Lead anchor and related methods of use

• US 8,892,216 B2
• Filed: 07/09/2013
• Issued: 11/18/2014
• Est. Priority Date: 07/11/2012
• 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): EVANISKO, GEORGE ROBERT
• Application Number:
  US13/937,937
• Publication Number:
  US 20140018884A1
• Time in Patent Office: 497 Days
• Field of Search: 604/175, 607/116, 607/119
• US Class Current: 607/119
• 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 2001/0582 Suture sleeves

Abstract

A lead anchor includes a core housing defining a cavity; a swivel anchor disposed in the cavity and having a tubular portion and a locking portion; at least two locking members; and at least two sleeves with a portion of each of the sleeves and each of the locking members disposed within the cavity at a periphery of the cavity. The tubular portion is adapted to receive an external tool to rotate the swivel anchor within the cavity. The lead anchor has an unlocked configuration, in which the swivel anchor can rotate within the cavity of the core housing without compressing the sleeves, and a locked configuration, in which opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and any lead disposed within the sleeves to hold that lead in place.

Claims

1. A lead anchor, comprising:

a core housing defining a cavity having a periphery;

a swivel anchor disposed in the cavity and comprising a tubular portion and a locking portion with opposing ends, the tubular portion adapted to receive an external tool, wherein the swivel anchor is configured and arranged to rotate within the cavity using the external tool;

at least two locking members, wherein at least a portion of each of the locking members is disposed within the cavity at the periphery of the cavity; and

at least two sleeves, wherein at least a portion of each of the sleeves is disposed within the cavity at the periphery of the cavity;

wherein the lead anchor is configured and arranged to have at least an unlocked configuration, in which the swivel anchor can rotate within the cavity of the core housing without necessarily compressing the sleeves, and a locked configuration, in which the opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and any lead disposed within the sleeves to hold that lead in place.

2. The lead anchor of claim 1, wherein the locking members are pins.

3. The lead anchor of claim 1, further comprising a flexible overmold disposed over the core housing.

4. The lead anchor of claim 1, wherein the swivel anchor further comprises a fitting disposed in the tubular portion to receive a tip of the external tool.

5. The lead anchor of claim 4, wherein the fitting is a hex fitting.

6. The lead anchor of claim 1, wherein the sleeves are flexible.

7. The lead anchor of claim 1, wherein the core housing is formed of a material selected from a metal, alloy, rigid plastic, or any combination thereof.

8. The lead anchor of claim 1, wherein the locking portion of the swivel anchor has an oval transverse cross-section.

9. The lead anchor of claim 1, wherein the at least two locking members are exactly two locking members disposed diagonally from each other at the periphery of the cavity.

10. The lead anchor of claim 1, wherein the lead anchor further comprises at least one endplate attached to the core housing.

11. A system, comprising:

the lead anchor of claim 1; and

at least one lead configured and arranged for a portion of the at least one lead to be received within at least one of the sleeves of the lead anchor.

12. The system of claim 11, wherein the at least one lead is at least two leads, wherein the lead anchor is configured and arranged so that a portion of each of the two leads is received in a different one of the sleeves.

13. The system of claim 11, further comprising a control module coupleable to the at least one lead and configured and arranged to provide electrical stimulation pulses to the at least one lead.

14. A method of implanting an electrical stimulation device, the method comprising:

implanting at least one lead near tissue to be stimulated;

disposing a lead anchor around a portion of the at least one lead, the lead anchor comprising a core housing defining a cavity having a periphery;

a swivel anchor disposed in the cavity and comprising a tubular portion and a locking portion with opposing ends, the tubular portion adapted to receive an external tool, wherein the swivel anchor is configured and arranged to rotate within the cavity using the external tool;

at least two locking members, wherein at least a portion of each of the locking members is disposed within the cavity at the periphery of the cavity; and

at least two sleeves carried within the channels, wherein at least a portion of each of the sleeves is disposed within the cavity at the periphery of the cavity, wherein as the lead anchor is disposed around the portion of the lead one lead, the swivel anchor is disposed in an unlocked position; and

rotating the swivel anchor to a locked position in which the opposing ends of the locking portion of the swivel anchor each lie between one of the sleeves and one of the locking members and compress the sleeves and the at least one lead disposed within the sleeves to hold the at least one lead in place of the lead anchor.

15. The method of claim 14, wherein disposing a lead anchor around a portion of the at least one lead comprises disposing the portion of the at least one lead into a one of the sleeves.

16. The method of claim 14, wherein rotating the swivel anchor comprises engaging a fitting disposed in the tubular portion of the swivel anchor with a tool and using the tool to rotate the swivel anchor into the locked position.

17. The method of claim 14, wherein implanting at least one lead and disposing a lead anchor around a portion of the at least one lead comprises implanting two leads and disposing the lead anchor around portion of the two leads.

18. The method of claim 14, further comprising rotating the swivel anchor from the locked position to the unlocked position to release the at least one lead.

19. The method of claim 14, wherein disposing a lead anchor around a portion of the at least one lead comprises sliding the lead anchor onto the at least one lead.

20. The method of claim 14, further comprising coupling the at least one lead to a control module and implanting the control module.