RU118864U1 - POLYMER COATING FOR LAPAROSTOMY IN COMMON PERITONITIS - Google Patents

Abstract

Polymer film for laparostomy with widespread peritonitis in newborns and young children in the form of an elastic, transparent rectangular film with rounded edges and through holes, both surfaces of which are smooth, characterized in that the smooth surfaces of the film are made with a roughness of no more than 8 nm , the distance between the centers of adjacent holes is from 5 to 10 mm, while with a side length of 80 mm, the hole diameter is 3 mm, with a side length of 120 mm, the hole diameter is 4 mm.

Description

The utility model relates to the field of medicine, namely to surgery, and can be used in pediatric surgery in newborns and infants to perform laparostomy for necrotic enterocolitis complicated by peritonitis.

Necrotic enterocolitis (NEC) is a severe, polyetiological disease of newborns and young infants, which is complicated by intestinal obstruction, severe hemocolitis, perforations, peritonitis, peritoneal shock, sepsis.

The absence of pathognomonic symptoms at the beginning of the disease complicates the timely detection of the disease. A continuously developing pathological process in the abdominal cavity leads to irreversible changes in the intestinal wall and the development of widespread peritonitis. In the group of operated patients, mortality is 50%, and with extensive necrosis - 100%. The most severe disorders of hemodynamics, microcirculation and homeostasis, due to massive resorption of toxic products from the inflammatory focus of a large area, dictate the need for active methods of surgical treatment of this pathological process.

The main method of treatment for NEC is median laparotomy, which includes: revision of the abdominal cavity, search and elimination of the source of peritonitis, adequate debridement, then the intervention is completed by suturing the abdominal cavity tightly or laparostomy is used.

In pediatric surgery, various materials are used (synthetic, biological) to isolate the intestinal loops from napkins and the environment and to preserve the outflow of purulent exudate from the abdominal cavity.

Most often, a polyethylene film is used to distinguish intestinal loops from napkins, tampons, and the environment (Buzunov AF Laparostomy. Treatment of surgical diseases of the abdomen with open abdominal cavity management. Practical medicine 2008: 202).

However, the plastic film does not have sufficient strength, therefore, does not prevent the development of eventation in the postoperative period. The absence of the “shape memory" effect contributes to this. The specified film is not produced by the medical industry. The lack of serial production of plastic films for laparostomy, forces the operating team to manufacture perforated plastic films (from improvised material — ordinary, pre-sterilized plastic bags) by applying perforations using scissors or a scalpel in any order directly in the absence of time inherent in urgent surgery. during surgery, therefore, the edges of the holes in the film, manually formed, lead to intestinal microtraumas.

The above factors make surgeons look for other materials to close the wounds of the abdominal wall.

For the prototype of the proposed utility model, a well-known polymer coating for laparostomy with diffuse peritonitis was selected (RU patent for utility model No. 102192, publ. In B.I. from 02.20.2011).

The well-known polymer coating is made of reference, a spatially cross-linked polymer obtained by photopolymerization of methacrylic series oligomers in the form of a film, one surface of which is smooth and designed to contact with the abdominal organs, and the other is rough or contains a relief pattern and is intended for contact with the abdominal wall and ensures its retention in the abdominal cavity without the formation of folds. The process of forming a polymer coating eliminates any mechanical effect, since any mechanical effect on the polymer provokes the formation of free radicals, which subsequently lead to polymer degradation and undesirable toxic reactions. The degree of roughness of the smooth surface of the film is from 10 to 20 nanometers, which eliminates the adhesion process of adjacent organs with a coating. The film has through holes with a diameter of 1 to 5 mm and a distance between the centers of the holes of 15 to 40 mm. Through the holes, drainage of the abdominal cavity is carried out in order to remove purulent exudate. The film has a rectangular shape with rounded edges with side lengths from 100 to 400 mm. The strength of the repeater material is comparable to the natural strength of the tissues of the abdominal wall (Romanov R.V. Reperenoplasty of ventral hernias in elderly and senile patients. Clinical Gerontology 2008; 4: 44-51).

