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US20150321021A1 - Method and device for treating cardiac arrhythmias - Google Patents

Method and device for treating cardiac arrhythmias Download PDF

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Publication number
US20150321021A1
US20150321021A1 US14/162,604 US201414162604A US2015321021A1 US 20150321021 A1 US20150321021 A1 US 20150321021A1 US 201414162604 A US201414162604 A US 201414162604A US 2015321021 A1 US2015321021 A1 US 2015321021A1
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Prior art keywords
frequency
arrhythmia
electrodes
administered
cardiac
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US14/162,604
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Harikrishna Tandri
Ronald David Berger
Seth Weinberg
Leslie Tung
Natalia Trayanova
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Johns Hopkins University
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Johns Hopkins University
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Priority to US14/162,604 priority Critical patent/US20150321021A1/en
Priority to PCT/US2015/012743 priority patent/WO2015112893A1/fr
Priority to US14/604,457 priority patent/US10532216B2/en
Publication of US20150321021A1 publication Critical patent/US20150321021A1/en
Priority to US15/826,498 priority patent/US11052261B2/en
Priority to US17/342,405 priority patent/US11717694B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3624—Heart stimulators for treating or preventing abnormally high heart rate occurring in the atrium, i.e. atrial tachycardia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3625—External stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3906—Heart defibrillators characterised by the form of the shockwave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/395—Heart defibrillators for treating atrial fibrillation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3987—Heart defibrillators characterised by the timing or triggering of the shock

Definitions

  • the present disclosure relates generally to medical treatments and more specifically to a method and device for treating arrhythmias of the heart, such as tachycardia and cardiac fibrillation.
  • Arrhythmia is a variation from the normal rhythm of the heart beat. Cardiac arrhythmias are an important cause of morbidity and mortality. The major cause of fatalities due to cardiac arrhythmias is the subtype of ventricular arrhythmias known as ventricular fibrillation (VF). Conduction of electrical impulse is a unique property of cardiac and skeletal muscle and nervous tissue and is fundamental to their physiologic function. Abnormal cardiac electrical impulse generation and propagation underlies the pathogenesis of several diseases, including ventricular fibrillation (see, Santinelli et al., Int J Cardiol., 3(1):109-111 (1983); Kanani et al., J Cardiovasc Pharmacol. 32(1):42-48 (1998); and Amitzur et al., Cardiovasc Drugs Ther., 17(3):237-247 (2003)), a leading cause of death in the developed world.
  • ventricular fibrillation see, Santinelli et al., Int J Cardiol., 3(1):109-111 (1983
  • AED automatic external defibrillators
  • implantable defibrillators are highly useful in management of a number of chronic heart conditions. For example, Sudden Cardiac Death (SCD), which is often due to ventricular fibrillation, accounts for over 400,000 deaths annually in the United States.
  • SCD Sudden Cardiac Death
  • Recent trials have shown survival benefit in SCD survivors who receive implantable defibrillators.
  • Recent trials have also shown that patients who are at risk for SCD also benefit from this therapy and implantable defibrillators have been used in this population with significant reduction in mortality.
  • defibrillator systems can be generally illustrated with reference to the implantable format.
  • Such defibrillator systems contain a hermetically sealed “Can” that houses the battery, electronic circuitry and capacitors. These devices are implanted in the chest wall and electrodes are deployed intravascularly to stimulate, pace and deliver high energy defibrillatory shocks to defibrillate the heart.
  • the electrode/lead is typically placed through the subclavian vein into the endocardium.
  • Three modes of therapies are used by the implantable defibrillators to treat dangerous arrythmias: 1) anti-tachycardia pacing; 2) low energy cardioversion; and 3) high energy defibrillation.
  • high energy defibrillaton has been shown to be effective in defibrillating the heart during ventricular fibrillation.
  • Electrodes have been used to deliver the high energy including, epicardial lead systems (U.S. Pat. Nos. 5,342,407 and 5,603,732), endocardial lead systems, and subcutaneous electrodes (U.S. Pat. Nos. 5,133,353, 5,261,400, and 5,620,477).
  • the housing of the defibrillator can also serve as an additional electrode during delivery of defibrillatory shocks and for pacing (U.S. Pat. No. 5,658,321).
  • a totally subcutaneous-non-vascular system that is capable of delivering pacing and high voltage defibrillatory shocks has also been described (U.S. Pat. No. 7,536,222).
  • the principal approach to terminating fibrillation using implantable or external systems is by delivering a high voltage DC shock to cause defibrillation of the heart. This is achieved by charging a capacitor and delivering the charge to the heart over a period of typically 4-16 msec.
  • the current defibrillator circuitry includes high performance capacitors capable of rapidly charging and discharging charge, causing a brief period of high current density in the myocardium that causes defibrillation.
