Abstract:
An apparatus and system for providing improved monitoring of diagnostic results of a user. The apparatus includes a diagnostic monitor that allows patients to easily, quickly and reliably enter information about daily health activity. Specifically, the apparatus has an integrated or removable secured reader for reading coded health related information. The reader may be a barcode scanner or imager. The user of the apparatus may use the apparatus to read coded information related to ingesting of food, taking medication, exercising, sleeping, experiencing stress related events, etc.

Description:
RELATED APPLICATION 
     This application claims the benefit of the filing date of provisional application No. 60/339,080 filed on Oct. 30, 2001, entitled “Medical Diagnostic Monitoring.” 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to medical diagnostic monitoring devices and methods of using the same. In particular, the present invention relates to a medical monitoring device having a reader for reading coded health related information. 
     BACKGROUND OF THE INVENTION 
     Portable medical diagnostic monitors are becoming more and more common as technology improves. A portable diagnostic monitor collects clinical information on or from a patient when he is out of the doctor&#39;s office carrying on with his daily routines. To better diagnose and manage certain medical conditions, it is important to track a patient&#39;s activities and match it to a diagnostic result such as but not limited to, a blood sugar reading from a portable diabetes monitor. Currently a patient either does not record his daily activities or writes his activities down on paper. Writing the information down is time consuming and prone to error. In some cases, certain portable diagnostic device may allow for limited key stroke/character entry. 
     Since it is important to keep the diagnostic monitor within a convenient size there is limited area on the device to provide input keys. Thus making inputting data cumbersome and time consuming. Additionally, many users of the diagnostic monitors may not be comfortable navigating through a series of menu displays in order to enter information on an electronic device. Other users may have difficulty reading the information on the limited display area or may have arthritic conditions that make it difficult or impossible to manipulate a series of keys on an electronic device. Thus, a need exists to provide a portable diagnostic monitor that allows patients to easily, quickly and reliably enter information about daily health activity. 
     SUMMARY OF THE INVENTION 
     The proposed invention would allow a patient to easily track and match his daily activities to the clinical information being collected by the diagnostic device. A preferred embodiment of the present invention enables a person to easily track daily activities via barcode input. 
     The basic components of a preferred embodiment of the present invention are a portable medical diagnostic device and a miniature identification capture reader. The identification capture reader could be a barcode scanner, imager, infrared identification reader or similar technology. 
     The subcomponents of the medical device may be a battery, display, keyboard, cradle, wireless communications circuitry, memory, housing, central processing unit (CPU) and telephony components. The medical device could be any portable diagnostic monitor that patients would carry around to monitor a specific vital health sign. For instance, the device may include, but not limited to, the following monitors: heart rate monitor, blood pressure monitor, cholesterol monitor and diabetes monitor. The portable diagnostic device could be portable digital assistance (“PDA”) or notebook computer that includes a module and/or software for monitoring a user&#39;s health signs. The barcode scanner could be integrated into the medical diagnostic device or attached to the medical diagnostic device via an accessory device. The barcode scanner could be formed as a sled type device that can be removably secured to the medical diagnostic device. 
     Along with carrying the portable diagnostic device, which may have a barcode scanner attached or integrated inside, a patient would also carry a small index or business sized cards with pre-printed 1D or 2D barcodes that relate to a specific health related activity. The health related activities could be eating certain types of food, eating certain amounts of food, taking medications, exercising, sleeping, experiencing stress related events, etc. In a preferred embodiment, meals could be available that include a barcode that includes specific health information to be registered with the portable diagnostic device of the present invention. For example, a line of frozen dinners could have a two-dimensional barcode that provides information about the food. In addition, to identifying the ingredients, the barcode could contain information about the amount of sugar, fat and cholesterol per serving. Similarly, restaurants could provide the barcodes for the food the customer ordered on menus or other printed sheets of paper. 
     Before or after one of the health related activities occur, the patient scans with the portable diagnostic device of the present invention a particular barcode associated with the activity. Barcode scanning allows for a quick and error proof way to enter and record the data. By comparing the clinical results from the diagnostic monitor to activities entered by the barcode scanner the patient and the doctor can provide a better and a more complete diagnosis. All the data would be stored in the monitor and/or sent over a wireless or wired connection to a database. 
     An object of the present invention is to provide a portable diagnostic device having a reader integrated therein which allows a patient to record accurately and easily daily health activity. 
     Another object of the present invention is to provide a portable diagnostic device accessory having an integrated scanner which can be removably secured to a portable diagnostic device, the combination allows a patient to record accurately and easily daily health activity. 
     A still further object of the present invention is to provide printed barcode labels that may be used with a portable diagnostic device for accurately and easily recording daily health activity. 
