Control device for a medical aerosol delivery device

11247002 · 2022-02-15

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Inventors

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International classification

Abstract

The invention relates to a control device (10) for a medical aerosol delivery device (2), a medical aerosol delivery system, a method for controlling a medical aerosol delivery device (2), a computer program element for controlling such device or system, and a computer readable medium having stored such computer program element. The control device is configured to provide inhalation length data and to select an aerosol delivery mode from at least a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data. The first aerosol delivery mode and the different, second aerosol delivery mode are one of a target inhalation mode, a tidal breathing mode, a continuous aerosol delivery mode and breath-actuated delivery mode. Optionally, the control device (10) comprises a provision unit (11) and a control unit (13). The provision unit (11) is configured to provide inhalation length data. The processing unit may be configured to select either a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data. The medical aerosol delivery system comprises an aerosol delivery device (2) and such control device (10). The control device (10) is configured to control the aerosol delivery device (2). The aerosol delivery device (2) is configured to deliver aerosol to a user.

Claims

1. A control device for a medical aerosol delivery device comprising: a provision unit, and a control unit, wherein the provision unit is configured to provide inhalation length data, wherein the control unit is configured to select an aerosol delivery mode from at least a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data, wherein the first aerosol delivery mode is a target inhalation mode and the second aerosol delivery mode is a tidal breathing mode, and wherein in the target inhalation mode the control unit is configured to guide a user to breathe for a first target inhalation time and in the tidal breathing mode the control unit is configured to adapt a tidal breathing mode target aerosol pulse length and a second target inhalation time to the user's breathing pattern.

2. The control device according to claim 1, wherein the control unit is further configured to control a switching of the aerosol delivery between the first aerosol delivery mode and the second aerosol delivery mode and to change between the two modes based on the provided inhalation length data.

3. The control device according to claim 1, wherein the switching takes between zero and ten seconds.

4. The control device according to claim 1, wherein the provided inhalation length data is based on a user inhalation time detected during a user's previous inhalation.

5. The control device according to claim 1, wherein the control unit is configured to calculate the first target inhalation time or the second target inhalation time for the user's subsequent inhalation based on the provided inhalation length data and the selection of the first aerosol delivery mode or the second aerosol delivery mode.

6. The control device according to claim 5, further comprising a vibration unit configured to indicate an end of the target inhalation time to the user by vibration.

7. The control device according to claim 5, wherein, in case the first aerosol delivery mode is selected, the control unit is configured to calculate the first target inhalation time based on the target inhalation mode.

8. The control device according to claim 5, wherein, in case the second aerosol delivery mode is selected, the control unit is further configured to process the provided inhalation length data into a three-breath-moving average value and to calculate the second target inhalation time based on the three-breath-moving average value.

9. The control device according to claim 5, wherein the control unit is further configured to calculate a target inhalation mode target aerosol pulse length or the tidal breathing mode target aerosol pulse length for the user's subsequent inhalation based on a breath hold value and one of the first target inhalation time or the second target inhalation time.

10. A medical aerosol delivery system, comprising: an aerosol delivery device, and a control device comprising: a provision unit, and a control unit, wherein the provision unit is configured to provide inhalation length data, wherein the control unit is configured to select an aerosol delivery mode from at least a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data, wherein the first aerosol delivery mode is a target inhalation mode and the second aerosol delivery mode is a tidal breathing mode, wherein in the target inhalation mode the control unit is configured to guide a user to breathe for a first target inhalation time and in the tidal breathing mode the control unit is configured to adapt a tidal breathing mode target aerosol pulse length and a second target inhalation time to the user's breathing pattern, and wherein the aerosol delivery device is configured to deliver aerosol to a user.

11. The medical aerosol delivery system of claim 10, wherein the control unit is further configured to control a switching of the aerosol delivery between the first aerosol delivery mode and the second aerosol delivery mode and to change between the two modes based on the provided inhalation length data.

12. The medical aerosol delivery system of claim 11, wherein the switching takes between zero and ten seconds.

13. The medical aerosol delivery system of claim 10, wherein the provided inhalation length data is based on a user inhalation time detected during a user's previous inhalation.

14. The medical aerosol delivery system of claim 10, wherein the control unit is configured to calculate the first target inhalation time or the second target inhalation time for a user's subsequent inhalation based on the provided inhalation length data and the selection of the first aerosol delivery mode or the second aerosol delivery mode.

15. The medical aerosol delivery system of claim 14, further comprising a vibration unit configured to indicate an end of the first target inhalation time or the second target inhalation time to the user by vibration.

16. The medical aerosol delivery system of claim 14, wherein, in case the first aerosol delivery mode is selected, the control unit is configured to calculate the first target inhalation time based on the target inhalation mode.

17. The medical aerosol delivery system of claim 14, wherein, in case the second aerosol delivery mode is selected, the control unit is further configured to process the provided inhalation length data into a three-breath-moving average value and to calculate the second target inhalation time based on the three-breath-moving average value.

