CN210541799U

CN210541799U - Low-temperature plasma incision knife surgical equipment

Info

Publication number: CN210541799U
Application number: CN201821749098.0U
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: 2020-05-19
Anticipated expiration: 2028-10-27
Also published as: CN107693111A

Abstract

The utility model discloses a low temperature plasma incision sword surgical equipment, equipment includes: a liquid input unit inputting a liquid to a target body in response to a liquid input signal to form a thin layer of a conductive medium between the emitter electrode and the return electrode; the bipolar electrode socket joint is connected with the high-frequency generator through a high-frequency connecting wire and used for receiving a first input voltage generated by the high-frequency generator; the transmitting electrode receives a first input voltage generated by the high-frequency generator through the bipolar electrode socket joint, the first voltage is applied between the transmitting electrode and the return electrode, so that the conductive medium reaches a first temperature and is promoted to be converted into a plasma layer, the conductive medium is excited by electric energy to generate plasma, and the target body is subjected to vaporization cutting based on the radio-frequency energy of the plasma, and the return electrode and the transmitting electrode are led in through the same guide pipe and form a conductive return circuit on the target body.

Description

Low-temperature plasma incision knife surgical equipment

Technical Field

The utility model relates to a radio frequency technology field to more specifically relates to a low temperature plasma incision sword surgical equipment.

Background

A high-frequency cutting electric knife is an electric surgical instrument for replacing a mechanical scalpel to cut tissues. The working principle of the high-frequency cutting electrotome is that the tissue is heated when high-frequency high-voltage current generated by the tip of the effective electrode is contacted with the organism, so that the organism tissue is separated and solidified, and the aims of cutting and hemostasis are fulfilled. The peak voltage of the electrocoagulation mode of the high-frequency cutting 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 achieved, but more obvious thermal injury can be caused. The high-frequency cutting electric knife is stable instantly and can reach more than 150 ℃, and the heating effect of the high-frequency cutting electric knife capable of cutting tissues is not caused by a heating electrode or a knife 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, a cutting and coagulation effect is produced.

The working temperature of the common high-frequency cutting 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 cutting. Especially, after the ordinary high-frequency cutting 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 cutting electrotome can have the reactions of operation area swelling, postoperative pain and the like.

In practical circumstances, when a high-frequency cutting electric knife is applied to a papillary cutting operation for duodenal lesion in a hospital gastroenterology, complications of pancreatitis (high mortality rate) are likely to occur because of damage to tissues due to temperature. The high-frequency cutting electrotome is provided with two electrodes, one electrode is attached to the body of a patient, the other electrode is placed at the position of the cutting knife, and an electric path is arranged on the handle. The high-frequency emission temperature is as high as 400-500 ℃, and the high-frequency emission temperature can accidentally injure surrounding good tissues, 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.

An Enteroscopy Retrograde Cholangiopancreatography (ERCP) method is that a duodenoscope is inserted to a descending segment of a duodenum, a duodenal papilla of which a pancreatic duct and a bile duct are opened on the inner side wall of an intestinal cavity is exposed, an angiography catheter is inserted through a duodenoscope treatment duct, a cholangiopancreatography opening is inserted through a papillary opening, or the cholangiopancreatography and the bile duct are jointly opened or sequentially and respectively enter the pancreatic duct and the bile duct, contrast medium is injected, and the pancreatic duct and the bile duct are examined under an X line.

A transendothelial papillary sphincters (ESTs) is a treatment technique developed further on the basis of the diagnostic ERCP technique, which is to incise the distal portions of the duodenal papillary sphincters and the common bile duct by using a special high-frequency electric incision knife under an endoscope.

The duodenal papilla includes a primary papilla and a secondary papilla, and the primary papilla is also called duodenal papilla or Watt papilla. It is usually located on the medial wall of the back of the middle section of the descending part of the duodenum, about 10cm away from the pylorus of the stomach, and is mostly nipple-shaped. The said papillotomy is mainly the incision of the main papilla. Under the duodenum lens, the location of the main nipple is typically all at the central approximately 12 o' clock location. Under the guidance of the duodenoscope and the adjustment of the front-end forceps raising device, a doctor operates an instrument, namely a high-frequency incision knife, to insert into a nipple, and high-frequency electricity is supplied to cut and coagulate tissues. The high-frequency emission temperature is as high as 400-500 ℃, the high-frequency emission temperature can accidentally injure good tissues around the duodenal papilla, complications such as pancreatitis (high mortality rate), bleeding and perforation are easily generated, the probability of bleeding is high, and meanwhile 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.

