RU2224554C1 - Device for obturation and treatment of intestinal fistula - Google Patents

Abstract

FIELD: medical engineering. SUBSTANCE: device has obturation member and draining tubes. The obturation member is produced from transparent material and has two openings and clamps at the top and circular balloon and container having sorbent agent in the base part. The container is arranged along internal balloon perimeter. Draining tubes has air cuffs, air ducts with sealing plugs and restricting washers. EFFECT: enhanced effectiveness in sealing fistula duct; active chyme selection and reinfusion. 2 cl, 1 dwg

Description

 The invention relates to medicine, in particular to abdominal surgery, and is intended for obstruction and treatment of external intestinal fistulas.

 The number of patients with external intestinal fistulas in surgical hospitals is high and mortality in this group reaches 62% and higher, and mortality in surgical treatment of intestinal fistulas is 3-30% [1, 2]. External fistulas bring with them pathophysiological disorders that capture, to varying degrees, all systems and organs. The leading links in these disorders are loss of protein, electrolytes, enzymes in the form of biological fluids, and dermatitis that develops around the external opening postpones surgical treatment. Prevention and relief of these phenomena plays an important role in the treatment of this pathology.

 In a patent information study, it was found that for the treatment of external fistulas, devices are used that close or close to this defect in the gut and devices for treatment when the defect in the gut cannot be closed tightly. Obturators are most often inserted into the lumen of the fistula (lumen of a hollow organ), obturation is most often due to additional sealing elements. With unformed fistulas, and especially with fistulas opening into the purulent cavity, the use of obturators is limited and not even possible. In such cases, devices are used in the construction of which there are elements for active or passive collection of the intestine. In other cases, in addition to active collection, active or passive administration of the collected discharge through tubes, catheters, and so on is provided.

 More than 100 devices and obturators have been proposed for both formed and unformed intestinal fistulas [1, 2].

 In domestic practice, the obturators Doronin, Mitrokhin, Kolchenogov, Küster, Vitsyn and many others were widely used. The appearance of new materials marked "approved for use in medicine", the combination of materials and structures made from them with new tubular elements equipped with inflatable balloons, sorption compositions, allows you to create new designs for obstruction and treatment of intestinal fistulas.

 Known obturator (A.S. 784685, M. class A 61 M 27/00, BI 1980, 35. Authors V. M. Udod and EG Karsten. Obturator for temporary closure of the fistula of the gastrointestinal tract - [3 ]), designed to close the fistula in order to prevent the formation of intestinal spur 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 fixing 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.

 A device is known (A.S. 1255144 A1, A 61 M 27/00, BI 1986, 33. Author V. A. Frank. A device for obstruction of the external intestinal fistula - [4]) for the treatment of large intestinal fistulas through the use of thick rubber plates with glued foam discs interconnected 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.

 A device is known (A. p. 98103011 C1, A 61 M 31/00, 1999. Author S. N. Hunafin. A device for temporary shunting of the external small intestinal fistula - [5]), designed to obstruct the external small intestinal fistula and restore the passage of intestinal contents in the early postoperative period. The device consists of a fixative intestinal bandage and a system for pumping intestinal contents. An inflatable cuff is attached around the fistula, which adheres to the skin and prevents leakage of contents. A container and a pumping system are attached to this area, with the help of which a discharge is supplied to the discharge fistula.

 However, this device is applicable to formed small intestinal fistulas, with liquid intestinal contents. When using it, it is assumed that there is an outlet and an inlet in the intestine that are distant from each other. Difficulties arise when observing the abdomen and when treating a postoperative wound, while the device is cumbersome to use and to sterilize.

 A device is known (A. p. 97107550 C1, A 61 M 25/06, 1999. Author AI Lobakov. Device for obturation of unformed intestinal fistulas - [6]), designed to close the fistulous passage, consisting of an elastic rod with an external and internal drives. The inner disk is adjacent to the defect of the intestinal wall from the outside, and the external disk closes the skin outer hole.

