The invention relates to a drug delivery apparatus and method and in particular to a nebulizer used for drug delivery, and a method of operating such a nebulizer.
Nebulizers, or atomizers as they are sometimes called, are devices that generate a fine spray or aerosol, usually of liquid. A particularly useful application for nebulizers is to provide a fine spray containing a dissolved or a suspended particulate drug for administration to a patient by inhalation.
Piezo-mesh based nebulizers are commonly used to generate aerosols in such drug delivery apparatus, whereby a piezoelectric element vibrates a mesh to produce the fine aerosol spray. In particular, droplets dispensed on the mesh are vibrated by the piezoelectric element to create the spray. There are two principle designs in such piezo-mesh based nebulizers. U.S. Pat. No. 5,938,117 and U.S. Pat. No. 6,983,747 disclose one type of design whereby the piezoelectric element is bonded to a mesh element, whereas U.S. Pat. No. 6,651,650 and U.S. Pat. No. 6,405,934 disclose designs whereby the mesh element is separate from the piezoelectric element. An advantage of having the mesh element separate from the piezoelectric element is that the mesh element is cheaper to manufacture and so can be replaced more frequently.
However, a common disadvantage of all mesh based nebulizers is that a user is required to clean the mesh after use, otherwise the mesh holes may become blocked. There are in the region 5000 2 μm holes in a typical mesh, and these can easily become blocked by particulates in the environment or from salt crystals (i.e. because the drugs are often saline based).
The cleaning method is normally to wash the mesh in warm soapy water for about five minutes, and then rinse and dry the mesh. This process can take as much time as the drug treatment itself, and is therefore a significant burden on the patient. Hence, over time, even with good cleaning the performance of the mesh will deteriorate as more holes become blocked—this may typically happen over a number of weeks. Once the mesh becomes blocked it is very difficult to clean the mesh and remove a particulate which is lodged in a hole, so it is necessary to replace the mesh. Although meshes are designed to last for up to twelve months, they typically have to be replaced every three months, or even on a monthly basis for some patients due to poor cleaning.
Such drug delivery apparatus also typically comprise one or more interchangeable parts, for example interchangeable mouthpieces, interchangeable plunger assemblies and/or interchangeable medication chambers. These interchangeable parts enable a nebulizer to be adapted or customized to best suit the needs of a particular patient. For example, different mouthpieces can be selected depending on the volume of inhalation preferred by a particular user, while different medication chambers can be selected to provide different volumes depending on the drug to be delivered.
A disadvantage of having such interchangeable parts is that the drug delivery apparatus must know which particular part from a set of interchangeable parts is fitted at any particular time, so that the drug delivery apparatus is able to control the delivery of the drug accordingly.
It is an aim of the present invention to provide a drug delivery system that helps alleviate or reduce one or more of the disadvantages mentioned above.
According to a first aspect of the invention there is provided a nebulizer comprising a removable component comprising a data carrier, and a data reader for communicating with the data carrier of the removable component.
The removable component may be one of a set of associated removable components. The data reader thereby enables the nebulizer to determine which removable component from the set of removable components is attached to the nebulizer, thus enabling the operation of the nebulizer to be controlled accordingly.
According to another aspect of the invention, there is provided a method of operating a nebulizer, the method comprising the steps of receiving information from a data carrier associated with a removable component of the nebulizer, and controlling the operation of the nebulizer based on the information received from the data carrier.
According to another aspect of the invention there is provided a mesh assembly for use in a nebulizer, the mesh assembly comprising a data carrier for communicating, in use, with a data reader provided in the nebulizer.
According to another aspect of the invention there is provided a mouthpiece for use with a drug delivery apparatus, the mouthpiece comprising a data carrier for communicating, in use, with a data reader provided in the nebulizer.
According to another aspect of the invention there is provided a medication chamber for use with a drug delivery apparatus, the medication chamber comprising a data carrier for communicating, in use, with a data reader provided in the nebulizer.
According to another aspect of the invention there is provided a metering chamber for use with a drug delivery apparatus, the metering chamber comprising a data carrier for communicating, in use, with a data reader provided in the nebulizer. The data carrier provides information relating to the metered drug dose to the nebulizer.
According to another aspect of the invention there is provided a plunger assembly for use with a drug delivery apparatus, the plunger assembly comprising a data carrier for communicating, in use, with a data reader provided in the nebulizer.
