CN210301194U

CN210301194U - Low-temperature plasma scalpel operating system

Info

Publication number: CN210301194U
Application number: CN201821749101.9U
Authority: CN
Inventors: 周平红; 严航; 郑忠伟
Original assignee: Shanghai Nuoying Medical Devices Co ltd
Current assignee: Shanghai Nuoying Medical Devices Co ltd
Priority date: 2017-10-27
Filing date: 2018-10-27
Publication date: 2020-04-14
Anticipated expiration: 2028-10-27
Also published as: CN107736932A; CN109907818A

Abstract

The utility model discloses a low temperature plasma scalpel operating system, the system includes: the input unit receives a control instruction input by a user and sends the control instruction to the control unit; the control unit is used for analyzing the control instruction, generating a first mode instruction when the control instruction indicates a first mode, calculating output power used in the first mode according to the current impedance and the control instruction, and sending the first mode instruction and a first voltage instruction associated with the output power to the interface unit; the interface unit forwards the first mode command and the first voltage indication to the plasma unit, receives the current impedance of the target contact terminal from the plasma unit and sends the current impedance to the control unit; a plasma unit, responsive to receiving a first mode command and a first voltage indication from the interface unit, to enter a first mode to vapor strip a target based on rf energy of a plasma.

Description

Low-temperature plasma scalpel operating system

Technical Field

The utility model relates to a radio frequency technology field to more specifically relates to a low temperature plasma scalpel operating system.

Background

With the continuous development of digestive endoscopy technology, endoscopic treatment of digestive tract diseases is also increasingly popular. Endoscopic submucosal dissection is used to treat early cancers of the digestive tract, allowing more digestive tract lesions to be resected endoscopically in large blocks at a time. Can avoid the treatment risk of the traditional operation, and has the characteristics of small wound, good curative effect, high operation technical requirement and the like.

A high-frequency stripping electrotome is an electrosurgical instrument for tissue stripping instead of a mechanical scalpel. The high-frequency stripping electrotome has the working principle that the tissue is heated when high-frequency high-voltage current generated by the tip of the effective electrode is contacted with the body, so that the separation and solidification of the body tissue are realized, and the purposes of stripping and hemostasis are achieved. The peak voltage of the electrocoagulation mode of the high-frequency stripping electrotome is larger than that of the electrotomy mode, and when high-frequency current passes through high-impedance tissues, the high-frequency current can cause the tissues to be gasified or solidified, so that a good hemostatic effect is produced, but more obvious thermal injury can be caused. The high-frequency stripping electrotome is stable instantly and can reach more than 150 ℃, and the heating effect of the high-frequency stripping electrotome capable of stripping tissues is not caused by a heating electrode or a cutter head. It collects the high-frequency current with high current density to directly destroy the tissue contacting with the tip of the effective electrode. When the temperature of the tissue or cells in contact with or adjacent to the active electrode is raised until the proteins in the cells denature, exfoliation and coagulation occur.

The working temperature of the common high-frequency stripping electrotome is usually 100-150 ℃, the working temperature is still high relative to human tissues, and after tissue cells are influenced by the temperature, tissue protein denaturation is caused by stripping. Especially, after the common high-frequency stripping electrotome continuously works for a certain time, the tissue can be thermally damaged. The degeneration and necrosis of the tissue cells are a gradually developing process, and the common high-frequency stripping electric knife can cause reactions such as operation area swelling, postoperative pain and the like.

In a practical environment, the application of the high-frequency stripping electric knife to the stripping operation of a lesion site such as early cancer inside the intestines and stomach in a hospital is likely to cause complications because of damage to tissues due to temperature. The high-frequency stripping electric knife is provided with two electrodes, one electrode is attached to the body of a patient, the other electrode is placed at the stripping knife part, and an electric path is arranged on the handle. The high-frequency emission temperature is as high as 400-500 ℃, and the surrounding good tissues can be accidentally injured by the high-frequency emission temperature, so that the bleeding problem is high in probability and pathological tissues are easily damaged. In this case, the doctor cannot perform pathological analysis, and trouble is caused in effective analysis of the section arrangement.

Utility model with application number CN201520088201.1 discloses a flexible mucous membrane stripping knife, it includes: a handle; the head of the catheter is provided with a traction bendable part, and the side wall of the tail end of the traction bendable part of the catheter is provided with a traction hole communicated with the bending traction cavity; one end of the branch cavity pipe is connected with the catheter, the other end of the branch cavity pipe is connected with the handle, the branch cavity of the branch cavity pipe is communicated with the bending traction cavity, and the main cavity of the branch cavity pipe is communicated with the electric cutter cavity; the traction handle is movably connected to the cavity dividing outlet of the cavity dividing pipe; the traction bending wire is connected with the head end of the catheter, penetrates into the push rod cavity of the catheter and the push rod cavity of the branch cavity tube from the outer side of the catheter through the traction hole and then is connected with the traction handle. The endoscope can successfully find out the lesion part in the stripping operation, thereby carrying out the operation without frequently adjusting the endoscope and carrying out the operation on the blind area.

Utility model with application number CN 201520088253.9 discloses a mucous membrane stripping knife with push rod, it includes: a handle; the catheter is internally provided with a push rod cavity and an electric cutter cavity; one end of the branch cavity pipe is connected with the catheter, the other end of the branch cavity pipe is connected with the handle, the branch cavity of the branch cavity pipe is communicated with the push rod cavity, and the main cavity of the branch cavity pipe is communicated with the electric cutter cavity; the push rod handle is movably connected to the cavity dividing outlet of the cavity dividing pipe; the push rod assembly sequentially penetrates through a push rod cavity of the catheter and a push rod cavity of the branch cavity tube and then is connected with the push rod handle, and a push rod is arranged at the head end of the push rod assembly; the slip ring is arranged on the handle, and an electrode is arranged on the slip ring; the electric knife component penetrates through the electric knife cavity of the catheter and the main cavity of the branch cavity tube in sequence and then is electrically connected with the electrode on the sliding ring, and the head end of the electric knife component is provided with an electric knife. The utility model discloses can obtain better field of vision in the operation is peeled off to the scope to avoid because the condition that the electrotome peeled off the tissue can't be observed to the camera lens, reduced the risk of operation.

The utility model with the application number of CN201420542621.8 discloses a curved handle microsurgery hoe scaler, which comprises a hilt and a scalpel head, wherein the lower end of the hilt is connected with the upper end of the scalpel head through a scalpel base; the upper end of the cutter head is fixedly connected with the lower end of the cutter holder, and the upper end of the cutter holder is connected with the lower end of the cutter handle in a clamping manner; the straight line where the upper clamping part and the lower clamping part are located is intersected with the straight line where the cutter head is located to form a first included angle; the handle of a knife divide into handle head section and handle tail section, the handle head section is the plate-type strip, the handle tail section is long cylinder, the handle head section with for smooth transition connect and form the second contained angle between the handle tail section. The utility model discloses a curved handle microsurgery scalpel not only easy dismounting, moreover, the easy sanitization can also change the angle of tool bit.

However, the above-mentioned dissecting knife can not avoid the accidental injury problem that the temperature is too high to tool bit and pipe can not be according to the shape homeomorphism of chamber in the process of getting into the human body, bring very big inconvenience for the operation.

SUMMERY OF THE UTILITY MODEL

According to an aspect of the present invention, there is provided a cryogenic plasma scalpel surgery system, the system comprising:

the input unit receives a control instruction input by a user and sends the control instruction to the control unit;

the control unit is used for analyzing the control instruction, generating a first mode instruction when the control instruction indicates a first mode, calculating output power used in the first mode according to the current impedance and the control instruction, and sending the first mode instruction and a first voltage instruction associated with the output power in the first mode 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 the plasma unit, and receiving a current impedance of a target contact terminal from the plasma unit and transmitting the current impedance to the control unit;

a plasma unit, responsive to receiving a first mode command and a first voltage indication from the interface unit, to enter a first mode: performing circuit activation between an emission electrode and a return electrode at a target contact end of the plasma unit through a conductive medium to form a thin layer, applying a first voltage between the emission electrode and the return electrode, so that the conductive medium reaches a first temperature and is converted into a plasma layer, exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on a target body based on radio frequency energy of the plasma;

wherein the emitter electrode, plasma sheath, return electrode, and target contact form a return.

The control unit is used for analyzing the control instruction, generating a second mode instruction when the control instruction indicates a second mode, calculating output power used in the second mode according to the current impedance and the control instruction, and sending the second mode instruction and a second voltage instruction associated with the output power in the second mode 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.

In response to receiving a second command and a second voltage indication from the interface unit, the plasma unit enters a second mode: applying a second voltage to maintain a target contact end of the plasma cell at a second temperature to ablate and coagulate a target.

The alarm unit is used for giving an alarm through sound prompt, text prompt and/or indicator light display when receiving the alarm signal;

and sending an alarm signal to a control unit after the plasma unit detects an operation fault, wherein the control unit sends the alarm signal to the alarm unit.

The input unit is a foot-operated input device, wherein a user generates the control instruction by operating the foot-operated input device, wherein the control instruction is a binary < mode, power >.

The control unit is configured to determine whether to generate the conductive medium input command based on the current remaining amount and to send the conductive medium input command to the drop input unit after determining to generate the conductive medium input command.

The system also comprises a display unit which is used for displaying the running state of the low-temperature plasma stripping knife surgical system in real time.

The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80 Vrms.

The first temperature is in the range of 35 ℃ to 40 ℃, the second temperature is in the range of 40 ℃ to 70 ℃, and

in the first mode, the heat penetration distance is less than or equal to 150 microns, and in the second mode, the heat penetration distance is less than or equal to 200 microns.

