The present invention is generally related to an apparatus for delivering an aerosolized liquid or substance
Devices for generating and delivering an aerosolized liquid or substance are used for various applications. For example, they can be used to deliver aerosolized medicine, or can be used to generate steam in other devices such as irons.
Medical devices used to deliver drugs in an aerosol form to patients have been used since the mid 1950s. Such devices are used to deliver inhaled pharmaceutical aerosols (IPAs) into lungs of patients to treat asthma, cystic fibrosis, and chronic obstructive pulmonary diseases (COPD), for example. Nebulizers are one type of device used for the delivery of aerosolized medicine. Nebulizers may use different types of mechanisms for aerosolizing medicine. An ultrasonic nebulizer employs an electrical source to provide energy to a vibratable element which generates high frequency vibrations. These vibrations cause small droplets of a medicine or liquid to form into an aerosol. Some nebulizers may employ a mesh having a number of apertures therein. When a vibration is induced in the mesh, a liquid with medicine may be delivered through the apertures in aerosol form to the mouthpiece and thus the patient. Generally, disposal of the mesh membrane is undesirable, as the vibratable element is made with a high quantity of lead, which can pollute the environment.
The company Quatek (of Taiwan) has a nebulizer, for example, MODEL NE403, which has a central functional part consisting of a 15 mm (hard) piezoelectric ring with a disk-shaped stainless steel spring glued on top. In the center of the device is a mesh membrane, with holes for producing a mist or aerosol, that is glued to the stainless steel spring. However, a mesh membrane, such as the one provided in the above Quatek device, is susceptible to deterioration over time, due to pollution by bacteria, inorganic contaminants, and/or accumulation of medicine on the mesh, for example. Such deterioration in the mesh decreases the effectiveness of the nebulizer. Cleaning of the mesh membrane is difficult and cumbersome, if possible at all.
One aspect of the invention, there is provided an apparatus for aerosol delivery of a substance having: a mouthpiece; a chamber for holding a liquid substance therein; a flexible membrane with a plurality of apertures therethrough; and a vibrator for vibrating the flexible membrane. The flexible membrane is made from a magnetic material that enables the flexible membrane to be coupled to the vibrator such that when the flexible membrane is vibrated by the vibrator a flow of aerosol droplets of the substance are ejected through the plurality of apertures and to the mouthpiece for delivery therefrom.
Another aspect of the invention includes a removable insert configured to be removably inserted into an apparatus for aerosol delivery of a substance. The apparatus has a vibrator. The removable insert has: a body; a flexible membrane with a plurality of apertures therethrough, and an attachment member for attaching the flexible membrane to the body. The flexible membrane is configured to be vibrated by the vibrator when the removable insert is inserted into the apparatus such that a flow of aerosol droplets of the substance are ejected through the plurality of apertures for delivery out of the apparatus.
Yet another aspect of the invention includes an apparatus for aerosol generation, the apparatus having: a chamber for holding a liquid substance therein; a flexible membrane with a plurality of apertures therethrough; a vibrator for vibrating the flexible membrane; and a magnetic member configured to magnetically couple the flexible membrane to the vibrator such that when the flexible membrane is vibrated by the vibrator a flow of aerosol droplets of the liquid substance are ejected through the plurality of apertures.
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 considering 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. 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.
Disclosed is an apparatus for delivery of an aerosol substance. In the illustrated embodiment, the apparatus is configured for medical (such as a respiratory drug) delivery to the lungs by aerosol. However, as noted further below, the features (e.g., flexible membrane, magnetic members, etc.) and their use in such an apparatus is not meant to be limiting. Rather, it is envisioned that the herein described features may be used in other apparatuses used for aerosol substance delivery, including, but not limited to, devices for steam delivery (e.g., humidifying devices), devices for moisturizing textiles (e.g., irons), devices for cleaning, and the like. The apparatus is configured to provide small droplets of a liquid (e.g., water) that carry a drug or substance are formed by a combination of a vibrator and a flexible membrane. As noted above, the membrane is subject to deterioration and cleaning is difficult and cumbersome. Thus, separating the vibrator from the membrane is accomplished by coupling the membrane magnetically to the vibrator via a magnetic member.
In the illustrated embodiment, as shown in
Apparatus 10 and its upper portion 12 and lower portion 14 may be formed from a suitable material. Suitable materials may be any biocompatible material, which is acceptable for a safe and effective use by a patient or a medical professional. Any commonly used material in the art of inhaled pharmaceutical aerosols delivery may be used. Examples of various suitable material may be a plastic, such as a polyethylene, polypropylene, polyurethane, polycarbonate, polysulfone, or a combination thereof.
