WO2003039650A2 - H-bridge with sensing circuit for a cardioverter-defibrillator system - Google Patents

H-bridge with sensing circuit for a cardioverter-defibrillator system Download PDF

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Publication number
WO2003039650A2
WO2003039650A2 PCT/IB2002/004514 IB0204514W WO03039650A2 WO 2003039650 A2 WO2003039650 A2 WO 2003039650A2 IB 0204514 W IB0204514 W IB 0204514W WO 03039650 A2 WO03039650 A2 WO 03039650A2
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WO
WIPO (PCT)
Prior art keywords
patient
circuit
electrical circuit
sensing
output circuit
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Application number
PCT/IB2002/004514
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French (fr)
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WO2003039650A3 (en
Inventor
William J. Rissmann
Alan H. Ostroff
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Cameron Health, Inc.
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Publication date
Application filed by Cameron Health, Inc. filed Critical Cameron Health, Inc.
Priority to AU2002350996A priority Critical patent/AU2002350996A1/en
Publication of WO2003039650A2 publication Critical patent/WO2003039650A2/en
Publication of WO2003039650A3 publication Critical patent/WO2003039650A3/en

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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
    • A61N1/3925—Monitoring; Protecting
    • A61N1/3931—Protecting, e.g. back-up systems
    • 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
    • A61N1/3912—Output circuitry therefor, e.g. switches

Definitions

  • the present invention relates generally to defib ⁇ llation/ cardioversion systems, and more particularly, to a defibnllation/cardioversion system having an H-b ⁇ dge with a sensing circuit used in pacing and shocking the heart
  • BACKGROUND OF THE INVENTION Defibnllation/cardioversion is a technique employed to counter arrhythmic heart conditions including some tachycardias in the atria and/or ventricles Typically, electrodes are employed to stimulate the heart with electrical impulses or shocks, of a magnitude substantially greater than pulses used in cardiac pacing
  • ICDs implantable cardioverter/defib ⁇ llators
  • the electrodes used in ICDs can be in the form of patches applied directly to epicardial tissue, or, more commonly, are on the distal regions of small cylindrical insulated catheters that typically enter the subclavian venous system, pass through the superior vena cava and, into one or more endocardial areas of the heart
  • Such electrode systems are called intravascular or transvenous electrodes
  • U S Pat Nos 4,603,705, 4,693,253, 4,944,300, 5,105,810 the disclosures of which are all incorporated herein by reference, disclose intravascular or transvenous electrodes, employed either alone, in combination with other intravascular or transvenous electrodes, or in combination with an epicardial patch or subcutaneous electrodes
  • Compliant epicardial defib ⁇ llator electrodes are disclosed in U S Pat
  • ICDs which are small enough to be implanted in the pectoral region
  • advances in circuit design have enabled the housing of the ICD to form a subcutaneous electrode
  • ICDs in which the housing of the ICD serves as an optional additional electrode are described in U S Pat Nos 5,133,353, 5,261,400, 5,620,477, and 5,658,321 the disclosures of which are incorporated herein by reference
  • ICDs are now an established therapy for the management of life threatening cardiac rhythm disorders, primarily ventricular fibrillation (V-Fib) ICDs are very effective at treating V-Fib, but are therapies that still require significant surgery
  • transvenous lead systems As ICD therapy becomes more prophylactic in nature and used in progressively less ill individuals, especially children at risk of cardiac arrest, the requirement of ICD therapy to use intravenous catheters and transvenous leads is an impediment to very long term management as most individuals will begin to develop complications related to lead system malfunction sometime in the 5-10 year time frame, often earlier
  • chronic transvenous lead systems can damage major cardiovascular venous systems and the tricuspid valve, as well as result in life threatening perforations of the great vessels and heart Consequently, use of transvenous lead systems, despite their many advantages, are not without their chronic patient management limitations in those with life expectancies of >5 years
  • the problem of lead complications is even greater in children where body growth can substantially alter transvenous lead function and lead to additional cardiovascular problems and revisions
  • transvenous ICD systems also increase cost and require specialized interventional rooms and equipment as well as special skill for insertion These systems are typically implanted by cardiac electrophysiologists who have had a great deal of extra training
  • the automatic external defib ⁇ llator (AED) AEDs employ the use of cutaneous patch electrodes, rather than implantable lead systems, to effect defib ⁇ llation under the direction of a bystander user who treats the patient suffering from V-
