Fixation device for a subcutaneous electrode

• US 10,226,618 B2
• Filed: 10/05/2016
• Issued: 03/12/2019
• Est. Priority Date: 10/06/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Reddy, G. Shantanu, De Kock, Andrew L., Fuhs, Christopher Alan, Overcash, Jay, Mindermann, Garth
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/285,519
• Publication Number:
  US 20170095657A1
• Time in Patent Office: 888 Days
• Field of Search: 607116, 607126
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes

Abstract

An illustrative anchoring mechanism is provided for attachment to an implantable subcutaneous lead to facilitate anchoring at the distal tip of the lead. The anchoring mechanism is attached to an opening in a distal portion of a subcutaneous lead prior to implantation. The anchoring mechanism may be designed to avoid covering the sensing electrode of the subcutaneous lead, to prevent interference with sensing. Use of such an apparatus may reduce the number of incisions needed to perform implantation.

Claims

1. A method of implanting a subcutaneous lead having a plurality of electrodes thereon and a distal tip having an opening for use in attaching to another element, the method comprising:

a physician securing an anchoring device to the distal tip using the opening prior to implanting the lead; and

the physician advancing the lead, with the anchoring device secured thereto, through a first incision and a subcutaneous tunnel to a desired implant location;

further comprising using an introducer tool having a sheath thereon for creating the subcutaneous tunnel and removing the introducer tool to leave the sheath in place,

wherein the step of advancing the lead, with the anchoring device secured thereto, is performed by advancing the lead and anchoring device through the sheath.

2. The method of claim 1 wherein:

the anchoring device comprises one or more arms thereon for anchoring in subcutaneous tissue;

the one or more arms are flexible;

the step of advancing the lead and anchoring device through the sheath is performed with the arms in a collapsed configuration; and

upon completion of the step of advancing the lead and anchoring device through the sheath, the sheath is removed, allowing the arms to return from the collapsed configuration to an extended configuration for anchoring within the subcutaneous tissue.

3. The method of claim 1 wherein the anchoring device comprises:

one or more arms;

a body coupling the one or more arms together and having a nose on one end thereof; and

an attachment feature for attaching to a distal tip of the subcutaneous lead.

4. The method of claim 3 wherein the attachment feature of the anchoring device comprises a post extending in a lateral direction relative to a direction from the attachment feature to the nose, wherein the method comprises placing the post through the opening in the distal tip of the subcutaneous lead.

5. The method of claim 4 further comprising snap fitting a securing piece to the post to secure the post to the lead.

6. The method of claim 5 wherein the securing piece, attachment feature and body are configured to mate together with the distal tip of the subcutaneous lead to form a smooth transition therebetween.

7. The method of claim 4 wherein the post includes an expanded portion at a tip therefor, such that the method comprises passing the expanded portion of the post through the opening in the distal tip of the lead in a snap-through fashion and such that the anchoring device and the subcutaneous lead are secured together.

8. The method of claim 3 wherein the attachment feature comprises a hook, and the method comprises passing the hook through the opening in the distal tip of the subcutaneous lead.

9. The method of claim 8 wherein the attachment feature further includes a latch to allow entry of the subcutaneous lead opening to the hook, but preventing escape therefrom.

10. The method of claim 3 wherein the body comprises a bore having a closed end near the nose and an open end for receiving a portion of the distal tip of the subcutaneous lead, and the method comprises securing a suture to the body within the bore to secure the subcutaneous lead to the body.

11. The method of claim 10 wherein the step of securing the suture is performed to leave the suture long enough to allow the lead to be outside the bore while remaining attached to the suture.

12. The method of claim 3 wherein the attachment feature is a tab having an opening therethrough, and the method comprises securing an attachment member between the tab and the opening in the distal tip of the subcutaneous lead.

13. The method of claim 3 wherein the arms, body and attachment feature are formed of a single piece.

14. The method of claim 3 wherein the anchoring device includes a dissolvable portion that acts as a filler during introduction of the anchoring device and an associated subcutaneous lead into a patient, and then, once dissolved by tissue fluids after implantation, to create a space between the body and the anchored subcutaneous lead.

15. The method of claim 3 wherein the arms are flexible and configured to collapse for introduction through an introducer sheath, and the step of advancing the lead through a subcutaneous tunnel comprises inserting the introducer sheath into the subcutaneous tunnel and inserting the anchoring device and lead into the patient through the introducer sheath.

16. The method of claim 1 wherein prior to the physician securing the anchoring device to the distal tip, the method further comprises using the introducer tool to pull the lead from a second incision subcutaneously to the first incision where the distal tip exits the first incision, and the physician then securing the anchoring device to the distal tip.

17. A method of implanting a subcutaneous lead having a plurality of electrodes thereon and a distal tip having an opening for use in attaching to another element, the method comprising:

a physician securing an anchoring device to the distal tip using the opening prior to implanting the lead; and

the physician advancing the lead, with the anchoring device secured thereto, through a first incision and a subcutaneous tunnel to a desired implant location;

wherein prior to the physician securing the anchoring device to the distal tip, an introducer tool is secured to the opening in the distal tip of the lead and used to pull the lead subcutaneously from a second incision to the first incision, and

the method further comprises releasing the introducer tool from the opening in the distal tip before the physician securing the anchoring device to the distal tip using the opening.

18. The method of claim 17, wherein after releasing the introducer tool from the opening in the distal tip, the method further comprises inserting the introducer tool into the first incision and creating the subcutaneous tunnel to the desired implant location.

19. The method of claim 17 wherein the introducer tool is secured to the opening in the distal tip with a suture.