WO2021208934A1 - 一种用于中耳炎微创手术的射频消融电极及其使用方法 - Google Patents

一种用于中耳炎微创手术的射频消融电极及其使用方法 Download PDF

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Publication number
WO2021208934A1
WO2021208934A1 PCT/CN2021/087088 CN2021087088W WO2021208934A1 WO 2021208934 A1 WO2021208934 A1 WO 2021208934A1 CN 2021087088 W CN2021087088 W CN 2021087088W WO 2021208934 A1 WO2021208934 A1 WO 2021208934A1
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Prior art keywords
electrode
inner tube
tip
tube
tube electrode
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PCT/CN2021/087088
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English (en)
French (fr)
Inventor
张志钢
林敏�
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珠海市司迈科技有限公司
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Priority claimed from CN202020541088.9U external-priority patent/CN213190034U/zh
Priority claimed from CN202010288603.1A external-priority patent/CN111643176A/zh
Application filed by 珠海市司迈科技有限公司 filed Critical 珠海市司迈科技有限公司
Publication of WO2021208934A1 publication Critical patent/WO2021208934A1/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
    • 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

Definitions

  • the invention relates to the technical field of medical devices, in particular to a radiofrequency ablation electrode used for minimally invasive surgery of otitis media and a method of use thereof.
  • Otitis media is an inflammatory lesion that affects all or part of the middle ear (including the Eustachian tube, tympanum, tympanic sinus, and mastoid air chamber), and it is more common in children.
  • otitis media There are different types of otitis media and different treatments. There are roughly two types: 1. Secretory otitis media, which is mainly caused by the obstruction of the Eustachian tube. In layman's terms, colds, rhinitis, etc. cause nasal congestion, which leads to changes in the pressure in the middle ear. Liquid, the formation of secretory otitis media.
  • Tympanic membrane puncture is currently a common clinical method for the treatment of otitis media.
  • the treatment method is to mechanically puncture the tympanic membrane and then inject liquid medicine into the tympanic cavity.
  • the effusion containing pus in the tympanic cavity gradually flows out.
  • the traditional tympanic membrane puncture surgery has the following significant defects: because mechanical puncture is a mechanical injury to the tympanic membrane tissue, the tympanic membrane heals too quickly, about one week, and the complete drainage of the effusion usually takes at least one month.
  • the effusion in the tympanic cavity is healed before it is completely drained, and it needs to be punctured again, or even more repeated punctures. This will cause the doctor's cumbersome operation, increase the patient's pain, and delay the treatment process. On the other hand, it is difficult to control the penetration depth during the puncture operation. If the tip of the tympanostomy is pierced too deeply, it is easy to damage the vascular and nerve plexus on the surface of the tympanic mucosa of the inner wall of the middle ear cavity. The safety is low and the doctor's operation requirements are high.
  • Another method that can be taken is laser puncture surgery.
  • the disadvantage is that it will cause permanent burns to the tympanic membrane tissue. After treatment, the tympanic membrane is difficult to heal. This is obviously not the result that doctors and patients hope.
  • the purpose of the present invention is to provide a surgical method that does not cause mechanical damage to the tympanic membrane, has appropriate healing time, does not require multiple punctures, is easy to operate, and has as little pain as possible for the patient.
  • Surgical Instruments are used to provide a surgical method that does not cause mechanical damage to the tympanic membrane, has appropriate healing time, does not require multiple punctures, is easy to operate, and has as little pain as possible for the patient.
  • a radio frequency ablation electrode for minimally invasive surgery of otitis media comprising a handle and an electrode connected to each other.
  • the electrode has a tubular structure and includes an inner tube electrode and an outer tube electrode.
  • the inner tube electrode and the outer tube electrode are connected to the power source respectively.
  • the two poles are connected, and the body of the outer tube electrode is sleeved outside the body of the inner tube electrode, and the tips of the outer tube electrode and the inner tube electrode are in the same direction and are exposed to form the electrode tip of the electrode ,
  • the outer surface of the inner tube electrode is set as an insulating surface, so that the tube body of the inner tube electrode and the outer tube electrode are insulated from each other, and the tip ends of the inner tube electrode and the outer tube electrode can achieve electrical conduction through physiological saline. Through, so that the electrode tip forms a plasma field to perform ablation and perforation on the tympanic membrane tissue.
  • the inner tube electrode and the outer tube electrode tip can be electrically connected through physiological saline, so that the electrode tip forms a plasma field to perform ablation and perforation on the tympanic membrane tissue, including the following methods:
  • the first method a gap penetrating the electrode is provided between the insulating surface and the outer tube electrode, a water injection tube is connected to the gap, the inner tube electrode is a hollow tube, and a water suction tube is connected to the electrode.
  • the hollow tube of the inner tube electrode is connected, and the physiological saline sequentially passes through the water injection tube and the gap to reach the tip of the electrode.
  • a plasma field is formed to ablate and perforate the tympanic membrane.
  • Physiological saline is continuously sucked out of the hollow tube of the inner tube electrode to the suction tube;
  • the second method a gap penetrating the electrode is provided between the insulating surface and the outer tube electrode, a water injection tube is connected to the gap, and the inner tube electrode is a hollow tube or a solid tube that is not used for water absorption. Tube, the physiological saline sequentially passes through the water injection tube and the gap to reach the electrode tip to form a plasma field to perform ablation and perforation of the tympanic membrane;
  • the third way a gap is provided between the insulating surface and the outer tube electrode, and the gap is not connected to the outside, or there is no gap between the insulating layer and the outer tube electrode, and the two are in direct contact
  • the inner tube electrode is a hollow tube or a solid tube that is not used for water absorption, and the physiological saline attached to the tips of the inner tube electrode and the outer tube electrode forms a plasma field under the action of the electromagnetic field between the two electrodes to ablate the tympanic membrane and perforate the tympanic membrane.
  • the fourth method a water absorbing material is arranged between the insulating surface and the outer tube electrode, the inner tube electrode is a hollow tube or a solid tube that is not used for water absorption, and the physiological saline in the water absorbing material is attached to the inner tube.
  • the tube electrode and the tip of the outer tube electrode form a plasma field under the action of the electromagnetic field between the two poles to ablate and perforate the tympanic membrane;
  • the inner tube electrode is a hollow tube
  • a water injection tube is connected to the hollow pipe of the inner tube electrode, and there is a gap or direct connection between the insulating layer and the outer tube electrode.
  • the physiological saline passes through the water injection tube and the hollow tube of the inner tube electrode to reach the tip ends of the inner tube electrode and the outer tube electrode, and a plasma field is formed under the action of the electromagnetic field between the two poles to ablate the tympanic membrane and perforate the tympanic membrane.
  • the inner tube electrode and the outer tube electrode are made of metal; the outer surface of the inner tube electrode is covered with an insulating layer to form the insulating surface, and the outer surface of the outer tube electrode is covered with an outer insulating layer .
  • the positional relationship of the inner tube electrode, the insulating layer, the outer tube electrode, and the outer insulating layer is one of the following solutions:
  • the first solution the tip of the insulating layer does not protrude from the tip of the inner tube electrode, the tip of the outer tube electrode does not protrude from the tip of the insulating layer, and the tip of the outer insulating layer The end does not protrude from the tip end of the outer tube electrode;
  • the head end of the insulating layer does not protrude from the head end of the inner tube electrode
  • the electrode head end of the outer tube does not protrude from the head end of the insulating layer
  • the outer insulating layer The tip end is flush with the tip end of the inner tube electrode or protrudes from the tip end of the inner tube electrode
  • the tip end of the inner tube electrode does not protrude from the tip end of the insulating surface, and the tip end of the outer tube electrode is flush with the tip end of the insulating surface or protrudes from the insulating surface.
