Systems and methods for making and using radially-aligned segmented electrodes for leads of electrical stimulation systems

• US 9,795,779 B2
• Filed: 02/05/2014
• Issued: 10/24/2017
• Est. Priority Date: 09/21/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret, Sundaramurthy, Priya
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/173,593
• Publication Number:
  US 20140155971A1
• Time in Patent Office: 1,357 Days
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• 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 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing

Abstract

An electrical stimulation lead includes a lead body insertable into a patient. Electrodes are disposed along the lead body. The electrodes include at least two sets of segmented electrodes. Each set of segmented electrodes includes a first segmented electrode and a second segmented electrode radially spaced apart from one another around a circumference of the lead body. A tab is disposed on the first segmented electrode of each set of segmented electrodes. The tabs extend into the lead body. A guide feature is disposed on the tabs. The guide features are each radially aligned with one another along the length of the lead body. Conductors extend along the length of the lead body from a proximal end to the electrodes. Each of the conductors is electrically coupled to at least one of the electrodes. At least one of the conductors extends through the radially-aligned guide features of the tabs.

Claims

1. An electrical stimulation lead comprising:

an elongated lead body having a distal end portion, a proximal end portion, a longitudinal length, and a circumference, the lead body configured and arranged for insertion into a patient;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors coupled to the plurality of terminals and extending along the longitudinal length of the lead body to the distal end portion of the lead body, the plurality of conductors comprising a first conductor and a second conductor;

a plurality of electrodes disposed along the distal end portion of the lead body and coupled to the plurality of conductors, the plurality of electrodes comprising

a first set of segmented electrodes comprising a first segmented electrode and a second segmented electrode spaced apart from one another around the circumference of the lead body, wherein the first conductor is coupled to the first segmented electrode, and

a second set of segmented electrodes comprising a third segmented electrode and a fourth segmented electrode spaced apart from one another around the circumference of the lead body, wherein the second conductor is coupled to the third segmented electrode,

wherein the first set of segmented electrodes is disposed proximal to the second set of segmented electrodes along the longitudinal length of the lead body,

wherein the first segmented electrode and the third segmented electrode are circumferentially-aligned with one another along the longitudinal length of the lead body;

a first tab disposed on the first segmented electrode, the first tab extending inwardly from the first segmented electrode into the lead body, the first tab comprising an aperture through the first tab and surrounded by the first tab and sized to receive only a single one of the conductors; and

a second tab disposed on the third segmented electrode, the second tab extending inwardly from the third segmented electrode into the lead body, the second tab comprising an aperture through the second tab and surrounded by the second tab sized to receive only a single one of the conductors;

wherein the second conductor is physically received within the apertures of both the first and second tabs.

2. The electrical stimulation lead of claim 1, further comprising a connection element disposed along the first segmented electrode, wherein the first conductor is coupled to the first segmented electrode along the connection element.

3. The electrical stimulation lead of claim 2, wherein the first tab is disposed apart from the connection element along the first segmented electrode so that the first tab does not interfere with the coupling of the first conductor to the connection element.

4. The electrical stimulation lead of claim 1, wherein the second segmented electrode and the fourth segmented electrode are circumferentially-aligned with one another along the longitudinal length of the lead body.

5. The electrical stimulation lead of claim 1, wherein the first set of segmented electrodes further comprising a fifth segmented electrode spaced apart from each of the first segmented electrode and the second segmented electrode around the circumference of the lead body.

6. The electrical stimulation lead of claim 5, wherein the second set of segmented electrodes further comprising a sixth segmented electrode spaced apart from each of the third segmented electrode and the fourth segmented electrode around the circumference of the lead body.

7. The electrical stimulation lead of claim 1. wherein the plurality of electrodes further comprises at least one ring electrode disposed along the distal end portion of the lead body.

8. The electrical stimulation lead of claim 7, wherein the at least one ring electrode is disposed proximal to each of the first set of segmented electrodes and the second set of segmented electrodes along the longitudinal length of the lead body.

9. The electrical stimulation lead of claim 7, wherein the at least one ring electrode is disposed distal to each of the first set of segmented electrodes and the second set of segmented electrodes along the longitudinal length of the lead body.

10. The electrical stimulation lead of claim 1, wherein the plurality of electrodes further comprises a first ring electrode disposed proximal to each of the first set of segmented electrodes and the second set of segmented electrodes along the longitudinal length of the lead body and a second ring electrode disposed distal to each of the first set of segmented electrodes and the second set of segmented electrodes along the longitudinal length of the lead body.

11. The electrical stimulation lead of claim 1, wherein the plurality of electrodes comprises eight electrodes.

12. An electrical stimulation system comprising:

the electrical stimulation lead of claim 1; and

a control module coupled to the proximal end portion of the electrical stimulation lead, the control module configured and arranged for providing stimulation energy to the plurality of electrodes.

13. A method of forming the electrical stimulation lead of claim 1 the method comprising:

forming a plurality of pre-electrodes that comprises a first pre-electrode and a second pre-electrode, wherein each of the plurality of pre-electrodes is formed in the shape of a ring, wherein each of the plurality of pre-electrodes comprises at least two thin-walled portions separated by at least two thick-walled portions, wherein the first pre-electrode comprises the first tab disposed on a first thick-walled portion of the at least two thick-walled portions of the first pre-electrode and the second pre-electrode comprises the second tab disposed on a first thick-walled portion of the at least two thick-walled portions of the second pre-electrode;

disposing the plurality of terminals along the proximal end portion of the lead body;

coupling the plurality of conductors to the plurality of terminals and extending the plurality of conductors along the longitudinal length of the lead body;

disposing the plurality of pre-electrodes along the distal end portion of the lead body with the first pre-electrode disposed proximal to the second pre-electrode along the longitudinal length of the lead body;

coupling the first conductor of the plurality of conductors to the first thick-walled portion of the first pre-electrode;

physically receiving the second conductor of the plurality of conductors within the apertures of both the first and second tabs to circumferentially-align the first thick-walled portion of the second pre-electrode with the first thick-walled portion of the first pre-electrode along the longitudinal length of the lead body; and

grinding the plurality of pre-electrodes to remove the thin-walled portions of each of the plurality of pre-electrodes to form the plurality of segmented electrodes, including the first segmented electrode, second segmented electrode, third segmented electrode, and fourth segmented electrode, from the thick-walled portions of the plurality of pre-electrodes.

14. The electrical stimulation lead of claim 1, wherein the first conductor is coupled to the first segmented electrode at connection element spaced apart from the first tab.

15. The electrical stimulation lead of claim 1, wherein no tab is disposed on the second segmented electrode and the fourth segmented electrode.