THREE-PIECE BUTTON ANCHOR AND METHODS AND DEVICES USING THE ANCHOR

• US 20100312319A1
• Filed: 06/04/2009
• Published: 12/09/2010
• Est. Priority Date: 06/04/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Granted Patent: US 8,412,349 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A lead anchor comprises a housing, and a plunger. The housing comprises a rigid body and a flexible covering disposed over at least a portion of the rigid body. The housing defines a first opening and a second opening configured and arranged to receive a lead. The housing further defines a transverse lumen. The rigid body comprises one or more projecting locking ridges extending into the transverse lumen. A plunger comprising one or more locking detents disposed thereon is configured and arranged for insertion into the transverse lumen and engaging a lead and locking with the housing by engagement of at least one of the one or more locking ridges of the housing with at least one of the one or more locking detents of the plunger. At least one suture element is formed by the flexible covering for receiving a suture to suture the lead anchor to patient tissue.

Claims

1. A lead anchor, comprising:

a housing comprising a rigid body and a flexible covering disposed over at least a portion of the rigid body, the housing defining a first opening and a second opening configured and arranged to receive a lead, the housing further defining a transverse lumen, the rigid body comprising one or more projecting locking ridges extending into the transverse lumen;

a plunger comprising one or more locking detents disposed thereon, wherein the plunger is configured and arranged for insertion into the transverse lumen and engaging a lead disposed through the first and second openings of the housing and wherein the plunger is configured and arranged for locking with the housing by engagement of at least one of the one or more locking ridges of the housing with at least one of the one or more locking detents of the plunger; and

at least one suture element formed by the flexible covering and configured and arranged for receiving a suture to suture the lead anchor to patient tissue.

2. The lead anchor of claim 1, wherein the rigid body and the flexible covering are unitary.

3. The lead anchor of claim 1, wherein at least one of the rigid body or the flexible covering is substantially disk-shaped.

4. The lead anchor of claim 1, wherein at least one of the rigid body or the flexible covering comprises silicone.

5. The lead anchor of claim 1, wherein at least one of the rigid body or the flexible covering comprises a metal material.

6. The lead anchor of claim 1, wherein the at least one suture element comprises at least one suture opening.

7. The lead anchor of claim 1, wherein the at least one suture element comprises at least one suture ridge.

8. The lead anchor of claim 1, wherein the plunger has a head that is configured and arranged to lie flush with a top surface of the housing when fully inserted into the housing.

9. The lead anchor of claim 1, wherein the rigid body and the flexible covering are formed of the same material.

10. The lead anchor of claim 1, wherein the housing and the plunger are formed of dissimilar material.

11. The lead anchor of claim 1, wherein the plunger further comprises a mechanism for releasing the plunger from a locked state within the housing.

12. The lead anchor of claim 1, wherein the flexible covering comprises at least one slit configured and arranged to mate with a portion of the rigid body.

13. The lead anchor of claim 1, wherein at least a portion of one of the housing or the plunger is radiopaque.

14. The lead anchor of claim 1, further comprising a base portion coupled to the housing.

15. An implantable stimulation device, comprising:

a lead having an electrode array; and

the lead anchor of claim 1, coupleable to the lead.

16. The implantable stimulation device of claim 15, further comprising a control module coupleable to the lead.

17. The implantable stimulation device of claim 15, wherein the implantable stimulation device is a spinal cord stimulator.

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

implanting a portion of a lead having an electrode array near tissue to be stimulated;

securing a distal end of the lead through a lead anchor, the lead anchor comprising a housing comprising a rigid body and a flexible covering disposed over at least a portion of the rigid body, the housing defining a first opening and a second opening configured and arranged to receive a lead, the housing further defining a transverse lumen, the rigid body comprising one or more projecting locking ridges, a plunger comprising one or more locking detents disposed thereon, wherein the plunger is configured and arranged for insertion into the transverse lumen and engaging a lead disposed through the first and second openings of the housing and wherein the plunger is configured and arranged for locking with the housing by engagement of at least one of the one or more locking ridges of the housing with at least one of the one or more locking detents of the plunger, and at least one suture element formed by the flexible covering and configured and arranged for receiving a suture to suture the lead anchor to patient tissue; and

securing the lead anchor to the surrounding tissue using sutures.

19. The method of claim 18, further comprising implanting a control module and coupling the electrode array to the control module using a lead.

20. The method of claim 18, wherein the step of securing the lead anchor to the surrounding tissue comprises tying a suture to a suture ridge on the exterior member.