Angeion Corporation

Angelon Corporation

Charles U Smith

Mark W Kroll

Theodore P Adams

Kenneth M Anderson

A capacitor-discharge implantable cardioverter defibrillator (ICD) has a relatively smaller mass of less than about 120 grams. The smaller mass of the ICD is achieved by selecting and arranging the internal components of the ICD to deliver a maximum defibrillation countershock optimized in terms of a minimum physiologically effective current (I.sub.pe), rather than a minimum defibrillation threshold energy (DFT). As a result of the optimization in terms of a minimum effective current I.sub.pe, there is a significant decrease in the maximum electrical charge energy (E.sub.c) that must be stored by the capacitor of the ICD to less than about 30 Joules, even though a higher safety margin is provided for by the device. Due to this decrease in the maximum E.sub.c, as well as corollary decreases in the effective capacitance value required for the capacitor and the net energy storage required of the battery, the overall displacement volume of the ICD is reduced to the point where subcutaneous implantation of the device in the pectoral region of human patients is practical. The size of the capacitor is reduced because the effective capacitance required can be less than about 125 .mu.F. By optimizing both the charging time and the countershock duration for the smaller maximum E.sub.c, the size of the battery is reduced because the total energy storage capacity can be less than about 1.0 Amp-hours. In the preferred embodiment, the charging time for each defibrillation countershock is reduced to less than about 10 seconds and the pulse duration of the countershock is reduced to less than about 6 milliseconds.

Implantable cardioverter defibrillator having a smaller mass

A capacitor-discharge implantable cardioverter defibrillator (ICD) has a relatively smaller energy storage capacity of less than about 1.0 Amp-hours. The smaller energy storage capacity of the ICD is achieved by selecting and arranging the internal components of the ICD to deliver a maximum defibrillation countershock optimized in terms of a minimum physiologically effective current (I.sub.pe) rather than a minimum defibrillation threshold energy (DFT). As a result of the optimization in terms of a minimum effective current I.sub.pe, there is a significant decrease in the maximum electrical charge energy (E.sub.c) that must be stored by the capacitor of the ICD to less than about 30 Joules, even though a higher safety margin is provided for by the device. Due to this decrease in the maximum E.sub.c, as well as corollary decreases in the effective capacitance value required for the capacitor and the net energy storage required of the battery, the overall displacement volume of the ICD is reduced to the point where subcutaneous implantation of the device in the pectoral region of human patients is practical. The size of the capacitor is reduced because the effective capacitance required can be less than about 125 .mu.F. By optimizing both the charging time and the countershock duration for the smaller maximum E.sub.c, the size of the battery is reduced because the total energy storage capacity can be less than about 1.0 Amp-hours. In the preferred embodiment, the charging time for each defibrillation countershock is reduced to less than about 10 seconds and the pulse duration of the countershock is reduced to less than about 6 milliseconds.

Implantable cardioverter defibrillator having a smaller energy storage

A capacitor-discharge implantable cardioverter defibrillator (ICD) has a relatively longer device life of greater that 5 years. The longer life of the ICD is achieved by selecting and arranging the internal components of the ICD to deliver a maximum defibrillation countershock optimized in terms of a minimum physiologically effective current (I.sub.pe), rather than a minimum defibrillation threshold energy (DFT). As a result of the optimization in terms of a minimum effective current I.sub.pe, there is a significant decrease in the maximum electrical charge energy (E.sub.c) that must be stored by the capacitor of the ICD to less than about 30 Joules, even though a higher safety margin is provided for by the device. Due to this decrease in the maximum E.sub.c, as well as corollary decreases in the effective capacitance value required for the capacitor and the net energy storage required of the battery, the overall displacement volume of the ICD is reduced to the point where subcutaneous implantation of the device in the pectoral region of human patients is practical. The size of the capacitor is reduced because the effective capacitance required can be less than about 125 .mu.F. By optimizing both the charging time and the countershock duration for the smaller maximum E.sub.c, the size of the battery is reduced because the total energy storage capacity can be less than about 1.0 Amp-hours. In the preferred embodiment, the charging time for each defibrillation countershock is reduced to less than about 10 seconds and the pulse duration of the countershock is reduced to less than about 6 milliseconds.

Implantable cardioverter defibrillator having a smaller displacement

The model that is developed in the present invention is based upon the pioneering neurophysiological models of Lapicque and Weiss. The present model determines mathematically the optimum pulse duration, d.sub.p, for a truncated capacitor-discharge waveform employed for defibrillation. The model comprehends the system time constant, RC, where R is tissue resistance and C is the value of the capacitor being discharged, and also the chronaxie time, d.sub.c, defined by Lapicque, which is a characteristic time associated with the heart. The present model and analysis find the optimum pulse duration to be d.sub.p =(0.58)(RC+d.sub.c). Taking the best estimate of the chronaxie value from the literature to be 2.7 ms, permits one to rewrite the optimum pulse duration as d.sub.p =(0.58)RC+1.6 ms. The present invention makes use of the mathematical definition of optimum pulse duration by storing in the control circuitry of the defibrillation system the actual measured value of the particular capacitor incorporated in the system. The optimized-pulse prescription of this invention can be applied to a monophasic waveform, or to either or both of the phases of a biphasic waveform.

Optimal pulse defibrillator

The model that is developed in the invention is based upon the pioneering neurophysiological models of Lapicque and Weiss. The present model determines mathematically the optimum pulse duration, d.sub.p, for a truncated capacitor-discharge waveform employed for defibrillation. The model comprehends the system time constant, RC, where R is tissue resistance and C is the value of the capacitor being discharged, and also the chronaxie time, d.sub.c, defined by Lapicque, which is a characteristic time associated with the heart. The present model and analysis find the optimum pulse duration to be d.sub.p =(0.58)(RC+d.sub.c). Taking the best estimate of the chronaxie value from the literature to be 2.7 ms, permits one to rewrite the optimum pulse duration as d.sub.p =(0.58)RC+1.6 ms. The apparatus makes use of the mathematical definition of optimum pulse duration by storing in the control circuitry of the defibrillation system the actual measured value of the particular capacitor incorporated in the system. The optimized-pulse prescription of this invention can be applied to a monophasic waveform, or to either or both of the phases of a biphasic waveform.

Method for optimal pulse defibrillation using an implantable

A capacitor-discharge implantable cardioverter defibrillator (ICD) has a relatively smaller displacement volume of less than about 90 cc. The smaller volume of the ICD is achieved by selecting and arranging the internal components of the ICD to deliver a maximum defibrillation countershock optimized in terms of a minimum physiologically effective current (I.sub.pe), rather than a minimum defibrillation threshold energy (DFT). As a result of the optimization in terms of a minimum effective current I.sub.pe, there is a significant decrease in the maximum electrical charge energy (E.sub.c) that must be stored by the capacitor of the ICD to less than about 30 Joules, even though a higher safety margin is provided for by the device. Due to this decrease in the maximum E.sub.c, as well as corollary decreases in the effective capacitance value required for the capacitor and the net energy storage required of the battery, the overall displacement volume of the ICD is reduced to the point where subcutaneous implantation of the device in the pectoral region of human patients is practical. The size of the capacitor is reduced because the effective capacitance required can be less than about 125 .mu. F. By optimizing both the charging time and the countershock duration for the smaller maximum E.sub.c, the size of the battery is reduced because the total energy storage capacity can be less than about 1.0 Amp-hours. In the preferred embodiment, the charging time for each defibrillation countershock is reduced to less than about 10 seconds and the pulse duration of the countershock is reduced to less than about 6 milliseconds.

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Minnetonka, MN, United States of America

Charles U Smith