WO2010017586A1

WO2010017586A1 - Inhaler with piercable vial and drug in liquid form

Info

Publication number: WO2010017586A1
Application number: PCT/AU2009/001029
Authority: WO
Inventors: Alexander James Kelly
Original assignee: SILPHION Pty Ltd
Current assignee: SILPHION Pty Ltd
Priority date: 2008-08-11
Filing date: 2009-08-11
Publication date: 2010-02-18
Anticipated expiration: 2011-02-11
Also published as: TW201010750A

Abstract

The invention provides a device for facilitating inhalation of an inhalable drug in liquid form comprising a barrel for holding a vial of the drug, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel, and a method of providing an inhalable drug in liquid form using the device of the invention.

Description

INHALER WITH PIERCABLE VIAL AND DRUG IN LIQUID FORM

TECHNICAL FIELD

The invention described herein relates generally to a device and method for the administration of volatile drugs in liquid form. In particular, the invention is directed to a device and method for inhalation administration of volatile drugs in liquid form, although the scope of the invention is not necessarily limited thereto.

BACKGROUND ART

In many medical circumstances, there is a need for rapid onset of analgesia. This is generally achieved by intravenous administration of opioid-based analgesics. There are many disadvantages associated both with the drugs used and with the method of administration.

Opioid analgesics are known to have the potential to cause dependency, and are therefore not always the drug of choice for these medical circumstances. Intravenous administration is a difficult mode of administration under many conditions, including for example emergency roadside incidents, non-compliant patients, or non-sterile environments.

The use of inhalation anesthetics has been contemplated for use in analgesia. There are devices which administer for example sevoflurane and methoxyflurane for inhalation, but these suffer from several disadvantages.

The device disclosed in PCT/US02/33190 administers the drug using compressed air/oxygen is cumbersome, expensive and not easily portable.

A further device which is a hand-held device, currently available in at least

Australia, suffers from the severe drawback that the drug has to be poured into the barrel of the device for administration. This pouring action easily results in spillage on the skin of the medical carer or patient, and release of the drug into the air space around these people, which is dangerous and inefficient as the actual dosage is then unknown. Therefore, there would be an advantage if it were possible to provide a device for administration of inhalable drugs which may overcome at least some of the above- mentioned disadvantages or provide a useful or commercial choice.

SUMMARY OF THE INVENTION In a first embodiment, the invention provides a device for facilitating inhalation of an inhalable drug in liquid form, the device comprising a barrel for holding a vial of the inhalable drug in liquid form, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel.

In a second embodiment, the invention provides a method of providing an inhalable drug in liquid form comprising inserting a vial of the drug into the barrel of the device of the first embodiment, piercing the seal of the vial with the piercing means, applying the mouthpiece to a subject wherein the subject inhales through the mouthpiece the drug released upon piercing of the seal.

With regard to the first and second embodiments as defined above, the drug can be any inhalable drug in liquid form that is sufficiently volatile to be available for inhalation upon release from the vial. The device is particularly suited to drugs such as analgesics, including but not limited to inhalable fiuorocarbon-based analgesics such as sevoflurane, methoxyflurane, desflurane, isoflurane, enfiurane, diethyl ether, methoxypropane, chloroform, and halothane. The barrel of the device can be any configuration which will accommodate a vial of inhalable drug in liquid form. Preferably the barrel is a substantially straight tube, or a tube including a substantially right angled bend towards the mouthpiece. The vial can be a standard commercially available vial, or a vial made specifically for the device of the invention. Preferably the vial is a standard 1-5OmL vial. The device of the invention can be a disposable, single-use device, or can be configured for repeated use. To this end, the barrel can be configured such that the vial is sealed inside the barrel upon manufacture of the device, or the barrel can be configured to reversibly open at one end to receive a vial when needed. The latter option can include any practicable reversible opening means, including a screw-type device, clip device or snap-lock device. The piercing means can be any means capable of piercing the seal of a drug vial. Preferably the piercing means is a plastic needle-type device, attached near to the vial end inside the barrel. The piercing means preferably is an integral part of the barrel moulding itself. When the vial is moved towards the piercing means, this can be effected in any practicable manner. Preferably the barrel has a rotatable actuator mechanism in contact with the base of the vial which, when twisted, forces the vial along the barrel until the piercing means pierces the seal of the vial.

