Mammary gland minimally invasive surgery cavity building method and negative pressure cover equipment thereof

Abstract

The invention discloses a mammary gland minimally invasive surgery cavity building method and negative pressure cover equipment thereof. The device comprises a breast-like rigid negative pressure cover and a negative pressure controller which are communicated through an air pipe. The negative pressure controller is provided with an air exhaust PLC (Programmable Logic Controller) control system for regulating and controlling the negative pressure air exhaust work of the whole equipment. Compared with the prior art, by means of the superficial property and plasticity of the mammary gland, the mammary gland is fixed to the rigid negative pressure cover through vacuum suction to complete cavity building. The device has the advantages that when the device is used for surgical cavity building, noninvasive and noninvasive effects are achieved, cavity building is stable, operation is easy, the surgical cavity building time can be greatly shortened, and cost is saved. The negative pressure cover can be selected according to the breast size or shape characteristics of a patient, and a personalized effective operation space is established to the maximum extent. The cavity building method is simple and easy to learn, doctors can learn quickly, the learning curve is shortened, and the method has good clinical popularization value especially for primary hospitals.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a cavity building method for creating a support space for breast laparoscopic minimally invasive surgery and a negative pressure device thereof. Background Art

[0002] Laparoscopic breast surgery has the advantages of minimally invasive surgery and concealed surgical incisions. However, due to the physiological structural characteristics of the breast itself, such as tight glandular structure, small size, soft superficial tissue, lack of bone rigid support, etc., it causes problems such as small operating space, difficult cavity creation, and poor stability. The current cavity creation methods mainly include liposuction and non-liposuction methods, as well as combined suspension method, CO2 inflation method or support method. However, these cavity creation methods all have disadvantages, which are summarized as follows:

[0003] 1. Disadvantages of liposuction. Currently, most laparoscopic breast surgeries at home and abroad use liposuction combined with CO2 inflation, suspension or support methods to create a cavity. The specific operation is: before the operation, the fat in the breast and axilla is dissolved and extracted under negative pressure, and then filled with CO2 gas to create a cavity. On this basis, special retractors, sutures, and towel clamps can be used to suspend the skin to form sufficient operating space. This method requires lipolysis, liposuction and inflation to complete the cavity creation. This violent operation can damage the skin or important blood vessels and nerves, suck away detached lymph nodes, and affect the accurate staging of the tumor; it may also cause the tumor and lymph nodes to break up, leading to tumor cell implantation and blood entry, increasing the risk of postoperative recurrence.

[0004] 2. Disadvantages of non-liposuction method. The main method is to use non-liposuction and CO2 inflation method to create the cavity. This method is safer and more complete than liposuction, but the cavity is smaller. Some surgeons use the suspension method to further expand the cavity, but special instruments are required to lift the flap, which has the disadvantages of cumbersome cavity creation operation, high destructiveness, poor stability of surgical space, and risk of CO2 poisoning.

[0005] Therefore, finding a simple, effective and stable method of breast laparoscopic cavity creation is a difficult problem that needs to be solved in the field of breast laparoscopic surgery. Summary of the invention

[0006] In order to overcome the above technical defects, the present invention provides a method for creating a breast cavity in minimally invasive surgery. The specific scheme is: a rigid mask body adapted to the size of the breast is placed on the breast; negative pressure is formed by sucking the gas in the gap between the breast epidermis and the mask body, so that the breast epidermis and the mask body fit together to form a stable support for the breast by the mask body to create a cavity.

[0007] The present invention further provides a negative pressure hood device for minimally invasive breast surgery, which can be used to build a cavity for minimally invasive breast laparoscopic surgery. The device includes a rigid negative pressure hood and a negative pressure controller, which are connected through a trachea to form a negative pressure channel for sucking gas. The negative pressure controller is a device with the function of sucking gas to form negative pressure adsorption. The negative pressure controller of this device can suck the gas in the negative pressure hood to form a negative pressure in the negative pressure hood.