18. The medical aerosol delivery system of claim 14, wherein the control unit is further configured to calculate a target inhalation mode target aerosol pulse length or the tidal breathing mode target aerosol pulse length for the user's subsequent inhalation based on a breath hold value and one of the first target inhalation time or the second target inhalation time.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Exemplary embodiments of the invention will be described in the following with reference to the accompanying drawings:

(2) FIG. 1 shows a schematic drawing of an example of a medical aerosol delivery system with a control device.

(3) FIG. 2 shows schematically and exemplarily how to choose between a device guided mode and a user guided mode.

(4) FIG. 3 shows schematically and exemplarily how to calculate and adapt the device guided target inhalation time and pulse length.

(5) FIG. 4 shows schematically and exemplarily how to calculate the user guided target inhalation time.

(6) FIG. 5 shows basic steps of an example of a method for controlling a medical aerosol delivery device.

DETAILED DESCRIPTION OF EMBODIMENTS

(7) FIG. 1 shows schematically and exemplarily an embodiment of a medical aerosol delivery system 1. The medical aerosol delivery system 1 comprises an aerosol delivery device 2 and a control device 10. The control device 10 controls the aerosol delivery device 2 and the aerosol delivery device 2 delivers aerosol to a user.

(8) The control device provides inhalation length data and selects an aerosol delivery mode from at least a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data. The first aerosol delivery mode and the different, second aerosol delivery mode are one of a target inhalation mode, a tidal breathing mode, a continuous aerosol delivery mode and breath-actuated delivery mode.

(9) The control device 10 comprises a provision unit 11 and a control unit 13. The provision unit 11 provides inhalation length data. The provided inhalation length data is here based on a user inhalation time detected during a user's previous inhalation.

(10) The processing unit selects either a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided last inhalation length data, T.sub.I, relative to a threshold, δ, as shown schematically in FIG. 2. The first aerosol delivery mode is here a device guided mode, namely a target inhalation mode (TIM). The second aerosol delivery mode is here a user guided mode, namely a tidal breathing mode (TBM).

(11) When the first or the second aerosol delivery mode is selected, the control unit 13 calculates a target inhalation time for the user's subsequent inhalation based on the provided inhalation length data and the selection of the first or the second aerosol delivery mode. In case the first aerosol delivery mode is selected, the control unit 13 calculates the target inhalation time based on a target inhalation mode. In case the second aerosol delivery mode is selected, the control unit 13 processes the provided inhalation length data into a three-breath-moving average value and calculates the target inhalation time based on this three-breath-moving average value. For both modes, a calculation of the target inhalation time will be shown in the following.

(12) In case the first, the target inhalation (TIM) aerosol delivery mode is selected, the control unit 13 calculates the target inhalation time based on the target inhalation mode. FIG. 3 shows schematically and exemplarily how to calculate and adapt the target inhalation time. A duration between a signal to the user to exhale and an actual exhaling is Δt. A mere expected reaction time between the signal to the user to exhale and the actual exhaling is κ. The coefficients for determining the next target are i and j. If the duration Δt is greater than a programmed threshold (e.g. 500 ms, to be programmable between 0 and 1000 ms), then the user may find the target inhalation volume too small and could be expected to cope with an increased target inhalation time. The target inhalation time is therefore increased by e.g. 2%. If the duration Δt is less than a programmed threshold (e.g. −300 ms, to be programmable between 0 and 1000 ms), then the user has reacted very quickly to the feedback signal and may urgently need to exhale. This suggests that the user is unable to cope with such a long target inhalation time. The target inhalation time will be reduced by e.g. 2%.

(13) Another factor is a duration of exhaling, T.sub.E. If the duration of exhaling, T.sub.E, is shorter than a last inhalation time, T.sub.I, then the user may be desperate to reach the next inhalation. This would suggest that a minute volume dictated by the target inhalation time might be insufficient. The target inhalation time will therefore be increased by 1%. If the duration of exhaling, T.sub.E, is long (greater than three times the inhalation duration, 3*T.sub.I), then this may indicate that the user has had to remove the medical aerosol delivery device 2 from his/her mouth and take multiple breaths to recover. The target inhalation time will therefore be reduced by 1%.

(14) A maximum target inhalation time is determined using the inhalation time, exhalation time, reaction time and the previous maximum target inhalation time as shown above.

(15) FIG. 3 further shows schematically and exemplarily how to calculate a target aerosol pulse length, ω.sub.n, for the user's subsequent inhalation as difference between the target inhalation time, θ.sub.n, and a breath hold value, B.sub.H, for operation in device guided mode.

(16) In case the second, the tidal breathing (TBM) aerosol delivery mode is selected, the control unit 13 processes the provided inhalation length data into a three-breath-moving average value and calculates the target inhalation time based on this three-breath-moving average value.

