Device for blocking and treatment of intestinal fistula

 

The invention relates to medicine, in particular to abdominal surgery, and is designed to seal and treat the external intestinal fistulas. The device contains an element of obturation and drainage tube. The element of obturation is made of a transparent material with two holes and brackets at the top and with an air bladder in the form of a circle and a container with a desiccant at the bottom. The container is made with the possibility of placing on the inner perimeter of the cylinder. Drainage tube provided with an air duct, the ducts with traffic and restrictive washers. The technical result - increasing the effectiveness of the sealing process fistulous course, active collection and active reinfuse chyme in elbow fistula, and stimulation of wound healing around the fistula and collect leaking chyme. 1 C.p. f-crystals, 1 Il.

The invention relates to medicine, in particular to abdominal surgery, and is designed to seal and treat the external intestinal fistulas.

The number of patients with external intestinal fistulas surgical hospitals and high mortality in this group is up to 62% and higher, and mortality in surgical treatment of intestinal fistula is 3-30% [1, 2]. and organs. Major parts of these disorders lead to loss of protein, electrolytes, enzymes in biological fluids, and paced around the external opening of dermatitis lays surgical treatment. Prevention and relief of these phenomena plays an important role in the treatment of this disease.

When patent information research has found that for the treatment of external fistula use device that is sealed or close to close the defect in the intestine and a device for the treatment, when the defect in the intestine tightly overlap is not possible. The obturators are often inserted into the lumen of the fistula lumen of a hollow organ), obturation is often at the expense of additional sealing elements. When immature fistula, and in particular, when the fistula opening in purulent cavity, the use of obturators limited or even not possible. In such cases, devices are used in the construction of which has elements for active or passive collection detachable intestine. In other cases, in addition to the active collection, provided by active or passive introduction of the collected discharge through the tubes, catheters, and so forth.

Proposed more than 100 devices and obturators for SF is Lucile obturators Doronina, Mitrokhin, Kolchanova, Kuster, Vicuna and many others. The emergence of new materials marked "approved for use in medicine, the combination of materials and are made of these structures with new tubular elements provided with inflatable balloons, sorption compositions, allows you to create new designs for obturation and treatment of intestinal fistula.

Known obturator (A. C. 784685, M. class. AND 61 M 27/00, BI 1980, 35. Authors C. M. hoopoe and E. G. Karsten. Obturator for the temporary closure of the fistula gastrointestinal tract [3]), designed to close the fistula to prevent the formation of intestinal spurs and reduce the height of the spurs. The obturator includes two plates with different degrees of elasticity for firmer of them attached the thread to secure it. Obturator covers the opening of the fistula only from the intestine, the outer side is covered with a bandage, which secures the retaining thread.

However, the known stiffness of the material of the plates of the obturator, do not provide complete air-tightness in the opening of the fistula. This fact and the absence of the outer sealing plate allows the contents of the intestine to leak into the skin and materiality her. The thread that secures the actors in the intestine, accompanied by obstruction.

A device (A. C. 1255144 A1, AND 61 M 27/00, B 1986, 33. Author C. A. Frank. Device for blocking external intestinal fistulas - [4]) for the treatment of external intestinal fistulas large size due to the use of plates of solid rubber with adhesive disks made of foam, all interconnected by a hinge attached to a single pole locking washer.

However, the obturator has drawbacks: it cannot long be insulated with fistulous opening, as the foam covering the gap between the wall of the intestine and washer, quickly absorbs intestinal contents and loses its sealing function.

A device (A. C. 98103011 C1, And 61 M 31/00, 1999. Author S. N. Hanafin. Device for temporary bypass of external intestinal fistulas - [5]) used for obturation of external intestinal fistulas and restore passage of intestinal contents in the early postoperative period. The device consists of a locking intestinal brace and system to pump intestinal contents. Around the leading of the fistula is attached an inflatable cuff which is attached to the skin and prevents leakage of the contents. This area is fixed capacitance and perekati is formed for small bowel fistula, liquid intestinal contents. When using it assumes that output and input openings in the gut, remote from each other. Difficult to monitor the abdomen and the processing of the surgical wound, the device is cumbersome to use and sterilization.

