CN113768617A

CN113768617A - Integrated incision and expansion knife and using method thereof

Info

Publication number: CN113768617A
Application number: CN202111072004.7A
Authority: CN
Inventors: 方军; 赵秋; 王帆
Original assignee: Zhongnan Hospital of Wuhan University
Current assignee: Zhongnan Hospital of Wuhan University
Priority date: 2021-09-13
Filing date: 2021-09-13
Publication date: 2021-12-10

Abstract

The invention relates to an integrated incision and expansion knife and a use method thereof, wherein the integrated incision and expansion knife comprises a metal knife head, an insulating sheath tube, an internal circuit, a handle, an expansion balloon, a pressure regulating pipeline and an adjustable pressure control meter; the metal tool bit is arranged in a conical shape, the larger end of the metal tool bit is fixedly connected with one end of the insulating sheath tube, the other end of the insulating sheath tube is connected with the handle, the internal circuit is arranged in the insulating sheath tube, the two ends of the internal circuit are respectively connected with the metal tool bit and the handle, and the handle is provided with a control switch; the expansion saccule is arranged around the periphery of the insulating sheath tube and is integrally connected with the metal tool bit; the pressure regulating pipeline is fixedly arranged along the outer surface of the insulating sheath pipe, one end of the pressure regulating pipeline is communicated with the expansion balloon, the other end of the pressure regulating pipeline is provided with a first branch pipe and a second branch pipe which are communicated in a Y shape, the first branch pipe is connected with an adjustable pressure control meter, the second branch pipe is connected with an external pressure pump, and the adjustable pressure control meter is linked with the pressure pump. The invention integrates incision and expansion into a whole, and the expansion size is quantitatively adjustable, thereby improving the working efficiency and reducing the tissue damage degree.

Description

Integrated incision and expansion knife and using method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to an integrated incision and dilation knife and a using method thereof.

Background

Pancreatic Pseudocysts (PP) are one of the common local complications of severe pancreatitis, and are fibrous encapsulated cysts formed gradually by accumulation of pancreatic necrotic tissue and exuded pancreatic juice in peripancreatic, omentum minor and reticulum, and stimulation of proliferation of peripheral connective tissue. Intragastric drainage under the guidance of ultrasonic gastroscope (EUS) is one of the main methods for minimally invasive treatment of pancreatic pseudocyst at present. Compared with the traditional surgical drainage operation, the technology has the advantages of small wound, small relative risk, quick recovery and the like. The ultrasonic gastroscope can be used for positioning the pancreatic pseudocyst, selecting the optimal needle insertion point, accurately puncturing the cyst and placing the stent for drainage.

Although the EUS-guided internal drainage has the advantages, if the stomach wall of a patient is thickened or the cystic fibrosis of the pancreatic pseudocyst is severe, the incision to the size of the stent which can be placed can be difficult. In addition, the general method of the operation is that EUS is guided to puncture focus by adopting a 19G puncture needle at a proper puncture point, a needle core is pulled out to place a guide wire, a ring-shaped knife or an expansion catheter or an air bag is inserted along the guide wire to enlarge the incision of a puncture channel, and then a stent is placed along the guide wire for drainage. The above method has the following disadvantages: 1. as previously mentioned, puncturing and cutting the stomach wall and pouch wall is difficult; 2. the incision is difficult to reach the proper size required for placing the stent, and multiple cuts or dilations or even replacement of instruments of different sizes are required, so that the operation by the operator is time-consuming and labor-consuming, and repeated cuts increase the mechanical damage of the tissue, with a consequent increase in the risk of complications.

Currently, researchers have proposed an improved EUS-guided transgastric wall fenestration drainage method, in which a puncture point is marked under the guidance of EUS, and after the gastric wall and the pancreatic pseudocyst wall are incised with a HOOK knife, the balloon is replaced to enter to dilate the incised part. The method solves the problem of serious mechanical damage, but the balloon needs to be replaced in the process, and the operation can still be considered to be simplified.

Disclosure of Invention

The invention provides an integrated incision and dilation knife and a using method thereof, aiming at the technical problems in the prior art, and the integrated incision and dilation knife can not only puncture an incision marked point to be incised efficiently, but also can quantitatively control the size of an incision caliber through a dilation balloon so as to solve the problems that the prior art provided by the background technology is low in working efficiency and increases risks of tissue injury and complications.

