Transcutaneous analyte sensor

• US 8,475,373 B2
• Filed: 07/17/2008
• Issued: 07/02/2013
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Neale, Paul V., Saint, Sean, Thrower, James Patrick, McGee, Thomas F., Codd, Daniel Shawn, Petersen, David Michael, Kline, Daniel S.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US12/175,391
• Publication Number:
  US 20080275313A1
• Time in Patent Office: 1,811 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 600/365
• 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 system for measuring an analyte concentration in a host, the system comprising:

a sensor adapted for transcutaneous placement through a skin of a host;

a housing adapted for placement adjacent to the skin of the host, wherein the housing comprises at least one electrical contact therein for providing an electrical connection between the sensor and sensor electronics; and

an applicator configured for inserting the sensor through the housing and into the skin of the host, wherein the applicator comprises at least one needle adapted for inserting the sensor into the host, wherein insertion of the needle or retraction of the needle disposes the sensor adjacent to the electrical contact or within the electrical contact.

2. The system of claim 1, wherein the electrical contact comprises an elastomeric contact and wherein the sensor is configured to extend through the elastomeric contact such that, in use, the elastomeric contact relaxes around the sensor.

3. The system of claim 1, comprising two electrical contacts.

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

a sensor adapted for transcutaneous placement through a skin of a host;

a housing adapted for placement adjacent to the skin of the host, wherein the housing comprises a recess;

an applicator comprising a needle comprising a lumen, wherein the applicator is configured for inserting the sensor through the housing and into the skin of the host, wherein the applicator comprises a base configured to fit within the recess of the housing, and wherein the applicator comprises at least one introducer adapted for inserting the sensor into the host; and

an electronics unit releasably attachable to the recess in the housing, wherein the electronics unit comprises a base configured to fit within the recess of the housing, wherein the base of the applicator and the base of the electronics unit have a similar footprint.

5. The system of claim 4, wherein the footprint of the base of the applicator and the footprint of the base of the electronics unit are sized and arranged to mate with the recess.

6. The system of claim 4, wherein the applicator is configured to insert the sensor in response to an activation of an automated mechanism.

7. The system of claim 4, wherein the applicator is configured to insert the sensor in response to a manual force applied to the applicator by a user.

8. An applicator system for inserting a transcutaneous sensor into a host, the applicator comprising:

a sensor configured for transcutaneous placement through a skin of a host;

a needle comprising a lumen and configured for inserting the sensor into the host, wherein the sensor is disposed within the lumen of the needle prior to insertion into the host;

a subassembly comprising a housing adapted for placement adjacent to the skin of the host and an electronics unit releasably attachable to the housing; and

an applicator configured for inserting the needle and the sensor into the skin of the host, wherein the needle and the sensor are disposed within the applicator prior to insertion of the sensor;

wherein the applicator is configured to insert the needle and the sensor into the skin of the host to leave the sensor transcutaneously placed within the host, and wherein the applicator is configured such that it must be released from the housing in order to allow the electronics unit to be attached to the housing.

9. The system of claim 8, wherein the applicator is configured to insert the sensor in response to an activation of an automated mechanism.

10. The system of claim 8, wherein the applicator is configured to insert the sensor in response to a manual force applied to the applicator by a user.

11. The system of claim 8, wherein of the applicator is configured to release from the housing after the sensor has been transcutaneously inserted into the host.

12. The system of claim 8, wherein the applicator is releasably attached to the housing prior to sensor insertion and during sensor insertion.