WO2022033172A1 - Folding-type electrode assembly and folding-type hemostatis instrument - Google Patents

Folding-type electrode assembly and folding-type hemostatis instrument Download PDF

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Publication number
WO2022033172A1
WO2022033172A1 PCT/CN2021/100931 CN2021100931W WO2022033172A1 WO 2022033172 A1 WO2022033172 A1 WO 2022033172A1 CN 2021100931 W CN2021100931 W CN 2021100931W WO 2022033172 A1 WO2022033172 A1 WO 2022033172A1
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WIPO (PCT)
Prior art keywords
folding
electrodes
electrode assembly
center line
foldable
Prior art date
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PCT/CN2021/100931
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French (fr)
Chinese (zh)
Inventor
冯曦
敬兴义
何朝东
魏永刚
赵金堂
李波
Original Assignee
四川大学华西医院
成都美创医疗科技股份有限公司
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Publication of WO2022033172A1 publication Critical patent/WO2022033172A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1402Probes for open surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00529Liver
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589Coagulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • A61B2018/143Needle multiple needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1465Deformable electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the invention belongs to the field of medical devices, and in particular relates to a foldable electrode assembly and a foldable hemostatic device.
  • abdominal and thoracic surgery are usually "open", that is, the patient's abdominal cavity or thoracic cavity is incised, the diseased organs are exposed, and the operation is performed in an open state.
  • This kind of open surgery causes great damage to the patient, and the patient has a long postoperative recovery period, obvious pain, and high hospitalization costs.
  • microscopic minimally invasive surgery must be the main trend in abdominal or thoracic surgery and other surgical procedures, such as microscopic hepatectomy.
  • liver is densely covered with blood vessels and rich in blood; liver incision surgery requires very high hemostasis and requires the help of powerful and effective hemostasis instruments.
  • electrosurgical hemostatic instruments such as electrosurgical knives, electrocoagulation forceps, ultrasonic knives, electrocoagulation forceps, etc.
  • these hemostatic instruments are usually used for surface hemostasis, and the hemostasis depth and hemostasis range are small. Hemostasis is less efficient when performing extensive incisions.
  • the above hemostatic instruments are bulky and cannot be passed through a trocar with a smaller diameter (5-15 mm in inner diameter) or an endoscope; they can only be used for open surgery, not for endoscopic surgery. Smaller hemostatic devices usually have weaker hemostatic ability and cannot meet the hemostasis requirements of dry resection. The lack of hemostatic devices that can be used for endoscopic procedures makes endoscopic liver resection difficult to achieve.
  • the purpose of the embodiments of the present invention is to provide a foldable electrode assembly, which can realize the unfolding or folding of a plurality of electrodes by enabling the electrodes to rotate on the fixing member.
  • the fixing member inner diameter 5-15mm
  • endoscope enter the part that needs hemostasis, the electrode is larger when unfolded, which can achieve ultra-large, powerful and effective hemostasis; and because the electrodes can be rotated independently, multiple electrodes have different arrangements , suitable for hemostasis of different shaped parts.
  • the purpose of the embodiments of the present invention is also to provide a foldable hemostasis device, including a foldable electrode assembly, which can not only be easily inserted into the site where hemostasis is required, but also can achieve ultra-large-scale, strong and effective hemostasis, and can also be arranged in different
  • the electrode arrangement method can stop bleeding in different shapes, and the operation is simple, fast and practical.
  • An embodiment of the present invention provides a foldable electrode assembly, the foldable electrode assembly includes a fixing member and at least two electrodes, the electrodes include a rotating part, a connecting part and a folded part connected in sequence, and the center of the folded part is The line does not coincide with the center line of the rotating part, the rotating part is penetrated through the fixing part, and the folding part is rotated around the center line of the rotating part, so as to realize the independent unfolding or folding of the electrodes.
  • the center line of the rotating portion and the center line of the folding portion are parallel.
  • the center line of the rotating part is parallel to the center line of the fixing part, and the rotating parts of the at least two electrodes are distributed around the center line of the fixing part.
  • the number of the electrodes is four, and the rotating parts of the four electrodes are distributed in a rectangular shape.
  • the electrode includes an inner tube and an outer tube, the inner tube is located inside the outer tube, the tail of the inner tube is provided with a water inlet, and the head communicates with the outer tube , the head of the outer tube is closed and the tail is provided with a water outlet, so that the inner tube and the outer tube form a cooling medium circulation channel.
  • the tail portion of the outer tube is closed with the outer surface of the inner tube, and the number of the water outlets is multiple and uniformly distributed along the circumference of the outer tube.
  • the diameter of the head of the outer tube is gradually reduced to form a needle tip.
  • the outer surface of the electrode is provided with a scale.
  • An embodiment of the present invention further provides a foldable hemostatic device, the foldable hemostatic device includes a handle, a support rod, a folding assembly and the above-mentioned foldable electrode assembly, the support rod is connected to the handle, and the electrode is fixed At one end of the support rod, the folding assembly is connected to the handle and is configured to drive the folding electrode assembly to fold or unfold.
  • the folding assembly includes a folding knob and a steel pipe, the folding knob is rotatably connected to the handle, and both ends of the steel pipe are respectively connected to the rotating part and the folding knob .
  • the foldable hemostatic device includes a handle, a support rod, a foldable assembly and a foldable electrode assembly.
  • the electrodes By enabling the electrodes to rotate on the fixing member, the unfolding or folding of multiple electrodes is realized, and the electrodes are small in size when folded. It is convenient to insert a trocar (inner diameter of 5-15mm) or an endoscope into the site where hemostasis is required.
  • the electrode is larger in size when deployed, which can achieve ultra-large, strong and effective hemostasis; and because the electrodes can be rotated independently, multiple electrodes have Different arrangement methods are suitable for hemostasis of different shapes of parts, and the operation is simple, fast and practical.
  • FIG. 1 shows a schematic structural diagram of a folded electrode assembly provided by the first embodiment of the present invention
  • Fig. 2 shows the sectional view of Fig. 1;
  • Fig. 3 shows the schematic diagram of the cooperation relationship between the working pole and the loop pole
  • Figure 4 shows a cross-sectional view of an electrode
  • FIG. 5 shows a schematic diagram of a folded state from one of the viewing angles of FIG. 1;
  • FIG. 6 shows a schematic diagram of a folded state from another viewing angle of FIG. 1;
  • FIG. 7 shows a schematic diagram of one of the unfolded modes of the electrode
  • FIG. 8 shows another schematic diagram of the development of the electrode
  • Fig. 9 shows the schematic diagram of the unfolded state of Fig. 8.
  • Fig. 10 shows a schematic structural diagram of a foldable hemostatic device provided by the second embodiment of the present invention.
  • Figure 11 shows the cross-sectional view of Figure 10
  • Figure 12 shows a schematic diagram of the structure of the steel pipe
  • Figure 13 shows a hierarchy diagram of a transmission element
  • Fig. 14 shows a schematic diagram of the cooperation relationship between the steel pipe and the foldable electrode assembly
  • Figure 15 shows a schematic diagram of the cooperation relationship between the transmission element and the foldable electrode assembly
  • Figure 16 shows a schematic diagram of the first working state of the foldable hemostatic device
  • Figure 17 shows a schematic diagram of the second working state of the foldable hemostatic device
  • Figure 18 shows a schematic diagram of the effect after multiple ablation in a linear arrangement
  • Figure 19 shows a schematic diagram of the third working state of the foldable hemostatic device
  • Figure 20 shows a schematic diagram of the effect of arc-shaped arrangement after multiple ablation.
  • 130-folding knob 131-steel pipe; 132-rigid part; 133-flexible part; 134-transmission part; 135-flexible insulating layer; 136-insulating hose; 140-fixing part; 141-electrode; 143-folding part; 144-connecting part; 145-inner pipe; 146-outer pipe; 147-water inlet; 148-water outlet.
  • the first embodiment of the present invention provides a foldable electrode assembly 14 , and the foldable electrode assembly 14 can play a role of hemostasis.
  • the foldable electrode assembly 14 includes a fixing member 140 and at least two electrodes 141 .
  • the number of electrodes 141 is four.
  • the fixing member 140 may adopt a block structure.
  • the fixing member 140 is cylindrical, and the fixing member 140 is provided with a plurality of installation through holes (please refer to FIG. Choose four in quantity).
  • the fixing member 140 may also adopt a regular shape such as a prism or other irregular shapes.