  • the head end, the head end of the outer insulating layer does not protrude from the electrode head end of the outer tube;
  • the third way, the fourth way, and the fifth way are only applicable to the second plan and the third plan.
  • the tip end surface of the insulating layer is 0-1.5 mm away from the tip end surface of the inner tube electrode, and the tip end surface of the outer tube electrode is away from the tip end surface of the inner tube electrode.
  • the tip end face of the outer insulating layer is 0-3.5mm away from the tip end face of the outer tube electrode; in the second solution, the tip end face of the insulating layer is away from the inner tube electrode.
  • the tip end face of the outer tube is 0-1.5mm
  • the tip end face of the outer tube electrode is 0-3.0mm away from the tip end face of the inner tube electrode
  • the tip end face of the outer insulating layer is 0-3.0 mm away from the tip end face of the inner tube electrode.
  • the tip end face of the insulating surface is 0-2.0mm away from the tip end face of the inner tube electrode, and the tip end face of the outer tube electrode is away from the tip end of the insulating surface
  • the end face is 0-1.5 mm, and the distance between the head end face of the outer insulating layer and the head end face of the outer tube electrode is 0-2.0 mm.
  • the electrode includes a child model and an adult model; the radial dimensions of each part of the child model are as follows: the outer diameter of the inner tube electrode is between 0.5-1.5 mm, and the outer insulating layer is the electrode The outer diameter of the electrode rod is between 0.9-2.9mm; the radial dimensions of each part of the adult model are as follows: the outer diameter of the inner tube electrode is between 0.6-1.6mm, and the outer diameter of the outer insulating layer That is, the outer diameter of the electrode rod of the electrode is between 1.2-3.2 mm.
  • the outer diameter of the outer insulating layer of the child model is 1.9 mm, and the outer diameter of the outer insulating layer of the adult model is 2.2 mm.
  • a plurality of electrode fixing mechanisms are provided between the tail end and the head end of the electrode, and the plurality of electrode fixing mechanisms are arranged at all
  • the insulating surface and the outer tube electrode are used to fix the relative position of the outer tube electrode and the inner tube electrode.
  • the electrode fixing mechanism is a first protruding from the inner wall of the outer tube electrode toward the insulating surface.
  • the electrode fixing mechanism is a second bump protruding from the inner surface of the insulating surface to the outer tube electrode
  • the vertices of the plurality of second bumps all abut or are close to the inner wall of the outer tube electrode.
  • the gap is an annular gap
  • the plurality of electrode fixing mechanisms form one or more electrode fixing rings, which are distributed in the annular gap between the tail end and the head end of the electrode.
  • the electrode fixing ring is arranged at a distance of 10-15 mm from the end surface of the electrode tip end of the inner tube.
  • the handle includes a handle front shell and a handle rear shell
  • the handle front shell is a corner structure
  • the tail end of the corner is connected to the handle rear shell
  • the front end of the corner is used to fix the electrode
  • the angle of the corner is It is designed to facilitate the operator to hold the handle back shell to penetrate the electrode into the human ear canal.
  • the folding angle of the front shell of the handle is 10-50°.
  • the handle further includes a handle insert embedded between the inner wall of the handle front shell and the outer wall of the electrode, and extends out of the front end of the beveled corner of the handle front shell to wrap around the handle.
  • the outer surface of the electrode is longer than a certain length.
  • the front section of the electrode is set in an arc shape with a curvature greater than or equal to R10.
  • a method for using a radio frequency ablation electrode for minimally invasive surgery of otitis media includes the following steps:
  • the physiological saline reaches the tip of the electrode through the gap between the outer tube electrode and the insulating layer outside the inner tube electrode to form connecting water droplets, and then turn on the The power switch of the electrode turns on the inner tube electrode and the outer tube electrode to generate a plasma field, and continue to advance the electrode, so that the plasma field ablates the tympanic membrane and perforates the tympanic membrane.
  • the physiological saline is continuously passed through the hollow tube of the inner tube electrode. Suck out
  • radiofrequency ablation electrode adopts the second method mentioned above, and includes the following steps:
  • the physiological saline reaches the electrode tip through the gap between the outer tube electrode and the insulating layer outside the inner tube electrode, and conducts the inner tube electrode and the outer tube
  • the electrode generates a plasma field, and continues to advance the electrode, so that the plasma field ablates the tympanic membrane and perforates;
  • radiofrequency ablation electrode adopts the third method mentioned above, and includes the following steps:
  • radio frequency ablation electrode adopts the fourth method mentioned above, and includes the following steps:
  • the radiofrequency ablation electrode adopts the fifth method mentioned above, and includes the following steps:
  • the physiological saline reaches the tip of the electrode through the hollow pipe of the inner tube electrode, conducts the inner tube electrode and the outer tube electrode, generates a plasma field, and continues to advance the The electrode makes the tympanic membrane ablation hole perforated by the plasma field;
  • the present invention has the following advantages:
  • the present invention provides a radiofrequency ablation bipolar electrode specially used in minimally invasive surgery for otitis media, which breaks through the traditional mindset of surgical methods such as mechanical puncture and laser puncture, and uses the principle of plasma to make the inner tube electrode and the outer tube
  • the saline between the ends of the electrodes conducts the inner tube electrode and the outer tube electrode, forming a plasma field at the tip of the electrode to ablate and perforate the tympanic membrane tissue. Since the plasma field acts on the tissue at a temperature of 40-70°, It will not cause permanent burns to the tissue, and it will heal more slowly than mechanical puncture wounds. In fact, according to clinical experiments, the healing time of the holes punched by the plasma ablation of the present invention is about 1-3 months.
  • the time required for drainage is matched, and the healing time is just enough for the drainage of effusion, avoiding the defects of repeated puncture or unhealable in the prior art, improving the efficiency and treatment effect of minimally invasive surgery for otitis media, and reducing the patient's physical damage and pain , Which reduces the difficulty of operation and the risk of operation.
  • the rigid metal at the tip of the electrode does not touch the tissue, but there is a distance of about 0.5mm from the tympanic membrane tissue, which can avoid possible burns or mechanical damage caused by the metal to the tissue. damage.
  • the physiological saline has the functions of cooling, antibacterial and anti-inflammatory, and protecting the wound surface during the operation, which further reduces the operation risk, improves the safety and postoperative recovery effect.
  • the size of the electrode tip in the present invention is designed so that when the tympanic membrane tissue is ablated and perforated, the perforation depth can be controlled to ensure that the internal nerves are not injured, and surgical accidents are avoided.
  • the radiofrequency ablation electrode of the present invention can complete the entire surgical process under visual conditions with the assistance of an endoscope.
  • the puncture effect is ideal, the tympanic membrane tissue is less damaged, and the healing effect is better, which is better than the traditional otitis media puncture operation.
  • the purpose of safety, higher efficiency, and quicker functional recovery after surgery is to reduce the negative effects to the lowest level, bring a good medical market, and achieve objective economic and social benefits.
  • FIG. 1 is a schematic diagram of the overall structure of a radiofrequency ablation electrode according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of the overall cross-sectional structure of a radiofrequency ablation electrode according to an embodiment of the present invention
  • FIG. 3 is a schematic cross-sectional structure diagram of part A in FIG. 2, corresponding to the first solution of the positional relationship between the layers of the electrode tip of the embodiment of the present invention
  • FIG. 4 is a schematic diagram of the three-dimensional structure of the electrode tip corresponding to FIG. 3;
  • 5 and 6 are respectively a cross-sectional and three-dimensional schematic diagram of a second solution of an electrode tip according to an embodiment of the present invention.
