External presentation of electrical stimulation parameters

• US 7,640,059 B2
• Filed: 09/08/2005
• Issued: 12/29/2009
• Est. Priority Date: 09/08/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Forsberg, John W., Michaels, Matthew J., Palm, Jeffry C.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US11/222,495
• Publication Number:
  US 20070055322A1
• Time in Patent Office: 1,573 Days
• Field of Search: 607/7, 607/11, 607/2, 607/8, 607/27, 607/45, 607/46, 607/52, 607/59, 607/61, 600/523, 600/554, 434/262
• US Class Current: 607/27
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A trial stimulation system and, more particularly, an indicator device within the trial stimulation system that measures and indicates energy amplitude levels for electrical stimulation therapy delivered to a patient. Specifically, the indicator device simultaneously indicates energy amplitude levels, such as electrical voltage, current, power, and electrical charge, as well as the polarity for each electrode in real-time without affecting the therapy delivered to the patient. For example, the indicator device may activate a number of lights in an array of lights in proportion to the measured energy amplitude level for each electrode and may activate a green LED or a red LED when a corresponding electrodes acts as a source or sink, respectively. In this manner, the indicator device allows a clinician to visualize the electrical fields produced by each electrode and, therefore, may assist stimulation steering, trouble shooting, and lead placement.

Claims

1. A method comprising:

measuring energy amplitude levels associated with electrical stimulation therapy delivered from an external electrical stimulation generator to an array of percutaneously implanted stimulation electrodes carried by one or more percutaneous leads via a measurement circuit in an external device housing, wherein the external device housing includes a first electrical connection from the measurement circuit to the external electrical stimulation generator and a second electrical connection from the measurement circuit to the implanted electrodes; and

indicating the measured energy amplitude levels delivered to one or more of the implanted electrodes within the array via an indicator,

wherein the indicator comprises a plurality of indicators, the method further comprising indicating the measured energy amplitude levels via the indicators, wherein each of the indicators corresponds to one of the electrodes, and the indicators are physically arranged to substantially correspond to the array of percutaneously implanted stimulation electrodes carried by the one or more percutaneous leads.

2. The method of claim 1, wherein the energy amplitude levels includes at least one of electrical voltage levels, electrical current levels, power levels, and electrical charge levels.

3. The method of claim 1, further comprising indicating a direction of flow of electrical current applied to respective electrodes within the array.

4. The method of claim 1, further comprising identifying electrodes in the array as cathodes or anodes.

5. The method of claim 1, further comprising updating the measured energy amplitude levels and indicating the updated energy amplitude levels on a periodic basis.

6. The method of claim 1, wherein indicating includes, for each of the electrodes, activating a number of indicator lights within an array of indicator lights in proportion to the measured energy amplitude levels in real-time.

7. The method of claim 1, wherein indicating includes, for each of the electrodes, graphically representing the measured energy amplitude level via a pixelized display device.

8. The method of claim 1, wherein the measurement circuit is placed in series with the electrical stimulation generator and the array of stimulation electrodes.

9. The method of claim 8, wherein the electrical stimulation generator includes a first electrical connector, the array of stimulation electrodes includes a second electrical connector that mates with the first electrical connector, and the measurement circuit includes a third electrical connector that mates with the first electrical connector to form the first electrical connection and a fourth electrical connector that mates with the second electrical connector to form the second electrical connection, the measurement circuit being placed in series between the third and fourth electrical connectors, and the electrodes being electrically connected to the electrical stimulation generator via the first, second, third and fourth connectors.

10. The method of claim 1, wherein indicating the measured energy amplitude levels includes simultaneously indicating the measured energy amplitude levels for each of the electrodes within the array.

11. The method of claim 1, wherein the measurement circuit and the indicator are provided together in the external device housing.

12. The method of claim 1, wherein the measurement circuit comprises a plurality of measurement circuits, each of the measurement circuits being configured to measure energy amplitude levels delivered to one of the electrodes, the method further comprising measuring the energy amplitude levels delivered to the electrodes via the measurement circuits.