  • an AED must be used by another individual, not the person suffering from the potential fatal rhythm It is more of a public health tool than a patient-specific tool like an ICD Because >75% of cardiac arrests occur in the home, and over half occur in the bedroom, patients at risk of cardiac arrest are often alone or asleep and can not be helped in time with an AED Moreover, its success depends to a reasonable degree on an acceptable level of skill and calm by the bystander user What is needed therefore, especially for children and for prophylactic long term use for those at risk of cardiac arrest, is a combination of the two forms of therapy which would provide prompt and near-certain
  • ICDs generate an electrical shock by charging a capacitance system to a high voltage from a low voltage power source and oscillator circuit Then, the power source is switched out of the circuit and the electrical charge stored in the capacitance system is discharged through electrodes implanted m a patient
  • Typical discharge waveforms used with ICDs include monophasic, biphasic or multiphasic waveforms delivered as capacitance discharges
  • a monophasic waveform is comprised of a single monotomcally decaying electrical pulse typically truncated before complete discharging of the capacitance system
  • Biphasic waveforms are comprised of a decaying electrical pulse having a pair of decaying electrical phases of opposite polarity
  • an H-bndge switch circuit is used, which is connected to the implanted electrodes The H-b ⁇ dge switches the polarity of the two phases
  • a first phase is discharged from the capacitance system, similar to a monophasic pulse
  • the H-bndge switch circuit immediately reverses the discharge polarity of the capacitance system as seen by the electrodes to generate the second phase of the biphasic waveform being of opposite polarity
  • An H-b ⁇ dge may be used in defib ⁇ llators that deliver high voltage electrical pulses, or shock, and also lower energy pacing pulses to a patient After a shock or pacing energy is delivered to a patient, normally there is residual voltage on implanted electrodes on the patient such that the sensing ability of those electrodes is reduced, thus hindering the observation of a heart signal through an electrocardiogram
  • An electrical circuit for a cardioverter-defib ⁇ llation system includes an energy storage device such as a capacitor, an output circuit for controlling delivery of defibnllation pulses from the energy storage device to a patient, and a sensing circuit coupled across the patient to sense the patient's heart signal
  • the output circuit may be in the form of an H- b ⁇ dge switching circuit wherein a pair of switches of the output circuit are simultaneously turned on to discharge residual voltage across the patient that remains after delivery of defibnllation pulses Thus, interference with sensing of the patient's heart signal is avoided
  • FIG 1 is a schematic diagram of a typical ICD circuit including an H-bndge output circuit
  • FIG 2 is a schematic diagram of an H-bndge with sensing circuitry according to an embodiment of the present invention DETAILED DESCRIPTION OF THE INVENTION
  • Circuit 10 includes a battery power source 12, a double secondary fly back transformer 15, a transistor switch 14, rectifying diodes 16, 18, high voltage storage capacitors 20, 22, circuit control 50, an output circuit 30 having four legs ananged in the fonn of an "H" (an “H-b ⁇ dge 30"), each leg of the H-bndge 30 having switches 32, 34, 36, and 38, respectively, and cardiac electrodes 40, 42
  • the H-bndge 30 is connected to cardiac electrodes 40, 42, and is used to generate a biphasic pulse
  • the H-bndge 30 switches the polarity of the two phases
  • a first phase is discharged from the high voltage storage capacitors 20, 22 by activating switches 32 and 38
  • the first phase is truncated, and the H-bndge 30 activates switches 36 and 34, and reverses the discharge polarity of the high voltage storage capacitors 20, 22 from the point of view of the cardiac electrodes 40, 42, to generate the second phase of the waveform with opposite polarity
  • FIG 2 a schematic diagram of an H-bndge with sensing circuitry according to an embodiment of the present invention is illustrated
  • An energy storage capacitor 62 is connected to an H-bndge 60
  • a sensing circuit 80 is connected across a patient at nodes 78 and 79 of the H-bndge 60
  • H-bndge output circuits such as the one described with respect to FIG 1 may be used within the scope of the present invention
  • additional semiconductor switches may be incorporated in each leg of the H-bndge to reduce the voltage that must be switched by each switch
  • FIG 2 shows a single energy storage capacitor 62, it is well-understood in the art that a bank of capacitors may be used, or any other energy storage device
  • the energy storage capacitor 62 can be charged to a range of voltage levels, with the selected level depending on the patient and other parameters The typical maximum voltage necessary for
  • ICDs using most biphasic waveforms is approximately 750 Volts with an associated maximum energy of approximately 41 Joules
  • the maximum voltages used may be in the range of about 50 to about 3150 Volts and are associated with energies of about 0 5 to about 350 Joules
  • the energy storage capacitor 62 may be controlled to deliver either defibnllation or pacing energy, and could range from about 25 to about 200 micro farads for a subcutaneous ICD After charging to a desired level, the energy stored in capacitor 62 may be delivered to the patient in the form of a defibnllation pulse or pacing energy H-b ⁇ dge 60 is provided as an output circuit to allow the controlled transfer of energy from the energy storage capacitor 62 to the patient
