RU145252U1 - DEVICE FOR APPLICATION OF CIRCULAR ANASTOMOSIS OF HOLLOW TUBULAR BODIES - Google Patents

Abstract

A device for applying a circular anastomosis of hollow tubular organs, comprising a cylindrical body inside which a pusher is located, the proximal end of the cylindrical body is fixed in the handle, on the side surface of which a window with a scale is made, in the handle there is a drive unit, in the body of which a flywheel connected to the pusher is placed , the distal end of the cylindrical body carries a stitching unit for connecting hollow tubular organs and applying a circular anastomosis containing a punch containing spruce, clip with titanium brackets arranged in two rows in a circular pattern in a checkerboard pattern, a circular knife and a removable supporting jaw with a matrix and a tip for tightening and fixing stitched fabrics and forming the ends of the brackets, characterized in that the cylindrical body is made of flexible polymeric material, the distal end of the flexible cylindrical body is equipped with a cap, the pusher is flexible, the proximal end of the pusher is equipped with a shank with the ability to connect with the plunger of the drive unit, which contains two mach one for moving the flexible pusher in the longitudinal direction through the plunger and nut, another handwheel for transmitting the rotational movement of the pusher to the screw of the punch holder of the stapling unit, the distal end of the flexible pusher is made in the form of a hexagon and is equipped with slots for fixing with the stapling unit, which is removable, on the end part of the removable stapling unit contains a plug with a locking rod for the latch of the latch, a sleeve-socket made in the form of a plug for connecting the removable supporting jaw with the matrix and tilt

Description

The utility model relates to medicine, namely to staplers for the formation of circular anastomoses and can be used in oncology, oncological coloproctology, general proctology, general surgery, bariatric surgery to form circular anastomoses at any level of resection of the 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. 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 colon cancer, and reducing the frequency of complications.

Typically, surgical devices for stapling hollow tubular organs include a handle, a rigid body for the working part of the device, starting from a handle with a trocar inside, a “fixed” head working part with a 2-row circular staggered arrangement of titanium brackets, a circular blade and a removable supporting jaw with a pin for fastening with a head part.

For the prototype of the proposed utility model, a well-known device for applying circular anastomoses of hollow tubular organs is selected, containing a cylindrical body, inside which a pusher is placed, the proximal end of the cylindrical body is fixed in the handle, on the side surface of which there is a window with a scale, in the handle there is a drive unit, in the case which has a flywheel connected to the pusher, the distal end of the cylindrical body carries a stitching unit for connecting hollow tubular organs and of a circular anastomosis containing a punch holder and a holder containing titanium brackets arranged in two rows in a staggered circle, a circular knife and a removable support jaw with a matrix and a tip for compressing and fixing the stitched fabrics and forming the ends of the brackets (US 6945444 B2, IPC A61B 17/00, A61B 17/115, A61B 17/34 "Surgical stapling device for the formation of a circular anastomosis")

The known device operates as follows. Parts of the colon and rectum with a pathological formation are removed. On the cult of the rectum, a scraper suture is performed. A removable supporting jaw is located in the colon, on the edge of which a purse string suture is applied and tightened around the tip of the support jaw. A cylindrical body, the distal end of which is provided with a stapling unit, is inserted through the anus, thereby placing it in the rectal stump. Then, turning the flywheel of the drive unit, which is located in the handle of the surgical device, put forward a pusher that punctures the wall of the rectal stump, next to the scraper suture. Next, the removable support jaw with the matrix and the tip is inserted into the distal part of the pusher and, rotating the flywheel of the drive unit in the opposite direction, the support jaw with the matrix and the tip and the stapling unit are brought together, which is controlled by a window with a scale located on the handle of the surgical device. The device is ready for firmware when a green mark appears in the handle window. After fixing the stitched tissues, the mechanism for pushing the U-shaped brackets out of the stitching unit is activated, which, passing through the edges of the fabrics, abut against the matrix of the supporting jaw and take a B-shape. Immediately after flashing fixed tissues, a circular knife is set in motion, with the help of which excess tissue immersed in purse-string and scraper seams is cut off. A circular anastomosis is formed. Next, with a gentle swaying and rotational movements, the surgical device is removed.

