Flexible electrode

• US 20080058912A1
• Filed: 09/06/2006
• Published: 03/06/2008
• Est. Priority Date: 09/06/2006
• Status: Active Grant

• Current Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Original Assignee: CardioMEMS Incorporated
• Inventors: O'Brien, David
• Granted Patent: US 7,908,018 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An electrode array has a flexible body supporting a plurality of electrodes. Each electrode comprises an exposed connector pad at the upper end of the body, an exposed recording/stimulating pad at the lower end of the body, and a conductor located within the body and electrically connecting the connector pad and the recording/stimulating pad. In one embodiment the electrode array has an elongated recording/stimulating portion coiled or folded to distribute the exposed recording/stimulating pads in three dimensions. An implantation method employs an introducer with a helical portion to which an end of the flexible electrode is attached. The helical portion straightens to pass through a small-diameter cannula and then resumes its helical configuration to place the recording/stimulating portion of the attached electrode in a helix within the patient'"'"'s tissues.

Claims

1. An apparatus comprising:

an introducer having an upper portion, a lower helical portion, and a distal tip; and

a flexible electrode having a connector area adjacent its upper end, an electrode recording/stimulating section adjacent its lower end, and a signal conducting region in its intermediate portion electrically interconnecting the connector area and the electrode recording/stimulating section;

said lower end of said electrode being attached to said lower portion of said introducer;

whereby rotation of said introducer rotates said flexible electrode.

2. The apparatus of claim 1, wherein said lower end of said electrode being attached to said lower portion of said introducer comprises said electrode recording/stimulating section of said electrode being attached to said lower helical portion of said introducer.

3. The apparatus of claim 1, wherein said lower end of said electrode being attached to said lower portion of said introducer electrode comprises said lower end of said electrode being adhesively bonded to said lower portion of said introducer.

4. The apparatus of claim 1, wherein said electrode is releasably attached to said introducer.

5. The apparatus of claim 3, wherein said electrode is adhesively bonded to said introducer by an adhesive that dissolves when exposed to fluids within the body of a patient.

6. The apparatus of claim 4, wherein said adhesive is mannitol.

7. The apparatus of claim 1, wherein said introducer is comprises of a shape-memory material.

8. An apparatus comprising:

a substantially planar electrode body,

an electrode comprising an electrode pad at a lower end, a connector pad at an upper end, and a conductor electrically connecting said electrode pad and said connector pad;

said conductor being enclosed within said body;

a first opening in said body in registry with said electrode pad so as to expose said electrode pad to the ambient; and

a second opening in said body in registry with said connector pad so as to expose said connector pad to the ambient.

9. The apparatus of claim 8, wherein said substantially planar electrode body comprises first and second sheets imposed against one another.

10. The apparatus of claim 9, wherein said flexible sheets comprise polyimide.

11. The apparatus of claim 9, wherein said conductor is sandwiched between said first and second sheets.

12. The apparatus of claim 11, wherein said apparatus has a thickness of from approximately 1 micron to approximately 10 microns.

13. The apparatus of claim 8,

wherein said body comprises a first elongated segment and a second elongated segment extending laterally from a lower portion of said first elongated segment;

and

wherein said electrode pads are elongated and extend along said second elongated segment.

14. The apparatus of claim 13, wherein said second elongated segment is coiled into a cylinder.

15. The apparatus of claim 13, wherein said second elongated segment is folded onto itself to create a three-dimensional structure.

16. The apparatus of claim 8, wherein said electrode comprises a first electrode, said electrode pad comprises a first electrode pad, said connector pad comprises a first connector pad, and said conductor comprises a first conductor, and wherein said apparatus further comprises:

an electrode comprising a second electrode pad at a lower end, a second connector pad at an upper end, and a second conductor electrically connecting said second electrode pad and said second connector pad.

17. The electrode of claim 8, further comprising a plurality of additional electrodes.

18. A method of introducing a portion of an electrode into the tissues of a patient, comprising:

providing an introducer having a proximal portion, a distal end, and a distal helical portion;

providing a flexible electrode having a proximal portion and a distal portion, said distal portion of said electrode being attached to said distal end of said introducer;

providing a cannula having an inner diameter smaller than the diameter of said helical portion of said introducer;

inserting a distal end of said cannula into the tissues of a patient and advancing said cannula until said distal end of said cannula is located proximate to a target site;

inserting the lower end of said introducer into the proximal end of said cannula; and

rotating said introducer in the direction of the helix of the distal portion of said introducer and advancing said introducer such that said distal helical portion of said introducer unwinds to pass through said cannula and resumes its helical configuration when it exits the distal end of said cannula;

decoupling said introducer from said flexible electrode; and

rotating said introducer in the direction opposite to the helix of the distal portion of said introducer and withdrawing said introducer such that said distal helical portion of said introducer unwinds to pass through said cannula, leaving said distal helical portion of said flexible electrode implanted in the tissues of said patient.

19. The method of claim 18, wherein said step of providing a flexible electrode rotatably coupled to said introducer comprises the step of providing a flexible electrode adhesively bonded to said introducer.

20. The method of claim 19,

wherein said flexible electrode is adhesively bonded to said introducer by an adhesive that dissolves when exposed to fluid within the tissues of the patient, and

wherein said step of decoupling said introducer from said flexible electrode comprises the step of allowing said adhesive to be dissolved by fluid within the tissues of the patient.