For a better understanding of the present invention, and to show more clearly how it may be carried into effect, reference will now be made, by way of example only, to the following drawings in which:
The embodiments below will be described in relation to piezo-mesh type drug delivery apparatus. It is noted, however, that some embodiments are not necessarily limited to such piezo-mesh drug delivery apparatus, for example the embodiments relating to nebulizers having interchangeable components such as mouthpieces and medication chambers. Also, it is noted that the term nebulizer can be used interchangeably with the term drug delivery apparatus or atomizer, and is intended to cover other forms and designs of nebulizer other than the specific type of nebulizer described below and illustrated in the Figures.
The data carrier 9a associated with the mesh 9b provides information relating to the mesh 9b to the nebulizer 1, as will be described later in the application.
In the embodiment of
Although the embodiment of
In a further embodiment, not shown in
The data carrier 9a associated with a mesh 9b of a mesh assembly 9 contains information pertaining to the mesh 9b, which can be read by the data reader 11 of the nebulizer 1. For example, the data carrier 9a may be used to identify the type of mesh 9b being used. The data carrier 9a may contain information on the intended use or lifespan of the mesh 9b, for example how many times the mesh 9b should be used before being replaced. Preferably the whole mesh assembly 9 (including the data carrier 9a and mesh 9b) is replaced after a predetermined number of uses.
Alternatively, if the data carrier 9a and the mesh 9b are detachably connected to the body of the mesh assembly 9, then the data carrier 9a and mesh 9b may be replaced independently of the main body of the mesh assembly 9. For example, the user may purchase a data carrier 9a and a mesh 9b which are replaced as a set, by fitting a new data carrier 9a and a new mesh 9b to the existing body of the mesh assembly 9.
The information received by the data reader 11 may be used by the nebulizer for a number of purposes. According to one embodiment the information received by the data reader 11 can be used to count the number of times a particular mesh 9b has been used, and then prevent the nebulizer from being operated after the mesh 9b has been used a predetermined number of times. The mesh 9b can therefore be prevented from being used in the drug delivery apparatus when its intended lifespan has expired. Alternatively, or in addition, the nebulizer may be configured to provide some form of indication or warning to the user once the intended lifespan has expired, i.e. rather than preventing the nebulizer from being used entirely. This type of indication or warning encourages the user to replace the mesh, but without preventing the nebulizer from being used.
If it is determined in step 403 that the count value is not equal to a predetermined value, then in step 405 the count value is updated (i.e. incremented or decremented), and the nebulizer operated to deliver a drug, step 407.
If it is determined in step 403 that the count value is equal to a predetermined value, thereby indicating that the mesh has been used a predetermined number of times, the nebulizer indicates in step 409 that the mesh requires replacing. This may involve disabling the nebulizer such that the mesh can no longer be used.
As mentioned above, as an alternative to preventing the nebulizer from being operated after the mesh has been used a predetermined number of times, the nebulizer may be configured instead (or in addition) to provide a warning to the user that the mesh should be replaced. For example, the nebulizer may be configured to provide a visual and/or audible warning when the mesh has reached its expected lifespan.
The nebulizer may also be configured to provide such a warning at a predetermined interval prior to the mesh coming to the end of its life, thereby warning the user to purchase a new mesh.
Preferably the updated count value shown in step 405 is stored on the data carrier 9a associated with the mesh 9b. As such, the data reader 11 acts as a data writer in addition to a data reader. In other words, the data reader 11 (for example an antenna) is adapted to transmit data to the data carrier 9a, as well as reading data from the data carrier 9a. In such an embodiment the data carrier will include, for example, an electrically erasable memory as will be familiar to those skilled in the art, such as an Electrically Erasable Programmable Read Only Memory (EEPROM). Other forms of data carriers that are capable of storing and updating a count value are also intended to be embraced by the present invention.
As an alternative to the above, the updated count value may be stored in the nebulizer itself. With such an embodiment the data carrier 9a may have a simpler form of memory device, such a Read Only Memory (ROM) which is programmed once during manufacture with a count value corresponding to the intended lifespan of the mesh. However, the former method has the advantage of retaining the count value with the device that is actually being monitored, which provides a more secure application.
It is noted that the data carrier 9a and data reader 11 can be realized in alternative ways to using an RFID tag and an antenna. For example, other identifying means such as a barcode, DX or serial interface can be used to communicate information between the mesh and the nebulizer. However, using an RFID tag and an antenna has the advantage of not requiring any interconnecting electrical contacts, which could otherwise become degraded in the type of environment found within a nebulizer device.