  • the center line of the mounting through hole may be parallel to the center line of the fixing member 140, and the four mounting through holes are evenly distributed around the center line of the fixing member 140.
  • the The center line and the center line of the fixing member 140 may also be out of plane or intersected.
  • the plurality of electrodes 141 are all unipolar electrodes, that is, each electrode is a working electrode. In this case, in actual operation, a negative electrode plate needs to be matched.
  • the number of electrodes 141 can also be selected from two, three, five, etc. After repeated experiments by researchers, it is known that due to the limitations of the surgical operation under the microscope, when the number of electrodes 141 is four, the efficiency is high and the hemostatic effect is good.
  • the electrodes 141 are connected to the fixing member 140 , and the four electrodes 141 are distributed in a rectangular shape, that is, the mounting through holes are distributed in a rectangular shape around the center line of the fixing member 140 .
  • the electrode 141 is divided into a working electrode and a return electrode.
  • one working electrode and one return electrode are a group of electrodes 141, and the electrode 141 is at least There is one group set, and the commonly used groups are 1 group, 2 groups or 3 groups.
  • the diameter of the endoscope choose whether to set it as a bending structure, that is, when the number of electrodes 141 is one group, it is usually not necessary to set the electrode 141 as a bending structure, only when the applicable trocar (inner diameter 5-15mm) or When the diameter of the endoscope is small, the electrode 141 with a bent structure needs to be used.
  • each electrode 141 When each electrode 141 is arranged in a row, the distal distance between the working electrode and the return electrode of the same group is 5-12 mm, the diameter of each electrode 141 is 1-3 mm, and each electrode 141 exposes the fixing member 140 or the first folding arm The length is 3-10cm.
  • the "distal end” here refers to the end that is closer to the site of action during endoscopic surgery.
  • the working electrodes and the return electrodes are alternately distributed, and the electrodes 141 are insulated from each other.
  • the alternating distribution of the working electrodes and the return electrodes can make the coagulation areas generated between the electrodes 141 connected to each other, thereby generating a larger coagulation area.
  • the on-off of the high-frequency current is controlled by the foot controller or manually, and the high-frequency current flows between the working pole and the loop pole. Because the tissue has a certain impedance, heat will be generated when the high-frequency current flows through the tissue, and the heat will cause the tissue helicin to shrink and dehydrate, and the blood vessels will be closed, thereby achieving the function of hemostasis.
  • the electrode 141 itself does not generate heat, and the heat for hemostasis comes from the heat generated by "ohmic heating" when current flows through the tissue.
  • the electrode 141 includes a rotating part 142 , a connecting part 144 and a folding part 143 which are connected in sequence.
  • the rotating part 142 is inserted through the installation through hole of the fixing block, and the rotating part 142 can rotate around its own center line. It should be noted that the rotating part 142 can only rotate and cannot slide along its own centerline.
  • the folding part 143 is connected to the rotating part 142 through the connecting part 144 . During the rotation of the rotating part 142 , the folding part 143 can be driven to rotate around the center line of the rotating part 142 .
  • the distance between the distal ends of the folded portions 143 of the same group of working electrodes and return electrodes is 5-12 mm.
  • the center line of the folding part 143 and the center line of the rotating part 142 do not overlap, and the center line of the folding part 143 and the center line of the rotating part 142 may be different planes, intersect, etc.
  • the center line of the folding part 143 It is parallel to the center line of the rotating part 142 .
  • the connecting portion 144 is used to connect the rotating portion 142 and the folding portion 143 .
  • the shape of the connecting portion 144 is not limited, for example, the connecting portion 144 adopts a curved structure, a straight structure, etc. In this embodiment, the connecting portion 144 adopts a straight structure.
  • the included angle between the center line of the connecting portion 144 and the center line of the rotating portion 142 and the included angle between the center line of the connecting portion 144 and the center line of the folding portion 143 are not limited.
  • the connecting part 144 is perpendicular to the rotating part 142 and the folding part 143 respectively, the angle between the center line of the connecting part 144 and the center line of the rotating part 142 and the center line of the connecting part 144 and the center line of the folding part 143
  • the included angle is an obtuse angle, etc.
  • the included angle between the center line of the connecting portion 144 and the center line of the rotating portion 142 is an obtuse angle
  • the included angle between the center line of the connecting portion 144 and the center line of the folding portion 143 is an obtuse angle
  • the obtuse angle is an obtuse angle.
  • the angle range can be controlled between 120°-150°, such as 120°, 135°, 150°, etc.
  • Such an angle range prevents different electrodes 141 from interfering with each other when they are rotated individually, so that the electrodes 141 can rotate 360° around the center line of the rotating part 142 .
  • the electrodes 141 When the electrodes 141 rotate around the center line of the rotating part 142, the electrodes 141 can be independently unfolded or folded, and the rotations of different electrodes 141 do not interfere with each other. and the angle of rotation are not affected.
  • the unfolding or folding of the electrode 141 means that the distance between the center line of the folded portion 143 and the center line of the fixing member 140 increases or decreases with the rotation of the electrode 141 .
  • the limit state of electrode 141 unfolding is that the distance between the center line of the folded part 143 and the center line of the fixed block is the largest, and the limit state of electrode 141 folding is that the distance between the center line of the folded part 143 and the center line of the fixed block is the smallest.
  • the four electrodes 141 do not exceed the diameter range of the fixing member 140 in the folded state.
  • the electrode 141 includes an inner tube 145 and an outer tube 146 .
  • Both the inner tube 145 and the outer tube 146 may be made of metal materials, and the inner tube 145 and the outer tube 146 are assembled with a single electrode 141, then welded and fixed, and finally bent.
  • the inner tube 145 is located inside the outer tube 146 , wherein there is a certain distance between the head of the inner tube 145 and the head of the outer tube 146 , and the outer surface of the inner tube 145 has a second space between the inner surface of the outer tube 146 . gap.
  • the tail of the inner tube 145 is provided with a water inlet 147 and the head communicates with the outer tube 146 .
  • the head and tail of the outer tube 146 and the inner tube 145 are relative, and the tail refers to the end of the electrode 141 close to the handle 11, that is, the end away from the coagulation area during operation; the head refers to the electrode 141 The end away from the handle 11, that is, the end inserted into the coagulation area during operation.
  • the left side is the tail of the outer tube 146 and the inner tube 145
  • the right side is the head of the outer tube 146 and the inner tube 145 .
  • the tail of the outer tube 146 and the outer surface of the inner tube 145 are closed, and the sealing method is not limited.
  • the number of the water outlets 148 is multiple and uniformly distributed along the circumferential direction of the outer pipe 146 .
  • the flow of the cooling liquid inside the electrode 141 the cooling liquid enters the inner tube 145 from the tail of the inner tube 145, flows out from the head of the inner tube 145 and enters the head of the outer tube 146, then enters the tail of the outer tube 146, and finally It flows along the second gap between the inner tube 145 and the outer tube 146 and flows out from the water outlet 148 .
  • the current density around the electrode 141 is much larger than that in the distance, which leads to the tissue around the electrode 141 being more prone to dehydration and drying. It is impossible to stop the bleeding of distant tissues, and the scope of hemostasis is greatly reduced.
  • each electrode 141 of the hemostatic device has an internal liquid circulation function; when the water inlet pipe is connected to a cooling liquid (but not limited to physiological saline), the water outlet 148 is communicated with the suction device, and the cooling liquid can flow through the entire electrode at this time. 141, so as to take away the heat of the electrode 141; the temperature of the electrode 141 will not be too high (keep at about 25 °C), so the tissue around the electrode 141 will not dry out prematurely, and it is not easy to appear "sticking knife phenomenon", At this time, the current can be transmitted, causing the distant tissue to generate heat, dehydrate, and stop bleeding.
  • a cooling liquid but not limited to physiological saline
  • the water outlet 148 may also be arranged at other positions, for example, the water outlet 148 may be arranged in the middle of the rotating part 142 or the connecting part 144 or the intersection of the folding part 143 and the connecting part 144 . But at this time, it is not convenient for the water outlet 148 to communicate with the suction equipment, and the cooling liquid can only flow out from the water outlet 148 to act on the part to be treated, and a suction equipment must be used to suck the waste water out of the body.
  • the diameter of the head of the outer tube 146 is gradually reduced to form a needle tip.
  • a scale can also be provided on the outer surface of the electrode 141, and the scale can enable the staff to know the depth of the electrode 141 inserted into the tissue.
