OCCLUSION RESOLUTION IN MEDICATION DELIVERY DEVICES, SYSTEMS, AND METHODS

• US 20170203036A1
• Filed: 01/12/2017
• Published: 07/20/2017
• Est. Priority Date: 01/14/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Mazlish, Bryan, Rontala Raghunathan, Ravi Shankar, Desborough, Lane
• Granted Patent: US 10,610,643 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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

Abstract

Methods, devices, and systems of delivering infusion fluid (e.g., medication such as insulin) can detect, at multiple times during a dispensation period of time, a pressure level of the infusion fluid in an infusion fluid pathway, either directly or indirectly. Based on the detected pressure levels, one or more actual dispensation times that are after an intended dispensation time can be determined. In some cases, methods, devices, and systems provided herein can use variable occlusion alarm thresholds, which can depend on variables such as an age of an infusion set and/or a current analyte level. In some cases, methods, devices, and systems provided herein can automate medication delivery and use the actual dispensation times in a control algorithm determining medication deliveries.

Claims

1. A method of operating a portable infusion pump system, the method comprising:

initiating a dispensation of an infusion fluid by a pump of the portable infusion pump system at an intended dispensation time;

detecting, at multiple times during a dispensation period of time, pressure measurements of the infusion fluid in an infusion fluid pathway of the pump;

comparing each of pressure measurements detected at the multiple times during the dispensation period to one or more threshold pressure values; and

determining, based on one or more of the detected pressure measurements exceeding the one or more of the threshold pressure values, that the dispensation occurred at an actual dispensation time that is after the intended dispensation time.

2. The method of claim 1, wherein the infusion fluid is insulin.

3. The method of claim 2, wherein control circuitry of the infusion pump system calculates an estimate of insulin-on-board using the actual dispensation time.

4. The method of claim 2, further comprising receiving, from a blood glucose detection device, at least one blood glucose level, wherein an amount of insulin in the dispensation is determined based at least in part upon the at least one blood glucose level and an estimate of insulin-on-board.

5. The method of claim 4, further comprising outputting an occlusion alarm if one or more of the detected pressure measurements exceeds a variable threshold, the variable threshold being dependent upon at least one detected blood glucose value.

6. The method of claim 5, wherein the variable threshold is further dependent on a timing of one or more recent dispensations, amount of one or more recent dispensations, type of one or more recent dispensations, or a combination thereof.

7. The method of claim 2, further comprising predicting a future blood glucose level based on the actual dispensation time.

8. The method of claim 2, further comprising determining an amount of insulin that is stuck in transit in the infusion fluid pathway of the pump due to an occlusion based on a current detected pressure level, wherein the actual dispensation time is determined based on a time that the detected pressure decreases from a previously detected pressure, wherein an amount of insulin stuck in transit is excluded from an insulin-on-board calculation performed by control circuitry of the portable infusion pump system.

9. The method of claim 1, wherein, in response to determining that the dispensation occurred at an actual dispensation time that is after the intended dispensation time, delaying or reducing a subsequent dispensation of the infusion fluid.

10. The method of claim 1, wherein the pressure level is determined or estimated using a pressure sensor or a force sensor.

11. A method of operating a portable infusion pump system, the method comprising:

initiating an intended dispensation of an infusion fluid to a user via an infusion set defining an infusion fluid pathway;

detecting, at multiple times during a dispensation period of time, pressure measurements a pressure level of the infusion fluid in an infusion fluid pathway of the pump;

comparing each of the pressure measurements detected at the multiple times during the dispensation period to one or more threshold pressure values; and

determining, based on one or more of the detected pressure measurements exceeding the one or more of the threshold pressure values, that the intended dispensation did not enter the user.

12. The method of claim 11, further comprising initiating a notification that the infusion set is not coupled to the user in response to determining that the intended dispensation did not enter the user.

13. A method for detecting an occlusion in an automated medication delivery system comprising:

detecting at least one real-time analyte level for a user;

determining a dosage of medication for delivery to the user based on the at least one real-time analyte level, wherein the dosage of medication is determined without user input;

initiating a dispensation of the determined dosage of the medication using a medication delivery device;

measuring a pressure of the medication in an infusion fluid pathway of the medication delivery device; and

initiating an occlusion alarm if the measured pressure exceeds a variable threshold, the variable threshold being dependent upon at least one detected blood glucose value.

14. The method of claim 13, wherein the variable threshold is further dependent on a timing of one or more recent dispensations, amount of one or more recent dispensations, type of one or more recent dispensations, or a combination thereof.

15. The method of claim 13, wherein the medication is insulin and the analyte levels are glucose levels.

16. The method of claim 15, wherein determining the dosage of insulin for delivery to the user includes using a control algorithm adapted to minimize variations of glucose levels from a desired target or range, wherein the control algorithm includes an estimation of insulin-on-board.

17. The method of claim 16, wherein the estimation of insulin-on-board excludes an estimation of insulin-in-transit, wherein the insulin-in-transit is estimated based on the detected pressure level.

18. The method of claim 17, wherein at least part of an estimated insulin-in-transit is added back to the estimated insulin-on-board if the detected pressure level decreases.

19. The method of claim 15, further comprising:

initiating an alarm inducing dispensation of insulin if the measured pressure is below the variable threshold but above a suspected occlusion threshold in response to determining that the delivery of the insulin-in-transit and the alarm inducing dispensation of insulin is safe based at least in part upon the at least one real-time blood glucose level; and

initiating an occlusion alarm if the measured pressure after the alarm inducing dispensation of insulin increases by a predetermined amount or above the variable threshold.

20. The method of claim 19, wherein the alarm inducing dispensation of insulin is less than or equal to a maximum basal insulin dose to be delivered to the user over the next hour;

wherein if the alarm inducing dispensation of insulin does not result in the initiation of the occlusion alarm and the control algorithm does not automate subsequent basal insulin deliveries, the alarm inducing dispensation of insulin is subtracted from future programmed basal insulin doses.