13. The method of claim 1, wherein the first electrical connection includes one or more first wires and the second electrical connection includes one or more second wires and a connector block, and wherein the electrodes are connected to the connector block via one or more of the leads.

14. An external indicator device comprising:

an external device housing;

an external measurement circuit, in the external device housing, that measures energy amplitude levels associated with electrical stimulation therapy delivered from an external electrical stimulation generator to an array of percutaneously implantable stimulation electrodes carried by one or more percutaneous leads, wherein the external device housing includes a first electrical connection from the measurement circuit to the external electrical stimulation generator and a second electrical connection from the measurement circuit to the percutaneously implantable electrodes; and

an indicator that indicates the measured energy amplitude levels delivered to respective electrodes within the array,

wherein the indicator comprises a plurality of the indicators, each of the indicators corresponds to one of the electrodes, and the indicators are physically arranged to substantially correspond to the array of percutaneously implanted stimulation electrodes carried by the one or more percutaneous leads.

15. The device of claim 14, wherein the energy amplitude levels include at least one of electrical voltage levels, electrical current levels, power levels, and electrical charge levels.

16. The device of claim 14, wherein the indicator indicates a direction of flow of electrical current applied to respective electrodes within the array.

17. The device of claim 14, wherein the indicator identifies electrodes in the array as cathodes or anodes.

18. The device of claim 14, wherein the measurement circuit updates the measured energy amplitude levels, and the indicator indicates the updated energy amplitude levels on a periodic basis.

19. The device of claim 14, wherein the indicator includes an array of indicator lights, and the indicator activates a number of indicator lights within the array of indicator lights in proportion to the measured energy amplitude level in real-time.

20. The device of claim 14, wherein the indicator includes a pixelized display device that graphically represents the measured energy amplitude level.

21. The device of claim 20, wherein the electrical stimulation generator includes a first electrical connector, the array of stimulation electrodes includes a second electrical connector that mates with the first electrical connector, and the measurement circuit includes a third electrical connector that mates with the first electrical connector to form the first electrical connection and a fourth electrical connector that mates with the second electrical connector to form the second electrical connection, the measurement circuit being placed in series between the third and fourth electrical connectors, and the electrodes being electrically connected to the electrical stimulation generator via the first, second, third and fourth connectors.

22. The device of claim 14, wherein the measurement circuit is placed in series with the electrical stimulation generator and the array of stimulation electrodes.

23. The device of claim 14, wherein the indicator simultaneously indicates the measured energy amplitude levels for each of the electrodes within the array.

24. The device of claim 14, wherein the measurement circuit and the indicator arc provided together in the external device housing.

25. The device of claim 14, wherein the measurement circuit comprises a plurality of measurement circuits, each of the measurement circuits measuring energy amplitude levels delivered to one of the electrodes.

26. The device of claim 14, wherein the first electrical connection includes one or more first wires and the second electrical connection includes one or more second wires and a connector block, and wherein the electrodes are connected to the connector block via one or more of the leads.

27. A system comprising:

an external electrical stimulation generator that generates stimulation energy associated with electrical stimulation therapy;

an array of percutaneously implantable stimulation electrodes coupled to the electrical stimulation generator and carried by one or more percutaneous leads;

a circuit to deliver the stimulation energy to selected electrodes within the array of electrodes;

an external measurement circuit in an external device housing that measures energy amplitude levels of the stimulation energy delivered from the electrical stimulation generator to the percutaneously implantable electrodes, wherein the external device housing includes a first electrical connection from the measurement circuit to the external electrical stimulation generator and a second electrical connection from the measurement circuit to the percutaneously implantable electrodes; and

an indicator that indicates the measured energy amplitude levels delivered to respective electrodes within the array,

wherein the indicator comprises a plurality of indicators, each of the indicators corresponds to one of the electrodes, and the indicators are physically arranged to correspond to the array of percutaneously implanted stimulation electrodes carried by the one or more percutaneous leads.

28. The system of claim 27, wherein the energy amplitude levels include at least one of electrical voltage levels, electrical current levels, power levels, and electrical charge levels.

