SYSTEMS AND METHODS FOR MAKING AND USING RADIALLY-ALIGNED SEGMENTED ELECTRODES FOR LEADS OF ELECTRICAL STIMULATION SYSTEMS

• US 20120071949A1
• Filed: 09/06/2011
• Published: 03/22/2012
• 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
• Granted Patent: US 8,694,127 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• 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, a proximal end, a length, a circumference, and an outer surface, the lead body configured and arranged for insertion into a patient;

a plurality of electrodes disposed along the outer surface of the lead body, the plurality of electrodes comprising at least two sets of segmented electrodes disposed at the distal end of the lead body, each set of segmented electrodes comprising a first segmented electrode and a second segmented electrode radially spaced apart from one another around the circumference of the lead body;

a first tab disposed on the first segmented electrode of each of the at least two sets of segmented electrodes, wherein each of the first tabs extends inwardly from the first segmented electrodes into the lead body;

a guide feature disposed on each of the first tabs, wherein the guide features are each radially aligned with one another along the length of the lead body; and

a plurality of conductors extending along the length of the lead body from the proximal end to the plurality of electrodes, wherein each of the conductors is electrically coupled to at least one of the plurality of electrodes, wherein at least one of the plurality of conductors extends through the radially-aligned guide features of the first tabs.

2. The electrical stimulation lead of claim 1, further comprising a second tab disposed on the second segmented electrode of each of the at least two sets of segmented electrodes, wherein each of the second tabs extend inwardly from the second segmented electrodes into the lead body.

3. The electrical stimulation lead of claim 1, wherein each of the guide features comprises an aperture defined in the first tab.

4. The electrical stimulation lead of claim 1, wherein each set of segmented electrodes further comprises a third segmented electrode radially spaced apart from the first segmented electrode and the second segmented electrode around the circumference of the lead body.

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

6. The electrical stimulation lead of claim 5, wherein the at least one ring electrode is disposed either proximal or distal to each of the at least two sets of segmented electrodes along the length of the lead body.

7. The electrical stimulation lead of claim 1, further comprising a plurality of terminals disposed at the proximal end of the lead body, wherein each of the conductors is electrically coupled to at least one of the plurality of terminals.

8. An electrical stimulation system comprising:

the electrical stimulation lead of claim 7; and

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

9. The electrical stimulation system of claim 8, wherein the electrical stimulation lead has at least eight electrodes, and wherein the control module has at least eight stimulation channels, each stimulation channel independently programmable to deliver a stimulus current through each channel.

10. A method of forming a lead for a stimulation device, the method comprising:

forming a plurality of pre-electrodes, wherein each of the 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 at least two of the plurality of pre-electrodes each comprise a first tab disposed on one of the at least two thick-walled portions, wherein each of the first tabs comprises a guide feature;

disposing the plurality of pre-electrodes near a distal end of a lead body;

joining at least one conductor to each thick-walled portion of each of the plurality of pre-electrodes such that at least one of the at least one conductor extends through each of the guide features, thereby radially aligning the guide features along a 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-electrode to form a plurality of segmented electrodes from the thick-walled portions of each of the plurality of pre-electrodes.

11. An electrical stimulation lead assembly comprising:

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

a membrane coupleable to the distal end of the lead body, the membrane comprising a rear face coupleable to the lead body, a front face opposite to the rear face, and a width, wherein when the membrane is coupled to the distal end of the lead body, the membrane is disposed over at least a portion of the outer surface of the distal end of the lead body such that the width of the membrane wraps around the circumference of the lead;

a plurality of electrodes disposed on the front face of the membrane; and

a plurality of conductors extending along the length of the lead body from the proximal end to the plurality of spaced-apart electrodes, wherein each of the conductors is electrically coupled to at least one of the plurality of electrodes.

12. The electrical stimulation lead assembly of claim 11, wherein the membrane defines a plurality of wells inset to the front face of the membrane.

13. The electrical stimulation lead assembly of claim 12, wherein the plurality of electrodes are disposed on the front face of the membrane such that at least one of the plurality of spaced-apart electrodes is disposed in one of the plurality of wells.

14. The electrical stimulation lead assembly of claim 13, wherein the at least one of the plurality of spaced-apart electrodes disposed in one of the plurality of wells is coupled to the well using adhesive.

15. The electrical stimulation lead assembly of claim 11, wherein the width of the membrane is equal in length to the circumference of the lead body.

16. The electrical stimulation lead assembly of claim 11, wherein at least one of the electrodes is formed from a conductive polymer.

17. The electrical stimulation lead assembly of claim 11, wherein the rear face of the membrane is coupled to the distal end of the lead body by an adhesive.

18. The electrical stimulation lead assembly of claim 11, wherein the plurality of spaced-apart electrodes disposed along the front face of the membrane further comprises at least one elongated electrode that extends along substantially entirely the width of the membrane such that, when the membrane is wrapped around and coupled to the lead the at least one elongated electrodes forms at least one ring electrode.

19. The electrical stimulation lead assembly of claim 11, wherein when the membrane is wrapped around and coupled to the lead body, the resulting electrodes comprise at least two sets of segmented electrodes, with three electrodes in each set of segmented electrodes.

20. A method of forming a lead for a stimulation device comprising:

disposing a plurality of electrodes along a front face of a membrane;

coupling a rear face of the membrane to an outer surface of a distal end of an elongated lead body such that the rear face of the membrane conforms to a shape of the outer surface of the lead body and a width of the membrane wraps around the outer surface of the lead body; and

coupling individual conductors extending along a length of the lead body to each of the plurality of electrodes.