WO2018006455A1 - 一种双极高频电刀 - Google Patents

一种双极高频电刀 Download PDF

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Publication number
WO2018006455A1
WO2018006455A1 PCT/CN2016/092846 CN2016092846W WO2018006455A1 WO 2018006455 A1 WO2018006455 A1 WO 2018006455A1 CN 2016092846 W CN2016092846 W CN 2016092846W WO 2018006455 A1 WO2018006455 A1 WO 2018006455A1
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WIPO (PCT)
Prior art keywords
electrode portion
electrode
insulating
distal end
bipolar
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PCT/CN2016/092846
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English (en)
French (fr)
Inventor
唐志
范茗侨
徐慧文
沙德青
Original Assignee
南京微创医学科技股份有限公司
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Application filed by 南京微创医学科技股份有限公司 filed Critical 南京微创医学科技股份有限公司
Priority to JP2018569140A priority Critical patent/JP2019521775A/ja
Priority to EP16907959.7A priority patent/EP3479786A4/en
Priority to US16/314,453 priority patent/US20190262068A1/en
Publication of WO2018006455A1 publication Critical patent/WO2018006455A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • the invention relates to a medical bipolar high-frequency electric knife, in particular to a bipolar high-frequency electric knife with minimum loop and insulation protection function.
  • Endoscopic submucosal dissection refers to endoscopic minimally invasive techniques for submucosal dissection of lesions larger than 2 cm using high frequency instruments. 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. Preferred treatment (Gotoda T, Kondo H, Ono H, et al. A new endoscopic mucosal resection procedure using an Insulation–tipped electrosurgical knife for rectal flat lesions:report of two cases [J]. Gastrointest Endosco, 1999, 50: 560-563).
  • ESD is to output high-frequency current through an external device, form a loop through the human body, and form a high-density current in a portion of the wire having a small cross-sectional area to achieve cutting.
  • the high-frequency knives used for endoscopic submucosal dissection can be divided into two types according to their current forming loops, one is a single-pole high-frequency electric knife, and the other is a bipolar high-frequency electric knife.
  • the disadvantage of the monopolar high-frequency electrosurgical knife is that the high-frequency current will pass through most of the human body.
  • the bipolar high-frequency electrosurgical high-frequency current only flows through the smallest human tissue area, that is, only flows around the diseased tissue, and is considered to be the safest because the high-frequency current passes through the small area of the human body and does not damage the mucosal muscle layer. a.
  • the active electrode and the inert electrode must ensure sufficient contact with the tissue part, but the current bipolar high-frequency electrosurgical product design is difficult to ensure the active electrode during the operation.
  • the object of the present invention is to provide a bipolar high-frequency scalpel with a stable minimum circuit for cutting and peeling early stage cancer and precancerous lesions and having an insulating protection head to ensure the reliability and safety of surgical cutting. .
  • the invention provides a bipolar high frequency electric knife, comprising: a cutter part, a main body part and an operation part;
  • the cutter portion is disposed at a distal end of the bipolar high-frequency electrosurgical knife, and includes a first electrode portion, a second electrode portion and an insulating member; the first electrode portion is an active electrode for tissue cutting, relative to the main body member The front end may be pushed out or retracted, including a tubular portion and a protrusion; the second electrode portion is an inert electrode including a rod portion and a convex portion at a distal end of the rod portion; and the convex portion of the second electrode portion is located at the a distal end of the electrode portion; the rod portion of the second electrode portion is inserted into the first electrode portion; the insulating member is for isolating the first electrode portion and the second electrode portion;
  • the main body member includes an insulating sheath and a limiting member, and the insulating sheath has at least an outer peripheral surface that is insulating and penetrates Between the cutter portion and the operating portion; the limiting member is located inside the insulating sheath, and includes a fixed insulating limit member and an active limiting member;
  • the operation portion is provided in a proximal direction of the body member, and has a first wire connecting the first electrode portion and a second wire connecting the second electrode portion, so that the cutter portion can be pushed out with respect to the front end of the body member Or withdraw;
  • a distal end of the first electrode portion extends outward from a direction perpendicular to an axis of the body member greater than a radius of a cross section of the tubular portion of the first electrode portion, and a protrusion is formed at a distal end of the first electrode portion;
  • the cross section of the protrusion is a circumferential distribution or a divergent distribution
  • a length of the protruding portion of the second electrode portion extending outward in a direction perpendicular to a longitudinal axis of the rod portion of the second electrode portion is larger than a radius of a rod portion of the second electrode portion, and a protrusion of the second electrode portion a portion of the surface is a smooth surface having no sharp edges, and a convex portion of the second electrode portion is located at a distal end of the first electrode portion;
  • the insulating member includes an insulating member and an insulating sleeve, the insulating member being located between the first electrode portion and the protruding portion of the second electrode portion for isolating the first electrode portion and the second electrode portion a protruding portion; the insulating sleeve is disposed on an outer surface of the rod portion of the second electrode portion, and the first electrode portion is overlaid on an outer surface of the insulating sleeve, and the three form a concentric structure;
  • the insulating member is embedded in the protruding portion of the second electrode portion or is aligned with the end surface of the protruding portion of the second electrode portion, and the first electrode portion is embedded in the insulating member.