A device (A. C. 97107550 C1, And 61 M 25/06, 1999. Author A. I. Lobanov. Device for blocking immature intestinal fistula - [6]), designed to close fistulous course, consisting of an elastic rod with the outer and inner disks. The internal disk is adjacent to the defect of the intestinal wall from the outside, and an external disk closes the skin outer hole.

However, loose obturation of the disk openings of the fistula leads to the leakage of the liquid contents and its accumulation in the surrounding tissues, since the outer hole on the skin closed outer disk of the obturator. Excessive pressure of the obturator to the intestinal wall can cause bedsores. This device is limited to applicable when immature fistula.

Known obturator proposed by F. I. Larionov [7], designed to close the intestinal fistula outside. It consists of a fragment of a rubber glove, worn on the end of elastic labor is e, but not firmly fixed in the fistula, there is no integrity and is not excluded leakage chyme and maceration of the skin.

Known obturator, B. A. Vicina and centuries Atamanova [8], designed for immature fistulas. Consists of a plate-obturator, which is introduced into the intestinal lumen, the locking device and the frame that holds the design, based on healthy skin areas. On the wound stack oil-balsamic napkins.

However, the force of the tension spring element and the pressure plate on the intestinal wall is not constant and can vary from mild to excessive, causing hyperextension and necrosis of the bowel wall, and a wire structure has insufficient stability over the wound, there is a limit to the resulting chyme.

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

Device for the treatment of nesfa the morning - biologically active composition), colbourne extended drainage, two tubes of smaller diameter, ending in the extension of the drainage. On the wound with a fistula placed the tampon, so that the base of the drainage comes to the area of the fistula. The suction in the drain creates a vacuum, and the two tubes are served jet of air, oppositely directed to the direction of discharge, which eliminates the adhesion of the tissues in the area of the fistula to the main drainage and the inner surface of the tampon.

The prototype has drawbacks. Due to the fact that the plugging portion is made with foam, hampered visibility region of the fistula and surrounding tissues with care. When using this device is not precluded by the flow of chyme from the area of the fistula and drainage under the plugging portion and further to the surrounding tissue, as it has no leaks. Plastic film covering the pad creates a cavity, which is maceration. The device does not provide a complete collection of chyme and system for introducing it, does not imply the sorption of wound and leaking chyme. Hard drainage is not securely fixed in a rather soft and small volume of plugging part.

For povides knee fistula, and stimulation of wound healing around the fistula and to collect leaking chyme, the proposed device consists of a transparent sphere with an air balloon and mesh container with the sorbent at the base, and with two holes and brackets for mounting on the top, and two dubrovitsy drainage tubes with cuffs at one end.

The device illustrated in the drawing, which shows a General view of a device that includes field 1, is made of thick transparent material, at the base it around the perimeter tightly connected in the form of elastic range of the cylinder 2 is made of soft material, filled with air. On the inner perimeter of the container, place the container 3 from mesh material, filled with an adsorbent, such as zeolite, the diameter of the cells of the material does not exceed the diameter of sorbent granules (0.1 to 0.3 cm). At the top of the sphere has two holes 4 diameter corresponding drainage tubes, two brackets 5 for fastening, and are located against each other. The two pipes 6, 7 duct 8, is made of transparent soft-elastic material and bent at an obtuse angle, injected into the cavity of the sphere through the holes 4 at the top. During the active part of the tubes are inflatable cuff 8 connected to Lena fistula. The tubes 6, 7, on the opposite side from the cuffs are restrictive washer 11, precluding migration of the tubes. The device is fixed to the body with hooks 5 on the top of the sphere 1 rubber band.

The device operates as follows. Before the introduction of endotracheal tubes 6, 7 sleeves 8 release air tube is introduced into leads 12 and outlet 13 of the tribe of the fistula, the cuff 8 through the duct 9 enter the air that held the tubes 10, around the fistula around the perimeter of the stack container 3 with the sorbent, which can be impregnated with an antiseptic, top impose sphere 1 so that the container was kept inside the sphere, in the 4 holes on the top of the display tube 6, 7, which are outside the scope wear restrictive washer 11, to prevent migration of the tube. The device secures the brace for the bracket 5. To the tube 6, resulting from the tribe of 12, is connected to the drain of the Reason for aspiration of intestinal contents, and to the tube 7 from the discharge loop 13 - system for introducing a mixture of intestinal contents collected, sorbent and nutrients.

