DEVICE FOR THE TRANSCUTANEOUS IMPLANTATION OF EPICARDIAL PACEMAKER ELECTRODES

• US 20170000523A1
• Filed: 11/27/2014
• Published: 01/05/2017
• Est. Priority Date: 11/27/2013
• Status: Active Grant

• Current Assignee: Deutsches Herzzentrum Berlin
• Original Assignee: Deutsches Herzzentrum Berlin
• Inventors: BARTOSCH, Marco, PETERS, Heiner, SCHMITT, Boris, PETERS, Bjrn
• Granted Patent: US 10,111,686 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

It is provided a device for the transcutaneous implantation of an epicardial pacemaker electrode, which is arranged in a tubular, flexible implantation catheter insertable into the pericardial space. The distal end area of the electrode is connected to a shape-variable element for aligning the electrode, in particular for adjusting the implantation angle thereof, and for stabilizing, in particular laterally stabilizing, the electrode.

Claims

1. A device for the transcutaneous implantation of an epicardial pacemaker electrode, which is arranged in a tubular, flexible implantation catheter insertable into the pericardial space,

wherein the distal end area of the electrode is connected to a shape-variable element for aligning the electrode, in particular for adjusting the implantation angle thereof, and for stabilizing, in particular laterally stabilizing, the electrode.

2. The device as claimed in claim 1, wherein the shape-variable element is composed of a fillable balloon, which is connected via a supply line to the proximal end of the implantation catheter.

3. The device as claimed in claim 1, wherein the distal end of the electrode is guided in an open or closed guide channel around the balloon.

4. The device as claimed in claim 1, wherein the shape-variable element has position stabilizers protruding from the balloon and preferably arranged diametrically with respect to each other.

5. The device as claimed in claim 4, wherein the position stabilizers are composed of wings which are deployable or extensible on two sides and which are part of a cross-shaped, hammer-shaped, cylinder-shaped or beam-shaped balloon.

6. The device as claimed in claim 1, wherein the shape-variable element is composed of an aligning and stabilizing element, which receives the electrode and which has open or closed end-side rings and struts connecting the end-side rings, which struts, during the advance of the implantation catheter from the puncture site to the implantation site, are oriented substantially parallel to the wall of the outer catheter and, after release of the aligning and stabilizing element, deploy to an implantation position.

7. The device as claimed in claim 6, wherein, in the implantation position, at least one central aligning strut aligns the electrode, and at least two support struts stabilize the alignment and position of the electrode.

8. The device as claimed in claim 6, wherein at least the struts of the aligning and stabilizing element that connect the end-side rings are made from a shape-memory material, in particular from nitinol, a spring material, in particular spring steel or plastic, or a pseudo-elastic material, in particular from nitinol.

9. The device as claimed in claim 6, wherein at least the struts of the aligning and stabilizing element that connect the end-side rings are made from a material with elastic restoring force.

10. The device as claimed in claim 1, wherein the electrode is arranged in a tubular, flexible inner catheter guided inside the outer catheter.

11. The device as claimed in claim 1, wherein the aligning and stabilizing element is arranged between the inner catheter and the outer catheter and is connected to the distal end of the inner catheter.

12. The device as claimed in claim 10, wherein the proximal end of the implantation catheter is connected to a device for sucking the distal end of the implantation catheter onto the epicardium.

13. The device as claimed in claim 2, wherein the supply line leading to the balloon is arranged between the inner catheter and the outer catheter.

14. The device as claimed in claim 2, wherein the supply line leading to the balloon is guided along the outer face of the outer catheter or is designed as an extra lumen of the inner catheter, said extra lumen extending along the inner catheter.

15. The device as claimed in claim 1, wherein the proximal end of the inner catheter and/or outer catheter is connected to a mechanism for longitudinally slitting open the inner catheter and/or outer catheter during the withdrawal of the inner catheter and/or outer catheter.

16. The device as claimed in claim 1, wherein the shape-variable element arranged at the distal end of the electrode is composed of an inflatable balloon, which is connected via a supply line to the proximal end of the implantation catheter, and of an aligning and stabilizing element with end-side rings and with flexible struts which connect the end-side rings and are made of a shape-memory material, in particular nitinol.