SUMMERY OF THE UTILITY MODEL

According to an aspect of the utility model, a low temperature plasma incision sword surgical equipment is provided, equipment includes:

a liquid input unit inputting a liquid to a target body in response to a liquid input signal to form a thin layer of a conductive medium between the emitter electrode and the return electrode;

the bipolar electrode socket joint is connected with the high-frequency generator through a high-frequency connecting wire and used for receiving a first input voltage generated by the high-frequency generator;

a transmitting electrode receiving a first input voltage generated by the high frequency generator via a bipolar electrode socket joint, applying the first voltage between the transmitting electrode and the return electrode such that the conductive medium reaches a first temperature and causes the conductive medium to be converted into a plasma sheath, exciting the conductive medium with electrical energy to generate plasma, and performing vaporization cutting on a target body based on radio frequency energy of the plasma,

a return electrode introduced through the same catheter as the emitter electrode and forming a conductive return path at the target.

The bipolar electrode socket connector receives a second input voltage generated by the high frequency generator and transmits the second input voltage to the emitter electrode, and the second voltage is applied between the emitter electrode and the return electrode to maintain the target at a second temperature, thereby promoting ablative coagulation of the target.

The low-temperature plasma incision surgical device further comprises a guide wire cavity, and a guide wire is input along the guide wire cavity and inserted into the head end of the low-temperature plasma incision surgical device, so that the transmitting electrode and the return electrode are placed at the target body.

The low-temperature plasma incision knife surgical equipment further comprises a liquid passing cavity, and the liquid is input into a liquid input unit based on a liquid input instruction, wherein the liquid input unit measures the current residual quantity of the liquid in real time and sends the current residual quantity to a control unit, and the control unit determines whether to generate the liquid input instruction based on the current residual quantity and sends the liquid input instruction to the liquid input unit after determining to generate the liquid input instruction.

The liquid input unit performs liquid input by one of the following modes: a titration mode and a continuous feed mode, and the liquid passing chamber is an annular chamber located outside the return electrode.

And coating an insulating layer on a part of the emitting electrode, which is far away from the top end of the low-temperature plasma incision scalpel surgical equipment, wherein the insulating layer is used for insulating and insulating heat.

And the infusion port of the liquid input unit is positioned between the emission electrode and the return circuit electrode.

The low-temperature plasma incision knife surgical equipment further comprises a pull rod for enabling an operator to provide supporting force by the pull rod, and the low-temperature plasma incision knife surgical equipment further comprises an outer pipe for providing an outer layer coating function.

In an initial state, the emission electrode and the return electrode are attached to each other, and after the emission electrode and the return electrode reach the target body, the emission electrode is pulled through the movement of the sliding block, so that the emission electrode and the return electrode form a bow shape.

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

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

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

The low-temperature plasma incision scalpel equipment sends an alarm signal to an alarm unit after detecting an operation fault, and the alarm unit gives an alarm through sound prompt, text prompt and/or indicator light display when receiving the alarm signal;

the low-temperature plasma incision surgery equipment is connected with a pedal input device, wherein a user generates a control instruction for controlling the output power of the low-temperature plasma incision surgery equipment by operating the pedal input device, and the control instruction is a binary group < mode, power >.

The low-temperature plasma incision knife surgical equipment is connected with the display unit, and the display unit is used for displaying the running state of the low-temperature plasma incision knife surgical equipment in real time.

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 low temperature plasma incision surgical system according to a preferred embodiment of the present invention;

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

FIG. 5 is a schematic structural view of a low temperature plasma incision 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 cryoplasma incision surgical apparatus in accordance with a preferred embodiment of the present invention;

fig. 9 is a side view of a cutting knife having a helical structure in accordance with the present invention;

fig. 10 is a longitudinal cross-sectional view within circle a of fig. 9 of a cutting knife having a helical configuration in accordance with the present invention;

FIG. 11 is a partial enlarged view of the vicinity of the spiral structure;

fig. 12 is a sectional view taken along line I-I in fig. 9.

