Insulin pump and methods for operating the insulin pump

• US 10,251,583 B2
• Filed: 08/24/2012
• Issued: 04/09/2019
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Bernini, Nicole, Galley, Paul J., Lindegger, Stefan, Price, John F., Sigrist, Reto, Wagner, Robin S., Wilson, Richard W.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/593,575
• Publication Number:
  US 20130041342A1
• Time in Patent Office: 2,419 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A device and method for delivering insulin to a patient is disclosed. The method includes receiving an amount of insulin to deliver to a patient and beginning delivery of the insulin to the patient. The method further includes monitoring the delivery of the insulin to determine whether the insulin pump is able to deliver the entire amount of insulin and maintaining a timer until the insulin pump recommences the delivery of the insulin. The method includes comparing an amount of time indicated by the timer to a threshold. The method further includes generating a first insulin delivery record indicating that a first amount of insulin was delivered when the amount of time indicated by the timer is less than the threshold and a second insulin record indicating that a second amount of insulin was delivered when the amount of time indicated by the timer is greater than the threshold.

Claims

1. A method for delivering insulin to a patient using an insulin pump having one or more processors, the insulin pump being configured to operate in a pause mode, the method comprising:

receiving, at the insulin pump, an amount of insulin to deliver to a patient from a remote device;

beginning, by the insulin pump, delivery of the insulin to the patient;

monitoring, by the insulin pump, the delivery of the insulin to determine whether the insulin pump is able to deliver the entire amount of insulin;

determining, by the insulin pump, stoppage of insulin delivery to the patient by the insulin pump;

initiating, by the insulin pump, a timer in response to detecting the stoppage of insulin delivery;

recommencing, by the insulin pump, delivery of insulin to the patient by the insulin pump;

detecting, by the insulin pump, completion of insulin delivery to the patient by the insulin pump;

comparing, by the insulin pump, an amount of time indicated by the timer to a pause threshold in response to detecting completion of insulin delivery;

when the amount of time indicated by the timer is less than the pause threshold, generating a first insulin delivery record indicating that a first amount of insulin was delivered to the patient, the first amount being the entire amount of insulin, and storing the first insulin delivery record on a computer readable medium of the insulin pump; and

when the amount of time indicated by the timer is greater than the pause threshold, generating a second insulin delivery record indicating that a second amount of insulin was delivered to the patient and storing the second insulin delivery record on the computer readable medium, the second amount being less than the entire amount of insulin that was to be delivered to the patient.

2. The method of claim 1, wherein maintaining a timer further comprises:

generating, at the insulin pump, a first time stamp when the insulin pump determines that the insulin pump is unable to deliver the insulin; and

generating, at the insulin pump, a second time stamp when the insulin pump recommences delivery of the insulin,

wherein the amount of time indicated by the timer is the difference between the first time stamp and the second time stamp.

3. The method of claim 1, wherein monitoring the delivery of the insulin further comprises monitoring one or more conditions of the insulin pump, the one or more conditions being indicative of an inability to complete delivery of the insulin.

4. The method of claim 3, wherein monitoring the one or more conditions include at least one of:

monitoring, at the insulin pump, an insulin cartridge to determine whether the insulin cartridge is empty;

monitoring, at the insulin pump, the insulin cartridge to determine whether the insulin cartridge has been removed from the insulin pump;

monitoring, at the insulin pump, a battery of the insulin pump to determine whether the battery has insufficient charge;

monitoring, at the insulin pump, the battery of the insulin pump to determine whether the battery has been removed from the insulin pump; and

monitoring, at the insulin pump, the insulin cartridge to determine whether an insulin delivery mechanism of the insulin pump has become occluded.

5. The method of claim 3, further comprising:

when a condition causing the inability to complete delivery of the insulin is determined, monitoring, at the insulin pump, the condition causing the inability to determine whether the condition has been resolved.

6. The method of claim 5, further comprising:

when the condition has been resolved, presenting, at the insulin pump, for display on a graphical user interface of the insulin pump a request for confirmation from the patient to recommence the delivery of the insulin; and

when the patient provides the confirmation, commencing the delivery of the insulin.

