RU2143285C1 - Device for obturation of external fistula of gastroenteric tract - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: device serves for temporary or constant closure of gastroenteric tract external fistulas. Fistulas of any depth and peptic activity of hollow organ content are obturated. Device has supporting tubes, fixing members, clamping nuts, and blow-up bottle communicating with internal tube space through channel and slide valve. Rigid fixing member is secured immovably, to external part of outer tube. Blow-up bottle is provided in intraenteric part. Counterlateral wall of bottle is fixed to internal tube end face by means of adjusting member. This provides for easy passage of enteric content and for toroidal feature of bottle itself. Internal space of tube is provided with bottle blowing-up regulator made as slide valve, which ensures bottle blowing up and going down. Device prevents overlapping of intestine space by blow-up bottle of obturating facility and allows pressure level regulation in it. EFFECT: enhanced efficiency of obturation. 2 dwg

Description

 The invention relates to medicine, in particular to abdominal surgery, and is intended for temporary closure of the external fistulas of the gastrointestinal tract. The invention is used for obturation of formed fistulas of the stomach, small and large intestines, having one stroke. Fistulas can be spontaneous or surgically imposed, temporary or permanent, tubular or lip-shaped. The use of the device is contraindicated for self-healing tubular fistulas.

 In a patent information study, it was found that the proposed obturators are intended mainly for unformed fistulas and have either one internal or external sealing element. In this case, rods with nuts and bearings, threads, inflatable cuffs and more are used as constrictors. All these clamping devices are based on rigid structures. Most obturators in their design carry elements that preserve the lumen of the intestine either by preventing the formation of a spur, or by reducing its height, which maintains the lumen of the intestine and maintains the natural continuity of the digestive tract, which favorably affects digestion. At the same time, all these devices are not very suitable for gastrostomy or end entero- or colostomy. Few devices have been proposed combining both of these advantages: to keep the intestinal lumen free and to reliably seal the hole from the external environment [1, 2].

 Known obturator / A.C. N 764685, authors V.M. Hoopoe and E.G. Karsten. Obturator for temporary closure of the fistula of the gastrointestinal tract. M Cl. 3 A 61 M 27/00, B.I. 1980, N35 / [3], designed to close fistula to prevent the formation of intestinal spurs and reduce the height of the spur. The obturator contains two plates with different degrees of elasticity, a thread is attached to the more elastic of them to fix it. The obturator covers the opening of the fistula only from the side of the intestine, while the outer side is covered with a bandage, to which the retaining thread is attached.

 However, the known stiffness of the material from which the obturator plates are made does not ensure its complete tightness in the opening of the fistula. This fact and the absence of an external sealing plate allows the contents of the intestine to leak onto the skin and macerate it. The thread that fixes the obturator can increase the area of the fistula with its cutting action and even come off, as a result of which it migrates through the intestine, which is accompanied by obstruction.

 The obturator / A.C. is also known. 1055520, authors V.F. Sharapov, E.P. Krivoshchekov and S.G. Grigoriev. Obturator for temporary closure of the intestinal fistula. A 61 M 27/00, B.I. 1983, N43 / [4], comprising a support, a hollow sleeve mounted on the support, and an elastic plate placed on the sleeve. The obturator can be used for fistulas of various shapes and localizations, for which a removable upper elastic plate is provided. The analogue prevents the formation of spurs, but its intracavitary part is stiff and causes pressure sores of both the intestinal wall and the skin. It does not have a mechanism for blowing and emptying the balloon, it does not provide complete tightness, and leakage of the contents of the intestine at the junction causes maceration.

 A device is known / A.C.1/1255144, A1, author V.A. Frank. A device for obstruction of the external intestinal fistula. A 61 M 27/00, B.I. 1986, N33 / [5] for the treatment of large intestinal external fistulas by reducing trauma to the wall of the fistulous opening and the wound of the abdominal wall during its movement with thick rubber plates with glued foam discs joined together by a hinge attached to a single support with a fixing washer.

