Integrated analyte sensor and infusion device and methods therefor

• US 9,119,582 B2
• Filed: 06/30/2006
• Issued: 09/01/2015
• 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:
  US11/428,299
• Publication Number:
  US 20080004515A1
• Time in Patent Office: 3,350 Days
• Field of Search: 600/309, 600345-366, 604 65- 67
• US Class Current: 1/1
• 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. An integrated therapy management system, comprising:

a housing including a bottom surface for placement on a skin layer;

a reservoir including a therapeutic agent provided within the housing;

a first cannula for transcutaneous placement under the skin layer of a patient at a first infusion site for a first time period, the first cannula connected to the reservoir at a first position on the reservoir;

a second cannula for transcutaneous placement under the skin layer of the patient at a second infusion site for a second time period, the second cannula connected to the reservoir at a second position on the reservoir, the second position on the reservoir different from the first position on the reservoir; and

a sensor configured for fluid contact with an analyte of the patient for a predetermined time period, the sensor having at least a portion coupled to the housing;

wherein the first cannula and the second cannula are configured to deliver the therapeutic agent to the patient during the predetermined time period; and

wherein at least a portion of the first cannula is configured to extend from the bottom surface of the housing at a first location and at least a portion of the sensor is configured to extend from the bottom surface of the housing at a second location when the housing is placed on the skin surface.

2. The system of claim 1 wherein the second cannula is connected to the housing by an infusion tubing.

3. The system of claim 1 wherein the first infusion site and the second infusion site are separated by a predetermined distance.

4. The system of claim 1 wherein the predetermined time period includes approximately seven days.

5. The system of claim 1 wherein the reservoir includes a first reservoir including the first position coupled to the first cannula, and a second reservoir including the second position coupled to the second cannula.

6. The system of claim 1 wherein when the second cannula is transcutaneously positioned, the first cannula is withdrawn from the first infusion site.

7. The system of claim 1 wherein the sensor includes an analyte sensor.

8. The system of claim 1 wherein the therapeutic agent includes insulin.

9. The system of claim 1 wherein the housing includes a port disposed thereon, the port configured for fluid communication with the reservoir in the housing.

10. The system of claim 9 wherein the port is coupled to the second position on the reservoir for fluid communication with the second cannula.

11. The system of claim 1 wherein the first cannula is entirely retained within the housing during the second time period.

12. The system of claim 1 wherein at least a portion of the second cannula is configured to extend from the bottom surface of the housing at a third location when the housing is placed on the skin surface.

13. The system of claim 1 wherein the first location and the second location on the bottom surface of the housing are spaced apart from each other.

14. An integrated therapy management system, comprising:

an on-body micropump including;

a pump housing including a reservoir for retaining a therapeutic agent, the housing including a bottom surface for placement on a skin layer;

a first cannula for transcutaneous placement under the skin layer of a patient at a first infusion site for a first time period, wherein at least a portion of the first cannula is configured to extend from the bottom surface of the pump housing at a first location on the housing when the housing is placed on the skin surface, and wherein the first cannula is connected to the reservoir at a first location on the reservoir;

a second cannula for transcutaneous placement under the skin layer of the patient at a second infusion site for a second time period, the second cannula coupled to the pump housing and connected to the reservoir at a second location on the reservoir; and

an analyte sensor configured for fluid contact with an analyte of the patient for a predetermined time period, the analyte sensor having at least a portion configured to extend from the bottom surface of the pump housing at a second location when the housing is placed on the skin surface; and

a controller in signal communication with the on-body micropump, the controller configured to transmit one or more signals to the micropump to control the delivery of the therapeutic agent from the reservoir to the patient using one or more of the first cannula and the second cannula.

15. The system of claim 14 wherein the micropump further includes a transmitter unit operatively coupled to the analyte sensor.

16. The system of claim 15 wherein the controller is configured to receive one or more signals associated with one or more analyte levels of the patient from the transmitter unit.

17. The system of claim 16 wherein the controller is further configured to receive one or more signals associated with the therapeutic agent delivery.

18. The system of claim 14 wherein the controller is in signal communication with the on-body micropump over a wireless communication link.

19. An integrated therapy management system, comprising:

a patch pump including;

a compact housing including a bottom surface for placement on a skin layer;

a reservoir provided in the compact housing;

a first cannula for transcutaneous placement under the skin layer of a patient at a first infusion site for a first time period to deliver a medication from the reservoir in the housing, the first cannula coupled to a first location on the reservoir;

a second cannula for transcutaneous placement under the skin layer of the patient at a second infusion site for a second time period to deliver the medication from the reservoir in the housing, the second cannula coupled to a second location on the reservoir; and

an analyte sensor in fluid contact with an analyte of the patient for a predetermined time period, the analyte sensor configured to monitor the analyte level of the patient, at least a portion of the analyte sensor operatively coupled to the compact housing;

wherein the first time period and the second time period are substantially nonoverlapping, and further the combined first and second time periods substantially correspond to the predetermined time period during which the analyte sensor is in fluid contact with the analyte of the patient; and

wherein at least a portion of the first cannula is configured to extend from the bottom surface of the housing at a first location and at least a portion of the analyte sensor is configured to extend from the bottom surface of the housing at a second location when the housing is placed on the skin surface.

20. The system of claim 19 wherein the analyte sensor is a glucose sensor.

21. The system of claim 19 including an infusion tubing connected to the compact housing, wherein the second cannula is connected to the infusion tubing.

22. The system of claim 19 including a controller provided in the housing and operatively coupled to the analyte sensor to process one or more signals received from the analyte sensor.

23. The system of claim 19 wherein the second cannula extends from the housing at a third location.

24. The system of claim 23 wherein the third location is not on the bottom surface of the housing.

25. An integrated therapy management system, comprising:

a fluid reservoir;

a first cannula for transcutaneous placement under a skin layer of a patient at a first infusion site for a first time period, the first cannula connected to the fluid reservoir at a first location on the fluid reservoir;

a second cannula for transcutaneous placement under the skin layer of the patient at a second infusion site for a second time period, the second cannula connected to the fluid reservoir at a second location on the fluid reservoir;

an analyte sensor configured for fluid contact with an analyte of the patient for a predetermined time period;

a housing having a bottom surface configured for contacting the skin surface, wherein at least a portion of the first cannula is configured to extend from the bottom surface of the housing at a first location and at least a portion of the analyte sensor is configured to extend from the bottom surface of the housing at a second location when the housing is placed on the skin surface; and

a control unit operatively coupled to the first cannula, the second cannula and the analyte sensor, the control unit configured to control, at least in part, the delivery of a therapeutic agent from the fluid reservoir via the first cannula and the second cannula, and further, to process one or more analyte related signals from the analyte sensor;

wherein the therapeutic agent is delivered via the first cannula during the first time period, and further, via the second cannula during the second time period;

wherein the sum of the first time period and the second time period substantially corresponds to the predetermined time period during which the analyte sensor is in fluid contact with the analyte; and

further wherein the therapeutic agent is delivered substantially continuously during the predetermined time period during which the analyte sensor is in fluid contact with the analyte.

26. The system of claim 25 wherein the second cannula extends from the housing at a third location.

27. The system of claim 26 wherein the third location is not on the bottom surface of the housing.