Universal diagnostic platform

• US 6,966,880 B2
• Filed: 10/16/2001
• Issued: 11/22/2005
• Est. Priority Date: 10/16/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M., Greenstein, Michael, Pittaro, Rick, Higgins, Michael C.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): FOREMAN, JONATHAN M
• Application Number:
  US09/981,483
• Publication Number:
  US 20030073931A1
• Time in Patent Office: 1,498 Days
• Field of Search: 600/573, 600/583, 600/584, 600/300, 128/903, 128/904, 120/920
• US Class Current: 600/583
• 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 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: H04L 67/025 for remote control or remote monitoring of applications
• CPC Class Codes: H04L 67/1097 for distributed storage of data in networks, e.g. transport arrangements for network file system [NFS], storage area networks [SAN] or network attached storage [NAS]
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A portable medical analyzer comprising a sampling module with a sample port for receiving body fluid, an assay sensor module for analysis of the body fluid, an analytical detector module with detection of information from the assay, and a communications module for transferring the information to a remote location via a wired or wireless network.

Claims

1. A portable medical analyzer comprising:

a sampling module comprising a lancet, a driving mechanism, and a sample port, wherein said sampling port receives at least one body fluid directly from a tissue punctured with said lancet driven by said driving mechanism;

an assay sensor module housed in a cartridge, said cartridge comprising an interface with said sample port and at least one passage way to transport said body fluid to at least one assay sensor in said assay sensor module;

an analytical detector module comprising at least one analytical detector positioned to correspond to said assay sensor, said detector is adapted to detect information from said assay sensor; and

a communication module adapted to communicate with an information management system;

wherein said sampling module is housed in said cartridge; and

wherein said analytical detector module is adapted to couple with said communication module via a PCMCIA interface.

2. A portable medical analyzer comprising:

a sampling module comprising a lancet, a driving mechanism, and a sample port, wherein said sampling port receives at least one body fluid directly from a tissue punctured with said lancet driven by said driving mechanism;

an assay sensor module housed in a cartridge, said cartridge comprising an interface with said sample port and at least one passage way to transport said body fluid to at least one assay sensor in said assay sensor module;

an analytical detector module comprising at least one analytical detector positioned to correspond to said assay sensor, said detector is adapted to detect information from said assay sensor; and

a communication module adapted to communicate with an information management system;

wherein said sampling module is housed in said cartridge; and

wherein said cartridge is adapted to a digital media standard interface, said analytical detector module is adapted to couple with said cartridge via said digital media standard interface, said analytical detector module is adapted to a standard port, and said communication module is adapted to couple with said analytical detector module via said standard port.

3. A method for portable medical analysis comprising:

obtaining a body fluid from a tissue punctured with a lancet, the lancet being driven by a driving mechanism, wherein the body fluid from the tissue flows directly into a cartridge having said lancet;

housing said body fluid within the cartridge comprising an assay sensor module;

positioning said cartridge into an analytical detector module;

obtaining information from said analytical detector module;

displaying said information locally on a display within said communication module; and

transferring said information to a remote location via a communication module;

wherein positioning said cartridge further comprises breaking a pressure seal on said cartridge, said breaking adapted to transfer said body fluid to at least one assay sensor in said assay sensor module.

4. A portable medical analyzer comprising:

a sampling module comprising a lancet, a driving mechanism, and a sample port, wherein said sampling port receives at least one body fluid from a tissue punctured with said lancet driven by said driving mechanism, said sampling module is housed in said cartridge;

an assay sensor module housed in a cartridge, said cartridge comprising an interface with said sample port and at least one passage way to transport said body fluid to at least one assay sensor in said assay sensor module;

an analytical detector module comprising at least one analytical detector positioned to correspond to said assay sensor, said detector is adapted to detect information from said assay sensor, said analytical detector module is adapted to couple with a communication module via a PCMCIA interface; and

said communication module adapted to communicate with an information management system.

5. A portable medical analyzer comprising:

a sampling module comprising a lancet, a driving mechanism, and a sample port, wherein said sampling port receives at least one body fluid from a tissue punctured with said lancet driven by said driving mechanism, said sampling module is housed in a cartridge,

an assay sensor module housed in said cartridge, said cartridge comprising an interface with said sample port and at least one passage way to transport said body fluid to at least one assay sensor in said assay sensor module;

an analytical detector module comprising at least one analytical detector positioned to correspond to said assay sensor, said detector is adapted to detect information from said assay sensor; and

a communication module adapted to communicate with an information management system, wherein said cartridge is adapted to a digital media standard interface, said analytical detector module is adapted to couple with said cartridge via said digital media standard interface, said analytical detector module is adapted to a standard port, and said communication module is adapted to couple with said analytical detector module via said standard port.

6. A method for portable medical analysis comprising:

obtaining a body fluid directly from a tissue puncture created by a lancet, wherein the lancet is driven outward from a cartridge by a lancet driver and wherein the body fluid from the tissue puncture flows into the cartridge;

housing said body fluid within the cartridge, said cartridge having an assay sensor;

obtaining information regarding said body fluid in the cartridge from an analytical detector in communication with the assay sensor; and

transferring said information to a remote location via a communication module;

wherein a pressure seal on the cartridge is broken, via interface with the analytical detector, during transfer of the body fluid to the assay sensor.

