RU2225229C1 - Device for restoring esophagus passability - Google Patents

Abstract

FIELD: medical engineering. SUBSTANCE: device has flexible rod with conic working end and threaded pair at the end. The rod is hollow. The working part has truncated cone shape with lateral holes. Double-leaflet valve is mounted in the inside of the truncated cone. Single- leaflet valve is mounted in proximal rod part. Two pairs of capillaries are made in lateral walls in front of each other, their proximal parts being arranged between single-leaflet valves and the threaded pair. The distal ends of the opposite capillaries are fixed at different heights in external cuff mounted in distal rod part. Distal ends of two other opposite capillaries are arranged in front of the cuff. EFFECT: enhanced effectiveness in treating children suffering from burns. 1 dwg

Description

 The invention relates to medicine, namely to surgery, and can be used to restore patency and prevent the formation of post-burn esophageal strictures.

 Various devices are known for treating and preventing the formation of post-burn esophageal constrictions.

 One of the most common devices for expanding the lumen of the esophagus during cicatricial narrowing is the bougie, which is an elastic polyvinyl chloride monolithic tube with a conical narrowing at one of its ends. Bougie is produced in two sets, which are divided according to the Charrier scale from numbers 6 to 40. The length of each bougie is 700 mm. The diameter of the bougie in the set varies from 2.0 mm, as the thinnest, to 13.33 mm - the thickest ("Cones of esophageal bugs". Label 0802.9.502.000 ET). When bouginating the esophagus, several bougie are used consistently, starting with the introduction of the thinnest.

 The disadvantages of this device include the low efficiency of restoring patency of the esophagus, due to the short duration of exposure to the post-burn stricture of the esophagus.

 The disadvantages of the known device should also include the invasiveness of the bougie procedure, because with the traction action of the bougie on a pathologically altered area, additional damage to the compromised section of the esophagus occurs. Repeated bougieurage leads to mechanical injury to the mucous membrane of the esophagus, which, in turn, causes degenerative and degenerative changes in the mucosa, leading to dysplasia. In addition, bougieurage in childhood is associated with anesthesia, which with repeated exercise adversely affects the children's body.

The closest in technical essence to the proposed is a device for arthroplasty of the esophagus and cardia (Application for the invention. Registration number 5002728/14, IPC ⁵ A 61 M 23/00, publication date of the claims 15.03.1994).

 The known device is a bougie with a cone at one end and a threaded pair at the other. The movable removable element of the screw pair is installed with an emphasis on the end face of the bougie and abuts against the spacer element resting against the endoprosthesis on the other end. After installing the endoprosthesis in the stricture region, the bougie with a movable mechanism is removed from the lumen of the prosthesis.

 The disadvantages of the known device include trauma to the pathologically altered esophagus wall due to the constant pressure of the inserted prosthesis on the esophagus wall, which, in turn, leads to a violation of microcirculation in the affected part of the esophagus.

 The design features of the known device do not provide the possibility of introducing drugs for local exposure to the affected surface in the esophagus.

 In addition, the installation of an endoprosthesis provides for the need for anesthetic management.

 The objective of the invention is to develop a device that allows atraumatic, reliable and in a short time to treat children with chemical burns and strictures of the esophagus.

 The technical result of this proposal is to increase the effectiveness of treatment by accelerating the restoration of the lumen and repair of the damaged esophagus, reducing trauma to the wall of the damaged esophagus during installation and operation of the device, as well as reducing the number of anesthetics.

 The technical result is achieved by the design of the proposed device for restoring patency of the esophagus, consisting of an elastic rod with a conical working end and a threaded pair at the end.

 Distinctive features of the claimed device are that the rod is hollow, the working end has the shape of a truncated cone with side holes. A double-petal valve is installed inside the truncated cone. Single leaf valves are located in the proximal portion of the stem. In the wall of the side surfaces of the rod, opposite each other, two pairs of capillaries are placed, the proximal ends of which are placed in the gap between the single-petal valves and the threaded pair. In this case, the distal ends of two opposite capillaries are fixed at different heights in the outer cuff, and the distal ends of two other opposite capillaries are placed in front of the cuff. The outer cuff is installed in the distal part of the shaft.