(17) FIG. 4 shows schematically and exemplarily how to calculate a minimum target aerosol pulse length, ω.sub.n, for a user's subsequent inhalation based on an inhalation time, T.sub.I, and a breath hold value, B.sub.H, for operation in patient guided mode. If the calculated tidal volume, T.sub.V, is less than a threshold TVL of e.g. 0.25 litres, or, a three breath moving average, 3BMA, minus the breath hold value, B.sub.H, is less than half the three breath moving average, 3BMA, then the minimum target aerosol pulse length, ω.sub.n, is calculated as half of the three breath moving average. However, if the three breath moving average, 3BMA, minus the breath hold value, B.sub.H, is greater than half three breath moving average, 3BMA, and the calculated tidal volume, T.sub.V, is larger than the threshold TVL, then the aerosol pulse length, ω.sub.n, is the three breath moving average, 3BMA, minus the breath hold value, B.sub.H.

(18) If the inhalation time is greater than a threshold, δ, of e.g. 2 seconds, then the target aerosol pulse length is a maximum target inhalation time minus the breath hold value and the target inhalation time is set to the maximum inhalation target time. Where the maximum target inhalation time is determined using the inhalation time, exhalation time, reaction time and the previous maximum target inhalation time as shown above. If the inhalation time is less than a threshold, δ, of e.g. 2 seconds, then the target aerosol pulse is the minimum target aerosol pulse length and minimum target inhalation time is calculated as a percentage of a three-breath-moving average. This may be a value between 50 and 95%.

(19) These determined values are stored in the medical aerosol delivery device 2 at the end of every inhalation cycle. When the medical aerosol delivery device 2 is switched on to begin a new treatment, the stored values are loaded and used. This means that the user can start the new treatment from the point at which the last finished.

(20) FIG. 5 shows a schematic overview of steps of a method for controlling a medical aerosol delivery device 2. The method comprises the following steps, not necessarily in this order: In a first step S1, providing inhalation length data. In a second step S2, selecting either a first aerosol delivery mode or a different, second aerosol delivery mode based on the provided inhalation length data.

(21) The method may comprise a further step to calculate a target inhalation time for the user's subsequent inhalation based on the provided inhalation length data and the selection of the first or the second aerosol delivery mode. In case the first aerosol delivery mode is selected, the method may comprise a step to calculate the target inhalation time based on a target inhalation mode. In case the second aerosol delivery mode is selected, the method may comprise a step to process the provided inhalation length data into a moving average value and preferably into a three-breath-moving average value and to calculate the target inhalation time based on this moving average value and preferably on this three-breath-moving average value. The method may comprise a further step to calculate a target aerosol pulse length for the user's subsequent inhalation based on the target inhalation time and a breath hold value.

(22) In another exemplary embodiment of the present invention, a computer program or a computer program element is provided that is characterized by being adapted to execute the method steps of the method according to one of the preceding embodiments, on an appropriate system.

(23) The computer program element might therefore be stored on a computer unit, which might also be part of an embodiment of the present invention. This computing unit may be adapted to perform or induce a performing of the steps of the method described above. Moreover, it may be adapted to operate the components of the above described apparatus. The computing unit can be adapted to operate automatically and/or to execute the orders of a user. A computer program may be loaded into a working memory of a data processor. The data processor may thus be equipped to carry out the method of the invention.

(24) This exemplary embodiment of the invention covers both, a computer program that right from the beginning uses the invention and a computer program that by means of an up-date turns an existing program into a program that uses the invention.

(25) Further on, the computer program element might be able to provide all necessary steps to fulfil the procedure of an exemplary embodiment of the method as described above.

(26) According to a further exemplary embodiment of the present invention, a computer readable medium, such as a CD-ROM, is presented wherein the computer readable medium has a computer program element stored on it, which computer program element is described by the preceding section.

(27) A computer program may be stored and/or distributed on a suitable medium, such as an optical storage medium or a solid state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the internet or other wired or wireless telecommunication systems.

(28) However, the computer program may also be presented over a network like the World Wide Web and can be downloaded into the working memory of a data processor from such a network. According to a further exemplary embodiment of the present invention, a medium for making a computer program element available for downloading is provided, which computer program element is arranged to perform a method according to one of the previously described embodiments of the invention.

(29) It has to be noted that embodiments of the invention are described with reference to different subject matters. In particular, some embodiments are described with reference to method type claims whereas other embodiments are described with reference to the device type claims. However, a person skilled in the art will gather from the above and the following description that, unless otherwise notified, in addition to any combination of features belonging to one type of subject matter also any combination between features relating to different subject matters is considered to be disclosed with this application. However, all features can be combined providing synergetic effects that are more than the simple summation of the features.

(30) While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. The invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing a claimed invention, from a study of the drawings, the disclosure, and the dependent claims.

(31) In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfil the functions of several items re-cited in the claims. The mere fact that certain measures are re-cited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.