Reconstitution of reconstitution drugs

Abstract

A mount (3) comprising a clamp (11) and a suction pad (13) for attaching a reconstitution device (1) containing the constituent parts of a reconstitution drug to a touch screen (15) of a smart phone (5). A control program (27) provided in a memory (21) of the smart phone (5) causes a processor (17) to compare motion of the smart phone (5) as detected by an accelerometer (19) to a required motion for mixing the constituent parts of a reconstitution drug contained a reconstitution device (1) and provide a user with feedback to a user indicating when the smart phone (5) to which a reconstitution device (1) containing the constituent parts of a reconstitution drug is attached by the mount (3) has been sufficiently shaken to reconstitute the drug contained within the reconstitution device (1).

Description

[0001] PAT24251-WO-PCT

[0002] RECONSTITUTION OF RECONSTITUTION DRUGS

[0003] BACKGROUND OF THE INVENTION

[0004] FIELD OF THE INVENTION

[0005] The present application concerns reconstitution of reconstitution drugs. More specifically the present application concerns the reconstitution and monitoring of reconstitution of reconstitution drugs.

[0006] DESCRIPTION OF THE RELATED ART

[0007] Reconstitution drugs are drugs that consist of two or more components that must be mixed before use. In many cases, the components will be in the form of a powder and a solvent / diluent. Numbers of reconstitution drugs have been increasing with the rise of biologies which often rely upon the use of lyophilization (freeze drying) to increase their longterm stability.

[0008] Drugs have various properties which affect how easily they dissolve.

[0009] Properties which may need to be considered include:

[0010] • Particle size (smaller particles will present a high surface area and therefore promote dissolution)

[0011] • Drug type (larger biomolecules tend to have a higher propensity to denature in certain environments)

[0012] • Physiochemistry (e.g. drug polarity; protonated versus free base)

[0013] • Formulation additives (additives to prevent caking or aid dissolution for instance)

[0014] • Diluent pH or ionic content; and

[0015] • Viscosity of the resultant solution (which may depend upon the temperature of the drug).

[0016] When creating drugs in the laboratory a formulation chemist can take these properties into account. However, with the number of lyophilized drugs on the rise, users (increasingly patients or carers in a non-clinical setting) are frequently faced with the burden of manual reconstitution.

[0017] Reconstitution devices exist to assist manual reconstitution. Such reconstitution devices will typically have two chambers - one for the powder / drug and one for the liquid dilutant / solvent. When the two components are brought together, a user must shake or roll the device to cause the powder / drug to dissolve in the liquid.

[0018] The manner in which a reconstitution drug is reconstituted can impact the efficacy or safety of a reconstitution drug. Incomplete or ineffective mixing can impact the effectiveness of reconstitution drugs. Further inappropriate agitation of a reconstitution drug may cause air bubbles to be created which can adversely impact patient safety.

[0019] Manufacturers attempt to address this problem with appropriate user instructions.

[0020] By way of example, a user might be instructed to slowly roll a bottle or vial between the hands, gently tipping the bottle / vial over a few times so as to avoid creating air bubbles. User instructions will expressly instruct a user not to shake a vial as this will cause air bubbles. Rather a user will be instructed to tap a reconstitution device against the palm of a user’s hand multiple times (e.g. 80 times) rotating a device after a set number of taps (e.g. every 10 taps).

[0021] However, compliance with prescribed reconstitution techniques is difficult to monitor, particularly in a non-clinical setting.

[0022] There is therefore a need to address or alleviate this problem and provide a means by which reconstitution of reconstitution drugs may be monitored or achieved in a more consistent manner.