Parts of the apparatus 10 may be formed by any means in the art used to form nebulizing medical devices. In one embodiment, injection molding may be used to form the lower portion 12 and upper portion 14, for example.
The lower portion 12 includes a power source (not shown) such as a battery pack, an activation button 16 for turning power on/off, a display 18 for displaying information regarding the use of the apparatus 10 (e.g., type and/or amount of drug, error readings, etc.), and a horn device 20 (see
Also provided on lower portion 12 is a disc slot 22 for receiving a disc 24 therein. Disc 24 may comprise data that is placed in disc slot 22 in order to transmit information related to drug treatment as input into the apparatus 10. For example, disc 24 may include information relating to the dosage of the drug, such as an output rate and other variables. Disc 24 may include an antenna and microchip therein that is programmed with information including delivery a pre-set volume of the liquid drug, a dosing frequency, a number of doses, etc. Although disc slot 22 and disc 24 are shown on the outside of the body of lower portion 12, the information related to treatment may also be provided inside the body.
The upper portion 14 includes a detachable mouthpiece 36 for delivering a flow of aerosol at a first end that is in fluid communication with a nebulization chamber 46 at a second end. Inside the upper portion 14 adjacent the mouthpiece 36 is a flap valve (not shown) which is used to assist in detecting a patient's breathing and delivering medication. The nebulization chamber 46 of upper portion 14 houses a medication chamber assembly 26. Medication chamber assembly 26 comprises a chamber lid 28, latch 29, a drug guide 32, and a medication chamber 34, generally shown in the exploded view of
Medication chamber 34 holds a liquid 52 containing a medication, drug, or other therapeutic substance therein. The liquid 52 may be transferred to medication chamber 34 via a pipette, or medication chamber 34 may comprise a disposable medication assembly (pre-sealed) which includes medication or substance in the form of liquid 52 therein. Medication chamber 34 and guide 32 are used to direct the liquid medication or substance 52 towards horn device 20. Medication chamber 34 is placed over the horn device 20 and secured in the lower portion 12 adjacent sensor port cover 23, for example. As shown in
The horn device 20 is in communication with a vibrator 44 that is communication with circuitry (e.g., connected to a printed circuit board) and a controller (not shown) contained within the body of the lower portion 12. Vibrational force of the vibrator 44 is transmitted to the horn device 20 which is in contact with the medication chamber 34. Accordingly, the horn device 20 and vibrator 44 are configured to ultrasonically vibrate a flexible membrane 38 in the medication chamber 34 to form an aerosol of the medicine or substance to be ejected therefrom. Such vibration pushes a liquid medication 52 through the flexible membrane 38 to form an aerosol 62.
As shown in detail in
The flexible membrane 38 may be a mesh or sieve that is provided in medication chamber 34. Flexible membrane 38 comprises a first (upper) surface 40 and a second (lower) surface 42 and has a plurality of apertures extending therethrough. The apertures of the flexible membrane 38 may be of any shape (e.g., conical, tapered) and/or any size and such embodiments are within the scope of this disclosure. In an embodiment, the apertures are conical in shape, with a circular cross-section comprising a diameter of 25 micrometers (μm) at the second surface 42 (e.g., liquid 52 input side) and circular cross-section comprising a diameter of 3 micrometers (μm) at the first surface 40 (e.g., aerosol output side). The apertures assist in creating an aerosolized form 62 of the liquid medication 52. The flexible membrane 38 may comprise any number of materials. In one embodiment, the flexible membrane 38 is made from a non-magnetic material. For example, the membrane 38 may be made from a polyimide material such as Kapton. In another embodiment, the membrane can a (soft) magnetic material such as Nickel or a Nickel-Palladium alloy.
The first (upper) surface 40 of flexible membrane 38, when assembled, is in fluid communication with mouthpiece 36. The second (lower) surface 42, when assembled, is in fluid communication with the liquid 52 contained in chamber 34. Referring back to
As discussed above, the flexible membrane 38 may become contaminated or deteriorated over time with use. The disclosed configuration provides a removable and disposable membrane 38 without having to pollute the environment (e.g., with the lead material (e.g., lead zirconium titanate (PZT)) or other materials) of the vibration (piezoelectric) element 44.
