spring tube, 24, insulated outer tube, 30, operating part, 31, high frequency connector , 32, slider, 33, core rod, 34, thumb ring, 35, liquid inlet, 40, diseased tissue
  • the multi-function high-frequency electric cutting blade of the present embodiment includes a treatment portion 10, a sheath portion 20, and an operation portion 30.
  • the processing portion 10 includes an electrode 11, a clip having a first collet 12a and a second collet 12b, a first pin 13a, a second pin 13b, a third pin 13c, a fourth pin 13d, and a first clamp arm 14a, second caliper arm 14b, third caliper arm 14c, fourth caliper arm 14d.
  • the first caliper arm 14a and the third caliper arm 14c are movably connected by a third pin 13c
  • the second caliper arm 14b and the fourth caliper arm 14d are movably connected by a fourth pin 13d
  • the first caliper arm 14a and The third caliper arm 14c can also be a movable connection of the hook structure 16a
  • the second caliper arm 14b and the fourth caliper arm 14d can also be movablely connected by the hook structure 16b
  • the first caliper arm 14a and the second caliper arm 14b is movablely connected by the second pin 13b.
  • the third caliper arm 14c and the fourth caliper arm 14d are movably coupled to the tail portions of the first and second collet 12a and 12b via the first pin 13a.
  • the first pin 13a is fixedly coupled to the distal end of the hollow rod 22, and the second pin 13b is movably coupled to the distal end of the hollow rod 22, and the hollow rod 22 is pulled to extend or withdraw the clip assembly.
  • the first collet 12a and the second collet 12b are cross-staggered, and the clip movably connected by the first pin 13a can be opened or closed, and in the open state, the first collet 12a and the second collet
  • the head 12b is cross-staggered, and the first collet 12a and the second collet 12b are symmetrical in shape to form a clip portion of the clip assembly for hemostasis the tissue.
  • the first chuck 12a and the second chuck 12b may be coated with a coating or ceramic to provide insulation.
  • the electrode 11 is connected from the distal end through the hollow rod 22 to the proximal operating line.
  • the electrode 11 may include a hollow tubular portion 111 extending in the axial direction and a protrusion 112 at the distal end, and the electrode 11 may also have only the hollow tubular portion 111 extending in the axial direction without the protrusion 112.
  • the distal end of the electrode 11 extends outward from the axis perpendicular to the axis of the hollow tubular portion 111 by a length greater than the cross-sectional radius of the hollow tubular portion 111 of the electrode, and the outwardly extending portion forms a projection 112 at the distal end of the electrode 11.
  • the projections 112 are circumferentially distributed in cross section, and the projections 112 are hemispherical.
  • the cross section of the protrusion 112 is circumferentially distributed, and the protrusion 112 is a sphere.
  • the cross section of the projection 112 is circumferentially distributed, and the projection 112 is a cylinder.
  • the cross section of the protrusion 112 is a triangular shape, and the protrusion 112 is a triangular prism.
  • FIG. 5A the projections 112 are circumferentially distributed in cross section, and the projections 112 are hemispherical.
  • the cross section of the protrusion 112 is circumferentially distributed, and the protrusion 112 is a sphere.
  • the cross section of the projection 112 is circumferentially distributed, and the projection 112 is a cylinder.
  • the cross section of the protrusion 112 is a triangular shape, and the protrusion 112 is a triangular pris
  • the cross section of the protrusion 112 is a Y-shaped profile, and the protrusion 112 is a Y font.
  • the electrode 11 may also have only the hollow tubular portion 111 extending in the axial direction.
  • the sheath portion 20 includes a fixing seat 21, a hollow rod 22, a spring tube 23, an insulating outer tube 24, a card member 15 and a limiting block 17.
  • the hollow tie rod 22 can be a hollow tie rod that allows the electrode 11 to pass therethrough.
  • the first pin 13a is fixedly coupled to the distal end of the hollow rod 22, and the third and fourth caliper arms 14c and 14d are movablely coupled to the tails of the first and second chucks 12a, 12b via the first pin 13a.
  • the second pin 13b is movably connected to the distal end of the hollow rod 22, and the first caliper arm 14a and the second caliper arm 14b are movably connected by the second pin 13b, movable It is fixed to the hollow rod 22 so that pulling the hollow rod 22 can extend or withdraw the clip assembly.
  • the outer surface of the distal end of the hollow rod 22 is covered with a fixing seat 21, and the fixing seat 21 can be connected to the distal end of the spring tube 23, and the spring tube 23 can increase the flexibility and flexibility of the multifunctional high-frequency electric cutting knife.
  • the insulated outer tube 24 has a lumen extending along the axis of the sheath portion 20 in which the hollow pull rod 22 is free to move.