  • Each leg of the H-bndge 60 contains a solid-state switch 64, 66, 68, and 70 Switches 64, 66, 68, and 70 may be silicon controlled rectifiers (SCRs), insulated gate bipolar transistors (IGBTs), or MOSFETs H-bndge 60 further includes electrodes 74 and 76 coupled to a patient
  • Switches 64 and 68 are coupled to the positive lead of the energy storage capacitor 62 via bridge line 65 It should be noted that a protective circuit (not shown) with inductive and resistive properties may be added, for example, at bridge line 65 between the positive lead of the capacitor 62 and the switch 64 to limit current and voltage changes from the storage capacitor 62 during a defibnllation pulse Switches 66 and 70 are coupled to the negative lead of the energy storage capacitor 62 via a bridge line 67
  • the patient is connected to the left side of the H-bndge by a line 63 and to the right side of the H-bndge by a line 69
  • Line 63 is connected to electrode 76 and line 69 is connected to electrode 74
  • a biphasic defibnllation pulse may be applied to the patient
  • Embodiments of the present invention may also use monophasic or multiphasic defibnllation pulses
  • the switches in the H-bndge are biased with a voltage that allows them to remain turned-on even when conducting low current
  • the switches 64 and 70 may be turned on to connect the energy storage capacitor 62 with lines 63 and 69 for the application of a first phase of a defibnllation pulse to the patient
  • the stored energy travels from the positive terminal of the energy storage capacitor 62 on line 65, through switch 64 and line 63, across the patient, and back through line 69 and switch 70 to the negative terminal of the capacitor
  • the first phase of the biphasic pulse is therefore a positive pulse
  • the switch 70 is biased off to prepare for the application of the second phase of the biphasic pulse
  • Sensing circuit 80 includes a sense amplifier 96 that senses differentially and is capacitively coupled across the patient
  • the sense amplifier 96 has a negative lead connected to node 79 in the H-bndge 60 through a capacitor 82
  • a resistor 84 is connected to capacitor 82 between ground and node 81 in a high-pass filter of approximately 0 5-20 Hz Resistor 84 may range in value between approximately 10 K ⁇ and 500 K ⁇
  • a resistor 92 is connected between node 81 and node 103
  • a capacitor 94 and a resistor 102 are connected in parallel at node 103 as a low pass filter of approximately 30-150 Hz It should be appreciated that there could be multiple low pass filters as well as multiple high pass filters connected to the negative lead of the sense amplifier 96
  • the sense amplifier 96 has a positive lead connected to node 78 via a capacitor 86
  • a resistor 88 is connected to capacitor 86 between ground and node 87 in a high-pass filter of approximately 0 5-20 Hz
  • an embodiment of the sensing circuit may comprise digital logic for overall control of the sensing circuit
  • the sensing circuit 80 allows constant observation of heart signals as an electrocardiogram When it is time to deliver therapy, a shock or pacing energy is delivered as required Switches 64, 70, 68, and 66 of the H-bndge 60 are sequenced to deliver monophasic, biphasic, or multiphasic pulses During shock or even during pacing, as soon as the therapy pulse is completed, there may be a residual voltage that remains on electrodes 74 and 76 as they are not simply resistors Capacitances may be involved in the patient such that after a pacing pulse or defibnllation shock there are residual voltages The residual voltages could, when present, limit the time that it takes for the differential sensing amplifier 96 to recover and allow proper continuing observation of the heart signal and determine whether the heart has returned to a normal rhythm or whether there is still an arrhythmia Thus, the amplifier needs to recover as soon as possible, for example, in much less than a second, and the voltages have to be within the common mode operating range of the amplifier as soon
  • switches 66 and 70 of the H-bndge 60 are turned on at the same time to discharge any residual voltage across the patient By turning on or closing both switches 66 and 70, the voltage across the electrodes 76 and 74 is effectively shorted out and the residual voltage across the patient is removed If there are any capacitances involved in series or in parallel with the patient, all that energy is dissipated After a monophasic, biphasic or multiphasic pacing pulse, or a shock is delivered, switches 66 and 70 are closed sometime after the end of the pulse, for example, after approximately 50 microseconds to 10 milliseconds, for a period of approximately 10 microseconds to up to approximately a second This will dissipate the residual voltage across the patient, and improve the recovery time of the sense amplifier Embodiments of the present invention allows the sensing to be done from the H-b ⁇ dge To dissipate energy, additional external switches may be used, however, using the switches

Abstract

In a cardioverter/defibrillator system, an electrical circuit includes an energy storage device, an output circuit for controlling delivery of pulse therapy from the energy storage device to a patient and a sensing circuit coupled across the patient to sense the patient's heart signal. The output circuit may be in the form of an H-bridge switching circuit wherein a pair of switches of the output circuit are simultaneously turned on to discharge residual voltage across the patient that remains after delivery of pulse therapy. Thus, interference with sensing of the patient's heart signal is avoided.

