EP4313231A1

EP4313231A1 - Tracheostoma device comprising a valve operated by an electrically controlled actuator

Info

Publication number: EP4313231A1
Application number: EP22781747.5A
Authority: EP
Inventors: Nataniel Jara BOLINDER; Struan Alastair MCBRIDE
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2021-03-31
Filing date: 2022-03-23
Publication date: 2024-02-07
Also published as: EP4313231A4; WO2022211698A1

Abstract

A tracheostoma device (100) adapted to control the flow of air through a tracheostoma of a user of the device, the tracheostoma device comprising a housing (102) having an open first end (104) configured to be connected to the tracheostoma, and a second end (106), the housing (102) comprising at least one opening (112), a shut-off valve member (114) actuatable between an open position and a closed position, the shut-off valve member configured to allow airflow through the opening when in the open position, and to prevent airflow through the opening when in the closed position, and an electrically controlled actuator (116) configured to actuate the shut-off valve member between the open position and the closed position based on a control signal.

Description

TRACHEOSTOMA DEVICE COMPRISING A VALVE OPERATED BY AN ELECTRICALLY CONTROLLED ACTUATOR

Field

This disclosure relates to a tracheostoma device adapted to control the flow of air through a tracheostoma of a user. In particular, the disclosure relates to a tracheostoma device comprising an electrically controlled actuator.

Background

Due to diseases of different kinds, it is sometimes necessary to remove the larynx of a patient by surgery. In order that the patient exposed to the surgery can breathe, it may also be necessary to provide an opening into the trachea of the patient, known as a tracheostoma. By removal of the larynx, the patient’s ability to speak will be lost, but can be restored to some extent by means of further surgery. In such surgery, a fistula is opened between the trachea and the esophagus of the patient. This allows air to be passed into the esophagus via the fistula to vibrate the mucous membranes of the esophagus such that speech is produced.

A one-way valve, known as a voice prosthesis is mounted in the fistula. The voice prosthesis allows air to pass from the trachea to the esophagus, but blocks flow in the opposite direction. For speech to be generated, the tracheostoma must also be closed so that air can be passed from the trachea into the esophagus via the voice prosthesis. The tracheostoma can be closed using a finger, but it is more convenient to use a tracheostoma device comprising a valve for this purpose.

A tracheostoma device comprising a valve is attached to the neck of the patient, in order to control the connection between the trachea and the ambient atmosphere via the tracheostoma. When using an automatic speaking valve, the tracheostoma device provides a hands-free control of this connection. The tracheostoma device is configured such that the valve will not be obstructed by clothing and, therefore, the tracheostoma device can be carried more discreetly under a shirt or the like. Known tracheostoma devices include those with mechanically operated valves such as disclosed in US 4,582,058 and US 5,059,208, and those operated by the pressure and flow rate of the expiratory flow, such as disclosed in US 7,370,654.

However, such arrangements require speech to be initiated by a forced exhalation, and require a relatively high pressure in the housing to keep the shut-off valve in the closed position during speech. High pressures in the device, for example when initiating speech, can lead to increased stress and wear on the adhesive fastening of the tracheostoma device, leading to reduced lifetime of the adhesive. Forced exhalations are exhausting for the user of the device, and hinder their ability to engage quickly and spontaneously in conversation.

Summary

This present disclosure attempts to solve the problems noted above by providing a tracheostoma device having a valve member that is operated by an electrically controlled actuator. The actuator is operated based on a signal coming from an input unit, such as sensor or a switch, configured to detect speech or a deliberate trigger action from the user. A control unit may receive an output from the input unit indicative of speech or the user wishing to commence speech, and provide a control signal to the actuator to operate the valve.

According to an aspect, there is provided a tracheostoma device adapted to control the flow of air through a tracheostoma of a user of the device, the tracheostoma device comprising a housing having an open first end configured to be connected to the tracheostoma, and a second end, the housing comprising at least one opening, a shut-off valve member actuatable between an open position and a closed position, the shut-off valve member configured to allow airflow through the opening when in the open position, and to prevent airflow through the opening when in the closed position and an electrically controlled actuator configured to actuate the shut-off valve member between the open position and the closed position based on a control signal.