  • a card member 15 is provided on the outer surface of the hollow tubular portion 111.
  • the card member 15 is block-shaped, ring-shaped or tubular, wherein the block-shaped card member can be a set of mutually spaced blocks.
  • a stopper 17 is provided on the outer wall of the hollow tubular portion 111 of the electrode, and the stopper 17 is caught by the first pin 13a to control the maximum distance at which the electrode 11 projects toward the front end, thereby controlling the length of the extension of the electrode 11.
  • the limiting block 17 is block or ring shaped.
  • the operating portion 30 is provided at the proximal end of the sheath portion 20, so that the electrode 11 and the clip assembly can be pushed out or retracted with respect to the front end of the sheath portion 20, and a lumen for injecting a liquid can be provided.
  • the operation unit 30 includes a high frequency joint 31, a slider 32, a core rod 33, a thumb ring 34, and a liquid inlet 35.
  • the proximal end of the thumb ring 34 is connected to the electrode 11 through an operation wire, thereby controlling the extension and withdrawal of the electrode 11, and the high-frequency connector 31 can be connected to the electrode 11 through a wire to supply a high-frequency current to the electrode 11.
  • the proximal end of the electrode 11 extends distally through the interior of the proximal hollow rod 22.
  • the slider 32 is coupled to the proximal end of the hollow rod 22, and the slider 32 is movable back and forth along the core rod 33 to drive the movement of the hollow rod 22 to extend or retract the clip assembly.
  • the slider 32 is pushed forward, and the hollow rod 22 drives the first chuck 12a and the second chuck 12b to move distally, gradually opening into a crisscross shape, and retracting the slider 32 backward, and the hollow rod 22 drives the first chuck 12a.
  • the second collet 12b is retracted into the insulating outer tube 24 to effect opening and closing of the first collet 12a and the second collet 12b.
  • the spring tube 23 and the electrode 11 serve as a driving portion, which is a torque transmitting member, and a double drive is formed inside the sheath portion 20, and the spring tube 23 increases the twisting force of the driving portion.
  • FIG. 6A-6D illustrate the operation flow of the multifunctional high-frequency electric cutting knife of the present invention: during actual operation, the multifunctional high-frequency electric cutting knife of the present invention is inserted through the endoscope channel as shown in FIG. 6A.
  • the electrode 11 In the vicinity of the diseased tissue 40, in the process, the electrode 11 is kept in the retracted state, the protrusion 112 of the electrode abuts against the first collet 12a and the second collet 12b, and the first collet 12a and the second collet 12b are contracted at Insulated outer tube 24.
  • the electrode 11 After the multi-function high-frequency electric cutting knife reaches the diseased tissue 40, the electrode 11 is still in the retracted state, and the high-frequency connector 31 of the multifunctional high-frequency electric cutting knife of the present invention is connected with the external high-frequency generator, wherein the high-frequency generator
  • the generator includes, not limited to, CONMED 60-8200-230, ERBE VIO300S, 300D, and the like. Thereby, a high-frequency current is supplied to the electrode 11, and a mark is placed around the diseased tissue 40, and after the mark is completed, the high-frequency current is stopped.
  • the multifunctional high-frequency electrosurgical incision of the present invention pushes the thumb ring 34 forward, projects the electrode 11, places the electrode 11 at the marking point and inserts it into the submucosal layer of the diseased tissue 40, through the liquid inlet. 35 Injecting physiological saline or rouge into the diseased tissue 40 causes the tissue to bulge.
  • the electrode is again supplied with a high-frequency current while the electrode 11 is cut in the direction shown in Fig. 6C.
  • the high-frequency current is stopped, the slider 32 is pushed forward, the hollow rod 22 is driven to move forward, the clip assembly is opened, and the first chuck 12a and the second chuck 12b are cross-staggered.
  • the opening is opened, and the electrode 11 is retracted backwards, so that the opened first collet 12a and the second collet 12b can be used as a hemostat to perform electrocoagulation and hemostasis, and the clip assembly can be freely rotated for convenient and accurate blood grabbing. point.
  • the thumb ring may be in the shape of a circle, a square, an ellipse or the like.
  • the multi-functional high-frequency electric cutting knife provided by the invention has the electrodes and the clip assembly, and can simultaneously realize the functions of liquid injection, cutting and hemostasis integration. During the operation, the instrument is not frequently changed, and the operation time is greatly reduced. Improve the safety of surgery.
  • the multi-functional high-frequency electric cutting knife provided by the invention has an electrode composed of a metal material having a hollow tubular portion, and the hollow portion forms a liquid passage, and the liquid can pass through the hollow tubular portion of the electrode to perform submucosal injection to bulge the mucosa. Tissue can also be used to clean the bleeding site.