29. The system of claim 27, wherein the indicator indicates a direction of flow of electrical current applied to respective electrodes within the array.

30. The system of claim 27, wherein the indicator identifies electrodes in the array as cathodes or anodes.

31. The system of claim 27, wherein the measurement circuit updates the measured energy amplitude levels, and the indicator indicates the updated energy amplitude levels on a periodic basis.

32. The system of claim 27, wherein the indicator includes an array of indicator lights, and the indicator activates a number of indicator lights within the array of indicator lights in proportion to the measured energy amplitude level in real-time.

33. The system of claim 27, wherein the indicator includes a pixelized display device that graphically represents the measured energy amplitude level.

34. The system of claim 27, wherein the measurement circuit is placed in series with the electrical stimulation generator and the array of stimulation electrodes.

35. The system of claim 34, wherein the electrical stimulation generator includes a first electrical connector, the array of stimulation electrodes includes a second electrical connector that mates with the first electrical connector, and the measurement circuit includes a third electrical connector that mates with the first electrical connector to form the first electrical connection and a fourth electrical connector that mates with the second electrical connector to form the second electrical connection, the measurement circuit being placed in series between the third and fourth electrical connectors, and the electrodes being electrically connected to the electrical stimulation generator via the first, second, third and fourth connectors.

36. The system of claim 27, wherein the indicator simultaneously indicates the measured energy amplitude levels for each of the electrodes within the array.

37. The system of claim 27, wherein the measurement circuit and the indicator are provided together in the external device housing.

38. The system of claim 37, wherein the first electrical connection includes one or mare first wires and the second electrical connection includes one or more second wires and a connector block, and wherein the electrodes are connected to the connector block via one or more of the leads.

39. The system of claim 27, wherein the measurement circuit comprises a plurality of measurement circuits, each of the measurement circuits measuring energy amplitude levels delivered to one of the electrodes.

40. A method comprising:

delivering stimulation energy for electrical stimulation therapy from an external electrical stimulation generator to an array of percutaneously implanted stimulation electrodes carried by one or more percutaneous leads;

measuring energy amplitude levels delivered from the external electrical stimulation generator to the array of percutaneously implanted stimulation electrodes via a plurality of measurement circuits, each of the measurement circuits measuring energy amplitude levels delivered to one of the electrodes, wherein the measurement circuits arc in an external indicator device housing, and wherein the external device housing includes one or more first electrical connections from the measurement circuits to the external electrical stimulator and one or more second electrical connections from the measurement circuits to the implanted electrodes; and

simultaneously indicating the measured energy amplitude levels delivered to a plurality of the electrodes within the array via a plurality of indicators,

wherein the measurement circuits and the indicators are provided in the external indicator device housing.

41. The method of claim 40, wherein the one or more first electrical connections include one or more first wires and the one or more second electrical connections include one or more second wires and a connector block, and wherein the electrodes are connected to the connector block via one or more of the leads.

42. A system comprising:

an external electrical stimulation generator that generates stimulation energy for electrical stimulation therapy;

an array of percutaneously implantable stimulation electrodes carried by one or more percutaneous leads and coupled to the external electrical stimulation generator;

a circuit that applies the stimulation energy to selected electrodes within the array of electrodes;

a plurality of measurement circuits, each of the measurement circuits measuring energy amplitude levels delivered to one of the electrodes from the external electrical stimulation generator, wherein the measurement circuits are in an external indicator device housing, and wherein the external device housing includes one or more first electrical connections from the measurement circuits to the external electrical stimulator and one or more second electrical connections from the measurement circuits to the implanted electrodes; and

a plurality of indicators that simultaneously indicate the measured energy amplitude levels delivered to respective electrodes within the array,

wherein the measurement circuits and the indicators are provided in the external indicator device housing.

43. The system of claim 42, wherein the one or more first electrical connections include one or more first wires and the one or more second electrical connections include one or more second wires and a connector block, and wherein the electrodes are connected to the connector block via one or more of the leads.