Description

H-BRIDGE WITH SENSING CIRCUIT
RELATED APPLICATIONS The present application may find use in systems such as are disclosed in the U S patent application entitled "SUBCUTANEOUS ONLY IMPLANT ABLE CARDIOVERTER-
DEFIBRILLATOR AND OPTIONAL PACER," having Serial No 09/663,607, filed September 18, 2000, pending, and U S patent application entitled "UNITARY SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND OPTIONAL PACER," having Serial No 09/663,606, filed September 18, 2000, pending, of which both applications are assigned to the assignee of the present application, and the disclosures of both applications are hereby incorporated by reference
Applications related to the foregoing applications include a U S patent application entitled "DUCKBILL-SHAPED IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND METHOD OF USE," U S patent application entitled "CERAMICS AND/OR OTHER MATERIAL INSULATED SHELL FOR ACTIVE AND NON-ACTIVE S-ICD CAN," U S patent application entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH IMPROVED INSTALLATION CHARACTERISTICS," U S patent application entitled "SUBCUTANEOUS ELECTRODE WITH IMPROVED CONTACT SHAPE FOR TRANSTHORACIC CONDUCTION," U S patent application entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH
HIGHLY MANEUVERABLE INSERTION TOOL," U S patent application entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH LOW-PROFILE INSTALLATION APPENDAGE AND METHOD OF DOING SAME," U S patent application entitled "SUBCUTANEOUS ELECTRODE FOR TRANSTHORACIC CONDUCTION WITH INSERTION TOOL," U S patent application entitled "METHOD OF INSERTION AND IMPLANTATION FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR CANISTERS," U S patent application entitled "CANISTER DESIGNS FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS," U S patent application entitled "RADIAN CURVED IMPLANTABLE CARDIOVERTER- DEFIBRILLATOR CANISTER," U S patent application entitled "CARDIOVERTER-
DEFIBRILLATOR HAVING A FOCUSED SHOCKING AREA AND ORIENTATION THEREOF," U S patent application entitled "BIPHASIC WAVEFORM FOR ANTI- BRADYCARDIA PACING FOR A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR," and U S patent application entitled "BIPHASIC WAVEFORM FOR ANTI-TACHYCARDIA PACING FOR A SUBCUTANEOUS
IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR," the disclosures of which applications are hereby incorporated by reference FIELD OF THE INVENTION The present invention relates generally to defibπllation/ cardioversion systems, and more particularly, to a defibnllation/cardioversion system having an H-bπdge with a sensing circuit used in pacing and shocking the heart
BACKGROUND OF THE INVENTION Defibnllation/cardioversion is a technique employed to counter arrhythmic heart conditions including some tachycardias in the atria and/or ventricles Typically, electrodes are employed to stimulate the heart with electrical impulses or shocks, of a magnitude substantially greater than pulses used in cardiac pacing
Defibnllation/cardioversion systems include body implantable electrodes that are connected to a hermetically sealed container housing the electronics, battery supply and capacitors The entire system is referred to as implantable cardioverter/defibπllators (ICDs) The electrodes used in ICDs can be in the form of patches applied directly to epicardial tissue, or, more commonly, are on the distal regions of small cylindrical insulated catheters that typically enter the subclavian venous system, pass through the superior vena cava and, into one or more endocardial areas of the heart Such electrode systems are called intravascular or transvenous electrodes U S Pat Nos 4,603,705, 4,693,253, 4,944,300, 5,105,810, the disclosures of which are all incorporated herein by reference, disclose intravascular or transvenous electrodes, employed either alone, in combination with other intravascular or transvenous electrodes, or in combination with an epicardial patch or subcutaneous electrodes Compliant epicardial defibπllator electrodes are disclosed in U S Pat Nos 4,567,900 and 5,618,287, the disclosures of which are incorporated herein by reference A sensing epicardial electrode configuration is disclosed in U S Pat No 5,476,503, the disclosure of which is incorporated herein by reference
In addition to epicardial and transvenous electrodes, subcutaneous electrode systems have also been developed For example, U S Patent Nos 5,342,407 and 5,603,732, the disclosures of which are incorporated herein by reference, teach the use of a pulse monitor/generator surgically implanted into the abdomen and subcutaneous electrodes implanted in the thorax This system is far more complicated to use than current ICD systems using transvenous lead systems together with an active can electrode and therefore it has no practical use It has in fact never been used because of the surgical difficulty of applying such a device (3 incisions), the impractical abdominal location of the generator and the electrically poor sensing and defibrillation aspects of such a system Recent efforts to improve the efficiency of ICDs have led manufacturers to produce
ICDs which are small enough to be implanted in the pectoral region In addition, advances in circuit design have enabled the housing of the ICD to form a subcutaneous electrode Some examples of ICDs in which the housing of the ICD serves as an optional additional electrode are described in U S Pat Nos 5,133,353, 5,261,400, 5,620,477, and 5,658,321 the disclosures of which are incorporated herein by reference
ICDs are now an established therapy for the management of life threatening cardiac rhythm disorders, primarily ventricular fibrillation (V-Fib) ICDs are very effective at treating V-Fib, but are therapies that still require significant surgery
As ICD therapy becomes more prophylactic in nature and used in progressively less ill individuals, especially children at risk of cardiac arrest, the requirement of ICD therapy to use intravenous catheters and transvenous leads is an impediment to very long term management as most individuals will begin to develop complications related to lead system malfunction sometime in the 5-10 year time frame, often earlier In addition, chronic transvenous lead systems, their reimplantation and removals, can damage major cardiovascular venous systems and the tricuspid valve, as well as result in life threatening perforations of the great vessels and heart Consequently, use of transvenous lead systems, despite their many advantages, are not without their chronic patient management limitations in those with life expectancies of >5 years The problem of lead complications is even greater in children where body growth can substantially alter transvenous lead function and lead to additional cardiovascular problems and revisions Moreover, transvenous ICD systems also increase cost and require specialized interventional rooms and equipment as well as special skill for insertion These systems are typically implanted by cardiac electrophysiologists who have had a great deal of extra training