In addition to the data carrier 9a being used to store information relating to the use of the corresponding mesh 9b, it is noted that the data carrier 9a may also be used to store other information, such as information relating to the drug being dispensed. In other words, since the data carrier 9a is used to store information about the use of the nebulizer, the data carrier 9a may also be used to store other information relating to such use, including the number of drug vials to be dispensed. Thus, if a mesh of the nebulizer is replaced at the same time as the drug container, the data carrier 9a of the mesh can be used to indicate when the drug container needs to be replaced. Also, as indicated above in
One or more of the removable components 5, 7 or 9 may be a removable component associated with a set of such removable components (i.e. a form of interchangeable part selected from a set of such interchangeable parts). For example, the removable mouthpiece 5 can be from a set of different mouthpieces that may be fitted to the nebulizer. The nebulizer comprises control means for controlling the operation of the nebulizer depending on the particular removable component that is attached to the nebulizer at a given time.
For example,
The mouthpiece 5 is part of a set of associated mouthpieces that may be used with the nebulizer, for example depending on the particular preference of the user, or which is best suited for delivery of a particular type of drug.
For example, patients could be supplied with two or more mouthpieces with varying resistances to suit their personal preference, such as a first mouthpiece giving a high resistance of about 14-18 liters/min, a second mouthpiece giving a low resistance of about 24-36 liters/min, and a third mouthpiece giving a resistance of about 40-60 liters/min. The control software in the nebulizer needs to know which mouthpiece is fitted in order to enable the nebulizer to operate correctly, and the data carrier 5a mounted on the mouthpiece can be used to store such information during manufacture.
The medication chamber 13 is part of a set of associated medication chambers 13 that may be used with the nebulizer, for example depending on which particular medication chamber is best suited for delivery of a particular type of drug.
In some applications more than one volume of drug can be delivered from the same drug pack by using different medication chambers. In such applications the drug dose information on the data carrier 9a associated with the mesh 9b may not be sufficient for the nebulizer software to accurately determine the drug dose. This is improved by adding a data carrier to the medication chamber 13 as described above (or to the metering system) for the medication chamber 13 to uniquely identify the drug dose which has been placed in the device.
The nebulizer may be configured to perform other features based on the information detected by the data reader 11. For example, the nebulizer can be configured to only start a treatment once a predetermined set of components are detected as being attached to the nebulizer, such as when the mesh assembly 9, mouthpiece 5, plunger assembly 7 and medication chamber 13 have been detected as being present.
Although the embodiment of
The range of the RFID system may be set so that only assembled components and their associated data carriers are detected by the data reader(s) 11. This has the advantage that RFID tagged components located nearby, but not affixed to the nebulizer, are not detected by the data reader(s) 11.
This may be achieved by designing and positioning the data reader 11 and associated data carriers 5a, 7a, 9a so that the field of operation is limited to the shortest range required, and positioning the data carriers close to the data reader.
The nebulizer described in the embodiments above may also adopt one or more other strategies to help reduce or prevent detection of unwanted items by the radio frequency tagging system. For example, shielding may be provided on the side of the data reader 11 that is opposite to the side where the data carriers 5a, 7a and 9a are positioned.
In the embodiments described above the RFID data transmission could be interrupted by an external RF source such as the piezoelectric element used to vibrate the mesh, or by mobile phones that are within close proximity. However, the former does not have a degrading effect on the operation of the RFID system, since the RFID tags are normally read prior to the drug delivery operation itself, i.e. prior to the piezoelectric circuit being activated, and hence prior to such interference being present. Interference from other sources such as mobile phones can be overcome using data correction techniques commonly found in wireless technology, as will be familiar to a person skilled in the art.
The RFID system may consist of an integrated circuit with a copper coil, which can be encapsulated within a thin plastic film. This may typically comprise a product that is about 10 mm in diameter and about 1-2 mm tick. It will be appreciated, however, that other dimensions can also be used depending on the particular nebulizer, and without departing from the scope of the invention.
The RFID tag may be integrated into a plastic housing either mechanically, by potting or over molding to produce a hermetically sealed assembly as shown in
It is noted that data carriers may also be added to other removable components of the nebulizer, such as ID cards or labels.
Table 1 below illustrates some parameters of the reader coil and tag coils that may be used, for example, in a nebulizer according to an embodiment of the invention.
