RU2784178C1 - Device for conducting a circular stapler through the intestine - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: inventions group relates to medical equipment, namely to surgery, and can be used to treat patients with intestinal stoma. The device for conducting a circular stapler through the intestine includes a handle of the stapler, a rod protruding from the handle, and a stapler head, a conductive element. The conductive element is made of an elastic material, the distal end of the conductive element is made of two layers, the layers of which form a container, the surface layer of which is made thinner than the inner layer. The conductive element has two input ports, one central port is fixed on the rod, the second port is made already central with the possibility of pumping fluid between the layers of the conductive element. In the second embodiment, the device for passing the circular stapling device through the intestine includes a stapling device handle, a rod protruding from the handle, and a stapling head, a conductive element. The conductive element is made by a modification of a two-way Foley catheter, in which a 7 mm long through incision is made at a distance of 1 cm from the balloon to insert the stem of the stapler. In the third embodiment, the device for passing the circular stapler through the intestine includes a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element. The conductive element is made of an elastic material, the distal end of the conductive element is made of a two-layer container, the surface layer of which is made thinner than the inner layer. The proximal end of the conductive element is made in the form of a sleeve connected to the distal end. The sleeve has a channel for pumping fluid between the layers of the capacitance of the conductive element. The channel is connected to a port for pumping fluid.

EFFECT: use of the inventions makes it possible to ensure the exclusion of trauma to the rectal wall and, as a result, a reduction in the risk of developing purulent-septic complications during a circular stapler.

3 cl, 4 dwg

Description

The invention relates to medicine, namely to surgery, and can be used to treat patients with intestinal stoma.

Intestinal stoma is an artificial fistula, surgically formed after removal of part of the intestine, brought to the anterior abdominal wall and designed to drain the contents of the intestine. The need for a stoma occurs when the bowel is unable to function. This can be caused by a birth defect, illness, or injury.

Ileostomy and colostomy lead to long-term or life-long disability. However, the rehabilitation of such patients is an extremely difficult task. Reconstructive and restorative interventions are the most technically complex, lengthy and difficult to tolerate by patients.

The most commonly used operation for the pathology of the left half of the colon is the Hartmann operation. As a result of this operation, the left sections of the colon are resected to the level of the upper ampullar section of the rectum, with the latter tightly sutured, and the adducting section of the colon is removed in the left half of the abdominal wall in the form of an end stoma.

To restore the continuity of the intestine, a single-row or double-row manual suture is most often used. After the Hartmann operation, the stump of the rectum is no more than 15 cm long from the anus and is located in the small pelvis, which greatly complicates the imposition of a manual suture during a reconstructive operation. In this connection, surgeons use circular staplers for mechanical suture, which allow to apply a sealed mechanical suture.

Staplers - devices for mechanical connection of organs and tissues during surgical operations. The earliest information about devices that make it possible to mechanize the process of applying surgical sutures dates back to the end of the 19th - beginning of the 20th century. The first stapler was proposed by M. Jeannel in 1904. Subsequently, Hultl (H. Hultl, 1908) created an apparatus that stitched tissues with nickel silver brackets, and Gan (F. Hahn, 1911) - an apparatus that stitched tissues chain of silk stitches. In Russia, N. Stakhovsky in 1907 described a method and special tools for stitching tissues with U-shaped metal brackets proposed by the French. surgeon Michel (P. Michel), and emphasized the promise of this method. In the 1920-1930s. with the help of significantly improved devices, favorable results in abdominal surgery have been demonstrated. In the late 1940s - early 1950s. in the USSR, various models of surgical staplers were created, analogues of which subsequently spread throughout the world. In the 1970-1980s. new staplers for gastrointestinal surgery were created. So, one of the developments of Professor N.N. Kanshin together with engineer V.A. Apparatus for applying circular compression anastomoses AKA-2 and AKA-4, which differed in that they did not crush the tissues along the fistula line, but only ensured their tight contact, became Lipatov. In the 1990s N.N. Kanshin and V.A. Lipatov created more advanced devices of the ASK series, which were produced in 2 versions: with a straight and curved body (for applying esophageal and rectal anastomoses). Currently, disposable circular staplers manufactured by Medtronic (Covidien-Tyco (USA), Johnson@Johnson (Ethicon (USA)) are widely used.

