WO2011089485A1

WO2011089485A1 - Nebulizing drug delivery device having an improved user interface and a method of manufacturing the same

Info

Publication number: WO2011089485A1
Application number: PCT/IB2010/055812
Authority: WO
Inventors: Wilhelmus Henricus Petrus Thijssen; Jonathan Stanley Harold Denyer; Ian Thomas Petherbridge; Dirk Jan Nelly Vananderoye; Eckhardt Henricus Matheus Schraven; Juliana Vorstenbosch-Kelly; Theodorus Martinus Maria Van Het Hof; Adriaan Johan Arnoldus Petrus Van Der Pluijm; Timothy A Nathan; Vanessa Sattele
Original assignee: Koninklijke Philips Electronics NV
Current assignee: Koninklijke Philips NV
Priority date: 2010-01-19
Filing date: 2010-12-14
Publication date: 2011-07-28
Anticipated expiration: 2012-07-19

Abstract

A nebulizing drug delivery device (10) is provided with a user interface (18) that is simple and intuitive. The user interface includes icons (42) provided on a body (22) of a housing (12) of the device. The icons are selectively illuminable to convey information to a subject related to therapy received from the device and/or operation of the device. The icons may be symbols representing information their illumination conveys.

Description

NEBULIZING DRUG DELIVERY DEVICE HAVING AN IMPROVED USER INTERFACE AND A

METHOD OF MANUFACTURING THE SAME

[01] The invention relates to nebulizing drug delivery devices, and in particular to user interfaces that convey information related to therapy received from and/or the operation of a nebulizing drug delivery device.

[02] Nebulizing drug delivery devices are known. These devices include portable, handheld devices that convert liquid drug solution into a nebulized particles that can be inhaled by a subject. The inhalation of nebulized drug solution may be implemented to treat various types of conditions, including respiratory diseases and/or conditions.

[03] User interfaces in these types of portable, handheld devices are typically over simplistic, or overly complicated. For example, some of these types of devices include liquid crystal displays that convey information to subjects. However, when employed in handheld nebulizing devices, these interfaces have various limitations (e.g., size, power requirements, complexity, and/or other limitations).

[04] One aspect of the invention relates to a nebulizing drug delivery device. In one embodiment, the device comprises one or more of a rigid housing a drug nebulization module, and a user interface. The rigid housing forms a mouthpiece and a body. The mouthpiece is configured to be engaged by a mouth of a subject in order to receive medicament therefrom. The mouthpiece extends from the body, and the body is generally opaque. The drug nebulization module is configured to nebulize drug solution within the body such that the nebulized drug solution is dispensed to the subject through the mouthpiece. The user interface is disposed on the body of the rigid housing, and comprises a set of icons separately formed in the body. The icons are selectably illuminable. The user interface is configured to illuminate the icons to convey information related to therapy received from the device and/or operation of the device to the subject.

[05] Another aspect of the invention relates to a method of manufacturing a nebulizing drug delivery device. In one embodiment, the method comprises forming a rigid housing having a mouthpiece configured to be engaged by a mouth of a subject in order to receive medicament therefrom, and a body from which the mouthpiece extends, wherein the body of the rigid housing is generally opaque; providing a drug nebulization module within the rigid housing, the drug nebulization module being configured to nebulize drug solution within the body such that the nebulized drug solution is dispensed to the subject through the mouthpiece; and forming a user interface on the body of the rigid housing, the user interface comprising a set of icons separately formed in the body, the icons being selectably illuminable, the user interface being configured to illuminate the icons to convey information related to therapy received from the device and/or operation of the device to the subject.

[06] Yet another aspect of the invention relates to a nebulizing drug delivery device. In one embodiment, the device comprises housing means, nebulizing means, and user interface means. The housing means comprises drug dispensing means for dispensing drug solution to a subject, the drug dispensing means being configured for engagement by a mouth of a subject in order to receive medicament therefrom; and body means for housing internal components of the device, wherein the body means is generally opaque. The nebulizing means is for nebulizing drug solution within the body means such that the nebulized drug solution is dispensed to the subject through the drug dispensing means. The user interface means is for conveying information related to therapy and/or operation of the device to the subject, the user interface comprising a set of icons separately formed in the body means, the icons being selectably illuminable to convey information.