  • FIG. 7 and 8 are respectively a cross-sectional and three-dimensional schematic diagram of a third solution of an electrode tip according to an embodiment of the present invention.
  • Fig. 9 is a schematic structural diagram of an electrode fixing ring according to an embodiment of the present invention.
  • Fig. 10 is a schematic cross-sectional structure view taken along B-B in Fig. 9.
  • this embodiment provides a radiofrequency ablation electrode for minimally invasive surgery of otitis media, which includes a handle and an electrode 10 connected to one end of the handle, and also includes a water injection tube 8 and a water suction tube 9.
  • the cable 11 is connected to the electrode circuit through the handle to provide working power for the electrode; the water injection pipe 8 and the water suction pipe 9 are both connected through the handle and the electrode, and are used to input and output physiological saline respectively.
  • the electrode 10 includes an inner tube electrode 1 and an outer tube electrode 3 made of metal, which are sleeved with each other to form a hollow tubular structure.
  • the inner tube electrode 1 and the outer tube electrode 3 are respectively connected to the two poles of the power supply, and the outer surface of the inner tube electrode 1 is covered with an insulating tube 2 to realize the mutual sleeve part of the inner tube electrode 1 and the outer tube electrode 3 They are insulated from each other, and the outer surface of the outer tube electrode 3 is tightly covered with the insulating heat-shrinkable tube 4 to prevent leakage and protect the electrode 10.
  • the head end of the annular gap 23 is a water injection port 230
  • the head end of the inner tube electrode 1 is a drainage port 11.
  • the water injection tube 8 Connected with the annular gap 23 the suction pipe 9 is connected with the inner tube electrode 1, and the physiological saline enters the annular gap 23 through the water injection pipe 8, and then flows through the annular gap 23 to reach the head end of the annular gap 23, and at the same time it contacts
  • the exposed conductive head ends of the inner tube electrode 1 and the outer tube electrode 3 conduct the inner tube electrode 1 and the outer tube electrode 3 to form a plasma field to ablate and perforate the tympanic membrane tissue.
  • the flowing physiological saline is continuously
  • the drainage port 11 of the inner tube electrode 1 is sucked out to the suction tube 9 and then discharged.
  • the physiological saline also reduces inflammation and temperature of the tympanic membrane tissue, reducing the suffering of the patient.
  • the positional relationship between the inner tube electrode 1, the insulating tube 2, the outer tube electrode 3, and the head end of the heat shrink tube 4 is one of the following schemes:
  • the first solution is shown in Figures 3 and 4:
  • the head end of the insulating tube 2 does not protrude from the head end of the inner tube electrode 1, and the head end of the outer tube electrode 3 does not protrude from the head end of the insulating tube 2.
  • the head end of the shrink tube 4 does not protrude from the head end of the outer tube electrode 3.
  • the head end faces of the four-layer tube from the inner tube electrode 1 to the heat shrinkable tube 4 can be all flush, or the head end faces of at least a pair of adjacent two-layer tubes are flush with each other, or the four-layer tube Retract layer by layer, the tip of the inner tube electrode 1 is located at the foremost end of the electrode; specifically, the tip end face of the insulating tube 2 is 0-1.5mm from the tip end face of the inner tube electrode 1, and the tip end face of the outer tube electrode 3 is away from the inner tube
  • the tip end face of the electrode 1 is 0-3.0mm, and the tip end face of the outer insulating layer 4 is 0-3.5mm away from the tip end face of the outer tube electrode 3.
  • the inner tube electrode 1 is stuck outside the tympanic membrane after ablation and perforation of the tympanic membrane. 1 Plays a limiting role, can prevent the inner tube electrode 1 from continuing to penetrate into the ear canal, causing damage.
  • the second solution is shown in Figures 5 and 6: the head end of the insulating tube 2 does not protrude from the head end of the inner tube electrode 1, and the head end of the outer tube electrode 3 does not protrude from the head end of the insulating tube 2.
  • the head end of the heat shrinkable tube 4 is flush with the head end of the inner tube electrode 1 or protrudes from the head end of the inner tube electrode 1.
  • the head end face of the heat shrinkable tube 4 can exceed the head end of the other tubes and serve as the electrode head end face; specifically, the head end face of the insulating tube 2 is at a distance from the head end face of the inner tube electrode 2 -1.5mm, the head end face of the outer tube electrode 3 is 0-3.0mm away from the head end face of the inner tube electrode 1, and the head end face of the heat shrinkable tube 4 is away from the head end of the inner tube electrode 1
  • the end surface is 0-1.0mm.
  • the heat shrinkable tube 4 is the longest and most protruding and has the largest diameter, it is convenient to locate the electrode tip, which improves the convenience of operation, and at the same time, it can also prevent the electrode tip from continuing to penetrate the ear canal from the hole on the tympanic membrane to cause damage .
  • the third solution is shown in Figures 7 and 8: the head end of the inner tube electrode 1 does not protrude from the head end of the insulating tube 2, and the head end of the outer tube electrode 3 is connected to the insulating tube 2 The head end is flush or protrudes from the head end of the inner tube electrode 1, and the head end of the heat shrinkable tube 4 does not protrude from the head end of the outer tube electrode 3.
  • the outer tube electrode 3 and the heat shrinkable tube 4 can protrude from the inner tube electrode 1 and the insulating tube 2 as the electrode tip end surface; specifically, the tip end surface of the insulating tube 2 is away from the tip end of the inner tube electrode 1
  • the end face is 0-2.0mm
  • the head end face of the outer tube electrode 3 is 0-1.5mm from the head end face of the insulating tube 2
  • the head end face of the heat shrinkable tube 4 is 0-2.0mm from the head end face of the outer tube electrode 3.
  • the electrode of the present invention includes a child model and an adult model.
  • the radial dimensions of each part of the children's model are as follows: the outer diameter of the inner tube electrode is between 0.5-1.5mm, and the outer diameter of the heat shrinkable tube, that is, the outer diameter of the electrode rod of the electrode is between 0.9-2.9mm;
  • the radial dimensions of each part of the adult model are as follows: the outer diameter of the inner tube electrode is between 0.6-1.6mm, and the outer diameter of the heat shrink tube, that is, the outer diameter of the electrode rod of the electrode is 1.2-3.2mm. between.
  • the outer diameter of the heat-shrinkable tube of the child model is 1.9 mm
  • the outer diameter of the heat-shrinkable tube of the adult model is 2.2 mm.
  • an electrode fixing ring is provided at a distance of 10-15 mm from the head end face of the inner tube electrode 1, as shown in FIG.
  • the electrode of this scheme is taken as an example.
  • the specific structure is: the outer tube electrode 3 is uniformly provided with three inner concave points 31 along its circumferential direction. The relative radial positions of the electrode 1 and the outer tube electrode 3 are fixed to ensure that the inner tube electrode 1 does not shake or deviate, and the part between the three inner concave points 31 can still be passed by the physiological saline.
  • the above-mentioned electrode fixing ring can also be designed in multiple, that is, one is set at different lengths of the electrode; moreover, the outer tube electrode is concave in this embodiment, and the inner tube can also be used in actual use.
  • the electrode and the insulating tube covered with it are uniformly provided with a plurality of convex points protruding outward along the circumferential direction, and the apexes of the plurality of convex points abut the inner surface of the outer tube electrode; in each of the above solutions, the outer tube electrode
  • the concave point or the convex point of the inner tube electrode may not completely abut the outer wall of the insulating tube or the inner wall of the outer tube electrode.