Detailed Description

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 cutting, ablating, coagulating, and stopping bleeding of the duodenal papilla. In addition, the plasma treatment apparatus 100 can be used for cutting, ablating, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skins, ears, noses, throats 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 (incision 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 cutting, ablation, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat 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 therapeutic apparatus 100 is applied to the footWith sufficient energy (voltage), the saline solution is converted into a gaseous 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 the gas is mixed, thereby completing the vaporization cutting 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 (incision knife) interface, a bipolar operation electrode (incision 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 cutting 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 cutting mode, and the gear level of the cutting mode is 1 to 9. That is, when the yellow pedal of the foot switch is stepped on, the plasma treatment apparatus 100 enters the cutting mode. The gear adjusting mode of the cutting mode comprises the following steps: the adjustment is performed by a black button on the foot switch (or a yellow button on the panel of the manual adjustment host) in the state of adjusting to the cutting mode. The cutting gear can be selected from any one of 1 to 9 gears. Wherein, the higher the gear, the larger the output voltage. In the cutting mode, the output voltages in gears 1 to 9 are shown in table 2:

TABLE 2 output gears in cutting 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 cutting 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 cutting mode and a coagulation mode. In the cutting 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 includes the steps of conducting circuit activation between an emitter electrode and a return electrode at a target contact end of the bipolar surgical electrode through a conductive medium to form a thin layer, applying a first voltage between the emitter 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 electrical energy to generate plasma, and conducting vaporization cutting 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 incision surgery 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 cutting mode, the bipolar surgical electrode has an operating temperature of 35 to 40 ℃ and the conventional electrosurgical knife has an operating temperature of 350 to 700 ℃. 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 the cutting mode is less than or equal to 150 microns and the heat penetration distance in the 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 bipolar cutting head is used for generating energy, the physiological saline is converted into a plasma thin layer, molecular bonds forming cell components in target tissues are dissociated, tissue coagulation necrosis is caused, and ablation or cutting effects are achieved. Because of the operation at a relatively low temperature, the thermal damage to the surrounding tissue is reduced to a minimum compared with the conventional high-frequency cutting electric knife. 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 ordinary high-frequency cutting 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 cutting 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 tissue protein denaturation caused by electrotome cutting can also occur, and particularly after the tissue cells are continued for a certain time, the tissue can also be thermally damaged. The degeneration and necrosis of the tissue cells are 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 cutting electrotome. The damage and thermal damage depth of the plasma therapeutic apparatus and the common high-frequency cutting electric knife are compared as shown in the following table 5:

