Integrated analyte sensor and infusion device and methods therefor

• US 8,512,244 B2
• Filed: 09/26/2008
• Issued: 08/20/2013
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jennewine, R. Curtis
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/238,902
• Publication Number:
  US 20090069650A1
• Time in Patent Office: 1,789 Days
• Field of Search: 600/309, 600345-366, 604/503, 604/504, 604/506
• US Class Current: 600/365
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.

Claims

1. A method, comprising:

positioning a portion of a first cannula under the skin of a patient for establishing a first fluid pathway for delivery of a therapeutic agent to within the patient;

delivering the therapeutic agent to within the patient through the first cannula;

positioning a portion of a sensor under the skin of the patient;

automatically connecting a second cannula to a port of a fluid reservoir;

automatically positioning a portion of the second cannula under the skin of a patient for establishing a second fluid pathway for delivery of the therapeutic agent to within the patient, the second cannula being wholly retained within a housing before the portion of the second cannula is automatically positioned under the skin of the patient;

delivering the therapeutic agent to within the patient through the second cannula; and

automatically retracting the first cannula into the housing while retaining the sensor position under the skin of the patient;

wherein the withdrawing of the first cannula from the patient and the positioning the portion of the second cannula are performed such that delivery of the therapeutic agent to within the patient is continuous and uninterrupted while the first cannula is withdrawn and the second cannula is positioned.

2. The method of claim 1 wherein the positioning the portion of the first cannula and the positioning the portion of the sensor are substantially simultaneously performed.

3. The method of claim 1 wherein the sensor is positioned under the skin of the patient for approximately seven days.

4. The method of claim 1 wherein the sensor includes an analyte sensor.

5. The method of claim 1 wherein the withdrawing the first cannula from the patient and the positioning the portion of the second cannula are performed such that delivery of the therapeutic agent to within the patient is continuous.

6. The method of claim 1 wherein the withdrawing of the first cannula and the positioning of the second cannula are substantially simultaneously performed.

7. The method of claim 1 wherein the positioning of the portion of the second cannula is performed approximately mid-point in the usage life of the sensor.

8. The method of claim 7 wherein the usage life of the sensor is approximately 7 days.

9. The method of claim 1 wherein the therapeutic agent is contained within a reservoir, and wherein each of establishing the first fluid pathway and the second fluid pathway comprises connecting an infusion tubing between the reservoir and the first cannula and the second cannula, respectively.

10. The method of claim 1 wherein the portion of the first cannula is transcutaneously positioned through the skin of the patient at a first location, and the portion of the sensor is transcutaneously positioned through the skin of the patient at a second location, wherein the first location is spaced apart from the second location.

11. The method of claim 10 wherein the portion of the second cannula is transcutaneously positioned through the skin of the patient at a third location, wherein the third location is spaced apart from both the first location and the second location.

12. The method of claim 1 wherein withdrawing the first cannula from the patient is performed at a predetermined time during the usage life of the sensor, and wherein positioning of the portion of the second cannula is also performed at the predetermined time.

13. The method of claim 1 further comprising:

affixing a patch pump to the skin of the patient, wherein the patch pump comprises a housing, the first cannula, the sensor and the fluid reservoir containing the therapeutic agent;

wherein the first cannula is automatically retracted into the housing of the patch pump.

14. The method of claim 13 wherein the first cannula is wholly retained within the housing of the patch pump after the first cannula is retracted into the housing of the patch pump.

15. The method of claim 13 wherein the patch pump further comprises the second cannula that is wholly retained within the housing of the patch pump before the second cannula is positioned under the skin of the patient.

16. The method of claim 1 further comprising delivering the therapeutic agent to the patient through the first cannula and the second cannula according to a preprogrammed basal profile.

17. The method of claim 1 further comprising:

continuously detecting an analyte level in the interstitial fluid of the patient; and

intermittently transmitting at periodic intervals data associated with the detected analyte level.

18. The method of claim 12 wherein the usage life of the sensor is longer than the usage life of the first cannula.