The working temperature of the low-temperature plasma scalpel operating system and the method is only 40-70 ℃, so that the accidental injury problem and the bleeding problem of peripheral good tissues are solved, and complications are reduced. In addition, the low-temperature plasma scalpel operating system and the method structurally adopt a bipolar mode, and a loop is directly formed on the guide pipe.

Drawings

A more complete understanding of exemplary embodiments of the present invention may be had by reference to the following drawings:

FIG. 1 is a schematic view of the main components of a plasma treatment apparatus according to the preferred embodiment of the present invention;

FIG. 2 is a schematic view of a plasma treatment apparatus according to a preferred embodiment of the present invention;

FIG. 3 is a schematic structural view of a cryogenic plasma scalpel surgical system according to a preferred embodiment of the present invention;

FIG. 4 is a flow chart of a method of cryogenic plasma scalpel surgery according to a preferred embodiment of the present invention;

FIG. 5 is a schematic structural view of a low temperature plasma scalpel surgical device according to a preferred embodiment of the present invention; and

FIGS. 6-8 are enlarged, partially schematic, or cross-sectional views of a cryogenic plasma scalpel surgical device according to a preferred embodiment of the present invention;

fig. 9 is a side view of a peel knife of the seal assembly according to the present invention;

FIG. 10 is an enlarged fragmentary view taken about circle A of FIG. 9 with the seal assembly removed from the stripping knife;

FIG. 11 is a partially exploded perspective view of circle A of FIG. 9 with the seal assembly removed from the stripper blade;

FIG. 12 is a longitudinal cross-sectional view of a partial peel knife; and

FIG. 13 is a cross-sectional view taken along line I-I in FIG. 9;

FIG. 14 is a schematic view of a scalpel having an anti-rotation device in accordance with the present invention;

FIG. 15 is a cross-sectional view taken along line I-I in FIG. 14;

FIG. 16 is a partial perspective exploded view of portion A of FIG. 14 of a scalpel having an anti-rotation device in accordance with the present invention;

FIG. 17 is a partially enlarged perspective view of the electrode holder, emitter electrode and square cannula in position within the lumen of the sheath;

FIG. 18 is an enlarged cross-sectional view of the anti-rotation device in place;

FIG. 19 is a side view of a snare with a helical structure according to the present invention;

FIG. 20 is a longitudinal cross-sectional view within circle A of FIG. 19 of a snare having a helical structure according to the present invention;

FIG. 21 is a partial enlarged view of the vicinity of the spiral structure;

fig. 22 is a sectional view taken along line I-I in fig. 19.

Detailed Description

The following description is provided for illustrative embodiments of the present invention, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein.

The exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, which, however, may be embodied in many different forms and are not limited to the embodiments described herein, which are provided for the purpose of thoroughly and completely disclosing the present invention and fully conveying the scope of the present invention to those skilled in the art. The terminology used in the exemplary embodiments presented in the accompanying drawings is not intended to be limiting of the invention. In the drawings, the same units/elements are denoted by the same reference numerals.

Unless otherwise defined, terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, it will be understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense.

Fig. 1 is a functional diagram of a plasma treatment apparatus 100 according to a preferred embodiment of the present invention. The plasma treatment apparatus 100 can be used for exfoliation, ablation and coagulation of a lesion inside the intestines and stomach such as early cancer and hemostasis. In addition, the plasma treatment apparatus 100 can be used for the dissection, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, ear, nose, throat and the like. The plasma treatment apparatus 100 of the present application is used for a period of time within 24 hours, is classified as temporary contact according to contact time, is classified as an external access device (and tissue/bone/dentin) according to the nature of a human body in contact, and is classified as an active medical device according to the structural characteristics of the medical device. The accessory bipolar operation electrode (stripping knife) head of the plasma therapeutic apparatus 100 belongs to a disposable sterile product.

The plasma treatment apparatus 100 employs a bipolar scheme and has an operating frequency of 110 kHz. The plasma therapeutic apparatus 100 realizes the stripping, ablation, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat and the like through a plasma technology. In operation, the plasma treatment apparatus 100 forms a thin layer when activated between the emitter electrode and the return electrode by using physiological saline as a conductive liquid. When the plasma treatment apparatus 100 is supplied with sufficient energy (voltage), the saline is converted into a gas layer (plasma layer) composed of energized charged particles. That is, the plasma treatment apparatus 100 excites the conductive medium (e.g., saline) with energy to generate plasma, and breaks the molecular bonds of the tissue by means of the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to the working tip of the plasma treatment apparatus 100, the electric field is below the threshold requirement for creating a plasma sheath and resistive heating of the tissue is generated, thereby causing ablative coagulation and hemostasis of the tissue.

As shown in FIG. 1, the functional architecture of the plasma treatment apparatus 100 comprises: the device comprises a main control program, an alarm unit, an interface unit, an output control unit, a bipolar operation electrode (stripping knife) interface, a bipolar operation electrode (stripping knife), a foot switch, a foot control interface, a drip control valve and a drip control valve interface. The main control program, the alarm unit, the interface unit, the output control, the bipolar operation electrode interface, the foot control interface and the drip control valve interface belong to the software part of the plasma therapeutic apparatus 100. The functional description of some components of the plasma treatment apparatus 100 is shown in table 1,

functional description of some parts of Table 1

Preferably, a foot switch is capable of controlling the operation mode of the plasma treatment apparatus 100. The operation modes of the plasma therapeutic apparatus 100 are divided into a stripping mode and a coagulation mode. The water-proof rating of the foot switch is the water-proof rating standard IPX8, and the foot switch is an electric foot switch.

Preferably, the yellow pedal of the foot switch corresponds to the peeling mode, and the shift level of the peeling mode is 1 to 9 steps. That is, when the yellow pedal of the foot switch is stepped on, the plasma treatment apparatus 100 enters the stripping mode. The gear adjusting mode of the stripping mode is as follows: the adjustment is performed by a black button on the foot switch (or a yellow button on the host panel by manual adjustment) in the state of being adjusted to the peeling mode. The stripping gear can be any one of 1 to 9 gears. Wherein, the higher the gear, the larger the output voltage. In the peeling mode, the output voltages of 1 to 9 steps are shown in table 2:

TABLE 2 output gears in peel-off mode

Preferably, the blue pedal of the foot switch corresponds to a coagulation mode, and the shift 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 treatment apparatus 100 enters the coagulation mode. The gear adjusting mode of the blood coagulation mode is as follows: in the state of adjusting to the blood coagulation mode (pressing a mode key can switch the stripping mode and the blood coagulation mode), the adjustment is carried out by a black button on the blue pedal (or manually adjusting a blue button on the upper part and the lower part of the host panel). When the black button is pedaled, the coagulation gear can select any one of 1 to 5 gears, wherein the higher the gear is, the higher the output voltage is. When blood coagulation is needed in clinical use, the blue pedal is stepped down to perform blood coagulation. In coagulation mode, the output voltages in gears 1 to 5 are shown in table 3:

TABLE 3 output gears in coagulation mode

Preferably, the foot control interface is used for receiving a control instruction of the foot switch and forwarding the control instruction to the main control program. Wherein, the control instruction is binary < mode, power >. The modes include: a peel mode and a coagulation mode. In the peel mode, the power includes 9 gears, and in the coagulation mode, the power includes 5 gears.

Preferably, the main control program analyzes the control instruction and generates a first mode instruction when the control instruction indicates a first mode, calculates an output power for the first mode according to the current impedance and the control instruction, and sends the first mode instruction and a first voltage instruction associated with the output power in the first mode to the output control unit. The initial current impedance is zero, i.e., the default current impedance is zero when the plasma treatment apparatus 100 is powered on for operation. The main control program analyzes the control instruction, generates a second mode instruction when the control instruction indicates a second mode, calculates output power used in the second mode according to the current impedance and the control instruction, and sends the second mode instruction and a second voltage instruction associated with the output power in the second mode to an output control unit. Wherein the present impedance includes a high impedance, a medium impedance, and a low impedance (0 impedance is a low impedance). Preferably, calculating the output power for the first mode based on the present impedance and the control instruction comprises: if the current impedance is high and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 3 rd gear; and setting the output power in the first mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the first mode. Preferably, calculating the output power for the second mode based on the present impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 3 rd gear; and setting the output power in the second mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the second mode. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is taken as the actual output power.

Preferably, the output control unit is configured to receive the first mode command and the first voltage indication from the master program, forward the first mode command and the first voltage indication to the bipolar surgical electrode interface, and receive the current impedance of the target contact terminal from the bipolar surgical electrode interface and send the current impedance to the master program. And the output control unit receives a second mode command and a second voltage indication from the master control program and forwards the second mode command and the second voltage indication to a bipolar surgical electrode interface.

Preferably, the bipolar surgical electrode interface is configured to receive a power indication of a master procedure and to transmit the power indication to the bipolar surgical electrode, and to measure a real-time impedance of the bipolar surgical electrode and to communicate the real-time impedance to the master procedure via the output control unit.

Preferably, the bipolar surgical electrode, in response to receiving a first mode command and a first voltage indication from the bipolar surgical electrode interface, enters a first mode: the method comprises the steps of conducting circuit activation between an emitting electrode and a return electrode at a target contact end of a bipolar surgical electrode through a conductive medium to form a thin layer, applying a first voltage between the emitting electrode and the return electrode, enabling the conductive medium to reach a first temperature and be converted into a plasma layer, exciting the conductive medium to generate plasma by utilizing electric energy, and conducting vaporization stripping on a target body based on radio frequency energy of the plasma. In response to receiving a second command and a second voltage indication from the bipolar surgical electrode interface, the bipolar surgical electrode enters a second mode: applying a second voltage to maintain a target contact end of the bipolar surgical electrode at a second temperature to cause ablative coagulation of a target volume.

