Method and system for providing an integrated analyte sensor insertion device and data processing unit

• US 10,362,972 B2
• Filed: 10/17/2017
• Issued: 07/30/2019
• Est. Priority Date: 09/10/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Hindenburg, Max F
• Application Number:
  US15/786,272
• Publication Number:
  US 20180049680A1
• Time in Patent Office: 651 Days
• 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. A method, comprising:

piercing a body of a subject with a sharp distal end of an introducer, the introducer having a portion disposed within a housing;

positioning a first portion of an analyte sensor in the body of the subject, wherein the first portion of the analyte sensor is at least partially disposed within the introducer prior to positioning the first portion of the analyte sensor, and wherein the analyte sensor includes a second portion coupled in electrical contact with a data processing unit disposed within the housing prior to positioning the first portion of the analyte sensor; and

removing the introducer from the housing after positioning the first portion of the analyte sensor such that the first portion of the analyte sensor remains positioned in the body of the subject.

2. The method of claim 1, further comprising attaching an adhesive layer provided on a lower surface of the housing to the body of the subject.

3. The method of claim 2, further comprising removing a protective layer from the adhesive layer prior to attaching the adhesive layer to the body of the subject.

4. The method of claim 1, wherein the first portion of the analyte sensor is in fluid contact with a biological fluid in the body after removing the introducer from the housing.

5. The method of claim 1, further comprising decoupling the introducer from the data processing unit after the first portion of the analyte sensor is positioned in the body of the subject.

6. The method of claim 1, further comprising receiving, by a data communication unit of the data processing unit, one or more signals associated with a monitored analyte level from the analyte sensor.

7. The method of claim 6, further comprising wirelessly communicating, by the data communication unit, data associated with the one or more signals received from the analyte sensor to a remote location.

8. The method of claim 1, wherein the introducer is positioned through an aperture of the housing.

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

10. A method, comprising:

piercing a body of a subject with a sharp distal end of an introducer, the introducer being at least partially disposed within a housing;

positioning a first portion of an analyte sensor in the body of the subject, wherein the analyte sensor is coupled to the housing, wherein the first portion of the analyte sensor is at least partially disposed within the introducer prior to positioning the first portion of the analyte sensor, wherein the analyte sensor includes a second portion in electrical communication with a data processing unit prior to positioning the first portion of the analyte sensor, and wherein the second portion of the analyte sensor and the data processing unit are disposed within the housing; and

removing the introducer from the housing through an aperture in the housing such that the first portion of the analyte sensor remains positioned in the body of the subject.

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

12. The method of claim 10, further comprising decoupling the introducer from the data processing unit after the first portion of the analyte sensor is positioned in the body of the subject.

13. The method of claim 10, further comprising receiving, by a data communication unit of the data processing unit, one or more signals associated with a monitored analyte level from the analyte sensor.

14. The method of claim 13, further comprising wirelessly communicating, by the data communication unit, data associated with the one or more signals received from the analyte sensor to a remote location.

15. The method of claim 10, further comprising attaching an adhesive layer on a lower surface of the housing to the body of the subject.

16. The method of claim 10, wherein the introducer is positioned through the aperture of the housing when the sharp distal end of the introducer pierces the body of the subject.

17. The method of claim 10, further comprising receiving the sharp distal end of the introducer through an opening in the data processing unit.

18. The method of claim of claim 10, further comprising engaging a proximal portion of the introducer to an outer surface of the data processing unit.