FIELD OF INVENTION

This invention relates generally to spacers, valved holding chambers and their accessories including but not limited to face masks for inhalers, and more particular to spacers and valved holding chambers that are expandable when in use and collapsible to a smaller size when not in use.

BACKGROUND OF INVENTION

Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section.

Asthma and Chronic obstructive pulmonary disease (COPD) are the two major airway diseases that globally affect nearly 500 million people. Pressurized metered-dose inhaler (pMDI) is a patient-administered device that allows a prescribed amount of medication to be administered as an inhaled aerosol to improve delivery of the medication. Usually the pMDI comprises a medicament-containing pressurized canister containing a mixture of an active medication and a propellant. In order to actuate the inhaler, the user applies a compressive force to a closed end of the canister to actuate a metering valve and cause a metered quantity of the medication and the propellant to be expelled through the valve stem into a mouthpiece of the inhaler, such that a user inhaling through the outlet of the inhaler will receive a prescribed dose of the medication. Although pMDI is the preferred device for drug delivery, poor synchronization between its actuation and drug inhalation by the user limits the effectiveness of pMDI. In addition a high proportion of the medication can get deposited in a mouth and throat of the user, where it can lead to irritation and mild infections. Valved Holding Chambers (VHC) or spacers are add-on accessory devices that have been developed to overcome those problems. VHC or spacer is a long tube that slows the delivery of medication from the pMDI. Instead of direct inhalation, the VHC is attached to the pMDI so that patients have time to inhale laminar flow of medication in multiple inspirations without worry about the need for synchronization. Moreover, larger particles that are normally absorbed in the user's upper airways, will impact a wall of the chamber and will deposit in the VHC body. Clinical and laboratory tests demonstrate that the efficacy of drug delivery using pMDI together with VHC is comparable to that of nebulizers. Despite being strongly recommended in clinical guidelines, only a very small portion of patients use VHCs mainly because of their obtrusiveness, bulkiness and cost. Such pMDI are less portable because the VHC takes up extra space in a purse or a bag. Although several small, foldable and compact VHC designs have been introduced, their low efficacy has prevented their widespread adoption. The present invention overcomes the limitations of the prior art by developing VHCs that are pocketable and can be compressed to fit inside a pMDI package and can expand to the same size and shape of a original high efficacy VHCs and spacers.

SUMMARY OF THE INVENTION

In one aspect a collapsible spacer is provided. The spacer comprises an outlet port adapted to be brought in communication with an oral cavity of a user and a body that has a first end connected to the outlet, a second end configured to be connectable to an inhaler and a wall extending between the first end and the second end. The wall comprises a collapsible body structure defining an outer wall of the body and an elastic body structure defining an inner wall of the body. When the spacer is in an extended position the collapsible body structure has sufficient rigidity to keep a predetermined shape and integrity of the spacer and the elastic body structure is entirely stretched defining a smooth inner wall of the spacer. Upon a force is applied to the collapsible body structure it collapses to a smaller size.

In one aspect the collapsible body structure is a foam-like structure and the elastic body structure is attached to the foam-like structure at least at two points. The collapsible body structure can be a foam spring or a foam cage-like frame.

In another aspect, the collapsible spacer is a spring.

In yet another aspect, the collapsible body structure comprises a plurality of O-rings space apart one from another. Each of the O-rings is attached to the elastic body structure.

In one aspect, the collapsible body structure comprises a slidable solid body having a multiple solid compartments. A compartment at the second end of the body has a biggest diameter and a compartment at the first end has a smallest compartment. The multiple compartments are configured to slide one into the other when in the collapsed position. The elastic body structure is attached to each of the compartments to at least one point.

In another aspect, the collapsible body structure comprises an annular ring and a plurality of the telescopic rods connected to the annular ring. The elastic structure is connected to the annular ring.

In yet another aspect, the collapsible spacer further comprises an inflatable system having a pump with a valve and a nozzle. The collapsible body structure has a wall defining a closed inner cavity of the collapsible body structure and an inlet port defined as a communication port with the inner cavity of the collapsible structure. The inlet port has a removable cap and the nozzle of the inflatable system is insertable into the inlet port when the cap is removed to inflate the collapsible body structure when the spacer is in the extended position. The elastic body structure being attached to the collapsible structure at least at two points.

In another aspect, the collapsible body structure and the elastic body structure each are attached to the first and the second end of the body and are spaced apart one from another defining a closed annular cavity formed between the inner wall and the outer wall of the body. An inlet port having a removable cap is configured as communication port with the annular cavity. The nozzle of the inflatable system is inserted into the inlet port when the cap is removed to inflate the spacer when it is in the extended position.

In one aspect, a collapsible face mask is attached at the outlet of the spacer. The face mask has a collapsible outside wall and an elastic inner wall.

In one aspect, an inhaler-based delivery system is provided. The system comprises an inhaler configured to discharge an aerosolized medication and a collapsible spacer connected thereto. The inhaler has an exit port. The spacer has an outlet port and a body with a first end connected to the outlet, a second end connectable to the exit port of the inhaler and a wall extending between the first end and the second end. The wall comprises a collapsible body structure defining an outer wall and an elastic body structure defining an inner wall of the body.

In another aspect, an inhaler-based delivery kit is provided. The kit comprises a package that includes an inhaler with an exit port and containing a substance for delivery and a collapsible spacer configured to be attachable to the exit port of the inhaler when the inhaler is in use.

In yet another aspect, a method of delivering a medication to a user is provided. The method comprises connecting a collapsible spacer to an exit port of an inhaler; erecting the collapsible spacer to its extended position; actuating the inhaler so that the medication flows through the exit port into the spacer; and inhaling the medication in the spacer through the outlet port.

In addition to the aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and study of the following detailed description.

