Selecting electrode combinations for stimulation therapy

• US 20080004675A1
• Filed: 06/07/2007
• Published: 01/03/2008
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wesselink, Wilbert A., Tidemand, Kevin K., Miyazawa, Gabriela C., King, Gary W., Greenberg, Jordan J.
• Granted Patent: US 8,744,597 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• 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 delivering stimulation via each of at least two electrode combination classes during a therapy evaluation period, wherein a first one of the classes comprises one or more electrode combinations that include electrodes within one or two electrode columns of an implantable array of electrodes that includes at least three electrode columns, and 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.

2. The method of claim 1, wherein the second class of electrode combinations comprises:

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 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 displaced substantially longitudinally relative to a second cathode of the longitudinal electrode combination, 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.

3. The method of claim 1, further comprising selecting one of the first or second electrode combination classes as a preferred class.

4. The method of claim 3, further comprising:

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

selecting the preferred class based on the feedback.

5. The method of claim 4, wherein receiving feedback from the patient comprises receiving feedback via a user interface of a programming device.

6. The method of claim 3, further comprising selecting a lead configuration for implantation within the patient based on the preferred class.

7. The method of claim 6, wherein selecting the lead configuration comprises selecting a number of implantable medical leads to implant within the patient.

8. The method of claim 3, further comprising:

selecting additional electrode combinations within the preferred class to test on the patient; and

delivering stimulation via the additional electrode combinations.

9. The method of claim 3, further comprising:

accessing a database comprising a list of electrode combinations from the first and second electrode combination classes and associated therapy metric values indicative of therapy efficacy; and

selecting at least one electrode combination from the preferred class based on the at least one therapy metric value associated with the selected electrode combination.

10. The method of claim 9, further comprising receiving user input selecting one of a plurality of therapy metrics, wherein the therapy metrics each comprise a quantifiable result of delivery of stimulation, and wherein selecting at least one electrode combination from the preferred class based on the at least one therapy metric value associated with the selected electrode combination comprises selecting at least one electrode combination from the preferred class based on the user-selected metric.

11. The method of claim 10, wherein selecting at least one electrode combination from the preferred class based on the user-selected metric comprises selecting at least one electrode combination that optimizes the user-selected therapy metric as compared to a remainder of electrode combinations within the list.

12. The method of claim 9, wherein the at least one therapy metric 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.

13. The method of claim 3, further comprising:

selecting at least one electrode combination from the preferred class based 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 therapy metrics comprise a quantifiable result of delivery of stimulation;

delivering 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 an additional electrode combination outside of the preferred class 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.

14. The method of claim 3, further comprising optimizing a member electrode combination from the preferred class.

15. The method of claim 14, wherein optimizing the member electrode combination from the preferred class comprises:

applying 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 a plurality of child electrode combinations based on the application of the rules to the member electrode combination.

16. The method of claim 14, further comprising:

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

generating 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.

17. The method of claim 14, wherein optimizing the member electrode combination from the preferred class comprises:

delivering electrical stimulation to the patient via the member electrode combination from the preferred class;

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

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

selecting an additional electrode combination by accessing a database comprising a list of electrode combinations from the first and second classes of electrode combinations and associated therapy metric values.

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

receiving patient feedback to the stimulation delivered via the plurality of trial electrode combinations; and

storing each trial electrode combination in a library if the patient provides a positive response to the respective trial electrode combination.

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

20. The method of claim 1, further comprising recording results relating to an efficacy of each of the electrode combinations.

21. The method of claim 1, further comprising:

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

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 at each of the longitudinal positions; and

selecting one of the longitudinal positions based on the feedback,

wherein delivering stimulation via each of the at least two electrode combination classes during a therapy evaluation period comprises delivering stimulation at the selected longitudinal position.

22. 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.

23. A method comprising:

controlling a medical device coupled to an electrode array including at least three columns of electrodes to deliver stimulation to a patient via a plurality of electrode combinations from a clinician library of electrode combinations, the clinician library comprising;

at least one electrode combination including electrodes within less than three columns,

at least one 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 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

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

storing 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 23 and further comprising:

loading the patient 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 patient library based on selections made by the patient using a the programmer.

25. A system comprising:

a medical device;

an array of implantable electrodes coupled to the medical device, wherein the array includes at least a first electrode column, a second electrode column, and a third electrode column, each of the first, second and third electrode columns including at least one of the electrodes of the array; and

a memory that stores electrode combinations representative of at least two classes of electrode combinations for testing during a therapy evaluation period, wherein the medical device delivers electrical stimulation to a patient via the array of implantable electrodes according to a plurality of the electrode combinations stored within the memory during the therapy evaluation period, the plurality of electrode combinations including at least one electrode combination in each of the two classes, the two classes comprising;

a first class including electrodes in no more than two of the first, second, and third electrode columns; and

a second class of electrode combinations including electrodes in each of the first, second, and third electrode columns.

26. The system of claim 25, wherein the second class of electrode combinations comprises:

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

27. The system of claim 25, wherein the second class of electrode combinations comprises:

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

28. The system of claim 25, further comprising a first implantable lead, a second implantable lead, and a third implantable lead, wherein the first electrode column is disposed on the first implantable lead, the second electrode column is disposed on the second implantable lead, and the third electrode column is disposed on the third implantable lead.

29. The system of claim 25, further comprising a paddle lead comprising at least the first and second columns of electrodes.

30. The system of claim 25, wherein the medical device comprises the memory.

31. The system of claim 25, further comprising a programming device comprising the memory, wherein the programming device is configured to control the medical device to deliver stimulation via each of the electrode combinations stored in the memory.

