Pressure- and aspiration-controlled double cuffed intubation tube control system

Abstract

The invention relates to the intubation tube control system (10) comprising at least one double cuffed intubation tube (1) and at least one pressure- and aspiration-controlling control unit (2) controlling the intubation tube (1) in order to reduce tracheal damage, post-extubating complications, and tracheomalacia caused by an intubation tube (1).

Description

[0001] PRESSURE- AND ASPIRATION-CONTROLLED DOUBLE CUFFED INTUBATION TUBE CONTROL SYSTEM

[0002] Technical Field

[0003] The invention relates to a pressure- and aspiration-controlled double cuffed intubation tube control system for reducing tracheal damage, post-extubating complications, and tracheomalacia caused by the intubation tube used in the present art.

[0004] State of the Art

[0005] Intubation tubes, which are in the known state of the art, are necessary to provide access to the patient's airways during the medical procedure, to give the patient general anesthesia and to ensure adequate breathing by securing the patient's airway. These intubation tubes are mainly used during mechanical ventilation or in cases requiring long-term intubation. These tubes are equipped with a special cuff. Cuffed intubation tubes should be selected in the appropriate size and type and then placed in the trachea.

[0006] The secretion going down the trachea is pushed forward by the breathing (ventilation) process in the bronchi in the branches of the trachea. This secretion contains the contents of the mouth and throat, and the amount of germs in it is high and causes infection in the lungs. Healthy people can remove the secretion accumulated in the trachea by coughing and moving the tracheal ciliated epithelium upwards. However, it is necessary to protect intubated patients from secretion, to reduce and take secretion, and to aspirate. Since the secretion infection accumulated in the trachea causes pneumonia, it causes an increase in the morbidity and mortality of the patient. Therefore, it is necessary to reduce and take all these negativities, that is, secretion formation, and to aspirate.

[0007] On the other hand, the intubation tubes used in the present art contain only one cuff. Since there is only one cuff and it is inflated inside the trachea, pressure is applied to the same spot in the trachea, which disrupts the blood supply to the wall and causes damage to the trachea. It causes the softening and loosening of the tracheal wall (tracheomalacia) and then hardening and narrowing of the trachea (tracheal stenosis). In both cases, respiratory distress may occur and even the patient may need to be operated on. In addition, there is no pressure and aspiration control in said intubation tubes. In addition, although there are intubation tubes containing two cuffs in another known state of the art, tracheal secretion accumulates on the cuffs in said double cuffed tubes and this accumulated secretion is not aspirated. In other words, there are no aspiration ports to aspirate the secretion accumulated in the trachea to the upper parts of the double cuffs contained in said tubes. Therefore, pressure and aspiration control should be performed to reduce tracheal damage, post-extubating complications and tracheomalacia caused by the patient's intubation tube.

[0008] Brief Description of the Invention

[0009] The object of the invention is to realize a pressure- and aspiration-controlled double cuffed intubation tube control system for reducing tracheal damage, post-extubating complications, and tracheomalacia caused by the intubation tube used in the present art.

[0010] With the system subject to the invention, the cuffs of the double-cuffed intubation tube, which is endotracheally intubated and placed in the trachea, are inflated and deflated at certain periods, and the tracheal damage of the endotracheal tube (ETT) and the tracheal secretion accumulated on the cuffs are minimized. In order to prevent the negativities in the intubation tubes used in the present art, two cuffs are preferably used in the invention and the cuffs are inflated and deflated one after the other at predetermined periods and the secretions on the cuffs are aspirated between the periods. While the first cuff is inflated, the secretion in the upper part of the trachea is aspirated, on the other hand, the second cuff is inflated and air leakage is prevented. Therefore, with the invention, it is ensured that the secretion collected around the cuffs of the ETT is also aspirated intermittently and in a balanced manner. Thus, the secretion collected in the trachea is prevented from causing lung infection.

[0011] Descriptions of the Figures

[0012] Figure 1. A representative view of the system comprising the single cuffed intubation tube and at least one external manometer-controlling control device of the prior art.

[0013] Figure 2. A representative view of the system of the intubation tube of the invention comprising the fully automatic control unit of the intubation tube. Figure 3.A block diagram of the intubation tube control unit developed for the intubation tube comprising two cuffs, A and B, in the preferred embodiment of the invention.

[0014] Figure 4. A representative view of the two cuffed intubation tubes contained in the system subject to the invention.

[0015] Figure 5. A block diagram of the intubation tube control unit contained in the system subject to the invention.

