RU192633U1 - Electromechanical apparatus for surgical staplers - Google Patents

Abstract

The proposed utility model relates to medicine, to auxiliary devices for surgical instruments intended for anastomosis, relates to an electromechanical apparatus for reusable surgical staplers (staplers), which can be used in oncology, oncological coloproctology, general proctology, general surgery for intersection, formation anastomoses or simultaneous removal of benign and / or malignant tumors and stitching of the tissue of the tumor bed from the side light hollow tubular organs. The electromechanical apparatus has a hollow body made of two connected symmetrical parts, with a middle cylindrical part, a handle, a battery compartment and a connector. The connector is cone-shaped with an opening at the end. The device comprises an on / off button, made on the rear surface of the case, an “open” button and a “close” button, made on the end surface of the handle, a “flash” button and a display, made on the side surface of the case, a battery installed in the compartment for battery. The device also contains an end switch “closed”, an end switch “flashing” and an end switch “open”, equipped with infrared LEDs reflecting the position of the staple cartridge, an engine with a driver, a shaft connected to the engine, made with a thread, on the distal end of which there is a sleeve for connection with stapler case shaft, flag nut mounted on the shaft with the possibility of movement along the thread and with the possibility of interaction with the limit switch “closed”, the end switch “flashing” and the end switch “open”, controller, t koogranichivayuschie resistors, a voltage regulator, a voltage divider, the LED reflecting battery level established inside the housing. At the same time, the on / off button, the open button, the close button, the flash button, the display, the battery, the end switch is “closed”, the end switch “flash” and the end switch “open”, infrared LEDs reflecting the position of the stapling cassette , motor, driver, current-limiting resistors, voltage stabilizer, voltage divider, LED, showing the battery charge level are connected to the controller that controls their operation. The technical result from the use of the utility model is to simplify the use, reduce the operation time, improve the quality of the seam. 8 s.p. f-ly, 5 ill.

Description

The proposed utility model relates to medicine, to auxiliary devices for surgical instruments intended for anastomosis, relates to an electromechanical apparatus for reusable surgical staplers (staplers), which can be used in oncology, oncology coloproctology, general proctology, general surgery for intersection, formation anastomoses or simultaneous removal of benign and / or malignant tumors and stitching of the tissue of the tumor bed from the side light hollow tubular organs.

          Anastomosis is understood as the surgical connection of individual sections of hollow tubular organs, after which they communicate with each other. As a rule, the formation of the anastomosis occurs after surgical removal of the pathological section of the hollow tubular organ, when the remaining end sections must be connected. Anastomosis can be formed by the type end to end, end to side, side to side depending on the surgical situation and the preferences of the surgeon.

          As a rule, surgical devices for stapling hollow tubular organs include a handle for manual use when stitching tissues, a rigid or flexible body of the working part of the device, starting from the handle with a trocar inside, a “non-removable” or removable, linear or circular head working part, with two or a three-row, linear or circular staggered arrangement of titanium brackets, a knife and a supporting jaw with the possibility of fastening with a head part (RU 145252 U1, class А61В17 / 115, publ. 09/10/2015; RU 158519 U1, RU 164604 U1, g )

          However, the above devices have a significant drawback: for stitching tissues it is necessary to make great physical efforts to the surgeon and, therefore, cannot be performed by female surgeons. The use of an electric motor of general economic value (screwdriver, drill), as described in patent RU 164604 U1, is prohibited.

The description of foreign-made devices using a medical electric motor is indicated in the following sources ( CN 10382998 A , CN 201320048686, publ. 24. 07.2014).

          However, these devices have the following disadvantages:

- firstly, the mechanism of electrical control of the operation of a circular or linear stapler in the above analogues can be used only for one patient, thus, it is disposable;

- secondly, each of these devices is not universal, since it is used only for a linear or circular device;

- thirdly, the mechanism of electrical control of the operation of a circular or linear stapler cannot be used with a flexible body, which makes it impossible to use it for endoluminal surgery (removal of tumors of the esophagus, stomach, colon);

- fourthly, the cost of using disposable devices significantly exceeds the cost of using the proposed reusable device;

- fifthly, these disposable devices are made only abroad.

          Closest to the proposed utility model is a device for endoscopic procedures, protected by patent US 20180021042 A1, cl. A61B17 / 07207, A61B17 / 00, A61B17 / 29, publ. 01/25/2018, taken as the closest analogue (prototype).