In the case of the formation of coloanastomosis (colon), a laparotomy is performed, part of the colon with a pathological substrate is removed, a removable supporting branch with a matrix and a tip is placed in the proximal part of the colon, a purse string suture is applied to the edge of it and a removable supporting bore is tightened around the tip matrix. The cylindrical body of the surgical device is inserted through a separate incision in the colon below the level of formation of the putative anastomosis. In order to start the working part of a rigid cylindrical body with a diameter of 33 mm, it is necessary to make a cut of at least 35 mm. In the future, the process of formation of coloanastomosis is similar to the above process for the formation of colorectal anastomosis. After removing the stapler from the colon, the incision in it is sutured.

However, the known device has the following disadvantages:

- limited mobility of the rigid cylindrical body, the length of which and the natural bends of the intestine do not allow the formation of an anastomosis without additional incisions above 15 cm from the anus, that is, the known surgical device without additional incisions can only be used to create a low circular anastomosis;

- the need to perform an additional cut. When a circular anastomosis is formed using a known surgical device on the colon in open operations, an incision is always made on the colon 25-35 mm long below the intended circular anastomosis to be inserted through the incision of the surgical stapler. An additional incision, almost ½ of the circumference of the colon, leads to additional trauma, as well as to the occurrence of postoperative complications in the form of inconsistency of the suture in this area, the risk of contamination of the abdominal cavity with intestinal contents increases, the time of surgery, anesthesia and the cost of surgery increase;

- the known device cannot be used when performing resection of the colon by the laparoscopic method;

- the known device is intended for single use only.

The utility model is aimed at achieving a technical result, which is expressed in the possibility of applying a circular anastomosis at different levels of resection of the hollow organs not only during open but also during laparoscopic operations, reducing trauma and the risk of intraoperative and postoperative complications, and shortening the patient’s time under anesthesia for expense reduction in transaction time; reduction in transaction costs.

The specified technical result is achieved by the fact that in the device for applying circular anastomoses of hollow tubular organs containing a cylindrical body, inside which there is a pusher, the proximal end of the cylindrical body is fixed in the handle, on the side surface of which there is a window with a scale, in the handle there is a drive unit, in the housing of which has a flywheel connected to the pusher, the distal end of the cylindrical body carries a stitching unit for connecting hollow tubular organs and is superimposed a circular anastomosis containing a punch holder, a holder, titanium brackets arranged in two rows in a circular pattern in a checkerboard pattern, a circular knife and a removable supporting jaw with a matrix and a tip for tightening and fixing the stitched fabrics and forming the ends of the brackets, the cylindrical body is made of flexible polymer material the distal end of the flexible cylindrical body is equipped with a cap, the pusher is flexible, the proximal end of the pusher is equipped with a shank with the possibility of connection with the plunger of the drive unit which contains two flywheels, one for moving the flexible pusher in the longitudinal direction through the plunger and nut, another flywheel for transmitting the rotational movement of the pusher to the screw of the punch holder of the stapling unit, the distal end of the flexible pusher is made in the form of a hexagon and provided with grooves for fixing with the stapling unit, which made removable, at the end of the removable stapling unit there is a plug with a locking rod for the latch of the latch, sleeve-socket, made in the form of a plug for connecting a removable support jaws with a matrix and a tip with a flexible pusher, the body of the stapling unit contains a punch holder, a screw for ensuring the translational movement of the punch holder, while the punch holder carries punches on it, the stapling unit contains a clip and a circular knife, the clip is equipped with sockets in the form of rectangular holes that are guides for punches, the inner surface of the holder is a guide for the knife, the proximal part of the punch holder is in the form of a fork, the inner part of which is threaded with Corresponding to the thread pitch of the screw, which is provided with a central hole with a hexagonal surface for connecting with the hexagon of the flexible pusher and for translating the punch holder, there are rectangular grooves on the end surface of the screw for engagement with the brake sleeve and a slot for engagement with the sleeve-socket, the brake sleeve has protrusions for coupling with the end grooves of the screw and rectangular protrusions for coupling with the rectangular grooves of the housing, the tip of the removable supporting jaw is made in the form of a tube for fixing on a hexagon of a pusher.