In addition to the background related to ICD therapy, the present invention requires a brief understanding of a related therapy, the automatic external defibπllator (AED) AEDs employ the use of cutaneous patch electrodes, rather than implantable lead systems, to effect defibπllation under the direction of a bystander user who treats the patient suffering from V-
Fib with a portable device containing the necessary electronics and power supply that allows defibnllation AEDs can be nearly as effective as an ICD for defibnllation if applied to the victim of ventricular fibrillation promptly, I e , within 2 to 3 minutes of the onset of the ventricular fibrillation AED therapy has great appeal as a tool for diminishing the risk of death in public venues such as in air flight However, an AED must be used by another individual, not the person suffering from the potential fatal rhythm It is more of a public health tool than a patient-specific tool like an ICD Because >75% of cardiac arrests occur in the home, and over half occur in the bedroom, patients at risk of cardiac arrest are often alone or asleep and can not be helped in time with an AED Moreover, its success depends to a reasonable degree on an acceptable level of skill and calm by the bystander user What is needed therefore, especially for children and for prophylactic long term use for those at risk of cardiac arrest, is a combination of the two forms of therapy which would provide prompt and near-certain defibnllation, like an ICD, but without the long-term adverse sequelae of a transvenous lead system while simultaneously using most of the simpler and lower cost technology of an AED What is also needed is a cardioverter/defibrillator that is of simple design and can be comfortably implanted in a patient for many years
Typically, ICDs generate an electrical shock by charging a capacitance system to a high voltage from a low voltage power source and oscillator circuit Then, the power source is switched out of the circuit and the electrical charge stored in the capacitance system is discharged through electrodes implanted m a patient
Typical discharge waveforms used with ICDs include monophasic, biphasic or multiphasic waveforms delivered as capacitance discharges A monophasic waveform is comprised of a single monotomcally decaying electrical pulse typically truncated before complete discharging of the capacitance system Biphasic waveforms are comprised of a decaying electrical pulse having a pair of decaying electrical phases of opposite polarity To generate a biphasic pulse, an H-bndge switch circuit is used, which is connected to the implanted electrodes The H-bπdge switches the polarity of the two phases In generating the biphasic pulse, a first phase is discharged from the capacitance system, similar to a monophasic pulse When the first pulse is truncated, the H-bndge switch circuit immediately reverses the discharge polarity of the capacitance system as seen by the electrodes to generate the second phase of the biphasic waveform being of opposite polarity
An H-bπdge may be used in defibπllators that deliver high voltage electrical pulses, or shock, and also lower energy pacing pulses to a patient After a shock or pacing energy is delivered to a patient, normally there is residual voltage on implanted electrodes on the patient such that the sensing ability of those electrodes is reduced, thus hindering the observation of a heart signal through an electrocardiogram
What is needed, therefore, is a defibrillator with an H-bndge switch circuit such that residual voltage is dissipated from electrodes after a shock or pacing energy is delivered to a patient so that sensing activity is not affected
SUMMARY OF THE INVENTION
An electrical circuit for a cardioverter-defibπllation system includes an energy storage device such as a capacitor, an output circuit for controlling delivery of defibnllation pulses from the energy storage device to a patient, and a sensing circuit coupled across the patient to sense the patient's heart signal The output circuit may be in the form of an H- bπdge switching circuit wherein a pair of switches of the output circuit are simultaneously turned on to discharge residual voltage across the patient that remains after delivery of defibnllation pulses Thus, interference with sensing of the patient's heart signal is avoided
BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the invention, reference is now made to the drawings where like numerals represent similar objects throughout the figures where
FIG 1 is a schematic diagram of a typical ICD circuit including an H-bndge output circuit, and
FIG 2 is a schematic diagram of an H-bndge with sensing circuitry according to an embodiment of the present invention DETAILED DESCRIPTION OF THE INVENTION
Referring first to FIG 1 , a schematic diagram of a typical ICD circuit including an H- bπdge output circuit is illustrated Circuit 10 includes a battery power source 12, a double secondary fly back transformer 15, a transistor switch 14, rectifying diodes 16, 18, high voltage storage capacitors 20, 22, circuit control 50, an output circuit 30 having four legs ananged in the fonn of an "H" (an "H-bπdge 30"), each leg of the H-bndge 30 having switches 32, 34, 36, and 38, respectively, and cardiac electrodes 40, 42
The H-bndge 30 is connected to cardiac electrodes 40, 42, and is used to generate a biphasic pulse The H-bndge 30 switches the polarity of the two phases A first phase is discharged from the high voltage storage capacitors 20, 22 by activating switches 32 and 38 Then the first phase is truncated, and the H-bndge 30 activates switches 36 and 34, and reverses the discharge polarity of the high voltage storage capacitors 20, 22 from the point of view of the cardiac electrodes 40, 42, to generate the second phase of the waveform with opposite polarity
Referring now to FIG 2, a schematic diagram of an H-bndge with sensing circuitry according to an embodiment of the present invention is illustrated An energy storage capacitor 62 is connected to an H-bndge 60 A sensing circuit 80 is connected across a patient at nodes 78 and 79 of the H-bndge 60
