[go: up one dir, main page]

WO2019080079A1 - 一种低温等离子切开刀手术设备、系统及方法 - Google Patents

一种低温等离子切开刀手术设备、系统及方法

Info

Publication number
WO2019080079A1
WO2019080079A1 PCT/CN2017/107944 CN2017107944W WO2019080079A1 WO 2019080079 A1 WO2019080079 A1 WO 2019080079A1 CN 2017107944 W CN2017107944 W CN 2017107944W WO 2019080079 A1 WO2019080079 A1 WO 2019080079A1
Authority
WO
WIPO (PCT)
Prior art keywords
plasma
mode
electrode
unit
command
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2017/107944
Other languages
English (en)
French (fr)
Inventor
严航
郑忠伟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Neowing Medical Co Ltd
Original Assignee
Neowing Medical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Neowing Medical Co Ltd filed Critical Neowing Medical Co Ltd
Priority to PCT/CN2017/107944 priority Critical patent/WO2019080079A1/zh
Priority to US16/349,577 priority patent/US20200179034A1/en
Priority to EP17929579.5A priority patent/EP3714824A4/en
Priority to JP2020564981A priority patent/JP2021516138A/ja
Publication of WO2019080079A1 publication Critical patent/WO2019080079A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—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
    • 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
    • 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
    • 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
    • A61B2018/00577—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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A61B2018/00583—Coblation, i.e. ablation using a cold plasma
    • 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
    • A61B2018/00589—Coagulation
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00625—Vaporization
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/144—Wire
    • 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
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation

Definitions

  • the present invention relates to the field of radio frequency technology and, more particularly, to a cryo-plasma incision surgical device, system and method.
  • the high frequency cutting electrosurgical unit is an electrosurgical instrument that replaces a mechanical scalpel for tissue cutting.
  • the working principle of the high-frequency cutting electric knife is to heat the tissue when the high-frequency high-voltage current generated by the effective electrode tip is in contact with the body, thereby achieving separation and solidification of the body tissue, thereby cutting and stopping bleeding.
  • the peak voltage of the high-frequency cutting electrosurgical electrocoagulation mode is larger than that of the electric cutting mode.
  • the high-frequency cutting electrosurgical knife can be stabilized for up to 150 °C, and the heating effect of the high-frequency cutting electric knife capable of cutting tissue is not caused by the heating electrode or the cutter head. It concentrates the high current density of high currents and directly destroys the tissue in contact with the effective electrode tip. When the temperature of the tissue or cells in contact with or adjacent to the effective electrode rises to the protein denatured in the cell, the action of cutting and coagulation occurs.
  • the operating temperature of a common high-frequency cutting electric knife is usually 100-150 ° C. This working temperature is still high temperature relative to human tissue. After the tissue cells are affected by this temperature, the tissue protein is denatured due to cutting. In particular, ordinary high-frequency cutting electric knives will cause thermal damage to tissues after they have been working for a certain period of time. The degeneration and necrosis of tissue cells is a gradual development process. The common high-frequency cutting electrosurgical unit will have swelling in the operation area and postoperative pain.
  • high-frequency cutting electric knife is used in the digestive department of the hospital for duodenal lesions for nipple cutting surgery, which is prone to complications of pancreatitis (high mortality) because temperature damages the tissue.
  • the high frequency cutting electrosurgical unit has two electrodes, one electrode attached to the patient, the other electrode placed on the cutting blade, and an electrical path is provided on the handle.
  • the high-frequency emission temperature is as high as 400-500 degrees. This temperature will cause accidental damage to the surrounding good tissue, which will make the bleeding problem have a high probability and easily damage the pathological tissue. In this case, the doctor cannot perform the pathological analysis and causes trouble in the effective analysis of the slicing.
  • Duodenoscopic retrograde cholangiopancreatography is a duodenal nipple that inserts a duodenoscope into the descending duodenum to reveal the pancreatic duct and bile duct opening in the lateral wall of the intestine.
  • the catheter is inserted into the tunnel through the duodenal endoscope, inserted into the common opening of the pancreaticobiliary duct through the nipple opening or into the pancreatic duct and bile duct respectively, and the contrast agent is injected, and the pancreatic duct and the bile duct are examined under the X-ray.
  • duodenal papillary sphincter incision is based on the diagnostic ERCP technique and is further developed by endoscopic use of a special high-frequency electric incision to treat the duodenal papillary sphincter and gallbladder.
  • the duodenal papilla includes the main nipple and the secondary nipple.
  • the primary nipple is also commonly referred to as the duodenal papilla or watt papilla. It is often located in the medial side of the posterior segment of the duodenal descending section, about 10 cm away from the gastric pylorus, and most of the morphology is papillary.
  • the nipple incision mainly refers to the incision of the main nipple. Under the duodenal lens, the position of the main nipple is usually at the center of approximately 12 o'clock.
  • the doctor Under the guidance of the duodenoscope and the adjustment of the front end lifter, the doctor operates the instrument high-frequency incision knife into the nipple, through high frequency electricity, to achieve tissue cutting and coagulation.
  • the high-frequency emission temperature is as high as 400-500 degrees. This temperature will cause accidental injury to the good tissue around the duodenal papilla. It is prone to complications such as pancreatitis (high mortality), bleeding, perforation, etc., and the probability of bleeding problems. High, but also easy to damage pathological tissue. In this case, the doctor cannot perform the pathological analysis and causes trouble in the effective analysis of the slicing.
  • a cryoplasmic incubator surgical apparatus comprising:
  • a liquid input unit that inputs a liquid to the target body in response to the liquid input signal to form a thin layer of the conductive medium between the emitter electrode and the return electrode;
  • a bipolar electrode socket connector connected to the high frequency generator through a high frequency connection line for receiving a first input voltage generated by the high frequency generator
  • a transmitting electrode receiving a first input voltage generated by the high frequency generator via a bipolar electrode socket connector, applying a first voltage between the transmitting electrode and the return electrode, causing the conductive medium to reach a first temperature and causing the The conductive medium is converted into a plasma layer to generate a plasma by exciting the conductive medium with electrical energy, and the plasma-based RF energy is used to vaporize and cut the target body.
  • a return electrode is introduced through the same conduit as the emitter electrode and forms a conductive loop in the target body.
  • the bipolar electrode socket connector receives a second input voltage generated by the high frequency generator and the second input The voltage is transmitted to the emitter electrode, and a second voltage is applied between the emitter electrode and the return electrode to maintain the target body at a second temperature, thereby causing the target body to undergo ablation solidification.
  • the cryoplasmic incubator surgical apparatus further includes a guidewire lumen for inputting a guidewire along the guidewire lumen and inserting the tip end of the cryo-plasma slitting knife surgical device to cause the emitter electrode and the return electrode Is placed at the target body.
  • the cryoplasmic incubator surgical apparatus further includes a liquid passing chamber that inputs the liquid to the liquid input unit based on a liquid input command, wherein the liquid input unit measures a current margin of the liquid in real time and the current margin Transmitted to the control unit, the control unit determines whether to generate the liquid input command based on the current margin and transmits the liquid input command to the liquid input unit after determining to generate the liquid input command.
  • the liquid input unit performs liquid input by one of the following modes: a titration mode and a continuous liquid supply mode, and the liquid passage chamber is an annular chamber located outside the return electrode.
  • a portion of the top surface of the emitter electrode remote from the top end of the cryo-plasma incubator surgical device is coated with an insulating layer for insulating and insulating purposes.
  • the infusion port of the liquid input unit is located between the emitter electrode and the return electrode.
  • the cryoplasmic incubator surgical device further includes a drawbar for enabling an operator to provide a support force by the drawbar, and the cryoplasmic slitter surgical device further includes an outer tube for providing an outer wrap function.
  • the emitter electrode and the return electrode are attached to each other, and after the emitter electrode and the return electrode reach the target body, the emitter electrode is pulled by a slider to move the emitter electrode and the loop
  • the electrodes form a bow shape.
  • the first voltage ranges from 100 Vrms to 300 Vrms
  • the second voltage ranges from 60 Vrms to 80 Vrms.
  • the first voltage ranges from 100 Vrms to 300 Vrms
  • the second voltage ranges from 60 Vrms to 80 Vrms.
  • the first temperature ranges from 35 ° C to 40 ° C and the second temperature ranges from 40 ° C to 70 ° C.
  • the low temperature plasma incision knife surgical device sends an alarm signal to the alarm unit after detecting the running fault, and the alarm unit performs an alarm by using an audible prompt, a text prompt and/or an indicator light when receiving the alarm signal;
  • the cryo-plasma incubator surgical device is coupled to a pedal-type input device, wherein the user operates the pedal-type input device to generate a control command for controlling the output power of the cryo-plasma incision surgical device, wherein
  • the control command is a binary group ⁇ mode, power>.
  • the low temperature plasma incisor surgical device is coupled to a display unit for displaying an operational state of the cryosurgical incision surgical device in real time.
  • a cryoplasmic incubator surgical system comprising:
  • the input unit receives a control command input by the user and sends the control command to the control unit;
  • control unit that parses the control instruction and generates a first mode instruction when the control instruction indicates the first mode, and calculates an output power for the first mode according to the current impedance and the control instruction, the first mode An instruction and a first voltage indication associated with the output power in the first mode are sent to the interface unit;
  • An interface unit receiving a first mode command and a first voltage indication from the control unit, and forwarding the first mode command and the first voltage indication to a plasma unit, and receiving a current impedance of the target contact from the plasma unit and Transmitting a current impedance to the control unit;
  • a plasma unit in response to receiving the first mode command and the first voltage indication from the interface unit, entering a first mode: circuit activation between a transmit electrode and a return electrode at a target contact end of the plasma unit via a conductive medium
  • circuit activation between a transmit electrode and a return electrode at a target contact end of the plasma unit via a conductive medium To form a thin layer, apply a first voltage between the emitter electrode and the return electrode such that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium with electrical energy to generate a plasma, and the plasma-based radio frequency Energy to vaporize and cut the target body;
  • the emitter electrode, the plasma layer, the return electrode and the target contact end form a loop.
  • the method further includes the control unit parsing the control instruction and generating a second mode instruction when the control instruction indicates the second mode, and calculating an output power for the second mode according to the current impedance and the control instruction, A second mode command and a second voltage indication associated with the output power in the second mode are sent to the interface unit.
  • the interface unit receives a second mode command and a second voltage indication from the control unit and forwards the second mode command and the second voltage indication to the plasma unit.
  • the plasma unit Responsive to the second command and the second voltage indication received from the interface unit, the plasma unit enters a second mode: applying a second voltage to maintain a target contact end of the plasma unit at a second temperature, thereby targeting The body undergoes ablation and solidification.
  • An alarm unit is further included for performing an alarm by an audible prompt, a text prompt, and/or an indicator light when an alarm signal is received;
  • the alarm unit sends an alarm signal to the control unit after detecting the operation fault, and the control unit sends an alarm signal to the alarm unit.
  • the input unit is a pedal type input device, wherein a user generates by operating the pedal input device
  • the control instruction wherein the control instruction is a binary group ⁇ mode, power>.
  • a drip input unit for inputting the conductive medium to a plasma unit based on a conductive medium input command of the control unit, wherein the plasma unit measures a current margin of the conductive medium in real time and the current margin Sending to the control unit, the control unit determines whether to generate the conductive medium input instruction based on the current margin and transmits the conductive medium input command to the drip input unit after determining to generate the conductive medium input instruction.
  • a display unit is also included for displaying the operational status of the cryosurgical slitting knife surgical system in real time.
  • the first voltage ranges from 100 Vrms to 300 Vrms
  • the second voltage ranges from 60 Vrms to 80 Vrms.
  • the first temperature ranges from 35 ° C to 40 ° C
  • the second temperature ranges from 40 ° C to 70 ° C
  • the thermal penetration distance is less than or equal to 150 microns, and in the second mode, the thermal penetration distance is less than or equal to 200 microns.
  • a cryo-plasma slitting knife surgical method comprising:
  • the emitter electrode, the plasma layer, the return electrode and the target contact end form a loop.
  • the method further includes parsing the control instruction and generating a second mode instruction when the control instruction indicates the second mode, calculating an output power for the second mode according to the current impedance and the control instruction, and determining A second voltage indication associated with the output power in the second mode.
  • the second mode command and the second voltage indication are forwarded to the plasma device.
  • the plasma device In response to receiving the second command and the second voltage indication, the plasma device enters the second mode: applying the second electrical Pressing to maintain the target contact end of the plasma device at a second temperature to ablate and solidify the target.
  • It also includes an alarm by an audible prompt, a text prompt, and/or an indicator light when an alarm signal is received;
  • An alarm signal is generated after an operational failure is detected.
  • the user generates the control command by operating a pedal input device, wherein the control command is a binary group ⁇ mode, power>.
  • the method further includes inputting the conductive medium to the plasma device based on a conductive medium input command, wherein the plasma device measures a current margin of the conductive medium in real time and determines whether to generate the conductive medium input command based on the current margin.
  • the first voltage ranges from 100 Vrms to 300 Vrms
  • the second voltage ranges from 60 Vrms to 80 Vrms.
  • the first temperature ranges from 35 ° C to 40 ° C
  • the second temperature ranges from 40 ° C to 70 ° C
  • the thermal penetration distance is less than or equal to 150 microns, and in the second mode, the thermal penetration distance is less than or equal to 200 microns.
  • the temperature of the plasma unit according to the present application is only 40-70 degrees, thereby solving the problem of accidental injury to surrounding good tissue, bleeding problems and reducing complications.
  • the plasma unit of the present application is constructed in a bipolar manner to form a loop directly on the conduit.
  • FIG. 1 is a schematic diagram of main parts of a plasma therapeutic apparatus according to a preferred embodiment of the present invention.
