Directional electrode devices with locating features

• US 10,434,302 B2
• Filed: 11/17/2015
• Issued: 10/08/2019
• 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, Greszler, Alan, Kokones, Scott
• Primary Examiner(s): Abreu, Michael J D
• Application Number:
  US14/943,857
• Publication Number:
  US 20160101279A1
• Time in Patent Office: 1,421 Days
• 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 assembly, comprising:

an elongate lead having a central longitudinal axis, a distal portion, a proximal portion, and at least one directional electrode positioned on the distal portion of the elongate lead; and

a lead guide that is slidably engageable with the elongate lead in a coaxial relationship and facilitates placement of the elongate lead within tissue of a patient, wherein the lead guide is a cannula or a stylet;

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

2. The assembly of claim 1, wherein the lead guide is the cannula and the lead guide has an inner channel for slidably receiving the elongate lead.

3. The assembly of claim 2, wherein the lead guide comprises one or more gripping elements for frictionally engaging the elongate lead.

4. The assembly of claim 3, wherein the one or more gripping elements comprises a pair of proximally located gripping elements disposed on opposite sides of the inner channel of the cannula.

5. The assembly of claim 4, Wherein the one or more gripping elements further comprises a pair of distally located gripping elements disposed on opposite sides of the inner channel of the cannula.

6. 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.

7. The assembly of claim 6, wherein the lead guide is the cannula and the first rotation locking structure is a groove and the second rotation locking structure is a key or a ridge.

8. The assembly of claim 6, wherein the lead guide is the cannula and the first rotation locking structure is a plurality of grooves and the second rotation locking structure is a plurality of keys or ridges.

9. The assembly of claim 6, wherein the lead guide is the stylet and the first rotation locking structure is a recess and the second rotation locking structure is a key.

10. The assembly of claim 1, wherein the lead guide is the stylet and the elongate lead has an inner channel for slidably receiving the lead guide.

11. The assembly of claim 10, wherein the stylet has an irregularly shaped tip and the lead comprises a receptacle into which the irregularly shaped tip locks.

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

13. The assembly of claim 12, wherein the delivery structure comprises one or more gripping elements for frictionally engaging the elongate lead and the lead guide.

14. 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.

15. The assembly of claim 14, wherein the lead guide holder comprises a ring having the rotational indictor.

16. The assembly of claim 1, wherein the elongate lead and the lead guide are rotationally fixed via a male/female connection.

17. The assembly of claim 1, wherein the elongate lead and the lead guide are rotationally fixed via a threadable engagement.

18. The assembly of claim 1, wherein the elongate lead and the lead guide are rotationally fixed via an interference fit.

19. The assembly of claim 1, wherein the lead guide is the stylet and the first orientation indicator is a first mark on the lead and the second orientation indicator is a second mark on the stylet.

20. The assembly of claim 1, Wherein the lead guide is the cannula and the first orientation indicator is a first mark on the lead and the second orientation indicator is a second mark on the cannula.