TRACHEAL INTUBATION FACILITATOR WITH SUPERIOR VENTILATING CAPABILITY, WITH A SYSTEM TO ACCURATELY PLACE ENDOBRONCHIAL TUBES IN THE DESIRED BRONCHUS

Abstract

We describe a Tracheal Tube insertion facilitator (modified bougie) with superior ventilating capability to enable medical/paramedical personnel to place tracheal/bronchial tubes reliably in trachea/bronchus of the patients under anaesthesia or patients in respiratory distress, and provide respiratory support. This device is particularly useful in situations where the conventional tracheal intubation technique using a laryngoscope is difficult or near impossible. This device has a outer cylindrical member, inner hollow stylet and a dynamic cuff which inflates during Positive Pressure Ventilation/Jet ventilation, and hence enabling oxygenation in patients with respiratory distress even before the tracheal tube is inserted into the patient's airway.

Claims

1. This is a Tracheal Tube Insertion Facilitator (modified bougie) with a) An outer cylindrical member with a proximal end and a distal tip which is bent forwards b) An inner hollow stylet with a proximal end and a distal end which serves the dual purpose of providing strength to the bougie as well as enabling jet ventilation through its ports.

2. The outer cylindrical member as set forth in claim 1 houses a Dynamic cuff whose inner surface is fluidly communicating with the inner lumen of the outer cylindrical member, enabling it to mimic the intraluminal pressures accurately without any time lag or pressure gradient, thereby facilitating its inflation during Positive Pressure Ventilation (PPV) and Jet Ventilation.

3. The dynamic cuff as set forth in claim 2, inflates during positive pressure ventilation preventing the leak through nose and mouth, during the inspiratory phase of the respiratory cycle.

4. The dynamic cuff as set forth in claim 2, deflates during expiratory phase of respiratory cycle leading to easy escape of expired gases around the outer surface of the modified bougie, exiting through the nasal and oral cavities.

5. An outer cylindrical member as set forth in claim 1 in which at/near its distal tip, lie ventilating ports in connection with the tube lumen for the purpose of ventilation.

6. An outer cylindrical member as set forth in claim 1 on whose body lie several apertures (inflation ports) over which lies the dynamic cuff and is in fluid continuity with the inner lumen of the bougie for the purpose of inflation of dynamic cuff during inspiration and deflation of cuff during expiration.

7. A modified bougie as set forth in claim 1, whose body has vibratory transmission properties such that contact between the distal end of the body with tracheal rings in the airway of the person can be felt by a user holding the proximal end, while attempting intubation.

8. The outer cylindrical member as set forth in claim 1, has markings in centimetres/any suitable units starting from the distal tip till the proximal tip, enabling identification of the level of insertion.

9. The outer cylindrical member as set forth in claim 1, is divided at the 35 cm mark from the distal end into a proximal portion and a distal portion.

10. The proximal portion of the outer cylindrical member as set forth in claim 9, coloured differently and has a different texture, enabling easy detection if the device is accidentally inserted into the esophagus instead of trachea.

11. The distal portion of the outer cylindrical member as set forth in claim 9, is coloured longitudinally in such a way the Right half and Left half of the device have different, suitably contrasting colours, enabling identification and accurate bronchial placement of the distal tip in the appropriate side.

12. The proximal end of the outer cylindrical member as set forth in claim 1, is connected to the distal end of a specialized connector, which creates an airtight seal by enveloping the outer cylindrical member from the outside.

13. The outer cylindrical member as set forth in claim 1, wherein its distal tip is flexible for in situ manipulation if the larynx lies anteriorly.

14. A tracheal tube introducer as set forth in claim 1, whose lumen can be used as a conduit for bronchoscopic confirmation and bronchial lavage.

15. A tracheal tube introducer as set forth in claim 1, whose lumen can be utilized for tracheal, bronchial suctioning and bronchial lavage, without requiring the use of a bronchoscope.

16. The inner hollow stylet as set forth in claim 1, has a proximal end to which a jet ventilation system can be connected to enable the ventilation of the patient

17. The inner hollow stylet as set forth in claim 1, has multiple small apertures near its distal end, coinciding with the position of the dynamic cuff situated over the outer cylindrical member, thereby, inflating the dynamic cuff through the inflation ports on the outer cylindrical member.

Description

DETAILED DESCRIPTION OF INVENTION

[0038] FIG. 1 is a longitudinal section of the Tracheal Tube Insertion Facilitator (modified bougie). It shows the different component of the apparatus which consists of body (1), dynamic inflatable cuff (2), bougie inflation ports (3), bougie ventilation ports (4), distal bougie tip (5), hollow stylet (6), dual purpose stylet inflation/ventilation ports (7), stylet distal tip (8), universal connector (9).

Further diagrams explain each component of the Bougie in detail.

[0039] FIG. 2 shows the bougie's ventilation ports (4), distal tip of the bougie (5), distal tip of the stylet (8). The two ventilation ports (4) lies on the lateral aspects of the bougie, in between the distal tip and the dynamic cuff and are in connection with the bougie lumen for the purpose of ventilation. The distal bougie tip (5), is bent forward with an angle of about 45 degrees. The stylet's distal tip (8) helps in ventilation during dire emergency situations where stylet can directly be attached to a jet ventilation device.

[0040] FIG. 3 shows the body (1), dynamic cuff (2), bougie inflation port (3), dual purpose stylet inflation/ventilation port (7), stylet (6). The body (1) can be made up of plastic or silicon or PVC or any suitable material and acts as a channel for inspiration and expiration of the air/oxygen. The body is malleable and can be bend with force and non kinkable. It has vibratory transmission properties such that when the distal tip comes into contact with tracheal rings and when moved over the rings, grating sensation is felt at the proximal end.

