Epicardial lead design

Patent metadata

Field	Value
Publication number	US-11724104-B2
Application number	US-202117336003-A
Country	US
Kind code	B2
Filing date	Jun 1, 2021
Priority date	May 8, 2013
Publication date	Aug 15, 2023
Grant date	Aug 15, 2023

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

The invention claimed is:

1. A minimally-invasive, modular epicardial pacemaker system, said system comprising:
a first pacemaker unit adapted to be implanted between atrial epicardial tissue of an atrium of a heart and a pericardial sac surrounding the heart, and electrically connected to atrial myocardial tissue of the heart;
a second pacemaker unit adapted to be embedded in ventricular tissue of a ventricle of the heart; and
wherein at least one of the first pacemaker unit and the second pacemaker unit has the following features:
an electrode for delivering an electrical pulse to myocardial tissue of the heart in need thereof;
the pacemaker suitable for delivering electrical pacing to the heart in need thereof; and
a hinge having asymmetric shoulders and 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 can lie substantially parallel to epicardium, and between the epicardium and the pericardial sac, while the electrode remains substantially perpendicular to the epicardium;

wherein the first and the second pacemakers communicate with each other to convey information about cardiac rhythm, pacing events, or both so as to coordinately pace the atrium and the ventricle of the heart, wherein the information comprises data indicative of respiration rate of a patient.

2. The system of claim 1 , wherein the information comprises data that match predetermined demand and pacing data for the first and second pacemakers.

3. The system of claim 2 , wherein the data is derived from measurements of changes in electrical currents between the two pacemakers, wherein changes indicate differences in density and/or volume of a chest cavity of the patient in which the system is deployed.

4. A process of implanting an atrial pacemaker unit into a patient, said process comprising:
using a hypodermic needle to introduce a guide wire into a pericardial space of a 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 skin and intervening tissues until their distal ends are also in the pericardial space;
removing the dilator and the guide wire from the sleeve;
replacing the dilator and the guide wire with an atrial insertion sheath, which includes an atrial module affixed within its distal portion, the atrial module including a separable base having a pair of substantially immovable barbs fixedly attached to and projecting permanently from the base portion in a perpendicular direction with respect to the longitudinal axis of the atrial module, wherein tip to tip distance of the barbs form a permanent fixed diameter which is larger than the atrial module outer diameter and adapted to push against the inside surface of the atrial insertion sheath whose internal diameter is greater than the atrial module outer diameter; and
advancing the atrial insertion sheath through a lumen of the sleeve until the atrial module is located adjacent to an atrium and within the pericardial space;
wherein the atrial module participates in pacing of a heart by electrical stimulation of myocardial tissue by sensing atrial contraction events and communicating the occurrence of such events to a second cardiac pacemaker, which is electrically connected to ventricular myocardial tissue of the heart.

5. The process of claim 4 , wherein the insertion sheath has a fenestration.

6. The process of claim 5 , wherein the fenestration is adapted to allow the electrode to make electrical contact with myocardial tissue.

7. The process of claim 6 , further comprising a sensor which detects P-waves during insertion and before release of the pacemaker module from the insertion sheath.

8. The process of claim 7 , wherein the pacemaker module is adapted to be expelled from the insertion sheath when a sufficient force is applied to overcome friction caused by tips of immovable barbs on the atrial module against the inside surface of the insertion sheath.

9. A process of implanting a pacemaker unit into a patient, said process comprising:
using a hypodermic needle to introduce a guide wire into a pericardial space of a heart from a subxyphoid approach;
withdrawing the hypodermic needle over the guide wire;
replacing the hypodermic needle with a dilator and a sleeve, which are advanced 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 a sheath, which includes a pacemaker unit affixed within its distal portion;
advancing the sheath through a lumen of the sleeve until the pacemaker unit is located adjacent to an atrium or ventricle and within the pericardial space; and
optionally implanting an electrode of the pacemaker unit into myocardium of the heart by way of epicardium,
wherein the pacemaker unit comprises:
an electrode for delivering an electrical pulse to myocardial tissue of the heart in need thereof;
a cardiac pacemaker suitable for delivering electrical pacing to the heart in need thereof; and
a hinge having asymmetric shoulders and 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 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.

10. The process of claim 9 , 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.

11. The process of claim 10 , 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

• A61N1/059

  Anchoring means · CPC title

• A61N1/362

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

• A61N1/3756

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

• A61N1/3787

  from an external energy source · CPC title