It should be appreciated that a variety of H-bndge output circuits such as the one described with respect to FIG 1 may be used within the scope of the present invention Furthermore, it should be noted that additional semiconductor switches may be incorporated in each leg of the H-bndge to reduce the voltage that must be switched by each switch
Although FIG 2 shows a single energy storage capacitor 62, it is well-understood in the art that a bank of capacitors may be used, or any other energy storage device The energy storage capacitor 62 can be charged to a range of voltage levels, with the selected level depending on the patient and other parameters The typical maximum voltage necessary for
ICDs using most biphasic waveforms is approximately 750 Volts with an associated maximum energy of approximately 41 Joules For subcutaneous ICDs, the maximum voltages used may be in the range of about 50 to about 3150 Volts and are associated with energies of about 0 5 to about 350 Joules The energy storage capacitor 62 may be controlled to deliver either defibnllation or pacing energy, and could range from about 25 to about 200 micro farads for a subcutaneous ICD After charging to a desired level, the energy stored in capacitor 62 may be delivered to the patient in the form of a defibnllation pulse or pacing energy H-bπdge 60 is provided as an output circuit to allow the controlled transfer of energy from the energy storage capacitor 62 to the patient
Each leg of the H-bndge 60 contains a solid-state switch 64, 66, 68, and 70 Switches 64, 66, 68, and 70 may be silicon controlled rectifiers (SCRs), insulated gate bipolar transistors (IGBTs), or MOSFETs H-bndge 60 further includes electrodes 74 and 76 coupled to a patient
Switches 64 and 68 are coupled to the positive lead of the energy storage capacitor 62 via bridge line 65 It should be noted that a protective circuit (not shown) with inductive and resistive properties may be added, for example, at bridge line 65 between the positive lead of the capacitor 62 and the switch 64 to limit current and voltage changes from the storage capacitor 62 during a defibnllation pulse Switches 66 and 70 are coupled to the negative lead of the energy storage capacitor 62 via a bridge line 67 The patient is connected to the left side of the H-bndge by a line 63 and to the right side of the H-bndge by a line 69 Line 63 is connected to electrode 76 and line 69 is connected to electrode 74
By selectively switching on pairs of switches in the H-bndge, a biphasic defibnllation pulse may be applied to the patient Embodiments of the present invention may also use monophasic or multiphasic defibnllation pulses The switches in the H-bndge are biased with a voltage that allows them to remain turned-on even when conducting low current When the energy storage capacitor 62 is charged to a selected energy level, the switches 64 and 70 may be turned on to connect the energy storage capacitor 62 with lines 63 and 69 for the application of a first phase of a defibnllation pulse to the patient The stored energy travels from the positive terminal of the energy storage capacitor 62 on line 65, through switch 64 and line 63, across the patient, and back through line 69 and switch 70 to the negative terminal of the capacitor The first phase of the biphasic pulse is therefore a positive pulse Before the energy storage capacitor 62 is completely discharged, the switch 70 is biased off to prepare for the application of the second phase of the biphasic pulse Once the switch 70 is biased off, switch 64 will also become non-conductive because the voltage falls to zero After the end of the first phase of the biphasic defibnllation pulse, switches 68 and 66 are switched on to start the second phase of the biphasic pulse Switches 68 and 66 provide a path to apply a negative defibnllation pulse to the patient The energy travels from the positive terminal of the energy storage capacitor 62 on line 65, through switch 68 and line 69, across the patient, and back through line 63 and switch 66 to the negative terminal of the energy storage capacitor The polarity of the second phase of the defibnllation pulse is therefore opposite in polarity to the first phase of the biphasic pulse The end of the second phase of the biphasic pulse may be truncated by switching on switch 64 to provide a shorted path for the remainder of the capacitor energy through switches 64 and 66 Digital logic (not shown) may be used to control the sequencing of the switches 64, 66, 68, and 70 such that the polarity can be inverted so that the first phase is negative instead of positive The digital logic generally controls the timing, the duration of each phase and the inter phase delay Sensing circuit 80 is connected to H-bndge 60 across the patient at nodes 78 and 79
Sensing circuit 80 includes a sense amplifier 96 that senses differentially and is capacitively coupled across the patient The sense amplifier 96 has a negative lead connected to node 79 in the H-bndge 60 through a capacitor 82 A resistor 84 is connected to capacitor 82 between ground and node 81 in a high-pass filter of approximately 0 5-20 Hz Resistor 84 may range in value between approximately 10 KΩ and 500 KΩ A resistor 92 is connected between node 81 and node 103 A capacitor 94 and a resistor 102 are connected in parallel at node 103 as a low pass filter of approximately 30-150 Hz It should be appreciated that there could be multiple low pass filters as well as multiple high pass filters connected to the negative lead of the sense amplifier 96 The sense amplifier 96 has a positive lead connected to node 78 via a capacitor 86 A resistor 88 is connected to capacitor 86 between ground and node 87 in a high-pass filter of approximately 0 5-20 Hz A resistor 91 is connected between node 87 and node 99 A capacitor 100 and a resistor 98 are connected in parallel at node 99 as a low pass filter of approximately 30-150 Hz It should be appreciated that there could be multiple low pass filters as well as multiple high pass filters connected to the positive lead of the sense amplifier
96 Furthermore, an embodiment of the sensing circuit may comprise digital logic for overall control of the sensing circuit
