This invention relates to tracheostomy tube water guards of the kind adapted to be fitted on an open machine end of a tracheostomy tube to reduce entry of water into the tube.

Tracheal tubes are used to enable ventilation, respiration or spontaneous breathing of a patient. Endotracheal tubes are inserted via the mouth or nose so that one end locates in the trachea and the other end locates outside the patient. Tracheostomy tubes are inserted into the trachea via a surgically-formed opening in the neck.

Tracheostomy tubes are generally used for more long-term ventilation or where it is not possible to insert an airway through the mouth or nose. The patient is often conscious while breathing through a tracheostomy tube, which may be open to atmosphere or connected by tubing to some form of ventilator. The tube is secured in position by means of a flange fixed with the machine end of the tube and positioned to extend outwardly on opposite sides of the tube. Patients with a tracheostomy tube inserted long-term and carrying out their normal daily life are presented with a number of difficulties because of the tracheostomy tube. One problem occurs during showering or bathing since there is a risk that water from the shower or bath may enter the open, machine end of the tube. If nothing is done to prevent this, water can enter the respiratory passages and cause breathing

difficulties. Similar problems are caused when the patient washes his hair, face or upper body. The usual way to overcome this problem is to wrap a towel or collar loosely around the neck, over the open end of the tube. The towel, however, makes it difficult to wash the neck and is difficult to hold in place. The towel can also obstruct air flow to and from the tube.

DE202012000002U1 and IN2014641025101 describe attachments for fitting on the machine end of the tracheostomy tube, the attachment being in the form of a bent tube with a connector at one end adapted to fit on the connector at the machine end of the tracheostomy tube. The other end of the tube is open, is angled at 90° downwardly so that it is less easy for water from above to enter the tracheostomy tube. These prior arrangements do not entirely prevent upward spray entering the tracheostomy tube. Water running down the outside of the attachments may also be drawn into the tube during inhalation as the water drips over the open end of the attachment. These arrangements also do not prevent water entering the tracheostomy tube while the user is bathing if he should lie down far enough to submerge the open end of the tube below the bath water level.

It is an object of the present invention to provide an alternative tracheostomy tube water guard and an assembly of a tracheostomy tube and water guard.

According to one aspect of the present invention there is provided a tracheostomy tube water guard of the above-specified kind, characterised in that the guard has a housing with a coupling adapted to fit on the machine end of the tracheostomy tube and a chamber arranged in use to extend generally downwardly and opening toward its upper end into the coupling, that the chamber opens towards its lower end via an opening, and that the guard includes a movable float arranged normally to rest towards the lower end of the chamber but to rise with any rise in water level in the chamber such that movement of the float causes the opening to be blocked and thereby prevent water flowing to the tracheostomy tube.

The float may be movable vertically in a float chamber, the float chamber having an opening at its upper end, and the float being arranged to contact and block the opening when the water level in the guard rises.

Alternatively, the float may be mounted at one end of a pivoted arm and a seal plate may be mounted at the opposite end of the arm, such that a rise in water level causes the pivoted arm to rotate and bring the seal plate into contact with the opening.

The guard may include a cover member extending over the coupling and having an adhesive region adapted to be adhered to the skin above the site of the tracheostomy so as to reduce the amount of water falling on the tracheostomy site.

According to another aspect of the present invention there is provided a tracheostomy water guard adapted to be fitted on the machine end of a tracheostomy tube to reduce entry of water into the tube, characterised in that the guard includes a housing with a coupling at its upper end adapted for connection to a connector at the machine end of the tracheostomy tube and with an opening towards its lower end through which air can flow to and from the tracheostomy tube, that the housing includes a float mounted with a pivoted arm such that the arm is rotated when water enters the housing through the lower opening causing the float to rise, and that the arm includes a seal that is normally positioned to allow air flow to and from the tracheostomy tube but is rotated to a sealing position when the float rises to prevent air flow to and from the tracheostomy tube, thereby preventing water flowing into the tube.

According to a further aspect of the present invention there is provided a

tracheostomy tube assembly including a tracheostomy tube and a water guard according to the above one or other aspect of the present invention, characterised in that water guard is fitted to protect the machine end of the tracheostomy tube from water ingress.

A tracheostomy water guard and an assembly of the guard on a tracheostomy tube according to the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which:

Figure 1 is a partly sectional side elevation view showing the guard fitted on the end of a tracheostomy tube in normal use;

Figure 2 is a perspective view of the guard separated from the tracheostomy tube;

Figure 3 is an elevation view of the rear of die guard;

Figure 4 is a side elevation view of the guard in use with an elevated level of water;

Figure 5 is a perspective view of a modified guard separated from the

tracheostomy tube; Figure 6 is a side elevation view of the modified guard of Figure 5 fitted on a tracheostomy tube;

Figure 7 is a sectional view of a part of an alternative modified guard;

Figure 8 is a perspective view of a second alternative modified guard;

Figure 9 is a side elevation cross-sectional view of the guard of Figure 8

without any water in the guard; and

Figure 10 is a side elevation cross-sectional view of the guard of Figure 8 after water has entered the guard.