Preferably, the alarm unit is used for giving an alarm through sound prompt, text prompt and/or indicator light display when receiving the alarm signal. Wherein an alarm signal is sent to a master control program after the bipolar surgical electrode detects an operation fault, and the master control program sends the alarm signal to the alarm unit.

Preferably, the interface unit is used for displaying the running state of the low-temperature plasma scalpel operating system in real time.

Preferably, the drip control valve is configured to input the conductive medium to a bipolar surgical electrode based on a conductive medium input instruction of the master control program, wherein the bipolar surgical electrode measures a current remaining amount of the conductive medium in real time and transmits the current remaining amount to the master control program, and the master control program determines whether to generate the conductive medium input instruction based on the current remaining amount and transmits the conductive medium input instruction to the drip control valve after determining to generate the conductive medium input instruction. Preferably, the drip control valve interface is used to enable bi-directional communication between the drip control valve and the main control program.

Preferably, the emitter electrode, the plasma sheath, the return electrode and the target contact at the bipolar surgical electrode tip catheter form a return. In the peel mode, the bipolar surgical electrode has an operating temperature of 35 to 40 degrees Celsius, while the conventional electrosurgical knife has an operating temperature of 350 to 700 degrees Celsius. The bipolar surgical electrode has a heat penetration distance that is less than a heat penetration distance of a conventional electrosurgical knife, wherein the heat penetration distance in peel mode is less than or equal to 150 microns and the heat penetration distance in coagulation mode is less than or equal to 200 microns, and the heat penetration distance of the conventional electrosurgical knife is greater than 9000 microns.

The working principle of the plasma therapeutic apparatus 100 is plasma cryoablation. The energy generated by the bipolar cutter head is used for converting the physiological saline into the plasma thin layer, and the molecular bonds forming cell components in the target tissue are dissociated, so that the tissue coagulation necrosis is caused, and the ablation or stripping effect is formed. Because of the operation at a relatively low temperature, the thermal damage to the surrounding tissue is minimized compared with the conventionally used high-frequency stripping electrotome. The volume of the target tissue can be reduced at the working temperature of about 35 ℃, the microvessels in the target tissue are sealed, and the lesion is excised. Compared with the common monopolar electric knife, the utility model has the advantages of shortening the postoperative recovery time, relieving the postoperative pain and reducing the operation treatment cost due to the low temperature and the tissue volume reduction ablation characteristic. Wherein, the temperature comparison of the plasma therapeutic apparatus and the common high-frequency stripping electrotome is shown in table 4:

TABLE 4

When the plasma therapeutic apparatus works, the temperature around a cutter head is lower than 70 ℃ (see the report of tissue thermal injury in vitro experimental study), and compared with a traditional common high-frequency stripping electrotome (with the temperature of 100-150 ℃), the working temperature is lower, although the treatment temperature of the low-temperature plasma electrotome is still high relative to human tissues, after tissue cells are influenced by the temperature, the electrotome stripping can also cause tissue protein denaturation, and particularly after the temperature lasts for a certain time, the tissue can also be thermally damaged. The degeneration and necrosis of the tissue cells is a gradually developing process, so that the reactions of the swelling of the operation area, the pain after the operation and the like of partial patients after the low-temperature plasma operation are no lighter than those of the high-frequency stripping electrotome. The damage and thermal damage depth of the plasma therapeutic apparatus and the common high-frequency stripping electric knife are compared as shown in the following table 5:

TABLE 5

	Depth of thermal damage during peeling	Depth of heat damage during blood coagulation
			Plasma therapeutic equipment	Average 150 μm	Average 200 μm
High-frequency stripping electrotome	1.23±0.24mm	1.37±0.26mm

Because the operation time of each time is different, the maximum operation time is selected in the report of the in vitro experimental study on the tissue thermal injury by the plasma therapeutic apparatus, and the thermal injury depth of the plasma therapeutic apparatus with the maximum operation time can be seen by comparing the thermal injury depth of the normally used high-frequency stripping electric knife with the thermal injury depth of the plasma therapeutic apparatus with the thermal injury depth of the normally used high-frequency stripping electric knife. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than that of the high-frequency stripping electric knife.

Fig. 2 is a schematic view of the main parts of a plasma treatment apparatus 200 according to a preferred embodiment of the present invention. As shown in FIG. 2, the main components of the plasma treatment apparatus 200 include: bipolar surgical electrode interface 201, drip control valve interface 202, footswitch interface 203, display screen 204, main board 205, horn 206, front panel 207, malfunction warning lamp 208, lower die 209, upper die 210, power module 211, drip control valve 212, and fan 213.

Preferably, the footswitch interface 203 is used to receive commands from a footswitch and is capable of controlling the operating mode of the plasma treatment apparatus 200. The operation modes of the plasma therapeutic apparatus 200 are divided into a stripping mode and a coagulation mode. The water-proof rating of the foot switch is the water-proof rating standard IPX8, and the foot switch is an electric foot switch.

Preferably, the yellow pedal of the foot switch corresponds to the peeling mode, and the shift level of the peeling mode is 1 to 9 steps. That is, when the yellow pedal of the foot switch is stepped on, the plasma treatment apparatus 200 enters the stripping mode. The gear adjusting mode of the stripping mode is as follows: the adjustment is performed by a black button on the foot switch (or a yellow button on the host panel by manual adjustment) in the state of being adjusted to the peeling mode. The stripping gear can be any one of 1 to 9 gears. Wherein, the higher the gear, the larger the output voltage.

Preferably, the blue pedal of the foot switch corresponds to a coagulation mode, and the shift 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 treatment apparatus 200 enters the coagulation mode. The gear adjusting mode of the blood coagulation mode is as follows: in the state of adjusting to the blood coagulation mode (pressing a mode key can switch the stripping mode and the blood coagulation mode), the adjustment is carried out by a black button on the blue pedal (or manually adjusting a blue button on the upper part and the lower part of the host panel). When the black button is pedaled, the coagulation gear can select any one of 1 to 5 gears, wherein the higher the gear is, the higher the output voltage is. When blood coagulation is needed in clinical use, the blue pedal is stepped down to perform blood coagulation.

Preferably, the footswitch interface 203 is configured to receive a control command of the footswitch and forward the control command to the main control program. Wherein, the control instruction is binary < mode, power >. The modes include: a peel mode and a coagulation mode. In the peel mode, the power includes 9 gears, and in the coagulation mode, the power includes 5 gears.

Preferably, the motherboard 205 is configured to receive firmware, and the firmware stores a master control program therein. The main control program analyzes the control instruction, generates a first mode instruction when the control instruction indicates a first mode, calculates output power used in the first mode according to the current impedance and the control instruction, and sends the first mode instruction and a first voltage instruction associated with the output power in the first mode to an output control unit. The initial current impedance is zero, i.e., the default current impedance is zero when the plasma treatment apparatus 200 is turned on for operation. The main control program analyzes the control instruction, generates a second mode instruction when the control instruction indicates a second mode, calculates output power used in the second mode according to the current impedance and the control instruction, and sends the second mode instruction and a second voltage instruction associated with the output power in the second mode to an output control unit. Wherein the present impedance includes a high impedance, a medium impedance, and a low impedance (0 impedance is a low impedance). Preferably, calculating the output power for the first mode based on the present impedance and the control instruction comprises: if the current impedance is high and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 3 rd gear; and setting the output power in the first mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the first mode. Preferably, calculating the output power for the second mode based on the present impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 3 rd gear; and setting the output power in the second mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the second mode. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is taken as the actual output power.

Preferably, the 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 to forward the first mode command and the first voltage indication to the bipolar surgical electrode interface 201, and to receive the current impedance of the target contact terminal from the bipolar surgical electrode interface 201 and to transmit the current impedance to the master program. And the output control unit receives second mode instructions and second voltage indications from the master control program and forwards the second mode instructions and second voltage indications to the bipolar surgical electrode interface 201.

Preferably, the bipolar surgical electrode interface 201 is configured to receive a power indication of a master procedure and to send the power indication to the bipolar surgical electrode, and to measure a real-time impedance of the bipolar surgical electrode and to pass the real-time impedance to the master procedure through the output control unit.

Preferably, a bipolar surgical electrode (not shown) enters a first mode in response to receiving a first mode command and a first voltage indication from the bipolar surgical electrode interface 201: the method comprises the steps of conducting circuit activation between an emitting electrode and a return electrode at a target contact end of a bipolar surgical electrode through a conductive medium to form a thin layer, applying a first voltage between the emitting electrode and the return electrode, enabling the conductive medium to reach a first temperature and be converted into a plasma layer, exciting the conductive medium to generate plasma by utilizing electric energy, and conducting vaporization stripping on a target body based on radio frequency energy of the plasma. In response to receiving a second command and a second voltage indication 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 at a second temperature to cause ablative coagulation of a target volume.

Preferably, the malfunction warning lamp 208 is used to alarm by indicating lamp display when an alarm signal is received. Wherein an alarm signal is sent to a master control program after the bipolar surgical electrode detects an operational failure, the master control program sending an alarm signal to the failure warning lamp 208. The speaker 206 is used for alarming by sound when receiving the alarm signal. Wherein an alarm signal is sent to a master program after the bipolar surgical electrode detects an operational failure, the master program sending an alarm signal to the horn 206.

Preferably, the display screen 204 is used for displaying the operation state of the low-temperature plasma scalpel operation system in real time.

