This invention relates to assemblies of the kind of a cuffed tracheostomy tube and a speaking valve, the assembly including an inflation lumen opening at one end into an inflatable sealing cuff embracing the tracheostomy tube and at its opposite end being terminated by a normally closed inflation valve.

Tracheostomy tubes are used to ventilate patients during and after surgery. As the patient begins to recover, it is preferable for him to be gradually weaned off breathing through the tube before it is completely removed. In order to enable the patient to speak it is necessary to allow at least a part of the air exhaled by the patient to flow up past the tracheostomy tube to the vocal folds instead of out through the machine end of the tube. This can be done by partially deflating the cuff of the tube. Alternatively, a fenestrated tracheostomy tube can be used having one or more small openings in its side wall, so that a part of the patient's breathing passes through these openings and via his nose or mouth, instead of through the machine end of the tracheostomy tube. When the patient needs to speak it is common practice to fit a speaking valve to the machine end of the tube. The speaking valve includes a one-way valve that enables air to be inhaled by the patient through the valve but prevents or limits flow out through the valve so that air instead flows to the larynx via the fenestrations or around the outside of a tube with a deflated cuff. Examples of speaking valves are described in, for example, US4325366, GB2164424, GB2214089, GB2313317, EP78685, EP214243, EP18461, DE2505123 and DE3503874.

A problem arises when a speaking valve is used with an unfenestrated tracheostomy tube if the sealing cuff is inadvertently not deflated since there is no path for exhaled air from the patient. This can lead to the patient suffocating. US2015/0013684 describes a speaking valve with a projection that can be used to open a valve at the end of a flexible inflation line extending to a sealing cuff, an electrical sensor being used to detect connection of the speaking valve on the tracheostomy tube. This arrangement relies on the user opening the sealing cuff valve by inserting the projection on the speaking valve either before or after the speaking valve is fitted on the tube. It is an object of the present invention to provide an improved speaking valve, tracheostomy tube and assembly.

According to one aspect of the present invention there is provided an assembly of the above-specified kind, characterised in that the assembly is arranged such that the speaking valve can only be brought into an operative condition on the assembly when the inflation valve on the inflation lumen has been opened to allow gas to vent from the sealing cuff and the cuff to deflate.

The inflation valve may be mounted on a flange of the assembly adjacent a machine end connector of the tracheostomy tube. The speaking valve preferably has a surface formation arranged to align with the inflation valve when the speaking valve is fitted on the machine end connector, the surface formation preventing full operative connection of the speaking valve on the machine end connector unless the surface formation is engaged with the inflation valve to open the inflation valve and allow gas to vent from the sealing cuff. The surface formation on the speaking valve may be a pin mounted with the speaking valve that projects beyond the patient end of the speaking valve and is adapted to engage and displace a valve member in the inflation valve.

Alternatively, the speaking valve may have a valve element that can be placed in an operative condition where it allows inspiratory gas flow but blocks expiratory gas flow or an inoperative condition where it allows gas flow in both directions, the valve element being arranged to be moved from the inoperative condition to the operative condition by connecting the inflation valve with the speaking valve in such a manner that the inflation valve is opened to allow gas to vent from the cuff.

The speaking valve preferably includes a movable member arranged to engage the inflation valve to open the valve, the movable member being connected with the valve element to displace the valve element from the inoperative condition to the operative condition only when the inflation valve is opened. In another arrangement the assembly includes a pilot balloon connected in the inflation lumen, the speaking valve being arranged to be operatively connected with the pilot balloon only when the pilot balloon and sealing cuff have been deflated, the pilot balloon providing an operative part of the speaking valve.

The pilot balloon preferably provides a flexible valve element when deflated, the speaking valve being arranged to retain the pilot balloon with the speaking valve, and the speaking valve only preventing exhalation from the tracheostomy tube when the pilot balloon is deflated and fitted with the speaking valve.

According to another aspect of the present invention there is provided a tracheostomy tube for an assembly according to the above one aspect of the present invention.

According to a further aspect of the present invention there is provided a speaking valve for an assembly according to the above one aspect of the present invention.

Several assemblies of a tracheostomy tube and speaking valve 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 perspective view of a first form of assembly with the speaking valve separated from the tube;

Figure 2 is an enlarged plan view of a part of the assembly and speaking tube;

Figure 3 is a side elevation view of a second form of assembly;

Figure 4 is a perspective view of a third form of assembly;

Figure 5 is a side elevation view of the assembly in Figure 4 before use; and Figure 6 is a perspective view of a modified form of the assembly shown in Figures 4 and 5.

