DIRECTIONAL ELECTRODE DEVICES WITH LOCATING FEATURES

• US 20090204192A1
• Filed: 02/11/2008
• Published: 08/13/2009
• Est. Priority Date: 02/11/2008
• Status: Active Grant

• Current Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Inventors: Carlton, Keith, Kokones, Scott, Greszler, Alan
• Granted Patent: US 9,220,889 B2
• Time in Patent Office: Days
• 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 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode

Abstract

Electrode devices having directional electrodes for use in deep brain stimulation or other uses. In one aspect, an electrode assembly comprises an elongate lead and a lead guide that are engageable with each other in a coaxial relationship. When the elongate lead and the lead guide are engaged with each other, the two components are rotationally fixed in relation to each other. In another aspect, an elongate lead comprises a radiologically-visible feature for indicating the orientation of the elongate lead. In yet another aspect, an electrode system is capable of determining the position and/or orientation of an electrode positioned within a body. In other aspects, methods for electrically stimulating a target site in the body are disclosed.

Claims

1. An electrode assembly comprising:

an elongate lead having at least one directional electrode positioned at a distal portion thereof; and

a lead guide that is slidably engageable with the elongate lead in a coaxial relationship;

wherein the elongate lead and the lead guide are rotationally fixed when they are engaged with each other.

2. The assembly of claim 1, wherein the elongate lead has a inner channel for receiving the lead guide.

3. The assembly of claim 1, wherein the lead guide has a inner channel for receiving the elongate lead.

4. The assembly of claim 1, wherein the elongate lead and the lead guide are rotationally fixed via a male/female connection, a threadable engagement, or an interference fit.

5. The assembly of claim 1, wherein the elongate lead comprises a first rotation locking structure, wherein the lead guide comprises a second rotation locking structure, and wherein the first rotation locking structure and the second rotation locking structure are configured to engage each other.

6. The assembly of claim 3, wherein the lead guide comprises one or more gripping elements for frictionally engaging the elongate lead.

7. The assembly of claim 1, further comprising a delivery structure having a inner channel for receiving the elongate lead, and wherein the lead guide has a inner channel for receiving the delivery structure.

8. The assembly of claim 7, wherein the delivery structure comprises one or more gripping elements for frictionally engaging the elongate lead and the lead guide.

9. The assembly of claim 1, wherein the elongate lead has a first orientation indicator and the lead guide has a second orientation indicator, and wherein the first orientation indicator aligns with the second orientation indicator when the elongate lead and the lead guide are engaged with each other.

10. The assembly of claim 1, further comprising a lead guide holder that holds the lead guide, wherein the lead guide holder has a rotational indicator.

11. An elongate lead comprising:

at least one directional electrode positioned on a distal portion of the elongate lead; and

at least one radiologically-visible feature for indicating the orientation of the at least one directional electrode when viewed under radiologic imaging.

12. The elongate lead of claim 11, wherein the radiologically-visible feature is a straight stripe extending lengthwise in relation to the elongate lead.

13. The elongate lead of claim 11, wherein the radiologically-visible feature has a shape that is asymmetric about the central longitudinal axis of the elongate lead.

14. The elongate lead of claim 11, wherein the radiologically-visible feature is radiopaque.

15. The elongate lead of claim 11, wherein the radiologically-visible feature is radiolucent.

16. The elongate lead of claim 11, wherein the elongate lead comprises two or more radiologically-visible features.

17. The elongate lead of claim 11, wherein the at least one directional electrode is aligned with the orientation of the radiologically-visible feature.

18. An electrode system comprising:

an elongate lead having at least one directional electrode positioned at a distal portion of the elongate lead; and

a position determining apparatus for determining the position, the orientation, or both, of the at least one directional electrode when the electrode is positioned in a patient'"'"'s body.

19. The electrode system of claim 18, wherein the position determining apparatus comprises a plurality of signal sensors.

20. The electrode system of claim 19, wherein the signal sensors are electroencephalogram sensors.

21. The electrode system of claim 19, wherein the signal sensors sense the electric field strength of the at least one electrode.

22. The electrode system of claim 19, wherein the position determining apparatus comprises at least three signal sensors.

23. The electrode system of claim 19, wherein the position determining apparatus further comprises a computer coupled to the signal sensors, wherein the computer receives the information from the signal sensors and calculates the position, the orientation, or both of the at least one directional electrode.

24. The electrode system of claim 23, further comprising software which instructs the computer to:

store one or more fiducial references contained within an orthogonal three-dimensional coordinate system; and

map the position, the orientation, or both, of the stimulation electrode in relation to the one or more fiducial references.

25. The electrode system of claim 23, further comprising a graphical display for displaying the position, the orientation, or both, of the at least one directional electrode.

26. The electrode system of claim 25, wherein the position, the orientation, or both, of the at least one stimulation electrode is displayed as a three-dimensional image.

27. The electrode system of claim 18, wherein the position determining apparatus comprises an electromechanical position transducer.

28. The electrode system of claim 18, wherein the elongate lead further comprises a sensing electrode, and wherein the position determining apparatus determines the position, the orientation, or both, of the at least one directional electrode using output from the sensing electrode.

29. The electrode system of claim 18, wherein the position determining apparatus comprises a user interface for receiving data relating to the position, the orientation, or both, of the at least one directional electrode.