[07] These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. In one embodiment of the invention, the structural components illustrated herein are drawn to scale. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not a limitation of the invention. In addition, it should be appreciated that structural features shown or described in any one embodiment herein can be used in other embodiments as well. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[08] FIG. 1 illustrates a sectional view of a nebulizing drug delivery device, according to one or more embodiments of the invention.

[09] FIG. 2 illustrates a nebulizing drug delivery device, according to one or more

embodiments of the invention.

[10] FIG. 3 a nebulizing drug delivery device, according to one or more embodiments of the invention.

[11] FIG. 4 illustrates a sectional view of a nebulizing drug delivery device, according to one or more embodiments of the invention.

[12] FIG. 5 illustrates a sectional view of a nebulizing drug delivery device, according to one or more embodiments of the invention.

[13] FIG. 6 illustrates a nebulizing drug delivery device, according to one or more

embodiments of the invention.

[14] FIG. 7 illustrates an exploded view of a housing of a nebulizing drug delivery device, according to one or more embodiments of the invention.

[15] FIG. 8 illustrates various types of icons that may be included in a user interface of a nebulizing drug delivery device, according to one or more embodiments of the invention.

[16] FIGS. 9A-J illustrate the manner in which icons of a user interface can be

selectively illuminated to convey information related to therapy received from a nebulizing drug delivery device and/or operation of the device to the subject, according to one or more embodiments of the invention.

[17] FIG. 10 illustrates a method of manufacturing a nebulizing drug delivery device, in accordance with one or more embodiments of the invention.

[18] FIG. 1 illustrates a sectional view of a nebulizing drug delivery device 10. The

device 10 is configured to nebulize a liquid drug solution for inhalation by a subject (not shown). The device 10 comprises a housing 12, a drug metering assembly 14, a drug nebulization module 16, a user interface 18, and/or other components. [19] The housing 12 is configured to house device 10. The housing 12 is formed from a rigid material. In one embodiment, this rigid material is covered, at least in part, by a softer material. This cover may enhance the grip of the subject on housing 12 and/or the comfort of gripping housing 12. The housing 12 may be formed as a single unit, or housing 12 may be formed from a set of different parts that are selectively detachable and/or replaceable. The housing 12 includes a mouthpiece 20 and a body 22.

[20] The mouthpiece 20 is configured to be engaged by a mouth of the subject to

receive nebulized drug solution therefrom. As is shown in FIG. 1 , mouthpiece 20 is hollow, providing a flow path for drug solution, and extends from body 22. The mouthpiece 20 has an opening 24 and a neck 26. The opening 24 is where the nebulized drug solution is communicated to the subject. The neck 26 connects opening 24 with the interior of body 22 to communicate drug solution from within body 22 to opening 24. The length of neck 26 may be sufficient to extend into the mouth of the subject far enough to bypass the teeth of the subject. The mouthpiece 20 (and/or a portion of body 22) may be removable from the rest of body 22. This may permit separate cleaning of mouthpiece 20, replacement of mouthpiece 20, and/or other activities.

[21] The body 22 is configured to house the internal components of device 10. The

body 22 is generally opaque. This may include drug metering assembly 14, drug nebulization module 16, one or more processors (not shown), one or more circuit boards (not shown), one or more batteries (not shown), one or more communication ports (not shown), one or more antennae (not shown), and/or other internal components. The body 22 may include a handle 28. The handle 28 is configured to be grasped by the subject during therapy. The handle 28 is an elongate section that runs generally transverse to mouthpiece 20, as can be seen in FIG. 1.