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

The sphere rests on the skin through the inflatable cochranae from bedsores.

The transparency of the sphere allows you to visually control the course of the wound process and efficiency of sealing in a timely manner to remove the device, replace the container with fresh, timely enter discharged intestinal contents in the elbow.

Applied natural sorbent (RIVERTWIN) has a number of medicinal properties, described in the literature (sorption, deodorizing, anti-inflammatory, etc.). Besides the fact that it absorbs streamed outside of the fistula intestinal contents, it has a bioactive effect on the skin, protects it from rust, promotes regeneration and epithelization desquamated epithelium.

Inflatable cuff located at the end of the tube introduced into the intestines, prevents leakage of significant amounts of chyme to the skin.

On transamidase enteral probes installed during surgery, can be as on the conductors strung tubes with cuffs and installed a device that will ensure the integrity of the area of the fistula in relation to the laparotomic wound and prevent infectious complications, Collection chyme is carried out not only through a tube inserted in the leading tribe of the fistula, but the spout is a mini-enteral nutrition, includes reinfusion collected intestinal discharge in a discharge loop.

In the device provided by the use of enterosorption sorbent, which absorbed its own (sick) intestinal chyme and, thus, affected the overall homeostasis. The sorbent, passing through the digestive tract, performs enterosorption, performs the sorption of toxins, bacteria, ion exchange occurs, from the sorbent are fragments of intestinal discharge, ions of potassium, sodium and other minerals found in it, and the pores are filled with harmful body substances.

Elastic fastening the device to the body allows the patient to visit the common areas, which improves the social content of the patient.

Tightness achieved inflatable balloon at the base of the sphere and its top, through which interesuushie tube, as well as the sorbent with a strong deodorizing properties, eliminates unpleasant odors that accompany all intestinal fistula, which further improves the social content of the patient.

The device can be sterilized and used on other patients.

Device for blocking and treatment of intestinal fistula was used in 12 patients.

KLINICHESKOI hospital with a functioning small bowel immature fistula. From the anamnesis it is known that 2 weeks ago he received a gunshot wound (charge soap) in the stomach. Operated in the linear hospital. On the 7th day postoperative period occurred eventrate it revealed small bowel fistula. When reaching the transportable state sanitary car delivered to the clinic. On admission, the patient's condition is severe, dehydrated, blood leukocytosis, stab shift, anemia (Hb - 92-94 g/l), urine insignificant proteinuria, single leukocyturia, erythrocyturia. On the abdominal wall at the umbilicus wound size 1012 cm, the wound loops of the small intestine, in one of the loops defect, you can see the leading and lateral knee, intestinal discharge. Patient assigned to anti-inflammatory therapy in the volume of the treatment of peritonitis, wound fistula installed the inventive device in the leading and lateral knee put drainage tubes around them was packing a container with a desiccant filled with sodium hypochlorite, has established field, recorded by the band. Collection chyme was performed using the system of Reason, but in a discharge loop was introduced intestinal detachable and filled with chyme sorbent for enterosorption. During the first 8 days of the change of container osushestvljali dry for collecting the resulting chyme and stimulation of granulation. To 32 days of a hospital stay, the fistula was completely isolated from the surrounding tissue connective tissue scar from the epidermal surface. In the intervals between removal of the device was carried out by a UFO on the scheme to the abdominal wall. Body weight increased by 4 kg, peritonitis was arrested. 36 day hospital stay unobrusive closed fistula 2-line seam. General condition did not suffer. Once in 2-3 days was observed independent chair. However, on the 9th day in the wound appeared small bowel contents. The sutures were removed, the wound divorced, fistula had anticipated. Re-applied the device. Installed the drain tube for draining the intestinal contents into the fistula, laid around the container with a desiccant filled with sodium hypochlorite, the top fixed area and bandage. For 18 days failed to arrest the inflammation of the wounds of the abdominal wall, after 22 days after recurrence of the fistula, re-operative intraperitoneal closing it. Laparotomic wound on longer stretches healed by first intention. Discharged in a satisfactory condition. Viewed through 6 months: episodic abdominal pain, from the proposed operations intestinally refused.