The author did not find any documents discrediting the novelty of the proposed device in accessible sources of information.

The utility model is industrially applicable, as it can be repeatedly repeated and used in healthcare during surgical treatment, in particular, colorectal cancer in specialized institutions, especially oncological ones: oncology dispensaries, oncological research institutes.

Technical effect. The implementation of the body and the pusher of the surgical stapler flexible allows the formation of circular anastomoses of hollow tubular organs at any level of resection. The device allows to reduce the morbidity and the risk of intraoperative and postoperative complications by eliminating the need to perform additional incisions during the formation of coloanastomoses, thus eliminating the risk of suture failure in the area of insertion of the apparatus (as in the case with a rigid body), eliminating the risk of contamination of the abdominal cavity with intestinal contents, reducing the time of surgery and anesthesia, reducing the cost of surgery. The proposed device can be used as a disposable device, there is also a variant of the device for reusable use with the replacement of only the stapling unit and a removable supporting jaw with a matrix and a tip. Easy to use, reliable, safe, inexpensive domestic device, will provide affordable treatment to a wide range of patients. The proposed device can be used in laparoscopic surgery and oncology, including bariatric surgery.

All the features of the device for applying circular anastomoses to hollow tubular organs of a utility model that are distinct from the prototype are aimed at obtaining and are sufficient to achieve a technical result, namely, to provide the possibility of applying a circular anastomosis at different levels during resection of hollow organs not only in open surgery, but also using laparoscopic techniques, reduce the morbidity and risk of intraoperative and postoperative complications, reduce the patient’s stay nta under general anesthesia by reducing the time of surgery and its cost.

A device for applying circular anastomoses to hollow tubular organs characterized by the described set of essential features is new and industrially applicable.

In the description of the surgical device, the terms "distal" and "proximal" are used to indicate the position of the instrument in space. In relation to the details of the device, the term "distal" means "directed to the oral opening", the term "proximal" means "directed to the anus."

The utility model is illustrated by graphic materials.

In FIG. 1 shows the proposed device in a prefabricated version in section.

In FIG. 2 shows a section of the drive assembly.

In FIG. 3 shows a distal part of a flexible cylindrical body with a cap in a section.

In FIG. 4 shows a cross-sectional stapling unit.

In FIG. 5 shows a latch - latch stapler

In FIG. 6 shows a sleeve socket stapler node

In FIG. 7 shows a punch holder.

In FIG. 8 shows the end portion of the punch holder.

In FIG. 9 shows the screw stapling unit

A device for applying circular anastomoses of hollow tubular organs (Fig. 1) consists of a cylindrical body 1 made of flexible polymer material, inside of which a flexible pusher 2 is placed, made in the form of a cable enclosed in a jacket 3. The proximal end of the cylindrical body 1 is fixed in the handle 4, with the drive assembly 5 located therein. The distal part of the cylindrical body 6 carries a stapling assembly 7 for connecting hollow tubular organs and applying a circular anastomosis, which when used and connect with a removable support matrix with jaws 8 and 9 for urging the ferrule and fixing crosslinkable tissue and forming the ends of staples. The tip 9 is made in the form of a tube with 6 protrusions on the inner surface with the possibility of fixation on the hexagon of the flexible pusher 2. The design of the supporting jaw with the matrix 8 and the tip 9 provides the possibility of preliminary adjustment of the gap between the nodes of the surgical device when stitching tissues. The proximal end of the flexible pusher 2 (Fig. 2) is equipped with a shank 10 with the possibility of connection with the plunger 11 of the drive unit 5. The drive unit contains two flywheels (12 and 13, respectively), one of which 12 is designed to move the flexible pusher 2 in the longitudinal direction by means of a plunger 11 and nuts 14. The second flywheel 13 is designed to transmit the rotational movement of the flexible pusher 2 to the screw of the punch holder of the stapling unit 7. The distal end of the flexible cylindrical body 1 is provided with a cap 15 (Fig. 3). The distal end of the flexible pusher 2 is made in the form of a hexagon 16 and is provided with grooves 17 for rigid fixation with a stapling unit 7. The stapling unit 7 is removable. At the end of the removable stapling unit 7 is placed a plug 18 (Fig. 4). On the other side of the removable stapling unit there is a latch 19 (Fig. 5) with a latch 20 and springs 21, 22. In the body of the stapling unit there is a sleeve - socket 23 (Fig. 6), made in the form of a fork and designed to orient the support branch with the matrix 8 and the tip 9 relative to the staples in the holder and the connection of the hexagon 16 with the tip 9 of the removable supporting jaw, the puncheon 24 with punches 25 (Fig. 7) designed to push the blanks of brackets from the sockets 26 of the holder 27 (Fig. 8), screw 28 (Fig. 9), which provides the forward movement of the pointe the holder 24. The inner surface of the holder 27 is a guide for the circular knife 29 (in Fig. 8) The proximal part of the punch holder (Fig. 7) has the shape of a fork, the inside of which is threaded corresponding to the thread pitch of the screw 28. The screw 28 (Fig. 9) is intended for imparting translational movement to the punch holder with the possibility of connecting with the hexagon 16 of the flexible pusher 2. On the end surface of the screw 28 there are rectangular grooves 29 for engagement with the brake sleeve (in FIG. not shown) and a slot 30 for engaging with the sleeve — the socket 23. The brake sleeve has protrusions for engaging with the rectangular grooves of the screw 28 and rectangular protrusions for engaging with the rectangular grooves of the body of the stapling assembly 7. The proposed device operates as follows.

