RU91279U1 - DEVICE FOR HEMOSTASIS WITH HEMORRHAGE FROM THE GALLERY BUBBLE BED - Google Patents

Abstract

1. A device for hemostasis for bleeding from the bed of the gallbladder, containing an inflatable balloon, a hollow flexible body having drainage holes at one end and two tubes at the other end, characterized in that the hollow flexible body is made in the form of a through tube, the inflatable balloon has the form cylinder with spherical bases and consists of the outer and inner elastic layers forming two air chambers, each connected to one of the tubes, and at least half of the surface of the outer elastic layer has perforation holes, and drainage holes arranged in a spiral starting from the outer layer of the elastic inflatable balloon. ! 2. The device according to claim 1, characterized in that the diameter of the inflatable balloon in the idle state does not exceed the internal diameter of the laparoport, and the surface of the balloon is made rough, with small protrusions.

Description

The utility model relates to medical equipment, namely to emergency surgery and will find application in hemostatic procedures for laparoscopic surgery, in particular for laparoscopic surgery for acute cholecystitis, including in conditions of inflammation and coagulopathy.

The incidence of cholelithiasis and the number of complications associated with it are steadily increasing, their share today reaches 40% among diseases of the gastrointestinal tract (Ermolov A.S., Annals of Surgery 1998; 3; 13-24). In Europe, including Russia, more than 20 million people suffer from cholelithiasis, every year it is diagnosed in 1 million people (Lapkin K.V., Endoscopic surgery 1998; 2; 3-9).

In hepatobiliary surgery, one of the most important tasks requiring new approaches to solving is reliable and non-traumatic hemostasis and bilistasis, on which the favorable course of the postoperative period largely depends. Many methods of stopping bleeding during liver operations have been described, but the problem remains unsolved (Borisov A.E., Levin V.A., Zemlyanoy V.P. et al. St. Petersburg, 2001. Nistor RF, Chiari FM, Maier N., Hehl K., Scull Base Surgery 1997; 7 (1): 23-30). Providing reliable hemostasis during laparoscopic surgery can be challenging. That is why bleeding is one of the main causes of conversion for laparoscopic cholecystectomy (Galinger Yu.I., Karpenkova V.I. Annals of surgical hepatology 2000; 5 (2): 103-4).

The greatest number of complications occurs, as a rule, during operations for destructive cholecystitis. One of these complications is hemorrhage from the liver parenchyma and gallbladder bed (GI) of 15% (A.F. Vasiliev, E.V. Bratchikov, V.N. Akimov, A.P. Bereznitsky; Endoscopic surgery, 1; 2004 ; 35-36). The conversion percentage associated with bleeding from the bed of the gallbladder and liver parenchyma is 5.1% (O.V. Galimov, E.I. Senderovich, Yu.N. Gololobov, V.O. Khanov, M.V. Timerbulatov; Endoscopic surgery, 1 ; 2004; 44).

Known methods for stopping bleeding by coagulation with an ultrasonic electrode, however, this is an expensive method that adversely affects the regeneration of liver tissue.

A device for hemostasis is known (USSR author's certificate No. 1088728, 1984), containing a catheter with an inflatable cone-shaped balloon at the working end with lead and outlet tubes located on the other end of the catheter with the base toward the working end of the catheter, while the thickness of the base of the cone-shaped balloon is less than the thickness its side wall, and the leading and outlet tubes of the cone-shaped balloon are connected to the local hypothermia apparatus. The disadvantage of this device is that it cannot be applicable to parenchymal organs, as it is intended for hemostasis of the urethral vessels.

A probe device for stopping bleeding from a duodenal ulcer is known (RF patent No. 2218948, 12/20/2003), which is made in the form of a double-lumen tube with a hemostatic balloon and a device for introducing a probe into the duodenal bulb. The tube has two holes. One is located in front of the balloon, the other is 5.0-8.0 cm behind the balloon. The balloon is located 3.0-3.5 cm from the beginning of the tube. The length of the tube is 130-150 cm. The device for introducing the probe is made in the form of a loop of synthetic thread fixed to a rubber tube in front of the balloon. As a result of the use of the probe, the results of treatment of the heavy contingent of patients are improved by reducing the number of patients requiring surgical treatment in an emergency.

