WO1997022297A1 - Medical information record system - Google Patents

Medical information record system Download PDF

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Publication number
WO1997022297A1
WO1997022297A1 PCT/US1996/020398 US9620398W WO9722297A1 WO 1997022297 A1 WO1997022297 A1 WO 1997022297A1 US 9620398 W US9620398 W US 9620398W WO 9722297 A1 WO9722297 A1 WO 9722297A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical
storage device
data storage
portable data
records
Prior art date
Application number
PCT/US1996/020398
Other languages
French (fr)
Inventor
Edward J. Yeager
Lee Brissey
Original Assignee
Life Alert, Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Life Alert, Ltd. filed Critical Life Alert, Ltd.
Priority to AU13409/97A priority Critical patent/AU1340997A/en
Publication of WO1997022297A1 publication Critical patent/WO1997022297A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6838Clamps or clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/681Wristwatch-type devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6822Neck
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6825Hand
    • A61B5/6826Finger
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus

Definitions

  • the present invention relates to medical information record systems, and more particularly, to a medical information record system for providing access to medical information of persons in emergency response situations.
  • Emergency response teams often lack critical medical information which may aid in the diagnosis and stabilization of an incapacitated person.
  • the elderly may be especially difficult to treat, often exhibiting the combination of complex medical conditions and limited communication ability. If the person under treatment is awake and coherent, some of this information may be obtained verbally. However, often the medically-incapacitated person is unconscious or unaware of the relevant medical information.
  • U.S. Patent No. 5,337,290 is directed to a health watch that provides instant access to critical medical data.
  • the health watch is worn on the wrist like a conventional wristwatch, and contains integrated circuit memory which includes data relating to medical conditions such as vital signs, chronic conditions, allergies, medications, etc.
  • the small digital wristwatch houses an 8051 microcomputer, memory, and an LCD screen. Buttons on the watch call up specified medical data which is shown on the LCD screen.
  • the electronic circuitry for computing, data storage and data I/O is contained within an Application Specific Integrated Circuit (ASIC) which is custom-designed for this application in order to meet the very restricted packaging constraints.
  • ASIC Application Specific Integrated Circuit
  • One drawback to the device of the '290 patent is that it is relatively expensive and thus drives the cost of every device by the cost of the custom ASIC and the required LCD display screen. Additionally, complex keystrokes are required to display the requested data on very limited display screen sizes. The device also has a limited memory capability and display capacity, requiring the operator to sequence through a number of keystrokes to display all required information.
  • Another device similar to the '290 patent is shown in U.S. Patent No.
  • 5,012,229 which is directed to a wearable/personal medical information device that includes a memory for storing medical information related to the person wearing the device.
  • the device described in the '229 patent is a flexible wristband and like the previous patent, it also uses a built-in LCD screen to display pertinent patient personal and/or medical data.
  • the device contains Read Only Memory (ROM) for storing certain data such as medical information, and a Random Access Memory (RAM) for other data which the user may change from time-to-time.
  • ROM Read Only Memory
  • RAM Random Access Memory
  • the '229 patented device also has a built- in computer and display electronics for accessing and displaying stored data with an eight character legend display showing the category of data and sixteen character data display showing the specific medical data.
  • this patent describes a very expensive solution requiring every wearer to effectively purchase an expensive computer/display.
  • the primary aim ofthe present invention to provide a medical information record system that provides rapid access to a person's current medical info ⁇ nation in emergency response situations.
  • Another object of this invention is to provide a portable data storage module containing current personal medical information that is easily identifiable and locatable.
  • a related object of the present invention is to provide a medical information record system that allows emergency medical personnel to rapidly gain access to medical information of incapacitated persons.
  • An additional object of this invention is to provide a simple, reliable, and inexpensive memor)' element, having the memory capacity to maintain all relevant medical data of a person in a compact, dime-sized package.
  • the medical information record system provides access to medical information of persons in emergency response situations by providing a portable data storage device located in a carrier worn by a person.
  • the portable data storage device contains current medical information specific to the person wearing the data storage device.
  • a handheld reading device accesses the medical information contained in the portable data storage device via a probe and a display for displaying the medical information to medical personnel.
  • the medical information record system of the present invention also includes a distributed medical record database .system that generates and manages personal medical information records.
  • the database system includes a central database system location in communication with at least one localized database system location for coordination of the medical information records on a national scale.
  • the database system also includes the ability to update personal medical records so that the records contain current personal medical information, and the ability to record the medical records on the portable data storage device.
  • FIG. 1 is a schematic diagram illustrating the components of the medical information record system ofthe present invention
  • FIG. 2 is a closeup view ofthe portable data storage device ofthe present invention shown in FIG. 1 ;
  • FIG. 3 A is a block diagram illustrating the process for creating and updating medical records in accordance with the present invention
  • FIG. 3B is a block diagram illustrating the process for accessing medical information from the medical information record system of the present invention.
  • FIG. 4 is a block diagram illustrating the components ofthe portable data storage device shown in FIG. 2;
  • FIG. 5 is a block diagram illustrating the central and local administration sites ofthe distributed medical record database system used in the present invention.