  • defibrillation systems While effective in many cases, existing defibrillation systems have drawbacks. For example, the energy delivered may be insufficient in magnitude or timing of delivery to stop fibrillation. Low frequency DC and AC are known to be pro-fibrilliatory. In addition, the large electric field applied in defibrillation also leads to significant skeletal muscle stimulation which has been implicated in the pain that follows defibrillation shocks.
  • the present invention is based on the discovery of the previously unrecognized biophysical phenomenon of reversible cardiac conduction block using sustained AC fields that is without residual electrophysiological consequence and can be applied with less perceived pain than existing defibrillatory methods.
  • Cardiac cells remain in a refractory state for the duration of field stimulation by elevation of V m , a phenomenon that is distinctly different from the effect of DC fields.
  • the cell response to sustained AC fields appears to be devoid of the deleterious effects commonly observed during DC field stimulation.
  • cardiac conduction block using AC may provide a safer alternative for terminating cardiac arrhythmias.
  • Roberts et al. evaluated the defibrillation efficacy of AC frequencies up to 1 kHz, but with a maximum duration of 32 cycles ( Pacing Clin Electrophysiol., 26(2 Pt 1):599-604 (2003). They concluded that a 200 Hz, 2 cycle waveform was most effective to achieve external defibrillation.
  • Sweeney et al. used monophasic rectangular pulses for open chest defibrillation in dogs and showed that the energy and current requirement was significantly higher at frequencies >1 kHz ( J Cardiovasc Electrophysiol., 7(2):134-143 (1996).
  • the mode of conduction block was demonstrated to be due to constant activation of potassium channels, thus antagonizing sodium channel induced depolarization (see, Zhang et al., IEEE Trans. Biomed. Eng., 53:2445-54 (2006)). To date, however, such methods are not being applied to the heart; e.g., to minimize pain associated with the delivery of a defibrillating current.
  • RF radio frequency
  • U.S. Pat. No. 6,431,173 describes a method of using electrical energy to produce temporary conduction block in a local region of the patient's myocardium to disrupt a reentry pathway through which an atrial or ventricular tachycardia (or other type of arrhythmia) is initiated and perpetuated, thereby resulting in cardioversion or defibrillation.
  • use of RF to for terminating tachyarrhythmias may cause permanent myocardial damage.
  • the present invention provides both a method and device for termination of arrhythmias, such as ventricular or atrial tachyarrhythmias.
  • the device and method involves application of alternating current (AC) for clinically significant duration within a selected range of therapeutic frequencies applied through the cardiac tissue of a subject experiencing arrhythmia.
  • AC alternating current
  • a method of treating cardiac arrhythmia in a subject in need thereof comprises administering a high frequency AC to a cardiac tissue of the subject, thereby treating the cardiac arrhythmia.
  • the AC is administered at a frequency between about 50 Hz to 20 KHz.
  • the AC is administered for a duration between about 0.025 to 2 seconds.
  • the AC is administered for at least 0.050 or 0.100 seconds.
  • the method includes a tiered therapy to alleviate or treat cardiac arrhythmia.
  • the method may include administration of AC in a staged progression of multiple tiers.
  • tiered therapy may include applying AC along a progression of different frequencies and durations, the progression continuing until the arrhythmia is terminated.
  • the method may include applying a series of different frequencies of AC, or AC in combination with DC, until the arrhythmia is terminated.
  • the method includes a combined approach to therapy to alleviate or treat cardiac arrhythmia as well as reducing pain.
  • the method may include applying AC at different distinct frequencies to achieve neuromuscular blocking effects in addition to arrhythmia termination.
  • a first frequency of between about 1 kHz to 20 kHz is applied to achieve neuromuscular blocking effects, such a reduction in pain stimulus.
  • a second frequency of between about 100 Hz to 1 kHz is applied to achieve arrhythmia termination. The frequencies may be applied simultaneously or the first frequency may be applied before the second to effectively block any pain associated with delivery of the second frequency.
  • the method includes a combined approach to therapy to alleviate or treat cardiac arrhythmia as well as reducing pain.
  • the method may include applying AC at one or more frequencies in combination with an electric shock, such as a monophasic or biphasic shock.
  • an electric shock such as a monophasic or biphasic shock.
  • application of the AC begins before application of the electric shock.
  • the electric shock is applied before application of the AC begins.
  • the electrical shock is monophasic, and the shock includes an onset prior to onset of the AC and the shock terminates after onset of the AC.
  • the method includes detecting the occurrence of arrhythmia before, after or during the AC is administered.
  • a method for treating tacharrhythmia in a subject for emergency life support of a subject having cardiac tissue that is in an intractably fibrillated state.
  • the method includes administering a plurality of high frequency alternating current (AC) pulses to a cardiac tissue of the subject, wherein the cardiac tissue is in an intractably fibrillated state between administration of each AC pulse, thereby treating the tacharrhythmia.
  • AC high frequency alternating current
  • each AC pulse has a duration of about 0.1 to 2 seconds. Pulsed AC application in this instance allows the cardiac muscle to fibrillate between AC pulses to achieve electrical activation of the ventricles and generation of a mechanical systole.