A removable supporting jaw with a matrix 8 and a tip 9 (im. 1) is immersed in the proximal section of the stitched organ (for example, the transverse colon). A purse string suture is applied on the edge of the intestine with monofilament and tightened around the tip 9 (Fig. 1). Through the anus, a flexible cylindrical body of the device 1 (Fig. 1) is held with a cap 15 (Fig. 3) to the distal edge of the stitched organ (for example, to the sigmoid colon). Remove the cap 15 (Fig. 3) from the flexible cylindrical body 1 (Fig. 1). Put on the hexagon of the flexible pusher 16 (Fig. 3) a removable stapling unit 7 (Fig. 5) and fix it with a nut located on the distal part of the flexible cylindrical body 1 (Fig. 1) and the thread of the stapling unit 7 (Fig. 4) . Remove the plug 18 (Fig. 5), then use the flywheel 12 (Fig. 2) to push the hexagon of the flexible pusher 16 (Fig. 3) around which the purse string suture of the distal edge of the intestine (in our case, sigmoid) is tightened. The tip 9 of the supporting jaw 8 (Fig. 1) is put on the hexagon of the flexible pusher 16 (Fig. 3). After that, rotating the flywheel 12 (Fig. 2) in the opposite direction, the supporting jaw and the stapler come together, the stitched surfaces of the colon (in our case, the transverse colon and sigmoid) are fixed between them. The device is ready for flashing after the mark located on the scale of the handle 4 (Fig. 1) reaches 1.5 mm, 2.0 mm or 2.5 mm (depending on the wall thickness of the stitched sections of the colon). After that, turn the flywheel 13 (Fig. 2). Thus, the mechanism for pushing U-shaped brackets is activated, which, passing through the edges of the tissues, abut against the matrix 8 of the supporting branch (Fig. 1) and take a B-shape. Immediately after flashing fixed tissues, a circular knife 29 (Fig. 8) is set in motion by which excess tissue immersed in purse string sutures is cut off. After that, the distal flywheel 13 is turned in the opposite direction, the knife returns to its original position, then the flywheel 12 is rotated in the opposite direction and the support jaw with the matrix 8 and tip 9 moves away a few mm from the stapler (Fig. 1). A circular anastomosis is formed, the apparatus is removed from the colon through the anus.

