TRANSCUTANEOUS ANALYTE SENSOR

• US 20100174157A1
• Filed: 03/22/2010
• Published: 07/08/2010
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Thrower, James Patrick, Saint, Sean, Neale, Paul V., Kline, Daniel S., Petersen, David Michael, Codd, Daniel Shawn, McGee, Thomas F.
• Granted Patent: US 8,801,611 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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. An insertion kit, comprising:

a sensor and an introducer needle, wherein the sensor and the introducer needle are configured and arranged with a shape, such that the sensor is retained in the introducer needle by a friction fit such that motion of the sensor with respect to the introducer needle is minimized prior to sensor insertion; and

an applicator configured to cause the needle to be inserted through a skin of a host, wherein the applicator is further configured to position at least a portion of the sensor in contact with a biological fluid of the host.

2. The kit of claim 1, wherein the sensor is retained in a lumen of the introducer needle.

3. The kit of claim 2, wherein the sensor is retained within the lumen.

4. The kit of claim 1, wherein the sensor is retained within the introducer needle.

5. The kit of claim 1, wherein the sensor is retained in the introducer needle by the friction fit of a contact point between the sensor and the introducer needle.

6. The kit of claim 1, wherein the motion is longitudinal motion.

7. The kit of claim 1, wherein the applicator is further configured to substantially completely withdraw the introducer needle from the host after the sensor is transcutaneously positioned in fluid contact with the biological fluid of the host.

8. The kit of claim 1, wherein the applicator includes a spring biased mechanism.

9. The kit of claim 1, wherein the shape is a bend.

10. An insertion kit, comprising:

a sensor and an introducer needle, wherein the sensor and the introducer needle are configured and arranged with a shape, such that the sensor is retained within a lumen of the introducer needle by a friction fit of multiple contact points separated by non-contact points between the sensor and the lumen of the introducer needle, such that longitudinal motion of the sensor with respect to the introducer needle is minimized prior to sensor insertion; and

an applicator configured to cause the needle to be inserted through a skin of a host, wherein the applicator is further configured to position at least a portion of the sensor in contact with a biological fluid of the host.

11. An analyte sensor system, comprising:

an analyte sensor and an applicator comprising an introducer needle, wherein the applicator is configured to position at least a portion of the sensor in contact with a biological fluid of a host by insertion of, and subsequent withdrawal of, the introducer needle through the skin of the host, wherein the analyte sensor is configured and arranged to be held by a friction fit of the surface of the sensor with the introducer needle in order to maintain the sensor longitudinally within the introducer needle prior to withdrawal of the introducer needle from the host and minimize motion of the sensor during withdrawal of the introducer needle from the host.

12. The system of claim 11, wherein the analyte sensor is configured and arranged to be held by the friction fit of the surface of the sensor with an inner lumen of the introducer needle.

13. The system of claim 11, wherein the sensor has a slight bend when the sensor is held within the introducer needle.

14. A method, comprising the steps of:

longitudinally maintaining an analyte sensor in a first configuration of the sensor within an introducer needle during insertion of the introducer needle into a host, wherein the first configuration uses a frictional force caused by the shape of the sensor against a surface of the introducer needle to maintain the sensor within the introducer needle; and

withdrawing the introducer needle from the host, wherein the step of withdrawing comprises releasing the sensor from the first configuration to a second configuration of the sensor that is different from the first configuration after release of the sensor from the introducer needle.

15. The method of claim 14, wherein the step of withdrawing comprises positioning the sensor to be in fluid contact with a biological fluid of a host.