 However, a loose disc obstruction of the fistula opening leads to leakage of the liquid contents and its accumulation in the surrounding tissues, since the outer hole on the skin is covered by the outer disc of the obturator. Excessive pressure of the obturator on the intestinal wall can cause a pressure sore. This device is limited applicable for unformed fistulas.

 Known obturator proposed by F. I. Larionov [7], designed to close the intestinal fistula from the outside. It consists of a piece of glove rubber worn on the end of an elastic tube filled with air. It is superimposed on the outer opening of the fistula from above. It is easy to execute and process, but it is not firmly fixed in the fistula, tightness is not achieved, and leakage of chyme and maceration of the skin are not excluded.

 The well-known obturator, B. A. Vitsyna and V. V. Atamanova [8], designed for unformed fistulas. It consists of an obturator plate, which is inserted into the intestinal lumen, a fixing device, and a frame that holds the structure, relying on healthy areas of the skin. Oil-balsamic napkins are placed on the wound surface.

 However, the tension force of the spring element and the pressure of the plate on the intestinal wall is not constant and can range from weak to excessive, causing overstretching and necrosis of the intestinal wall, and the wire structure has insufficient stability over the wound, there is no restriction for the resulting chyme.

 The closest analogue, taken as a prototype, is a device (A. p. 98103531 A, A 61 M 27/00, 1999. Authors N. A. Nikitin, D. A. Karaulov. Device for the treatment of unformed fistulas - [9] ), which includes an element for obturation of a cavity or wound with a fistula of polymer material and its drainage using a drainage tube embedded in a foam swab and connected to a vacuum suction.

 A device for the treatment of unformed fistulas consists of a three-layer swab (the outer layer is an insulating film, the middle is foam rubber, the inner is a biologically active composition), flask-like expanded drainage, two tubes of smaller diameter, ending in the expansion of the drainage. A swab is placed on the wound with a fistula, so that the base of the drainage approaches the zone of the fistula. Vacuum is created by suction in the drainage, and air jets are supplied through two tubes opposite to the discharge vector, which eliminates the suction of tissues in the fistula to the main drainage and the inner surface of the tampon.

 The prototype has disadvantages. Due to the fact that the plugging part is made of foam rubber, visual inspection of the fistula area and surrounding tissues is difficult when leaving. When using this device, leakage of the chyme from the fistula and drainage area under the plugging part and further onto the surrounding tissue is not excluded, since it does not have tightness. The plastic film covering the swab creates a cavity under which maceration occurs. The device does not provide for the complete collection of chyme and a system for introducing it; it does not imply sorption of the wound discharge and leaking chyme. Hard drainage is not securely fixed in a sufficiently soft and small volume plugging part.

 To increase the efficiency of the process of sealing the fistulous passage, the active collection and active reinfusion of the chyme into the outlet knee of the fistula, as well as the stimulation of the wound process around the fistula and the collection of leaking chyme, a device is proposed that consists of a transparent sphere with an air cylinder and a mesh container with a sorbent at the base, and with two holes and brackets for fastening on top, and of two double-lumen drainage tubes with cuffs at one end.

 The device is illustrated in the drawing, which shows a General view of the device, which includes a sphere 1 made of a dense transparent material, at the base of it around the entire perimeter is hermetically connected in the form of an elastic circle a balloon 2 of soft material filled with air. A container 3 of mesh material filled with a sorbent, for example zeolite, is placed along the inner perimeter of the balloon; the diameter of the material cells does not exceed the diameter of the sorbent granules (0.1-0.3 cm). At the top of the sphere there are two holes 4 with a diameter corresponding to the drainage tubes, two brackets 5 for fastening, located opposite each other. Two tubes 6, 7 with air ducts 8, made of a transparent soft-elastic material and bent at an obtuse angle, are introduced into the cavity of the sphere through holes 4 on the top. On the active part of the tubes there are inflatable cuffs 8 with ducts 9 connected to them with plugs 10, through which the cuffs inflate and fit snugly against the inner wall of the fistula. On the tubes 6, 7, on the opposite side of the cuffs, there are restriction washers 11, which exclude the migration of the tubes. The device is fixed to the body using brackets 5 on top of a sphere 1 with a rubber band.