With reference first to Figures 1 and 2, the assembly comprises a tracheostomy tube 1 and a speaking valve 3, shown separated in Figure 1 but, in use, fitted on to the machine end of the tube.

The tracheostomy tube 1 includes a curved shaft 10 of a plastics material and having a circular cross-section. The tube 1 extends from a patient end 11 to a neck flange 12 and a machine end coupling 13 of the conventional 15mm male tapered kind. A sealing member in the form of an inflatable cuff 14 encircles the shaft 10 towards the patient end 11, the interior of the cuff communicating with an inflation line 15 extending along the shaft. The inflation line 15 includes an inflation indicator in the form of a pilot balloon 16 and, at its machine end, a sealing valve 17. The sealing valve 17 is of the conventional kind having a movable valve member 18 urged towards the machine end 19 of its housing 20 by some form of spring element 21. In its natural state with the valve member 18 at the machine end of the housing 20 the valve 17 is closed and prevents flow of gas through it, thereby preventing escape of gas from the sealing cuff 14. The valve 17 can be opened by inserting the nose of a syringe or the like into the its machine end so as to push the valve member 18 towards the patient end of the valve and out of sealing engagement with the machine end 19 of the housing 20. In this way, gas can be supplied to the cuff 14 to inflate it, or gas can be removed from the cuff to deflate it. The inflation valve 17 is mounted on the neck flange 12, extending orthogonally to the flange and being located in a recess 23 in the flange just to one side of the machine end coupling 13. In normal use, without a speaking valve, the sealing cuff 14 is inflated by pushing the nose of a syringe (not shown) into the open end of the inflation valve 17 where it extends through the flange 12. This opens the valve 17 and allows air to be expelled from the syringe, through the valve and via the inflation line 15 and pilot balloon 16 to the sealing cuff 14. When the syringe is pulled out of the inflation valve 17 it seals closed, trapping air in the cuff 14 to maintain its inflated state. When the cuff 14 needs to be deflated, such as to remove the tube assembly from the patient, the syringe is reinserted in the valve 17 and the plunger of the syringe is withdrawn to aspirate air from the cuff and deflate it. The speaking valve 3 is of cylindrical shape with an outer housing 31. The housing 31 has a cross configuration of support beams 32 extending laterally across its machine end that support the centre of a membrane flap valve 33 on the patient side of the beams. The flap valve 33 allows air to flow through the valve 3 from the machine to the patient end, that is, inspired air, but blocks substantially all air flow in the opposite direction. The patient end of the housing 31 has a female tapered internal surface shaped to make a sealing fit on the outside of the machine end coupling 13 of the tracheostomy tube 1. The speaking valve 3 differs from conventional speaking valves in that its housing 31 includes a surface formation on its outside in the form of a cylindrical actuating pin 35. The actuating pin 35 may be moulded integrally with the housing 31 or attached after forming the housing. The actuating pin 35 extends parallel to the axis of the housing 31 to one side of the housing and projects forwardly beyond the patient end of the housing. The location and shape of the actuating pin 35 are such that, when the speaking valve 3 is fitted over the machine end coupling 13 in the correct orientation, the actuating pin aligns with the recess 23 in the neck flange 12 and the inflation valve 17 located in the recess. The length of the actuating pin 35 is such that it depresses the valve member 18 and fully opens the inflation valve 17 as the speaking valve 3 is pushed into full engagement with the machine end coupling 13. The shape of the actuating pin 35 is chosen to allow it to be freely inserted in the inflation valve 17 and to allow air to flow out of the valve around the outside of the pin. In this respect, the pin 35 may be formed with grooves or other channels to facilitate air flow. When the actuating pin 35 is inserted in the inflation valve 17 air from the cuff 14 will flow out to atmosphere and the cuff will deflate to a condition that allows exhaled air from the lungs to flow up the trachea past the tracheostomy tube to the vocal folds. Where the sealing cuff is of an elastic, low volume/high pressure kind, the elevated pressure within the cuff is sufficient to force air out of the cuff, once the inflation valve is opened. Where the sealing cuff is inelastic and of the high volume/low pressure kind the internal pressure within the cuff will be less but the external air pressure during exhalation will help collapse the cuff and force the air out through the valve. The configuration of the actuating pin 35 and the speaking valve 30 are such that the speaking valve cannot be fully fitted on the machine end coupling 13 to an operative mating condition unless the actuating pin is correctly aligned with the valve 17 and the sealing cuff 14 is thereby deflated. This, therefore, automatically ensures that the speaking valve 3 cannot be fitted operatively on the tracheostomy tube 1 without the sealing cuff 14 first being deflated, thereby ensuring that the patient is always provided with an exhalation path.