32. The system of claim 25, further comprising a computing device comprising a user interface, a processor, and the memory, wherein the processor is configured to receive user input via the user interface selecting one electrode combination class as a preferred electrode combination class and generate a list including further electrode combinations to test based on the preferred electrode combination class.

33. The system of claim 25, wherein the memory further stores a plurality of rules, each of the rules defining a respective electrode combination modification based on at least one of proximity of active electrodes to each other, proximity of inactive electrodes to active electrodes, or number of active electrodes within a representative electrode combination of the selected class, and the processor is configured to select a parent stimulation program, the parent stimulation program including a parent electrode combination, apply each of the plurality of rules to the parent electrode combination, and generates the list of electrode combinations based on application of the rules to the parent electrode combination.

34. The system of claim 25, wherein the memory stores a plurality of electrode combinations from the first and second electrode combination classes and associated therapy metric values, wherein the therapy metric values each comprise a quantifiable result of delivery of stimulation according to an associated electrode combination.

35. The system of claim 34, further comprising a computing device comprising a user interface, a processor, and the memory, wherein the processor is configured to control a medical device to deliver electrical stimulation therapy to a patient via a baseline electrode combination selected from the preferred electrode combination class, receive patient feedback relating to the therapy delivery via the baseline electrode combination, select a therapy metric based on the patient feedback, and select an additional electrode combination from among the plurality of electrode combinations stored within the memory based on the selected therapy metric.

36. The system of claim 35, wherein the baseline electrode combination is within one of the first or second classes of electrode combinations, and wherein the additional electrode combination is within the same class as the baseline electrode combination.

37. The system of claim 35, wherein the baseline electrode combination is within one of the first or second classes of electrode combinations, and wherein the additional electrode combination is not within the same class as the baseline electrode combination.

38. The system of claim 34, further comprising a computing device comprising a user interface, a processor, and the memory, wherein the processor is configured to receive user input selecting a therapy metric and select an additional electrode combination from among the plurality of electrode combinations stored within the memory based on the selected therapy metric.

39. A medical device programmer comprising:

a memory that stores a plurality of electrode combinations for delivery of therapy to a patient by an electrical stimulator during a therapy evaluation period, wherein the electrical stimulator is coupled to an array of implantable electrodes including at least a first electrode column, a second electrode column, and a third electrode column, each of the first, second and third electrode columns including at least one of the electrodes of the array, wherein the plurality of electrode combinations comprises;

a first electrode combination from a first class of electrode combinations with electrodes in no more than two of the columns; and

a second electrode combination from a second class of electrode combinations with electrodes disposed in each of the columns; and

a processor that controls delivery of electrical stimulation to a patient via the electrical stimulator in accordance with the first and second electrode combinations during the therapy evaluation period.

40. The programmer of claim 39, wherein the plurality of electrode combinations includes:

the first electrode combination from the first class of electrode combinations;

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

a third electrode combination from the second class of electrode combinations, the second electrode combination being a longitudinal electrode combination, wherein a second set of anodes of the third electrode combination displaced substantially longitudinally relative to a second cathode of the third electrode combination, and a stimulation field resulting from delivery of stimulation via the combination is oriented substantially longitudinally relative to the target tissue.

41. The programmer of claim 39, further comprising a user interface to receive input from a user, wherein the input comprises feedback relating to therapy effects from the delivery of electrical stimulation to a patient via the electrical stimulator in accordance with the first and second electrode combinations.

42. The programmer of claim 39, wherein the memory stores a plurality of electrode combinations from the first and second electrode combination classes and associated therapy metric values, wherein the therapy metrics comprise a quantifiable result of delivery of stimulation.

43. The programmer of claim 42, further comprising a display, wherein the processor presents an interactive graphical interface via the display, the graphical interface comprising a first section for receiving user input relating to a selected therapy metric and a second section, wherein the processor provides an output via the second section that indicates of at least one of a preferred class of electrode combinations selected from the first and second electrode combination classes, or a preferred electrode combination from within the first or second electrode combination classes based on the selected therapy metric.

44. A computer-readable medium comprising instructions that cause a processor to control an electrical stimulator, the electrical stimulator being coupled to an array of implantable electrodes, wherein the array includes at least a first electrode column, a second electrode column, and a third electrode column, each of the first, second and third electrode columns including at least one of the electrodes of the array, wherein the instructions cause the processor to:

control delivery of electrical stimulation to a patient via the array of electrodes according to a first electrode combination within a first electrode combination class, the first class including electrodes in no more than two of the first, second, and third electrode columns; and

control delivery of electrical stimulation to the patient via the array of electrodes according to a second electrode combination within a second electrode combination class, the second class including electrodes in each of the first, second, and third electrode columns.

45. The computer-readable medium of claim 44, wherein the second electrode combination is a transverse electrode combination, wherein a first set of anodes of the second electrode combination are displaced substantially transversely relative to a first cathode of the second electrode combination, and a stimulation field resulting from delivery of stimulation via the combination is oriented substantially transversely relative to a target tissue for the stimulation, and the computer-readable medium further comprises instructions that cause the processor to deliver electrical stimulation to the patient via the array of electrodes according to a third electrode combination within the second electrode combination class, wherein the third electrode combination is a longitudinal electrode combination, wherein a second set of anodes of the third electrode combination displaced substantially longitudinally relative to a second cathode of the third electrode combination, and a stimulation field resulting from delivery of stimulation via the combination is oriented substantially longitudinally relative to the target tissue.