Subcutaneous only implantable cardioverter defibrillator and optional pacer

A method for providing anti-arrhythmia therapy via a subcutaneous cardioverter-defibrillator, comprising:

• implanting a canister comprising a biocompatible housing subcutaneously in a patient in the anterior thorax approximately level with the inframammary crease, the biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
• implanting an electrically inert lead subcutaneously in the posterolateral thorax extending circumferentially around the thorax to a position approximately lateral to the tip of the left inferior portion of the scapula, the electrically inert lead comprising a substantially pliant and directable cannula adaptably connected to the canister with a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced to the cardioversion-defibrillation circuitry;
• and
• delivering an electrical therapy comprising an anti-arrhythmia waveform from the lead electrode to the at least one electrically conductive surface.

A method for providing anti-arrhythmia therapy via a posterolateral implanted subcutaneous cardioverter-defibrillator, comprising:

• implanting a canister comprising a biocompatible housing subcutaneously in a patient to a position approximately lateral to the left scapula, the biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
• implanting an electrically inert lead subcutaneously in the anterior thorax extending around the thorax approximately level with the inframammary crease, the electrically inert lead comprising a substantially pliant and directable cannula adaptably connected to the canister with a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced to the cardioversion-defibrillation circuitry;
• and
• delivering an electrical therapy comprising an anti-arrhythmia waveform from the lead electrode to the at least one electrically conductive surface.

A method of implanting a subcutaneous cardioverter-defibrillator in a patient comprising the steps of;

• making only one skin incision in the left anterior axillary line approximately at the level of the patient's cardiac apex;
• inserting a curved introducer through the skin incision to make a subcutaneous path in the thoracic region such that the path terminates subcutaneously at a location that if a straight line were drawn from the skin incision to the path termination the line would intersect the heart of the patient;
• implanting an electrode subcutaneously at the path termination point;
• placing an electrically active canister subcutaneously at the skin incision point and implanting it subcutaneously implanted in the left inframammary crease of the patient, wherein the canister contains a source of electrical energy and operational circuitry that senses the presence of potentially fatal heart rhythms and has means for delivering electrical cardioversion-defibrillation energy using the canister as either the anode or the cathode and using the electrode as the opposite electrode from the canister, and wherein the canister is electrically connected to the electrode;
• and
• closing the skin incision.

A method of implanting a subcutaneous cardioverter-defibrillator in a patient comprising the steps of;

• making only one skin incision in in the left posterior axillary line of the patient approximately at a level lateral to the tip of the left scapula of the patient;
• inserting a curved introducer through the skin incision to make a subcutaneous path in the thoracic region such that the path terminates subcutaneously at a location that if a straight line were drawn from the skin incision to the path termination the line would intersect the heart of the patient;
• implanting an electrode subcutaneously at the path termination point;
• placing an electrically active canister subcutaneously at the skin incision point,
• wherein the canister contains a source of electrical energy and operational circuitry that senses the presence of potentially fatal heart rhythms and has means for delivering electrical cardioversion-defibrillation energy using the canister as either the anode or the cathode and using the electrode as the opposite electrode from the canister, and wherein the canister is electrically connected to the electrode;
• and
• closing the skin incision.

A subcutaneous implantable cardioverter-defibrillator comprising:

• an electrically active canister that serves as either an anode or a cathode of the cardioverter-defibrillator wherein the canister houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms;
• a subcutaneous electrode that serves as the opposite electrode from the canister (either the anode or the cathode);
• a lead system electrically attaching the electrode to the canister;
• means for delivering electrical cardioversion-defibrillation energy when the operational circuitry senses a potentially fatal heart rhythm;
• and
• the absence of a transvenous, intracardiac, or epicardial electrode.

A cardioverter-defibrillator for subcutaneous implantation, comprising:

• a canister comprising a biocompatible housing enclosing and containing cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
• an electrically inert lead comprising a substantially pliant and directable cannula adaptably connected to the canister;
• and
• a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced to the cardioversion-defibrillation circuitry to deliver an electrical therapy with the at least one electrically conductive surface to the heart of a patient without a transvenous, intracardiac or epicardial electrode.

