Patient event indication

• US 9,529,972 B2
• Filed: 09/23/2008
• Issued: 12/27/2016
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Giftakis, Jonathon E., Werder, Jonathan C., Graves, Nina M., Ullestad, David C.
• Primary Examiner(s): Ng, Jonathan K
• Application Number:
  US12/236,316
• Publication Number:
  US 20090082641A1
• Time in Patent Office: 3,017 Days
• Field of Search: 705/2, 705/3, 600/9, 600/407, 600/510, 600/523
• US Class Current: 1/1
• 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, with at least one of a medical device programmer or a medical device, a plurality of indications, each indication of the plurality of indications indicating an occurrence of a patient event, wherein the patient event is related to a condition of the patient;

for each indication of the plurality of indications, generating, with at least one of the medical device programmer or the medical device, an event marker based on the respective indication of the occurrence of the patient event;

with at least one of the medical device programmer or the medical device, associating each event marker with at least one therapy program of a plurality of stored therapy programs, wherein the medical device is configured to deliver therapy to the patient according to the plurality of therapy programs, and wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with different threshold values;

determining, with at least one of the medical device programmer or the medical device, an event metric for a therapy program of the plurality of stored therapy programs based on a number of event markers associated with the therapy program;

determining, with at least one of the medical device programmer or the medical device, whether the event metric indicates the therapy program is ineffective for the patient condition, and wherein determining whether the event metric indicates the therapy program is ineffective for the patient condition comprises comparing the event metric to the threshold value associated with the therapy program; and

with at least one of the medical device programmer or the medical device, automatically adjusting therapy delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition.

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 at least one indication of the plurality of indications comprises receiving input from the patient indicating an occurrence of the patient event.

4. The method of claim 1, wherein receiving the plurality of indications of the patient event comprises receiving an indication of the occurrence of the patient event by at least:

monitoring, with a sensing module, at least one physiological parameter of the patient;

detecting an occurrence of the patient event based on the at least one physiological parameter; and

with at least one of the medical device programmer or the medical device, automatically generating the indication of the patient event based on the detection of the patient event.

5. The method of claim 1, further comprising storing the event metric in a memory of at least one of the medical device programmer or the medical device.

6. The method of claim 1, wherein adjusting therapy comprises generating a signal to control the medical device to adjust therapy delivery to the patient when the event metric indicates the therapy program is ineffective for the patient condition.

7. The method of claim 1, wherein the therapy program defines a therapy parameter value, and adjusting the therapy delivered to the patient by the medical device comprises modifying the therapy parameter value.

8. The method of claim 1, wherein adjusting the therapy delivered to the patient by the medical device comprises selecting a different therapy program for the medical device.

9. The method of claim 1, wherein the therapy program comprises a group including two or more therapy programs.

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

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

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

13. The method of claim 12, 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.

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

15. 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 therapy program is ineffective for the patient condition after the time period has expired.

16. The method of claim 1, further comprising:

determining whether a predetermined time period has expired; and

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

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

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

with at least one of the medical device programmer or the medical device, receiving input from a user identifying a suspension period during which no indications of the patient event are provided by the patient; and

determining, with at least one of the medical device programmer or the medical device, the event metric based on the suspension period.

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

19. The method of claim 18, wherein confirming the indication of the patient event comprises, with at least one of the medical device programmer or the medical device, receiving input from the patient confirming the indication of the patient event.

20. The method of claim 1, wherein the plurality of indications comprises a first plurality of indications, the method further comprising receiving a second plurality of indications, each indication of the second plurality of indications indicating an occurrence of the patient event, wherein generating the event marker comprises:

clustering a first indication of the first plurality of indications and a second indication of the second plurality of indications; and

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

21. 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.

22. The method of claim 21, wherein the event metric comprises an event score, wherein comparing the event metric to the threshold value comprises comparing the event score to the threshold value and wherein adjusting therapy delivered to the patient by the medical device comprises adjusting at least one therapy parameter value of the therapy program when the event score is greater than the threshold value.

23. The method of claim 1, wherein the plurality of stored therapy programs are arranged in a predetermined order, wherein adjusting the therapy delivered by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition comprises selecting a next therapy program of the plurality of stored therapy programs indicated by the predetermined order.

24. The method of claim 1, wherein determining whether the event metric indicates the therapy program is ineffective for the patient condition comprises comparing the event metric to the threshold value associated with the therapy program and determining the event metric indicates the therapy program is ineffective for the patient condition when the event metric is greater than or equal to the threshold value.

25. The method of claim 1, wherein the medical device delivers neurostimulation to the patient and adjusting therapy delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition comprises adjusting neurostimulation delivered to the patient by the medical device.