  • FIG. 2 is a schematic structural view of a plasma therapeutic apparatus according to a preferred embodiment of the present invention.
  • FIG. 3 is a schematic structural view of a cryo-plasma slitting knife surgical system according to a preferred embodiment of the present invention
  • FIG. 4 is a flow chart of a low temperature plasma incision surgical procedure in accordance with a preferred embodiment of the present invention.
  • FIG. 5 is a schematic structural view of a cryo-plasma slitting knife surgical apparatus according to a preferred embodiment of the present invention.
  • FIGS. 6-8 are partial enlarged or cross-sectional views of a cryo-plasma incubator surgical device in accordance with a preferred embodiment of the present invention.
  • the plasma therapy apparatus 100 can be used for cutting, ablation, coagulation, and hemostasis of the duodenal papilla.
  • the plasma therapeutic apparatus 100 can also be used for cutting, ablation, coagulation, and hemostasis of soft tissues in joints, spines, skin, ENT, and the like.
  • the plasma therapeutic apparatus 100 of the present application is used within 24 hours, classified according to contact time, is temporarily contacted, classified according to the nature of the contact human body, belongs to an external access device (with tissue/bone/dentine), and is classified according to the structural characteristics of the medical device.
  • the accessory bipolar surgical electrode (cutting knife) head of the plasma therapeutic apparatus 100 is a disposable sterile product.
  • the plasma therapy apparatus 100 employs a bipolar scheme and operates at a frequency of 110 kHz.
  • the plasma therapeutic apparatus 100 realizes cutting, ablation, coagulation, and hemostasis of soft tissues in operations such as ENT, and the like by plasma technology.
  • the plasma therapy apparatus 100 forms a thin layer by activating physiological saline as a conductive liquid between the emitter electrode and the return electrode.
  • the plasma therapeutic apparatus 100 gives sufficient energy (voltage)
  • the physiological saline is converted into a gas layer (plasma layer) composed of energized charged particles. That is, the plasma therapeutic apparatus 100 utilizes energy to excite a conductive medium (eg, physiological saline) to generate a plasma, and relies on the energy of the plasma to break tissue molecular bonds.
  • a conductive medium eg, physiological saline
  • the energy of the plasma directly cleaves biomacromolecules such as proteins into gases such as O 2 , CO 2 , N 2 , etc., thereby completing vaporization and cutting of the tissue.
  • gases such as O 2 , CO 2 , N 2 , etc.
  • the functional architecture of the plasma therapy apparatus 100 includes: a main control program, an alarm unit, an interface unit, an output control unit, a bipolar surgical electrode (cutting knife) interface, and a bipolar surgical electrode (cutting knife). , foot switch, foot control interface, drip control valve and drip control valve interface.
  • the main control program, the alarm unit, the interface unit, the output control, the bipolar surgical electrode interface, the foot control interface, and the drip control valve interface belong to the software part of the plasma therapeutic apparatus 100.
  • the function of some parts of the plasma therapy apparatus 100 is shown in Table 1.
  • the foot switch is capable of controlling the mode of operation of the plasma therapy apparatus 100.
  • the working mode of the plasma therapeutic apparatus 100 is divided into a cutting mode and a coagulation mode.
  • the waterproof level of the foot switch is the waterproof level standard IPX8, and the foot switch is an electric foot switch.
  • the yellow pedal of the foot switch corresponds to the cutting mode
  • the gear level of the cutting mode is 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the plasma therapy apparatus 100 enters the cutting mode.
  • the gear position adjustment mode of the cutting mode is: by adjusting the black button on the foot switch (or manually adjusting the yellow button on the main panel) in the state of adjusting to the cutting mode.
  • the cutting gear can be selected from any of the 1 to 9 gears. Among them, the higher the gear position, the larger the output voltage. In the cutting mode, the output voltages of 1 to 9 are as shown in Table 2:
  • the blue pedal of the foot switch corresponds to the coagulation mode
  • the gear level of the coagulation mode is 1 to 5 steps. That is, when the blue pedal of the foot switch is stepped on, the plasma therapy apparatus 100 enters the blood coagulation mode.
  • the position adjustment mode of the coagulation mode is: in the state of adjusting to the coagulation mode (pressing the mode button to switch the cutting mode and the coagulation mode), the black button on the blue pedal (or manually adjusting the upper and lower blue buttons of the main panel) is adjusted.
  • the black button is pressed, the coagulation position can be selected from any of the 1st to the 5th. The higher the gear, the higher the output voltage.
  • step on the blue pedal for coagulation In coagulation mode, the output voltages of 1 to 5 are shown in Table 3:
  • the foot control interface is configured to receive a control command of the foot switch and forward the control command to the main control program.
  • the control command is a binary group ⁇ mode, power>.
  • Modes include: cutting mode and coagulation mode. In the cutting mode, the power includes 9 gear positions, and in the coagulation mode, the power includes 5 gear positions.
  • the main control program parses the control instruction and generates a first mode instruction when the control instruction indicates the first mode, and calculates an output power for the first mode according to the current impedance and the control instruction, A first mode command and a first voltage indication associated with the output power in the first mode are sent to an output control unit.
  • the initial current impedance is zero, that is, when the plasma therapy apparatus 100 is powered on, the default current impedance is zero.
  • the master program parses the control command and generates a second mode command when the control command indicates the second mode, and calculates an output power for the second mode according to the current impedance and the control command, A two mode command and a second voltage indication associated with the output power in the second mode are sent to the output control unit.
  • calculating the output power for the first mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then the first mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the first mode, the output power in the first mode is set to the third gear; and if the current impedance is When the impedance is low and the control command indicates the second gear in the first mode, the output power in the first mode is set to the second gear.
  • calculating the output power for the second mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, then the second mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the second mode, the output power in the second mode is set to the third gear; and if the current impedance is When the impedance is low and the control command indicates the second gear in the second mode, the output power in the second mode is set to the second gear.
  • the calculated output power exceeds the highest level in the first mode or the second mode, the highest gear is used as the actual output power.
  • the output control unit is configured to receive the first mode command and the first voltage indication from the master program, and forward the first mode command and the first voltage indication to the bipolar surgical electrode interface, and from the bipolar
  • the surgical electrode interface receives the current impedance of the target contact and transmits the current impedance to the master program.
  • the output control unit receives the second mode command and the second voltage indication from the master program and forwards the second mode command and the second voltage indication to the bipolar surgical electrode interface.
  • the bipolar surgical electrode interface is configured to receive a power indication of the master program and transmit the power indication to the bipolar surgical electrode, and measure the real-time impedance of the bipolar surgical electrode and pass the real-time impedance through the output control The unit is passed to the master program.
  • the bipolar surgical electrode enters the first mode in response to receiving the first mode command and the first voltage indication from the bipolar surgical electrode interface: emission at the target contact end of the bipolar surgical electrode through a conductive medium Electrode and loop Circuit activation is performed between the poles to form a thin layer, a first voltage is applied between the emitter electrode and the return electrode, such that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium to generate plasma by using electrical energy, And plasma-based RF energy is used to vaporize and cut the target body.
  • the bipolar surgical electrode enters a second mode in response to a second command and a second voltage indication received from the bipolar surgical electrode interface: applying a second voltage to maintain a target contact end of the bipolar surgical electrode The second temperature is such that the target body is ablated and solidified.
  • the alarm unit is configured to perform an alarm by an audible prompt, a text prompt, and/or an indicator light when the alarm signal is received.
  • the alarm signal is sent to the main control program after the bipolar surgical electrode detects an operational fault, and the main control program sends an alarm signal to the alarm unit.
  • the interface unit is configured to display the operating state of the cryosurgical slitting knife surgical system in real time.
  • a drip control valve is configured to input the conductive medium to a bipolar surgical electrode based on a conductive medium input command of the master program, wherein the bipolar surgical electrode measures a current margin of the conductive medium in real time and The current margin is sent to a main control program, and the main control program determines whether to generate the conductive medium input instruction based on the current margin and sends the conductive medium input instruction after determining to generate the conductive medium input instruction.
  • the drip control valve interface is used to effect two-way communication between the drip control valve and the main control program.
  • the emitter electrode, the plasma layer, the return electrode, and the target contact end at the end of the bipolar surgical electrode form a loop.
  • the operating temperature of the bipolar surgical electrode is 35 to 40 ° C
  • the conventional electrosurgical knife has an operating temperature of 350 to 700 ° C.
  • the thermal penetration distance of the bipolar surgical electrode is smaller than the thermal penetration distance of the conventional electrosurgical blade, wherein the thermal penetration distance in the cutting mode is less than or equal to 150 micrometers and the thermal penetration distance in the coagulation mode is less than or equal to 200 micrometers.
  • the traditional electrosurgical knife has a thermal penetration distance greater than 9000 microns.
  • the plasma therapy device 100 works on the principle of plasma cryoablation.
  • the bipolar cutter head generates energy, converts the physiological saline into a thin layer of plasma, and dissociates the molecular bonds constituting the cellular components in the target tissue, causing coagulative necrosis of the tissue to form an ablation or cutting effect. Due to the operation at relatively low temperatures, thermal damage to surrounding tissue is minimized compared to conventional high frequency cutting electrosurgical knives.
  • a working temperature of about 35 ° C the target tissue volume is reduced, the microvessels in the target tissue are closed, and the lesion is removed.
  • the temperature around the cutter head is lower than 70 °C (see the thermal damage report of the in vitro experimental study), and the working temperature is higher than that of the conventional high-frequency cutting electric knife (100-150 ° C high temperature).
  • the treatment temperature of the low-temperature plasma knife is still high temperature relative to human tissue, and the tissue cells are affected by this temperature, the electrosurgical cutting will also cause tissue protein denaturation, especially after a certain period of time, it may also cause thermal damage to the tissue.
  • the degeneration and necrosis of tissue cells is a gradual development process. Therefore, some patients underwent low-temperature plasma surgery, and the reaction of swelling and postoperative pain in the operation area is not lighter than that of high-frequency cutting electrosurgical.
  • the damage thermal damage depth of the plasma therapeutic apparatus and the ordinary high-frequency cutting electric knife is shown in Table 5 below:
  • Thermal damage depth during cutting Depth of thermal damage during coagulation Plasma therapy device Average 150 microns Average 200 microns High frequency cutting electric knife 1.23 ⁇ 0.24mm 1.37 ⁇ 0.26mm
  • the plasma treatment instrument selected the maximum operation time in the thermal injury report of the in vitro experimental study, and compared the plasma treatment instrument with the maximum operation time and the heat loss depth of the normally used high-frequency cutting electric knife. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than the heat loss depth of the high frequency cutting electric knife.
  • FIG. 2 is a schematic diagram of the main parts of a plasma therapeutic apparatus 200 in accordance with a preferred embodiment of the present invention.
  • the main components of the plasma therapeutic apparatus 200 include: a bipolar surgical electrode interface 201, a drip control valve interface 202, a tread switch interface 203, a display screen 204, a main board 205, a horn 206, a front panel 207, and a fault alarm.
  • the tread switch interface 203 is for receiving an instruction of the foot switch, the foot switch and capable of controlling the operating mode of the plasma therapy apparatus 200.
  • the working mode of the plasma therapeutic apparatus 200 is divided into a cutting mode and a coagulation mode.
  • the waterproof level of the foot switch is the waterproof level standard IPX8, and the foot switch is an electric foot switch.
  • the yellow pedal of the foot switch corresponds to the cutting mode
  • the gear level of the cutting mode is 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the plasma therapy apparatus 200 enters the cutting mode.
  • the gear position adjustment mode of the cutting mode is: by adjusting the black button on the foot switch (or manually adjusting the yellow button on the main panel) in the state of adjusting to the cutting mode.
  • the cutting gear can be selected from any of the 1 to 9 gears. Among them, the higher the gear position, the larger the output voltage.
  • the blue pedal of the foot switch corresponds to the coagulation mode
  • the gear level of the coagulation mode is 1 to 5 steps. That is, when the blue pedal of the foot switch is stepped on, the plasma therapy apparatus 200 enters the blood coagulation mode.
  • the position adjustment mode of the coagulation mode is: in the state of adjusting to the coagulation mode (pressing the mode button to switch the cutting mode and the coagulation mode), the black button on the blue pedal (or manually adjusting the upper and lower blue buttons of the main panel) is adjusted.
  • the black button is pressed, the coagulation position can be selected from any of the 1st to the 5th. The higher the gear, the higher the output voltage.
