TRANSCUTANEOUS ANALYTE SENSOR

• US 20090156919A1
• Filed: 02/26/2009
• Published: 06/18/2009
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Masterson, Steve, Thrower, James Patrick, Saint, Sean, Neale, Paul V., Kline, Daniel S., Codd, Daniel Shawn
• Granted Patent: US 8,515,519 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 transcutaneous analyte sensor assembly, the assembly comprising:

a housing comprising a first side adapted for mounting on a skin of a host and a second side located substantially opposite the first side, wherein the housing comprises one or more electrical contacts;

a sensor electronics unit comprising one or more electrical contacts, wherein the sensor electronics unit is configured to releasably mate with the second side of the housing such that the one or more electrical contacts of the housing electrically connect with the one or more electrical contacts of the sensor electronics unit; and

a sensor configured to continuously and/or intermittently measure a level of an analyte in a tissue of the host, wherein the sensor comprises one or more electrical contact points configured to electrically connect to the electrical contacts of the sensor electronics unit via the electrical contacts of the housing when the sensor electronics unit is mated to the housing, wherein the housing is configured to continuously support the sensor within the tissue of the host during a time period of continuous or intermittent measurement.

2. The assembly of claim 1, wherein the sensor electronics unit is configured to releasably mate to the housing by a mechanical fit selected from the group consisting of a slide fit, a snap fit, a press fit, and an interference fit.

3. The assembly of claim 1, wherein the sensor electronics unit comprises a tab extending therefrom and the housing comprises a tab extending therefrom, wherein the tabs are configured to guide mating of the sensor electronics unit with the housing.

4. The assembly of claim 1, further comprising at least one release latch configured to release the sensor electronics unit from the housing when releasably mated thereto.

5. The assembly of claim 4, wherein the release latch is located on the housing and is configured to manually release the sensor electronics unit from the housing releasably mated thereto.

6. The assembly of claim 1, wherein the time period of continuous or intermittent measurement is from about 1 day to about 14 days.

7. The assembly of claim 1, wherein the one or more electrical contacts of the housing comprise a conductive elastomer.

8. The assembly of claim 1, wherein the sensor is configured to penetrate through the one or more electrical contacts of the housing.

9. The assembly of claim 1, wherein the one or more electrical contacts points of the sensor comprise two or more electrical contacts points aligned along a longitudinal axis of the sensor.

10. The assembly of claim 9, wherein the one or more electrical contacts of the housing comprise two or more electrical contacts aligned along the longitudinal axis of the sensor.

11. The assembly of claim 10, wherein the one or more electrical contacts of the sensor electronics unit comprise two or more electrical contacts aligned along the longitudinal axis of the sensor.

12. A transcutaneous analyte sensor assembly, the assembly comprising:

a housing adapted for mounting on a skin of a host;

a sensor comprising at least two electrodes, wherein the sensor is configured to extend through the housing;

sensor electronics configured to electrically connect with the at least two electrodes;

at least two electrical contacts aligned longitudinally along and extending circumferentially around a central longitudinal axis, wherein the at least two electrical contacts are configured to provide an electrical connection between the at least two electrodes and the sensor electronics; and

a needle comprising a lumen, wherein the sensor is dimensioned and arranged such that the sensor has a width that fits within the lumen of the needle.

13. The assembly of claim 12, wherein the at least two electrodes comprise at least one wire.

14. The assembly of claim 13, wherein a diameter of the at least one wire is no more than about 0.010 inches.

15. The assembly of claim 12, wherein the electrical contacts of the housing comprise a conductive elastomer.

16. The assembly of claim 12, wherein the housing comprises a flexible material.

17. The assembly of claim 12, wherein the at least two electrical contacts comprise electrically exposed portions of the sensor.

18. A transcutaneous analyte sensor assembly, the assembly comprising:

a housing adapted for mounting on a skin of a host;

sensor electronics associated with the housing;

a sensor configured to measure a level of an analyte in the host, wherein the sensor comprises at least two electrode materials, wherein the sensor is configured to operably connect to the sensor electronics; and

at least two electrical contacts aligned along a single longitudinal axis of the sensor wherein the electrode materials are configured to penetrate through the at least two electrical contacts to enable the operable connection of the sensor to the sensor electronics.

19. The assembly of claim 18, wherein the at least two electrode materials comprise at least one wire.

20. The assembly of claim 19, wherein a diameter of the at least one wire is no more than about 0.010 inches.

21. The assembly of claim 18, wherein the electrical contacts of the housing comprise an elastomer.