ENDOTRACHEAL INTUBATION DEVICE

Abstract

An endotracheal intubation device has a flexible main tube having an outer end and a patient end for permitting passage of air from an environment outside a patient into a trachea of the patient when the patient is intubated with the device. An inflatable and deflatable balloon is attached to the main tube at a position closer to the patient end than the outer end of the main tube. The balloon is inflatable in the trachea to immobilize the main tube in the trachea. The balloon has a wall and the wall has a recess in a top surface thereof for collecting fluid secretions of the patient intubated with the device to prevent the fluid secretions from passing down the trachea into lungs when the balloon is deflated in the trachea. Preventing fluid from reaching the lungs when the device is removed reduces risk of ventilator associated pneumonia (VAP).

Claims

1. An endotracheal intubation device comprising: a flexible main tube having an outer end and a patient end for permitting passage of air from an environment outside a patient into a trachea of the patient when the patient is intubated with the device; and, an inflatable and deflatable balloon attached to the main tube at a position closer to the patient end than the outer end of the main tube, the balloon inflatable in the trachea to immobilize the main tube in the trachea when the patient is intubated with the device, the balloon comprising a wall and the wall having a recess in a top surface thereof for collecting fluid secretions of the patient intubated with the device to prevent the fluid secretions from passing down the trachea into lungs of the patient when the balloon is deflated in the trachea.

2. The device of claim 1, wherein the recess is concave.

3. The device of claim 1, wherein the recess comprises a pocket open to the trachea between the wall of the balloon and an outer surface of the main tube.

4. The device of claim 1, wherein the recess forms a cup on the top surface of the balloon within which the fluid secretions pool to be prevented from passing down through the trachea into the lungs.

5. The device of claim 1, wherein the balloon forms a cuff around the main tube whereby a patient end portion of the wall of the balloon is sealingly attached to an outer surface portion of the main tube, and the recess comprises an annular volume between the wall of the balloon and the outer surface portion of the main tube open to the trachea above the sealing attachment of the wall of the balloon to the outer surface of the main tube.

6. The device of claim 2, wherein the recess is maintained by struts between the wall of the balloon and the outer surface of the main tube.

7. The device of claim 1, wherein the balloon comprises a lumen created by the wall of the balloon, whereby the wall of the balloon where the lumen is created wraps around the main tube and is connected to the main tube in an airtight manner around the main tube at a first place closer to the outer end of the main tube and at a second place closer to the patient end of the main tube.

8. The device of claim 1, wherein the balloon is symmetrical around a centerline of the main tube.

9. The device of claim 1, wherein the balloon comprises a flexible plastic material that allows the balloon to inflate to a configuration that blocks the trachea and deflate to a configuration that allows removal of the device from the trachea without loss of shape or material integrity of the balloon.

10. The device of claim 1, further comprising an inflating tube for inflating and deflating the balloon, the inflating tube providing fluid connection between an interior of the balloon and the environment outside the patient when the patient is intubated with the device.

11. The device of claim 1, further comprising a draining tube for draining fluid secretions from the recessed portion, the draining tube providing fluid connection between the recess and the environment outside the patient when the patient is intubated with the device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] For clearer understanding, preferred embodiments will now be described in detail by way of example, with reference to the accompanying drawings, in which:

[0028] FIG. 1 depicts a prior art endotracheal intubation device showing a larger flexible main tube and a smaller inflation tube for inflating and deflating a balloon at a patient end of the main tube;

[0029] FIG. 2 depicts the endotracheal intubation device of FIG. 1 in place within the trachea of an unconscious patient with the balloon at the patient end inflated;

[0030] FIG. 3 depicts a schematic drawing of an endotracheal intubation (ETT) device of the present invention with an inflated cuff balloon;

[0031] FIG. 4A depicts a magnified view of a balloon section of the endotracheal intubation device of FIG. 3;

[0032] FIG. 4B depicts the balloon shown in FIG. 4A disassociated from the main tube and other tubes;

[0033] FIG. 5 depicts an oblique view of the balloon section of FIG. 4A, where the near field view is a top side of the balloon and main tube, the far field is the patient end of the main tube that is deepest in a trachea, and the view shows a cup formed by a top surface of the inflated balloon integral with the main tube;

[0034] FIG. 6 depicts a lateral view across the top surface of the inflated balloon in the balloon section of FIG. 5;

[0035] FIG. 7 depicts a top view of the top surface of the inflated balloon of FIG. 6; and,

[0036] FIG. 8 depicts a lateral view of the inflated balloon of FIG. 6.