  • step on the blue pedal for coagulation is required in clinical use, step on the blue pedal for coagulation.
  • the tread switch interface 203 is configured to receive a control command of the foot switch and forward the control command to the main control program.
  • the control command is a binary group ⁇ mode, power>.
  • Modes include: cutting mode and coagulation mode. In the cutting mode, the power includes 9 gear positions, and in the coagulation mode, the power includes 5 gear positions.
  • the main board 205 is for housing firmware, and the firmware stores the main control program.
  • the main control program parses the control instruction and generates a first mode instruction when the control instruction indicates the first mode, and calculates an output power for the first mode according to the current impedance and the control instruction, A mode command and a first voltage indication associated with the output power in the first mode are sent to an output control unit.
  • the initial current impedance is zero, that is, when the plasma therapy device 200 is powered on, the default current impedance is zero.
  • the master program parses the control command and generates a second mode command when the control command indicates the second mode, and calculates an output power for the second mode according to the current impedance and the control command, A two mode command and a second voltage indication associated with the output power in the second mode are sent to the output control unit.
  • the current impedance includes high impedance, medium impedance, and low impedance (zero impedance is low impedance).
  • calculating the output power for the first mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then the first mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the first mode, the output power in the first mode is set to the third gear; and if the current impedance is When the impedance is low and the control command indicates the second gear in the first mode, the output power in the first mode is set to the second gear.
  • calculating the output power for the second mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, then the second mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the second mode, the output power in the second mode is set to the third gear; and if the current impedance is When the impedance is low and the control command indicates the second gear in the second mode, the output power in the second mode is set to the second gear.
  • the calculated output power exceeds the highest level in the first mode or the second mode, the highest gear is used as the actual output power.
  • an output control unit (not shown in FIG. 2) is configured to receive the first mode command and the first voltage indication from the master program, and forward the first mode command and the first voltage indication to the bipolar
  • the surgical electrode interface 201 is received, and the current impedance of the target contact is received from the bipolar surgical electrode interface 201 and the current impedance is sent to the master program.
  • the output control unit receives the second mode command and the second voltage indication from the master program, and forwards the second mode command and the second voltage indication to the bipolar surgical electrode interface 201.
  • the bipolar surgical electrode interface 201 is configured to receive a power indication of the master program and transmit the power indication to the bipolar surgical electrode, and measure the real-time impedance of the bipolar surgical electrode and pass the real-time impedance through the output
  • the control unit is passed to the master program.
  • a bipolar surgical electrode (not shown) is responsive to receiving a first mode command and a first voltage indication from the bipolar surgical electrode interface 201 into a first mode: through the conductive medium at the bipolar surgery Circuit activation between the emitter electrode and the return electrode at the target contact end of the electrode to form a thin layer, applying a first voltage between the emitter electrode and the return electrode such that the conductive medium reaches a first temperature and is converted into a plasma layer Thereby, the electrical energy is excited by the electrical energy to generate a plasma, and the plasma-based radio frequency energy is used to vaporize and cut the target body.
  • the bipolar surgical electrode In response to the second command and the second voltage indication received from the bipolar surgical electrode interface 201, the bipolar surgical electrode enters a second mode: applying a second voltage to maintain a target contact end of the bipolar surgical electrode The second temperature is such that the target body is ablated and solidified.
  • the fault warning light 208 is configured to perform an alarm by means of an indicator light when an alarm signal is received.
  • the alarm signal is sent to the main control program after the bipolar surgical electrode detects an operational fault, and the main control program sends an alarm signal to the fault alarm light 208.
  • the horn 206 is used to alarm by sound when an alarm signal is received.
  • the alarm signal is sent to the main control program after the bipolar surgical electrode detects an operational fault, and the main control program sends an alarm signal to the horn 206.
  • the display screen 204 is used to display the operational status of the cryosurgical slitting knife surgical system in real time.
  • the drip control valve 212 is configured to input the conductive medium to a bipolar surgical electrode based on a conductive medium input command of the master program, wherein the bipolar surgical electrode measures a current margin of the conductive medium in real time and Transmitting the current margin to a main control program, the main control program determining whether to generate the conductive medium input instruction based on the current margin and inputting the conductive medium into an instruction after determining to generate the conductive medium input instruction It is sent to the drip control valve 212.
  • the drip control valve interface 202 is used to effect two-way communication between the drip control valve 212 and the master program.
  • the present application employs a dual mode liquid outlet: 1. a titration mode, ie a drop of supply as in the case of a bottle infusion; and a continuous supply mode, ie a mode of continuous supply of liquid flow.
  • Bipolar surgical electrode interface The port is connected to the bipolar electrode socket connector (cutting knife connector) of FIG. 5 as described below through a patch cord, and the drip control valve interface is connected to the liquid passing chamber of FIG. 5 through a connecting pipe.
  • the foot switch port is connected to an external foot pedal through a connecting line to control the supply and disconnection of energy and drip. When the foot pedal is depressed, energy and drip are supplied; when the foot pedal is released, energy and dripping are broken.
  • the emitter electrode, the plasma layer, the return electrode, and the target contact end at the end of the bipolar surgical electrode form a loop.
  • the operating temperature of the bipolar surgical electrode is 35 to 40 ° C
  • the conventional electrosurgical knife has an operating temperature of 350 to 700 ° C.
  • the thermal penetration distance of the bipolar surgical electrode is smaller than the thermal penetration distance of the conventional electrosurgical blade, wherein the thermal penetration distance in the cutting mode is less than or equal to 150 micrometers and the thermal penetration distance in the coagulation mode is less than or equal to 200 micrometers.
  • the traditional electrosurgical knife has a thermal penetration distance greater than 9000 microns.
  • the upper mold 210 and the lower mold 209 protect the main board by a combination.
  • the fan 213 is used for heat dissipation, and the power module 211 is used to supply power to the plasma therapy apparatus 200.
  • the front panel 207 is used for data display and operation control.
  • FIG. 3 is a schematic block diagram of a cryo-plasma slitting knife surgical system 300 in accordance with a preferred embodiment of the present invention.
  • the cryoplasmic incubator surgical system 300 can be used for the cutting, ablation, and coagulation and hemostasis of the duodenal papilla.
  • the cryo-plasma slitting knife surgical system 300 can also be used for cutting, ablation, coagulation, and hemostasis of soft tissues in joints, spine, skin, ENT, and the like.
  • the cryo-plasma incubator surgical system 300 of the present application is used within 24 hours, classified according to contact time, is temporarily contacted, classified according to the nature of the contact human body, belongs to an external access device (with tissue/bone/dentine), and according to the structure of the medical device Feature classification is an active medical device.
  • the cryoplasmic incubator surgical system 300 employs a bipolar solution and operates at 110 kHz.
  • the cryoplasmic plasma incision surgical system 300 achieves cutting, ablation, coagulation, and hemostasis of soft tissues during surgery such as ENT, and the like by plasma technology.
  • the cryoplasmic incubator surgical system 300 forms a thin layer by activating saline between the emitter electrode and the return electrode.
  • the cryo-plasma incision surgery system 300 gives sufficient energy (voltage), the saline is converted into a gas layer (plasma layer) composed of energized charged particles.
  • the cryoplasmic incubator surgical system 300 utilizes energy to excite a conductive medium (eg, saline) to generate a plasma, and relies on the energy of the plasma to break tissue molecular bonds.
  • the energy of the plasma directly cleaves biomacromolecules such as proteins into gases such as O 2 , CO 2 , N 2 , etc., thereby completing vaporization and cutting of the tissue.
  • a low voltage is applied to the working tip of the plasma therapeutic apparatus 100, the electric field is lower than the domain value requirement for generating the plasma layer and heat of tissue resistance is generated, thereby ablation and hemostasis of the tissue.
  • the cryoplasmic incubator surgical system 300 includes an input unit 301, a control unit 302, an interface unit 303, a plasma unit 304, an alarm unit 305, a drip input unit 306, and a display unit 307.
  • the input unit 301 is, for example, a foot switch, and the foot switch can control the operating mode of the cryo-plasma slitting surgery system 300.
  • the working mode of the cryoplasmic incubator surgical system 300 is divided into a cutting mode and a coagulation mode.
  • the waterproof level of the foot switch is the waterproof level standard IPX8, and the foot switch is an electric foot switch.
  • the yellow pedal of the foot switch corresponds to the cutting mode
  • the gear level of the cutting mode is 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the cryo-plasma cutting knife surgical system 300 enters the cutting mode.
  • the gear position adjustment mode of the cutting mode is: by adjusting the black button on the foot switch (or manually adjusting the yellow button on the main panel) in the state of adjusting to the cutting mode.
  • the cutting gear can be selected from any of the 1 to 9 gears. Among them, the higher the gear position, the larger the output voltage.
  • the blue pedal of the foot switch corresponds to the coagulation mode
  • the gear level of the coagulation mode is 1 to 5 steps. That is, when the blue pedal of the foot switch is stepped on, the cryo-plasma cutting knife surgical system 300 enters the coagulation mode.
  • the position adjustment mode of the coagulation mode is: in the state of adjusting to the coagulation mode (pressing the mode button to switch the cutting mode and the coagulation mode), the black button on the blue pedal (or manually adjusting the upper and lower blue buttons of the main panel) is adjusted.
  • the black button is pressed, the coagulation position can be selected from any of the 1st to the 5th. The higher the gear, the higher the output voltage.
  • step on the blue pedal for coagulation is required in clinical use, step on the blue pedal for coagulation.
  • the foot control interface is configured to receive a control command of the foot switch and forward the control command to the main control program.
  • the control command is a binary group ⁇ mode, power>.
  • Modes include: cutting mode and coagulation mode. In the cutting mode, the power includes 9 gear positions, and in the coagulation mode, the power includes 5 gear positions.
  • control unit 302 parses the control instruction and generates a first mode instruction when the control instruction indicates the first mode, and calculates an output power for the first mode according to the current impedance and the control instruction,
  • the first mode command and the first voltage indication associated with the output power in the first mode are sent to the interface unit 303.
  • the initial current impedance is zero, that is, when the low temperature plasma incision surgery system 300 is turned on, the default current impedance is zero.
  • the control unit 302 parses the control instruction and generates a second mode instruction when the control instruction indicates the second mode, and calculates an output power for the second mode according to the current impedance and the control instruction,
  • the two mode command and the second voltage indication associated with the output power in the second mode are sent to the interface unit 303.
  • the current impedance includes high impedance, medium impedance, and low impedance (zero impedance is low impedance).
  • calculating the output power for the first mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then the first mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the first mode, the output power in the first mode is set to the third gear; And if the current impedance is low impedance and the control command indicates the second gear in the first mode, the output power in the first mode is set to the second gear.
  • calculating the output power for the second mode according to the current impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, then the second mode is The output power is set to the fourth gear; if the current impedance is the medium impedance and the control command indicates the second gear in the second mode, the output power in the second mode is set to the third gear; and if the current impedance is When the impedance is low and the control command indicates the second gear in the second mode, the output power in the second mode is set to the second gear.
  • the calculated output power exceeds the highest level in the first mode or the second mode, the highest gear is used as the actual output power.
  • the interface unit 303 is configured to receive the first mode instruction and the first voltage indication from the control unit 302, and forward the first mode instruction and the first voltage indication to the plasma unit 304, and receive from the plasma unit 304.
  • the current impedance of the target contact end and the current impedance is sent to the control unit 302.
  • the interface unit 303 receives the second mode command and the second voltage indication from the control unit 302, and forwards the second mode command and the second voltage indication to the plasma unit 304.
  • the interface unit 303 is configured to receive the power indication of the control unit 302 and transmit the power indication to the plasma unit 304, and measure the real-time impedance of the plasma unit 304 and pass the real-time impedance to the control through the interface unit 303.