[0023] SUMMARY OF THE INVENTION

[0024] One aspect of the present invention provides a system for monitoring reconstitution of a reconstitution drug. The system comprises the provision of a computing device having a processor, a memory and an accelerometer operable to detect motion of the computing device; and a mount operable to mount a reconstitution device to the computing device, wherein the memory of the computing device is configured to store a computer program which is operable to compare motion of the computing device as detected by the accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0025] In another aspect, the present application provides a method of reconstituting a reconstitution drug. In accordance with such a method, a reconstitution device may be mounted to a computing device having a processor, and a memory, wherein the computing device also includes an accelerometer operable to detect motion of the computing device. Computer program instructions may be stored in the memory of the computing device which when interpreted by the processor, cause the processor to compare motion of the computing device as detected by the accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device. In use, a computing device to which a reconstitution device has been mounted may be shaken and the motion of the computing device as detected by the accelerometer may be compared to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device and a signal may be outputted to a user when the required motion for mixing the constituent parts of a reconstitution drug contained within the reconstitution device has been completed.

[0026] Another aspect of the present application provides a system for reconstituting the constituent parts of a reconstitution drug contained within a reconstitution device, comprising: a computing device having a processor, and a memory wherein the computing device includes a vibration motor operable to cause the computing device to vibrate; and a mount operable to mount a reconstitution device containing the constituent parts of a reconstitution drug to the computing device, wherein the memory of the computing device stores computer program instructions which when interpreted by the processor, cause the processor to activate the vibration motor to cause the computing device to vibrate in accordance with a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0027] A yet further aspect of the present invention provides a method of reconstituting a reconstitution drug, the method comprising: mounting a reconstitution device on a computing device having a processor, and a memory wherein the computing device includes a vibration motor operable to cause the computing device to vibrate in accordance with instructions from a control program stored in the memory; activating, by the control program, the vibration motor to cause the computing device to which a reconstitution device has been mounted to vibrate; and deactivating the vibration motor when a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device has been completed.

[0028] In some embodiments the mount may comprise a holder operable to receive a reconstitution device and a mounting element operable to attach the mount to the computing device. In such embodiments the mounting element may comprise a suction pad and the holder may comprise a mounting clamp.

[0029] In some embodiments the computer program instructions stored in the memory of the computing device may cause the computing device to: identify the initiation of a mixing process; compare motion of the computing device as detected by an accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device; and provide a user with feedback when the extent of agitation of a reconstitution drug contained within a reconstitution device mounted to the computing device corresponds to a required extent of agitation for reconstituting the reconstitution drug.

[0030] In embodiments where the computing device comprises a touch screen, the computer program instructions stored in the memory of the computing device may cause the computing device to display a user interface on the touch screen including a button for indicating the initiation of a mixing process and the computing device may be configured to identify the initiation of a mixing process in response to user selection of the displayed button.

[0031] Alternatively, in some embodiments, the computing device may comprise a camera, and the computer program instructions stored in the memory of the computing device may cause the computing device to identify a reconstitution drug on the basis of the imaging of a QR code by the camera.

[0032] In some embodiments, the memory of the computing device may store data identifying the required motion for mixing the constituent parts of one or more reconstitution drugs. In such embodiments, the stored data may identify one or more of the duration of a required motion; a required minimum level of agitation; and / or a required maximum level of agitation; required for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device. In some embodiments, the computer program instructions may cause the computing device to identify a reconstitution drug; and determine a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device. In such embodiments, the determination of a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device may be based upon the weight of a reconstitution device, the weight of the constituent parts of a reconstitution drug contained within the reconstitution device, and / or the weight of a mount for mounting a reconstitution device to a computing device.

[0033] In some embodiments the computer program instructions stored in the memory of the computing device may cause the computing device to monitor a period of time before the initiation of a mixing process or after the completion of the mixing process.

[0034] In some embodiments, the computing device may be operable to infer the temperature of a reconstitution drug contained within a reconstitution device mounted to the computing device. In such embodiments, such an inferred temperature may be used to determine an appropriate start time for mixing the constituent parts of a reconstitution drug.

[0035] In some embodiments the computing device may comprise a smart phone or a tablet computer.

[0036] These features and advantages of the present invention will be come more fully apparent from the following description and appended claims.