In apparatus 10 a magnetic coupling member 54 may be provided that is configured to removably attach the flexible membrane 38 and the oscillating spring element 48 together. Magnetic member 54 may of any shape that permits it to be attached to membrane 38 while allowing membrane 38 to vibrate to generate aerosol. In an embodiment, the magnetic coupling member 54 and membrane 38 are formed as a single, inseparable element. In another embodiment, the magnetic coupling member 54 and membrane 38 may be removably attached to each other.
In one embodiment, magnetic member 54 is in the shape of a ring. Magnetic member or ring 54 is provided on one of the first surface 40 or the second surface 42 of the flexible membrane 38. In the illustrated embodiment, the magnetic ring 54 is provided on the first (upper) surface of the flexible membrane 38. In embodiments, the flexible membrane 38 may include a (soft) magnetic ring 54 glued to it, deposited on it, or grown on it by galvanic means. In one embodiment, the magnetic force between magnetic ring 54 and membrane 38 (which can be made from a material that is attracted to magnetic ring 54) alone secures the magnetic ring 54 to membrane 38. The magnetic ring 54 is configured to magnetically couple the flexible membrane 38 to the vibrator 44 (e.g., by way of spring element 48, as shown in
In another embodiment, magnetic ring 54 may be removably and magnetically coupled with another element in the apparatus. For example, a second magnetic member 64 may be provided in apparatus 10, as shown in
The magnetic force used to attract the membrane 38, spring element 48, magnetic ring 54 and/or second magnetic member 64 in the above embodiments may be determined based on the materials used to form each of the elements. For example, in the exemplary embodiment shown in
Alternatively, in an embodiment wherein the spring element 48 is made of non-magnetic material, second magnetic member 64 could be provided so that the magnetic ring 54A can be magnetically coupled to the vibrator 44 in the apparatus 10, such as shown in
In an embodiment, if the second magnetic member 64 is magnetized, (i.e., produces a magnetic field), then magnetic ring can be made of magnetic material(s). Alternatively, in an embodiment, magnetic ring 54 may be made of a magnetized material and second magnetic member 64 may be made of a magnetic material.
In yet another embodiment, as shown in
In the above embodiments, magnetic ring 54 enables the flexible membrane 38 to be exchanged during cleaning, for example. However, it is also within the scope of this disclosure that magnetic ring 54 need not be provided with flexible membrane 38 in apparatus 10, as shown by the exemplary embodiments of
In an embodiment, a removable insert 30 (shown in greater detail in
In an embodiment, the magnetic ring 54 may be attached to the bottom part 33 of the removable insert body 30 via an attachment member 56, which may be in the form of a spring, a set of springs, tubes, or bellows. For example, the attachment member 56 may be of circular or disc shape and attached to the bottom part of the body, such as shown by the spring 56 in
The attachment member 56 may be provided such that the flexible membrane 38 and magnetic ring 54 are capable of vibrating as well as allowing an aerosolized drug therethrough. Therefore, the removable insert 30 with the magnetic ring 54 attached thereto allows for the flexible membrane 38 to be removed from the medication chamber assembly 26 and exchanged. Its construction also centers the flexible membrane 38 with respect to the opening of the spring element 48 such that the membrane 38 may be pulled into position by magnetic forces present close to the spring element 48 (e.g., via the spring element 48 itself or second magnetic member 64). In an embodiment, the suspension of the attachment member 56 is light-weight.
For example, in an embodiment, the entire insert 30 may be removed and replaced with a new insert 30 with a new, unused or clean flexible membrane 38 and magnetic ring 54 attached thereto. In another embodiment, the flexible membrane 38 may be removed from the insert 30 and replaced with a new, unused or clean flexible membrane 38. In another embodiment, both of the flexible membrane 38 and magnetic coupling ring 54 may be removed and replaced.
In an embodiment, the magnetic coupling ring 54 may have a thickness between approximately 0.2 and approximately 50 microns, depending on the magnetic susceptibility of the magnetic material and the size of the ring, none of which should be limiting. In one embodiment, the magnetic coupling ring 54 may have a thickness of approximately 1 micron. In an embodiment, a magnetic ring 54 made of iron can have a relative permeability on the order of 5000. Alternatively, a magnetic ring 54 made of nickel may have a relative permeability on the order of 600, or made of ferrite T38 on the order of 10000, and or made of Kovar (Fe54Ni29Co17) on the order of 1000-5000. In an embodiment, magnetic ring 54 may be made of Neoflux (NiFeB) material or an Fe/Ni material.