The technical scheme for solving the technical problems is as follows:

the invention provides an integrated incision and dilation knife, which comprises an incision knife body, a dilation balloon, a pressure regulating pipeline and an adjustable pressure control meter, wherein the incision knife body is provided with a cutting edge; the incision knife comprises a incision knife body and is characterized in that the incision knife body comprises a metal knife head, an insulating sheath tube, an internal circuit and a handle, wherein the metal knife head is arranged in a conical shape, the larger end of the metal knife head is fixedly connected with one end of the insulating sheath tube, the other end of the insulating sheath tube is connected with the handle, the internal circuit is arranged in the insulating sheath tube, the two ends of the internal circuit are respectively connected with the metal knife head and the handle, and the handle is provided with a control switch; the expansion saccule is arranged around the periphery of the insulating sheath tube and is integrally connected with the metal cutter head; the pressure regulating pipeline is fixedly arranged on the outer surface of the insulating sheath pipe, one end of the pressure regulating pipeline is communicated with the expansion balloon, the other end of the pressure regulating pipeline is provided with a first branch pipe and a second branch pipe which are communicated in a Y shape, the first branch pipe is connected with an adjustable pressure control meter, the second branch pipe is connected with an external pressure pump, and the adjustable pressure control meter is linked with the pressure pump.

The conical metal cutter head is aligned with the point to be cut marked in advance to cut and puncture, and then the metal cutter head is continuously pushed, so that the periphery of the expansion balloon is positioned in the cut. And selecting a corresponding gear on the adjustable pressure control table according to the expected value of the diameter of the expansion balloon, wherein the gear corresponds to the pressure of the filling medium in the expansion balloon. The adjustable pressure control table is communicated with the pressure regulating pipeline through the first branch pipe, the pressure value of the pressure regulating pipeline is monitored in real time, the detected pressure value is compared with the pressure value corresponding to the selected gear, and then a control signal for adjusting the pressure is output. The pressure pump controls the filling medium to flow into or flow out of the pressure regulating pipeline according to the control signal output by the adjustable pressure control meter, so that the pressure in the pressure regulating pipeline and the expansion balloon is controlled, and the expansion diameter of the expansion balloon is controlled. When the diameter of the expansion balloon is expanded, the incision is opened in a blunt manner, so that the incision size is accurately expanded, and the size of the incision allows the stent to pass through. The incision dilating knife can not only puncture the point to be incised of the incision mark with high efficiency, but also quantitatively control the size of the incision caliber through the dilating saccule, and can accurately regulate and control the diameter of the dilating saccule through the adjustable pressure control meter and the pressure pump so as to realize the accurate control of the incision caliber.

On the basis of the technical scheme, the invention can be further improved as follows.

Preferably, the metal tool bit is provided with an electrode, and the electrode is electrically connected with the metal tool bit and the internal circuit respectively.

The beneficial effect of adopting the further scheme is that: the electrode transmits the high-frequency voltage and current conducted by the internal circuit to the metal cutter head and the cut point so as to realize the cutting of the tissue.

Preferably, the adjustable pressure control table is provided with a plurality of pressure adjusting gears, and each pressure adjusting gear corresponds to one expansion diameter of the expansion balloon; the adjustable pressure control meter is used for detecting the current pressure value in the pressure regulating pipeline and outputting a pressure control signal according to the current pressure value and the selected pressure regulating gear so as to control the pressure pump to increase or decrease pressure.

The beneficial effect of adopting the further scheme is that: the pressure value corresponding to each expected expansion diameter of the expansion balloon is adjusted in advance, and a plurality of pressure adjusting gears are arranged corresponding to a plurality of expected pressure values. When a certain regulating gear is selected, the adjustable pressure control meter detects the current pressure value in the pressure regulating pipeline, compares the current pressure value with the pressure value corresponding to the selected pressure regulating gear, and outputs a pressure control signal. The pressure control signal is used for controlling the pressure pump to pressurize or depressurize the pressure-regulating pipeline (i.e. inject the filling medium or release the filling medium), thereby realizing the regulation and control of various expansion diameters of the expansion balloon.

Preferably, the pressure adjusting gears correspond to the unfilled state of the expansion balloon and various inflated states of the expansion balloon 2 with the diameter of 0.6-1.2 cm in a one-to-one mode.

The beneficial effect of adopting the further scheme is that: the specification of a general stent is within the range of 0.6-1.2 cm, and the diameter range of the expansion saccule is set within the range so as to adapt to the size of an incision required to be cut and the size of a drainage stent to be subsequently placed.

Preferably, the pressure adjusting gears comprise five gears of 0, 6, 8, 10 and 12, which respectively correspond to several filling states of the inflated balloon, the diameter of the inflated balloon being 0.6cm, the diameter of the inflated balloon being 0.8cm, the diameter of the inflated balloon being 1.0cm and the diameter of the inflated balloon being 1.2 cm.