          The prototype device is designed for reusable use, it contains a fully automated system for opening / closing branches, flashing fabrics, light indication of each stage in the process of flashing fabrics, an indicator of the number of flashing. However, the known device has the following disadvantages. The weight of the device is 1.5 kg, which significantly increases the physical load on the operating surgeon. After the process of tissue fixation between the branches, before flashing, the surgeon needs to withstand a technological pause of 20 seconds. During this time, the surgeon must fix the device motionlessly on the weight. When resecting the stomach, sometimes up to 7 consecutive stitches are sometimes required. Such a load can not withstand a female surgeon. Difficulty in management: there are six buttons on the motor handle and the surgeon needs to look not only at the surgical field, but also “search” for the desired button to perform a certain stage during tissue stitching. This distracts the surgeon from work, increases his energy consumption. The number of errors increases, the operation time is lengthened. The device connector can only be used to connect to a rigid case for a linear staple cartridge. In addition, the prototype device cannot be combined with staplers, for example, described in patents RU 158519 U1 and RU 164604 U1, which makes it impossible to use it for endoluminal surgery (removal of tumors of the esophagus, stomach, colon).

          The objective of the utility model is to improve the electromechanical stapler for reusable surgical staplers, compatible with staplers with both a rigid and flexible body, using both linear and circular cassettes.

          The technical result from the use of the utility model is to simplify the use, reduce the operation time, improve the quality of the seam.

          This object is achieved in that the electromechanical apparatus for reusable surgical staplers has a hollow body made of two symmetrical parts to be connected, with a middle cylindrical part, a handle, a battery compartment and a connector made in a cone shape with an opening at the end, the “on / off” button shutdown ”, performed on the rear surface of the case, the“ open ”button and the“ close ”button, made on the end surface of the handle, the“ flash ”button and the display, you filled on the side surface of the housing, the battery installed in the battery compartment, the device also contains a limit switch “closed”, a terminal “flashing” and an end switch “open”, equipped with infrared LEDs that reflect the position of the staple cartridge, a motor with a driver, a shaft connected to the motor , at the distal end of the shaft there is a sleeve for connecting to the shaft of the body of the stapling cartridge, a nut with a flag mounted on the shaft with the possibility of movement along the thread and with the possibility of interaction with the end life, “flashing” end switch and “open” end switch, controller, current-limiting resistors, voltage regulator, voltage divider, LED indicating the battery charge level installed inside the case, with the on / off button, open button, button “Close”, “flash” button, display, battery, limit switch “closed”, limit switch “flash” and limit switch “open”, infrared LEDs reflecting the position of the staple cartridge, motor, driver, current limiting resistors, voltage regulator Voltage divider, LED indicating the battery level are connected to a controller controlling their operation.

          The utility model is illustrated by the following graphic materials.

          In FIG. 1 shows a 3D model of an electromechanical apparatus for reusable surgical staplers.

          In FIG. 2 shows a photo of an electromechanical apparatus assembled with a reusable surgical stapler.

          In FIG. Figure 3 shows a photo of an electromechanical apparatus for reusable surgical staplers after being turned on.

          In FIG. 4 shows a photo of the electromechanical apparatus for surgical staplers reusable unassembled.

          In FIG. 5 is an electrical schematic diagram of an electromechanical apparatus for reusable surgical staplers.

          Structurally, the electromechanical apparatus for reusable surgical staplers in FIG. 1-5 contains:

1 - case;

2 - handle;

3 - battery compartment;

4 - connector;

5 - button “on / off”;

6 - button "open";

7 - button "close";

8 - button “flash”;

9 - display;

10 - battery;

11 - trailer “closed”;

12 - trailer “flashing”;

13 - limit switch “open”;

14 - infrared LEDs reflecting the position of the staple cartridge;

15 - engine;

16 - engine driver;

17 - a shaft;

18 - a nut;

19 - controller;

20, 21, 22 - current-limiting resistors;

23 - voltage stabilizer;

24 - voltage divider;

25 - LED, reflecting the battery charge level.

          The housing 1 is made hollow, consisting of two connected symmetrical parts. The housing 1 contains the middle cylindrical part, the handle 2, the compartment 3 for the battery 10, made above the handle 2, and the connector 4, made on the end surface of the housing 1. The handle 2, the compartment 3 for the battery 10 and the connector 4 are solid, integral with the housing 1 .

          The connector 4 is conical in shape, with an opening at the end for connecting with any kind of surgical staple cassettes, for example, for connecting to a circular cassette with a rigid casing, or with a linear cassette with a rigid casing, or with a circular cassette with a flexible casing, or with a linear cassette with flexible body.

          The on / off button 5 is located on the rear surface of the housing 1.

          The “open” button 6 and the “close” button 7 are made on the front wall of the handle 2 of the housing 1.