  • the spring tube of the sheath portion is provided with a spiral coated with an insulating coating or a hollow hose with a conductive layer, so that the electric cutting knife can freely bend in the endoscope.
  • the multi-function high-frequency electric cutting knife provided by the invention can freely close and open the first chuck and the second chuck, and the clip assembly is transmitted to the clip assembly by the torque of the spring tube, and can be freely rotated and convenient. Accurately remove blood spots.
  • the multi-functional high-frequency electric cutting knife provided by the invention has a card member and a limiting block on the hollow tubular portion of the electrode, can realize free positioning, and select different electrode protruding lengths according to actual conditions.

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Abstract

本发明属于内窥镜领域，提供了一种多功能高频电切开刀，包括处理部，护套部，操作部。处理部具有电极和夹子组件，电极可用于组织切割和注射液体，电极具有空心管状部，电极相对于护套部的远端可以推出或收回，夹子组件用于组织止血，所述夹子组件相对于护套部的远端可以推出或收回；护套部，位于所述处理部的近端，包括空心拉杆和弹簧管；操作部，位于所述护套部的近端，包括通过导线连接所述电极的高频接头，通过操作线驱动所述电极移动的组件，驱动所述空心拉杆移动的构件，以及可以使液体流通到所述电极的空心管状部的液体入口。液体可从电极空心管状部中通过，进行粘膜下层注射以便隆起粘膜组织，也可以对出血部位进行清洗。

Description

一种多功能高频电切开刀 技术领域
本发明涉及一种医疗器械领域内窥镜引导下进行病变组织高频切割的电切开刀，特别是涉及一种切割、注射和止血功能一体的高频电切开刀。
背景技术
内镜技术诞生50多年来，经历了从疾病诊断到疾病治疗的阶段，对于治疗一些消化疾病已经十分有效和可靠，甚至成为治疗的首选疗法。近年来随着内窥镜技术的发展，内镜下组织活检、内镜下黏膜切除术(Endoscopic mucosal resection，EMR)、内镜下黏膜剥离术(Endoscopic submucosal dissection，ESD)得到广泛应用，其对消化道出血、息肉切除和早癌症的治疗，正逐渐成为首选的治疗手段。其中，尤其是ESD对早癌的发现、诊断和切除起到了关键作用。
内镜黏膜下剥离术是指利用高频器械对大于2cm的病变进行黏膜下剥离的内镜微创技术。这一技术实现了较大病变的整块切除，为病变提供了准确的病理诊断分期。与传统外科手术相比，ESD在根治肿瘤的基础上，较好地保留消化道生理功能，明显改善了患者术后生活质量，目前已成为了包括食管在内的消化道早期癌及癌前病变的首选治疗方法。