  • the limiting component comprises a fixed insulation limiting member fixed at a distal end of the insulating sheath, and an active limiting member disposed at a proximal end of the first electrode portion, the movable limiting member along The length of the main component extending outward in the vertical direction is smaller than the length of the fixed insulation limiting member extending outward in the vertical direction of the main body member, and the distal end surface of the fixed insulating limiting member extends beyond the distal end of the insulating sheath The end face is at least flush, and the proximal end face is inserted into the insulating tube sheath.
  • the outer surface of the fixed insulation stop is rough or barbed.
  • the operating portion further includes a handle having a button thereon, the button on the handle being linearly slidable along the axis of the handle, and the action of pushing out and retracting the tool portion by pushing or retracting the button.
  • the invention also provides a bipolar cutter head for a high frequency electric knife, comprising:
  • first electrode portion a first electrode portion, a second electrode portion and an insulating member
  • the first electrode portion being an active electrode for tissue cutting, which may be pushed out or withdrawn with respect to a front end of the body member, including a tubular portion and a protrusion
  • the electrode portion is an inert electrode including a rod portion and a convex portion located at a distal end of the rod portion; a convex portion of the second electrode portion is located at a distal end of the first electrode portion; and a rod portion of the second electrode portion is interposed
  • a length of the protruding portion of the second electrode portion extending outward in a direction perpendicular to a longitudinal axis of the rod portion of the second electrode portion is greater than a radius of a rod portion of the second electrode portion
  • the convex portion surface of the portion is a smooth surface having no sharp edges; the insulating member is for isolating the first electrode portion and the second electrode portion;
  • the distal end of the first electrode portion extends outward from the axial direction of the body member in a direction larger than the radius of the cross section of the tubular portion of the first electrode portion, and a protrusion is formed at the distal end of the first electrode portion.
  • the cross section of the protrusion is a circumferential distribution or a divergent distribution.
  • the insulating member includes an insulating member and an insulating sleeve, the insulating member being located between the first electrode portion and the protruding portion of the second electrode portion for isolating the first electrode portion and the second electrode portion a protruding portion; the insulating sleeve is disposed on an outer surface of the rod portion of the second electrode portion, and the first electrode portion is overlaid on an outer surface of the insulating sleeve, and the three form a concentric structure;
  • the protruding portion of the second electrode portion is located at a distal end of the first electrode portion
  • the insulating member is embedded in the protruding portion of the second electrode portion or is aligned with the end surface of the protruding portion of the second electrode portion, and the first electrode portion is embedded in the insulating member.
  • the bipolar high-frequency electric knife provided by the invention has a smaller current circuit of the two electrodes and is insulated by the head end, so that the operation is safer.
  • the bipolar high-frequency electric knife provided by the invention is opposite to the existing bipolar electric knife, the inert electrode is in front, the active electrode is behind, and the electrosurgical knife enters the digestive environment through the endoscope guided by the natural cavity (oral, anal cavity) of the human body.
  • the two electrodes can ensure contact with the tissue at any angle or direction, thereby forming a current loop for tissue cutting, ensuring the reliability of the surgical cutting and making the operation safer.
  • the bipolar high-frequency electrosurgical active electrode provided by the invention has an insulating protective layer between the active electrode and the inert electrode, which can prevent the perforation of the tissue base layer caused by high-frequency electric shock during cutting.
  • the cross-sectional area of the inert electrode of the bipolar high-frequency electrosurgical tool provided by the invention is larger than the cross-sectional area of the active electrode, and the inert electrode is at the distal end, which can protect the perforation and the hemorrhage during cutting.
  • the bipolar high-frequency electrosurgical tool provided by the invention has a protrusion formed by a contact portion between the distal end of the active electrode and the insulating member, and can lift the tissue raised after the liquid injection during cutting to prevent the perforation from being away from the mucosal muscle layer, and at the same time, The projections cut the tissue as it moves longitudinally.
  • Figure 1 is the overall structure of the bipolar high frequency electric knife
  • Figure 2 is a partial enlarged view of the bipolar high frequency electric knife head
  • 3A-3B are cross-sectional views showing an electrode and an insulating member of a bipolar high-frequency electric knife.
  • 4A-4D are different cutting angle diagrams of the electric knife
  • Figure 5A-5D is a process description of the use of an electric knife
  • 6A-6B are the cutting process of the electric knife
  • 7A-7B are cross-sectional views of a protrusion of a first electrode portion
  • the bipolar high-frequency electric knife of the present embodiment includes a cutter portion 21, a body member 22, and an operation portion 23.
  • one end of the cutter portion 21 is referred to as a distal end
  • one end of the operation portion 23 is referred to as a proximal end.
  • the cutter portion 21 is disposed at a distal end of the bipolar high-frequency electric knife, and includes a first electrode portion 3, a second electrode portion 1, and an insulating member 11, and the cutter portion 21 can be along the The axial movement of the body member 22 and the front end of the body member 22 can protrude and enter;
  • the first electrode portion 3 is an active electrode for tissue cutting, and can be pushed out or retracted with respect to the front end of the body member 22, including the tubular portion 18 and the protrusion 19;
  • the second electrode portion 1 is an inert electrode, including a rod shape a portion 1a and a convex portion 1b at a distal end of the rod portion 1a; a convex portion 1b of the second electrode is located at a distal end of the first electrode portion 3, and a convex portion 1b of the second electrode portion 1 is from the second electrode portion 1
  • the length of the rod portion 1a extending outward in the vertical direction is larger than the radius of the rod portion 1a of the second electrode portion 1.