 However, the obturator has drawbacks - it cannot seal the fistulous opening for a long time, since the foam covering the gap between the intestinal wall and the washer is quickly impregnated with intestinal contents and loses its sealing function.

 Devices are already being used in which a metered adherence of the obturator to the wall of the intestine is provided / A.C. 1747089 A 1, authors S.G. Grigoriev, N.I. Zyuzgin, O. B. Borsky, E.P. Krivoshchekov and A.M. Savin. A device for obstruction of the intestinal fistula. A 61 M 27/00, B.I. 1992, N26 / [6] due to ferromagnetic elements. An elastic material is taken as an obturator, in the lumen of which elements are placed. A tube is attached to it, on which a magnet is mounted, attracting ferromagnetic elements located in the lumen of the obturator by the force of electromagnetic interaction.

 However, the device has disadvantages. There is no external sealing device in it, a constant magnet trauma injures the skin and intestines. The obturator, introduced into the lumen of the intestine through the fistula, has a small area of contact, therefore, does not guarantee from leakage of intestinal contents onto the skin.

 The device is known / A.C. 1771756, A 1, authors N.I. Zyuzgin, E.P. Krivoshchekov and A.M.Savin. A device for obstruction of the intestinal fistula. A 61 M 27/00, B.I. 1992, N40 / [7] for obturation of an unformed intestinal fistula, in which an elastic obturator inserted into the intestinal lumen closes the defect in it with a rod rod that slides in the sleeve and rests on a support from the outside. Adjustment is made by a nut rotating on the sleeve and compressing the support on the skin.

 Its intestinal part, made of metal, except for its elastic obturator, does not adapt well to changing intra-intestinal pressure. The stiffness of the connections of the elements of the device causes a pressure sore both in the wall of the intestine and on the skin. An elastic obturator blocks the lumen of the fistula only from the inside, which does not provide tightness.

 Known pneumatic obturator for controlled colostomy (A. S. 1099958, authors B. D. Savchuk, V. I. Ulyanov, F. Schmidt. Pneumatic locking device for colostomy. "Surgery", 1986, No. 4, S. 121- 123) [8]. The obturator is a mushroom-shaped body made of silicone rubber, equipped with a check valve and an elastic diaphragm. The device is equipped with a booster bulb with two check valves.

 However, the pneumoobturator is devoid of the regulatory mechanism for changing the toroidity of the inflatable balloon and is intended only for the formed single-barrel colostomy. It is not used for gastrostomy, enterostomy.

 The closest analogue, taken as a prototype, is the device / A.C. 1456165, A 1, authors A.A. Burka, V.N. Korotky and A.K. Guly. Device for obstruction of the external intestinal fistula. Cl. A 61 M 27/00, B.I. 1989, N5 / [9]. The device is made in the form of a tube, a rubber balloon with longitudinally located reinforcing threads in its wall is glued to the end that plunges into the intestine.

 The prototype consists of an outer tube, a porous gasket, a movable retainer - a pressure washer and a friction ring. The fixed retainer-cylinder is glued to a tube having a channel in its wall, which is brought out and communicates with the tube by means of a control canister. The cylinder has reinforcing threads located in the longitudinal direction. They give the balloon the shape of a regular toroid even with a significant increase in atmospheric pressure.

 The prototype has drawbacks: the size of the toroid when blowing pushes the opposite wall so that it closes the lumen during bowel spasm. After inflating, there is no way for the doctor or patient to reduce the pressure in the balloon as necessary and, thus, regulate the intra-intestinal obstruction, and, therefore, the possibility of the contents of the intestinal cavity passing past the obturator into the lumen of the fistula.

 An unresolved problem is the lack of the ability to control the shape of the inflatable balloon required for different types of fistulas. If in the small intestine the height of the balloon should be minimal, then in the large intestine and in the stomach, in particular, its height and the area of contact can be maximum. In addition, the lack of a spool does not allow you to adjust the pressure level in the cylinder, affecting the force of contact with the intestinal wall and / or fistula channel, which affects the tightness of the fistulous course.