由于ESD切除粘膜面积大，因此，所需时间较长，出血、穿孔等并发症也较高。目前用于内镜粘膜下剥离术的各种切开刀，一般只有切开组织的功能，很少有电凝止血的功能，一旦碰到出血必须将切开刀自内镜钳道内取出，更换热电凝钳进行电凝止血，特别是遇到粘膜下血供丰富的病人，需要反复更换器械，这样不仅大大增加手术操作时间，有时还会失去最佳止血时机，导致患者过多的失血和一些不必要的周围组织的损伤。此外，ESD手术过程繁杂，一般耗时很长，且需在内镜引导下进行手术。内镜先进入人体发现病变组织，器械在内镜钳道进入人体内，进行病变标记，标记后退出器械，换用注射针进行粘膜下层注射，注射后再用适合的电切开刀进行手术，大约1～2个小时左右才能成功切除一个3cm左右的早癌病变，并去除标本做病理分析。手术中需要更换器械，这使手术变的更加繁琐，并且延长了手术时间，给患者带来了痛苦。因此有必要开发一种集切割、注射、凝血功能于一体的高频电切开刀。
发明内容
本发明的目的在于提供一种多功能高频电切开刀装置，可对人体病变组织进行切割，高频凝血、高温烧灼，注液，实现集切割、注液、凝血为一体的，可定位的多功能高频电切开 刀。
以下，将处理部的一端定义为远端，将操作部的一端定义为近端。
一种多功能高频电切开刀，包括：处理部、护套部、操作部；处理部，位于多功能高频电切开刀的远端，包括电极用于组织切割和注射液体，所述电极相对于护套部的远端可以推出或收回，所述电极具有沿着轴向延伸的空心管状部；夹子组件用于组织止血，所述夹子组件相对于护套部的远端可以推出或收回，所述夹子组件包括第一夹头和第二夹头，第一销轴，所述第一夹头和第二夹头通过第一销轴连接，驱动第一销轴可实现夹子组件的打开和闭合；护套部，位于所述处理部的近端，包括空心拉杆，所述电极的近端可穿过近端空心拉杆的内部向远端延伸，所述空心拉杆通过第一销轴与所述第一夹头和第二夹头连接，操纵空心拉杆可驱动夹子组件相对于护套部的远端推出或收回；绝缘外管，所述绝缘外管具有沿着护套部的轴线延伸的管腔，可容纳空心拉杆和夹子组件；夹子组件打开状态时，所述第一夹头和第二夹头呈十字交错状，第一夹头和第二夹头的形状对称，从而形成夹子组件的夹部。在所述电极空心管状部外表面上设有卡件，在所述电极空心管状部外壁设有限位块，可通过所述限位块和所述第一销轴配合，控制所述电极向远端伸出的最大距离。当第一夹头和第二夹头闭合时，卡件被第一夹头和第二夹头卡住，控制所述电极向远端伸出的最小距离。操作部，位于所述护套部的近端，包括通过导线连接所述电极的高频接头；通过操作线驱动所述电极移动的组件；驱动所述空心拉杆移动的构件；以及可以使液体流通到所述电极的空心管状部的液体入口。
优选地，构件为滑块，滑块沿着芯杆前后滑动可以使夹子组件伸出或缩回。
优选地，驱动所述电极移动的组件为拇环，设于操作部近端末端，拇环沿着芯杆前后滑动可以使电极伸出或缩回。
护套部还包括弹簧管，外嵌在空心拉杆的外层。空心拉杆的远端外表面覆有固定座，固定座连接弹簧管的远端末端。操作部还包括芯杆，沿着高频电切开刀的轴向延伸，芯杆的远端与绝缘外管相连。
护套部，具有挠性，包括固定座，空心拉杆，弹簧管，绝缘外管。处理部，其设置于比所述护套部更靠远端侧的位置上，包括：夹子组件和电极；操作部，其设置于所述护套部的近端，用于操作所述处理部，包括高频接头，滑块，液体入口，拇环，芯杆。
处理部具有：夹子组件和电极。其中夹子组件包括：第一夹头和第二夹头，第一销轴，第二销轴，第三销轴和第四销轴，第一钳臂，第二钳臂，第三钳臂，第四钳臂，夹子组件用于组织止血，所述夹子组件相对于护套部的远端可以推出或收回，夹子组件包括第一夹头和 第二夹头，第一夹头和第二夹头通过第一销轴连接，驱动第一销轴可实现夹子组件的打开和闭合。空心拉杆还通过第一销轴与第三钳臂和第四钳臂活动连接，第三钳臂和第一钳臂通过第三销轴可活动的连接，第四钳臂和第二钳臂通过第四销轴可活动的连接，第一钳臂和第二钳臂通过第二销轴与空心拉杆活动连接。第一夹头和第二夹头十字交错，其交错位置通过第一销轴活动连接，形成夹子组件的夹部。第一夹头和第二夹头的形状对称，且第一夹头和第二夹头和合并后，其端部形成T形，L形，圆柱形或者球形中的任意一种。电极凸起部分在与病变组织接触时，第一夹头和第二夹头呈闭合状。第一夹头和第二夹头外覆镀膜或者陶瓷，可以起到绝缘的作用。第一钳臂和第二钳臂也可以是在末端呈钩式结构，分别通过第三销轴和第四销轴活动连接第一夹头和第二夹头；电极包括：沿着轴向延伸的空心管状部和在远端末端的凸起。电极远端从空心管状部的轴线垂直方向向外延伸的长度大于电极的空心管状部横截面的半径，向外延伸部分在电极的远端末端形成凸起。优选地，凸起的横截剖面为发散分布，例如圆周分布，三角形分布，Y字形分布。