DETAILED DESCRIPTION

[0037] With reference to FIG. 3 to FIG. 8, a preferred embodiment of an endotracheal intubation device 1 of the present invention comprises a flexible plastic main tube 10. The main tube 10 has two ends 12, 14, where one end is an outer end 12 (also called a machine end), which is the end that remains exterior to a patient when the endotracheal intubation device 1 is positioned within a trachea of the patient, and where another end is a patient end 14, which is the end that is deepest within the patient when the endotracheal intubation device 1 is positioned within the trachea.

[0038] In a preferred embodiment the main tube 10 may comprise a medical grade polyvinyl chloride, which is a clear flexible plastic. In other embodiments the main tube may be composed of silicone rubber, latex rubber, polypropylene, polyethylene, polystyrene, polyethylene terephthalate or any other clear flexible plastic, semi-opaque flexible plastic or opaque flexible plastic. Preferably, the plastic of the main tube is safe for use in human patients according to appropriate regulatory agencies.

[0039] The main tube 10 preferably has an inner diameter in a range of from 2.5 mm to 5.5 mm for pediatric patients or 4 mm to 9 mm for adult patients. The main tube 10 may be manufactured in multiple sizes of inner diameter at discrete increments between the above-mentioned ranges of diameters. Wall thickness of main tube 10 may be between 0.65 mm and 1.2 mm. However, the wall thickness may be greater provided flexibility of the main tube 10 is maintained. The main tube 10 may have a length of between 8 cm and 18 cm for pediatric patients or 18 cm and 21 cm for adult patients. The main tube 10 may be manufactured in multiple tube lengths at discrete increments between the above-mentioned ranges of lengths.

[0040] The machine end 12 of the main tube 10 may be fitted with a connector 16 having a flange 18, which is used for connecting the main tube 10 to an airbag or mechanical ventilator as with a conventional endotracheal intubation device. The patient end 14 of the main tube 10 may be cut with a beveled end. In other embodiments, the patient end may be a butt end or a second hole may be provided in the wall of the main tube near the patient end (not shown) as with conventional endotracheal intubation devices.

[0041] The main tube 10 may comprise permanent visible markings 20 (only one labeled), which may be integral within the plastic of the main tube 10 to indicate the depth of the main tube 10 within the trachea. The main tube 10 may also have a radio-opaque wire 22 running along a length of the main tube 10, which is integral within the plastic of the main tube 10 or is adhered to an inside or outside of the main tube 10. The wire 22 is present so that the main tube 10 may be visualized with x-ray and computed tomography medical imaging.

[0042] The endotracheal intubation device 1 further comprises an inflatable and deflatable cuff balloon 24 attached to the main tube 10 closer to the patient end 14 of the main tube 10 than to the machine end 12. When the endotracheal intubation device 1 is positioned correctly within the trachea of the patient the balloon 24 is deep in relation to the vocal folds. The balloon 24, when inflated, holds the main tube 10 in place within the trachea by applying outward pressure on the inner wall of the trachea and upward pressure on the inferior surface of the vocal folds.

[0043] The balloon 24 comprises a lumen 43 created by a single flexible wall 26 of the balloon 24, the wall 26 attached to the main tube 10 at both ends of the lumen 43. The balloon wall 26 wraps around the main tube 10 and is connected in an airtight manner around the main tube 10 in two places: a first place 28 closer to the machine end 12 and a second place 30 closer to the patient end 14 of the main tube 10.

[0044] The balloon wall 26 is symmetrical around a centerline of the main tube 10. The balloon wall 26 preferably comprises a medical grade polyvinyl chloride, which is a clear flexible plastic. In other embodiments the balloon wall may be composed of silicone rubber, latex rubber, polypropylene, polyethylene, polystyrene, polyethylene terephthalate or any other clear flexible plastic, semi-opaque flexible plastic or opaque flexible plastic. The material of the balloon wall 26 is preferably flexible enough to allow the balloon 24 to inflate to the desired configuration and deflate to a configuration that allows for the endotracheal intubation device 1 to be removed from the trachea without loss of shape or material integrity. Also, the material of the balloon wall 26 is preferably flexible enough so that the balloon 24 can be inflated and deflated using a hand operated syringe without excessive resistance. Preferably, the plastic of the balloon wall 26 is safe for use in human patients according to appropriate regulatory agencies.

