Tension clamp side loading lead anchor and methods and systems using the lead anchor

• US 9,504,839 B2
• Filed: 07/08/2014
• Issued: 11/29/2016
• Est. Priority Date: 07/15/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Leven, Jacob B.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/326,233
• Publication Number:
  US 20150018916A1
• Time in Patent Office: 875 Days
• Field of Search: 607/116, 607/36, 607/37
• US Class Current: 1/1
• 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 1/3752 Details of casing-lead connections

Abstract

An implantable lead anchor includes a first anchor shell having a first hinge element and a second anchor shell, disposed opposite the first anchor shell, having a second hinge element. The first and second anchor shells define a lead channel and the first and second hinge elements form a hinge. The lead anchor includes at least one tensioning element that is configured and arranged to increase in tension upon elongation. The first and second anchor shells, and the tensioning element provide an open position and a closed position. In the open position, a lead can be side loaded side loaded into the lead channel. In the closed position, the first and second anchor shells grip a portion of the lead disposed in the lead channel and, in combination with the at least one tensioning element, resist disengagement of the lead from the lead anchor.

Claims

1. An implantable lead anchor, comprising:

a first anchor shell comprising a first hinge element;

a second anchor shell disposed opposite the first anchor shell and comprising a second hinge element, the first and second anchor shells defining a lead channel between the first and second anchor shells and the first and second hinge elements forming a hinge; and

at least one tensioning element coupled to the first and second anchor shells, wherein each of the at least one tensioning element is configured and arranged to increase in tension upon elongation;

wherein the first and second anchor shells and the at least one tensioning element are configured and arranged to provide an open position and a closed position, wherein, in the open position, a lead can be side loaded into the lead channel and, in the closed position, the first and second anchor shells grip a portion of the lead disposed in the lead channel and, in combination with the at least one tensioning element, resist disengagement of the lead from the lead anchor, wherein the lead anchor is configured and arranged to move between the open position and the closed position using the hinge and the lead anchor further defines an intermediate position between the open position and the closed position in which, in the intermediate position, the at least one tensioning element is more elongated than in both the open position and the closed position.

2. The implantable lead anchor of claim 1, the at least one tensioning element is a plurality of tensioning elements.

3. The implantable lead anchor of claim 1, wherein the first anchor shell comprises a first rod and the second anchor shell comprises a second rod and the at least one tensioning element is in contact with the first and second rods.

4. The implantable lead anchor of claim 3, wherein the first anchor shell comprises a first portion and a second portion, wherein the first rod is disposed between the first and second portions of the first anchor shell.

5. The implantable lead anchor of claim 1, wherein the first and second anchor shells are identical.

6. The implantable lead anchor of claim 1, further comprising at least one pin disposed within the first hinge element and the second hinge element.

7. The implantable lead anchor of claim 1, wherein each of the at least one tensioning element is elastomeric.

9. The implantable lead anchor of claim 1, wherein the at least one tensioning element comprises a spring.

11. The implantable lead anchor of claim 1, wherein the first and second anchor shells have different longitudinal lengths.

12. A kit, comprising:

the implantable lead anchor of claim 1; and

at least one electrical stimulation lead, wherein the implantable lead anchor is configured and arranged to receive a portion of one of the at least one electrical stimulation lead in the lead channel.

13. The kit of claim 12, further comprising a control module coupleable to the at least one electrical stimulation lead.

14. The kit of claim 13, further comprising a lead extension coupleable to the lead and to the control module.

15. A method of implanting an electrical stimulation lead, the method comprising:

side loading a portion of an electrical stimulation lead into the lead channel of the implantable lead anchor of claim 1, wherein the first and second anchor shells of the implantable lead anchor are in the open position; and

closing the first and second anchor shells to the closed position to lock the first electrical stimulation lead in the implantable lead anchor.

16. The method of claim 15, wherein closing the first and second anchor shells comprises squeezing the first and second anchor shells together.

17. The method of claim 15, wherein closing the first and second anchor shells comprises transitioning from the open position to the intermediate position by elongating the at least one tensioning element.

18. The method of claim 17, wherein closing the first and second anchor shells further comprises transitioning from the intermediate position to the closed position by reducing elongation of the at least one tensioning element.

19. The method of claim 15, wherein at least one of the first and second anchor shells defines at least one suture opening, the method further comprising suturing the implantable lead anchor to tissue using the at least one suture opening of each of the first and second shells.

20. The method of claim 15, further comprising opening the first and second anchor shells prior to side loading the portion of the electrical stimulation lead.

8. An implantable lead anchor, comprising:

a first anchor shell comprising a first hinge element;

a second anchor shell disposed opposite the first anchor shell and comprising a second hinge element, the first and second anchor shells defining a lead channel between the first and second anchor shells and the first and second hinge elements forming a hinge; and

at least one tensioning element coupled to the first and second anchor shells, wherein each of the at least one tensioning element is configured and arranged to increase in tension upon elongation;

wherein the first and second anchor shells and the at least one tensioning element are configured and arranged to provide an open position and a closed position, wherein, in the open position, a lead can be side loaded into the lead channel and, in the closed position, the first and second anchor shells grip portion of the lead disposed in the lead channel and, in combination with the at least one tensioning element, resist disengagement of the lead from the lead anchor, wherein the lead anchor is configured and arranged to move between the open position and the closed position using the hinge and the lead anchor further defines an intermediate position between the open position and the closed position in which, in the intermediate position, the at least one tensioning element is more elongated than in both the open position and the closed position, wherein each of the at least one tensioning element comprises an elastomeric polymer band.

10. An implantable lead anchor, comprising:

a first anchor shell comprising a first hinge element;

a second anchor shell disposed opposite the first anchor shell and comprising a second hinge element, the first and second anchor shells defining a lead channel between the first and second anchor shells and the first and second hinge elements forming a hinge; and

at least one tensioning element coupled to the first and second anchor shells, wherein each of the at least one tensioning element is configured and arranged to increase in tension upon elongation;

wherein the first and second anchor shells and the at least one tensioning element are configured and arranged to provide an open position and a closed position, wherein, in the open position, a lead can be side loaded into the lead channel and, in the closed position, the first and second anchor shells grip a portion of the lead disposed in the lead channel and, in combination with the at least one tensioning element, resist disengagement of the lead from the lead anchor, wherein the lead anchor is configured and arranged to move between the open position and the closed position using the hinge and the lead anchor further defines an intermediate position between the open position and the closed position in which, in the intermediate position, the at least one tensioning element is more elongated than in both the open position and the closed position, wherein the first anchor shell defines at least one suture opening therethrough.