凸起可以为半球体，球体，圆柱体，三棱柱，Y字体等立体状，电极接通电源，凸起部分可以切割目标病变组织，作为整个高频电切开刀的刀头部分。电极也可仅具有沿着轴向延伸的空心管状部，此时空心管状部作为整个高频电切开刀的刀头部分。电极的空心管状部外壁上设有卡件，卡件为块状、环状或管状，其中块状卡件可以为一组相互间隔的卡块。电极由金属材料组成，金属材料不限于不锈钢、钛、钨等具有导电性的材料，电极可以推出或收回，推出时切割目标病变组织。电极的空心管状部的一部分位于芯杆内，另一部分伸出芯杆，电极的空心管状部伸出芯杆的部分设有绝缘外管，绝缘外管位置固定。其中，电极空心管状部在护套部的轴线方向上从护套部的远端侧延伸至操作部，通过操作线和操作部拇环相连接。
护套部设置于处理部的近端，包括：固定座，空心拉杆，弹簧管，绝缘外管，卡件。绝缘外管外覆绝缘涂层，起到绝缘的作用。绝缘外管具有沿着护套部的轴线延伸的管腔，绝缘外管内的电极的空心管状部外壁上设有卡件，当卡件移动到闭合状态的第一夹头和第二夹头远端末端时，卡件被夹头卡住，实现定位，此时电极伸出长度最小。也可以根据需求，在电极空心管状部外壁上设有限位块，限位块向电切开刀远端移动被第一销轴卡住，通过限位块和第一销轴的配合，从而控制刀头伸出的最大距离。
限位块为块状或环状。卡件和限位块可以带有绝缘涂层或自身绝缘。限位块可以以一定距离设置于电极空心管状部外壁，预留出刀头长度，使得电极的空心管状部和凸起可以完全收入绝缘外管。卡件的位置与绝缘外管远端末端平齐时，刀头仅部分收入绝缘外管。弹簧管采用外覆绝缘涂层的螺旋件或者具有导电层的空心软管，使得护套部能够在内窥镜中自由弯曲，可以更好的通过内窥镜弯道。在电极空心管状部的近端外层，外嵌一层空心拉杆。空心 拉杆的外层，外嵌一层弹簧管。弹簧管和电极空心管状部的作为驱动部分，是扭矩传递的部件，在护套部内部形成双驱动，同时弹簧管近端和电极空心管状部相连通，实现电路的导通。在弹簧管的远端末端，具有固定座，可以连接拉杆和弹簧管远端。
操作部具有：高频接头，滑块，液体入口，芯杆，拇环。芯杆沿着高频电切开刀的轴向延伸，芯杆的远端与绝缘外管相连，在芯杆的末端上设有用于控制电极的空心管状部移动的拇环，拇环可以是圆形，方形，椭圆形等形状。拇环和电极的空心管状部近端相连，电极的空心管状结构内径小于芯杆的内径，使得拉动拇环，可使电极的空心管状沿着芯杆内部来回拉动，以退出或收回电极，通过空心管状部外壁的限位块与第一销轴相抵触，实现对刀头伸出量的精确限制。在具体操作时，如遇到弯道等情况，电极到芯杆之间有足够的长度，保证刀头伸出量盈余。在芯杆中部，设有滑块，推动滑块，空心拉杆可以沿着芯杆在腔内往复运动，以推出或者收回夹子组件。芯杆内腔直径尺寸大于弹簧管内腔直径尺寸，弹簧管内腔直径尺寸大于空心拉杆的内腔直径尺寸，空心拉杆的内腔直径尺寸大于电极空心管状部的直径尺寸，保证电极的空心管状部同轴地插入弹簧管内部。在芯杆的末端，同时设有液体入口，例如6％鲁尔接头。可将注射器或注液泵连接至6％鲁尔接头，进行注液，例如注射生理盐水等。高频接头位于操作部的远端末端，高频接头在电切开刀内部和弹簧管相连，高频接头外接高频电源发生器，其中高频发生器包括不限于康美(CONMED)的60-8200-230、爱尔博(ERBE)VIO300S、300D等。
在实际操作过程中，可先将绝缘外管向近端移动，推动滑块向高频电切开刀远端移动，空心拉杆驱动第一夹头和第二夹头运动，第一夹头和第二夹头可在弹簧管和电极空心管状部的带动下开合和旋转，使得第一夹头和第二夹头张开，可作为止血钳进行电凝止血，夹子组件可自由旋转，方便准确抓取出血点。止血完毕时，推动滑块向高频电切开刀近端移动，第一夹头和第二夹头闭合。推动拇环向高频电切开刀远端移动，伸出电极，电极凸起做为切开刀进行病变组织的切割。电极也可仅具有沿着轴向延伸的空心管状部，利用空心管状部进行病变组织的切割。需要对组织进行注液时，可将电极远端末端置于目标粘膜组织内部，将注液泵或者外接的注射器连接至6％鲁尔接头，注射生理盐水或靛胭脂，以便隆起粘膜组织，并在黏膜下形成液体缓冲层即“水垫”，“水垫”在肌层和病变组织间形成有效隔离，同时也有效阻止了热传导，使手术视野更清晰，血管受到水垫的挤压封闭，出血的风险显著降低。此液体通道也可以对出血部位进行清洗。在手术操作中无需频繁更换配件，大大缩减手术用时，提高手术安全性。
有益效果：
本发明提供的多功能高频电切开刀，电极由具有空心管状部的金属材料构成，从而形成液体通道，液体可从电极空心管状部中通过，进行粘膜下层注射以便隆起粘膜组织，也可以对出血部位进行清洗。
本发明提供的多功能高频电切开刀，护套部的弹簧管采用外覆绝缘涂层的螺旋件或者具有导电层的空心软管，使得电切开刀能够在内窥镜中自由弯曲。
本发明提供的多功能高频电切开刀，第一夹头和第二夹头可以自由闭合和张开，闭合时夹子组件可自由旋转，方便准确抓取出血点。
本发明提供的多功能高频电切开刀，在电极空心管状部外表面具有卡件和限位块，可以实现自由定位，根据实际情况来选择不同的出刀长度。
附图说明
图1是多功能高频电切开刀示意图
图2是夹头闭合状态下局部放大的多功能高频电切开刀示意图
图3A-3B是夹头张开状态下局部放大的多功能高频电切开刀示意图
图4A-4B是不同出刀长度状态下的多功能高频电切开刀示意图
图5A-5F是电极的远端末端示意图
图6A-6D是多功能高频电切开刀使用过程的说明示意图
图7是拇环示意图
10、处理部，11、电极，111、空心管状部，112、凸起，12a、第一夹头，12b、第二夹头，13a、第一销轴，13b、第二销轴，13c、第三销轴，13d、第四销轴，14a、第一钳臂，14b、第二钳臂，14c、第三钳臂，14d、第四钳臂，15、卡件，16a、钩式结构，16b、钩式结构，17、限位块，20、护套部，21、固定座，22、空心拉杆，23、弹簧管，24、绝缘外管，30、操作部，31、高频接头，32、滑块，33、芯杆，34、拇环，35、液体入口，40、病变组织
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
实施例
以下，将处理部的一端定义为远端，将操作部的一端定义为近端。如图1-3所示，本实施方式的多功能高频电切开刀，包括处理部10，护套部20和操作部30。处理部10包括电极 11，具有第一夹头12a和第二夹头12b的夹子，第一销轴13a，第二销轴13b，第三销轴13c，第四销轴13d，第一钳臂14a，第二钳臂14b，第三钳臂14c，第四钳臂14d。第一钳臂14a和第三钳臂14c通过第三销轴13c可活动的连接，第二钳臂14b和第四钳臂14d通过第四销轴13d可活动的连接，第一钳臂14a和第三钳臂14c也可以呈钩式结构16a可活动的连接，第二钳臂14b和第四钳臂14d也可以呈钩式结构16b可活动的连接，第一钳臂14a和第二钳臂14b通过第二销轴13b可活动的连接。第三钳臂14c和第四钳臂14d通过第一销轴13a与第一夹头12a和第二夹头12b的尾部可活动的连接。第一销轴13a固定连接在空心拉杆22的远端，第二销轴13b可活动的连接在空心拉杆22的远端，拉动空心拉杆22可伸出或撤回夹子组件。
如图3A和3B所示，第一夹头12a和第二夹头12b十字交错，通过第一销轴13a活动连接的夹子可打开或闭合，打开状态时，第一夹头12a和第二夹头12b呈十字交错状，第一夹头12a和第二夹头12b的形状对称，从而形成夹子组件的夹部，用来对组织止血。第一夹头12a和第二夹头12b可以外覆镀膜或者陶瓷，起到绝缘的作用。
如图5A-5F所示，电极11从远端穿过空心拉杆22与近端的操作线连接。电极11可包括沿着轴向延伸的空心管状部111和在远端末端的凸起112，电极11也可仅具有沿着轴向延伸的空心管状部111而不具有凸起112。电极11远端从空心管状部111的轴线垂直方向向外延伸的长度大于电极的空心管状部111的横截面半径，向外延伸部分在电极11的远端末端形成凸起112。
如图5A所示，凸起112横截剖面为圆周分布，凸起112为半球体。如图5B所示，凸起112的横截剖面为圆周分布，凸起112为球体。如图5C所示，凸起112的横截剖面为圆周分布，凸起112为圆柱体。如图5D所示，凸起112的横截剖面为三角形分布，凸起112为三棱柱。如图5E所示，凸起112的横截剖面为Y形分布，凸起112为Y字体。如图5F所示，电极11也可以仅具有沿着轴向延伸的空心管状部111。