Known, for example, is a circular stapling apparatus for applying an intestinal-food anastomosis (patent RU 183782, application No. 2018100140, publication date 02.10.2018, bull. No. 28, IPC class A61B 17/11).

Known circular stapling apparatus for applying enteroesophageal anastomosis contains a tubular housing, which houses the drive connected to the movable cylindrical knife and staple head, as well as a thrust head with holes for bending brackets. In addition, the stapler contains a guide tube with a cable installed inside the housing with the possibility of movement, while the cable is located inside the guide tube, and the thrust head contains a pointed guide rod connected by a tip to the cable, the cable having a diameter equal to from 1/3 to 1/2 of the largest diameter of the sharpening of the rod, is made for insertion into the inside of the guide tube and is equipped with a locking mark on the drive side to indicate the connection of the bracket and thrust head when reducing tissues.

Similar designs of staplers are known from patent sources, such as, for example, US 2006201993.

The disadvantage of the known stapling devices is significant difficulty in passing through the stump of the rectum associated with:

1. Narrowing of the lumen of the rectum with a long-existing stoma as a result of the absence of passage of feces and not a rare development of diversion colitis.

2. Features of the anatomy of the rectum, the presence of transverse folds of Houston.

3. Design feature of the circular stapler. At the end of the device there is a head, which is a cylinder, which makes it difficult to pass the device through the intestine, and can cause trauma to the intestine.

Known introductor of a circular stitching tool with a multi-lumen tube (patent RU 2557693, application No. 2012125269, publication date on the territory of Russia 27.07.2015, class IPC A61B 17/115).

The known introducer includes a tube that defines a first lumen having a closed end and an open end. The size of the first lumen allows at least the distal end portion of the stapling head of the stapling instrument to be placed within the closed end. The hollow tube may have a weakened area which, under the action of a releasing force, breaks and allows the hollow tube to be removed from the stapling tool. As a result, the surgical instrument can be easily inserted through the patient's anus into the lower colon or other areas in the patient's body.

The disadvantage of the known introductor is that devices such as a cap are used, which is put on the stapling head. But this device is not universal, the devices have different diameters and you need to have these caps of different diameters. Thus, it is not always convenient to use in a hospital setting.

The technical result of the proposed device is to exclude traumatization of the rectal wall and, as a result, to reduce the risk of purulent-septic complications during the circular stapler.

The terms "proximal" and "distal" in this application are defined in relation to the doctor operating the handle of a surgical instrument. The term "proximal" refers to the part closest to the doctor, and the term "distal" refers to the part farthest from the doctor.

The essence of the claimed device for conducting a circular stapler through the intestine (hereinafter referred to as the Device) is shown in Fig. 1 and FIG. 2, fig. 3, fig. 4, where in FIG. 1 schematically shows the device according to the first independent claim, FIG. 2 and FIG. 3 shows a device according to the second independent claim, namely, a general view of the device in operation (with a swollen distal end according to the second independent claim), FIG. 4 device according to the third independent claim (diagram).

A device for conducting a circular stapler through the intestine (first independent item), including a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element.

The difference is that the conductive element is made of an elastic material, the distal end of which is made of two layers, the layers of which form a container, the surface layer of which is made thinner than the inner layer, the conductive element has two input ports, one central port is fixed on the rod, the second port made already central with the possibility of pumping liquid between the layers of the conductive element and connected to the outer layer of the distal end. The two layers of the distal end of the conductive element form a container into which the liquid is pumped.

In FIG. 1 the handle of the stapler is shown 1, the shaft protruding from the handle is shown 2, the distal end of the conductive element is shown 3, the central port of the conductive element is shown 4, the second fluid injection port is shown 5.

As an elastic material, such materials as latex, silicone, latex coated with silicone, elastic polymeric materials physiologically harmless to humans, polymeric materials with various antibacterial coatings can be used.