A device is known for the prevention, stopping and control of bleeding during laparoscopic operations (RF patent No. 2243728, 01/10/2005). The device comprises a thread connected to the web, a web that plugs the wound and is removed by pulling the thread, connected to the inner surface of the film by a collagen gel. The film covers the area of the canvas and has an opening equal to the double-lumen drainage channel, which is attached to the outer surface of the film and in which one channel is longer than the other. The distal end of the short channel is connected to the hole in the film, and the distal end of the long channel is out of its limits, the proximal ends can be connected to a vacuum receiver. The thread from the web is drawn from the inner surface into a short channel and is fixed to the outer wall of the short channel. The disadvantage of this device is the inability to use for bleeding from the bed of the gallbladder.

A device is known for performing hemostasis in parenchymal bleeding (RF patent No. 64504, 07/10/2007), consisting of an electrode, characterized in that the electrode is connected through an adapter to the cannula of a long needle, which is located inside the movable current-insulating tube, and at the ends of the needle free of insulation. marks are plotted. The disadvantage of this device is the inability to use for bleeding from the bed of the gallbladder.

A device for hemostasis during operations on parenchymal organs is known (RF patent No. 64895, 07/27/2007), containing a plate of biologically intact material with through holes, characterized in that decalcified, crushed and then pressed chicken bones are used as the material: plate length by 1 / 4 exceeds the size of the surgical wound, and the width is 1/5 of its length, through holes are removed from each other by a distance of the screed. The disadvantage of this device is the difficulty of use for bleeding from the bed of the gallbladder.

In general, it should be noted that most of the currently developed devices for hemostasis cause destructive changes in the parenchymal organs, and complete restoration of tissue structures is not observed even several months after the operation.

The prototype of the utility model is a device for hemostasis of parenchymal organs according to the utility model patent No. 30072 (2003.06.20), which contains a hollow flexible body with an inflatable balloon at the rounded end and outlet tubes at the other end, the hollow flexible body inside is divided by a through impenetrable partition into two parts in communication with the outlet tubes, while on the rounded end of the hollow flexible body there are several holes that communicate with one of the outlet tubes, and on the guide of the hollow flexible core There are several openings in the pus that communicate with another outlet tube, and there are recesses for fixing the inflatable balloon on both sides of the area where these holes are located on the circumference of the hollow flexible body. The diameter of the inflatable balloon in the idle state does not exceed the diameter of the hollow flexible body, and cuffs of smaller diameter are made at both ends of the balloon, the width of which is equal to the width of the recesses on the circumference of the hollow flexible body, in addition, the surface of the balloon is roughened with small protrusions. However, this device is not applicable for hemostasis in case of bleeding from the gallbladder bed due to the inability to fix it in the projection of the gallbladder bed and the mismatch between the device diameters and the diameter of the laparoport during video laparoscopic operations to stop bleeding from the gallbladder bed.

The objective of the utility model is to reduce blood loss and ensure reliable hemostasis during bleeding from the gallbladder bed with the possibility of drainage and drip irrigation.

The problem is solved in that the device for hemostasis during bleeding from the bed of the gallbladder contains an inflatable balloon having the shape of a cylinder with spherical bases and consisting of the outer and inner elastic layers forming two air chambers, each connected to one of the tubes, and at least half of the surface the outer elastic layer has perforations, a hollow flexible body made in the form of a through tube having drainage holes at one end and two tubes at the other end, and the drainage holes are arranged in a spiral starting from the outer elastic layer of the inflatable balloon. The diameter of the inflatable balloon inoperative does not exceed the internal diameter of the laparoport, and the surface of the balloon is roughened, with small protrusions.

A new and positive technical result achieved using the inventive device for hemostasis for bleeding from the bed of the gallbladder is that it provides high hemostasis, characterized by hemostatic activity, significantly reduces the time taken to achieve complete hemostasis, counting from the moment the hemostatic benefits to a complete stop of bleeding from the wound surface, reduces the amount of blood loss.