  • a device for treating arrhythmia includes a computer-readable program containing one or more algorithms for generating and/or delivering AC and/or electrical shock, a plurality of electrodes, a waveform generator generating high frequency AC and/or electrical shock, and optionally, a sensing circuit allowing detection of arrhythmia in a subject and automatic administration of AC.
  • the device is configured to generate AC having a frequency between about 50 Hz to 20 kHz in response to operation of the computer-readable program.
  • the device is configured to deliver tiered therapy to a subject to alleviate or treat cardiac arrhythmia.
  • the device is configured to generate and apply one or more different frequencies of AC.
  • the device is configured to administer emergency assistance to a subject experiencing intractable cardiac fibrillation.
  • the device of the present invention may be configured such that the plurality of electrodes are disposed intravascularly or intracardiacly, extravascularly or externally, or both.
  • the device may be fully or partially implantable, or be configured wholly external to the subject.
  • a method of generating local conduction block of cardiac tissue includes administering alternating current (AC) to a targeted site of a heart during an arrhythmia to cause termination of the arrhythmia.
  • the AC is administered at a frequency between about 100 Hz to 1 kHz.
  • the AC is delivered via a catheter including a plurality of electrodes.
  • delivery of the AC is timed to a surface electrocardiogram or an intracardiac electrocardiogram.
  • FIG. 1 shows a graphical representation of one embodiment of the device of the present invention, wherein the device is configured as an automatic internal defibrillator (AID).
  • AID automatic internal defibrillator
  • FIG. 2 shows a graphical representation of one embodiment of the device of the present invention wherein the device is configured as an automatic external defibrillator (AED).
  • AED automatic external defibrillator
  • FIG. 3A is a graphical representation of the effects of application of a 1 kHz AC field.
  • FIG. 3B is a graphical representation of the effects of application of a 100 kHz AC field.
  • FIG. 3C is a graphical representation of the effects of application of a 10 kHz AC field.
  • the top panels of each show voltage maps before, during, and after AC field. For each, the monolayer was paced from the left edge by a bipolar point electrode at 6 Hz (for A) or 3 Hz (for B and C).
  • the bottom panels in each case show a representative voltage trace from the center of the monolayer at site x.
  • Vertical lines along the x-axis denote the time of point stimuli, while the gray bar denotes the time AC field is on.
  • AC field stimulation is effective in producing propagation block when applied at some frequencies (e.g. 1000 Hz in FIG. 3A ), but not at others (e.g. 100 Hz in FIG. 3B or 10 kHz in FIG. 3C ).
  • FIG. 4 shows graphical representations of AC electric field pulse terminating pinned spiral wave reentry.
  • FIG. 4A shows a series of voltage maps before, during, and after a 1 kHz 1-sec duration AC pulse. Numbers above maps denote time in msec. Maps with gray background indicate that the AC pulse is on.
  • FIG. 4B shows a representative voltage trace from site a of FIG. 4A (top left) showing stable train of action potentials before the AC pulse, and sustained partial depolarization during AC delivery, with prompt return to resting potential when AC stimulation is turned off.
  • Figure C shows voltage traces at sites a-f of FIG. 4A (top row) at an expanded time scale at the time of AC field onset.
  • the gray bar denotes the time the AC pulse was on.
  • FIG. 6A shows a plot summarizing conduction experiments. In conduction experiments, the response during the pulse was characterized as no effect, field-evoked activity (FEA), or block, as described in FIG. 3 . Post-pulse ectopic activity (PPEA), as shown in FIG. 3 , was also identified separately.
  • FIG. 5B shows a plot summarizing reentry experiments. In reentry experiments, the response was characterized as no effect, FEA+termination, termination, or re-initiation, as described in Examples. Note similarity in the parameter spaces for conduction and reentry, with regions of block in FIG. 5A corresponding to termination in FIG. 5B (X for each), FEA in FIGS. 5A and 5B (triangles), and no effect (circles).
  • FIG. 6 shows graphical representations of simulations of AC field pulses.
  • the top panels show voltage maps before, during, and after a 500 Hz, 300-arbitrary units (a.u.) field strength, 1-sec duration AC pulse. Time (in msec) is denoted above the maps. Maps with gray background denote times during which the AC pulse is on.
  • the bottom panels show the transmembrane voltage (V m ), sodium current (I Na ), and intracellular calcium ([Ca],) at a site denoted by the pink dot on the first voltage map. The gray bar denotes the time the AC field pulse is on.
  • FIG. 6A shows application of 500 Hz AC field. Vertical lines along the lower x-axis denote the times of point stimuli.
  • FIG. 6B shows application of a 500 Hz AC field.
  • FIG. 7 shows graphical representations of defibrillation of a whole heart by a 1 second duration pulse of AC.
