Method and System for Providing an Integrated Analyte Sensor Insertion Device and Data Processing Unit

• US 20150018639A1
• Filed: 09/26/2014
• Published: 01/15/2015
• Est. Priority Date: 09/10/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Stafford, Gary Ashley
• Granted Patent: US 9,808,186 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/1411 by percutaneous method, e.g. by lancet
• 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 5/14514 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

Claims

1. An apparatus, comprising:

a housing;

a data processing unit disposed in the housing;

an introducer disposed within the housing and including a portion having a sharp distal end configured for piercing through a skin layer, wherein the portion of the introducer is removed from the housing after piercing through the skin layer; and

an analyte sensor including a first portion and a second portion, the first portion of the analyte sensor coupled to the portion of the introducer, and the second portion of the analyte sensor coupled to the data processing unit;

wherein the first portion of the analyte sensor is configured for transcutaneous positioning and in fluid contact with interstitial fluid under the skin layer, and the second portion of the analyte sensor is in electrical contact with the data processing unit prior to transcutaneous positioning of the first portion of the analyte sensor.

2. The apparatus of claim 1, further including an adhesive layer provided on a lower surface of the housing, wherein the adhesive layer is configured to removably attach the housing to the skin layer.

3. The apparatus of claim 2, wherein the adhesive layer includes a removable protective layer.

4. The apparatus of claim 1, wherein the portion of the introducer includes a sharp tip for piercing through the skin layer, wherein when the sharp tip is pierced through the skin layer, the first portion of the analyte sensor is transcutaneously positioned under the skin layer and in fluid contact with the interstitial fluid.

5. The apparatus of claim 1, wherein the introducer is configured to decouple from the data processing unit after the first portion of the analyte sensor is transcutaneously positioned under the skin layer.

6. The apparatus of claim 1, wherein the data processing unit includes a data communication unit configured to receive one or more signals associated with a monitored analyte level from the analyte sensor.

7. The apparatus of claim 6, wherein the data communication unit is configured to wirelessly communicate data associated with the one or more signals received from the analyte sensor to a remote location.

8. The apparatus of claim 1, wherein the introducer is positionable through an aperture of the housing.

9. The apparatus of claim 1, wherein the second portion of the analyte sensor extends substantially transverse to the first portion of the analyte sensor.

10. An assembly, comprising:

a housing;

a data processing unit disposed within the housing;

an introducer disposed within the housing and including a portion having a sharp distal end configured for piercing through a skin layer, wherein the portion of the introducer is removed from the housing after piercing through the skin layer; and

an analyte sensor coupled to the housing, a first portion of the analyte sensor configured for transcutaneous positioning and in fluid contact with interstitial fluid under the skin layer, and a second portion of the analyte sensor disposed within the housing and in electrical communication with the data processing unit prior to transcutaneous positioning of the first portion of the analyte sensor;

wherein the housing includes an aperture through which the introducer is removable.

11. The assembly of claim 10, wherein the second portion of the analyte sensor is permanently coupled to the data processing unit.

12. The assembly of claim 10, wherein the introducer is configured to decouple from the data processing unit after the first portion of the analyte sensor is transcutaneously positioned under the skin layer.

13. The assembly of claim 10, wherein the data processing unit includes a data communication unit configured to receive one or more signals associated with a monitored analyte level from the analyte sensor.

14. The assembly of claim 13, wherein the data communication unit is configured to wirelessly transmit data associated with the one or more signals received from the analyte sensor.

15. The assembly of claim 10, further including an adhesive layer provided on a lower surface of the housing, wherein the adhesive layer is configured to removably attach the housing to the skin layer.

16. The assembly of claim 10, wherein the introducer is positionable through the aperture of the housing.

17. The assembly of claim 10, wherein an opening in the data processing unit is configured to receive the portion of the introducer.

18. The assembly of claim 10, wherein the introducer further includes a proximal portion configured for engaging an outer surface of the data processing unit.