Analyte sensor devices, connections, and methods

• US 9,693,713 B2
• Filed: 06/27/2016
• Issued: 07/04/2017
• Est. Priority Date: 12/11/2011
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: DiPalma, Vincent Michael, Robinson, Peter G., Pace, Louis, Curry, Samuel Mason, Carter, Phillip William, Hoss, Udo, Olson, Jennifer, Donnay, Manuel Luis Miguel, Mhatre, Amit, Taub, Marc Barry
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/193,499
• Publication Number:
  US 20170042457A1
• Time in Patent Office: 372 Days
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• 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 5/1411 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 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150335 by radiation
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150847 Communication to or from blood sampling device transmitting measured data A61B5/0002
• CPC Class Codes: A61B 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150877 : with implanted devices
• CPC Class Codes: A61B 5/15105 : Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15144 : comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 50/3001 : for sharps
• CPC Class Codes: H04L 67/12 : specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

Claims

1. A method comprising:

applying a first force to an applicator assembly along a longitudinal axis to drive a guide sleeve of the applicator assembly into a container that releasably holds a sensor assembly, wherein the applicator assembly includes a housing in locked engagement with the guide sleeve;

engaging a platform retaining the sensor assembly in the container with the guide sleeve to release the sensor assembly; and

coupling an electronics assembly releasably held within the applicator assembly to the sensor assembly to form an on-body device.

2. The method of claim 1, wherein the sensor assembly comprises a sensor, a sharp supporting the sensor, a support structure, and a connector coupled to the sensor, the support structure supporting the connector and the sensor, and releasably supporting the sharp.

3. The method of claim 2, wherein coupling the electronics assembly within the applicator assembly to the sensor assembly includes coupling the connector to sensor electronics.

4. The method of claim 3, wherein the electronics assembly includes a socket affixed to a circuit board, wherein the socket includes electrical contacts and is configured to receive the sensor assembly.

5. The method of claim 1, further comprising sealing an enclosure of the electronics assembly with the sensor assembly, wherein the electronics assembly includes sensor electronics within the enclosure, and wherein the sensor electronics comprises a processor and a communications facility.

6. The method of claim 5, wherein sealing the enclosure of the electronics assembly with the sensor assembly further comprises mating a first snap mechanism of the electronics assembly with a corresponding second snap mechanism of the sensor assembly.

7. The method of claim 5, wherein sealing the enclosure of the electronics assembly with the sensor assembly further comprises coupling the electronics assembly with the sensor using a light press fit.

8. The method of claim 1, further comprising:

engaging a guide sleeve unlock abutment disposed within the container to unlock the guide sleeve from the housing and to allow the guide sleeve to be translated along the longitudinal axis from an extended position to a retracted position relative to the housing; and

removing the applicator assembly including the on-body device from the container.

9. The method of claim 8, wherein the guide sleeve includes lock arms configured to engage with a sleeve lock ledge in the electronics assembly when the housing is in locked engagement with the guide sleeve.

10. The method of claim 9, wherein the guide sleeve unlock abutment is configured to disengage the locks arms from the sleeve lock ledge as the guide sleeve is advanced into the container.

11. The method of claim 8, wherein the sensor assembly comprises a sensor, a sharp supporting the sensor, and a support structure, the method further comprising:

applying a second force to the applicator assembly along the longitudinal axis with the extended, unlocked guide sleeve held against a user;

urging the extended, unlocked guide sleeve to translate along the longitudinal axis to the retracted position;

positioning the sharp and at least a portion of the sensor of the on-body device through a skin surface of the user in a direction along the longitudinal axis;

releasing the on-body device from the applicator assembly upon the guide sleeve reaching the retracted position;

adhering the on-body device to the skin of the user; and

retracting the sharp into the applicator assembly leaving the sensor in the user and the on-body device sealed from moisture.

12. The method of claim 11, wherein the guide sleeve includes an electronics assembly decouple mechanism configured to release the electronics assembly from the applicator assembly when the guide sleeve is in the retracted position.

13. The method of claim 11, wherein positioning at least a portion of the sensor through a skin surface of the user further comprises placing at least a portion of the sensor in contact with an interstitial fluid of the user.

14. The method of claim 11, wherein retracting the sharp into the applicator assembly further comprises releasing a compressed coil return spring to drive a sharp retraction assembly in a direction away from the skin surface.

15. The method of claim 1, further comprising disengaging, by the guide sleeve, the platform from a plurality of guide ribs within the container and advancing the platform, housing and electronics assembly along the longitudinal axis to a position further within the container.

16. The method of claim 15, wherein the platform includes a plurality of platform lock arms releasably coupled with a plurality of locking groves in the guide ribs, wherein the platform arms are configured to deflect in an inward direction in response to force from the guide sleeve.

17. The method of claim 15, wherein the sensor assembly comprises a sensor, a sharp supporting the sensor, and a support structure, the method further comprising passing a sharp boss of the sharp through a central opening in the platform, as the platform, housing and electronics assembly advance along the longitudinal axis to a position further within the container.

18. The method of claim 17, further comprising advancing the housing and the electronics assembly along a longitudinal axis to a position further within the container, after the platform abuts a bottom surface of the container.

19. The method of claim 18, further comprising engaging the sharp boss with a sharp retraction assembly within the guide sleeve.

20. The method of claim 19, wherein the sharp retraction assembly includes a plurality of flexible arms configured to grasp a neck portion of the sharp boss.