  • plasma unit 304 enters a first mode in response to receiving a first mode command and a first voltage indication from said plasma unit 304: a transmitting electrode and a return electrode at a target contact end of said plasma unit 304 through a conductive medium Circuit activation is performed to form a thin layer, a first voltage is applied between the emitter electrode and the return electrode such that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium with electrical energy to generate a plasma, and Plasma-based RF energy is used to vaporize and cut the target.
  • the plasma unit 304 In response to the second command and the second voltage indication received from the plasma unit 304, the plasma unit 304 enters a second mode: applying a second voltage to maintain the target contact end of the plasma unit 304 at a second temperature, Thereby the target body is ablated and solidified.
  • the alarm unit 305 is configured to perform an alarm by an audible prompt, a text prompt, and/or an indicator light when the alarm signal is received.
  • the alarm unit sends an alarm signal to the control unit 302 after detecting the operation fault, and the control unit 302 sends an alarm signal to the alarm unit 305.
  • the drip input unit 306 is configured to input the conductive medium to the plasma unit 304 based on the conductive medium input command of the control unit 302, wherein the plasma unit 304 measures the current margin of the conductive medium in real time and Transmitting the current margin to the control unit 302, the control unit 302 determining whether to generate the conductive medium input instruction based on the current margin and inputting the conductive medium into the instruction after determining to generate the conductive medium input instruction It is sent to the drip input unit 306.
  • the emitter electrode, the plasma layer, the return electrode, and the target contact end at the end of the plasma unit 304 form a loop.
  • the operating temperature of the plasma unit 304 is 35 to 40 ° C
  • the conventional electrosurgical knife has an operating temperature of 350 to 700 ° C.
  • the thermal penetration distance of the plasma unit 304 is smaller than the thermal penetration distance of the conventional electrosurgical blade, wherein the thermal penetration distance in the cutting mode is less than or equal to 150 micrometers and the thermal penetration distance in the coagulation mode is less than or equal to 200 micrometers, and Conventional electrosurgical knives have a thermal penetration distance greater than 9000 microns.
  • the display unit 307 is configured to display an operating state of the cryoplasmic incubator surgical system in real time.
  • the working principle of the cryoplasmic incubator surgical system 300 is plasma cryoablation.
  • the bipolar cutter head generates energy, converts the physiological saline into a thin layer of plasma, and dissociates the molecular bonds constituting the cellular components in the target tissue, causing coagulative necrosis of the tissue to form an ablation or cutting effect. Due to the operation at relatively low temperatures, thermal damage to surrounding tissue is minimized compared to conventional high frequency cutting electrosurgical knives.
  • a working temperature of about 35 ° C the target tissue volume is reduced, the microvessels in the target tissue are closed, and the lesion is removed.
  • the temperature of the low temperature plasma incision surgery system 300 is less than 70 ° C during operation (see the thermal injury report of the in vitro experimental study), and the ordinary high frequency cutting electrosurgical knife (100 ⁇ 150 ° C high temperature) in the traditional sense.
  • the treatment temperature of the low temperature plasma knife is still high temperature compared with human tissue, the tissue cells are affected by this temperature, and the electrosurgical cutting will also cause tissue protein denaturation, especially after a certain period of time. Tissue causes thermal damage. The degeneration and necrosis of tissue cells is a gradual development process.
  • the plasma treatment instrument selected the maximum operation time in the thermal injury report of the in vitro experimental study, and compared the plasma treatment instrument with the maximum operation time and the heat loss depth of the normally used high-frequency cutting electric knife. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than the heat loss depth of the high frequency cutting electric knife.
  • FIG. 4 is a flow chart of a cryo-plasma slitting knife surgical procedure 400 in accordance with a preferred embodiment of the present invention. As shown in FIG. 4, method 400 begins at step 401. At step 401, a control command entered by the user is received.
  • control command is parsed and a first mode command is generated when the control command indicates the first mode, and the output power for the first mode is calculated based on the current impedance and the control command.
  • a first voltage indication associated with the output power in the first mode is determined.
  • the first mode command and the first voltage indication are forwarded to the plasma device, and the current impedance of the target contact is received from the plasma device.
  • step 405 in response to receiving the first mode command and the first voltage indication, causing the plasma device to enter a first mode: circuit activation between a transmit electrode and a return electrode of a target contact end of the plasma unit via a conductive medium
  • circuit activation between a transmit electrode and a return electrode of a target contact end of the plasma unit via a conductive medium To form a thin layer, apply a first voltage between the emitter electrode and the return electrode such that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium with electrical energy to generate a plasma, and the plasma-based radio frequency Energy to vaporize and cut the target body;
  • the emitter electrode, the plasma layer, the return electrode and the target contact end form a loop.
  • the method further includes parsing the control instruction and generating a second mode instruction when the control instruction indicates the second mode, calculating an output power for the second mode according to the current impedance and the control instruction, and determining A second voltage indication associated with the output power in the second mode.
  • the second mode command and the second voltage indication are forwarded to the plasma device.
  • the plasma device In response to receiving the second command and the second voltage indication, the plasma device enters a second mode: applying a second voltage to maintain the target contact end of the plasma device at a second temperature, thereby ablating the target body .
  • It also includes an alarm by an audible prompt, a text prompt, and/or an indicator light when an alarm signal is received; wherein an alarm signal is generated after an operational fault is detected.
  • the user generates the control command by operating a pedal input device, wherein the control command is a binary group ⁇ mode, power>.
  • the method further includes inputting the conductive medium to the plasma device based on a conductive medium input command, wherein the plasma device measures a current margin of the conductive medium in real time and determines whether to generate the conductive medium input command based on the current margin.
  • Method 400 displays the operational status of the plasma device in real time.
  • FIG. 5 is a schematic structural view of a cryo-plasma slitting knife surgical apparatus according to a preferred embodiment of the present invention.
  • the cryo-plasma incubator surgical apparatus includes: a transmitting electrode (cutting wire) 501, a return electrode (circle) 502, a sheath 503, a guide wire lumen interface 504, an injection cavity interface 505, and a pull rod cap 506.
  • Pad 507, slider (with socket hole) 508, socket Pin 509 and tie rod 510 Preferably, the emitter electrode (cut wire) 501 and the return electrode (circle) 502 are introduced through the same conduit and form a conductive loop in the target body.
  • a transmitting electrode (cutting wire) 501 receives the first input voltage generated by the high frequency generator via the socket Pin 509, and applies a first between the transmitting electrode (cutting wire) 501 and the return electrode (circle) 502
  • the voltage is such that the conductive medium reaches a first temperature and causes the conductive medium to be converted into a plasma layer, thereby exciting the conductive medium to generate plasma using electrical energy, and the plasma-based radio frequency energy is applied to the target body Vaporization cutting.
  • the emitter electrode 501 and the return electrode 502 are substantially linearly attached to facilitate entry of the front end of the sheath 503 into the human body.
  • the slider 508 moves backward, pulling the emitter electrode 501 to form the emitter electrode 501 and the return electrode 502 in a bow shape.
  • An insulating layer (not shown in Fig. 5) coats the emitter electrode (cut wire) 501 wire, and the insulating layer serves to function as insulation and heat insulation.
  • the sheath is used to provide an outer covering function.
  • the injection chamber interface 505 inputs the liquid to a liquid input unit based on a liquid input command, wherein the liquid input unit measures a current margin of the liquid in real time and transmits the current margin to a control unit, the control unit is based on The current margin determines whether the liquid input command is generated and sends the liquid input command to the drip input unit after determining to generate the liquid input command.
  • the injection chamber interface 505 is an annular chamber located outside of the return electrode lead.
  • a guidewire lumen interface 504 is for inputting a guidewire along the guidewire lumen and inserting it into the head end of the cryosurgical slitting knife surgical device to cause the emitter electrode 501 and the return electrode 502 to be placed at the target body .
  • the pull rod 510 is used to enable the operator to provide a supporting force by pulling the lever 510.
  • the socket Pin 509 is connected to the high frequency generator through a high frequency connection line for receiving the first input voltage generated by the high frequency generator.
  • the socket Pin 509 receives the second input voltage generated by the high frequency generator and transmits the second input voltage to the transmitting electrode, and applies a second voltage between the transmitting electrode 501 and the return electrode 502 to keep the target body It is the second temperature, thereby causing the target body to undergo ablation and coagulation.
  • a liquid input unit (not shown in FIG. 5), in response to the liquid input signal, inputs a liquid to the target to form a thin layer of the conductive medium between the emitter electrode and the return electrode.
  • the liquid input unit performs liquid input by one of the following modes: a titration mode and a continuous supply mode.
  • the material of the transmitting electrode (cutting wire) 501 is stainless steel 304
  • the material of the return electrode (round sleeve) 502 is stainless steel 304
  • the material of the sheath 503 is polytetrafluoroethylene PTFE
  • the material of the wire cavity interface 504 is propylene.
  • the material of the nitrile-butadiene-styrene copolymer ABS, the injection cavity interface 505 is ABS, the material of the pull rod cap 506 is ABS, the material of the spacer 507 is ABS, and the material of the slider (with socket hole) is ABS
  • socket The material of the pin is stainless steel 304 and the material of the tie rod 510 is ABS.
  • the length of the return electrode 502 can be any reasonable value, such as 4 to 5 mm.
  • the distance between the end of the return electrode 502 near the top of the sheath 503 and the junction of the emitter electrode 501 and the sheath 503 may be any reasonable value, for example, 2 to 3 mm.
  • the water outlet (or referred to as an infusion port) is disposed between a side of the return electrode adjacent to the top end of the cryo-plasma incubator surgical device and a side of the emitter electrode that is not covered with the insulating layer, that is, the water outlet is set In the range of 2 to 3 mm shown in Fig. 5.
  • the emitter electrode 501 and the return electrode 502 are substantially linearly attached to facilitate the sheath 503.
  • the front end enters the human body.
  • the slider 508 moves backward, pulling the emitter electrode 501 to form the emitter electrode 501 and the return electrode 502 in a bow shape.
  • Slider 508 is at the socket aperture and receptacle Pin 509 is disposed within the socket aperture.
  • FIG. 6 shows a partial enlarged schematic view of a bipolar electrode socket connector (cutting knife joint) 600 including a return electrode lead 601 and an emitter electrode lead (cut wire lead) 602.
  • the cryo-plasma incubator surgical device can be used for the cutting, ablation, coagulation and hemostasis of the duodenal papilla.
  • low-temperature plasma incision surgery equipment can also be used for cutting, ablation, coagulation and hemostasis of soft tissue in joints, spine, skin, ENT, etc.
  • the cryo-plasma incubator surgical device of the present application is used within 24 hours, classified according to contact time, is temporarily contacted, classified according to the nature of the contact human body, belongs to an external access device (with tissue/bone/dentine), and according to the structural characteristics of the medical device Classification is an active medical device.
  • the accessory bipolar surgical electrode of the cryo-plasma incubator surgical device is a disposable sterile product.
  • the cryo-plasma incubator surgical device uses a bipolar solution and operates at 110 kHz.
  • the plasma therapeutic apparatus 100 realizes cutting, ablation, coagulation, and hemostasis of soft tissues in operations such as ENT, and the like by plasma technology.
  • the cryo-plasma incubator surgical device uses physiological saline as a conductive fluid to form a thin layer between the emitter electrode and the return electrode.
  • the plasma therapy device gives enough energy (voltage)
  • the physiological saline is converted into a gas layer (plasma layer) composed of energized charged particles.
  • the cryo-plasma incubator surgical device utilizes energy to excite a conductive medium (eg, saline) to generate a plasma, and relies on the energy of the plasma to break tissue molecular bonds.
  • the energy of the plasma directly cleaves biomacromolecules such as proteins into gases such as O 2 , CO 2 , N 2 , etc., thereby completing vaporization and cutting of the tissue.
  • a low voltage is applied to the working tip of the cryo-plasma incubator surgical device, the electric field is lower than the domain value requirement for generating the plasma layer and tissue resistance heat is generated, thereby ablation and hemostasis of the tissue.
  • FIG. 7 is a schematic cross-sectional view along B-B including a return electrode lead 701, an emitter lead (cut wire) 702, a guide lumen 703, a liquid passage 704, and a emitter electrode chamber 705.
  • FIG. 7 shows a cross-sectional view 706 of the return electrode lead 701 including an insulating layer 707 and a wire 708.
  • the return electrode wire requires an insulating layer for insulation and heat insulation, and the emitter electrode wire (cut wire) may be provided without an insulating layer.
  • the emitter electrode cavity 705 as a liquid passing chamber as needed, and when the emitter electrode cavity 705 is used as a liquid passing chamber, the emitter electrode wire (cut wire wire) needs to be provided with an insulating layer.
  • Fig. 8 shows a schematic cross-sectional view along C-C including a return electrode lead 801 and an emitter lead lead (cut wire lead) 802.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)

