WEARABLE, PROGRAMMABLE AUTOMATED BLOOD TESTING SYSTEM

• US 20080200838A1
• Filed: 09/01/2006
• Published: 08/21/2008
• 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, Klomhaus, Jill, Bitton, Gabby, Pesach, Gidi, Argaman, Dalia, Bellomo, Stephen, Goldberger, Daniel, Johnson, Larry, Pesach, Benny
• Application Number:
  US11/469,586
• Publication Number:
  US 20080200838A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• 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 5/150412 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• 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 5/15087 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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

Abstract

The present invention is a programmable, automated device for measurement and analysis of blood analytes and blood parameters. The device components are preferably combined in a single housing and either programmed to initiate automatic, periodic blood sampling or initiate automatic blood sampling via operator input or in response to a predefined event or in response to a signal from another instrument. The device operates automatically to draw blood samples and analyze the drawn blood samples to 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 in said sample, wherein the sampling and measurement unit further comprises a plurality of lancet and blood analyte measuring element pairs; and

a control unit for controlling the periodic sampling of blood and measurement of blood analytes.

2. The automated blood testing device of claim 1 wherein the control unit is programmable to initiate blood sampling for measurement of blood analytes at pre-determined time intervals.

3. The automated blood testing device of claim 1 wherein the control unit is programmable to initiate blood sampling for measurement of blood analytes based upon a pre-defined event.

4. The automated device of claim 1 wherein the lancet in each pair withdraws blood from a different location for each sample.

5. The automated device of claim 1 wherein the lancet vibrates to withdraw a blood sample.

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

7. The automated device of claim 1 wherein lancet is disposable.

8. The automated device of claim 1 wherein lancet is contained in a disposable cartridge or cassette.

9. The automated device of claim 1 wherein the blood analyte measurement element is a glucose oxidase test strip.

10. The automated device of claim 1 wherein the lancet and blood analyte measurement element in each pair is arranged in a “

V”

configuration.

11. The automated device of claim 1 wherein each lancet is coated with an anticoagulant.

12. The automated device of claim 1 wherein each lancet is coated with an anesthetic.

13. The automated device of claim 1 wherein each lancet is provided with a flexible cover that deforms to expose the lancet tip when the lancet is actuated for sampling.

14. The automated device of claim 1 wherein the device is wearable.

15. The automated device of claim 1 wherein the device further comprises an inflatable cuff.

16. The automated device of claim 15 wherein the inflatable cuff is used for obtaining a blood sample via applying pressure.

17. The automated device of claim 15 wherein the inflatable cuff comprises a plurality of cavities, wherein each cavity can be individually inflated.

18. The automated device of claim 15 wherein the inflatable cuff is used for non-invasive measurement of blood pressure.

19. The automated device of claim 15 wherein the inflatable cuff comprises a warming pad.

20. An automated device for obtaining a blood sample and measuring blood analytes and blood parameters in said sample, comprising:

a plurality of lancets in physical proximity for drawing a blood sample;

a plurality of blood analyte measuring elements, each in physical proximity to at least one of said lancets; and

at least one processor for calculating numerical value of the blood analyte measured by said blood analyte measuring element.

21. The automated device of claim 20 wherein the lancet, the blood analyte measuring element and the processor are integrated into a single unit.

22. The automated device of claim 21 wherein said unit is replaceable.

23. The automated device of claim 22 wherein said unit is disposable.

24. The automated device of claim 21 wherein said unit is capable of being connected to a physiological parameter monitoring device.

25. The automated device of claim 20 wherein said plurality of lancets and said plurality of blood analyte measuring elements are contained in a cassette and wherein said processor is contained a housing capable of detachably receiving said cassette.

26. The automated device of claim 25 wherein said cassette is replaceable.

27. The automated device of claim 26 wherein said cassette is disposable.

28. The automated device of claim 25 wherein said cassette is assigned a unique code.

29. The automated device of claim 28 wherein said unique code is stored either in mechanical or electrical form.

30. The automated device of claim 28 wherein said unique code is used by the device to determine if the cassette is authentic.

31. The automated device of claim 25 wherein said cassette comprises calibration information.

32. The automated device of claim 31 wherein said calibration information is communicated to the device to enable the at least one processor to accurately calculate the numerical value of the blood analyte measured by said blood analyte measuring element.