Systems, devices and methods for in situ calibration of implantable sensors

• US 10,010,274 B2
• Filed: 12/17/2012
• Issued: 07/03/2018
• Est. Priority Date: 12/16/2011
• Status: Active Grant

• Current Assignee: James Winkelman
• Original Assignee: James Winkelman
• Inventors: Winkelman, James
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/365,172
• Publication Number:
  US 20140371553A1
• Time in Patent Office: 2,024 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0228 using calibration standards
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

The systems, methods, and devices described herein generally involve monitoring and/or quantification of various analyte levels in a biological fluid using one or more implantable sensors. In various aspects, systems, methods, and devices described herein can provide for the in situ calibration and/or cleaning of such sensors when implanted in the patient. The systems and devices disclosed herein can, for example, continuously or serially measure analytes within a biological fluid in vivo (e.g., without extracting the biological fluid from the patient) and periodically calibrate and/or clean the sensor without using finger sticks or additional, invasive calibration techniques. By way of non-limiting example, systems and devices disclosed herein can enable continuous monitoring of analyte concentrations (e.g., glucose) in subcutaneous interstitial fluid for several hours to a few days.

Claims

1. A system for monitoring the concentration of an analyte, comprising:

a housing configured to be disposed on a patient'"'"'s skin surface, the housing comprising;

a reservoir configured to hold a glucose calibration fluid, the glucose calibration fluid having a known concentration of glucose included therein, the reservoir being in fluid connection with a conduit through which the glucose calibration fluid is delivered from the reservoir to an implant site positioned at a depth under the patient'"'"'s skin surface; and

a sensor assembly comprising a glucose sensor, the glucose sensor being configured to extend from the housing to the implant site when the housing is disposed on the patient'"'"'s skin surface, said glucose sensor being configured to obtain measurements of concentration level of glucose present in a subcutaneous interstitial fluid at the implant site at a plurality of points in time before and after delivery of the calibration fluid to the implant site; and

a calibration system configured to calibrate the glucose sensor in situ using the measurements of the concentration level of glucose in the subcutaneous interstitial fluid following delivery of the glucose calibration fluid to the implant site.

2. The system of claim 1, wherein the glucose sensor comprises a microneedle configured to pierce the skin.

3. The system of claim 1, wherein the glucose sensor extends through a fluid pathway defined by said conduit.

4. The system of claim 3, wherein the conduit comprises a sheath enclosing a distal end of the glucose sensor and wherein the glucose calibration fluid is delivered to the implant site through the fluid pathway between the sheath and the sensor.

5. The system of claim 1, wherein the housing comprises a transmitting unit.

6. The system of claim 1, wherein the housing further comprises a pump configured to pump said glucose calibration fluid through said conduit.

7. The system of claim 6, further comprising a controller configured to control the pump to deliver a predetermined amount of the glucose calibration fluid to the implant site.

8. The system of claim 7, wherein the controller is configured to control the pump to deliver the predetermined amount of the glucose calibration fluid to the implant site a predetermined number of times with a predetermined time interval.

9. The system of claim 7, wherein the controller controls a number of repetitions of glucose calibration fluid delivery, an amount of the glucose calibration fluid delivered, and a time interval between each delivery.

10. The system of claim 9, wherein the controller is configured to control the number of repetitions of the delivery of the glucose calibration fluid to be in a range of 1 to 5, to control the amount of the glucose calibration fluid delivered to be in a range of from about 2 to about 50 microliters for each delivery, and to control the time interval between each delivery to be in a range of from about 1 minute to about 24 hours.

11. The system of claim 1, wherein said glucose sensor comprises one of an electrochemical sensor and an optical sensor.

12. The system of claim 1, wherein the glucose sensor comprises one or more sensing sites.

13. The system of claim 12, wherein an outlet of the conduit is disposed relative to the one or more sensing sites such that the glucose calibration fluid delivered by the conduit to the implant site is directed at the one or more sensing sites.

14. The system of claim 13, wherein an outlet of the conduit is further configured such that the glucose calibration fluid delivered to the implant site also removes contaminants from the sensor.