Alternatively, the piercing means can be moved towards the seal of the vial. In this embodiment, the barrel can have any practicable mechanism for activation to move the needle towards the piercing means, such as a depressable actuator or more than one depressable actuators on the exterior of the device which, when depressed, moves the needle towards the seal of the vial and forces the needle to pierce that seal.

The device of the invention can also include a wick of any practicable material inside the barrel. Upon piercing of the seal of the vial, the contents of the vial run or disperse onto the wick, increasing the available surface area for active evaporation. This assists vaporization and retention of the drug for inhalation.

The mouthpiece is attached to an end of the barrel by any means, and can be fixed or movable. If the mouthpiece is movable, which is generally when the barrel is a straight tube, preferably that mouthpiece is movable through approximately 180°, allowing the subject to access the mouthpiece and thereby the drug from any body position or recline. The mouthpiece can also be fitted into a standard medical mask to assist with administration of the drug to an incapacitated patient.

The device can also include a filter in communication with the mouthpiece. The filter can be located in any practicable position on the device but is preferably located in an exhalation port on the barrel of the device. The filter can be made any material capable of absorbing vapours of the inhalable drug in liquid form. The filter is preferably made of activated carbon matrix or another equivalent solvent-retaining medium.

The device of the invention can be made of any practicable material but is preferably made from solvent-resistant plastic. The device can be any colour, including different colours to indicate the nature of the inhalable drug in liquid form in the vial in the barrel of the device. The device can also be colourless or coloured translucent plastic so that the level of drug in the vial in the barrel of the device is visible. The material of manufacture can also have an additive to render the device able to glow in the dark. This would assist patients and care providers in emergency situations where lighting is not available.

The device of the invention can also include a strap reversibly or irreversibly attached to any practicable position on the barrel. The strap can be intended for use around the wrist or neck of a patient. The strap is preferably attached to the end of the barrel furthest from the mouthpiece. The strap is preferably attached by one or more snap- tag to prevent trapping or strangulation of the patient. The snap-tag can be easily removed with a sharp pull to release the strap from the barrel.

The device can also include a nozzle or port on the barrel for attachment of a medical standard oxygen hose if required.

In order that the invention may be more readily understood and put into practice, one or more preferred embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a representation of a first embodiment of the device showing internal and external features. Figure 2 is a perspective view of the external features of a first embodiment of the device.

Figure 3 is a top view of the external features of a first embodiment of the device. Figure 4 is a side view of the external features of a first embodiment of the device.

Figure 5 is a top view of the external features of a second embodiment of the device.

Figure 6 is a side view of the external features of a second embodiment of the device.

Figure 7 is an exploded view of a second embodiment of the device. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Figures 1 to 4 refer to a first embodiment of the invention.

Referring firstly to Figure 1 , which shows internal and external features of the device (1), the vial (2) containing the inhalable drug in liquid form is loaded in the barrel (3) of the device. By loading the sealed vial into the barrel, any wastage or potentially harmful spillage of the drug is avoided. This also ensures that the patient dose is accurately known.

The actuator (4) is turned, forcing the seal of the vial (2) onto a piercing means (5). The piercing means (5) pierces the seal of the vial (2) and releases the drug in the barrel (3) and onto a wick (not shown).

The patient places the mouth around the mouthpiece (6), which can be swiveled around an axis (7). This function of the mouthpiece allows for administration of the drug to a patient in any physical position.

Referring also to Figures 2 and 4, the patient then inhales through the mouthpiece (6), inhalation made possible by inlet air vents included in the actuator section (8).

Upon exhalation, any remaining drug is absorbed by the filter (not shown) in the outlet vents (9), thereby preventing escape of any drug into the environment of the patient and caregiver.