A subcutaneous cardioverter-defibrillator with electrically active canister for minimally invasive implantation, comprising:

• a subcutaneously implantable, canister comprising a sterilizable biocompatible housing enclosing and containing cardioversion-defibrillation circuitry interfaceable through the biocompatible housing via an electrically isolated connector block, the biocompatible housing defining at least one electrically conductive surface on the outer surface of the biocompatible housing and electrically connected to the cardioversion-defibrillation circuitry;
• an electrically inert lead comprising a substantially pliant and directable cannula enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block;
• and
• a lead electrode formed on a distal end of the electrically inert lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy with the at least one electrically conductive surface to the heart of a patient without a transvenous, intracardiac or epicardial electrode.

A cardioversion-defibrillation device with electrically conductive housing means for subcutaneous implantation, comprising:

• means for housing and hermetically containing cardioversion-defibrillation circuitry, the housing means comprising electrically isolated means for externally interfacing to the cardioversion-defibrillation circuitry and defining at least one electrically conductive surface on an outer surface of the housing means that is electrically connected to the cardioversion-defibrillation circuitry through internal interfacing means;
• means for guiding and enclosing one or more conductors connected to the cardioversion-defibrillation circuitry via the external interfacing means, the enclosing means being substantially pliant and directable;
• and
• means for delivering an electrical therapy to a patient's heart between a distal end of the guiding means and the at least one electrically conductive surface without a transvenous, intracardiac or epicardial electrode, the electrical therapy delivering means being responsive to an autonomously detected arrhythmic condition and being electrically connected via the one or more conductors to the cardioversion-defibrillation circuitry.

An implantable subcutaneous cardioverter-defibrillator with electrically active canister, comprising:

• an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining a discrete electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode.

An implantable subcutaneous cardioverter-defibrillator with discrete electrically active canister, comprising:

• an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining a discrete electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry, the housing further defining an electrically insulated surface juxtaposed to the discrete electrically conductive surface and substantially interposed therefrom by an electrically insulated area;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode.

An implantable subcutaneous cardioverter-defibrillator providing antiarrhythmia therapy, comprising:

• an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry, the cardioversion-defibrillation circuitry monitoring cardiac physiological conditions;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an anti-arrhythmic waveform responsive to an arrhythmic condition autonomously detected by the cardioversion-defibrillation circuitry without a transvenous, intracardiac or epicardial electrode.

An implantable subcutaneous cardioverter-defibrillator monitoring cardiac physiological conditions, comprising:

• an implantable canister providing a housing enclosing and containing cardioversiondefibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a sensing electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to sensing circuitry within the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode;
• and
• monitoring circuitry integral to the cardioversion-defibrillation circuitry and deriving cardiac physiological measures relating to at least one of QRS signal morphology, QRS signal frequency content, QRS R-R interval stability data, and QRS amplitude characteristics.

An implantable subcutaneous cardioverter-defibrillator providing cardiac pacing, comprising:

• an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode;
• and
• pacing circuitry operatively conjunctive to the cardioversion-defibrillation circuitry which generates at least one of an anti-bradycardia and an anti-tachycardia pacing waveform via the electrically conductive surface and the lead electrode responsive to the cardioversion-defibrillation circuitry.

An implantable subcutaneous cardioverter-defibrillator inducing cardiac fibrillating episodes, comprising:

• an implantable canister providing a housing enclosing and containing cardioversion-defibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a lead electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode;
• and
• induction circuitry integral to the cardioversion-defibrillation circuitry which generates low amplitude voltage on a T-wave of an ECG via the electrically conductive surface and the lead electrode responsive to the cardioversion-defibrillation circuitry.

An implantable subcutaneous cardioverter-defibrillator detecting cardiopulmonary physiological conditions, comprising:

• an implantable canister providing a housing enclosing and containing cardioversiondefibrillation circuitry externally interfaceable via an electrically isolated connector block on a proximal end of the housing, the housing defining an electrically conductive surface on an outer surface and internally connecting electrically to the cardioversion-defibrillation circuitry;
• a substantially pliant and directable lead enclosing and guiding one or more conductors adaptably connected to the electrically isolated connector block, the lead being electrically inert;
• and
• a sensing electrode circumferentially formed on a distal end of the lead and electrically interfaced via the one or more conductors to sensing circuitry within the cardioversion-defibrillation circuitry to deliver an electrical therapy responsive to an autonomously detected arrhythmic condition without a transvenous, intracardiac or epicardial electrode;
• and
• detection circuitry integral to the cardioversion-defibrillation circuitry and deriving physiological measures relating to at least one of atrial fibrillation, ventricular fibrillation, transthoracic impedance, respiratory rate, heart rate, cardiac output, ECG shape and temperature.