When assembled, the lower portion 12 and upper portion 14 encapsulate the medication chamber assembly 26. Also provided therein is removable insert 30 with the flexible membrane 38 attached thereto.
In an embodiment, the spring element 48 is made from a material such that a magnetic force attracts the magnetic coupling ring 54 to the spring element 48. The second (lower) surface 42 of the flexible membrane 38 may contact a top surface of the spring element 38 (as well as a top surface 20a of the horn 20). The spring element 48 may be also positioned against an o-ring 50 in lower portion 12, as shown in
The vibrator 44 is structured to vibrate (or oscillate) when driven by circuitry contained within the body of lower portion 12. For illustration purposes only,
The magnetic coupling member in any of the embodiments discussed herein allows for replacement of the flexible membrane 38, without wasting or disposal of the vibrator 44.
The herein described illustrated embodiment of a magnetic coupling ring 54 should not be limiting. For example, in an embodiment the magnetic coupling ring 54 is attached to the second (lower) surface 42 of the flexible membrane 38 for removable attachment to the spring element 48 and vibrator 44.
In another embodiment, the flexible membrane 38 may be attached to the removable insert 30 (e.g., via attachment member 56). In such an embodiment, the magnetic ring 54 would not be attached to the removable insert 30 as shown in
In any case, the order and connection of any of the elements described herein should be such that the flexible membrane 38 will be magnetically attracted by the spring element 48 of the apparatus 10.
The apparatus 10 described herein may be used for the treatment of cystic fibrosis, asthma and COPD (pulmonary arterial hypertension (PAH)), for example. Although discussed in the context of the nebulizer 10 shown in the Figures, it is contemplated that the present invention may be utilized with other nebulizers and/or devices. Also, apparatus 10 is designed to work with any aerosol of any common particle size and the particle size distribution should not be limited. In an embodiment, the mean aerosol particle size is 0.1 to 10 micrometers. In another embodiment, the mean aerosol particle size is 0.5 to 5 micrometers. In yet another embodiment, the aerosol particle size is submicron size. An example of particles with submicron size is nanoparticles.
In an embodiment, removable insert 30 may comprise a smaller configuration, or not provided at all. For example, in an embodiment the insert 30 may comprise body 31 that is formed and/or shaped to fit with respect to the lower portion 12, so as long as the flexible membrane 38 and spring element 48 are connected to each other. Also, the body 31 does not need to be formed such that it fits or slides within or directly adjacent walls of the upper portion 14 and/or lower portion 12. Alternatively, in another embodiment, the flexible membrane 38 and magnetic coupling ring 54 may not include a removable insert 30, and may be removable from the apparatus 10 by grasping the membrane 38 and/or ring 54 directly to break the magnetic connection.
Also, it should be noted that the above described features of apparatus 10 are not meant to be limiting. Furthermore, other known features, which may not have been described in detail herein, should not be limiting. For example, the number of treatments and/or treatment time(s) should not be limited. Also pressure, flow rate, operating pressure, operating flow rate, and frequency of dosage of the medication/liquid for apparatus 10 is not limited.
Flexible membrane 38 may have any number of apertures or micropores of any size. In an embodiment, for example, the membrane may comprise a mesh that comprises 5000-6000 holes that are 3 microns in size. Moreover, the use of flexible membrane 38, magnetic member 54, and/or other elements as described above is not meant to be limited to use with an apparatus 10 that is used for medical treatment. For example, it is envisioned that such features may be used in an appliance that is configured to deliver an aerosol as other forms of treatment. The flexible membrane 38 and magnetic member 54 may be used in household appliances. In an embodiment, the features may be used in an apparatus for moisturizing textiles, such as in steam ironing with an iron. Alternatively, such features may be used in alternate devices for steam delivery (e.g., humidifying devices), devices for cleaning, and the like.
A patient is a person to whom it is desired that an inhaled pharmaceutical aerosols be delivered; the definition of the term “patient” includes both a sick person as well as a healthy person.
The threshold of mist formation may be at a driving voltage of 10 Volts peak-to-peak, at 98 kHz. In some cases, materials or elements that may come into contact with the liquid 52 may have to be covered or coating with a shielding layer to prevent deterioration. For example, materials such as Nickel, Gold, or any other suitable, non-toxic and non-corrosive material may be applied in the form of a layer on one or more elements.
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.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2010/055676 | 12/8/2010 | WO | 00 | 7/10/2012 |
Publishing Document | Publishing Date | Country | Kind |
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WO2011/083380 | 7/14/2011 | WO | A |
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