Abstract:
A digital pillbox, a personal alert device, and a computer-implemented system and method for aiding a patient in maintaining a desirable dosage schedule of medicines. Sensors and logic determine a time and quantity of a dosage taken, if any, and the system keeps records and monitors against a schedule and against a dynamic, learning, behavioral model of the patient. The schedule is remotely updateable by e.g. the patient&#39;s pharmacist. The system is equipped to alert e.g. a friend of the patient, or emergency services, if the patient fails to take the desired medications or if the patient&#39;s dosage behavior exhibits a significant change.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Technical Field of the Invention  
           [0002]    The present invention relates generally to monitoring a patient&#39;s consumption of medication, and more specifically to an apparatus and computer-implemented method for such.  
           [0003]    2. Background Art  
           [0004]    Medication delivery and monitoring systems typically rely heavily upon human attention and human action. If a patient fails to take prescribed medication, or to take it in a timely manner, it might be that nobody notices, including the patient herself. If the patient&#39;s supply of a particular medication has, or is about to, run out, it may again be that nobody notices. Some patients are required to take a large number of medications, each perhaps having a unique dosage schedule. Patients frequently make mistakes in calculating the timing and/or quantity of medications. Except in very narrowly defined circumstances, there is no automated or computed delivery mechanism to ensure that patients receive medications properly. One such limited example is the electrically-controlled plunger mechanism which hospitals employ to deliver painkillers or other single, liquid medications at a predetermined, constant rate. But that mechanism is not suitable for delivering multiple medications, nor medications which come in non-liquid form. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]    The invention will be understood more fully from the detailed description given below and from the accompanying drawings of embodiments of the invention which, however, should not be taken to limit the invention to the specific embodiments described, but are for explanation and understanding only.  
         [0006]    [0006]FIG. 1 shows a system according to one embodiment of this invention, highlighting a digital pillbox of the system.  
         [0007]    [0007]FIG. 2 shows one embodiment of an exemplary computing device such as may be used in the system of FIG. 1.  
         [0008]    [0008]FIG. 3 shows one exemplary embodiment of a method of operating the computing device.  
     
    
     DETAILED DESCRIPTION  
       [0009]    [0009]FIG. 1 illustrates one exemplary embodiment of a system  10  utilizing this invention. The system includes a digital pillbox  12  which can communicate with a computing device  14 . The computing device can, optionally, communicate with a personal alert device  16 , a pharmacy  18 , and/or emergency services.  
         [0010]    The digital pillbox includes one or more containers (Container  1 -N) which have one or more corresponding sensors (Sensors  1 -N) which are adapted to determine a quantity of medication in their respective containers. In one embodiment, the sensors measure weight. In other embodiments, the sensors may measure some other characteristic such as volume, or they may be adapted for e.g. computer vision to detect the medication. The invention may be used with other than medication, but will be described with respect to medication for purposes of illustration. In some embodiments, the containers may not be an integral part of the digital pillbox. The digital pillbox may, in some embodiments, incorporate logic for performing various functions such as calibrating the sensors or for operating the communication interface to the computing device. In various embodiments, the functionalities of the digital pillbox and the computing device may be distributed between them differently than described herein, without departing from the principles of this invention. In some embodiments, the digital pillbox may further include an alarm for alerting the patient that, for example, it is time to take a medication, or that a medication is nearly gone, or the like. The logic of the digital pillbox may be constituted in hardware, software, firmware, a combination, or other suitable means.  
         [0011]    The computing device may be embodied as a personal computer, an appliance, a dedicated device, or any suitable form, and may be implemented using hardware, software, firmware, a combination, or any suitable means.  
         [0012]    The personal alert device may be, in one embodiment, an RF receiver bracelet or key chain. In other embodiments, it may be some other form. In many embodiments, the personal alert device will be suitable for wearing on or carrying by the patient, to enable the computing device to deliver alerts to the patient. In other embodiments, it may be, for example, a remote device suitable for placing on a bedside table, or the like. In many embodiments of the system, the personal alert device may be optional or omitted entirely, such as where the alerts are delivered solely through the computing device itself and/or the digital pillbox.  
         [0013]    The pharmacy  18  may constitute any sort of communication mechanism at a pharmacy. In one desirable embodiment, the pharmacy  18  represents a computing platform operated by the patient&#39;s pharmacy and including therein a database of medication data pertaining to the patient and her medications. In other embodiments, the pharmacy  18  may simply represent a telephone or fax machine or other such data delivery apparatus located at the patient&#39;s pharmacy. It is, of course, not strictly necessary that it be an actual pharmacy, even though it is being explained here as a pharmacy. It could alternatively be a doctor&#39;s office or other such entity having or needing information about this patient and her medications.  
         [0014]    Similarly, the emergency services  20  may constitute a computing platform, telephone, fax machine, or other data delivery mechanism, and may represent 9-1-1 or even a friend or relative of the patient.  