 The device operates as follows. Before the introduction of the endotracheal tubes 6, 7, air is released from the cuffs 8, the tubes are introduced into the fistula 12 and outlet 13, into the cuffs 8 air is introduced through the duct 9, which is held by the plugs 10, a container 3 with the sorbent is placed around the fistula around the perimeter, which it can be impregnated with an antiseptic, put a sphere 1 on top so that the container is held inside the sphere, tubes 6, 7 are brought into the holes 4 on the top, on which restrictive washers 11 are put on the outside of the sphere to prevent tube migration. The device is fastened with a bandage for the brackets 5. To the tube 6, from the lead knee 12, connect the Rezon drain for aspiration of intestinal contents, and to the tube 7 from the discharge loop 13 - a system for introducing a mixture of collected intestinal contents, sorbent and nutrients.

 The proposed device for obstruction and treatment of intestinal fistula has the following distinctive features.

 The sphere rests on the skin through an inflatable balloon and seals the entire space around the fistula, reduces leakage of chyme outside the zone of the fistula, and protects from pressure sores.

 The transparency of the sphere allows you to visually monitor both the course of the wound process and the effectiveness of sealing, timely remove the device, replace the container with fresh, timely enter the intestinal contents released outward into the outlet knee.

 The used sorbent of natural origin (shivyrtuin) has a number of medicinal properties described in the literature (sorption, deodorizing, anti-inflammatory and others). Besides the fact that it absorbs intestinal contents poured out of the fistula, it has a biologically active effect on the skin, protects it from corroding, and promotes the regeneration and epithelization of desquamated epithelium.

 An inflatable cuff located at the end of the tube inserted into the intestine prevents a significant amount of chyme from leaking onto the skin.

On transstomy enteral probes installed during surgery, tubes with cuffs are strung along the conductors and a device is installed, which will ensure the integrity of the fistula zone with respect to the laparotomy wound and prevent infectious complications,
The collection of chyme is carried out not only through a tube installed in the leading knee of the fistula, but also the outflowing part of the sorbent in the container.

 The proposed device provides through a probe transstomy enteral nutrition, includes reinfusion of the collected intestinal discharge into a discharge loop.

 The device provides for the use of enterosorption by a sorbent that has absorbed its own (sick) intestinal chyme and, thus, acted as a whole on homeostasis. The sorbent, passing through the digestive tract, performs enterosorption, sorption of toxins, bacteria, ion exchange occurs, fragments of intestinal secretion, potassium, sodium ions and other mineral substances present in it leave the sorbent, and the pores are filled with substances harmful to the body.

 The elastic fastening of the device to the torso allows the patient to visit public places, which improves the social content of the patient.

 The tightness achieved by the inflatable balloon at the base of the sphere and its apex through which the endotracheal tubes pass, as well as the sorbent, which has a powerful deodorizing property, eliminates unpleasant odors that accompany all intestinal fistulas, which further improves the patient’s social content.

 The device allows it to be sterilized and used on other patients.

 A device for obstruction and treatment of intestinal fistula was used in 12 patients.

