The present invention relates to a device and system for tracking medical events, more particularly for tracking both time elapsed since a medication dosage was administered and time elapsed since one or more symptoms were noted by the patient.
Chronic illnesses may require regular medical treatments, as well as close monitoring of the condition. For example, a hemophiliac may require one or more medications to be administered on a regular basis, such as every several hours, once per day, once per week, etc. It would be impractical and expensive for the patient to schedule visits with a health care professional for each medication administration. Accordingly, patients typically self-administer these regimented medications. Adherence to the medication schedule is typically an important aspect of treatment.
Further, some medications are volatile. To help provide medications with an increased shelf life, they are provided to the patient or caregiver in a deactivated state. Prior to administration, the medication is activated. If the activation is performed incorrectly, the medication may be less effective than intended. Accordingly, patients are conventionally encouraged to correctly follow activation procedures for any prescribed medications. Suitable medicinal reconstitution devices for such application are disclosed in U.S. Pat. Nos. 8,734,420 and 8,545,476, both of which are incorporated by reference.
Moreover, treatment for some chronic diseases may be based on the presence or absence of particular symptoms. For example, a medication dosage for a hemophiliac patient may be increased if the patient's annual bleed rate exceeds a certain threshold. Moreover, such symptom tracking may help the patient and/or practitioner identify conditions which trigger the symptoms. Such information may prove valuable in further defining treatments for the patient.
Thus, there is a need to encourage patients to adhere to administration instructions for medications, including both scheduling and activation of the treatment. Additionally, there is a need to encourage patients to more accurately track their symptoms.
A device for encouraging adherence to a medication schedule and proper administration technique addresses these needs. The device allows for tracking of time since a last medication dose was administered, as well as tracking time since a particular symptom was experienced by the patient. Further, use of the device facilitates proper administration technique of the medication. In addition, the present device motivates the user to set and achieve desired therapeutic outcome, and provides positive reinforcement of therapeutic techniques.
In a first aspect, a method of using a device for encouraging adherence to a medication schedule and proper administration technique is provided, the method including placing the device on a surface. The device has a body, a timer associated with the body for measuring and displaying an elapsed time since an immediately prior medication dose was administered, and a button on the body that, when depressed relative to the body, resets the timer. The button is sized and shaped for accommodating a medication container used to store or activate the medication. The button and the body are configured for cooperating with the medication container for facilitating mixing of the medication. The method further includes a step of engaging the medication container with the button and resetting the timer.
In another aspect, a device for encouraging adherence to a medication schedule and proper administration technique is provided and includes a body, a timer associated with the body for measuring and displaying an elapsed time since an immediately prior medication dose was administered; and a button on the body that, when depressed relative to the body, resets the timer, the button being sized and shaped for accommodating a medication container used to store or activate the medication. The button and the body are configured for cooperating with the medication container for facilitating mixing of the medication.
In yet another aspect, a device for encouraging adherence to a medication schedule and proper administration technique is provided and includes a microprocessor configured for generating a clock signal. A first timer receives the clock signal from the microprocessor as an input, and is configured for measuring a time elapsed since an immediately prior medication dose was administered on the basis of the input clock signal. A second timer receives the clock signal from the microprocessor as an input and is configured for measuring a time since a particular symptom presented in a user on the basis of the input clock signal. A first button, when activated, resets the first timer. The first button is sized and shaped to accommodate a medication container used to store or activate the medication, wherein the first button is constructed and arranged for cooperating with the medication container for mixing the medication. A second button resets the second timer.
In still another embodiment, a medication administering system is provided and includes a medication container including a plurality of components held separated by the container, and a device for encouraging adherence to a medication schedule and proper administration technique. Included in the device is a body, a timer associated with the body for measuring and displaying an elapsed time since an immediately prior medication dose was administered, and a button on the body that, when depressed relative to the body, resets the timer, the button being sized and shaped for accommodating the medication container used to store or activate the medication. The medication container is used to depress the button, thereby allowing mechanical breach of partitions separating the components.
Referring now to
The device 10 includes a main body 12 and, optionally, a cover 14. The main body 12 and cover 14 are preferably formed from a light weight, low cost, durable material such as a thermoplastic resin, polycarbonate, or the like. The body 12 is sized and shaped to be easily portable by the user. As non-limiting examples, the body 12 is optionally approximately the same size and shape as a mobile phone or personal digital assistant, a key fob, or a utility knife. Alternatively, the body 12 may be formed in other useful shapes, such as a lid sized to fit a prescription pill bottle.