  • a fixed ring is provided with a plurality of electrode fixing points, which are the above-mentioned inner concave points or convex points. As long as the plurality of electrode fixing points are distributed along the radial and axial directions of the electrode, the inner tube electrode and the outer tube electrode can be opposed to each other. Just fix it.
  • the handle of this embodiment includes a handle front shell 6 and a handle rear shell 10.
  • the handle rear shell 10 is mainly used for holding, and the handle front shell 6 is mainly used for connecting the fixed electrode 10.
  • the handle front shell 6 has a folded angle structure, the rear end of the folded corner is connected to the handle rear shell 10, the front end of the folded corner is used to fix the electrode 10, and the angle of the folded corner is designed to facilitate the operator to hold the handle rear shell 10 and hold the handle.
  • the electrode 10 penetrates into the human ear canal. Specifically, an angle of 10-50° can be selected.
  • the handle also includes a handle inner insert 5, which is embedded between the inner wall of the handle front shell 6 and the outer wall of the rear end of the electrode 10, and extends out of the front end of the beveled corner of the handle front shell 6 to wrap Covering a certain length of the outer surface of the electrode 10, the electrode 10 and the handle are further fixed firmly to prevent the slender electrode 10 from shaking during use and affecting the safety of the operation.
  • the steel pipe plug 7 is used to increase the internal sealing of the product.
  • the electrode 10 in this embodiment can be straight tubular, or its front section can be set to an arc with a curvature greater than or equal to R10.
  • the purpose of this design is to make the front end of the electrode 10 closer to the working surface tissue more compatible with the structure of the human ear canal. It is easy to operate and does not block the doctor's field of vision. Based on the angled structure of the front shell 6 of the handle, the comfort and convenience of the operation are further improved, thereby improving the efficiency and safety of the operation.
  • the radiofrequency ablation electrode of this embodiment further includes a foot switch, and the foot switch is a power switch of the electrode 10 and a water intake and suction switch of physiological saline.
  • the electrode can be a solid tube
  • a water suction tube is connected to the inner tube electrode and attached to the tip of the electrode in advance. After ablation and perforation, it is sucked out from the inner tube electrode to the suction tube.
  • the outer tube electrode and the insulating tube outside the inner tube electrode can be in direct contact with no gap;
  • the saline pre-attached to the tip of the electrode forms a plasma field to ablate the tympanic membrane. As long as the saline can form a plasma field at the tip of the electrode, it is enough.
  • the tube electrode and the insulating tube outside the inner tube electrode can be in direct contact with no gap, and the inner tube electrode can also be a solid tube;
  • a water absorbing material is arranged between the insulating tube and the outer tube electrode.
  • the sufficient amount of normal saline pre-absorbed in the water absorbing material is attached to the normal saline at the tip of the electrode to form a plasma field on the tympanic membrane.
  • the inner tube electrode can also be a solid tube;
  • the inner tube electrode is a water injection channel, which is connected to the water injection pipe, and there is no water absorption channel: the inner tube electrode is a hollow tube, a water injection tube is connected to the hollow pipe of the inner tube electrode, and physiological saline passes through the water injection tube and the inner tube. After the hollow tube of the tube electrode reaches the tip ends of the inner tube electrode and the outer tube electrode, a plasma field is formed under the action of the electromagnetic field between the two poles to perform ablation and perforation of the tympanic membrane.
  • the function and connection relationship of the foot switch should be adjusted accordingly.