  • FIG. 8 shows graphical representations of successful defibrillation of a whole heart by a 50 ms pulse (A) and failed defibrillation by a 30 ms pulse (B).
  • FIG. 9 shows graphical representations of administration of a ramped high frequency AC waveform plus biphasic shock and subsequent response thereto.
  • FIG. 9A shows an illustrative ascending high frequency AC ramp followed immediately by biphasic shock.
  • FIG. 9B shows skeletal muscle force response (black) to ramped high frequency AC stimulation that precedes 400 V biphasic shock (grey).
  • FIG. 9C shows muscle force response (black) to 400 V biphasic shock alone (grey).
  • the present invention provides methods for using selected therapeutic frequencies of AC to cause termination of arrhythmia.
  • the mechanisms by which the AC terminates arrhythmia are based on the generation of positively- and negatively-polarized areas in the heart by the applied field, separately by a voltage gradient.
  • the sequential reversal of the polarity of these regions of membrane polarization by the applied AC, combined with the non-linear response of the membrane to the shock-induced polarization, results in a sequential decrease in the voltage gradient between the regions of opposite polarity until this gradient reaches a value that is insufficient for the generation of a new wavefront at the border between regions of opposite membrane polarity.
  • the frequency range minimizes proarrythmia, which has been the major drawback of low frequency electrical current.
  • the invention provides additional embodiments wherein the high frequency AC is provided in combination with AC at other frequencies or DC in a tiered therapy to terminate arrhythmia and/or co-terminously to block pain.
  • the present invention provides an alternative mechanism to use of DC fields to achieve termination of cardiac arrhythmias by causing conduction block using sustained AC field. It is expected that AC field-induced, reversible conduction block will have widespread applicability in both external and implantable medical devices to treat arrhythmias. Finally, based the observations discussed herein using AC in cardiac tissue, in conjunction with reports on nerve block using high frequency AC, it can be expected that AC stimulation could be utilized to block both cardiac and nerve conduction during arrhythmias to achieve painless defibrillation.
  • the present invention is based in part on the discovery of a novel biophysical phenomenon of reversible block of cardiac conduction during sustained sinusoidal alternating current (AC) field stimulation. While not wishing to be bound by any theory as to mechanism of action, it is believed that, when applied according to the invention, an appropriate (not pro-fibrillatory) AC field paralyzes affected cardiac cells by maintaining them in a partially depolarized state and rendering them refractory to pacing stimuli. This effect is completely reversible on cessation of the AC field (see, e.g., Example 1 and FIGS. 3-7 ).
  • the present invention is based on the seminal discovery of a reversible conduction block in cardiac tissue using sustained AC field that provides a novel method to terminate cardiac arrhythmias.
  • Reversible conduction block by AC has broad applicability in clinical cardiac electrophysiology.
  • the present invention provides both a method and device for termination of arrhythmias, such as ventricular or atrial tachyarrhythmias.
  • the device and method involves application of high frequency alternating current or electric field through the cardiac tissue to a subject experiencing arrhythmia, such as tachyarrhythmia.
  • a method of treating cardiac arrhythmia in a subject in need thereof comprises administering a high frequency alternating current (AC) to a cardiac tissue of the subject, thereby treating the cardiac arrhythmia.
  • AC high frequency alternating current
  • the method includes a combined approach to therapy to alleviate or treat cardiac arrhythmia as well as reducing pain.
  • the method may include applying AC at different distinct frequencies to achieve neuromuscular effects in addition to arrhythmia termination.
  • a first frequency of between about 1 kHz to 20 kHz is applied to achieve neuromuscular effects, such a reduction in pain stimulus.
  • a second frequency of between about 100 Hz to 1 kHz is applied to achieve arrhythmia termination. The frequencies may be applied simultaneously or the first frequency may be applied before the second to effectively block any pain associated with delivery of the second frequency.
  • the method includes a combined approach to therapy to alleviate or treat cardiac arrhythmia as well as reducing pain.
  • the method may include applying AC at one or more frequencies in combination with an electric shock, such as a monophasic or biphasic shock.
  • an electric shock such as a monophasic or biphasic shock.
  • application of the AC begins before application of the electric shock.
  • the electric shock is applied before application of the AC begins.
  • the electrical shock is monophasic, and the shock includes an onset prior to onset of the AC and the shock terminates after onset of the AC.
  • the method includes detecting the occurrence of arrhythmia before, after or during the AC is administered.
  • a method for treating tacharrhythmia in a subject for emergency life support of a subject having cardiac tissue that is in an intractably fibrillated state.
  • the method includes administering a plurality of high frequency alternating current (AC) pulses to a cardiac tissue of the subject, wherein the cardiac tissue is in an intractably fibrillated state between administration of each AC pulse, thereby treating the tacharrhythmia.
  • AC high frequency alternating current
  • each AC pulse has a duration of about 0.1 to 2 seconds. Pulsed AC application in this instance allows the cardiac muscle to fibrillate between AC pulses to achieve electrical activation of the ventricles and generation of a mechanical systole.
  • a method of generating local conduction block of cardiac tissue includes administering alternating current (AC) to a targeted site of a heart during an arrhythmia to cause termination of the arrhythmia.
  • the AC is administered at a frequency between about 100 Hz to 1 kHz.
  • delivery of the AC is timed to a surface electrocardiogram or an intracardiac electrocardiogram.
  • the method of local conduction block is used during diagnostic or therapeutic electrophysiologic procedures, where the arrhythmia is electrically mapped and a region critical to the arrhythmia is identified using a catheter based approach. To decide whether to ablate the region, before application of therapeutic energy (RF or Cryo), alternating current is applied locally to cause conduction block. If this terminates the arrhythmia then this information will be useful both for diagnostic and therapeutic purposes.
  • RF or Cryo therapeutic energy
  • Ablation may be performed as described in U.S. Pat. No. 6,431,173.
  • ablative therapy There are two types of ablative therapy, namely, surgical and catheter ablative therapy.
  • the aim of either type of ablative therapy is to permanently destroy (irreversibly damage) the myocardium which constitutes the critical part of the reentrant circuit of the ventricular or a trial tachycardia which is required to sustain or perpetuate the ventricular or a trial tachycardia.
  • the ablation of the critical region of the myocardium acts to permanently eliminate the conduction or impulse formation through the reentrant pathway which is required to sustain or perpetuate the ventricular or a trial tachycardia.
  • Diagnostic techniques used to localize the reentry circuit include analysis of a 12-lead ECG, catheter mapping during a trial or ventricular tachycardia, and pace mapping. Once the site of origin of ventricular or a trial tachycardia is localized, ablative procedures (surgical or catheter directed) can be performed.
  • catheter-based electrodes are used to permanently disable myocardium tissue adjacent to the electrode without affecting more distant tissue.
  • tissue extending several mm from the electrode is heated to 65-100° C.
  • specific anatomical structures are often associated with reentry pathways required to sustain arrhythmias. As a result, the incidence of arrhythmias may decrease and/or the arrhythmias may be better organized, thereby leading to a higher degree of success with low energy shock therapies.
  • the term “subject” is intended to refer to any individual or patient to which the method described herein is performed. Generally the subject is human, although as will be appreciated by those in the art, the subject may be an animal. Thus other animals, including mammals such as rodents (including mice, rats, hamsters and guinea pigs), cats, dogs, rabbits, farm animals including cows, horses, goats, sheep, pigs, etc., and primates (including monkeys, chimpanzees, orangutans and gorillas) are included within the definition of subject.
  • rodents including mice, rats, hamsters and guinea pigs
  • cats dogs, rabbits, farm animals including cows, horses, goats, sheep, pigs, etc.
  • primates including monkeys, chimpanzees, orangutans and gorillas
  • administering are intended to include an act of applying or delivering alternating current to cardiac tissue or cells. Typically administration is performed via externally disposed or implanted electrodes as described herein.
  • a device for treating arrhythmia includes a computer or microprocessor-readable program containing one or more algorithms for generating and/or delivering AC and/or electrical shock, a plurality of electrodes, a waveform generator generating high frequency AC and/or electrical shock, and optionally, a sensing circuit allowing detection of arrhythmia in a subject and automatic administration of AC.
  • high frequency (HF) alternating current (AC) is intended to include frequencies of between about 50 Hz and 20 kHz.
  • the device and method utilize frequencies of between about 50 Hz and 1 kHz, 50 Hz and 900 Hz, 50 Hz and 800 Hz, 50 Hz and 700 Hz, 50 Hz and 600 Hz, 50 Hz and 500 Hz, 100 Hz and 500 Hz, 100 Hz and 400 Hz, 100 Hz and 300 Hz, 100 Hz and 200 Hz, 150 Hz and 500 Hz, 150 Hz and 400 Hz, 150 Hz and 300 Hz, and 150 Hz and 200 Hz.
  • Frequencies above 1 kHz are anticipated to be ineffective. Further, it is anticipated that most effective results will be obtained, depending to a degree on duration, within frequency ranges of 150 Hz and 300 Hz, including at 200 Hz.
  • alternating current may be delivered in any number of waveforms or combinations or waveforms.
  • the waveform may be a sinusoidal, triangular, or square-wave, as well as any combinations thereof. Additionally, square-waves, may have a duty-cycle of about 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%. Further, the waveform may switch on or off abruptly, or may be shaped by an envelope waveform to effect more gradual onset or offset.
  • alternating current may be applied or administered for various durations of time ranging from about 0.025 second to 2 seconds to accomplish termination of the arrhythmia.
  • alternating current may be applied or administered for about 0.025 second to 1.5 seconds, or 0.025 second to 1 second, 0.025 to 0.5 second.
  • alternating current may be applied or administered for about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 seconds.
  • alternating current may be delivered in a ramped waveform, e.g., a waveform having increasing amplitude over time.