Uncuffed tracheostomy tubes could also have a recess in their flange to accommodate speaking valves with an actuating pin. Speaking valves with the actuating pin could not be fitted to existing tracheostomy tubes since the actuating pin would prevent full mating engagement.

With reference now to Figure 3 there is shown an alternative assembly that again is arranged such that the speaking valve cannot be put into an operative condition without the sealing cuff having been first deflated. The speaking valve 130 shown in Figure 3 has a valve element 131 that can be placed in either an operative condition (shown by the unbroken lines) or an inoperative condition (shown by the broken lines). In the operative condition the edge of the valve element 131 engages a peripheral seat 132 and acts as a conventional one-way valve to allow inspiratory air to flow through the valve 130 but prevents expiratory flow through the valve. In the inoperative condition the valve element 131 does not act as a valve but instead allows air flow in both directions. The valve element 131 is moved between its operative and inoperative conditions by means of a movable member in the form of a rod 133 coupled at one end to the centre of the valve element 131 and extending axially of the speaking valve 130 to its opposite end 134 where it extends through an opening in the wall of the valve. The opposite end 134 of the rod 133 is shaped to be able to be extended into the open machine end of the inflation valve 135. The shape of the end 134 of the rod 133 is such that it can displace the valve element 131 in the inflation valve 135 to an open condition and enable air from the sealing cuff to flow out of the valve. The natural condition of the speaking valve 130 is with the valve element 131 in a safe, inoperative condition, so that air can flow freely in both directions through the valve and through the tracheostomy tube. The only way in which the speaking valve 130 can be switched to an operative condition, where it acts as a one-way valve, is by pushing the inflation valve 135 over the opposite end 134 of the rod 133 and pushing inwardly so that the rod displaces the centre of the valve element 131 and it snaps to its operative condition. At the same time, the opposite end of the rod 133 applies a force to the valve element in the inflation valve 135 thereby causing it to unseat and open the valve and allow gas from the cuff to escape to atmosphere. This arrangement ensures safety because the assembly provides that there is always an expiratory gas flow path, either via the bore of the tracheostomy tube and the speaking valve 130 or around the outside of the tracheostomy tube when the cuff is deflated.

There are various other forms of valves that can be switched between an operative and an inoperative condition.

A further alternative assembly is shown in Figures 4 and 5. In this arrangement the speaking valve 230 comprises a cylindrical housing 231 with a patient end 232 having a 15mm female tapered surface adapted to fit the machine end coupling of a tracheostomy tube. At the opposite, machine end 233 of the valve the housing 231 supports a plate 234 hinged with the housing at one edge 235. The opposite edge of the plate 234 has a clip 236 that can be clipped onto the outside of the housing 231. The plate 234 is formed with one or more apertures or openings so that gas can flow through it. The plate 234 acts to trap the valve element between the plate and the machine end 233 of the housing 231. The valve element is provided by a generally rectangular pilot balloon 238 connected in line with the inflation line 239 extending to the sealing cuff of the tracheostomy tube. The gap between the hinged plate 234 and the machine end 233 of the housing 231 is chosen such that, the plate can only be clipped closed if the pilot balloon 238 is deflated, and hence if the sealing cuff is also deflated. Thus, before the pilot balloon 238 is fitted, the speaking valve 230 does not provide any restriction to air flow through it in either direction. The speaking valve 230 will only become operative and act as a speaking valve to prevent exhalation through it if the sealing cuff has first been deflated. This assembly ensures that the speaking valve 230 cannot be put into an operative condition without first making the tracheostomy tube safe by deflating the sealing cuff.

Instead of having a hinged plate, the speaking valve could have a slot or gap into which a deflated pilot balloon could be slid as a snug fit.

Figure 6 shows a modification of the arrangement shown in Figures 4 and 5 where the pilot balloon 238' is of a circular shape that engages with a circular valve seat 239' on the housing 240' of a speaking valve 241 '.