 To improve the efficiency of the process of obstruction of the fistulous passage in any segment of the digestive tract, to prevent the intestinal lumen from being blocked by an inflatable balloon of the obstructing device with the possibility of regulating the pressure level in it, and to create optimal conditions for patient rehabilitation, a device is proposed.

 The essence of the device for obstructing the fistula of the gastrointestinal tract is that the tube consists of an inner and an outer part located coaxially with the possibility of mutual movement by means of threaded threads, the inner tube on the intestinal part contains a slot on which the carrier washer is freely placed, and the outer part is made with a groove, the rigid retainer is fixedly fixed on the outer part of the outer tube, the intestinal part of the outer tube is equipped with an inflatable balloon, reinforced around the perimeter and overlapping the pipe end k peak cylinder fixed to a supporting washer regulating member, the lumen of the inner tube is provided with a regulator podduvaniya cylinder made of spool type. The device prevents overlap of the lumen of the intestine, regulates fixation from the side of the cavity of the hollow organ and enhances the integrity of the fistulous canal. The device is shown in FIG. 1-2. Figure 1 in a longitudinal section shows a General view of the section frontally from the center. In FIG. 2 is a General view in section in the frontal plane in the working position.

 The device for obstructing the external fistula of the gastrointestinal tract has an inner tube 1, a retainer 2, an inflatable balloon 3, a bandage 4, a variable-length adjusting element 5, restriction washers 6 and 7, nuts: an external adjusting 8 and an inner 9, an external tube 10. The outer end of the inner tube has a groove 11 for regulating the mutual movement of the tubes, for example, with a screwdriver. A cap 12 is screwed onto the end. The intestinal part of the inner tube ends with a slot 13 with a bearing washer 14 freely mounted on it, to which a variable-length adjusting element 5 is attached. The bearing washer is secured with a collar 15 and an antifriction washer 16, the rubber collar of the inflatable balloon 17 is fixed between the fixed retainer 2 and washer 6.

 The device has three parts. The outer part to the skin A, the middle part - channel B, located in the fistula, and the inner part B, located in the lumen of the intestine or stomach (figure 2). There is a thread on the outer tube, through which the nut 8 presses the retainer 2 through the washer 6 and the shoulder 17 of the inflatable balloon. This design allows the device to disassemble, rinse, sterilize, replace the balloon, change the length of the regulating element 5, i.e., simulate the toroidity of the balloon. The presence of the brace allows you to adjust the distance between the retainer 2 and the cylinder 3 in relation to the pre-measured thickness of the abdominal wall and intestine. On the end part of the inner tube located in the cylinder 3, there is a regulating element with a variable length of 5. The surgeon changes the length of the regulating element before the operation with respect to the patient’s age, to the diameter of the intestine / thin, thick, stomach /, to the contents of the intestine / thin chyme of lean feces of sigma. It is the regulating element with a variable length that ensures, when inflated, the expansion of the side walls and the increase in the contact area of the balloon inside its lumen and of the retainer 2 on the abdominal wall. This dramatically improves the controllability of tightness.

 The inner tube 1 is made of an indifferent metal or polymer resistant to gastric and intestinal juices. Inside the tube there is a cylinder blow regulator, made as a spool 18 (Fig. 2) with a spring-loaded, for example, rubber tube, which, when pressed, provides a communication between the cylinder cavity and the external environment, and when the balloon is inflated, it seals the channel inside the tube 1 and ensures constant size and shape balloon. If the bowel spasm is completely emptied and the patient has obstructive phenomena for passage of intestinal contents, the spool is pressed by the doctor or patient, air is released, the balloon drops, which increases the gap between it and the intestinal wall, the lumen is restored.