Preferably, 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 remaining amount of the conductive medium in real time and transmits the current remaining amount to the master program, and the master program determines whether to generate the conductive medium input command based on the current remaining amount and transmits the conductive medium input command to the drip control valve 212 after determining to generate the conductive medium input command. Preferably, drip control valve interface 202 is used to enable bi-directional communication between drip control valve 212 and the host program.

Preferably, the present application employs a dual mode liquid outlet: 1. titration mode, i.e. delivery of one drop per drop as in infusion bottles; and 2, continuous feed mode, i.e., a mode in which a liquid stream is continuously supplied. The bipolar surgical electrode interface (scalpel interface) is connected to a bipolar electrode socket joint (scalpel joint) of fig. 5 described below by a patch cord, and the drip control valve interface is connected to the fluid lumen of fig. 5 by a connecting tube. The foot switch port is connected with an external foot pedal through a connecting wire and is used for controlling the supply and disconnection of energy and dropping liquid. When the pedal is pressed, energy and dropping liquid are supplied; when the foot pedal is released, energy and drip are disconnected.

Preferably, the upper mold 210 and the lower mold 209 protect the main board in a combined manner. The fan 213 is used for dissipating heat, and the power module 211 is used for supplying power to the plasma treatment apparatus 200. The front panel 207 is used for data display and operation control.

Fig. 3 is a schematic structural view of a cryogenic plasma scalpel surgery system 300 according to a preferred embodiment of the present invention. The cryogenic plasma scalpel surgical system 300 can be used for exfoliation, ablation and coagulation and hemostasis of lesions inside the gastrointestinal tract, such as early cancers. In addition, the low temperature plasma scalpel operating system 300 can also be used for soft tissue dissection, ablation, coagulation and hemostasis in surgical operations such as joints, spine, skin, ear, nose and throat, and the like. The cryogenic plasma scalpel surgical system 300 of the present application is used for less than 24 hours, is classified as temporary contact by contact time, is classified as an external access device (and tissue/bone/dentin) by contact body properties, and is classified as an active medical device by medical device structural features.

The cryogenic plasma scalpel surgical system 300 employs a bipolar scheme and has an operating frequency of 110 kHz. The low-temperature plasma scalpel operation system 300 realizes the stripping, ablation, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat and the like through a plasma technology. In operation, the low temperature plasma scalpel operating system 300 forms a thin layer when activated between the emitter electrode and the return electrode by using physiological saline as a conductive fluid. When sufficient energy (voltage) is applied by cryogenic plasma scalpel surgical system 300, the saline is converted into a gaseous layer (plasma layer) comprised of energized charged particles. That is, the cryogenic plasma scalpel operating system 300 excites a conductive medium (e.g., saline) with energy to generate plasma, and breaks molecular bonds of tissue by means of the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to the working head of the plasma treatment apparatus 100, the electric field is below the threshold for producing the plasma sheathResistive tissue heat is required and generated to ablate coagulation and stop bleeding of tissue.

As shown in fig. 3, the cryogenic plasma scalpel surgery 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. Preferably, the input unit 301 is, for example, a foot switch, and the foot switch can control the operation mode of the low temperature plasma scalpel operating system 300. The operation modes of the low temperature plasma scalpel operating system 300 are divided into a stripping mode and a coagulation mode. The water-proof rating of the foot switch is the water-proof rating standard IPX8, and the foot switch is an electric foot switch.

Preferably, the yellow pedal of the foot switch corresponds to the peeling mode, and the shift level of the peeling mode is 1 to 9 steps. That is, when the yellow pedal of the foot switch is stepped on, the low temperature plasma scalpel operating system 300 enters the stripping mode. The gear adjusting mode of the stripping mode is as follows: the adjustment is performed by a black button on the foot switch (or a yellow button on the host panel by manual adjustment) in the state of being adjusted to the peeling mode. The stripping gear can be any one of 1 to 9 gears. Wherein, the higher the gear, the larger the output voltage.

Preferably, the blue pedal of the foot switch corresponds to a coagulation mode, and the shift level of the coagulation mode is 1 to 5 steps. That is, when the blue pedal of the foot switch is stepped on, the low temperature plasma scalpel operating system 300 enters the coagulation mode. The gear adjusting mode of the blood coagulation mode is as follows: in the state of adjusting to the blood coagulation mode (pressing a mode key can switch the stripping mode and the blood coagulation mode), the adjustment is carried out by a black button on the blue pedal (or manually adjusting a blue button on the upper part and the lower part of the host panel). When the black button is pedaled, the coagulation gear can select any one of 1 to 5 gears, wherein the higher the gear is, the higher the output voltage is. When the clinical application needs to perform blood coagulation, the blue pedal is stepped down to perform blood coagulation.

Preferably, the control unit 302 parses the control instruction and generates a first mode instruction when the control instruction indicates a first mode, calculates an output power for the first mode according to the current impedance and the control instruction, and sends the first mode instruction and a first voltage instruction associated with the output power in the first mode to the interface unit 303. The initial current impedance is zero, that is, the default current impedance is zero when the cryogenic plasma scalpel operating system 300 is turned on for operation. The control unit 302 parses the control instruction and generates a second mode instruction when the control instruction indicates a second mode, calculates an output power for the second mode according to the current impedance and the control instruction, and sends the second mode instruction and a second voltage instruction associated with the output power in the second mode to the interface unit 303. Wherein the present impedance includes a high impedance, a medium impedance, and a low impedance (0 impedance is a low impedance). Preferably, calculating the output power for the first mode based on the present impedance and the control instruction comprises: if the current impedance is high and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the first mode, setting the output power in the first mode to be the 3 rd gear; and setting the output power in the first mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the first mode. Preferably, calculating the output power for the second mode based on the present impedance and the control instruction comprises: if the current impedance is high impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 4 th gear; if the current impedance is the middle impedance and the control instruction indicates the 2 nd gear in the second mode, setting the output power in the second mode to be the 3 rd gear; and setting the output power in the second mode to gear 2 if the present impedance is low and the control instruction indicates gear 2 in the second mode. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is taken as the actual output power.

Preferably, the interface unit 303 is adapted to receive the first mode command and the first voltage indication from said control unit 302 and to forward said first mode command and first voltage indication to the plasma unit 304, and to receive the present impedance of the target contact terminal from the plasma unit 304 and to send said present impedance to said control unit 302. And 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.

Preferably, the interface unit 303 is configured to receive a power indication from the control unit 302 and to send the power indication to the plasma unit 304, and to measure a real-time impedance of the plasma unit 304 and to communicate the real-time impedance to the control unit 302 via the interface unit 303.

Preferably, the plasma cell 304 enters the first mode in response to receiving a first mode command and a first voltage indication from the plasma cell 304: the method comprises the steps of performing circuit activation between an emission electrode and a return electrode at a target contact end of the plasma unit 304 through a conductive medium to form a thin layer, applying a first voltage between the emission electrode and the return electrode, enabling the conductive medium to reach a first temperature and be converted into a plasma layer, exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on a target body based on radio frequency energy of the plasma. In response to receiving a second command and a second voltage indication from the plasma cell 304, the plasma cell 304 enters a second mode: a second voltage is applied to maintain a target contact end of the plasma cell 304 at a second temperature to ablate and coagulate the target.

Preferably, the alarm unit 305 is configured to alarm through an audio prompt, a text prompt and/or an indicator light display when receiving the alarm signal. Wherein an alarm signal is sent to the control unit 302 after the plasma unit 304 detects an operation failure, and the control unit 302 sends the alarm signal to the alarm unit 305.

Preferably, the drip input unit 306 is configured to input the conductive medium to the plasma unit 304 based on a conductive medium input command of the control unit 302, wherein the plasma unit 304 measures a current remaining amount of the conductive medium in real time and transmits the current remaining amount to the control unit 302, and the control unit 302 determines whether to generate the conductive medium input command based on the current remaining amount and transmits the conductive medium input command to the drip input unit 306 after determining to generate the conductive medium input command.

Preferably, the emitter electrode, plasma sheath, return electrode, and target contact at the end conduit of plasma unit 304 form a return. In the stripping mode, the operating temperature of the plasma unit 304 is 35 to 40 ℃, whereas the operating temperature of the conventional electrosurgical knife is 350 to 700 ℃. The plasma cell 304 has a heat penetration distance that is less than or equal to 150 microns in the peel mode and less than or equal to 200 microns in the coagulation mode, as compared to a conventional electrosurgical knife having a heat penetration distance greater than 9000 microns.

Preferably, the display unit 307 is used for displaying the running state of the low-temperature plasma scalpel operating system in real time. The working principle of the cryogenic plasma scalpel operating system 300 is plasma cryoablation. The energy generated by the bipolar cutter head is used for converting the physiological saline into the plasma thin layer, and the molecular bonds forming cell components in the target tissue are dissociated, so that the tissue coagulation necrosis is caused, and the ablation or stripping effect is formed. Because of the operation at a relatively low temperature, the thermal damage to the surrounding tissue is minimized compared with the conventionally used high-frequency stripping electrotome. The volume of the target tissue can be reduced at the working temperature of about 35 ℃, the microvessels in the target tissue are sealed, and the lesion is excised. Compared with the common monopolar electric knife, the utility model has the advantages of shortening the postoperative recovery time, relieving the postoperative pain and reducing the operation treatment cost due to the low temperature and the tissue volume reduction ablation characteristic. When the low-temperature plasma scalpel operation system 300 works, the ambient temperature of a scalpel head is lower than 70 ℃ (see the report of in vitro experimental study on tissue thermal damage), and compared with a traditional common high-frequency scalpel (with the high temperature of 100-150 ℃), although the treatment temperature of the low-temperature plasma scalpel is still high relative to human tissues, tissue cells are affected by the temperature, the tissue proteins can be denatured due to electrotome dissection, and particularly after the tissue cells are continuously maintained for a certain time, the tissue can also be thermally damaged. The degeneration and necrosis of the tissue cells is a gradually developing process, so that the reactions of the swelling of the operation area, the pain after the operation and the like of partial patients after the low-temperature plasma operation are no lighter than those of the high-frequency stripping electrotome. Because the operation time of each time is different, the maximum operation time is selected in the report of the in vitro experimental study on the tissue thermal injury by the plasma therapeutic apparatus, and the thermal injury depth of the plasma therapeutic apparatus with the maximum operation time can be seen by comparing the thermal injury depth of the normally used high-frequency stripping electric knife with the thermal injury depth of the plasma therapeutic apparatus with the thermal injury depth of the normally used high-frequency stripping electric knife. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than that of the high-frequency stripping electric knife.