TABLE 5

	Depth of thermal damage during cutting	Depth of heat damage during blood coagulation
			Plasma therapeutic equipment	Average 150 μm	Average 200 μm
High-frequency cutting electric knife	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 and the normally used high-frequency cutting electric knife can be seen by comparison. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than that of the high-frequency cutting 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 plasma therapeutic apparatus 200 has a cutting 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 cutting mode, and the gear level of the cutting mode is 1 to 9. That is, when the yellow pedal of the foot switch is stepped on, the plasma treatment apparatus 200 enters the cutting mode. The gear adjusting mode of the cutting mode comprises the following steps: the adjustment is performed by a black button on the foot switch (or a yellow button on the panel of the manual adjustment host) in the state of adjusting to the cutting mode. The cutting gear can be selected from 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 cutting 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 cutting mode and a coagulation mode. In the cutting 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 includes the steps of conducting circuit activation between an emitter electrode and a return electrode at a target contact end of the bipolar surgical electrode through a conductive medium to form a thin layer, applying a first voltage between the emitter 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 electrical energy to generate plasma, and conducting vaporization cutting 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 incision surgical 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 (incision knife interface) is connected to a bipolar electrode socket joint (incision knife joint) of fig. 5 described below by a patch cord, and the drip control valve interface is connected to the fluid passage chamber of fig. 5 by a connection 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 low-temperature plasma incision surgical system 300 according to a preferred embodiment of the present invention. The cryogenic plasma incision surgical system 300 can be used for the cutting, ablation and coagulation of duodenal papilla and hemostasis. In addition, the low temperature plasma incision knife surgical system 300 can also be used for cutting, ablating, coagulating and stopping bleeding of soft tissues in surgical operations of joints, spines, skin, ears, noses, throats and the like. The cryoplasma incision 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 incision surgical system 300 employs a bipolar scheme and has an operating frequency of 110 kHz. The cryoplasma incision surgical system 300 is implemented by plasma technologyThe cutting, the ablation, the coagulation and the hemostasis of soft tissues in the operations of ear, nose, throat and the like are realized. In operation, the low temperature plasma incision knife system 300 forms a thin layer when activated between the emitter electrode and the return electrode by using saline as a conductive fluid. When sufficient energy (voltage) is applied by cryoplasma incision surgical system 300, the saline is converted into a gaseous layer (plasma layer) comprised of energized charged particles. That is, the cryosurgical system 300 excites a conductive medium (e.g., saline) with energy to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of plasma directly cracks biological macromolecules such as protein and the like into O²，CO²，N²And the gas is mixed, thereby completing the vaporization cutting 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. 3, the cryogenic plasma incision surgical system 300 includes: an input unit 301, a control unit 302, an interface unit 303, a plasma unit 304, an alarm unit 305, a drip input unit 306, and a display unit 307. 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 incision surgical system 300. The operation modes of the cryoplasma incision surgical system 300 are divided into a cutting 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 cutting mode, and the gear level of the cutting mode is 1 to 9. That is, when the yellow pedal of the foot switch is stepped on, the cryogenic plasma incision surgical system 300 enters the incision mode. The gear adjusting mode of the cutting mode comprises the following steps: the adjustment is performed by a black button on the foot switch (or a yellow button on the panel of the manual adjustment host) in the state of adjusting to the cutting mode. The cutting gear can be selected from 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 incision surgical 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 cutting 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 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 incision surgical system 300 is powered 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 includes performing circuit activation between an emitter 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 emitter electrode and the return electrode so that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium with electric energy to generate plasma, and performing vaporization cutting 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 cutting 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 cutting 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 operation state of the cryogenic plasma incision surgery system in real time. The working principle of the cryoplasma incision surgical system 300 is plasma cryoablation. The bipolar cutting head is used for generating energy, the physiological saline is converted into a plasma thin layer, molecular bonds forming cell components in target tissues are dissociated, tissue coagulation necrosis is caused, and ablation or cutting effects are achieved. Because of the operation at a relatively low temperature, the thermal damage to the surrounding tissue is reduced to a minimum compared with the conventional high-frequency cutting electric knife. 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 incision knife operation system 300 works, the ambient temperature of a knife head is lower than 70 ℃ (see the report of tissue thermal injury in vitro experimental study) and is lower than the working temperature of a traditional common high-frequency incision electrotome (100-150 ℃), although the treatment temperature of the low-temperature plasma incision knife is still high relative to human tissues, tissue cells are affected by the temperature, the tissue protein denaturation caused by electrotome incision can also occur, and particularly after the tissue cells are continued for a certain time, the tissue can also be thermally damaged. The degeneration and necrosis of the tissue cells are 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 cutting 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 and the normally used high-frequency cutting electric knife can be seen by comparison. Therefore, the heat loss depth of the normally used plasma therapeutic apparatus should be lower than that of the high-frequency cutting electric knife.

Fig. 4 is a flow chart of a method 400 for cryoplasma incision surgery in accordance with 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, thereby exciting the conductive medium with electric energy to generate plasma, and performing vaporization cutting 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.

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 incision surgical apparatus according to a preferred embodiment of the present invention. As shown in fig. 5, the cryogenic plasma incision surgical apparatus includes: a transmitting electrode (cut-open wire) 501, a return electrode (round sleeve) 502, a sheath 503, a guidewire lumen interface 504, an injection lumen interface 505, a pull rod cap 506, a spacer 507, a slider (with socket hole) 508, a socket Pin 509, and a pull rod 510. Preferably, the emitter electrode (cutting wire) 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 (cutting wire) 501 receives a first input voltage generated by the high frequency generator via the socket Pin 509, and a first voltage is applied between the transmitting electrode (cutting wire) 501 and the loop electrode (circular sleeve) 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 cutting on a target body based on radio frequency energy of the plasma. In the initial state, the emitter electrode 501 and the return electrode 502 are substantially attached in a straight line shape, so that the front end of the sheath 503 can enter the human body conveniently. When the predetermined position is reached, the slider 508 moves backward, and pulls the emitter electrode 501, so that the emitter electrode 501 and the return electrode 502 form a curved shape. An insulating layer (not shown in fig. 5) covers the emitter electrode (cut wire) 501 wire, and the insulating layer serves to insulate and insulate. And the tube sheath is used 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 lumen located outside the return electrode lead.

The guidewire lumen interface 504 is used to feed a guidewire along the guidewire lumen and insert it into the head end of the cryosurgical device to facilitate placement of the emitter electrode 501 and return electrode 502 at the target. 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.