  • the surface of the convex portion 1b of the second electrode portion 1 is a smooth surface having no sharp edges.
  • the cross-sectional diameter is larger than the cross-sectional diameter of the first electrode portion 3; the rod-shaped portion 1a of the second electrode portion is inserted into the first electrode portion 3 and communicates with the operation portion 23; the insulating member 11 is used to isolate
  • the first electrode portion 3 and the second electrode portion 1 ensure that the active electrode and the inert electrode are in contact with the tissue at the same time during the operation, including the insulating member 2 and the insulating sleeve 4;
  • the insulating member 2 is located at the first electrode portion 3 and a protruding portion 1b for isolating the first electrode portion 3 and the second electrode portion 1 between the protruding portions 1b of the second electrode portion 1; the insulating sleeve 4 is overlaid on the outer surface of the rod portion of the second electrode portion
  • the first electrode portion is outsourced to the outer surface of the insulating slee
  • the insulating member 11 is made of an insulating material, and is preferably made of a material having heat resistance such as a ceramic material;
  • the first electrode portion and the second electrode portion are insulated by an insulating material to prevent the first electrode and the second electrode from being directly turned on and then electrically
  • the knife fails, the inactive second electrode portion is in front, the active first electrode portion is behind, and when the electrosurgical knife enters the digestive tract lesion through the endoscope guided by the natural cavity (oral, anal cavity) of the human body, any angle Or the two electrode parts can ensure contact with the tissue, thereby forming a current loop for tissue cutting, ensuring the reliability of the surgical cutting and making the operation safer.
  • the main body member 22 includes an insulating sheath 6 and a limiting member 5;
  • the insulating sheath has an outer diameter and a flexibility that can be inserted through the channel of the endoscope, and at least the outer peripheral surface is insulating and can withstand high temperatures, and penetrates through the cutter portion and Between the operating portions;
  • the limiting member 5 is located inside the insulating sheath 6 for defining the pushing amount of the first electrode portion to push out the distal end of the insulating sheath; and to limit the position when the cutter portion 21 is retracted into the insulating sheath And protection.
  • the limiting component 5 includes a fixed insulation limiting member 12 fixed at a distal end of the insulating sheath, and an active limiting member 13 disposed at a proximal end of the first electrode portion 3, the movable limit The member 13 and the fixed insulation limiting member 12 are limited by steps formed by different sizes, thereby controlling the amount of protrusion of the first electrode portion.
  • the limiting component 5 includes a fixed insulation limiting member 12 fixed at a distal end of the insulating sheath, and an active limiting member 13 disposed at a proximal end of the first electrode portion, the movable limiting member 13 A length extending outward in a direction perpendicular to an axis of the main body member is smaller than a length of the fixed insulation limiting member 12 extending outward in a direction perpendicular to an axis of the main body member, and a distal end surface of the fixed insulation limiting member 12 extends beyond the insulating sheath The distal end face is at least flush, and the proximal end face is inserted into the insulating tube sheath.
  • the movable limiting member 13 is a metal member fixed to a fixed point of the first electrode portion 3; the fixed insulating limiting member 12 is fixed at a distal end of the insulating sheath, and the fixed insulating limiting member 12 is resistant to high temperature.
  • the insulating material is preferably made of a heat-resistant material such as a ceramic material. The friction with the insulating sheath 6 is increased by making the surface of the fixed insulating stopper 12 rough or barbed.
  • the button 8 on the operating portion 23 When the button 8 on the operating portion 23 is pushed, the first electrode portion 3 and the movable limiting member 13 are extended to the distal end together, when the distal end surface of the movable limiting member 13 hits the proximal end of the fixed insulating limiting member 12. When the end face is different, it cannot continue to extend to the distal end due to the difference in size, thereby functioning as a limit.
  • the button 8 on the operating portion 23 is pulled back, the cutter portion 21 is caused to be recovered into the insulating sheath 6.
  • the insulating member 2 in the cutter portion 21 hits the side surface of the fixed insulating stopper 12, the step formed by the difference in size is formed.
  • the limited tool portion 21 cannot continue to be retracted, and functions as a limit.
  • the fixed insulation limiting member 12 is an insulating material, which well protects the insulation of the entire electric knife except for the active electrode.
  • the operation portion 23 is provided in the proximal direction of the main body member 22, so that the cutter portion 21 can be pushed out or retracted with respect to the front end of the main body member 22; the operation portion includes the handle 7, the button 8, the socket 9, and the connection The first wire 10a of the first electrode portion 3 and the second wire 10b connected to the second electrode portion 1.
  • the first electrode portion 3 and the second electrode portion 1 are connected to the tail of the handle by wires, and are respectively led out to the socket 9 by the first wire 10a and the second wire 10b, and connected to the high frequency generator through the socket 9 to input the electric knife high. Frequency current.
  • the button 8 on the handle 7 can slide linearly along the axis of the handle 7, and the action of pushing out and retracting the tool portion is achieved by pushing or pushing the button 8.
