Selecting electrode combinations for stimulation therapy

• US 8,620,452 B2
• Filed: 06/07/2007
• Issued: 12/31/2013
• 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., Miyazawa, Gabriela C., Greenberg, Jordan J., Goetz, Steven M.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US11/810,943
• Publication Number:
  US 20080046036A1
• Time in Patent Office: 2,399 Days
• Field of Search: 607/67, 607115-117, 607/152
• 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 five combination groups. A first group of electrode combinations is characterized by the presence of a caudal anode. A second group of electrode combinations is characterized by the presence of a rostral anode. A third group of electrode combinations is characterized by the presence of a single anode above and a single anode below the cathode(s) of the combination. A fourth group of electrode combinations is characterized by the presence of multiple anodes above and below the cathode(s) of the combination. A fifth group of electrode combinations is characterized by the presence of transverse anodes. A sixth group of electrode combination is characterized by at least one off-center cathode. One or more preferred electrode combinations groups, and/or a number of leads to implant within the patient, may by selected based on patient feedback.

Claims

1. A method comprising delivering stimulation to a patient via at least one of three columns of electrodes implanted within the patient, wherein at least one of the three columns of electrodes extends in a longitudinal direction wherein the stimulation is delivered according to a trial electrode combination from each of at least five groups of electrode combinations during a therapy evaluation period, wherein a first group is characterized by a rostral anode electrode pattern, a second group is characterized by a caudal anode electrode pattern, a third group is characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same column of electrodes, a fourth group is characterized by a second cathode disposed between a first row of anodes and a second row of anodes, and a fifth group is characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to the longitudinal direction, 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.

2. The method of claim 1, further comprising:

selecting the trial electrode combination from one of the at least five groups;

delivering stimulation via electrodes 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 according to the trial electrode combination from each of the at least five groups of electrode combinations comprises delivering stimulation at the selected longitudinal position.

3. The method of claim 1, further comprising selecting at least one of the groups as a preferred group.

4. The method of claim 3, further comprising:

receiving feedback from a patient relating to the stimulation delivered; and

selecting the preferred group 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 4, further comprising selecting a lead configuration for implantation within the patient based on the preferred group.

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

8. The method of claim 3, further comprising:

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

delivering stimulation via the additional electrode combinations.

9. The method of claim 3, wherein selecting at least one of the groups as the preferred group comprises selecting at least two of the groups as first and second preferred groups, the method further comprising:

selecting a first set of additional electrode combinations within the first preferred group to test on the patient; and

delivering stimulation via the first set of additional electrode combinations;

receiving patient feedback relating to the stimulation via the first set of additional electrode combinations;

selecting a second set of additional electrode combinations within the second preferred group to test on the patient;

delivering stimulation via the second set of additional electrode combinations; and

receiving patient feedback relating to the stimulation via the second set of additional electrode combinations; and

selecting the first preferred group or the second preferred group as a better fit for the patient based on the patient feedback.

10. The method of claim 9, further comprising selecting an additional electrode combination for the patient from within the first and second sets based on the patient feedback.

11. The method of claim 3, further comprising:

accessing a database comprising a list of electrode combinations from the at least five groups of electrode combinations and at least one associated therapy metric value indicative of therapy efficacy; and

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

12. The method of claim 11, 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 group 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 group based on the user-selected metric.

13. The method of claim 12, wherein selecting at least one electrode combination from the preferred group 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.

14. The method of claim 13, 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.

15. The method of claim 13, further comprising:

selecting at least one electrode combination from the preferred group based on information associating a plurality of electrode combinations from the at least five groups 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; and

selecting an additional electrode combination outside of the preferred group based on the information associating the plurality of electrode combinations from the at least five groups with the value of at least one therapy metric.

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

17. The method of claim 16, wherein optimizing the member electrode combination from the preferred group 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.