[22] The drug metering assembly 14 includes a plunger assembly 30. The plunger

assembly 30 comprises a medication metering chamber 32. The medication metering chamber 32 is arranged to feed the drug to be nebulized to the drug nebulization module 16 for nebulization. Any drug in excess of the appropriate dosage volume held in the medication metering chamber 32 may be retained within drug nebulization module 16. This allows a unit dose (i.e. vial) of a drug to be nebulized to be poured into medication metering chamber 32, but only the metered volume of the medication metering chamber 32 to be nebulized during treatment, with the remainder or excess of the drug being retained in the drug nebulization module 16. Further details of the drug metering assembly 14 and its operation can be found in United States patent US2003/0146300A1 , which is hereby incorporated by reference in its entirety into this disclosure.

[23] The drug nebulization module 16 is configured to nebulize drug solution within the body such that the nebulized drug solution is dispensed to the subject through mouthpiece 20. The drug nebulization module 16 includes a medication chamber 34 and a mesh 36. The medication chamber 34 is configured to hold excess drug solution introduced into medication metering chamber 32. The mesh 36 is vibrated by a piezoelectric element (not shown) to generate a fine spray or aerosol that is communicated to the subject through body 22. The drug nebulization module 16 may include one or more components configured to monitor various information related to mesh 36. Such information may include usage (e.g., time, treatments, amount of drug, and/or other metrics of usage), situation within drug nebulization module 16 (e.g., seated properly, not seated properly, and/or other information), occlusion (e.g., occluded, unoccluded, and/or other information), and/or other information related to operation of mesh 36. Communication may be to other components within device 10 (e.g., a processor, a printed circuit board, electronic storage, user interface 18, and/or other components) and/or external systems. The communication of the information may be accomplished via wired and/or wireless communication media.

[24] FIGS. 2 and 3 illustrate perspective views of device 10. As can be seen in FIG. 2, device 10 may include a cover 38. The cover 38 is configured to sit on top of mouthpiece 20 while device 10 is not being used for therapy. The cover 38 may protect mouthpiece 20, and may reduce the amount of debris and/or bacteria picked up by mouthpiece 20.

[25] In FIG. 3, a port 40 is shown. In one embodiment, through port 40, device 10 can communicate with external entities. Such entities may include, for example, a personal computer, a laptop computer, a handheld computer, a SmartPhone, a personal digital assistant, and/or other computing platforms. Through port 40, device 10 may

communicate with a server over a network, such as the Internet. The device 10 may upload information about operation and/or therapy to the server, and/or may receive software and/or firmware updates, control inputs, and/or other information. In one embodiment, device 10 may receive power through port 40. The power may be used to recharge a battery within device 10 and/or to power device 10 during therapy or for other functions.

[26] Turning back to FIG. 2, user interface 18 is disposed on body 22. The user

interface 18 includes a set of icons 42 (illustrated in FIG. 2 as icons 42a-42e). The handle 28 is shown in FIG. 2 having rounded corners and being covered with a softer material to facilitate gripping and comfort of device 10 during therapy. The icons 42 are formed in handle 28, and are selectively illuminable to convey information to the subject about the operation of device 10 and/or therapy. The selective illumination of icons 42 is

accomplished via backlighting with light sources disposed within handle 28. The sources may include, for example, colored LEDs, and/or other sources. The icons 42 may be formed on handle 28 from relatively transparent (and/or tinted) materials so that illumination of the sources results in the emission of electromagnetic radiation out of the corresponding ones of icons 42.

[27] The user interface 18 may provide for enhanced utility with respect to conventional interfaces for handheld and/or portable nebulizers. Such conventional interfaces may include, for example, liquid crystal displays. The icons 42 of user interface 18 may be more robust (e.g., resistive to breakage and/or malfunction) than conventional interface, while still providing useful and accessible information to the subject. Placement of icons 42 on handle 28 toward the subject during use may make icons 42 easily viewable for the subject.

[28] The user interface 18 may include a processor, a circuit, and/or other information processing component within device 10 configured to control the light sources that selectively illuminate icons 42. The processor may illuminate the light sources in accordance with an interface scheme. The interface scheme may include some or all of the functionality described herein with respect to user interface 18.