 The latch 2 is made of an easily sterilizable polymer, for example, fluoroplast - 4, tetrafluoroethylene, which are not wetted by wound and have permission for internal use. With a nut 8 and a screwdriver inserted in the groove 11, it is possible to adjust the intraluminal part covered with a retaining material. The bandage material provides support between the retainer and the outer tube 10, sealing the lumen of the cylinder. The purpose of the bandage is also to fix the edges of the inflatable balloon and to replace the balloon itself when it ruptures, with loss of elasticity, etc. It is the bandage fixation method that allows the surgeon to perform these technological actions at the time of dressing. We found that welding or gluing reduces the applicability of the obstructive device in surgery. The presence of thread on the tube 1 along its end part with the simultaneous change of the regulating element with a variable length allows you to make the container rather flat or give it a pear-shaped shape with increasing height by lengthening the regulating element.

 Cylinder 3 is made of well-known medical rubbers as cuffs on endotracheal tubes. However, a sobutylene polymer is added to the latex, which prevents its corrosion in the conditions of gastric and intestinal juices and, at the same time, increases the mechanical properties.

 The preoperative assembly of the obturation device is as follows. After sterilization according to OST 42-21-2-85, a tube 10 is mounted on the tube 1, which is fixed with a washer 7 and a nut 9. With the balloon 3 deployed, an element with a variable length of 5 is adjusted, increasing or shortening it. Then the cylinder, turning inside out, is applied to the outer tube 10, where its edges are fixed with a bandage. The turns of the bandage are subsequently twisted depending on the precisely calibrated fistulous canal. A balloon is blown into the tube lumen 1 through a spool. This checks the tightness of the applied bandage, the shape of the toroidality of the balloon and its compliance with the lumen of the intestine. Experimentally, the balloon is inflated to triple the pressure, thereby checking the mechanical resistance to rupture, and immersion in water confirms the safety of the air in the cylinder.

 Treatment of all types of fistulas of the hollow organs of the abdominal cavity is carried out using the device as follows.

 Before the device is introduced into the fistula, air is released from the cylinder through the spool and introduced into the lumen of the fistula until it fully enters the hollow organ. The balloon 3 is inflated, after which the accuracy of the support of the latch 2 appears. It is fixed with a nut 8 through the washer 6 and the rubber flange of the inflatable balloon 17. A foam pad is placed under the latch 2 on the skin. The balloon is inflated by the pump through the spool, they are convinced of the tightness of the obstruction of the fistula. A cap is screwed onto the outer end of the inner tube.

 When using the obturator for the first time, it is possible to control the supporting part from the side of the intestinal lumen by inflating the balloon. The passage in the gut is regulated in the same way. By increasing the area of the balloon toroid, a large area (8–9 cm in diameter) is achieved, which is especially important when obstructing organs with a wide clearance, for example, gastrostomy. The dimensions of the retaining part make the device suitable for any thickness of the abdominal wall with optimal pressure from the skin to the inner wall of the organ, including the fistulous canal.

 We found that this ensures adhesion and flat adhesion between the parietal and visceral peritoneal sheets. Suture connection of the hollow organ to the peritoneum is excluded. Any ligatures in the fistula area are extremely undesirable, since they are the cause of the branching of the fistula. To blow the balloon through the spool, the air is supplied with any medical device, for example, with a Janet syringe, a pear, a pump from the endoscope illuminator. It is possible that the cap from the valve of the motor-camera is screwed onto the outer end of the tube 1, thereby preventing accidental release of air.

 The high obstructive ability of the device allows you to completely seal the wound and control the fixation area from the intestinal lumen, which is not achieved by other devices. In cases of bowel spasm, deterioration of the patient’s condition outside the operation, it is first achieved by drowning the spool that completely relieves intracavitary pressure until the fistula is completely removed from the lumen, which other devices do not provide. The spool is recessed with any blunt object, for example, the end of a ballpoint pen or clamp, which is taught to all staff and the patient himself. If there is no discharge in the fistula, then the balloon in a collapsed state can be for a long time and can blow out when the discharge appears. Although incidental, in our opinion, family care for the condition of the fistula is socially significant, which is not provided by other medical obturators.