  • this embodiment uses four electrodes 141 . After the electrodes 141 are completely folded, the folded portions 143 of the four electrodes 141 are gathered together, and the distance from the center line of the fixing member 140 is relatively close, and the four electrodes 141 are not beyond the diameter of the first folding arm.
  • the folded portions 143 of the four electrodes 141 can be arranged in various ways, such as a straight line, a circular arc, a rectangle, and the like.
  • the second embodiment of the present invention further provides a foldable hemostatic device 10 .
  • the foldable hemostatic device 10 includes a handle 11 , a support rod 12 , a foldable assembly 13 and the foldable electrode in the first embodiment. Component 14.
  • the handle 11 mainly plays the role of supporting the support rod 12, the folding assembly 13, etc., and is convenient for the staff to operate by hand.
  • the style of the handle 11 is not limited.
  • the handle 11 can adopt but is not limited to the following structures:
  • the handle 11 has a mounting portion and a hand-holding portion, the interior of the mounting portion is hollow for accommodating part of the component structure, and the hand-holding portion is used for the staff to hold.
  • the support rod 12 mainly serves to connect the handle 11 and the foldable electrode assembly 14 , and can drive the electrode 141 to reach the designated coagulation area.
  • the material and type of the support rod 12 are not limited.
  • the support rod 12 adopts a circular tubular structure, and the interior of the support rod 12 is hollow so that other components can be installed therein.
  • the support rod 12 may also adopt a solid structure, and the shape is not limited to a cylindrical shape.
  • the support rod 12 is connected to the handle 11 , and the end of the support rod 12 can be inserted into the handle 11 .
  • the fixing member 140 can close the end of the support rod 12 , and the installation through hole communicates with the inside of the support rod 12 .
  • the center line of the mounting through hole may be parallel to the center line of the support rod 12 .
  • the rotation of the electrode 141 is realized by the folding assembly 13, and the folding assembly 13 is used to drive the electrode 141 of the electrode 141 assembly to rotate, so as to fold or unfold the electrode 141 assembly.
  • the folding assembly 13 can adopt but is not limited to the following structures:
  • the folding assembly 13 includes a folding knob 130 and a transmission member 134 , wherein the transmission member 134 includes a steel pipe 131 .
  • the folding knob 130 is rotatably connected to the handle 11 , one end of the steel pipe 131 is connected to the rotating part 142 and the other end is connected to the folding knob 130 .
  • the electrode 141 can be driven to rotate through the steel pipe 131 .
  • the steel pipe 131 includes a rigid portion 132 and a flexible portion 133 .
  • the rigid portion 132 cannot be deformed, the flexible portion 133 is adjacent to the folding knob 130 , and the flexible portion 133 can bend and transmit torque.
  • the flexible portion 133 is located outside the support rod 12 , and the flexible portion enables the distance between the transmission members 134 to be increased as required to prevent mutual interference.
  • the steel pipe 131 is a circular metal pipe, and the flexible portion 133 is made into a spiral shape by means of helical cutting.
  • the flexible portion 133 may also adopt other structures.
  • the transmission member 134 further includes a flexible insulating layer 135 and an insulating hose 136 .
  • the flexible insulating layer 135 covers the outer surface of the steel pipe 131, the insulating hose 136 is located inside the steel pipe 131, and there is a first gap between the outer surface of the insulating hose 136 and the inner surface of the steel pipe 131, when the water outlet 148 is arranged on the outer pipe At the end of 146, the flexible insulating layer 135 and the insulating hose 136 enclose an auxiliary cooling medium circulation channel.
  • the tail of the inner tube 145 is communicated with the insulating hose 136, and the first gap and the second gap are communicated through the water outlet 148, that is, the cooling medium circulation channel and the auxiliary cooling medium circulation channel are communicated to form a complete cooling medium circulation channel.
  • FIG. 14 Please refer to FIG. 14 for the matching relationship between the steel pipe 131 and the foldable electrode assembly 14 (the flexible portion 133 in FIG. 14 may be present or not), and the matching relationship between the transmission member 134 and the foldable electrode assembly 14 is shown in FIG. 15 .
  • the tail of the steel pipe 131 is electrically connected to the host through a welded and sealed cable.
  • FIGS. 16-20 Please refer to FIGS. 16-20 for the working state of the foldable hemostatic device 10 .

Abstract

A folding-type electrode assembly (14) and a folding-type hemostasis instrument (10) relating to the field of medical instruments. The folding-type hemostasis instrument (10) comprises a handle (11), a support rod (12), a folding assembly (13) and the folding-type electrode assembly (14). The folding-type electrode assembly (14) comprises a fixed piece (140) and at least two electrodes (141). The electrodes (141) comprise a rotating part (142), a connecting part (144), and a folding part (143) connected in succession. A center line of the folding part (143) does not coincide with a center line of the rotating part (142). The rotating part (142) is penetratingly arranged on the fixed piece (140), such that the folding part (143) rotates around the center line of the rotating part (142), thereby achieving independent unfolding or folding of the electrodes (141). By means of causing the electrodes (141) to rotate on the fixed piece (140), achieving the unfolding or folding of multiple electrodes (141), the volume of the electrodes (141) is relatively small when folded, and said electrodes can be conveniently inserted into a part in need of hemostasis. The volume of the electrodes (141) is relatively large when unfolded, achieving hemostasis that covers a huge area and is greatly effective. Additionally, because the electrodes (141) rotate independently, multiple electrodes (141) are provided with different arrangement methods, and are suited for providing hemostasis to differently shaped parts, and the present invention is simple to operate, convenient, and very practical.

Description

一种折叠式电极组件及折叠式止血器械A foldable electrode assembly and a foldable hemostatic device 技术领域technical field
本发明属于医疗器械领域,具体涉及一种折叠式电极组件及折叠式止血器械。The invention belongs to the field of medical devices, and in particular relates to a foldable electrode assembly and a foldable hemostatic device.
背景技术Background technique
目前,腹腔及胸腔手术通常采用的是“开放式”,即将患者腹腔或胸腔切开,将病症器官外露,在开放状态下进行手术。这种开放式手术对患者的损伤极大,患者术后恢复期很长,疼痛感明显,住院费用高昂。At present, abdominal and thoracic surgery are usually "open", that is, the patient's abdominal cavity or thoracic cavity is incised, the diseased organs are exposed, and the operation is performed in an open state. This kind of open surgery causes great damage to the patient, and the patient has a long postoperative recovery period, obvious pain, and high hospitalization costs.
将来,镜下微创手术必定是腹腔或胸腔手术及其他外科手术的主要趋势,如镜下切肝术。In the future, microscopic minimally invasive surgery must be the main trend in abdominal or thoracic surgery and other surgical procedures, such as microscopic hepatectomy.
肝脏血管密布、血液丰富;切肝手术对止血要求非常高,需要借助强力有效的止血器械。The liver is densely covered with blood vessels and rich in blood; liver incision surgery requires very high hemostasis and requires the help of powerful and effective hemostasis instruments.
然而,目前切肝手术中经常会用到电外科止血器械,例如电刀、电凝钳、超声刀、电凝镊等;这些止血器械通常是用于表面止血,止血深度和止血范围较小,在进行大范围切割手术时止血效率较低。并且,以上的止血器械体积庞大,不能通过口径较小的穿刺器(内径5-15mm)或内窥镜;它们只能用于开放式手术,不适用于镜下手术。而体积较小的止血器械通常止血能力更弱,不能满足干切除手术的止血要求。缺少能够用于镜下操作的止血器械使得镜下切肝手术难以实现。However, electrosurgical hemostatic instruments, such as electrosurgical knives, electrocoagulation forceps, ultrasonic knives, electrocoagulation forceps, etc., are often used in liver incision at present; these hemostatic instruments are usually used for surface hemostasis, and the hemostasis depth and hemostasis range are small. Hemostasis is less efficient when performing extensive incisions. Moreover, the above hemostatic instruments are bulky and cannot be passed through a trocar with a smaller diameter (5-15 mm in inner diameter) or an endoscope; they can only be used for open surgery, not for endoscopic surgery. Smaller hemostatic devices usually have weaker hemostatic ability and cannot meet the hemostasis requirements of dry resection. The lack of hemostatic devices that can be used for endoscopic procedures makes endoscopic liver resection difficult to achieve.
