Method of Implanting and Using a Subcutaneous Defibrillator
First Claim
1. A method of treating a patient comprising:
- implanting a defibrillator system in the patient including a canister containing operational circuitry for operating the defibrillator system and a lead, the canister and lead each including at least one electrode for use in sensing of cardiac activity and/or therapy delivery, wherein;
the lead includes a first end for attachment to the canister and a second end having an anchoring system;
the lead is implanted with numerous waves or bends;
the lead and canister are implanted subcutaneously on the thorax of the patient over the ribcage of the patient without any part of the defibrillator system entering the patient'"'"'s vasculature or touching the patient'"'"'s heart; and
the patient is expected to grow and the implantation is performed such that as the patient grows, the waves or bends of the lead will straighten out to maintain proper electrode placement; and
the defibrillator system detecting ventricular tachycardia or fibrillation by examining QRS waves of the patient and determining whether the patient'"'"'s cardiac activity includes a ventricular rate that exceeds a predetermined rate for a first fixed period of time and, if so, the defibrillator system charging a capacitor for therapy delivery and, once the capacitor is charged, the defibrillator system performing a confirmatory rhythm check before discharging the capacitor for therapy delivery, therapy delivery utilizing an electrode of the canister and an electrode of the lead.
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Accused Products
Abstract
A subcutaneous implantable cardioverter-defibrillator is disclosed which has an electrically active canister which houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms. At least one subcutaneous electrode that serves as the opposite electrode from the canister is attached to the canister via a lead system. Cardioversion-defibrillation energy is delivered when the operational circuitry senses a potentially fatal heart rhythm. There are no transvenous, intracardiac, or epicardial electrodes. A method of subcutaneously implanting the cardioverter-defibrillator is also disclosed as well as a kit for conducting the method.
12 Citations
17 Claims
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1. A method of treating a patient comprising:
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implanting a defibrillator system in the patient including a canister containing operational circuitry for operating the defibrillator system and a lead, the canister and lead each including at least one electrode for use in sensing of cardiac activity and/or therapy delivery, wherein; the lead includes a first end for attachment to the canister and a second end having an anchoring system; the lead is implanted with numerous waves or bends; the lead and canister are implanted subcutaneously on the thorax of the patient over the ribcage of the patient without any part of the defibrillator system entering the patient'"'"'s vasculature or touching the patient'"'"'s heart; and the patient is expected to grow and the implantation is performed such that as the patient grows, the waves or bends of the lead will straighten out to maintain proper electrode placement; and the defibrillator system detecting ventricular tachycardia or fibrillation by examining QRS waves of the patient and determining whether the patient'"'"'s cardiac activity includes a ventricular rate that exceeds a predetermined rate for a first fixed period of time and, if so, the defibrillator system charging a capacitor for therapy delivery and, once the capacitor is charged, the defibrillator system performing a confirmatory rhythm check before discharging the capacitor for therapy delivery, therapy delivery utilizing an electrode of the canister and an electrode of the lead. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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- 12. A method of treating a patient comprising implanting a subcutaneous-only defibrillator comprising a subcutaneous lead having a single high voltage electrode and a plurality of sense electrodes and a canister coupled to the subcutaneous lead and including at least a high voltage electrode, the subcutaneous lead being formed of insulation having conductors therethrough and electrodes thereon, the single high voltage electrode being approximately 5-10 cm in length, wherein implanting is performed by implanting the canister at the left anterior mid-clavicular line beneath the left areolus, directing a curved introducer laterally and posteriorly for positioning the subcutaneous lead, introducing the subcutaneous lead to a left posterior thoracic position and placing the subcutaneous-only defibrillator at the incision location, wherein the subcutaneous-only defibrillator comprises sense circuitry designed to be sensitive to detection of ventricular fibrillation or tachyarrhythmia at rates above 240 bpm.
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17. A cutaneous test electrode system designed to simulate a subcutaneous high voltage shock and QRS rhythm detection system of an implantable subcutaneous defibrillator which has a canister and lead including a defibrillation electrode and sensing electrodes comprising:
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a cutaneous patch electrode of similar surface area and impedance to that of the canister; a plurality of cutaneous strip electrodes each having a defibrillation strip and button electrodes at different bipole spacings allowing testing of leads of different length and electrode spacing and configuration; wherein the cutaneous test electrode system is configured for estimating the best location of the implantable subcutaneous defibrillator for individual patients.
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Specification