WO2016079461A1

WO2016079461A1 - Respiratory therapy apparatus

Info

Publication number: WO2016079461A1
Application number: PCT/GB2015/000295
Authority: WO
Inventors: Michael L. Blomquist
Original assignee: Smiths Medical International Limited
Priority date: 2014-11-19
Filing date: 2015-10-28
Publication date: 2016-05-26
Also published as: GB201420518D0

Abstract

An expiratory therapy device (100) includes a sensor (30) responsive to operation of the device that transmits a signal to a smartphone (200) or the like programmed to process the signal and generate an audible output. The audible output may be a musical tone, tune or the like that can be heard by the user and changes according to how the therapy device is used. This prompts the user to correct incorrect use or reinforces correct use.

Description

RESPIRATORY THERAPY APPARATUS

This invention relates to respiratory therapy apparatus of the kind including a respiratory therapy device arranged to produce an alternating resistance to respiratory flow through the device.

Positive expiratory pressure (PEP) devices, that is, devices that present a resistance to expiration through the device, are now widely used to help treat patients suffering from a range of respiratory impairments, such as chronic obstructive pulmonary disease, bronchitis, cystic fibrosis and atelectasis. More recently, such devices that provide an alternating resistance to flow have been found to be particularly effective. One example of such a device is sold under the trade mark Acapella (a registered trade mark of Smiths Medical) by Smiths Medical and is described in US6581598, US6776159, US7059324 and US7699054.

US8534284 describes a device with an interrupter valve driven by pressurised gas delivered to the apparatus. The speed of the valve is dependent on the back pressure created by expired breaths from the patient. Other devices are described, for example, in WO2013/182853, WO2014/202924, WO2014/202923, WO2015/008013, WO2015/036723, WO2015/104522, PCT/GB2015/000097, PCT/GB2015/000161 and PCT/GB2015/000178.

Other vibratory respiratory therapy devices are available, such as "Quake"

manufactured by Thayer, "AeroPEP" manufactured by Monaghan, "TheraPEP"

manufactured by Smiths Medical and 'TPV Percussionator" manufactured by Percussionaire Corp and the "Flutter" and "Lung Flute" devices, amongst others. EP2636420 describes an oscillatory PEP device with a nebulizer. These devices are used by patients who suffer from mucus hyper-secretions and retention to help them clear the secretions from their lungs. It has been reported that some patients may benefit from playing a harmonica:

http://denver.cbslocal.com/2015/03/03/colorado-patients-coping-with-copd-hum-on-the- harmo nica-for-help/ The Acapella O-PEP device combines the principles of low-frequency oscillation and positive expiratory pressure by employing a counterweighted lever and magnet to produce oscillatory positive pressures during expiration. This generated oscillating positive pressure works by mechanically reducing the viscoelasticity of the sputum by breaking down the bonds of mucus macromolecules which, in turn, enhances mucociliary clearance. Alternative apparatus such as "CoughAssist" manufactured by Philips is also available. Respiratory therapy devices can instead provide an alternating resistance to flow during inhalation.

Although these devices can be highly effective at treating respiratory impairments, the relief obtained is dependent on how closely the patient adheres to the prescribed treatment regime: how regularly he uses the device and the manner in which the device is used. Patients are trained to use the devices by a clinician in a hospital but it is essential that the devices are used regularly by the patient in the prescribed manner at home where there is no clinical supervision. The problem is, however, that the patient may not use the device at the required frequency, or for the required duration, or in the required manner when unsupervised, outside a clinical environment. The clinician is unable to determine whether any lack of improvement or deterioration in the patient's condition is due to his failure to adhere to the treatment regime or other factors so this makes control of the patient's condition very difficult.

It is an object of the present invention to provide an alternative respiratory therapy device.

According to one aspect of the present invention there is provided a respiratory therapy apparatus of the above-specified kind, characterised in that the apparatus including a device for generating an audible signal that can be heard by the user and provides the user with information about use of the therapy device. The audible signal may be indicative of actual use of the device or may be indicative of how actual use differs from prescribed use. The audible signal may be musical. The audible signal may be generated to indicate one or more of the following: desired duration of use of the device, desired frequency of breaths through the device, desired generated pressure, desired generated flow, achievement of a desired parameter, deviation from a desired parameter or other error in use of the device. The device for generating an audible signal may include a sensor mounted with the therapy device arranged to transmit a signal to a separate audible device arranged to provide the audible signal. The sensor could transmit the signal wirelessly. The separate audible device may be a mobile phone, tablet computer, PDA or the like. The respiratory therapy device is preferably a vibratory expiratory therapy device.

