Percutaneous electrode

• US 10,035,012 B2
• Filed: 02/21/2011
• Issued: 07/31/2018
• Est. Priority Date: 02/22/2010
• Status: Active Grant

• Current Assignee: Nuvectra Corporation
• Original Assignee: Nuvectra Corporation
• Inventors: North, Richard B.
• Primary Examiner(s): Evanisko, George
• Application Number:
  US13/640,616
• Publication Number:
  US 20130110210A1
• Time in Patent Office: 2,717 Days
• Field of Search: 607116, 607117, 607119, 607125
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

Disclosed is a system including an electrode and a stylet configured to steer the electrode towards its intended position during implantation, and a method for such system'"'"'s use. An electrode is provided having regions with varied flexibility. A stylet having bends that are indexed to specific regions of flexibility of the electrode may be inserted into the electrode, and upon minimal radial and/or longitudinal movement of the stylet within the electrode, will cause the magnitude of the angle to which the lead is bent to either increase or decrease so as to aid the operator in placement of the electrode.

Claims

1. A system for positioning a lead within a patient, comprising:

a lead comprising a shaft having a plurality of electrode contacts disposed thereon and a flexible spacer portion between each of said electrode contacts, said shaft having a section defining a cylindrical exterior wall, which section includes at least one of said electrode contacts and at least one of said flexible spacer portions, which section has a uniform outer diameter along the length of the section, and a stylet lumen extending into said lead from a proximal end thereof towards a distal end thereof, wherein one or more planar cross-sections through said lead taken in a direction perpendicular to a major axis extending lengthwise through a center of said lead and through said section defining a cylindrical exterior wall include a portion of said at least one electrode contact and a portion of said at least one flexible spacer portion, and wherein said portion of said at least one electrode contact is asymmetrically positioned with respect to said major axis in said one or more planar cross-sections; and

a stylet having a plurality of bends therein and relatively straight portions extending between said bends, wherein said bends are positioned a distance apart from one another so as to simultaneously align with said flexible spacer portions of said lead when said stylet is positioned within said stylet lumen;

wherein a first one of said flexible spacer portions has greater flexibility than a second one of said flexible spacer portions, such that one of said bends in said stylet engaging said first one of said flexible spacer portions will cause said lead to bend at a larger angle than said one of said bends in said stylet engaging said second one of said flexible spacer portions.

2. The system of claim 1, wherein said first one of said flexible spacer portions comprises a cylindrical wall having a first thickness, and a second flexible spacer portion comprises a cylindrical wall having a second thickness that is greater than said first thickness.

3. The system of claim 1, wherein said first one of said flexible spacer portions is formed of a first material, and said second flexible spacer portion is formed of a second material, wherein said first material has a greater flexibility than said second material.

4. The system of claim 1, said second flexible spacer portion further comprising at least one stiffening insert embedded within said second flexible spacer portion.

5. The system of claim 1, wherein at least a first one of said electrode contacts has a first length L, and at least two second electrode contacts each have a second length that is less than L/2, and wherein said first flexible spacer portion is positioned between said first one of said electrodes and one of said second electrodes, and said second flexible spacer portion is positioned between said at least two second electrodes.

6. The system of claim 5, wherein a combined length of two of said second electrodes and said second flexible spacer portion equals L.

7. The system of claim 1, wherein said system is configured such that aligning said one of said bends in said stylet with said first one of said flexible spacer portions will cause said lumen to bend at an angle, and rotation of said stylet within said stylet lumen when said one of said bends in said stylet is aligned with said first one of said flexible spacers will cause the magnitude of said angle to vary.

8. The system of claim 7, wherein said first one of said flexible spacer portions further comprises a cylindrical section formed of compressible material having a top side and a bottom side opposite said top side, and wherein said top side has a first durometer rating and said bottom side has a second durometer rating different from said first durometer rating.

9. The system of claim 7, wherein said first one of said flexible spacer portions further comprises a cylindrical section formed of compressible material, and wherein said stylet lumen extends through said first one of said flexible spacer portions along an axis that is set off from a central axis of said at least one flexible spacer portion.

10. The system of claim 7, wherein at least one of said electrode contacts is radially asymmetric such that a first side of said at least one electrode contact is of a greater length than a second side of said at least one electrode contact opposite said first side, and wherein said first one of said flexible spacer portions is adjacent said at least one electrode and has a radially asymmetric configuration that is complementary to said at least one electrode contact.

11. The system of claim 7, said stylet further comprising an indicia configured to indicate both a radial orientation and a longitudinal orientation of said stylet with respect to said stylet lumen.

12. A method of using the system of claim 1, comprising the steps of:

inserting said stylet into said stylet lumen toward said distal end of said lead a sufficient distance so that at least one of said bends in said stylet is aligned with at least one of said electrode contacts;

moving said lead within a patient in a first direction;

moving said stylet in said stylet lumen so as to align said one of said bends in said stylet with one of said flexible spacer portions so as to change the angle of at least a portion of said lead; and

further moving said lead within said patient in a second direction different from said first direction.

13. The method of claim 12, further comprising the steps of:

further moving said stylet in said stylet lumen toward said distal end of said lead so as to further change the angle of at least a portion of said lead; and

further moving said lead within said patient in a third direction different from said second direction.

14. The method of claim 12, wherein said step of moving said stylet in said stylet lumen further comprises rotating said stylet within said stylet lumen.

15. The method of claim 14, wherein rotation of said stylet within said stylet lumen causes a magnitude of an angle to which said lead is bent to vary.