The beneficial effect of adopting the further scheme is that: the gears are adjusted through the pressure of the five gears, so that the diameter of the expansion balloon is divided into five fixed gears, and each gear corresponds to five diameter sizes of the expansion balloon so as to adapt to the fact that the stents with various sizes pass through the incision.

Preferably, the first branch is shorter than the second branch, and the adjustable pressure control gauge is detachably connected to the first branch.

The beneficial effect of adopting the further scheme is that: when no pressure is applied to the inside of the expansion saccule, the adjustable pressure control meter can be detached to prevent the adjustable pressure control meter from interfering with other equipment in the previous process; when the expansion balloon needs to be filled with a medium, the adjustable pressure control table is hermetically connected with the first branch pipe so as to detect a real-time pressure value in the pressure regulating pipeline and adjust the pressure value. The first branch pipe is arranged to be shorter, so that pressure change in the pressure regulating pipeline can be quickly transmitted to the detection point of the adjustable pressure control table, and more accurate and efficient pressure regulation is realized.

Preferably, the handle is connected with an external circuit interface, one end of the external circuit interface is respectively in communication connection with the internal circuit and the adjustable pressure control meter, and the other end of the external circuit interface is in communication connection with the host.

The beneficial effect of adopting the further scheme is that: the incision expanding knife is in communication connection with the host through the external circuit interface, and parameter setting can be performed on the incision expanding knife through the host. The control switch on the handle outputs a control instruction to the host computer, and the host computer outputs a control signal of an internal circuit to the handle after operation so as to realize the control of the cutting action of the metal cutter head.

Preferably, the larger end of the metal insert has a circumference of no more than 6 Fr.

The beneficial effect of adopting the further scheme is that: when the marking points of the stomach wall and the cyst wall are cut by the metal cutter head of the cutting knife, the metal cutter head of 6Fr is thinner than the commonly used 10Fr, and the energy is more concentrated and focused, thereby being beneficial to cutting; the conical metal cutter head has higher incision efficiency and is small compared with a mechanical incision of a circular knife or a HOOK knife, and later recovery of a patient is facilitated.

Preferably, the axis of the metal cutter head and the axis of the insulating sheath tube are provided with communicated instrument channels, hollow puncture needles are arranged in the instrument channels, the puncture needles penetrate through the whole instrument channels, and the axis of the puncture needles is provided with guide wires or contrast agent channels.

The beneficial effect of adopting the further scheme is that: the puncture needle is arranged at the axis of the metal cutter head, before the metal cutter head is electrified for cutting, the puncture needle firstly extends out of the smaller end of the metal cutter head to puncture the mark point, and then the metal cutter head is electrified to continue to advance along the puncture point and cut the surrounding tissues through high-frequency voltage current. In the cutting process of the metal cutter head, when the conical surface of the metal cutter head cuts the tissues, the cut is small, and the tissues around the cut are prevented from being accidentally injured. After the incision has been made through the severed tissue, a guidewire may be placed through the guidewire or contrast passage in the center of the needle in preparation for further manipulation.

In a second aspect of the present invention, a method for using the above one-piece incision dilation knife is provided, the method comprising the following steps:

aligning the smaller end of the metal cutter head to a point to be cut, operating a control switch on a handle, electrifying the electrode through an internal circuit, and cutting the metal cutter head;

pushing a metal cutter head in the notch, wherein the conical surface of the metal cutter head performs blunt expansion on the notch;

continuously pushing the metal cutter head in the incision, adjusting the adjustable pressure control table to a pressure adjusting gear corresponding to the expected incision aperture, and filling the medium into the pressure adjusting pipeline by the pressure pump until the diameter of the expansion balloon is full to the expected size;

withdrawing the incision dilation knife.

The invention has the beneficial effects that:

1. the invention integrates the incision knife and the expansion saccule into a whole, firstly, the marked stomach wall and pancreas pseudocyst wall are incised by the incision knife, the tightly connected expansion saccule is pushed along, and at the moment, filling medium (such as air, physiological saline or contrast medium) is injected into the saccule to dilate the incision, and instruments do not need to be replaced in the process, thereby solving the problem that the existing incision knife and the expansion saccule are two separate instruments, providing the working efficiency and leading the operation to be more convenient.

2. The incision knife adopts a 6Fr metal knife head, is designed into a cone or pyramid shape, and the thin and sharp knife head has higher incision efficiency and smaller mechanical wound, is favorable for cutting thickened stomach walls and cyst walls with serious fibrosis, reduces the difficulty of cutting, and is favorable for reducing tissue injury and later recovery of patients.

3. The cyst cutting knife adopts the expansion saccule to replace a mechanical knife to further cut and expand the stomach wall and the incision of the cyst wall, the expansion saccule can blunt separate mucous membrane and stomach wall tissues, the damage to adjacent nerves or blood vessels in the operation process is effectively prevented, the excessive opening of the tissues is avoided, and the damage to the tissue function is reduced.