The material of the emitter electrode (cutting wire) 501 is stainless steel 304, the material of the loop electrode (circular sleeve) 502 is stainless steel 304, the material of the sheath 503 is polytetrafluoroethylene PTFE, the material of the guide wire cavity interface 504 is acrylonitrile-butadiene-styrene ABS, the material of the injection cavity interface 505 is ABS, the material of the pull rod cap 506 is ABS, the material of the spacer block 507 is ABS, the material of the slider (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 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 junction of the emitter electrode 501 and the sheath 503 may be any reasonable value, for example, 2 to 3 mm. Wherein, the water outlet (or called as transfusion port) is arranged between the side of the loop electrode close to the top end of the low-temperature plasma incision surgical equipment and the side of the transmitting electrode without the insulating layer, namely the water outlet is arranged in the range of 2 to 3 mm shown in figure 5.

In the initial state, the emitter electrode 501 and the return electrode 502 are substantially attached in a straight line shape, so that the front end of the sheath 503 can enter the human body conveniently. When the predetermined position is reached, the slider 508 moves backward, and pulls the emitter electrode 501, so that the emitter electrode 501 and the return electrode 502 form a curved shape. 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 incision 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 (incision knife joint) 600, including: a return electrode wire 601 and a transmitting electrode wire (cut wire) 602. The low-temperature plasma incision knife surgical equipment can be used for cutting, melting, coagulating and hemostasis of duodenal papilla. In addition, the low-temperature plasma incision knife surgical equipment 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 cryosurgical device of the present application is used for less than 24 hours, is classified as temporary contact by contact time, is classified as external access device (and tissue/bone/dentin) by contact body properties, and is classified as active medical device by medical device structural features. An accessory bipolar operation electrode of low-temperature plasma incision knife operation equipment belongs to a disposable sterile product.

The cryosurgical device uses a bipolar scheme and has an operating frequency of 110 kHz. The plasma therapeutic apparatus 100 realizes cutting, ablation, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat through a plasma technology. When the plasma cutting knife is in work, the low-temperature plasma cutting knife surgical equipment forms a thin layer when activating the space between the transmitting electrode and the loop electrode by using physiological saline as a conductive liquid. When the plasma therapeutic apparatus gives sufficient energy (voltage), the physiological saline is converted into a gas composed of energized charged particlesLayer (plasma layer). That is, the cryosurgical device 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 the gas is mixed, thereby completing the vaporization cutting of the tissue. When a low voltage is applied to a working cutter head of the low-temperature plasma incision knife surgical equipment, the electric field is lower than the threshold requirement for generating a plasma layer and tissue resistance heat is generated, so that the tissue is subjected to ablation coagulation and hemostasis.

Fig. 7 shows a schematic cross-sectional view along B-B, including: a return electrode lead 701, a transmit electrode lead (incisor lead) 702, a guidewire lumen 703, a fluid lumen 704, and a transmit electrode lumen 705. In more detail, fig. 7 shows a cross-section 706 of the return electrode lead 701, including an insulating layer 707 and a wire 708. The return electrode wire needs an insulating layer to perform the functions of insulation and heat insulation, and the transmitting electrode wire (cut wire) may not be provided with the insulating layer.

In addition, a person skilled in the art may use the emitter electrode cavity 705 as a liquid passing cavity as needed, and when the emitter electrode cavity 705 is used as a liquid passing cavity, an insulating layer is required to be provided on the emitter electrode lead (cut wire lead).

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

Fig. 9 is a side view of a cutting knife (low temperature plasma cutting knife) of a seal assembly according to the present invention. The incision knife in the utility model can be used for cutting, melting, coagulating and hemostasis of duodenal papilla. In addition, the incision 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 incision knife 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 human body in contact, and is classified as an active medical device according to the structural characteristics of the medical device. The cutting knife adopts a bipolar scheme and has an operating frequency of 105kHz. Alternatively, the operating frequency of the cutting knife may be in the range of 100-110. The incision knife realizes cutting, melting, coagulation and hemostasis of soft tissues in operations such as ear, nose and throat and the like through a plasma technology. When the cutting knife works, physiological saline is used as a conductive liquid, and a thin layer is formed between the active emitting electrode and the return circuit electrode. When the incision knife imparts sufficient energy (voltage), the saline is converted into a gaseous layer (plasma layer) composed of energized charged particles. That is, the incision knife excites a conductive medium (e.g., physiological saline) with energy 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 the gas is mixed, thereby completing the vaporization cutting of the tissue. When a low voltage is applied to the working bit of the incision knife, the electric field is lower than the threshold requirement for generating the plasma layer and generates resistive heat of the tissue, so that the tissue is subjected to ablation coagulation and hemostasis.