  • a ramped waveform e.g., a waveform having increasing amplitude over time.
  • Such waveforms are useful for blocking or decreasing sensitivity of the muscle to a subsequent delivery of an electrical shock, e.g., a monophasic shock, a biphasic shock, or a combination thereof.
  • High frequency AC administered via a ramped waveform blunts the amplitude and the rate of force developed in skeletal muscle, which results in substantial mitigation of defibrillation-induced pain.
  • a ramped waveform of the present invention employs an extended, gradual rise, instead of rising rapidly to its maximum level.
  • the rise time of the ramped waveform should be a substantial portion of the duration of the waveform and, preferably, at least about 50%, 60%, 70%, 80%, 90%, 95% or greater, of the total duration of the waveform.
  • the ramped waveform may be applied or administered for various durations of time ranging from about 0.025 second to 2 seconds to accomplish termination of the arrhythmia.
  • ramped alternating current may be applied or administered for about 0.025 second to 1.5 seconds, or 0.025 second to 1 second, 0.025 to 0.5 second.
  • ramped alternating current may be applied or administered for about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 seconds or greater.
  • the maximum reduction in muscle stimulation occurs with a fully ramped waveform, for example, 1 second total duration and approximately a 1 second rise time.
  • the output pulse may continue at this current level for a short period of time, and then rapidly returns to 0 over a short fall time.
  • the time period during which the pulse is at its maximum current level may be, for example, 0-0.1 seconds.
  • a high frequency waveform may be continuously ramped in amplitude during the total duration of application.
  • the amplitude may be ramped from about 0 to 25, 50, 75, 100, 125, 150, 175, 200, 225, 250, 300, 350, 400 or 500 volts or greater.
  • the present invention contemplates administration of a ramped waveform in combination with an electrical, for instance, a monophasic or biphasic shock.
  • the electrical shock may follow the ramped waveform.
  • the shock waveform that is administered to the high frequency AC ramp is a decaying exponential with time constant 1-10 ms.
  • the peak rising edge voltage of the shock may be less than, equal to, or greater than the peak of the high frequency AC ramp.
  • the peak rising edge voltage of the shock is greater than the peak of the high frequency AC ramp, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 120%, 140%, 160%, 180%, 200% or greater than the peak of the high frequency AC ramp.
  • the shock duration may be 4-16 ms.
  • the first phase may be 2-6 ms and the second phase may be 2-12 ms.
  • the shock is preferably applied at the peak or end of the HFAC ramp.
  • the device may be configured to apply alternating current manually at the discretion of a health care worker, either by an internally implanted or externally applied device, or may be applied automatically in response to a detected arrhythmia, either by an implanted or externally disposed device.
  • alternating current manually at the discretion of a health care worker, either by an internally implanted or externally applied device, or may be applied automatically in response to a detected arrhythmia, either by an implanted or externally disposed device.
  • Such applications may coincide with detection of arrhythmia in the subject by a sensing circuit allowing detection of the arrhythmia, which may be included in or external to the device.
  • the device and methodology may be used to treat a number of different types of arrhythmias.
  • the arrhythmia is a tachyarrhythmia, such as ventricular tachyarrhythmia, or atrial tachyarrhythmia.
  • Ventricular tachyarrhythmias may include, but are not limited to ventricular fibrillation.
  • Atrial tachyarrhythmias may include, but are not limited to atrial fibrillation and atrial flutter.
  • the device and methodology utilize a plurality of electrodes which may be configured in a variety of ways to administer alternating current.
  • Alternating current may be administered via a number of electrode configurations as described.
  • the alternating current is preferably applied via large electrodes placed on the skin across the heart as is typically done with external defibrillators.
  • Automatic response to arrhythmia detection can be implemented using separate skin electrodes to detect the ECG, or using the same large electrodes through which the alternating current is then applied.
  • the alternating current is preferentially applied via electrodes placed in or about the cardiac chambers, or via electrodes placed in the chest outside the rib cage, for example in the subcutaneous layers including the housing of the implanted device itself, or using a combination of such electrodes.
  • Automatic response to arrhythmia detection can be accomplished using electrodes placed in or about the cardiac chamber or chambers susceptible to tachyarrhythmia, or using electrodes placed in the chest outside the ribcage, for example in the subcutaneous layers.
  • a device may be in electrical communication with a subject's heart by way of one or more leads, suitable for delivering multi-chamber stimulation and pacing therapy. Not every configuration has all of the electrodes to be described below, but a particular configuration may include some of these electrodes. Other configurations of the device may include even more electrodes than discussed herein. For example, alternating current may be applied by other, additional electrodes than those described below. Further, the electrodes and device may be configured to apply alternating current using a tiered approach.
  • Additional electrodes for delivering alternating current can include combinations or electrodes situated over the epicardium (e.g., multiple pacing and relatively larger surface area defibrillation electrodes that may be used for optimizing cardiac resynchronization therapy and providing defibrillation).