The diameter of the central port of the conductive element 4 is made less than the diameter of the rod 2 protruding from the handle of the stapler. The central port can be made in the form of a sleeve integrally connected to the device. The sleeve can be made of dense elastic material. For example, from rubber, flexible and dense plastic. The conductive element can be made of an elastic material and, for stable fixation, is connected to the rod 2 by pulling on the central port 4 for a snug fit to the rod. Port 5 is loaded with liquid, such as saline. Port 5 is connected to the outer surface of the distal element and is a channel for pumping fluid between the outer surface of the distal element and its inner surface. Under the control of ultrasound, the device is carried out, port 5 allows you to increase or decrease the diameter of the distal end of the conductive element 3.

The distal element 3 is made of two layers, forming a container for pumping liquid. At the same time, the upper layer is made more elastic from a thinner material in order to provide an easy increase in diameter. In addition, due to the fact that the outer surface of the distal element is made of a thinner material, it is softer and, when the device is passed through the intestine, creates more comfortable conditions for the device to pass, eliminating intestinal trauma. The ratio of the thickness of the upper and lower layers is 1:2, the main feature is that the upper layer must be made soft, elastic. Therefore, the claimed technical result is thus achieved. The design features of the invention according to claim 1 completely eliminate the traumatization of the rectal wall and, as a result, reduce the risk of purulent-septic complications during the circular stapler.

The elastic surface of the device and the ability to adjust the diameter of the distal end of the device allows exclude traumatization of the walls of the rectum during the stapler. If necessary, the liquid is removed, the distal end is reduced in volume.

A device for conducting a circular stapler through the intestine according to the second independent claim, including a handle, a rod protruding from the handle, and a staple head, a conductive element.

The difference is that the conductive element is made as a modification of a two-way Foley catheter, in which a through cut 7 mm long is made at a distance of 1 cm from the balloon and where the stem of the stapler is inserted.

The device according to the second independent claim is shown in FIG. 2 and FIG. 3. The cylinder is shown 6, the through section (in working condition on the stem) is shown 7, the stem of the apparatus is shown 8.

This task is achieved by using a conductive element, which is installed on the stem of the stapler. As a device, as one of the options for how the conductive element can be made, a sterile medical device is used - a latex 2-way Foley catheter. The catheter has two channels, one of which is through and opens at the end of the catheter, and the second channel serves to inflate the balloon. For installation on the rod of a circular stapler, a modification is required, which consists in opening the through channel with a longitudinal incision of 7 mm 1 cm below the inflated balloon. An incision of 7 mm is optimal, with standard dimensions of the rod 8 it provides a snug fit and eliminates uncontrolled removal during the operation. The length of the cut was confirmed experimentally. A cut of a larger size leads to slipping of the conductive element, a cut of less than 7 mm does not allow "pulling" the conductive element onto the stem. The rod of the apparatus is inserted into the hole formed and the balloon is inflated with saline to the required diameter above it, the rod of the apparatus and the balloon are lubricated with a lubricant. Next, the device with the installed conductor is inserted into the lumen of the rectum through the anus. The use of a conductor makes it possible to facilitate the passage of the apparatus by inflating the balloon, as well as to additionally inflate the periballoon space with air to increase the diameter of the intestine with the ability to control the pressure exerted on the balloon to prevent injury to the intestine. The presence of a non-return valve in the Foley catheter guarantees the exclusion of spontaneous "deflation" of the ejection of liquid from the balloon.

In addition, the use (in some versions) of the Foley catheter allows in a hospital setting, if necessary, to quickly manufacture the device.

A device for conducting a circular stapler through the intestine (third independent item), including a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element.

The difference is that the conductive element is made of an elastic material, the distal end of the conductive element is made of a two-layer container, the surface layer of which is made thinner than the inner layer, the proximal end of the conductive element is made in the form of a sleeve connected to the distal end, the sleeve has a channel for pumping fluid between the layers of the capacitance of the conductive element, which is connected to the port for pumping fluid.