[0037] BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order for the advantages of the invention to be readily understood, a more particular description of the invention briefly described above will be rendered by reference to embodiments illustrated in the appended drawings. Understanding that these drawings depict only exemplary embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0039] Figure 1 is a schematic perspective view of a reconstitution device attached via a mount to a smart phone;

[0040] Figure 2 is a schematic block diagram of functional elements of the smart phone of Figure 1 ; Figure 3 is a flow diagram illustrating a method of reconstituting a reconstitution drug using the apparatus depicted in Figure 1 in accordance with an embodiment of the present invention; and

[0041] Figure 4 a flow diagram illustrating a method of reconstituting a reconstitution drug using the apparatus depicted in Figure 1 in accordance with another embodiment of the present invention.

[0042] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the exemplary embodiment illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the invention as illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the invention.

[0043] DETAILED DESCRIPTION OF THE INVENTION

[0044] Figure 1 is a schematic perspective view of a reconstitution device 1 attached via a mount 3 to a smart phone 5.

[0045] In this embodiment, the reconstitution device 1 comprises a reconstitution device 1 in the form of a syringe having a main chamber 7 which is cylindrical in shape and which contains the constituents of a reconstitution drug (e.g. a powder / drug and a dilutant / solvent) and a plunger 9. The end of the reconstitution device 1 remote from the plunger 9 is configured to receive a needle (not shown in Figure 1) which facilitates the injection of the reconstitution drug contained within the reconstitution device 1 once the component parts of the reconstitution drug have been appropriately reconstituted.

[0046] The mount 3 in this embodiment comprises a clamp 11 which is attached to a suction pad 13. In the illustrated embodiment the clamp 11 comprises a hollow cylindrical tube having an inner diameter which is slightly larger than the outer diameter of the main chamber 7 of the reconstitution device 1 so that when the reconstitution device 1 is inserted into the clamp 11 the clamp holds the reconstitution device 1 in place.

[0047] It will be appreciated that in other embodiments, the clamp 11 could take other forms. Thus, for example, in another embodiment the clamp 11 could be of the form of a spring clip clamp. Alternatively, in another embodiment the clamp 11 could be of the form of a flexible band which is configured to grip a reconstitution device 1 when the reconstitution device 1 is inserted into the hole defined by the flexible band. In such an embodiment the flexible band could be elastic. Alternatively in another embodiment, a tightening mechanism could be provided configured to reduce the size of the hole defined by the extent of the band after a reconstitution device 1 had been inserted into the void, thereby causing the band to grip the reconstitution device 1. More generally, it will be appreciated the dimensions and form of the clamp 11 could vary depending upon the nature of the reconstitution device 1 with which it is intended to be used.

[0048] In this embodiment, the suction pad 13 attached to the clamp 11 , provides a convenient means by which the mount 3 can be removably attached to the smart phone 5. A smart phone 5 typically includes a touch screen 15. This provides both an input / output device enabling a user to input data into the smart phone 5 and for information to be displayed to a user. The touch screen 15 also provides a smooth surface which is suitable for using the suction pad 13 to attach the mount 3 to the smart phone 5, although the suction pad may instead be attached to a rear surface of the smart phone 5 that has sufficient smoothness. Again, it will be appreciated that although the mount 3 in the embodiment illustrated in Figure 1 comprises a suction pad 13, in other embodiments other forms of attachment mechanism could be used to removably attach the mount 3 to a smart phone 5.

[0049] Turning now to Figure 2 which is a schematic block diagram of functional elements of the smart phone 5 of Figure 1 , in addition to a touch screen 15, in this embodiment the smart phone 5 also comprises a processor 17, an accelerometer 19 for monitoring the motion of the smart phone 5, a vibration motor 20 for causing the smart phone 5 to vibrate (e.g. to provide haptic feedback) and a memory 21. In this embodiment the memory 21 stores a set of weight parameters 23; a medication database 25 and a control program 27. More specifically, in this embodiment the memory 21 stores weight parameters 23 identifying the weight of the smart phone 5. The medication database 25 stores data identifying, for a number of different reconstitution drugs: the weights of the reconstitution devices 1 used for reconstituting the drugs and the weights of the constituent parts of the reconstitution drugs contained within such reconstitution devices 1 and the weights of mounts 3 used to attach such reconstitution devices 1 to a smart phone 5 along with data identifying the required motion (e.g. the frequency, strength and / or duration of the extent of agitation) required for mixing that particular reconstitution drug.

