Implantable medical pump diagnostics

• US 9,192,719 B2
• Filed: 11/01/2010
• Issued: 11/24/2015
• Est. Priority Date: 11/01/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rogers, Charles R., Ali, Irfan Z., Mezera, Ronald L., Miesel, Keith A., Sarkinen, Scott A., Whitehead, Nicholas R.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US12/916,720
• Publication Number:
  US 20120109099A1
• Time in Patent Office: 1,849 Days
• Field of Search: 604 65- 67, 604/890.1, 604/891.1, 604/151, 73/10.2, 4174131-4132
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142

Abstract

A method of detecting a fault condition within an implantable medical pump comprises delivering therapeutic fluid using a medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke, detecting a property associated with energizing the actuation mechanism, and determining whether the property associated with energizing the actuation mechanism indicates that a fault condition exists with the medical pump.

Claims

1. A medical device system comprising:

a medical pump configured to deliver a therapeutic fluid to a patient, the medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke;

a sensor configured to detect a property associated with energizing the actuation mechanism, the property associated with energizing the actuation mechanism comprising a shape of at least a waveform portion of an electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke; and

a processor configured to;

store a baseline shape that indicates one of a normal pump stroke and a fault condition in a memory,

compare the baseline shape to the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke, and

determine, based on the comparison, whether the shape of at least the waveform portion of the electrical waveform indicates that a fault condition exists within the medical pump.

2. The system of claim 1, wherein the processor is further configured to initiate a recovery action to attempt to remedy the fault condition if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

3. The system of claim 2, wherein the recovery action comprises a recovery sequence initiated by the processor.

4. The system of claim 2, wherein the recovery action comprises at least one of:

delivering a bolus of fluid through the medical pump;

increasing a drive voltage of the actuation mechanism;

increasing or decreasing a charge time of a capacitor that drives the actuation mechanism;

increasing a rate of pump strokes delivered by the medical pump;

initiating a pump reset; and

reinitializing the medical pump.

5. The system of claim 2, wherein the processor is further configured to determine whether the recovery action resolved the fault condition after initiating the recovery action.

6. The system of claim 1, wherein the processor is configured to monitor the medical pump to determine whether the fault condition has been resolved if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

7. The system of claim 6, wherein the processor is configured to determine that the fault condition has been resolved when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition has been resolved, or when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition has been resolved.

8. The system of claim 6, wherein the processor is configured to log a time stamp indicating a time at which the fault condition was determined to have been resolved if the processor determines that the fault condition has been resolved.

9. The system of claim 6, wherein the processor is configured to initiate an alarm when the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists and to clear the alarm when if the processor determines that the fault condition has been resolved.

10. The system of claim 1, wherein the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke is a first shape of at least a first waveform portion of a first electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide a first pump stroke, and wherein:

the sensor is configured to detect a second shape of at least a second waveform portion of a second electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide a second pump stroke subsequent to the first pump stroke, the second shape being different than the first shape,

the processor is configured to recognize a progression from the first shape of the at least first waveform portion to the second shape of the at least second waveform portion; and

the processor is configured to determine, according to the progression from the first shape to the second shape, that the fault condition exists within the medical pump.

11. The system of claim 10, wherein the processor is configured to determine that the fault condition exists by determining that the progression from the first shape of the at least first waveform portion to the second shape of the at least second waveform portion occurs within a predetermined number of pump strokes.

12. The system of claim 1, wherein the actuation mechanism comprises a coil configured to be energized to provide a pump stroke and an actuator that is movable in response to the energization of the coil.

13. The system of claim 1, wherein the fault condition comprises one of a plurality of fault condition types, and wherein the processor is further configured to identify which of the plurality of fault condition types exists if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

14. The system of claim 1, wherein the fault condition comprises at least one of:

a full stall of the actuation mechanism;

a partial stall of the actuation mechanism;

a high energy pump stroke;

a low energy pump stroke;

gas accumulation within the medical pump;

air locking of the medical pump;

voltage depletion of a power source;

blockage in a flow path of the medical pump;

an electrical short in the actuation mechanism;

an open switch between the power source and the actuation mechanism; and

an electrical open circuit in the actuation mechanism.

15. The system of claim 1, wherein the processor is configured to determine that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition exists, or when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition exists.

16. The system of claim 1, wherein the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke comprises a shape of at least a waveform portion of an electrical current waveform through the actuation mechanism when the actuation mechanism is energized to provide the pump stroke, and wherein the shape of at least the waveform portion of the electrical current waveform is defined by at least one of:

a time from a start of the electrical current waveform to an initial peak current of the electrical current waveform;

a change in time between the initial peak current and one of a subsequent nadir and a subsequent peak current of the electrical current waveform;

a change in time between a start and an end of the subsequent nadir;

a time from the start of the electrical current waveform to a nadir indicating an end of a pump stroke;

an amplitude value of one or more of the initial peak current, the subsequent nadir, and the subsequent peak current;

a change in current value between the initial peak current and the subsequent nadir;

an initial current rise rate of change of the electrical current waveform; and

a current rate of change of the nadir indicating the end of the pump stroke.