It is contemplated that the device 10 is used by a patient who routinely uses a medication provided in a dispensing container 16. A suitable container, also referred to as a reconstitution device, is disclosed in U.S. Pat. Nos. 8,734,420 and 8,545,476, both of which are incorporated by reference. Generally, the dispensing container 16 includes a main housing 18 retaining in a first end a first container or vial 20 of a first medicine or composition 20, and at an opposite end a second container or vial 22 of a second medicine or composition. Certain drugs are supplied in lyophilized form. It is customary that a lyophilized drug is mixed with water or other diluent or carrier solution to reconstitute the drug into a form suitable for injection into a patient. The dispensing container 16 is configured for retaining two compositions, each in one of the two vials 20 and 22, physically separated until use.
As best shown in
It will be seen that the vials, 20, 22 each have a diameter smaller than a diameter of the main housing 18. The dispenser 16 is configured so that a first impact causes the first vial 20 to move upward as shown in
Referring again to the device 10, disposed on the main body 12 is a first display 24 that shows a time since a last medication dose was administered and a second display 26 that shows a time since a particular symptom was last experienced by the patient. The main body 12 further includes an activation button 28 used to indicate that the patient has administered a medication dosage, and first and second symptom indicator buttons 30, 32 used to indicate, update and or reset an indication of the presence or absence of a particular symptom. A symptom indicator 34 is associated with the buttons 30, 32 to instruct the user about the purpose of those buttons, and may optionally include a backlit or flashing indicator 36.
Referring now to
The attachment portion 40 releasably affixes the cover 14 to the body 12 using mating tabs, snaps, hook-and-loop fastening material, retaining loops, magnets, threaded fasteners, and/or other similar fastening technologies used in mobile phone or e-book reader or tablet covers. More permanent fastening, as by chemical adhesives, is also contemplated. As shown in
The leaflet 46 may include information such as directions for administration of a drug, directions for use of the device 10, a log for noting the date and time of each medication dose administered, one or more pages for cataloging medication doses using a sticker from the medication packaging, information regarding the effects of the medication prescribed to the user, an area for the user to log treatment goals, an area for handwritten notes, and/or other information which may be useful to the user. Alternatively, the information is optionally printed directly onto the protective portion 38 and/or the attachment portion 40.
As discussed previously, the main body 12 is preferably sized and shaped to be similar to a mobile phone. The main body 12 surrounds a power source (not shown) and a logic board 48. Additionally, the main body 12 includes label text associated with each of the first and second displays 24 and 26. For example, label text associated with the first display may indicate “hours since my last dose” or the like. Similarly, label text for the second display indicates time period since the user's last symptom presentation. As a non-limiting example, when the device 10 is used to track a hemophilia patient, the label for the second display may read “days since my last bleed.” Those of skill in the art will recognize that the label text for both the first and second displays 24, 26 may be altered to suit the situation. In particular, the units of time used in the label text may be altered. First label text may indicate that the time unit is, for example, minutes, hours, days, or weeks, depending upon how often the medication is to be administered. Similarly, the time units for the second display may be, for example, days, weeks, or months.
Referring now to
The symptom indicator buttons 30, 32 are designed to be activated by the user to indicate, update and/or reset the presence or absence of a particular symptom. The specific configuration of the buttons 30, 32 may vary to suit the situation, and it will be seen that the shape and positioning of these buttons vary between the embodiments of
Referring now to
The first timer 54 is electrically connected to the microprocessor 52 for receiving at least a clock signal and a reset signal. The first timer 54 uses the input clock signal to measure an elapsed time since an immediately previous medication dose was administered. For example, the clock signal connected to the first timer 54 optionally causes the timer to measure elapsed time in increments of hours, tenths of an hour, minutes, or other time increments meaningful for measuring the elapsed time since the last medication dose was administered, which is triggered by the depression of the activation button 28. The microprocessor 52 also selectively provides a reset signal to the first timer 54, which is used to reset the timer to zero. In one embodiment, the reset signal is generated in response to a user depressing the activation button 28. However, other actions for resetting the first timer 54 are contemplated, such as pressing and holding the activation button 28 or simultaneous depressing first and second symptom indicator buttons 30, 32.
The first display 24 is operatively connected to the first timer 54, and displays the value maintained by the first timer. The display 24 is preferably a relatively low-power display, such as a liquid crystal display, a light emitting diode (LED) display, an e-ink display, or the like. The first display 24 may be formed integrally with the first timer 54, or may be a separate element electrically connected to the timer via, for example, electrically conductive wiring.
The second timer 56 is also electrically connected to the microprocessor 52 to receive at least a clock signal and a reset signal. The clock signal provided to the second timer 56 may be the same as the clock signal provided to the first timer 54, or a separate signal. The second timer 56 uses the input clock signal for measuring an elapsed time since a particular symptom presented in a user. For example, the second timer may measure time in increments of hours, days, tenths of a day, weeks, or any other regular time unit useful for providing information to a user. The reset signal is preferably provided to the second timer 56 when the first symptom indicator button 30 is depressed by a user.