The antenna may be a dedicated antenna, which can be tuned to 13.56 MHz, for example. The antenna may comprise four circular windings with a diameter of 40 mm.
It is also noted that the RFID tag associated with the mesh may contain a number of fields related to the mesh and/or the drug and/or the delivery system. For example, a “Vial Count Remaining” field may be used to determine when the tag can no longer be used as it is decremented by one each time a treatment is delivered.
Although the embodiments described above have been made in relation to interchangeable mouthpieces, medication chambers or meshes, it will be appreciated that the invention is equally applicable to any other interchangeable part of a drug delivery apparatus, and in particular interchangeable parts from a set of such interchangeable parts.
The term “removable component” is intended to embrace a part or component of the nebulizer, at least part of which contributes to the actual functioning of the nebulizer, rather than a non-functioning part such as the actual drug to be dispensed. In other words, at least part of the removable component is a physical part of the actual nebulizer, which contributes to the physical working of the nebulizer.
Furthermore, although the embodiments of
It will be appreciated from the above that RFID tags are ideally suited to the described embodiments, as they require no electrical contacts that may be affected by the saline based drugs often used in the drug products to be inhaled, which would otherwise affect alternative embodiments such as DX or serial interfaces that require electrical contacts. RFID tags are also more suitable than bar codes as the vial count can be decremented in the tag itself after each treatment which is more secure than reading a bar code and decrementing the count within the delivery system itself. However, as mentioned above, the invention is not limited to just RFID tags, and that other identification systems can be used without departing from the scope of the invention.
It is also noted that the invention can be used with piezo-mesh type nebulizers in which the piezoelectric element and the mesh are bonded together, or with piezo-mesh type nebulizers in which the piezoelectric element and mesh are formed separately.
It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. The word “comprising” does not exclude the presence of elements or steps other than those listed in a claim, “a” or “an” does not exclude a plurality, and a single processor or other unit may fulfill the functions of several units recited in the claims. Any reference signs in the claims shall not be construed so as to limit their scope.
Number | Date | Country | Kind |
---|---|---|---|
09175628 | Nov 2009 | EP | regional |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/IB2010/054951 | 11/2/2010 | WO | 00 | 7/13/2012 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2011/058477 | 5/19/2011 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5170782 | Kocinski | Dec 1992 | A |
5593390 | Castellano et al. | Jan 1997 | A |
5938117 | Ivri | Aug 1999 | A |
6405934 | Hess et al. | Jun 2002 | B1 |
6651650 | Yamamoto et al. | Nov 2003 | B1 |
6851626 | Patel et al. | Feb 2005 | B2 |
6983747 | Gallem et al. | Jan 2006 | B2 |
20020157662 | Stenzler | Oct 2002 | A1 |
20030146300 | Denyer et al. | Aug 2003 | A1 |
20040094152 | Harvey et al. | May 2004 | A1 |
20040158349 | Bonney et al. | Aug 2004 | A1 |
20040231667 | Horton et al. | Nov 2004 | A1 |
20050081846 | Barney | Apr 2005 | A1 |
20060243277 | Denyer | Nov 2006 | A1 |
20070074722 | Giroux et al. | Apr 2007 | A1 |
20070076067 | Hamano et al. | Apr 2007 | A1 |
20070163583 | Brand et al. | Jul 2007 | A1 |
20080060641 | Smith et al. | Mar 2008 | A1 |
20090120431 | Borgschulte et al. | May 2009 | A1 |
20090126731 | Dunsmore | May 2009 | A1 |
20090133691 | Yamada et al. | May 2009 | A1 |
20090194104 | Van Sickle | Aug 2009 | A1 |
20090200397 | Sheiman | Aug 2009 | A1 |
20110120456 | Immel | May 2011 | A1 |
20120285446 | Van Der Mark | Nov 2012 | A1 |
Number | Date | Country |
---|---|---|
1257913 | Nov 2002 | EP |
1800705 | Jun 2007 | EP |
H5277188 | Oct 1993 | JP |
8317978 | Dec 1996 | JP |
2002540857 | Dec 2002 | JP |
2004503338 | Feb 2004 | JP |
2005509499 | Apr 2005 | JP |
2006506150 | Feb 2006 | JP |
WO0158236 | Aug 2001 | WO |
WO03043684 | May 2003 | WO |
WO 2006084543 | Aug 2006 | WO |
Number | Date | Country | |
---|---|---|---|
20120266870 A1 | Oct 2012 | US |