Selecting electrode combinations for stimulation therapy

• US 8,744,597 B2
• Filed: 06/07/2007
• Issued: 06/03/2014
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: King, Gary W., Tidemand, Kevin K., Wesselink, Wilbert A., Miyazawa, Gabriela C., Greenberg, Jordan J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US11/810,967
• Publication Number:
  US 20080004675A1
• Time in Patent Office: 2,553 Days
• Field of Search: 607/67, 607115-117, 607/152, 607/2, 607/118, 607/119
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• 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

Techniques for selecting electrode combinations for stimulation therapy include delivering stimulation via each of at least two electrode combination classes during a therapy evaluation period. A first one of the classes comprises one or more electrode combinations that include electrodes within one or two columns of an implantable array of electrodes. The array may include at least three electrode columns. A second one of the classes comprises one or more electrode combinations that include electrodes within at least three electrode columns of the implantable array of electrodes. A preferred one of the electrode combination classes for a patient, and/or a number of leads to implant within the patient, may by selected based on feedback collected from the patient during the therapy evaluation period.

Claims

1. A method comprising:

with a medical device, delivering stimulation to a patient via at least a plurality of predetermined electrode combinations from a first electrode combination class and a plurality of predetermined electrode combinations from a second electrode combination class during a therapy evaluation period, wherein the first electrode combination class comprises electrode combinations that include electrodes within only one or two electrode columns of an implantable array of electrodes that includes at least three electrode columns, and the second electrode combination class comprises electrode combinations that include electrodes within at least three electrode columns of the implantable array of electrodes, wherein at least one of the three electrode columns of the implantable array of electrodes extends in a longitudinal direction, the second electrode combination class comprising;

a transverse electrode combination, wherein a first set of anodes of the transverse electrode combination are displaced substantially transversely relative to a first cathode of the transverse electrode combination and relative to the longitudinal direction, and a stimulation field resulting from delivery of stimulation via the transverse electrode combination is oriented substantially transversely relative to a target tissue for the stimulation; and

a longitudinal electrode combination, wherein a second set of anodes of the longitudinal electrode combination are displaced substantially longitudinally relative to a second cathode of the longitudinal electrode combination and relative to the longitudinal direction, and a stimulation field resulting from delivery of stimulation via the longitudinal combination is oriented substantially longitudinally relative to the target tissue for the stimulation;

selecting one of the first or second electrode combination classes based on the delivery of electrical stimulation according to the plurality of predetermined electrode combinations from the first electrode combination class and the plurality of electrode combinations from the second electrode combination class; and

determining, with a processor, additional electrode combinations to test on the patient based on the selected one of the first or second electrode combination classes.

2. The method of claim 1, further comprising:

receiving feedback from the patient relating to the stimulation delivered during the therapy evaluation period; and

selecting the one of the first or second electrode combination classes based on the feedback.

3. The method of claim 2, wherein receiving feedback from the patient comprises receiving feedback via a user interface of a programming device.

4. The method of claim 1, further comprising selecting a lead configuration for implantation within the patient based on the selected one of the first or second electrode combination classes.

5. The method of claim 4, wherein selecting the lead configuration comprises selecting a number of implantable medical leads to implant within the patient.

6. The method of claim 1, wherein determining additional electrode combinations to test on the patient based on the selected one of the first or second electrode combination classes comprises:

selecting, with the processor, additional electrode combinations within the selected one of the first or second electrode combination classes to test on the patient; and

delivering, with the medical device, stimulation via the additional electrode combinations.

7. The method of claim 1, wherein determining additional electrode combinations to test on the patient based on the selected one of the first or second electrode combination classes comprises:

accessing, with the processor, a database comprising a list of electrode combinations from the first and second electrode combination classes and at least one associated numerical therapy metric value indicative of a quantifiable result of delivery of stimulation and

selecting, with the processor, at least one electrode combination from the selected one of the first or second electrode combination classes based on the at least one therapy metric value associated with the selected electrode combination.

8. The method of claim 7, further comprising receiving, with the processor, user input selecting one type of therapy metric from a plurality of therapy metric types, wherein the therapy metrics each comprise a quantifiable result of delivery of stimulation, and wherein selecting at least one electrode combination from the selected one of the first or second electrode combination classes based on the at least one therapy metric value associated with the selected electrode combination comprises selecting at least one electrode combination from the selected one of the first or second electrode combination classes based on the user- selected type of therapy metric.