  • the device in order to sense atrial cardiac signals and to provide right atrial chamber stimulation therapy, the device may be coupled to an implantable right atrial lead, typically having an atrial tip electrode and an atrial ring electrode, which may be implanted in the subject's right atrial appendage.
  • the device is also known as and referred to as a pacing device, a pacing apparatus, a cardiac rhythm management device, or an implantable cardiac stimulation device.
  • the device may be coupled to a “coronary sinus” lead configured for placement in the “coronary sinus region” via the coronary sinus opening for positioning a distal electrode adjacent to the left ventricle or additional electrode(s) adjacent to the left atrium.
  • coronary sinus region refers to the vasculature of the left ventricle, including any portion of the coronary sinus, great cardiac vein, left marginal vein, left posterior ventricular vein, middle cardiac vein, and/or small cardiac vein or any other cardiac vein accessible by the coronary sinus.
  • a coronary sinus lead may be configured to receive atrial and ventricular cardiac signals and to deliver left ventricular pacing therapy using a left ventricular (LV) tip electrode and a LV ring electrode.
  • Left atrial pacing therapy may use, for example, first and second left atrial (LA) ring electrodes.
  • Administration of alternating current can also be performed using at least a coronary sinus coil electrode.
  • Administration of alternating current can also be performed using a pair of right atrial (RA) ring electrodes.
  • the device may also be in electrical communication with a subject's heart by way of an implantable right ventricular lead, typically having a right ventricular (RV) tip electrode, an RV ring electrode, an RV coil electrode, and a superior vena cava (SVC) coil electrode (also known as a right atrial (RA) coil electrode).
  • RV right ventricular
  • SVC superior vena cava
  • RA right atrial
  • the components of the device may be contained in a case, which is often referred to as the “can”, “housing”, “encasing”, or “case electrode”, and may be programmably selected to act as the return electrode for unipolar operational modes.
  • the case may further be used as a return electrode alone or in combination with one or more additional electrodes for stimulating purposes.
  • the case may further include a connector having a plurality of terminals for connecting one or more of the following electrodes in various configurations:
  • tiered therapy which provides an adaptive and refined therapy for arrhythmias.
  • the tiered approach divides therapy for arrhythmias into a progression of multiple tiers.
  • tiered therapy may include applying alternating current along a progression of different frequencies and durations, the progression continuing until the arrhythmia is terminated.
  • the progression of tiered therapy may proceed from a least invasive frequency and duration (e.g., vector) to a more invasive vector, stopping the progression whenever the arrhythmia ceases.
  • the progression of vectors reflects a progression in the size of electrodes used to deliver alternating current, and/or a progression in the area or volume of electrically excitable cardiac tissue to be stimulated. This exemplary technique of tiering the vectors may minimize pain, especially if the patient is responsive to the least invasive vector.
  • tiered therapy may also include application of electric shock in addition to application of AC.
  • monophasic or biphasic shock may be administered after or before AC is applied in a tiered approach.
  • Neonatal rat ventricular myocytes were dissociated from 2-day old Sprague-Dawley rat hearts with the use of the enzymes, trypsin and collagenase, as previously described (see, Iravanian et al., AJP Heart Circ., 285(1):H4449-56 (2003)).
  • the resulting cell suspension was plated at high density onto 21 mm diameter plastic coverslips (106 myocytes per coverslip) to form monolayers that became confluent after 3-4 days of culture. Experiments were performed on days 6 to 8 after plating. For reentry experiments, prior to plating, a 4-mm diameter hole was punched in the coverslip.
  • Electrophysiological recording was performed as follows. Transmembrane voltage was recorded using contact fluorescent imaging as previously described (see, Entcheva et al., J Cardiovasc Electrophysiol., 11(6):665-76 (2000)). Briefly, maps of transmembrane potential were recorded by placing the cell monolayer directly on top of a bundle of 253 optical fibers 1 mm in diameter, arranged in a tightly packed, 17-mm-diameter hexagonal array.
  • the cell monolayers were stained during the experiment with 10 ⁇ M di-4-ANEPPS, a fluorescent voltage-sensitive dye, and continually superfused with warmed (37° C.) Tyrode's solution (in mmol/L: 135 NaCl, 5.4 KCl, 1.8 CaCl2, 1 MgCl2, 0.33 NaH2PO4, 5 HEPES, 5 glucose).
  • Electric field stimulation was applied across a parallel set of platinum wires 2.5-cm long placed in the bath outside the monolayer preparation.
  • the field intensity was calibrated from the peak voltage across a pair of AgCl test electrodes placed at a 1.4-cm spacing in the chamber.
