Infusion pump system and methods

• US 8,287,487 B2
• Filed: 10/15/2008
• Issued: 10/16/2012
• Est. Priority Date: 10/15/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Estes, Mark C.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Gilbert, Andrew
• Application Number:
  US12/251,629
• Publication Number:
  US 20100094251A1
• Time in Patent Office: 1,462 Days
• Field of Search: 604/504, 604/890.1, 604 65- 67, 604/131, 604/151
• US Class Current: 604/66
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user'"'"'s insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user'"'"'s blood glucose characteristics, the user'"'"'s insulin load information, or the like.

Claims

1. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing; and

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user,

wherein the controller outputs an alarm when the glucose information indicates that the blood glucose level reaches beyond a glucose alarm limit parameter, the glucose alarm limit parameter being adjustable by the controller in response to an insulin load of the user.

2. The system of claim 1, wherein the controller is a reusable device and the pump housing and pump drive system are disposable and nonreusable.

3. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user, wherein the portable pump housing receives a prefilled cartridge of the insulin;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user,

wherein the controller outputs an alarm when the glucose information indicates that the blood glucose level reaches beyond a glucose alarm limit parameter, the glucose alarm limit parameter being adjustable by the controller in response to an insulin load of the user.

4. The system of claim 3, wherein the insulin load of the user represents an estimated amount of insulin delivered to the user'"'"'s body which has not yet acted in the user.

5. The system of claim 4, wherein the insulin load of the user is calculated as a total insulin load indicative of bolus and basal insulin dosages that have dispensed but not yet acted in the user.

6. The system of claim 5, wherein the total insulin load is determined by the controller according to a function that accounts for (i) a bolus insulin load indicative of one or more bolus insulin dosages that have been dispensed into the user but not yet acted in the user, (ii) a basal insulin load indicative of one or more basal insulin dosages that have been dispensed into the user from the portable infusion pump system but not yet acted in the user;

and (iii) a previous food component based upon previous food intake that has not yet metabolized in the user.

7. The system of claim 3, further comprising a computer-readable memory device coupled to the controller that stores the glucose information received from the monitoring device and time values associated with the glucose information.

8. The system of claim 3, wherein the controller outputs the alarm when the glucose information indicates that the blood glucose level increases above an upper glucose alarm limit parameter or decreases below a lower glucose alarm limit parameter.

9. The system of claim 3, further comprising a user interface coupled to the controller, the user interface including a display device that indicates when the glucose alarm limit parameter is adjusted by the controller in response to the insulin load of the user.

10. The system of claim 9, wherein the display device contemporaneously displays a glucose value indicative of the blood glucose level of the user and a calculated insulin load value indicative of estimated amount of insulin delivered to the user'"'"'s body which has not yet acted.

11. The system of claim 3, wherein the glucose alarm limit parameter is dynamically changed over time by the controller as the insulin load of the user increases or decreases.

12. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user, the glucose information being stored in a computer-readable memory device over a period of time,

wherein the controller accesses the glucose information stored in the memory device to detect a glucose information pattern indicative of a missed insulin bolus,

wherein the computer-readable memory device stores the glucose information received from the monitoring device and time values associated with the glucose information, and

wherein the glucose information pattern indicative of the missed insulin bolus comprises a local minimum within a blood glucose curve based upon the glucose information stored in the memory device over the period of time.

13. The system of claim 12, wherein the controller outputs an alarm when the controller detects a glucose information pattern indicative of a missed insulin bolus.

14. The system of claim 13, further comprising a user interface coupled to the controller, wherein the user interface prompts the user for corrective action when the controller detects a glucose information pattern indicative of a missed insulin bolus.

15. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a monitoring device that communicates glucose information to the controller, the glucose information being indicative of a blood glucose level of the user, the glucose information being stored in a computer-readable memory device over a period of time;

wherein the controller accesses the glucose information stored in the memory device to detect a glucose information pattern indicative of missed food intake.

16. The system of claim 15, wherein the controller outputs an alarm when the controller detects a glucose information pattern indicative of the missed food intake.

17. The system of claim 16, further comprising a user interface coupled to the controller, wherein the user interface prompts the user for corrective action when the controller detects a glucose information pattern indicative of the missed food intake.

18. The system of claim 15, wherein the computer-readable memory device stores the glucose information received from the monitoring device and time values associated with the glucose information.

19. The system of claim 18, wherein the glucose information pattern indicative of the missed food intake comprises a local maximum within a blood glucose curve based upon the glucose information stored in the memory device over the period of time.