[0016] Description of References in Figures

[0017] The corresponding numbers in the figures are given below in order to better understand the invention:

[0018] 10. System

[0019] 1. Intubation tube

[0020] 1.1. Body

[0021] 1.2. Connector

[0022] 1.3. Radiopaque line

[0023] 1.4. Pilot balloon

[0024] 1.4.1. Valve

[0025] 1.5. Connection tubing

[0026] 1.6. First Cuff

[0027] 1.7. Second Cuff

[0028] 1.8. Hole

[0029] 1.9. Outlet end

[0030] 1.9.1. First outlet opening

[0031] 2. Intubation tube control unit

[0032] 2.1. Pressure control module

[0033] 2.2. Timing module

[0034] 2.3. Pump module

[0035] 2.4. Aspiration control module

[0036] 2.4.1. Electronic valve

[0037] 2.5. Main control module

[0038] CU. A control unit included in the prior art and operating only in recording mode

[0039] M. Manometer VC. Vocal cords

[0040] T. Trachea

[0041] CPL. Cuff pressure line / connection / tubing

[0042] SL. Suction lumen / line

[0043] CO2 Lumen. Carbon dioxide suction and analysis tubing / lumen / duct

[0044] P. Period button

[0045] S. Period time set button

[0046] TS. Time set

[0047] TSCD. Time set countdown

[0048] PA. Pressure of cuff A

[0049] PB. Pressure of cuff B

[0050] On / Off. Aspirator on / off button

[0051] Open / close. Button that turns the alarm on and off

[0052] TTC. Total time counter with the device active

[0053] CS. Connection status of the device

[0054] CA. Connection of cuff A

[0055] CB. Connection of cuff B

[0056] CIL. Cuff inflation line

[0057] AP. Air provision to the cavity between cuffs

[0058] Detailed Description of the Invention

[0059] The intubation tube control system (10) of the invention comprises at least one intubation tube (1) and at least one control unit (2) controlling the intubation tube (1) in order to reduce tracheal damage, post-extubating complications, and tracheomalacia caused by an intubation tube (1) used in the present art.

[0060] In particular, the intubation tube (1) included in the intubation tube control system (10) of the invention in order to prevent or minimize all complications by providing a homogeneous distribution of positive compressed air to the lung trachea and bronchi, comprises the following: a) at least one cylindrical body (1.1) of a predetermined length and thickness, with two ends open, hollow and at least one length marking, for providing air passage, b) at least one connector (1.2) at one end of said body (1.1), c) at least two radiopaque lines (1.3) on said body (1.1), preferably in a region close to the end of said connector (1.2) and used for determining the position of said body (1.1), d) at least one pilot balloon (1.4) separated from an opening on the body (1.1) by a connection tubing (1.5), e) at least one first cuff (1.6) and at least one second cuff (1.7) at the other end of the body (1.1) without the connector (1.2) and at a predetermined distance from each other, and f) at least one hole (1.8) positioned between the first cuff (1.6) and the second cuff (1.7), and g) an outlet end (1.9) (Bevel) at the bottom of the first cuff (1.6) at the other end of the body (1.1) without the connector (1.2), increasing the forward and both-way orientation of the inlet air.

[0061] In one embodiment of the invention, the outlet end (1.9) comprises a first outlet opening (1.9.1) and / or a second outlet opening (not shown and numbered in the figures) in different geometric diameters and forms facing each other.

[0062] The pilot balloon (1.4) comprises at least one one one-way valve (1.4.1) that allows one-way air passage.

[0063] The cuff is at a predetermined distance from each other in the preferred embodiment of the invention and consists of two pieces. The tracheal secretion accumulated on the cuffs is aspirated. In other words, there are aspiration ports in the upper parts of the double cuffs to aspirate the secretion accumulated in the trachea. In other words, the intubation tube (1) preferably comprises two cuffs containing at least one aspiration port to reduce tracheal damage and prevent secretion from descending to the lungs and lung infection by aspirating the secretion.

[0064] Double cuffed intubation tube control unit (2) of the invention comprises at least one pressure control module (2.1) that continuously measures the pressure of both cuffs in real time, generates a signal for the activation of a pump module (2.3) and generates a signal for the activation of an aspiration control module (2.4), at least one timing module (2.2) that generates the signal necessary for the cuffs to inflate and deflate and enables said pump module to be activated, at least one pump module (2.3) that activates at least one pump motor for the inflation of the cuffs, selects the relay according to the cuff to be inflated, and also selects the relay of the cuff to be depressurized and reduces the pressure, at least one aspiration control module (2.4) operating an aspirator circuit that may be within the device at specified time intervals or operating the aspirator circuit connected to the central system or capable of generating the signal to operate the mobile aspirator device, and at least one main control module (2.5) that enables the management of at least one touch screen and the communication of all control modules.