发明内容SUMMARY OF THE INVENTION
鉴于此,本发明实施例的目的在于提供一种折叠式电极组件,通过使电极能够在固定件上旋转,实现多根电极的展开或折叠,电极折叠时体积较小,可以方便的插入穿刺器(内径5-15mm)或内窥镜,进入需要止血的部位,电极展开时体积较大,可以实现超大范围、强力有效的止血;并且由于电极能够独立转动,多个电极具有不同的排布方式,适用于对不同形状的部位止血。In view of this, the purpose of the embodiments of the present invention is to provide a foldable electrode assembly, which can realize the unfolding or folding of a plurality of electrodes by enabling the electrodes to rotate on the fixing member. (inner diameter 5-15mm) or endoscope, enter the part that needs hemostasis, the electrode is larger when unfolded, which can achieve ultra-large, powerful and effective hemostasis; and because the electrodes can be rotated independently, multiple electrodes have different arrangements , suitable for hemostasis of different shaped parts.
本发明实施例的目的还在于提供过一种折叠式止血器械,包含折叠式电极组件,既能够方便插入至需要止血的部位,又能够实现超大范围、强力有效的止血,还可以排列出不同的电极排布方式对不同形状的部位止血,操作简便、快捷,实用性强。The purpose of the embodiments of the present invention is also to provide a foldable hemostasis device, including a foldable electrode assembly, which can not only be easily inserted into the site where hemostasis is required, but also can achieve ultra-large-scale, strong and effective hemostasis, and can also be arranged in different The electrode arrangement method can stop bleeding in different shapes, and the operation is simple, fast and practical.
本发明的实施例是这样实现的:Embodiments of the present invention are implemented as follows:
本发明实施例提供了一种折叠式电极组件,所述折叠式电极组件包括固定件和至少两根电极,所述电极包括依次连接的转动部、连接部和折叠部,所述折叠部的中心线与所述转动部的中心线不重合,所述转动部穿设于所述固定件,使所述折叠部围绕所述转动部的中心线旋转,以实现所述电极的独立展开或折叠。An embodiment of the present invention provides a foldable electrode assembly, the foldable electrode assembly includes a fixing member and at least two electrodes, the electrodes include a rotating part, a connecting part and a folded part connected in sequence, and the center of the folded part is The line does not coincide with the center line of the rotating part, the rotating part is penetrated through the fixing part, and the folding part is rotated around the center line of the rotating part, so as to realize the independent unfolding or folding of the electrodes.
作为上述实施例的可选方案,所述转动部的中心线和所述折叠部的中心线平行。As an optional solution of the above embodiment, the center line of the rotating portion and the center line of the folding portion are parallel.
作为上述实施例的可选方案,所述转动部的中心线与所述固定件的中心线平行,所述至少两根电极的转动部围绕所述固定件的中心线分布。As an optional solution of the above embodiment, the center line of the rotating part is parallel to the center line of the fixing part, and the rotating parts of the at least two electrodes are distributed around the center line of the fixing part.
作为上述实施例的可选方案,所述电极的数量为四根,四根所述电极 的转动部呈矩形分布。As an optional solution of the above embodiment, the number of the electrodes is four, and the rotating parts of the four electrodes are distributed in a rectangular shape.
作为上述实施例的可选方案,所述电极包括内管和外管,所述内管位于所述外管的内部,所述内管的尾部设置有进水口且头部与所述外管连通,所述外管的头部封闭且尾部设置有出水口,以使所述内管和所述外管构成冷却介质循环通道。As an optional solution of the above embodiment, the electrode includes an inner tube and an outer tube, the inner tube is located inside the outer tube, the tail of the inner tube is provided with a water inlet, and the head communicates with the outer tube , the head of the outer tube is closed and the tail is provided with a water outlet, so that the inner tube and the outer tube form a cooling medium circulation channel.
作为上述实施例的可选方案,所述外管的尾部与所述内管的外表面封闭,所述出水口的数量为多个且沿所述外管的周向均匀分布。As an optional solution of the above-mentioned embodiment, the tail portion of the outer tube is closed with the outer surface of the inner tube, and the number of the water outlets is multiple and uniformly distributed along the circumference of the outer tube.
作为上述实施例的可选方案,所述外管的头部直径逐渐减小形成针尖状。As an optional solution of the above embodiment, the diameter of the head of the outer tube is gradually reduced to form a needle tip.
作为上述实施例的可选方案,所述电极的外表面设置有刻度。As an optional solution of the above-mentioned embodiment, the outer surface of the electrode is provided with a scale.
本发明实施例还提供了一种折叠式止血器械,所述折叠式止血器械包括手柄、支撑杆、折叠组件和上述的折叠式电极组件,所述支撑杆连接于所述手柄,所述电极固定于所述支撑杆的一端,所述折叠组件连接于所述手柄且被构造成驱动所述折叠式电极组件折叠或展开。An embodiment of the present invention further provides a foldable hemostatic device, the foldable hemostatic device includes a handle, a support rod, a folding assembly and the above-mentioned foldable electrode assembly, the support rod is connected to the handle, and the electrode is fixed At one end of the support rod, the folding assembly is connected to the handle and is configured to drive the folding electrode assembly to fold or unfold.
作为上述实施例的可选方案,所述折叠组件包括折叠旋钮和钢管,所述折叠旋钮可转动的连接于所述手柄,所述钢管的两端分别连接于所述转动部和所述折叠旋钮。As an optional solution of the above embodiment, the folding assembly includes a folding knob and a steel pipe, the folding knob is rotatably connected to the handle, and both ends of the steel pipe are respectively connected to the rotating part and the folding knob .
本发明的有益效果是:The beneficial effects of the present invention are:
本发明提供的折叠式止血器械,包含手柄、支撑杆、折叠组件和折叠式电极组件,通过使电极能够在固定件上旋转,实现多根电极的展开或折叠,电极折叠时体积较小,可以方便的插入穿刺器(内径5-15mm)或内窥镜,进入需要止血的部位,电极展开时体积较大,可以实现超大范围、强 力有效的止血;并且由于电极能够独立转动,多个电极具有不同的排布方式,适用于对不同形状的部位止血,操作简便、快捷,实用性强。The foldable hemostatic device provided by the present invention includes a handle, a support rod, a foldable assembly and a foldable electrode assembly. By enabling the electrodes to rotate on the fixing member, the unfolding or folding of multiple electrodes is realized, and the electrodes are small in size when folded. It is convenient to insert a trocar (inner diameter of 5-15mm) or an endoscope into the site where hemostasis is required. The electrode is larger in size when deployed, which can achieve ultra-large, strong and effective hemostasis; and because the electrodes can be rotated independently, multiple electrodes have Different arrangement methods are suitable for hemostasis of different shapes of parts, and the operation is simple, fast and practical.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。通过附图所示,本发明的上述及其它目的、特征和优势将更加清晰。在全部附图中相同的附图标记指示相同的部分。并未刻意按实际尺寸等比例缩放绘制附图,重点在于示出本发明的主旨。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the accompanying drawings required in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some of the present invention. In the embodiments, for those of ordinary skill in the art, other drawings can also be obtained according to these drawings without any creative effort. The above and other objects, features and advantages of the present invention will become more apparent from the accompanying drawings. The same reference numerals refer to the same parts throughout the drawings. The drawings are not intentionally scaled to actual size, and the emphasis is on illustrating the gist of the present invention.
图1示出了本发明第一实施例提供的一种折叠式电极组件的结构示意图;FIG. 1 shows a schematic structural diagram of a folded electrode assembly provided by the first embodiment of the present invention;
图2示出了图1的剖视图;Fig. 2 shows the sectional view of Fig. 1;
图3示出了工作极与回路极的配合关系示意图;Fig. 3 shows the schematic diagram of the cooperation relationship between the working pole and the loop pole;
图4示出了电极的剖视图;Figure 4 shows a cross-sectional view of an electrode;
图5示出了图1的其中一个视角下的折叠状态示意图;FIG. 5 shows a schematic diagram of a folded state from one of the viewing angles of FIG. 1;
图6示出了图1的另外一个视角下的折叠状态示意图;FIG. 6 shows a schematic diagram of a folded state from another viewing angle of FIG. 1;
图7示出了电极的其中一种展开方式示意图;FIG. 7 shows a schematic diagram of one of the unfolded modes of the electrode;
图8示出了电极的另外一种展开方式示意图;FIG. 8 shows another schematic diagram of the development of the electrode;
图9示出了图8的展开状态示意图;Fig. 9 shows the schematic diagram of the unfolded state of Fig. 8;
图10示出了本发明第二实施例提供的一种折叠式止血器械的结构示意图;Fig. 10 shows a schematic structural diagram of a foldable hemostatic device provided by the second embodiment of the present invention;
图11示出了图10的剖视图;Figure 11 shows the cross-sectional view of Figure 10;
图12示出了钢管的结构示意图;Figure 12 shows a schematic diagram of the structure of the steel pipe;
图13示出了传动件的层次图;Figure 13 shows a hierarchy diagram of a transmission element;
图14示出了钢管与折叠式电极组件的配合关系示意图;Fig. 14 shows a schematic diagram of the cooperation relationship between the steel pipe and the foldable electrode assembly;
图15示出了传动件与折叠式电极组件的配合关系示意图;Figure 15 shows a schematic diagram of the cooperation relationship between the transmission element and the foldable electrode assembly;
图16示出了折叠式止血器械的第一种工作状态示意图;Figure 16 shows a schematic diagram of the first working state of the foldable hemostatic device;
图17示出了折叠式止血器械的第二种工作状态示意图;Figure 17 shows a schematic diagram of the second working state of the foldable hemostatic device;
图18示出了直线状排列多次消融后的效果示意图;Figure 18 shows a schematic diagram of the effect after multiple ablation in a linear arrangement;
图19示出了折叠式止血器械的第三种工作状态示意图;Figure 19 shows a schematic diagram of the third working state of the foldable hemostatic device;
图20示出了弧状排列多次消融后的效果示意图。Figure 20 shows a schematic diagram of the effect of arc-shaped arrangement after multiple ablation.