With reference first to Figures 1 to 3, the tracheostomy tube water guard 1 is arranged for fitting on the standard 15mm connector 2 attached with the machine end 3 of a tracheostomy tube 4 where it projects outwardly from the tracheostomy stoma of a patient The guard 1 acts to prevent or restrict water flowing into the tracheostomy tube 4 while the wearer is showering, bathing or washing.

The guard 1 has a generally rectangular housing 10 with a flat front face 11 facing away from the patient, a flat rear face 12 facing the patient and having a female coupling 13 of circular section projecting rearwardly centrally and close to the upper end of the housing. The upper and lower walls, or roof and floor 14 and 15 of the housing are plain and uninterrupted. The two side walls 16 and 17 are plain and flat but are interrupted by a row of slots 18. Typically there may be about six or seven slots 18 and these are angled at about 45° to the horizontal and are spaced from one another along the major part of the height of the housing 10 with the uppermost slot being positioned approximately level with the centre of the coupling 13 and spaced from the upper end of the housing. The slots are preferably arranged such that the upper end of one slot overlaps the lower end of an adjacent slot.

Internally, the housing 10 is divided into a forward, float chamber 20 and a rear chamber 21 opening into the female coupling 13. The female coupling 13 and the rear chamber 21 together provide a first portion of the housing 10, the float chamber 20 providing a second portion of the housing. The forward chamber 20 is open to external air along most of its height by the row of slots 18. In particular, the slots 18 are arranged so that the chamber 20 is open to air at a location below the opening provided by the female coupling 13. The chamber 20 is formed by a solid, imperforate wall 22 extending across the entire width of the inside of the housing 10, this wall extending parallel to and is spaced from the rear face 12 by a distance about half the thickness of the housing 10. The internal wall 22 extends from the floor 15 of the housing 10 upwardly to a location spaced from the roof 14 and approximately level with the upper edge of the inside of the female coupling 13. The chamber 20 is completed by a cover plate 23 extending from the top of the internal wall 22 horizontally and forwardly to the inside of the front face 11 of the housing 10. The cover plate 23 has an elongate opening 24 located centrally and extending across the major part of the width of the plate.

It can be seen that the guard 1, when fitted on the tracheostomy tube 4, allows free flow of air to and from the tube via the guard. Inhaled air can flow though the slots 18 into the forward chamber 20, up the chamber and then out through the opening 24 in its cover plate 23. From there the air flows into the rear chamber 21 and out through the female coupling 13. When the patient exhales air flows back through the guard 1 along the same path but in the opposite direction.

The guard 1 also includes a movable float 30 loosely enclosed within the forward chamber 20. The float 30 is preferably lightweight and of plastics and could be hollow or formed of a foamed material. Other, non-plastics materials could be used providing the float is buoyant in water. In normal use, the guard 1 extends generally downwardly from the tracheostomy, whether the patient is standing, sitting upright or is inclined rearwardly such as when lying in a bath. The mass of the float 30 and gravity therefore act to keep the float at the lower end of the chamber 20. If, however, the forward chamber 20 of the guard 1 should suddenly fill with water, such as caused, for example, by the patient slipping under the water level in a bath, the float 30 would rise up the chamber 20 to the level of water in the chamber until its upper surface contacts the inside of the cover plate 23, as shown in Figure 4. In this position the float 30 stops water flowing through the opening 24 and hence prevents water flowing through the guard 1 and into the tracheostomy tube 4.

The sealing effect of the float 30 in its upper position could be achieved by a close sliding, sealing engagement of the outer peripheral edge of the float with the inner surface of the float chamber 20 so that when it rises above the level of the uppermost one of the slots 18 it prevents water reaching the opening 24. In order, however, to enable freer movement of the float 30 it may be preferable for the outer edge of the float to be a relatively loose, nonsealing fit with the inside of the compartment. In such an arrangement an effective seal could be provided by engagement of the upper surface of the float 30 around the edge of the opening 24. This sealing engagement could be enhanced by making the upper surface of the float 30 of a relatively soft, compliant material and providing the lower surface of the cover plate 23 around the opening 24 with a downwardly-projecting sealing lip (not shown).

It can be seen that a guard according to the present invention can be used to reduce the risk water inadvertently entering the tracheostomy tube 4. When the float 30 moves to the sealing position this will prevent air flow to and from the tracheostomy tube 4 but the guard 1 can be rapidly opened simply by raising it above the water level and allowing the water to drain out through the slots 18. This is much less traumatic and dangerous than would be the case if water were to enter the respiratory passages via the tracheostomy tube.