         [0015]    The computing device may communicate with each of the digital pillbox, the personal alert device, the pharmacy, and the emergency services unidirectionally in some embodiments, and bidirectionally in others. The link between them may be any mechanism suitable for the application at hand. For example, in some embodiments, the link may be wired or wireless, radio frequency, laser, optical, infrared, Ethernet, USB, Firewire, serial, parallel, cellular, home wiring based, and so forth. The data transmitted to and/or from the computing device and the other entities may constitute digital data, digitized or synthesized or recorded audio data, or any other suitable data delivery form.  
         [0016]    [0016]FIG. 2 illustrates one embodiment of the system  10  utilizing this invention, with more detail shown regarding the computing device  14 . The computing device includes one or more interfaces to the various other entities with which it can communicate, including a pillbox interface  22 , a pharmacy interface  24 , an emergency services interface  26 , and a personal alert device interface  28 . In various embodiments, certain ones of these interfaces may be combined as a single interface. In various embodiments, certain ones of these interfaces may utilize the same communication technology. In one embodiment, the digital pillbox interface is a USB interface, the pharmacy and emergency services interfaces use the regular telephone system, and the personal alert device interface uses RF.  
         [0017]    The computing device further includes a controller  30  which performs many of the functionalities of the computing device. In some embodiments, the controller may comprise a microprocessor and one or more programs for it. In other embodiments, the controller may comprise hard-wired logic, or other suitable means. The computing device includes a real-time clock  32  which is coupled to the controller and which is used in performing time-based calculations. The real-time clock may be a stand-alone semiconductor device, or it may simply be software running on the controller, or it may include a radio receiver to receive a time broadcast such as from a centralized or atomic clock, or other suitable means.  
         [0018]    The computing device also includes an alert generator  34  coupled to the controller, and an alert timer  36  coupled to the alert generator. The alert generator and alert timer may be separate devices or they may be constructed as one unitary device. Alternatively, they could be implemented as additional programming of the controller, or in other suitable ways. The alert timer is used in performing calculations used in generating and sending alerts.  
         [0019]    The computing device further includes a record keeper  38  which has storage for records  40  regarding the patient and medications. The record keeper may be implemented in hardware, software, or a combination. The storage may include a hard disk, optical disc, semiconductor memory device, or other suitable storage mechanism. The record keeper may be autonomous, or it may be implemented as, for example, one or more programs to be executed on the microprocessor of the controller.  
         [0020]    The computing device further includes a behavior monitor  42  which has storage for a behavioral model  44  which is used in monitoring the medication-taking behavior of the patient. The behavioral model may be implemented as a database, an expert system, using artificial intelligence techniques, or any other suitable means.  
         [0021]    [0021]FIG. 3 illustrates one exemplary method of operation of the computing device. The reader should continue to refer also to FIGS. 1 and 2. The skilled reader will readily appreciate that this is only one example of a multitude of suitable methods, and that various changes, omissions, modifications, and additions may be made to the illustrated method without departing from the scope of the invention.  
         [0022]    The method begins with the computing device querying ( 50 ) the pillbox to, for example, gather a starting point for initializing ( 51 ) the records of the record keeper. The controller may query the digital pillbox&#39;s logic to determine the quantity of medication in each of the containers. This may, in some modes, include establishing a baseline or zero setting for each, which may later be used in determining whether the container is empty. In one mode, the computing device may prompt the patient to place the empty containers on their sensors and, for example, press a key. In other modes, the empty weight may be pre-programmed, especially in those embodiments in which the containers are an integral part of the digital pillbox. This may further include the sensors re-measuring the containers after the patient fills the containers with the respective medications. The controller can then relay this information to the record keeper for initialization of the records in storage. In some instances, such as upon first usage by a new patient, the controller may also trigger the behavior monitor to initialize the behavioral model for this patient.  
         [0023]    The computing device may receive ( 52 ) data from the pharmacy identifying the medications, in which containers they should be placed, their dosage schedule, the patient, and so forth. Alternatively, the patient could manually enter this information. This information is stored in the record storage by the record keeper. In one embodiment, the pharmacy may program the records with information specifying how much each dosage weighs. In another embodiment, the patient may train the records by adding or subtracting a specified number of dosages, with the logic and/or controller doing the math on the before and after weight. Other methods will be appreciated by the skilled reader who is armed with this disclosure.  
         [0024]    The computing device&#39;s alert timer waits ( 53 ) for a next dosage time, and at the appointed time, the alert generator sends ( 54 ) an alert to the personal alert device if one is in use, and sends ( 55 ) an alert to the digital pillbox if the digital pillbox is equipped with an alarm device. In some embodiments, the alerts may include data such as text or synthesized speech indicating “3:30 pm, take 100 mg (two tablets) of thorazine from container  4 ” or the like. In other embodiments, the alerts may simply be a voltage level that activates the alarm device. Any suitable alert system may be employed, independently, for the personal alert device and for the digital pillbox.  
         [0025]    The computing device queries ( 56 ) the digital pillbox to determine whether ( 57 ) the medication has been taken within a period of time specified by the record keeper. The sensors, together with the digital pillbox&#39;s logic and the computing device&#39;s controller and records, may combine to determine how much medication was taken from which containers.  