  • the positional relationship between the inner tube electrode, the insulating tube, the outer tube electrode, and the heat shrinkable tube is not suitable for the above-mentioned first because the physiological saline needs to be attached to the tip of the electrode in advance.
  • a scheme. The fifth structure is also not applicable to the first scheme described above.
  • the above-mentioned annular gap may also be a gap with a cross-section of other shapes, which can allow physiological saline to pass through.
  • the physiological saline reaches the tip of the electrode through the gap between the outer tube electrode and the insulating tube outside the inner tube electrode to form a connecting water drop, and then step on the foot Step on the switch to turn on the inner tube electrode and the outer tube electrode to generate a plasma field, and continue to advance the electrode, so that the plasma field perforates the tympanic membrane, and at the same time, physiological saline is continuously sucked out through the hollow tube of the inner tube electrode;
  • the method of using radiofrequency ablation electrodes for minimally invasive surgery of otitis media includes the following steps:
  • the method of using the radiofrequency ablation electrode for minimally invasive surgery of otitis media includes the following steps:
  • Step on the foot switch turn on the power supply of the electrode, make the saline at the tip of the electrode conduct the inner tube electrode and the outer tube electrode to generate a plasma field, and continue to advance the electrode to make the plasma field ablate the tympanic membrane Punch
  • the method of using the radiofrequency ablation electrode for minimally invasive surgery of otitis media includes the following steps:
  • Step on the foot switch turn on the power supply of the electrode, the physiological saline reaches the tip of the electrode through the hollow tube of the inner tube electrode, conducts the inner tube electrode and the outer tube electrode, generates a plasma field, and continues to advance the An electrode to make the plasma field perforate the tympanic membrane ablation;

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Abstract

一种用于中耳炎微创手术的射频消融电极及其使用方法，射频消融电极包括相互连接的手柄和电极(10)，电极(10)为管状结构，包括内管电极(1)和外管电极(3)，内管电极(1)、外管电极(3)分别和电源的两极连接，且外管电极(3)的管身套设于内管电极(1)的管身之外，外管电极(3)和内管电极(1)的头端同向且均裸露，构成电极(10)的头端，内管电极(1)的外表面设为绝缘面，内管电极(1)和外管电极(3)的管身相互绝缘，二者的头端通过生理盐水实现电导通，使得电极(10)头端形成等离子场，对鼓膜组织消融打孔。利用低温等离子原理，在电极(10)头端形成等离子场，在较低的温度下对鼓膜组织进行消融打孔，提高了中耳炎微创手术的效率和治疗效果。

Description

一种用于中耳炎微创手术的射频消融电极及其使用方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种用于中耳炎微创手术的射频消融电极及其使用方法。
 背景技术
中耳炎是累及中耳（包括咽鼓管、鼓室、鼓窦及乳突气房）全部或部分结构的炎性病变，好发于儿童。中耳炎类型不同，治疗也不同，大概分为两种：一、 分泌性中耳炎，主要是因为咽鼓管不通畅导致的，通俗的说就是感冒，鼻炎等引起鼻塞，导致中耳的压力改变，产生液体，形成分泌性中耳炎。只要没有结构的异常，感冒好了以后，鼻子通气了，咽鼓管功能恢复好，中耳的液体就能排出去，分泌性中耳炎也就算自愈了。可以吃感冒药和促徘的药治疗，积液多的话需要鼓膜穿刺治疗；二、化脓性中耳炎：一般就是有炎症的意思了，轻微的可以自愈，严重的会有耳朵流脓、听力下降等症状，主要用抗生素治疗；再严重的形成胆脂瘤了就需要手术了。
鼓膜穿刺术是目前临床常用的治疗中耳炎的方法，治疗方式为机械刺穿鼓膜，然后向鼓室腔内注入药液，鼓室腔内的含有脓液的积液渐渐流出。但是临床发现，传统的鼓膜穿刺手术具有以下显著的缺陷：由于机械刺穿对鼓膜组织属于机械伤害，因此鼓膜愈合过快，约为一个星期，而积液彻底排出时间一般需要至少一个月，从而导致鼓室内积液尚未排干净就愈合，需要重新穿刺，甚至更多次反复穿刺，造成医生操作繁琐，更会增加患者痛苦，延缓治疗进程，另一方面，在穿刺手术时不易控制刺入深度，如鼓膜切开刀尖刺入过深，易伤及中耳腔内壁鼓岬黏膜表面的血管神经丛，安全性低，对医生的操作要求高。
另一种可以采取的方式为激光穿刺手术方法，其缺陷是会对鼓膜组织造成永久性灼伤，治疗后鼓膜难以愈合，这显然不是医生和患者希望的结果。
发明内容
为解决现有技术缺陷与不足，本发明的目的是提供一种对鼓膜既不造用机性伤害，愈合时间合适，不需要多次穿刺，而且易于操作、患者痛苦尽可能小的手术方法和手术器械。
本发明的目的是通过以下技术方案实现的：
一种用于中耳炎微创手术的射频消融电极，包括相互连接的手柄和电极，所述电极为管状结构，包括内管电极和外管电极，所述内管电极和外管电极分别和电源的两极连接，且所述外管电极的管身套设于所述内管电极的管身之外，外管电极和内管电极的头端同向且均裸露，构成所述电极的电极头端，所述内管电极的外表面设为绝缘面，使得所述内管电极和外管电极的所述管身相互绝缘，而所述内管电极和外管电极头端可以通过生理盐水实现电导通，使得所述电极头端形成等离子场，对鼓膜组织进行消融打孔。
作为优选，所述的所述内管电极和外管电极头端可以通过生理盐水实现电导通，使得所述电极头端形成等离子场，对鼓膜组织进行消融打孔，包括以下方式：
第一种方式：所述绝缘面和所述外管电极之间设有贯通所述电极的间隙，一注水管与所述间隙连通，所述内管电极为中空管，一吸水管与所述内管电极的中空管道连通，生理盐水顺序经由注水管和所述间隙到达所述电极头端，在外管电极和内管电极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔，同时生理盐水由内管电极的中空管道持续被吸出至所述吸水管；
第二种方式：所述绝缘面和所述外管电极之间设有贯通所述电极的间隙，一注水管与所述间隙连通，所述内管电极为不用于吸水的中空管或实心管，生理盐水顺序经由所述注水管和所述间隙到达所述电极头端形成等离子场对鼓膜进行消融打孔；
第三种方式：所述绝缘面和所述外管电极之间设有间隙，所述间隙不与外部连通，或者所述绝缘层和所述外管电极之间不设间隙，二者直接接触，所述内管电极为不用于吸水的中空管或实心管，附着于所述内管电极和外管电极头端的生理盐水在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔；
第四种方式：所述绝缘面与外管电极之间设有吸水材料，所述内管电极为不用于吸水的中空管或实心管，所述吸水材料内的生理盐水附着于所述内管电极和外管电极头端，在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔；