图标:icon:
10-折叠式止血器械;10-foldable hemostatic device;
11-手柄;12-支撑杆;13-折叠组件;14-折叠式电极组件;11-handle; 12-support rod; 13-foldable assembly; 14-foldable electrode assembly;
130-折叠旋钮;131-钢管;132-刚性部;133-挠性部;134-传动件;135-挠性绝缘层;136-绝缘软管;140-固定件;141-电极;142-转动部;143-折叠部;144-连接部;145-内管;146-外管;147-进水口;148-出水口。130-folding knob; 131-steel pipe; 132-rigid part; 133-flexible part; 134-transmission part; 135-flexible insulating layer; 136-insulating hose; 140-fixing part; 141-electrode; 143-folding part; 144-connecting part; 145-inner pipe; 146-outer pipe; 147-water inlet; 148-water outlet.
具体实施方式detailed description
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments These are some embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.
此外,术语“第一”、“第二”等仅用于区分描述,而不能理解为指示或暗示相对重要性。Furthermore, the terms "first", "second", etc. are only used to differentiate the description and should not be construed to indicate or imply relative importance.
第一实施例first embodiment
请参照图1所示,本发明的第一实施例提供了一种折叠式电极组件14,该折叠式电极组件14能够起到止血作用。Referring to FIG. 1 , the first embodiment of the present invention provides a foldable electrode assembly 14 , and the foldable electrode assembly 14 can play a role of hemostasis.
其中,折叠式电极组件14包括固定件140和至少两根电极141,在本实施例中,电极141的数量为四根。The foldable electrode assembly 14 includes a fixing member 140 and at least two electrodes 141 . In this embodiment, the number of electrodes 141 is four.
固定件140可以采用块状结构,在本实施例中,固定件140为圆柱状,固定件140上设置有多个安装通孔(请结合图2所示,本实施例中,安装通孔的数量选用四个)。The fixing member 140 may adopt a block structure. In this embodiment, the fixing member 140 is cylindrical, and the fixing member 140 is provided with a plurality of installation through holes (please refer to FIG. Choose four in quantity).
当然,固定件140还可以采用棱柱等规则形状或者其他不规则形状。Of course, the fixing member 140 may also adopt a regular shape such as a prism or other irregular shapes.
在本实施例中,安装通孔的中心线可以与固定件140的中心线平行,并且四个安装通孔围绕固定件140的中心线均匀分布,当然,在其他实施例中,安装通孔的中心线与固定件140的中心线还可以异面或者相交。In this embodiment, the center line of the mounting through hole may be parallel to the center line of the fixing member 140, and the four mounting through holes are evenly distributed around the center line of the fixing member 140. Of course, in other embodiments, the The center line and the center line of the fixing member 140 may also be out of plane or intersected.
在一种实施例中,多根电极141均为单极电极,即每根电极都是工作极,此时,实际操作时,需要配合负极板。电极141的数量还可以选用两根、三根、五根等,经过研究人员反复试验得知,受限于镜下手术操作的 局限性,电极141数量为四根时,效率高、止血效果好。In one embodiment, the plurality of electrodes 141 are all unipolar electrodes, that is, each electrode is a working electrode. In this case, in actual operation, a negative electrode plate needs to be matched. The number of electrodes 141 can also be selected from two, three, five, etc. After repeated experiments by researchers, it is known that due to the limitations of the surgical operation under the microscope, when the number of electrodes 141 is four, the efficiency is high and the hemostatic effect is good.
在本实施例中,电极141连接于固定件140上,四根电极141呈矩形分布,即安装通孔围绕固定件140的中心线呈矩形分布。In this embodiment, the electrodes 141 are connected to the fixing member 140 , and the four electrodes 141 are distributed in a rectangular shape, that is, the mounting through holes are distributed in a rectangular shape around the center line of the fixing member 140 .
请参照图3所示,在另一种更优的实施例中,电极141分为工作极和回路极,采用此方式时,一根工作极和一根回路极为一组电极141,电极141至少设置有一组,常用的组数为1组、2组或3组。根据内窥镜的口径尺寸选择是否设置为弯折结构,即电极141组数为1组时,通常不需要将电极141设置为弯折结构,只有当适用的穿刺器(内径5-15mm)或内窥镜口径较小时需要用到弯折结构的电极141。当各个电极141排列成一排时,同一组的工作极和回路极之间远端间距5-12mm,每根电极141的直径为1-3mm,每根电极141露出固定件140或第一折臂的长度为3-10cm。此处的“远端”指镜下手术操作时,更接近作用部位的一端。Referring to FIG. 3, in another preferred embodiment, the electrode 141 is divided into a working electrode and a return electrode. In this way, one working electrode and one return electrode are a group of electrodes 141, and the electrode 141 is at least There is one group set, and the commonly used groups are 1 group, 2 groups or 3 groups. According to the diameter of the endoscope, choose whether to set it as a bending structure, that is, when the number of electrodes 141 is one group, it is usually not necessary to set the electrode 141 as a bending structure, only when the applicable trocar (inner diameter 5-15mm) or When the diameter of the endoscope is small, the electrode 141 with a bent structure needs to be used. When each electrode 141 is arranged in a row, the distal distance between the working electrode and the return electrode of the same group is 5-12 mm, the diameter of each electrode 141 is 1-3 mm, and each electrode 141 exposes the fixing member 140 or the first folding arm The length is 3-10cm. The "distal end" here refers to the end that is closer to the site of action during endoscopic surgery.
当设置有多组电极141时,工作极和回路极呈交替分布,各电极141之间相互绝缘。When multiple groups of electrodes 141 are provided, the working electrodes and the return electrodes are alternately distributed, and the electrodes 141 are insulated from each other.
工作极和回路极交替分布这种方式可以使各电极141之间产生的凝血区域相互连接在一起,从而产生更大的凝血区域。The alternating distribution of the working electrodes and the return electrodes can make the coagulation areas generated between the electrodes 141 connected to each other, thereby generating a larger coagulation area.
当然,在另一种变劣的实施例中也可以采用“工作极-回路极-回路极-工作极”或“回路极-工作极-工作极-回路极”这种方式。这种方式产生的凝血区域是断开的,不同组之间没有形成较好的凝血区域。Of course, in another degraded embodiment, the manner of "working pole-return pole-return pole-working pole" or "return pole-working pole-working pole-return pole" can also be used. The coagulation areas produced in this way were disconnected, and no better coagulation areas were formed between the different groups.
在射频主机的作用下,利用脚踏控制器或手动控制高频电流的通断,高频电流在工作极和回路极之间流动。由于组织具有一定的阻抗,高频电流流经组织时会产生热量,而该热量令组织螺旋蛋白收缩、脱水,使血管闭合,从而实现止血功能。在止血时,电极141本身不会发热,止血的热 量来自电流流经组织时“欧姆发热”产生的热量。Under the action of the radio frequency host, the on-off of the high-frequency current is controlled by the foot controller or manually, and the high-frequency current flows between the working pole and the loop pole. Because the tissue has a certain impedance, heat will be generated when the high-frequency current flows through the tissue, and the heat will cause the tissue helicin to shrink and dehydrate, and the blood vessels will be closed, thereby achieving the function of hemostasis. During hemostasis, the electrode 141 itself does not generate heat, and the heat for hemostasis comes from the heat generated by "ohmic heating" when current flows through the tissue.