         [0026]    If the correct dosage of the correct medication was taken within the allotted time window, the computing device may turn off ( 58 ) the alarms of the digital pillbox and the personal alert device (in embodiments where those need turning off). The record keeper updates ( 59 ) the records, and the behavior monitor updates ( 60 ) the learning in the behavioral model.  
         [0027]    The behavioral model may, in one embodiment, be set up to watch for changes in behavior. For example, if the patient has, in the past, consistently taken her heart medication within ten minutes of being notified by the personal alert device, but suddenly starts waiting an hour or more before taking it, this may indicate some cognitive or other problem which may warrant intervention by emergency services, the patient&#39;s friends or family, a hospice aide, or the like. The skilled reader will appreciate the variety of possibilities for such a behavioral model.  
         [0028]    The record keeper determines ( 61 ) whether any of the medications are running low. It may advantageously utilize a pre-programmed or a trained zero baseline measure for the empty containers. If a medication is running low, and if ( 62 ) the computing device has not already sent notification to the pharmacy, it now sends ( 63 ) notification. The notification may take any suitable form. In one embodiment, a text or fax message is sent, for example saying “Patient Henrietta James ID number 12348765 has only three days&#39; worth of AZT left.” As another example, the computing device could place a voice synthesized phone call to the pharmacy. The parameters controlling the sending of such an alert may vary from patient to patient, from medication to medication, and so forth. They may be pre-programmed in the computing device, or they may be downloaded from the pharmacy, or other suitable means for establishing them.  
         [0029]    The system then returns to waiting for the next medication time.  
         [0030]    If ( 57 ), however, the patient failed to take her medication within the appointed window of time, or if the patient has taken the wrong medication, or the wrong amount of medication, the computing device sends ( 64 ) an alert to the pharmacy. This alert may, again, take any suitable form. The computing device may resend ( 65 ) the alerts to the personal alert device and the digital pillbox. The behavior monitor may update ( 66 ) the behavioral model as appropriate.  
         [0031]    If ( 67 ) the behavioral model identifies a behavioral change that meets predetermined criteria in the model, the computing device sends ( 68 ) an alert to emergency services, a pre-specified friend or neighbor, a doctor, or the like. The skilled reader will appreciate that various criteria may be defined, taking into account characteristics of the medication, of the type or extent of the behavioral change, or even of the patient&#39;s status such as age or infirmity. In some embodiments, the behavioral model may exhibit adaptive learning. In others, it may simply apply predetermined rules such as if ( 69 ) the medication which has been missed is of a critical nature, such as a cancer treatment or a heart medication, the alert should be sent immediately, without waiting to see if any long-term behavioral change is exhibited. The computing device then returns to wait for a next medication time.  
         [0032]    While FIG. 3 has been explained as illustrating a method of operation of the invention, it may also be interpreted as representing a computer-accessible delivery mechanism in which is embodied instructions, routines, programs, control codes, interpretive language, firmware, or the like which, when accessed by a machine, cause the machine to perform the method as explained above. In one embodiment, this delivery mechanism may be a recordable medium such as a CD-ROM, tape, flash memory device, DVD, removable hard drive, floppy disk, or the like. In another embodiment, it may be a communication means such as the internet, a LAN, a cellular network, or other such means, in which such instructions etc. are represented as voltage levels, data packets, or the like.  
         [0033]    In the interest of clarity and simplicity, the invention has been described in terms of a single patient. However, the skilled reader will appreciate that the invention may readily be employed in monitoring a plurality of patients. Similarly, the invention has been described in terms of a system having a single digital pillbox, a single personal alert device, a single pharmacy, and a single emergency service provider, but the skilled reader will appreciate that the invention may be implemented to support a plurality of any or all of those, either in conjunction with a single computing device or a plurality of computing devices. The skilled reader will further appreciate that various of the functionalities described herein may in some embodiments be practiced at different locations or upon different hardware than that disclosed herein. As but one example, the records database and/or the behavioral model might be implemented at the pharmacy rather than at the patient&#39;s location, without departing from the scope of this invention.  
         [0034]    Reference in the specification to “an embodiment,” “one embodiment,” “some embodiments,” or “other embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least some embodiments, but not necessarily all embodiments, of the invention. The various appearances “an embodiment,” “one embodiment,” or “some embodiments” are not necessarily all referring to the same embodiments.  
         [0035]    If the specification states a component, feature, structure, or characteristic “may”, “might”, or “could” be included, that particular component, feature, structure, or characteristic is not required to be included. If the specification or claim refers to “a” or “an” element, that does not mean there is only one of the element. If the specification or claims refer to “an additional” element, that does not preclude there being more than one of the additional element.  
         [0036]    Those skilled in the art having the benefit of this disclosure will appreciate that many other variations from the foregoing description and drawings may be made within the scope of the present invention. Indeed, the invention is not limited to the details described above. Rather, it is the following claims including any amendments thereto that define the scope of the invention.