Analyte sensor

• US 10,722,152 B2
• Filed: 11/05/2019
• Issued: 07/28/2020
• 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:
  US16/674,610
• Publication Number:
  US 20200077932A1
• Time in Patent Office: 266 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 a glucose concentration in a host, the system comprising:

a mounting unit;

an electronics unit; and

an assembly comprising;

a contact holder;

an elastomeric sealing member at least partially disposed over the contact holder, wherein the elastomeric sealing member comprises an upper portion with a first hole and a second hole extending therethrough and a lower portion;

a transcutaneous glucose sensor having a first sensor electrical contact and a second sensor electrical contact on an ex vivo portion of the transcutaneous glucose sensor, wherein at least a portion of the ex vivo portion of the transcutaneous glucose sensor is positioned between the upper portion of the sealing member and the lower portion of the sealing member;

a first sealing member electrical contact positioned in the first hole in the upper portion of the elastomeric sealing member; and

a second sealing member electrical contact positioned in the second hole in the upper portion of the elastomeric sealing member.

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

3. The system of claim 1, wherein the elastomeric sealing member comprises at least one gap maintained between a portion of the upper portion and a portion of the lower portion, when the first sealing member electrical contact is operably connected to the electronics unit.

4. The system of claim 3, wherein at least a portion of the ex vivo portion of the transcutaneous glucose sensor at least partially extends into the gap.

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

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

7. The system of claim 1, wherein the first sensor electrical contact is adjacent to the first hole extending through the upper portion of the elastomeric sealing member and the first sealing member electrical contact has a first end in contact with the first sensor electrical contact, wherein the second sensor electrical contact is adjacent to the second hole extending through the upper portion of the elastomeric sealing member and the second sealing member electrical contact has a first end in contact with the second sensor electrical contact.

8. The system of claim 7, wherein the first sealing member electrical contact has a second end exposed to an outside of the elastomeric sealing member to engage a first electrical contact of sensor electronics, wherein the second sealing member electrical contact has a second end exposed to the outside of the elastomeric sealing member to engage a second electrical contact of the sensor electronics.

9. The system of claim 8, wherein the second end of the first sealing member electrical contact is flush with an outer surface of the upper portion of the elastomeric sealing member, wherein the second end of the second sealing member electrical contact is flush with the outer surface of the upper portion of the elastomeric sealing member.

10. The system of claim 8, wherein the elastomeric sealing member has a durometer hardness of from about 5 Shore A to about 80 Shore A.

11. The system of claim 8, wherein the first sealing member electrical contact and the second sealing member electrical contact each comprises a conductive elastomeric material.

12. A glucose monitoring system comprising:

sensor electronics;

a contact holder;

an elastomeric sealing member at least partially disposed over the contact holder, wherein the elastomeric sealing member comprises an upper portion and a lower portion, wherein the upper portion has a first hole extending therethrough and a second hole extending therethrough;

a transcutaneous glucose sensor having a first sensor electrical contact and a second sensor electrical contact on an ex vivo portion of the transcutaneous glucose sensor, wherein the first sensor electrical contact and the second sensor electrical contact of the ex vivo portion of the transcutaneous glucose sensor are positioned between the upper portion of the elastomeric sealing member and the lower portion of the elastomeric sealing member;

a first sealing member electrical contact positioned in the first hole in the upper portion of the elastomeric sealing member; and

a second sealing member electrical contact positioned in the second hole in the upper portion of the elastomeric sealing member; and

wherein the upper portion of the elastomeric sealing member is connected to the lower portion of the elastomeric sealing member.

13. The system of claim 12, wherein the elastomeric sealing member has a durometer hardness of from about 5 Shore A to about 80 Shore A.

14. The system of claim 12, wherein the elastomeric sealing member comprises at least one gap that is maintained between the upper portion and the lower portion when the first sealing member electrical contact is operably connected to the sensor electronics.

15. The system of claim 14, wherein at least a portion of the transcutaneous glucose sensor at least partially extends into the gap.

16. The system 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.

17. The system of claim 12, wherein the elastomeric sealing member comprises a material selected from silicone, silicone/polyurethane hybrid, polyurethane, and polysulfide.

18. The system of claim 12, wherein the first sensor electrical contact is adjacent to the first hole extending through the upper portion of the elastomeric sealing member and the first sealing member electrical contact has a first end in contact with the first sensor electrical contact, wherein the second sensor electrical contact is adjacent to the second hole extending through the upper portion of the elastomeric sealing member and the second sealing member electrical contact has a first end in contact with the second sensor electrical contact.

19. The system of claim 18, wherein the first sealing member electrical contact has a second end exposed to an outside of the elastomeric sealing member to engage a first electrical contact of the sensor electronics, wherein the second sealing member electrical contact has a second end exposed to the outside of the elastomeric sealing member to engage a second electrical contact of the sensor electronics.

20. The system of claim 19, wherein the second end of the first sealing member electrical contact is flush with an outer surface of the upper portion of the elastomeric sealing member, wherein the second end of the second sealing member electrical contact is flush with the outer surface of the upper portion of the elastomeric sealing member.

21. The system of claim 19, wherein the elastomeric sealing member has a durometer hardness of from about 5 Shore A to about 80 Shore A.

22. The system of claim 19, wherein the first sealing member electrical contact and the second sealing member electrical contact each comprises a conductive elastomeric material.