Optionally, the control signal is based on an output from an input unit. Optionally, the input unit comprises a sensor configured to sense a condition of the user. Optionally, the sensor comprises at least one of an electroencephalographic (EEG) sensor configured to sense electrical impulses from brain activity of the user, an electromyographical (EMG) sensor configured to sense electrical impulses from muscular activity of the user, a flex sensor configured to sense flexing motions on the skin of the user, and a surface strain gauge configured to sense strain in the skin of the user.

Optionally, the input unit comprises a switch configured to be operated by the user. Optionally, the output from the input unit is indicative of the beginning of speech, and the electrically controlled actuator is configured to actuate the shut-off valve member from the open position to the closed position in response to receiving the control signal. Optionally, the output from the input unit is indicative of the end of speech, and the electrically controlled actuator is configured to actuate the shut-off valve member from the closed position to the open position in response to receiving the control signal.

Optionally, the electrically controlled actuator is communicatively coupled to a control unit, the control unit configured to receive the output from the input unit, generate the control signal based on the output, and transmit the control signal to the electrically controlled actuator. Optionally, the control unit is further configured to filter noise from the output when generating the control signal. Optionally, the control unit is configured to filter noise from the output based on a calibration procedure. Optionally, the control unit is disposed within the tubular housing.

Optionally, the shut-off valve member is selectively configured to be maintained in the closed position by the pressure in the airway of the user or by the electrically controlled actuator. Optionally, the tracheostoma device further comprises a biasing arrangement configured to releasably maintain the shut-off valve member in the open position. Optionally, the electrically controlled actuator comprises at least one of a linear actuator such as a solenoid, a rotary actuator such as a stepper motor, and a fluid power actuator such as a piezo-compressor. Optionally, the shut-off valve member is configured to allow airflow through the housing from the first end to the ambient atmosphere via the opening when in the open position, and to prevent airflow through the housing from the first end to the ambient atmosphere via the opening when in the closed position.

According to an aspect, there is provided a system for controlling the flow of air through a tracheostoma of a user, the system comprising the tracheostoma device, an input unit, and a control unit.

The disclosed tracheostoma device does not rely on speech to be initiated by a forced exhalation or on high pressure to be maintained during speech, meaning a lower average speaking pressure can be applied. This requires less effort from the user and puts less strain on the device attachment. The valve can be operated as soon as the user wishes to initiate speech, meaning the user may engage quickly and spontaneously in conversation. Falsely detected initiations and interruptions of speech can also be detected and eliminated, so that speech is identified and maintained at the correct time.

Brief Description of the Drawings

Exemplary embodiments of the disclosure shall now be described with reference to the drawings in which: FIG. 1 shows an example of a tracheostoma device;

FIG. 2 shows different example implementations of an input unit on a user; and FIG. 3 schematically shows an example of a control system for use with a tracheostoma device.

Throughout the description and the drawings, like reference numerals refer to like parts.

Description

Fig. 1 shows an example of a tracheostoma device 100. The tracheostoma device 100 may be similar to that described in US Patent No. 7,370,654. The tracheostoma device 100 is adapted to control the flow of air through a tracheostoma of a user. The tracheostoma device 100 comprises a housing 102 having a first end 104 and a second end 106. The housing may be generally tubular, and have a side wall 108 extending between the first end 104 and the second end 106. The housing 102 can be made of a plastics material. The first end 104 is open and configured to be connected to a tracheostoma of the user. The first end 104 may be connected to an adapter on a self-adhesive plaster to be attached to the user’s neck over the tracheostoma, or to a laryngectomy tube to be inserted into the trachea through the tracheostoma. The second end 106 may be closed by a cover 110. In some embodiments, the cover 110 is openable. An openable cover 110 may function as a pressure relief valve in case the user coughs. It will be appreciated that the housing 102 can take other forms that provide an enclosed volume with an open end configured to be connected to a tracheostoma of the user.