 A device for obstruction of the external intestinal fistula has been clinically tested in 26 patients. Clinical trials have established the advantage of its folding and modeling as applied to the length of the fistula, the lumen of the hollow organ, and the depth of the fistulous canal.

 Compared with the prototype, which has reinforcement in the form of threads imposed on the outside of the cylinder, the proposed variable-length regulating element more accurately and reliably adjusts its volume in relation to the lumen of the hollow organ. Replacing the reinforcing threads with a ligature stop located in the cavity of the container ensures its toroidity and wide area, which is quite essential for closing fistulas of various sizes in the lumen of different hollow organs. The adjustability of the retaining part between the retainer 2 and the toroid of the balloon 3 provides the individuality of hermetic standing, which is quite important for the large proteolytic enzymatic activity of the juices of the stomach, duodenum and jejunum. Significantly increased tightness. The wound canal itself / fistula cavity / does not undergo autotrophic effects / does not digest itself /. The very fact of increased tightness is subject to control. With connective tissue aging of the course, scarring and narrowing of the fistulous canal, adhesion of the parietal and visceral sheets of the peritoneum, complete isolation from the external environment of the cavity of the hollow organ is achieved. The spool system of blowing and bleeding air from a cylinder is freely carried out even using spools from automobile cameras, it is easily made by a surgeon in a hospital setting.

 Of the 26 clinical applications, the best results were obtained when closing the fistula of the stomach / gastrostomy /, in which it was the wide toroid of the balloon that provided sealing of the capillary gap between the visceral and parietal peritoneum of the abdominal wall in 12 cases.

 The presence of a retainer 2 guarantees against migration of the obturator into the intestinal lumen and, thus, prevents iatrogenic obstructive intestinal obstruction.

 Using the device in outpatient settings significantly increased the rehabilitation effect. The flow of gases from sigma, deterioration of clothing with small intestinal fistulas, elimination of discomfort with increased intestinal motility is prevented.

 This obturator is made in a small series of 8 pieces and applied to 26 patients. Clinical trials were conducted at the Department of General Surgery of the Chita State Medical Academy and at the Road Clinical Hospital st. Chita 2. Clinical trials have established that the obturator is installed atraumatically, as it has a rubber balloon inserted into the intestinal lumen in a collapsed state and an external pressure device covered with a foam pad. In all necessary cases, sealing of the fistula was achieved, which three times accelerated the process of preparing the skin for reconstructive surgery on the gastrointestinal tract.

 These design features of the obturator: maintaining the balloon in a swollen state with the help of a spool guarantees against depressurization, the thrust created by the swollen balloon presses the outer stop more tightly against the skin surface. If, according to the prototype, the balloon withstood 4-5 installations in the patient, then according to the claimed form, one obturator was enough for the entire two-month cycle of treating the patient and preparing him for reconstructive surgery.

 Thus, the claimed device with existing design features is easily installed in the fistula, reliably seals the lumen of the hollow organ, is equally applicable to gastric, small intestine and large intestine formed and unformed fistulas. Clinical trials have established that with formed gastro-and enterostomy patients use the proposed device for many months and even years, while doing work that is not associated with significant physical stress.

 Clinical example 1. Patient Cat Yu.I. 52 years old, and / b 1063, was admitted to the hospital on 04/04/1993 with a direct diagnosis of Chemical burn of the esophagus and stomach, stricture of the esophagus. It was established that on March 12, 1993 he drank vodka of an unknown bottling, felt sharp pain behind his sternum and abdomen. At the place of residence, the stomach was washed, anti-inflammatory and detoxification therapy was carried out. Dysphagia appeared, with an X-ray examination, esophageal stricture was diagnosed. Directed to the clinic. Upon receipt, a moderate condition, weight loss of 13%. Confirmed esophageal stricture. For gastric esophageal gastrosis, a gastrostomy was applied according to Kader, a circular thread was performed. A device for gastrostomy obstruction has been manufactured and installed. Bougienage and sealing of the fistula was carried out for two and a half years. In this case, the patient could perform light work, performed household duties, there was no maceration of the skin. In mid-1996, the gastrostomy was closed, the patient returned to normal life. It is regularly observed.

