LEAD ANCHOR WITH PIVOTABLE PADDLES AND SYSTEMS AND METHODS USING THE LEAD ANCHOR

• US 20150119965A1
• Filed: 10/21/2014
• Published: 04/30/2015
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Govea, Michael X.
• Granted Patent: US 9,302,094 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A lead anchor includes a first paddle assembly and a flexible housing. The first paddle assembly includes an assembly housing, an actuator, and at least one pivotable paddle attached to the housing and operably coupled to the actuator. The at least one pivotable paddle is suitably arranged to pivot out of the assembly housing when a user operates the actuator. The lead anchor also includes a flexible housing disposed around the first paddle assembly and defining at least one lead lumen extending adjacent to the first paddle assembly so that the at least one pivotable paddle pivots into a one of the at least one lead lumen to constrain any lead disposed within the one of the at least one lead lumen.

Claims

1. A lead anchor, comprising:

a first paddle assembly comprising an assembly housing, an actuator, and at least one pivotable paddle attached to the housing and operably coupled to the actuator, wherein the at least one pivotable paddle is configured and arranged to pivot out of the assembly housing when a user operates the actuator; and

a flexible housing disposed around the first paddle assembly and defining at least one lead lumen extending adjacent to the first paddle assembly so that the at least one pivotable paddle pivots into a one of the at least one lead lumen to constrain any lead disposed within the one of the at least one lead lumen.

2. The lead anchor of claim 1, wherein the at least one pivotable paddle is two pivotable paddles and the at least one lead lumen is two lead lumens, wherein each of the two pivotable paddles is configured and arranged to pivot into a respective one of the two lead lumens.

3. The lead anchor of claim 1, wherein the actuator is a screw.

4. The lead anchor of claim 1, wherein the at least one pivotable paddle is retractable using the actuator.

5. The lead anchor of claim 1, further comprising a second paddle assembly disposed within the flexible housing, the second paddle assembly comprising an assembly housing, an actuator, and at least one pivotable paddle attached to the housing and operably coupled to the actuator, wherein the at least one pivotable paddle is configured and arranged to pivot out of the assembly housing when a user operates the actuator, wherein the second paddle assembly is disposed within the flexible housing so that the at least one pivotable paddle of the second paddle assembly pivots into a one of the at least one lead lumen.

13. A kit, comprising:

a first implantable stimulation lead; and

the lead anchor of claim 1 configured and arranged to receive a portion of the first implantable stimulation lead within one of the at least one lead lumen of the lead anchor.

14. The kit of claim 13, further comprising a control module coupleable to the first implantable stimulation lead.

17. A method of using a lead anchor, the method comprising:

inserting a portion of a first electrical stimulation lead into one of the at least one lead lumen of the lead anchor of claim 1; and

actuating the actuator of the first paddle assembly to pivot the at least one paddle so that at least one of the at least one paddle engages the first electrical stimulation lead and constrains the first electrical stimulation lead within the one of the at least one lead lumen.

18. The method of claim 17, further comprising actuating the actuator to pivot the at least one paddle back into the assembly housing and out of engagement with the first electrical stimulation lead.

19. The method of claim 17, further comprising suturing the lead anchor to patient tissue.

6. A lead anchor, comprising:

a first paddle assembly comprising an assembly housing, an actuator, and two pivotable paddles attached to the housing and operably coupled to the actuator, wherein the two pivotable paddles are configured and arranged to pivot out of opposite sides of the assembly housing when a user operates the actuator; and

a flexible housing disposed around the first paddle assembly and defining two lead lumens extending adjacent to the opposite sides of the first paddle assembly so that the two pivotable paddles each pivot into a respective one of the two lead lumens.

7. The lead anchor of claim 6, further comprising a second paddle assembly disposed within the flexible housing, the second paddle assembly comprising an assembly housing, an actuator, and two pivotable paddles attached to the housing and operably coupled to the actuator, wherein the two pivotable paddles are configured and arranged to pivot out of opposite sides of the assembly housing when a user operates the actuator, wherein the second paddle assembly is disposed within the flexible housing so that the two pivotable paddles of the second paddle assembly each pivot into a respective one of the two lead lumens.

8. The lead anchor of claim 7, wherein the lead anchor has a first end and a second end opposite the first end, wherein the lead lumens extend from the first end to the second end and wherein the actuator of the first paddle assembly is accessible from the first end and the actuator of the second paddle assembly is accessible from the second end.

9. The lead anchor of claim 6, wherein the actuator is a screw.

10. The lead anchor of claim 6, wherein the two pivotable paddles are retractable using the actuator.

11. The lead anchor of claim 6, wherein the flexible housing is formed of silicone.

12. The lead anchor of claim 6, wherein the flexible housing comprises a body and at least one suture tab extending from the body.

15. A kit, comprising:

a first implantable stimulation lead; and

the lead anchor of claim 6 configured and arranged to receive a portion of the first implantable stimulation lead within one of the two lead lumens of the lead anchor.

16. The kit of claim 15, further comprising a second implantable stimulation lead configured and arranged for a portion for a portion of the second implantable stimulation lead to be received within another one of the two lead lumens of the lead anchor.

20. A method of using a lead anchor, the method comprising:

inserting a portion of a first electrical stimulation lead into one of the two lead lumens of the lead anchor of claim 6;

inserting a portion of a second electrical stimulation lead into another one of the two lead lumens of the lead anchor of claim 6; and

actuating the actuator of the first paddle assembly to pivot the two paddles into contact with the first and second electrical stimulation leads, respectively, to constrain the first and second electrical stimulation leads within the two lead lumens.