The housing 102 comprises at least one opening 112, which allows fluid communication between the interior of the housing 102 and the ambient atmosphere. In Fig. 1, the opening 112 is shown in the closed second end 106. It is equally possible to position the opening 112 in the side wall 108 of the housing 102. The tracheostoma device 100 further comprises a shut off valve member 114 in cooperation with the opening 112. The shut-off valve member 114 preferably comprises an elastic material that cooperates with and seals the opening 112 when activated. The shut-off valve member 114 may comprise a magnetic element that is magnetically actioned to close the opening 112 when activated. It may also comprise a mechanical closing mechanism, such as a pin being moved behind the shut-off valve member 114 to move it into cooperation with the opening 112 to close the opening 112. The shut-off valve member 114 is actuatable between an open position and a closed position. In the open position, the shut-off valve member 114 is configured to allow airflow through the opening 112. More specifically, in the open position, the shut-off valve member 114 is configured to allow airflow through the housing 102 from the first end 104 to the ambient atmosphere via the opening 112. In this case, air from the user’s lungs passes through the tracheostoma device 100, rather than through a voice prosthesis to the oral cavity of the user, and so no speech is produced. In the closed position, the shut-off valve member 114 is configured to prevent airflow through the opening 112. More specifically, in the closed position, the shut-off valve member 114 is configured to prevent airflow through the housing 102 from the first end 104 to the ambient atmosphere via the opening 112. In this case, air from the user’s lungs cannot pass through the housing 102. Instead, the air passes through the voice prosthesis to the oral cavity of the user, and from there through the mouth to the ambient atmosphere, such that speech is produced.

In some embodiments, the shut-off valve member 114 may be configured to rest in the open position. For example, the tracheostoma device 100 may comprise a biasing arrangement (not shown) configured to releasably maintain the shut-off valve member 114 in the open position. The biasing arrangement may be, for example, a spring or magnet arrangement. The biasing arrangement may be configured to maintain the shut-off valve member 114 in the open position until a threshold force is provided to overcome the biasing arrangement and move the shut-off valve member 114 to the closed position.

The tracheostoma device 100 further comprises an electrically controlled actuator 116 (shown in Fig. 3). The actuator 116 is configured to actuate the shut-off valve member 114 between the open and closed positions. In some embodiments, the actuator 116 is a linear actuator such as a solenoid. In other embodiments, the actuator 116 is a rotary actuator such as a stepper motor. In other embodiments, the actuator 116 is a fluid power actuator, such as a piezo-compressor. The piezo-compressor may increase the pressure in an elastic chamber connected to the valve member 114 and force it to close. The piezo-compressor may alternatively blow directly on the valve member 114 to force it to close momentarily. The actuator 116 is configured to receive a control signal and operate the shut-off valve member 114 based on the control signal.

The control signal received by the actuator 116 may be based on an indication relating to speech by the user. For example, the control signal may be based on an indication that the user is beginning speech and may cause the actuator 116 to close the valve 114. The control signal may alternatively be based on an indication that the user is ending speech and may cause the actuator 116 to open the valve 114.

The indication relating to speech may be an output from an input unit 118, for example a sensor 120 or a switch 122 (shown in Figs. 2 and 3). The input unit 118 is configured to receive an input indicative of speech and provide a corresponding output. For example, a sensor 120 may be configured to sense a condition of the user indicative of the user beginning or ending speech. A switch 122 may be configured to be actively and voluntarily operated by the user when they wish to begin or end speech. The output from the input unit 118 is then provided to the actuator 116 as a control signal, and the actuator 116 operates the shut-off valve member 114. If the output from the input unit 118 indicates that the user is beginning speech, the actuator 116 operates the shut-off valve member 114 to close the opening 112 such that speech can be produced. If the output from the input unit 118 indicates that the user is ending speech, the actuator 116 operates the shut-off valve member 114 to open the opening 112 such that speech is not produced. In some embodiments, the control signal may be based on outputs from more than one input unit 118.