26. A system comprising:

a medical device that delivers therapy to a patient according to a plurality of stored therapy programs; and

a processor that receives a plurality of indications, each indication of the plurality of indications indicating an occurrence of a patient event of the patient, wherein the patient event is related to a condition of the patient, and wherein the processor generates, for each indication of the plurality of indications, an event marker based on the respective indication, associates each event marker with at least one therapy program of the plurality of stored therapy programs, determines an event metric for a therapy program of the plurality of stored therapy programs based on a number of event markers associated with the therapy program, and determines whether the event metric indicates the therapy program is ineffective for the patient condition, wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value and at least two therapy programs are associated with different threshold values, wherein the processor further determines whether the event metric indicates the therapy program is ineffective for the patient condition by at least comparing the event metric to the threshold value associated with the therapy program, and automatically adjusts therapy delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition.

27. The system of claim 26, wherein the processor receives at least one indication of the plurality of indications by at least receiving input from the patient indicating an occurrence of the patient event.

28. The system of claim 27, further comprising a medical device programmer comprising an event indication input mechanism, wherein the processor receives at least one indication of the plurality of indications by at least receiving input from the patient via the event indication input mechanism.

29. The system of claim 28, wherein the medical device programmer comprises the processor.

30. The system of claim 26, wherein the medical device comprises the processor.

31. The system of claim 26, further comprising a sensing module that generates a signal indicative of at least one physiological parameter of the patient, wherein the processor receives at least one indication of the plurality of indications by at least receiving the signal from the sensing module and detecting an occurrence of the patient event based on the at least one physiological parameter.

32. The system of claim 26, 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.

33. The system of claim 32, 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.

34. The system of claim 26, wherein therapy program defines a therapy cycle comprising a therapy on-cycle and a therapy off-cycle, wherein the processor determines, for at least one indication of the plurality of indications, whether the at least one indication was received during the therapy off-cycle, wherein the event metric indicates a number of times indications of the plurality of indications were received during the therapy off-cycle.

35. The system of claim 26, wherein the event metric comprises a number of event markers per unit of time, and 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.

36. The system of claim 26, wherein the processor confirms the indication of the patient event prior to generating the event marker.

37. The system of claim 26, wherein the plurality of indications comprises a first plurality of indications, and the processor receives a second plurality of indications, each indication of the second plurality of indications indicating an occurrence of the patient event, clusters a first indication of the first plurality of indications and a second indication of the second plurality of indications, and generates a single event marker based on the first and second indications of the patient event.

38. The system of claim 26, wherein, for an indication of the plurality of indications, 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 based on the indication 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.

39. The system of claim 38, wherein the event metric comprises an event score and the processor compares the event score to the threshold value and adjusts at least one therapy parameter value of the therapy program if the event score is greater than the threshold value.

40. The system of claim 26, wherein the plurality of stored therapy programs are arranged in a predetermined order, and the processor adjusts the therapy delivered by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition by at least selecting a next therapy program of the plurality of stored therapy programs indicated by the predetermined order.

41. The system of claim 26, wherein the processor determines whether the event metric indicates the therapy program is ineffective for the patient condition by at least comparing the event metric to the threshold value associated with the therapy program and determining the event metric indicates the therapy program is ineffective for the patient condition when the event metric is greater than or equal to the threshold value.

42. The system of claim 26, wherein the processor adjusts the therapy by at least one of modifying a therapy parameter value of the therapy program or selecting a different therapy program for the medical device.

43. The system of claim 26, wherein the processor starts a timer, determines whether a predetermined time period has expired based on the timer, and determines whether the event metric indicates the therapy program is ineffective for the patient condition after the time period has expired.

44. The system of claim 26, wherein the processor determines whether a predetermined time period has expired, and determines whether the event metric indicates the therapy program is ineffective for the patient condition after the time period has expired, wherein the processor adjusts the therapy by at least adjusting a therapy parameter value of the therapy program if either the time period has expired or the event metric indicates the at least one therapy program is ineffective for the patient condition.

45. The system of claim 26, wherein the medical device delivers neurostimulation to the patient and the processor adjusts neurostimulation delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition.

46. A system comprising:

means for receiving a plurality of indications, each indication of the plurality of indications indicating an occurrence of a patient event of a patient, wherein the patient event is related to a condition of the patient;

means for generating, for each indication of the plurality of indications, an event marker based on the respective indication;

means for associating each event marker with at least one therapy program of a plurality of stored therapy programs, wherein a medical device is configured to deliver therapy to the patient according to the plurality of therapy programs, wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with different threshold values;

means for determining an event metric for a therapy program of the plurality of therapy programs based on a number of event markers associated with the therapy program;

means for determining whether the event metric indicates the therapy program is ineffective for the patient condition by at least comparing the event metric to the threshold value associated with the therapy program; and

means for automatically adjusting therapy delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition.

47. The system of claim 46, wherein the plurality of stored therapy programs are arranged in a predetermined order, and the means for adjusting the therapy delivered by the medical device by at least selecting a next therapy program of the plurality of stored therapy programs indicated by the predetermined order.

48. The system of claim 46, wherein the means for determining whether the event metric indicates the therapy program is ineffective for the patient condition compares the event metric to the threshold value associated with the therapy program and determines the event metric indicates the therapy program is ineffective for the patient condition when the event metric is greater than or equal to the threshold value.

49. The system of claim 46, wherein the medical device delivers neurostimulation to the patient and the means for adjusting adjusts neurostimulation delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition.