UA151355U - Bandage for the prevention of complications during the vacuum treatment of patients with peritonitis, with fistulas and wounds (options) - Google Patents

Abstract

The bandage for the prevention of complications during the vacuum treatment of patients with peritonitis, fistulas and wounds, which ensures the absorption and pumping of excess exudate and/or pus from the wound by placing the bandage in the abdominal cavity or on the surface of the wound and connecting it through a flexible connector tube to the device for creating negative pressure, characterized by the fact that the core of the bandage made of elastic porous material is surrounded on all sides by a partially perforated shell made of biologically inactive inert soft hydrophilic and resistant to the action of gastric juice and bile elastomer. Through holes in the perforated elastomeric shell are designed to allow excess fluid to pass through to the porous core of the dressing, from which exudate or pus is pumped out through a flexible connecting tube using a negative pressure device. The use of hydrophilic elastomer as a shell material prevents the formation of mechanical damage to the walls of hollow organs and significantly reduces the trauma associated with the bandage removal procedure. The bandage can be made in the form of a flat bag or a cylinder for use depending on the nature, size and location of the affected area and can be used both in the postoperative therapy of internal hollow organs and for the prevention and treatment of superficial wounds, in particular burns, purulent wounds, ulcers on the skin. When connecting the bandage to a reservoir with liquid medicines instead of a device for creating negative pressure, it can be used to deliver medical fluids directly to a wound, fistula or affected area of a hollow organ.

Description

The useful model belongs to medicine, namely to medical devices that are used for the treatment of various types of wounds and damage to hollow internal organs, and, in particular, can be used to prevent complications during the vacuum treatment of patients with peritonitis, fistulas and wounds.

The well-known bandage for the treatment of patients with wounds, peritonitis and fistulas was taken as a prototype.

This bandage is made in the form of a plate made of elastic porous material and is intended for connection to the VAK-therapy device, which creates negative pressure, with the possibility of absorbing and pumping out excess wound exudate and/or pus (Petrenko O.M., Macheret I .Yu,.,

Tikhomirov A.V. The role of vacuum therapy in the treatment of chronic wounds. - Internet - resource "Ukrainian Medical Journal", issue Mo 4 (108) - MM 2015, pErzuumlmlu. those hundred pa/apisiye/88472/g01-maKyit-Tegarii-y-yiKimappi-rgi-khgopisnpih-gapahi|.

The disadvantage of such a bandage in the treatment of postoperative complications in patients with peritonitis is the formation of damage to the walls of hollow organs with the possible subsequent formation of fistulas from the reaction to the bandage itself, which is tightly pressed against the wound surface with a porous surface. The formation of fistulas leads to a significant extension of the treatment period, an increase in its cost, and in addition, in many cases, it ends with a fatal outcome. The cause of similar postoperative complications after the use of VAK therapy with traditional vacuum bandages, which are released serially, is the aggressive simultaneous effect on the serous surface of the organs of the abdominal cavity of several factors, in particular, enzymatically active pathological exudate, which is produced by the body due to inflammation in the abdominal cavity, mechanical effects of the bandage material on the surface of the hollow organ under the influence of negative pressure, microcracks that appear on the serous membrane of the intestine under the influence of the structure of the bandage itself and due to high intra-intestinal pressure and pathological microcirculation disorders in the wall of the organ caused by intestinal paresis.

The task of the utility model is to develop a new type of bandage with a protective coating, intended for use with a device for creating negative pressure, which, regardless of configuration and linear dimensions, would combine the function of active drainage with the maximum possible surface area and the minimization of mechanical the effect of the dressing material on body tissues in order to prevent the formation of mechanical damage to the mucous membrane

From the shell of hollow internal organs.

The task is solved by the fact that the composition of the bandage intended for the treatment of patients with peritonitis, fistulas and wounds, which provides the possibility of absorbing excess wound exudate and/or pus and pumping it out of the wound by placing the bandage in the abdominal cavity or on surface of the wound and connecting it through a flexible connecting tube to a device for creating negative pressure, includes, according to a useful model, a core of elastic porous material (sponge), surrounded on all sides by a shell of biologically inactive inert soft hydrophilic and resistant to the action of gastric juice and bile elastomer, while part of the shell contains through-holes for access of pumped liquid from the wound into the porous core of the bandage and subsequent removal of this liquid through a flexible connecting tube inserted into the porous core, which connects the connection with a device for creating negative pressure.

Surrounding the porous core, the perforated shell of hydrophilic elastomer 85...90 95 consists of water, thanks to which it is very soft and does not stick to the surface of inflamed tissues and, unlike the prototype, does not mechanically damage them. This allows exudate or pus to be pumped out without the formation of bedsores and subsequently atraumatically remove the bandage as a whole, without causing the patient a painful reaction.

The proposed bandage can be made in two configurations: a flat bag and a cylinder for application depending on the nature, size and location of the affected area.

Accordingly, the porous core has the form of a flat rectangular plate with a length of 100...200 mm, a width of 50...100 mm and a thickness of 5...15 mm or a cylinder with a diameter of up to 12...15 mm and a height of 30...35 mm .