The guard could be modified in the manner shown in Figures 5 and 6 by the inclusion of a cover member 200 to reduce the amount of water falling on the tracheostomy site. The guard 101 includes a housing 110 of the same kind as shown in Figures 1 to 4 and has an internal compartment with a float and with side slots 118 through which air flows to and from the tracheostomy tube. The modification is provided by the cover member 200 attached at one end with the guard housing 110 and at its opposite end is attached to the skin surface above the tracheostomy. More particularly, the cover member is a one-piece moulded member 200 of a stiff but bendable plastics material and has a generally U shape with an inverted channel 201 having two side walls 202 and a roof 203 extending between them. The forward, machine end of the channel 201 has a thin inwardly-directed flange 204 by which the cover 200 is adhered to the rear, patient-facing face 112 of the housing 110 so that the channel forms a rearwardly-extending extension of the outside of the housing of the guard. The side walls 202 extend down from the upper end of the housing 110 about half its height and, in particular they extend below the level of the coupling 113 and of the tracheostomy site. The rear, patient end of the channel 200 also has a flange 205 but this extends outwardly and its size and shape is arranged such that the flange contacts the skin surface of the neck above the tracheostomy site and extends down below the site on opposite sides. This flange 205 has a skin-compatible adhesive 206 providing an adhesive region, the adhesive being of a hydrocolloid although other adhesives could be used. This cover 200 helps reduce water spray falling on the tracheostomy during showering or bathing. The lower end of the housing 70 may be formed with drip lips 71 to encourage water to drip away from the housing, as shown in Figures 6 and 7.

Movement of the float could be arranged to cause flow to the tracheostomy tube to be blocked without the float itself directly occluding flow through the guard, as shown in the arrangement of Figures 8 to 10. In this arrangement the guard 300 has a housing 301 with a generally rounded, rectangular shape and enclosing within it a chamber 309. The plane of the housing 301 includes the axis of the tracheostomy tube 302 to which it is fitted. The housing 301 has an opening at its upper patient side in the form of a projecting female coupling 303 adapted to make a sealing fit with a conventional 15mm male connector 304 on the machine end of the tracheostomy tube 302. The lower end 305 of the housing 301 opens through a number of apertures 306 through the wall of the housing. The opposite side walls 307 of the housing 301 each include a transparent window 308 through which the user can view the interior of the housing. The guard 300 also includes a float mechanism 310 mounted within the housing 301. The float mechanism 310 comprises an L-shape arm 311 divided into an upwardly-extending seal limb 312 and a float limb 313 angled at about 50° to the seal limb and extending generally horizontally in the normal, open state. The seal limb 312 has a seal plate 314 mounted to the limb at its upper end and facing towards the female coupling 303. The seal plate 314 is of a soft, conformable material that forms an effective seal with the opening 320 at the machine end of the male connector 304 and that is not damaged by contact with water. The float limb 313 has a generally rectangular float 316 mounted at its outer end. The float 316 could (as shown) be a hollow chamber or could be of a solid material less dense than water. The comer angle 317 between the two limbs 312 and 313 is hingedly or pivotally mounted with the housing 301 about a horizontal axis at right-angles to the plane of the housing in its lower comer towards the patient.

The shape, dimensions and mounting of the arm 311 are such that, in its normal position, as shown in Figure 9, where the guard 300 is not exposed to water, the float 316 rests on the inside of the lower end of the housing 301 and the seal limb 312 extends upwardly at an angle of about 30° away from the vertical with the seal plate 314 spaced away from the opening 320 of the male connector 304. In this position air can flow freely through the guard 300 in either direction to and from the tracheostomy tube 302.

If, however, the guard 300 should be exposed to water, such as by its lower end 305 being immersed below the surface of water in a bath, as shown in Figure 10, the water will start to flow into the inside of the housing 301 through the apertures 306. As this happens the float 316 starts to lift as it floats on the water entering the housing 301. This causes the float limb 313 to rotate clockwise, thereby rotating the arm 311 and the seal limb 312 until the seal plate 314 comes into contact with the opening 320 at the machine end of the connector 304. This prevents air flow to the tracheostomy tube 302 so becomes immediately apparent to the patient. The patient responds to this by sitting more upright in the bath thereby raising the guard 300 above the water level and allowing water in the guard to drain out and the arm 311 to rotate back to its initial position. This allows air to flow to and from the tracheostomy tube 302 again. The user can ensure that the guard 300 is empty by removing it from the tracheostomy tube, shaking it and then checking that all the water has been drained from the guard by looking into the guard through the windows 308.