Tracheal intubation facilitator with superior ventilating capability

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. A tracheal tube insertion facilitator having capability of ventilating a human or an animal, comprising: a) an outer cylindrical member with a proximal end, a hollow body and a distal tip which is configured to bend forward; wherein the outer cylindrical member near its distal tip houses one or more ventilation ports that is in fluid communication with an inner lumen of the outer cylindrical member allowing escape of ventilated gases into lungs; a self-inflating dynamic cuff disposed on a portion of the outer cylindrical member, proximal to the ventilation ports, said self-inflating dynamic cuff including an inner surface being in fluid communication with the inner lumen of the outer cylindrical member through inflation ports and configured to mimic intraluminal pressures without any time lag or pressure gradient, thereby facilitating inflation of the self-inflating dynamic cuff during positive pressure ventilation (PPV) and jet ventilation; b) a hollow metallic stylet with a proximal end, a hollow body and a distal end, the hollow metallic stylet being positioned in the inner lumen of the outer cylindrical member; wherein the hollow metallic stylet is configured to support the outer cylindrical member and provide jet ventilation through an interior of the hollow metallic stylet; wherein the body of the hollow metallic stylet houses one or more inflation apertures at a position enclosed by the self-inflating dynamic cuff; wherein the air from jet ventilation into the hollow metallic stylet, traverses through the inflation apertures to the inflation ports.

2. The tracheal tube insertion facilitator of claim 1, wherein the self-inflating dynamic cuff inflates during positive pressure ventilation and seals a tracheal lumen, thereby preventing the escape of respiratory gases to the nose and mouth, during an inspiratory phase of a respiratory cycle.

3. The tracheal tube insertion facilitator of claim 1, wherein the self-inflating dynamic cuff is configured to deflate during an expiratory phase of a respiratory cycle, and configured to allow expired gases to escape around the outer surface of the outer cylindrical member, and exit through nasal and oral cavities of the human or the animal.

4. The tracheal tube insertion facilitator of claim 1, wherein the body of the outer cylindrical member has vibration transmitting properties.

5. The tracheal tube insertion facilitator of claim 1, wherein the outer cylindrical member has markings starting from the distal tip till the proximal end, enabling identification of level of insertion.

6. The tracheal tube insertion facilitator of claim 1, wherein the outer cylindrical member is divided into a distal portion and a proximal portion about 35 centimeters from the distal tip.

7. The tracheal tube insertion facilitator of claim 6, wherein the proximal portion of the outer cylindrical member has a different color and texture than the distal portion of the outer cylindrical member.

8. The tracheal tube insertion facilitator of claim 6, wherein the distal portion of the outer cylindrical member is colored longitudinally in contrasting colors to demarcate the hollow body of the outer cylindrical member into a right half and a left half, enabling identification and accurate placement of the distal tip in the desired bronchus.

9. The tracheal tube insertion facilitator of claim 1, wherein the proximal end of the outer cylindrical member is connected to a specialized connector configured to create an airtight seal enabling positive pressure ventilation (PPV) or jet ventilation.

10. The tracheal tube insertion facilitator of claim 1, wherein the proximal end of the hollow metallic stylet is configured to work with a jet ventilation system.

Description

OBJECTS OF THE INVENTION

(1) The main object of this invention is to give a Tracheal Tube Insertion Facilitator (modified bougie) to ensure adequate oxygenation during difficulty in tracheal intubation.

(2) Another object of this invention is to ensure adequate oxygenation and removal of carbon di oxide from the lungs.

(3) Still another object of this invention is to enable confirmation of tracheal placement of the bougie by auscultation of the chest during positive pressure ventilation (PPV).

(4) Yet another object is to give a modified bougie which helps in exchanging an existing tracheal tube with a new tube without the need of laryngoscopy

(5) Still another object is to provide tracheal tube introducer with a flexible distal tip, which can be maneuverer while attempting intubation, so that difficult intubations can be made easier.

(6) Another object is to give a modified ventilation bougie where its 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 of the body while inserting the bougie device into the airway.

(7) Another object is to give a modified bougie where chances of reinsertion, hypoxia and hyperdynamic response are minimized.

(8) Further object is to give a modified bougie with a system enabling proper bronchial placement of Double lumen tubes (DLT)/Bronchial tubes by using a colour/texture coding system.

(9) Further object is to give a modified bougie with a system to detect accidental oesophageal insertion of the device by using a colour/texture coding system.

(10) Yet further object of the modified bougie is to enable tracheal/bronchial suction and lavage through the lumen of the introducer (bougie)

(11) Still further object of the modified bougie is to enable fiberoptic bronchosopy either through its lumen or through an inbuilt mechanism.

(12) A still further object of the device is to provide a modified bougie with a specialized connector which fits on the proximal end of the outer cylindrical member from outside.

(13) Still further object is to give a modified ventilation bougie which can be used in any age group. Yet further object is to give a cost effective modified bougie by making it reusable.

DETAILED DESCRIPTION OF INVENTION

(14) 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).

(15) Further diagrams explain each component of the Bougie in detail.

(16) 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.

(17) 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.

(18) 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.

(19) 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.

(20) 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.

(21) 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.

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

(23) 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.

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

(25) 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.

(26) 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.

(27) 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.

(28) 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.

(29) 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.

(30) 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:

(31) 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.

(32) 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

(33) 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.

(34) 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.

(35) 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)

(36) 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.

(37) 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)

(38) 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.