 Clinical example 1. Patient Afanasyev AB, 27 years old, medical history 7171, was admitted to the hospital 10/30/89, where he was transferred from a linear hospital with a functioning small bowel unformed fistula. From the anamnesis it is known that 2 weeks ago he received a gunshot wound (a charge with soap) in the stomach. Operated in a linear hospital. On the 7th day of the postoperative period, eventation occurred, and a small intestinal fistula opened. Upon reaching a transportable state, the ambulance delivered to the clinic. Upon admission, the patient’s condition is severe, dehydrated, in blood tests leukocytosis, stab shift, anemia (Hb - 92-94 g / l), minor proteinuria in the urine, single leukocyturia, erythrocyturia. On the abdominal wall in the area of the navel, a wound 10 × 12 cm in size, in the wound of the loop of the small intestine, in one of the loops there is a defect, the leading and abducting knee, intestinal discharge are visible. The patient was prescribed anti-inflammatory therapy in the scope of treatment of peritonitis, the claimed device was installed on the fistula wound: drainage tubes were introduced into the lead and discharge knees, a container with sorbent filled with sodium hypochloride was placed around them, a sphere was fixed, and fixed with a bandage. The chyme was collected using the Rezon system, and an intestinal discharge and a chyme-filled sorbent for enterosorption were introduced into the discharge loop. During the first 8 days, the container was changed 5-7 times a day, the wound was gradually covered with granulations, epithelization started, the sorbent in the container was laid dry to collect spilled chyme and stimulate granulation. By 32 days of the patient's stay in the hospital, the fistula was completely isolated from the surrounding tissues by a connective tissue scar with an epidermal coating. In the intervals between the removal of the device, UV was carried out according to the scheme on the abdominal wall. Body weight increased by 4 kg, peritonitis was stopped. On the 36th day of hospital stay, fistula is closed nonperitoneally with a 2-row suture. General condition did not suffer. Once every 2-3 days there was an independent chair. However, on the 9th day, small bowel contents appeared in the wound. The sutures were removed, the wound was diluted, the fistula recurred. Reapplied device. A drainage tube was installed to divert intestinal contents into the fistula, a container with a sorbent filled with sodium hypochlorite was placed around, and a sphere and bandage were fixed on top. Over the course of 18 days, it was possible to stop the inflammation of the wound of the abdominal wall, 22 days after the relapse of the fistula, repeated surgical intraperitoneal closure of it. Laparotomic wound over a longer extent healed by primary intention. Discharged in satisfactory condition. Examined after 6 months: episodic abdominal pain, refused the proposed surgery of intestinal infection.

 Clinical example 2. Patient Pribytkov VG, 43 years old, medical history 5716, delivered from a linear hospital with functioning small and large intestinal fistula in the right iliac region and fistula in the area of the iliac wing on the right. From the anamnesis, it is known that on July 15, 1995 he received a gunshot and bullet wound to the abdomen with damage to the ileocecal angle and ileum wing, was operated on in a linear hospital. However, in connection with the limited peritonitis on July 27, 1995, a small intestinal fistula was formed. Upon receipt, the condition is serious. Laparotomic wound 2/3 healed by secondary intention, in the right iliac region an unformed small- and colonic fistula, x-ray osteomyelitis of the iliac wing, feces periodically leaves through the wound in the lumbar region. Fistulography revealed that there is a small and large intestinal fistula that opens through wounds in the lumbar and iliac region through the iliac wing. From 2.09.95 to 13.10.95, the inventive device was used, the small intestinal discharge was discharged through the drainage tube, the intestinal discharge and the used sorbent were introduced from the container, which was placed around the tubes on the wound, everything was fixed with a transparent sphere, the container was changed as it got wet. It was possible to close the small intestinal fistula, the fecal discharge through the fistula in the lumbar region ceased, and a large intestinal fistula was formed. 10/13/95 operation: extraperitoneal closure of the fistula, resection of the iliac wing, flow-suction drainage. However, 2.11.95 recurrence of colonic fistula, suppuration of the postoperative wound in its anterior part. The device was again used, but the intestine was only intubated with a single tube for enteral nutrition and enterosorption. It was possible to quickly clean the wound, stop the inflammation, and on 13.12.95 it was decided to close the fistula intraperitoneally. Performed relaparotomy, end-to-side ileotransverse anastomosis, nasointestinal intubation with an enteral probe (patent 2121376). Performed seamless intestinoplication (patent 2177741). The fistula is not closed, used as an option for drainage of the intestine, was periodically drained by the device (patent 2143285). In early January 1996, the fistula closed. Discharged home with recovery. Examined after a year: I felt healthy.

