Analyte sensor

• US 10,813,576 B2
• Filed: 11/21/2019
• Issued: 10/27/2020
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark C., Masterson, Steve, Nolting, John, Petisce, James R., Pryor, Jack, Saint, Sean, Simpson, Peter C., Swanson, Vance, Wightlin, Matthew D.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US16/691,382
• Publication Number:
  US 20200085351A1
• Time in Patent Office: 341 Days
• Field of Search: 600309, 600345-366
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/14735 : comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 : using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/1495 : Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 : for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/68335 : including release sheets or liners
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• 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: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable 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: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A system for measuring an analyte concentration in a host, the system comprising:

a sensor system comprising;

a first package comprising;

a transcutaneous analyte sensor configured to measure a signal indicative of analyte concentration in the host; and

electrical contacts operably connected to the transcutaneous analyte sensor, wherein the electrical contacts are configured to form an operable connection to sensor electronics prior to sensor use;

wherein the transcutaneous analyte sensor is associated with an alphanumeric code, and

wherein the first package is labeled with the alphanumeric code; and

a second package comprising;

sensor electronics configured to be operably connected to the transcutaneous analyte sensor through the electrical contacts when the sensor electronics are operably connected to the transcutaneous analyte sensor by the host prior to sensor use, wherein the sensor electronics also comprise an RF module for wireless communications, wherein the sensor electronics are associated with the alphanumeric code, and

wherein the second package is labeled with the alphanumeric code;

wherein the sensor electronics are configured to communicate with a receiver that comprises;

a processor configured to receive sensor information from the sensor electronics and to process the sensor information received from the sensor electronics, and

a display configured to display an estimated analyte concentration value associated with the sensor information; and

wherein the sensor electronics are configured to transmit information associated with the alphanumeric code to the receiver.

2. The system of claim 1, wherein the transcutaneous analyte sensor comprises a transcutaneous sensor having an in vivo portion and an ex vivo portion.

3. The system of claim 2, wherein the electrical contacts are operably connected to the ex vivo portion of the transcutaneous analyte sensor.

4. The system of claim 1, wherein the first package comprises a contact holder.

5. The system of claim 4, wherein the first package comprises a seal at least partially disposed over the contact holder.

6. The system of claim 5, wherein the seal at least partially surrounds the ex vivo portion of the transcutaneous analyte sensor.

7. The system of claim 5, wherein the seal at least partially surrounds the electrical contacts.

8. The system of claim 1, wherein the transcutaneous analyte sensor is radiation sterilized.

9. The system of claim 8, wherein the sensor electronics are not radiation sterilized.

10. The system of claim 1, additionally comprising an applicator.

11. The system of claim 10, wherein one or both of the sensor first component and the second component sensor electronics is coupled to the applicator.

12. The system of claim 11, wherein the first package additionally comprises a mounting unit operably connectable to the transcutaneous analyte sensor.

13. The system of claim 12, wherein the mounting unit is operably connectable to the applicator.

14. The system of claim 12, wherein the applicator and the mounting unit are configured to be operably connected by the host prior to sensor use.

15. The system of claim 14, wherein the mounting unit and the sensor electronics are configured to be operably connected by the host prior to sensor use.

16. The system of claim 1, wherein the alphanumeric code is a serial number that identifies both the transcutaneous analyte sensor and the sensor electronics.