[29] It will be appreciated that the particular configuration of device 10 provided above is not intended to be limiting. One more of housing 12, drug metering assembly 14, and/or user interface 18 may be configured differently without departing from the scope of this disclosure. By way of example, FIG. 4 illustrates an alternate configuration of device 10 in which drug metering assembly 14 is disposed on a side of housing 12 facing toward the subject during therapy. On an opposite side of housing 12 from drug metering assembly 14 a resting surface 44 is formed in housing 12. The resting surface 44 is flat to permit device 10 to be laid down on a flat surface while drug solution is poured into drug metering assembly 14. Then, when the subject picks up device 10 to begin therapy, drug solution within medication chamber 34 flows down to mesh 36, as is shown in FIG. 5.

[30] FIG. 6 illustrates a perspective view of the configuration of device 10 shown in

FIGS. 4 and 5. FIG. 7 illustrates an exploded view of the configuration, showing how various portions of housing 12 may be selectively separable from each other. FIG. 7 further shows how partial disassembly of housing 12 provides access to portions of drug nebulization module 16 (e.g., mesh 36).

[31] FIG. 8 provides examples of several types of icons 42 that may be included in user interface 18. As is shown in FIG. 8, the icons may include a power icon 42a, a treatment status icon 42b, a mesh icon 42c, a fault icon 42d, a drug level icon 42e, a communication status icon 42f, and/or other icons (e.g., 42g). It will be appreciated that the visual depictions of the types of icons provided in FIG. 8 (and/or in FIG. 2) are not intended to be limiting. Further, the icons 42 included in the user interface may include more or less than the icon types provided in FIG. 8.

[32] FIGS. 9A-9J illustrate the manner in which various one of the icons 42 can be

selectively illuminated by user interface 18 to convey information related to therapy received from device 10 and/or operation of device 10 to the subject. For example, FIG. 9A illustrates an implementation in which power icon 42a is not illuminated (not even partially). This may indicate to the subject that device 10 is not activated, or OFF.

[33] FIG. 9B illustrates an implementation in which power icon 42a is illuminated (at least partially). This may indicate to the subject that device 10 is activated, or ON. The amount of power icon 42a that is illuminated (e.g., three bars as shown, two bars, or one bar) may indicate a level of the battery currently powering device 10.

[34] FIG. 9C illustrates an implementation in which treatment status icon 42b is

illuminated. This may indicate to the subject that device 10 that treatment is complete. The user interface 18 may illuminate treatment status icon 42b responsive to determination that a treatment session has been completed. This may be based on monitoring an amount of time device 10 is used to administer drug, an amount of drug administered, and/or other parameters related to therapy.

[35] FIG. 9D illustrates an implementation in which fault icon 42d is illuminated. This may indicate to the subject that device 10 is not operating properly. The user interface 18 may illuminate mesh icon 42c responsive to determination that one or more components within device 10 is not operating properly. For example, the determination may be that the mesh, the piezoelectric actuator, the drug metering assembly, and/or other components of device 10 are not operating properly.

[36] FIG. 9E illustrates an implementation in which mesh icon 42c is illuminated. In the implementation illustrated in FIG. 9E, the illumination of mesh icon 42c may be

intermittent, causing mesh icon 42c to flash. The flashing mesh icon 42c may indicate to the user that the mesh within device 10 is nearing the end of its life. The user interface 18 may cause mesh icon 42c to flash responsive to determination that a threshold amount of therapy sessions have been performed without cleaning and/or replacing the mesh. This determination may be based on counting a number of therapy sessions, monitoring replacement and/or cleaning of the mesh, monitoring flow through the mesh, and/or other parameters. The flashing mesh icon 42c may prepare the subject to replace and/or clean the mesh.