[0050] Figure 3 is a flow diagram illustrating the use of the reconstitution device 1 , mount 3 and smart phone 5 of Figure 1 in a method of reconstituting a reconstitution drug.

[0051] Initially, in this embodiment, the control program 27 in the memory 21 of the smart phone 5 causes the processor 17 to display a user interface on the touch screen 15 of the smart phone 5 enabling a user to identify the reconstitution drug which they wish to reconstitute, and the user identifies (s1) the reconstitution drug to the smart phone 5 via appropriate input via the touch screen 15.

[0052] The control program 27, then (s2) causes instructions to be displayed on the touch screen 15, instructing the user to mount the mount 3 and the reconstitution device 1 containing the constituent parts of a reconstitution drug to the smart phone 5 using the suction pad 13 and the clamp 11.

[0053] When (s3) the user has attached the reconstitution device 1 to the mount 3 and the mount 3 to the smart phone 5, the control program 27 then causes (s4) the processor 17 to monitor the output of the accelerometer 19 and provide (s5) the user with feedback comparing the detected agitation of the smart phone 5 to which the reconstitution device 1 is attached with required agitation required to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1 .

[0054] In some embodiments, the control program 27 may enable a user to indicate the initiation of the mixing process, by causing the touch screen 15 to display a user interface providing a user with the ability to select a button or icon (more generally a control) to confirm that the mixing process has started. Alternatively, in other embodiments, the control program 27 may cause the processor 17 to monitor the output of the accelerometer 19 to determine when a mixing process has been initiated.

[0055] The control program 27 may cause the processor 17 to determine whether or not the constituent parts of the reconstitution drug contained within the reconstitution device 1 have been sufficiently mixed. Such a comparison may be based on a comparison determined using the weight parameters 23 identifying the weight of the smart phone 5 and weight data extracted from the medication database 25 identifying the weights of the reconstitution device 1 , the constituent parts of the reconstitution drugs contained within the reconstitution device 1 , and the mount 3 used to attach the reconstitution device 1 to a smart phone 5. The selection of weight data from the medication database 25 to be used may be based upon user input (s1) input via the touch screen identifying the reconstitution drug being reconstituted.

[0056] In some embodiments, the control program 27 may cause the processor 17 to compare the determined agitation against data identifying the required motion (e.g. the frequency, strength and / or duration of the extent of agitation required) for mixing the identified reconstitution drug. Alternatively, in other embodiments, the control program 27 may extract data and parameters from the memory 11 and may use the data and parameters to calculate a required motion for mixing the constituent parts of a reconstitution drug.

[0057] In some embodiments, the control program 27 may cause the smart phone 5 to provide visual, audio or haptic feedback indicating when the reconstitution device 1 has been sufficiently agitated to cause the constituent parts of a reconstitution drug contained within the reconstitution device 1 to be mixed. In some cases, the control program 27 may cause the smart phone 5 to provide a user with instructions relating to injecting the reconstitution drug after the reconstitution drug has been reconstituted.

[0058] In some embodiments, the comparison of a determined motion of a smart phone 5 to which a reconstitution device 1 has been mounted may involve a determination of the number of times a reconstitution device 1 mounted to the smart phone 5 has been shaken. In some embodiments, the control program 27 may cause the processor 17 to monitor the intensity with which a reconstitution device 1 mounted to the smart phone 5 is shaken. In other embodiments, the control program 27 may cause the processor 17 to monitor the duration of time during which a reconstitution device 1 mounted to the smart phone 5 is shaken. In other embodiments, the control program 27 may cause the processor 17 to monitor a combination of the number of times, the intensity or the duration of time over which a smart phone 5 is shaken.

