Tree-based electrical stimulator programming

• US 7,715,920 B2
• Filed: 04/28/2006
• Issued: 05/11/2010
• Est. Priority Date: 04/28/2006
• 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): Layno; Carl H
• Assistant Examiner(s): Kimball; Jeremiah T
• Application Number:
  US11/414,527
• Publication Number:
  US 20070255346A1
• Time in Patent Office: 1,474 Days
• Field of Search: 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The disclosure describes an implantable stimulation system that guides programming with a therapeutic tree. All possible stimulation parameters are arranged on the therapeutic tree, with each level of the therapeutic tree containing a different stimulation parameter type. Each level includes nodes that are connected to nodes of adjacent levels. A user, such as a clinician or a patient, creates a program path by moving through nodes of lower levels. The stimulation parameter types are arranged so that coarse adjustments occur at higher levels of the tree and fine adjustments occur at lower levels of the tree. The nodes of the program path define the stimulation parameters of the delivered stimulation therapy. In addition, a sensor may detect a physiological function to allow the system to automatically identify therapy efficacy and create the most efficacious program path for the patient.

Claims

1. A method for providing electrical stimulation therapy, the method comprising:

defining a tree structure having a plurality of levels and a plurality of nodes in each of the levels, wherein each of the nodes is interconnected with at least one node above and at least two nodes below in the tree, each node defines a set of electrical stimulation parameters, the nodes in each level specify an adjustment to at least one of the parameters, and the node in different levels specify the adjustment to different parameters;

defining a program path through the tree along a series of the interconnected nodes, wherein defining the program path comprises;

selecting one of the nodes in the program path, wherein the selected node is associated with a selected level;

delivering stimulation therapy to a patient based on a first set of parameters defined by the selected node, the first set of parameters comprising a first stimulation parameter and a second stimulation parameter different than the first stimulation parameter;

determining an efficacy of stimulation therapy based on the first set of parameters;

modifying the first stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is less than or equal to a threshold level, wherein the first stimulation parameter is associated with the selected level or a higher level of the tree structure relative to the selected level; and

modifying the second stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is greater than the threshold level, wherein the second stimulation parameter is associated with a lower level of the tree structure relative to the selected level.

2. The method of claim 1, wherein the stimulation therapy is configured to treat urinary incontinence.

3. The method of claim 1, further comprising specifying which stimulation parameters are adjusted at which levels of the tree based on user input.

4. The method of claim 1, further comprising receiving efficacy input indicating the efficacy of the delivered stimulation therapy.

5. The method of claim 4, further comprising receiving the efficacy input from a user.

6. The method of claim 4, wherein receiving the efficacy input includes determining the efficacy input based on physiological information obtained via a sensor.

7. The method of claim 1, wherein the tree comprises at least four levels.

8. The method of claim 7, wherein a first, top level of the tree specifies an adjustment to stimulation electrode configuration, a second level specifies an adjustment to stimulation pulse rate, a third level specifies an adjustment to stimulation pulse width, and a fourth, bottom level specifies an adjustment to stimulation pulse amplitude.

9. The method of claim 1, wherein the stimulation parameters include stimulation electrode configuration, stimulation pulse rate, stimulation pulse width, and stimulation pulse amplitude.

10. The method of claim 1, further comprising defining the tree within an external programmer associated with an implantable electrical stimulator.

32. The method of claim 1, wherein the threshold level comprises a percent increase of efficacy relative to a baseline condition of the patient and determining the efficacy comprises determining an increase in efficacy.

11. A system for providing electrical stimulation therapy, the system comprising:

a memory defining a tree structure having a plurality of levels and a plurality of nodes in each of the levels, wherein each of the nodes is interconnected with at least one node above and at least two nodes below in the tree, each node defines a set of electrical stimulation parameters, the nodes in each level specify an adjustment to at least one of the parameters, and the node in different levels specify the adjustment to different parameters; and

a processor that defines a program path through the tree along a series of the interconnected nodes, wherein the processor defines the program path by at least

selecting one of the nodes in the program path, wherein the selected node is associated with a selected level;

controlling delivery of stimulation therapy to a patient based on a first set of parameters defined by the selected node, the first set of parameters comprising a first stimulation parameter and a second stimulation parameter different than the first stimulation parameter;

determining an efficacy of stimulation therapy based on the first set of parameters; and

modifying the first stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is less than or equal to a threshold level, wherein the first stimulation parameter is associated with the selected level or a higher level of the tree structure relative to the selected level; and

modifying the second stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is greater than the threshold level, wherein the second stimulation parameter is associated with a lower level of the tree structure relative to the selected level.

12. The system of claim 11, wherein the stimulation therapy is configured to treat urinary incontinence.

13. The system of claim 11, wherein the processor specifies which stimulation parameters are adjusted at which levels of the tree based on user input.

