Drug delivery apparatus and method
09744319 · 2017-08-29
Assignee
Inventors
- Jonathan Stanley Harold Denyer (Chichester, GB)
- Anthony Dyche (Hayling Island, GB)
- Michael James Robbert Leppard (Hunston, GB)
- Ian Thomas Petherbridge (Bognor Regis, GB)
- Alphonsus Tarcisius Jozef Maria Schipper (Eindhoven, NL)
Cpc classification
International classification
Abstract
A nebulizer (1) comprises one or more removable components (5,7,9,13), for example a mesh assembly (9), mouthpiece, plunger assembly (7) and medication chamber (13), each having an associated data carrier (5a, 7a, 9a). The data carrier (5a, 7a, 9a) can be used to store information indicating the type of removable component (5,7,9,13) that is fitted to the nebulizer (1). A removable component (5,7,9,13) may be from a set of such removable components. For example, a mouthpiece (5) fitted to the nebulizer (1) may be from a set of mouthpieces having different flow rates. The data carrier (5a, 7a, 9a) may also be used to control operation of the nebulizer (1). A data carrier (9a) attached to a mesh (9) may be used to prevent the nebulizer (1) from being used when the mesh (9) has been used a predetermined number of times.
Claims
1. A nebulizer comprising: a first removable component comprising a first data carrier, wherein the first removable component is a mouthpiece and the first data carrier stores information about the mouthpiece; a second removable component comprising a second data carrier, wherein the second removable component is a mesh assembly that is attached to a medication chamber such that the second data carrier stores information related to both the mesh assembly and the medication chamber; a third removable component comprising a third data carrier, wherein the third removable component is a plunger assembly, the plunger assembly including a medication metering chamber, the third data carrier storing information related to the plunger assembly; and at least one data reader for communicating with the first data carrier of the first removable component, the second data carrier of the second removable component, and the third data carrier of the third removable component, wherein the first removable component, the second removable component, and the third removable component are useable as part of the nebulizer at the same time.
2. A nebulizer as claimed in claim 1, wherein the first removable component, the second removable component, and the third removable component are individual ones of sets of associated removable components.
3. A nebulizer as claimed in claim 2, wherein the at least one data reader is adapted to identify a particular removable component from its associated set of removable components using information contained in the first data carrier of the first removable component, the second data carrier of the second removable component, or the third data carrier of the third removable component.
4. A nebulizer as claimed in claim 2, wherein the first removable component is a mouthpiece from a set of removable mouthpieces, wherein the mouthpieces in the set of removable mouthpieces are differentiated by their resistance; wherein the second removable component is a mesh assembly from a set of removable mesh assemblies; and wherein the mesh assemblies in the set of removable mesh assemblies are differentiated by a type of medication in corresponding medication chambers.
5. A nebulizer as claimed in claim 1, further comprising one or more processors configured to execute control software for controlling an operation of the nebulizer, wherein the one or more processors are configured to control the operation of the nebulizer based on information provided by the first data carrier, the second data carrier, and the third data carrier.
6. A nebulizer as claimed in claim 4 wherein the one or more processors are configured such that the operation of the nebulizer is only possible once a of the first, second, and third removable components are detected as being attached to the nebulizer.
7. A nebulizer as claimed in claim 1, wherein the first data carrier, second data carrier, the third data carrier, and the at least one data reader comprise a radio frequency identification (RFID) tagging system.
8. A nebulizer as claimed in claim 7, wherein the first data carrier comprises a first RFID tag, the second data carrier comprises a second RFID tag, the third data carrier comprises a third RFID tag, and the at least one data reader comprises an antenna.
9. A nebulizer as claimed in claim 7, wherein the RFID tagging system is configured to communicate with RFID tags mounted in removable components attached to the nebulizer.
10. A nebulizer as claimed in claim 1, wherein, in use, the same single data reader communicates with the first data carrier, the second data carrier, and the third data carrier.
11. A nebulizer as claimed in claim 1, wherein the first data carrier is adapted to store information that indicates a type of mouthpiece formed by the first removable component, and wherein the second data carrier is adapted to store information for preventing a mesh from being used in the nebulizer after a predetermined number of uses.
