RU168959U1 - Device for early diagnosis of anastomotic insolvency - Google Patents

Abstract

The utility model relates to the field of diagnostic medical equipment, in particular to special reusable diagnostic tools. A device for conducting an early diagnosis of anastomosis insolvency, consisting of two electrodes, a thermistor and a dielectric layer for interconnecting the electrodes, transmits information about the voltage drop between the electrodes, as well as the voltage drop across the thermistor, through wires enclosed in a silicone sealed flexible wire to the hardware of the firmware a complex of early diagnosis of anastomotic insufficiency between the hollow organs of the gastrointestinal tract for the purpose of automated anal for sample temperature and conductivity measurements. The advantages of the claimed utility model are the possibility of introducing the sensor directly during the operation, the ability to constantly monitor the condition of the suture area in the postoperative period without the need for drainage, the ability to control the patient’s body temperature and the ability to remove the sensor without surgical intervention after the need to use it.

Description

The utility model relates to the field of diagnostic medical equipment, in particular to special reusable diagnostic tools. The device can be used for electrolytic diagnosis of insolvency of a pancreatic stump in the early postoperative period as part of a hardware-software complex for early diagnosis of anastomotic insolvency between the hollow organs of the gastrointestinal tract.

Most patients who underwent surgery on the organs of the gastrointestinal tract have complications associated with the healing of sutures of the hollow organs (anastomosis). Mortality in such cases reaches 20-40%. In normal mode, in the area of the pancreatic stump there is serous fluid, the composition of which depends on the consistency of the stump sutures.

However, serous fluid is also an electrolyte that changes its electrical properties with a change in composition, which indicates a change in the state of stump sutures. For example, in the case of insolvency of the pancreatic stump in the vestibule region formed around the pancreatic stump during surgery, the pancreatic juice flows, which has completely different electrochemical properties. Pancreatic juice is mixed with serous fluid, as a result of which the ion content in the stump area in the tambour cavity changes, which causes a change in the electrical parameters of the electrolyte.

From the known electrolyte indicators, the conductivity index is used to evaluate the studied liquid, which is uniquely determined through the measured voltage drop between the electrodes of the sensor in the liquid. The electrical conductivity most fully reflects the properties of the electrolyte and the methods for measuring it are described in more detail in electrochemistry theory.

There is a need to ensure the sterility of the sensor along with maintaining the electrical properties of its electrodes in the aggressive environment of the vestibule region. Radium alloyed brass was chosen as the material for the electrodes.

In addition to measuring the electrical properties of the fluid surrounding the sensor, it is also necessary to measure the temperature of the patient's vestibule region, which may signal other postoperative complications. For this purpose, a thermistor is integrated in the sensor.

To determine sharp changes in the electrical properties of liquids, as well as the temperature of the patient in the vestibule region, a special sensor is used that is placed in the patient's body in the seam area. It allows you to timely detect emerging complications and perform the necessary surgical intervention. Subsequently, the sensor is removed from the body without surgical intervention.

In a usual situation, the most accessible opportunity for personnel to analyze the composition of the liquid in the vestibule area was drainage, which is associated with a certain risk for the patient and, undoubtedly, much more complicated and less reliable.

Thus, this inventive model has no analogues.

The technical result of the proposed device is the ability to conduct electrolytic diagnostics of the failure of the joints of the esophageal-intestinal or esophageal-gastric anastomoses by analyzing the electrical properties of the serous fluid located in this area.

The technical result is achieved by the fact that the device for conducting early diagnosis of anastomotic insolvency, consisting of two electrodes, a thermistor and a dielectric layer for the mutual insulation of the electrodes, transmits information about the voltage drop between the electrodes, as well as the voltage drop across the thermistor through wires enclosed in a silicone sealed flexible wire to the hardware of the hardware-software complex of early diagnosis of anastomotic insolvency between the hollow organs of the gastrointestinal tract for the purpose of automated analysis of a sample of temperature and conductivity measurements.

The electrode “-” is a brass part (LS59 brand of brass) alloyed with radium, in FIG. 1 is depicted by the number "1". The item has a mushroom shape. The diameter of the wide part is 3.6 mm, the height is 2 mm. On the reverse side of the "cap" is a straight section, 2 mm long and with an external thread under M3, which determines the diameter of this section of the part. On the back side of the “hat” side there is a recess with a depth of 1.5 mm and a diameter of 1 mm. Connected to the wire, which in FIG. 1 is depicted with the number "5". Screwed into the dielectric, which in FIG. 1 is shown at number 4. The detail is shown in FIG. 2.

The electrode “+” is a brass component (brass brand LS59) doped with radium, in FIG. 1 is depicted with the number "2". The item is in the shape of a ring. The outer diameter is 3.6 mm. The width of the ring is 3 mm. On the inside there is a thread under M3, which determines the internal diameter of the part. Screwed onto the holder, which in FIG. 1 is shown under number 8. In addition to the main function, it ensures the tightness of the silicone tube. The detail is shown in FIG. 3.

