Compact On-Body Physiological Monitoring Devices and Methods Thereof

• US 20100198034A1
• Filed: 02/01/2010
• Published: 08/05/2010
• Est. Priority Date: 02/03/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, He, Lei, Fennell, Martin J., Yee, Phillip, Thomas, Christopher Allen, Love, Michael
• Application Number:
  US12/698,124
• Publication Number:
  US 20100198034A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2560/0487 Special user inputs or interfaces
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3286 : Needle tip design, e.g. for improved penetration
• CPC Class Codes: C12Q 1/001 : Enzyme electrodes
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G06K 7/10366 : the interrogation device being adapted for miscellaneous applications
• 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

Abstract

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned analyte sensor automatically or on demand upon request from a user.

Claims

1. An integrated analyte monitoring device assembly, comprising:

an analyte sensor for transcutaneous positioning through a skin layer and maintained in fluid contact with an interstitial fluid under the skin layer during a predetermined time period, the analyte sensor having a proximal portion and a distal portion; and

sensor electronics coupled to the analyte sensor, the sensor electronics comprising;

a circuit board having a conductive layer and a sensor antenna disposed on the conductive layer;

one or more electrical contacts provided on the circuit board and coupled with the proximal portion of the analyte sensor to maintain continuous electrical communication; and

a data processing component provided on the circuit board and in signal communication with the analyte sensor, the data processing component configured to execute one or more routines for processing signals received from the analyte sensor, the data processing component configured to control the transmission of data associated with the processed signals received from the analyte sensor to a remote location using the sensor antenna in response to a request signal received from the remote location.

2. The assembly of claim 1 wherein the proximal portion of the analyte sensor and the circuit board are encapsulated.

3. The assembly of claim 2 wherein the proximal portion of the analyte sensor and the circuit board are encapsulated with a potting material.

4. The assembly of claim 1 wherein the circuit board includes an upper layer and a lower layer, where the conductive layer is disposed between the upper layer and the lower layer.

5. The assembly of claim 1 wherein the antenna includes a loop antenna or a dipole antenna.

6. The assembly of claim 1 wherein the antenna is printed on the conductive layer.

7. The assembly of claim 1 further including a plurality of inductive components coupled to the sensor antenna on the conductive layer of the circuit board.

8. The assembly of claim 7 wherein the plurality of inductive components are coupled in series to the sensor antenna.

9. The assembly of claim 7 wherein the plurality of inductive components are positioned substantially around an outer edge of the circuit board.

10. The assembly of claim 9 wherein the circuit board is substantially circular, and the plurality of components are positioned around the outer circumference of the circular circuit board.

11. The assembly of claim 7 wherein each of the plurality of the inductive components are positioned substantially equidistant to each other on the circuit board.

12. The assembly of claim 1 including a power supply to provide power to the sensor electronics.

13. The assembly of claim 1 wherein the data processing component includes an application specific integrated circuit (ASIC) disposed on the circuit board and configured to process signals from the analyte sensor.

14. The assembly of claim 1 wherein the data processing component includes a state machine.

15. The assembly of claim 14 wherein the state machine is configured to execute one or more programmed or programmable logic for processing the signals received from the analyte sensor.

16. The assembly of claim 1 wherein the analyte sensor includes a glucose sensor.

17. An analyte data acquisition device, comprising:

a control unit configured to generate a control command based on a carrier signal;

an antenna section coupled to the control unit to transmit the control command with the carrier signal and to receive a backscatter response data packet using the carrier signal; and

a receiver section coupled to the antenna section and the control unit to process the received backscatter response data packet and to generate an output glucose data.

18. The device of claim 17 wherein the control unit includes a signal resonator coupled to an oscillator, and configured to generate RF power.

19. The device of claim 18 wherein the signal resonator includes a surface acoustic wave resonator.

20. The device of claim 18 wherein the generated RF power and the control command are transmitted with the carrier signal.

21. The device of claim 17 wherein the control command includes an RF control command transmitted with the carrier signal to a remote location.