其中,请结合图2、图3所示,电极141包括依次连接的转动部142、连接部144和折叠部143。Wherein, as shown in FIG. 2 and FIG. 3 , the electrode 141 includes a rotating part 142 , a connecting part 144 and a folding part 143 which are connected in sequence.
转动部142穿设于固定块的安装通孔内,转动部142能够围绕自身的中心线转动。需要注意的是,转动部142只能转动,不能沿自身中心线滑动。The rotating part 142 is inserted through the installation through hole of the fixing block, and the rotating part 142 can rotate around its own center line. It should be noted that the rotating part 142 can only rotate and cannot slide along its own centerline.
折叠部143通过连接部144连接于转动部142,转动部142转动过程中,能够带动折叠部143围绕转动部142的中心线转动。当各个电极141排列成一排时,同一组工作极和回路极的折叠部143之间远端间距为5-12mm。The folding part 143 is connected to the rotating part 142 through the connecting part 144 . During the rotation of the rotating part 142 , the folding part 143 can be driven to rotate around the center line of the rotating part 142 . When the electrodes 141 are arranged in a row, the distance between the distal ends of the folded portions 143 of the same group of working electrodes and return electrodes is 5-12 mm.
其中,折叠部143的中心线与转动部142的中心线不重合,折叠部143的中心线与转动部142的中心线可以异面、相交等,在本实施例中,折叠部143的中心线与转动部142的中心线平行。The center line of the folding part 143 and the center line of the rotating part 142 do not overlap, and the center line of the folding part 143 and the center line of the rotating part 142 may be different planes, intersect, etc. In this embodiment, the center line of the folding part 143 It is parallel to the center line of the rotating part 142 .
连接部144用于连接转动部142和折叠部143。The connecting portion 144 is used to connect the rotating portion 142 and the folding portion 143 .
连接部144的形状不限,例如连接部144采用弯曲结构、直线结构等,在本实施例中,连接部144采用直线结构。The shape of the connecting portion 144 is not limited, for example, the connecting portion 144 adopts a curved structure, a straight structure, etc. In this embodiment, the connecting portion 144 adopts a straight structure.
连接部144的中心线与转动部142的中心线之间的夹角、连接部144的中心线与折叠部143的中心线之间的夹角不限。例如,连接部144分别与转动部142和折叠部143垂直、连接部144的中心线与转动部142的中心线之间的夹角以及连接部144的中心线与折叠部143的中心线之间的夹角为钝角等。The included angle between the center line of the connecting portion 144 and the center line of the rotating portion 142 and the included angle between the center line of the connecting portion 144 and the center line of the folding portion 143 are not limited. For example, the connecting part 144 is perpendicular to the rotating part 142 and the folding part 143 respectively, the angle between the center line of the connecting part 144 and the center line of the rotating part 142 and the center line of the connecting part 144 and the center line of the folding part 143 The included angle is an obtuse angle, etc.
在本实施例中,连接部144的中心线与转动部142的中心线之间的夹角为钝角,并且连接部144的中心线与折叠部143的中心线之间的夹角为 钝角,钝角的角度范围可以控制在120°-150°之间,例如120°、135°、150°等。In this embodiment, the included angle between the center line of the connecting portion 144 and the center line of the rotating portion 142 is an obtuse angle, and the included angle between the center line of the connecting portion 144 and the center line of the folding portion 143 is an obtuse angle, and the obtuse angle is an obtuse angle. The angle range can be controlled between 120°-150°, such as 120°, 135°, 150°, etc.
这种角度范围,使得不同的电极141单独转动时不会相互干涉,从而使得电极141可以围绕转动部142的中心线实现360°旋转。Such an angle range prevents different electrodes 141 from interfering with each other when they are rotated individually, so that the electrodes 141 can rotate 360° around the center line of the rotating part 142 .
电极141在围绕转动部142的中心线转动时,能够实现电极141的独立展开或折叠,不同的电极141的转动互不干涉,即其中一个电极141转动时,其余的电极141是否转动、转动方向以及转动角度均不受影响。When the electrodes 141 rotate around the center line of the rotating part 142, the electrodes 141 can be independently unfolded or folded, and the rotations of different electrodes 141 do not interfere with each other. and the angle of rotation are not affected.
需要说明的一点是:电极141的展开或折叠是指折叠部143的中心线与固定件140的中心线之间的距离随着电极141的转动增大或减小。电极141展开的极限状态是折叠部143的中心线与固定块的中心线之间的距离最大,电极141折叠的极限状态是折叠部143的中心线与固定块的中心线之间的距离最小。It should be noted that the unfolding or folding of the electrode 141 means that the distance between the center line of the folded portion 143 and the center line of the fixing member 140 increases or decreases with the rotation of the electrode 141 . The limit state of electrode 141 unfolding is that the distance between the center line of the folded part 143 and the center line of the fixed block is the largest, and the limit state of electrode 141 folding is that the distance between the center line of the folded part 143 and the center line of the fixed block is the smallest.
连接部144与转动部142之间、连接部144与折叠部143之间平滑过渡。There is a smooth transition between the connecting portion 144 and the rotating portion 142 and between the connecting portion 144 and the folding portion 143 .
此外,为了尽可能的方便镜下手术操作,需要控制在折叠状态下,四根电极141不超出固定件140的直径范围。In addition, in order to facilitate the operation under the microscope as much as possible, it needs to be controlled that the four electrodes 141 do not exceed the diameter range of the fixing member 140 in the folded state.
电极141的整体弯曲,而内部中空,具体的,请参照图4所示,电极141包括内管145和外管146。The whole of the electrode 141 is curved, and the interior is hollow. Specifically, as shown in FIG. 4 , the electrode 141 includes an inner tube 145 and an outer tube 146 .
内管145和外管146均可以由金属材料制成,单根电极141先将内管145和外管146装配,然后焊接固定,最后再进行折弯。Both the inner tube 145 and the outer tube 146 may be made of metal materials, and the inner tube 145 and the outer tube 146 are assembled with a single electrode 141, then welded and fixed, and finally bent.
内管145位于外管146的内部,其中,内管145的头部与外管146的头部之间具有一定的距离,内管145的外表面于外管146的内表面之间具 有第二间隙。The inner tube 145 is located inside the outer tube 146 , wherein there is a certain distance between the head of the inner tube 145 and the head of the outer tube 146 , and the outer surface of the inner tube 145 has a second space between the inner surface of the outer tube 146 . gap.
内管145的尾部设置有进水口147且头部与外管146连通,外管146的头部封闭且尾部设置有出水口148,以使内管145和外管146构成冷却介质循环通道。The tail of the inner tube 145 is provided with a water inlet 147 and the head communicates with the outer tube 146 .
需要说明的是:外管146及内管145的头部及尾部是相对而言的,尾部是指电极141的靠近手柄11的一端,即工作时远离凝固区域的一端;头部是指电极141的远离手柄11的一端,即工作时插入凝固区域的一端。以附图图4中的方位来说,左侧为外管146及内管145的尾部,右侧为外管146及内管145的头部。It should be noted that: the head and tail of the outer tube 146 and the inner tube 145 are relative, and the tail refers to the end of the electrode 141 close to the handle 11, that is, the end away from the coagulation area during operation; the head refers to the electrode 141 The end away from the handle 11, that is, the end inserted into the coagulation area during operation. Referring to the orientation in FIG. 4 , the left side is the tail of the outer tube 146 and the inner tube 145 , and the right side is the head of the outer tube 146 and the inner tube 145 .
其中,外管146的尾部与内管145的外表面封闭,封闭方式不限,例如可以采用焊接工艺将外管146的尾部与内管145封闭等。The tail of the outer tube 146 and the outer surface of the inner tube 145 are closed, and the sealing method is not limited.
出水口148的数量为多个且沿外管146的周向均匀分布。The number of the water outlets 148 is multiple and uniformly distributed along the circumferential direction of the outer pipe 146 .
冷却液体在电极141内部的流动方式:冷却液体从内管145的尾部进入内管145,从内管145的头部流出并进入外管146的头部,然后进入到外管146的尾部,最后沿着内管145和外管146之间的第二间隙流动且从出水口148流出。The flow of the cooling liquid inside the electrode 141: the cooling liquid enters the inner tube 145 from the tail of the inner tube 145, flows out from the head of the inner tube 145 and enters the head of the outer tube 146, then enters the tail of the outer tube 146, and finally It flows along the second gap between the inner tube 145 and the outer tube 146 and flows out from the water outlet 148 .