Fig. 2 shows different example implementations of input units 118 disposed on a user. As discussed above, a sensor 120 may be configured to sense a condition of the user indicative of speech. In some embodiments, the sensor 120 is an electroencephalographic (EEG) sensor 120a configured to sense electrical impulses from brain activity of the user. As such, the EEG sensor 120a may be disposed on the head of the user. The EEG sensor 120a is configured to detect electrical brain impulses indicative of speech, and provide an output indicating that speech is intended, ongoing, or ending. In some embodiments, the sensor 120 is an electromyographical (EMG) sensor 120b configured to sense electrical impulses from muscular activity of the user. The EMG sensor 120b is configured to detect electrical muscle impulses indicative of speech, and provide an output indicating that speech is intended, ongoing, or ending. As such, the EMG sensor 120b may be disposed on the neck or jaw of the user where the muscles associated with speech are found. Alternatively, the EMG sensor 120b may be disposed on another part of the user’s body to detect a deliberate triggering of the valve by the user. For example the EMG sensor 120b may be disposed on the lower arm of the user and be configured to detect a certain finger movement pattern or gesture by the user intended to indicate the beginning or end of speech (as muscles moving the fingers are located in the lower arm). For example, EMG sensor 120b may detect the deliberate pinching of the ring finger against the thumb by the user. In some embodiments, the sensor 120 is a flex sensor 120c configured to sense flexing motions in the skin of the user As such, the flex sensor 120c may be disposed on the neck or jaw of the user, where the skin is liable to move during speech. The flex sensor 120c is configured to detect flexing motions in the skin indicative of speech, and provide an output indicating that speech is intended, ongoing, or ending. In some embodiments, the sensor 120 is a surface strain gauge 120d configured to sense strain or elongation in the skin of the user. As such, the surface strain gauge 120d may also be disposed on the neck of the user. The surface strain gauge 120d is configured to detect skin strain or elongation indicative of speech, and provide an output indicating that speech is intended, ongoing, or ending.

As discussed above, a switch 122 may be configured to be actively and voluntarily operated by the user when they wish to begin or end speech. The switch 122 may be a mechanical switch operable between an on position and an off position. The switch 122 may also be a pressure sensitive switch or pressure sensor configured to sense an input pressure from the user. In some embodiments, the switch 122 may be a handheld switch 122a, which the user can press to activate. In some embodiments, the switch 122 may be a switch 122b disposed in the armpit of the user, such that it can be discreetly operated. It will be envisaged that such a switch 122b could be disposed at other locations on the user’s body.

The system could include more than one input unit 118, such that a number of outputs can be used to determine the beginning of speech. This may be helpful to determine false positives. For example, the user may accidentally press a switch 122, but if an EEG sensor 120a does not detect any relevant brain activity, a control signal may not be generated.

Fig. 3 schematically shows an example of a control system for use with the tracheostoma device 100. As discussed above, the actuator 116 is configured to actuate the shut-off valve member 114 between the open and closed positions. As such, the actuator 116 may be mechanically coupled to the shut-off valve member 114. Alternatively, the actuator 116 may be disposed next to the shut-off valve member 114 and configured to operate it without contact, for example by blowing on the valve member 114 to force it to close or operating the valve member 114 magnetically. In some embodiments, the valve member 114 and the actuator 116 may be integrated into a single unit. For example, the actuator 116 could be an electromagnet operating on a ferromagnetic valve member 114, such that they work together as a solenoid actuator. The actuator 116 is communicatively coupled to an input unit 118, such as a sensor 120 or a switch 122. For example, the actuator 116 may have a wired or wireless connection to the input unit 118, capable of transmitting a data signal between the input unit 118 and the actuator 116. As such, the actuator 116 may receive a control signal based on an output from the input unit 118. In some embodiments, the control system comprises a control unit 124. The control unit 124 is communicatively coupled to the actuator 116 and to the input unit 118. For example, the control unit 124 may have a wired or wireless connection to the actuator 116, capable of transmitting a data signal between the control unit 124 and the actuator 116. The control unit 124 may also have a wired or wireless connection to the input unit 118, capable of transmitting a data signal between the input unit 118 and the control unit 124. As such, the control unit 124 may receive an output from the input unit 118 and provide a control signal to the actuator 116.

In some embodiments, the control unit 124 may be integrated in the housing 102. In other embodiments, the control unit 124 may be integrated separately to the housing 102, for example with the input unit 118, or disposed elsewhere such as in a pocket of the user, around the user’s neck or strapped against the user’s body. The control unit 124 is powered by a battery unit. The battery unit may be either integrated in the control unit 124, or implemented separately and connected to the control unit 124 with a wired connection.

The control unit 124 is configured to receive the output from the input unit 118. The control unit 124 may also be configured to generate the control signal for the actuator 116 based on the output from the input unit 118. For example, the control unit 124 may operate software that compares the output from a sensor 120 to a threshold value, and provides a control signal accordingly. The control unit 124 is also configured to transmit the control signal to the actuator 116. In some embodiments, the control unit 124 may merely act as a relay. That is to say, the control unit 124 receives the output from the input unit 118 and transmits it directly to the actuator 116. This may be the case where the input unit 118 is an on/off switch from which the output signal can be used directly to control the actuator 116.