Clinical example 2. The patient Increase Century. m in the right iliac region and fistula in the area of the wing of the Ilium on the right. From the anamnesis it is known that 15.07.95 received gunshot Grabovoi and gunshot wound in the stomach with damage ileocecal angle and the wing of the ileum, operated in the linear hospital. However, due to the limited peritonitis 27.07.95 formed small bowel fistula. When entering a serious condition. Laparotomic wound to 2/3 healed by second intention, in the right iliac region unformed thin - colonic fistula, radiography osteomyelitis of the wing of the Ilium, through the wound in the lumbar region periodically moves the feces. If fistulography established that there is a thin - colonic fistula opening through wounds in the lumbar and iliac wing of the Ilium. With 2.09.95 on 13.10.95 applied the proposed device, small bowel detachable played through the drainage tube was inserted into the intestinal detachable and used sorbent from the container, which was placed around the tube to the wound, all recorded in a transparent sphere, the container was changed as wet. Managed to achieve the closure of small bowel fistula, stopped fecal discharge through a fistula in the lumbar region, formed colonic fistula. 13.10.95 operation: unobrusive closure of the fistula is about fistula, suppuration of postoperative wounds in the front part thereof. Re-applied the device, but only intubirovannah gut one tube for enteral nutrition and enterosorption. Managed to clean the wound, to stop the inflammation and 13.12.95 decided to close the fistula intraperitoneally. Performed relaparotomy, retransportation end-to-side, nasointestinal enteral intubation probe (patent 2121376). Made seamless intestinally (patent 2177741). The fistula is not closed, used as a variant of the drainage of the intestine, was periodically drained by device (patent 2143285). In early January 1996, the fistula closed. Discharged home from the recovery. Viewed through the year: felt healthy.

Clinical example 3. Patient Ogarev N. D., 38 years old, medical history, 7831, translated from linear hospital 23.11.95 with immature double-barreled small bowel fistula. From the anamnesis it is known that at the age of 19 years operated on for ectopic pregnancy. 20.11.95 operated in a base hospital (Karymskaya station) for acute intestinal obstruction, performed resection of the ileum, formed 2-barrel colostomy. But there has been a retraction and the fistula was unformed. When you receive a state taulu, abusing alcohol. Over 1.5 months the patient was prepared for surgery, applied the proposed device, the sorbent in the container was soaked with sodium hypochlorite, intestinal detachable were taken from the wound in the abdominal wall with drainage tubes and sorbent. Failed to arrest the inflammation of the abdominal wall, to stabilize the General condition, improve kidney function. When the last unit was established that the distal portion of the endotracheal tube with cuff broke away and went into the intestinal lumen. 12.01.96 with old scar excision performed laparotomy, visceralis, the resected part of the ileum with fistula formed retransportation, nasointestinal intubation of the small intestine enteric probe (patent 2121376) made seamless intestinally (patent 2177741), the abdominal cavity sanitized, drained, sutured tightly. In the postoperative period was used enterosorption (patent 2122868). Detached fragment of the tube came out naturally in 5 days. In the postoperative period developed acute renal failure, oliguria. Used intensive therapy was able to improve the condition. Issued on the 23rd day after the operation. On inspection appeared CEA disease 2840, operated in December 1995 regarding benign prostatic hyperplasia, a failure of the suture of the bladder. 1.06.96 performed relaparotomy, suturing wounds of the bladder. 6.06.96 in connection with postoperative peritonitis, relaparotomy, resection loop of the ileum, 2-barrel ileostomy, intubation of the intestine. Postoperative suppuration laparotomic wound and wound around the fistula - cellulitis of the abdominal wall. Laparotomic wound was treated using sorption-official methods. The wound around the fistula applied the proposed device: the leading and lateral knee was intubated drainage tubes, the wound was packing container with a sorbent filled with sodium hypochlorite, transparent sphere were fixed tube and the container, allowing active control of the area of the fistula. Collected from the discharge tube chyme was introduced with the sorbent by enterosorption. After cleansing the wound sorbent laid dry. For 24 days continued General and local treatment. Laparotomic wound ended with the healing with the formation of multiple ligature fistula. In connection with increasing cachexia, renal failure, decided to operate in the background purulent ligature fistula and urinary bladder. Mypointer, between the leaves of the mesentery revealed many microabscesses. The ileum is resected with fistula formed retransportation, nasointestinal enteral intubation probe (patent 2121376), seamless intestinally (patent 2177741). In the postoperative period of rapid detoxification therapy, enterosorption, the use of efferent therapy. Issued on the 31st day after surgery in satisfactory condition.

