Health monitoring and diagnostic device and network-based health assessment and medical records maintenance system

• US 7,767,149 B2
• Filed: 08/26/2003
• Issued: 08/03/2010
• Est. Priority Date: 11/09/1998
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Nesbitt, Kenn A., Maus, Christopher T., Connolly, Jackson B., Moody, James L., Coad, Craig A., Clegg, Kenneth D., Coad, Noah M.
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US10/649,293
• Publication Number:
  US 20040037738A1
• Time in Patent Office: 2,534 Days
• Field of Search: 422/68.1, 422/811, 600/309, 600/310
• US Class Current: 422/68.1
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4261 Evaluating exocrine secretion production A61B3/101 takes precedence
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 10/65 : stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 436/811 : Test for named disease, body condition or organ function

Abstract

A health monitoring and diagnostic device (LIFESTREAM cholesterol meter) configured as a self-contained testing and diagnostic unit in a clam-shell type case. One side of the case includes a spring-loaded finger stick and a compartment for carrying one or more packages of disposable items including a test strip, a needle for the finger stick, and an alcohol swipe. The other half of the case includes a test strip reader, a key pad, and a liquid crystal display. The meter reads a test strip carrying a droplet of blood and receives additional diagnostic information from the patient, such as age, gender, weight, and family history of heart disease. Within minutes, the meter displays test results, including total cholesterol levels. The meter also displays additional diagnostic results, such as the patient'"'"'s “cardiac age,” recommended weight loss, and a cardiac risk assessment. The meter also works in connection with a network-based comprehensive health analysis and reporting system. The meter writes patient data to a smartcard. This patient data typically includes patient identification information, the test results, the diagnostic information, and the diagnostic results. A computer station reads the smartcard and establishes a network connection with a health report server over the Internet. The computer then downloads the patient data to the health report server, which prepares a comprehensive health report. Within minutes, this report is transmitted back to the computer station, where it is printed out and delivered to the patient.

Claims

1. A system for remotely producing health reports, comprising:

a health monitoring device including;

a test strip reader operable for reading a test strip carrying a sample of biological fluid or tissue and obtaining test results based on the sample of biological tissue or fluid and calibration data specific to the test strip, wherein the test strip reader is operable for reading a second type of test strip carrying a second sample of biological fluid or tissue and obtaining health-related test results based on the second sample of biological tissue or fluid and calibration data specific to the second type of test strip, further comprising;

a second memory reading device functionally connected to the test strip reader and operable for reading calibration data from a second memory device corresponding to the second type of test strip,

a memory reading device functionally connected to the test strip reader and operable for reading the calibration data from a memory device, and

a data drive functionally connected to the test strip reader and operable for writing the test results to a memory storage device;

a health report server operable for;

receiving the test results and additional diagnostic information,

compiling a health report based on the test results and the additional diagnostic information, said health report including one or more of the following data items;

a five-year risk of heart attack, a ten-year risk of heart attack, a cardiac age, an extended age, or a risk of stroke, and

transmitting the health report; and

a computer station operable for;

reading the test results from the memory storage device,

establishing a network connection with the health report server,

receiving the additional diagnostic information,

transmitting the test results and the additional diagnostic information to the health report server,

receiving the health report from the health report server, and

printing the health report.

2. The system for remotely producing health reports of claim 1, wherein the health report includes a trend analysis including test results compiled for a number of samples of the biological fluid or tissue.

3. The system for remotely producing health reports of claim 1, wherein:

the biological fluid or tissue includes a droplet of human blood;

the test results include blood lipid levels; and

the additional diagnostic information includes one or more of the following data items corresponding to a person providing the droplet of human blood;

gender, ethnicity, family history of heart disease, personal history of heart disease, personal history of diabetes, personal history of smoking, height, weight, age, blood pressure, and fitness level.

4. The system for remotely producing health reports of claim 1, wherein:

the health report includes one or more of the following data items;

a medical risk index and a recommended weight loss.

5. The system for remotely producing health reports of claim 4, wherein:

the additional diagnostic information includes a newly-prescribed drug and other currently-prescribed drugs; and

the health report includes a data sheet for the newly-prescribed drug and information relating to cross-reactions between the newly-prescribed drug and the other currently-prescribed drugs.

6. The system for remotely producing health reports of claim 5, wherein the health report further includes one or more of the following items:

target weight and blood lipid levels;

a schedule for future testing using the health monitoring device;

a health assessment summary;

a coronary risk assessment; and

dietary guidelines to lower cholesterol.

7. The system for remotely producing health reports of claim 1 wherein:

the test results include blood glucose levels; and

the health report further includes a trend analysis including test results compiled for a number of samples of the biological fluid or tissue.

8. The system of claim 1 wherein the health monitoring device further includes a secure data system for maintaining the security of the test results.