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

• US 9,940,440 B2
• Filed: 04/28/2011
• Issued: 04/10/2018
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ali, Irfan Z., Villalta, Donald L., Sarkinen, Scott A.
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): STILES, AMBER R.
• Application Number:
  US13/096,756
• Publication Number:
  US 20120277716A1
• Time in Patent Office: 2,539 Days
• Field of Search: 604 65, 604 67, 604151
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

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.

Claims

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 error has occurred in delivering the one individual unit dose segment comprises:

determining a maximum number of pump cycles;

decrementing a first counter corresponding to the maximum number of pump cycles and a second counter corresponding to a number of pump cycles in the one set of pump cycles, while delivering the one set of pump cycles; and

comparing a value in the first counter to a value in the second counter.

22. The method of claim 21, further comprising controlling the pump of the infusion device to execute at least one of the maximum number of pump cycles or a therapeutically-safe number of pump cycles instead of the one set of pump cycles.

23. The method of claim 21, further comprising controlling the pump to stop delivering the therapeutic agent to the patient and generating an alarm.

24. The method of claim 21, wherein the maximum number of pump cycles comprises the number of pump cycles in the one set of pump cycles.

25. The method of claim 20, wherein determining whether the error in delivering the one individual unit dose segment comprises:

determining a maximum time over which to deliver the one set of pump cycles;

decrementing a first counter corresponding to the maximum time over which to deliver the one set of pump cycles and a second counter corresponding to a number of pump cycles in the one set of pump cycles, while delivering the one set of pump cycles; and

stopping delivery of the one set of pump cycles when at least one of the first counter or the second counter reaches zero.

26. The method of claim 20 further comprising:

determining a threshold time between successive pump cycles of the one set of pump cycles for delivering the one set of pump cycles, based on one or more of the following;

a cycle time of the pump of the infusion device;

a maximum infusion rate of the therapeutic agent to the patient;

a voltage level of a power source of the infusion device; and

a time to complete all pump cycles in the one set of pump cycles.

27. The method of claim 20,

wherein automatically programming the infusion device to deliver the one set of pump cycles further comprises automatically programming the infusion device to deliver to the patient one or more undelivered pump cycles from a previously-delivered set of pump cycles, and

wherein delivering the one set of pump cycles further comprises delivering the one or more undelivered pump cycles.

28. A fluid delivery system comprising:

a pump configured to deliver a therapeutic agent to a patient;

a memory containing a total dose of the therapeutic agent to be delivered to the patient by the pump over a total period of time; and

a processor configured to 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 pump over a respective unit period of time equal to a respective fraction of the total period of time, automatically program an infusion device comprising the pump 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, control the pump to deliver to the patient the one individual unit dose segment, and determine whether an error has occurred in delivering the one individual unit dose segment to the patient.

29. The system of claim 28, wherein the processor is further configured to, upon determining that no error has occurred in delivering the one individual unit dose segment to the patient, automatically program 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, control the pump to deliver the other individual unit dose segment to the patient, and determine whether an error has occurred in delivering the other individual unit dose segment to the patient.

30. The system of claim 28, wherein the processor is further configured to iteratively automatically program the infusion device to deliver to the patient successive individual unit dose segments 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 control the pump to deliver the successive individual unit dose segments until at least one of the total dose is delivered, or the total period of time elapses.

31. The system of claim 28, wherein the processor comprises a first processor and a second processor, and wherein the first processor is configured to automatically determine the plurality of individual unit dose segments, and the second processor is configured to automatically program the infusion device to deliver the one individual unit dose segment, control the pump to deliver the one individual unit dose segment, and determine whether the error has occurred in delivering the one individual unit dose segment to the patient.

32. The system of claim 31, wherein the second processor is associated with the infusion device and the first processor is associated with an external programmer configured to communicate with the infusion device.

33. The system of claim 28, wherein the processor is further configured to determine a maximum unit dose deliverable to the patient, and compare the one individual unit dose segment to be delivered to the patient by the infusion device to the maximum unit dose.

34. The system of claim 33, wherein the processor is further configured to control the pump to deliver to the patient at least one of the maximum unit dose or a therapeutically-safe unit dose instead of the one individual unit dose segment.

35. The system of claim 33, wherein the processor is further configured to:

determine that the one individual unit dose segment exceeds the maximum unit dose; and

responsive to the determination, control the pump to stop delivering the therapeutic agent to the patient and generate an alarm.

36. The system of claim 33, wherein the maximum unit dose is one of a plurality of maximum unit doses, and wherein the processor configured to determine the maximum unit dose comprises:

the processor configured to determine 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 divide 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.

37. The system of claim 36, wherein the processor configured to determine the total maximum dose comprises the processor configured to determine the total maximum dose based on an infusion schedule that defines delivery of the therapeutic agent to the patient by the infusion device.

