TRANSCUTANEOUS ANALYTE SENSOR

• US 20140142405A1
• Filed: 01/24/2014
• Published: 05/22/2014
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Neale, Paul V., Petisce, James R., Thrower, James, Saint, Sean, Nolting, John
• Granted Patent: US 10,524,703 B2
• Time in Patent Office: Days
• 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 method for maintaining an analyte measuring system on a host'"'"'s skin, the method comprising:

providing an analyte monitoring system comprising sensor electronics and a mounting unit having an adhesive pad, wherein the adhesive pad comprises first and second releasable backing layers,

removing a first releasable backing layer from the adhesive pad prior to positioning the mounting unit on a host'"'"'s skin;

positioning the mounting unit on the host'"'"'s skin;

removing the second releasable backing layer from the adhesive pad after the positioning.

2. The method of claim 1, further comprising inserting a sensor through the mounting unit and through the host'"'"'s skin.

3. The method of claim 2, further comprising connecting the sensor electronics to the mounting unit after the sensor insertion.

4. The method of claim 3, further comprising placing an adhesive covering over at least a portion of the analyte measuring system after the sensor insertion.

5. The method of claim 3, further comprising placing a water-tight adhesive covering over the entire analyte measuring system after the sensor insertion.

6. The method of claim 1, wherein the adhesive pad is adhered to a skin-facing surface of the mounting unit by a bonding agent activated by or accelerated by at least one of ultraviolet cure, acoustic cure, radio frequency cure, or humidity cure.

7. The method of claim 1, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 1.25 times greater than a surface area of a skin-facing surface of the mounting unit of the analyte measuring system.

8. The method of claim 7, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 1.5 times greater than a surface area of a skin-facing surface of the mounting unit of the analyte measuring system.

9. The method of claim 8, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 2 times greater than a surface area of a skin-facing surface of the mounting unit.

10. The method of claim 1, wherein the adhesive pad comprises a non-adhesive portion.

11. A system for maintaining an analyte measuring system on a host'"'"'s skin, the system comprising:

an analyte monitoring system comprising sensor electronics and a mounting unit having an adhesive pad, wherein the adhesive pad comprises first and second releasable backing layers, wherein the first releasable backing layer is adapted to be removed from the adhesive pad prior to positioning the mounting unit on a host'"'"'s skin, and wherein the second releasable backing layer is adapted to be removed after positioning the mounting unit on the host'"'"'s skin.

12. The system of claim 11, further comprising a sensor configured to extend through the mounting unit and through the host'"'"'s skin.

13. The system of claim 12, wherein the sensor electronics are configured to connect to the mounting unit after sensor insertion.

14. The system of claim 11, further comprising an adhesive covering sized to cover at least a portion of the analyte measuring system.

15. The system of claim 11, further comprising a water-tight adhesive covering sized to cover the entire analyte measuring system.

16. The system of claim 11, further comprising a bonding agent activated by or accelerated by at least one of ultraviolet cure, acoustic cure, radio frequency cure, or humidity cure, whereby the adhesive pad is adhered to the mounting unit.

17. The system of claim 11, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 1.25 times greater than a surface area of a skin-facing surface of the mounting unit of the analyte measuring system.

18. The system of claim 17, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 1.5 times greater than a surface area of a skin-facing surface of the mounting unit of the analyte measuring system.

19. The system of claim 18, wherein the adhesive pad has a surface area on a side to be adhered to the host'"'"'s skin that is 2 times greater than a surface area of a skin-facing surface of the mounting unit.

20. The system of claim 11, wherein the adhesive pad comprises a non-adhesive portion.