System for permanent electrode placement utilizing microelectrode recording methods

• US 7,177,701 B1
• Filed: 06/11/2003
• Issued: 02/13/2007
• Est. Priority Date: 12/29/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Pianca, Anne M
• Primary Examiner(s): Schaetzle; Kennedy
• Application Number:
  US10/459,068
• Time in Patent Office: 1,343 Days
• Field of Search: 600/378, 600/373, 600/544, 600/585, 607/37, 607/38, 607/116, 607/117, 439/909, 128/898, 128/899
• US Class Current: 607/116
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

A lead stimulation/recording system is provided, which is a combination of a permanent DBS stimulating lead and a recording microelectrode. The DBS lead has a lumen extending from the proximal to the distal end of the lead, the lumen having an opening on each end of the lead. The microelectrode is configured and dimensioned to be insertable into the DBS lead from either the distal or proximal opening of the DBS lead, thereby permitting the microelectrode to be placed before, concurrently with, or after placement of the DBS lead. In addition, the system may be used with known microelectrode recording systems and methods of inserting the electrodes, such as the five-at-a-time method, the dual-microdrive method, or the single microdrive method.

Claims

1. A system for recording and stimulating excitable tissue, the system comprising:

a stimulation lead, having a lumen along its axial length, said lumen having two openings, a first opening at the proximal end of the lead, a second opening at the distal end of the lead;

a microelectrode, configured and dimensioned to be completely passable through the lumen of the lead, commencing from either the first opening or the second opening of the lead; and

a removable connector, which can be attached and detached to the proximal end of the microelectrode, said connector including a locking mechanism.

2. The system of claim 1,

wherein the locking mechanism is selected from the group consisting of a threaded connection, a set screw connection, a spring-loaded connection, a Bal Seal connection, and a collet connection.

3. The system of claim 1,

wherein the stimulation lead contains a conductor coil, said coil defining an axial lumen.

4. The system of claim 1,

wherein the stimulation lead has, at its proximal end, a connector portion that is angled from the remainder of the lead.

5. The system of claim 1,

wherein the stimulation lead has an array of electrodes placed on the distal portion of the lead in an in-line placement.

6. A method of recording and stimulating neural tissue, the method comprising:

(a) inserting a microelectrode into a tissue site to be recorded;

(b) attaching a removable connector to the proximal end of the microelectrode;

(c) recording the neural tissue with the microelectrode;

(d) repeating the previous steps (a), (b) and (c) until a tissue site is confirmed which provides an acceptable neural recording;

(e) detaching the removable connector attached to the microelectrode; and

(f) slipping the distal end of a stimulating lead having a lumen over the proximal end of the microelectrode, substantially covering the microelectrode, said lumen having a first opening at the proximal lead end and a second opening at the distal lead end,

wherein the microelectrode, without the connector attached, is configured and dimensioned to be completely passable through the lumen of the DBS lead, entering either at the first opening or the second opening.

7. The method of claim 6, wherein the step (b) of attaching a removable connector is accomplished by using a connector having a connection mechanism selected from the group consisting of a threaded connection, a set screw connection, a spring loaded connection, a Bal Seal connection, and a collet connection.

8. The method of claim 6, wherein the step (b) is performed before step (a).

9. A method of recording and stimulating neural tissue, the method comprising:

(a) inserting a microelectrode into a stimulating lead, said stimulating lead having a lumen with a first opening at the proximal lead end and a second opening at the distal lead end, said microelectrode configured and dimensioned to be completely passable through the lumen of the stimulating lead, entering either at the first opening or the second opening;

(b) attaching a removable connector to the distal end of the microelectrode;

(c) inserting the combination of microelectrode inserted within the stimulating lead into a target tissue,

(d) recording the neural tissue with the microelectrode;

(e) repeating the previous steps (c) and (d) until a tissue site is confirmed to provide an acceptable neural tissue recording; and

(f) removing the microelectrode from the stimulating lead and leaving the stimulating lead in the target tissue.

10. The method of claim 9, wherein step (b) occurs before step (a).

11. The method of claim 9, wherein step (b) occurs after step (c).

12. The method of claim 9, wherein the step (b) of attaching a removable connector is accomplished by using a connector having a connection mechanism selected from the group consisting of a threaded connection, a set screw connection, a spring loaded connection, a Bal Seal connection, and a collet connection.

13. A method of recording and stimulating neural tissue, the method comprising:

(a) inserting a stimulating lead into a target tissue, which stimulating lead has a lumen having a first opening at the proximal lead end and a second opening at the distal lead end;

(b) inserting a microelectrode from its distal end, into said lumen of the stimulating lead at its first opening, said microelectrode configured and dimensioned to be completely passable through the lumen of the stimulating lead;

(c) attaching a removal connector to the proximal end of the microelectrode;

(d) recording the neural tissue with the microelectrode;

(e) repeating the previous steps until a site is confirmed to provide an acceptable recording; and

(f) removing the microelectrode from the stimulating lead.

14. The method of claim 13, wherein step (c) occurs before step (b).

15. The method of claim 13, wherein the step (c) attaching a removable connector is accomplished by using a connector having a connection mechanism selected from the group consisting of a threaded connection, a set screw connection, a spring loaded connection, a Bal Seal connection, and a collet connection.

16. The method of claim 13, further comprising the step:

stimulating the located tissue site with the stimulating lead, which step is performed between steps (e) and (f).