如图2所示护套部20包括固定座21，空心拉杆22，弹簧管23，绝缘外管24，卡件15和限位块17。空心拉杆22可以为空心拉杆，允许电极11从中通过。第一销轴13a固定连接在空心拉杆22的远端，第三钳臂14c和第四钳臂14d通过第一销轴13a与第一夹头12a和第二夹头12b的尾部可活动的连接，固定于空心拉杆22上，第二销轴13b可活动的连接在空心拉杆22的远端，第一钳臂14a和第二钳臂14b通过第二销轴13b可活动的连接，可活动的固定于空心拉杆22上，从而拉动空心拉杆22可实现伸出或撤回夹子组件。在空心拉杆22的远端外表面覆有固定座21，固定座21可连接弹簧管23的远端末端，弹簧管23可增加多功能高频电切开刀的挠性和弯曲性。绝缘外管24具有沿着护套部20的轴线延伸的管腔，空心拉 杆22可在其中自由移动。
如图2及图4A-4B所示，在空心管状部111外表面上设有卡件15。卡件15为块状、环状或管状，其中块状卡件可以为一组相互间隔的卡块。在电极的空心管状部111的外壁上设有限位块17，限位块17被第一销轴13a卡住，控制电极11向前端伸出的最大距离，从而控制电极11伸出的长度。当卡件15移动到闭合状态的第一夹头12a和第二夹头12b远端末端时，卡件15被两个夹头卡住，实现定位，此时电极11伸出长度最小。限位块17为块状或环状。
如图1和图2所示，操作部30设在护套部20的近端，可以使电极11和夹子组件相对于护套部20的前端推出或收回，并且可以提供注射液体的管腔。操作部30包括高频接头31，滑块32，芯杆33，拇环34，液体入口35。近端的拇环34通过操作线与电极11相连接，从而控制电极11的伸出和撤回，高频接头31可通过导线与电极11相连接，为电极11提供高频电流。电极11的近端穿过近端空心拉杆22的内部向远端延伸。滑块32与空心拉杆22的近端相连，滑块32可沿芯杆33前后移动，从而带动空心拉杆22的移动用以伸出或收回夹子组件。向前推动滑块32，空心拉杆22驱动第一夹头12a和第二夹头12b向远端运动，逐渐打开呈十字交错状，向后收回滑块32，空心拉杆22带动第一夹头12a和第二夹头12b收缩进绝缘外管24内，实现第一夹头12a和第二夹头12b的打开和闭合。弹簧管23和电极11作为驱动部分，是扭矩传递的部件，在护套部20内部形成双驱动，弹簧管23增加了驱动部分的扭曲力。
图6A-6D说明本发明中多功能高频电切开刀的操作流程：在实际操作过程中，如图6A所示将本发明的多功能高频电切开刀通过内窥镜腔道插入病变组织40附近，在此过程中要保持电极11处于收回状态，电极的凸起112紧靠第一夹头12a和第二夹头12b，且第一夹头12a和第二夹头12b收缩在绝缘外管24内。多功能高频电切开刀达到病变组织40后，仍保持电极11处于收回状态，将本发明多功能高频电切开刀的高频接头31与外接的高频发生器连接，其中高频发生器包括不限于康美(CONMED)的60-8200-230、爱尔博(ERBE)VIO300S、300D等。从而给电极11通入高频电流，并在病变组织40周围进行标记，标记完成后，停止通入高频电流。
如图6B所示，本发明的多功能高频电切开刀，推动拇环34向前移动，伸出电极11，将电极11置于标记点并插入病变组织40的粘膜下层，通过液体入口35向病变组织40中注射生理盐水或靛胭脂使组织隆起。
如图6C-6D所示，病变组织隆起后，再次给电极通入高频电流，同时使电极11沿着图6C所示方向进行切割。如图6D所示，切割结束之后，停止通入高频电流，向前推动滑块32， 驱动空心拉杆22向前移动，打开夹子组件，第一夹头12a和第二夹头12b呈十字交错状张开，向后收回拇环34撤回电极11，使得张开的第一夹头12a和第二夹头12b，可作为止血钳进行电凝止血，夹子组件可自由旋转，方便准确抓取出血点。
如图7所示，拇环可以是圆形，方形，椭圆形等形状。
利用上述构造的仪器能实现四种功能。其一，本发明提供的多功能高频电切开刀，同时具有电极和夹子组件，可同时实现注液，切割和止血一体化的功能，手术过程中，不用频繁更换器械，大大缩减手术用时，提高了手术安全性。其二，本发明提供的多功能高频电切开刀，电极由具有空心管状部的金属材料构成，空心部分形成液体通道，液体可从电极空心管状部中通过，进行粘膜下层注射以便隆起粘膜组织，也可以对出血部位进行清洗。其三，护套部的弹簧管采用外覆绝缘涂层的螺旋件或者具有导电层的空心软管，使得电切开刀能够在内窥镜中自由弯曲。其四，本发明提供的多功能高频电切开刀，第一夹头和第二夹头可以自由闭合和张开，夹子组件，通过弹簧管的扭力传动到夹子组件，可自由旋转，方便准确抓取出血点。其五，本发明提供的多功能高频电切开刀，在电极空心管状部上具有卡件和限位块，可以实现自由定位，根据实际情况来选择不同的电极伸出长度。