第五种方式：所述内管电极为中空管，一注水管和所述内管电极的中空管道连通，所述绝缘层和所述外管电极之间有不与外部连通的间隙或直接接触，生理盐水经由所述注水管和内管电极的中空管道后到达所述内管电极和外管电极头端，在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔。
作为优选，所述内管电极和外管电极均为金属材质；所述内管电极的外表面包覆有绝缘层，形成所述绝缘面，所述外管电极外表面包覆有外绝缘层。
作为优选，在所述电极头端，所述内管电极、绝缘层、外管电极和外绝缘层的位置关系为以下方案之一：
第一种方案：所述绝缘层的头端不凸出于所述内管电极头端，所述外管电极头端不凸出于所述绝缘层的头端，所述外绝缘层的头端不凸出于所述外管电极头端；
第二种方案：所述绝缘层的头端不凸出于所述内管极的头端，所述外管电极头端不凸出于所述绝缘层的头端，所述外绝缘层的头端和所述内管电极头端平齐或者凸出于所述内管电极头端;
第三种方案：所述内管电极头端不凸出于所述绝缘面的头端，所述外管电极头端与所述绝缘面的头端平齐或者凸出于所述绝缘面的头端，所述外绝缘层的头端不凸出于所述外管电极头端；
以上三种方案均适用于所述第一种方式和第二种方式；
所述第三种方式、第四种方式及第五种方式仅适用于所述第二种方案和第三种方案。
作为优选，所述第一种方案中，所述绝缘层的头端端面距离所述内管电极头端端面0-1.5mm,所述外管电极头端端面距离所述内管电极头端端面0-3.0mm,所述外绝缘层的头端端面距离所述外管电极头端端面0-3.5mm；所述第二种方案中，所述绝缘层的头端端面距离所述内管电极头端端面0-1.5mm,所述外管电极头端端面距离所述内管电极头端端面0-3.0mm,所述外绝缘层的头端端面距离所述内管电极头端端面0-1.0mm; 所述第三种方案中，所述绝缘面的头端端面距离所述内管电极的头端端面0-2.0mm,所述外管电极的头端端面距离所述绝缘面的头端端面0-1.5mm,所述外绝缘层的头端端面距离所述外管电极的头端端面0-2.0mm。
作为优选，所述电极包括儿童款和成人款；所述儿童款的各部分径向尺寸如下：所述内管电极的外径为0.5-1.5mm之间，所述外绝缘层即所述电极的电极杆的外径为0.9-2.9mm之间；所述成人款的各部分径向尺寸如下：所述内管电极的外径为0.6-1.6mm之间，所述外绝缘层的外径即所述电极的电极杆的外径为1.2-3.2mm之间。
作为优选，所述儿童款的外绝缘层的外径为1.9mm，所述成人款的外绝缘层的外径为2.2mm。
作为优选，当所述外管电极和所述绝缘面之间有间隙时，在所述电极的尾端和头端之间设有多个电极固定机构，所述多个电极固定机构设置于所述绝缘面和所述外管电极之间，用于将所述外管电极和内管电极的相对位置固定，电极固定机构是由所述外管电极的内壁向所述绝缘面突出的第一凸点，多个第一凸点的顶点均抵接或者接近所述绝缘面的外表面，或者，电极固定机构是由所述绝缘面的内表面向所述外管电极突出的第二凸点，多个第二凸点的顶点均抵接或者接近所述外管电极的内壁。
作为优选，所述间隙为环形间隙，所述多个电极固定机构形成一个或多个电极固定环，分布于所述电极的尾端和头端之间的环形间隙内。更优选的，所述电极固定环设置于距离所述内管电极头端端面10-15mm处。
作为优选，所述手柄包括手柄前壳和手柄后壳，所述手柄前壳为折角结构，折角的尾端连接所述手柄后壳，折角的前端用于固定所述电极，所述折角的角度设计为便于操作者手持所述手柄后壳而将所述电极深入人体耳道内。作为优选，所述手柄前壳的折角为10-50°。
作为优选，所述手柄还包括手柄内嵌件嵌设于所述手柄前壳的内壁和所述电极的外壁之间，并延伸出所述手柄前壳的所述折角的前端进而包覆于所述电极外表面一段长度外。
作为优选，所述电极的前段设为弯度大于或等于R10的弧形。
一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用上述的第一种方式，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S2、先打开所述电极生理盐水的注水和吸水控制开关，生理盐水经由外管电极和内管电极外的绝缘层之间的间隙到达所述电极的头端形成连接水珠，再打开所述电极的电源开关，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔，同时生理盐水不断经由所述内管电极的中空管道被吸出；
S3、关闭所述电极的电源开关和生理盐水的注水和吸水控制开关，将内窥镜和电极均取出。
另一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用上述的第二种方式，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S2、打开所述电极的电源开关和生理盐水的注水控制开关，生理盐水经由外管电极和内管电极外的绝缘层之间的间隙到达所述电极头端，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S3、关闭所述电极的电源开关和生理盐水的注水控制开关，将内窥镜和电极均取出。
另一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用上述的第三种方式，包括以下步骤：
S1、在所述手持射频消融电极的电极头端附着生理盐水；
S2、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S3、打开所述电极的电源开关，接通所述电极的电源，使电极头端的生理盐水导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S4、关闭所述电极的电源开关，将内窥镜和电极均取出。
另一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用上述的第四种方式，包括以下步骤：
S1、使所述吸水材料吸收足够的生理盐水；
S2、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S3、打开所述电极的电源开关，接通所述电极的电源，使电极头端的生理盐水导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S4、关闭所述电极的电源开关，将内窥镜和电极均取出。
另一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用上述的第五种方式，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S2、打开所述电极的电源开关和生理盐水的注水控制开关，生理盐水经由内管电极的中空管道到达所述电极头端，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S3、关闭所述电极的电源开关和生理盐水的注水控制开关，将内窥镜和电极均取出。
相对于现有技术，本发明具有以下优点：
本发明提供一种专门用于中耳炎微创手术中的射频消融双极电极，突破了传统的机械刺穿和激光刺穿等手术方式的思维定势，利用等离子原理，使内管电极和外管电极的端部之间的生理盐水将内管电极和外管电极导通，在电极头端形成等离子场，对鼓膜组织进行消融打孔，由于等离子场对组织的作用温度为40-70°，不会对组织形成永久性的灼伤，又比机械刺穿的伤口愈合得慢，事实上根据临床实验，采用本发明的等离子消融打孔的孔洞愈合时间约为1-3个月，与积液排出需要的时间相匹配，愈合的时间恰好可以供积液排出，避免了现有技术重复刺穿或无法愈合的缺陷，提高中耳炎微创手术的效率和治疗效果，减少了患者的身体损伤和痛苦，降低了手术的操作难度及手术风险。同时，由于实际接触组织的是生理盐水形成的等离子场，电极头端的刚性金属并不接触组织，而是与鼓膜组织之间存在0.5mm左右的距离，可避免金属对组织可能造成的灼伤或机械损伤。而且，生理盐水在手术过程中兼具降温、抗菌消炎、保护创面的作用，进一步降低了手术风险，提高了安全性和术后恢复效果。
另外，本发明中电极头端的尺寸设计，使得对鼓膜组织进行消融打孔时，可以控制打孔深度，保证不伤及内部神经，避免手术事故。
综上所述，本发明之射频消融电极可在内窥镜的辅助下，在可视条件下完成整个手术过程，穿刺效果理想，鼓膜组织损伤小，愈合效果佳，达到比传统中耳炎穿刺手术操作安全、效率更高、术后功能恢复快的目的，将负面效应降低到最低水平，带来良好的医疗市场，取得客观的经济效益和社会效益。
 附图说明
图1是本发明实施例的射频消融电极的整体结构示意图；
图2是本发明实施例的射频消融电极的整体剖面结构示意图；
图3是图2中的A部分的剖面结构示意图，对应本发明实施例的电极头端的各层之间的位置关系的第一种方案；
图4是与图3对应的电极头端的立体结构示意图；
图5和图6分别为本发明实施例的电极头端的第二种方案的剖面和立体结构示意图；
图7和图8分别为本发明实施例的电极头端的第三种方案的剖面和立体结构示意图；
图9是本发明实施例的电极固定环的结构示意图；
图10是图9中沿B-B的剖面结构示意图。
具体实施方式
如图1和图2所示，本实施例提供一种用于中耳炎微创手术的射频消融电极，包括手柄和连接于手柄一端的电极10，还包括一注水管8和一吸水管9。电缆线11通过手柄与电极电路连接，为电极提供工作电源；注水管8和吸水管9均通过手柄和电极连接，分别用于输入和输出生理盐水。