  • the insulating member 11 is shown to include an insulating member 2 and an insulating sleeve 4, the insulating member 2 being located at the Between the electrode portion 3 and the protruding portion 1b of the second electrode portion 1, the convex portion 1b for isolating the first electrode portion 3 and the second electrode portion 1 can effectively isolate the active electrode from the inert electrode.
  • the insulating sleeve 4 is overwrapped on the outer surface of the rod portion of the second electrode portion, and the first electrode portion is overlaid on the outer surface of the insulating sleeve 4, the three forming a concentric structure; the insulating member 2
  • the convex portion 1b embedded in the second electrode portion is aligned with the end surface of the convex portion 1b of the second electrode portion, and the first electrode portion 3 is embedded in the insulating member 2.
  • the parallel portion of the first electrode portion 3 and the insulating sleeve 4 is the tubular portion 18 of the first electrode portion, and the distal end of the first electrode portion 3 extends outward from the axial direction of the body member by a length greater than the tubular portion 18 of the first electrode portion 3.
  • the radius of the cross section forms a projection 19 at the distal end of the first electrode portion 3, and the cross section of the projection 19 may be a circumferential distribution, a divergent distribution or the like, as shown in Figs. 7A and 7B.
  • the projection 19 can lift the tissue raised after the injection to prevent the perforation from being separated from the mucosal muscle layer during cutting, and the projection 19 can cut the tissue when the cutter portion 21 moves longitudinally.
  • FIGS. 4A-4D are different cutting angle views of the electric knife
  • FIGS. 4A and 4B are diagrams showing different cutting angles of the prior art common bipolar electric knife
  • FIGS. 4C and 4D show the bipolar height provided by the present invention.
  • the first electrode 31 of the bipolar electric knife is located at the distal end of the second electrode 32, and the insulating portion 33 is disposed between the first electrode 31 and the second electrode 32. Only at certain angles (as shown in Figure 4A) can the two electrodes be in contact with the tissue at the same time, thereby completing the purpose of tissue cutting. When the angle is cut as shown in FIGS.
  • the first electrode and the second electrode simultaneously contact the diseased mucosa layer 16 on the basis of not contacting the mucosal muscle layer 17, when the angle is cut as shown in FIGS. 4B and 4D,
  • the bipolar electrocautery ensures that the first electrode does not contact the mucosal muscle layer 17, the second electrode is detached from the diseased mucosa 16, causing the circuit to be broken and the cutting cannot be continued.
  • the first electrode is inserted into the deep part.
  • the mucosal muscle layer 17 increases the likelihood of bleeding and perforation.
  • the high-frequency bipolar electric knife provided by the present invention can ensure the first electrode portion 3 at the same cutting angle (as shown in FIG.
  • the convex portion 1b of the second electrode portion 1 is located at the distal end of the first electrode portion 3. Simultaneous contact with the diseased tissue 16 simultaneously with the second electrode portion 1 allows both electrodes at any angle or direction to ensure contact with the tissue. Further, the convex portion 1b of the second electrode portion 1 is an inert electrode, and even if it is inserted deep into the mucosa muscle layer 17 during operation, no cutting occurs, and bleeding and perforation are prevented, and a better technical effect is achieved.
  • the surgeon first marks the diseased tissue with a needle knife for 16 weeks (as shown in Fig. 5A), and then uses the injection needle to inject the physiological saline into the diseased tissue 16 to make it bulge, and then the high-frequency electrosurgical body
  • the member 22 is inserted into the vicinity of the diseased tissue 16 through the endoscope channel, in order to keep the cutter portion 21 received inside the sheath 7 (as shown in Fig. 5B), the protective cutter portion 21 and the endoscope are not in the process.
  • the cutter portion 21 is pushed out by the button 8 of the operation portion 23 (as shown in Fig.
  • the cutter is cut in the direction of Fig. 5D (as shown in Fig. 5D).
  • vertical cutting can be used, as shown in Figures 6A-6B, after the tissue is pulled up, the lesion The tissue 16 is deposited on the projection 19 of the first electrode portion 3, at which time the projection 19 serves as a cutting action.

