Therapy program modification based on therapy guidelines

• US 8,792,991 B2
• Filed: 01/22/2009
• Issued: 07/29/2014
• Est. Priority Date: 04/29/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Rondoni, John C.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/989,774
• Publication Number:
  US 20110040547A1
• Time in Patent Office: 2,014 Days
• Field of Search: 607 1- 2, 607/59, 607/62, 607/66, 607/115, 600300-301, 600/512
• US Class Current: 607/62
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

Techniques for modeling therapy fields for therapy delivered by medical devices are described. Each therapy field model is based on a set of therapy parameters and represents where therapy will propagate from the therapy system delivering therapy according to the set of therapy parameters. Therapy field models may be useful in guiding the modification of therapy parameters. As one example, a processor compares an algorithmic model of a therapy field to a reference therapy field and adjusts at least one therapy parameter based on the comparison. As another example, a processor adjusts at least one therapy parameter to increase an operating efficiency of the therapy system while substantially maintaining the modeled therapy field.

Claims

1. A method comprising:

generating an algorithmic model of a therapy field based on a first therapy program that comprises a set of therapy parameter values, wherein the algorithmic model of the therapy field represents where therapy will propagate from a therapy system delivering therapy according to the first therapy program;

automatically determining, by a processor, therapy guidelines based on a patient condition selected from a list of patient conditions, wherein the therapy guidelines comprise a reference therapy field;

comparing, by the processor, the algorithmic model of the first therapy field to the reference therapy field; and

automatically adjusting, by the processor and based on the comparison, a value of at least one of the therapy parameters of the first therapy program to generate a second therapy program.

2. The method of claim 1, wherein the reference therapy field comprises at least one of a stimulation field, electrical field or activation field with known efficacy for at least one of treating the patient condition or producing a therapeutic outcome.

3. The method of claim 1, wherein the therapy guidelines identify an anatomical target within the patient for therapy delivery.

4. The method of claim 1, further comprising delivering therapy to the patient according to the second therapy program.

5. The method of claim 1, wherein the algorithmic model comprises a first algorithmic model of a first therapy field, the method further comprising generating a second algorithmic model of a second therapy field that represents where the therapy will propagate from the therapy system based on the second therapy program.

6. The method of claim 5, further comprising:

monitoring a signal indicative of a patient parameter;

controlling the therapy system to deliver therapy to the patient according to the second therapy program;

detecting a patient event based on the signal;

in response to detecting the patient event, comparing the therapy guidelines and the second algorithmic model of the second therapy field; and

adjusting a value of at least one therapy parameter of the second therapy program to generate a third therapy program based on the comparison.

7. The method of claim 6, wherein detecting the patient event comprises detecting a threshold number of patient events.

8. The method of claim 6, wherein the patient parameter comprises at least one of an activity level, sleep quality, heart rate, respiration rate, respiratory volume, core temperature, blood pressure, blood oxygen saturation, partial pressure of oxygen within blood, partial pressure of oxygen within cerebrospinal fluid, muscular activity, arterial blood flow of the patient, bladder pressure, bladder contractile force, urinary sphincter pressure, urine flow rate, urine flow pressure, or voiding amount.

9. The method of claim 6, wherein the patient event comprises a seizure event or an involuntary voiding event.

10. The method of claim 6, wherein comparing the therapy guidelines and the second algorithmic model of the second therapy field comprises comparing the second algorithmic model of the second therapy field to the reference therapy field of the therapy guidelines.

11. The method of claim 5, further comprising:

monitoring a signal indicative of a patient parameter;

controlling the therapy system to deliver therapy to the patient according to the second therapy program;

detecting a patient event based on the signal; and

analyzing the therapy guidelines based on the detected patient event.

12. The method of claim 11, further comprising:

determining a second set of therapy guidelines based on the analysis of the therapy guidelines based on the detected patient event;

comparing the second set of therapy guidelines to the second algorithmic model of the second therapy field; and

adjusting a value of at least one therapy parameter of the second therapy program to generate a third therapy program based on the comparison.

13. The method of claim 11, wherein the patient condition includes a first patient condition, and analyzing the therapy guidelines comprises determining a second patient condition based on the detected patient event and determining whether the therapy guidelines are applicable to the second patient condition.

14. The method of claim 5, further comprising presenting the first algorithmic model of the first therapy field and the second algorithmic model of the second therapy field to a user.

15. The method of claim 1, wherein generating the algorithmic model comprises determining where the therapy will propagate from the therapy system based upon the first therapy program and an anatomical data set.

16. The method of claim 15, wherein the anatomical data set comprises at least one of an anatomical image of the patient, a reference anatomical image, an anatomical atlas, or a tissue conductivity data set.

17. The method of claim 1, wherein generating the algorithmic model of the therapy field comprises:

rendering a digital representation of at least a portion of a patient anatomical feature within a three dimensional (3D) environment;

determining the therapy field based on the therapy system and the first therapy program; and

rendering the algorithmic model of the therapy field relative to the digital representation of the patient anatomical feature within the 3D environment.

18. The method of claim 1, wherein determining the therapy guidelines comprise at least one of generating the therapy guidelines based on the patient condition or selecting the therapy guidelines from a memory of a device based on the patient condition.

19. The method of claim 1, wherein the reference therapy field comprises at least one of a centroid of stimulation, a total volume of an electrical field, a total volume of an activation field, a region of patient anatomy recruited by the reference therapy field, a charge density within the reference therapy field, or an amplitude within the reference therapy field.