Abstract

一种低温等离子切开刀手术设备、系统及方法，该设备包括：液体输入单元，响应于液体输入信号，向目标体处输入液体从而在发射电极(501)和回路电极(502)之间形成导电介质的薄层；双极电极插口接头(600)，通过高频连接线与高频发生器连接，用于接收高频发生器所产生的第一输入电压；发射电极(501)，经由双极电极插口接头(600)接收高频发生器所产生的第一输入电压，在发射电极(501)和回路电极(502)之间施加第一电压，使得导电介质达到第一温度并且促使该导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割，回路电极(502)与发射电极(501)通过相同的导管导入并且在目标体形成导电回路。

Description

一种低温等离子切开刀手术设备、系统及方法 技术领域
本发明涉及射频技术领域，并且更具体地，涉及一种低温等离子切开刀手术设备、系统及方法。
背景技术
高频切割电刀是一种取代机械手术刀进行组织切割的电外科器械。高频切割电刀的工作原理是通过有效电极尖端产生的高频高压电流与机体接触时对组织进行加热，实现对机体组织的分离和凝固，从而起到切割和止血的目的。高频切割电刀电凝模式的峰值电压较电切模式大，高频电流通过高阻抗的组织时，会在组织中热量，导致组织气化或凝固，产生良好的止血效果，但同时也会造成更加明显的热损伤。高频切割电刀瞬间稳定可高达150℃以上，能切割组织的高频切割电刀的加热效应，并不是由加热电极或刀头造成的。它是将高电流密度的高频电流聚集起来，直接摧毁处于与有效电极尖端相接触的组织。当与有效电极相接触或相邻近的组织或细胞的温度上升到细胞中的蛋白质变性时，便产生切割及凝固的作用。
普通高频切割电刀的工作温度通常是100～150℃，这个工作温度相对人组织仍属于高温，组织细胞受此温度影响后，由于切割所造成组织蛋白变性。尤其是普通高频切割电刀持续工作一定时间后，会对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，普通高频切割电刀会出现术区肿胀、术后疼痛等反应。
在实际环境中，高频切割电刀应用在医院消化科进行十二指肠病变的乳头切割手术时，容易产生胰腺炎(死亡率高)的并发症，这是因为温度对组织有损伤。高频切割电刀有两个电极，一个电极贴在患者身上，另一个电极放置在切割刀部位，并且在手柄上设置电通路。高频发射温度高达400-500度，这个温度对周边良好的组织会误伤，进而使得出血问题产生的概率高、容易损坏病理组织。在这种情况下，医生无法进行病理分析，并且对切片整理有效分析时造成麻烦。
经十二指肠镜逆行性胰胆管造影术(ERCP)，是将十二指肠镜插至十二指肠降段，显露胰管、胆管在肠腔内侧壁开口的十二指肠乳头，经十二指肠镜治疗孔道插入造影导管，经乳头开口插入胰胆管共同开口或先后分别进入胰管、胆管，注射造影剂，在X线下对胰管、胆管进行检查的方法。
经十二指肠乳头括约肌切开术(EST)，是在诊断性ERCP技术的基础上，进一步发展起来的在内镜下利用专用的高频电切开刀将十二指肠乳头括约肌及胆总管末端部分切开的一种治疗技术。
十二指肠乳头包括主乳头及副乳头，主乳头通常又称十二指肠乳头或瓦特乳头。它常位于十二指肠降部中段后背内侧壁，距胃幽门约10cm处，形态大多呈乳头型。所述的乳头切开术主要都是指主乳头的切开。在十二指肠镜头下，主乳头的位置通常都在中心近似12点位置处。在十二指肠镜的引导和前端抬钳器的调节下，医生操作器械高频切开刀插入到乳头内，通高频电，实现组织的切割和凝固。高频发射温度高达400-500度，这个温度对十二指肠乳头周边良好的组织会误伤，容易产生胰腺炎(死亡率高)，出血，穿孔等的并发症，进而使得出血问题产生的概率高、同时也容易损坏病理组织。在这种情况下，医生无法进行病理分析，并且对切片整理有效分析时造成麻烦。
发明内容
根据本发明的一个方面，提供一种低温等离子切开刀手术设备，所述设备包括：
液体输入单元，响应于液体输入信号，向目标体处输入液体从而在发射电极和回路电极之间形成导电介质的薄层；
双极电极插口接头，通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压；
发射电极，经由双极电极插口接头接收所述高频发生器所产生的第一输入电压，在发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割，
回路电极，与所述发射电极通过相同的导管导入并且在所述目标体形成导电回路。
所述双极电极插口接头接收所述高频发生器所产生的第二输入电压并且将所述第二输入 电压传输给发射电极，在发射电极和回路电极之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。
所述低温等离子切开刀手术设备还包括导丝腔，用于将导丝沿所述导丝腔输入并且插至所述低温等离子切开刀手术设备的头端，以促使发射电极和回路电极被置于所述目标体处。
所述低温等离子切开刀手术设备还包括通液腔，基于液体输入指令向液体输入单元输入所述液体，其中所述液体输入单元实时测量所述液体的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后将所述液体输入指令发送给液体输入单元。
所述液体输入单元通过以下模式中的一种进行液体输入：滴定模式和连续供液模式，并且所述通液腔是位于回路电极之外的环形腔。
为所述发射电极的远离所述低温等离子切开刀手术设备的顶端的一部分包覆绝缘层，所述绝缘层用于起绝缘和隔热的作用。
所述液体输入单元的输液口位于所述发射电极和回路电极之间。
所述低温等离子切开刀手术设备还包括拉杆，用于使操作者通过把拉杆来提供支撑力，并且所述低温等离子切开刀手术设备还包括外管，用于提供外层包覆功能。
在初始状态下，所述发射电极和回路电极彼此贴合，当所述发射电极和回路电极到达所述目标体处后，通过滑块移动拉动所述发射电极，以使得所述发射电极和回路电极形成弯弓状。
所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
优选地，所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
优选地，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃。
所述低温等离子切开刀手术设备检测到运行故障后向报警单元发送报警信号，所述报警单元在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；
所述低温等离子切开刀手术设备与脚踏式输入设备连接，其中用户通过对所述脚踏式输入设备进行操作来生成用于控制低温等离子切开刀手术设备输出功率的控制指令，其中所述控制指令为二元组<模式，功率>。
所述低温等离子切开刀手术设备与显示单元连接，所述显示单元用于实时显示所述低温等离子切开刀手术设备的运行状态。
根据本发明的另一个方面，提供一种低温等离子切开刀手术系统，所述系统包括：
输入单元，接收用户输入的控制指令并将所述控制指令发送给控制单元；
控制单元，对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给接口单元；
接口单元，从所述控制单元接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给等离子单元，以及从等离子单元接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述控制单元；
等离子单元，响应于从所述接口单元接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述等离子单元的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割；
其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。
还包括所述控制单元对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给接口单元。
所述接口单元从所述控制单元接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给等离子单元。
响应于从所述接口单元接收的第二指令和第二电压指示，所述等离子单元进入第二模式：施加第二电压以将所述等离子单元的目标接触端保持为第二温度，从而将目标体进行消融凝固。
还包括报警单元，用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；
其中在所述等离子单元检测到运行故障后向控制单元发送报警信号，所述控制单元将报警信号发送给所述报警单元。
所述输入单元为脚踏式输入设备，其中用户通过对所述脚踏式输入设备进行操作来生成 所述控制指令，其中所述控制指令为二元组<模式，功率>。
还包括滴液输入单元，用于基于所述控制单元的导电介质输入指令向等离子单元输入所述导电介质，其中所述等离子单元实时测量所述导电介质的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液输入单元。
还包括显示单元，用于实时显示所述低温等离子切开刀手术系统的运行状态。
所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃，以及
在第一模式下，热穿透距离小于或等于150微米，并且在第二模式下，热穿透距离小于或等于200微米。
根据本发明的另一方面，提供一种低温等离子切开刀手术方法，所述方法包括：
接收用户输入的控制指令；
对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，以及确定与所述第一模式下的输出功率相关联的第一电压指示；
将所述第一模式指令和第一电压指示转发给等离子设备，以及从所述等离子设备接收目标接触端的当前阻抗；
响应于接收到第一模式指令和第一电压指示，促使所述等离子设备进入第一模式：通过导电介质在所述等离子单元的目标接触端的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割；
其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。
还包括对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，以及确定与所述第二模式下的输出功率相关联的第二电压指示。
将所述第二模式指令和第二电压指示转发给等离子设备。
响应于从接收到第二指令和第二电压指示，所述等离子设备进入第二模式：施加第二电 压以将所述等离子设备的目标接触端保持为第二温度，从而将目标体进行消融凝固。
还包括在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；
其中在检测到运行故障后生成报警信号。
其中用户通过对脚踏式输入设备进行操作来生成所述控制指令，其中所述控制指令为二元组<模式，功率>。
还包括基于导电介质输入指令向所述等离子设备输入所述导电介质，其中所述等离子设备实时测量所述导电介质的当前余量并且基于所述当前余量确定是否生成所述导电介质输入指令。
还包括实时显示所述等离子设备的运行状态。
所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃，以及
在第一模式下，热穿透距离小于或等于150微米，并且在第二模式下，热穿透距离小于或等于200微米。
根据本申请的等离子单元的工作的温度只有40-70度，从而解决了对周边良好组织的误伤问题、出血问题并且减少并发症。此外，本申请的等离子单元结构上采用双极方式，直接在导管上形成回路。
附图说明
通过参考下面的附图，可以更为完整地理解本发明的示例性实施方式：
图1为根据本发明优选实施方式的等离子治疗仪的主要零件示意图；
图2为根据本发明优选实施方式的等离子治疗仪的结构示意图；
图3为根据本发明优选实施方式的低温等离子切开刀手术系统的结构示意图；
图4为根据本发明优选实施方式的低温等离子切开刀手术方法的流程图；
图5为根据本发明优选实施方式的低温等离子切开刀手术设备的结构示意图；以及
图6-8为根据本发明优选实施方式的低温等离子切开刀手术设备的局部放大或截面示意图。
具体实施方式
现在参考附图介绍本发明的示例性实施方式，然而，本发明可以用许多不同的形式来实施，并且不局限于此处描述的实施例，提供这些实施例是为了详尽地且完全地公开本发明，并且向所属技术领域的技术人员充分传达本发明的范围。对于表示在附图中的示例性实施方式中的术语并不是对本发明的限定。在附图中，相同的单元/元件使用相同的附图标记。
除非另有说明，此处使用的术语(包括科技术语)对所属技术领域的技术人员具有通常的理解含义。另外，可以理解的是，以通常使用的词典限定的术语，应当被理解为与其相关领域的语境具有一致的含义，而不应该被理解为理想化的或过于正式的意义。
图1为根据本发明优选实施方式的等离子治疗仪100的功能示意图。等离子治疗仪100能够用于十二指肠乳头的切割、消融和凝固与止血。此外，等离子治疗仪100还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的切割、消融、凝固与止血。本申请的等离子治疗仪100使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。等离子治疗仪100的附件双极手术电极(切开刀)头属于一次性无菌产品。
等离子治疗仪100采用双极方案，并且其工作频率为110kHz。等离子治疗仪100通过等离子技术实现对耳鼻喉等手术中软组织的切割、消融、凝固与止血。工作时，等离子治疗仪100通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当等离子治疗仪100给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，等离子治疗仪100利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化切割。当对等离子治疗仪100的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。
如图1所示，等离子治疗仪100的功能体系结构包括：主控程序、报警单元、界面单元、输出控制单元、双极手术电极(切开刀)接口、双极手术电极(切开刀)、脚踏开关、脚控接口、滴液控制阀以及滴液控制阀接口。其中，主控程序、报警单元、界面单元、输出控制、双极手术电极接口、脚控接口以及滴液控制阀接口属于等离子治疗仪100的软件部分。等离子治疗仪100的部分部件的功能介绍如表1所示，
表1部分部件的功能介绍
Figure PCTCN2017107944-appb-000001
优选地，脚踏开关能够控制等离子治疗仪100的工作模式。等离子治疗仪100的工作模式分为切割模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。
优选地，脚踏开关的黄色踏板对应于切割模式，并且切割模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，等离子治疗仪100进入切割模式。切割模式的档位调节方式为：在调节至切割模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。切割档位可以选择从1至9档中的任意一档。其中，档位越高，输出电压越大。在切割模式中，1至9档的输出电压如表2所示：
表2切割模式中的输出档位
Figure PCTCN2017107944-appb-000002
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，等离子治疗仪100进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换切割模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用中需要进行凝血时，踏下蓝色踏板进行凝血。在凝血模式中，1至5档的输出电压如表3所示：
表3凝血模式中的输出档位
Figure PCTCN2017107944-appb-000003
优选地，脚控接口用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：切割模式和凝血模式。在切割模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。
优选地，主控程序对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给输出控制单元。其中，初始的当前阻抗为零，即在等离子治疗仪100开机进行操作时，默认的当前阻抗为零。所述主控程序对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给输出控制单元。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗(0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。
优选地，输出控制单元用于从所述主控程序接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给双极手术电极接口，以及从双极手术电极接口接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述主控程序。以及所述输出控制单元从所述主控程序接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给双极手术电极接口。
优选地，双极手术电极接口用于接收主控程序的功率指示并且将所述功率指示发送给双极手术电极，以及对双极手术电极的实时阻抗进行测量并且将所述实时阻抗通过输出控制单元传递给主控程序。
优选地，双极手术电极响应于从所述双极手术电极接口接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述双极手术电极的目标接触端处的发射电极和回路电 极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割。响应于从所述双极手术电极接口接收的第二指令和第二电压指示，所述双极手术电极进入第二模式：施加第二电压以将所述双极手术电极的目标接触端保持为第二温度，从而将目标体进行消融凝固。
优选地，报警单元用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述报警单元。
优选地，界面单元，用于实时显示所述低温等离子切开刀手术系统的运行状态。
优选地，滴液控制阀用于基于所述主控程序的导电介质输入指令向双极手术电极输入所述导电介质，其中所述双极手术电极实时测量所述导电介质的当前余量并且将所述当前余量发送给主控程序，所述主控程序基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液控制阀。优选地，滴液控制阀接口用于实现滴液控制阀和主控程序之间的双向通信。
优选地，双极手术电极末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在切割模式中，双极手术电极的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。双极手术电极的热穿透距离比传统电外科刀的热穿透距离小，其中切割模式中的热穿透距离小于或等于150微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米。
等离子治疗仪100工作原理是等离子体低温消融术。利用双极刀头产生能量，将生理盐水转换成等离子体薄层，解离靶组织中构成细胞成分的分子键，造成组织凝固性坏死，形成消融或切割的效果。由于在相对较低的温度下工作，比传统使用的高频切割电刀对周边组织的热损伤降到最小程度。在35℃左右工作温度可使靶组织体积缩小，靶组织中的微血管封闭，切除病变。其低温和组织减容消融特性，较常用的单极电刀更具有缩短术后恢复时间、减轻术后疼痛和减少手术治疗费用的优点。其中，等离子治疗仪与普通高频切割电刀的温度比较如表4所示：
表4
Figure PCTCN2017107944-appb-000004
Figure PCTCN2017107944-appb-000005
等离子治疗仪在工作时刀头周围温度低于70℃(详见离体实验研究组织热损伤报告)，与传统意义上的普通高频切割电刀(100～150℃高温)相比工作温度更低，虽然低温等离子刀的治疗温度相对人组织仍属于高温，组织细胞受此温度影响后，同样会出现电刀切割造成组织蛋白变性，尤其是持续一定时间后，亦可对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，故部分患者行低温等离子手术后，其术区肿胀、术后疼痛等反应不比高频切割电刀反应轻。等离子治疗仪与普通高频切割电刀的损伤热损伤深度比较如下表5所示：
表5
  切割时热损伤深度 凝血时热损伤深度
等离子治疗仪 平均值150微米 平均值200微米
高频切割电刀 1.23±0.24mm 1.37±0.26mm
由于每次手术时间存在差异所以等离子治疗仪在离体实验研究组织热损伤报告中选用了最大手术时间，由对比可见最大手术时间的等离子治疗仪和正常使用的高频切割电刀热损深度。故正常使用的等离子治疗仪的热损深度应低于高频切割电刀热损深度。
图2为根据本发明优选实施方式的等离子治疗仪200的主要零件示意图。如图2所示，等离子治疗仪200的主要零件包括：双极手术电极接口201、滴液控制阀接口202、踩踏开关接口203、显示屏204、主板205、喇叭206、前面板207、故障报警灯208、下模209、上模210、电源模块211、滴液控制阀212以及风扇213。