18. The method of claim 17, 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.

19. The method of claim 18, wherein optimizing the member electrode combination from the preferred group comprises:

delivering electrical stimulation to the patient via the member electrode combination;

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; and

selecting an additional electrode combination by accessing a database comprising a list of electrode combinations from the at least five groups of electrode combinations and at least one associated therapy metric value.

20. The method of claim 1, further comprising ordering the groups based on a user-selected criterion.

21. The method of claim 20, wherein the user-selected criterion comprises a patient-specific therapy requirement, a clinician preference, a pain location or a lead implant site.

22. The method of claim 1, further comprising:

receiving patient feedback to the stimulation delivered via each trial electrode combination; and

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

23. The method of claim 22, further comprising delivering stimulation according to each trial electrode combination stored within the library based on selections made by the patient.

24. The method of claim 1, wherein the at least five groups of electrode combinations further comprises a sixth group characterized by at least one off-center cathode.

25. A system comprising:

a medical device;

an array of implantable electrodes coupled to the medical device, wherein the array defines a first electrode column and wherein at least one of the first, second, and third electrode columns extends in a longitudinal direction, a second electrode column, and a third electrode column; and

a memory that stores at least one electrode combination from each one of at least five groups of electrode combinations, wherein the medical device delivers therapy to a patient via the array of implantable electrodes according to a trial electrode combination from each of the at least five groups, the at least five groups comprising;

a first group characterized by a rostral anode electrode pattern;

a second group characterized by a caudal anode electrode pattern;

a third group characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same one of the first, second or third electrode columns;

a fourth group characterized by a second cathode disposed between a first row of anodes and a second row of anodes; and

a fifth group characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to the longitudinal direction, 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.

26. The system of claim 25, wherein the at least five groups comprises a sixth group of electrode combinations characterized by an off-center cathode.

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

28. 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.

29. 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 of the at least five groups of electrode combinations as a preferred group and generate a list of electrode combinations based on the preferred group of electrode combinations for further testing.

30. The system of claim 29, 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 preferred group, and the processor is configured to select a parent electrode combination within the preferred group, 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.

31. The system of claim 25, wherein the memory stores a plurality of electrode combinations from each one of the at least five groups of electrode combinations and associated values of at least one therapy metric.

32. The system of claim 31, further comprising a computing device comprising the memory, wherein the computing device further comprises a processor and a user interface configured to receive an indication of a selected therapy metric from a user, and wherein the processor outputs at least one selected electrode combination from within the plurality of electrode combinations based on the selected therapy metric.

33. The system of claim 31, 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 a preferred group, 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.

34. The system of claim 33, wherein the baseline electrode combination is within one of the at least five groups of electrode combinations, and wherein the additional electrode combination is within the same group as the baseline electrode combination.

35. The system of claim 33, wherein the baseline electrode combination is within one of the at least five groups of electrode combinations, and wherein the additional electrode combination is not within the same group as the baseline electrode combination.

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

37. The system of claim 25, wherein at least two of the first, second or third columns of electrodes are disposed on a paddle lead.

38. The system of claim 25, wherein the medical device comprises an implantable or external medical device.

39. A medical device programmer comprising:

a memory that stores a plurality of electrode combinations for an electrical stimulator, wherein the plurality of electrode combinations includes at least one electrode combination from each of at least five groups of electrode combinations, the at least five groups comprising;

a first group characterized by a rostral anode electrode pattern;

a second group characterized by a caudal anode electrode pattern;

a third group characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same column of electrodes;

a fourth group characterized by a second cathode disposed between a first row of anodes and a second row of anodes; and

a fifth group characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to a longitudinal direction defined by at least one column of electrodes extending in the longitudinal direction, 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; and

a processor that controls delivery of electrical stimulation to a patient via the electrical stimulator in accordance with at least one electrode combination from each of the first, second, third, fourth, and fifth groups.

40. The programmer of claim 39, wherein the at least five groups comprises a sixth group characterized by an off-center cathode.