 Clinical example 3. Patient Ogareva ND, 38 years old, medical history 7831, transferred from a linear hospital on 11/23/95 with an unformed double-barreled intestinal fistula. From the anamnesis it is known that at the age of 19 years was operated on for an ectopic pregnancy. 11.20.95 operated on in a nodal hospital (Karymskaya station) for acute intestinal obstruction, resection of the ileum was performed, a 2-stem colostomy was formed. However, a retraction occurred and the fistula became unformed. Upon receipt, the condition is serious. Additionally, it was found that he suffers from chronic pyelonephritis with chronic renal failure, and abuses alcohol. For 1.5 months, the patient was preparing for surgery, the inventive device was used, the sorbent in the container was saturated with sodium hypochlorite, the intestinal discharge was removed from the wound on the abdominal wall using drainage tubes and a sorbent. I managed to stop the inflammation of the abdominal wall, stabilize the general condition, improve kidney function. At the last removal of the device, it was found that the distal part of the endotracheal tube with the cuff came off and went into the intestinal lumen. 01/12/96 with excision of the old scar, a laparotomy, viscerolysis was performed, a part of the ileum with fistulas was resected, ileotransverse anastomosis was formed, nasointestinal intubation of the small intestine with an enteral probe (patent 2121376) was performed, 41 had been inserted into the patient, and 211 patients had been transferred. In the postoperative period, enterosorption was used (patent 2122868). The detached tube fragment came out naturally on day 5. In the postoperative period, acute renal failure, oliguria developed. Intensive therapy was used, it was possible to improve the condition. Discharged 23 days after surgery. At the follow-up examination appeared after 2 years, the condition is considered satisfactory.

 Clinical example 4. Patient Bykov II, 59 years old, medical history 2840, operated on in December 1995 for prostate adenoma, failure of the bladder suture. 1.06.96 performed relaparotomy, suturing wounds of the bladder. 06/06/96 due to postoperative peritonitis, relaparotomy, resection of the ileum loop, 2-barrel ileostomy, intestinal intubation. In the postoperative period, suppuration of the laparotomy wound and the wound around the fistula - phlegmon of the abdominal wall. Laparotomy wound was treated using sorption-application techniques. The inventive device was used on the wound around the fistula: the bringing and removing knees were intubated with drainage tubes, a container with a sorbent filled with sodium hypochlorite was placed on the wound, a transparent sphere fixed the tubes and the container, allowing for active control of the fistula zone. The chyme collected from the discharge tube was introduced with a sorbent, performing enterosorption. After cleansing the wound, the sorbent was laid dry. General and local treatment was continued for 24 days. The laparotomic wound ended in healing with the formation of multiple ligature fistulas. In connection with the increase in cachexia, renal failure, it was decided to operate on the background of purulent ligature fistulas and the bladder. A relaparotomy was performed with excision of the postoperative scar, viscerolysis, during the operation in interloop spaces, many microabscesses were opened between the mesentery sheets. The ileum with fistulas was resected, an ileotransverse anastomosis was formed, nasointestinal intubation with an enteral probe (patent 2121376), seamless intestinal replication (patent 2177741). In the postoperative period, active detoxification therapy, enterosorption, the use of efferent therapy. Discharged 31 days after surgery in satisfactory condition.

