Detecting and responding to software and hardware anomalies in a fluid delivery system

Patent metadata

Field	Value
Publication number	US-9940440-B2
Application number	US-201113096756-A
Country	US
Kind code	B2
Filing date	Apr 28, 2011
Priority date	Apr 28, 2011
Publication date	Apr 10, 2018
Grant date	Apr 10, 2018

Abstract

A total dose of a therapeutic agent to be delivered to a patient by an infusion device over a total period of time is automatically divided into a plurality of unit doses to be delivered to the patient over a plurality of unit periods of time. The infusion device is automatically programmed to deliver one of the unit doses of the therapeutic agent to the patient over its respective unit period of time, after which the one unit dose is delivered, and a determination is made of whether an error occurred in delivering the one unit dose to the patient. Delivery of the total dose of the therapeutic agent to the patient may include iteratively automatically programming the infusion device to deliver successive unit doses upon determining that no error occurred in delivering a previous unit dose to the patient. Accordingly, the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced.

First claim

The invention claimed is:

1. A method comprising:
receiving a total dose of a therapeutic agent to be delivered to a patient by an infusion device over a total period of time;
automatically determining a plurality of individual unit dose segments from the total dose, each of the individual unit dose segments being equal to a respective fraction of the total dose, and each of the individual unit dose segments configured to be delivered to the patient by the infusion device over a respective unit period of time equal to a respective fraction of the total period of time;
automatically programming the infusion device to deliver to the patient one individual unit dose segment of the plurality of individual unit dose segments over its respective unit period of time;
delivering to the patient, by the infusion device, the one individual unit dose segment; and
determining whether an error has occurred in delivering the one individual unit dose segment to the patient.

2. The method of claim 1 , further comprising:
upon determining that no error has occurred in delivering the one individual unit dose segment to the patient, automatically programming the infusion device to deliver to the patient another one of the plurality of individual unit dose segments over its respective unit period of time, delivering, by the infusion device, the other individual unit dose segment to the patient, and determining whether an error has occurred in delivering the other individual unit dose segment to the patient.

3. The method of claim 1 , further comprising:
iteratively automatically programming the infusion device to deliver to the patient successive ones of the plurality of individual unit dose segments over their respective unit periods of time upon determining that no error has occurred in delivering a previous one of the plurality of individual unit dose segments to the patient, and delivering the successive individual unit dose segments until at least one of the total dose is delivered, or the total period of time elapses.

4. The method of claim 1 , wherein automatically determining the plurality of individual unit dose segments is performed by a processor of an external programmer, the method further comprising transmitting the plurality of individual unit dose segments from the external programmer to the infusion device.

5. The method of claim 4 , wherein automatically determining the plurality of individual unit dose segments is performed by a user using the external programmer.

6. The method of claim 4 , wherein automatically determining the plurality of individual unit dose segments comprises determining, by the processor, a plurality of total dose divisions and a user selecting one of the plurality of total dose divisions determined by the processor.

7. The method of claim 1 , wherein automatically determining the plurality of individual unit dose segments is performed by a processor of the infusion device.

8. The method of claim 1 , wherein the infusion device comprises a processor configured to automatically program the infusion device to deliver to the patient the one individual unit dose segment over its respective unit period of time, delivering to the patient, by the infusion device, the one individual unit dose segment, and determining whether the error has occurred in delivering the one individual unit dose segment to the patient.

9. The method of claim 1 , further comprising:
determining a maximum unit dose deliverable to the patient; and
comparing the one individual unit dose segment to be delivered to the patient by the infusion device to the maximum unit dose.

10. The method of claim 9 , further comprising delivering to the patient, by the infusion device, at least one of the maximum unit dose or a therapeutically-safe unit dose instead of the one individual unit dose segment.

11. The method of claim 9 , further comprising:
determining that the one individual unit dose segment exceeds the maximum unit dose; and
responsive to the determination, stopping delivering the therapeutic agent to the patient and generating an alarm.

12. The method of claim 9 , wherein the maximum unit dose is one of a plurality of maximum unit doses, and wherein determining the maximum unit dose comprises:
determining a total maximum dose of the therapeutic agent to be delivered to the patient by the infusion device over the total period of time; and
automatically dividing the total maximum dose into the plurality of maximum unit doses, each of which is equal to a fraction of the total maximum dose corresponding to the unit period of time equal to the fraction of the total period of time, wherein the maximum unit dose comprises one of the plurality of maximum unit doses corresponding to its respective unit period of time.

13. The method of claim 12 , wherein determining the total maximum dose comprises automatically determining the total maximum dose based on an infusion schedule that defines delivery of the therapeutic agent to the patient by the infusion device.

14. The method of claim 9 , further comprising indicating that an error condition is present in the event that the one determined individual unit dose segment is greater than the maximum unit dose.

15. The method of claim 14 , further comprising generating an alarm if it is indicated that the error condition is present.

16. The method of claim 9 , further comprising storing the one individual unit dose segment in a first portion of a memory and storing the maximum unit dose in a second portion of the memory.

17. The method of claim 16 , wherein the first portion of the memory is a first type of memory and the second portion of the memory is a second type of memory.

18. The method of claim 16 , wherein the first portion of the memory and the second portion of the memory are contained within a single memory.

19. The method of claim 16 , wherein the second portion of the memory comprises a locked memory, and wherein storing the maximum unit dose in the second portion of the memory comprises:
writing predetermined data to a first location in the locked memory to unlock a second, non-contiguous, different location in the locked memory for a predetermined period of time; and

subsequently storing, within the predetermined period of time, the maximum unit dose in the second location.

20. The method of claim 1 ,
wherein the total dose of the therapeutic agent to be delivered to the patient by the infusion device over the total period of time defines a total number of cycles of a pump of the infusion device to be performed over the total period of time,
wherein automatically determining the plurality of individual unit dose segments comprises automatically dividing the total number of cycles into a plurality of sets of pump cycles, each set of pump cycles being equal to a fraction of the total number of cycles configured to be delivered to the patient by the infusion device over the respective unit period of time equal to the respective fraction of the total period of time,
wherein automatically programming the infusion device to deliver the one individual unit dose segments comprises automatically programming the infusion device to deliver to the patient one of the plurality of sets of pump cycles over its respective unit period of time, and
wherein delivering the one individual unit dose segment comprises controlling the pump of the infusion device to execute the one set of pump cycles.

21. The method of claim 20 , wherein determining whether the

Assignees

• Ali Irfan Z
• Villalta Donald L
• Sarkinen Scott A
• Medtronic Inc

Inventors

• Ali Irfan Z
• Villalta Donald L
• Sarkinen Scott A

Classifications

• G06F19/3468 Primary

  Physics · mapped topic

• A61M2205/3569

  sublocal, e.g. between console and disposable · CPC title

• A61M2005/14208

  with a programmable infusion control system, characterised by the infusion program · CPC title

• A61M2205/3523

  using telemetric means · CPC title

• A61M2205/3561

  local, e.g. within room or hospital · CPC title