Apparatus including a vibratory PEP device according to the present invention will now be described, by way of example, with reference to the accompanying drawing, which is a perspective view of the apparatus showing the therapy device in an exploded view.

The apparatus includes a modified respiratory therapy device 100 and separate means for generating an acoustic signal in the form of an appropriately programmed "smart" mobile phone 200.

The respiratory therapy device 100 is of a kind that produces vibration within the user's lungs similar to an Acapella respiratory expiratory therapy device as sold by Smiths Medical. The device 100 comprises a rocker assembly 1 contained within an outer housing 2 provided by an upper part 3 and a lower part 4 of substantially semi-cylindrical shape. The device is completed by an adjustable dial 5 of circular section. The rocker assembly 1 includes an air flow tube 6 with a breathing inlet 7 with a removable mouthpiece (not shown) at one end and an inspiratory inlet 8 at the opposite end including a one-way valve (not shown) that allows air to flow into the air flow tube 6 but prevents air flowing out through the inspiratory inlet. The air flow tube 6 has an outlet opening 10 with a non-linear profile that is opened and closed by a conical valve element 11 mounted on a rocker arm 12 pivoted midway along its length about a transverse axis. The air flow tube 6 and housing 2 provide a structure with which the rocker arm 12 is mounted. At its far end, remote from the breathing inlet 7, the rocker arm 12 carries an iron pin 13 that interacts with the magnetic field produced by a permanent magnet (not visible) mounted on an adjustable support frame 14. The magnet arrangement is such that, when the patient is not breathing through the device, the far end of the rocker arm 12 is held down such that its valve element 11 is also held down in sealing engagement with the outlet opening 10. A cam follower projection 15 at one end of the support frame 14 locates in a cam slot 16 in the dial 5 such that, by rotating the dial, the support frame 14, with its magnet, can be moved up or down to alter the strength of the magnetic field interacting with the iron pin 13. The dial 5 enables the frequency of operation and the resistance to flow of air through the device to be adjusted for maximum therapeutic benefit to the user.

When the patient inhales through the breathing inlet 7 air is drawn through the inspiratory inlet 8 and along the air flow tube 6 to the breathing inlet. When the patient exhales, the one-way valve in the inspiratory inlet 8 closes, preventing any air flowing out along this path. Instead, the expiratory pressure is applied to the underside of the valve element 11 on the rocker arm 12 causing it to be lifted up out of the opening 10 against the magnetic attraction, thereby allowing air to flow out to atmosphere. The opening 10 has a non-linear profile, which causes the effective discharge area to increase as the far end of the rocker arm 12 lifts, thereby allowing the arm to fall back down and close the opening. As long as the user keeps applying sufficient expiratory pressure, the rocker arm 12 will rise and fall repeatedly as the opening 10 is opened and closed, causing a vibratory, alternating or oscillating resistance to expiratory breath flow through the device.

The device also includes a sensor 30 connected with a transmitter 31 arranged to transmit a signal to the smart phone 200 indicative of operation of the device. The sensor 30 could transmit wirelessly using infra-red radiation, in which case the smart phone would need a suitable infra-red receiver, but would preferably transmit using radio frequency signals such as with the Bluetooth protocol. The sensor 30 includes some form of arrangement responsive to use of the therapy device, such as a flow or pressure sensor mounted inside the air flow tube 6 to monitor flow or pressure in the housing. Alternatively, the sensor 30 could be a vibration sensor responsive to vibration within the housing 2 caused by movement of the rocker arm 12. Such a vibration sensor could be mounted on the outside of the housing 2 and could be removable and reusable for use on a different device. The sensor could be responsive to movement of the iron pin 13 on the rocker arm 12 and, in this respect the sensor could be of an inductive, magnetic or capacitive kind. The sensor could be responsive to other parameters such as temperature, movement/acceleration (such as along three axes) and compass orientation or the like.