     A still further object of the present invention is to provide a portable diagnostic device that can be calibrated easily by scanning a calibration barcode. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a preferred embodiment of the present invention being used to scan a barcode on a drug canister; 
     FIG. 1A is another embodiment of the present invention having a removably secured sled accessory; 
     FIG. 2 is the embodiment shown in FIG. 1 being used to scan a calibration barcode; 
     FIG. 3 shows two cards containing information relating to food that may be used to input data into the portable diagnostic device of the present invention; 
     FIG. 4 shows two cards containing information relating to an activity and time period that may be used to input data into the portable diagnostic device of the present invention; 
     FIG. 5 shows two cards containing information about other activities that may be used to input data into the portable diagnostic device of the present invention; 
     FIG. 6 shows a carton of a prepared meal that contains a two-dimensional barcode used to input data into the portable diagnostic device of the present invention; 
     FIG. 7 shows a can of food that contains a one-dimensional barcode used to input data into the portable diagnostic device of the present invention; 
     FIG. 8 shows other cards that may be used to input data into the portable diagnostic device of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention will now be described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. 
     Referring to FIGS. 1 and 2, a preferred embodiment of a portable diagnostic device  20  is shown. In this embodiment of the invention, portable diagnostic device  20  is a device used by patients that have diabetes. The term “patient” is used herein to describe a person who uses a portable diagnostic device to periodically monitor his or her health signs. Portable diagnostic device  20  includes a meter  22  for reading a patient&#39;s blood glucose level. The patient tests his or her blood glucose level by placing over meter  22  a test strip that has a sample of the patient&#39;s blood. The results of the test can be displayed to the user on display  24 . Portable diagnostic device  20  also includes internal memory for recording the results as well as the date and time. A carrying case  26  may be provided for storing portable diagnostic device  20  when it is not being used. 
     FIG. 1A shows an alternative embodiment of the present invention. A portable diagnostic device  20 A can be secured to a sled accessory  21  that contains an integrated barcode scanner. Sled accessory  21  contains latching mechanisms  25  that allow a user to removably secure sled accessory  21  to portable diagnostic device  20 A. When the two components are secured together, a communications port  27  on sled accessory  21  engages with a similar port on the back of portable diagnostic device  20 A (not shown). Thus, data and information can be transferred between the two components. Sled accessory also has a trigger  23  for activating the scanning function. 
     In addition to measuring a patient&#39;s blood glucose level, portable diagnostic device  20  is able to input data via a barcode scanner. The data may include information about the patient&#39;s health related activities. Portable diagnostic device  20  includes an integrated scanner for scanning a barcode  30  to input health related activity data. Portable diagnostic device  20  includes a trigger for activating the scanner. In FIG. 1, barcode  30  is associated with a prescription drug stored within a canister  40 . Thus, barcode  30  may include data relating to the prescription drug being taken by the patient. Thus, after a patient takes a does of the drug, he scans barcode  30  with portable diagnostic device  20 . Portable diagnostic device  20  records at least part of the data stored in barcode  30 . Portable diagnostic device  20  may also record a date/time stamp to provide a record of the approximate time the patient took the drug. Alternatively, the patient could input a different time representing when he took the drug. The portable diagnostic device  20  may also record the dosage of the drug taken by the patient. A single scan of barcode  30  could represent a patient&#39;s normal drug dosage. Alternatively, a scan could represent one pill. Thus, if a patient takes two pills from canister  40 , he would scan barcode  30  two times. After a successful scan, portable diagnostic device  20  could display on display  24  the drug taken by the patient, the dosage and the time of consumption. 
     Portable diagnostic device  20  could store a patient&#39;s prescription drug schedule. The prescription drug schedule provides information about what prescription drugs the patient is supposed to take and when the patient should take them. The prescription drug table may be entered by the patient or downloaded from a computer associated with a doctor or pharmacist. Thus, portable diagnostic device  20  could provide a reminder to the patient to take a certain prescription drug upon a triggering event. The triggering event could be the time of day, the user&#39;s ingesting of food, the user&#39;s monitored daily activity, etc. Portable diagnostic device  20  could also help prevent the patient from taking a drug at an inappropriate time. After the patient scans a canister of the drug he is about to take, portable diagnostic device  20  compares the information from the barcode to the prescription drug schedule. Portable diagnostic device  20  could provide a warning (audible and/or visual) to the patient if a) the scanned drug is not one prescribed to the patient, b) the scanned drug would conflict with a previously scanned prescription drug taken by the patient, c) it is not the proper time of the day for the patient to be taking the drug, d) the patient has not eaten enough food (as determined by codes previously scanned by the user), or e) the patient would be exceeding the proper dosage. If the patient has improperly taken a drug, portable diagnostic device  20  could provide precautionary instructions could be provided to the patient. For instance, portable diagnostic device  20  may display a message that the patient should contact has doctor immediately. Portable diagnostic device  20  may also automatically send a notification to a doctor, guardian or emergency personnel of the patient&#39;s activity. The notification could be sent via a wireless communications circuitry within portable diagnostic device  20 . 
     FIG. 3 shows two cards  50  and  52  that may be used in conjunction with portable diagnostic device  20 . The cards contain human recognizable information and a two-dimensional barcode  51  and  53 . The human recognizable information may include a type of food and nutritional information about the food. The nutritional information may include the amount fat, protein, carbohydrates (complex and simple), calories, vitamins, nutrients, additives, etc. Barcodes  51  and  53  contain information that needs to be monitored by the patient. For instance, barcodes  51  and  53  may include all or some of the nutritional information listed above. Barcodes  51  and  53  may also include information about all of the ingredients in the food. 
     In a preferred embodiment of the present invention, a patient would have available a plurality of cards similar to those shown in FIG.  3 . After (or before) a patient eats a certain food, the patient would scan with portable diagnostic device  20  a barcode on a card that represents the type of food eaten by the patient. A single scan could represent one serving of the food. If the patient has multiple servings of the food, he could scan the card multiple times. Alternatively, the card could include a barcode that represents the number of servings eaten by the patient to be scanned by the patient or the patient could manually enter the number of servings he has eaten. Portable diagnostic device  20  may record the date and time of the approximate time the patient ate the food. Alternatively, the patient could input a different time representing when he ate the food. In another embodiment, the patient could scan one of the cards right before he begins to eat a meal and then scan the card a second time when he completes his meal. Portable diagnostic device  20  could record (and display) the elapsed time the patient eats his meal. 
     Before the patient eats, portable diagnostic device  20  may analyze the information provided on the food to determine whether the patient should eat the food. If the food is determined to be something that the patient should not eat, a warning may be provided to the patient. The warning could be written on display  24  or it could be an audible warning. Portable diagnostic device  20  may determine that the patient should avoid a certain food by comparing the food to be eaten to a database of foods to be avoided. The database may be stored locally on portable diagnostic device  20  or at a remote location. The database of foods to be avoided could be derived from those that are known in the scientific community to be problematic, e.g., junk food. Additionally, the database of foods to be avoided could be derived from the patient&#39;s personal responses to certain foods. For instance, by analyzing a patient&#39;s diagnostic monitoring results and the foods the patient has eaten, portable diagnostic device  20  (or a remote computer that downloads the information stored on portable diagnostic device  20 ) could determine that certain foods are problematic to the patient. If the patient scans a barcode indicating that the patient is about to eat a food that has shown to be problematic, a warning could be displayed to the patient reminding him of the results of previous times the patient ate the food. In another embodiment, after a patient scans a barcode associated with a piece of cake he is considering eating, portable diagnostic device  20  could display how much sugar is in the cake. 
     FIG. 6 shows a two-dimensional barcode  61  on a carton  60  of a prepared meal that may be used in conjunction with portable diagnostic device  20 . The prepared meal could be a single item of food, e.g., lasagna, or it could be a complete meal, e.g., chicken with rice and peas. Two-dimensional barcode  61  contains the necessary health information that needs to be monitored by the patient and recorded by portable diagnostic device  20 . 
     FIG. 7 shows a one-dimensional barcode  63  on a can  62  of food. Barcode  63  may be a universal product code (UPC) or other identification code that uniquely identifies the food. Barcode  63  does not contain all of the information that the patient needs to monitor, but it contains an identification code that can be used to access the information from a nutritional information database. In one embodiment of the present invention, portable diagnostic device  20  includes a memory that stores the database that contains identification codes and the corresponding nutritional information for the identification codes. In another embodiment, the database is located at a remote location. Portable diagnostic device  20  could have a radio that enables a wireless link to the database or a batch connection for a hard wire link to the database. In another embodiment, portable diagnostic device  20  could transmit the identification codes entered by the scanner to a remote computing device that has access to the nutritional information database. The remote computing device could be a home computer associated with the patient or a third party that monitors the patient&#39;s daily activity. In another embodiment, a combination of these approaches could be employed. For instance, since portable diagnostic device  20  has limited memory available, it could store only the nutritional information for foods previously or frequently eaten by the patient. The information for other foods could be obtained from a remote source. 
     FIG. 4 shows two cards  70  and  72  that may be used in conjunction with portable diagnostic device  20 . The cards contain human recognizable information and a 2 dimensional barcode  71  and  73 . The human recognizable information may include an activity and a unit of time. Barcodes  71  and  73  contain information that needs to be monitored by the patient. For instance, the barcodes may include information about a type of activity and the amount of time spent doing the activity. After (or before) a patient engages in a certain activity, the patient would scan with portable diagnostic device  20  a barcode on a card that represents the activity engaged by the patient. A patient that has jogged for 15 minutes would scan card  70 . A patient that has jogged for 1 hour would scan card  72 . If the patient jogged for a half hour, he could scan card  70  two times. If the patient jogged for an hour and 15 minutes, he could scan card  70  once and card  72  once. 