The second display 26 is electrically connected to the second timer 56 such that the value of the second timer is displayed on the second display. The second display 26 is preferably selected to match the first display 24. As is the case with the first display 24, the second display 26 may be formed integrally with the second timer 56, or may be a separate element electrically connected to the timer by electrically conductive wiring.
The one or more LEDs 58 are optionally disposed within the body 12 so that the LEDs illuminate at least a portion of the activation button 28, the beveled ring 50, the first display 24, and/or the second display 26. When a user depresses the activation button 28 (i.e., when the user properly activates the medication in the first vial 20), the first timer 54 is preferably reset as discussed above. In addition, depressing the button 28 preferably causes the microprocessor 52 to provide an electrical signal to one or more of the LEDs 58, the speaker 60, and/or the haptic feedback generator 66, causing a visual, audio, and/or tactile cue to be emitted from the device 10. These visual, audio, and/or tactile cues are designed to be pleasing to the user and thus provide positive reinforcement for proper use of the device 10.
Additionally, any or all of the one or more LEDs 58 are optionally illuminated at particular times. For example, the LEDs 58 may be illuminated after the first timer measures that a set amount of time has elapsed (i.e., a particular amount of time has passed since the last medication dose was administered). This serves, for an example, as a reminder that the use is due to administer another dose of the medication. In addition to or in place of illumination of the one or more LEDs 58 at these particular times, an audible tone may be emitted from the speaker 60, and/or a tactile cue may be created by the haptic feedback generator 66. Further, any or all of the LEDs 58 are optionally illuminated for a particular amount of time immediately following depression of the activation button 28. This may serve to indicate the length of time a user should perform the steps of medication activation.
Similarly, in response to a user depressing the second symptom indicator button 30, indicating that a symptom has not been present since the last use of the device 10, the microprocessor 52 transmits a signal to one or more of the LEDs 58, the speaker 60, and/or the haptic feedback generator 66, resulting in an audio, visual, and/or tactile display (e.g., one or more of a flashing LED, an audio tone or series of tones emitted from the speaker, and a tactile cue produced by the haptic feedback generator). This audio, visual, and/or tactile cue is intended to instill a sense of accomplishment in the user, and to offset any negative feelings associated with administration of the medication.
Additionally, the device 10 optionally includes one or more communication interfaces 62. For example, the device 10 may include a radio-frequency identification (RFID) reader capable of reading data from an RFID tag optionally included on the medication container 16 during the medication activation. The data is then stored within the memory 64.
The memory 64 is preferably a non-transitory computer readable medium, such as a random access memory, flash memory, a magnetic or magneto-optical memory, or the like. An additional wired or wireless communication interface 62 such as a serial port, parallel port, universal serial bus (USB), local area network (i.e., IEEE 802.3 specification or similar), wireless local area network (i.e., IEEE 802.11a/b/g/n/ac specification or similar), Bluetooth (per IEEE 802.15.1 specification or similar), or the like is optionally included on the logic board 48 for retrieving the data stored in the memory 64.
The elements of the logic board 48 are powered by a power source, such as a battery, such as a replaceable or non-replaceable alkaline battery. Preferably, battery capacity provides power to the logic board 48 for a period of time that greatly exceeds a meaningful patient goal for the outcome timer 56, such as 1 year. Alternatively, a rechargeable power source (e.g., a nickel metal hydride battery, lithium ion battery, or lithium polymer battery) or a renewable power source (e.g., a photovoltaic panel) is used to power the elements of the logic board 48.
Referring now to
The cavity 74 is sized to retain at least one instruction panel 80 which includes printed material as described above. In the preferred embodiment, the panel 80 is formed as a series of one or more sub-panels that are pivotably retained within the cavity 74. Pivoting action occurs about a point approximately coaxial with the activation button 28. Thus, the cavity 74 accommodates a pivoting action of the panel 80 under user control from a concealed position within the cavity and an exposed position, as seen in
The multifunction display 76 is operatively connected to both the first timer 54 and the second timer 56, and is thus capable of displaying the elapsed time measured by each timer, together with a brief text label. For example, the display includes both an elapsed time measured by the second counter and the text label “days since my last bleed”. The user operates the toggle button 78 to toggle between at least a first display function displaying the elapsed time measured by the first timer 54 and a first display label, and a second display function displaying the elapsed time measured by the second timer 56 and a second display label. Further, additional display functions are contemplated. For example, a clock display function displaying a current time is optionally included.
While the principles of the present device to encourage adherence to medication schedules and proper administration techniques have been described above in connection with specific apparatus and applications, it is to be understood that this description is made only by way of example and not as a limitation on the scope of the claims following below.
This application claims priority under 35 USC 119(e) from U.S. Provisional Application Ser. No. 61/867,856 filed Aug. 20, 2013.
Number | Date | Country | |
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61867856 | Aug 2013 | US |