Epicardial lead design

Patent metadata

Field	Value
Publication number	US-11020588-B2
Application number	US-201414889853-A
Country	US
Kind code	B2
Filing date	May 8, 2014
Priority date	May 8, 2013
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

The present invention provides advancements in the art of cardiac pacemakers. The invention provides a pacemaker system that comprises at least one pacemaker and that is, to a large extent, self-controlled, allows for long-term implantation in a patient, and minimizes current inconveniences and problems associated with battery life. The invention further includes a mechanism in which at least two pacemakers are implanted in a patient, and in which the pacemakers communicate with each other at the time of a given pacing or respiratory event, without any required external input, and adjust pacing parameters to respond to the patient's need for blood flow. The invention further provides a design for a pacemaker in which the pacemaker electrode is connected to the pacemaker body by a lead that is configured to allow the pacemaker to lie parallel to the epicardial surface and to reduce stress on the pacemaker and heart tissue.

First claim

The invention claimed is:

1. A minimally-invasive, epicardial pacemaker unit comprising:
an insertion sheath having an inside surface and an internal diameter;
an electrode for delivering an electrical pulse to myocardial tissue of a heart in need thereof;
a cardiac pacemaker module having a longitudinal axis and an outer diameter, and suitable for delivering electrical pacing to a heart in need thereof;
a separable base portion which houses the electrode on a first side and is connected to the pacemaker module on a second side, the base portion having the same diameter as the pacemaker module;
a pair of substantially immovable barbs fixedly attached to and projecting permanently outwardly from the base portion in a perpendicular direction with respect to the longitudinal axis of the pacemaker module, wherein tip to tip distance of the barbs form a permanent fixed diameter which is larger than the pacemaker module outer diameter and adapted to push against the inside surface of the insertion sheath whose internal diameter is greater than the pacemaker module outer diameter; and
a hinge physically positioned on the second side of the base portion, and connecting the base portion to the pacemaker module, wherein the hinge allows the electrode and pacemaker module to be angularly aligned substantially along a same path prior to deployment into cardiac tissue, but then allows the two to pivot with respect to each other such that the pacemaker module can lie substantially parallel to the epicardium/myocardium/pericardial sac, and between the epicardium and pericardial sac, while the electrode remains substantially perpendicular to the epicardium/myocardium.

2. The pacemaker unit of claim 1 , wherein the hinge comprises a lead that includes a coiled bend that allows the pacemaker module to lie substantially parallel to the epicardium/myocardium/pericardial sac, and between the epicardium and pericardial sac, while the electrode remains substantially perpendicular to the epicardium/myocardium.

3. The pacemaker unit of claim 2 , wherein there is a single bend in the lead, which is approximately 90 degrees.

4. The pacemaker unit of claim 1 , wherein the hinge comprises nitinol.

5. The pacemaker unit of claim 1 , wherein the hinge comprises a hollow structural element comprising an element wall having openings in the element wall.

6. The pacemaker unit of claim 5 , wherein the hollow structural element is in the form of a cylinder.

7. The pacemaker unit of claim 1 , wherein the hinge comprises one or more hollow structures having walls with openings.

8. The pacemaker unit of claim 1 , wherein the hinge comprises one or more bends prior to or after deployment into the cardiac tissue.

9. The pacemaker unit of claim 1 , wherein the insertion sheath has a fenestration.

10. The pacemaker unit of claim 9 , wherein the fenestration is adapted to allow the electrode to make electrical contact with the myocardial tissue.

11. The pacemaker unit of claim 10 , further comprising a sensor which detects P-waves during insertion and before release of the pacemaker module from the insertion sheath.

12. The pacemaker unit of claim 11 , wherein the pacemaker module is adapted to be expelled from the insertion sheath when a sufficient force is applied to overcome friction caused by the tips of the immovable barbs against the inside surface of the insertion sheath.

Assignees

• Los Angeles Childrens Hospital
• Univ Southern California

Inventors

• Bar-Cohen Yaniv
• Loeb Gerald
• Zhou Li
• Peck Raymond
• Nutt Steven

Classifications

• A61N1/3756

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/362

  Heart stimulators (heart defibrillators A61N1/39) · CPC title

• A61N1/37512

  Pacemakers · CPC title

• A61N1/3787

  from an external energy source · CPC title

• A61N1/059

  Anchoring means · CPC title