The description of the claimed useful model is clearly explained with the help of drawings on the example of a flat package bandage:

Fig. 1. Schematic image of a flat package bandage in a longitudinal section: 1 - porous core, 2 - upper part of the C elastomer shell with a central hole, C - a retainer with a connecting cone (luer lock) brought out from a standard disposable syringe; 4 - flexible connecting tube used when applying a bandage; 5 - the lower part of the elastomer shell with perforated holes; 6 - perforated holes.

Fig. 2. Photograph of a flat package bandage in the assembled state before hermetic packaging and sterilization, top view. For clarity, a flexible connecting tube is already attached to the bandage.

Prepare the proposed flat packet bandage as follows: 1. For the core of the bandage, take a rectangular plate made of soft elastic porous material (foam, polyurethane sponge, etc.) 100...200 mm long, 50...100 mm wide and 5...15 mm thick. In the middle of one of the flat surfaces of the plate, a hard disk with a diameter of up to 80 mm and a thickness of 1...1.5 mm, made of a neutral plastic, such as kapron, with a hole drilled in the center with a diameter of 4 mm, through which the connecting cone is brought out ( luer lock) of a standard disposable syringe designed to connect a flexible connecting tube to a negative pressure device. 2. Two rectangular plates of biologically inactive, inert, soft, hydrophilic and resistant to the action of gastric juice and bile elastomer made of radiation-crosslinked hydrogel, manufactured according to the technology described in the patent, are used to form the bandage shell.

of Ukraine for the invention Mo 113797 "Method of manufacturing hydrogel bandages for wounds", authors V.B.

Neimash, O.M. Kabaldin, published on 10/03/2017, Bulletin Mo 5/2017. The linear geometric dimensions of the elastomer plates should exceed the corresponding dimensions of the porous base of the bandage by 15...20 mm on each side, the thickness of the elastomer plates is 2...4 mm. 3. On one of these elastomer plates, 20-30 through holes with a diameter of 3...5 mm are cut with a tubular perforator in such a way that the distance between the holes is 2-4 times greater than their diameter. The holes should be located no closer than 20 mm to the edges of the elastomer plate. 4. In the middle of the other elastomer plate, a hole is cut, the diameter of which is half the diameter of the connecting cone of the syringe, fixed with a hard plastic disk on the porous core. 5. On one of the surfaces of both elastomer plates, a layer of liquid hydrogel, made according to the above method, up to 1 mm thick, is applied. 6. On the hydrogel-soaked surface of the perforated elastomer plate, a porous core is placed with its free flat surface so that the excess length and width of the elastomer plate over the length and width of the porous core is distributed

From evenly along the perimeter of such a "sandwich". 7. The free end of the connecting cone of the syringe fixed on the porous core is inserted into the central hole of the other elastomer plate from the side of its hydrogel-moistened surface, after which the porous core is covered with the entire hydrogel-moistened elastomer surface and the two elastomer plates are glued together, tightly and evenly pressing to each other, their redundant edges over the porous core, like how dumplings are molded. 8. The bandage formed in this way with the connecting cone of the syringe brought out is placed in a bag made of multi-layer metal-polyethylene film for packaging food and medical products and the bag is sealed by thermal welding. 9. A sealed package with a bandage is irradiated with electrons with an energy of 2...6 MeV and a dose of 25...30 kGray. Under the influence of radiation, radiation crosslinking of the hydrogel occurs, that is, the transition of the adhesive layer from the state of a thick liquid to the state of an elastic elastomer, thanks to which both original elastic plates are connected into a monolithic soft shell around the porous core.

At the same time, radiation sterilization of the product takes place together with the packaging.

Thus, the flat package bandage for the prevention of complications in patients with peritonitis, fistulas and wounds during treatment with negative pressure, which is claimed, is a flat rectangular elastic porous core with a knot placed in the middle of its upper flat surface for connecting from above a flexible connecting tube to the device for creating negative pressure, surrounded on all sides by a shell made of biologically inactive inert, soft, hydrophilic and resistant to the action of gastric juice and bile elastomer with a partially perforated surface in a special way, which ensures the passage of liquid pumped from the wound into the porous core . The flexible connecting tube to the device for creating negative pressure is put on the connecting cone of the syringe immediately before applying the bandage, after opening the sterile package. After that, the bandage is placed in the abdominal cavity and applied to the affected area with a perforated surface. The use of a soft and moist elastomer as a shell material prevents the formation of mechanical damage to the walls of hollow organs when applying a bandage and significantly reduces the number of complications during vacuum treatment, in particular, it almost completely eliminates injury to the affected area when removing the bandage.

A variant of the proposed bandage is that it is made in the form of a cylinder of an elastic porous core with a diameter of up to 12...16 mm and a height of 30...35 mm, surrounded on all sides by a circularly perforated elastomer shell in a special way, with a end with a flexible connecting tube to the negative pressure device. In this case, the connecting tube with a beveled end is inserted directly into the porous core in the center of the end surface and is sewn to the base with surgical threads.