4. An adjustable pressure control table is connected to the pressure regulating pipeline of the expansion saccule, so that an operator can conveniently control the size of the notch by controlling the expansion diameter of the expansion saccule, and only a pointer of the adjustable pressure control table is required to be shifted to a gear scale corresponding to the required saccule diameter before inflation. And through improvement, the pressure of the medium filled in the expansion balloon is tested in advance when the expansion balloon is expanded to be 0.6cm, 0.8cm, 1.0cm and 1.2cm, namely the position of the corresponding gear to which the pointer on the gauge rotates is correspondingly marked with scales of 6, 8, 10 and 12, so that the quantitative pressure control gauge does not need to convert the expected pressure value into the corresponding medium filling amount every time, and the operation is simpler, more efficient and more convenient.

Drawings

FIG. 1 is a schematic view of the overall structure of the present invention;

FIG. 2 is a schematic structural diagram of an embodiment of the present invention;

FIG. 3 is a schematic diagram showing the positional relationship between the metal cutting head and the dilatation balloon according to the present invention and the comparison of the filling states of different diameters of the dilatation balloon;

FIG. 4 is a schematic diagram of the dial structure of the adjustable pressure control gauge of the present invention;

FIG. 5 is a schematic diagram of the control relationship of the present invention;

FIG. 6 is a schematic view of the operation of the present invention (a);

FIG. 7 is a schematic diagram of the operation of the present invention (b);

FIG. 8 is a schematic view of the operation of the present invention (c);

FIG. 9 is a schematic diagram (d) of the operation of the present invention.

In the drawings, the components represented by the respective reference numerals are listed below:

1. the device comprises a metal cutter head, 101, electrodes, 2, an expansion balloon, 3, an insulating sheath, 4, a pressure regulating pipeline, 401, a first branch pipe, 402, a second branch pipe, 5, an adjustable pressure control table, 501, a touch control knob switch, 6, a handle, 601, a control switch, 7, a pressure pump, 8, an external circuit interface, 9, a host, 10, a puncture needle, 11, a guide wire, A, an instrument channel, B, the guide wire or a contrast agent channel.

Detailed Description

The principles and features of this invention are described below in conjunction with the following drawings, which are set forth by way of illustration only and are not intended to limit the scope of the invention.

The first embodiment is as follows:

as shown in fig. 1 to 5, the present embodiment provides an integrated incision and dilation knife, which includes a incision knife body, a dilation balloon 2, a pressure regulating pipeline 4 and an adjustable pressure control meter 5; the incision knife comprises a incision knife body and is characterized in that the incision knife body comprises a metal knife head 1, an insulating sheath tube 3, an internal circuit and a handle 6, wherein the metal knife head 1 is arranged in a conical shape, the larger end of the metal knife head 1 is fixedly connected with one end of the insulating sheath tube 3, the other end of the insulating sheath tube 3 is connected with the handle 6, the internal circuit is arranged in the insulating sheath tube 3, the two ends of the internal circuit are respectively connected with the metal knife head 1 and the handle 6, and the handle 6 is provided with a control switch 601; the expansion saccule 2 is arranged around the periphery of the insulating sheath tube 3 and is integrally connected with the metal tool bit 1; pressure regulating pipeline 4 passes through the fixed setting of blank pressing technique along the surface of insulating sheath pipe 3, and its one end communicates with expansion sacculus 2, and its other end is equipped with first branch pipe 401 and the second branch pipe 402 that is Y type intercommunication, adjustable pressure control table 5 is connected to first branch pipe 401, outside force pump 7 is connected to second branch pipe 402, adjustable pressure control table 5 and force pump 7 linkage.

The insulating sheath 3 may be made of a flexible high-molecular insulating material, such as nylon (PA), Polyethylene (PE), Polytetrafluoroethylene (PTFE), or a composite material of a polymer and a metal. The insulating sheath 3 made of the composite material can comprise an insulating layer and a metal conducting layer, and the metal conducting layer can be buried in the insulating layer, so that accidental conduction can be prevented.

