Epicardial lead design

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.

A process of implanting an atrial 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 atrial insertion sheath, which includes an atrial module affixed within its distal portion;
• and
• advancing the atrial sheath through the lumen of the sleeve until the atrial module is located adjacent to the right or left atrium and within the pericardial sac;
• wherein the atrial pacemaker unit 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, or both.

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.