Flexible sensor apparatus

• US 9,072,476 B2
• Filed: 09/23/2005
• Issued: 07/07/2015
• Est. Priority Date: 09/23/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Gottlieb, Rebecca K., Larson, Eric A.
• Primary Examiner(s): D'Angelo, Michael
• Assistant Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US11/234,722
• Publication Number:
  US 20070073129A1
• Time in Patent Office: 3,574 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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

Abstract

A flexible mounting base to hold a sensor at an infusion site, the sensor being a removable in vivo sensor for monitoring analyte concentration level in a patient, such as blood glucose (BG) level. The mounting base comprises a flexible adhesive that anchors the flexible sensor set at an infusion site to provide stability for the sensor set in a convenient and comfortable manner. Placement of the mounting base onto the patient'"'"'s skin causes the insertion needle to pierce the skin for transcutaneous placement of the cannula with the sensor therein. The insertion needle can then be withdrawn to leave the cannula and sensor at the selected insertion position, with the distal segment of the sensor being exposed to patient extracellular fluid via apertures formed in the cannula.

Claims

1. A sensor apparatus comprising:

a flexible analyte sensor; and

a flexible mounting base to carry the flexible analyte sensor including;

a flexible adhesive layer to removably attach to a skin surface;

a housing disposed on the adhesive layer to receive the flexible analyte sensor, said housing including a base layer and a plurality of sidewalls depending from said base layer; and

a one-piece outer flexible layer that is entirely separate from the housing and from the flexible adhesive layer, wherein, once assembled, the flexible adhesive layer and the outer flexible layer enclose therebetween the entirety of the housing, including said plurality of sidewalls.

2. The sensor apparatus of claim 1, wherein the adhesive layer includes an opening for needle entry.

3. The sensor apparatus of claim 1, wherein the housing includes:

a depression in said base layer adapted to receive the flexible analyte sensor; and

a first opening in the base layer for needle entry.

4. The sensor apparatus of claim 3, wherein the housing further includes a second opening in the base layer to provide a path for a cable coupling the flexible analyte sensor to an external device.

5. The sensor apparatus of claim 4, wherein the first opening is located in one end of the base layer and the second opening is located on an opposing end of the base layer.

6. The sensor apparatus of claim 1, wherein the housing is flexible.

7. The sensor apparatus of claim 1, wherein the housing is semi-rigid.

8. The sensor apparatus of claim 1, wherein the housing comprises medical grade nylon.

9. The sensor apparatus of claim 1, wherein the flexible mounting base further includes a sealing layer disposed between the housing and the outer flexible layer.

10. The sensor apparatus of claim 9, wherein the sealing layer includes an area for needle entry.

11. The sensor apparatus of claim 10, wherein the sealing layer includes an opening to provide a path for a cable coupling the flexible analyte sensor to an external device.

12. The sensor apparatus of claim 11, wherein the area for needle entry is located in one end of the sealing layer and the opening is located on an opposing end of the sealing layer.

13. The sensor apparatus of claim 1, wherein the sealing layer comprises silicone.

14. The sensor apparatus of claim 1, wherein the sealing layer comprises a material selected from the group consisting of silicone, rubber latex, neoprene, nitrile, butyl, and vitron.

15. The sensor apparatus of claim 1, wherein the outer flexible layer includes an area for needle entry.

16. The sensor apparatus of claim 15, wherein the outer flexible layer further includes an opening to provide a path for a cable coupling the flexible analyte sensor to an external device.

17. The sensor apparatus of claim 16, wherein the area for needle entry is located in one end of the outer flexible layer and the opening is located on an opposing end of the outer flexible layer.

18. The sensor apparatus of claim 1, wherein the outer flexible layer includes a needle guide for needle entry.

19. The sensor apparatus of claim 1, wherein the outer flexible layer comprises cloth.

20. The sensor apparatus of claim 1, wherein the outer flexible layer comprises a material selected from the group consisting of polyurethane, polyethylene, polyester, polypropylene, and PTFE.

21. The sensor apparatus of claim 1, wherein the flexible analyte sensor is a thin film sensor.

22. The sensor apparatus of claim 1, wherein the flexible analyte sensor is an electrochemical sensor.

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

24. The sensor apparatus of claim 1, wherein the flexible analyte sensor includes a proximal segment carried by the flexible mounting base, and a distal segment protruding from the flexible mounting base.

25. The sensor apparatus of claim 24, wherein the sensor proximal segment is connected to an external device through wired communication.

26. The sensor apparatus of claim 24, wherein the sensor proximal segment is connected to an external device through wireless communication.

27. The sensor apparatus of claim 26, wherein the wireless communication is selected from the group consisting of radio frequency and infrared.

28. The sensor apparatus of claim 24 further including a cannula protruding from the flexible mounting base, wherein at least a portion of the flexible analyte sensor is within the cannula.

29. The sensor apparatus of claim 28 further including a hollow insertion needle carried by the flexible mounting base to protrude therefrom and having at least a portion of the cannula nested therein, the insertion needle defining a longitudinally extending slot along one side thereof to permit sliding withdrawal of the needle from the flexible mounting base and the nested portion of the cannula.

30. The sensor apparatus of claim 29, wherein the insertion needle extends through the flexible mounting base, the insertion needle being manually withdrawable from the flexible mounting base for separation from the nested portion of the cannula.

31. The sensor apparatus of claim 29, wherein the needle further comprises a handle covering one end of the needle with a guide shaft contained therein.

32. The sensor apparatus of claim 31, wherein the handle further includes a lock to secure the guide shaft in a selected position.

33. The sensor apparatus of claim 32, wherein the selected position covers the entire needle.

34. The sensor apparatus of claim 1, wherein, once assembled, the outer flexible layer is in direct contact with the flexible adhesive layer about the entire periphery of the housing.

35. A sensor apparatus comprising:

a flexible analyte sensor; and

a flexible mounting base to carry the flexible analyte sensor including;

a flexible adhesive layer to removably attach to a skin surface;

a housing disposed on the adhesive layer to receive the flexible analyte sensor;

a sealing layer; and

a one-piece outer flexible layer that is entirely separate from the housing and from the flexible adhesive layer, wherein the sealing layer is disposed atop the housing and beneath the outer flexible layer, wherein the sealing layer fully covers the housing, and wherein the flexible adhesive layer and the outer flexible layer enclose therebetween the entirety of the housing and the entirety of the sealing layer.

36. The sensor apparatus of claim 35, wherein the housing includes a base layer and a plurality of sidewalls depending from said base layer.

37. The sensor apparatus of claim 36, wherein the sealing layer includes a multiplicity of sidewalls, and wherein the sealing layer'"'"'s side walls are in physical contact with, and cover, said sidewalls of the housing.

38. The sensor apparatus of claim 35, wherein the outer flexible layer includes an area for needle entry through an upper surface thereof.