The drawing shows a device for hemostasis for bleeding from the bed of the gallbladder, a General view in section.

The inventive device for hemostasis for bleeding from the bed of the gallbladder allows you to simultaneously perform compression, application of a wound surface with a hemostatic preparation and control the effectiveness of the procedure.

The device for hemostasis for bleeding from the bed of the stomach consists of a hollow flexible body in the form of an elastic tube (1) 600 mm long, having two ends A and B. The diameter of the elastic tube (1) is 8 mm (which does not exceed the inner diameter of the laparoport), inside There are two outlet tubes (2), (3) with a diameter of 2 mm each, which are marked at the end with different colors to facilitate the work of the doctor. A two-layer elastic inflatable balloon (4) made of thin medical rubber is hermetically fixed to the tube (1). Between the two layers of the balloon and between the inner layer and the tube (1), two air chambers are formed. Each chamber is connected to tubes (2), (3). The cylinder has the shape of a cylinder with a length of 120 mm with spherical bases; in an unfilled state, the outer diameter of the cylinder is 10 mm (which corresponds to the inner diameter of the laparoport). The diameter of the cylinder formed by the inner layer in the idle state is 8 mm. The walls of the cylinder (4) in an empty state are adjacent to the walls of the tube (1). The tube (3) through the hole (5) communicates with the chamber of the inner layer (6) of the container (4), into which air or physiological saline solution is injected through it, and through the tube (2) and through the hole (7) the device communicates with the camera the outer layer (8) of the cylinder (4). The surface of the outer layer (8) is made rough for more tight fixation to the bed of the gallbladder. Also, the outer layer (8) of the container (4) has through holes (9) in the form of small perforations on one side on ½ of its surface. At a distance of 250 mm to 350 mm from the end of "B" a few millimeters from the outer surface of the cylinder (4) in the tube (1) made drainage holes (10) with a diameter of 4 mm located in a spiral. Hemostasis is carried out by injecting air or physiological solution of room temperature through the tube (3) through the hole (5) into the chamber of the inner layer (6) of the cylinder (4), and then feeding the hemostatic gel through the tube (2) and the hole (7) into the chamber between the outer layer (8) and the inner layer (6) of the container (4). Hemostatic gel with the help of perforations (9) enters the outer surface of the balloon (4), which is adjacent to the bed of the gallbladder and thus, will enter the gallbladder bed performing hemostasis.

A device for hemostasis works as follows. After removal of the gallbladder by laparoscopy and the development of uncontrolled bleeding from the bed of the gallbladder through the laparoport in the projection of the bottom of the gallbladder, this device is led to the bed with the end of the tube “1” (1) so that the balloon (4) is located in the bed of the gallbladder with that outer surface layer (8), which has perforations (9). Then the end “B” of the tube (1) is brought to the front abdominal wall and fixed on the skin with interrupted sutures. The end “A” of the tube (1) is also fixed on the skin with interrupted sutures. This allows you to reliably fix the hemostatic balloon (4) along the longitudinal axis of the gallbladder bed. Under the control of the endovideo camera, the inner layer (6) of the balloon (4) is inflated by introducing air or physiological solution of room temperature into the tube (3), which through the hole (5) enters the chamber formed by the inner layer (6) until it is completely filled with air or liquid and achieving hemostasis. The open end of the tube (3) is pinched to prevent leakage of the contents of the chamber. Thus, plugging with an inflatable balloon (4) of the gallbladder bed is achieved in order to compress the source of bleeding.

Then, a hemostatic gel is injected into the tube (2), which enters through the hole (7) into the chamber lumen formed by the outer layer (8) and the inner layer (6) of the balloon (4). The gel from this chamber through the holes (9) enters the bed of the gallbladder uniformly filling the entire bed. The end of the tube (3) is also pinched. Thus, complete hemostasis of the wound surface of the pancreas is achieved. Compression on the bed continues for 12-24 hours, after which the ends of the tubes (2 and (3) are released, the balloon (4) is deflated. Post-operative hemostasis is controlled by evaluating the discharge that comes from the abdominal cavity through the drainage holes (10) at the end "B" of the tube (1). Depending on the discharge (serous, serous-hemorrhagic or blood), the dynamics of the process is judged. After 48 hours, the device is removed. The tube (1) at the end of "B" located outside the abdominal cavity is tightened and cut so way to remove that part of the tube that is on walked outside the abdominal cavity and through the hole in the projection of the bottom of the gallbladder beyond the end of "A" is removed from the abdominal cavity.

