PATIENT EVENT INDICATION

• US 20090082641A1
• Filed: 09/23/2008
• Published: 03/26/2009
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Werder, Jonathan C., Giftakis, Jonathon E., Graves, Nina M., Ullestad, David C.
• Granted Patent: US 9,529,972 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An indication that a patient event occurred may be used to evaluate the efficacy of at least one therapy program and/or adjust therapy delivery to the patient. In some examples, the patient event indication includes patient input that may be received via an event indication button of a programming device. In addition to or instead of the patient input, the patient event indication may be generated based on a physiological parameter of the patient. In some examples, therapy delivery may be adjusted by adjusting at least one therapy parameter value, switching therapy programs or therapy program groups or restarting a therapy cycle of a medical device. The patient input via an event indication button may also help evaluate whether a therapy system is useful for the patient.

Claims

1. A method comprising:

receiving an indication of a patient event, wherein the event is related to a condition of the patient;

generating an event marker based on the indication of the patient event;

associating the event marker with at least one therapy program, wherein a medical device is configured to deliver therapy to the patient according to the at least one therapy program; and

determining an event metric for the at least one therapy program.

2. The method of claim 1, wherein the patient condition comprises at least one of a seizure disorder, a psychiatric disorder, urinary incontinence, fecal incontinence, chronic headaches or a movement disorder.

3. The method of claim 1, wherein receiving the indication of the patient event comprises receiving input from the patient indicating an occurrence of the patient event.

4. The method of claim 1, wherein receiving the indication of the patient event comprises:

monitoring at least one physiological parameter of the patient; and

detecting the patient even based on the at least one physiological parameter.

5. The method of claim 1, further comprising storing the event metric in a memory.

6. The method of claim 1, further comprising determining whether the event metric indicates the at least one therapy program is effective for the patient condition.

7. The method of claim 6, wherein determining whether the event metric indicates the at least one therapy program is effective for the patient condition comprises comparing the event metric to a threshold value.

8. The method of claim 6, further comprising generating a signal to control the medical device to adjust therapy delivery to the patient if the event metric indicates the at least one therapy program is not effective for the patient condition.

9. The method of claim 1, further comprising adjusting the therapy delivery by the medical device based on the event metric.

10. The method of claim 9, wherein the at least one therapy program defines a therapy parameter value, and adjusting the therapy delivery by the medical device comprises modifying the therapy parameter value.

11. The method of claim 9, wherein adjusting the therapy delivery by the medical device comprises selecting a different therapy program for the medical device.

12. The method of claim 1, wherein the at least one therapy program comprises a group including two or more therapy programs.

13. The method of claim 1, wherein the event metric comprises a total number of event markers.

14. The method of claim 1, wherein the event metric comprises a number of event markers per unit of time.

15. The method of claim 1, wherein the event metric comprises a change from a baseline condition of the patient.

16. The method of claim 15, wherein the baseline condition comprises a number of event markers per unit of time during a period prior to implementation of therapy delivery by the medical device to manage the patient condition.

17. The method of claim 1, wherein the at least one therapy program defines a therapy cycle comprising a therapy on-cycle and a therapy off-cycle, the method further comprising determining whether the indication of the patient event was received during the therapy off-cycle, and the event metric indicates a number of times the indication of the patient event was received during the therapy off-cycle.

18. The method of claim 17, wherein the at least one therapy program defines at least one therapy parameter value, the method further comprising:

comparing the event metric to a threshold value; and

adjusting the at least one therapy parameter value if the event metric is greater than the threshold value.

19. The method of claim 1, further comprising:

starting a timer;

determining whether a predetermined time period has expired based on the timer; and

determining whether the event metric indicates the at least one therapy program is ineffective for the patient condition after the time period has expired.

20. The method of claim 1, further comprising:

determining whether a predetermined time period has expired; and

determining whether the event metric indicates the at least one therapy program is ineffective for the patient condition after the time period has expired; and

adjusting a therapy parameter value if either the time period has expired or the event metric indicates the at least one therapy program is ineffective for the patient condition.

21. The method of claim 1, wherein the event metric comprises a number of event markers per unit of time further, the method comprising:

receiving input from a user identifying a suspension period during which no indications of the patient event are provided by the patient; and

determining the event metric based on the suspension period.

22. The method of claim 1, further comprising confirming the indication of the patient event prior to generating the event marker.

23. The method of claim 22, wherein confirming the indication of the patient event comprising receiving input from the patient confirming the indication of the patient event.

24. The method of claim 1, wherein the indication of the patient event comprises a first indication of the patient event, the method further comprising receiving a second indication of the patient event, wherein generating the event marker comprises:

clustering the first and second indications of the patient event; and

generating a single event marker based on the first and second indications of the patient event.

