Systems and methods for making and using an electrical stimulation system for peripheral nerve stimulation

• US 10,709,888 B2
• Filed: 07/21/2017
• Issued: 07/14/2020
• Est. Priority Date: 07/29/2016
• 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
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/656,734
• Publication Number:
  US 20180028804A1
• Time in Patent Office: 1,089 Days
• 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: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An electrical stimulation lead includes a lead body; a terminal disposed along the proximal end portion of the lead body; a single electrode disposed at the distal end of the lead body; a conductor extending along the lead body and electrically coupling the terminal to the single electrode; and an adjustable sheath disposed over a portion of the lead body to cover a selected portion of the single electrode by displacing the sheath forwards or backwards relative to the single electrode to control a size of a portion of the electrode exposed for stimulation of tissue. Another electrical stimulation lead has a low-profile distal portion that has a smaller lateral width in at least one direction than a remainder of the lead body. Yet another arrangement includes a guidewire with a mapping electrode to map a region around a peripheral nerve prior to implantation of an electrical stimulation lead.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a proximal end portion and a distal end portion, wherein the distal end portion has a smaller lateral width in at least one direction than a remainder of the lead body;

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

a plurality of electrodes disposed at the distal end portion of the lead body; and

a plurality of conductors extending along the lead body and electrically coupling the plurality of terminals to the plurality of electrodes.

2. The electrical stimulation lead of claim 1, wherein the distal end portion has a circular cross-section.

3. The electrical stimulation lead of claim 2, wherein the distal end portion of the lead body of the electrical stimulation lead has a diameter of 0.020 inch or less.

4. The electrical stimulation lead of claim 3, wherein the remainder of the lead body of the electrical stimulation lead has a diameter of at least 0.040 inch.

5. The electrical stimulation lead of claim 1, Therein at least one electrode of the plurality of electrodes does not extend around a full perimeter of the distal end portion of the lead body of the electrical stimulation lead.

6. The electrical stimulation lead of claim 1, wherein the distal end portion has a cross-section with a major axis width and a minor axis width of different values.

7. The electrical stimulation lead of claim 6, wherein the minor axis width of the distal end portion of the lead body of the electrical stimulation lead has a value of 0.020 inch or less.

8. The electrical stimulation lead of claim 1, wherein the distal end portion has a square or rectangular cross-section with or without rounded corners.

9. The electrical stimulation lead of claim 1, wherein the distal end portion has an oval cross-section.

10. The electrical stimulation lead of claim 1, wherein the lead body also has a diminishing width portion between the distal end portion and the remainder of the lead body.

11. An electrical stimulation lead, comprising:

a lead body having a proximal end portion and a distal end portion, wherein the distal end portion has a smaller lateral width in at least one direction than a remainder of the lead body, wherein the distal end portion has a cross-section with a major axis width and a minor axis width of different values;

at least one terminal disposed at the proximal end portion of the lead body;

at least one electrode disposed at the distal end portion of the lead body; and

at least one conductor extending along the lead body and electrically coupling the at least one terminal to the at least one electrode.

12. The electrical stimulation lead of claim 11, wherein the minor axis width of the distal end portion of the electrical stimulation lead has a value of 0.020 inch or less.

13. The electrical stimulation lead of claim 11, wherein the at least one electrode is a plurality of electrodes.

14. The electrical stimulation lead of claim 11, wherein at least one of the at least one electrode does not extend around a full perimeter of the distal end portion of the lead body of the electrical stimulation lead.

15. The electrical stimulation lead of claim 11, wherein the distal end portion has a rectangular cross-section with or without rounded corners.

16. The electrical stimulation lead of claim 11, Wherein the distal end portion has an oval cross-section.

18. The electrical stimulation lead of claim 11, wherein the lead body also has a diminishing width portion between the distal end portion and the remainder of the lead body.

19. The electrical stimulation lead of claim 11, wherein the minor axis width is 0.020 inch or less.

20. The electrical stimulation lead of claim 19, wherein the remainder of the lead body of the electrical stimulation lead has a diameter of at least 0.040 inch.

17. An electrical stimulation lead, comprising:

a lead body having a proximal end portion and a distal end portion, wherein the distal end portion has a smaller lateral width in at least one direction than a remainder of the lead body, Wherein the distal portion has a cross-section with a major axis width and minor axis width of different values, wherein the major axis width is equal to a diameter of the remainder of the lead body;

at least one terminal disposed at the proximal end portion of the lead body;

at least one electrode disposed at the distal end portion of the lead body; and

at least one conductor extending along the lead body and electrically coupling the at least one terminal to the at least one electrode.