[37] FIG. 9F illustrates an implementation in which mesh icon 42c is illuminated without flashing. The fault icon 42d may be illuminated simultaneously. This may indicate to the subject that the mesh should be replaced and/or cleaned before another therapy session is administered by device 10. The user interface 18 may cause mesh icon 42c to be illuminated responsive to determination that a threshold amount of therapy sessions have been performed without cleaning and/or replacing the mesh. This determination may be based on counting a number of therapy sessions, monitoring replacement and/or cleaning of the mesh, monitoring flow through the mesh, and/or other parameters. The illuminated mesh icon 42c (and/or the simultaneously illuminated fault icon 42d) may prompt the subject to replace and/or clean the mesh. [38] FIG. 9G illustrates an implementation in which drug level icon 42e is illuminated. The user interface 18 may cause drug level icon 42e to be illuminated responsive to a determination that there is no (or an insufficient amount of) drug available for nebulization within housing 12 of device 10. This determination may be based on a detection of drug level within device 10, by monitoring an amount of therapy sense drug was previously added to device 10, and/or other parameters. The illuminated drug level icon 42e may indicate to the subject that additional drug should be added to device 10.

[39] FIG. 9H illustrates an implementation in which communication status icon 42f is illuminated. The user interface 18 may cause communication status icon 42f to be illuminated if device 10 is communicating with an external entity. Such communication may be accomplished via wired (e.g., through a port on device 10) or wireless (e.g., through an antennae included in device 10) communication media. Illumination of communication status icon 42f may indicate to the subject that device 10 is operating to exchange information with an external entity. For example, illumination of communication status icon 42f may indicate that device 10 is operating in an online mode to upload and/or download information.

[40] FIG. 9I illustrates an implementation in which power icon 42a is illuminated in an intermittent fashion, causing power icon 42a to flash. The user interface 18 may cause power icon 42a responsive to a determination that a battery powering device 10 is depleted. The determination may be made based on monitoring the battery. The flashing power icon 42a may indicate to the subject that the battery should be charged and/or replaced before further operation.

[41] FIG. 9J illustrates an implementation in which the sections of power icon 42a are illuminated in a staggered fashion (denoted by the arrows). The user interface 18 may cause power icon 42a to be illustrated in this staggered fashion responsive to a

determination that a battery powering device 10 is being charged. The determination may be made based on monitoring the battery and/or a power connection to an external power source.

[42] It will be appreciated that the examples of the manner in which the icons 42 may be illuminated to convey information to the subject related to therapy received from device 10 and/or operation of device 10 is not intended to be limiting. Other combinations of icons 42 may be illuminated and/or illuminated in different fashions {e.g., staggered, flashing, and/or other illumination techniques) to convey the statuses set forth above and/or other information related to therapy and/or operation of device 10 without departing from the scope of this disclosure.

[43] FIG. 10 illustrates a method 46 of manufacturing a nebulizing drug delivery device.

The operations of method 46 presented below are intended to be illustrative. In some embodiments, method 46 may be accomplished with one or more additional operations not described, and/or without one or more of the operations discussed. Additionally, the order in which the operations of method 46 are illustrated in FIG. 10 and described below is not intended to be limiting.

[44] At an operation 48, a rigid housing is formed and/or assembled. The housing may be formed as a single component. The housing may be formed as a plurality of selectively separable and/or replaceable components. The housing may be similar to or the same as housing 12 (shown in FIGS. 1 -9 and described above). The housing may include a mouthpiece and a body. The body may include a handle formed as an elongate section running generally transverse to the mouthpiece. The body may be generally opaque.

[45] At an operation 50, a drug nebulization module may be provided within the housing.

The drug nebulization module may be configured to nebulize drug solution for delivery to a subject through the mouthpiece. The drug nebulization module may be similar to or the same as drug nebulization module 16 (shown in FIGS. 1 and 4, and described above).

[46] At an operation 52, a user interface is formed. The user interface may include a set of icons formed in the body. The icons are selectively illuminable to convey information to the subject related to therapy received from the device and/or operation of the device. The user interface may be similar to or the same as user interface 18 (shown in FIGS. 1 , 2, and 9, and described above).