 A comparative analysis of the proposed solution and the prototype shows that the proposed device differs from the known shape and functions of the constituent elements, namely: the claimed device is hollow, has two groups of valves made in the working and distal parts of the device, and capillaries that are installed in front and directly in the outdoor cuff.

 From the above comparative analysis it follows that the claimed device for restoring patency of the esophagus and preventing the formation of post-burn narrowing of the esophagus meets the criteria of the invention of "novelty."

 The device for restoring patency of the esophagus is intended for use in healthcare. The implementation of its capabilities is confirmed by the methods and means described in the application.

 The inventive device ensures the achievement of a technical result, namely, increasing the effectiveness of treatment, reducing trauma to the wall of the damaged esophagus during installation and operation of the device and reducing the number of anesthetic benefits.

 The developed device provides the possibility of prolonged exposure to the pathological area in the esophagus by varying pressure on its wall and injecting drugs directly into the area of the esophagus affected by the chemical agent and thereby preventing the formation of post-burn constrictions in the esophagus at any level.

 From the above it follows that the claimed proposal meets the condition of patentability "industrial applicability".

 The implementation of the hollow rod allows you to increase the effectiveness of the treatment by providing a prolonged effect on the pathological focus in the esophagus with the possibility of enteral nutrition.

 The implementation of the working end in the form of a truncated cone with side openings allows food to be carried into the stomach when treating and preventing the formation of stricture of the esophagus. If the device abuts against the wall of the stomach, then the food masses through the lateral openings fall into the cavity of the stomach.

 To prevent the reflux of food masses from the stomach into the device, a two-leaf valve is installed inside the working end.

 The location of the group of single-petal valves in the proximal part of the device prevents the development of the aspiration syndrome - aspiration pneumonia.

 Placing two pairs of capillaries in the lateral wall surface of the proximal part of the rod opposite each other allows to increase the effectiveness of treatment and reduce the invasiveness of the affected part of the esophagus wall.

 The location of the outer cuff in the distal part of the proposed device is determined by the affected area and allows mechanical and therapeutic effects on the affected wall of the esophagus, since through a pair of capillaries going into the wall of the device and ending with cannulas in its proximal part, fluid is injected to inflate the cuff. Fixing the distal ends of two opposite capillaries at different heights in the outer cuff allows fluid to circulate in it. The amount of pressure created in the cuff is easily adjustable, which allows you to change its volume, respectively, and diameter, thereby ensuring the prevention of pressure sores.

 The location of the second group of capillaries, also passing in the wall of the device and having openings directly in front of the cuff, allows the supply of drugs directly to the affected area.

 The implementation of the inventive device to restore patency and prevent the formation of post-burn constriction of the esophagus from an elastic biologically inert material - polyvinyl chloride can minimize the reaction of body tissues to a foreign body.

 In the analysis of known devices for restoring patency of the esophagus and endoprosthetics of its strictures, a lack of information about the influence of the distinctive features of the proposed device to achieve a technical result was revealed, which allows us to consider the claimed invention to meet the criterion of "inventive step".

 The essence of the invention is illustrated in the drawing, which shows a device for restoring patency of the esophagus in longitudinal section.

 The device is made in the form of a rod 1 with a conical working end 2 and a threaded plug 3 at the end. Along the entire length of the rod 1, a longitudinal channel 4 passes. On the lateral surfaces of the rod 1, from the screw plug 3, there are two pairs of capillaries 5 and 6. The proximal ends 7 of the capillaries 5 are located in front of the cuff 8. The cuff 8 contains the proximal ends 9 of the capillaries 6. B the cone 2 of the working end of the device 2 has side holes 10 and a two-leaf valve 11. A group of one-leaf valves 12 is located in the proximal part of the shaft 1.

 The inventive device operates as follows.

 When installing the device through the nasal passage with a cone 2 pass into the cavity of the oropharynx and then into the esophagus. In this case, it is necessary to position the device so that the saliva traps - single-leaf valves 12 are placed in the oropharynx. The cuff 8 is installed directly in the area of the affected esophagus affected by a chemical agent. The distal end of the device with a cone 2 and a two-leaf valve 11 is located directly in the stomach.

 After installing the device in a given section of the esophagus, the volume of the cuff 8 is increased by introducing fluid through the capillaries 6. The volume of fluid introduced into the cuff should create a cuff diameter corresponding to the age diameter of the esophagus.