The conical metal cutter head 1 is aligned with the point to be cut marked in advance to cut and puncture, and then the metal cutter head 1 is continuously pushed, so that the periphery of the expansion balloon 2 is positioned in the cut. According to the expected value of the diameter of the expansion balloon 2, a corresponding gear is selected on the adjustable pressure control table 5, and the gear corresponds to the pressure of the filling medium in the expansion balloon 2. The adjustable pressure control table 5 is communicated with the pressure regulating pipeline 4 through the first branch pipe 401, monitors the pressure value of the pressure regulating pipeline in real time, compares the detected pressure value with the pressure value corresponding to the selected gear, and then outputs a control signal for regulating the pressure. The pressure pump 7 controls the flow of the filling medium into or out of the pressure regulating line 4 in accordance with the control signal outputted from the adjustable pressure control table 5, thereby controlling the pressure in the pressure regulating line 4 and the inflatable balloon 2, and thus controlling the inflatable diameter of the inflatable balloon 2. When the diameter of the expansion balloon 2 is expanded, the incision is opened in a blunt manner, so that the incision can be accurately expanded, and the size of the incision allows the stent to pass through. The incision dilating knife can not only puncture the point to be incised of the incision mark with high efficiency, but also quantitatively control the size of the incision caliber through the dilating saccule 2, and can accurately regulate and control the diameter of the dilating saccule 2 through the adjustable pressure control table 5 and the pressure pump 7, thereby realizing the accurate control of the incision caliber.

In this embodiment, the metal tool bit 1 is provided with an electrode 101, and the electrode 101 is electrically connected to the metal tool bit 1 and the internal circuit respectively. As shown in fig. 3, a ring-shaped electrode 101 may be used, which is fixedly disposed between the metal cutter 1 and the dilation balloon 2. If necessary, a wire electrode 101 wound in a wire-like serpentine shape on the surface of the tapered metal chip 1 may be used, and this structure will not be further described in this embodiment. The electrode 101 transmits the high-frequency voltage and current conducted by the internal circuit to the metal cutter head 1 and the cut point to realize the cutting of the tissue.

As shown in fig. 1 and 2, an external circuit interface 8 is connected to the handle 6, one end of the external circuit interface 8 is respectively connected to the internal circuit and the adjustable pressure control table 5 in a communication manner, and the other end of the external circuit interface 8 is connected to the host 9 in a communication manner. The external circuit interface 8 at least comprises the following functions: the connection between the internal circuit in the insulating sheath 3 and the external high-frequency voltage current source, the communication connection between the adjustable pressure control table 5 and the host machine 9, and the communication connection between the control circuit in the handle 6 and the host machine 9 are provided.

The incision dilation knife is in communication connection with a host machine 9 through an external circuit interface 8, and parameter setting can be carried out on the incision dilation knife through the host machine 9. The control switch 601 on the handle 6 outputs a control instruction to the host machine 9, and the host machine 9 outputs a control signal of an internal circuit to the handle 6 after operation so as to control the cutting action of the metal cutter head 1. Further, as shown in the control relationship diagram of fig. 5, the signal output ends of the pressure pump 7 and the host 9 are in communication connection, so that a closed-loop feedback control is formed among the adjustable pressure control table 5, the host 9 and the pressure pump 7, and the accurate control of the pressure in the dilatation balloon 2 is realized, thereby realizing the accurate control of the radial size of the dilatation balloon 2.

As shown in fig. 4, the adjustable pressure control table 5 is provided with a plurality of pressure adjustment gears, and each pressure adjustment gear corresponds to one expansion diameter of the expansion balloon 2; the adjustable pressure control meter 5 is used for detecting the current pressure value in the pressure regulating pipeline 4 and outputting a pressure control signal according to the current pressure value and the selected pressure regulating gear so as to control the pressure pump 7 to increase or decrease pressure.

The pressure value corresponding to each desired expansion diameter of the expansion balloon 2 is adjusted in advance, a plurality of pressure adjustment gears are set corresponding to a plurality of desired pressure values, and the pressure value corresponding to each pressure adjustment gear is stored in the host machine 9. When a certain regulating gear is selected, the adjustable pressure control table 5 detects the current pressure value in the pressure regulating pipeline 4, compares the current pressure value with the pressure value corresponding to the selected pressure regulating gear, and outputs a pressure control signal. The pressure control signal is used for controlling the pressure pump 7 to pressurize or depressurize the pressure regulating pipeline (i.e. inject the filling medium or release the filling medium), thereby realizing the regulation and control of various expansion diameters of the expansion balloon 2.

Preferably, the pressure adjusting gears correspond to the unfilled state of the expansion balloon 2 and various inflated states of the expansion balloon 2 with the diameter of 0.6-1.2 cm in a one-to-one mode.

The specification of a general stent is within the range of 0.6-1.2 cm, and the diameter range of the expansion saccule 2 is set within the range so as to adapt to the size of an incision to be cut and the size of a drainage stent to be subsequently placed.