具体的，参见图3-8所示，所述电极10包括金属材质的内管电极1和外管电极3，二者相互套设，形成中空管状结构。内管电极1和外管电极3分别和电源的两极连接，内管电极1的外表面包覆有绝缘管2，以实现内管电极1和外管电极3的相互套设的管身部分的相互绝缘，外管电极3的外表面紧密包覆绝缘热缩管4，用于防止漏电和保护电极10。，所述绝缘管2和外管电极3之间为环形间隙23，该环形间隙23的头端为注水口230，内管电极1的头端为引流口11，具体的：所述注水管8和所述环形间隙23连通，所述吸水管9和内管电极1连通，生理盐水经注水管8进入环形间隙23内，流经环形间隙23后到达环形间隙23的头端部，同时接触到内管电极1和外管电极3的裸露的导电的头端，从而导通内管电极1和外管电极3，形成等离子场，对鼓膜组织进行消融打孔，流动的生理盐水同时被不断地经由内管电极1的引流口11被吸出至吸水管9然后排出，在此过程中，生理盐水还对鼓膜组织进行消炎、降温，降低患者痛苦。
在电极10头端，内管电极1、绝缘管2、外管电极3和热缩管4的头端的位置关系，为以下方案之一：
第一种方案，如图3和4所示：绝缘管2的头端不凸出于内管电极1的头端，外管电极3的头端不凸出于绝缘管2的头端，热缩管4的头端不凸出于外管电极3的头端。也就是说，由内管电极1至热缩管4的四层管的头端端面可全部平齐，或者其中至少一对相邻的两层管的头端端面相互平齐，或者四层管层层后缩，内管电极1的头端位于电极最前端；具体的，绝缘管2的头端端面距离内管电极1头端端面0-1.5mm,外管电极3头端端面距离内管电极1头端端面0-3.0mm,外绝缘层4的头端端面距离外管电极3头端端面0-3.5mm。该方案使用时，由于外管电极3及热缩管4相对于内管电极1构成台阶，因此，内管电极1在对鼓膜消融打孔后，该台阶卡设于鼓膜外，对内管电极1起到限位作用，可避免内管电极1继续深入耳道，造成损伤。
第二种方案，如图5和图6所示：绝缘管2的头端不凸出于内管电极1的头端，外管电极3的头端不凸出于绝缘管2的头端，热缩管4的头端和内管电极1的头端平齐或者凸出于内管电极1的头端。也就是说，热缩管4的头端端面可以超出其余各管的头端而作为电极头端端面；具体的，所述绝缘管2的头端端面距离所述内管电极2头端端面0-1.5mm,所述外管电极3的头端端面距离所述内管电极1的头端端面0-3.0mm,所述热缩管4的头端端面距离所述内管电极1的头端端面0-1.0mm。该方案使用时，由于热缩管4最长最突出且直径最大，因此，便于定位电极头端，提高了操作便利性，同时也可避免电极头端继续由鼓膜上的孔深入耳道内造成损伤。
第三种方案，如图7和图8所示：所述内管电极1的头端不凸出于所述绝缘管2的头端，所述外管电极3的头端与绝缘管2的头端平齐或者凸出于内管电极1的头端，热缩管4的头端不凸出于外管电极3的头端。也就是说，外管电极3和热缩管4可以凸出于内管电极1和绝缘管2而作为电极头端端面；具体的，绝缘管2的头端端面距离内管电极1的头端端面0-2.0mm,外管电极3的头端端面距离绝缘管2的头端端面0-1.5mm,热缩管4的头端端面距离外管电极3的头端端面0-2.0mm。该方案在使用时和第二种方案有相同的优势。
径向尺寸方面，本发明之电极包括儿童款和成人款。儿童款的各部分径向尺寸如下：内管电极的外径为0.5-1.5mm之间，所述热缩管的外径即所述电极的电极杆的外径为0.9-2.9mm之间；成人款的各部分径向尺寸如下：所述内管电极的外径为0.6-1.6mm之间，所述热缩管的外径即所述电极的电极杆的外径为1.2-3.2mm之间。优选的，所述儿童款的热缩管的外径为1.9mm，所述成人款的热缩管的外径为2.2mm。
在电极10的尾端和头端之间的某个长度处，例如距离所述内管电极1的头端端面10-15mm处设有一个电极固定环，如图9所示，以上述第一种方案的电极为例，具体结构为：外管电极3沿其周向均匀设置三个内凹点31，该三个内凹点31的顶点抵接绝缘管2的外表面，从而将内管电极1和外管电极3的相对的径向位置固定，保证内管电极1不晃动，不偏移，而三个内凹点31之间的部分还是可以供生理盐水通过。
事实上，上述的电极固定环还可以设计为多个，就是在电极的不同的长度处，分别设置一个；而且，本实施例采用的是外管电极内凹，实际使用中也可以由内管电极和其外包覆的绝缘管的沿其周向均匀设置多个向外突出的凸点，该多个凸点的顶点抵接外管电极的内表面；上述各个方案中，外管电极的凹点或者内管电极的凸点也可以不完全抵接绝缘管外壁或外管电极内壁，二者接近也可以实现内外管电极的相对固定，只是效果略差；而且，也可以不设为电极固定环，而是设置多个电极固定点，即为上述的内凹点或凸点，只要多个电极固定点沿电极的径向和轴向的分布可以实现内管电极和外管电极的相对固定即可。
如图2所示，本实施例之手柄包括手柄前壳6和手柄后壳10，手柄后壳10主要用于握持，手柄前壳6主要用于连接固定电极10。具体的，手柄前壳6为折角结构，折角的尾端连接手柄后壳10，折角的前端用于固定所述电极10，折角的角度设计为便于操作者手持所述手柄后壳10而将所述电极10深入人体耳道内，具体的，可以选择10-50°的角度。而且，手柄还包括手柄内嵌件5，该手柄内嵌件5嵌设于手柄前壳6的内壁和电极10后端的外壁之间，并延伸出手柄前壳6的所述折角的前端进而包覆于电极10外表面一段长度外，进一步将电极10与手柄固定牢固，避免细长的电极10在使用中发生晃动而影响手术安全性。图2中，钢管塞子7用于增加产品内部的密封性。
本实施例之电极10可以为直管状，也可以将其前段设为弯度大于或等于R10的弧形，这样设计的目的在于使电极10的靠近工作面组织的前端与人体耳道结构更加匹配，便于操作，且不遮挡医生视野，在手柄前壳6的折角结构的基础上，进一步提高操作的舒适度、便捷度，从而提高手术效率和安全性。
作为优选，本实施例之射频消融电极还包括脚踏开关，所述脚踏开关为所述电极10的电源开关和生理盐水的进水和吸水开关。
本发明不限于本实施例所述结构，还可以有多种变形，如：
1、可以不设吸水管，一注水管和所述环形间隙连通，生理盐水顺序经由注水管和环形间隙到达电极头端形成等离子场对鼓膜进行消融打孔后不再回流，该情况下内管电极可以为实心管；
2、不设注水管，一吸水管与所述内管电极连通，预先附着于所述电极头端，即内管电极头端和外管电极头端之间的生理盐水形成等离子场对鼓膜进行消融打孔后，由内管电极吸出至所述吸水管，这种情况下，外管电极和内管电极外的绝缘管可以直接接触，不设间隙；
3、不设注水管和吸水管，预先附着于所述电极头端的生理盐水形成等离子场对鼓膜进行消融打孔，只要生理盐水可以在电极头端形成等离子场即可，这种情况下，外管电极和内管电极外的绝缘管可以直接接触，不设间隙，内管电极也可以为实心管；
4、不设注水管和吸水管，在绝缘管与外管电极之间设有吸水材料，吸水材料内预先吸收的足量的生理盐水附着于所述电极头端的生理盐水形成等离子场对鼓膜进行消融打孔，只要生理盐水可以在电极头端形成等离子场即可，这种情况下，内管电极也可以为实心管；
5、内管电极为注水通道，与注水管连通，不设吸水通道：内管电极为中空管，一注水管和所述内管电极的中空管道连通，生理盐水经由所述注水管和内管电极的中空管道后到达所述内管电极和外管电极头端，在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔。
以上列举的几种情况下，脚踏开关的功能和连接关系也相应调整。其中，不设注水管的电极中，由于需要预先附着生理盐水在电极头端，因此内管电极、绝缘管、外管电极和热缩管的头端的位置关系不适用于上文所述的第一种方案。第5种结构，也不适用于上文所述的第一种方案。
上文所述的环形间隙也可以是截面为其他形状的间隙，可供生理盐水通过即可。
本实施例的用于中耳炎微创手术的射频消融电极的使用方法，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至接近鼓膜位置；
S2、先打开所述电极生理盐水的注水和吸水控制开关，生理盐水经由外管电极和内管电极外的绝缘管之间的间隙到达所述电极的头端形成连接水珠，然后踩下脚踏开关，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔，同时生理盐水不断经由所述内管电极的中空管道被吸出；
S3、放松脚踏开关，将内窥镜和电极均取出。
如不设吸水管，用于中耳炎微创手术的射频消融电极的使用方法，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至接近鼓膜位置；
S2、踩下脚踏开关，接通所述电极的电源，同时生理盐水被输送至环形间隙的头端的注水口，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S3、放松脚踏开关，将内窥镜和电极均取出。
如不设注水管和吸水管，用于中耳炎微创手术的射频消融电极的使用方法，包括以下步骤：
S1、在所述手持射频消融电极的电极头端尽可能多地附着生理盐水；
S2、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至接近鼓膜位置；
S3、踩下脚踏开关，接通所述电极的电源，使电极头端的生理盐水导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S4、放松脚踏开关，将内窥镜和电极均取出。
如将内管电极的中空通道作为注水通道，用于中耳炎微创手术的射频消融电极的使用方法，包括以下步骤：
S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
S2、踩下脚踏开关，接通所述电极的电源，生理盐水经由内管电极的中空管道到达所述电极头端，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
S3、放松脚踏开关，将内窥镜和电极均取出。
应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (17)