The sensing circuit 80 allows constant observation of heart signals as an electrocardiogram When it is time to deliver therapy, a shock or pacing energy is delivered as required Switches 64, 70, 68, and 66 of the H-bndge 60 are sequenced to deliver monophasic, biphasic, or multiphasic pulses During shock or even during pacing, as soon as the therapy pulse is completed, there may be a residual voltage that remains on electrodes 74 and 76 as they are not simply resistors Capacitances may be involved in the patient such that after a pacing pulse or defibnllation shock there are residual voltages The residual voltages could, when present, limit the time that it takes for the differential sensing amplifier 96 to recover and allow proper continuing observation of the heart signal and determine whether the heart has returned to a normal rhythm or whether there is still an arrhythmia Thus, the amplifier needs to recover as soon as possible, for example, in much less than a second, and the voltages have to be within the common mode operating range of the amplifier as soon as possible
To improve the post-shock or post-pacing recovery time on the amplifiers, switches 66 and 70 of the H-bndge 60 are turned on at the same time to discharge any residual voltage across the patient By turning on or closing both switches 66 and 70, the voltage across the electrodes 76 and 74 is effectively shorted out and the residual voltage across the patient is removed If there are any capacitances involved in series or in parallel with the patient, all that energy is dissipated After a monophasic, biphasic or multiphasic pacing pulse, or a shock is delivered, switches 66 and 70 are closed sometime after the end of the pulse, for example, after approximately 50 microseconds to 10 milliseconds, for a period of approximately 10 microseconds to up to approximately a second This will dissipate the residual voltage across the patient, and improve the recovery time of the sense amplifier Embodiments of the present invention allows the sensing to be done from the H-bπdge To dissipate energy, additional external switches may be used, however, using the switches of the H-bndge itself saves the complexity of using external switches
Numerous characteristics and advantages of the invention covered by this document have been set forth in the foregoing description It will be understood, however, that this disclosure is, in many aspects, only illustrative Changes may be made in details, particularly in matters of shape, size and arrangement of parts without exceeding the scope of the invention The invention's scope is defined in the language in which the appended claims are expressed

Claims

What is claimed is
1 An electrical circuit for a cardioverter-defibπllation system comprising an energy storage device, an output circuit coupled to the energy storage device, wherein the output circuit comprises switching means for controlling delivery of defibnllation pulses from the energy storage device to a patient, and a sensing circuit coupled across the patient to sense a patient's heart signal, wherein at least two of the switching means of the output circuit are simultaneously turned on to discharge residual voltage across the patient, thus avoidmg interference with sensing of the patient's heart signal
2 The electrical circuit of claim 1, wherein the cardioverter/defibπllation system further comprises an implantable cardioverter defibπllator
3 The electrical circuit of claim 2, wherein the cardioverter/defibπllation system further comprises a subcutaneous implantable cardioverter defibπllator
4 The electrical circuit of claim 1 , wherein the output circuit further comprises an H-bndge output circuit
5 The electrical circuit of claim 1 , wherein the sensing circuit further comprises a differential amplifier
6 The electrical circuit of claim 1 , wherein the switching means further comprises at least one SCR
7 The electrical circuit of claim 1 , wherein the switching means further comprises at least one IGBT
8 The electrical circuit of claim 1 , wherein the switching means further comprises at least one MOSFET
9 " The electrical circuit of claim 1 , wherein the sensing circuit further comprises digital logic for control
10 The electrical circuit of claim 1 , wherein the output circuit is sequenced to deliver a biphasic pulse to the patient
11 The electrical circuit of claim 1 , wherein the output circuit is sequenced to deliver a monophasic pulse to the patient 12 The electrical circuit of claim 1 , wherein the output circuit is sequenced to deliver a multiphasic pulse to the patient
13 The electrical circuit of claim 1 wherein the sensing circuit further comprises at least one low pass filter
14 The electrical circuit of claim 1 wherein die sensing circuit further comprises at least one high pass filter
15 The electrical circuit of claim 14, wherein the high pass filter operates in a frequency range of approximately 1 to 20 Hz
16 The electrical circuit of claim 13, wherein the low pass filter operates in a frequency range of approximately 30-150 Hz
17 The electrical circuit of claim 1, wherein the energy storage device further comprises at least one capacitor
18 An electrical circuit for a cardioverter/ defibπllator comprising a storage circuit connected to a power source, an output circuit coupled to the storage circuit that controls delivery of defibnllation pulse therapy to a patient, and a sensing circuit coupled to the output circuit across the patient such that the sensing circuit immediately recovers after delivery of pulse therapy by removal of residual voltage across the patient
19 The electrical circuit of claim 18, wherein the cardioverter/ defibπllator is implantable in the patient
20 The electrical circuit of claim 19, wherein the cardioverter/defibrillator further comprises a subcutaneous cardioverter/defibrillator
21 The electrical circuit of claim 18, wherein the output circuit further comprises an H-bndge
22 The electrical circuit of claim 21 , wherein the H-bndge further comprises switches
23 The electrical circuit of claim 22, wherein the switches further comprise at least one SCR 24 The electrical circuit ot claim 22, wherein the switches further comprise at least one IGBT
25 The electrical circuit of claim 22, wherein the switches further comprise at least one MOSFET
26 The electrical circuit of claim 18, wherein the storage circuit further comprises at least one capacitor
27 The electrical circuit of claim 18, wherein the storage circuit is charged to approximately between 0 5 Joules and 350 Joules for internal application to the patient
28 The electrical circuit of claim 18, wherein the output circuit is sequenced to deliver a biphasic defibnllation pulse to the patient
29 The electrical circuit of claim 18, wherein the output circuit is sequenced to deliver a monophasic defibnllation pulse to the patient