 When drugs are introduced through openings 7, capillaries 5 are placed in the cavity of the esophagus, directly to its site affected by a chemical agent.

 Enteral nutrition is carried out through channel 4.

 The cuff is controlled and drugs are administered either manually by administering fluid and drugs using a syringe, or automatically using an automatic device such as an infusamate. The latter makes it possible to fully automate the treatment of children according to the developed specific treatment regimen. Autonomy of nutrition and electronic control of the infusamate ensures the absolute mobility of the child during treatment.

 The performance of the proposed device is confirmed by clinical examples.

 Clinical example 1.

 Patient G., 3 years old, was admitted to the Department of General Surgery of the IGODKB on August 24, 2002 in connection with complaints of vomiting that occurs after each meal, regardless of the quantity and quality of the latter, weight loss. From the anamnesis it was established that on 07/13/2002, a child, due to an oversight of his parents, drank a concentrated solution of sodium hypochloride, after which he underwent treatment at the Central District Hospital of Slyudyanka. 08/22/2002, the child developed complete obstruction of the esophagus against the background of the defeat of the latter by a chemical agent. Upon receipt of the child, the condition is serious, due to the phenomena of violation of the passage of food through the esophagus and, as a result, the phenomena of malnutrition. The survey was conducted: 08/24/2002 - FES - in the upper third of the esophagus circular after burn narrowing with a pinhole in the center up to 1 mm. According to urgent indications, on August 25, 2002, a gastrostomy operation was performed according to Kader. Final diagnosis: Chemical burn of the esophagus, subtotal lesion. Post-burn stricture of the esophagus in the upper third. Hypotrophy 2 degrees. November 20, 2002 - esophagoplasty by the stomach with the imposition of high esophagogastroanastomosis up to 2 cm from the entrance to the esophagus. In the postoperative period (after 6 weeks), the phenomena of stenosis of esophagogastroanastomosis were determined. On examination, the narrowing diameter was up to 4 mm. The treatment using esophageal conical bougie for 12 weeks had no effect due to restenosis of the anastomotic zone at a speed of 1 mm in diameter per day. It was decided to use the proposed device in the treatment of postoperative stenosis of the anastomosis zone. 02/26/2002 - through the left nasal passage, the device was inserted into the oropharynx and then into the stomach so that the cuff was located in the anastomosis zone. The pressure created in the cuff corresponded to 11-12 mm RT. Art. and the age diameter of the esophagus is 10 mm, when the latter is inflated. A change in pressure (prevention of pressure sores) in the cuff occurs every 90-120 minutes, from 11-12 mm Hg. up to 8-9 mmHg and, accordingly, the change in cuff diameter from 10 mm to 8 mm. The increase and decrease in cuff pressure occurs within 30 minutes. Medicines are introduced through capillaries, which open with holes located above the cuff, into the esophagus lumen directly to the affected area.

 All drugs are administered 15 minutes before the cuff pressure drops at the rate of 1 ml per 1 square centimeter of the affected esophagus wall.

 Curiosinum - 3 times a day, 10 days.

 Phospholugel - 4 times a day, 10 days.

 Sea buckthorn oil - 5 times a day, 10 days.

 Antibacterial therapy: cefazolin 100 thousand / kg / day, 10 days.

 Hormone therapy: prednisone 3-5 mg / kg / day, 5 days.

 Nonsteroidal anti-inflammatory drugs: Ketanal 1 ml / vm, 10 days.

 The introduction of drugs and the management of the cuff was performed by two micropumps (manufactured in the USA, model MP-11V 3.1), which have autonomous power and software that allows you to enter the necessary drugs and fluid into the cavity of the cuff according to a given program automatically. Feeding the child during treatment is carried out with regular homogenized food according to age-related needs through the lumen of the device.

 The duration of the device in the esophagus was 10 days. After treatment, the diameter of the anastomosis zone was 10 mm, which corresponds to the age norm. Removing the device is done with a deflated cuff in the same way as a regular stomach tube. To monitor the area of the anastomosis, the child once every 2 months is performed FEGS. For 7 months, the phenomena of restenosis of the anastomotic zone were not noted.