Fig. 4 is a flow chart of a cryogenic plasma scalpel surgery method 400 according to a preferred embodiment of the present invention. As shown in fig. 4, method 400 begins at step 401. In step 401, a control instruction input by a user is received.

In step 402, the control instruction is parsed and a first mode instruction is generated when the control instruction indicates a first mode, and an output power for the first mode is calculated based on the current impedance and the control instruction.

At step 403, a first voltage indication associated with the output power in the first mode is determined.

In step 404, the first mode command and the first voltage indication are forwarded to the plasma device and a current impedance of the target contact terminal is received from the plasma device.

In step 405, in response to receiving a first mode command and a first voltage indication, causing the plasma apparatus to enter a first mode: performing circuit activation between an emission electrode and a return electrode of a target contact end of the plasma unit through a conductive medium to form a thin layer, applying a first voltage between the emission electrode and the return electrode, so that the conductive medium reaches a first temperature and is converted into a plasma layer, exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on a target body based on radio frequency energy of the plasma;

Further comprising interpreting the control instruction and generating a second mode instruction when the control instruction indicates a second mode, calculating an output power for the second mode from the current impedance and the control instruction, and determining a second voltage indication associated with the output power in the second mode. Forwarding the second mode command and the second voltage indication to a plasma device. In response to receiving the second command and the second voltage indication from the plasma apparatus, the plasma apparatus enters a second mode: applying a second voltage to maintain a target contact end of the plasma device at a second temperature to ablate and coagulate a target volume.

When the alarm signal is received, alarming is carried out through voice prompt, text prompt and/or indicator light display; wherein an alarm signal is generated upon detection of an operational failure.

Wherein the control instruction is generated by a user operating the foot-operated input device, wherein the control instruction is a binary < mode, power >.

Further comprising inputting the conductive medium to the plasma device based on a conductive medium input instruction, wherein the plasma device measures a current balance of the conductive medium in real time and determines whether to generate the conductive medium input instruction based on the current balance. The method 400 displays the operating state of the plasma apparatus in real time.

Fig. 5 is a schematic structural view of a low temperature plasma scalpel operation device according to a preferred embodiment of the present invention. As shown in fig. 5, the low temperature plasma scalpel operation apparatus includes: a transmitting electrode (stripping bit) 501, a loop electrode (round sleeve) 502, a tube sheath 503, an injection cavity interface 505, a pull rod cap 506, a cushion block 507, a sliding block (with socket hole) 508, a socket Pin 509 and a pull rod 510. Preferably, the emitter electrode (dissector bit) 501 and return electrode (circular sheath) 502 are introduced through the same catheter and form a conductive return path at the target. The transmitting electrode (stripping tip) 501 receives a first input voltage generated by the high-frequency generator via the socket Pin 509, and applies the first voltage between the transmitting electrode (stripping tip) 501 and the loop electrode (dome) 502 so that the conductive medium reaches a first temperature and is caused to be converted into a plasma layer, thereby exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on the target based on the radio-frequency energy of the plasma. A sheath 503 for providing an outer coating function. The infusion chamber interface 505 inputs the liquid to a liquid input unit based on a liquid input command, where the liquid input unit measures a current balance of the liquid in real time and sends the current balance to a control unit that determines whether to generate the liquid input command based on the current balance and sends the liquid input command to a drip input unit upon determining to generate the liquid input command. The injection lumen interface 505 is an annular cavity located outside the emitter electrode lead (the stripping bit lead).

The pull rod 510 is used to allow an operator to provide a supporting force by manipulating the pull rod 510. The jack Pin 509 is connected to the high-frequency generator by a high-frequency connection for receiving a first input voltage generated by said 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 the second voltage is applied between the transmitting electrode 501 and the return electrode 502 to maintain the target body at the second temperature, thereby promoting ablation coagulation of the target body. And a liquid input unit (not shown in fig. 5) for inputting 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. The liquid input unit performs liquid input by one of the following modes: titration mode and continuous feed mode.

Wherein, the material of the emitter electrode (stripping head) 501 is stainless steel 304, the material of the loop electrode (circular sleeve) 502 is stainless steel 304, the material of the tube sheath 503 is polytetrafluoroethylene PTFE, the material of the injection cavity interface 505 is acrylonitrile-butadiene-styrene ABS, the material of the pull rod cap 506 is ABS, the material of the cushion block 507 is ABS, the material of the slide block (with socket hole) is ABS, the material of the socket Pin is stainless steel 304 and the material of the pull rod 510 is ABS.

As shown in fig. 5, the stripping tip of the emitter electrode 2 may be in the shape of a hook, a hemisphere, a quincunx, a cylinder, or a sphere to adapt to different target shapes for cutting. The length of the return electrode 502 may be any reasonable value, such as 4 to 5 millimeters. The distance between the end of the return electrode 502 near the top of the sheath 503 and the top end surface of the sheath 503 may be any reasonable value, such as 2 to 3 mm. The water outlet 511 (or referred to as an infusion port) is provided on the distal end surface of the sheath 503.

The emitter electrode 501 is telescopically arranged by a slider 508. In the initial state, the emitter electrode 501 is retracted into the sheath 503 to facilitate the entrance of the front end of the sheath 503 into the human body. When the specified position is reached, the slider 508 moves forward, pushing the emitter electrode 501 out of the tip end surface of the sheath 503. The slider 508 is at the socket hole and the socket Pin 509 is disposed within the socket hole.

Fig. 6-8 are enlarged partial or cross-sectional views of a cryoplasma scalpel surgical device according to a preferred embodiment of the present invention. Fig. 6 shows a partially enlarged schematic view of a bipolar electrode socket joint (peel blade joint) 600, including: a transmitting electrode lead (a stripping tip lead) 601 and a return electrode lead 602. The cryoplasma scalpel surgical device can be used for the dissection, ablation and coagulation and hemostasis of lesions inside the intestines and stomach, such as early cancers. In addition, the low-temperature plasma stripper knife operation equipment can also be used for stripping, melting, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skins, ears, noses, throats and the like. The low-temperature plasma scalpel operating equipment has the service time within 24 hours, belongs to temporary contact according to the contact time classification, belongs to external access instruments (and tissues/bones/dentin) according to the contact human body property classification and belongs to active medical instruments according to the medical instrument structure characteristic classification. An accessory bipolar operation electrode of low-temperature plasma stripping knife operation equipment belongs to a disposable sterile product.

The cryogenic plasma scalpel surgical device employs a bipolar scheme and has an operating frequency of 110 kHz. The plasma therapeutic apparatus 100 realizes the stripping, ablation, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat and the like through a plasma technology. When the low-temperature plasma scalpel is in work, the low-temperature plasma scalpel surgical equipment takes physiological saline as conductive liquid, and a thin layer is formed when the emitting electrode and the loop electrode are activated. When sufficient energy (voltage) is supplied by the plasma treatment apparatus, the saline is converted into a gas layer (plasma layer) composed of energized charged particles. That is, the cryogenic plasma scalpel surgical device excites a conductive medium (e.g., physiological saline) with energy to generate plasma, and breaks a tissue molecular bond depending on the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to a working cutter head of the low-temperature plasma scalpel surgical equipment, an electric field is lower than a threshold requirement for generating a plasma layer and resistive heat of tissues is generated, so that the tissues are subjected to ablation coagulation and hemostasis.

Fig. 7 shows a schematic cross-sectional view along B-B, including: a transmitting electrode lead (peel tip lead) 701, a return electrode lead 702, a fluid lumen 704, and a transmitting electrode lumen 705. In more detail, FIG. 7 shows a cross-section 706 of a transmitting electrode lead (stripping tip lead) 701 including an insulating layer 707 and a wire 708. The emitter electrode wire (the stripping tip wire) requires an insulating layer for insulation and thermal isolation, and the return electrode wire 702 may not be provided with an insulating layer.

In addition, a person skilled in the art may use the loop electrode cavity 705 as a liquid passing cavity as needed, and when the loop electrode cavity 705 is used as a liquid passing cavity, the loop electrode lead 702 needs to be provided with an insulating layer.

Fig. 8 shows a schematic cross-sectional view along C-C, including a transmitting electrode lead (stripping tip lead) 801 and a return electrode lead 802.