Fig. 4 is a schematic diagram of the dial structure of the adjustable pressure control table 5, and as shown by dial scale values, the plurality of pressure adjustment gears include five gears "0, 6, 8, 10, and 12", which respectively correspond to the unfilled state of the inflatable balloon 2, the diameter of the inflatable balloon 2 being 0.6cm, the diameter of the inflatable balloon 2 being 0.8cm, the diameter of the inflatable balloon 2 being 1.0cm, and the diameter of the inflatable balloon 2 being 1.2 cm. FIG. 3 shows the inflated state of the dilatation balloon 2 and four inflated states with diameters of 0.6cm, 0.8cm, 1.0cm and 1.2cm, respectively

The gears are adjusted by setting the pressure of five gears, so that the diameter of the expansion balloon 2 is divided into five fixed gears, and each gear corresponds to five diameter sizes of the expansion balloon 2 so as to adapt to the passing of the stents with various sizes and specifications through the incision. The dial is provided with a multi-gear touch knob switch 501, and a control instruction for adjusting the diameter of the dilatation balloon 2 can be output by rotating and selecting the gear of the touch knob switch 501. As a further improvement, it is tested in advance that the pressure of the filling medium inside the dilatation balloon 2 is stored in the host machine 9 when the dilatation balloon 2 is dilated to "0.6 cm", "0.8 cm", "1.0 cm" and "1.2 cm", and the scales marked with "6", "8", "10" and "12" are respectively used at the positions corresponding to the gears, while the gear when the dilatation balloon 2 is not used is marked with "0". When the touch knob switch 501 on the meter controls the position of the corresponding gear to which the pointer rotates, the adjustable pressure control meter 5 does not need to convert the expected pressure value into the corresponding medium filling amount during each operation, when a certain gear is selected, the adjustable pressure control meter 5 directly outputs a corresponding control instruction, and the host 9 controls the pressure pump 7 to regulate the pressure immediately, so that the operation is simpler, more efficient and more convenient.

As shown in fig. 2, the first branch pipe 401 is shorter than the second branch pipe 402, and the adjustable pressure control table 5 is detachably connected to the first branch pipe 401.

Before the metal cutter head 1 is used for cutting the resistance value and applying pressure to the interior of the expansion saccule 2, the adjustable pressure control table 5 can be detached to prevent the adjustable pressure control table from interfering with other equipment in the previous process or avoiding obstructing the cutting operation in the previous stage; when the incision expansion of the filling medium of the expansion balloon 2 is needed, the adjustable pressure control table 5 is hermetically connected with the first branch pipe 401 to detect the real-time pressure value in the pressure regulating pipeline 4 and regulate the pressure value. The first branch pipe 401 is arranged to be short, so that pressure change in the pressure regulating pipeline 4 can be quickly transmitted to the detection point of the adjustable pressure control table 5, and more accurate and efficient pressure regulation is realized.

In this embodiment, the circumference of the larger end of the metal cutting insert 1 does not exceed 6 Fr.

When the marking points of the stomach wall and the cyst wall are cut by the metal cutter head 1 of the cutting knife, the 6Fr metal cutter head 1 is thinner than a commonly used 10Fr mechanical knife, and the energy is more concentrated and focused to be beneficial to cutting; the conical metal cutter head 1 has higher incision efficiency and has small mechanical incision relative to a circular knife or a HOOK knife, thereby being beneficial to the later recovery of patients.

As shown in fig. 1, an instrument channel a is provided between the axis of the metal tool bit 1 and the axis of the insulating sheath 3, a hollow puncture needle 10 is provided in the instrument channel a, the puncture needle 10 penetrates through the whole instrument channel a, and a guide wire or contrast agent channel B is provided at the axis of the puncture needle 10.

The puncture needle 10 is arranged at the axis of the metal cutter head 1, before the metal cutter head 1 is electrified and cut, the puncture needle 10 firstly extends out of the smaller end of the metal cutter head 1 to puncture the mark point, and then the metal cutter head 1 is electrified to continue to advance along the puncture point and cut the surrounding tissues through high-frequency voltage current. In the cutting process of the metal cutter head 1, when the conical surface of the metal cutter head 1 cuts the tissue, the cut is small, and the tissue around the cut is prevented from being accidentally injured. After the incision has been made through the severed tissue, a guidewire 11 may be placed through a guidewire or contrast passage B in the center of the needle 10 in preparation for further manipulation.