38. The system of claim 33, wherein the processor is further configured to indicate that an error condition is present in the event that the one determined individual unit dose segment is greater than the maximum unit dose.

39. The system of claim 38, wherein the processor is further configured to generate an alarm if it is indicated that the error condition is present.

40. The system of claim 33, wherein the memory comprises a plurality of portions, and wherein the processor is further configured to store the one individual unit dose segment in a first portion of the memory, and store the maximum unit dose in a second portion of the memory.

41. The system of claim 40, 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.

42. The system of claim 40, wherein the first portion of the memory and the second portion of the memory are contained within a single memory.

43. The system of claim 40, wherein the second portion of the memory comprises a locked memory, and wherein the processor configured to store the maximum unit dose in the second portion of the memory comprises:

the processor configured to store predetermined data in 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 store, within the predetermined period of time, the maximum unit dose in the second location.

44. The system of claim 28,

wherein the total dose of the therapeutic agent to be delivered to the patient by the pump over the total period of time defines a total number of cycles of the pump to be performed over the total period of time,

wherein the processor configured to automatically determine the plurality of individual unit dose segments comprises the processor configured to automatically divide 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 the processor configured to automatically program the infusion device to deliver the one individual unit dose segment comprises the processor configured to automatically program 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 the processor configured to control the pump to deliver the one individual unit dose segment comprises the processor configured to control the pump to execute the one set of pump cycles.

45. The system of claim 44, wherein the processor configured to determine whether the error has occurred in delivering the one individual unit dose segment to the patient comprises the processor configured to:

determine a maximum number of pump cycles;

decrement a first counter corresponding to the maximum number of pump cycles and a second counter corresponding to a number of pump cycles in the one set of pump cycles, while controlling the pump to deliver the one set of pump cycles; and

compare a value in the first counter to a value in the second counter.

46. The system of claim 45, wherein the processor is further configured to control the pump to deliver at least one of the maximum number of pump cycles or a therapeutically-safe number of pump cycles instead of the one set of pump cycles.

47. The system of claim 45, wherein the processor is further configured to control the pump to stop delivering the therapeutic agent to the patient and generate an alarm.

48. The system of claim 45, wherein the maximum number of pump cycles comprises the number of pump cycles in the one set of pump cycles.

49. The system of claim 44, wherein the processor configured to determine whether the error has occurred in delivering the one individual unit dose segment to the patient comprises the processor configured to:

determine a maximum time over which to deliver the one set of pump cycles;

decrement a first counter corresponding to the maximum time over which to deliver the one set of pump cycles and a second counter corresponding to a number of pump cycles in the one set of pump cycles, while delivering the one set of pump cycles; and

control the pump to stop executing the one set of pump cycles when at least one of the first counter or the second counter reaches zero.

50. The system of claim 44, wherein the processor is further configured to determine a threshold time between successive pump cycles of the one set of pump cycles for delivering the one set of pump cycles, based on one or more of the following:

a cycle time of the pump of the infusion device;

a maximum infusion rate of the therapeutic agent to the patient;

a voltage level of a power source of the infusion device; and

a time to complete all pump cycles in the one set of pump cycles.

51. The system of claim 44,

wherein the processor configured to automatically program the infusion device to deliver the one set of pump cycles comprises the processor further configured to automatically program the infusion device to deliver to the patient one or more undelivered pump cycles from a previously-delivered set of pump cycles, and

wherein the processor configured to control the pump to deliver the one set of pump cycles comprises the processor further configured to control the pump to deliver the one or more undelivered pump cycles.

52. The system of claim 51, wherein the processor is configured to compare the one or more undelivered pump cycles to a threshold, and, if the one or more undelivered pump cycles exceeds the threshold, generate an alarm.

53. A computer-readable storage medium comprising instructions for causing a programmable processor to:

receive a total dose of a therapeutic agent to be delivered to a patient by an infusion device over a total period of time;

automatically determine a plurality of individual unit dose segments from the total dose, each individual unit dose segment being equal to a respective fraction of the total dose, and each individual unit dose segment 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 program 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;

deliver to the patient, by the infusion device, the one individual unit dose segment; and

determine whether an error has occurred in delivery of the one individual unit dose segment to the patient.

54. A fluid delivery system comprising:

means for receiving a total dose of a therapeutic agent to be delivered to a patient by an infusion device over a total period of time;

means for automatically determining a plurality of individual unit dose segments from the total dose, each individual unit dose segment being equal to a respective fraction of the total dose, and each individual unit dose segment 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;

means for 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;

means for delivering to the patient, by the infusion device, the one individual unit dose segment; and

means for determining whether an error has occurred in delivering the one individual unit dose segment to the patient.