  • FIG. 6 is a functional flow diagram illustrating the process for creating, updating, and verifying medical records in accordance with the present invention
  • FIG. 7A shows a detailed layout of the main display of the medical information record system ofthe present invention
  • FIG. 7B shows a series of screen captures of various medical-related information used in the medical information record system of the present invention
  • FIG. 8 is a block diagram further illustrating the details of the handheld reading device for accessing medical information shown in FIG. 1 ;
  • FIG. 9 is a diagram illustrating the keyboard/display of the handheld reading device shown in FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
  • a medical information record system is broadly designated in FIG. 1 by the reference numeral 20.
  • Medical record system 20 is a distributed medical record database system designed to provide rapid access to critical patient medical data for clinics, paramedics, and ER response teams.
  • the medical record system 20 of the present invention employs a PC-based medical record system to create, maintain, and update a portable data storage device 22 which contains current medical data and is worn by a patient or subscriber with a critical medical history.
  • the portable data storage device 22 is in the form of a bracelet, although the device 22 could be worn by a user in a necklace, badge, wristwatch, etc.
  • Portable data storage device 22 includes a small, compact datacell which contains current medical information specific to the person wearing device 22.
  • handheld reading device 30 includes a datacell probe 32 for electronically reading the data from datacell 24 in wireless fashion. Reader 30 also includes a data viewing screen 34 so that medical personnel can view a person's medical information after being accessed by probe 32. A printer 36 allows medical personnel to optionally obtain a paper tape printout ofthe medical data accessed by reader 30. Additionally, reader 30 includes a keyboard 38 for controlling various functions of reader 30.
  • datacell 24 is shown located on a bracelet 40 and alternatively on a badge 42.
  • the medical information storable in datacell 24 includes information such as subscriber ID number, subscriber name, date of birth, bloodtype, existing medical conditions (diabetes, epilepsy, etc.), current medications, sensitivities or allergies (poison oak, bee, venom, etc.), allergies to medication, emergency contact phone number, physician contact number, organ donor status, revision level of datacell, date of datacell creation, etc.
  • Candidates for a portable data storage device 22 include elderly patients in a nursing home or managed care living environment, patients with severe allergic sensitivities, epileptic patients, patients with serious heart disease, diabetic patients, etc.
  • another application of medical record system 20 includes a medical datacell 24 integrated with an employee badge to allow medical response teams to rapidly access critical data in the event of a medical emergency at the workplace.
  • FIG. 3A illustrates the process of both creating and updating database records in medical information record system 20 and in associated datacells 24.
  • Those individuals or institutions subscribing to the services provided by medical information record system 20 ofthe present invention would compile new patient data at step 44 and enter this new patient data into the database associated with medical information record system 20 as denoted at step 46.
  • This information is both stored in a database hard disk location 48 as well as in a datacell itself as shown in step 50.
  • Datacells 24 are marked in an easily-recognizable form and worn on the patient in the form of a bracelet, necklace, ring, etc as mentioned above.
  • the datacell 24 provides a compact, rugged, semi ⁇ permanent and readily-accessible data storage medium for medical records.
  • FIG. 3B illustrates the use of datacell 24 in an emergency response call situation.
  • the facility medical staff or response team After responding to an emergency call, the facility medical staff or response team would locate the medical datacell as denoted at step 52. and would access or read the current medical data from datacell 24 with handheld reader 30 as shown in step 54.
  • Handheld reader 30 displays the medical data on the display screen as shown by step 56, and optionally prints a hardcopy of the record as shown in step 58.
  • the emergency response team could optionally transmit the pertinent medical data forward to the emergency room staff as indicated at step 60 using facilities equivalent to those used to forward EKG data.
  • the key memory technology employed by the present invention for the portable data storage device is a small, rugged, self-contained memory device with built-in power as required for long-term data retention and self-contained data communication circuitry.
  • FIG. 4 illustrates that datacell 24. in the preferred embodiment, is "dime-sized" (about 16mm or less in diameter and 6mm or less in height) and thus suitable for mounting and comfortably worn in a bracelet, necklace, or some other easily located and accessed carrier.
  • Datacell 24, as shown in the block diagram of FIG. 4 contains a microcircuit non-volatile memory 62 in the form of either a battery powered Static Random Access Memory (SRAM) or Electrically Programmable Read Only Memory (EPROM).
  • SRAM Static Random Access Memory
  • EPROM Electrically Programmable Read Only Memory
  • Datacell 24 contains a minimum of 4,096 bits of non-volatile read/write memory with data storage provisions to provide at least a ten year data retention.
  • Datacell 24 contains all necessary data transfer circuitry 64 for read/write operations, and a cyclic redundancy check (CRC) circuit 66 for transmission error detection.
  • the device also contains a permanently stored and externally readable digital ID code 68 to uniquely identify the physical device and allow it to be associated with the specific subscriber's medical record.
  • the sealed and durable datacell is designed to be highly resistant to environmental hazards such as dirt, moisture, temperature, and shock. Data access is via single wire serial data communication and provides a full 4,096 bit transfer in less than 500ms.
  • Datacell 24 also includes a datacell power source 70, memory address/control circuitry 72, and data registers 74.
  • a suitable portable data storage device 22 for purposes of the present invention includes the Dallas Semiconductor 19XX family of Touch Memory devices.
  • the medical information record system of the present invention includes a distributed medical record database system for generating, maintaining, and updating personal medical information records.
  • the distributed medical record database system is a database management system hosted on a Windows-based computing platform, and performs the following major functions: (1 ) creation and storage of subscriber records on hard disk; (2) display and printing of subscriber records;
  • FIG. 5 shows a simplified block diagram ofthe distributed medical record database system, broadly designated in the drawing by reference numeral 76.
  • System 76 includes both a central administration site 78 and at least one local administration site 80, although it is envisioned that the present invention will include multiple local administration sites across the country so that medical information records can be coordinated on a national scale.
  • each administration site includes a CPU/Memory 82, a display 84, hard disk storage 86, keyboard capability 88, a printer interface 90, and a modem interconnect 92 for communication between sites.
  • each administration site includes a probe I/O port 94 for downloading of the medical records maintained by the administration sites to datacells 24.
  • Subscriber medical data files are generated and maintained on the distributed medical record database system 76 using a standard Database Management System (DBMS). Individual subscriber records are maintained with the database records structure and data contents as shown in the following Table 1.
  • DBMS Database Management System
  • FIG. 6 shows the three primary operating modes of distributed medical record database system 76 of medical record system 20. These three primary operating modes are: (A) file generation and datacell creation, (B) file and datacell updates, and (C) datacell verification.
  • the Create mode (A) is invoked with a new subscriber and results in the creation of both a new record and a new datacell as denoted at step 96. Following the entry of new updated subscriber data at step 98, a file verification process 100 is performed. The subscriber data is then written to the datacell at step 102, and CRC error-checking is performed at step 104 to ensure that subscriber data has been transferred to the datacell error free.
  • the datacell ROM ID is read into the system from the permanent, internal datacell ROM at step 108 and stored with the subscriber record at step 1 10.
  • the datacell ROM ID is read into the system from the permanent, internal datacell ROM at step 108 and stored with the subscriber record at step 1 10.
  • a file administrator can call up an existing subscriber's file at step 1 14 by searching for name, social security number, or datacell ID.
  • the file is then updated at step 98, and either a new datacell written, or the original datacell updated with the new subscriber data.
  • the Verify mode (C) the datacell verification process begins at step 1 16.
  • the datacell is probed and both the datacell ID and the data contents are read in the PC memory for display.
  • CRC error-checking is performed at step 120 and a determination is made as to whether a data transfer error exists as shown in block 122. If a repeated error occurs as shown in block 124, the system declares the datacell as bad at step 126 such that a new datacell is required.
  • the database system is searched by datacell ID at step 128, and if no record is found which matches the datacell ID as determined in step 130, an error message is displayed at step 132 indicating that no record is found. If a record is found but there is a mismatch in the data fields as determined by step 134, a data error message is displayed at step 136 indicating that the datacell is invalid. In this situation, the data has either been corrupted or the subscriber database record updated without a co ⁇ esponding datacell written. In this case, a new datacell must be written from the latest subscriber record. If a record is found with matching data fields, the subscriber data is displayed and a record match message 138 is displayed to the operator.
  • FIGS. 7A and 7B illustrate representative data screens for the medical information record system 20 according to the present invention.
  • FIG. 7A shows the main screen of system 20 allowing selection of each ofthe major record field categories.
  • FIG. 7B shows each of the individual data entry screen for seven specific data types. These include subscriber/patient basic information screen 140, address information screen 142. emergency contact and physician information screen 144, insurance information screen 146, relevant medical conditions information screen 148, special medications information screen 150, and allergies information screen 152. Pull-down menus are used to select from standard data categories, and fill-in screens are used to allow for entry of non-standard conditions.
  • FIG. 8 provides further details ofthe handheld reader 30 shown in FIG. 1. More specifically, FIG.
  • FIG. 8 is a simplified block diagram illustrating the main components of handheld reader 30 which include a display 34, CPU/Memory 154. communications interface 156, keypad 38, printer interface 36, and power source 158. Additionally, reader 30 includes a probe I/O port 160 for the data probe 32. As shown in FIG. 8, communications interface 156 can optionally communicate with a remote data terminal 162 to provide access to database system 76 for real-time record verification or to a local hospital or emergency medical center for data transmission for emergency room notification. Thus, remote data terminal 162 can include a satellite link 164, an RF datalink 166, and/or a cellular datalink 168. This capability allows the present invention to be used, for example, by emergency medical personnel to communicate with an organ donor network to aid in the rapid identification of candidate organ recipients.
  • FIG. 9 provides further details ofthe keyboard and display of reader 30.
  • reader 30 When the operator probes a datacell, reader 30 immediately responds with a display of the subscriber name, donor status, bloodtype, social security number, emergency contacts, etc. A single keystroke brings up a display of current medical conditions, existing medications, and known allergies. Both horizontal and vertical scrolling is used to maximize utilization of the LCD screen. This scrolling is performed with scroll arrow keys 170 on keyboard 38. The down arrow on keyboard 38 allows the operator to scroll down the retrieved medical record selecting four of seven lines of medical data for review. If the data displayed on the screen is too long for the 20 character screen, the reader will automatically scroll side-to-side to allow the operator to view the entire line content.
  • the left direction arrow key stops side-to-side scrolling and the right direction arrow key restarts scrolling.
  • the "EXE” button allows the operator to view the first of three medical screens, i.e., conditions, medications, allergies.
  • the "EXE” button is pressed to view each screen. If a hardcopy printout of the medical data is desired, the operator presses the "MODE” button to start the print function.
  • the medical information record system ofthe present invention provides rapid access to critical patient medical data for paramedics, ER response teams, and other medical personnel.
  • the invention utilizes small, compact, portable data storage devices worn by patients with critical medical histories and contain current medical data important for rapid stabilization and treatment of an emergency medical condition.
  • the present invention also utilizes a distributed medical record database system to establish, maintain, and update patient records and datacells for nationwide coordination and rapid update of patient records.

Abstract

A medical information record system provides access to medical information of persons in emergency response situations. The system includes a portable data storage device (22) located in a carrier worn by a person. The portable data storage device contains current medical information records specific to the person wearing the device. A handheld reader (30) accesses the medical records contained in the portable data storage device via a probe (32) and a display for displaying the information to medical personnel. A distributed medical record database system (76) operates in conjuction with the reader and portable storage device for managing the personal medical informaion records. The distributed database system includes a central database location in communication with at least one localized database system location for coordination of medical records on a national scale. The distributed medical record database system includes the capability of creating and managing the personal medical records, and recording the personal medical records on the portable data storage device.

Description

MEDICAL INFORMATION RECORD SYSTEM
FIELD OF THE INVENTION
The present invention relates to medical information record systems, and more particularly, to a medical information record system for providing access to medical information of persons in emergency response situations.
BACKGROUND OF THE INVENTION
Emergency response teams often lack critical medical information which may aid in the diagnosis and stabilization of an incapacitated person. The elderly may be especially difficult to treat, often exhibiting the combination of complex medical conditions and limited communication ability. If the person under treatment is awake and coherent, some of this information may be obtained verbally. However, often the medically-incapacitated person is unconscious or unaware of the relevant medical information.
A number of potential data storage and retrieval systems have been proposed to address this problem. These include wristwatches with internal storage memory, wristbands with small LCD displays, smart cards, or optical disks. For example, U.S. Patent No. 5,337,290 is directed to a health watch that provides instant access to critical medical data. The health watch is worn on the wrist like a conventional wristwatch, and contains integrated circuit memory which includes data relating to medical conditions such as vital signs, chronic conditions, allergies, medications, etc. Specifically, in the '290 patent, the small digital wristwatch houses an 8051 microcomputer, memory, and an LCD screen. Buttons on the watch call up specified medical data which is shown on the LCD screen. The electronic circuitry for computing, data storage and data I/O is contained within an Application Specific Integrated Circuit (ASIC) which is custom-designed for this application in order to meet the very restricted packaging constraints. One drawback to the device of the '290 patent is that it is relatively expensive and thus drives the cost of every device by the cost of the custom ASIC and the required LCD display screen. Additionally, complex keystrokes are required to display the requested data on very limited display screen sizes. The device also has a limited memory capability and display capacity, requiring the operator to sequence through a number of keystrokes to display all required information. Another device similar to the '290 patent is shown in U.S. Patent No. 5,012,229 which is directed to a wearable/personal medical information device that includes a memory for storing medical information related to the person wearing the device. The device described in the '229 patent is a flexible wristband and like the previous patent, it also uses a built-in LCD screen to display pertinent patient personal and/or medical data. The device contains Read Only Memory (ROM) for storing certain data such as medical information, and a Random Access Memory (RAM) for other data which the user may change from time-to-time. The '229 patented device also has a built- in computer and display electronics for accessing and displaying stored data with an eight character legend display showing the category of data and sixteen character data display showing the specific medical data. Again, like the '290 patent, this patent describes a very expensive solution requiring every wearer to effectively purchase an expensive computer/display.
None ofthe systems proposed to date adequately address the problem of acquiring, maintaining, and updating the critical wearer's data. For example, card-based medical data systems require that response teams locate and then access relevant data from a card often located in a wallet or purse. Such a system is described in U.S. Patent No. 4,491,725 which is directed to a medical insurance verification processing system that uses a medical information card to determine a patient's background, medical, and insurance information. The system uses a card that can be in the form of a "smart card" having an integrated circuit chip which is accessible by means of an appropriate communication device.
Another disadvantage of card and optical disk-based systems is that they suffer from lack of data standards, making it difficult to broadly distribute the technology. Thus, there is a need for a system that provides response teams with critical medical information that is easily located and accessed. SUMMARY OF THE INVENTION
In view ofthe foregoing, it is the primary aim ofthe present invention to provide a medical information record system that provides rapid access to a person's current medical infoπnation in emergency response situations. In accomplishing that aim, it is an object of the present invention to provide a distributed medical database system designed to provide rapid access to critical patient medical data for clinics, paramedics, and emergency response teams.
Another object of this invention is to provide a portable data storage module containing current personal medical information that is easily identifiable and locatable.
A related object of the present invention is to provide a medical information record system that allows emergency medical personnel to rapidly gain access to medical information of incapacitated persons.
An additional object of this invention is to provide a simple, reliable, and inexpensive memor)' element, having the memory capacity to maintain all relevant medical data of a person in a compact, dime-sized package.
These and other important aims and objectives are accomplished in accordance with the medical information record system of the present invention. The medical information record system provides access to medical information of persons in emergency response situations by providing a portable data storage device located in a carrier worn by a person. The portable data storage device contains current medical information specific to the person wearing the data storage device. A handheld reading device accesses the medical information contained in the portable data storage device via a probe and a display for displaying the medical information to medical personnel. The medical information record system of the present invention also includes a distributed medical record database .system that generates and manages personal medical information records. The database system includes a central database system location in communication with at least one localized database system location for coordination of the medical information records on a national scale. The database system also includes the ability to update personal medical records so that the records contain current personal medical information, and the ability to record the medical records on the portable data storage device.
BRIEF DESCRIPTION OF THE DRAWINGS
The various aspects of the invention are described in detail below, with reference to the drawings, in which:
FIG. 1 is a schematic diagram illustrating the components of the medical information record system ofthe present invention;
FIG. 2 is a closeup view ofthe portable data storage device ofthe present invention shown in FIG. 1 ; FIG. 3 A is a block diagram illustrating the process for creating and updating medical records in accordance with the present invention;
FIG. 3B is a block diagram illustrating the process for accessing medical information from the medical information record system of the present invention;
FIG. 4 is a block diagram illustrating the components ofthe portable data storage device shown in FIG. 2;
FIG. 5 is a block diagram illustrating the central and local administration sites ofthe distributed medical record database system used in the present invention;
FIG. 6 is a functional flow diagram illustrating the process for creating, updating, and verifying medical records in accordance with the present invention; FIG. 7A shows a detailed layout of the main display of the medical information record system ofthe present invention;
FIG. 7B shows a series of screen captures of various medical-related information used in the medical information record system of the present invention;
FIG. 8 is a block diagram further illustrating the details of the handheld reading device for accessing medical information shown in FIG. 1 ; and
FIG. 9 is a diagram illustrating the keyboard/display of the handheld reading device shown in FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
A medical information record system according to the present invention is broadly designated in FIG. 1 by the reference numeral 20. Medical record system 20 is a distributed medical record database system designed to provide rapid access to critical patient medical data for clinics, paramedics, and ER response teams. As shown in FIG. 1. the medical record system 20 of the present invention employs a PC-based medical record system to create, maintain, and update a portable data storage device 22 which contains current medical data and is worn by a patient or subscriber with a critical medical history. In the illustrated embodiment, the portable data storage device 22 is in the form of a bracelet, although the device 22 could be worn by a user in a necklace, badge, wristwatch, etc. Portable data storage device 22 includes a small, compact datacell which contains current medical information specific to the person wearing device 22.
As shown in FIG. 1, medical infoπnation important for rapid stabilization and treatment in emergency medical situations, as well as other pertinent medical and personal information, is downloaded to datacell 24 of portable data storage device 22 via a datacell probe 26. Probe 26 is part of a distributed medical record database system 28 for generating, maintaining, and updating personal medical information records. The medical information from datacell 24 can then be accessed by a handheld reading device 30. As shown in FIG. 1 , handheld reading device or reader 30 includes a datacell probe 32 for electronically reading the data from datacell 24 in wireless fashion. Reader 30 also includes a data viewing screen 34 so that medical personnel can view a person's medical information after being accessed by probe 32. A printer 36 allows medical personnel to optionally obtain a paper tape printout ofthe medical data accessed by reader 30. Additionally, reader 30 includes a keyboard 38 for controlling various functions of reader 30.
Referring now to FIG. 2, datacell 24 is shown located on a bracelet 40 and alternatively on a badge 42. The medical information storable in datacell 24 includes information such as subscriber ID number, subscriber name, date of birth, bloodtype, existing medical conditions (diabetes, epilepsy, etc.), current medications, sensitivities or allergies (poison oak, bee, venom, etc.), allergies to medication, emergency contact phone number, physician contact number, organ donor status, revision level of datacell, date of datacell creation, etc. Candidates for a portable data storage device 22 include elderly patients in a nursing home or managed care living environment, patients with severe allergic sensitivities, epileptic patients, patients with serious heart disease, diabetic patients, etc. As shown in FIG. 2, another application of medical record system 20 includes a medical datacell 24 integrated with an employee badge to allow medical response teams to rapidly access critical data in the event of a medical emergency at the workplace.
FIG. 3A illustrates the process of both creating and updating database records in medical information record system 20 and in associated datacells 24. Those individuals or institutions subscribing to the services provided by medical information record system 20 ofthe present invention would compile new patient data at step 44 and enter this new patient data into the database associated with medical information record system 20 as denoted at step 46. This information is both stored in a database hard disk location 48 as well as in a datacell itself as shown in step 50. Datacells 24 are marked in an easily-recognizable form and worn on the patient in the form of a bracelet, necklace, ring, etc as mentioned above. The datacell 24 provides a compact, rugged, semi¬ permanent and readily-accessible data storage medium for medical records.
FIG. 3B illustrates the use of datacell 24 in an emergency response call situation. After responding to an emergency call, the facility medical staff or response team would locate the medical datacell as denoted at step 52. and would access or read the current medical data from datacell 24 with handheld reader 30 as shown in step 54. Handheld reader 30 displays the medical data on the display screen as shown by step 56, and optionally prints a hardcopy of the record as shown in step 58. Additionally, the emergency response team could optionally transmit the pertinent medical data forward to the emergency room staff as indicated at step 60 using facilities equivalent to those used to forward EKG data.
In accordance with the present invention, the key memory technology employed by the present invention for the portable data storage device is a small, rugged, self-contained memory device with built-in power as required for long-term data retention and self-contained data communication circuitry. FIG. 4 illustrates that datacell 24. in the preferred embodiment, is "dime-sized" (about 16mm or less in diameter and 6mm or less in height) and thus suitable for mounting and comfortably worn in a bracelet, necklace, or some other easily located and accessed carrier. Datacell 24, as shown in the block diagram of FIG. 4, contains a microcircuit non-volatile memory 62 in the form of either a battery powered Static Random Access Memory (SRAM) or Electrically Programmable Read Only Memory (EPROM). Datacell 24 contains a minimum of 4,096 bits of non-volatile read/write memory with data storage provisions to provide at least a ten year data retention.
Datacell 24 contains all necessary data transfer circuitry 64 for read/write operations, and a cyclic redundancy check (CRC) circuit 66 for transmission error detection. The device also contains a permanently stored and externally readable digital ID code 68 to uniquely identify the physical device and allow it to be associated with the specific subscriber's medical record. The sealed and durable datacell is designed to be highly resistant to environmental hazards such as dirt, moisture, temperature, and shock. Data access is via single wire serial data communication and provides a full 4,096 bit transfer in less than 500ms. Datacell 24 also includes a datacell power source 70, memory address/control circuitry 72, and data registers 74. A suitable portable data storage device 22 for purposes of the present invention includes the Dallas Semiconductor 19XX family of Touch Memory devices. As mentioned previously, the medical information record system of the present invention includes a distributed medical record database system for generating, maintaining, and updating personal medical information records. The distributed medical record database system is a database management system hosted on a Windows-based computing platform, and performs the following major functions: (1 ) creation and storage of subscriber records on hard disk; (2) display and printing of subscriber records;
(3) loading (writing) of datacells; (4) reading and verification of datacells against subscriber files; and (5) updating of subscriber medical files and datacells.
FIG. 5 shows a simplified block diagram ofthe distributed medical record database system, broadly designated in the drawing by reference numeral 76. System 76 includes both a central administration site 78 and at least one local administration site 80, although it is envisioned that the present invention will include multiple local administration sites across the country so that medical information records can be coordinated on a national scale. As shown in FIG. 5, each administration site includes a CPU/Memory 82, a display 84, hard disk storage 86, keyboard capability 88, a printer interface 90, and a modem interconnect 92 for communication between sites. Additionally, each administration site includes a probe I/O port 94 for downloading of the medical records maintained by the administration sites to datacells 24.
Subscriber medical data files are generated and maintained on the distributed medical record database system 76 using a standard Database Management System (DBMS). Individual subscriber records are maintained with the database records structure and data contents as shown in the following Table 1.
Table 1 - Subscriber File Structure
Field ID Field Name Data Description Datacell Type Bytes
Data Fields
1 Last Name Text Last Name of 15 Subscriber
2 First Name Text First Name of 10 Subscriber
3 Middle Initial Text Middle Initial of 1 Subscriber
4 Sex Text Sex of Subscriber 1
5 Date of Birth Text Birthdate of patient 8
6 Social Security # Text SSN of Wearer 8
7 Blood Type Blood Type Code designating 1 Code subscribers Blood Type
8 Religion Religion Code Code designating 1 subscriber's religion
9 Donor Card Status Yes/No Code Indicating 1 Donor Status
10 Code Yes/No Code Indicating 1 CODE/NO CODE Field ID Field Name Data Description Datacell Type Bytes
11 Street Text Physical Address -
Physical Street Address
12 City Text Physical Address -
Physical City Address
13 State Text Physical Address -
Physical State Address
14 Zip Code Text Physical Address Zip -
Physical Code Address
15 Street Text Mailing Address -
Mailing Street Address
1 City Text Mailing Address -
Mailing City Address
17 State Text Mailing Address - Mailing State Address
18 Zip Code Text Mailing Address -
Mailing Zip Code Address
19 EC First Name Text First Name of 10 emergency contact
20 EC Last Name Text Last Name of 15 emergency contact
21 EC Phone Number Text Phone number of 10 emergency contact
22 Physician First Text First Name of 10 Name Physician
23 Physician Last Text Last Name of 15 Name Physician
24 Physician Phone Text Phone number of 10 Number Physician Field ID Field Name Data Description Datacell Type Bytes
25 Insurance Carrier Text Subscriber's - Insurance Carrier
26 Policy Number Text Subscriber's Policy - Number
27 Current Medical Special Medical Code designating 1 Condition A Condition Code- Special Medical
A Condition - A
28 Current Medical Special Medical Code designating 1 Condition B Condition Code- Special Medical
B Condition - B
29 Cuπent Medical Special Medical Code designating 1 Condition C Condition Code- Special Medical
C Condition - C
30 Special Medical Text Text describing 15 Condition D Special Medical Condition not found in standard table
31 Special Medical Text Text describing 15 Condition E Special Medical Condition not found in standard table
32 Current Cuπent Medical Text describing 1
Medications A Condition Code- prescription
A medication
33 Current Cuπent Medical Text describing 1 Medications B Condition Code- prescription
B medication
34 Current Cuπent Medical Text describing 1 Medications C Condition Code- prescription
C medication
35 Special Text Text describing 15 Medications D prescription medication not in the standard medication table Field ID Field Name Data Description Datacell Type Bytes
36 Special Text Text describing 15 Medications E prescription medication not in the standard medication table
37 Allergy Field A Allergy Code-A Code designating 1 Allergy Type-A
38 Allergy Field B Allergy Code-B Code designating 1 Allergy Type-B
39 Allergy Field C Allergy Code-C Code designating 1 Allergy Type-C
40 Creation Date Text Date Of Record/ 8 Datacell creation
41 Revision Date Text Date of Record/ 8 Datacell revision
41 Revision # Text Revision # Of 1 Record/Datacell
42 Datacell ROM ID Text ROM ID of 0 Subscribers Datacell (This ID is (This ID is unique to stored as each Datacell and is part of the permanently stored subscriber (burned) in ROM at Database the factory) file but is burned into a permanent
ROM)
As can be seen, FIG. 6 shows the three primary operating modes of distributed medical record database system 76 of medical record system 20. These three primary operating modes are: (A) file generation and datacell creation, (B) file and datacell updates, and (C) datacell verification. The Create mode (A) is invoked with a new subscriber and results in the creation of both a new record and a new datacell as denoted at step 96. Following the entry of new updated subscriber data at step 98, a file verification process 100 is performed. The subscriber data is then written to the datacell at step 102, and CRC error-checking is performed at step 104 to ensure that subscriber data has been transferred to the datacell error free. Following successful data transfer as determined at step 106, the datacell ROM ID is read into the system from the permanent, internal datacell ROM at step 108 and stored with the subscriber record at step 1 10. By this method, there is always a recorded association between the subscriber record and a specific, unique datacell. Following this step, the entire subscriber record is stored in the distributed database system 76 at step 1 12.
In the Update record mode (B), a file administrator can call up an existing subscriber's file at step 1 14 by searching for name, social security number, or datacell ID. The file is then updated at step 98, and either a new datacell written, or the original datacell updated with the new subscriber data. In the Verify mode (C). the datacell verification process begins at step 1 16. At step 1 18. the datacell is probed and both the datacell ID and the data contents are read in the PC memory for display. CRC error-checking is performed at step 120 and a determination is made as to whether a data transfer error exists as shown in block 122. If a repeated error occurs as shown in block 124, the system declares the datacell as bad at step 126 such that a new datacell is required. The database system is searched by datacell ID at step 128, and if no record is found which matches the datacell ID as determined in step 130, an error message is displayed at step 132 indicating that no record is found. If a record is found but there is a mismatch in the data fields as determined by step 134, a data error message is displayed at step 136 indicating that the datacell is invalid. In this situation, the data has either been corrupted or the subscriber database record updated without a coπesponding datacell written. In this case, a new datacell must be written from the latest subscriber record. If a record is found with matching data fields, the subscriber data is displayed and a record match message 138 is displayed to the operator.
FIGS. 7A and 7B illustrate representative data screens for the medical information record system 20 according to the present invention. FIG. 7A shows the main screen of system 20 allowing selection of each ofthe major record field categories. FIG. 7B shows each of the individual data entry screen for seven specific data types. These include subscriber/patient basic information screen 140, address information screen 142. emergency contact and physician information screen 144, insurance information screen 146, relevant medical conditions information screen 148, special medications information screen 150, and allergies information screen 152. Pull-down menus are used to select from standard data categories, and fill-in screens are used to allow for entry of non-standard conditions. FIG. 8 provides further details ofthe handheld reader 30 shown in FIG. 1. More specifically, FIG. 8 is a simplified block diagram illustrating the main components of handheld reader 30 which include a display 34, CPU/Memory 154. communications interface 156, keypad 38, printer interface 36, and power source 158. Additionally, reader 30 includes a probe I/O port 160 for the data probe 32. As shown in FIG. 8, communications interface 156 can optionally communicate with a remote data terminal 162 to provide access to database system 76 for real-time record verification or to a local hospital or emergency medical center for data transmission for emergency room notification. Thus, remote data terminal 162 can include a satellite link 164, an RF datalink 166, and/or a cellular datalink 168. This capability allows the present invention to be used, for example, by emergency medical personnel to communicate with an organ donor network to aid in the rapid identification of candidate organ recipients.
FIG. 9 provides further details ofthe keyboard and display of reader 30. When the operator probes a datacell, reader 30 immediately responds with a display of the subscriber name, donor status, bloodtype, social security number, emergency contacts, etc. A single keystroke brings up a display of current medical conditions, existing medications, and known allergies. Both horizontal and vertical scrolling is used to maximize utilization of the LCD screen. This scrolling is performed with scroll arrow keys 170 on keyboard 38. The down arrow on keyboard 38 allows the operator to scroll down the retrieved medical record selecting four of seven lines of medical data for review. If the data displayed on the screen is too long for the 20 character screen, the reader will automatically scroll side-to-side to allow the operator to view the entire line content. The left direction arrow key stops side-to-side scrolling and the right direction arrow key restarts scrolling. The "EXE" button allows the operator to view the first of three medical screens, i.e., conditions, medications, allergies. The "EXE" button is pressed to view each screen. If a hardcopy printout of the medical data is desired, the operator presses the "MODE" button to start the print function. As is evident from the foregoing description, the medical information record system ofthe present invention provides rapid access to critical patient medical data for paramedics, ER response teams, and other medical personnel. The invention utilizes small, compact, portable data storage devices worn by patients with critical medical histories and contain current medical data important for rapid stabilization and treatment of an emergency medical condition. The present invention also utilizes a distributed medical record database system to establish, maintain, and update patient records and datacells for nationwide coordination and rapid update of patient records.