 Clinical example 2.

Patient F., 2 years old, was admitted on 07.07.2002 to the General Surgery Department of the IHCHD in connection with complaints of the child's refusal to eat, fever up to 37.8 ^o C, hypersalivation, vomiting, lethargy, and adynamia. From the anamnesis it was revealed that the child on July 4, 2002, drank, according to his mother, 2 sips of 70% acetic acid. They did not apply to the medical institution, the child was forced to drink a large amount of milk, after which they caused vomiting. Against the background of detoxification, antibacterial and anti-inflammatory therapy, July 10, 2002, diagnostic fibroesophagogastroscopy was performed. Conclusion: Chemical burn of the esophagus, subtotal form, in the upper third - 2 degrees, in the middle third - 3 degrees with the phenomena of the formation of post-burn narrowing of the esophagus.

 07/14/2002, the claimed device is installed so that the cuff is located in the middle third, in the area of the narrowing of the esophagus. The pressure in the cuff ranged from 90 to 120 minutes and amounted to 11-12 mm RT. Art. , which corresponded to the diameter of the last 10 mm, the pressure in the cuff decreases in 30 minutes and equals 8-9 mm Hg. and a cuff diameter of 8 mm and after 90 minutes the pressure returns to maximum within 30 minutes. Medicines used in the treatment are divided into local and general use. Topical drugs are administered through capillaries located in the device and opening with holes located above the cuff, 15 minutes before the cuff pressure is reduced at the rate of 1 ml of the drug per 1 square centimeter of the affected esophagus wall: Curiosin - 3 times / day, 10 days ; Phospholugel - 4 times / day, 10 days; Sea buckthorn oil - 5 times / day, 10 days. Antibacterial therapy (cephalosporins 3 generations): cefazolin - 100 mcg / kg / day, 10 days. Hormone therapy: prednisone 3-5 mg / kg, 5 days. Nonsteroidal anti-inflammatory drugs: ketonal - 1 ml / vm, 10 days, etc. Drugs and fluids were injected into the cuff automatically using micropomps (manufactured in the USA, model MP-11V 3.1), which made it possible to fully automate the treatment of children with this pathology and significantly to improve the quality of life of the child, in the course of treatment abandoning multiple bougienages of the esophagus and related anesthetic benefits. The child was fed a homogenized food mass according to age requirements through the channel of the proposed device. No complications were noted. The duration of the device in the esophagus is 10 days. Removing the device from the esophagus is done with a deflated cuff similar to removing a gastric tube.

 During the control examination revealed: there was a complete epithelization of the burn surface, the mucous membrane with the phenomena of subatrophy, no post-burn constrictions were detected, the diameter of the esophagus was up to 10 mm, which corresponds to the age norm. Control monitoring of the child for 6 months - the phenomena of stenosis of the esophagus were not detected, no complaints.

 Thus, the claimed device provides the treatment of chemical burns of the esophagus and the prevention of the formation of its stenosis, eliminates repeated bougienage of the esophagus, therefore, reduces the number of anesthetics, eliminates the effect of anesthesia on the child's body, since it is possible to install and operate the device without anesthesia, regardless of age a child. Reducing the duration of treatment using this device to 1-2 months versus 6-12 months with the use of conical esophageal bougie in the treatment and from 3-4 months when using endoprostheses. This device allows you to create the effect of prolonged prolonged esophagus esophagus and provide the necessary exposure to drugs in the field of chemical burns of the esophagus. The design of the proposed device allows for the complete automation of the treatment of children with chemical burns of the esophagus, thereby improving the quality of life of children during treatment, reducing the bed-day.

Claims (1)

A device for restoring patency of the esophagus, consisting of an elastic rod with a cone-shaped working end and a threaded pair at the end, characterized in that the rod is hollow, the working end has the shape of a truncated cone with side holes, inside of which a two-leaf valve is installed, in the proximal part of the rod are single-leaf valve, in the wall of the side surfaces of the rod opposite each other there are two pairs of capillaries, the proximal ends of which are placed in the gap between the one-petal valves and a threaded pair, and the distal ends of two opposite capillaries are fixed at different heights in the outer cuff installed in the distal part of the rod, and the distal ends of two other opposite capillaries are placed in front of the cuff.