[0059] In some embodiments the control program 27 may cause the smart phone 5 to provide a user with a warning if the strength or duration of the shaking of smart phone 5 to which a reconstitution device 1 has been mounted is detected to be inappropriate or inadequate.

[0060] Thus, for example, the control program 27 may cause the smart phone 5 to provide a user with a warning if the detected shaking is less than a required strength or duration required for mixing the constituent parts of the reconstitution drug contained within a reconstitution device 1 . Alternatively, the control program 27 may cause the smart phone 5 to provide a user with a warning if the detected shaking is determined to be excessively vigorous and otherwise inappropriate such as might be the case when it is desired not to create air bubbles in the reconstituted drug.

[0061] In some embodiments, the control program 27 may cause the smart phone 5 to provide an output only when the strength and / or duration of the shaking of a smart phone 5 to which a reconstitution device 1 has been mounted is sufficient for adequate mixing of a reconstitution drug as identified based on user input (s1).

[0062] When the control program 27 determines that sufficient agitation of a reconstitution device 1 for mixing the constituent parts of a reconstitution drug has occurred, the control program 27 may then cause information relating to the application of the drug such as instructions relating to injection of a reconstitution drug to be displayed on the touch screen 15.

[0063] In the above embodiment a control program 27 for monitoring manual agitation of a smart phone 5 to which a reconstitution device 1 has been mounted has been described. However, in other embodiments, where the smart phone 5 includes means for causing the smart phone 5 to vibrate with a strength sufficient to mix a reconstitution drug, the control program 27 may cause the smart phone 5 to vibrate for a fixed period of time at a certain frequency when a user confirms that a reconstitution device 1 has been mounted to the smart phone 5.

[0064] An example of the reconstitution of a reconstitution drug in accordance with an embodiment in which a smart phone 5 agitates a reconstitution device 1 mounted on the smart phone 5 will now be described with reference to the flow diagram of Figure 4.

[0065] Turning to Figure 4, the initial steps (s1 & s2) in this embodiment are similar to those in the embodiment of Figure 3, in that initially (s1) the control program 27 in the memory 21 of the smart phone 5 causes the processor 17 to display a user interface on the touch screen 15 of the smart phone 5 enabling a user to identify the reconstitution drug which they wish to reconstitute, and the user identifies (s1) the reconstitution drug to smart phone 5 via appropriate input via the touch screen 15.

[0066] Then, as in the previous embodiment, the control program 27, then (s2) causes instructions to be displayed on the touch screen 15, instructing the user to mount the mount 3 and the reconstitution device 1 containing the constituent parts of a reconstitution drug to the smart phone 5 using the suction pad 13 and the clamp 11 .

[0067] When the user has attached the reconstitution device 1 to the mount 3 and the mount 3 to the smart phone 5, the user then (s6) indicates to the smart phone 5 that the reconstitution device 1 and the mount 3 have been mounted to the smart phone 5. In some embodiments, this can be achieved by the control program 27 being arranged to detect an input by the user via the touch screen 15. Alternatively, in other embodiments the control program 27 may be arranged to detect the mounting of the mount 3 to the touch screen 15 of the smart phone 5 directly.

[0068] When a user has confirmed to the control program 27 that the mount 3 to which a reconstitution device 1 is attached has been mounted on the smart phone 5 or the control program 27 has made its own confirmation that a mount 3 to which a reconstitution device 1 is attached has been mounted on the smart phone 5, the control program 27 then (s7) causes the smart phone 5 to vibrate for a period of time in order to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1 .

[0069] More specifically, in embodiments of the present invention, the control program 27 may access the weight parameters 23 and the medication database 25 to determine an appropriate manner and extent of agitation of the smart phone 5 to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1. The control program 25 then proceeds to activate the vibration motor 20 within the smart phone 5 to cause the smart phone 5 to vibrate for a period of time determined to correspond to the vibration required to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1 .