Abstract

一种双极高频电刀，包括刀具部（21）、主体部件（22）和操作部（23），刀具部（21）包括第一电极部（3），第二电极部（1）和绝缘构件（11）；主体部件（22）包括限位部件（5）和绝缘管鞘（6）；操作部（23）包括手柄（7），按钮（8），插座（9），第一导线（10a）和第二导线（10b）。可以防止切割时高频电击引起的组织基层穿孔，又可以确保任何方向或角度两个电极同时与组织充分接触，保证手术切割的可靠性。

Description

一种双极高频电刀 技术领域
本发明涉及一种医用双极高频电刀，特别是一种最小回路并带绝缘保护功能的双极高频电刀。
技术背景
内镜黏膜下剥离术(Endoscopic submucosal dissection,ESD)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。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(Gotoda T，Kondo H，Ono H，et al.A new endoscopic mucosal resection procedure using an Insulation–tipped electrosurgical knife for rectal flat lesions:report of two cases[J].Gastrointest Endosco，1999，50：560-563)。
ESD是通过外部设备输出高频电流，通过人体形成回路，并在截面积较小的刀丝部分形成高密度电流实现切割。目前用于内镜粘膜下剥离术的高频刀按其电流形成回路方式可分为两类，一种是单极高频电刀，一种是双极高频电刀。单极高频电刀的缺点是高频电流会通过人体大部份面积。而双极高频电刀高频电流仅流经最小的人体组织区域，即仅流经病变组织周围，由于高频电流通过人体面积小，且不会伤害粘膜肌层而被认为是最安全的高频电刀。而为了确保高频电流能通过导线顺利到达待治疗病变组织，活性电极与惰性电极必须保证与组织部分充分接触，但目前的双极高频电刀的产品设计很难保证在手术过程中活性电极与惰性电极同时与组织接触，尤其是在人体自然腔道一些难于操作的部位，很难保证电流回路的形成，从而导致切割不可靠且不稳定，直接影响手术的效率及病人的安全性。因此有必要开发一种切割更可靠而稳定且刀头带绝缘保护，安全性能更高的双极高频电刀。
发明内容
本发明的目的是：提供一种治疗消化道早期癌及癌前病变切割、剥离用的稳定的最小回路并带有绝缘保护头的双极高频手术刀，确保手术切割的可靠性和安全性。
本发明提供一种双极高频电刀，包括：刀具部、主体部件和操作部；
所述刀具部，设在双极高频电刀的远端，包括第一电极部，第二电极部和绝缘构件；所述第一电极部为活性电极，用于组织切割，相对于主体部件的前端可以推出或收回，包括管状部分和凸起；所述第二电极部为惰性电极，包括棒状部分和位于棒状部分远端的凸出部分；所述第二电极部的凸出部分位于第一电极部远端；所述第二电极部的棒状部分内插于第一电极部中；所述绝缘构件用来隔绝第一电极部和第二电极部；
所述主体部件包括绝缘管鞘和限位部件，所述绝缘管鞘，至少外周面具有绝缘性，贯穿 于刀具部和操作部之间；所述限位部件位于绝缘管鞘内部，包括固定绝缘限位件和活动限位件；
操作部，设在所述主体部件的近端方向，具有连接所述第一电极部的第一导线和连接所述第二电极部的第二导线，可以使刀具部相对于主体部件的前端推出或收回；
优选地，第一电极部远端从主体部件的轴线垂直方向向外延伸的长度大于第一电极部的管状部分横截面的半径，在第一电极部的远端形成凸起；
优选地，所述凸起的横截剖面为圆周分布或发散分布；
优选地，所述第二电极部的凸出部分沿第二电极部的棒状部分轴线垂直方向向外延伸的长度大于所述第二电极部的棒状部分半径，所述第二电极部的凸出部分表面为没有锐利棱边的光滑表面，所述第二电极部的凸出部分位于第一电极部远端；
优选地，所述绝缘构件包括绝缘件和绝缘套，所述绝缘件位于第一电极部与所述第二电极部的凸出部分之间，用于隔绝第一电极部和第二电极部的凸出部分；所述绝缘套外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套外表面，三者形成同心结构；
优选地，所述绝缘件内嵌于第二电极部的凸出部分或与第二电极部的凸出部分端面贴齐，所述第一电极部内嵌于绝缘件内。
优选地，所述限位部件，包括固定在所述绝缘管鞘远端的固定绝缘限位件，以及设在所述第一电极部近端的活动限位件，所述活动限位件沿主体部件的轴线垂直方向向外延伸的长度小于所述固定绝缘限位件沿主体部件的轴线垂直方向向外延伸的长度，所述固定绝缘限位件的远端端面超出绝缘管鞘的远端端面或至少平齐，近端端面内插于绝缘管鞘内。
优选地，固定绝缘限位件的外表面是粗糙或带有倒刺的。
优选地，所述操作部还包括手柄，手柄上有按钮，所述手柄上的按钮可以沿着手柄的轴线直线滑动，通过推出或收回按钮实现推出和收回刀具部的动作。
本发明还提供一种高频电刀的双极刀头，包括：
