Tree-based electrical stimulator programming for pain therapy

• US 7,801,619 B2
• Filed: 04/30/2007
• Issued: 09/21/2010
• 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:
  US11/799,114
• Publication Number:
  US 20070265681A1
• Time in Patent Office: 1,240 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 program path is created 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. The user may provide information such as efficacy input and/or medication dosage information to the system for identifying the most efficacious program path in treating pain of the patient. Additionally or alternatively, efficacy feedback may be received from physiological parameter sensors.

Claims

1. A method for providing electrical stimulation therapy to treat pain, 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 structure, each node defines respective values for a set of electrical stimulation parameters, the nodes in each level specify an adjustment to a value of at least one type of stimulation parameter, the nodes in different levels specify adjustments to the value of different types of stimulation parameters, and the adjustments to the value of each type of stimulation parameter are limited to a single level of the tree structure;

defining a program path through the tree structure along a series of the interconnected nodes for which efficacy of stimulation therapy delivered according to the stimulation parameters defined by the nodes in treating pain exceeds a threshold level;

selecting one of the nodes in the program path; and

delivering the stimulation therapy to a patient based on the parameters defined by the selected node to treat patient pain.

2. The method of claim 1, wherein the stimulation therapy comprises at least one of spinal cord stimulation, deep brain stimulation, peripheral nerve stimulation, and peripheral nerve field stimulation.

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.

5. The methods of claim 4, wherein receiving efficacy input comprises:

prompting a user to provide the efficacy input;

receiving the efficacy input via an external programmer; and

displaying the efficacy input to the user.

6. The method of claim 4, wherein receiving efficacy input comprises receiving the efficacy input via at least one sensor that measures a physiological parameter.

7. The method of claim 1, further comprising receiving medication input from a user indicating a dosage of medication taken by the patient.

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

9. The method of claim 8, 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.

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

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

12. The method of claim 1, further comprising:

detecting an activity undertaken by the patient;

defining a program path specific to the activity through the tree structure along a series of the interconnected nodes for which performance feedback regarding stimulation therapy delivered according to the stimulation parameters defined by the nodes during the activity exceeds a threshold level;

subsequently detecting the activity; and

delivering the stimulation therapy to the patient according to the previously defined program path specific to the activity.

13. A system for providing electrical stimulation pain 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 structure, each node defines respective values for a set of electrical stimulation parameters, the nodes in each level specify an adjustment to a value of at least one type of stimulation parameter, the nodes in different levels specify adjustments to the value of different types of stimulation parameters, and the adjustments to the value of each type of stimulation parameter are limited to a single level of the tree structure; and

a processor that is configured to define a program path through the tree structure along a series of the interconnected nodes for which efficacy of stimulation pain therapy delivered according to the stimulation parameters defined by the nodes exceeds a threshold level, selects one of the nodes in the program path, and controls delivery of the stimulation pain therapy to a patient based on the parameters defined by the selected node to treat patient pain.

14. The system of claim 13, wherein the stimulation therapy comprises at least one of spinal cord stimulation, deep brain stimulation, peripheral nerve stimulation, and peripheral nerve field stimulation.

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

16. The system of claim 13, wherein the processor receives efficacy input indicating the efficacy of the delivered stimulation pain therapy.

17. The system of claim 16, further comprising a user interface, wherein:

the processor prompts the user via the user interface to provide the efficacy input;

the processor receives the efficacy input from a user via the user interface; and

the user interface displays the efficacy input to the user.

18. The system of claim 16, further comprising a sensor that measures a physiological parameter of the patient, wherein the processor receives the efficacy input from the sensor.

19. The system of claim 13, wherein the processor receives a medication input from a user indicating a dosage of medication taken by the patient.

20. The system of claim 13, wherein the tree structure comprises at least four levels.

21. The system of claim 20, 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.

22. The system of claim 13, wherein the stimulation parameters include stimulation electrode configuration, stimulation pulse rate, stimulation pulse width, and stimulation pulse amplitude.

23. The system of claim 13, wherein the processor resides within an external programmer associated with an implantable electrical stimulator.

24. The system of claim 13, wherein the processor:

detects an activity undertaken by the patient;

defines a program path specific to the activity through the tree structure along a series of the interconnected nodes for which performance feedback regarding stimulation therapy delivered according to the stimulation parameters defined by the nodes during the activity exceeds a threshold level;

subsequently detects the activity; and

controls delivery of the stimulation therapy to the patient according to the previously defined program path specific to the activity.

25. A non-transitory 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 structure, each node defines respective values for a set of electrical stimulation parameters, the nodes in each level specify an adjustment to a value of at least one type of stimulation parameter, the nodes in different levels specify adjustments to the value of different types of stimulation parameters, and the adjustments to the value of each type of stimulation parameter are limited to a single level of the tree structure;

define a program path through the tree structure along a series of the interconnected nodes for which efficacy of stimulation pain therapy delivered according to the stimulation parameters defined by the nodes exceeds a threshold level;

select one of the nodes in the program path; and

control delivery of the stimulation pain therapy to a patient based on the parameters defined by the selected node to treat patient pain.

26. The computer-readable medium of claim 25, wherein the stimulation therapy comprises at least one of spinal cord stimulation, deep brain stimulation, peripheral nerve stimulation, and peripheral nerve field stimulation.

27. The computer-readable medium of claim 25, wherein the instructions cause the processor to specify which stimulation parameters are adjusted at which levels of the tree based on user input.

28. The computer-readable medium of claim 25, wherein the instructions cause the processor to receive efficacy input indicating the efficacy of the delivered stimulation pain therapy.

29. The computer-readable medium of claim 28, wherein the instructions that cause the processor to receive the efficacy input comprise instructions that cause the processor to:

prompt the user to provide the efficacy input;

receive the efficacy input via an external programmer; and

display the efficacy input to the user.

30. The computer-readable medium of claim 28, wherein the instructions tat cause the processor to receive the efficacy input further comprise instructions that cause the processor to receive the efficacy input from a sensor that measures a physiological parameter of the patient.

31. The computer-readable medium of claim 25, further comprising instructions that cause the processor to receive medication input from a user indicating a dosage of medication taken by the patient.

32. The computer-readable medium of claim 25, wherein the tree structure comprises at least four levels.

33. The computer-readable medium of claim 32, 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.

34. The computer-readable medium of claim 25, wherein the stimulation parameters include stimulation electrode configuration, stimulation pulse rate, stimulation pulse width, and stimulation pulse amplitude.

35. The computer-readable medium of claim 25, wherein the instructions cause the processor to define the tree within an external programmer associated with an implantable electrical stimulator.

36. The computer-readable medium of claim 25, further comprising instructions that cause the processor to:

detect an activity undertaken by the patient;

define a program path specific to the activity through the tree structure along a series of the interconnected nodes for which performance feedback regarding stimulation therapy delivered according to the stimulation parameters defined by the nodes during the activity exceeds a threshold level;

subsequently detect the activity; and

control delivery of the stimulation therapy to the patient according to the previously defined program path specific to the activity.