7. A method as in claim 6 further comprising displaying said information locally on a display coupled to said communication module.

8. A method as in claim 6 wherein said communication module is adapted to transfer said information to a remote location.

9. A method as in claim 6 wherein said cartridge includes a plurality of assay sensors, each of said sensors performing the same analysis on the body fluid.

10. A method as in claim 6 wherein said communication module uses at least one interface chosen from radio frequency, infrared and standard ports.

11. A method as in claim 6 wherein said lancet is driven by an electromechanical lancet driver.

12. A method as in claim 6 wherein said lancet is driven by an electrical lancet driver.

13. A method as in claim 6 wherein said cartridge includes a plurality of assay sensors, each of said sensors performing a variety of different analysis on the body fluid.

14. A method as in claim 13 wherein at least one of said sensors provides analysis for one of the following:

a blood chemistry, hematology, immuno-diagnostics those for drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy, ovulation, DNA based assays, immuno assays, proteomics and genomics.

15. A method for portable medical analysis comprising:

obtaining a body fluid;

housing said body fluid within a cartridge comprising art assay sensor module;

positioning said cartridge into an analytical detector module, wherein positioning said cartridge comprises breaking a pressure seal on said cartridge, said breaking adapted to transfer said body fluid to at least one assay sensor in said assay sensor module;

obtaining information from said analytical detector module;

displaying said information locally on a display within communication module; and

transferring said information to a remote location via the communication module.

16. The method of claim 15 wherein the communication module includes a receiver adapted to communicate with a remote location.

17. The method of claim 15 wherein the communication module includes one or more of the following:

a processor, a display, a radio frequency chip, an antenna, memory containing an operating system, RAM, DRAM or a PCMIA interface.

18. The method of claim 15 wherein the positioning of the cartridge into the analytic detector module provides connection via a digital media standard interface.

19. The method of claim 15 wherein the positioning of the cartridge into the analytic detector module provides connection via a PCMCIA interface.

20. The method of claim 15 wherein the cartridge is adapted to a digital media standard interface, wherein the positioning of the cartridge into the analytic detector module provides connection via a digital media standard interface, wherein the analytical detector module is adapted to a standard port, and wherein the communication module is adapted to couple with said analytical detector module via the standard port.

21. The method of claim 15 wherein the processing of information is accomplished via an information management system that includes procedures for administering the medical analysis.

22. The method of claim 15 wherein the sensor provides analysis for one of the following:

a blood chemistry, hematology, immuno-diagnostics those (or drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy, ovulation, DNA-based assays, immuno assays, proteomics or genomics.

23. The method of claim 15 wherein the sensor provides analysis for one or more of the following:

a blood chemistry, hematology, immuno-diagnostics those for drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy, ovulation, DNA-based assays, immuno assays, proteomics or genomics.

24. The method of claim 15 further comprising the step of storing the information locally in an information storage unit associated with the portable medical analyzer.

25. The method of claim 15 wherein the communication module includes a transmitter and a receiver, both in communication with an information management system, wherein the information management system is a centralized means for collecting and processing information for functions.

26. The method of claim 15 further comprising acquiring historical data locally via the communication module.

27. The method of claim 15 further comprising storing historical data locally in association with the communication module, the analytical detector module, the cartridge or the assay sensor module.

28. The method of claim 15 further comprising displaying historical data locally on the display.

29. The method of claim 15 wherein the transferring of information is accomplished via an information management system.

30. The method of claim 15 wherein the processing of information is accomplished via an information management system that includes procedures for brokering medical data.

31. The method of claim 15 wherein the processing of information is accomplished via an information management system that includes patient management procedures.

32. The method of claim 15 wherein the processing of information is accomplished via an information management system that includes procedures for administering the medical analysis.

33. The method of claim 15 wherein the communication module includes a transmitter.

34. The method of claim 33 wherein the transmitter is adapted to one or more of interface selected from the group consisting of radio frequency, infrared and standard ports.

35. The method of claim 33 wherein the transmitter is adapted to communicate with a remote database.

36. The method of claim 15 wherein the cartridge houses a sampling module.

37. The method of claim 36 wherein the positioning of the cartridge into the analytic detector module provides connection via a digital media standard interface.

38. The method of claim 36 wherein the positioning of the cartridge into the analytic detector module provides connection via a PCMCIA interface.

39. The method of claim 36 wherein the cartridge is adapted to a digital media standard interface, wherein the positioning of the cartridge into the analytic detector module provides connection via a digital media standard interface, wherein the analytical detector module is adapted to a standard port, and wherein the communication module is adapted to couple with said analytical detector module via the standard port.

40. The method of claim 15 wherein said cartridge includes a plurality of assay sensors, each of said sensors performing the same analysis on the body fluid.

41. The method of claim 40 wherein at least one of said sensors provides analysis for one of the following:

a blood chemistry, hematology, immuno-diagnostics those for drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy, ovulation, DNA based assays, immuno assays, proteomics and genomics.

42. The method of claim 15 wherein said cartridge includes a plurality of assay sensors, and two or more of the sensors perform different analyses on the body fluid.

43. The method of claim 42 wherein at least one of said sensors provides analysis for one of the following:

a blood chemistry, hematology, immuno-diagnostics those for drugs of abuse, serum cholesterol, glucose, FOBT, pregnancy, ovulation, DNA based assays, immuno assays, proteomics and genomics.