[0070] In some embodiments the control program 27 may monitor the vibration of the smart phone 5 based on signals received from the accelerometer 19 to determine the strength and / or extent of vibration of the reconstitution device 1 mounted on the smart phone 5 and adjust the duration or strength of the vibrations generated by the vibration motor 20 within the smart phone 5 so as to match the vibration of the smart phone 5 with agitation required to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1.

[0071] When (s8) the required agitation of the reconstitution drug required to mix the constituent parts of the reconstitution drug contained within the reconstitution device 1 has been completed, the control program 27 stops the vibration motor 20 within the smart phone 5 and displays instructions for administering the reconstitution drug contained within the reconstitution device 1 (e.g. providing instructions to a user for mounting a needle on the reconstitution device 1 and injecting the reconstitution drug).

[0072] Although in the above described embodiments, a smart phone 5 has been described in which a memory 21 stores a set of weight parameters 23 and a medication database 25 storing data identifying the required motion for mixing the constituent parts of a reconstitution drug, it will be appreciated that in other embodiments, such information could instead be stored in a remote database and control program 27 could cause the smart phone 5 to contact the remote database to obtain such information when it is required.

[0073] Although in the above-described embodiments, the mounting of a reconstitution device 1 to a smart phone 5 has been described, it will be appreciated that rather than a smart phone 5 any other similar computing device suitable for monitoring and / or shaking or agitation of a reconstitution device 1 (e.g. a tablet computer or another handheld, portable, battery-powered device) to which the reconstitution device 1 could be mounted using a mount 3 could be utilized.

[0074] Although in the above-described embodiments, a user has been described as identifying a reconstitution drug to a smart phone 5 via appropriate input via a touch screen 15, it will be appreciated that in other embodiments, a user might identify a reconstitution drug to a smart phone 5 in other ways. Thus, for example, in some embodiments a QR (quick response) code might be printed on the exterior of a reconstitution device 1 and a user might identify the reconstitution device 1 to a smart phone 5 by scanning the QR code. Alternatively, where a reconstitution drug or a portion of a reconstitution drug is stored in a separate vial before being inserted into reconstitution device 1 , a user might scan a QR code provided on such a vial.

[0075] In some embodiments, in addition to monitoring the shaking of a reconstitution device 1 mounted on a smart phone 5, the control program 27 may cause a smart phone 5 to monitor a time period prior to or subsequent to shaking a reconstitution device 1 .

[0076] In many cases a reconstitution drug may be required to be refrigerated when stored, however, it may be preferable to reconstitute the drug at room temperature as the temperature may adversely impact the viscosity of components of a reconstitution drug. In such embodiments, it may be preferable to require a period of time to pass before shaking to reconstitute the reconstitution drug.

[0077] In some such embodiments, it may be preferable to assist a user in providing adequate time for a reconstitution drug to reach room temperature, by having the control program 27 initiate a timer by scanning a QR code provided on a reconstitution device 1 or vial as such scanning is likely only to occur when a reconstitution device 1 or vial is removed from refrigeration.

[0078] In some embodiments, it may be desirable to measure or infer the temperature of a reconstitution drug more precisely. Thus, for example, in some embodiments, a smart phone 5 may include a thermometer which can measure ambient temperature and the control program 27 could be arranged to calculate an expected time for a reconstitution drug to reach a particular temperature from the measured ambient temperature and the expected temperature at which a reconstitution drug may have been stored. In other embodiments, where a smart phone 5 was not able to measure ambient temperature directly, an expected ambient temperature might be inferred based upon, for example location data for the smart phone 5.

[0079] In addition, or alternatively to monitoring a time period prior to shaking a reconstitution device 1 , a control program 27 might monitor a period of time required to enable a reconstitution drug to rest or settle after having been reconstituted. Thus, for example, where a reconstitution drug contains a surfactant, foaming may occur when the reconstitution drug is shaken and a period of time may be required in order for bubbles created in the reconstitution drug to dissipate prior to use.