In embodiments where the control unit 124 acts as a relay, the output signal from the input unit 118 is transmitted directly to the actuator 116. Similarly, in embodiments where the control unit 124 is configured to generate the control signal for the actuator 116, the control unit 124 may generate the control signal for the actuator 116 as soon as the output is received from the input unit 118. In this way, the actuator 116 can operate the shut-off valve member 114 to close the opening 112 as soon as the user wishes to initiate speech. This means that there will be no delay in the initiation of speech.

In embodiments where the output unit 118 is a sensor 120, the control unit 124 is configured to filter noise from the sensor output when generating the control signal. The control unit 124 may be configured to generate the control signal for the actuator 116 based on the filtered output being above a certain threshold level. Thresholds and filter parameters for filtering noise from the output may be fixed or set for a specific situation by carrying out a calibration procedure. The calibration procedure may include: a) placement of the sensor 120, initiation of a calibration sequence, b) definition of a noise threshold, c) reading naturally occurring signals from the sensor in normal conditions, d) reading signals from the sensor during normal movements of the head (for example side to side and up and down) to define the noise level, and e) setting thresholds for control signals. After the calibration procedure, the control unit 124 is able to distinguish between signals indicating the intention of the user to initiate or end speech and sensor noise generated from other actions, for example body movements not related to speech.

The tracheostoma device 100 can be operated in two different modes. In a first mode of operation, known as a “kick-and-release” mode, a biasing arrangement is used to releasably maintain the shut-off valve member 114 in the open position. In the kick-and-release mode, the actuator 116 actuates the shut-off valve member 114 to the closed position such that speech can begin. During speech, the actuator 116 releases the shut-off valve member 114, but the shut-off valve member 114 stays in the closed position if the pressure in the airway of the user is sufficient to overcome the force of the biasing arrangement. As such, speaking can continue even though the actuator 116 has released the shut-off valve member 114. Once speaking ends, the pressure in the airway is reduced such that it no longer overcomes the force of the biasing arrangement, and the shut-off valve member 114 returns to the open position under action of the biasing arrangement. Since the opening of the shut-off valve member 114 is triggered by loss of speaking pressure, the kick-and-release mode has the benefit of being insensitive to falsely detected interruptions of speech, for example erroneous sensor signals. Furthermore, the system does not need an indication relating to the end of speech, as the valve member 114 is automatically opened once speech ends. Furthermore, the shut-off valve member 114 and the biasing arrangement can be selected based on the natural air flowrate and pressure in the airway of the user. For example, a softer membrane closes more easily than a harder membrane, and so a softer membrane can be used for a user with a lower natural pressure in the airway.

In a second mode of operation, known as a “kick-and-hold” mode, the actuator 116 actuates the shut-off valve member 114 to the closed position and maintains the shut-off valve member 114 in the closed position until a second control signal is received indicating that speaking has ended. When the second control signal is received, the actuator 116 releases the shut-off valve member 114 or actuates it to the open position. The second control signal may be based on an output from the input unit 118 that is indicative that speech has ended. Alternatively, the second control signal may be based on an absence of a speech-indicative output from the input unit 118 for a certain period. Alternatively, a pressure sensor disposed in the airway could be used to provide an indication of lower pressure in the airway, which indicates the end of speech. Once it is determined that speech has ended, a timer may be initiated to determine when the valve member 114 can be activated again. For example, the timer can be calibrated to a particular user’s speech patterns to determine whether a pause in speech is a break or merely the end of sentence. In the kick-and-hold mode, a biasing arrangement may be present to return the shut-off valve member 114 to the open position once it has been released by the actuator 116. Alternatively, the actuator 116 may itself return the shut-off valve member 114 to the open position, in which case a biasing arrangement is not required. The kick-and-hold mode has the benefit of being independent of the pressure in the airway. Therefore, there is less risk of the shut-off valve member 114 returning to the open position before a sentence has been completed. Furthermore, a lower average speaking pressure can be applied by the user, which requires less effort, and puts less strain on the attachment between the tracheostoma device and the user.