 Clinical example 2. Patient Ogneva NP, 39 years old, and / b 2316, was admitted to the clinic on September 13, 1996 with a double-barreled, small bowel unformed fistula for reconstructive surgery. From the anamnesis it was found that three months ago in a district hospital was operated on for adhesive intestinal obstruction with intestinal necrosis, peritonitis. Performed a laparotomy, resection of the ileum, a double-barreled ileostomy was formed, the abdominal cavity was sanitized, drained. In the postoperative period, suppuration of the suture and wounds around the stoma with partial necrosis of the intestine. The fistula became unformed, there was a wound around the fistula, the skin was macerated over a large area. Upon receipt, the condition is serious, body weight deficit of more than 15%. Anti-inflammatory, restorative, detoxification therapy, parenteral and enhanced enteral nutrition, and local drug treatment of the wound have begun. The lead loop was intubated with the probe and the discharge was carefully collected, followed by a batch introduction into the lead loop. The end of the outlet loop in the intervals between the introduction of the chyme was obstructed by the claimed device. The chair became regular, and body weight was increasing. After healing of the wound around the fistula, the inventive device was introduced into the leading end first at night, and later in the afternoon, continuing to collect the chyme in between and introduce it into the discharge loop. For 44 days it was possible to prepare the skin and the patient. Under anesthesia, a laparotomy, viscerolysis was performed, an end-to-side inter-intestinal anastomosis of the Maidl type was applied due to significant changes in the intestinal wall, and a huge number of adhesions. The single-barrel ileostomy was reformed, for the obturation of which the inventive device was used. After 33 days, an extraperitoneal closure of the small intestinal fistula was performed. The patient was discharged with recovery in satisfactory condition.

 Clinical example 3. Patient Formalyukova F.Kh., 63 years old, and / b 2351 was admitted to the clinic on September 19, 1996 with a single-barrel colostomy. A year and a half ago, the patient was operated on in the clinic for perforated fecal peritonitis. The cause of peritonitis is diverticulosis of the colon, perforation of the sigmoid colon diverticulum. Under anesthesia, a laparotomy, resection of the sigmoid colon (Hartmann's surgery) was performed, a single-barrel colostomy was formed, the abdominal cavity was sanitized, drained. The postoperative period was difficult. Discharged on the 38th day from the moment of receipt, learned to use the inventive device, managed to regain stool through the stoma up to 1-2 times a day, the gases were retained. Reconstructive surgery was postponed due to concomitant pathology: hypertension, diabetes mellitus, obesity. The inventive device has been successfully used for 1.5 years. Reconstructive surgery: lowering of the colon, colorectoanastomosis, unloading cecostomy was performed as planned on 02.10.1996. The postoperative period was uneventful, the inventive device was manufactured and installed. It was possible to achieve an independent chair in a natural way. Three months later, the extraperitoneal closure of the cecostomy was performed as planned. A device for obstruction of the intestinal fistula was successfully used in this patient at the terminal and "lateral" parietal colostomy, complete tightness was achieved.

Claims (1)

 A device for obstructing the external fistula of the gastrointestinal tract, containing a tube, an external fixator and an internal, made in the form of an inflatable balloon, a communication channel with a balloon, characterized in that the tube consists of an inner and an outer part located coaxially, with the possibility of mutual movement using a threaded thread, the inner tube on the intestinal part contains a slot, on which the carrier washer is freely placed, and the outer part is made with a groove, a rigid retainer is fixedly mounted on the outer outer tube, ishechnaya portion of the outer tube is provided with a inflatable balloon, reinforced perimeter and overlapping tube end, the balloon tip is fixed to the bearing washer regulating member, the lumen of the inner tube is provided with a regulator podduvaniya cylinder made of spool type.

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