9. The method of claim 8, wherein selecting at least one electrode combination from the selected one of the first or second electrode combination classes based on the user-selected type of therapy metric comprises selecting at least one electrode combination that optimizes the user-selected type of therapy metric as compared to a remainder of electrode combinations within the list.

10. The method of claim 7, wherein the at least one therapy metric value includes at least one of:

a dorsal column current;

usage range;

a ratio of dorsal column stimulation threshold voltage to dorsal root stimulation threshold voltage;

a recruitment area;

an area factor;

a maximum output voltage;

or a dorsal column stimulation threshold voltage.

11. The method of claim 7, wherein the at least one therapy metric value includes at least one of a ratio of dorsal column stimulation threshold to dorsal root stimulation threshold or a dorsal column stimulation threshold.

12. The method of claim 1, further comprising:

selecting at least one electrode combination from the selected one of the first or second electrode combination classes based on information associating a plurality of electrode combinations from the first and second electrode combination classes with a value of at least one therapy metric, wherein the at least one therapy metric comprises a quantifiable result of delivery of stimulation;

delivering, with the medical device, stimulation via the at least one selected electrode combination;

receiving patient feedback relating to the stimulation delivered via the at least one selected electrode combination;

selecting, with the processor, an additional electrode combination outside of the selected one of the first or second electrode combination classes based on the information associating the plurality of electrode combinations from the first and second electrode combination classes with the value of at least one therapy metric.

13. The method of claim 1, further comprising optimizing a member electrode combination from the selected one of the first or second electrode combination classes.

14. The method of claim 13, wherein optimizing the member electrode combination from the selected one of the first or second electrode combination classes comprises:

applying, with the processor, each of a plurality of rules to the member electrode combination, each of the rules defining a respective electrode combination modification based on at least one of proximity of active electrodes within the member electrode combination to each other, proximity of inactive electrodes within the member electrode combination to active electrodes, or number of active electrodes within the member electrode combination; and

generating, with the processor, a plurality of child electrode combinations based on the application of the rules to the member electrode combination.

15. The method of claim 14, further comprising:

applying, with the processor, at least one of the rules to at least one of the child electrode combinations; and

generating, with the processor, at least one second generation child program based on the application of the rule to the child electrode combination, the second generation child program including a second generation child electrode combination.

16. The method of claim 13, wherein optimizing the member electrode combination from the selected one of the first or second electrode combination classes comprises:

delivering, with the medical device, electrical stimulation to the patient via the member electrode combination from the selected one of the first or second electrode combination classes;

receiving patient feedback relating to the efficacy of the therapy delivered via the member electrode combination;

selecting at least one type of therapy metric indicative of therapy efficacy based on the patient feedback, wherein the at least one type of therapy metric comprises a quantifiable result of delivery of stimulation; and

selecting an additional electrode combination by accessing, with the processor, a database comprising a list of electrode combinations from the first and second electrode combination classes and associated therapy metric values for the at least one type of therapy metric.

17. The method of claim 1, wherein delivering stimulation via at least the plurality of predetermined electrode combinations from the first electrode combination class and the plurality of predetermined electrode combinations from the second electrode combination class during the therapy evaluation period comprises delivering stimulation via a plurality of trial electrode combinations from the first class and a plurality of trial electrode combinations from the second electrode combination class, the method further comprising:

receiving patient feedback to the stimulation delivered via the plurality of trial electrode combinations from the first electrode combination class and the plurality of trial electrode combinations from the second electrode combination class; and

with the processor, for each of the plurality of trial electrode combinations from the first electrode combination class and each of the plurality of trial electrode combinations from the second electrode combination class, storing the respective trial electrode combination in a library if the patient provides a positive response to the respective trial electrode combination.

18. The method of claim 17, further comprising delivering stimulation according to each trial electrode combination stored within the library based on selections made by the patient.

19. The method of claim 1, further comprising recording results relating to an efficacy of each of the plurality of predetermined electrode combinations from the first electrode combination class and each of the plurality of predetermined electrode combinations from the second electrode combination class.