电极141周边的电流密度远大于远处的密度,这就导致电极141周边的组织会更加容易脱水干结,如果电极141周边的组织过早脱水干结,则电流无法传输到更远的组织去,那么就无法对远处的组织止血,止血范围大大减小。The current density around the electrode 141 is much larger than that in the distance, which leads to the tissue around the electrode 141 being more prone to dehydration and drying. It is impossible to stop the bleeding of distant tissues, and the scope of hemostasis is greatly reduced.
而该止血装置的每根电极141具有内部液体循环功能;当进水管接入冷却液体(可以采用但不限于生理盐水),出水口148与吸引设备连通, 此时冷却液体可以流经整根电极141的内部,从而带走电极141的热量;电极141的温度则不会过高(保持在25℃左右),所以电极141周围的组织不会过早干结,不容易出现“粘刀现象”,此时电流可以传输出去,令远处的组织产热、脱水、止血。And each electrode 141 of the hemostatic device has an internal liquid circulation function; when the water inlet pipe is connected to a cooling liquid (but not limited to physiological saline), the water outlet 148 is communicated with the suction device, and the cooling liquid can flow through the entire electrode at this time. 141, so as to take away the heat of the electrode 141; the temperature of the electrode 141 will not be too high (keep at about 25 ℃), so the tissue around the electrode 141 will not dry out prematurely, and it is not easy to appear "sticking knife phenomenon", At this time, the current can be transmitted, causing the distant tissue to generate heat, dehydrate, and stop bleeding.
此外,在其他实施例中,还可以将出水口148设置在其他位置,例如将出水口148设置在转动部142中部或连接部144或折叠部143与连接部144相交处等。但此时,出水口148不便于连通吸引设备,冷却液体只能从出水口148流出,作用于待处理的部位,须单独采用吸引设备将废水抽吸出体外。In addition, in other embodiments, the water outlet 148 may also be arranged at other positions, for example, the water outlet 148 may be arranged in the middle of the rotating part 142 or the connecting part 144 or the intersection of the folding part 143 and the connecting part 144 . But at this time, it is not convenient for the water outlet 148 to communicate with the suction equipment, and the cooling liquid can only flow out from the water outlet 148 to act on the part to be treated, and a suction equipment must be used to suck the waste water out of the body.
为了便于将电极141插入组织内,外管146的头部直径逐渐减小形成针尖状。In order to facilitate the insertion of the electrode 141 into the tissue, the diameter of the head of the outer tube 146 is gradually reduced to form a needle tip.
此外,还可以在电极141的外表面设置刻度,刻度可以使工作人员得知电极141插入组织的深度。In addition, a scale can also be provided on the outer surface of the electrode 141, and the scale can enable the staff to know the depth of the electrode 141 inserted into the tissue.
请参照图5所示,本实施例采用四根电极141,电极141完全折叠后,四根电极141的折叠部143聚拢在一起,与固定件140的中心线距离较近,四根电极141不超出第一折臂的直径范围。Referring to FIG. 5 , this embodiment uses four electrodes 141 . After the electrodes 141 are completely folded, the folded portions 143 of the four electrodes 141 are gathered together, and the distance from the center line of the fixing member 140 is relatively close, and the four electrodes 141 are not beyond the diameter of the first folding arm.
请参照图6-图9所示,随着电极141的转动,四根电极141的折叠部143可以呈现出多种排列方式,例如一字形、圆弧形、矩形等。Referring to FIGS. 6-9 , with the rotation of the electrodes 141 , the folded portions 143 of the four electrodes 141 can be arranged in various ways, such as a straight line, a circular arc, a rectangle, and the like.
第二实施例Second Embodiment
请参照图10所示,本发明第二实施例还提供了一种折叠式止血器械10,折叠式止血器械10包括手柄11、支撑杆12、折叠组件13和第一实施例中的折叠式电极组件14。Referring to FIG. 10 , the second embodiment of the present invention further provides a foldable hemostatic device 10 . The foldable hemostatic device 10 includes a handle 11 , a support rod 12 , a foldable assembly 13 and the foldable electrode in the first embodiment. Component 14.
首先,作为整个结构的基础,手柄11主要起到支撑支撑杆12、折叠组件13等的作用,并且便于工作人员手持操作等。First of all, as the basis of the whole structure, the handle 11 mainly plays the role of supporting the support rod 12, the folding assembly 13, etc., and is convenient for the staff to operate by hand.
手柄11的样式不限,在本实施例中,手柄11可以采用但不限于下列结构:The style of the handle 11 is not limited. In this embodiment, the handle 11 can adopt but is not limited to the following structures:
手柄11具有安装部和手持部,安装部的内部中空,用于容纳部分部件结构,手持部用于供工作人员手持。The handle 11 has a mounting portion and a hand-holding portion, the interior of the mounting portion is hollow for accommodating part of the component structure, and the hand-holding portion is used for the staff to hold.
其次,作为折叠式止血器械10的主体,支撑杆12主要起到连接手柄11和折叠式电极组件14的作用,并且可以带动电极141到达指定的凝固区域。Secondly, as the main body of the foldable hemostatic device 10 , the support rod 12 mainly serves to connect the handle 11 and the foldable electrode assembly 14 , and can drive the electrode 141 to reach the designated coagulation area.
支撑杆12的材料及类型不限,在本实施例中,支撑杆12采用圆管状结构,支撑杆12内部中空,以使其内部可以安设其他零部件。The material and type of the support rod 12 are not limited. In this embodiment, the support rod 12 adopts a circular tubular structure, and the interior of the support rod 12 is hollow so that other components can be installed therein.
当然,在其他实施例中,支撑杆12也可以采用实心结构,形状也不限于圆柱形。Of course, in other embodiments, the support rod 12 may also adopt a solid structure, and the shape is not limited to a cylindrical shape.
支撑杆12连接于手柄11,支撑杆12的端部可以插入手柄11内。The support rod 12 is connected to the handle 11 , and the end of the support rod 12 can be inserted into the handle 11 .
其中,固定件140可以将支撑杆12的端部封闭,安装通孔与支撑杆12的内部连通。The fixing member 140 can close the end of the support rod 12 , and the installation through hole communicates with the inside of the support rod 12 .
在本实施例中,安装通孔的中心线可以与支撑杆12的中心线平行。In this embodiment, the center line of the mounting through hole may be parallel to the center line of the support rod 12 .
然后,电极141的转动是通过折叠组件13实现的,折叠组件13用于驱动电极141组件的电极141转动,从而使电极141组件折叠或展开。Then, the rotation of the electrode 141 is realized by the folding assembly 13, and the folding assembly 13 is used to drive the electrode 141 of the electrode 141 assembly to rotate, so as to fold or unfold the electrode 141 assembly.
折叠组件13可以采用但不限于下列结构:The folding assembly 13 can adopt but is not limited to the following structures:
请参照图11所示,折叠组件13包括折叠旋钮130和传动件134,其中, 传动件134包括钢管131。Referring to FIG. 11 , the folding assembly 13 includes a folding knob 130 and a transmission member 134 , wherein the transmission member 134 includes a steel pipe 131 .
折叠旋钮130可转动的连接于手柄11,钢管131的一端连接于转动部142且另一端连接于折叠旋钮130。折叠旋钮130转动时,能够通过钢管131带动电极141转动。The folding knob 130 is rotatably connected to the handle 11 , one end of the steel pipe 131 is connected to the rotating part 142 and the other end is connected to the folding knob 130 . When the folding knob 130 is rotated, the electrode 141 can be driven to rotate through the steel pipe 131 .
由于支撑杆12的直径较小,而钢管131位于支撑杆12内部,钢管131的数量较多,导致钢管131之间的间距较小,不容易控制,为了改善这一问题,在本实施例中,请参照图12所示,钢管131包括刚性部132和挠性部133。Because the diameter of the support rod 12 is small, and the steel pipes 131 are located inside the support rod 12, the number of steel pipes 131 is large, resulting in a small distance between the steel pipes 131, which is not easy to control. In order to improve this problem, in this embodiment 12 , the steel pipe 131 includes a rigid portion 132 and a flexible portion 133 .