Both versions of the bandage can be used for dosed long-term delivery of medical fluids (saline solutions, antibiotics, antiseptics, etc.) to the damaged area without using a device to create negative pressure. In this case, a reservoir with a drug solution is connected to the bandage through a flexible connecting tube, and the pressure required to inject the solution is provided by gravity when the reservoir is raised above the level of the wound surface or fistula. Adjusting the dose and speed of drug delivery is carried out in the same way as in a regular dropper.

In addition to being used in the postoperative therapy of internal hollow organs, the applied bandage can be used for the prevention and treatment of superficial wounds, in particular burns, purulent wounds, ulcers.

Ways of practical use of the claimed useful model: 1. After laparotomy, the source of peritonitis is removed - gall bladder, appendix, necrotized part of the intestine, or the defect of the hollow organ is sutured. After washing the abdominal cavity, a flat bandage with a flexible connecting tube is placed on top. The tube is brought out through the laparotomy incision and connected to the device to create negative pressure. They provide continuous maintenance of a negative pressure of 125 mm Hg. Art. The bandage is replaced after 48-96 hours, depending on its saturation with exudative fluid or purulent contents. On average, in the treatment of peritonitis, depending on the complexity of the patient's condition, from 3 to 9 bandage changes are required. 2. When endoscopically confirming the presence of an anastomosis defect or perforation of a hollow organ (esophagus-intestinal junction, defect in the line of gastric sutures, low anastomosis of the rectum), after passing the probe below the detected defect, under the control of the endoscope, a cylindrical bandage is brought to the site of the defect, for example, a fistula , and flexible

The connecting tube is brought out and connected to the device that creates a negative pressure of 75...100 mm Hg. Art. If necessary, the bandage is replaced after 72-120 hours.

Examples of clinical use of a useful model: 1. Patient S., 58 years old, was diagnosed with acute appendicitis and local peritonitis. After median laparotomy, destructive, perforating, necrotic appendicitis and peritonitis were detected. The destructive appendix was removed, the abdominal cavity was washed with 6.0 liters of physiological solution. A flat pack bandage was installed in the sealed abdominal cavity and connected to a device for creating a continuous negative pressure of 125 mm Hg. Art. The bandage was changed every 72 hours, four times. After the last removal of the bandage, the phenomena of peritonitis were eliminated, the abdominal cavity was closed. On the 15th day after operative treatment, the patient was discharged for outpatient supervision. 2. Patient V., 28 years old, was operated on for metabolic syndrome, overweight: height 168 cm, weight 159 kg. A laparoscopic drainage-resection of the stomach was performed, but on the third day, partial failure in the area of the stomach suture was revealed. Diagnosis: perforation of the stomach stump, local peritonitis. With the help of an endoscope, the proposed variant of the cylindrical bandage is introduced into the stomach to the perforation site, the flexible connecting tube to the device for creating negative pressure is brought out through the nose. A negative pressure of 75 mm Hg was created. Art. in continuous mode. The bandage was changed four times after 120 hours.

The failure of the anastomosis line was eliminated, the patient was discharged for outpatient observation.

Claims (4)

USEFUL MODEL FORMULA 1. A bandage containing a core of elastic porous material, for the prevention of complications during the vacuum treatment of patients with peritonitis, fistulas and wounds, which ensures the absorption and pumping of excess exudate and/or pus from the wound by placing the bandage in the abdominal cavity or on the surface of the wound and connecting it through a flexible connecting tube to the device for creating negative pressure, which is characterized by the fact that the core made of elastic porous material is surrounded on all sides by a partially perforated shell made of biologically neutral inert soft hydrophilic and because gastric juice and bile resistant elastomer. 2. A bandage for the prevention of complications during vacuum treatment according to claim 1, which is characterized by the fact that it is made in the form of a flat bag of hydrophilic elastomer with an elastic porous core, tightly closed on all sides, except for one plane, which contains perforated through holes, and on the opposite side of the porous core, through the elastomeric shell, the connecting cone of a standard disposable syringe for connecting the flexible connecting tube to the device for creating negative pressure is brought out. 3. A bandage for the prevention of complications during vacuum treatment according to claim 1, which is distinguished by the fact that for placement in the fistula area or in an internal hollow organ it is made in the form of a cylinder made of an elastic porous core, surrounded on all sides by a circularly perforated shell in a special way hydrophilic elastomer and with a flexible connecting tube leading through the end of the cylinder to the device for creating negative pressure. 4. Bandage for the prevention of complications during vacuum treatment according to claim 1 or 2, which is characterized by the fact that it is used to deliver therapeutic fluids to a wound, fistula or affected area of a hollow organ by connecting to a reservoir with drugs instead of a device for creating a negative pressure and placement of such a tank above the level of the bandage. z - 5 y, K- and KI i ku st. sleeping slya Eis metu U she I Uh h N h kikom u h i: y kh kh o Her ukh kh svorye ron noo pi suku ih khkkk yuki Zk АЖ uUu u u t tu hu Ж, ож ки и и в and MM Chan AJ i kt "U MK vshem x S Y i sy y Y y x Ko N OBU "U Fig. Z dream NN tttKNaah VZ o EV V: p Fig. and