Continuous analyte monitor with multi-point self-calibration

• US 20080234562A1
• Filed: 03/19/2007
• Published: 09/25/2008
• Est. Priority Date: 03/19/2007
• Status: Abandoned Application

• Current Assignee: ArKal Medical, Inc.
• Original Assignee: ArKal Medical, Inc.
• Inventors: Jina, Arvind N.
• Application Number:
  US11/725,624
• Publication Number:
  US 20080234562A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/15061 by material engagement, e.g. welding, bonding
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• 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

Abstract

Analyte monitors and their methods of use. The analyte monitors include multiple calibration fluids which may have different known concentrations of an analyte, such as glucose. The analyte monitors may also include sensing or washing fluids. The analyte monitors are configured to be calibrated with the multiple calibration fluids to potentially provide a more accurate determination of analyte concentrations. The analyte monitors can be adapted to be self-calibrating with the multiple calibration fluids.

Claims

1. An analyte monitor, comprising:

a plurality of tissue piercing elements each having a distal opening, a proximal opening, and an interior lumen extending between the distal and proximal openings;

a sensing area in fluid communication with the proximal openings of the plurality of tissue piercing elements;

a plurality of calibration fluid reservoirs each adapted to house a calibration fluid, wherein the plurality of calibration fluid reservoirs are in fluid communication with the sensing area; and

a sensor configured to detect an analyte and provide an output indicative of the analyte concentration of a fluid in the sensing area.

2. The monitor of claim 1 wherein the plurality of calibration fluid reservoirs comprise a first calibration fluid reservoir adapted to house a first calibration fluid and a second calibration fluid reservoir adapted to house a second calibration fluid.

3. The monitor of claim 2 wherein the first calibration fluid and the second calibration fluid have different known concentrations of the analyte.

4. The monitor of claim 3 wherein the first calibration fluid has a glucose concentration between about 0 mg/dl and about 100 mg/dl and the second calibration fluid has a glucose concentration of between about 100 mg/dl and about 400 mg/dl.

5. The monitor of claim 1 further comprising an actuator configured to move the calibration fluids from the plurality of calibration fluid reservoirs into the sensing area.

6. The monitor of claim 5 wherein the actuator comprises at least one pump.

7. The monitor of claim 6 further comprising a plurality of valves configured to facilitate the movement of the calibration fluids unidirectionally from the plurality of calibration fluid reservoirs into the sensing area.

8. The monitor of claim 5 wherein the actuator is configured to be manually actuated.

9. The monitor of claim 5 wherein the actuator is configured to be automatically actuated.

10. The monitor of claim 9 wherein the monitor further comprises a programmable component in communication with the actuator wherein the programmable component is programmed to automatically actuate the actuator.

11. The monitor of claim 10 wherein the monitor further comprises a remote device and wherein the programmable component is disposed in a housing with the sensor, wherein the programmable component in configured to be wirelessly programmed using the remote device.

12. The monitor of claim 10 wherein the monitor further comprises a remote device and wherein the programmable component is disposed in the remote device, the programmable component is configured to be programmed using the remote device, and wherein the programmable component is configured to be in wireless communication with the actuator to automatically actuate the actuator.

13. The monitor of claim 5 wherein the actuator is configured to move a first calibration fluid with a first known analyte concentration from a first calibration fluid reservoir into the sensing area and then move a second calibration fluid with a second known analyte concentration from a second calibration fluid reservoir into the sensing area, thereby displacing the first calibration fluid from the sensing area.

14. The monitor of claim 13 wherein the sensor is configured to detect the analyte in the first and second calibration fluids when in the sensing area, the monitor further comprising a memory to store sensor calibration data, the sensor calibration data comprising the first and second known analyte concentrations and a first output and a second output from the sensor indicative of the first and second known analyte concentrations.

15. The monitor of claim 14 wherein the monitor further comprises a remote device, the memory disposed in the remote device.

16. The monitor of claim 15 further comprising a transmitter configured to transmit an output from the sensor indicative of the analyte that has diffused from the patient'"'"'s interstitial fluid into the sensing area to a receiver disposed in the remote device, the remote device further comprising a processor adapted to determine an analyte concentration based on the output from the sensor and the sensor calibration stored in the memory.

17. The monitor of claim 16, wherein the transmitter is either fabricated without a power source or the transmitter comprises a rechargeable power source.

18. The monitor of claim 16 further comprising a display adapted to display the analyte concentration determined by the processor.

19. The monitor of claim 18 wherein the display is disposed in the remote device.

20. The monitor of claim 18 wherein the analyte concentration is the patient'"'"'s blood glucose concentration.

21. The monitor of claim 1 further comprising at least one waste reservoir in fluid communication with the sensing area adapted to receive fluid moved from the sensing area.

22. The monitor of claim 1 further comprising a housing comprising a disposable portion and reusable portion, the disposable portion being adapted to support the plurality of tissue piercing elements, the plurality of calibration fluid reservoirs, the sensing area, and at least part of the analyte sensor, the reusable portion comprising an electrical connection to the at least part of the analyte sensor in the disposable portion, the housing further comprising a connector adapted to connect and disconnect the disposable portion from the reusable portion.

23. The monitor of claim 1 further comprising a sensing fluid reservoir in fluid communication with the sensing area, wherein the sensing fluid reservoir is adapted to house a sensing fluid which does not comprise the analyte.

24. The monitor of claim 23 wherein the sensing fluid comprises at least one of the group consisting of de-ionized water, buffer, and preservative.

