Portable analytical device

• US 9,149,215 B2
• Filed: 12/20/2006
• Issued: 10/06/2015
• Est. Priority Date: 12/30/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Werner, Karl, Afshar, Nader, Young, Morris J., Greenburg, Alan, Galley, Paul
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US12/158,558
• Publication Number:
  US 20090304547A1
• Time in Patent Office: 3,212 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/65 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A portable analytical device is provided for analysis of a component of a body fluid. A measuring facility within the device may carry out the analysis on a test element inserted therein. The test element may contain a reagent that reacts with a liquid sample of the body fluid when the test element is contacted thereby to produce a change that is characteristic of the analysis. A processor may process measuring values determined by the measuring facility to yield analytical measuring data taking into account calibration values. A standardized, wire-based computer interface may be provided on the analytical device via which the analytical device can be operated by a computer, the analytical measuring data can be transmitted from the analytical device to the computer, the analytical device can be supplied with electrical power by the computer, and the analytical device can provide software to be read-out by the computer.

Claims

1. A portable, patient-operable analytical device for analysis of a medically significant component of a body fluid for self-monitoring by a patient, comprising:

a device housing defining an opening therein,

a measuring facility arranged inside the device housing and configured to receive a test element that is inserted through the housing opening into the measuring facility, the measuring facility configured to analyze one of an optical and electrochemical change in a received test element upon which a liquid sample of the body fluid has been deposited and to generate measuring values resulting from the analysis,

a processor arranged inside the device housing and including a memory having software stored therein, the processor configured to execute at least a portion of the software to process the measuring values to yield analytical measuring data taking into account calibration values, and

an electrical connector carried by the housing and electrically connected to the processor, the electrical connector configured to operatively connect to an external electronic device, the electrical connector configured to transmit the analytical measuring data from the analytical device to the external electronic device, the electrical connector comprising a voltage supply input configured to transmit an external supply of electrical power to the analytical device from the external electronic device, wherein the analytical device is further configured to provide one or more portions of the software through the electrical connector to the external electronic device when the electrical connector is operatively connected to the external electronic device.

2. The analytical device of claim 1, wherein the measuring facility is configured to analyze an electrochemical change in the received test element, the measuring facility comprising measuring electronics comprising at least one electrode configured to produce the measuring values based on an electro-chemical reaction between the liquid sample and a reagent in the test element.

3. The analytical device of claim 2 wherein the electrochemical reaction between the liquid sample and the reagent in the test element results in a change of one of a voltage signal and a current signal that is measured by the measuring electronics and the detectable electrochemical change is one of voltage and current respectively.

4. The analytical device of claim 1 wherein the measuring facility is configured to analyze an optical change in the received test element, the measuring facility comprising a photometric measuring facility, and wherein the photometric measuring facility comprises an optical detector configured to produce the measuring values based on at least one optical property resulting from a reaction between the liquid sample and a reagent in the test element.

5. The analytical device of claim 4 wherein the reaction between the liquid sample and the reagent in the test element results in a color change of the test element such that the at least one optical property includes color and the optically detectable change is the color change.

6. The analytical device of claim 1 wherein operation of the analytical device is controlled by the external electronic device via a USB communications protocol when the electrical connector is operatively connected to the external electronic device.

7. The analytical device of claim 1 wherein the electrical connector comprises a multi-wire connector.

8. The analytical device of claim 1 wherein the electrical connector comprises a male plug contact attached on the housing of the analytical device.

9. The analytical device of claim 1 wherein the measuring facility comprises one of a colorimetric measuring facility wherein the one of the optical and electrochemical change in the received element is an optically detectable change and an electrochemical measuring facility wherein the one of the optical and electrochemical change in the received element is a detectable electrochemical change.

10. The analytical device of claim 1 wherein the analytical device comprises one of a blood glucose meter, a cholesterol measuring device and a blood coagulation parameter measuring device.

11. A portable, patient-operable analytical device for analysis of a medically significant component of a body fluid for self-monitoring by a patient, comprising:

a device housing defining an opening therein,

a measuring facility arranged inside the device housing configured to receive a test element via the housing opening and configured to analyze one of an optical and electrochemical change in the test element upon which a liquid sample of the body fluid is deposited and generating measuring values resulting from the analysis,

a processor arranged inside the device housing and including a memory having stored therein software at least a portion of which is executable by the processor to process the measuring values to produce analytical measuring data taking into account calibration values, and

an electrical connector having one end attached to the housing and electrically connected to the processor and having an opposite end extending from the device housing, the opposite end of the electrical connector receiving electrical power to operate the processor and the measuring facility from an external device connectable to the electrical connector.

12. The analytical device of claim 11 wherein the processor provides one or more portions of the software via the electrical connector to the external device when the external device is connected to the analytical device via the electrical connector.

13. A system for analyzing a medically significant component of a body fluid for self-monitoring by a patient, comprising:

an electronic device comprising a display, a first electrical connector and a first processor electrically connected to the display and the first electrical connector, and an analytical system comprising;

a device housing defining an opening therein,

a test element comprising a reagent configured to react with a body fluid to generate a detectable change, the test element being insertable through the opening,

a measuring facility arranged inside the device housing and configured to receive the test element via the opening, the measuring facility configured to analyze the detectable change in the test element having a liquid sample of the body fluid received thereon and to generate measuring values resulting from the analysis,

a second processor arranged inside the device housing and including a memory having stored therein software at least a portion of which is executable by the at least one of the first and second processors to process the measuring values to produce analytical measuring data, and

a second electrical connector carried by the device housing and electrically connected to the second processor,

wherein the first and second electrical connectors are configured to be directly connected to each other to define an operative connection between the first and second processors, the operative connection comprising a data connection through which the analytical measuring data is provided from the second processor to the first processor and through which controlling signals are exchanged between the first and second processors to control the display to convey the analytical measuring data display in at least one of a textual and a graphic form,

wherein the first processor is configured to one of control operation of the analytical device via the operative connection and trigger actions of the analytical device via the operative connection to analyze the detectable change in the test element inserted into the measuring facility and having the liquid sample of the body fluid received thereon.

14. The analytical device of claim 13 wherein the electronic device comprises at least one of a keyboard, a point and select device and a microphone,

and wherein the first processor is configured to control the display to display user input instructions and/or information relating to the analysis,

and wherein user input required in response to the user input instructions and/or information is provided by the user via the at least one of the keyboard, the point and select device and the microphone.

15. The analytical device of claim 13 wherein the electronic device comprises a speaker operatively connected to the first processor,

and wherein the first processor is configured to control the speaker to display the analytical measuring data by audibly conveying the analytical measuring data.