Claims

WE CLAIM:
1. A medical information record system for providing access to medical information of persons in emergency response situations, the medical information system comprising: a portable data storage device located in a carrier worn by a person, the portable data storage device containing current personal medical records of medical information specific to the person wearing the data storage device; a handheld reading device for accessing the personal medical records contained in the portable data storage device, the handheld reading device including probe means for accessing the medical records, and means for displaying the medical records on the handheld reading device to medical personnel; and a distributed medical record database system for managing the personal medical records, said database system including a central database system location in communication with at least one localized database system location for coordination of the medical records on a national scale, the distributed medical record database system including means for creating and managing the personal medical records, and means for recording the personal medical records on the portable data storage device.
2. The medical information record system as defined in claim 1 wherein the portable data storage device comprises a self-contained semiconductor memory device.
3. The medical information record system as defined in claim 2 wherein the carrier comprises a bracelet, necklace, badge, or other easily located and accessible carrier.
4. The medical information record system as defined in claim 2 wherein the portable data storage device includes a permanently stored and externally readable identification number to provide a permanent association between a person and a specific storage device.
5. The medical information record system as defined in claim 2 wherein the portable data storage device includes data transfer circuitry for read/write operations.
6. The medical information record system as defined in claim 5 wherein the portable data storage device includes cyclic redundancy check circuitry for transmission eπor detection.
7. The medical infoπnation record system as defined in claim 1 wherein the handheld reading device includes communication means for communicating a person's medical records accessed from the portable data storage device to a medical facility.
8. The medical information record system as defmed in claim 7 wherein the communication means also communicates with the distributed medical record database system to provide substantially instantaneous verification of a person's medical records.
9. The medical information record system as defined in claim 1 wherein the probe means accesses the medical infoπnation contained in the portable data storage device via wireless communication.
10. The medical information record system as defined in claim 1 wherein the means for displaying of the handheld reading device comprises an LCD screen.
1 1. The medical information record system as defined in claim 10 wherein the means for displaying of the handheld reading device further comprises a printer for printing a hardcopy ofthe medical information accessed from the portable data storage device.
12. The medical information record system as defined in claim 1 wherein the means for creating and managing includes means for updating the personal medical records so that said records contain current personal medical information.
13. The medical information record system as defined in claim 1 wherein the distributed medical record database system further includes means for verifying the contents ofthe portable data storage device to ensure the accuracy and integrity ofthe personal medical records stored in the portable data storage device.
14. The medical information record system as defined in claim 1 wherein the personal medical records comprise data on a person's name, date of birth, address, blood type, existing medical conditions, medications, sensitivities or allergies, emergency contact phone number, physician contact number, organ donor status, and identification number.
15. A method of maintaining personal medical information records to provide access to medical information of persons in emergency response situations, the method comprising: generating and storing personal medical records on a distributed medical record database system; recording the personal medical records on portable data storage devices; providing a person with a portable data storage device located in a carrier worn by the person, the portable data storage device containing personal medical records specific to the person; updating the personal medical records as necessary in the distributed medical record database system and in the portable data storage device so that said records contain current personal medical information; and accessing the personal medical records from the portable data storage device worn by the person with a handheld reading device to display the personal medical records to medical personnel in emergency response situations.
16. The method as defined in claim 15 further comprising the step of: providing a central medical record database system location and at least one localized medical record database system location for coordination ofthe personal medical records on a national scale.
17. The method as defined in claim 15 further comprising the step of: verifying the contents of the portable data storage device to ensure the accuracy and integrity ofthe personal medical records stored in the portable data storage device.
18. The method as defined in claim 15 further comprising the step of: communicating the personal medical records accessed from the portable data storage device to a medical facility.
19. The method as defined in claim 15 wherein the portable data storage device comprises a self-contained semiconductor memory device.
20. The method as defined in claim 15 wherein the canier comprises a bracelet, necklace, badge, or other easily located and accessible carrier.
21 . The method as defined in ciaim 15 wherein the portable data storage device includes a permanently stored and externally readable identification number to provide a permanent association between a person and a specific storage device.
22. The method as defined in claim 15 wherein the personal medical records comprise data on a person's name, date of birth, address, blood type, existing medical conditions, medications, sensitivities or allergies, emergency contact phone number, physician contact number, organ donor status, and identification number.
23. A medical information record system for providing access to medical information of persons in emergency response situations, the medical information system comprising: a portable data storage device located in a carrier worn by a person, the portable data storage device containing current personal medical records of medical information specific to the person wearing the data storage device; a handheld reading device for accessing the personal medical records contained in the portable data storage device, the handheld reading device including probe means for accessing the medical records, and means for displaying the medical records on the handheld reading device to medical personnel; and a distributed medical record database system for generating, maintaining, and updating the personal medical records, said database system including a central database system location in communication with at least one localized database system location for coordination of the medical records on a national scale, the distributed medical record database system including means for creating and storing the personal medical records, means for updating the personal medical records so that said records contain cuπent personal medical information, means for recording the personal medical records on the portable data storage device, and means for verifying the contents of the portable data storage device to ensure the accuracy and integrity of the personal medical records stored in the portable data storage device.
24. The medical information record system as defined in claim 23 wherein the handheld reading device includes communication means for communicating a person's medical records accessed from the portable data storage device to a medical facility.
25. The medical information record system as defined in claim 23 wherein the portable data storage device comprises a self-contained semiconductor memory device.
26. The medical information record system as defined in claim 25 wherein the carrier comprises a bracelet, necklace, badge, or other easily located and accessible carrier.
PCT/US1996/020398 1995-12-20 1996-12-16 Medical information record system WO1997022297A1 (en)

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