20. The method of claim 1, further comprising:

selecting a trial electrode combination from the first or second electrode combination classes;

with the medical device, delivering stimulation via the trial electrode combination at a plurality of longitudinal positions of the columns of electrodes;

receiving feedback from the patient relating to delivery of stimulation via the trial electrode combination at each of the longitudinal positions; and

selecting one of the longitudinal positions based on the feedback,

wherein delivering stimulation via at least the plurality of predetermined electrode combinations from the first electrode combination class and the plurality of predetermined electrode combinations from the second electrode combination class during a therapy evaluation period comprises delivering stimulation at the selected longitudinal position.

21. The method of claim 1, further comprising:

receiving feedback from a patient relating to the stimulation delivered during the therapy evaluation period; and

determining a therapy configuration based on the feedback.

22. The method of claim 1, wherein delivering stimulation via at least the plurality of predetermined electrode combinations from the first electrode combination class and the plurality of predetermined electrode combinations from the second electrode combination class comprises controlling the medical device coupled to the implantable array of electrodes to deliver stimulation to the patient via a plurality of electrode combinations from a stored library of electrode combinations, the stored library comprising at least one electrode combination including electrodes within less than three columns, at least one transverse electrode combination, and at least one longitudinal electrode combination.

23. The method of claim 22, further comprising storing, with the processor, each of the electrode combinations within a patient library if the patient provided a positive response to the electrode combination.

24. The method of claim 22, further comprising:

loading the library into a memory of at least one of the medical device or a medical device programmer; and

delivering stimulation according to each of the electrode combinations within the library based on selections made by the patient using the programmer.

25. The method of claim 1, further comprising:

delivering, with the medical device, electrical stimulation therapy to the patient via a baseline electrode combination selected from the selected one of the first or second electrode combination classes;

receiving patient feedback relating to the therapy delivery via the baseline electrode combination;

selecting a type of therapy metric based on the patient feedback; and

selecting, with the processor, an additional electrode combination from among a plurality of electrode combinations stored within a memory based on the selected type of therapy metric.

26. The method of claim 25, wherein the baseline electrode combination is within one of the first or second electrode combination classes, and wherein selecting the additional electrode combination comprises selecting the additional electrode combination from within the same class as the baseline electrode combination.

27. The method of claim 25, wherein the baseline electrode combination is within one of the first or second electrode combination classes, and wherein selecting the additional electrode combination comprises selecting the additional electrode combination from a different class than that of the baseline electrode combination. stimulation threshold or a dorsal column stimulation threshold.

28. The method of claim 1, wherein determining additional electrode combinations to test on the patient based on the selected one of the first or second electrode combination classes comprises determining additional electrode combinations within only the selected one of the first or second electrode combination classes to test on the patient.

29. A method comprising:

controlling a medical device to deliver stimulation to a patient via at least a plurality of predetermined electrode combinations from a first electrode combination class and a plurality of predetermined electrode combinations from a second electrode combination class during a therapy evaluation period, wherein the first electrode combination class comprises electrode combinations that include electrodes within only one or two electrode columns of an implantable array of electrodes that includes at least three electrode columns, and the second electrode combination class comprises electrode combinations that include electrodes within at least three electrode columns of the implantable array of electrodes, wherein at least one of the three electrode columns of the implantable array of electrodes extends in a longitudinal direction, the second electrode combination class comprising;

a transverse electrode combination, wherein a first set of anodes of the transverse electrode combination are displaced substantially transversely relative to a first cathode of the transverse electrode combination and relative to the longitudinal direction, and a stimulation field resulting from delivery of stimulation via the transverse electrode combination is oriented substantially transversely relative to a target tissue for the stimulation; and

a longitudinal electrode combination, wherein a second set of anodes of the longitudinal electrode combination are displaced substantially longitudinally relative to a second cathode of the longitudinal electrode combination and relative to the longitudinal direction, and a stimulation field resulting from delivery of stimulation via the longitudinal combination is oriented substantially longitudinally relative to the target tissue for the stimulation;

selecting one of the first or second electrode combination classes based on the delivery of electrical stimulation according to the plurality of predetermined electrode combinations from the first electrode combination class and the plurality of predetermined electrode combinations from the second electrode combination class; and

selecting a lead configuration for chronic implantation within the patient based on the selected one of the first or second electrode combination classes.

30. The method of claim 29, wherein selecting the lead configuration comprises selecting a number of implantable medical leads to implant within the patient.

31. The method of claim 29, further comprising determining additional electrode combinations to test on the patient based on the selected one of the first or second electrode combination classes.