FIG. 9 shows a block diagram of a block diagram according to the present embodimentSide view of a peel knife (low temperature plasma peel knife) with a novel seal assembly. The utility model provides a stripper can be used for the intestines and stomach the inside such as peeling off of pathological change position of early cancer, melt and solidify and stanch. In addition, the dissecting knife can also be used for cutting, melting, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skins, ears, noses, throats and the like. The scalpel is used for less than 24 hours, is classified as temporary contact according to contact time, is classified as an external access device (and tissue/bone/dentin) according to the nature of a contacted human body, and is classified as an active medical device according to the structural characteristics of the medical device. The stripping knife used a bipolar scheme and its operating frequency was 105 kHz. Optionally, the operating frequency of the stripping knife may be in the range of 100-110. The dissector realizes cutting, melting, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat through a plasma technology. When the device works, the stripping knife takes physiological saline as conductive liquid, and a thin layer is formed when the emitting electrode and the loop electrode are activated. When the dissector imparts sufficient energy (voltage), the saline is converted into a gaseous layer (plasma layer) composed of energized charged particles. That is, the scalpel uses energy to excite a conductive medium (e.g., physiological saline) to generate plasma, and breaks tissue molecular bonds by means of the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to the working cutter head of the stripping knife, the electric field is lower than the threshold requirement for generating the plasma layer and generates tissue resistance heat, so that the tissue is subjected to ablation coagulation and hemostasis.

The operation part of the stripping knife comprises a handle 1, a pull rod 2, a socket Pin3, a slide block 4, a cushion block 5, a front rod 6 (also called a pull rod cap), a tube sheath 7, an injection cavity interface 8, push

rods

9 and 10 and the like. The pull rod 2 is held by an operator to conveniently operate the stripping knife. The sheath 7 is an elongated tube extending longitudinally from the anterior rod 16, and the sheath 7 is to be inserted into a subject (a lesion of a human body).

As shown in fig. 12, a chamber 6a is formed in the front rod 6, and an injection cavity port 8 is formed on the outer periphery of the front rod 6. A liquid inlet port 8a is formed in the injection chamber port 8 on the outer periphery of the front rod 6.

A liquid passage chamber 18 is provided in the sheath 7, and the liquid passage chamber 18 leads from a chamber 6a formed in the front rod 6 to the tip of the sheath 7. A fluid lumen 18 surrounds the emitter electrode lead 16 (see fig. 13). Liquid (e.g., conductive medium, cleaning water, etc.) enters the liquid passing chamber 18 through the chamber 6a via the liquid inlet port 8 a.

The sheath 7 serves to provide an outer coating function. The infusion chamber interface 8 inputs a liquid (e.g., an electrically conductive medium) based on a liquid input command from a not-shown controller, wherein a current remaining amount of the liquid is measured in real time and the current remaining amount is transmitted to the controller, which determines whether to generate the liquid input command based on the current remaining amount and controls the input from the liquid inlet port 8a to the liquid passing chamber 18 and ultimately to the subject via the chamber 6a after determining to generate the liquid input command.

Still further, as shown in fig. 10-4, the peel knife also includes a sealing assembly. Specifically, the seal assembly includes a seal ring 11 and a fixing screw member 12 that fixes the seal ring 11 to a side of the chamber 6a, the side of the chamber 6a being a side of the chamber 6a opposite to the liquid passage chamber 18.

More specifically, a wall portion of one side of the chamber 6a is formed with a first stepped hole 6b, a second stepped hole 6c is provided outside the first stepped hole 6b, and the diameter of the second stepped hole 6c is larger than that of the first stepped hole 6 c. The seal ring 11 is fixed to the first stepped hole 6 b. An internal thread is formed on the inner wall of the second stepped hole 6c, and an external thread is formed on the outer periphery of the fixing threaded member 12. Thereby, the fixing threaded member 12 is threadedly engaged in the second stepped hole 6 c. Further, the fixing screw member 12 is a hollow substantially cylindrical body.

Further, the seal assembly according to the preferred embodiment of the present invention further includes a stopper 13 disposed between the seal ring 11 and the fixing screw member 12. The stopper 13 includes a circular portion and two lugs 13a projecting from the circular portion. The lug 13a is fitted in the catch 15 of the second stepped bore 6 c. When the fixing screw member 12 is tightened with the lug 13a fitted in the snap groove, the stopper 13 is fixed in the second stepped hole 6c and the seal ring 11 is fixed in the first stepped hole 6 b. The stopper 13 is a hollow substantially circular thin plate member.

Furthermore, the push rod 9 penetrates the sealing ring 11 and enters the passage chamber 18 through the chamber 6a, and the push rod 9 is slidable with respect to the sealing assembly. Likewise, the push rod 10 penetrates the sealing ring 11 and enters, through the chamber 6a, inside the sheath 7, in a cavity 7a formed in said sheath 7 in a position offset from said passage chamber 18. In this embodiment, the pushrod 10 is fixed relative to the seal assembly. Further, a tube 14 is inserted into the cavity 7a and protrudes outwardly from (the fixed tube threaded member 12 of) the seal assembly, the push rod 10 being slidable in the tube 14. That is, the tube 14 is disposed between the cavity 7a and the push rod 10.

Further, as shown in fig. 9, the operation portion of the scalpel further includes an emitter electrode 21 and a return electrode 22 provided at the tip of the sheath 7. The emitter electrode 21 is telescopically arranged by means of a push rod 9.

The emitter electrode 21 (stripping bit) and the return electrode 22 (circular sleeve) are introduced into the target body through the sheath 7 and form a conductive return path in the target body. The transmitting electrode 21 receives a first input voltage generated by a high frequency generator (not shown) via a socket Pin3 connected to the high frequency generator through a high frequency connection line to apply the first voltage between the transmitting electrode 21 and the return electrode 22, so that the conductive medium reaches a first temperature and is caused to be converted into a plasma layer, thereby exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on the target based on the radio frequency energy of the plasma.

As shown in fig. 9, the stripping tip of the emitter electrode 21 may be in the shape of a hook, a hemisphere, a quincunx, a cylinder, or a sphere to adapt to different target shapes for vaporization stripping.

The emitter electrode 21 is telescopically arranged by the slider 4. In the initial state, the emitter electrode 21 is retracted into the sheath 7 to facilitate the entrance of the front end of the sheath 7 into the human body. When the specified position is reached, the slider 4 moves forward, pushing the emitter electrode 21 out of the tip end surface of the sheath 7.

The pull rod 2 is used for the operator to provide a supporting force by the pull rod 2. The socket Pin3 is connected with the high-frequency generator through a high-frequency connecting wire and is used for receiving a first input voltage generated by the high-frequency generator. The socket Pin3 receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the emitter electrode 21, and the second voltage is applied between the emitter electrode 21 and the return electrode 22 to maintain the target body at the second temperature, thereby promoting ablation coagulation of the target body.

For example, the first temperature may range from 35 ℃ to 40 ℃ and the second temperature may range from 40 ℃ to 70 ℃. The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80 Vrms.

The length L1 of return electrode 22 can be any reasonable value, such as 4 to 5 millimeters. The distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top end surface of the sheath 7 may be any reasonable value, such as 2 to 3 mm. In which a water outlet 23 (or referred to as an infusion port, see fig. 9) is provided at the top end of the sheath 7, and liquid entering from a liquid inlet port 8a described later enters the subject from the water outlet 23.

Wherein, for example, the material of the emitter electrode 21 is stainless steel 304, the material of the return electrode 22 is stainless steel 304, the material of the sheath 7 is polytetrafluoroethylene PTFE, the material of the injection cavity interface 8 is ABS, the material of the front rod 6 is ABS, the material of the spacer 5 is ABS, the material of the slider 4 is ABS, the material of the socket Pin3 is stainless steel 304 and the material of the handle 1 is ABS.

As shown in FIG. 13, the emitter electrode lead (peel tip lead) 16, the return electrode lead 17, the fluid lumen 18, and the emitter electrode lumen 19 are illustrated. In more detail, the enlarged view in fig. 13 shows a cross-sectional view of the emitter electrode lead 16, including the insulating layer 16a and the wire 16 b. The emitter electrode wire 16 requires an insulating layer for insulation and thermal insulation, and the return electrode wire 17 may not be provided with an insulating layer.

The emitter electrode lead 16 and the return electrode lead 17 are connected to the emitter electrode 21 and the return electrode 22, respectively. Further, a transmission electrode wire 16 and a return electrode wire 17 are passed through the insides of the push rod 9 and the push rod 10, respectively, and connected to a high-frequency generator, not shown. When the slider 4 is operated to move forward as described above so that the push rod 9 moves relative to the seal assembly and the push rod 10 is fixed relative to the seal assembly, the emitter electrode lead 16 and the return electrode lead 17 are held inside the push rod 9 and the push rod 10, respectively.

Furthermore, the sealing ring 11 may preferably be molded from, for example, ethylene propylene diene monomer. However, the present invention is not limited thereto. For example, the sealing ring 11 may be made of any material capable of achieving a seal, such as rubber or the like.

Further, it is preferable that one side (outer side) of the fixing screw member 12 is provided with a notch 12 a. However, the present invention is not limited thereto. For example, a lug may be provided on the outer side of the fixing screw 12 and the fixing screw 12 may be rotated by the lug.

Effects achieved according to the preferred embodiments of the present invention are described below.

First, since a seal assembly including the seal ring 11 and the fixing screw member 12 for fixing the seal ring 11 to one side of the chamber is provided at the side of the chamber 6a opposite to the liquid passing chamber 18 and the push rod 9 penetrates the seal ring 11 and enters the liquid passing chamber 18 through the chamber 6a, the push rod 10 seal assembly can seal the outer peripheries of the push rod 9 and the push rod 10. As a result, when liquid (for example, a conductive medium) is introduced from the liquid inlet port 8a into the chamber 6a and the liquid passage chamber 18 during a surgical operation using the scalpel, the seal ring 11 can prevent the liquid entering the chamber 6a and the liquid passage chamber 18 from the liquid inlet port 8a from leaking outward from the outer peripheries of the two

push rods

9, 10 on the side of the chamber 6a due to its own pressure.