20. The method of claim 1, further comprising:

controlling the therapy system to deliver therapy to the patient according to the first therapy program;

monitoring a signal from a sensor, wherein the signal changes as a function of a patient parameter; and

detecting a patient event based on the signal, wherein determining the therapy guidelines based on the patient condition comprises determining the therapy guidelines based on the patient condition and the detected patient event.

21. A system comprising:

a therapy system configured to deliver a therapy to a patient according to a first therapy program comprising a set of therapy parameter values; and

a processor configured to generate, based on the therapy program, an algorithmic model of a therapy field, the model representing where the therapy will propagate from the therapy system when the therapy system delivers therapy according to the first therapy program, automatically determine therapy guidelines based on a patient condition selected from a list of patient conditions, wherein the therapy guidelines comprise a reference therapy field, compare the algorithmic model of the therapy field to the reference therapy field, and, based on the comparison, automatically adjust a value of at least one of the therapy parameters of the first therapy program to generate a second therapy program.

22. The therapy system of claim 21, wherein the reference therapy field comprises at least one of a stimulation field, electrical field or activation field with known efficacy for at least one of treating the patient condition or producing a therapeutic outcome.

23. The therapy system of claim 21, wherein the therapy guidelines identify an anatomical target for therapy delivery.

24. The therapy system of claim 21, wherein the processor is configured to control the therapy system to deliver therapy from the therapy system to the patient according to the second therapy program.

25. The therapy system of claim 21, wherein the algorithmic model comprises a first algorithmic model of a first therapy field, and wherein the processor is configured to generate a second algorithmic model of a second therapy field that represents where the therapy will propagate from the therapy system when the therapy system delivers therapy according to the second therapy program.

26. The therapy system of claim 25, further comprising a sensor configured to generate a signal indicative of a patient parameter, wherein the processor is configured to receive the signal, detect a patient event based on the signal, in response to detecting the patient event, compare the therapy guidelines and the second algorithmic model of the second therapy field, and, based on the comparison, adjust a value of at least one therapy parameter of the second therapy program to generate a third therapy program.

27. The therapy system of claim 25, wherein the processor is configured to compare the therapy guidelines and the second algorithmic model of the second therapy field by comparing the second algorithmic model of the second therapy field to the reference therapy field of the therapy guidelines.

28. The therapy system of claim 21 further comprising a sensor configured to generate a signal indicative of a patient parameter, wherein the processor is configured to receive the signal, detect a patient event based on the signal, and analyze the therapy guidelines based on the detected patient event.

29. The therapy system of claim 28, wherein the processor is configured to determine a second set of therapy guidelines based on the analysis, compare the second set of therapy guidelines to the second algorithmic model of the second therapy field, and adjust a value of at least one therapy parameter of the second therapy program to generate a third therapy program based on the comparison.

30. The therapy system of claim 28, wherein the patient condition includes a first patient condition, and the processor is configured to analyze the therapy guidelines by at least determining a second patient condition based on the detected patient event and determining whether the therapy guidelines are applicable to the second patient condition.

31. The therapy system of claim 21, wherein the processor is configured to determine the therapy guidelines by at least one of generating the therapy guidelines based on the patient condition or selecting the therapy guidelines from a memory of the therapy system based on the patient condition.

32. The therapy system of claim 21, wherein the therapy system is configured to deliver therapy to the patient according to the first therapy program, and wherein the processor is configured to monitor a signal from a sensor, detect a patient event based on the signal, and determine the therapy guidelines based on the patient condition and the detected patient event.

33. The therapy system of claim 21, wherein the therapy system comprises a medical device comprising the processor.

34. The therapy system of claim 21, further comprising a medical device programmer that comprises the processor.

35. The therapy system of claim 21, wherein the reference therapy field comprises at least one of a centroid of stimulation, a total volume of an electrical field, a total volume of an activation field, a region of patient anatomy recruited by the reference therapy field, a charge density within the reference therapy field, or an amplitude within the reference therapy field.

36. A therapy system comprising:

means for determining a first therapy program that comprises a set of therapy parameter values;

means for delivering a therapy to a target therapy site in a patient according to the first therapy program;

means for generating, based on the first therapy program, an algorithmic model of a therapy field, the model representing where the therapy will propagate from the means for delivering;

means for automatically determining therapy guidelines based on a patient condition selected from a list of patient conditions, wherein the therapy guidelines comprise a reference therapy field;

means for comparing the algorithmic model of the therapy field to the reference therapy field; and

means for automatically adjusting, based on the comparison, a value of at least one therapy parameter of the first therapy program to generate a second therapy program.

37. The therapy system of claim 36, wherein the reference therapy field comprises at least one of a centroid of stimulation, a total volume of an electrical field, a total volume of an activation field, a region of patient anatomy recruited by the reference therapy field, a charge density within the reference therapy field, or an amplitude within the reference therapy field.

38. A system comprising:

a therapy system configured to deliver a therapy to a patient according to a first therapy program comprising a set of therapy parameter values; and

a processor configured to generate an algorithmic model of a therapy field based on the therapy program, the algorithmic model representing where the therapy will propagate from the therapy system when the therapy system delivers therapy according to the first therapy program, detect a patient event, in response to detecting the patient event, automatically determine therapy guidelines associated with the patient event, wherein the therapy guidelines comprise a reference therapy field, compare the algorithmic model of the therapy field to the reference therapy field, and automatically adjust a value of at least one therapy parameter of the therapy program based on the comparison between the algorithmic model of the therapy field and the reference therapy field.

39. The system of claim 38, further comprising a sensor configured to generate a signal indicative of a patient parameter, wherein the processor is configured to receive the signal from the sensor and detect, based on the signal, the patient event.