[0041] The dynamic cuff (2), can be made up of silicone, rubber, polythene or any suitable material. This dynamic cuff inflates during inspiration so that the sides of the cuff come into contact with tracheal mucosa, creating the seal so that the air/oxygen delivered through AMBU bag/ventilation circuit will be delivered into the bronchial tree, preventing the leak through nose and mouth during inspiration. This cuff deflates during expiration leading to easy escape of expired gases through the nasal and oral cavity.

[0042] The multiple inflation ports (3), which lies within the tube lumen, communicate into the lumen of the dynamic cuff and, helps in inflation of dynamic cuff during inspiration. Since the luminal pressure falls during deflation of the AMBU bag/Ventilation circuit, the dynamic cuff collapses and allows the expiration to begin, enabling the exhaled air to escape through the sides of the cuff, into the oral cavity and nostrils.

[0043] The stylet has side ports (7) coinciding with the inflation ports (3) on the body of the apparatus. These ports help in inflating the dynamic cuff when the stylet is used to ventilate using a jet ventilation device (venturi) during emergency situations.

[0044] The dual purpose stylet inflation/ventilation port (7), helps in inflation of the dynamic cuff as well as ventilation through it. Hence its dual purpose helps in preventing air leak by inflating the dynamic cuff as well as helps in ventilating the patient's lungs.

[0045] The stylet (6) is made up of a suitable metal and beside serving its purpose of ventilation it also gives strength to the bougie.

[0046] FIG. 4 shows tube body (1), universal connector (9), stylet (6). The 15 mm standard universal connector (9), is made up of hard plastic and connects to the body for the ventilation purpose.

Next five figures show the working of the apparatus as a whole.

[0047] FIG. 5 shows the inflation of the dynamic cuff during the inspiration when the stylet is inside the bougie and stylet proximal end is connected to the jet ventilation cannula.

[0048] FIG. 6 shows the inflation of the dynamic cuff during the inspiration when the stylet is not there and the bougie is connected to the universal connector which can be connected to the ambu bag or any oxygen tubings.

[0049] FIG. 7 shows the deflation of the dynamic cuff during the expiration. It also shows the neutral position of the distal flexible tip which is bent about 45 degree anteriorly.

[0050] FIG. 8 shows the modified bougie in the patient's airway which is put through the mouth, wherein the dynamic cuff lies inside the trachea, and deflates during expiration. Hence the expired gases exits through two channels one through the natural airway (sides of the bougiemouth/nostrils) and other through the lumen of the bougie. This results in complete expiration with no residual expired gas left behind or getting trapped, thereby preventing barotrauma to lungs.

[0051] FIG. 9 shows the modified bougie in the patient's airway, which is put through the mouth, wherein the dynamic cuff lies inside the trachea, which inflates during inspiration and helps in sealing the trachea from within thereby helps in preventing the backflow of the air through the mouth or nose during the inspiration, hence maximum amount of air goes into the lung for respiration which helps in proper ventilation of the lungs. Different sizes are available which can be used in patients of variable age.

[0052] A single embodiment of the invention has been described herein. Many a variation could be made without departing from the spirit of invention. Another invention pertaining to the same device is shown in FIGS. 1A and 1B:

Where in, modified bougie, the distal tip (5a) is made flexible and attached via flexi-tip cord (6a) to a button (7a) with serrated markings (8a). These three black serrated markings on the body, help in achieving the desired angle of distal flexible tip. Where each marking above to previous corresponds to further bend of 10 degree. While the flexi-tip cord helps in flexing the distal tip at the predecided angle fixed by the serrated markings.

[0053] FIG. 1A is a longitudinal section of the modified bougie. It shows the different component of the apparatus which consists of body (1a), dynamic inflatable cuff (2a), inflation ports (3a), ventilation ports (4a), flexible distal tip (5a), button (7a) with serrated markings (8a), flexi tip cord (6a), universal connector (9a). It also shows the neutral position of the distal flexible tip which is at 45 degree anteriorly and corresponds to the +1 marking on the body

[0054] FIG. 1B shows the distal flexible tip of the modified bougie at 10 degree anteriorly (over and above the 45 degree anteflexion) which corresponds to the +2 marking on the body, it helps in passing through the laryngeal inlet if it lies anteriorly.

[0055] Usually the neutral position of the distal tip in this modified bougie is 45 degree flexion which corresponds to the :+1 marking on the body.

[0056] Another invention pertaining to the same device is shown in FIGURE XX: This invention will aid in endobronchial tube placement and visual confirmation of the same. Where in, modified ventilating bougie, describe above, the distal end of the body, till the 35 cm mark, will be colored in such a way that, longitudinally, the Right half will be in one colour and the Left half will be in another colour of sufficient contrast (For ex: Right half of the tube can be white and Left half can be blue)

[0057] Another invention pertaining to the same device is shown in FIGURE XX, wherein the modified ventilating bougie will have a different colour in is proximal portion, that is beginning from the 35 cm mark till the proximal end. The appearance of this colour at the level of the lip will indicate that the distal end of the modified bougie is lying in the oesophagus and not in the trachea.

[0058] By virtue of the bent distal tip, which is bent at 45 degrees anteriorly, when the distal tip enters the Right bronchus, the Left half of the bougie will face anteriorly at the level of the lips, which can be immediately recognized by the colour code (i.e, Blue colour anteriorly at the mouth). The vice versa is true when the distal tip is placed at the Left bronchus (i.e, White colour anteriorly at the mouth). This will give a visual confirmation of the placement of the tip of the bougie in the desired bronchus. (FIG. NO. XX)

[0059] The body of the bougie will be marked in centimetres from the distal tip till the proximal tip. This will enable the physician to know how much of the bougie has entered the airway.