25. The method of claim 1, further comprising receiving input indicating at least one of a severity of the patient event or a type of patient event, wherein generating the event marker comprises applying a weight to the indication of the patient event based on the at least one of the severity of the patient event or the type of patient event.

26. The method of claim 25, wherein the event metric comprises an event score, the method further comprising:

comparing the event score to a threshold value; and

adjusting at least one therapy parameter value of the therapy program if the event score is greater than the threshold value.

27. A system comprising:

a medical device that delivers therapy to a patient according to at least one therapy program;

a processor that receives an indication of a patient event, wherein the event is related to a condition of the patient, generates an event marker based on the indication of the patient event, associates the event marker with the at least one therapy program, and determines an event metric for the at least one therapy program.

28. The system of claim 27, wherein the processor receives the indication of the patient event by at least receiving input from the patient indicating an occurrence of the patient event.

29. The system of claim 28, further comprising a medical device programmer comprising an event indication input mechanism, wherein the processor receives the input from the patient via the event indication input mechanism.

30. The system of claim 29, wherein the medical device programmer comprises the processor.

31. The system of claim 27, wherein the medical device comprises the processor.

32. The system of claim 27, further comprising a sensing module that generates a signal indicative of at least one physiological parameter of the patient, wherein the processor receives the indication of the patient event by at least receiving the signal from the sensing module and detecting the patient event based on the at least one physiological parameter.

33. The system of claim 27, wherein the processor determines whether the event metric indicates the at least one therapy program is effective for the patient condition.

34. The system of claim 33, wherein the processor compares the event metric to a threshold value to determine whether the event metric indicates the at least one therapy program is effective for the patient condition.

35. The system of claim 33, wherein the processor controls the medical device to adjust therapy delivery to the patient if the event metric indicates the therapy program is not effective for the patient condition.

36. The system of claim 27, wherein the processor adjusts the therapy delivery by the medical device based on the event metric.

37. The system of claim 27, wherein the event metric comprises at least one of a total number of event markers, a number of event markers per unit of time or a change from a baseline condition of the patient.

38. The system of claim 37, wherein the baseline condition comprises a number of event markers per unit of time during a period prior to implementation of therapy delivery by the medical device to manage the patient condition.

39. The system of claim 27, wherein the at least one therapy program defines a therapy cycle comprising a therapy on-cycle and a therapy off-cycle, wherein the processor determines whether the indication of the patient event was received during the therapy off-cycle, and the event metric indicates a number of times the indication of the patient event was received during the therapy off-cycle.

40. The system of claim 27, wherein the event metric comprises a number of event markers per unit of time further, wherein the processor receives input from a user identifying a suspension period during which no indications of the patient event are provided by the patient and determines the event metric based on the suspension period.

41. The system of claim 27, wherein the processor confirms the indication of the patient event prior to generating the event marker.

42. The system of claim 27, wherein the indication of the patient event comprises a first indication of the patient event, and the processor receives a second indication of the patient event, clusters the first and second indications of the patient event, and generates a single event marker based on the first and second indications of the patient event.

43. The system of claim 27, wherein the processor receives input indicating at least one of a severity of the patient event or a type of patient event, and generates the event marker by at least applying a weight to the indication of the patient event based on the at least one of the severity of the patient event or the type of patient event

44. The system of claim 43, wherein the event metric comprises an event score and the processor compares the event score to a threshold value and adjusts at least one therapy parameter value of the therapy program if the event score is greater than the threshold value.

45. A system comprising:

means for receiving an indication of a patient event, wherein the event is related to a condition of the patient;

means for generating an event marker based on the indication of the patient event;

means for associating the event marker with at least one therapy program, wherein a medical device is configured to deliver therapy to the patient according to the at least one therapy program; and

means for determining an event metric for the at least one therapy program.

46. The system of claim 45, further comprising adjusting the therapy delivery by the medical device based on the event metric.

47. A method comprising:

controlling therapy delivery to a patient according to at least one therapy program;

receiving an indication of a patient event from the patient, wherein the event is related to a condition of the patient;

generating an event marker based on the indication; and

maintaining therapy delivery according to the at least one therapy program after the event marker is generated.

48. The method of claim 47, further comprising receiving input from the patient relating to an occurrence of the patient event and associating the input with the event marker.

49. The method of claim 47, further comprising notifying the patient that the indication of the patient event was received.

50. A system comprising:

a medical device that delivers therapy to a patient according to at least one therapy program; and

a processor that receives an indication of a patient event from the patient, wherein the event is related to a condition of the patient and generates an event marker based on the indication,

wherein the medical device maintains therapy delivery according to the at least one therapy program after the event marker is generated.

51. The system of claim 50, wherein the processor notifies the patient that the indication of the patient event was received.