Method and apparatus for providing analyte sensor and data processing device

• US 9,398,882 B2
• Filed: 09/10/2006
• Issued: 07/26/2016
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/530,473
• Publication Number:
  US 20080009692A1
• Time in Patent Office: 3,607 Days
• Field of Search: 600345-366, 600/309
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

Method and apparatus for integrated sensor and data processing assembly is provided.

Claims

1. An apparatus comprising:

a base layer;

a data processing unit disposed on an upper surface of the base layer;

an analyte sensor coupled to the base layer and in electrical communication with the data processing unit, the analyte sensor including a plurality of electrical contacts provided on a planar portion of the sensor, the plurality of electrical contacts coupled to the data processing unit for the electrical communication; and

a sensor introducer assembly disposed on the upper surface of the base layer, a needle of the sensor introducer assembly operatively coupled to an insertion portion of the analyte sensor to transcutaneously position the insertion portion of the analyte sensor under a skin layer and in contact with fluid at a sensor insertion site, the sensor introducer assembly including a spring biased mechanism configured to retract the portion of the sensor introducer assembly operatively coupled to the insertion portion of the analyte sensor upon transcutaneous positioning of the insertion portion of the analyte sensor,

wherein the base layer including the data processing unit has an opening to pass therethrough the needle and the insertion portion of the analyte sensor during transcutaneous positioning of the insertion portion of the analyte sensor, and to retract therethrough and retain on the base layer the needle of the sensor introducer assembly by the spring biased mechanism upon the transcutaneous positioning of the insertion portion of the analyte sensor.

2. The apparatus of claim 1, wherein the base layer includes one or more of a polymer film, a woven layer, a knit layer, or a laminated layer.

3. The apparatus of claim 1, further including an adhesive layer disposed on a bottom surface of the base layer.

4. The apparatus of claim 3, wherein the adhesive layer is configured to substantially and securely retain the base layer adhered to the skin layer for a predetermined time period.

5. The apparatus of claim 4, wherein the predetermined time period includes one or more of a useful life of the analyte sensor or a useful life of the data processing unit.

6. The apparatus of claim 1, wherein the insertion portion of the analyte sensor is configured to be transcutaneously positioned by the sensor introducer assembly when the base layer is placed on the skin layer.

7. The apparatus of claim 1, wherein the data processing unit is configured to receive one or more signals associated with a corresponding one or more analyte levels of a patient from the analyte sensor.

8. The apparatus of claim 7, wherein the data processing unit further includes a data transmission unit configured to wirelessly transmit one or more data associated with the received one or more signals.

9. The apparatus of claim 1, wherein the analyte sensor is a glucose sensor.

10. The apparatus of claim 1, wherein the planar portion of the sensor is disposed substantially in parallel to and on the upper surface of the base layer, and the insertion portion of the analyte sensor is maintained at a predetermined angle relative to the planar portion of the sensor when the insertion portion is in fluid contact.

11. The apparatus of claim 10, wherein the predetermined angle is approximately 90 degrees.

12. The apparatus of claim 1, wherein the base layer is flexible.

13. The apparatus of claim 1, wherein the data processing unit is laminated to the upper surface of the base layer.

14. The apparatus of claim 1, wherein the spring biased mechanism is dome shaped.

15. The apparatus of claim 1, wherein the needle is retained on the base layer after retraction during substantially the entire time that a patient is wearing the analyte sensor.

16. The apparatus of claim 1, wherein the sensor introducer assembly is further configured to substantially seal the area around the sensor insertion site.

17. The apparatus of claim 1, wherein the analyte sensor further includes an intermediate portion extending between the planar portion and the insertion portion, the intermediate portion including a substantially straight central segment, a first end angularly coupled to the insertion portion and a second end angularly coupled to the planar portion, and wherein the intermediate portion of the sensor is positioned at an angle relative to the base layer and, upon transcutaneous positioning of the insertion portion, is positioned substantially parallel to the base layer.

18. An apparatus comprising:

a base layer;

a data processing unit disposed on an upper surface of the base layer;

a sensor in electrical communication with the data processing unit, the sensor including an insertion portion configured for transcutaneous positioning, a planar portion, an intermediate portion extending between the insertion portion and the planar portion, and the sensor further including a plurality of electrical contacts provided on the planar portion and coupled to the data processing unit for the electrical communication; and

a sensor introducer assembly mounted on the upper surface of the base layer, a needle of the sensor introducer assembly configured to transcutaneously position an insertion portion of the sensor at a sensor insertion site and in fluid contact with a biological fluid under a skin surface, the sensor introducer assembly including a portion for engaging the intermediate portion of the sensor upon manual activation of the sensor introducer assembly,

wherein the base layer including the data processing unit has an opening to pass therethrough the needle and the insertion portion of the sensor during transcutaneous positioning of the insertion portion of the sensor, and to retract therethrough and retain on the base layer the needle of the sensor introducer assembly by a refraction mechanism upon the transcutaneous positioning of the insertion portion of the sensor.

19. The apparatus of claim 18, wherein the base layer includes one or more of a flexible polymer film, a woven layer, a knit layer, or a laminated layer.

20. The apparatus of claim 18, further including an adhesive layer disposed on a bottom surface of the base layer.

21. The apparatus of claim 20, wherein the adhesive layer is configured to removably retain the base layer adhered to the skin surface for a predetermined time period.

22. The apparatus of claim 21, wherein the predetermined time period includes one or more of a useful life of the sensor or a useful life of the data processing unit.

23. The apparatus of claim 18, wherein the insertion portion of the sensor is in fluid contact with the biological fluid under the skin surface when the base layer is placed on the skin surface.

24. The apparatus of claim 23, wherein the data processing unit is configured to receive one or more signals from the sensor.

25. The apparatus of claim 24, wherein the data processing unit further includes a data transmission unit configured to wirelessly transmit one or more data associated with the received one or more signals.

26. The apparatus of claim 18, wherein the sensor is a glucose sensor.

27. The apparatus of claim 18, wherein the planar portion is disposed substantially in parallel to and on the upper surface of the base layer, and the insertion portion of the sensor is maintained at a predetermined angle relative to the planar portion of the sensor when the insertion portion is in fluid contact with the biological fluid.

28. The apparatus of claim 27, wherein the predetermined angle is approximately 90 degrees.

29. The apparatus of claim 18, wherein the base layer is flexible.

30. The apparatus of claim 18, wherein the data processing unit is laminated to the upper surface of the base layer.

31. The apparatus of claim 18, wherein the portion of the sensor introducer assembly configured for engaging the intermediate portion of the sensor comprises a ledge segment extending from the portion configured to transcutaneously position the insertion portion of the sensor.

32. The apparatus of claim 31, wherein the intermediate portion of the sensor extends substantially laterally from the insertion portion of the sensor.

33. The apparatus of claim 18, wherein the sensor introducer assembly is further configured to substantially seal the area around the sensor insertion site.

34. The apparatus of claim 18, wherein the intermediate portion of the sensor includes a substantially straight central segment, a first end angularly coupled to the insertion portion, and a second end angularly coupled to the planar portion, and is positioned at an angle relative to the base layer and, upon transcutaneous positioning of the insertion portion, is positioned substantially parallel to the base layer.