Devices, systems, methods and tools for continuous glucose monitoring

• US 8,280,476 B2
• Filed: 03/28/2006
• Issued: 10/02/2012
• Est. Priority Date: 03/29/2005
• Status: Active Grant

• Current Assignee: Arkal, Inc.., Pent Technologies, Inc.
• Original Assignee: ArKal Medical, Inc.
• Inventors: Jina, Arvind N.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): D'Angelo, Michael
• Application Number:
  US11/277,731
• Publication Number:
  US 20060219576A1
• Time in Patent Office: 2,380 Days
• Field of Search: 600/309, 600/319, 600/345, 600/347, 600/354, 600/362, 600/372, 600/365, 600/366, 600/386, 20440301-40306, 204/400, 204/432, 20440311-40314, 205/779, 205/792, 128/903, 435/4, 435/14, 702/19
• US Class Current: 600/347
• 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

Abstract

One aspect of the invention provides a glucose monitor having a plurality of tissue piercing elements, each tissue piercing element having a distal opening, a proximal opening and interior space extending between the distal and proximal openings; a sensing area in fluid communication with the proximal openings of the tissue piercing elements; sensing fluid extending from the sensing area into substantially the entire interior space of the tissue piercing elements; and a glucose sensor adapted to detect a concentration of glucose in the sensing fluid within the sensing area. Another aspect of the invention provides a method of in vivo monitoring of an individual'"'"'s interstitial fluid glucose concentration including the following steps: inserting distal ends of a plurality of tissue piercing elements through a stratum corneum area of the individual'"'"'s skin, the tissue piercing elements each having a distal opening, a proximal opening, an interior space extending between the distal and proximal openings, and a sensing fluid filling substantially the entire interior space; and sensing a glucose concentration of the sensing fluid.

Claims

1. an analyte monitor comprising

a plurality of tissue piercing elements, each tissue piercing element comprising a distal opening, a proximal opening and an interior space extending between the distal and proximal openings;

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

sensing fluid extending from the sensing area into substantially the entire interior space of the tissue piercing elements;

a sensing fluid reservoir;

an actuator adapted to move sensing fluid out of the sensing fluid reservoir into the sensing area; and

an analyte sensor adapted to detect a concentration of an analyte in the sensing fluid within the sensing area.

2. The analyte monitor of claim 1 further comprising a removable cover extending over the distal openings of the tissue piercing elements.

3. The analyte monitor of claim 1 further comprising a display adapted to display an analyte concentration sensed by the sensor.

4. The analyte monitor of claim 3 wherein the display is disposed in a housing separate from the sensor, the analyte monitor further comprising a communicator adapted to wirelessly communicate sensor information from the sensor to the display.

5. The analyte monitor of claim 1 wherein the actuator comprises a manual actuator.

6. The analyte monitor of claim 1 further comprising a waste reservoir adapted to receive sensing fluid from the sensing area.

7. The analyte monitor of claim 6 further comprising a housing comprising a first part and a second part, the first part of the housing being adapted to support the tissue piercing elements, the sensing fluid reservoir, the sensing area, and at least part of the sensor, the second part of the housing comprising an electrical connection to the at least part of the sensor in the first part of the housing, the housing further comprising a connector adapted to connect and disconnect the first part of the housing from the second part of the housing.

8. The analyte monitor of claim 7 wherein the first part of the housing is further adapted to support the actuator.

9. The analyte monitor of claim 7 wherein the first part of the housing is further adapted to support the waste reservoir.

10. The analyte monitor of claim 7 further comprising a communicator supported by the second part of the housing and adapted to communicate sensor information to a display.

11. The analyte monitor of claim 1 wherein the sensing fluid in the sensing fluid reservoir has a glucose concentration of between about 0 mg/dl and about 400 mg/dl.

12. The analyte monitor of claim 11 wherein the actuator is adapted to move the sensing fluid out of the sensing fluid reservoir into the sensing area to calibrate the sensor.

13. The analyte monitor of claim 1 further comprising an adhesive element adjacent the tissue piercing elements and adapted to attach to a user'"'"'s skin.

14. The analyte monitor of claim 1 wherein the analyte sensor, tissue piercing elements and sensing area are further adapted to detect a concentration of an analyte in the sensing fluid within the sensing area without extracting interstitial fluid through the distal openings into the interior space.

15. The analyte monitor of claim 1 wherein the actuator comprises a pump.

16. A method of in vivo monitoring of an individual'"'"'s interstitial fluid comprising:

inserting distal ends of a plurality of tissue piercing elements through a stratum corneum area of the individual'"'"'s skin, the tissue piercing elements each comprising a distal opening, a proximal opening, an interior space extending between the distal and proximal openings, and a sensing fluid filling substantially the entire interior space;

moving sensing fluid from a sensing fluid reservoir into a sensing area in fluid communication with the proximal openings of the tissue piercing elements; and

sensing an analyte concentration of the sensing fluid.

17. The method of claim 16 further comprising removing a cover from the distal openings of the tissue piercing elements prior to the inserting step.

18. The method of claim 16 further comprising displaying analyte concentration information remote from the stratum corneum area of the individual'"'"'s skin.

19. The method of claim 18 further comprising wirelessly communicating analyte concentration information to a display.

20. The method of claim 16 wherein the sensing step is performed by a sensor in fluid communication with the sensing area and the interior spaces of the tissue piercing elements, the method further comprising calibrating the sensor by moving sensing fluid into the sensing area.

21. The method of claim 20 wherein the sensing fluid reservoir, sensing area, tissue piercing elements and at least part of the sensor being supported by a first part of a housing, the method further comprising attaching the first part of the housing to a second part of the housing prior to the inserting step, the second part of the housing comprising an electrical connection to the at least part of the sensor in the first part of the housing.

22. The method of claim 21 further comprising separating the second part of the housing from the first part of the housing after the sensing step.

23. The method of claim 16 further comprising moving sensing fluid out of the sensing area as sensing fluid is moved into the sensing area.

24. The method of claim 16 wherein the step of moving sensing fluid comprises operating an actuator.

25. The method of claim 16 wherein the step of moving sensing fluid comprises moving sensing fluid having a glucose concentration of between about 0 mg/dl and about 400 mg/dl.

26. The method of claim 16 further comprising attaching the tissue piercing elements to the individual with adhesive.

27. The method of claim 16 further comprising permitting an analyte to diffuse from interstitial fluid of the individual into the sensing area without extracting interstitial fluid through the distal openings into the interior space.

28. An analyte monitor comprising

a plurality of tissue piercing elements, each tissue piercing element comprising a distal opening, a proximal opening and an interior space extending between the distal and proximal openings;

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

sensing fluid extending from the sensing area into substantially the entire interior space of the tissue piercing elements; and

an analyte sensor adapted to continuously detect a concentration of an analyte in the sensing fluid within the sensing area

and further adapted to be self-calibrating.