Infusion pump system

• US 9,731,072 B2
• Filed: 07/24/2014
• Issued: 08/15/2017
• Est. Priority Date: 05/05/2008
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Estes, Mark C.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Stiles, Amber
• Application Number:
  US14/339,642
• Publication Number:
  US 20140336570A1
• Time in Patent Office: 1,118 Days
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Some embodiments of a portable infusion pump system can be configured to can be configured to adjust the sensitivity of particular detectors or alert systems based (at least in part) on information received from a monitoring device. For example, a glucose monitoring device can communication with an infusion pump assembly used to supply insulin or another medication to a user. In such circumstances, the data received from the monitoring device can be used to adjust the sensitivity of an occlusion detection system.

Claims

1. A method of operating an insulin infusion pump system, comprising:

activating an occlusion detection system to detect a fluid pressure in a flow path extending from an insulin reservoir in a portable insulin pump apparatus to a user, the portable insulin pump apparatus including a pump drive system to dispense insulin through the flow path to the user;

activating the pump drive system to deliver an incremental dosage of insulin;

in response to a signal from the occlusion detection system indicating a fluid pressure greater than a threshold pressure limit for the incremental dosage of insulin, increasing a counter value stored in a memory device of the portable insulin pump apparatus while foregoing output of an occlusion alarm;

in response to a signal from the occlusion detection system indicating a fluid pressure less than or equal to the threshold pressure limit for each incremental dosage of insulin, resetting the counter value to zero;

adjusting a threshold counter value based on glucose information; and

in response to the counter exceeding the threshold counter value, outputting the occlusion alarm from portable insulin pump apparatus to the user.

2. The method of claim 1, wherein the portable insulin pump apparatus comprises:

a portable pump housing that receives insulin for dispensation to the user, and a controller that provides electrical signals to activate the pump drive system to dispense the insulin from the portable pump housing.

3. The method of claim 2, wherein the controller operates the occlusion detection system that detects the fluid condition in the flow path.

4. The method of claim 2, wherein the controller is removably attachable to the portable pump housing, the controller comprising:

a controller housing that removably attaches to the portable pump housing, a user interface that includes a display device, and an electrical connector that mates with a complementary electrical connector of the portable pump housing when the controller housing is removably attached to the portable pump housing.

5. The method of claim 1, wherein the flow path comprises the insulin reservoir in which the insulin is retained, at least a portion of a cap device that secures to a portable pump housing of the portable insulin pump apparatus so as to cover an external opening of the portable pump housing, and an infusion set tube that extends from the cap device to the user.

6. The method of claim 1, wherein the occlusion detection system comprises at least one of a pressure transducer and a pressure switch to communicate signals to a controller of the portable insulin pump apparatus indicative of fluid pressure in the flow path of the insulin.

7. The method of claim 1, wherein the occlusion detection system comprises an optical sensor arranged proximate to the flow path of the insulin.

8. A method of operating an insulin infusion pump system, comprising:

activating an occlusion detection system to detect a fluid condition in a flow path extending from an insulin reservoir in a portable insulin pump apparatus to a user, the portable insulin pump apparatus including a pump drive system to dispense insulin through the flow path to the user;

activating the pump drive system to deliver a first incremental dosage of insulin;

in response to a first signal from the occlusion detection system indicating an occlusion in the flow path, increasing a counter value stored in a memory device of the portable insulin pump apparatus while foregoing output of an occlusion alarm;

activating the pump drive system to deliver one or more subsequent incremental dosages of insulin;

in response to a predetermined quantity of consecutive signals from the occlusion detection system indicating the occlusion in the flow path, outputting the occlusion alarm from portable insulin pump apparatus to the user

receiving glucose information from a monitoring device, the glucose information being indicative of a detected blood glucose level of the user; and

adjusting a sensitivity of the occlusion detection system based upon the glucose information from the monitoring device, wherein the sensitivity of the occlusion detection system is adjusted by altering a value of the predetermined quantity of consecutive signals from the occlusion detection system indicating the occlusion.

9. The method of claim 8, wherein the sensitivity of the occlusion detection system is increased in response to glucose information received from the monitoring device that indicates the detected blood glucose level is greater than a predetermined value.

10. The method of claim 9, further comprising outputting an alarm via a user interface to indicate the detected blood glucose level is outside of a normal range.

11. The method of claim 9, further comprising outputting an alarm via a user interface to indicate a change to the occlusion detection system.

12. The method of claim 8, wherein the sensitivity of the occlusion detection system is increased in response to glucose information received from the monitoring device that indicates the detected blood glucose level is rising at a rate greater than a predetermined rate.

13. The method of claim 12, further comprising outputting an alarm via a user interface to indicate a change to the occlusion detection system.

14. The method of claim 8, wherein the sensitivity of the occlusion detection system is decreased in response to glucose information received from the monitoring device that indicates the detected blood glucose level is less than a predetermined value.

15. The method of claim 14, further comprising outputting an alarm via a user interface to indicate the detected blood glucose level is outside of a normal range.

16. The method of claim 14, further comprising outputting an alarm via a user interface to indicate a change to the occlusion detection system.

17. The method of claim 8, wherein the sensitivity of the occlusion detection system is decreased in response to glucose information received from the monitoring device that indicates the detected blood glucose level is decreasing at a rate greater than a predetermined rate.

18. The method of claim 17, further comprising outputting an alarm via a user interface to indicate a change to the occlusion detection system.

19. The method of claim 8, further comprising resetting the counter value to zero in response to a signal from the occlusion detection system indicating no occlusion in the flow path.

20. The method of claim 8, wherein each signal from the occlusion detection system indicating the occlusion is representative of a detected pressure in the flow path that is greater than a threshold pressure limit.