To form colorectal anastomoses, the cap 15 (Fig. 3) is removed as the first step, then the stapling unit 7 (Fig. 4) is fixed to the flexible cylindrical body 1 (Fig. 1) and the plug 18 is removed (Fig. 4). A support jaw with a matrix of 8 and a tip of 9 (Fig. 1) is immersed into the proximal part of the colon, a purse string suture is applied on the edge of it with monofilament and tightened around the tip of the 9 supporting jaw with the matrix of 8 (Fig. 1). Next, a stitching unit with a flexible cylindrical body is passed through the anus (Fig. 1). Using the proximal flywheel 12 (Fig. 2), the hexagon of the flexible pusher 16 is pushed forward, which pierces the wall of the rectal stump, next to the scraper suture. The tip 9 of the supporting jaw 8 (Fig. 1) is put on the hexagon of the flexible pusher 16 (Fig. 3). After that, rotating the proximal flywheel 12 (Fig. 2) in the opposite direction, the supporting jaw and the stapling device come together, the stitched surfaces of the colon (in our case, sigmoid and straight) are fixed between them. The device is ready for flashing after the mark located on the scale of the handle 4 (Fig. 1) reaches 1.5 mm, 2.0 mm or 2.5 mm (depending on the wall thickness of the stitched sections of the colon). After that, turn the distal flywheel 13 (Fig. 2). Thus, the mechanism of ejection of U-shaped brackets is activated, which, passing through the edges of the tissues, abut against the matrix of the supporting branch 8 (Fig. 1) and take a B-shape. Immediately after flashing fixed tissues, a circular knife 29 (Fig. 8) is set in motion by which excess tissue immersed in purse string sutures is cut off. After that, the distal flywheel 13 is turned in the opposite direction, the knife returns to its original position, then the proximal flywheel 12 is rotated in the opposite direction and the support jaw with the matrix 8 and tip 9 moves away a few mm from the stapler (Fig. 1). A circular anastomosis is formed, the apparatus is removed from the colon through the anus.

The utility model is illustrated by the following example.

The first stage of the experiment was carried out on autopsy male cadaveric material. Through the median laparotomy, the left half of the colon is mobilized, the inferior mesenteric artery and vein are crossed at the base. The intersection of the transverse colon at the level of the middle third and the sigmoid colon at the level of the upper third. A detachable supporting jaw with a matrix and a tip was immersed in the proximal colon (transverse colon). Monofilament was applied to this edge of the intestine with a purse string suture and tightened around the tip. Next, a flexible cylindrical body of the device with a cap to the distal edge of the stitched organ (sigmoid colon) was passed through the anus; the cap was removed from the flexible cylindrical body. Next, the removable stapling unit is put on the hexagon of the flexible pusher, thus the stapling unit is fixed to the flexible cylindrical body using a nut located on its distal part. The next step is removing the stitch of the stapling unit, then using the proximal flywheel the hexagon of the flexible pusher is pulled out around which the purse string suture of the distal edge of the stapling organ (sigmoid colon) is pulled. Then the tip of the supporting jaw with the matrix is put on the hexagon of the flexible pusher until it clicks lightly. After that, rotating the proximal flywheel in the opposite direction, the supporting jaw with the matrix and the tip and the stapler close together, the stitched surfaces of the transverse colon and sigmoid colon become tightly fixed. The device is ready for firmware after the mark located on the handle scale has reached the value of 1.5 mm. After that, turn the distal flywheel. Thus, the mechanism for pushing U-shaped brackets is activated. Immediately after flashing fixed tissues, a circular knife is set in motion, with the help of which excess tissue immersed in purse-string sutures is cut off. After that, the distal flywheel is turned in the opposite direction, the knife returns to its original position, then the proximal flywheel is rotated in the opposite direction and the support branch with the matrix and tip moves 20 mm from the stapler. A circular anastomosis is formed, the apparatus is removed from the colon through the anus. A tight comparison of both ends of the stitched organs, tightness of the reconstruction zone are provided.

The second stage of the experiment was carried out on a pig weighing 28 kg.