The smart phone 200 is programmed by downloading a suitable program or app arranged to determine how well the therapy device 100 is being used and to what extent the user is complying with prescribed use of the device. In this respect the smart phone 200 could determine from the output of the sensor 30 the flow rate and, or alternatively, the pressure exerted by the user during each breath. It could also monitor the duration and profile of each breath, the rate of breathing (number of breaths per minute) and the duration of the complete treatment session. The smart phone 200 then generates an audible feedback signal via its speaker 201, such as a suitable audible tone or tones, or a sequence of musical notes that can be heard by the user and give him feedback on how well he is using the device 100. This could take the form of a single tone or tune that varies in pitch, timbre or amplitude according to how the user uses the device. Alternatively, the smart phone 200 could be arranged to play different tunes according to how well the device 100 is being used, such as by selecting from a play list set up by the user arranged in order of preference. If the user fails to use the device 100 correctly, a tune would be played that the user dislikes. The apparatus could be arranged to generate a tune at the correct speed when the user was breathing at the correct rate but would reduce or increase the speed appropriately if the rate of breathing should drop below the prescribed level or should be too quick. At the end of the prescribed therapy session the audible signal would stop or would change to indicate successful completion. The program in the smart phone 200 could be arranged to change the audible feedback signal in response to changes in various parameters. These parameters could be any one or more of the following, although the list is not exhaustive:

• Duration - such as a sound to indicate the start or end of a therapy session, a continuous signal while the session should be undertaken, or a sequence of signals indicating successive breaths;

• Frequency of breaths - a sound could indicate that frequency should be increased, decreased or maintained;

• Length of breath - a sound could indicate the desired start and finish of each breath or a continuous sound while a breath was to be maintained;

• Pressure - the sound could indicate that the pressure of exhalation should be increased, decreased or maintained; and

Flow - the sound could indicate that the flow rate should be increased, decreased or maintained.

The apparatus could be arranged such that the user can change the audible feedback by how he manipulates the respiratory device 100. For example, the output of an

accelerometer in the sensor 30 could be used to change the tone of the feedback tune or signal when the user tilts the device 100. Alternatively, or additionally, the output of a compass sensor could be used to alter the audible feedback by simply pointing the therapy device 100 in different directions.

The audible signal is preferably given via the speaker 201 in the smart phone 200 or could be given by headphones 202 worn by the user and plugged into the smart phone.

Instead of using a smart phone 200 to provide the audible feedback, other devices could be used, such as a laptop or tablet computer, PDA or a dedicated, stand-alone device for this application only. The audible feedback device could be mounted on the therapy device, either permanently or removably so that it could be detached and reused on another therapy device. The means 200 for generating the audible signal preferably also includes a memory 203 in which information is stored about how the user is using the apparatus.

Alternatively this information could be transmitted to a remote data store, such as a hospital information system or a cloud-based data store. By storing information in this way the clinician is able to monitor compliance and determine whether the therapy needs to be changed

The musical or other audible feedback generated by apparatus according to this invention makes using the apparatus a novel and amusing event, thereby encouraging compliance by the user by correcting incorrect use or reinforcing correct use. This could be of particular advantage with younger users where it is normally more difficult to ensure strict adherence to a treatment regime. Various other audible features could be included, such as, spoken commands giving instructions how to use the device, how to remedy incorrect use, congratulations on successful completion of a session or the like. The apparatus could incorporate novelty features, such as, being programmed to play "Happy Birthday" to the user when it was his birthday.

Claims

1. Respiratory therapy apparatus including a respiratory therapy device (100) arranged to produce an alternating resistance to respiratory flow through the device (100), characterised in that the apparatus including a device (200) for generating an audible signal that can be heard by the user and provides the user with information about use of the therapy device (100).

2. Respiratory therapy apparatus according to Claim 1, characterised in that the audible signal is indicative of actual use of the device.

3. Respiratory therapy apparatus according to Claim 1, characterised in that the audible signal is indicative of how actual use differs from prescribed use.

4. Respiratory therapy apparatus according to any one of the preceding claims,

characterised in that the audible signal is musical.

5. Respiratory therapy apparatus according to any one of the preceding claims,

characterised in that the audible signal is generated to indicate one or more of the following: desired duration of use of the device (100), desired frequency of breaths through the device (100), desired generated pressure, desired generated flow, achievement of a desired parameter, deviation from a desired parameter or other error in use of the device (100).

6. Respiratory therapy apparatus according to any one of the preceding claims,

characterised in that the device (100) for generating an audible signal includes a sensor (30) mounted with the therapy device (100) arranged to transmit a signal to a separate audible device arranged to provide the audible signal.

7. Respiratory therapy apparatus according to Claim 6, characterised in that the sensor (30) transmits the signal wirelessly.

8. Respiratory therapy apparatus according to Claim 6 or 7, characterised in that the separate audible device (200) includes a mobile phone, tablet computer, PDA or the like.

9. Respiratory therapy apparatus according to any one of the preceding claims,

characterised in that the respiratory therapy device (100) is a vibratory expiratory therapy device.