Electrode paddle for neurostimulation

• US 8,942,821 B2
• Filed: 10/08/2013
• Issued: 01/27/2015
• Est. Priority Date: 01/25/2007
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Giancarlo Barolat
• Inventors: Barolat, Giancarlo
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US14/048,962
• Publication Number:
  US 20140039580A1
• Time in Patent Office: 476 Days
• Field of Search: 607/2, 607/46, 607/116
• 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
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An implantable electrode paddle for use in a neurostimulation system may include a dorsally-projecting lead that allows all of the edges of the electrode paddle to be situated near a vertebral body for stimulation of neural structures. Embodiments may include one or more flanges for cooperating with a vertebral body and thereby stabilizing the electrode paddle. Embodiments of the present invention may also include features to allow an electrode paddle to be divided during surgery. Embodiments of the present invention may also include an electrode paddle having a plurality of paddle sections, wherein at least one of the paddle sections comprises a plurality of asymmetrically configured contacts. Embodiments of the invention include a method of assembling a neurostimulation system and a method of implanting an implantable system in a body, wherein the implantable system includes an electrode paddle that may be divided into a plurality of paddle sections.

Claims

1. An electrode paddle for use in an implantable neurostimulation system for implanting into a patient to stimulate neural structures within the patient, the implantable neurostimulation system including an implantable pulse generator and an electrode lead, the electrode lead in electrical communication with the implantable pulse generator, the implantable pulse generator for sending an electrical current to the electrode paddle by way of the electrode lead, the electrode paddle comprising:

a plurality of paddle sections formed of an implantable tissue compatible material including a first paddle section and a second paddle section wherein each of the plurality of paddle sections includes a stimulation surface including a plurality of conductive contacts in electrical communication with the electrode lead and an opposing insulating surface, the first paddle section detachably attached to the second paddle section;

a stabilization flange formed of an implantable tissue compatible material located along at least a portion of at least one exterior side edge of a plurality of side edges of the first paddle section, wherein the at least one exterior side edge of the plurality of side edges of the first paddle section faces away from each of the plurality of paddle sections;

a lead connection joined to the opposing insulating surface of the first paddle section and extending substantially perpendicular away from the opposing insulating surface of the first paddle section, the lead connection spaced from the first end, second end, first lateral side, and second lateral side;

a plurality of electrical conductors extending through the lead connection to the plurality of conductive contacts disposed on the stimulation surface of the first paddle section; and

wherein the stimulation surface lies within a first plane, and the stabilization flange lies within a second plane, the second plane intersecting the first plane.

2. The electrode paddle of claim 1, wherein the flange is angled and non-planar relative to the dorsal surface of the first paddle section.

3. The electrode paddle of claim 1, wherein the flange comprises a gap, the gap extending from an outer lateral edge of the flange to the at least one exterior side edge of the first paddle section.

4. The electrode paddle of claim 1, wherein at least two contacts of each of the first and second paddle sections are aligned along a first axis and at least two contacts of each of the first and second paddle sections are aligned along a second axis, and wherein the first axis and the second axis are substantially perpendicular to one another.

5. The electrode paddle of claim 1, wherein at least one contact of the plurality of contacts of the first paddle section is offset laterally from a linearly aligned group of the plurality of contacts.

6. The electrode paddle of claim 1, wherein the stimulation surface defines a plane and the lead connection intersects the plane containing the stimulation surface.

7. The electrode paddle of claim 1, wherein the electrical conductors include a coupling end spaced from the first paddle section and further including a pulse generator having a passage to receive the coupling end, wherein the pulse generator is configured to selectively energize the electrical conductors to thereby energize the interconnected conductive electrodes.

8. The electrode paddle of claim 1, wherein the stabilization flange extends laterally away from the first lateral side of the first paddle section, the stabilization flange configured to engage adjacent tissue of a patient to stabilize the position of the electrode paddle.

9. The electrode paddle of claim 8, wherein the stabilization flange further includes at least one groove extending laterally away from the lateral side.

10. An implantable neurostimulation apparatus, comprising:

a paddle lead section formed of an insulating tissue compatible material having a stimulation side surface including a plurality of conductive electrodes disposed thereon and an opposing insulating surface, wherein the paddle has a thickness between the stimulation side surface and the opposing insulating surface, the paddle lead section further including a length extending along a longitudinal axis between a first end and an opposing second end, and a width extending between a first lateral side and an opposing second lateral side, the length being greater than the width and the width being greater than the thickness;

a lead connection portion joined to the insulating side and extending away from the insulating side, the lead connection spaced from the first end, second end, first lateral side and second lateral side, the lead connection portion extending away from the insulating side in a direction substantially perpendicular to the longitudinal axis of the paddle lead section; and

a plurality of electrical conductors extending through the lead connection to the plurality of conductive electrodes disposed on the stimulation side surface of the paddle lead section; and

further including a stabilization flange formed of tissue compatible material and extending laterally away from the first lateral side, wherein the stabilization flange is configured to engage adjacent tissue of a patient to stabilize the position of the paddle lead section, wherein the stimulation surface lies within a first plane, and the stabilization flange lies within a second plane, the second plane intersecting the first plane.

11. The apparatus of claim 10, wherein the stimulation side surface defines a plane and the lead connection portion intersects the plane containing the stimulation side surface.

12. The apparatus of claim 10, wherein the stabilization flange further includes at least one groove extending laterally away from the lateral side.

13. The apparatus of claim 10, further including a second paddle lead section formed of an insulating tissue compatible material having a stimulation side surface including a plurality of conductive electrodes disposed thereon and an opposing insulating surface, wherein the paddle has a thickness between the stimulation side surface and the opposing insulating surface, the paddle lead section further including a length extending along a longitudinal axis between a first end and an opposing second end, and a width extending between a first lateral side and an opposing second lateral side, the length being greater than the width and the width being greater than the thickness;

a second lead connection portion joined to the insulating side and extending away from the insulating side, the lead connection spaced from the first end, second end, first lateral side and second lateral side; and

a plurality of electrical conductors extending through the lead connection to the plurality of conductive electrodes disposed on the stimulation side surface of the paddle lead section;

wherein the second paddle lead section is detachably joined to the paddle lead section.

14. The apparatus of claim 10, wherein the plurality of conductive electrodes are disposed asymmetrically on the stimulation side surface.