[0080] Further aspects of the present disclosure are summarized in the following numbered clauses:

[0081] 1 . A method of reconstituting a reconstitution drug, the method comprising: mounting a reconstitution device on a computing device having a processor, and a memory wherein the computing device includes an accelerometer operable to detect motion of the computing device, wherein the memory of the computing device stores computer program instructions which when interpreted by the processor, cause the processor to compare motion of the computing device as detected by the accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device; shaking the computing device to which a reconstitution device has been mounted; comparing the motion of the computing device as detected by the accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device; and outputting a signal to a user when the required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device has been completed.

[0082] 2. A system for reconstituting the constituent parts of a reconstitution drug contained within a reconstitution device, comprising: a computing device having a processor, and a memory wherein the computing device includes a vibration motor operable to cause the computing device to vibrate; and a mount operable to mount a reconstitution device containing the constituent parts of a reconstitution drug to the computing device, wherein the memory of the computing device stores computer program instructions which when interpreted by the processor, cause the processor to activate the vibration motor to cause the computing device to vibrate in accordance with a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0083] 3. The system of clause 2, wherein the mount comprises a holder operable to receive a reconstitution device and a mounting element operable to attach the mount to the computing device.

[0084] 4. The system of clause 3 wherein the mounting element comprises a suction pad.

[0085] 5. The system of clause 3 wherein the holder comprises a mounting clamp.

[0086] 6. The system of clause 2 wherein the computing device comprises an accelerometer operable to detect motion of the computing device and the computer program instructions stored in the memory of the computing device cause the computing device to compare motion of the computing device as detected by the accelerometer to a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0087] 7. The system of clause 2 wherein the computing device comprises a touch screen wherein the computer program instructions stored in the memory of the computing device cause the computing device to: display a user interface on the touch screen including a button for indicating the initiation of a mixing process; wherein the computing device is configured to activate the vibration motor to cause the computing device to vibrate in response to user selection of the displayed button.

[0088] 8. The system of clause 2 wherein the computing device comprises a camera, and the computer program instructions stored in the memory of the computing device cause the computing device to identify a reconstitution drug on the basis of the imaging of a QR code by the camera.

[0089] 9. The system of clause 2 wherein the memory of the computing device stores data identifying the required motion for mixing the constituent parts of one or more reconstitution drugs.

[0090] 10. The system of clause 9 wherein the data identifying the required motion for mixing the constituent parts of one or more of reconstitution drugs comprises data identifying one or more of: the duration of a required motion; a required minimum level of agitation; and / or a required maximum level of agitation; required for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0091] 11. The system of clause 9 wherein the computer program instructions cause the computing device to: identify a reconstitution drug; and determine a required motion for reconstituting the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0092] 12. The system of clause 11 wherein the determination of a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device comprises a determination of required motion based upon the weight of a reconstitution device mounted to the computing device and the weight of constituent parts of a reconstitution drug contained within the reconstitution device; and / or the weight of a mount for mounting a reconstitution device to the computing device.

[0093] 13. The system of clause 2, wherein the computer program instructions stored in the memory of the computing device cause the computing device to monitor a period of time before the initiation of a mixing process or after the completion of the mixing process.

[0094] 14. The system of clause 2, wherein the computing device is operable to infer the temperature of a reconstitution drug contained within a reconstitution device mounted to the computing device.

[0095] 15. The system of clause 2 wherein the computing device comprises a smart phone or a tablet computer.

[0096] 16. A method of reconstituting a reconstitution drug, the method comprising: mounting a reconstitution device on a computing device having a processor, and a memory wherein the computing device includes a vibration motor operable to cause the computing device to vibrate in accordance with instructions from a control program stored in the memory; activating, by the control program, the vibration motor to cause the computing device to which a reconstitution device has been mounted to vibrate; and deactivating the vibration motor when a required motion for mixing the constituent parts of a reconstitution drug contained within a reconstitution device mounted to the computing device has been completed. Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "one embodiment," "an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, different embodiments, or component parts of the same or different illustrated invention. Additionally, reference to the wording "an embodiment," or the like, for two or more features, elements, etc. does not mean that the features are related, dissimilar, the same, etc. The use of the term "an embodiment," or similar wording, is merely a convenient phrase to indicate optional features, which may or may not be part of the invention as claimed.