第一电极部，第二电极部和绝缘构件；所述第一电极部为活性电极，用于组织切割，相对于主体部件的前端可以推出或收回，包括管状部分和凸起；所述第二电极部为惰性电极，包括棒状部分和和位于棒状部分远端的凸出部分；所述第二电极部的凸出部分位于第一电极部远端；所述第二电极部的棒状部分内插于第一电极部中，所述第二电极部的凸出部分沿第二电极部的棒状部分轴线垂直方向向外延伸的长度大于所述第二电极部的棒状部分半径，所述第二电极部的凸出部分表面为没有锐利棱边的光滑表面；所述绝缘构件用来隔绝第一电极部和第二电极部；
优选地，第一电极部远端从主体部件的轴线垂直方向向外延伸的长度大于第一电极部的管状部分横截面的半径，在第一电极部的远端形成凸起。
优选地，所述凸起的横截剖面为圆周分布或发散分布。
优选地，所述绝缘构件包括绝缘件和绝缘套，所述绝缘件位于第一电极部与所述第二电极部的凸出部分之间，用于隔绝第一电极部和第二电极部的凸出部分；所述绝缘套外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套外表面，三者形成同心结构；
优选的，所述第二电极部的凸出部分位于第一电极部远端；
优选地，所述绝缘件内嵌于第二电极部的凸出部分或与第二电极部的凸出部分端面贴齐，所述第一电极部内嵌于所述绝缘件内。
有益效果：
本发明提供的双极高频电刀相对现有双极电刀，两个电极电流回路更小，且有头端绝缘保护，使操作更安全。
本发明提供的双极高频电刀相对现有双极电刀，惰性电极在前，活性电极在后，当电刀从人体自然腔道(口腔、肛腔)通过内窥镜引导下进入消化道病变时，在任何角度或方向两个电极都能保证与组织接触，从而形成电流回路进行组织切割，保证手术切割的可靠性，使操作更安全。
本发明提供的双极高频电刀活性电极与惰性电极之间有绝缘保护层，可以防止切割时高频电击引起的组织基层穿孔。
本发明提供的双极高频电刀惰性电极截面积大于活性电极截面积，且惰性电极在远端，可以在切割时起到防止穿孔和出血的保护作用。
本发明提供的双极高频电刀，活性电极远端与绝缘件接触部分形成的凸起，可以在切割时可以将注液后隆起的组织提起，使其远离粘膜肌层防止穿孔，同时，凸起可以在刀具部纵向移动时对组织进行切割。
附图说明
图1是双极高频电刀总体结构图
图2是双极高频电刀刀头局部放大图
图3A-图3B是双极高频电刀的电极与绝缘件结合剖面图
图4A-图4D是电刀不同切割角度图
图5A-图5D是电刀使用的过程说明
图6A-图6B是电刀的切割过程
图7A-图7B是第一电极部凸起的横截剖面图
1、第二电极部，1a、棒状部分，1b、凸出部分，2、绝缘件，3、第一电极部，4、绝缘套，5、限位部件，6、绝缘管鞘，7、手柄，8、按钮，9、插座，10a、第一导线，10b、第二导线，11、绝缘构件，12、固定绝缘限位件，13、活动限位件，16、病变组织，17、粘膜肌层，18、管状部分，19、凸起，21、刀具部，22、主体部件，23、操作部，31、第一电极，32、第二电极，33、绝缘部分
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。
下面结合附图和实施方式对本发明作进一步说明，但本发明绝不限于下述实施例。
实施例1
如图1所示，本实施方式的双极高频电刀包括刀具部21、主体部件22和操作部23。
以下，将刀具部21的一端称为远端，将操作部23的一端称为近端。
如图2所示，所述刀具部21设在双极高频电刀的远端，包括第一电极部3，第二电极部1和绝缘构件11，所述刀具部21可以沿着所述主体部件22的轴向移动，并且相对所述主体部件22前端可以突出和进入；
所述第一电极部3为活性电极，用于组织切割，相对于主体部件22的前端可以推出或收回，包括管状部分18和凸起19；所述第二电极部1为惰性电极，包括棒状部分1a和位于棒状部分1a远端的凸出部分1b；所述第二电极的凸出部分1b位于第一电极部3远端，第二电极部1的凸出部分1b从第二电极部1棒状部分1a轴线垂直方向向外延伸的长度大于所述第二电极部1棒状部分1a的半径。所述第二电极部1的凸出部分1b表面为没有锐利棱边的光滑表面。横剖面直径大于所述第一电极部3的横剖面直径；所述第二电极部的棒状部分1a内插于第一电极部3中并与操作部23连通；所述绝缘构件11用来隔绝第一电极部3和第二电极部1，保证在手术过程中活性电极与惰性电极同时与组织接触，包括绝缘件2和绝缘套4；所述绝缘件2位于第一电极部3与所述第二电极部1的凸出部分1b之间，用于隔绝第一电极部3和第二电极部1的凸出部分1b；所述绝缘套4外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套4外表面，三者形成同心结构；
所述绝缘构件11为绝缘材质，优选利用陶瓷材料等具有耐热性的材料制成；
采用绝缘材料将第一电极部和第二电极部隔绝，防止第一电极和第二电极直接导通后电 刀失效，不活跃的第二电极部在前，活跃的第一电极部在后，当电刀从人体自然腔道(口腔、肛腔)通过内窥镜引导下进入消化道病变时，任何角度或方向两个电极部都能保证与组织接触，从而形成电流回路进行组织切割，保证手术切割的可靠性，使操作更安全。