17. The system of claim 1, wherein the sensor comprises at least one of a current sensor and a voltage sensor.

18. The system of claim 1, wherein the processor is configured to initiate an alarm if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

19. The system of claim 1, wherein the processor is configured to log a time stamp indicating a time at which the fault condition was determined to exist if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

20. The system of claim 1, wherein the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke comprises a shape of at least a waveform portion of a voltage waveform across one or more of the actuation mechanism and a capacitor that drives the actuation mechanism when the actuation mechanism is energized to provide the pump stroke, and wherein the shape of at least the waveform portion of the voltage waveform is defined by at least a rate at which a voltage declines over time following a start of the voltage waveform.

21. A medical device system comprising:

a medical pump configured to deliver a therapeutic fluid to a patient, the medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke;

a sensor configured to detect a property associated with energizing the actuation mechanism, the property associated with energizing the actuation mechanism comprising a shape of at least a waveform portion of an electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke; and

a processor configured to determine whether the shape of at least the waveform portion of the electrical waveform indicates that a fault condition exists within the medical pump, wherein;

the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke is a first shape of at least a first waveform portion of a first electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide a first pump stroke, and wherein;

the sensor is configured to detect a second shape of at least a second waveform portion of a second electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide a second pump stroke subsequent to the first pump stroke, the second shape being different than the first shape,

the processor is configured to recognize a progression from the first shape of the at least first waveform portion to the second shape of the at least second waveform portion, and

the processor is configured to determine that the fault condition exists within the medical pump by determining that the progression from the first shape of the at least first waveform portion to the second shape of the at least second waveform portion occurs within a predetermined number of pump strokes.

22. The system of claim 21, wherein the processor is further configured to initiate a recovery action to attempt to remedy the fault condition if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

23. The system of claim 22, wherein the recovery action comprises a recovery sequence initiated by the processor.

24. The system of claim 22, wherein the recovery action comprises at least one of:

delivering a bolus of fluid through the medical pump;

increasing a drive voltage of the actuation mechanism;

increasing or decreasing a charge time of a capacitor that drives the actuation mechanism;

increasing a rate of pump strokes delivered by the medical pump;

initiating a pump reset; and

reinitializing the medical pump.

25. The system of claim 22, wherein the processor is further configured to determine whether the recovery action resolved the fault condition after initiating the recovery action.

26. The system of claim 21, wherein the processor is configured to monitor the medical pump to determine whether the fault condition has been resolved if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

27. The system of claim 26, wherein the processor is configured to determine that the fault condition has been resolved when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition has been resolved, or when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition has been resolved.

28. The system of claim 26, wherein the processor is configured to log a time stamp indicating a time at which the fault condition was determined to have been resolved if the processor determines that the fault condition has been resolved.

29. The system of claim 26, wherein the processor is configured to initiate an alarm when the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists and to clear the alarm when if the processor determines that the fault condition has been resolved.

30. The system of claim 21, wherein the actuation mechanism comprises a coil configured to be energized to provide the pump stroke and an actuator that is movable in response to an energization of the coil.

31. The system of claim 21, wherein the fault condition comprises one of a plurality of fault condition types, and wherein the processor is further configured to identify which of the plurality of fault condition types exists if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

32. The system of claim 21, wherein the fault condition comprises at least one of:

a full stall of the actuation mechanism;

a partial stall of the actuation mechanism;

a high energy pump stroke;

a low energy pump stroke;

gas accumulation within the medical pump;

air locking of the medical pump;

voltage depletion of a power source;

blockage in a flow path of the medical pump;

an electrical short in the actuation mechanism;

an open switch between the power source and the actuation mechanism; and

an electrical open circuit in the actuation mechanism.

33. The system of claim 21, wherein the processor is configured to determine that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition exists, or when the processor determines that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition exists.

34. The system of claim 21, wherein the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke comprises a shape of at least a waveform portion of an electrical current waveform through the actuation mechanism when the actuation mechanism is energized to provide the pump stroke, and wherein the shape of at least the waveform portion of the electrical current waveform is defined by at least one of:

a time from a start of the electrical current waveform to an initial peak current of the electrical current waveform;

a change in time between the initial peak current and one of a subsequent nadir and a subsequent peak current of the electrical current waveform;

a change in time between a start and an end of the subsequent nadir;

a time from the start of the electrical current waveform to a nadir indicating an end of a pump stroke;

an amplitude value of one or more of the initial peak current, the subsequent nadir, and the subsequent peak current;

a change in current value between the initial peak current and the subsequent nadir;

an initial current rise rate of change of the electrical current waveform; and

a current rate of change of the nadir indicating the end of the pump stroke.