The holder is a brass part (brass brand LS59). In FIG. 1 is shown at number 8. The part has a complex shape. The total length is 10 mm. On both sides there is an external thread under M3, which determines the diameter of these sections of the part. In the center there is already an area - with a diameter of 2.3 mm and a length of 1.5 mm. The two threaded areas are respectively 4 and 4.5 mm long. Along the entire part there is a through hole with a diameter of 1.6 mm for wires. An electrode “+” is screwed on it (in figure 1 the number “2”), and a dielectric is screwed on it (in figure 1 the number “4”). Connected to the wire, which in FIG. 1 is shown at number "7" (on the inside). The detail is shown in FIG. four.

A thermistor is an electronic component with a deterministic resistance value depending on the degree of heating or cooling. In FIG. 1 is depicted with the number "3". It has a size of "0805", or 2.1 × 1.3 × 0.5 mm. It is also connected by one contact pad to the wire, which in FIG. 1 is depicted with the number "5". Another contact pad is connected to a wire, which in FIG. 1 is shown at number "6".

Between the electrodes is a plastic part - a dielectric. In FIG. 1 is shown at number "4". It is a hollow plastic tube 7.5 mm long with an outer diameter of 4 mm, and with a thread under M3 on the inner diameter. An electrode "-" (in Fig. 1, number "1") and a dielectric (in Fig. 1, number "4") are screwed into this part. The detail is shown in FIG. 5.

Three MGTF wires are also needed. In FIG. 1 are depicted under the numbers "5", "6", "7".

The objective of the utility model "A device for early diagnosis of anastomotic insolvency" is to determine the electrical parameters of the surrounding electrolyte, which is serous fluid in the vestibule region in the patient's suture area.

The constructive ability of the utility model we have developed allows us to diagnose anastomotic insolvency using this sensor many times (with mandatory sterilization of the sensor before each introduction into the patient’s body). Moreover, removing the sensor is possible without surgery.

The essence of the proposed utility model is illustrated in the drawing.

In FIG. 1 schematically shows the entire sensor.

The electrolytic changes in the abdominal cavity of immobilized and anesthetized white outbred rats were scanned using a useful biosensor model. A 15 mm long incision is made on the skin of the animal, the edges of the skin are opened and held. Then the abdominal wall is cut by 5-6 mm and a hole is formed into which the sensor is inserted so that its connector remains outside. Then a suture is applied to the skin of the abdomen with the output of the sensor tube; departing from the seam of 3 mm, medical glue is applied and a medical patch is applied, the dressing is fixed with a sticky bandage with free access to the sensor tube. A series of measurements is taken at intervals of one hour.

The testing of this device was carried out during laboratory studies on the basis of the RNII on 30 laboratory outbred rats. A scan of the biosensor registration indicators of changes in the abdominal cavity of rats with intracavitary administration of free biofluid (serous fluid, pancreatic juice, bile) was performed. In total, 5 series of measurements were made, 6 measurements in each series, with a pause of 90 minutes; The beginning of measurements was carried out from 9 am The data during the measurements were formatted in typical plots of dependencies on the measurement number. A quantitative assessment of the electrolytic analysis in dynamics, using software processing of electrochemical parameters, allowed us to assess the failure of the anastomosis.

The main advantages of the claimed utility model "Device for early diagnosis of anastomosis insolvency" are the ability to implement the sensor directly during the operation, the ability to constantly monitor the condition of the suture area in the postoperative period without the need for drainage, the ability to control the patient’s body temperature and the ability to remove the sensor without surgery expiration of the need for its use.

The proposed "Device for conducting early diagnosis of anastomotic insolvency" can be manufactured industrially using modern materials and technologies, highly efficient, technologically advanced, convenient and reliable.

Claims (8)

1. A device for early diagnosis of insolvency of the anastomosis, which is a biosensor consisting of a sensor for recording parameters of the electrical properties of serous fluid, including: electrode “-” mushroom-shaped with a straight section and with an external thread on the back of the cap, and on the back side there is a recess, a plastic dielectric into which the “-” electrode is screwed, made in the form of a tube with a thread on the inner diameter, a thermistor, which is an electronic component with a deterministic resistance value depending on the degree of heating or cooling, placed in a straight section of the electrode “-”, a holder having an external thread on both sides, and a through hole for the wires is made along the entire holder, the electrode “-” being screwed onto the holder, electrode "+", made in the form of a ring having a thread on the inner side, connected to the holder. 2. The device according to p. 1 is that the diameter of the parameter registration sensor should not exceed 4 mm, the length of the parameter registration sensor should not exceed 30 mm. 3. The device according to claim 1, consists in the fact that the materials used to manufacture the sensor are stainless steel, copper, brass, and medical plastics.

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