However, the technical characteristics of the known polymer coating do not allow its use in newborns and young infants due to the thickness of the coating and, accordingly, the inelasticity (roughness) of the film, which will lead to trauma to the internal organs (edges of the liver, stomach, peritoneum). The size of the known coating exceeds the required size of the coating for children of a younger age group, and an independent change in size during surgery will lead to a gross violation of the physicochemical properties of the material. In addition, changing the size of the coating and, accordingly, reducing the number of holes may be inadequate for passive sanitation of the abdominal cavity with peritonitis in newborns. The rough surface of one of the sides and the relief pattern can contribute to increased trauma to the soft tissues during laparostomy in newborns and young children.

The objective of the proposed utility model is the creation of a polymer coating for laparostomy with widespread peritonitis in newborns and young infants.

The problem is solved in that in the known polymer coating for laparostomy with widespread peritonitis made of spatially cross-linked polymer obtained by photopolymerization of methacrylic series oligomers, in the form of an elastic, transparent film of rectangular shape with rounded edges and through holes, for laparostomy with widespread peritonitis in newborns and young infants, the polymer coating is made with both smooth surfaces with a degree of roughness no more than 8 nanometers, the distance between the centers of adjacent holes from 5 to 10 mm, while with a side length of 80 mm, the diameter of the holes is 3 mm, with a length of 120 mm the diameter of the holes is 4 mm.

The utility model is illustrated by graphic material.

In Fig 1 shows the proposed polymer coating for laparostomy with widespread peritonitis in newborns and young infants. The polymer coating is made in the form of a film of a biocompatible, biostable, non-toxic reference material. Both surfaces of the film are made smooth with a roughness of not more than 8 nm. The film has a thickness of 100 to 200 μm (0.1-0.2 mm), side length 1 from 80 to 120 mm. Through holes 2 are made with a diameter of 3 to 4 mm, with a side length of 80 mm, the diameter of the holes is 3 mm, with a side length of 120 mm the diameter of the holes is 4 mm, the distance between the centers of 3 adjacent holes is from 5 to 10 mm,

The technical result is achieved by the fact that the polymer coating for laparostomy in the form of a film, both surfaces of which are smooth, allowing a degree of roughness of not more than 8 nm, which eliminates the adhesion process of the adjacent organs with the coating. The specified degree of roughness of the material is achieved directly in the production process.

In the clinic of the Nizhny Novgorod State Medical Academy on the basis of the Children's City Hospital No. 1, 80 patients with necrotic enterocolitis aged 1 to 12 days were observed. There were 46 boys (57.5%), 34 girls (42.5%). Upon admission, the condition of the newborns was regarded as severe, corresponding to the NEC II-III degree.

Given the severity of the condition, 42 patients underwent median laparotomy. The laparostomy technique was used in 11 of the most severe patients with widespread purulent peritonitis. In the main group (n = 7), the inventive polymer coating was used, in the control group, a polyethylene film was used (n = 4). The results were statistically analyzed using the Mann - Whitney test using Origin Pro in Windows 7 on an Emachines computer.

There were no complications in the main group, in the control group, complications were observed in 3 children (p = 0.014).

In the main group, all patients recovered, in the control group there were 3 fatal outcomes (p = 0.014).

Thus, the use of the inventive polymer coating significantly reduces the frequency of complications and mortality from common peritonitis in children with necrotic enterocolitis.

An example of a specific performance is given in the form of extracts from medical records.

Patient Sh. (Case history No. 14455), age 2 days, was born from the third pregnancy and first birth (mother's age 25 years). Pregnancy proceeded with late toxicosis, high blood pressure and edematous syndrome in the 3rd trimester. At 32-33 weeks. pregnancy, the threat of interruption is noted, at 40 weeks - an urgent delivery in the head presentation, complicated by the early outflow of amniotic fluid: 1st period - 7 hours 20 minutes, 2nd period - 25 minutes, anhydrous period - 8 hours 40 minutes . The water is stained with meconium. A full-term boy was born weighing 3000 g, 52 cm long, with an Apgar score of 2 points. The condition at birth was regarded as serious due to aspiration of amniotic fluid. The newborn cried out after the sanitation of the upper respiratory tract and resuscitation measures (mechanical ventilation). 3 hours after birth, bloating appeared, general anxiety. From the maternity hospital, a resuscitation team was delivered to the neonatal surgery department with a diagnosis of meconium aspiration, severe asphyxiation, ulcerative necrotic enterocolitis, occipital cephalohematoma.

