Analyte sensor

• US 10,709,363 B2
• Filed: 11/21/2019
• Issued: 07/14/2020
• 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:
  US16/691,422
• Publication Number:
  US 20200100713A1
• Time in Patent Office: 236 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 device for measuring a glucose concentration in a host, the system comprising:

a transcutaneous glucose sensor;

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

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

an elastomeric sealing member at least partially surrounding a portion of the transcutaneous glucose sensor and at least partially surrounding the at least one elastomeric electrical contact;

a contact holder, wherein each of the portion of the transcutaneous glucose sensor, the at least one elastomeric electrical contact, and the elastomeric sealing member is at least partially disposed over the contact holder; and

a mounting unit configured to operably connect to the contact holder,

wherein a durometer hardness of the at least one elastomeric electrical contact is higher than a durometer hardness of the elastomeric sealing member.

2. The device of claim 1, wherein the at least one electrical contact is formed from a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.

3. The device of claim 2, wherein the sealing member is formed from a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.

4. The device of claim 2, wherein the durometer hardness of the at least one electrical contact is about 50 Shore A.

5. The device of claim 1, wherein the durometer hardness of the sealing member is about 20 Shore A to about 50 shore A.

6. The device of claim 1, wherein the durometer hardness of the sealing member is about 50 Shore A.

7. The device of claim 1, further comprising a sealant adjacent to the sealing member.

8. The device of claim 1, wherein the at least one electrical contact extends through a portion of the sealing member.

9. The device of claim 1, wherein the mounting unit and the contact holder are connected to the sensor electronics.

10. A device for transcutaneous measurement of a glucose concentration in a host, the device comprising:

a transcutaneous glucose sensor;

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

one or more electrical contacts configured to operably connect the transcutaneous glucose sensor to the sensor electronics;

a sealing member at least partially surrounding a portion of the transcutaneous glucose sensor and at least partially surrounding the one or more electrical contacts;

a contact holder over which the portion of the transcutaneous glucose sensor, the one or more electrical contacts, and the sealing member are at least partially disposed; and

a mounting unit configured to operably connect to the contact holder,

wherein a durometer hardness of at least one of the one or more electrical contacts is higher than a durometer hardness of the sealing member, wherein the sealing member comprises an upper portion and a lower portion, wherein the portion of the transcutaneous glucose sensor is positioned between the upper portion and the lower portion of the sealing member, wherein the upper portion of the sealing member has one or more through holes therein, and wherein at least one of the one or more electrical contacts is located in one of the one or more holes of the upper portion of the sealing member.

11. The device of claim 10, wherein the durometer hardness of the at least one electrical contact is from about 5 Shore A to about 80 Shore A, and wherein the durometer hardness of the sealing member is from about 5 Shore A to about 80 Shore A.

12. The device of claim 11, wherein the durometer hardness of the sealing member is about 50 Shore A.

13. The device of claim 11, wherein the durometer hardness of the sealing member is about 20 Shore A to about 50 Shore A.

14. The device of claim 10, wherein the durometer hardness of the at least one electrical contact is about 80 Shore A.

15. The device of claim 10, further comprising a sealant adjacent to the sealing member.

16. A device for transcutaneous measurement of a glucose concentration in a host, the device comprising:

a glucose sensor;

sensor electronics configured to operably connect to the glucose sensor;

at least one electrical contact configured to electrically connect the glucose sensor to the sensor electronics, wherein the at least one electrical contact comprises a material having a durometer hardness of from about 20 Shore A to about 80 Shore A; and

a sealing member at least partially surrounding a portion of the glucose sensor and at least partially surrounding the at least one electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 10 Shore A to about 50 Shore A, and wherein the durometer hardness of the at least one electrical contact is higher than the durometer hardness of the sealing member.

17. The device of claim 16, wherein the durometer hardness of the sealing member is about 20 Shore A.

18. The device of claim 16, wherein the durometer hardness of the sealing member is about 50 Shore A.

19. The device of claim 18, wherein the durometer hardness of the at least one electrical contact is about 80 Shore A.

20. The device of claim 16, further comprising a sealant adjacent to the sealing member.

21. The device of claim 16, wherein the at least one electrical contact extends through a portion of the sealing member.

22. The device of claim 16, further comprising a contact holder over which the glucose sensor, the at least one electrical contact, and the sealing member are at least partially disposed.

23. The device of claim 22, wherein the contact holder is connected to a mounting unit.

24. The device of claim 23, further comprising sensor electronics, wherein the mounting unit and the contact holder are connected to the sensor electronics.

25. A device for transcutaneous measurement of a glucose concentration in a host, the device comprising:

a glucose sensor;

sensor electronics configured to operably connect to the glucose sensor;

at least one electrical contact configured to electrically connect the glucose sensor to the sensor electronics;

a sealing member at least partially surrounding a portion of the glucose sensor and at least partially surrounding the at least one electrical contact;

a contact holder over which the glucose sensor, the at least one electrical contact, and the sealing member are at least partially disposed;

a mounting unit configured to operably connect to the contact holder; and

sensor electronics configured to operably connect to the mounting unit,

wherein a durometer hardness of the at least one electrical contact is higher than a durometer hardness of the sealing member, and wherein the sealing member and the at least one electrical contact are compressed between the contact holder and the sensor electronics.

26. The device of claim 25, wherein the at least one electrical contact is formed from a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.

27. The device of claim 25, wherein the sealing member is formed from a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.

28. The device of claim 27, wherein the durometer hardness of the sealing member is about 50 Shore A.

29. The device of claim 28, wherein the durometer hardness of the sealing member is about 50 Shore A.

30. The device of claim 29, wherein the durometer hardness of the at least one electrical contact is about 80 Shore A.

31. The device of claim 25, further comprising a sealant adjacent to the sealing member.