7. The method of claim 1, wherein when the amount of time indicated by the timer is greater than the pause threshold, the method further comprises:

determining an amount of insulin delivered after the condition was resolved;

generating, at the insulin pump, a third insulin delivery record indicating a third amount of insulin was delivered to the patient, the third amount being the amount of insulin delivered after the condition was resolved; and

storing the third record on the computer readable medium.

8. The method of claim 7, further comprising:

when the amount of time indicated by the timer is greater than the pause threshold, communicating the second and third records to a diabetes management device.

9. The method of claim 1, further comprising:

when the amount of time indicated by the timer is less than the pause threshold, communicating the first record to a diabetes management device.

10. The method of claim 1, further comprising:

when the insulin pump is able to deliver the entire amount of insulin without interruption, generating the first insulin delivery record indicating that the entire amount of insulin was delivered to the patient.

11. An insulin pump configured to operate in a pause mode, the insulin pump comprising:

an insulin delivery mechanism that delivers insulin to a patient;

an insulin cartridge that couples to the insulin delivery mechanism, wherein the insulin delivery mechanism delivers insulin contained in the insulin cartridge to the patient;

a battery that powers the insulin pump;

an insulin delivery controller configured to;

receive an instruction indicating an amount of insulin to deliver to a patient;

instruct the insulin delivery mechanism to begin delivery of the insulin to the patient;

monitor the delivery of the insulin to determine whether the insulin pump is able to deliver the entire amount of insulin;

maintain a timer until the insulin pump recommences the delivery of the insulin when the insulin pump is unable to deliver the entire amount of insulin;

compare an amount of time indicated by the timer to a time threshold when the insulin pump recommences the delivery of the insulin;

generate a first insulin delivery record indicating that a first amount of insulin was delivered to the patient and storing the first record on a computer readable medium of the insulin pump when the amount of time indicated by the timer is less than the pause threshold, the first amount being the entire amount of insulin; and

generate a second insulin record indicating that a second amount of insulin was delivered to the patient and store the second record on the computer readable medium when the amount of time indicated by the timer is greater than the pause threshold, the second amount being less than the entire amount of insulin that was to be delivered to the patient.

12. The insulin pump of claim 11, wherein the insulin delivery controller is further configured to:

generate a first time stamp when the insulin pump determines that the insulin pump is unable to deliver the insulin; and

generate a second time stamp when the insulin pump recommences delivery of the insulin,

wherein the amount of time indicated by the timer is the difference between the first time stamp and the second time stamp.

13. The insulin pump of claim 11, wherein the insulin delivery controller, when monitoring the delivery of the insulin, is further configured to monitor one or more conditions of the insulin pump, the one or more conditions being indicative of an inability to complete delivery of the insulin.

14. The insulin pump of claim 13, wherein the insulin delivery controller, when monitoring the delivery of the insulin, is further configured to:

monitor the insulin cartridge to determine whether the insulin cartridge is empty;

monitor the insulin cartridge to determine whether the insulin cartridge has been removed from the insulin pump;

monitor the battery to determine whether the battery has insufficient charge;

monitor the battery to determine whether the battery has been removed from the insulin pump; and

monitor the insulin cartridge to determine whether an insulin delivery mechanism of the insulin pump has become occluded.

15. The insulin pump of claim 13, wherein when a condition causing the inability to complete delivery of the insulin is determined, the insulin delivery controller is further configured to monitor the condition causing the inability to determine whether the condition has been resolved, and when the condition has been resolved, to present on a graphical user interface of the insulin pump a request for confirmation from the patient to recommence the delivery of the insulin, wherein the insulin delivery controller recommences delivery of the insulin when the patient provides the confirmation.

16. The insulin pump of claim 11, wherein when the amount of time indicated by the timer is greater than the pause threshold, the insulin delivery controller is further configured to:

determine an amount of insulin delivered after the condition was resolved and to generate a third insulin delivery record indicating a third amount of insulin was delivered to the patient, the third amount being the amount of insulin delivered after the condition was resolved; and

store the third record on the computer readable medium.

17. The insulin pump of claim 11, wherein the insulin delivery controller is further configured to communicate the second and third records to a diabetes management device when the amount of time indicated by the timer is greater than the pause threshold, and to communicate the first record to a diabetes management device when the amount of time indicated by the timer is less than the pause threshold.