When viewed in a hospital, the condition is very serious. The skin is pale pink, clean, dry, moderate cyanosis of the nasolabial triangle, acrocyanosis. Neurological symptoms were noted: lethargy, muscular dystonia, hyporeflexia, a large fontanel 1 × 1 cm in size. In the lungs, breathing is shallow with retraction of the intercostal spaces, there are no wheezing. Heart sounds are rhythmic, muffled, noises were not heard. BH 58 in 1 min., Heart rate 130 in 1 min. The abdomen is swollen, soft, with deep palpation painful in all departments, peritoneal symptoms are negative. The liver +2.5 cm from the edge of the costal arch, the spleen is not palpable. Auscultatory - weakened peristalsis. Hemorrhagic discharge was discharged through the gastric tube. The stool is sparse, without blood impurities. In an emergency, the child underwent a panoramic radiography of the abdominal cavity, on which extended bowel loops, a thickening of the intestinal wall, pneumatosis, and the presence of multiple different levels were found. In the cavity of the small pelvis - free fluid. An ultrasound scan revealed data for dynamic obstruction. In a general blood test, leukocytosis is up to 18 × 10 ⁹ / L with a shift of the formula to the left. The presence of young forms (myelocytes - 1%). Increased activity of liver enzymes (AsAT - 1.64, AlAT - 2.2 0 μmol / l * h). Traces of protein in the analysis of urine up to 0.172 g / l.

In the intensive care unit, preoperative therapy was carried out, including full parenteral nutrition, an infusion program, antibacterial therapy (cefotaxime, amikacin in combination with metrogyl in age doses).

At the age of 2 days, the child underwent mid-median laparotomy. When opening the abdominal cavity, a purulent effusion in a moderate amount was obtained. The wound was inflated, hyperemic loops of the small intestine. Throughout the ileum of the small intestine, multiple sites of subserous necrosis were identified. At 15 cm from the ileocecal angle, a perforation hole of 0.2 × 0.2 cm was found, the latter was sutured. The abdominal cavity was washed with a solution of metrogil.

Taking into account the performed manipulation and a large number of doubtful foci, a laparostomy was applied according to the accepted method for further dynamic observation of the intestinal wall, the main point of which was covering the intestinal loops with the proposed polymer coating for laparostomy, which was wound several centimeters beyond the edges of the laparotomy wound. 1-2 sutures were applied at the corners of the incision through all layers and an aseptic sticker.

After a day, the patient underwent a revision of the abdominal organs. Positive changes were noted in the operations: there was no failure of the suture of the perforation hole, there were no subserous necrosis in the intervention area, the color of the intestinal wall was restored, peristalsis was distinct, sluggish. There were no new foci of inflammation and necrosis. The abdominal cavity was sutured in layers tightly.

After surgery, continued infusion and antibacterial therapy, on the 6th day they started feeding with an adapted mixture. In control tests of blood and urine - without pathology. The sutures were removed on the 10th day, the surgical wound healed without suppuration.

There were no complications in the immediate postoperative period. In satisfactory condition on the 18th day the child was discharged home.

Claims (1)

A polymer film for laparostomy in cases of peritonitis in infants and young children in the form of an elastic, transparent rectangular film with rounded edges and through holes, both surfaces of which are smooth, characterized in that the smooth surfaces of the film are made with a roughness of not more than 8 nm , the distance between the centers of adjacent holes is from 5 to 10 mm, while with a side length of 80 mm, the diameter of the holes is 3 mm, with a side length of 120 mm the diameter of the holes is ene 4 mm.