Epicardial lead design

Patent metadata

Field	Value
Publication number	US-2024050737-A1
Application number	US-202318234269-A
Country	US
Kind code	A1
Filing date	Aug 15, 2023
Priority date	May 8, 2013
Publication date	Feb 15, 2024
Grant date	—

Abstract

The present invention provides an advancement in the art of cardiac pacemakers. The invention provides a novel and unobvious 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 novel 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

1 . A minimally-invasive, epicardial pacemaker unit comprising:
an electrode for delivering an electrical pulse to myocardial tissue of a heart in need thereof; a cardiac pacemaker suitable for delivering electrical pacing to a heart in need thereof; and a hinge physically connecting the electrode to the pacemaker, wherein the hinge allows the electrode and pacemaker 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 portion 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 portion 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 1 , wherein the hinge comprises nitinol.

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

5 . The pacemaker unit of claim 4 , wherein the hollow structural element is in the form of a cylinder.

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

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

8 . The pacemaker unit of claim 7 , wherein there is a single bend in the lead, which is approximately 90°.

9 . A minimally-invasive, modular epicardial pacemaker system, said system comprising:
at least two pacemakers, at least one of which being embedded in, and electrically connected to, myocardial tissue of a heart by way of transit through epicardial tissue, wherein at least one of said pacemakers is implanted between atrial epicardial tissue and the pericardial sac, and is optionally embedded in atrial myocardial tissue of the heart by way of an electrically conductive electrode, and wherein at least one of said pacemakers is embedded in ventricular tissue of the heart, and wherein one or more of the pacemakers communicates electrically, electronically, or both with one or more of the other pacemakers of the system to convey information about cardiac rhythm, pacing events, or both so as to coordinately pace the atrium and ventricle of the heart, wherein the information comprises data indicative of the respiration rate of the patient.

10 . The system of claim 9 , wherein the information comprises data that match demand and pacing for the at least two pacemakers.

11 . The system of claim 10 , wherein the data is derived from measurements of changes in electrical currents between the various pacemakers, wherein changes indicate differences in the density and/or volume of the chest cavity of the patient in which the system is deployed.

12 . The system of claim 10 , wherein the system comprises one or more pacemaker units having the following features:
an electrode for delivering an electrical pulse to myocardial tissue of a heart in need thereof; a cardiac pacemaker suitable for delivering electrical pacing to a heart in need thereof; and a hinge physically connecting the electrode to the pacemaker, wherein the hinge allows the electrode and pacemaker 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 portion 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.

13 . (canceled)

14 . A process of implanting a pacemaker unit into a patient, said process comprising:
using a hypodermic needle to introduce a guide wire into the pericardial space of the heart from a subxyphoid approach; withdrawing the hypodermic needle over the wire; replacing the hypodermic needle with a dilator and a sleeve, which are advanced through the skin and intervening tissues until their distal ends are also in the pericardial space; removing the dilator and guide wire from the sleeve; replacing the dilator and guide wire with an insertion sheath, which includes a module affixed within its distal portion; advancing the sheath through the lumen of the sleeve until the module is located adjacent to the right or left atrium or ventrical and within the pericardial sac; and optionally implanting an electrode of the pacemaker into the myocardium of the patient's heart by way of the epicardium, wherein the pacemaker unit comprises: an electrode for delivering an electrical pulse to myocardial tissue of a heart in need thereof; a cardiac pacemaker suitable for delivering electrical pacing to a heart in need thereof; and a hinge physically connecting the electrode to the pacemaker, wherein the hinge allows the electrode and pacemaker 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 portion 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.

15 . The process of claim 14 , wherein the hinge comprises a lead that includes a bend that allows the pacemaker portion 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.

16 . The process of claim 14 , wherein the bend in the lead is approximately 90°.

Assignees

• Los Angeles Childrens Hospital
• Univ Southern California

Inventors

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

Classifications

• A61N1/0587 Primary

  Epicardial electrode systems; Endocardial electrodes piercing the pericardium · CPC title

• A61N1/3756

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

• A61N1/059

  Anchoring means · CPC title

• A61N1/362

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

• A61N1/37205

  Microstimulators, e.g. implantable through a cannula · CPC title