  1. 一种用于中耳炎微创手术的射频消融电极，其特征在于：包括相互连接的手柄和电极，所述电极为管状结构，包括内管电极和外管电极，所述内管电极和外管电极分别和电源的两极连接，且所述外管电极的管身套设于所述内管电极的管身之外，外管电极和内管电极的头端同向且均裸露，构成所述电极的电极头端，所述内管电极的外表面设为绝缘面，使得所述内管电极和外管电极的所述管身相互绝缘，而所述内管电极和外管电极头端可以通过生理盐水实现电导通，使得所述电极头端形成等离子场，对鼓膜组织进行消融打孔。
  2. 根据权利要求1所述的射频消融电极，其特征在于：所述的所述内管电极和外管电极头端可以通过生理盐水实现电导通，使得所述电极头端形成等离子场，对鼓膜组织进行消融打孔，包括以下方式：
    第一种方式：所述绝缘面和所述外管电极之间设有贯通所述电极的间隙，一注水管与所述间隙连通，所述内管电极为中空管，一吸水管与所述内管电极的中空管道连通，生理盐水顺序经由注水管和所述间隙到达所述电极头端，在外管电极和内管电极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔，同时生理盐水由内管电极的中空管道持续被吸出至所述吸水管；
    第二种方式：所述绝缘面和所述外管电极之间设有贯通所述电极的间隙，一注水管与所述间隙连通，所述内管电极为不用于吸水的中空管或实心管，生理盐水顺序经由所述注水管和所述间隙到达所述电极头端形成等离子场对鼓膜进行消融打孔；
    第三种方式：所述绝缘面和所述外管电极之间设有间隙，所述间隙不与外部连通，或者所述绝缘层和所述外管电极之间不设间隙，二者直接接触，所述内管电极为不用于吸水的中空管或实心管，附着于所述内管电极和外管电极头端的生理盐水在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔；
    第四种方式：所述绝缘面与外管电极之间设有吸水材料，所述内管电极为不用于吸水的中空管或实心管，所述吸水材料内的生理盐水附着于所述内管电极和外管电极头端，在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔；
    第五种方式：所述内管电极为中空管，一注水管和所述内管电极的中空管道连通，所述绝缘层和所述外管电极之间有不与外部连通的间隙或直接接触，生理盐水经由所述注水管和内管电极的中空管道后到达所述内管电极和外管电极头端，在两极之间的电磁场作用下形成等离子场对鼓膜进行消融打孔。
  3. 根据权利要求2所述的射频消融电极，其特征在于：所述内管电极和外管电极均为金属材质；所述内管电极的外表面包覆有绝缘层，形成所述绝缘面，所述外管电极外表面包覆有外绝缘层。
  4. 根据权利要求3所述的射频消融电极，其特征在于：在所述电极头端，所述内管电极、绝缘层、外管电极和外绝缘层的位置关系为以下方案之一：
    第一种方案：所述绝缘层的头端不凸出于所述内管电极头端，所述外管电极头端不凸出于所述绝缘层的头端，所述外绝缘层的头端不凸出于所述外管电极头端；
    第二种方案：所述绝缘层的头端不凸出于所述内管极的头端，所述外管电极头端不凸出于所述绝缘层的头端，所述外绝缘层的头端和所述内管电极头端平齐或者凸出于所述内管电极头端;
    第三种方案：所述内管电极的头端不凸出于所述绝缘面的头端，所述外管电极的头端与所述绝缘面的头端平齐或者凸出于所述绝缘面的头端，所述外绝缘层的头端不凸出于所述外管电极的头端；
    以上三种方案均适用于所述第一种方式和第二种方式；
    所述第三种方式、第四种方式及第五种方式仅适用于所述第二种方案和第三种方案。
  5. 根据权利要求4所述的射频消融电极，其特征在于：所述第一种方案中，所述绝缘层的头端端面距离所述内管电极头端端面0-1.5mm,所述外管电极头端端面距离所述内管电极头端端面0-3.0mm,所述外绝缘层的头端端面距离所述外管电极头端端面0-3.5mm；所述第二种方案中，所述绝缘层的头端端面距离所述内管电极头端端面0-1.5mm,所述外管电极头端端面距离所述内管电极头端端面0-3.0mm,所述外绝缘层的头端端面距离所述内管电极头端端面0-1.0mm;所述第三种方案中，所述绝缘面的头端端面距离所述内管电极的头端端面0-2.0mm,所述外管电极的头端端面距离所述绝缘面的头端端面0-1.5mm,所述外绝缘层的头端端面距离所述外管电极的头端端面0-2.0mm。
  6. 根据权利要求4或5所述的射频消融电极，其特征在于：所述电极包括儿童款和成人款；所述儿童款的各部分径向尺寸如下：所述内管电极的外径为0.5-1.5mm之间，所述外绝缘层即所述电极的电极杆的外径为0.9-2.9mm之间；所述成人款的各部分径向尺寸如下：所述内管电极的外径为0.6-1.6mm之间，所述外绝缘层的外径即所述电极的电极杆的外径为1.2-3.2mm之间。
  7. 根据权利要求6所述的射频消融电极，其特征在于：所述儿童款的外绝缘层的外径为1.9mm，所述成人款的外绝缘层的外径为2.2mm。
  8. 根据权利要求1所述的射频消融电极，其特征在于：当所述外管电极和所述绝缘面之间有间隙时，在所述电极的尾端和头端之间设有多个电极固定机构，所述多个电极固定机构设置于所述绝缘面和所述外管电极之间，用于将所述外管电极和内管电极的相对位置固定，电极固定机构是由所述外管电极的内壁向所述绝缘面突出的第一凸点，多个第一凸点的顶点均抵接或者接近所述绝缘面的外表面，或者，电极固定机构是由所述绝缘面的内表面向所述外管电极突出的第二凸点，多个第二凸点的顶点均抵接或者接近所述外管电极的内壁。
  9. 根据权利要求8所述的射频消融电极，其特征在于：所述间隙为环形间隙，所述多个电极固定机构形成一个或多个电极固定环，分布于所述电极的尾端和头端之间的环形间隙内。
  10. 根据权利要求1所述的射频消融电极，其特征在于：所述手柄包括手柄前壳和手柄后壳，所述手柄前壳为折角结构，折角的尾端连接所述手柄后壳，折角的前端用于固定所述电极，所述折角的角度设计为便于操作者手持所述手柄后壳而将所述电极深入人体耳道内。
  11. 根据权利要求10所述的射频消融电极，其特征在于：所述手柄还包括手柄内嵌件嵌设于所述手柄前壳的内壁和所述电极的外壁之间，并延伸出所述手柄前壳的所述折角的前端进而包覆于所述电极外表面一段长度外。
  12. 根据权利要求11所述的射频消融电极，其特征在于：所述电极前段设为弯度大于或等于R10的弧形。
  13. 一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用权利要求2所述的第一种方式，其特征在于，包括以下步骤：
    S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
    S2、先打开所述电极的生理盐水的注水和吸水控制开关，生理盐水经由外管电极和内管电极外的绝缘面之间的间隙到达所述电极头端形成连接水珠，再打开所述电极的电源开关，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔，同时生理盐水不断经由所述内管电极的中空管道被吸出；
    S3、关闭所述电极的电源开关和生理盐水的注水和吸水控制开关，将内窥镜和电极均取出。
  14. 一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用权利要求2所述的第二种方式，其特征在于，包括以下步骤：
    S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
    S2、打开所述电极的电源开关和生理盐水的注水控制开关，生理盐水经由外管电极和内管电极外的绝缘层之间的间隙到达所述电极头端，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
    S3、关闭所述电极的电源开关和生理盐水的注水控制开关，将内窥镜和电极均取出。
  15. 一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用权利要求2所述的第三种方式，其特征在于，包括以下步骤：
    S1、在所述手持射频消融电极的电极头端附着生理盐水；
    S2、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
    S3、打开所述电极的电源开关，接通所述电极的电源，使电极头端的生理盐水导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
    S4、关闭所述电极的电源开关，将内窥镜和电极均取出。
  16. 一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用权利要求2所述的第四种方式，其特征在于，包括以下步骤：
    S1、使所述吸水材料吸收足够的生理盐水；
    S2、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
    S3、打开所述电极的电源开关，接通所述电极的电源，使电极头端的生理盐水导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
    S4、关闭所述电极的电源开关，将内窥镜和电极均取出。
  17. 一种用于中耳炎微创手术的射频消融电极的使用方法，所述射频消融电极采用权利要求2所述的第五种方式，其特征在于，包括以下步骤：
    S1、一手持耳道内窥镜，另一手持射频消融电极的手柄，在耳道内窥镜的辅助作用下，将电极送入耳道内直至电极头端接近鼓膜位置；
    S2、打开所述电极的电源开关和生理盐水的注水控制开关，生理盐水经由内管电极的中空管道到达所述电极头端，导通内管电极和外管电极，产生等离子场，继续推进所述电极，使得所述等离子场对鼓膜消融打孔；
    S3、关闭所述电极的电源开关和生理盐水的注水控制开关，将内窥镜和电极均取出。
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