刚性部132不可变形,挠性部133与折叠旋钮130相邻,挠性部133能够弯曲且传递扭矩。挠性部133位于支撑杆12的外部,性部使得传动件134之间的距离可以根据需要增大,防止相互干扰。The rigid portion 132 cannot be deformed, the flexible portion 133 is adjacent to the folding knob 130 , and the flexible portion 133 can bend and transmit torque. The flexible portion 133 is located outside the support rod 12 , and the flexible portion enables the distance between the transmission members 134 to be increased as required to prevent mutual interference.
钢管131采用圆形金属管,挠性部133采用螺旋切削加工的方式制成螺旋形。The steel pipe 131 is a circular metal pipe, and the flexible portion 133 is made into a spiral shape by means of helical cutting.
当然,在其他实施例中,挠性部133还可以采用其他结构。Of course, in other embodiments, the flexible portion 133 may also adopt other structures.
此外,请参照图13所示,传动件134还包括挠性绝缘层135和绝缘软管136。In addition, as shown in FIG. 13 , the transmission member 134 further includes a flexible insulating layer 135 and an insulating hose 136 .
挠性绝缘层135包覆于钢管131的外表面,绝缘软管136位于钢管131的内部,绝缘软管136的外表面与钢管131的内表面存在第一间隙,当出水口148设置于外管146的尾部时,挠性绝缘层135和绝缘软管136围成辅助冷却介质循环通道。The flexible insulating layer 135 covers the outer surface of the steel pipe 131, the insulating hose 136 is located inside the steel pipe 131, and there is a first gap between the outer surface of the insulating hose 136 and the inner surface of the steel pipe 131, when the water outlet 148 is arranged on the outer pipe At the end of 146, the flexible insulating layer 135 and the insulating hose 136 enclose an auxiliary cooling medium circulation channel.
内管145的尾部与绝缘软管136连通,第一间隙和第二间隙通过出水口148连通,即冷却介质循环通道和辅助冷却介质循环通道连通,构成完 整的冷却介质循环通道。The tail of the inner tube 145 is communicated with the insulating hose 136, and the first gap and the second gap are communicated through the water outlet 148, that is, the cooling medium circulation channel and the auxiliary cooling medium circulation channel are communicated to form a complete cooling medium circulation channel.
钢管131与折叠式电极组件14的配合关系请参照图14所示(图14中的挠性部133可有可无),传动件134与折叠式电极组件14的配合关系请参照图15所示。钢管131的尾部通过焊接密封的线缆与主机的电气连接。Please refer to FIG. 14 for the matching relationship between the steel pipe 131 and the foldable electrode assembly 14 (the flexible portion 133 in FIG. 14 may be present or not), and the matching relationship between the transmission member 134 and the foldable electrode assembly 14 is shown in FIG. 15 . . The tail of the steel pipe 131 is electrically connected to the host through a welded and sealed cable.
折叠式止血器械10的工作状态请参照图16-图20所示。Please refer to FIGS. 16-20 for the working state of the foldable hemostatic device 10 .
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims (10)

  1. 一种折叠式电极组件,其特征在于,所述折叠式电极组件(14)包括固定件(140)和至少两根电极(141),所述电极(141)包括依次连接的转动部(142)、连接部(144)和折叠部(143),所述折叠部(143)的中心线与所述转动部(142)的中心线不重合,所述转动部(142)穿设于所述固定件(140),使所述折叠部(143)围绕所述转动部(142)的中心线旋转,以实现所述电极(141)的独立展开或折叠。A foldable electrode assembly, characterized in that the foldable electrode assembly (14) comprises a fixing member (140) and at least two electrodes (141), the electrodes (141) comprising rotating parts (142) connected in sequence , a connecting part (144) and a folding part (143), the center line of the folding part (143) does not coincide with the center line of the rotating part (142), and the rotating part (142) passes through the fixed part The component (140) is used to rotate the folding part (143) around the center line of the rotating part (142), so as to realize the independent unfolding or folding of the electrode (141).
  2. 根据权利要求1所述的折叠式电极组件,其特征在于,所述转动部(142)的中心线和所述折叠部(143)的中心线平行。The foldable electrode assembly according to claim 1, wherein the center line of the rotating part (142) and the center line of the folding part (143) are parallel.
  3. 根据权利要求1所述的折叠式电极组件,其特征在于,所述转动部(142)的中心线与所述固定件(140)的中心线平行,所述至少两根电极(141)的转动部(142)围绕所述固定件(140)的中心线分布。The foldable electrode assembly according to claim 1, wherein the center line of the rotating part (142) is parallel to the center line of the fixing member (140), and the rotation of the at least two electrodes (141) The portions (142) are distributed around the centerline of the fixing member (140).
  4. 根据权利要求3所述的折叠式电极组件,其特征在于,所述电极(141)的数量为四根,四根所述电极(141)的转动部(142)呈矩形分布。The foldable electrode assembly according to claim 3, wherein the number of the electrodes (141) is four, and the rotating parts (142) of the four electrodes (141) are distributed in a rectangular shape.
  5. 根据权利要求1所述的折叠式电极组件,其特征在于,所述电极(141)包括内管(145)和外管(146),所述内管(145)位于所述外管(146)的内部,所述内管(145)的尾部设置有进水口(147)且头部与所述外管(146)连通,所述外管(146)的头部封闭且尾部设置有出水口(148),以使所述内管(145)和所述外管(146)构成冷却介质循环通道。The foldable electrode assembly according to claim 1, wherein the electrode (141) comprises an inner tube (145) and an outer tube (146), and the inner tube (145) is located in the outer tube (146) Inside, the tail of the inner pipe (145) is provided with a water inlet (147) and the head is communicated with the outer pipe (146), the head of the outer pipe (146) is closed and the tail is provided with a water outlet ( 148), so that the inner tube (145) and the outer tube (146) constitute a cooling medium circulation channel.
  6. 根据权利要求5所述的折叠式电极组件,其特征在于,所述外管(146)的尾部与所述内管(145)的外表面封闭,所述出水口(148)的数量为多个且沿所述外管(146)的周向均匀分布。The foldable electrode assembly according to claim 5, wherein the tail of the outer tube (146) is closed with the outer surface of the inner tube (145), and the number of the water outlets (148) is multiple and evenly distributed along the circumferential direction of the outer tube (146).
  7. 根据权利要求5所述的折叠式电极组件,其特征在于,所述外管(146)的头部直径逐渐减小形成针尖状。The foldable electrode assembly according to claim 5, wherein the diameter of the head of the outer tube (146) is gradually reduced to form a needle tip.
  8. 根据权利要求1所述的折叠式电极组件,其特征在于,所述电极(141)的外表面设置有刻度。The foldable electrode assembly according to claim 1, wherein a scale is provided on the outer surface of the electrode (141).
  9. 一种折叠式止血器械,其特征在于,所述折叠式止血器械(10)包括手柄(11)、支撑杆(12)、折叠组件(13)和权利要求1-8任意一项所述的折叠式电极组件(14),所述支撑杆(12)连接于所述手柄(11),所述电极(141)固定于所述支撑杆(12)的一端,所述折叠组件(13)连接于所述手柄(11)且被构造成驱动所述折叠式电极组件(14)折叠或展开。A foldable hemostatic device, characterized in that the foldable hemostatic device (10) comprises a handle (11), a support rod (12), a folding assembly (13) and the folding device according to any one of claims 1-8 type electrode assembly (14), the support rod (12) is connected to the handle (11), the electrode (141) is fixed to one end of the support rod (12), and the folding assembly (13) is connected to The handle (11) is configured to drive the foldable electrode assembly (14) to fold or unfold.
  10. 根据权利要求9所述的折叠式止血器械,其特征在于,所述折叠组件(13)包括折叠旋钮(130)和钢管(131),所述折叠旋钮(130)可转动的连接于所述手柄(11),所述钢管(131)的两端分别连接于所述转动部(142)和所述折叠旋钮(130)。The folding hemostatic device according to claim 9, wherein the folding assembly (13) comprises a folding knob (130) and a steel pipe (131), and the folding knob (130) is rotatably connected to the handle (11), both ends of the steel pipe (131) are respectively connected to the rotating part (142) and the folding knob (130).
PCT/CN2021/100931 2020-08-14 2021-06-18 Folding-type electrode assembly and folding-type hemostatis instrument WO2022033172A1 (en)

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CN111839720A (en) * 2020-08-14 2020-10-30 四川大学华西医院 Foldable electrode subassembly and foldable hemostasis apparatus
CN113616327B (en) * 2021-09-13 2022-05-03 上海睿刀医疗科技有限公司 Intracavity electrode needle set and operation method thereof

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