Clinical example 5. Patient Petrenko, B. C., 64 years old, medical history, 3343, delivered from linear hospital with undetermined small bowel fistula, abscess of the abdominal wall. From the anamnesis it is known that in 1995 he had an appendectomy, 1996 myocardial infarction, in 1998, re-myocardial infarction. 18.04.2000 adhesive intestinal obstruction, bowel resection, anastomosis end-to-end. In connection with the failure of the anastomosis and postoperative peritonitis, 21.04.2000 brigade ambulance made a relaparotomy, resection of the colon, 2-hand enterostomy, sanitation, drainage of the abdominal cavity, transported in road hospital sanitary train. In the right iliac region 2-barreled intestinal fistula with severe maceration of the skin, wounds of the abdominal cavity around the fistula. On patianna preparation. 15.08.2000 with excision of the scar made laparotomy, visceralis, nasointestinal intubation (patent 2121376), intestinally (patent 2177741), interventionists "side-to-side between the leading and lateral loops. Due to the severity of the condition and comorbidity from the elimination of fistula decided to give up. The postoperative course was hard. Clinically anastomosis became operational only on 23-25 day, appeared chair, decreased discharge the fistula. The claimed device was used in the postoperative period by the same method. Discharged, re-entered after 2 months. All this time was used improvised the obturator and the obturator our design. 16.11.2000 made unobrusive closure of the fistula. In the postoperative period, a partial failure of the anastomosis formed tubular fistula, which managed to close the filling composition and tamponade.

Thus, of the 12 cases of successful use of the device for blocking and treatment of intestinal fistula, in only one case was complicated by separation and migration of the fragment of the tube in the intestine with its natural way without obstructive ileus. It is established that the terms 2D/chr/177.gif">7 days to 214 days.

Sources of information 1. Vicin B. A., Blagica E. M. Formed and unformed external intestinal fistulas. - Novosibirsk: Nauka. -1983. - S.

2. Makarenko, T. P., Bogdanov, A. C. Fistulas of the gastrointestinal tract. - M.: Medicine. - 1986. - -144 p.

3. A. C. the USSR 764685, M. class. And 61 M 27/00. Obturator for the temporary closure of the fistula gastrointestinal tract / C. M. hoopoe and E. G. Karsten. The application 2723729/28-13. Declared 22.12.78. Publ. 23.09.80. BI 35.

4. A. C. the USSR 1255144 A1, class a 61 M 27/00. Device for blocking external intestinal fistulas / Century A. Frank. The application 3798847/28-14. Declared 18.07.84. Publ. 07.07.86. B 33.

5. A. C. RF 98103011 C1, class a 61 M 31/00. Device for temporary bypass of external intestinal fistulas / S. N. Hanafin, A. C. Vlasov, P. C. Popov and others. Declared 12.02.98. Publ. 08.10.99.

6. A. C. RF 97107550 C1, class a 61 M 25/06. Device for blocking immature intestinal fistula / A. I. Lobanov, A. C., WATAIN, A. M. Savov. Declared 07.05.97. Publ. 01.20.99.

7. Vicin B. A., Blagica E. M. Formed and unformed external intestinal fistulas. - Novosibirsk: Nauka. - 1983. - S. 71-72.

8. Vicin B. A., Blagica E. M. Formed and unformed external intestinal fistulas. - Novosibirsk: Nauka. - 1983. - S. 74-75.

9. A. C. RF 98103531, class. And 61 is tyle="text-align:center; margin-top:2mm;">Claims

1. Device for blocking and treatment of intestinal fistula containing an element for blocking and drainage tube, characterized in that the element for the seal is made of a transparent material with two holes and brackets at the top and with an air bladder in the form of a circle and a container with a desiccant at the base, and the container is made with the possibility of placing on the inner perimeter of the container and the drainage tube provided with an air duct, ducting tubes and restrictive washers.

2. The device under item 1, characterized in that the container is made of mesh material, the cell diameter of which does not exceed the diameter of sorbent granules.

 

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