Examples of clinical application of the device.

Example 1

Patient D-ko A.V., 71 years old, was admitted to the surgical department No. 1 of the State Health Institution of the Regional Hospital No. 2 on 08/11/09 as an ambulance complaining of pain in the right hypochondrium, epigastrium, nausea, bitterness in the mouth, and temperature rise to 38.0C. He considers himself sick for 10 hours, when after the error in the diet (eating fatty and fried foods), the above complaints appeared. An objective examination of the tongue is dry, the abdomen is moderately swollen, painful on palpation in the epigastrium and right hypochondrium. Symptoms of Kera, Murphy, Ortner positive. Symptoms of peritoneal irritation are negative. On ultrasound of the abdominal organs, the enlarged gallbladder is 103 × 42 mm, in the neck, the calculus is 21 mm. In OAK, leukocytosis is noted up to 17.9, hemoglobin - 145, erythrocytes - 4.64. Coagulogram: MHO - 0.92, fibrinogen - 2.2, APTT - 35.2, TV - 14.0, RFMC - 4.5. The patient refused the proposed operation. Against the background of conservative therapy, the patient's condition with insignificant positive dynamics, however, an attack repeated on 13.08.09 and the patient was operated on in the amount of laparoscopic cholecystectomy. At the operation, a sharply enlarged, dense gall bladder is 110 × 50 mm, the wall is thickened, purplish-cyanotic. Given the inflammatory changes and bleeding from the bed of the GP, which is not amenable to coagulation, it was decided to use the developed device for hemostasis. The duration of the operation was 68 minutes. In the p / o period, there were no signs of bleeding, the balloon was deflated after 24 hours, the drainage was removed on the 2nd day. At OAK 08/14/09: Er. - 3.69, hemoglobin - 117. The patient was discharged on the 7th day in a satisfactory condition.

Example 2

Patient A-va T.M., 38 years old, was admitted to the surgical department No. 1 of the State Health Institution of the Regional Hospital No. 2 08/18/09 in a planned manner with complaints of paroxysmal pain in the right hypochondrium, epigastrium, nausea, vomiting, temperature rise to 37.5 ° C, yellowing skin integument. He considers himself sick during the day when, after an error in the diet (eating fatty and fried foods), the above complaints appeared. A history of chronic hepatitis of unknown origin. An objective examination of the tongue is dry, the abdomen is moderately swollen, painful on palpation in the epigastrium and right hypochondrium. Symptoms of Kera, Murphy, Ortner positive. Symptoms of peritoneal irritation are negative. On ultrasound of the abdominal organs, the enlarged gallbladder is 80 × 38 mm, the calculus in the lumen is up to 14 mm, the wall is thickened to 6 mm. In OAK, white blood cells - 8.1, hemoglobin - 139, erythrocytes - 4.86. Coagulogram: MHO - 0.87, fibrinogen - 4.3, APTT - 38.2, TV - 16.7, RFMC - neg. In biochemistry, bilirubinemia is noted - 48.2, due to the indirect fraction 29.2, ACT - 0.52, ALT - 1.2. Against the background of conservative therapy, the patient's condition with a slight positive dynamics. 08/20/09 the patient was operated on in the amount of laparoscopic cholecystectomy. At the operation, a sharply enlarged, dense gall bladder is 105 × 40 mm, the wall is thickened, purplish-cyanotic. A puncture of the bladder was performed in which up to 150 ml of thick bile with pus was obtained. When bile was isolated, taking into account inflammatory changes, there was increased bleeding from the bed that was not amenable to coagulation, and therefore the inventive device for hemostasis was used. The duration of the operation was 76 minutes. In the p / o period, there were no signs of bleeding, the balloon was deflated after 24 hours, the drainage was removed on the 2nd day. At OAK 08.24.09: Er. - 4.02, hemoglobin - 117. The patient was discharged on the 7th day in a satisfactory condition.