[0065] The timing module (2.2) comprises three-time intervals as 5, 10, 15-minute periods set as standard. The periods refer to the time when each cuff will remain inflated. The cuffs are inflated and deflated one after the other at predetermined periods and the secretions on the cuffs are aspirated between the periods. While the first cuff (1.6) is inflated, the secretion in the upper part of the trachea is aspirated, on the other hand, the second cuff (1.7) is inflated and air leakage is prevented. In addition, the timing module (2.2) comprises a time interval set by the user. The time interval is from 1 minute to 180 minutes.

[0066] Network connections, power module, battery status, alarm, fault, error and all similar controls are controlled by the main control module (2.5).

[0067] In one embodiment of the invention, the aspiration control module (2.4) comprises at least one electronic valve (2.4.1) for remote control of the central aspiration system.

[0068] Industrial Applicability

[0069] The invention relates to the intubation tube control system (10) for reducing tracheal damage, post-extubating complications and tracheomalacia caused by the intubation tube and is applicable to the industry.

[0070] The invention is not limited to the above explanations; however, a person skilled in the art can easily present different embodiments of the invention. They must be assessed within the scope of the protection claimed by the claims of the invention.

Claims

CLAIMS1. An intubation tube control system, comprising the following to reduce tracheal damage, post extubation complications, and tracheomalacia caused by an intubation tube (1) used in the present art: a) at least one cylindrical body (1.1) of a predetermined length and thickness, with two ends open, hollow and at least one length marking, for providing air passage, b) at least one connector (1.2) at one end of said body (1.1), c) at least two radiopaque lines (1.3) on said body (1.1), preferably in a region close to the end of said connector (1.2) and used for determining the position of said body (1.1), at least one intubation tube (1) comprising at least one pilot balloon (1.4) and at least one suction port separated from an opening on the body (1.1) by a connection tubing (1 5), characterized in that it comprises the following d) at least one first cuff (1.6) and at least one second cuff (1.7) at the other end of the body (1.1) without the connector (1.2) and at a predetermined distance from each other, and e) at least one hole (1.8) positioned between the first cuff (1.6) and the second cuff (1-7), f) an intubation tube (1) comprising an outlet end (1.9) (Bevel) at the bottom of the first cuff (1.6) at the other end of the body (1.1) without the connector (1.2), increasing the forward and both-way orientation of the inlet air, and at least one control unit (2) comprising at least one pressure control module (2.1) that continuously measures the pressure of both cuffs in real time, generates a signal for the activation of a pump module (2.3) and generates a signal for the activation of an aspiration control module (2.4), at least one timing module (2.2) that generates the signal necessary for the cuffs to inflate and deflate and enables said pump module to be activated, at least one pump module (2.3) that activates at least one pump motor for the inflation of the cuffs, selects the relay according to the cuff to be inflated, and also selects the relay of the cuff to be depressurized and reduces the pressure, at least one aspiration control module (2.4) operating an aspirator circuit that may be within the device at specified time intervals or operating the aspirator circuit connected to thecentral system or capable of generating the signal to operate the mobile aspirator device, and at least one main control module (2.5) that enables the management of at least one touch screen and the communication of all control modules, therefore, controlling the said intubation tube (1).

2. An intubation tube control system (10) according to claim 1, characterized by an outlet end (1.9) comprising a first outlet opening (1.9.1) and / or a second outlet opening (not shown and not numbered in the figures) with different geometric diameter and shape facing each other.

3. An intubation tube control system (10) according to claim 2, characterized by a pilot balloon (1.4) comprising at least one one-way valve (1.4.1) that allows air to pass in one direction only.

4. An intubation tube control system (10) according to claim 3, characterized by a timing module (2.2) comprising three-time intervals as 5, 10, 15-minute periods set as standard.

5. An intubation tube control system (10) according to claim 4, characterized by a timing module (2.2) with a time interval set by the user between 1 minute and 180 minutes.

6. An intubation tube control system (10) according to claim 5, characterized by a main control module (2.5) that performs all controls such as network connections, power module, battery status, alarms, faults, errors, and similar functions.

7. An intubation tube control system (10) according to claim 6, characterized by an aspiration control module (2.4) comprising at least one electronic valve (2.4.1) for remote control of the central aspiration system.

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