30 The electrical circuit of claim 18, wherein the output circuit is sequenced to deliver a multiphasic defibnllation pulse to the patient
31 The electrical circuit of claim 18, wherein the sensing circuit further comprises a differential amplifier
32 The electrical circuit of claim 18, wherein the sensing circuit further comprises digital logic for control
33 The electrical circuit of claim 18, wherein the sensing circuit further comprises at least one high-pass filter
34 The electrical circuit of claim 33, wherein the high-pass filter comprises a gain of approximately between 0 5-20 Hz
35 The electrical circuit of claim 18, wherein the sensing circuit further comprises at least one low-pass filter
36 An electrical circuit for a cardioverter/ defibπllator comprising power storage means connected to a power source, switching means for controlling the delivery of defibnllation pulse dierapy from the power storage means to a patient, and sensing means for sensing a patient's heart signal wherein interference with the sensing means is avoided by sequencing the switching means to remove residual voltage across the patient that results from the defibnllation pulse therapy
37 The electrical circuit of claim 36, wherein the cardioverter/defibrillator further comprises an implantable cardioverter/defibrillator
38 The electrical circuit of claim 37, wherein the cardioverter/defibrillator further comprises a subcutaneous implantable cardioverter/defibrillator
39 The electrical circuit of claim 36, wherein the power storage means further comprises at least one capacitor
40 The electrical circuit of claim 36, wherein the switching means is arranged in an H-bndge output circuit
41 The electrical circuit of claim 36, wherein the sensing means further comprises a differential amplifier
42 The electrical circuit of claim 36, wherein the sensing means further comprises at least one low pass filter
43 The electrical circuit of claim 36, wherein the sensing means further comprises at least one high pass filter
44 The electrical circuit of claim 36, wherein the sensing means further comprises digital means for controlling the sensing means
45 The electrical circuit of claim 36, wherein the switching means further comprises at least one SCR
46 The electrical circuit of claim 36, wherein the switching means further comprises at least one IGBT
47 The electrical circuit of claim 36, wherein the switching means further comprises at least one MOSFET
48 The electrical circuit of claim 36, wherein at least two switching means are shorted to remove residual voltage across the patient 49 A method for defϊbπllating a patient using an implantable cardioverter/defibrillator comprising the steps of sensing a heart signal, sequencing switches of an output circuit to deliver pulse therapy to the patient based on the sensing of the heart signal, after delivery of the pulse therapy to the patient, turning on at least two switches of the output circuit to discharge residual voltage across the patient that remains after delivery of the pulse therapy
50 The method of claim 49, wherein the step of sequencing switches of an output circuit to deliver pulse therapy to the patient further comprises delivering a defibnllation shock
51 The method of claim 49, wherein the step of sequencing switches of an output circuit to deliver pulse therapy to the patient further comprises delivering pacing energy
52 The method of claim 49, wherein the step of sequencing switches of an output circuit to deliver pulse therapy to the patient further comprises delivering biphasic pulses
53 The method of claim 49, wherein the step of sequencing switches of an output circuit to deliver pulse therapy to the patient further comprises delivering monophasic pulses
54 The method of claim 49, wherein the step of sequencing switches of an output circuit to deliver pulse therapy to the patient further comprises delivering multiphasic pulses
55 The method of claim 49, wherein the step of turning on at least two switches further comprises closing the at least two switches at the same time for a period of approximately 10 microseconds to a second
56 The method of claim 49 further comprising the step of continuing sensing of the heart signal after delivery of the pulse therapy
57 The method of claim 49 further comprising a subcutaneous implantable cardioverter/defibrillator 58 A method tor sensing a heart signal ot a patient and providing pulse therapy to the patient using a subcutaneous implantable cardioverter/defibrillator, the method comprising the steps of providing an output circuit having switching means coupled to electrodes proximate to a patient's heart, providing a sensing circuit coupled across the patient for monitoring the heart signal of the patient, sequencing the output circuit to deliver therapy pulses to the patient, and when the therapy pulses are completed, turning on a pair of switching means of the output circuit at the same time effectively shorting voltage across the electrodes and discharging residual voltage across the patient, thus avoiding interference with immediate recovery of the sensing circuit and thus allowing proper observation of the heart signal
59 The method of claim 58, wherein the step of providing an output circuit further comprises providing an H-bndge circuit
60 The method of claim 58, wherein the step of sequencing the output circuit to deliver therapy pulses to the patient further comprises delivering a defibnllation shock
61 The method of claim 58, wherein the step of sequencing the output circuit to deliver therapy pulses to the patient further comprises delivering pacing energy
62 The method of claim 58, wherein the step of sequencing the output circuit to deliver therapy pulses to the patient further comprises delivering biphasic pulses
63 The method of claim 58, wherein the step of sequencing the output circuit to deliver therapy pulses to the patient further comprises delivering monophasic pulses
64 The method of claim 58, wherein the step of sequencing the output circuit to deliver therapy pulses to the patient further comprises delivering multiphasic pulses
65 The method of claim 58, wherein the step of turning on a pair of switching means further comprises closing the pair of switching means at the same time for a period of approximately 10 microseconds to a second
66 The method of claim 58 further comprising the step of continuing sensing of the heart signal after delivery of the pulse therapy
PCT/IB2002/004514 2001-11-05 2002-10-28 H-bridge with sensing circuit for a cardioverter-defibrillator system WO2003039650A2 (en)

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