A tracheostoma device and control system has been disclosed that does not rely on high pressure in the housing to close the shut-off valve or maintain it in the closed position during speech. The device also does not require speech to be initiated by a forced exhalation. Therefore, a lower average speaking pressure can be applied by the user, which requires less effort and puts less strain on the attachment between the tracheostoma device and the user. The shut-off valve member 114 can be operated as soon as the user wishes to initiate speech, meaning there will be no delay in the initiation of speech and the user may engage quickly and spontaneously in conversation. The device is configured such that falsely detected initiations and interruptions of speech can be detected. For example, the device is able to distinguish between signals indicating the intention of the user to initiate speech and noise generated from other actions not related to speech. In this way, speech is identified and maintained at the correct times. The device is adaptable to the natural air flowrate and pressure in the airway of the user.

Although the present disclosure has been made above with reference to specific embodiments, the invention is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the appended claims and embodiments other than the specific embodiments above are equally possible within the scope of these claims.

In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second” etc. do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

1. A tracheostoma device (100) adapted to control the flow of air through a tracheostoma of a user of the device, the tracheostoma device comprising: a housing (102) having an open first end (104) configured to be connected to the tracheostoma, and a second end (106), the housing (102) comprising at least one opening (112); a shut-off valve member (114) actuatable between an open position and a closed position, the shut-off valve member configured to allow airflow through the opening when in the open position, and to prevent airflow through the opening when in the closed position; and an electrically controlled actuator (116) configured to actuate the shut-off valve member between the open position and the closed position based on a control signal.

2. The tracheostoma device (100) of claim 1, wherein the control signal is based on an output from an input unit (118).

3. The tracheostoma device (100) of claim 2, wherein the input unit (118) comprises a sensor (120) configured to sense a condition of the user.

4. The tracheostoma device (100) of claim 3, wherein the sensor (120) comprises at least one of: an electroencephalographic, EEG, sensor (120a) configured to sense electrical impulses from brain activity of the user; an electromyographical, EMG, sensor (120b) configured to sense electrical impulses from muscular activity of the user; a flex sensor (120c) configured to sense flexing motions on the skin of the user; and a surface strain gauge (120d) configured to sense strain in the skin of the user.

5. The tracheostoma device (100) of any of claims 2 to 4, wherein the input unit (118) comprises a switch (122) configured to be operated by the user.

6. The tracheostoma device (100) of any of claims 2 to 5, wherein the output from the input unit (118) is indicative of the beginning of speech, and the electrically controlled actuator (116) is configured to actuate the shut-off valve member (114) from the open position to the closed position in response to receiving the control signal.

7. The tracheostoma device of (100) any of claims 2 to 5, wherein the output from the input unit (118) is indicative of the end of speech, and the electrically controlled actuator (116) is configured to actuate the shut-off valve member (114) from the closed position to the open position in response to receiving the control signal.

8. The tracheostoma device (100) of any of claims 2 to 7, wherein the electrically controlled actuator (116) is communicatively coupled to a control unit (124), the control unit configured to receive the output from the input unit (118), generate the control signal based on the output, and transmit the control signal to the electrically controlled actuator.

9. The tracheostoma device (100) of claim 8, wherein the control unit (124) is further configured to filter noise from the output when generating the control signal.

10. The tracheostoma device (100) of claim 9, wherein the control unit (124) is configured to filter noise from the output based on a calibration procedure.

11. The tracheostoma device (100) of any of claims 8 to 10, wherein the control unit (124) is disposed within the tubular housing (102).

12. The tracheostoma device (100) of any preceding claim, wherein the shut-off valve member (114) is selectively configured to be maintained in the closed position by the pressure in the airway of the user or by the electrically controlled actuator (116).

13. The tracheostoma device (100) of any preceding claim, further comprising a biasing arrangement configured to releasably maintain the shut-off valve member (114) in the open position.

14. The tracheostoma device (100) of any preceding claim, wherein the electrically controlled actuator (116) comprises at least one of: a linear actuator such as a solenoid; a rotary actuator such as a stepper motor; and a fluid power actuator such as a piezo-compressor.

15. The tracheostoma device (100) of any preceding claim, wherein the shut-off valve member (114) is configured to allow airflow through the housing (102) from the first end (104) to the ambient atmosphere via the opening (112) when in the open position, and to prevent airflow through the housing from the first end to the ambient atmosphere via the opening when in the closed position.

16. A system for controlling the flow of air through a tracheostoma of a user, the system comprising: a tracheostoma device (100) as defined in claims 1 to 15; an input unit (118); and a control unit (124).