Example two:

the embodiment provides a use method of an integrated incision and dilation knife based on the first embodiment, and the method comprises the following steps:

aligning the smaller end of the metal cutter head 1 to a point to be cut, operating a control switch 601 on the handle 6, electrifying the electrode 101 through an internal circuit, and cutting the mark point by the metal cutter head 1;

pushing the metal cutter head 1 in the notch, wherein the conical surface of the metal cutter head 1 performs blunt expansion on the notch;

continuously propelling the metal cutter head 1 in the incision to enable the expansion balloon 2 to be placed in the incision, adjusting the adjustable pressure control table 5 to a pressure adjusting gear corresponding to the expected incision aperture, filling media into the pressure adjusting pipeline by a pressure pump 7, and feeding back a real-time pressure value of the expansion balloon 2 by the adjustable pressure control table 5 until the pressure value in the pressure adjusting pipeline reaches a pressure value corresponding to the selected pressure adjusting gear and the diameter of the expansion balloon 2 is full of an expected size;

withdrawing the incision dilation knife.

The working principle is as follows:

clinically, as shown in fig. 6, under guidance of EUS (ultrasonic gastroscope), the position and size of PP (pancreatic pseudocyst) are probed, the optimal incision site is selected, and under guidance of EUS, biopsy forceps are used to take a mucosa mark incision point; as shown in fig. 7, the incision dilation knife of the present invention is then guided through the instrument channel of the EUS to reach the marking point where the metal blade 1 of the incision dilation knife of the present integral cyst is placed; as shown in fig. 8, the puncture needle 10 advances to position the mark point puncture hole, the metal cutter head 1 is electrified to cut, and after the stomach wall and the cyst wall are cut, the guide wire 11 is released; as shown in fig. 9, the incision is continued to a certain depth under the guidance of the guide wire 11 so that the dilatation balloon 2 is placed into the cyst. According to the cyst and the size of the drainage bracket to be selected, a contact knob switch of the adjustable pressure control meter 5 is toggled, so that the pointer is turned to the gear to be used; the adjustable pressure control meter 5 detects the real-time pressure value in the pressure regulating pipeline and sends the real-time pressure value and the selected gear information to the host 9, and the host 9 sends a pressurization control signal to the pressure pump 7 after comparison operation. The pressure pump 7 is communicated with the pressure regulating pipeline through a filling medium inlet, and after receiving a pressurization control signal, the pressure pump injects a filling medium into the pressure regulating pipeline, so that the expansion balloon 2 starts to be filled until the pressure corresponding to the selected gear on the adjustable pressure control table 5 is reached, and at the moment, the diameter of the expansion balloon 2 reaches the expected size. The incision is subjected to blunt expansion in the process of filling the expansion balloon 2, and the mucous membrane and the stomach wall tissue can be separated bluntly. At the moment, the incision knife is completed, the puncture needle 10 can be returned into the instrument channel A, the pressure regulating gear of the adjustable pressure control table 5 is selected to be 0, the pressure pump 7 receives a pressure reducing control signal at the moment, the filling media in the expansion saccule 2 and the pressure regulating pipeline are released, after the diameter of the expansion saccule 2 is reduced, the incision knife is taken out from the incision, and then the drainage bracket is placed in the incision after the expansion.

Compared with the traditional technical scheme, the invention has the following advantages:

1. the invention integrates the incision knife and the expansion saccule 2, firstly, the marked stomach wall and pancreas pseudocyst wall are incised by the incision knife, the tightly connected expansion saccule 2 is pushed along, and at the moment, filling medium (such as air, physiological saline or contrast medium) is injected into the expansion saccule 2 to dilate and incise the incision, and the instrument does not need to be replaced in the process, thereby solving the problem that the existing incision knife and the expansion saccule 2 are two separated instruments, providing the working efficiency and leading the operation to be more convenient.

2. The incision knife adopts the 6Fr metal knife head 1, is designed to be conical or pyramid, has higher incision efficiency and smaller mechanical trauma due to a thin and sharp knife head, is favorable for cutting thickened stomach walls and cyst walls with serious fibrosis, reduces the difficulty of cutting, and is favorable for reducing tissue injury and later recovery of patients.

3. This cyst incision sword adopts expansion sacculus 2 to replace mechanical sword to further open and expand stomach wall and cyst wall's incision, and expansion sacculus 2 can blunt nature separation mucous membrane and stomach wall tissue, effectively prevents the damage to adjacent nerve or blood vessel in the operation process, avoids the tissue to open excessively, reduces the tissue function destruction.