The snap-tags (10) for attachment of a strap are shown in the Figures, as is the optional nozzle (11) for attachment of an oxygen hose.

Figures 5 to 7 refer to a second embodiment of the invention.

Referring to the exploded view of the second embodiment, Figure 7, which shows internal and external features of the device, the vial (12) containing the inhalable drug in liquid form is loaded in the barrel (13) of the device. By loading the sealed vial into the barrel, any wastage or potentially harmful spillage of the drug is avoided. This also ensures that the patient dose is accurately known.

The depressable actuators (14) are depressed and the piercing means (15) pierces the seal of the vial (12) and releases the drug in the barrel (13). Figure 7 represents the piercing means (15) after piercing the vial seal. Referring also to Figures 5 and 6, the patient places the mouth around the mouthpiece (16), which is at the end of a substantially right angle in the barrel, furthest from the depressable actuators. This position of the mouthpiece allows for administration of the drug to a patient in any physical position. The patient then inhales through the mouthpiece (16), inhalation made possible by inlet air vents included in the actuator portion (17).

Upon exhalation, any remaining drug is absorbed by the filter (18) in the outlet vents (not shown) in the actuator portion (17), thereby preventing escape of any drug into the environment of the patient and caregiver. Attachment of a strap (not shown in the Figures) is preferably on the side of the mouthpiece (20), opposite the air inlet (see Figure 6). The optional nozzle (19) for attachment of an oxygen hose is also shown in the Figures.

The many advantages of the device of the invention will be clear from the above discussion and from the Figures. The invention therefore provides a novel and efficient way of administering an inhalable drug in liquid form to a patient, without wastage or spillage of the drug, contamination of the surroundings, or discomfort to the patient. The device also provides a portable administration unit which is easy to operate, allowing a patient to self-administer should the need arise. The device can be disposable which improves the safety and reproducibility of administration of the drug. The foregoing embodiments are illustrative only of the principles of the invention, and various modifications and changes will readily occur to those skilled in the art. The invention is capable of being practiced and carried out in various ways and in other embodiments. It is also to be understood that the terminology employed herein is for the purpose of description and should not be regarded as limiting. The term "comprise" and variants of the term such as "comprises" or

"comprising" are used herein to denote the inclusion of a stated integer or stated integers but not to exclude any other integer or any other integers, unless in the context or usage an exclusive interpretation of the term is required.

Any reference to publications cited in this specification is not an admission that the disclosures constitute common general knowledge in Australia.

Claims

The claims defining the invention are as follows:

I . A device for facilitating inhalation of an inhalable drug in liquid form, the device comprising a barrel for holding a vial of the inhalable drug in liquid form, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel. 2. The device of claim 1 including a filter in communication with the mouthpiece.

3. The device of claim 1 wherein the drug is a volatile analgesic.

4. The device of claim 3 wherein the drug is a fluorocarbon-based analgesic.

5. The device of claim 1 wherein the barrel is a substantially straight tube.

6. The device of claim 1 wherein the barrel is a tube including a substantially right angled bend towards the mouthpiece.

7. The device of claim 1 wherein the device is disposable.

8. The device of claim 1 wherein the piercing means is a needle.

9. The device of claim 1 additionally including a means external of the barrel for moving the vial towards the piercing means or the piercing means towards the vial. 10. A method of providing an inhalable drug in liquid form comprising inserting a vial of the drug into the barrel of the device of claim 1 , piercing the seal of the vial with the piercing means enabling release of the drug, applying the mouthpiece to a subject wherein the subject inhales through the mouthpiece the released drug.

I 1. The method of claim 10 wherein the drug is a volatile analgesic. 12. The method of claim 10 wherein the piercing means is a needle.

13. The method of claim 10 wherein the seal of the vial is moved towards the piercing means.

14. The method of claim 10 wherein the piercing means is moved towards the seal of the vial. 15. The method of claim 14 wherein the piercing means is moved towards the seal of the vial by activation of at least one depressable actuator external to the barrel.