优选地，踩踏开关接口203用于接收脚踏开关的指令，脚踏开关并且能够控制等离子治疗仪200的工作模式。等离子治疗仪200的工作模式分为切割模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。
优选地，脚踏开关的黄色踏板对应于切割模式，并且切割模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，等离子治疗仪200进入切割模式。切割模式的档位调节方式为：在调节至切割模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。切割档位可以选择从1至9档中的任意一档。其中，档位越高，输出电压越大。
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，等离子治疗仪200进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换切割模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用中需要进行凝血时，踏下蓝色踏板进行凝血。
优选地，踩踏开关接口203用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：切割模式和凝血模式。在切割模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。
优选地，主板205用于容纳固件，所述固件中存储主控程序。其中，主控程序对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给输出控制单元。其中，初始的当前阻抗为零，即在等离子治疗仪200开机进行操作时，默认的当前阻抗为零。所述主控程序对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给输出控制单元。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗(0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。
优选地，输出控制单元(图2中未示出)用于从所述主控程序接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给双极手术电极接口201，以及从双极手术电极接口201接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述主控程序。以及所述输出控制单元从所述主控程序接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给双极手术电极接口201。
优选地，双极手术电极接口201用于接收主控程序的功率指示并且将所述功率指示发送给双极手术电极，以及对双极手术电极的实时阻抗进行测量并且将所述实时阻抗通过输出控制单元传递给主控程序。
优选地，双极手术电极(图中未示出)响应于从所述双极手术电极接口201接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述双极手术电极的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割。响应于从所述双极手术电极接口201接收的第二指令和第二电压指示，所述双极手术电极进入第二模式：施加第二电压以将所述双极手术电极的目标接触端保持为第二温度，从而将目标体进行消融凝固。
优选地，故障报警灯208用于在接收到报警信号时，通过指示灯显示进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述故障报警灯208。喇叭206用于在接收到报警信号时，通过声音进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述喇叭206。
优选地，显示屏204用于实时显示所述低温等离子切开刀手术系统的运行状态。
优选地，滴液控制阀212用于基于所述主控程序的导电介质输入指令向双极手术电极输入所述导电介质，其中所述双极手术电极实时测量所述导电介质的当前余量并且将所述当前余量发送给主控程序，所述主控程序基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液控制阀212。优选地，滴液控制阀接口202用于实现滴液控制阀212和主控程序之间的双向通信。
优选地，本申请采用双模式液体出口：1、滴定模式，即像吊瓶输液的方式一样一滴一滴的供给；以及2、连续供给模式，即连续供应液体流的模式。双极手术电极接口(切开刀接 口)通过插接线与如下所述的图5的双极电极插口接头(切开刀接头)连接，滴液控制阀接口通过连接管与图5的通液腔连接。脚踏开关口通过连接线与外置的脚踏板连接，用来控制能量和滴液的供应和断开。当脚踏板踩下时，能量和滴液供应；当脚踏板松开时，能量和滴液断开。
优选地，双极手术电极末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在切割模式中，双极手术电极的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。双极手术电极的热穿透距离比传统电外科刀的热穿透距离小，其中切割模式中的热穿透距离小于或等于150微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米。
优选地，上模210和下模209通过组合的方式来保护主板。风扇213用于散热，并且电源模块211用于为等离子治疗仪200提供电力。前面板207用于进行数据显示和操作控制。
图3为根据本发明优选实施方式的低温等离子切开刀手术系统300的结构示意图。低温等离子切开刀手术系统300能够用于十二指肠乳头的切割、消融和凝固与止血。此外，低温等离子切开刀手术系统300还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的切割、消融、凝固与止血。本申请的低温等离子切开刀手术系统300使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。
低温等离子切开刀手术系统300采用双极方案，并且其工作频率为110kHz。低温等离子切开刀手术系统300通过等离子技术实现对耳鼻喉等手术中软组织的切割、消融、凝固与止血。工作时，低温等离子切开刀手术系统300通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当低温等离子切开刀手术系统300给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，低温等离子切开刀手术系统300利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化切割。当对等离子治疗仪100的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。
如图3所示，低温等离子切开刀手术系统300包括：输入单元301、控制单元302、接口单元303、等离子单元304、报警单元305、滴液输入单元306以及显示单元307。优选地， 输入单元301例如是脚踏开关，并且脚踏开关能够控制低温等离子切开刀手术系统300工作模式。低温等离子切开刀手术系统300的工作模式分为切割模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。
优选地，脚踏开关的黄色踏板对应于切割模式，并且切割模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，低温等离子切开刀手术系统300进入切割模式。切割模式的档位调节方式为：在调节至切割模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。切割档位可以选择从1至9档中的任意一档。其中，档位越高，输出电压越大。
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，低温等离子切开刀手术系统300进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换切割模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用中需要进行凝血时，踏下蓝色踏板进行凝血。
优选地，脚控接口用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：切割模式和凝血模式。在切割模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。
优选地，控制单元302对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给接口单元303。其中，初始的当前阻抗为零，即在低温等离子切开刀手术系统300开机进行操作时，默认的当前阻抗为零。所述控制单元302对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给接口单元303。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗(0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档； 以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。
优选地，接口单元303用于从所述控制单元302接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给等离子单元304，以及从等离子单元304接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述控制单元302。以及所述接口单元303从所述控制单元302接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给等离子单元304。
优选地，接口单元303用于接收控制单元302的功率指示并且将所述功率指示发送给等离子单元304，以及对等离子单元304的实时阻抗进行测量并且将所述实时阻抗通过接口单元303传递给控制单元302。
优选地，等离子单元304响应于从所述等离子单元304接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述等离子单元304的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割。响应于从所述等离子单元304接收的第二指令和第二电压指示，所述等离子单元304进入第二模式：施加第二电压以将所述等离子单元304的目标接触端保持为第二温度，从而将目标体进行消融凝固。
优选地，报警单元305用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警。其中在所述等离子单元304检测到运行故障后向控制单元302发送报警信号，所述控制单元302将报警信号发送给所述报警单元305。
优选地，滴液输入单元306用于基于所述控制单元302的导电介质输入指令向等离子单元304输入所述导电介质，其中所述等离子单元304实时测量所述导电介质的当前余量并且 将所述当前余量发送给控制单元302，所述控制单元302基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液输入单元306。
优选地，等离子单元304末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在切割模式中，等离子单元304的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。等离子单元304的热穿透距离比传统电外科刀的热穿透距离小，其中切割模式中的热穿透距离小于或等于150微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米。
优选地，显示单元307，用于实时显示所述低温等离子切开刀手术系统的运行状态。低温等离子切开刀手术系统300工作原理是等离子体低温消融术。利用双极刀头产生能量，将生理盐水转换成等离子体薄层，解离靶组织中构成细胞成分的分子键，造成组织凝固性坏死，形成消融或切割的效果。由于在相对较低的温度下工作，比传统使用的高频切割电刀对周边组织的热损伤降到最小程度。在35℃左右工作温度可使靶组织体积缩小，靶组织中的微血管封闭，切除病变。其低温和组织减容消融特性，较常用的单极电刀更具有缩短术后恢复时间、减轻术后疼痛和减少手术治疗费用的优点。低温等离子切开刀手术系统300在工作时刀头周围温度低于70℃(详见离体实验研究组织热损伤报告)，与传统意义上的普通高频切割电刀(100～150℃高温)相比工作温度更低，虽然低温等离子刀的治疗温度相对人组织仍属于高温，组织细胞受此温度影响后，同样会出现电刀切割造成组织蛋白变性，尤其是持续一定时间后，亦可对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，故部分患者行低温等离子手术后，其术区肿胀、术后疼痛等反应不比高频切割电刀反应轻。由于每次手术时间存在差异所以等离子治疗仪在离体实验研究组织热损伤报告中选用了最大手术时间，由对比可见最大手术时间的等离子治疗仪和正常使用的高频切割电刀热损深度。故正常使用的等离子治疗仪的热损深度应低于高频切割电刀热损深度。
图4为根据本发明优选实施方式的低温等离子切开刀手术方法400的流程图。如图4所示，方法400从步骤401处开始。在步骤401，接收用户输入的控制指令。
在步骤402，对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率。
在步骤403，确定与所述第一模式下的输出功率相关联的第一电压指示。
在步骤404，将所述第一模式指令和第一电压指示转发给等离子设备，以及从所述等离子设备接收目标接触端的当前阻抗。
在步骤405，响应于接收到第一模式指令和第一电压指示，促使所述等离子设备进入第一模式：通过导电介质在所述等离子单元的目标接触端的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割；
其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。
还包括对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，以及确定与所述第二模式下的输出功率相关联的第二电压指示。将所述第二模式指令和第二电压指示转发给等离子设备。响应于从接收到第二指令和第二电压指示，所述等离子设备进入第二模式：施加第二电压以将所述等离子设备的目标接触端保持为第二温度，从而将目标体进行消融凝固。
还包括在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；其中在检测到运行故障后生成报警信号。
其中用户通过对脚踏式输入设备进行操作来生成所述控制指令，其中所述控制指令为二元组<模式，功率>。
还包括基于导电介质输入指令向所述等离子设备输入所述导电介质，其中所述等离子设备实时测量所述导电介质的当前余量并且基于所述当前余量确定是否生成所述导电介质输入指令。方法400实时显示所述等离子设备的运行状态。
图5为根据本发明优选实施方式的低温等离子切开刀手术设备的结构示意图。如图5所示，低温等离子切开刀手术设备包括：发射电极(切开丝)501、回路电极(圆套)502、管鞘503、导丝腔接口504、注射腔接口505、拉杆帽506、垫块507、滑块(带插座孔)508、插座Pin 509和拉杆510。优选地，发射电极(切开丝)501和回路电极(圆套)502通过相同的导管导入并且在目标体形成导电回路。发射电极(切开丝)501，经由插座Pin 509接收所述高频发生器所产生的第一输入电压，在发射电极(切开丝)501和回路电极(圆套)502之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行 汽化切割。在初始状态下，发射电极501和回路电极502为基本依附的直线状，以方便管鞘503的前端进入人体。当到达指定位置后，滑块508向后移动，拉动发射电极501，使发射电极501和回路电极502形成弯弓状。绝缘层(图5中未示出)包覆发射电极(切开丝)501导线，并且所述绝缘层用于起绝缘和隔热的作用。管鞘，用于提供外层包覆功能。注射腔接口505基于液体输入指令向液体输入单元输入所述液体，其中所述液体输入单元实时测量所述液体的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后将所述液体输入指令发送给滴液输入单元。注射腔接口505是位于回路电极导线外的环形腔。
导丝腔接口504用于将导丝沿所述导丝腔输入并且插至所述低温等离子切开刀手术设备的头端，以促使发射电极501和回路电极502被置于所述目标体处。拉杆510用于使操作者通过把拉杆510来提供支撑力。插座Pin 509通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压。插座Pin 509接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极，在发射电极501和回路电极502之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。液体输入单元(图5中未示出)，响应于液体输入信号，向目标体处输入液体从而在发射电极和回路电极之间形成导电介质的薄层。液体输入单元通过以下模式中的一种进行液体输入：滴定模式和连续供液模式。
其中，发射电极(切开丝)501的材料是不锈钢304、回路电极(圆套)502的材料是不锈钢304、管鞘503的材料是聚四氟乙烯PTFE、导丝腔接口504的材料是丙烯腈-丁二烯-苯乙烯共聚物ABS、注射腔接口505的材料是ABS、拉杆帽506的材料是ABS、垫块507的材料是ABS、滑块(带插座孔)的材料是ABS、插座Pin的材料是不锈钢304以及拉杆510的材料是ABS。
如图5所示，回路电极502的长度可以是任意合理的数值，例如4至5毫米。其中，回路电极502的靠近管鞘503顶部的一端与发射电极501与管鞘503的连接处的距离可以是任意合理的数值，例如2至3毫米。其中，出水口(或被称为输液口)设置在回路电极的靠近低温等离子切开刀手术设备的顶端的一侧和发射电极的未包覆绝缘层的一侧之间，即出水口被设置在图5所示的2至3毫米的范围内。
在初始状态下，发射电极501和回路电极502为基本依附的直线状，以方便管鞘503的 前端进入人体。当到达指定位置后，滑块508向后移动，拉动发射电极501，使发射电极501和回路电极502形成弯弓状。滑块508在插座孔处，并且插座Pin 509设置在插座孔内。
图6-8为根据本发明优选实施方式的低温等离子切开刀手术设备的局部放大或截面示意图。图6示出了双极电极插口接头(切开刀接头)600的局部放大示意图，其中包括：回路电极导线601和发射电极导线(切开丝导线)602。低温等离子切开刀手术设备能够用于十二指肠乳头的切割、消融和凝固与止血。此外，低温等离子切开刀手术设备还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的切割、消融、凝固与止血。本申请的低温等离子切开刀手术设备使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。低温等离子切开刀手术设备的附件双极手术电极属于一次性无菌产品。
低温等离子切开刀手术设备采用双极方案，并且其工作频率为110kHz。等离子治疗仪100通过等离子技术实现对耳鼻喉等手术中软组织的切割、消融、凝固与止血。工作时，低温等离子切开刀手术设备通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当等离子治疗仪给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，低温等离子切开刀手术设备利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化切割。当对低温等离子切开刀手术设备的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。
图7示出了沿B-B的截面示意图，其中包括：回路电极导线701、发射电极导线(切开丝导线)702、导丝腔703、通液腔704和发射电极腔705。更为详细地，图7示出了回路电极导线701的剖面图706，其中包括绝缘层707和金属丝708。回路电极导线需要绝缘层，起作绝缘和隔热的作用，发射电极导线(切开丝导线)可以不设置绝缘层。
另外，本领域的技术人员根据需要，也可以将发射电极腔705作为通液腔，在发射电极腔705作为通液腔时，发射电极导线(切开丝导线)需设置绝缘层。
图8示出了沿C-C的截面示意图，其中包括回路电极导线801和发射电极导线(切开丝导线)802。
已经通过参考少量实施方式描述了本发明。然而，本领域技术人员所公知的，正如附带 的专利权利要求所限定的，除了本发明以上公开的其他的实施例等同地落在本发明的范围内。
通常地，在权利要求中使用的所有术语都根据他们在技术领域的通常含义被解释，除非在其中被另外明确地定义。所有的参考“一个/所述/该[装置、组件等]”都被开放地解释为所述装置、组件等中的至少一个实例，除非另外明确地说明。这里公开的任何方法的步骤都没必要以公开的准确的顺序运行，除非明确地说明。