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 at least one electrode combination from the first, second, third, fourth, and fifth groups.

42. The programmer of claim 39, wherein the memory associates a value of at least one therapy metric with each electrode combination of the plurality of electrode combinations.

43. The programmer of claim 42, further comprising a user interface to receive input from a user indicating a selected therapy metric, wherein the processor outputs at least one selected electrode combination from within the plurality of electrode combinations based on the selected therapy metric.

44. A non-transitory computer-readable medium comprising instructions that cause a processor to control an electrical stimulator to:

deliver electrical stimulation to a patient during a therapy evaluation period via an electrode combination from each of at least five groups of electrode combinations, the at least five groups comprising;

a first group of electrode combinations characterized by a rostral anode electrode pattern;

a second group of electrode combinations characterized by a caudal anode electrode pattern;

a third group of electrode combinations characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same column of electrodes;

a fourth group of electrode combinations characterized by a second cathode disposed between a first row of anodes and a second row of anodes; and

a fifth group of electrode combinations characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to a longitudinal direction defined by at least one column of electrodes extending in a longitudinal direction, 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.

45. The computer-readable medium of claim 44, wherein the at least five groups comprises a sixth group characterized by an off-center cathode.

46. A computing device comprising:

a memory comprising a plurality of electrode combinations and associated therapy metric values, wherein the plurality of electrode combinations comprises at least one electrode combination from at least five groups of electrode combinations, the at least five groups comprising;

a first group characterized by a rostral anode electrode pattern;

a second group characterized by a caudal anode electrode pattern;

a third group characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same column of electrodes;

a fourth group characterized by a second cathode disposed between a first row of anodes and a second row of anodes; and

a fifth group characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to a longitudinal direction defined by at least one column of electrodes extending in the longitudinal direction, 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;

a display; and

a processor that generates a graphical display illustrating at least one electrode combination from the plurality of electrode combinations and the associated therapy metric value to a user via the display.

47. The computing device of claim 46, wherein the processor presents an interactive graphical interface via the display, the graphical interface comprising a first section for receiving user input selecting a therapy metric and a second section, wherein the processor provides an output via the second section that indicates at least one of a preferred group of electrode combinations selected from the first, second, third, fourth or fifth groups, or an additional electrode combination that optimizes the therapy metric.

48. The computing device of claim 46, wherein processor presents a data structure presenting the plurality of electrode combinations and associated therapy metric values via the display.

49. The computing device of claim 46, wherein the 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.

50. The computing device of claim 46, wherein the at least five groups of electrode combinations comprises a sixth group characterized by an off-center cathode.

51. A method comprising:

selecting, by a medical device programmer, a therapy metric; and

selecting, by the medical device programmer, at least one group from a set of at least five groups of electrode combinations that optimizes the therapy metric, the set of at least five groups comprising;

a first group of electrode combinations characterized by a rostral anode electrode pattern;

a second group of electrode combinations characterized by a caudal anode electrode pattern;

a third group of electrode combinations characterized by a first cathode disposed between two anodes, the first cathode and anodes being located in a same column of electrodes;

a fourth group of electrode combinations characterized by a second cathode disposed between a first row of anodes and a second row of anodes; and

a fifth group of electrode combinations characterized by a transverse electrode combination, wherein anodes of the transverse electrode combination are displaced substantially transversely relative to a third cathode of the transverse electrode combination and relative to a longitudinal direction defined by at least one column of electrodes extending in the longitudinal direction, 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.

52. The method of claim 51, wherein selecting, by the medical device programmer, at least one group from the set of at least five groups of electrode combinations that optimizes the therapy metric comprises reviewing, by the medical device programmer, a data structure comprising at least one electrode combination from each of the at least five groups and associated metric values.

53. The method of claim 51, wherein the set of at least five groups comprises a sixth group of electrode combinations characterized by an off-center cathode.