Analyte sensor

• US 10,799,158 B2
• Filed: 11/21/2019
• Issued: 10/13/2020
• 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:
  US16/691,438
• Publication Number:
  US 20200100714A1
• Time in Patent Office: 327 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 transcutaneous analyte sensor;

sensor electronics configured to operably connect to the transcutaneous analyte sensor;

at least one electrical contact configured to operably connect the transcutaneous analyte sensor to the sensor electronics;

a sealing member comprising a sealing member upper portion and a sealing member lower portion, wherein the sealing member at least partially surrounds the at least one electrical contact and at least a portion of the transcutaneous analyte sensor when the transcutaneous analyte sensor is operably connected to the sensor electronics, wherein the sealing member substantially seals the at least one electrical contact from moisture, and wherein an ex vivo portion of the transcutaneous analyte sensor is positioned between the sealing member upper portion and the sealing member lower portion; and

a contact holder over which the sealing member and the transcutaneous analyte sensor are at least partially disposed.

2. The system of claim 1, wherein the sealing member upper portion and the sealing member lower portion are connected.

3. The system of claim 1, wherein the sealing member has a durometer hardness of from about 5 Shore A to about 80 Shore A.

4. The system of claim 1, wherein the sealing member comprises at least one gap that is maintained when the at least one electrical contact is operably connected to the sensor electronics.

5. The system of claim 4, wherein the transcutaneous analyte sensor at least partially extends into the gap.

6. The system of claim 1, wherein the sealing member comprises a material selected from the group consisting of silicone, silicone/polyurethane hybrid, polyurethane, polysulfide, and mixtures thereof.

7. The system of claim 1, wherein the ex vivo portion of the transcutaneous analyte sensor comprises sensor electrical contacts.

8. The system of claim 1, wherein one of the at least one electrical contact has a first end exposed to the outside of the sealing member to engage an electrical contact of the sensor electronics.

9. The system of claim 8, wherein one of the at least one electrical contact has a second end engaging an electrical contact of the transcutaneous analyte sensor.

10. The system of claim 1, wherein the at least one electrical contact comprises a conductive elastomeric material.

11. The system of claim 1, wherein one end of the at least one electrical contact is flush with an outer surface of the sealing member.

12. A glucose monitoring kit comprising:

an assembly comprising;

a contact holder,

an elastomeric sealing member with an upper portion and a lower portion positioned at least partially disposed over the contact holder,

a transcutaneous glucose sensor having an ex vivo portion positioned between the upper portion and the lower portion of the elastomeric sealing member, and

one or more electrical contacts at least partially surrounded by the sealing member and having an exposed portion outside of the sealing member; and

an electronics unit unconnected from the assembly,

wherein the electronics unit is configured to connect to the assembly during a sensor session.

13. The glucose monitoring kit of claim 12, further comprising an applicator.

14. The glucose monitoring kit of claim 13, wherein the assembly is coupled to the applicator.

15. The glucose monitoring kit of claim 13, additionally comprising an adhesive backed mounting unit.

16. The glucose monitoring kit of claim 15, wherein the adhesive backed mounting unit is coupled to the applicator.

17. The glucose monitoring kit of claim 12, wherein the upper portion and the lower portion are connected.

18. The glucose monitoring kit of claim 12, wherein the elastomeric sealing member has a durometer hardness of from about 5 Shore A to about 80 Shore A.

19. The glucose monitoring kit of claim 12, wherein the elastomeric sealing member comprises at least one gap that is maintained when one of the one or more electrical contacts is operably connected to the electronics unit.

20. The glucose monitoring kit of claim 19, wherein the transcutaneous glucose sensor at least partially extends into the gap.

21. The glucose monitoring kit of claim 12, wherein the elastomeric sealing member comprises a material selected from the group consisting of silicone, silicone/polyurethane hybrid, polyurethane, polysulfide, and mixtures thereof.