主体部件22包括绝缘管鞘6和限位部件5；绝缘管鞘具有可以在内窥镜的沟道中插通的外径和挠性，至少外周面具有绝缘性且能耐高温，贯穿于刀具部和操作部之间；限位部件5位于绝缘管鞘6内部，用于限定第一电极部推出所述绝缘管鞘远端的推出量；在刀具部21收回到绝缘管鞘内时起到限位和保护作用。刀具部推出时，第一电极部3进行切割，收回时刀头退回到绝缘管鞘6内，通过限位部件5进行限位和保护。
所述限位部件5，包括固定在所述绝缘管鞘的远端的固定绝缘限位件12，以及设在所述第一电极部3近端的活动限位件13，所述活动限位件13与所述固定绝缘限位件12由于尺寸不同形成的台阶进行限位，从而控制所述第一电极部的伸出量。
所述限位部件5，包括固定在所述绝缘管鞘远端的固定绝缘限位件12，以及设在所述第一电极部近端的活动限位件13，所述活动限位件13沿主体部件的轴线垂直方向向外延伸的长度小于所述固定绝缘限位件12沿主体部件的轴线垂直方向向外延伸的长度，所述固定绝缘限位件12的远端端面超出绝缘管鞘的远端端面或至少平齐，近端端面内插于绝缘管鞘内。所述活动限位件13为金属部件，固定到第一电极部3的固定点；所述固定绝缘限位件12固定在所述绝缘管鞘远端，固定绝缘限位件12由耐高温的绝缘材料，优选利用陶瓷材料等有耐热性的材料构成。通过将固定绝缘限位件12表面做粗糙或带倒刺增加与绝缘管鞘6的摩擦力。
当推动操作部23上的按钮8时带动第一电极部3和活动限位件13一同向远端伸出，当活动限位件13的远端端面碰到固定绝缘限位件12的近端端面时，因尺寸不同不能继续向远端伸出从而起到限位作用。当回拉操作部23上的按钮8时带动刀具部21向绝缘管鞘6内回收，当刀具部21中的绝缘件2碰到固定绝缘限位件12的侧面时，由于尺寸差形成的台阶限定刀具部21不能继续回撤，起到限位作用，同时固定绝缘限位件12为绝缘材料，很好的保护整个电刀除活性电极以外其他部位的绝缘性。
如图1所示，操作部23设在所述主体部件22的近端方向，可以使刀具部21相对于主体部件22的前端推出或收回；操作部包括手柄7，按钮8，插座9，连接所述第一电极部3的第一导线10a和连接所述第二电极部1的第二导线10b。第一电极部3和第二电极部1通过导线连接到手柄尾部，分别由第一导线10a和第二导线10b引出到插座9上，通过插座9连接到高频发生器上给电刀输入高频电流。手柄7上的按钮8可以沿着手柄7的轴线直线滑动，通过推出或推进按钮8实现推出和收回刀具部的动作。
如图3A-图3B所示，所示绝缘构件11包含绝缘件2和绝缘套4，所述绝缘件2位于第 一电极部3与所述第二电极部1的凸出部分1b之间，用于隔绝第一电极部3和第二电极部1的凸出部分1b，可以有效的隔绝活性电极与惰性电极，确保两电极间绝缘；所述绝缘套4外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套4外表面，三者形成同心结构；所述绝缘件2内嵌于第二电极部的凸出部分1b或与第二电极部的凸出部分1b端面贴齐，所述第一电极部3内嵌于所述绝缘件2内。第一电极部3与绝缘套4平行部分为第一电极部的管状部分18，第一电极部3远端从主体部件的轴线垂直方向向外延伸的长度大于第一电极部3的管状部分18横截面的半径，在第一电极部3的远端形成凸起19，所述凸起19的横截剖面可以为圆周分布、发散分布或其他形状，如图7A和图7B所示。凸起19在切割时可以将注液后隆起的组织提起，使其远离粘膜肌层防止穿孔，同时，凸起19可以在刀具部21纵向移动时对组织进行切割。
图4A-图4D是电刀不同切割角度图，图4A和图4B表达的是现有技术普通双极电刀不同切割角度示例，图4C和图4D所示为本发明所提供的双极高频电刀，如图4A和图4B所示，现有技术中，双极电刀第一电极31位于第二电极32远端，第一电极31和第二电极32之间设有绝缘部分33，只有在某些特定的角度(如图4A所示)才能满足两个电极同时与组织接触的要求，从而完成组织切割的目的。当如图4A和4C所示切割角度时，第一电极与第二电极在不接触粘膜肌层17的基础上同时与病变粘膜层16接触，当如图4B和4D所示切割角度时，普通双极电刀在保证第一电极不接触粘膜肌层17时，第二电极便与病变粘膜16脱离，导致回路断开，不能继续切割，为了保证切割的进行则要将第一电极插入到深部粘膜肌层17，加大了出血和穿孔的可能性。本发明提供的高频双极电刀由于第二电极部1的凸出部分1b位于第一电极部3远端，在同样的切割角度(如图4D所示)依然能保证第一电极部3与第二电极部1同时与病变组织16同时接触，可以使任何角度或方向两个电极都能保证与组织接触。且第二电极部1的凸出部分1b为惰性电极，即使操作时插入过深到粘膜肌层17也不会产生切割，起到防止出血和穿孔的作用，达到了更好的技术效果。
下面采用图5A-图5D说明所述双极高频电刀的操作流程：