[47] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred

embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

CLAIMS:

1. A nebulizing drug delivery device, the device comprising: a rigid housing forming:

a mouthpiece configured to be engaged by a mouth of a subject in order to receive medicament therefrom; and

a body from which the mouthpiece extends, wherein the body of the rigid housing is generally opaque;

a drug nebulization module configured to nebulize drug solution within the body such that the nebulized drug solution is dispensed to the subject through the mouthpiece; and

a user interface disposed on the body of the rigid housing, the user interface comprising a set of icons separately formed in the body, the icons being selectably illuminable, the user interface being configured to illuminate the icons to convey information related to therapy received from the device and/or operation of the device to the subject.

2. The device of claim 1 , wherein the body includes a handle configured to be grasped by the subject during therapy, the handle being an elongate section that runs generally transverse to the mouthpiece, and wherein the set of icons are formed in the handle.

3. The device of claim 1 , wherein the icons include images that depict the aspects of therapy and/or the operation of device about which information is conveyed by the selective illumination of the icons.

4. The device of claim 3, wherein the icons include one or more of a treatment status icon, a drug level icon, an communication status icon, or a mesh icon.

5. The device of claim 1 , wherein the user interface is configured such that the selective illumination of the icons conveys information regarding one or more of whether a current treatment is complete, a level of drug solution in the device,

implementation of an online mode, or a status of a mesh.

6. A method of manufacturing a nebulizing drug delivery device, the method comprising:

forming a rigid housing having:

providing a drug nebulization module within the rigid housing, the drug nebulization module being configured to nebulize drug solution within the body such that the nebulized drug solution is dispensed to the subject through the mouthpiece; and

forming a user interface on the body of the rigid housing, the user interface comprising a set of icons separately formed in the body, the icons being selectably illuminable, the user interface being configured to illuminate the icons to convey

information related to therapy received from the device and/or operation of the device to the subject.

7. The method of claim 6, wherein the body includes a handle configured to be grasped by the subject during therapy, the handle being an elongate section that runs generally transverse to the mouthpiece, and wherein forming the user interface comprises forming the set of icons in the handle.

8. The method of claim 6, wherein the icons include images that depict the aspects of therapy and/or the operation of device about which information is conveyed by the selective illumination of the icons.

9. The method of claim 8, wherein the icons include one or more of a treatment status icon, a drug level icon, an communication status icon, or a mesh icon.

10. The method of claim 6, wherein the user interface is configured such that the selective illumination of the icons conveys information regarding one or more of whether a current treatment is complete, a level of drug solution in the device,

implementation of an online mode, or a status of a mesh

1 1. A nebulizing drug delivery device, the device comprising:

housing means comprising:

drug dispensing means for dispensing drug solution to a subject, the drug dispensing means being configured for engagement by a mouth of a subject in order to receive medicament therefrom; and

body means for housing internal components of the device, wherein the body means is generally opaque;

nebulizing means for nebulizing drug solution within the body means such that the nebulized drug solution is dispensed to the subject through the drug dispensing means; and

user interface means for conveying information related to therapy and/or operation of the device to the subject, the user interface comprising a set of icons separately formed in the body means, the icons being selectably illuminable to convey information.

12. The device of claim 1 1 , wherein the body means includes a handle configured to be grasped by the subject during therapy, the handle being an elongate section that runs generally transverse to the mouthpiece, and wherein the set of icons are formed in the handle.

13. The device of claim 1 1 , wherein the icons include images that depict the aspects of therapy and/or the operation of device about which information is conveyed by the selective illumination of the icons.

14. The device of claim 13, wherein the icons include one or more of a treatment status icon, a drug level icon, an communication status icon, or a mesh icon.

15. The device of claim 1 1 , wherein the user interface means is configured such that the selective illumination of the icons conveys information regarding one or more of whether a current treatment is complete, a level of drug solution in the device, implementation of an online mode, or a status of a mesh.