Methods and devices for three-stage ventricular therapy
First Claim
1. A ventricular arrhythmia treatment apparatus, comprising:
- at least one electrode adapted to be implanted proximate a ventricle of a heart of a patient to deliver far field pulses;
at least one electrode adapted to implanted proximate the ventricle of the heart of the patient to deliver near field pulses and sense cardiac signals;
an implantable therapy generator adapted to be implanted in a patient and operably connected to the electrodes, including;
sensing circuitry that senses cardiac signals representative of ventricular activity;
detection circuitry operably connected to the sensing circuitry to evaluate the cardiac signals representative of ventricular activity to determine a ventricular cycle length and detect a ventricular arrhythmia based at least in part on the ventricular cycle length;
control circuitry operably connected to the sensing circuitry that, in response to the ventricular arrhythmia, controls generation and selective delivery of a three-stage ventricular therapy to the electrodes with each stage having an inter-stage delay of between 50 to 800 milliseconds; and
therapy circuitry operably connected to the electrodes and the control circuitry including;
at least one first stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores energy for a first stage of the three-stage ventricular therapy having at least two and not more than ten ventricular pulses of at least 2 volts and not more than 100 volts to unpin one or more singularities associated with the ventricular arrhythmia;
at least one second stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores a second stage of the three-stageventricular therapy having at least six and not more than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia after the first stage therapy is applied, wherein the second stage prevents repinning of the one or more singularities associated with the ventricular arrhythmia that are unpinned by the first stage; and
at least one third stage charge delivery circuit selectively coupled to the near field electrode that selectively delivers a third stage of the three-stage cardioversion therapy having at least eight and not more than twelve near field pulses at a voltage substantially ranging from two to four times the diastolic pacing threshold, with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia, wherein the third stage extinguishes the one or more singularities associated with the ventricular arrhythmia that are unpinned by the first stage and prevented from repining by the second stage; and
a battery system operably coupled and providing power to the sensing circuitry, the detection circuitry, the control circuitry and the therapy circuitry.
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Abstract
Methods and apparatus for a three-stage ventricular cardioversion and defibrillation therapy that treats ventricular tachycardia and fibrillation at low energy levels. An implantable therapy generator adapted to generate and selectively deliver a three-stage ventricular therapy and at least two leads operably each having at least one electrode adapted to be positioned proximate the ventricle of the patient. The device is programmed to deliver a three-stage therapy via both a far-field configuration and a near-field configuration of the electrodes upon detection of a ventricular arrhythmia. The three-stage therapy includes a first stage for unpinning of one or more singularities associated with the ventricular arrhythmia, a second stage for anti-repinning of the one or more singularities, both of which are delivered via the far-field configuration of the electrodes, and a third stage for extinguishing of the one or more singularities associated delivered via the near-field configuration of the electrodes.
127 Citations
24 Claims
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1. A ventricular arrhythmia treatment apparatus, comprising:
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at least one electrode adapted to be implanted proximate a ventricle of a heart of a patient to deliver far field pulses; at least one electrode adapted to implanted proximate the ventricle of the heart of the patient to deliver near field pulses and sense cardiac signals; an implantable therapy generator adapted to be implanted in a patient and operably connected to the electrodes, including; sensing circuitry that senses cardiac signals representative of ventricular activity; detection circuitry operably connected to the sensing circuitry to evaluate the cardiac signals representative of ventricular activity to determine a ventricular cycle length and detect a ventricular arrhythmia based at least in part on the ventricular cycle length; control circuitry operably connected to the sensing circuitry that, in response to the ventricular arrhythmia, controls generation and selective delivery of a three-stage ventricular therapy to the electrodes with each stage having an inter-stage delay of between 50 to 800 milliseconds; and therapy circuitry operably connected to the electrodes and the control circuitry including; at least one first stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores energy for a first stage of the three-stage ventricular therapy having at least two and not more than ten ventricular pulses of at least 2 volts and not more than 100 volts to unpin one or more singularities associated with the ventricular arrhythmia; at least one second stage charge storage circuit selectively coupled to the at least one far field electrode that selectively stores a second stage of the three-stageventricular therapy having at least six and not more than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia after the first stage therapy is applied, wherein the second stage prevents repinning of the one or more singularities associated with the ventricular arrhythmia that are unpinned by the first stage; and at least one third stage charge delivery circuit selectively coupled to the near field electrode that selectively delivers a third stage of the three-stage cardioversion therapy having at least eight and not more than twelve near field pulses at a voltage substantially ranging from two to four times the diastolic pacing threshold, with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia, wherein the third stage extinguishes the one or more singularities associated with the ventricular arrhythmia that are unpinned by the first stage and prevented from repining by the second stage; and a battery system operably coupled and providing power to the sensing circuitry, the detection circuitry, the control circuitry and the therapy circuitry. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A ventricular arrhythmia treatment apparatus, comprising:
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an implantable therapy generator adapted to be implanted in a patient, including; means for detecting a ventricular arrhythmia and determining a cycle length of the ventricular arrhythmia; means for generating a three-stage ventricular therapy, including; means for generating a first stage of the three-stage ventricular therapy having at least two and not more than ten monophasic ventricular pulses of at least 2 volts and not more than 100 volts for unpinning of one or more singularities associated with a ventricular arrhythmia; means for generating a second stage of the three-stage atrial cardioversion therapy having at least six and not more than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia for anti-repinning of the one or more singularities associated with the ventricular arrhythmia; and means for generating a third stage of the three-stage cardioversion therapy having at least eight and not more than twelve near field pulses at a voltage substantially ranging from two to four times the diastolic pacing threshold with a pulse coupling interval of between 70-100% of the cycle length of the atrial arrhythmia for extinguishing of the one or more singularities associated with the ventricular arrhythmia; and means for controlling delivery of the three-stage ventricular therapy in response to detection of the ventricular arrhythmia with each stage having an inter-stage delay of between 50 to 800 milliseconds; and at least two leads adapted to be operably connected to the implantable therapy generator, each lead having at least one electrode adapted to be positioned proximate a ventricle of a heart of the patient through which the three-stage ventricular therapy is selectively delivered to the ventricle of the heart, such that the means for generating the first stage and the means for generating the second stage are selectively coupled by the means for controlling delivery to a far-field configuration of the electrodes and the means for generating the third stage are selectively coupled by the means for controlling delivery to a near-field configuration of the electrodes. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of treating ventricular arrhythmias comprising:
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(a) causing a ventricular arrhythmia treatment device to be manufactured and made available to a user, ventricular arrhythmia treatment device including an implantable therapy generator adapted to generate and selectively deliver a three-stage ventricular therapy and at least two leads operably connected to the implantable therapy generator, each lead having at least one electrode adapted to be positioned proximate the ventricle of a heart of the patient; (b) causing a ventricular arrhythmia treatment device to be manufactured and made available to a user;
providing instructions for implanting the ventricular arrhythmia treatment device in a patient during a surgical procedure;(c) causing a ventricular arrhythmia treatment device to be manufactured and made available to a user;
providing instructions for configuring the ventricular arrhythmia treatment device at a time after completion of the surgical procedure, including instructions for programming the ventricular arrhythmia treatment device with a set of therapy parameters for delivering a three- stage ventricular therapy to a patient via both a far-field configuration and a near-field configuration of the electrodes upon detection of a ventricular arrhythmia by the ventricular arrhythmia treatment device, wherein the three-stage ventricular therapy includes;
a first stage of the three-stage ventricular therapy having at least two and not more than ten ventricular pulses of at least 2 volts and not more than 100 volts for unpinning of one or more singularities associated with a ventricular arrhythmia;
a second stage of the three-stage ventricular cardioversion therapy having at least six and not more than ten far field pulses of less than a ventricular far-field excitation threshold with a pulse coupling interval of 70-100% of the cycle length of the ventricular arrhythmia for anti-repinning of the one or more singularities associated with the ventricular arrhythmia; and
athird stage of the three-stage cardioversion therapy having at least eight and not more than twelve near field pulses at a voltage substantially ranging from two to four times the diastolic pacing threshold with a pulse coupling interval of between 70-100% of the cycle length of the ventricular arrhythmia for extinguishing of the one or more singularities associated with the ventricular arrhythmia, and wherein the three-stage ventricular therapy is delivered in response to detection of the ventricular arrhythmia with each stage having an inter-stage delay of between 50 to 800 milliseconds.
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Specification