Systems and methods for making and using reversible mechanical lead anchors for electrical stimulation systems

• US 9,987,482 B2
• Filed: 05/22/2015
• Issued: 06/05/2018
• Est. Priority Date: 05/27/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Nageri, Ranjan Krishna Mukhari, Villarta, Geoffrey Abellana
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/720,708
• Publication Number:
  US 20150343198A1
• Time in Patent Office: 1,110 Days
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A lead anchor includes a flexible housing having a first end and a second end opposite to the first end, the flexible housing defining a lead lumen forming a continuous passageway through the flexible housing. The lead anchor also includes a compressible retention ring disposed within the flexible housing and around a portion of the lead lumen. The retention ring defines an uncompressed position in which the retention ring has an elongate shape, with a major axis and a minor axis, to hold a portion of a lead received within the lead lumen. The retention ring further defines a compressed position achieved by compressing opposite ends of the major axis of the retention ring to transition the retention ring to a more circular shape that allows the lead to slidingly pass through the retention ring. Upon release of the compression, the retention ring returns to the uncompressed position.

Claims

1. A lead anchor comprising:

a flexible housing having a first end and a second end opposite to the first end, the flexible housing defining a lead lumen forming a continuous passageway through the flexible housing, the lead lumen having a first opening defined along the first end of the flexible housing and a second opening defined along the second end of the flexible housing; and

a compressible, metal retention ring disposed within the flexible housing and around a portion of the lead lumen, the retention ring defining an uncompressed position in which the retention ring has an elongate shape, with a major axis and a minor axis, that is configured and arranged to directly engage and hold a portion of a lead, if present, received within the lead lumen, the retention ring further defining a compressed position achieved by compressing opposite ends of the major axis of the retention ring to transition the retention ring to a more circular shape that allows the lead to slidingly pass through the retention ring, wherein, upon release of the compression, the retention ring is configured and arranged to return to the uncompressed position.

2. The lead anchor of claim 1, wherein the retention ring is made of spring steel or stainless steel.

3. The lead anchor of claim 1, further comprising two tabs extending from the flexible housing on opposite sides of the flexible housing with an eyelet formed in each tab.

4. The lead anchor of claim 3, wherein the major axis of the retention ring is in a plane parallel to a plane defined by the two tabs.

5. The lead anchor of claim 3, wherein the major axis of the retention ring is in a plane perpendicular to a plane defined by the two tabs.

6. The lead anchor of claim 3, wherein the two tabs are longitudinally offset.

7. The lead anchor of claim 6, wherein at least a portion of the retention ring is disposed between the two tabs.

8. The lead anchor of claim 3, wherein the two tabs are disposed at a same longitudinal position along the lead anchor.

9. The lead anchor of claim 8, wherein the retention ring is disposed between the two tabs.

10. The lead anchor of claim 1, wherein, in the uncompressed position, the retention ring has an oval shape.

11. The lead anchor of claim 1, wherein the retention ring has an interior surface and the interior surface has surface features which facilitate holding the portion of the lead.

12. The lead anchor of claim 11, wherein the surface features are selected from serrations, sharp teeth, or non-sharp teeth.

13. The lead anchor of claim 1, wherein the first end of the flexible housing has an elongated, tapered shape.

14. An implantable stimulation arrangement, comprising:

the lead anchor of claim 1; and

an electrical stimulation lead comprising an electrode array, wherein the lead anchor is configured and arranged for receiving a portion of the electrical stimulation lead and removably retaining the received portion of the electrical stimulation lead.

15. An implantable stimulation device, comprising:

the lead anchor of claim 1;

an electrical stimulation lead comprising an electrode array and coupleable to the lead anchor; and

a control module coupleable to the electrical stimulation lead.

16. A method of implanting an implantable stimulation device, the method comprising:

providing the lead anchor of claim 1;

advancing an electrode array of an electrical stimulation lead into a patient to a target stimulation location;

compressing the retention ring of the lead anchor to the compressed position and sliding the lead anchor along the electrical stimulation lead to a desired placement position along the electrical stimulation lead with a portion of the electrical stimulation lead disposed within the lead lumen of the lead anchor; and

releasing the compression of the retention ring so that the retention ring returns to the uncompressed position and holds the lead.

17. The method of claim 16, further comprising securing the lead anchor to patient tissue in proximity to the lead anchor.

18. The method of claim 16, further comprising coupling the electrical stimulation lead to a control module.

19. The method of claim 16, wherein the lead anchor comprises two tabs extending from the flexible housing on opposite sides of the flexible housing and at a same longitudinal position along the lead anchor,

wherein compressing the retention ring comprises compressing the lead anchor at the two tabs.

20. The method of claim 16, wherein the lead anchor comprises two tabs extending from the flexible housing on opposite sides of the flexible housing and longitudinally offset from each other,

wherein compressing the retention ring comprises compressing the lead anchor between the two tabs.