14. The system of claim 11, wherein the processor receives efficacy input indicating the efficacy of the delivered stimulation therapy.

15. The system of claim 14, wherein the processor receives the efficacy input from a user.

16. The system of claim 14, wherein the processor receives the efficacy input by at least determining the efficacy input based on physiological information obtained via a sensor.

17. The system of claim 11, wherein the tree comprises at least four levels.

18. The system of claim 17, wherein a first, top level of the tree specifies an adjustment to stimulation electrode configuration, a second level specifies an adjustment to stimulation pulse rate, a third level specifies an adjustment to stimulation pulse width, and a fourth, bottom level specifies an adjustment to stimulation pulse amplitude.

19. The system of claim 11, wherein the stimulation parameters include stimulation electrode configuration, stimulation pulse rate, stimulation pulse width, and stimulation pulse amplitude.

20. The system of claim 11, wherein the processor resides within an external programmer associated with an implantable electrical stimulator.

33. The system of claim 11, wherein the threshold level comprises a percent increase of efficacy relative to a baseline condition of the patient and the processor determines the efficacy of stimulation therapy by at least determining an increase in efficacy.

21. A computer-readable medium comprising instructions to cause a processor to:

define a tree structure having a plurality of levels and a plurality of nodes in each of the levels, wherein each of the nodes is interconnected with at least one node above and at least two nodes below in the tree, each node defines a set of electrical stimulation parameters, the nodes in each level specify an adjustment to at least one of the parameters, and the node in different levels specify the adjustment to different parameters;

define a program path through the tree along a series of the interconnected nodes;

select one of the nodes in the program path, wherein the selected node is associated with a selected level;

control delivery of stimulation therapy to a patient based on a first set of parameters defined by the selected node, the first set of parameters comprising a first stimulation parameter and a second stimulation parameter;

determine an efficacy of the stimulation therapy based on the first set of parameters;

modify the first stimulation parameter of the first set if the efficacy of the stimulation therapy based on the first set of parameters is less than or equal to a threshold level, wherein the first stimulation parameter is associated with the selected level or a higher level of the tree structure relative to the selected level; and

modify the second stimulation parameter of the first set if the efficacy of the stimulation therapy based on the first set of parameters is greater than the threshold level, wherein the second stimulation parameter is associated with a lower level of the tree structure relative to the selected level.

22. The computer-readable medium of claim 21, wherein the stimulation therapy is configured to treat urinary incontinence.

23. The computer-readable medium of claim 21, wherein the instructions cause the processor to specify which stimulation parameters are adjusted at which levels of the tree based on user input.

24. The computer-readable medium of claim 21, wherein the instructions cause the processor to receive efficacy input indicating the efficacy of the delivered stimulation therapy.

25. The computer-readable medium of claim 24, wherein the instructions cause the processor to receive the efficacy input from a user.

26. The computer-readable medium of claim 24, wherein the instructions cause the processor to receive the efficacy input includes determining the efficacy input based on physiological information obtained via a sensor.

27. The computer-readable medium of claim 21, wherein the tree comprises at least four levels.

28. The computer-readable medium of claim 27, wherein a first, top level of the tree specifies an adjustment to stimulation electrode configuration, a second level specifies an adjustment to stimulation pulse rate, a third level specifies an adjustment to stimulation pulse width, and a fourth, bottom level specifies an adjustment to stimulation pulse amplitude.

29. The computer-readable medium of claim 21, wherein the stimulation parameters include stimulation electrode configuration, stimulation pulse rate, stimulation pulse width, and stimulation pulse amplitude.

30. The computer-readable medium of claim 21, wherein the instructions cause the processor to define the tree within an external programmer associated with an implantable electrical stimulator.

31. A system for providing electrical stimulation therapy, the system comprising:

means for defining a tree structure having a plurality of levels and a plurality of nodes in each of the levels, wherein each of the nodes is interconnected with at least one node above and at least two nodes below in the tree, each node defines a set of electrical stimulation parameters, the nodes in each level specify an adjustment to at least one of the parameters, and the node in different levels specify the adjustment to different parameters;

means for defining a program path through the tree along a series of the interconnected nodes, wherein the means for defining comprises;

means for selecting one of the nodes in the program path, wherein the selected node is associated with a selected level;

means for delivering stimulation therapy to a patient based on a first set of parameters defined by the selected node, the first set of parameters comprising a first stimulation parameter and a second stimulation parameter different than the first stimulation parameter;

means for determining an efficacy of stimulation therapy based on the first set of parameters;

means for modifying the first stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is less than or equal to a threshold level, wherein the first stimulation parameter is associated with the selected level or a higher level of the tree structure relative to the selected level; and

means for modifying the second stimulation parameter of the first set if the efficacy of stimulation therapy based on the first set of parameters is greater than the threshold level, wherein the second stimulation parameter is associated with a lower level of the tree structure relative to the selected level.