GB2530397A

GB2530397A - Respiratory therapy devices

Info

Publication number: GB2530397A
Application number: GB1513787.0A
Authority: GB
Inventors: Mohammad Qassim Mohammad Khasawneh; Anthony Lucio Belisario; Mark Charles Oliver; Mark Sinclair Varney
Original assignee: Smiths Medical International Ltd
Current assignee: Smiths Medical International Ltd
Priority date: 2014-08-29
Filing date: 2015-08-04
Publication date: 2016-03-23
Also published as: GB201415323D0; GB201513787D0

Abstract

An expiratory, vibratory therapy device with a rocker arm 12 that opens and closes an outlet10 opening during expiration. A sensor 30 responsive to flow through or pressure in the device provides a signal to a control unit 31. A mouthpiece 70 of the device includes a tactile signal generator in the form of a rotary motor 74 with an eccentric mass 76 mounted on its shaft 75. The control unit 31 drives the motor 74 to generate a vibrating tactile signal to indicate to the user how the device should be used, such as the duration of use.

Description

flSPIRATORY TJEERAPY DEVICES This invention relates to respiratory therapy devices.

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 1.156581598, US6776 159, 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 vibratory respiratory therapy devices are available, such as "Quake" manufactured by Thayer, "AeroPEP" manufactured by Monaghan, "TheraPEP" manufactured by Smiths Medical and "WV Percussionator" manufactured by Percussionaire Corp. These devices generate vibratory positive pressures mechanically and fluctuating exhalation flows that help overcome the inertia and stiction of the sputum within the bronchi and lower passages of the lung. This 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 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 the present invention there is provided a respiratory therapy device arranged to produce an alternating resistance to respiratory flow through the device, the device including means for generating a tactile signal that can be perceived by the user and that is instructive of the desired use of the device.

The device may produce the tactile signal where it will be perceived by the user's mouth. The tactile generating means may be mounted in a mouthpiece of the device. The means for generating a tactile signal is preferably arranged to produce a vibrating signal. The means for generating a tactile signal may include a rotary motor arranged to rotate an cccentric mass. The device preferably includes a sensor responsive to use of the device, such as a sensor responsive to flow of gas through the device or pressure of gas in the device. The tactile 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, and deviation from a desired parameter or other error in use of the device. The device preferably includes a rocker assembly arranged to open and close an outlet opening during expiration and thereby produce the alternating resistance to flow.

A vibratory PEP device according to the present invention will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is an exploded perspective view of the device; and Figure 2 is an enlarged perspective view of the mouthpiece of the device.

With reference first to Figure 1 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 lincludes an aft flow tube 6 with a breathing inlet 7 having a removable mouthpiece 70 (that will be described in detail below) 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 aft flowing out through the inspiratory inlet.

The aft 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 housisig 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 a 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.

A flow or pressure sensor 30 is mounted inside the air flow tube 6 to monitor flow or pressure in the housing. The output of the sensor 30 is supplied to a control unit 31 where it is recorded for subsequent monitoring of use of the device. The output of the sensor 30 could also be used to trigger the start of recording. The control unit 31 includes a processor and a downloadable embedded memory component or removable storage device in which is stored information about the duration of use, settings, frequency of operation and the like so that this information can be analysed to determine the effectiveness of the device at different settings and to provide instructional feedback to the user in the manner described below.

With reference now to Figure 2, the mouthpiece 70 includes a flattened patient end 71 shaped to fit sealingly in the mouth between the lips of the user. The opposite machine end 71 has a circular section with a slightly tapered inner surface 72 adapted to make a sealing slip fit on the breathing inlet 7. The wall of the machine end 71 is increased internally in thickness at its upper side to accommodate a cylindrical recess 73. The recess 73 contains a small electric rotary motor 74 the shaft of which supports an eccentric, mass 76 of semi-circular section. The motor 74 is connected via an electrical cable 78 to an output of the control unit 31, which drives the motor to rotate when it is necessary to generate an instructional feedback signal to the user. It will be appreciated that, when the motor 74 is rotated it will rotate the shaft 75 and also the eccentric mass 76. This will be perceived by the user as a tactile, vibration signal. As the vibration is generated in the mouthpiece 70 the vibration will be felt by the user's mouth, lips or teeth.