The operation part of the incision knife comprises a handle 1, a pull rod 2, a socket Pin 3, 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 incision 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. 10, 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. A fluid lumen 18 surrounds the emitter electrode lead 16 (see fig. 12). 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. 9, the operation portion of the incision knife 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 as a cut wire.

The emitter electrode 21 (incised wire) and the return electrode 22 (circular sheath) 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 Pin 3 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 vapor cutting on a target based on radio frequency energy of the plasma.

In the initial state, the emitter electrode 21 and the return electrode 22 are substantially attached in a straight line shape to facilitate the entrance of the front end of the sheath 7 into the human body, as shown by the broken line in fig. 9. When the specified position is reached, the slider 4 moves backward, pulling the emitter electrode 21 via the emitter electrode lead 16, and causing the emitter electrode 21 and the return electrode 22 to form a bow shape as shown by the solid line in fig. 9.

As shown in fig. 9, the incision knife includes a guidewire lumen for feeding a guidewire along the guidewire lumen and inserting the guidewire to the tip of the sheath 7 to cause the emitter electrode 21 and the return electrode 22 to be positioned at the target. Thus, the emitter electrode 21 and the return electrode 22 can smoothly reach the target body by the guide wire.

The guidewire lumen interface 23 is used to feed a guidewire along the guidewire lumen and insert it to the tip of the cutting blade to facilitate placement of the emitter electrode 21 and return electrode 22 at the target. The pull rod 2 is used for the operator to provide a supporting force by the pull rod 2. The socket Pin 3 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 Pin 3 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. A water outlet (also referred to as an infusion port, not shown) is provided at the top end of the sheath 7, and liquid entering from a liquid inlet port 8a in the injection lumen interface 8 enters the subject from the water outlet.

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 Pin 3 is stainless steel 304 and the material of the handle 1 is ABS.

Further, as shown in fig. 12, an emitter electrode wire (incisor wire) 16, a return electrode wire 17, a liquid passage chamber 18, a return electrode chamber 19, and a guide wire chamber B are illustrated. In more detail, the enlarged view in fig. 12 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. 10-3, 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 incision surgical apparatus, the apparatus comprising:

2. The cryoplasma incision surgical apparatus of claim 1, wherein the bipolar electrode socket connector receives a second input voltage generated by the high frequency generator and transmits the second input voltage to the emitter electrode, the second voltage being applied between the emitter electrode and the return electrode to maintain the target at a second temperature to promote ablative coagulation of the target.

3. The cryogenic plasma incision surgical device of claim 1, further comprising a guidewire lumen for feeding a guidewire along the guidewire lumen and inserting the guidewire into a head end of the cryogenic plasma incision surgical device to cause the emitter electrode and the return electrode to be positioned at the target.

4. The cryogenic plasma incision surgical apparatus of claim 1, further comprising a liquid passage chamber that inputs the liquid to the liquid input unit based on a liquid input command.

5. The cryoplasma incision surgical apparatus of claim 4, wherein the liquid input unit performs liquid input by one of the following modes: a titration mode and a continuous feed mode, and the liquid passing chamber is an annular chamber located outside the return electrode.

6. The cryogenic plasma incision surgical device of claim 3, wherein a portion of the emitter electrode distal from the tip of the cryogenic plasma incision surgical device is covered with an insulating layer, the insulating layer serving to insulate and insulate the emitter electrode.

7. The cryogenic plasma incision knife surgical apparatus of claim 6, wherein an infusion port of the liquid input unit is located between the emitter electrode and a return electrode.

8. The cryoplasma incision surgical apparatus of claim 1, further comprising a pull rod for allowing an operator to provide a supporting force by pulling the pull rod, and further comprising an outer tube for providing an outer cladding function.

9. The cryoplasma incision surgical apparatus of claim 1, wherein the emitter electrode and the return electrode are attached to each other in an initial state, and when the emitter electrode and the return electrode reach the target, the emitter electrode is pulled by moving the slider so that the emitter electrode and the return electrode form a bow shape.

10. The cryoplasma incision surgical apparatus of claim 2, wherein the first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80 Vrms.