22. The device of claim 21 wherein the backscatter response data packet is received from the remote location when the antenna is positioned no more than approximately ten inches from the remote location.

23. The device of claim 22 wherein the antenna is positioned about five inches or less from the remote location.

24. The device of claim 17 wherein the antenna section includes one or more of a loop antenna, or a dipole antenna.

25. The device of claim 17 wherein the control unit is configured to generate the carrier signal.

26. The device of claim 17 wherein the receiver section includes a filter to filter the received backscatter response data packet.

27. The device of claim 17 including an output unit operatively coupled to the control unit to output an indication corresponding to the generated glucose data.

28. The device of claim 27 wherein the outputted indication includes one or more of a visual output, an audible output, a vibratory output, or one or more combinations thereof.

29. The device of claim 17 wherein the control unit generates a receipt confirmation signal upon successful receipt of the backscatter response data packet.

30. The device of claim 29 wherein the generated receipt confirmation signal is output to the user.

31. The device of claim 17 further including a storage device coupled to the control unit to store the generated control command, carrier signal, the received backscatter response data packet, the generated output glucose data, or one or more combinations thereof.

32. The device of claim 31 wherein the storage device includes a nonvolatile memory device.

33. The device of claim 17 wherein the control unit includes a microprocessor.

34. The device of claim 17 wherein the control unit includes an application specific integrated circuit.

35. The device of claim 17 further including a strip port for receiving an in vitro blood glucose test strip, the strip port including an electrical connection in signal communication with the control unit.

36. The device of claim 35 wherein the control unit is configured to process a sample on the test strip to determine a corresponding blood glucose level.

37. An integrated analyte monitoring device, comprising:

a sensor electronics assembly including;

an analyte sensor;

a power supply;

an activation switch operatively coupled to the power supply and the analyte sensor;

a controller unit in electrical contact with the analyte sensor and the activation switch having one or more programming instructions stored therein for execution, the controller unit configured to process one or more signals received from the analyte sensor when the activation switch is triggered; and

an insertion device including;

a housing;

an introducer coupled to the housing configured to move between a first position and a second position; and

a bias mechanism operatively coupled to the housing configured to automatically retract the introducer from the second position to the first position.

38. The device of claim 37 wherein the sensor electronics assembly is retained entirely within the housing of the insertion device prior to the introducer movement from the first position to the second position.

39. The device of claim 37 wherein the activation switch is not triggered until the introducer has reached the second position.

40. The device of claim 37 wherein the analyte sensor includes a glucose sensor.

41. The device of claim 37 wherein the activation switch is triggered after the introducer has reached the second position, and prior to the introducer refraction from the second position to the first position.

42. The device of claim 37 wherein the introducer engages with the analyte sensor during its movement from the first position to the second position, and further, wherein the introducer disengages from the analyte sensor during its movement from the second position to the first position.

43. The device of claim 37 wherein the movement of the introducer from the first position to the second position is in response to a manual force applied on the housing.

44. The device of claim 37 wherein the bias mechanism includes a spring.

45. The device of claim 37 including an adhesive layer provided on a bottom surface of the housing for placement on a skin layer.

46. The device of claim 45 wherein the adhesive layer is configured to retain the sensor electronics assembly on the skin layer for a predetermined time period.

47. The device of claim 37 wherein the power supply includes a single use disposable battery.

48. The device of claim 37 wherein the active operational life of the power supply exceeds the active operational life of the analyte sensor.

49. The device of claim 37 including a cap configured to mate with an open end of the housing of the insertion device.

50. The device of claim 49 wherein when the cap is coupled to the housing, the interior space of the housing is maintained in a substantially contaminant free environment.

51. The device of claim 37 wherein the sensor electronics assembly includes a printed circuit board including a portion of the analyte sensor permanently connected thereto.

52. The device of claim 37 wherein the controller unit includes an application specific integrated circuit (ASIC).

53. The device of claim 37 wherein the movement of the introducer between the first position and the second position is at an angle at approximately 90 degrees or less from a skin surface.

54. The device of claim 37 wherein the sensor electronics assembly includes a housing having a height of less than approximately 4 mm.