 Clinical example 5. Patient Petrenko BV, 64 years old, medical history 3343, delivered from a linear hospital with an unformed small bowel fistula, phlegmon of the abdominal wall. From the anamnesis it is known that in 1995 he underwent appendectomy, in 1996 - myocardial infarction, in 1998 - repeated myocardial infarction. 04/18/2000 adhesive intestinal obstruction, bowel resection, end-to-end anastomosis. Due to the failure of the anastomosis and postoperative peritonitis, on April 21, 2000, the medical aviation brigade performed relaparotomy, bowel resection, 2-barreled enterostomy, debridement, abdominal drainage, and was transported to a road hospital by a sanitary carriage. In the right iliac region, there is a 2-barrel intestinal fistula with severe maceration of the skin, wounds of the abdominal cavity around the fistula. For 24 days using the inventive device according to the same methodology as in example 4, preoperative preparation was performed. 08/15/2000 with excision of the postoperative scar performed laparotomy, viscerolysis, nasointestinal intubation (patent 2121376), intestinoplication (patent 2177741), enteroenteroanastomosis "side to side" between the leading and outlet loops. Due to the severity of the condition and concomitant pathology, it was decided to refuse to eliminate fistulas. The postoperative period was difficult. Clinically, the anastomosis began to function only on the 23-25th day, there was a stool, decreased discharge from the fistula. The inventive device was used in the postoperative period according to the same technique. Discharged, re-admitted after 2 months. All this time I used improvised obturators and obturators of our design. 11.16.2000 performed extraperitoneal closure of the fistula. In the postoperative period, partial failure of the anastomosis, a tubular fistula was formed, which was able to close with a filling composition and tamponade.

 Thus, out of 12 cases of successful use of the device for obstruction and treatment of intestinal fistula, in only one case there was a complication - separation and migration of a tube fragment through the intestine with its natural release without obstructive obstruction. It was found that the terms of preoperative preparation using the inventive device for surgical closure of the fistula decreased from 48 ± 7 days to 21 ± 4 days.

Sources of information
1. Vitsyn B.A., Blagitko E.M. Formed and unformed external intestinal fistulas. - Novosibirsk: Science. -1983. - 142s.

 2. Makarenko TP, Bogdanov A.V. Fistulas of the gastrointestinal tract. - M.: Medicine. - 1986. - 144s.

 3. A.S. USSR 764685, M. cl. A 61 M 27/00. Obturator for temporary closure of the fistula of the gastrointestinal tract / V.M. Udod and E.G. Karsten. According to the application 2723729 / 28-13. Declared 12/22/78. Publ. 09/23/80. BI 35.

 4. A. p. USSR 1255144 A1, cl. A 61 M 27/00. Device for obstruction of the external intestinal fistula / V.A. Frank. According to the application 3798847 / 28-14. Declared July 18, 84. Publ. 07/07/86. BI 33.

 5. A. p. RF 98103011 C1, cl. A 61 M 31/00. A device for temporary shunting of external small intestinal fistulas / S.N. Khunafin, A.V. Vlasov, P.V. Popov and others. Declared 02/12/98. Publ. 10/08/99.

 6. A.S. RF 97107550 C1, cl. A 61 M 25/06. A device for obturation of unformed intestinal fistulas / A.I. Lobakov, A.V. Vatazin, A.M. Savov. Declared 05/07/97. Publ. 20/01/99.

 7. Vitsyn B.A., Blagitko E.M. Formed and unformed external intestinal fistulas. - Novosibirsk: Science. - 1983 .-- S. 71-72.

 8. Vitsyn B.A., Blagitko E.M. Formed and unformed external intestinal fistulas. - Novosibirsk: Science. - 1983 .-- S. 74-75.

 9. A. p. RF 98103531, class A 61 M 27/00. A device for the treatment of unformed fistulas / N. A. Nikitin, D. A. Karaulov. Declared 02.24.98. Publ. 10/10/99.

Claims (2)

1. A device for obturation and treatment of intestinal fistula, containing an element for obstruction and drainage tubes, characterized in that the element for obstruction is made of a transparent material with two holes and brackets on top and with an air balloon in the form of a circle and a container with a sorbent in the base, the container is made with the possibility of placement along the inner perimeter of the container, and the drainage tubes are equipped with air cuffs, air vents with plugs and restrictive washers. 2. The device according to claim 1, characterized in that the container is made of mesh material, the diameter of the cells of which does not exceed the diameter of the sorbent granules.