[0045] The balloon 24 may be inflated via an inflating tube 32 that runs along the main tube 10 on either the inner or outer surfaces of the main tube 10. The inflating tube 32 may leave the main tube 10 at some point along the length of the main tube 10 and is separate from the main tube 10 at the machine end 12 of the main tube 10. In another embodiment, the inflating tube may integral with the main tube along the entire length of he inflating tube. The balloon 24 may be inflated by forcing air into an out-of-patient end 34 of the inflating tube 32 with a syringe (not shown), which is temporarily attached to the inflating tube 32 at syringe connector 36. The balloon 24 may be deflated by forcing air out of the end 34 of the inflating tube 32 with a syringe that is temporarily attached at the syringe connector 36.

[0046] The balloon 24 comprises a concave recess 38 on a machine side (i.e. in a top surface 37) of the balloon 24. The recess 38 is created by the flexible wall 26 of the balloon 24 at the top surface 37 not attaching flush to main tube 10. Rather the recess 38 deepens to comprise a pocket 40 between the wall 26 of the balloon 24 and the main tube 10 bottoming where the wall 26 of the balloon 24 attaches at the first place 28 to the main tube 10. The balloon wall 26 at a patient end of the balloon 24 attaches flush with the main tube 10 of the endotracheal intubation device 1 at the second place 30 on the main tube 10.

[0047] The recess 38 in the top surface 37 of the balloon 24 may be accessed by a small diameter draining tube 42 that runs along the main tube 10 on either the inner or outer surfaces of the main tube 10. This draining tube 42 is used for draining fluids from the recess 38 of the balloon 24 without the need for removing the endotracheal intubation device 1 from the patient. The draining tube 42 may leave the main tube 10 at some point along the length of the main tube 10 and is separate from the main tube 10 at the machine end 12 of the main tube 10. In another embodiment, the draining tube may be integral with the main tube along its entire length. The recess 38 may be drained via the draining tube 42 by temporarily attaching a hand syringe (not shown) at an out-of-patient end 44 of the draining tube 42 and drawing the fluid into the syringe. In another embodiment, the recess 38 may be drained by temporarily attaching a suctioning device onto the end 44 of the draining tube 42 and suctioning the fluid out.

[0048] The recess 38 in the top surface 37 of the balloon 24 may be maintained by the stiffness of balloon wall 26 while it is inflated. However, the recess 38 may be further maintained by stiff struts 46 located between the balloon wall 26 and an outer surface of the main tube 10. The stiff struts may be formed in an annular support collar 49 disposed between the balloon wall 26 and the main tube 10. The number of struts may be one, or more than one. The struts 46 may comprise polyvinyl chloride, but in other embodiments, the struts can be composed of silicone rubber, latex rubber, polypropylene, polyethylene, polystyrene, polyethylene terephthalate or any other clear flexible plastic, semi-opaque flexible plastic or opaque flexible plastic. Preferably, the plastic of the struts 26 is safe for use in human patients according to appropriate regulatory agencies.

[0049] The endotracheal intubation device disclosed herein features a recess in the top surface of the cuff balloon. The cuff balloon serves to hold the device in position in the trachea of the patient when inflated. The device can be repositioned or removed from the trachea when the cuff balloon is deflated. The recess in the top surface of the cuff balloon is capable of trapping secreted fluids that would otherwise pass beyond the cuff balloon and into the patient's lungs, where the fluids could cause ventilator associated pneumonia (VAP). The recess is capable to retaining secreted fluids when the cuff balloon is deflated, and the device repositioned or removed from the trachea. The secreted fluids can be removed from the recess via a small diameter draining tube that communicates with the recess and is accessible from the patient's mouth. Also, the secreted fluids can be directly suctioned from the recess with the device in position in the trachea. By avoiding passage of secreted fluids into the lungs, the endotracheal intubation device improves the health and welfare of the intubated patient, especially when the patient is unconscious. Thus, use of the endotracheal intubation device of the present invention reduces risk of ventilator associated pneumonia (VAP) in patients who have been intubated.

[0050] The novel features will become apparent to those of skill in the art upon examination of the description. It should be understood, however, that the scope of the claims should not be limited by the embodiments but should be given the broadest interpretation consistent with the wording of the claims and the specification as a whole.