Electrical stimulation leads and systems with elongate anchoring elements

• US 9,533,141 B2
• Filed: 06/29/2015
• Issued: 01/03/2017
• Est. Priority Date: 07/07/2014
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Wechter, David Ernest, Black, James Robert, Leven, Jacob B.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/754,430
• Publication Number:
  US 20160001060A1
• Time in Patent Office: 554 Days
• Field of Search: 607/128
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An electrical stimulation lead includes at least one lead body and at least one thin, elongate anchoring element. The lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot in the lead body where each anchoring lumen is open at one of the at least one open slot. For each anchoring element, the first end of the anchoring element is disposed in one of the at least one anchoring lumen and the second end of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the anchoring lumen and away from the lead body in a deployed configuration unless the second end is constrained in a constrained configuration adjacent or within the lead body.

Claims

1. An electrical stimulation lead, comprising:

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length, wherein the lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot extending longitudinally along the lead body, wherein each anchoring lumen has a distal end portion and a proximal end portion, wherein the distal end portion of the anchoring lumen is exposed by the at least one open slot associated with the anchoring lumen;

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

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

at least one conductor electrically coupling the at least one terminal to the at least one electrode;

at least one thin, elongate anchoring element having a distal end portion and a proximal end portion, each of the distal end portion and the proximal end portion having a longitudinal length, wherein, for each anchoring element, the proximal end portion of the anchoring element is disposed in the proximal end portion of a one of the at least one anchoring lumen and the distal end portion of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the one of the at least one anchoring lumen and away from the lead body in a deployed configuration unless the distal end portion of the anchoring element is constrained in a constrained configuration with the distal end portion of the anchoring element lying in the distal end portion of the one of the at least one anchoring lumen and completely exposed by the open slot associated with the one of the at least one anchoring lumen.

2. The electrical stimulation lead of claim 1, wherein, in the deployed configuration, each of the at least one anchoring element forms a hook.

3. The electrical stimulation lead of claim 1, wherein, in the deployed configuration, each of the at least one anchoring element forms a tine extending straight out of the anchoring lumen.

4. The electrical stimulation lead of claim 3, wherein, in the deployed configuration, each of the at least one anchoring element extends perpendicularly from the lead body.

5. The electrical stimulation lead of claim 3, wherein, in the deployed configuration, each of the at least one anchoring element extends at an angle in a range of 10 to 170 degrees relative to the lead body.

6. The electrical stimulation lead of claim 1, wherein the lead body comprises a multi-lumen tubing defining the at least one anchoring lumen and one or more conductor lumens.

7. The electrical stimulation lead of claim 1, wherein the distal end portion of the at least one anchoring element is constrained in a constrained configuration adjacent to or within the lead body using an introducer.

8. The electrical stimulation lead of claim 1, wherein the at least one anchoring element is formed of a superelastic material configured and arranged to change from the constrained configuration to the deployed configuration by heating the anchoring element above a transformation temperature which is a temperature below body temperature.

9. The electrical stimulation lead of claim 1, wherein the at least one anchoring element is formed of a superelastic material configured and arranged to change from the constrained configuration to the deployed configuration by heating the anchoring element above a transformation temperature which is a temperature between room temperature and body temperature.

10. The electrical stimulation lead of claim 1, wherein the lead body comprises a multi-lumen tubing defining the at least one anchoring lumen and a central lumen separate from the at least one anchoring lumen.

11. An electrical stimulating system comprising:

the electrical stimulation lead of claim 1; and

a control module coupleable to the electrical stimulation lead.

12. An electrical stimulation lead, comprising:

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length;

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

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

at least one conductor electrically coupling the at least one terminal to the at least one electrode; and

at least one thin, elongate anchoring element having a first end and a second end, wherein the lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot extending along the longitudinal length of the lead body and open along the longitudinal length, wherein each of the at least one anchoring lumen is open at one of the at least one open slot associated with the anchoring lumen, wherein, for each anchoring element, the first end of the anchoring element is disposed in one of the at least one anchoring lumen and the second end of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the anchoring lumen and away from the lead body in a deployed configuration unless the second end is constrained in a constrained configuration adjacent or within the lead body, wherein the at least one anchoring element is formed of a superelastic material configured and arranged to change from the constrained configuration to the deployed configuration by heating the anchoring element above a transformation temperature which is a temperature below body temperature.

13. The electrical stimulation lead of claim 12, wherein, unless constrained, the second end of each anchoring element extends at an angle in a range from 10 to 170 degrees relative to the lead body.

14. The electrical stimulation lead of claim 12, wherein the lead is configured and arranged for retraction of the at least one anchoring element by application of at least a predetermined amount of pulling force to the lead when the lead is implanted.

15. The electrical stimulation lead of claim 12, wherein the transformation temperature is between room temperature and body temperature.

16. The electrical stimulation lead of claim 12, wherein the lead body comprises a multi-lumen tubing defining the at least one anchoring lumen and one or more conductor lumens.

17. The electrical stimulation lead of claim 12, wherein the lead body comprises a multi-lumen tubing defining the at least one anchoring lumen and a central lumen separate from the at least one anchoring lumen.

18. An electrical stimulating system comprising:

the electrical stimulation lead of claim 12; and

a control module coupleable to the electrical stimulation lead.