[0008] In order to obtain a stable, effective and easy-to-operate cavity building effect, as one of the preferred solutions, the negative pressure controller of the present invention includes a vacuum pump and a vacuum PLC (programmable logic controller) control system connected thereto, and the vacuum pump is connected to the negative pressure hood through an air pipe. This solution regulates the working time, frequency and pressure of the negative pressure hood of the vacuum pump through the vacuum PLC control system. The PLC control system of this solution includes a touch serial port screen mainly used for inputting instructions for human-computer interaction, a PLC module for setting the control program, an analog module for comparing parameters and a solenoid valve.

[0009] In order to create the most effective surgical space with the minimum negative pressure, in addition to selecting the most suitable size of negative pressure mask, the selection of vacuum pressure threshold is very critical. The preferred working vacuum pressure threshold of this device is 2-3kpa, and the floating value of the vacuum pressure threshold is ±0.2kpa.

[0010] In order to prevent blood from being sucked back into the device due to negative pressure, a detachable air filter is provided between the negative pressure cover and the negative pressure controller to filter the air entering the airway of the negative pressure controller from the negative pressure cover.

[0011] In order to maintain the pressure of the negative pressure mask at an appropriate and stable level, the negative pressure controller of this device is equipped with a gas storage tank connected to a vacuum pump. When working, the vacuum pump can simultaneously suck the gas from the negative pressure mask and the gas storage tank to buffer the airflow pressure and stabilize the surgical space.

[0012] In order to facilitate the surgeon to monitor and detect the negative pressure mask pressure and transmit the negative pressure mask pressure parameters to the analog module in real time, this device is equipped with a vacuum pressure gauge.

[0013] In order to make the negative pressure shield fit the human breast better, the negative pressure shield is shaped like a breast, including a hemispherical breast shield and a hemispherical nipple shield arranged at the upper end of the breast shield. The diameter of the breast shield base is preferably 10-18 cm and the height is 8-12 cm; the diameter of the nipple shield bottom is preferably 2-4 cm and the height is 1-3 cm. The shape and size of the negative pressure shield can be set to different specifications according to the conditions of the human breast.

[0014] In order to reduce the compression injury of the skin at the edge of the negative pressure shield under negative pressure, the base edge of the breast shield is made of smooth round strips made of silicone or rubber.

[0015] In order to prevent negative pressure damage and facilitate observation of breast conditions, the negative pressure hood is preferably made of transparent materials such as PMMA, PC, ABS or glass.

[0016] Compared with the prior art, the present invention utilizes the superficiality of the mammary gland and the soft plasticity of the tissue to fix the breast on a rigid negative pressure hood through vacuum suction to complete external fixation and cavity building. Its main advantages are: when using the present invention to build a cavity, since negative pressure is used to apply force, the force on each part of the breast is uniform and controllable, and the cavity building is stable; it is non-invasive and non-damaging, reduces surgical bleeding, is simple to operate, and can greatly shorten the surgical cavity building time and save costs. The negative pressure hood can also be selected according to the size or shape of the patient's breast to maximize the establishment of a personalized and effective surgical space. The cavity building method is simple and easy to learn, and doctors can quickly learn and get started, shortening the learning curve. It has great clinical promotion value, especially in grassroots hospitals. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the overall structure of this embodiment;

[0018] Figure 2 Schematic diagram of the structure of the negative pressure cover of this embodiment;

[0019] Figure 3 is a schematic diagram of the structure of a negative pressure controller in an embodiment;

[0020] Figure 4 is a schematic diagram of airway and circuit connection in this embodiment;

[0021] Figure 5 It is a diagram of the operating principle of this embodiment.

[0022] Figure 6 This is a test diagram of skin damage in rats using negative pressure hood equipment.

[0023] Figure numerals: 1. Negative pressure mask, 2. Negative pressure controller, 3. Vacuum pressure gauge, 4. Air filter, 5. First three-way air pipe quick-change joint, 6. Nipple shield, 7. Ball handle, 9. Inverted L-shaped trachea, 10. Trachea quick-change joint, 11. Breast shield, 12. Smooth round strip, 13. Switching power supply, 14. PLC, 15. Vacuum pump, 16. Relay, 17. Touch serial port screen, 18. Analog module, 19. Gas tank, 20. Second three-way air pipe quick-change joint, 21. Solenoid valve, 22. Third three-way air pipe quick-change joint. DETAILED DESCRIPTION

[0024] The present invention will be further described below in conjunction with specific embodiments.