上所述仅是本申请的优选实施方式，使本领域技术人员能够理解或实现本申请的发明。对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本申请的精神或范围的情况下，在其他实施例中实现。因此，本申请将不会被限制在本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (15)

  1. 一种多功能高频电切开刀，其特征在于，所述多功能高频电切开刀包括：
    处理部、护套部、操作部；
    所述处理部，位于多功能高频电切开刀的远端，包括电极用于组织切割和注射液体，所述电极相对于护套部的远端可以推出或收回，所述电极具有沿着轴向延伸的空心管状部；夹子组件用于组织止血，所述夹子组件相对于护套部的远端可以推出或收回，所述夹子组件包括第一夹头和第二夹头，第一销轴，所述第一夹头和第二夹头通过第一销轴连接，驱动第一销轴可实现夹子组件的打开和闭合；
    所述护套部，位于所述处理部的近端，包括空心拉杆，所述电极的近端可穿过近端空心拉杆的内部向远端延伸，所述空心拉杆通过第一销轴与所述第一夹头和第二夹头连接，操纵空心拉杆可驱动夹子组件相对于护套部的远端推出或收回；绝缘外管，所述绝缘外管具有沿着护套部的轴线延伸的管腔，可容纳空心拉杆和夹子组件；
    所述操作部，位于所述护套部的近端，包括通过导线连接所述电极的高频接头；通过操作线驱动所述电极移动的组件；驱动所述空心拉杆移动的构件；以及可以使液体流通到所述电极的空心管状部的液体入口。
  2. 根据权利要求1所述的多功能高频电切开刀，其特征在于，所述电极远端从空心管状部的轴线垂直方向向外延伸的长度大于所述电极的空心管状部横截面的半径，向外延伸部分在电极的远端末端形成凸起。
  3. 根据权利要求2所述的多功能高频电切开刀，其特征在于，所述凸起的横截剖面为发散分布。
  4. 根据权利要求1所述的多功能高频电切开刀，其特征在于，所述处理部还包括，第二销轴，第三销轴和第四销轴，第一钳臂，第二钳臂，第三钳臂，第四钳臂，所述空心拉杆还通过第一销轴与第三钳臂和第四钳臂活动连接，所述第三钳臂和第一钳臂通过第三销轴可活动的连接，所述第四钳臂和第二钳臂通过第四销轴可活动的连接，所述第一钳臂和第二钳臂通过第二销轴与所述空心拉杆活动连接。
  5. 根据权利要求4所述的多功能高频电切开刀，其特征在于，所述第一钳臂和第三钳臂呈钩式结构可活动的连接，所述第二钳臂和第四钳臂呈钩式结构可活动的连接。
  6. 根据权利要求1所述的多功能高频电切开刀，其特征在于，所述护套部还包括弹簧管，外嵌在空心拉杆的外层。
  7. 根据权利要求6所述的多功能高频电切开刀，其特征在于，在所述空心拉杆的远端外表面覆有固定座，固定座连接弹簧管的远端末端。
  8. 根据权利要求1或4所述的多功能高频电切开刀，其特征在于，夹子组件打开状态时，所述第一夹头和第二夹头呈十字交错状，第一夹头和第二夹头的形状对称，从而形成夹子组件的夹部。
  9. 根据权利要求1所述的多功能高频电切开刀，其特征在于，第一夹头和第二夹头可以外覆镀膜或陶瓷。
  10. 根据权利要求1所述的多功能高频电切开刀，其特征在于，在所述电极空心管状部外表面上设有卡件，在所述空心管状部外壁设有限位块，通过所述限位块和所述第一销轴配合控制所述电极向远端伸出的最大距离，通过卡件，第一夹头和第二夹头的配合，控制所述电极向远端伸出的最小距离。
  11. 根据权利要求10所述的多功能高频电切开刀，其特征在于，所述卡件为块状、环状或管状。
  12. 根据权利要求10所述的多功能高频电切开刀，其特征在于，所述限位块为块状或环状。
  13. 根据权利要求1所述的多功能高频电切开刀，其特征在于，所述操作部还包括芯杆，沿着高频电切开刀的轴向延伸，芯杆的远端与绝缘外管相连。
  14. 根据权利要求13所述的多功能高频电切开刀，其特征在于，所述构件为滑块，所述滑块沿所述芯杆前后滑动可以使夹子组件伸出或缩回。
  15. 根据权利要求1所述的多功能高频电切开刀，其特征在于，所述驱动所述电极移动的组件为拇环，设于操作部近端末端，所述拇环沿所述芯杆前后滑动可以使电极伸出或缩回。
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