          Button "flash" 8 is made on the side surface of the housing 1.

          The display 9, showing the number of remaining firmwares, is made in a rectangular shape next to the “flash” button 8 on the side surface of the housing 1.

          The battery 10 is installed inside the housing 1 in the compartment 3. The battery 10 is made with the possibility of charging from a 220 V network. For example, use the battery brand A-BLOCK Model: 3.1, rechargeable battery Li-Ion, 2200mAh 12V.

          The end switch “closed” 11 (A), the end switch “flashing” 12 (B) and the end switch “open” 13 (C) are integrated into the housing 1. As the end switches 11, 12, 13, for example, optical sensors of the TCST 2103 brand are used. 11, 12 and 13 are equipped with infrared LEDs 14, which show the position of the process of the staple cartridge (the process of opening, closing, flashing).

The engine 15 is installed inside the housing 1 under the battery 10. As the engine 15, for example, a motor of the brand GA25 is used. Engine characteristics: voltage 12 V DC, 1200 rpm, length: - 64 mm, diameter - 25 mm, shaft length - 9.5 mm, shaft diameter - 4 mm, torque - 0.5 kg · cm.

         The operation of the engine 15 starts the driver 16, which is a circuit board with a chip, for example, brand L298n.

         The engine 15 is connected to the shaft 17.

         A thread with a pitch of 0.2 mm is made on the shaft 17. At the distal end of the shaft 17, a sleeve is installed for connecting to the shaft (pusher) of the body of the stapler. The sleeve can be made, for example, with a hole of square cross section for aligning with the proximal ends of the shafts (pushers) of the staplers described in patents RU 158519 U1 and RU 164604 U1 having a square section.

          The nut 8 is made with a flag and mounted on the shaft 17 with the possibility of movement along the thread of the shaft 17, as well as with the possibility of interaction with the limit switch “closed” 11, the limit switch “flashing” 12 and the limit switch “open” 13.

          The motor 15 can rotate the shaft 17 both clockwise and counterclockwise 360 degrees a large number of times. In this case, the nut 18, respectively, moves forward or backward.

          As the controller 19, for example, an Arduino Nano brand controller with specially designed software is used.

          As current-limiting resistors 20, 21, 22 for limit switches 11, 12 and 13, for example, current-limiting resistors with a resistance of 150 Ohms are used.

          LEDs 14, current-limiting resistors 20, 21, 22, voltage stabilizer 23, voltage divider 24 and LED 25 are installed on one board.

          As a voltage stabilizer 23 use, for example, a voltage stabilizer brand LM7806.

          As a voltage divider 24, for example, two resistors with a resistance of 1.8 kOhm and 1.2 kOhm are used.

          LED 25 shows the charge level of battery 9, for example, using a three-color LED (red / yellow / green) of the brands 5ARYG9HW-C / BL-L2506PGC.

          A battery 10 is installed inside the housing 1 in the battery compartment 3. In one of the connected parts of the housing 1, the end switch is “closed” 11, the end switch is “flashing” 12 and the end switch is “open” 13, equipped with infrared LEDs 14 that reflect the position of the staple cartridge. In another of the connected parts of the housing 1, a motor 15 with a driver 16 is installed, a shaft 17 connected to a motor 15, made with a thread, on which a nut 18 with a flag is installed, a controller 19, current-limiting resistors 20, 21, 22, a voltage regulator 23, a divider voltage 24, LED 25 showing the battery charge level.

          On / off button 5, open button 6, close button 7, flash button 8, display 9, battery 10, end switch “closed” 11, end switch “flash” 12 and end switch “open” 13, infrared LEDs 14, reflecting the position of the staple cartridge, motor 15, driver 16, current-limiting resistors 20, 21, 22, voltage stabilizer 23, voltage divider 24, LED 25 showing the battery charge level are connected to the controller 19 that controls their operation.

          The proposed electromechanical device for surgical stapling devices reusable works as follows.

          An electromechanical apparatus (EMA) for reusable surgical staplers is connected to the stapler body by installing the proximal end of the shaft (pusher) of the stapler through the hole of the connector 4 into the sleeve mounted on the distal end of the shaft 17 of the EMA (Fig. 2). The connection is fixed, for example, using a latch with a forced release made on the proximal end of the body of the stapling cassette, described, for example, in patent RU 158519 U1.

          Turning on the EMA is carried out by pressing the “on / off” button 5. At the same time, the display 9 (Fig. 3) lights up, which displays the number of firmwares, LED 25 shows the charge level: green - battery 10 is charged; yellow - the device is working, but the battery 10 requires charging; red - the device does not work, battery 10 is completely discharged. LEDs 14 (Fig. 3, 5) show the position (process) of the stapling cassette: position A — the cassette is open, position B — the cassette is closed, position C — the flashing process. If the battery 10 is charged (LED 25 is green), one or more firmwares are displayed on display 7, then the EMA is ready for use.

          After pressing the "open" button 6 on the handle 2 of the housing 1 (Fig. 3), the LED 14 corresponding to position A lights up, the voltage 12 V from the battery 10 is supplied to the voltage regulator 23, which reduces the voltage to 5 V for the controller 19 and the limit switches 11, 12, 13. An electrical signal is supplied to the controller 19. The latter transmits a signal to the driver 16 of the engine 15. In the event that an electric voltage of 5 V is supplied to the socket IN1 of the driver 16 of the engine 15 and no voltage is supplied to the IN2 socket of the driver 16 of the engine 15 then engine 15 will be r generate the rotation of the shaft 17 with the staple cartridge clockwise. If no voltage is supplied to IN1, and 5 V is supplied to IN2, then motor 15 will generate a counterclockwise rotation of shaft 17 with the staple cassette. The rotation of the shaft 17 of the EMA is synchronized with the rotation of the screw of the stapling cutting unit of the stapling cartridge. Thus, the position of the flag of the nut 18 in the "open" position coincides with the opening of the stapling head, the "close" position coincides with the fact that the stapling cassette is fully closed, the "flash" position coincides with the flashing process.

          The engine 15 starts to rotate the shaft 17, on which the nut is located 18. After pressing the “close” button 7, a flag made in the form of a horizontal protrusion on the nut 18, when the shaft 17 rotates, reaches the slot of the end switch “closed” 11. At the same time, the electric closes circuit and the flashing process is blocked. At point (B), the staple cartridge is completely closed. At this moment, the middle LED 14 corresponding to position B lights up. The end switch “closed” 11 (B) sends a signal to the controller 19, which recognizes that the staple cartridge is in the closed position and sends a signal to the driver 16 of the engine 15 to stop the engine 15. Next the surgeon estimates the position of the stapling cassette in the closed position and presses the flash button 8. After that, the signal from the controller 19 is sent to the driver 16 of the engine 15, the motor 15 rotates the shaft 17 with the stapling cassette clockwise, which gives the nut 18 the input forward movement. In this case, the LED 14 corresponding to position C lights up. When the nut 18 reaches the “flashing” 12 (C) limit switch, the signal is sent to the controller 19, which gives the command for the driver 16 of the engine 15 and the rotation of the shaft 17 with the stapling cassette occurs counterclockwise to the limit switch is “open” 13 (A) until the staple cartridge is fully opened. During the movement from the limit switch “flashing” 12 (C) to the limit switch “open” 13 (A), on the display 9 (Fig. 2, 3) the figure showing the number of flashing changes in decreasing order, thereby showing how many flashing remains run using the device. The trailer "open" 13 (A) (Fig. 5) sends a signal to the controller 19, which, through the driver 16 of the engine 15, stops the engine 14. The flashing process is completed.

          The universality of the proposed device lies in the possibility of connecting with both a rigid and a flexible body of surgical stapling devices using both linear and circular cassettes. At the same time, the electromechanical apparatus, when connected to the flexible body of the surgical stapler, provides the possibility of intraluminal removal of the tumor-like formation of the wall of the hollow organ at any distance from the natural openings of the body and the application of a linear brace suture, reducing trauma and the risk of intraoperative and postoperative complications, and reducing the patient’s time under anesthesia by reducing the time of surgery, the exclusion of fragmentation of the tumor, which corresponds complies with modern oncological principles of tumor removal (en bloc) and significantly improves the quality and objectivity of pathomorphological examinations, reducing the cost of surgery and expanding the indications for endoscopic surgery (removal of polyps on a broad basis, the possibility of a full-layer resection of a hollow organ, resection of hollow organs about malignant neoplasms in the early stages).

Performing an EMA with the electric drive of closing, opening and stitching the stapling cassette makes it possible to rotate the working part of the cassette of any kind by 360 ⁰ either clockwise or counterclockwise, with a forced stop by 180 ⁰ , which makes it possible to bring the device to the internal organ at any angle with the possibility of its intersection in various planes.

          Control of the number of firmwares displayed on the display and the light weight of the device due to the optimal selection of the battery and engine by weight and power allows the use of EMA by female surgeons. The presence of only two buttons on the handle of the device makes its control simple and allows the surgeon to focus only on the crossed organ.

          The advantages of a mechanical suture over a manual suture are obvious: reducing the time of surgery and anesthesia, high quality and reliability in the hands of surgeons with different clinical experiences, eliminating the forced colostomy during surgery for low-lying rectal cancer, and reducing the frequency of complications.

          The proposed utility model is illustrated by the following examples.

          Example 1

          The experiment was carried out on autopsy male cadaveric material. A section of the small intestine was washed from the contents and prepared for the experiment. Next, made the assembly of the device. An electromechanical device (EMA) for surgical stapling devices is fixed to the flexible casing of a device with a linear stitching head, for example, described in patent RU 164604 U1, using a latch with a forced release, which is located at the proximal end of this device. After turning on the EMA by pressing the “on / off” button, the display was lit, which showed the number 60 (the number of remaining firmwares), the LED reflecting the battery charge level was lit in green. LEDs showing the position of the staple cartridge have fixed position A - the cartridge is open. EMA is ready for flashing. A section of the small intestine was placed between the branches of the stapling linear cassette. Then they pressed the close button on the EMA handle - the branches closed and tightly clamped the small intestine. Then they pressed the flash button on the side surface of the EMA. Flashing was performed with simultaneous flashing of the small intestine section until the staple cassette was fully opened. Drug: crossed small intestine with three rows of brackets at both ends of the intestine.

          Example 2

         The second stage of the experiment was conducted on male cadaveric material. A section of the colon was washed from the contents and prepared for the experiment. Next, made the assembly of the device. An electromechanical device (EMA) for surgical staplers with a forced release lock located on the proximal end of the device is fixed to the rigid body of the device with a circular stapling head, for example, described in RU 158519 U1. After turning on the EMA by pressing the “on / off” button, the display was lit, which showed the number 59 (the number of remaining firmwares), the LED reflecting the battery charge level was lit in green. LEDs showing the position (process) of the stapling cassette have fixed position A - the cassette is open. EMA is ready for flashing. A small intestine section was placed between the jaws of the stapling circular cassette. Then they pressed the close button on the EMA handle - the branches closed and tightly clamped the small intestine. Then they pressed the flash button on the side surface of the EMA. Flashing was performed with simultaneous flashing of the small intestine section until the circular stapling cassette was fully opened. Preparation: in the center of the small intestine, there is a hole in the circle of which there are two rows of brackets that hold the front and back walls of the small intestine.

Claims (9)

1. The electromechanical apparatus for reusable surgical staplers has a hollow body made of two symmetrical parts to be connected, with a middle cylindrical part, a handle, a battery compartment and a connector made in a cone shape with an opening at the end, an on / off button, made on the back surface of the case, the “open” button and the “close” button, made on the end surface of the handle, the “flash” button and the display, made on the side surface of the housing a, the battery installed in the battery compartment, the device also contains the end switch “closed”, the end switch “flashing” and the end switch “open”, equipped with infrared LEDs reflecting the position of the staple cartridge, a motor with a driver, a shaft connected to the motor, made with thread , on the distal end of which there is a sleeve for connecting to the shaft of the stapler housing, a flag nut mounted on the shaft with the possibility of movement along the thread and with the possibility of interaction with the limit switch “closed”, end Evik “flashing” and limit switch “open”, controller, current-limiting resistors, voltage regulator, voltage divider, LED, reflecting the battery charge level installed inside the case, with the on / off button, open button, close button , “flash” button, display, battery, limit switch “closed”, limit switch “flash” and limit switch “open”, infrared LEDs reflecting the position of the staple cartridge, motor, driver, current limiting resistors, voltage regulator, share s voltage, the LED indicating the battery level are connected to a controller controlling their operation. 2. The electromechanical apparatus according to claim 1, characterized in that the handle, the battery compartment and the connector are solid, integral with the housing. 3. The electromechanical apparatus according to claim 1, characterized in that the battery is configured to be charged from a 220 V network. 4. The electromechanical apparatus according to claim 1, characterized in that the optical sensors of the TCST 2103 brand are used as limit switches. 5. The electromechanical apparatus according to claim 1, characterized in that a driver of the brand L298n is used. 6. The electromechanical apparatus according to claim 1, characterized in that an Arduino Nano brand controller is used with specially developed software. 7. The electromechanical apparatus according to claim 1, characterized in that current limiting resistors with a resistance of 150 Ohms are used as current-limiting resistors for the limit switches. 8. The electromechanical apparatus according to claim 1, characterized in that a voltage stabilizer of the brand LM7806 is used as a voltage stabilizer. 9. The electromechanical apparatus according to claim 1, characterized in that two resistors with a resistance of 1.8 kOhm and 1.2 kOhm are used as a voltage divider.

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