[0097] Each statement of an embodiment is to be considered independent of any other statement of an embodiment despite any use of similar or identical language characterizing each embodiment. Therefore, where one embodiment is identified as "another embodiment," the identified embodiment is independent of any other embodiments characterized by the language "another embodiment." The independent embodiments are considered to be able to be combined in whole or in part one with another as the claims and / or art may direct, either directly or indirectly, implicitly or explicitly.

[0098] While the present invention has been fully described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred embodiments of the invention, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function and manner of operation, assembly and use may be made, without departing from the principles and concepts of the invention as set forth in the claims.

Claims

CLAIMSWhat is claimed is:1 . A system for monitoring reconstitution of a reconstitution drug, the system comprising: a reconstitution device; a mount operable to mount the reconstitution device to a computing device; and computer program instructions operable, when executed by a processor of a computing device, to cause the processor to compare motion of the computing device as detected by the computing device to a required motion for mixing the constituent parts of a reconstitution drug contained within the reconstitution device.

2. The system of claim 1 , wherein the mount comprises a holder operable to receive the reconstitution device and a mounting element operable to attach the mount to the computing device.

3. The system of claim 2, wherein the mounting element comprises a suction pad, and / or wherein the holder comprises a mounting clamp.

4. The system of any preceding claim, wherein the computer program instructions are operable to cause the computing device to: identify the initiation of a mixing process; and provide a user with feedback when the extent of agitation of a reconstitution drug contained within a reconstitution device mounted to the computing device corresponds to a required extent of agitation for reconstituting the reconstitution drug.

5. The system of claim 4, wherein the computer program instructions are operable to cause the computing device to: display a user interface on a touch screen of the computing device, the user interface including a control, e.g. a button, for indicating the initiation of a mixingprocess, and to identify the initiation of a mixing process in response to user selection of the control.

6. The system of any preceding claim, wherein the computer program instructions are operable to cause the computing device to: identify a reconstitution drug; and determine a required motion for mixing the constituent parts of the reconstitution drug contained within a reconstitution device mounted to the computing device.

7. The system of claim 6, wherein the computer program instructions are operable to identify a reconstitution drug on the basis of the imaging of a code by a camera of the computing device.

8. The system of any preceding claim, wherein the memory of the computing device stores data identifying the required motion for mixing the component parts of reconstitution drugs.

9. The system of claim 8, wherein the data identifying the required motion for mixing the constituent parts of reconstitution drugs comprises data identifying one or more of: the duration of a required motion; a required minimum level of agitation; and / or a required maximum level of agitation; required for mixing the constituent parts of the reconstitution drug contained within the reconstitution device.

10. The system of any of claims 6 to 9, wherein the determination of a required motion for mixing the constituent parts of the reconstitution drug comprises a determination of required motion based upon the weight of the reconstitution device and the weight of constituent parts of the reconstitution drug contained within the reconstitution device; and / or the weight of the mount.

11. The system of any preceding claim, wherein the computer program instructions areoperable to cause the computing device to monitor a period of time before the initiation of a mixing process or after the completion of the mixing process.

12. The system of any preceding claim, comprising the computing device.

13. The system of claim 12, wherein the computing device is operable to infer the temperature of the reconstitution drug contained within the reconstitution device.

14. A method of reconstituting a reconstitution drug, the method comprising: mounting a reconstitution device on a computing device having a processor and a memory storing computer program instructions; comparing, by the computing device under control of the program instructions, motion of the computing device as detected by the computing device to a required motion for mixing the constituent parts of a reconstitution drug contained within the reconstitution device; and outputting, by the computing device under control of the program instructions, a signal to a user when the required motion for mixing the constituent parts of the reconstitution drug contained within the reconstitution device has been completed.

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