12. A nebulizer as claimed in claim 1, wherein one or more of the first data carrier or the second data carrier stores a count value, the count value being incremented or decremented after each use of the mesh.
13. A nebulizer as claimed in claim 1, wherein a mesh of the second removable component and the second data carrier are coplanar in the second removable component.
14. A nebulizer, the nebulizer comprising: a removable mouthpiece comprising an associated first data carrier for communicating, in use, with a data reader provided in the nebulizer, the first data carrier forming part of the mouthpiece such that removal of the mouthpiece removes the first data carrier therewith; a removable mesh assembly that is attached to a medication chamber such that a second data carrier stores information related to both the mesh assembly and the medication chamber, the removable mesh assembly comprising the second data carrier that communicates, in use, with the data reader; and a removable plunger assembly comprising a third data carrier, the plunger assembly including a medication metering chamber, the third data carrier storing information related to the plunger assembly.
15. A nebulizer as claimed in claim 14, wherein the removable mouthpiece, the removable mesh assembly, and the removable plunger assembly individually form parts of sets of interchangeable removable components for use with the nebulizer, and wherein the data carriers provide, in use, information relating to which removable components from the sets of interchangeable removable components are being used with the nebulizer.
16. A method of operating a nebulizer, the method being implemented in a computer system including one or more processors configured to execute software, the method comprising: receiving information from a first data carrier associated with a removable mouthpiece of the nebulizer, the first data carrier storing information about the mouthpiece; receiving information from a second data carrier associated with a removable mesh assembly of the nebulizer, which is attached to a medication chamber such that the second data carrier stores information related to both the mesh assembly and the medication chamber; receiving information from a third data carrier associated with a removable plunger assembly, the plunger assembly including a medication metering chamber, the third data carrier storing information related to the plunger assembly; operating a data reader to receive the information from the first data carrier, the information from the second data carrier, and the information from the third data carrier; and controlling an operation of the nebulizer based on the information received from the first data carrier, the second data carrier, and the third data carrier.
17. A method as claimed in claim 16, further comprising preventing the nebulizer from being used when the mesh assembly has been used a predetermined number of times.
18. A method as claimed in claim 17, further comprising controlling the operation of the nebulizer based on a type of mouthpiece fitted to the nebulizer, a type of plunger assembly fitted to the nebulizer, a type of medication chamber in the mesh assembly fitted to the nebulizer, and a number of times the mesh of the mesh assembly fitted to the nebulizer has been used.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) 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:
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DETAILED DESCRIPTION OF THE EMBODIMENTS
(10) 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.
(11)
(12) 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.
(13) In the embodiment of
(14) Although the embodiment of
(15)
(16) In a further embodiment, not shown in
(17)
(18) 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.
(19) 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.
(20) 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.
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(22) 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.
(23) 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.
(24) 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.
(25) 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.
(26) 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.
(27) 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.
(28) 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.
(29) 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
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(31) 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.
(32) For example,
(33) 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.
(34) 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.
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(36) 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.
(37) 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.
(38) 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.
(39) Although the embodiment of
(40) 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.
(41) 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.
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(43) 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.
(44) 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.
(45) 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.
(46) 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
(47) It is noted that data carriers may also be added to other removable components of the nebulizer, such as ID cards or labels.
(48) 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.
(49) TABLE-US-00001 TABLE 1 Diameter Distance Offset [cm] Windings [cm] [cm] Alpha Reader coil 4.0 2 0.0 0 Mesh coil 1.0 18 1.3 1.4 0 Mouthpiece coil 1.0 18 1.5 1.5 45 Plunger 1.0 18 5.6 3.0 45 ID card coil 2.0 0.0 0 Label coil 2.0 0.0 0 Diameter: Diameter of coil Windings: Number of windings Offset: Offset from center of reader coil Alpha: Angle from plane parallel to reader coil plan
(50) 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.
(51) 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.
(52) 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.
(53) 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.
(54) Furthermore, although the embodiments of
(55) 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.
(56) 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.
(57) 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.