Further, since the stopper 13 is provided between the seal ring 11 and the fixing screw member 12. Therefore, when the seal ring 11 is fixed to one side of the chamber 6a by rotating the fixing threaded member 12, the stopper 13 can be tightly sandwiched between the seal ring 11 and the fixing threaded member 12, thereby firmly fixing the seal ring 11 while preventing the seal ring 11 from following the fixing threaded member 12 when the fixing threaded member 12 is rotated, for example, when it is necessary to disassemble the seal assembly.

Further, by the lug 13a of the stopper 13, the stopper 13 can be reliably held in its position without rotating with the fixing screw member 13.

Further, since the seal ring 11 is molded from ethylene propylene diene monomer, the seal ring 11 can have superior oxidation resistance, corrosion resistance, and the like, compared to a conventional seal member made of rubber or the like. Therefore, the service life of the seal ring can be prolonged.

Further, one side of the fixing screw member 12 is provided with a notch. Thus, the fixing screw member 12 can be screwed easily by a special tool being caught in the notch.

Further, a tube 14 is inserted into the cavity 7a and protrudes outward from the sealing assembly, and the push rod 10 is inserted into the tube 14. Thus, the liquid introduced into the chamber 6a from the liquid inlet port 8a can be isolated from the cavity 7a by the tube 14. In other words, the liquid can only enter the liquid passage chamber 10 from the liquid inlet port 8a through the chamber 6a, and not the cavity 7 a.

Further, since the peeling blade of the emitter electrode 21 may have a hook shape, a hemispherical shape, a quincunx shape, a cylindrical shape, or a spherical shape, it is possible to perform vaporization peeling on targets having different shapes.

Although the liquid passing chamber is formed around the emitter electrode lead 16 as described above, a person skilled in the art may use the return electrode chamber 19 as the liquid passing chamber if necessary, and the return electrode lead 17 needs to be provided with an insulating layer when the return electrode chamber 19 is used as the liquid passing chamber.

Fig. 14 is a side view of a stripper knife (low temperature plasma stripper knife) of a seal assembly according to the present invention. The utility model provides a stripper can be used for the intestines and stomach the inside such as peeling off of pathological change position of early cancer, melt and solidify and stanch. In addition, the dissecting knife can also be used for dissecting, ablating, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skins, ears, noses, throats and the like. The scalpel has a lifetime of less than 24 hours, is classified as temporary contact according to contact time, is classified as an external access device (tissue/bone/dentin) according to the nature of a human body in contact, and is classified as an active medical device according to the structural characteristics of the medical deviceA therapeutic apparatus. The stripping knife used a bipolar scheme and its operating frequency was 105 kHz. Optionally, the operating frequency of the stripping knife may be in the range of 100-110. The dissector realizes the dissection, ablation, coagulation and hemostasis of soft tissues in the operations of ear, nose, throat and the like through a plasma technology. When the device works, the stripping knife takes physiological saline as conductive liquid, and a thin layer is formed when the emitting electrode and the loop electrode are activated. When the dissector imparts sufficient energy (voltage), the saline is converted into a gaseous layer (plasma layer) composed of energized charged particles. That is, the scalpel uses energy to excite a conductive medium (e.g., physiological saline) to generate plasma, and breaks tissue molecular bonds by means of the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to the working cutter head of the stripping knife, the electric field is lower than the threshold requirement for generating the plasma layer and generates tissue resistance heat, so that the tissue is subjected to ablation coagulation and hemostasis.

The operating part of the stripping knife comprises a handle 1, a pull rod 2, a socket Pin3, a slide block 4, a cushion block 5, a front rod 6 (also called a pull rod cap), a tube sheath 7, an injection cavity interface 8 and the like. The pull rod 2 is held by an operator to conveniently operate the stripping knife. The sheath 7 is an elongated tube extending longitudinally from the front shaft 6, and the sheath 7 is to be inserted into a subject (lesion of the human body).

A liquid passage chamber 18 is provided in the sheath 7, the liquid passage chamber 18 leading from a chamber formed in the front rod 6 to the tip of the sheath 7. A fluid lumen 18 surrounds the emitter electrode lead 16 (see fig. 18). Liquid (e.g., conductive medium, wash water, etc.) enters the weep cavity 18 through a chamber in the front stem 6 via a liquid inlet port formed in the injection lumen interface 8.

The sheath 7 serves to provide an outer coating function. The infusion chamber interface 8 inputs liquid (e.g., an electrically conductive medium) based on a liquid input command from a controller, not shown, wherein a current remaining amount of the liquid is measured in real time and the current remaining amount is transmitted to the controller, which determines whether to generate the liquid input command based on the current remaining amount and controls the input of liquid from a liquid inlet port 8a within the infusion chamber interface 8 to the liquid passage chamber 18 and ultimately to the subject via the chamber within the front stem 6 after determining that the liquid input command is generated.

Further, as shown in fig. 14, the operation portion of the scalpel further includes an emitter electrode 21 and a return electrode 22 provided at the tip of the sheath 7. The emitter electrode 21 is formed with a hook-shaped stripping bit, and the return electrode 22 is fitted over the outer peripheral surface of the sheath 7. The emitter electrode 21 (stripping bit) and the return electrode 22 (circular sleeve) are introduced into the target body through the sheath 7 and form a conductive return path in the target body. The transmitting electrode 21 receives a first input voltage generated by a high frequency generator (not shown) via a socket Pin3 connected to the high frequency generator through a high frequency connection line to apply the first voltage between the transmitting electrode 21 and the return electrode 22, so that the conductive medium reaches a first temperature and is caused to be converted into a plasma layer, thereby exciting the conductive medium with electric energy to generate plasma, and performing vaporization stripping on the target based on radio frequency energy of the plasma.

Further, the emitter electrode 21 is telescopically arranged by the slider 4. In the initial state, the emitter electrode 21 is retracted into the sheath 7 to facilitate entry of the leading end of the sheath 7 into the human body. When the specified position is reached, the slider 4 moves forward, pushing the emitter electrode 21 out of the tip end surface of the sheath 7.

The length L1 of return electrode 22 can be any reasonable value, such as 4 to 5 millimeters. The distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top end surface of the sheath 7 may be any reasonable value, such as 2 to 3 mm. Wherein a water outlet (or referred to as an infusion port) is provided at the top end of the sheath 7, and liquid entering from a liquid inlet port formed in the infusion lumen interface 8 enters the subject from the water outlet.

As shown in FIG. 15, the emitter electrode lead (the stripping tip lead) 16, the return electrode lead 17, the fluid passage lumen 18, and the return electrode lumen 19 are illustrated. In more detail, the enlarged view in fig. 18 shows a cross-sectional view of the emitter electrode lead 16, including the insulating layer 16a and the wire 16 b. The emitter electrode wire 16 requires an insulating layer for insulation and thermal insulation, and the return electrode wire 17 may not be provided with an insulating layer.

Further, as shown in fig. 16, the peeling blade further includes a square sleeve 24 and an electrode holder 25. The emitter electrode 21 is mounted on the tip of the sheath 7 by an electrode mount 25. More specifically, as shown in fig. 17, the electrode holder 25 is made of, for example, ceramic, and is formed with a circular hole 25a and a square hole 25b at both end portions, respectively. In the present embodiment, the diameter of the circular hole 25a is smaller than the side length of the square hole 25 b. The size and shape of the cross section of the square sleeve 24 substantially correspond to those of the cross section of the square hole 25b, the length of the square sleeve 24 is longer than that of the square hole 25b, and the square sleeve 24 can be inserted into the square hole 25b and slidably moved in the square hole 25 b. In this embodiment, the square sleeve 24 and the square hole 25b of the electrode holder 25 constitute the rotation preventing means of the present invention.

The electrode seat 25 is in interference fit with the liquid through cavity 18 of the tube sheath 7. Specifically, in the case where the sheath 7 is heated to expand, the electrode holder 25 made of ceramic is inserted into the liquid passage chamber 18 of the sheath 7. After the sheath 7 has cooled, the electrode holder 25 is firmly inserted into the lumen 18 of the sheath 7. With the above configuration, the electrode holder 25 can be reliably fixed in the liquid passing chamber 18 without being easily detached from the liquid passing chamber 18. As a result, the emitter electrode 21 mounted to the electrode holder 25 and the square sleeve 24 can reliably maintain their positions.

Further, the square sleeve 24 is made of, for example, stainless steel and is fitted over the emitter electrode 21, and the emitter electrode 21 and the square sleeve 24 are fixed together by welding. Further, the square sleeve 24 and the emitter electrode 21 fixed together are inserted into the square hole 25b and can slide in the square hole 25 b. The hook-shaped portion of the emitter electrode 21 protrudes from the tip of the sheath 7 through the circular hole 25a of the electrode holder 25.

Since the square sleeve 24 fixed with the emitter electrode 21 is inserted into the square hole 25b, when the slider 4 is moved to push the emitter electrode 21 out of the sheath 7, the emitter electrode 21 is not rotated but protruded from the electrode holder 25 in the hook orientation of the stripping head shown in fig. 17, for example, and on the other hand, when the slider 4 is moved to retract the emitter electrode 21 into the sheath 7 (electrode holder 25), the emitter electrode 21 is not rotated to be retracted into the electrode holder 25 in the hook orientation of the stripping head shown in fig. 17, for example.

In the prior art, since the square sleeve and the square hole as described above are not provided, when the emitter electrode is retracted, the emitter electrode may rotate to cause the hook orientation of the stripping bit to become an angle of about 180 degrees from the hook orientation as shown in fig. 17, which may cause the hook of the stripping bit to protrude from the outer circumferential surface of the sheath 7 when viewed from the longitudinal direction when the emitter electrode is retracted. As a result, when it is necessary to eject the peeler blade from the human body after, for example, the vaporization peeling is completed, the protruding portion may scratch the human body or prevent the peeler blade from being ejected from the human body.