35. The system of claim 21, wherein the sensor comprises at least one of a current sensor and a voltage sensor.

36. The system of claim 21, wherein the processor is configured to initiate an alarm if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

37. The system of claim 21, wherein the processor is configured to log a time stamp indicating a time at which the fault condition was determined to exist if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

38. The system of claim 21, wherein the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke comprises a shape of at least a waveform portion of a voltage waveform across one or more of the actuation mechanism and a capacitor that drives the actuation mechanism when the actuation mechanism is energized to provide the pump stroke, and wherein the shape of at least the waveform portion of the voltage waveform is defined by at least a rate at which a voltage declines over time following a start of the voltage waveform.

39. A method of detecting a fault condition within an implantable medical pump, the method comprising:

delivering, by the medical pump, a therapeutic fluid to a patient, the medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke;

detecting, by a sensor, a property associated with energizing the actuation mechanism, the property associated with energizing the actuation mechanism comprising a shape of at least a waveform portion of an electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke;

storing, by a processor, a baseline shape that indicates one of a normal pump stroke and a fault condition in a memory;

comparing, by the processor, the baseline shape to the shape of at least the waveform portion of the electrical waveform applied to the actuation mechanism when the actuation mechanism is energized to provide the pump stroke; and

determining, by the processor and based on the comparing, whether the shape of at least the waveform portion of the electrical waveform indicates that a fault condition exists within the medical pump.

40. The method of claim 39, further comprising performing a recovery action to attempt to remedy the fault condition if it is determined that the shape of at least the waveform portion of the electrical waveform indicates the fault condition exists.

41. The method of claim 40, wherein performing the recovery action comprises initiating a recovery sequence.

42. The method of claim 40, wherein the recovery action comprises at least one of:

delivering a bolus of fluid through the medical pump;

increasing a drive voltage of the actuation mechanism;

increasing or decreasing a charge time of a capacitor that drives actuation mechanism, increasing a rate of pump strokes delivered by the medical pump, initiating a pump reset, reinitializing the medical pump, and placing the medical pump into a reduced delivery mode.

43. The method of claim 40, further comprising determining whether the recovery action resolved the fault condition after performing the recovery action.

44. The method of claim 39, further comprising monitoring the medical pump and determining whether the fault condition has been resolved.

45. The method of claim 44, wherein determining whether the fault condition has been resolved comprises at least one of:

determining that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition has been resolved, or determining that the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition has been resolved.

46. The method of claim 44, if it is determined that the fault condition has been resolved, further comprising logging a time stamp indicating the time at which the fault condition was resolved.

47. The method of claim 44, further comprising initiating an alarm when it is determined that the shape of at least the waveform portion of the electrical waveform indicates the fault condition exists and clearing the alarm when it is determined that the fault condition has been resolved.

48. The method of claim 39, wherein the fault condition comprises one of a plurality of fault condition types, the method further comprising identifying, by the processor, which of the plurality of fault condition types exists if the processor determines that the shape of at least the waveform portion of the electrical waveform indicates that the fault condition exists.

49. The method of claim 39, wherein the fault condition comprises at least one of:

a full stall of the actuation mechanism, a partial stall of the actuation mechanism, a high energy pump stroke, a low energy pump stroke, gas accumulation within the medical pump, air locking of the medical pump, voltage depletion of a power source, blockage in a flow path of the medical pump, an electrical short in the actuation mechanism, and on open switch between a power source and the actuation mechanism.

50. The method of claim 39, wherein determining whether the shape of at least the waveform portion of the electrical waveform indicates that a fault condition exists comprises at least one of:

determining whether the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of a set of prior pump strokes indicates that the fault condition exists, or determining whether the shape of at least the waveform portion of the electrical waveform of each of a predetermined number of consecutive pump strokes indicates that the fault condition exists.

51. The method of claim 39, wherein the shape of at least the waveform portion of the electrical waveform comprises a shape of at least a waveform portion of an electrical current waveform through the actuation mechanism when the actuation mechanism is energized to provide a pump stroke, wherein the shape of the current waveform is defined by at least one of:

a time from a start of the current waveform to an initial peak current;

a change in time between the initial peak current and a subsequent nadir in the current waveform;

an amplitude value of the initial peak current;

a change in current value between the initial peak current and the subsequent nadir; and

a time from the start of the current waveform to a nadir indicating an end of a pump stroke.

52. The method of claim 39, further comprising storing a baseline shape that indicates a normal pump stroke in a memory, and comparing the baseline shape to the shape of the waveform portion of the electrical waveform through the actuation mechanism when the actuation mechanism is energized to provide the pump stroke to determine if the fault condition exists.

53. The method of claim 39, further comprising initiating an alarm if it is determined that the shape of at least the portion of the electrical waveform indicates the fault condition exists.

54. The method of claim 39, further comprising logging a time stamp indicating the time at which the fault condition was determined to exist.