Claims (30)

  1. 一种低温等离子切开刀手术设备，其特征在于，所述设备包括：
    液体输入单元，响应于液体输入信号，向目标体处输入液体从而在发射电极和回路电极之间形成导电介质的薄层；
    双极电极插口接头，通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压；
    发射电极，经由双极电极插口接头接收所述高频发生器所产生的第一输入电压，在发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割，
    回路电极，与所述发射电极通过相同的导管导入并且在所述目标体形成导电回路。
  2. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，所述双极电极插口接头接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极，在发射电极和回路电极之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。
  3. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，还包括导丝腔，用于将导丝沿所述导丝腔输入并且插至所述低温等离子切开刀手术设备的头端，以促使发射电极和回路电极被置于所述目标体处。
  4. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，还包括通液腔，基于液体输入指令向液体输入单元输入所述液体，其中所述液体输入单元实时测量所述液体的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后将所述液体输入指令发送给液体输入单元。
  5. 根据权利要求4所述的低温等离子切开刀手术设备，其特征在于，所述液体输入单元通过以下模式中的一种进行液体输入：滴定模式和连续供液模式，并且所述通液腔是位于回路电极之外的环形腔。
  6. 根据权利要求3所述的低温等离子切开刀手术设备，其特征在于，所述发射电极的远 离所述低温等离子切开刀手术设备的顶端的一部分包覆绝缘层，所述绝缘层用于起绝缘和隔热的作用。
  7. 根据权利要求6所述的低温等离子切开刀手术设备，其特征在于，所述液体输入单元的输液口位于所述发射电极和回路电极之间。
  8. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，所述低温等离子切开刀手术设备还包括拉杆，用于使操作者通过把拉杆来提供支撑力，并且所述低温等离子切开刀手术设备还包括外管，用于提供外层包覆功能。
  9. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，在初始状态下，所述发射电极和回路电极彼此贴合，当所述发射电极和回路电极到达所述目标体处后，通过滑块移动拉动所述发射电极，以使得所述发射电极和回路电极形成弯弓状。
  10. 根据权利要求1所述的低温等离子切开刀手术设备，其特征在于，所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
  11. 一种低温等离子切开刀手术系统，其特征在于，所述系统包括：
    输入单元，接收用户输入的控制指令并将所述控制指令发送给控制单元；
    控制单元，对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给接口单元；
    接口单元，从所述控制单元接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给等离子单元，以及从等离子单元接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述控制单元；
    等离子单元，响应于从所述接口单元接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述等离子单元的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割；
    其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。
  12. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，还包括所述控制单元对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二 模式下的输出功率相关联的第二电压指示发送给接口单元。
  13. 根据权利要求12所述的系统，所述接口单元从所述控制单元接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给等离子单元。
  14. 根据权利要求13所述的低温等离子切开刀手术系统，其特征在于，响应于从所述接口单元接收的第二指令和第二电压指示，所述等离子单元进入第二模式：施加第二电压以将所述等离子单元的目标接触端保持为第二温度，从而将目标体进行消融凝固。
  15. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，还包括报警单元，用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；
    其中在所述等离子单元检测到运行故障后向控制单元发送报警信号，所述控制单元将报警信号发送给所述报警单元。
  16. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，所述输入单元为脚踏式输入设备，其中用户通过对所述脚踏式输入设备进行操作来生成所述控制指令，其中所述控制指令为二元组<模式，功率>。
  17. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，还包括滴液输入单元，用于基于所述控制单元的导电介质输入指令向等离子单元输入所述导电介质，其中所述等离子单元实时测量所述导电介质的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液输入单元。
  18. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，还包括显示单元，用于实时显示所述低温等离子切开刀手术系统的运行状态。
  19. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
  20. 根据权利要求11所述的低温等离子切开刀手术系统，其特征在于，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃，以及
    在第一模式下，热穿透距离小于或等于150微米，并且在第二模式下，热穿透距离小于或等于200微米。
  21. 一种低温等离子切开刀手术方法，其特征在于，所述方法包括：
    接收用户输入的控制指令；
    对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据 当前阻抗和所述控制指令计算用于第一模式下的输出功率，以及确定与所述第一模式下的输出功率相关联的第一电压指示；
    将所述第一模式指令和第一电压指示转发给等离子设备，以及从所述等离子设备接收目标接触端的当前阻抗；
    响应于接收到第一模式指令和第一电压指示，促使所述等离子设备进入第一模式：通过导电介质在所述等离子单元的目标接触端的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化切割；
    其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。
  22. 根据权利要求21所述的方法，还包括对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，以及确定与所述第二模式下的输出功率相关联的第二电压指示。
  23. 根据权利要求22所述的方法，将所述第二模式指令和第二电压指示转发给等离子设备。
  24. 根据权利要求23所述的低温等离子切开刀手术方法，其特征在于，响应于从接收到第二指令和第二电压指示，所述等离子设备进入第二模式：施加第二电压以将所述等离子设备的目标接触端保持为第二温度，从而将目标体进行消融凝固。
  25. 根据权利要求21所述的方法，还包括在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；
    其中在检测到运行故障后生成报警信号。
  26. 根据权利要求21所述的低温等离子切开刀手术方法，其特征在于，其中用户通过对脚踏式输入设备进行操作来生成所述控制指令，其中所述控制指令为二元组<模式，功率>。
  27. 根据权利要求21所述的低温等离子切开刀手术方法，其特征在于，还包括基于导电介质输入指令向所述等离子设备输入所述导电介质，其中所述等离子设备实时测量所述导电介质的当前余量并且基于所述当前余量确定是否生成所述导电介质输入指令。
  28. 根据权利要求21所述的低温等离子切开刀手术方法，其特征在于，还包括实时显示所述等离子设备的运行状态。
  29. 根据权利要求21所述的低温等离子切开刀手术方法，其特征在于，所述第一电压的 范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。
  30. 根据权利要求21所述的低温等离子切开刀手术方法，其特征在于，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃，以及
    在第一模式下，热穿透距离小于或等于150微米，并且在第二模式下，热穿透距离小于或等于200微米。
PCT/CN2017/107944 2017-10-27 2017-10-27 一种低温等离子切开刀手术设备、系统及方法 Ceased WO2019080079A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/CN2017/107944 WO2019080079A1 (zh) 2017-10-27 2017-10-27 一种低温等离子切开刀手术设备、系统及方法
US16/349,577 US20200179034A1 (en) 2017-10-27 2017-10-27 Low temperature sphincterotome surgical device, system and method
EP17929579.5A EP3714824A4 (en) 2017-10-27 2017-10-27 LOW TEMPERATURE PLASMA INCISION SCALPEL SURGICAL DEVICE, SYSTEM AND METHOD
JP2020564981A JP2021516138A (ja) 2017-10-27 2017-10-27 低温プラズマ型切開メスデバイス、システム及び方法

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2017/107944 WO2019080079A1 (zh) 2017-10-27 2017-10-27 一种低温等离子切开刀手术设备、系统及方法

Publications (1)

Publication Number Publication Date
WO2019080079A1 true WO2019080079A1 (zh) 2019-05-02

Family

ID=66246105

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2017/107944 Ceased WO2019080079A1 (zh) 2017-10-27 2017-10-27 一种低温等离子切开刀手术设备、系统及方法

Country Status (4)

Country Link
US (1) US20200179034A1 (zh)
EP (1) EP3714824A4 (zh)
JP (1) JP2021516138A (zh)
WO (1) WO2019080079A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110236666A (zh) * 2019-06-19 2019-09-17 北京市隆福医院 一种脊柱经皮穿刺等离子体手术刀头及其操作方法

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020142581A1 (en) * 2019-01-03 2020-07-09 Boston Scientific Scimed, Inc. Devices, systems and methods for accessing a body lumen
CN115005966B (zh) * 2022-05-31 2023-07-14 上海意昕医疗科技有限公司 一种手术电极及手术系统
CN118453100B (zh) * 2024-07-09 2024-11-05 广东医科大学附属医院 一种双极电凝套的滴水装置精确控制方法及系统

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103932780A (zh) * 2013-01-17 2014-07-23 亚瑟罗凯尔公司 用于鼻甲缩小的系统和方法
CN105338918A (zh) * 2013-05-08 2016-02-17 科瑞欧医疗有限公司 用于控制由电外科探针递送的功率的方法和设备
CN105792764A (zh) * 2014-04-11 2016-07-20 奥林巴斯株式会社 等离子体处置系统
CN105828735A (zh) * 2013-11-08 2016-08-03 库克医药技术有限责任公司 用于双极性电外科装置的手柄和电源线组件
CN106456237A (zh) * 2014-02-14 2017-02-22 亚瑟罗凯尔公司 与电外科控制器相关的方法和系统
WO2017034863A1 (en) * 2015-08-24 2017-03-02 Smith & Nephew, Inc. Electrosurgical wand with a spacer and with an active electrode, an associated system and an ablation method including generating a plasma
CN107072705A (zh) * 2014-07-24 2017-08-18 亚瑟罗凯尔公司 增强防电弧的电外科系统和方法
CN107693111A (zh) * 2017-10-27 2018-02-16 上海诺英医疗器械有限公司 一种低温等离子切开刀手术设备
CN107736935A (zh) * 2017-10-27 2018-02-27 上海诺英医疗器械有限公司 一种低温等离子切开刀手术系统及方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6896674B1 (en) * 1993-05-10 2005-05-24 Arthrocare Corporation Electrosurgical apparatus having digestion electrode and methods related thereto
EP1039862B1 (en) * 1997-12-15 2008-05-21 ArthroCare Corporation Systems for electrosurgical treatment of the head and neck
EP4282363A3 (en) * 2011-01-19 2024-01-10 Fractyl Health, Inc. Devices for the treatment of tissue
US10806509B2 (en) * 2012-12-27 2020-10-20 Cook Medical Technologies Llc Method of adhering a conductive coating to an adhesion-resistant outer surface
WO2017095935A1 (en) * 2015-11-30 2017-06-08 Latterell Scott T Saline field electrosurgical system

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103932780A (zh) * 2013-01-17 2014-07-23 亚瑟罗凯尔公司 用于鼻甲缩小的系统和方法
CN105338918A (zh) * 2013-05-08 2016-02-17 科瑞欧医疗有限公司 用于控制由电外科探针递送的功率的方法和设备
CN105828735A (zh) * 2013-11-08 2016-08-03 库克医药技术有限责任公司 用于双极性电外科装置的手柄和电源线组件
CN106456237A (zh) * 2014-02-14 2017-02-22 亚瑟罗凯尔公司 与电外科控制器相关的方法和系统
CN105792764A (zh) * 2014-04-11 2016-07-20 奥林巴斯株式会社 等离子体处置系统
CN107072705A (zh) * 2014-07-24 2017-08-18 亚瑟罗凯尔公司 增强防电弧的电外科系统和方法
WO2017034863A1 (en) * 2015-08-24 2017-03-02 Smith & Nephew, Inc. Electrosurgical wand with a spacer and with an active electrode, an associated system and an ablation method including generating a plasma
CN107693111A (zh) * 2017-10-27 2018-02-16 上海诺英医疗器械有限公司 一种低温等离子切开刀手术设备
CN107736935A (zh) * 2017-10-27 2018-02-27 上海诺英医疗器械有限公司 一种低温等离子切开刀手术系统及方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110236666A (zh) * 2019-06-19 2019-09-17 北京市隆福医院 一种脊柱经皮穿刺等离子体手术刀头及其操作方法

Also Published As

Publication number Publication date
US20200179034A1 (en) 2020-06-11
EP3714824A4 (en) 2021-09-29
EP3714824A1 (en) 2020-09-30
JP2021516138A (ja) 2021-07-01

Similar Documents

Publication Publication Date Title
CN210301195U (zh) 一种低温等离子切开刀手术系统
CN210301193U (zh) 一种低温等离子圈套刀手术设备
CN210541800U (zh) 一种低温等离子剥离刀手术设备
US8303584B2 (en) Electrosurgical instrument for tissue coagulation and cut
US20050085726A1 (en) Therapy probe
CN210541799U (zh) 一种低温等离子切开刀手术设备
Odell Electrosurgery: principles and safety issues
WO2019080079A1 (zh) 一种低温等离子切开刀手术设备、系统及方法
WO2019080078A1 (zh) 一种低温等离子圈套刀手术设备、系统及方法
WO2019080081A1 (zh) 一种低温等离子剥离刀手术设备、系统及方法
CN210521086U (zh) 一种低温等离子圈套刀手术系统
CN210301194U (zh) 一种低温等离子剥离刀手术系统
CN110115624A (zh) 一种低温等离子剥离刀手术设备
CN109907817A (zh) 一种低温等离子圈套刀手术设备
US11857242B2 (en) Attachment for electrosurgical system
JP2003305055A (ja) レゼクトスコープ装置
CN208212070U (zh) 一种低温等离子剥离刀手术系统
CN208212071U (zh) 一种低温等离子圈套刀手术设备
JP2003305054A (ja) 電気手術装置
CN209153964U (zh) 一种用于切开刀的密封组件
CN109907816A (zh) 一种低温等离子切开刀手术设备
CN208910476U (zh) 一种可转向低温等离子切开刀
JP2003265497A (ja) 電気手術装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17929579

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2017929579

Country of ref document: EP

Effective date: 20200527

ENP Entry into the national phase

Ref document number: 2020564981

Country of ref document: JP

Kind code of ref document: A