4. An adjustable pressure control table 5 is connected to the pressure regulating pipeline of the expansion saccule 2, so that an operator can conveniently control the size of the incision by controlling the expansion diameter of the expansion saccule 2, and only a pointer of the adjustable pressure control table 5 needs to be shifted to a gear scale corresponding to the required saccule diameter before inflation. And the pressure gauge is improved, the pressure of the filling medium in the expansion balloon 2 is tested in advance when the expansion balloon 2 is expanded to be 0.6cm, 0.8cm, 1.0cm and 1.2cm, namely the position of the corresponding gear rotated by the pointer on the gauge is correspondingly marked as scales of 6, 8, 10 and 12, so that the quantitative pressure control gauge does not need to convert the expected pressure value into the corresponding medium filling amount every time, and the operation is simpler, more efficient and more convenient.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. An integrated incision and dilation knife is characterized by comprising an incision knife body, a dilation balloon (2), a pressure regulating pipeline (4) and an adjustable pressure control meter (5); the incision knife comprises a incision knife body and is characterized in that the incision knife body comprises a metal knife head (1), an insulating sheath tube (3), an internal circuit and a handle (6), wherein the metal knife head (1) is arranged in a conical shape, the larger end of the metal knife head is fixedly connected with one end of the insulating sheath tube (3), the other end of the insulating sheath tube (3) is connected with the handle (6), the internal circuit is arranged in the insulating sheath tube (3), the two ends of the internal circuit are respectively connected with the metal knife head (1) and the handle (6), and a control switch (601) is arranged on the handle (6); the expansion saccule (2) is arranged around the periphery of the insulating sheath tube (3) and is integrally connected with the metal tool bit (1); pressure regulating pipeline (4) are along the external fixed surface setting of insulating sheath pipe (3), and its one end and expansion sacculus (2) intercommunication, its other end are equipped with first branch pipe (401) and second branch pipe (402) that are Y type intercommunication, adjustable pressure control table (5) is connected in first branch pipe (401), outside force pump (7) are connected in second branch pipe (402), adjustable pressure control table (5) and force pump (7) linkage.

2. The integrated incision and dilation knife according to claim 1, wherein the metal blade (1) is provided with an electrode (101), and the electrode (101) is electrically connected with the metal blade (1) and the internal circuit respectively.

3. The integrated incision dilation knife according to claim 2, wherein the adjustable pressure control table (5) is provided with a plurality of pressure adjustment gears, each pressure adjustment gear corresponds to one dilation diameter of the dilation balloon (2); the adjustable pressure control meter (5) is used for detecting the current pressure value in the pressure regulating pipeline (4) and outputting a pressure control signal according to the current pressure value and the selected pressure regulating gear so as to control the pressure pump (7) to increase or decrease pressure.

4. The integrated incision and dilation knife according to claim 3, wherein the pressure adjusting gears correspond to an unfilled state of the dilation balloon (2) and a plurality of filled states of the dilation balloon (2) with a diameter in a range of 0.6-1.2 cm in a one-to-one mode.

5. The integrated incision and dilation knife according to claim 4, wherein the pressure adjusting gears comprise five gears of 0, 6, 8, 10 and 12, which respectively correspond to the unfilled state of the dilation balloon (2), the diameter of the dilation balloon (2) being 0.6cm, the diameter of the dilation balloon (2) being 0.8cm, the diameter of the dilation balloon (2) being 1.0cm and the inflated state of the dilation balloon (2) being 1.2 cm.

6. An integrated slitting spreader knife according to any one of claims 1 to 5, characterised in that the first branch (401) is shorter than the second branch (402), the adjustable pressure control gauge (5) being detachably connected to the first branch (401).

7. The integrated incision and dilation knife according to any one of claims 1-5, wherein an external circuit interface (8) is connected to the handle (6), one end of the external circuit interface (8) is respectively in communication connection with the internal circuit and the adjustable pressure control meter (5), and the other end of the external circuit interface (8) is in communication connection with the host (9).

8. An integrated incision dilation knife according to claim 7, characterised in that the larger end circumference of the metal blade (1) does not exceed 6 Fr.

9. The integrated incision and dilation knife according to claim 1 or 8, wherein the axis of the metal knife head (1) and the axis of the insulating sheath (3) are provided with a communicated instrument channel (A), a hollow puncture needle (10) is arranged in the instrument channel (A), the puncture needle (10) penetrates through the whole instrument channel (A), and the axis of the puncture needle (10) is provided with a guide wire or a contrast agent channel (B).

10. The method for using the integrated incision dilation knife according to claim 5, comprising the steps of:

the smaller end of the metal cutter head (1) is aligned to a point to be cut, a control switch (601) on a handle (6) is operated, the electrode (101) is electrified through an internal circuit, and the metal cutter head (1) cuts;

propelling the metal cutter head (1) at the notch, wherein the conical surface of the metal cutter head (1) performs blunt expansion on the notch;

the metal cutter head (1) is continuously pushed in the incision, the adjustable pressure control table (5) is adjusted to a pressure adjusting gear corresponding to the expected incision caliber, and the pressure pump (7) fills medium into the pressure adjusting pipeline until the diameter of the expansion balloon (2) is full to the expected size;

withdrawing the incision dilation knife.