However, with the present invention constructed as described above, the peeling blade includes the rotation preventing means for preventing the rotation of the emitter electrode 21, i.e., the square sleeve 24 and the square hole 25 b. Therefore, when the emitter electrode 21 is retracted into the sheath 7 by the movement of the slider via the emitter electrode lead 16, since the square sleeve 24 and the emitter electrode 21 fixed together are inserted into the square hole 25b, the square sleeve 24 and the emitter electrode 21 can only slide along the square hole 25b without rotation. Therefore, the hook of the peeling bit of the emitter electrode 21 does not protrude from the outer circumferential surface of the sheath 7. As a result, scratching of the human body or blocking of the peeling knife from exiting the human body can be avoided.

Further, the square sleeve 24 slides in the square hole 25b without rotating. When the slider 4 is moved to push out the emitter electrode 21, the movement of the emitter electrode 21 and the square sleeve 24 is stopped when the end face (left end face in fig. 18) of the square sleeve 24 abuts against the bottom wall 25c of the square hole 25 b. As a result, the protruding length of the emitter electrode 21 from the tip of the sheath 7 is limited. Therefore, the protrusion length can be defined to be suitable for vapor stripping without being too long or too short.

In the above embodiments, the electrode holder is made of ceramic. When the electrode seat 25 is inserted into the tube sheath 7 to be in interference fit with the liquid through cavity 18, the electrode seat 25 is not deformed. However, the present invention is not limited thereto, and the electrode holder may be made of other hard insulating materials.

Fig. 19 is a side view of a stripper knife (low temperature plasma stripper knife) of a seal assembly according to the present invention. The utility model provides a stripper can be used for the intestines and stomach the inside such as peeling off of pathological change position of early cancer, melt and solidify and stanch. In addition, the dissecting knife can also be used for dissecting, ablating, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skins, ears, noses, throats and the like. The scalpel is used for less than 24 hours, is classified as temporary contact according to contact time, is classified as an external access device (and tissue/bone/dentin) according to the nature of a contacted human body, and is classified as an active medical device according to the structural characteristics of the medical device. The stripping knife used a bipolar scheme and its operating frequency was 105 kHz. Optionally, the operating frequency of the stripping knife may be in the range of 100-110. The dissector realizes the dissection, ablation, coagulation and hemostasis of soft tissues in the operations of ear, nose, throat and the like through a plasma technology. When the device works, the stripping knife takes physiological saline as conductive liquid, and a thin layer is formed when the emitting electrode and the loop electrode are activated. When the dissector gives sufficient energy (voltage), the physiological saltThe water is converted into a gas layer (plasma layer) consisting of energized charged particles. That is, the scalpel uses energy to excite a conductive medium (e.g., physiological saline) to generate plasma, and breaks tissue molecular bonds by means of the energy of the plasma. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And waiting for the gas to complete the vaporization stripping of the tissue. When a low voltage is applied to the working cutter head of the stripping knife, the electric field is lower than the threshold requirement for generating the plasma layer and generates tissue resistance heat, so that the tissue is subjected to ablation coagulation and hemostasis.

The operation part of the stripping knife comprises a handle 1, a pull rod 2, a socket Pin3, a slide block 4, a cushion block 5, a front rod 6 (also called a pull rod cap), a tube sheath 7, an injection cavity interface 8, a push rod 9 (a first push rod) and a push rod 10 (a second push rod), and the like. The pull rod 2 is held by an operator to conveniently operate the stripping knife. The sheath 7 is an elongated tube extending longitudinally from the anterior rod 16, and the sheath 7 is to be inserted into a subject (a lesion of a human body).

As shown in fig. 20 and 4, a liquid passage chamber 18 is provided in the sheath 7, and the liquid passage chamber 18 leads from a chamber formed in the front rod 6 to the tip of the sheath 7. The fluid passage lumen 18 surrounds the emitter electrode lead 16 (see fig. 22). Liquid (e.g., conductive medium, cleaning water, etc.) enters the liquid passing chamber 18 through a chamber within the front stem 6 via a liquid inlet port 8a in the injection chamber interface 8.

The sheath 7 serves to provide an outer coating function. The infusion chamber interface 8 inputs liquid (e.g., an electrically conductive medium) based on a liquid input command from a controller, not shown, wherein a current remaining amount of the liquid is measured in real time and the current remaining amount is transmitted to the controller, which determines whether to generate the liquid input command based on the current remaining amount and controls the input of the liquid from a liquid inlet port 8a in the infusion chamber interface 8 to the liquid passage chamber 18 and ultimately to the subject via the chamber within the front stem 6 after determining to generate the liquid input command.

Further, as shown in fig. 19, the operation portion of the scalpel further includes an emitter electrode 21 and a return electrode 22 provided at the tip of the sheath 7. The emitter electrode 21 is telescopically arranged by means of a push rod 9. As shown in fig. 19, the peeling head of the emitter electrode 21 may be hook-shaped. However, the present invention is not limited thereto, and the peeling blade may be formed in a semi-spherical shape, a quincunx shape, a cylindrical shape, or a spherical shape to adapt to different shapes of the target body to perform vaporization peeling.

The length L1 of return electrode 22 can be any reasonable value, such as 4 to 5 millimeters. The distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top end surface of the sheath 7 may be any reasonable value, such as 2 to 3 mm. In which a water outlet 23 (or referred to as an infusion port, see fig. 19) is provided at the top end of the sheath 7, and liquid entering from a liquid inlet port 8a described later enters a subject from the water outlet 23.

As shown in FIG. 22, the emitter electrode lead (the stripping tip lead) 16, the return electrode lead 17, the fluid passage lumen 18, and the return electrode lumen 19 are illustrated. In more detail, the enlarged view in fig. 22 shows a cross-sectional view of the emitter electrode lead 16, including the insulating layer 16a and the wire 16 b. The emitter electrode wire 16 requires an insulating layer for insulation and thermal insulation, and the return electrode wire 17 may not be provided with an insulating layer.

Incidentally, the return electrode chamber 19 and the liquid passing chamber 18 are formed in parallel with each other in the sheath 7 and penetrate the sheath 7. The push rod 9 and the push rod 10 are inserted into the liquid passing chamber 18 and the return electrode chamber 19, respectively, and the emitter electrode 21 and the return electrode 22 are connected to a high-frequency generator (not shown) through the emitter electrode lead 16 and the return electrode lead 17, respectively, which penetrate the push rod 9 and the push rod 10.

As shown in fig. 20, a portion of the return electrode lead 17 located in the second pushrod 10 is formed in a spiral shape. The diameter of the portion 17a is slightly smaller than the diameter of the second push rod 10.

With the above configuration, when the second push rod 10 is pushed, the spiral-shaped part 17a of the return electrode lead 17 allows mutual sliding between the return electrode lead 17 and the second push rod 10, and the return current between the return electrode lead 17 and the second push rod 10 is conducted by contact between the spiral-shaped part 17a and the inner surface of the second push rod 10. In addition, since the return electrode lead 17 is in contact with the inner surface of the second plunger 10, the return electrode lead 17 does not move radially in the second plunger 10. Further, since the portion 17a is located inside the second plunger 10, even if the second plunger 10 is pushed, it is ensured that the portion 17a is always located in the sheath 7(PTFE tube) and is not pushed out.

The invention has been described with reference to a few embodiments. However, other embodiments of the invention than the above disclosed are equally possible within the scope of the invention, as would be apparent to a person skilled in the art, as defined by the appended patent claims.

Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the [ device, component, etc ]" are to be interpreted openly as referring to at least one instance of said device, component, etc., unless explicitly stated otherwise. The steps of any method disclosed herein do not have to be performed in the exact order disclosed, unless explicitly stated.

Claims

1. A cryogenic plasma scalpel surgery system, the system comprising:

the control unit is used for analyzing the control instruction, generating a first mode instruction when the control instruction indicates a first mode, calculating output power used in the first mode according to impedance and the control instruction, and sending the first mode instruction and a first voltage instruction associated with the output power in the first mode to the interface unit;

wherein the emitter electrode, plasma sheath, return electrode, and target contact form a return;

the stripping tool bit of the emitting electrode is in a hook shape, a semi-sphere shape, a quincuncial shape, a cylindrical shape or a spherical shape.

2. The cryogenic plasma scalpel surgery system of claim 1, further comprising the control unit parsing the control command and generating a second mode command when the control command indicates a second mode, calculating an output power for the second mode based on a current impedance and the control command, and sending the second mode command and a second voltage indication associated with the output power in the second mode to an interface unit.

3. The cryogenic plasma scalpel surgery system of claim 2, wherein 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 a plasma unit.

4. The cryogenic plasma scalpel surgery system of claim 3, wherein in response to a second command and a 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 cell at a second temperature to ablate and coagulate a target.

5. The cryogenic plasma scalpel surgery system of claim 1, further comprising an alarm unit for alarming by voice prompt, text prompt and/or indicator light display upon receiving an alarm signal;

6. The cryogenic plasma scalpel surgery system of claim 1, wherein the input unit is a foot-operated input device, wherein a user generates the control command by operating the foot-operated input device, wherein the control command is binary < mode, power >.

7. The cryogenic plasma scalpel surgery system of claim 1, further comprising a drip input unit for inputting the conductive medium to the plasma unit based on a conductive medium input command of the control unit.

8. The cryogenic plasma scalpel system of claim 1, further comprising a display unit for displaying an operating state of the cryogenic plasma scalpel system in real time.

9. The cryogenic plasma scalpel surgery system of claim 2, wherein the first voltage ranges from 100Vrms to 300Vrms and the second voltage ranges from 60Vrms to 80 Vrms.