Cardiac electrode anchoring system

• US 9,220,891 B2
• Filed: 04/09/2004
• Issued: 12/29/2015
• Est. Priority Date: 04/10/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Osypka, Peter
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US10/821,421
• Publication Number:
  US 20050033396A1
• Time in Patent Office: 4,281 Days
• Field of Search: 607/116, 607/119, 607/126, 607/130, 607/132, 600/375, 600/386, 606/129
• US Class Current: 1/1
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A cardiac electrode arrangement has one or several heart electrodes arranged on the exterior surface of a heart or attached to the heart from the outside and/or arranged with a pole in the cardiac tissue. The electrodes, which can be fixed in the operating position by an anchor, run to an implanted heart pacemaker. For positioning and affixing the anchor, a tool is used that is designed as a rod or stylet and acts on an attachment site of the anchor, whereby the anchor can be pushed into or through the myocardium. The anchor is, at the same time, attached to a tension element or thread, over which the electrode, which has an inner guide channel that accommodates the tension element or thread, can be moved in a fitted and controlled manner. In the operating position, the electrode can be connected to the tension element or thread located in the guide channel.

Claims

1. An apparatus for inserting an electrode into a myocardium of the heart, the apparatus comprising:

an anchor including a tip portion configured to penetrate the myocardium in a first orientation and at least one rod-shaped portion configured to anchor against an outside surface of the heart in a second orientation;

a tension element having a proximal end and a distal end, the distal end fastened to the anchor; and

an electrode having an inner guide channel to accommodate the tension element and having a pole at an end adapted for stimulating the myocardium, the electrode and the tension element configured such that the electrode can be threaded over the proximal end of the tension element and slideably advanced over the tension element towards the anchor during implantation, the guide channel disposed at a connection point such that the tension element is attachable to the electrode and having a proximal opening adapted to allow the proximal end of the tension element to exit therethrough, the proximal opening being closed by a medical adhesive;

wherein the anchor and the tension element are configured to couple to the electrode, thereby chronically retaining the distal end of the electrode in the heart after implantation.

2. The apparatus of claim 1 further comprising:

a tool for inserting the anchor through the myocardium to an operating position; and

a receiver tube for pre-forming a canal through the myocardium, the tube defining a lumen adapted to hold the anchor and the tool during insertion into the heart.

3. The apparatus of claim 2 wherein the anchor includes an attachment area having a receiving aperture disposed at a trailing end of the anchor for fittingly receiving the tool.

4. The apparatus of claim 2 wherein the at least one rod-shaped portion includes a first end and a second end and an attachment area comprising a longitudinal opening at the first end for receiving the tool and wherein the tension element is attached to the anchor between the first end and the second end.

5. The apparatus of claim 4 wherein the tension element is attached to the anchor at a location between the center of the anchor and a leading end.

6. The apparatus of claim 2 wherein the tool is a thin, flexible stylet.

7. The apparatus of claim 1 wherein the anchor further comprises at least one element having a position for deployment into the myocardium and an expanded position at the operating position.

8. The apparatus of claim 7 wherein a spring force biases the at least one element to the expanded operating position.

9. The apparatus of claim 1 wherein the anchor is disk-shaped and the attachment area is a radially-oriented aperture in the anchor adapted for receiving the tool.

10. The apparatus of claim 1 wherein the anchor has a first angled leg and a second angled leg, the first leg having an aperture forming the attachment area for receiving the tool.

11. The apparatus of claim 1 wherein the anchor further comprises:

a central leg;

at least two outer legs; and

a membrane stretched between the central leg and the outer legs.

12. The apparatus of claim 1 wherein the anchor includes a plurality of legs defining a star-shape and the attachment area is an aperture in one of the legs adapted for receiving the tool.

13. The apparatus of claim 1 wherein the anchor has a plurality of leaves defining a cloverleaf-shape and the attachment area is an aperture adapted for receiving the tool and is disposed between two of the individual leaves.

14. The apparatus of claim 1 wherein the connection point includes a fastening element for attaching the tension element to the electrode.

15. The apparatus of claim 1 wherein the tension element includes a stop located at a distance from the anchor for fixing the electrode to prevent movement in either of a forward or a rearward direction.

16. The apparatus of claim 15 wherein the stop comprises a thickening on the tension element having a diameter which exceeds an inner diameter of the guide channel.

17. The apparatus of claim 1 wherein the pole includes an anode spaced apart from a cathode.

18. The apparatus of claim 1 further comprising a first and a second electrode branching from a common supply lead, each electrode having an inner guide channel sized to accommodate a first and a second tension element, respectively, and each electrode having a pole at an end adapted for stimulating the myocardium.

19. The apparatus of claim 18 wherein the proximal opening from the guide channel is disposed near the branch of the supply lead.

20. The apparatus of claim 19 wherein the tension elements extend through the guide channels and are knotted together outside the proximal opening.

21. The apparatus of claim 18 further comprising an anode positioned on the common supply lead and a cathode positioned on each of the first and second electrodes.

22. An apparatus for inserting an electrode into a myocardium of the heart, the apparatus comprising:

an anchor including a tip portion configured to advance into and through the myocardium and at least one rod-shaped portion configured to anchor against an outside surface of the heart, said at least one rod-shaped portion having an attachment area;

a tension element having a proximal end and a distal end, the distal end structurally independent from and fastened to the anchor;

a first electrode having an inner guide channel, wherein the tension element and first electrode are configured such that the electrode can be threaded over the proximal end of the tension element and slideably advanced over the tension element toward the anchor during implantation and having a pole near a distal end adapted for stimulating the myocardium;

a tool detachably coupled to the attachment area for inserting the anchor through the myocardium to an operating position; and

a receiver tube for creating a canal through the myocardium, the receiver tube defining a lumen sized for holding the anchor and the tool during insertion into the heart;

wherein the guide channel has a proximal opening adapted to allow the proximal end of the tension element to exit therethrough.

23. The apparatus of claim 22 wherein the pole includes an anode spaced apart from a cathode.

24. The apparatus of claim 22 further comprising a second electrode having an inner guide channel to accommodate the tension element and having a pole at an end for stimulating the myocardium, the second electrode branching from a common supply lead with the first electrode.

25. An apparatus for inserting an electrode into a myocardium of a heart, the apparatus comprising:

a tension element having a proximal end and a distal end;

an electrode having an inner guide channel, wherein the tension element and electrode are configured such that the electrode can be threaded over the proximal end of the tension element and slideably advanced over the tension element towards the heart during implantation and having a pole at an end for stimulating the myocardium, the guide channel having a proximal opening adapted to allow the proximal end of the tension element to exit therethrough;

means for anchoring a distal end of the tension element within the myocardium, the means for anchoring structurally independent from and attached to the distal end of the tension element and including a tip portion configured to penetrate the myocardium and at least one rod-shaped portion configured to anchor against an outside surface of the heart;

a tool for inserting the means for anchoring through the myocardium to an operating position; and

a receiver tube for pre-forming a canal through the myocardium, the tube defining a lumen adapted to hold the means for anchoring and the tool during insertion into the heart.