The control unit 30 is arranged to drive the motor 74 and produce the vibrating signal in one or more of a variety of situations where it is necessary to provide an instructional feedback signal to the user. These situations could be any one or more of the following, although the list is not exhaustive: * Duration -such as a signal 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 signal could indicate that frequency should be increased, decreased or maintained; * Length of breath -a signal could indicate the desired start and finish of each breath or a continuous signal while a breath was to be maintained; * Pressure -the signal could indicate that the pressure of exhalation should be increased, decreased or maintained; and * Flow -the signal could indicate that the flow rate should be increased, decreased or maintained.

There are various ways in which the vibrating signal could be varied to provide different instructions. For example, the speed of vibration could be varied, either at discrete levels or by varying the speed in different ways, such as gradually increasing or decreasing. Alternatively, the vibration could be interrupted or pulsed in different patterns and with different magnitudes/speeds during the "mark" part of the pulsed signal. In this way, different feedback instructions can be provided to the user.

The vibration need not be produced only in the mouthpiece 70 but could instead, or additionally, be produced in the main part of the housing 2 so that it would be felt by the user's hands rather than in his mouth.

Other forms of tactile feedback could alternatively be used. For example, a slow movement of a mass could be used to produce a wobble effect. The control unit could be used to displace a movable member such as a pin or peg that could be directly engaged by the user. Mechanisms used to produce a tactile feedback could include piezo transducers or other devices.

The tactile feedback of the present invention has various advantages over other forms of feedback, such as visual or audible feedback. One important advantage is that the tactile feedback can be more discrete than other forms of feedback in that it is only perceived by the user. In this way the user avoids drawing attention to himself or it avoids disturbing other people nearby. Visual feedback signals could be difficult to see when the therapy device is held up to the mouth and might not be suitable for people with impaired vision. Audible feedback signals could also be a problem for users who have hearing problems.

Claims

CLAIMS1. A respiratory therapy device arranged to produce an alternating resistance to respiratory flow through the device, wherein the device includes means (30, 31, 74, 75, 76) for generating a tactile signal that can be perceived by the user and that is instructive of the desired use of the device.
2. A respiratory therapy device according to Claim 1, wherein device produces the tactile signal where it will be perceived by the user's mouth.
3. A respiratory therapy device according to Claim 2, wherein the tactile generating means (30, 31, 74, 75, 76) is mounted in a mouthpiece (7) of the device.
4. A respiratory therapy device according to any one of the preceding claims, wherein the tactile signal is produced where it will be perceived by the user's hand holding the device,
5. A respiratory therapy device according to any one of the preceding claims, wherein the means for generating a tactile signal (30, 31, 74, 75, 76) is arranged to produce a vibrating signal.
6. A respiratory therapy device according to Claim 5, wherein the means for generating a tactile signal includes a rotary motor (74) arranged to rotate an eccentric mass (76).
7. A respiratory therapy device according to any one of the preceding claims including a sensor (30) responsive to use of the device.
8. A respiratory therapy device according to any one of the preceding claims, wherein the sensor (30) is responsive to flow of gas through the device or pressure of gas in the device.
9. A respiratory therapy device according to any one of the preceding claims, wherein the tactile signal is 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, and deviation from a desired parameter or other error in use of the device.
10. A respiratory therapy device according to any one of the preceding claims, wherein the device includes a rocker assembly (1) arranged to open and close an outlet opening (10) during expiration and thereby produce the alternating resistance to flow.
11. A respiratory therapy device substantially as hereinbefore described with reference to the accompanying drawings.
12. Any novel feature or combination of features as hereinbefore described.