     FIG. 5 shows two cards  80  and  82  that may be used in conjunction with portable diagnostic device  20 . Cards  80  and  82  contain barcodes  81  and  83 , respectively, that contain information that needs to be monitored by the patient. These barcodes may include only information about a type of activity engaged by the patient. For instance, barcode  81  represents sleeping and barcode  83  represents swimming. A patient who is about to start swimming uses portable diagnostic device  20  to scan barcode  83  on card  82 . Portable diagnostic device  20  records the time the patient begins the activity. The patient scans barcode  83  on card  82  a second time when he completes his swimming laps. Portable diagnostic device  20  could calculate the total amount of time the patient engages in the activity. While the patient is swimming display  24  could display “Swimming” and the elapsed time spent swimming. The patient could also enter into portable diagnostic device  20  (either manually or via scanning a barcode) the number of laps during the swimming exercise. 
     FIG. 8 shows additional cards that could be used in conjunction with portable diagnostic device  20 . Card  90  provides information about a unit of time. An alternative way for a patient to provide information about an activity is to scan a card representing a certain activity, e.g., biking, and than scanning a second card, i.e., one similar to card  90  representing the amount of time engaged in the activity. The patient could employ multiple cards containing various time intervals. Card  92  provides information about a patient&#39;s pulse. 
     Card  94  contains a barcode  95  that can be for a user-defined activity. A user could program portable diagnostic device  20  so that barcode  95  on card  94  represents a particular exercise, food, stress related event, medications, etc. For instance, if a patient enjoys rowing, he could program portable diagnostic device  20  to recognize barcode  95  as rowing. Portable diagnostic device  20  could be set up so when the patient scans barcode  95 , display  24  displays “Rowing.” Card  94  contains a blank line  96 . The patient could write over blank line  96  the activity programmed into portable diagnostic device  20 , i.e., rowing. 
     Programming portable diagnostic device  20  to associate a particular activity with barcode  95  may be done as follows. The patient could set portable diagnostic device  20  to a program mode. Then the patient could scan barcode  95 . Next the patient could input into portable diagnostic device  20  the specific activity. The patient could input the information via a small keypad on portable diagnostic device  20  (not shown). Alternatively, a home computer or personal digital assistant could be used to program portable diagnostic device  20 . Instead of inputting information directly into portable diagnostic device  20 , the information could be entered into the home computer or personal digital assistant and downloaded to portable diagnostic device  20 . 
     In a preferred embodiment of the present invention, the scanner on portable diagnostic device  20  could be used to read information related to the performance of diagnostic monitor. In the case of diagnostic devices that measure blood glucose level by placing test strips over a meter, it is necessary to calibrate the diagnostic device for the particular lot of test strips being employed. This is customarily done today by including with the lot of test strips a small chip that contains information about the lot. This chip is inserted into the diagnostic device and read by the diagnostic device. In accordance with the principles of the present invention the information about the lot of strips could be inputted to the diagnostic device via the barcode reader. Thus, it would not be necessary to include the chip with the lot of test strips. 
     FIG. 2 shows a case  28  that holds a lot of testing strips. Case  28  includes a calibration barcode  29  that contains information about the lot of test strips. By scanning calibration barcode  29 , portable diagnostic device  20  receives the necessary information for calibrating the device for the particular lot of strips being used by the patient. Portable diagnostic device  20  calibrates the testing meter for the particular lot of test strips being used by the patient. 
     In a preferred embodiment, portable diagnostic device  20  has a communications link for downloading the diagnostic monitoring results and the health related activities that are stored in portable diagnostic device  20 . The communications link may be a wireless link or a hard wire connection. The information may be downloaded to a computer associated with the patient and/or the patient&#39;s doctor. Periodic reports and graphs could be printed showing the correlations between the diagnostic monitoring results and the patient&#39;s health related activities. The information from portable diagnostic device  20  can be analyzed to determine the effect of food, exercise, stress and/or drugs on the patient&#39;s health. This analysis may be used to adjust the patient&#39;s diet, exercise regimen or drug prescriptions. Further monitoring with portable diagnostic device  20  may determine the effectiveness of these adjustments. 
     The herein described embodiments of the present invention are intended to provide the preferred embodiments of the present inventions currently contemplated by the applicant. It would be obvious to any one of skill in the relevant art, based on the herein described examples that numerous modifications could be made to the described preferred embodiments without straying from the present invention. Accordingly, the herein described embodiments are merely exemplary in nature and are not intended to represent every possible embodiment of the present invention.