Example 3

Patient A-yan K.K., 43 years old, was transferred from the gastroenterological department to the surgical department No. 1 of the State Health Institution of the Regional Hospital No. 2 08/20/09 where he was treated for the hepatitis C-associated virus of cirrhosis of the liver with complaints of pain in the right hypochondrium , epigastrium, nausea, vomiting with an admixture of bile, temperature rise to 38.0C. An objective examination of the tongue is dry, the abdomen is moderately swollen, painful on palpation in the epigastrium and right hypochondrium. Symptoms of Kera, Murphy, Ortner positive. Symptoms of peritoneal irritation are negative. On ultrasound of the abdominal organs, the enlarged gall bladder is 145 × 48 mm, the wall is flattened to 7-8 mm, the contents are inhomogeneous, and the calculus is 12 mm in the neck. In OAK, leukocytosis up to 15.9 is noted, hemoglobin - 144, erythrocytes - 4.18. Coagulogram: MHO - 0.83, fibrinogen - 4.0, APTT - 39.4, TV - 17.4, RFMC - 4.5. Hepatitis C is positive, core = 2.93, OPCRIT = 0.238 .. Against the background of conservative therapy, the patient's condition was not dynamic, 08/21/09 the patient was operated on in the amount of laparoscopic cholecystectomy. At the operation, a sharply enlarged, dense gallbladder 150 × 60 mm is noted, the wall is thickened to 8 mm, purple-cyanotic in color with a touch of fibrin. A puncture of the bladder was performed in which up to 190 ml of thick bile with pus was obtained. When allocating the gallbladder, taking into account inflammatory changes, there was an increased bleeding from the bed that was not amenable to coagulation, and therefore the inventive device for hemostasis was used. The duration of the operation was 89 minutes. In the p / o period, there were no signs of bleeding, the balloon was deflated after 24 hours, the drainage was removed on the 2nd day. At OAK 08.24.09: Er. - 3.08, hemoglobin - 129. The patient was discharged on the 8th day in a satisfactory condition.

The inventive device for hemostasis was used in 17 patients with their informed consent and approval of the local ethics committee. In all 17 patients, the postoperative period was uneventful.

The practical significance of the inventive device for hemostasis in case of bleeding from the bed of the gallbladder is that the results of surgical treatment of patients have been significantly improved. An algorithm for phased surgical treatment has been developed, which allows to reduce the duration of an emergency operation and techniques for its implementation.

The device developed by us ensures high hemostasis efficiency, which is characterized in hemostatic activity, significantly reduces the time taken to achieve complete hemostasis, counting from the moment the hemostatic benefit begins to completely stop bleeding from the wound surface, it allows to reduce the amount of blood loss. It can be used for any localization of the gallbladder, in the presence of liver pathology that caused coagulopathy (hepatitis, cirrhosis), as well as with controlled drug hypocoagulation.

- The advantages of the claimed device for hemostasis compared with the prototype are that:

- it is easy to use and can reduce blood loss during laparoscopic interventions;

- allows you to reduce the number of complications;

- allows you to reduce the% conversion (i.e., transitions from laparoscopic surgery to open).

The inventive device is tested in a clinic of hepatobiliary surgery and can be recommended for use in surgical hospitals.

Claims (2)

1. A device for hemostasis for bleeding from the bed of the gallbladder, containing an inflatable balloon, a hollow flexible body having drainage holes at one end and two tubes at the other end, characterized in that the hollow flexible body is made in the form of a through tube, the inflatable balloon has the form cylinder with spherical bases and consists of the outer and inner elastic layers forming two air chambers, each connected to one of the tubes, and at least half of the surface of the outer elastic layer has perforation holes, and drainage holes arranged in a spiral starting from the outer layer of the elastic inflatable balloon. 2. The device according to claim 1, characterized in that the diameter of the inflatable balloon in the idle state does not exceed the inner diameter of the laparoport, and the surface of the balloon is made rough, with small protrusions.