  • a bipolar point electrode was placed near the edge of the monolayer and used to pace the monolayer at 2-6 Hz (10 ms monophasic pulse, 1.5 ⁇ threshold). Each recording was 3 sec long, with point pacing either on for the entire recording or turned off for the last 500 ms. After 1 sec, a 1-sec duration AC or DC pulse was applied to the monolayer. For reentry experiments, rapid point pacing was used to induce a stable spiral wave reentry. Stable reentry was considered successful if the wave pinned to the hole for at least 1 min. Each recording was 3 sec, in which a 1-sec duration AC or DC pulse was applied to the monolayer 1 sec after the start of the recording.
  • a cell monolayer model was set-up and represented by a 4.4 cm ⁇ 4.4 cm ⁇ 0.25 mm tissue mesh centered at the bottom of a perfusate-filled chamber.
  • the electrical properties of the tissue were modeled using an isotropic bidomain representation.
  • the intracellular conductivities were varied randomly (Plank et al., J Cardiovasc Electrophysiol, 16(2):205-216 (2005)).
  • Membrane kinetics of the monolayer were represented using the Luo-Rudy dynamic guinea pig ventricular model (Faber et al., Biophys J, 78(5):2392-2404 (2000)), with modifications for modeling large external field stimulation (Ashihara et al., Europace, 7(s2), S155-S165)).
  • a simulation protocol was also used.
  • conduction block simulations a point electrode was used to pace the tissue at 2 Hz before, during, and after the AC field pulse.
  • an 8-mm hole was introduced in the center of the monolayer to allow attachment of the spiral wave.
  • a spiral wave was initiated using an S1-S2 cross-stimulation protocol.
  • a one second-duration AC field pulse was then applied at varying field strengths and frequencies.
  • AC field stimulation was delivered from line electrodes located in the superfusing bath, as in the experimental setup.
  • V m transmembrane voltage
  • the degree of conduction block was frequency- and field strength-dependent. At the highest field strength tested (22 V/cm), AC frequencies less than 50 Hz resulted in repetitive depolarizations of the monolayer, which we term field-evoked activity (FEA) ( FIGS. 3B and 5A ), while frequencies above 2 kHz had no effect on the monolayer ( FIGS. 3C and 5A ). FEA was also elicited at lower field strengths ( ⁇ 10 V/cm) for all frequencies below 2 kHz ( FIG. 5A ).
  • FEA field-evoked activity
  • AC Field vs. Direct Current Field Point-pacing during the DC field initiated new propagating waves, indicating lack of conduction block ( FIG. 5A ). A second rapid depolarization was observed at the field offset. Following cessation of the DC field, in all cases, the monolayer was severely damaged, identified by a rapid decline in optical signal intensity and point pacing initiating highly heterogeneous propagation, producing rapid ectopic activity, or failing to elicit any response. High-strength DC field stimulation terminated spiral wave reentry by depolarization of the entire excitable gap, similarly to that observed during AC field stimulation ( FIG. 5B ). However, as during conduction experiments, during the DC field pulse V.
  • FIGS. 5A and B Computational Modeling of Reentry Termination and Conduction Block by AC: Computer simulations were used of a three-dimensional bidomain model of guinea pig ventricular tissue to dissect the biophysical mechanisms of conduction block by sustained AC field stimulation.
  • This example presents data showing termination of fibrillation in whole guinea pig hearts in vivo upon application of AC.
  • Guinea pigs were perfused as Langendorff preparations.
  • Hearts were stained with the voltage-sensitive dye di-4-ANEPPS (10 ⁇ mol/L) by direct coronary perfusion for 10 minutes.
  • An EC uncoupler (diacetyl monoxime) was used to arrest mechanical deformation and the hearts were placed in a custom-built chamber that was attached to a micromanipulator.
  • Optical action potential mapping was performed from 128 sites of the intact guinea pig heart. Total mapping field was Ian xl cm with an estimated depth of field of 0.2 mm.
  • the ventricular epicardial surface was stimulated using bipolar electrodes to induce ventricular fibrillation. Two field electrodes placed on either side of the heart delivered the AC electric field.
  • Pulses of AC administered to whole guinea pig hearts was performed. As shown in FIG. 7 , defibrillation of a whole heart is evidenced by a 1 second pulse of AC. As shown in FIG. 8 , successful defibrillation of a whole heart by a 50 ms pulse (A) and failed defibrillation by a 30 ms pulse (B) is evidenced at a frequency of 200 Hz.
  • This example presents data showing administration of high frequency AC having a ramped waveform to skeletal muscle of adult swine.

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US14/604,457 US10532216B2 (en) 2009-09-03 2015-01-23 Method and device for treating cardiac arrhythmias
US15/826,498 US11052261B2 (en) 2009-09-03 2017-11-29 Method and device for treating cardiac arrhythmias
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US11717694B2 (en) 2023-08-08
US20150258344A1 (en) 2015-09-17
WO2015112893A1 (fr) 2015-07-30
US20180085594A1 (en) 2018-03-29
US20210290967A1 (en) 2021-09-23
US11052261B2 (en) 2021-07-06
US10532216B2 (en) 2020-01-14

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