[0025] like Figure 1As shown, this embodiment is mainly composed of a negative pressure mask 1 and a negative pressure controller 2. An air filter 4 is provided on the airway between the negative pressure mask 1 and the negative pressure controller 2, and an external vacuum pressure gauge 3 is provided on the negative pressure controller.

[0026] like Figure 2 As shown, the negative pressure shield 1 of this embodiment includes a hemispherical breast shield 11 and a nipple shield 6 connected thereto, the nipple shield 6 is provided with a spherical handle 7, the breast shield 11 is provided with an inverted L-shaped trachea 9, and the inverted L-shaped trachea 9 is connected to a trachea quick-change joint 10. The bottom edge of the breast shield 11 is a smooth round strip 12 made of silicone or rubber material.

[0027] like Figure 3 As shown, the negative pressure controller 2 of this embodiment mainly includes a switching power supply 13, a PLC 14, a vacuum pump 15, a relay 16, a touch serial port screen 17, an analog module 18, a gas storage tank 19 and a solenoid valve 21.

[0028] like Figure 4 As shown, the negative pressure hood 1 is connected to the vacuum pressure gauge 3 through the air filter 4 and the first three-way quick-change joint 5, the vacuum pressure gauge 3 is connected to the analog module 18, and the analog module 18 is connected to the PLC 14 to form a pressure detection airway.

[0029] One end of the first three-way air pipe quick-change joint 5 is connected to the third three-way air pipe quick-change joint 22, and the third three-way air pipe quick-change joint 22 is simultaneously connected to the second three-way air pipe quick-change joint 20 and the solenoid valve 21. The second three-way air pipe quick-change joint 20 is respectively connected to the vacuum pump 15 and the gas storage tank 19, the vacuum pump 15 is connected to the relay 16 and the power switch 13, the power switch 13 is connected to the touch serial port screen 17, and the relay 16 is connected to the PLC 14 and the power switch 13. The solenoid valve 21 is connected to the PLC 14.

[0030] like Figure 4 and Figure 5 As shown, the working mode of this embodiment is as follows: when the vacuum pump 15 is in suction operation, the vacuum pressure gauge 3 detects the pressure of the negative pressure hood 1 in real time and transmits it to the analog module 18, and the analog module 18 converts the above pressure value and transmits it to the PLC 14; the PLC 14 continuously compares the pressure value read with the set vacuum pressure setting value ± floating value in real time. When the pressure value read is less than the vacuum pressure setting value ± floating value, the PLC 14 controls the relay 14 to disconnect and the vacuum pump 15 works; when the pressure value read is greater than the vacuum pressure setting value ± floating value, the PLC 14 controls the relay 16 to disconnect and the vacuum pump 15 stops working.

[0031] PLC 14 plays the role of program setting, operation instruction and parameter setting, and touch serial port screen 17 is a human-computer interaction terminal. Touch serial port screen 17 can control functions and set working parameters through human-computer interaction. The specific control functions of PLC 14 are suction and stop, and the suction function is mainly set as: duty cycle (time of suction and non-suction), vacuum pressure setting value and floating value. PLC 14 performs instruction programming according to the value set by touch serial port screen 17. When the "suction" function on the touch serial port screen 17 is touched, the relay 16 will control the opening and closing time ratio of the relay 16 according to the duty cycle set by PLC 14, that is, by adjusting the duty cycle of suction time and stop suction time, thereby controlling the regular suction and stop suction of the vacuum pump 15. This design forms the PWM wave principle, and controls the air in the gap between the suction negative pressure mask 1 and the breast in a pulsed manner, minimizing the damage of the equipment to the tissue and ensuring the stability during the negative pressure process. Since the vacuum pressure fluctuates during the process of negative force formed by the air between the negative pressure mask 1 and the breast, it is necessary to set an upper and lower floating value in order to stabilize the vacuum pressure fluctuation within a small range.

[0032] The vacuum pump 15 simultaneously draws air from the breast negative pressure mask 1 and the air storage tank 19, and simultaneously draws air from the air storage tank 19, which can play the role of buffering the air flow to maintain the stability of the vacuum pressure value.