25. The monitor of claim 23 further comprising an actuator configured to move fluid from the plurality of calibration reservoirs and the sensing reservoir into the sensing area.

26. The monitor of claim 25 wherein the actuator comprises at least one pump.

27. The monitor of claim 25 wherein the actuator is configured to be manually actuated.

28. The monitor of claim 25 wherein the actuator is configured to be automatically actuated.

29. The monitor of claim 28 wherein the actuator is further configured to automatically first move a first calibration fluid from a first calibration reservoir into the sensing area and then automatically move a second calibration fluid from a second calibration reservoir into the sensing area, thereby displacing the first calibration fluid from the sensing area, and then automatically move sensing fluid from the sensing fluid reservoir into the sensing area, thereby displacing the second calibration fluid from the sensing area.

30. The monitor of claim 29 wherein the sensor is configured to detect the analyte in the first and second calibration fluids when in the sensing area, the monitor further comprising a memory to store a sensor calibration, the sensor calibration comprising the first and second known analyte concentrations and a first output and a second output from the sensor indicative of the first and second known analyte concentrations.

31. The monitor of claim 1 further comprising

a transmitter adapted to transmit the output indicative of the analyte concentration of the fluid in the sensing area to a remote device;

at least one power source, a reusable portion comprising the transmitter;

a disposable portion comprising the at least one power source, wherein the at least one power source is adapted to be disposable and wherein the transmitter is adapted to be reusable.

32. The monitor of claim 1 wherein the analyte is glucose.

33. A method of monitoring a concentration of an analyte in a patient'"'"'s interstitial fluid in vivo, the method comprising:

calibrating an analyte monitor, the analyte monitor comprising;

a plurality of tissue piercing elements each having a distal opening, a proximal opening, and an interior lumen extending between the distal and proximal openings;

a sensing area in fluid communication with the proximal openings of the plurality of tissue piercing elements;

a plurality of calibration fluid reservoirs each adapted to house a calibration fluid, wherein the plurality of calibration fluid reservoirs are in fluid communication with the sensing area;

a sensor configured to detect the analyte and provide an output indicative of the analyte concentration of a fluid in the sensing area;

at least one waste reservoir in fluid communication with the sensing area configured to receive fluid from the sensing area; and

a memory in communication with the sensor;

wherein calibrating the analyte monitor comprises;

moving a first calibration fluid with a first known analyte concentration from a first calibration reservoir into the sensing area;

sensing an analyte concentration in the first calibration fluid while in the sensing area with the analyte sensor, the sensor providing a first output indicative of the analyte concentration of the first calibrating fluid;

moving a second calibration fluid with a second known analyte concentration from a second calibration reservoir into the sensing area thereby displacing the first calibration fluid with the second calibration fluid into the at least one waste reservoir;

sensing an analyte concentration in the second calibration fluid while in the sensing area with the analyte sensor, the sensor providing a second output indicative of the analyte concentration of the second calibrating fluid; and

storing a sensor calibration in the memory, the sensor calibration comprising an association between the first and second known analyte concentrations and the first and second outputs indicative of the first and second known analyte concentrations.

34. The method of claim 33 wherein the second calibration fluid is a sensing fluid that does not comprise the analyte, and wherein moving the sensing fluid into the sensing area comprises washing the sensing area with the sensing fluid.

35. The method of claim 34 wherein the sensing fluid comprises at least one of the group consisting of de-ionized water, buffer, and preservative.

36. The method of claim 33 further comprising piercing only as deep as into the epidermis layer of a patient or user'"'"'s skin with the plurality of tissue piercing elements.

37. The method of claim 36 wherein piercing only as deep as into the epidermis layer of the patient or user'"'"'s skin with the plurality of tissue piercing elements allows diffusion of the analyte from the patient'"'"'s interstitial fluid through the plurality of tissue piercing elements and into the sensing area substantially without extracting interstitial fluid through the plurality of tissue piercing elements.

38. The method of claim 37 further comprising sensing the analyte concentration of the diffused analyte using the sensor and determining the patient'"'"'s analyte concentration using the sensor calibration stored in the memory.

39. The method of claim 38 wherein the monitor further comprises a remote device, and wherein the memory is disposed in a remote device, the method further comprising wirelessly transmitting the outputs from the sensor to the remote device before determining the patient'"'"'s analyte concentration.

40. The method of claim 38 wherein the method further comprises displaying the determined analyte concentration.

41. The method of claim 40 wherein displaying the determined analyte concentration comprises displaying the determined analyte concentration using a remote device.

42. The method of claim 38 further comprising moving a sensing fluid which does not comprise the analyte from a sensing fluid reservoir into the sensing area thereby displacing the second calibration fluid with the sensing fluid into the at least one waste reservoir, wherein moving the sensing fluid occurs before the piercing step.

43. The method of claim 38 further comprising recalibrating the sensor after determining the patient or user'"'"'s analyte determination.

44. The method of claim 33 wherein moving the first and second calibration fluids comprises actuating an actuator.

45. The method of claim 44 wherein actuating the actuator comprising automatically actuating the actuator.

46. The method of claim 45 further comprising programming the monitor to automatically actuate the actuator.

47. The method of claim 46 wherein the monitor comprises a remote device and programming the monitor to automatically actuate the actuator comprises programming the monitor using the remote device.

48. The method of claim 44 further comprising recalibrating the sensor, wherein recalibrating comprises actuating the actuator.

49. The method of claim 44 wherein actuating the actuator comprises manually actuating the actuator.

50. The method of claim 33 wherein the analyte is glucose.