The device according to the third independent claim is shown in FIG. 4. The handle of the stapler is shown 1, the rod protruding from the handle is shown 2, the distal end of the conductive element is shown 3, the container is shown 9, the sleeve is shown 10, the fluid injection port is shown 11. The device according to the third independent claim as a variant of the device according to the first independent claim. It differs by the presence of a sleeve with an internal channel and the fact that the port for pumping fluid is connected to the sleeve, namely, to the channel that runs inside the sleeve. The device is made in a more compact and convenient in a hospital version. The presence of an internal channel allows (in some cases) to use the device in an already slightly inflated form. In addition, the device in this embodiment is more reliable in operation.

The sleeve can be made of dense elastic material. For example, from rubber, flexible and dense plastic. The channel in the sleeve can be made in the form of an internal rod, in the form of a channel in the "body" of the sleeve, or other possible options for the passage for the liquid in this case. The most reliable in this case is the embodiment of the channel in the form of an internal rod, which eliminates the possibility of pinching the channel during the injection of the solution, and therefore makes it easy to pass the device through the intestine. The channel in Fig. 4 is not shown.

The conductive element according to the first, second and third claims is elastic and it can adapt to the "relief" of the intestine itself, which eliminates trauma.

Thus, the proposed device makes it possible to facilitate the passage of a circular stapler through the rectal stump and reduce the risk of damage to the intestinal wall and the development of purulent-septic complications.

Example

Patient K, 55 years old, was admitted to the hospital with complaints of terminal colostomy. From the anamnesis it is known that 1 year ago the patient underwent the Hartmann operation for perforation of the diverticulum of the sigmoid colon.

On objective examination: there is a terminal colostomy in the left half of the abdomen. According to irrigoscopy and colonoscopy, the rectal stump is 15 cm with a narrowing of the lumen in the upper ampullar region to 25 mm. No diverticula were found in the adducting colon.

Dianosis: Terminal colostomy in the outcome of treatment of complicated course of diverticular disease of the sigmoid colon.

After carrying out the necessary additional examinations, the patient was transported to the operating room. Laparotomy was performed under endotracheal anesthesia. In the pelvis, the stump of the rectum was isolated and prepared for anastomosis. A colostomy was removed from the abdominal wall, and the abdominal wall part was resected. In the leading end of the descending section of the colon, the head of the circular stapler is installed, around which a purse-string suture is applied. After the preparation of the rectum, a circular stapler with an installed conductor device was inserted into the lumen and carried out to the stump. Next, the balloon is deflated, the rod of the apparatus is retracted, and the device is removed from the lumen of the rectum. The lumen of the rectal stump is opened, a pouch is placed on the extended rod of the apparatus. The head, installed in the leading section of the colon, is combined with the rod. The ends of the apparatus are brought together and a circular hardware suture is applied. The device has been removed. Checking the anastomosis for tightness. Hemostasis control. Layered suturing. Aseptic bandage.

The postoperative period proceeded without complications. The patient after 12 hours began to drink, activated, food was allowed on the 2nd day, gases passed on the 3rd day, stool took place. On the 9th day, the patient was discharged for outpatient treatment. The wound healed by first intention.

Thus, 15 operations were performed in the clinical hospital in patients with colostomy. No complications were observed in all patients.

Claims (3)

1. A device for conducting a circular stapler through the intestine, including a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element, characterized in that the conductive element is made of an elastic material, the distal end of the conductive element is made of two layers, the layers of which form container, the surface layer of which is made thinner than the inner layer, the conductive element has two input ports, one central port is fixed on the rod, the second port is made already central with the possibility of pumping liquid between the layers of the conductive element. 2. A device for conducting a circular stapler through the intestine, including a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element, characterized in that the conductive element is a modification of a two-way Foley catheter, in which a through incision 7 mm long for inserting the stem of the stapler. 3. A device for conducting a circular stapler through the intestine, including a stapler handle, a rod protruding from the handle, and a stapler head, a conductive element, characterized in that the conductive element is made of an elastic material, the distal end of the conductive element is made of a two-layer container, the surface layer which is made thinner than the inner layer, the proximal end of the conductive element is made in the form of a sleeve connected to the distal end, the sleeve has a channel for pumping liquid between the layers of the container of the conductive element, the channel is connected to a port for pumping liquid.

Images