Electrical stimulation leads and systems with elongate anchoring elements and methods of making and using

• US 10,709,886 B2
• Filed: 02/26/2018
• Issued: 07/14/2020
• Est. Priority Date: 02/28/2017
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Nagaoka, Eric Koji, Leven, Jacob B., Molina Ortega, Abraham
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/905,398
• Publication Number:
  US 20180243551A1
• Time in Patent Office: 869 Days
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An electrical stimulation lead includes a body having distal and proximal end portions, a longitudinal length, at least one anchoring lumen, and at least one open slot spaced apart from each end of the lead body. Each anchoring lumen is open at a slot and extends both distally and proximally from the slot. The lead also includes electrodes; terminals; conductors electrically coupling the terminals to the electrodes; and at least one anchoring element at least partially disposed in an anchoring lumen. Each anchoring element includes at least one bent portion biased to extend an extension portion of the anchoring element out of a slot when the anchoring element is in a deployed position and can retract the extension portion into an anchoring lumen when the anchoring element is in a constrained position. The lead further includes an attachment member attached to each anchoring element and disposed proximal to each slot.

Claims

1. An electrical stimulation lead, comprising:

a lead body comprising a distal end portion, a proximal end portion, and a longitudinal length, wherein the lead body further comprises at least one anchoring lumen that extends longitudinally along at least a portion of the lead body, wherein the lead body further comprises at least one open slot that is spaced apart from each end of the lead body, wherein each of the at least one anchoring lumen is open at one of the at least one open slot and extends both distally and proximally from the one of the at least one open slot;

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

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

a plurality of conductors electrically coupling the terminals to the electrodes;

at least one anchoring element at least partially disposed in one of the at least one anchoring lumen, wherein each of the at least one anchoring element comprises at least one bent portion that is biased to extend an extension portion of the anchoring element out of one of the at least one slot when the anchoring element is in a deployed position and can retract the extension portion into the respective anchoring lumen when the anchoring element is in a constrained position; and

an attachment member attached to each of the at least one anchoring element, wherein the attachment member is disposed proximal to each of the at least one slot, wherein the attachment member is a band disposed along the lead body.

2. The electrical stimulation lead of claim 1, wherein the lead body has an outer diameter that exceeds an inner diameter of the band.

3. The electrical stimulation lead of claim 1, wherein the attachment member comprises at least two separate attachment members and the at least one anchoring element comprises a plurality of anchoring elements, each of the at least two separate attachment members being attached to different ones of the anchoring elements.

4. The electrical stimulation lead of claim 1, wherein the at least one anchoring element comprises a plurality of anchoring elements, the anchoring elements being spaced apart from each other around the lead.

5. The electrical stimulation lead of claim 4, wherein the anchoring elements are uniformly spaced apart from each other around the electrical stimulation lead.

6. The electrical stimulation lead of claim 4, wherein the anchoring elements are non-uniformly spaced apart from each other around the electrical stimulation lead.

7. The electrical stimulation lead of claim 4, wherein the extension portions of at last two of the anchoring elements have different shapes.

8. The electrical stimulation lead of claim 1, wherein, when the extension portion of one of the at least one anchoring element extends out of the slot associated with the anchoring element, the extension portion forms two sides of a triangular shape that extends away from the lead body.

9. The electrical stimulation lead of claim 8, wherein the two sides of the triangular shape include a distal side and a proximal side, the proximal side being shorter than the distal side.

10. The electrical stimulation lead of claim 8, wherein the two sides of the triangular shape include a distal side and a proximal side, the distal side being shorter than the proximal side.

11. The electrical stimulation lead of claim 1, wherein, when the extension portion of one of the at least one anchoring element extends out of the slot associated with the one anchoring element, the extension portion has an arc shape.

12. The electrical stimulation lead of claim 1, wherein each of the at least one anchoring element is attached to at least one of the plurality of electrodes.

13. An electrical stimulating system, comprising:

the electrical stimulation lead of claim 1; and

a control module coupleable to the electrical stimulation lead.

14. A method of implanting the electrical stimulation lead of claim 1, the method comprising:

sliding an introducer over the lead body to push each of the at least one anchoring element through the slot associated with the anchoring element into the constrained position in the anchoring lumen in which the anchoring element is disposed;

implanting the electrical stimulation lead into tissue of a patient while the introducer constrains each of the at least one anchoring element in the constrained position; and

removing the introducer to extend each of the at least one anchoring element from the constrained position to the deployed position in the tissue of the patient.

15. A method of explanting the electrical stimulation lead of claim 1, the method comprising:

pulling the attachment member in a direction away from the at least one slot, thereby retracting each extension portion of each of the at least one anchoring element through the slot associated with the anchoring element into the anchoring lumen in which the anchoring element is disposed; and

explanting the lead body from tissue of a patient after pulling the attachment member.

16. The method of claim 15, further comprising:

prior to pulling the attachment member, cutting the lead body proximal to the attachment member so that the attachment member can be disengaged from the lead body.

17. The method of claim 15, further comprising:

while pulling the attachment member, compressing a portion of the lead body distal to the attachment member.

18. The method of claim 15, wherein pulling the attachment member in the direction away from the at least one slot comprises completely removing each of the at least one anchoring element from the lead body.

19. The method of claim 15, wherein explanting the lead body from the tissue of the patient after pulling the attachment member comprises explanting the lead body from the tissue of the patient while each of the at least one anchoring element is at least partially disposed in the lead body in a restrained position and each extension portion of each of the at least one anchoring element is retracted into the anchoring lumen in which the anchoring element is disposed.