Wearable, programmable automated blood testing system

• US 20070123801A1
• Filed: 11/28/2005
• Published: 05/31/2007
• Est. Priority Date: 11/28/2005
• Status: Abandoned Application

• Current Assignee: IntelliDx, Inc.
• Original Assignee: IntelliDx, Inc.
• Inventors: Siebrecht, Wayne, Nagar, Ron, Shreve, Eric, Larson, Robert, Bitton, Gabby, Pesach, Gidi, Argaman, Dalia, Bellomo, Stephen, Goldberger, Daniel, Pesach, Benny
• Application Number:
  US11/287,897
• Publication Number:
  US 20070123801A1
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150412 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: G01N 33/80 involving blood groups or blood types or red blood cells white blood cells G01N33/56972

Abstract

The present invention is a programmable, automated device for the measurement and analysis of blood analytes and blood parameters. The device components are combined in a single apparatus and either programmed to initiate automatic, periodic blood sampling or initiate automatic blood sampling via operator input. The device operates automatically to draw blood samples at suitable, programmable frequencies to analyze the drawn blood samples and obtain the desired blood readings.

Claims

1. An automated blood testing device comprising:

a sampling and measurement unit for obtaining a blood sample and measuring blood analytes and blood parameters in said sample, wherein the sampling and measurement unit further comprises a lancet, a lancet launching mechanism, and a blood analyte measuring element; and

a control unit for controlling the periodic sampling of blood and measurement of blood analytes and blood parameters, wherein the control unit is programmable to initiate blood sampling for measurement of blood analytes at pre-determined time intervals wherein said control unit and sampling and measurement unit are positioned in a wearable cuff.

2. The automated device of claim 1 wherein the control unit is a microprocessor or state machine.

3. The automated device of claim 1 wherein the device is capable of being worn on a patient'"'"'s arm.

4. The automated device of claim 3 wherein the wearable device further comprises an inflatable cuff.

5. The automated device of claim 4 wherein the inflatable cuff is used for obtaining a blood sample via applying pressure.

6. The automated device of claim 4 wherein the inflatable cuff is used for non-invasive measurement of blood pressure.

7. The automated device of claim 4 wherein the inflatable cuff is used for measurement of blood pressure via a capillary parameter.

8. The automated device of claim 1 wherein the lancet withdraws blood from the same point for each sample.

9. The automated device of claim 1 wherein the lancet withdraws blood from a different point for each sample.

10. The automated device of claim 1 wherein the lancet is a single-use lancet.

11. The automated device of claim 1 wherein blood contacting elements are disposable.

12. The automated device of claim 11 wherein blood contacting elements are contained in a disposable cartridge or cassette.

13. The automated device of claim 1 wherein the sampling and measurement unit further comprises at least one measurement element for measuring at least one blood parameter.

14. The automated device of claim 13 wherein the measurement element is a glucose oxidase test strip.

15. The automated device of claim 13 wherein the measurement element is a sensor.

16. The automated device of claim 15 wherein the sensor is contained in a sensor cassette.

17. The automated device of claim 16 wherein the sensor cassette is disposable.

18. The automated device of claim 17 wherein the cassette is coded or keyed to insure proper operation.

19. The automated device of claim 17 wherein the sensor cassette comprises at least one pre-calibrated single use sensor.

20. The automated device of claim 17 wherein the sensor cassette comprises a plurality of sensors arranged in a multiple layer tape structure.

21. The automated device of claim 19 wherein each single-use sensor is advanced sequentially and positioned for direct contact with a blood sample through an advancement means.

22. The automated device of claim 17 wherein the sensor cassette includes a plurality of sensor cassettes, each comprising a different type of sensor.

23. The automated device of claim 15 wherein the sensor is an electrochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood sample via electrochemical oxidation and reduction reactions at the sensor.

24. The automated device of claim 15 wherein the sensor is an optochemical sensor capable of detecting the presence of and enabling the measurement of the level of an analyte in a blood or plasma.

25. The automated device of claim 15 wherein the sensor determines the oxygenation level of the blood and uses the oxygenation level to calibrate the glucose calculation.

26. The automated device of claim 15 wherein the sensor determines the hemoglobin concentration and/or hematocrit of the blood and calibrates the glucose calculation.

27. A method for automatically measuring blood analytes and blood parameters, the method comprising:

programming a control unit to obtain a blood sample from a blood sampling and measurement unit at predetermined time intervals wherein said control unit and blood sampling and measurement unit are positioned in a wearable cuff;

initiating a blood sample from the blood sampling and measurement unit at said predetermined time interval;

launching a lancet via an automated launching mechanism located in said blood sampling and measurement unit when said blood sample is initiated;

allowing said lancet to pierce the skin;

retracting said lancet after said blood sample is obtained; and

measuring analytes and parameters of said blood sample using an analyte measuring element in said blood sampling and measurement unit.