[0033] The vacuum pump 15 is on the airway of the breast negative pressure hood 1, and the solenoid valve 21 passes through the third three-way quick-change joint 22. When the "stop" function on the touch serial port screen 17 is pressed, a stop command is issued to reach the PLC 14, the solenoid valve 21 opens, the vacuum airway is connected to the atmosphere, and the vacuum is broken instantly. At the same time, the vacuum pump 15 stops operating as the relay 16 cuts off the current, so that the breast negative pressure hood is quickly loosened from the breast. This design can prevent the patient from experiencing any discomfort or adverse conditions during the operation, and the negative pressure can be quickly stopped and the work can be stopped.

[0034] Negative pressure hood equipment rat skin damage test: using the equipment of the present invention, different negative pressures and different negative pressure action times were set to test the effect of the equipment on the back skin of rats.

[0035] Experimental groups: control group, 2Kp negative pressure group (lasting 30 min) X3, 2Kp negative pressure group (lasting 60 min) X3, 4Kp negative pressure group (lasting 30 min) X3, 4Kp negative pressure group (lasting 60 min) X3.

[0036] The experimental method is as follows:

[0037] (1) Skin preparation: Shave the hair on the back of the rat.

[0038] (2) Experimental process:

[0039] a. Use 400 μl of 2% sodium amobarbital solution for intraperitoneal injection;

[0040] b. After the rat is anesthetized, fix the rat on a rat fixer to fully expose the back skin of the rat;

[0041] c. Adjust the suction force of the negative pressure device and place the suction cup on the exposed skin area on the back of the rat. Turn on the negative pressure device and record the time. At this time, you can see that the skin in the area is sucked up and bulges;

[0042] d. Turn off the negative pressure device at the corresponding time. After removing the suction cup, it can be observed that the skin in the negative pressure area is concave at the edges and bulging in the center.

[0043] The results are as follows Figure 6 As shown, the area was marked, and when the rats regained consciousness, it was observed that the bulging skin color at the marked area of ​​all treated rats had returned to normal, and there was no skin blistering, congestion, or necrosis.

Claims

1. A method for creating a breast cavity in minimally invasive surgery, characterized in that: The cavity building method comprises the following steps: placing a rigid mask body adapted to the size of the breast on the breast; and forming a negative pressure by sucking the gas in the gap between the breast epidermis and the mask body, so that the breast epidermis and the mask body fit together, thereby forming a stable support of the mask body on the breast to build the cavity.

2. A negative pressure mask device for minimally invasive breast surgery, characterized in that: The negative pressure mask device comprises a rigid negative pressure mask adapted to the size of the breast and a negative pressure controller, which are connected through a trachea to form a negative pressure channel for suctioning gas.

3. The negative pressure hood device according to claim 2, characterized in that: The negative pressure controller includes a vacuum pump and an air extraction PLC control system connected thereto, and the vacuum pump is connected to the negative pressure hood through an air pipe.

4. The negative pressure hood device according to claim 3, characterized in that: The air extraction PLC control system includes a touch serial port screen, a PLC module, an analog quantity module and a solenoid valve.

5. The negative pressure hood device according to claim 3, characterized in that: The vacuum pressure threshold value set by the vacuum PLC control system is between 2-3 kPa, and its floating value is ±0.2 kPa.

6. The negative pressure hood device according to claim 2 or 3, characterized in that: A detachable air filter is arranged between the negative pressure cover and the negative pressure controller.

7. The negative pressure hood device according to claim 2 or 3, characterized in that: The negative pressure controller also includes a gas storage tank connected to the vacuum pump.

8. The negative pressure hood device according to claim 2 or 3, characterized in that: The negative pressure controller is provided with a vacuum pressure gauge.

9. The negative pressure hood device according to claim 2, characterized in that: The negative pressure shield is in the shape of a breast, comprising a hemispherical breast shield, a hemispherical nipple shield arranged at the upper end of the breast shield and a trachea joint. The base diameter of the breast shield is 10-18cm and the height is 8-12cm; the bottom diameter of the nipple shield is 2-4cm and the height is 1-3cm.

10. The negative pressure hood device according to claim 9, characterized in that: The base edge of the breast shield is in the shape of a smooth round strip made of silica gel or rubber.

11. The negative pressure hood device according to claim 2 or 3, characterized in that: The negative pressure cover is made of transparent materials, including PMMA, PC, ABS or glass.

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