手术过程中，手术医生先通过针状刀在病变组织16一周进行标记(如图5A所示)，接着再用注射针在病变组织16中注射生理盐水使之隆起，然后将高频电刀主体部件22通过内窥镜腔道插入病变组织16附近，此过程要保持刀具部21内收于管鞘7内部(如图5B所示)，保护刀具部21以及内窥镜在此过程中不被损坏，到达病变组织16后通过操作部23的按钮8推出刀具部21(如图5C所示)，然后将其放入针状刀初期切开孔中，然后一面给第一电极部3供给高频电，一面是刀具沿着图5D的方向进行切割(如图5D所示)。当处于消化道一些横向切割操作不便利的位置，可以改用纵向切割，如图6A-图6B所示，将组织拉起后，病变 组织16堆积到第一电极部3的凸起19，此时凸起19起到切割作用。
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 (14)

  1. 一种双极高频电刀，其特征在于，所述双极高频电刀包括：
    刀具部、主体部件和操作部；
    所述刀具部，设在双极高频电刀的远端，包括第一电极部，第二电极部和绝缘构件；所述第一电极部为活性电极，用于组织切割，相对于主体部件的前端可以推出或收回，包括管状部分和凸起；所述第二电极部为惰性电极，包括棒状部分和位于棒状部分远端的凸出部分；所述第二电极部的凸出部分位于第一电极部远端；所述第二电极部的棒状部分内插于第一电极部中；所述绝缘构件用来隔绝第一电极部和第二电极部；
    所述主体部件包括绝缘管鞘和限位部件，所述绝缘管鞘，至少外周面具有绝缘性，贯穿于刀具部和操作部之间；所述限位部件位于绝缘管鞘内部，包括固定绝缘限位件和活动限位件；
    操作部，设在所述主体部件的近端方向，具有连接所述第一电极部的第一导线和连接所述第二电极部的第二导线，可以使刀具部相对于主体部件的前端推出或收回；
  2. 根据权利要求1所述的双极高频电刀，其特征在于，第一电极部远端从主体部件的轴线垂直方向向外延伸的长度大于第一电极部的管状部分横截面的半径，在第一电极部的远端形成凸起。
  3. 根据权利要求2所述的双极高频电刀，其特征在于，所述凸起的横截剖面为圆周分布或发散分布。
  4. 根据权利要求1所述的双极高频电刀，其特征在于，所述第二电极部的凸出部分沿第二电极部的棒状部分轴线垂直方向向外延伸的长度大于所述第二电极部的棒状部分半径，所述第二电极部的凸出部分表面为没有锐利棱边的光滑表面，所述第二电极部的凸出部分位于第一电极部远端。
  5. 根据权利要求1所述的双极高频电刀，其特征在于，所述绝缘构件包括绝缘件和绝缘套，所述绝缘件位于第一电极部与所述第二电极部的凸出部分之间，用于隔绝第一电极部和第二电极部的凸出部分；所述绝缘套外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套外表面，三者形成同心结构；
  6. 根据权利要求5所述的双极高频电刀，其特征在于，所述绝缘件内嵌于第二电极部的凸出部分或与第二电极部的凸出部分端面贴齐，所述第一电极部内嵌于绝缘件内。
  7. 根据权利要求1或2所述的双极高频电刀，其特征在于，所述限位部件，包括固定在所述绝缘管鞘远端的固定绝缘限位件，以及设在所述第一电极部近端的活动限位件，所述活 动限位件沿主体部件的轴线垂直方向向外延伸的长度小于所述固定绝缘限位件沿主体部件的轴线垂直方向向外延伸的长度，所述固定绝缘限位件的远端端面超出绝缘管鞘的远端端面或至少平齐，近端端面内插于绝缘管鞘内。
  8. 根据权利要求6所述的双极高频电刀，其特征在于，固定绝缘限位件的外表面是粗糙或带有倒刺的。
  9. 根据权利要求1所述的双极高频电刀，其特征在于，所述操作部还包括手柄，手柄上有按钮，所述手柄上的按钮可以沿着手柄的轴线直线滑动，通过推出或收回按钮实现推出和收回刀具部的动作。
  10. 一种高频电刀的双极刀头，包括：
    第一电极部，第二电极部和绝缘构件；
    所述第一电极部为活性电极，用于组织切割，相对于主体部件的前端可以推出或收回，包括管状部分和凸起；
    所述第二电极部为惰性电极，包括棒状部分和和位于棒状部分远端的凸出部分；所述第二电极部的凸出部分位于第一电极部远端；所述第二电极部的棒状部分内插于第一电极部中，所述第二电极部的凸出部分沿第二电极部的棒状部分轴线垂直方向向外延伸的长度大于所述第二电极部的棒状部分半径，所述第二电极部的凸出部分表面为没有锐利棱边的光滑表面；
    所述绝缘构件用来隔绝第一电极部和第二电极部；
  11. 根据权利要求10所述的高频电刀的双极刀头，其特征在于，第一电极部远端从主体部件的轴线垂直方向向外延伸的长度大于第一电极部的管状部分横截面的半径，在第一电极部的远端形成凸起。
  12. 根据权利要求11所述的高频电刀的双极刀头，其特征在于，所述凸起的横截剖面为圆周分布或发散分布。
  13. 根据权利要求10所述的高频电刀的双极刀头，其特征在于，所述绝缘构件包括绝缘件和绝缘套，所述绝缘件位于第一电极部与所述第二电极部的凸出部分之间，用于隔绝第一电极部和第二电极部的凸出部分；所述绝缘套外包于所述第二电极部棒状部分外表面，所述第一电极部外包于所述绝缘套外表面，三者形成同心结构；
  14. 根据权利要求13所述的高频电刀的双极刀头，其特征在于，所述绝缘件内嵌于第二电极部的凸出部分或与第二电极部的凸出部分端面贴齐，所述第一电极部内嵌于所述绝缘件内。
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