Under intravenous anesthesia, five laparoscopic ports were installed. The transverse colon with a large omentum was mobilized, the middle colon artery and vein were crossed at the base. The transverse colon was intersected at the level of the hepatic and splenic bends using a laparoscopic linear stapler. Minilaparotomy was performed along the midline above the navel (5 cm), through which the drug was removed (transverse colon). Further, the proximal end of the colon is removed to the anterior abdominal wall. Scraper sutures were cut off, a removable supporting jaw with a matrix and a tip was immersed in the proximal section of the transverse colon. Monofilament was applied to this edge of the intestine with a purse string suture and tightened around the tip. The proximal section of the transverse colon with a removable supporting jaw with a matrix and a tip is immersed in the abdominal cavity. Next, a flexible cylindrical body of the device with a cap to the distal edge of the stitched organ (sigmoid colon) is passed through the anus. The distal section of the stitched organ is brought to the front abdominal wall, the scraper suture is cut off, the cap is removed from the flexible cylindrical body. Next, the removable stapling unit is worn on the hexagon of the flexible pusher, thus the stapling unit is fixed to the flexible cylindrical body using a nut located on its distal part. The next step was to remove the stitch of the stapling unit, then using the proximal flywheel, the hexagon of the flexible pusher was pulled out around which the purse string suture of the distal edge of the stapling organ (transverse colon) was pulled. Then the distal colon is immersed in the abdominal cavity. Then, using laparoscopic instruments, the tip of the support jaw with the matrix is put on the hexagon of the flexible pusher until it clicks lightly. After that, rotating the proximal flywheel in the opposite direction, the supporting jaw with the matrix and the tip and the stapler closer together, the stitched surfaces of the transverse colon became tightly fixed to each other. The device is ready for flashing after the mark located on the handle scale has reached the value of 2.5 mm. After that, the distal flywheel is turned. Thus, the mechanism for pushing U-shaped brackets is activated. After that, the distal flywheel was turned in the opposite direction. Next, the proximal flywheel was rotated in the opposite direction and the supporting jaw with the matrix and the tip moved 20 mm from the stapler. A circular anastomosis is formed, the apparatus is removed from the colon through the anus. A tight comparison of both ends of the stitched organs, tightness of the reconstruction zone are provided. Tissues in the area of anastomosis are viable, hemostasis is complete. Suture of postoperative wounds.

Claims (1)

A device for applying a circular anastomosis of hollow tubular organs, comprising a cylindrical body inside which a pusher is located, the proximal end of the cylindrical body is fixed in the handle, on the side surface of which a window with a scale is made, in the handle there is a drive unit, in the body of which a flywheel connected to the pusher is placed , the distal end of the cylindrical body carries a stitching unit for connecting hollow tubular organs and applying a circular anastomosis containing a punch containing spruce, clip with titanium brackets arranged in two rows in a circular pattern in a checkerboard pattern, a circular knife and a removable supporting jaw with a matrix and a tip for tightening and fixing stitched fabrics and forming the ends of the brackets, characterized in that the cylindrical body is made of flexible polymeric material, the distal end of the flexible cylindrical body is equipped with a cap, the pusher is flexible, the proximal end of the pusher is equipped with a shank with the ability to connect with the plunger of the drive unit, which contains two mach one for moving the flexible pusher in the longitudinal direction through the plunger and nut, another handwheel for transmitting the rotational movement of the pusher to the screw of the punch holder of the stapling unit, the distal end of the flexible pusher is made in the form of a hexagon and is provided with slots for fixing with the stapling unit, which is removable on the end part of the removable stapling unit has a plug with a locking rod for the latch of the latch, a sleeve-socket made in the form of a plug for connecting the removable supporting jaw with the matrix and tilt with a flexible pusher, the body of the stapling unit contains a punch holder, a screw for ensuring the translational movement of the punch holder, while the punch holder carries punches on it, the stapling unit contains a clip and a circular knife, the clip is equipped with nests in the form of rectangular holes that are guides for punches, the inner surface the holder is a knife guide, the proximal part of the punch holder has the shape of a fork, the inside of which is provided with a thread corresponding to the thread pitch the screw, which is equipped with a central hole with a hexagonal surface to ensure docking with the flexible pusher hexagon and impart translational movement to the punch holder, there are rectangular grooves on the end surface of the screw for engagement with the brake sleeve and a slot for engagement with the sleeve-socket, the brake sleeve has protrusions for coupling with the end grooves of the screw and rectangular protrusions for coupling with the rectangular grooves of the housing, the tip of the removable supporting jaw is made in the form of a tube for fixing on the hexagon of the pusher.