`
`[19]
`
`[11] Patent Number:
`
`4,850,357
`
`Bach, Jr.
`
`[45] Date of Patent:
`
`Jul. 25, 1989
`
`[54] BIPHASIC PULSE GENERATOR FOR AN
`IMPLANTABLE DEFIBRILLATOR
`
`[75]
`
`Inventor:
`
`Stanley M. Bach, Jr., Shoreview,
`Minn.
`
`[73] Assignee: Cardiac Pacemakers, Inc., St. Paul,
`Minn.
`
`[21] Appl. No.: 146,061
`[22] Filed:
`Jan. 12, 1988
`[51]
`Int. Cl.4 ............................................... A61N 1/00
`
` [52] US. Cl. ................ 128/419 D
`[58] Field of Search ............ 128/419 D, 419 PG, 421.
`128/696; 307/106
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`3,206,313 12/1972 Milani et al.
`................... 128/419 D
`.. 128/419 D
`3,241,555 3/1966 Caywood et al.
`.. 128/419 D
`4,440,172 4/1984 Langer .....
`.. 128/419 D
`4,504,773
`3/1985 Suzuki et all .
`.. 128/419 D
`
`
`4,637,397
`....... 128/419 D
`1/1987 Bach, Jr.
`OTHER PUBLICATIONS
`
`3,359,984 12/1967 Daniher
`
`Dahlback, O. et 31., “Venticular Defibrillation with
`Square—Waves”, Letters to the Editor, The Lancet, vol.
`2, pp. 50—51, Jul. 2, 1966.
`Schuder, John C. et al., “Transthoracic Ventricular
`Defibrillation with Square—Wave Stimuli: One—Half
`
`Cycle, One Cycle, and Multi—Cycle Waveforms”, Cir-
`culation Research, vol. NV, pp. 258—264, Sep. 1964.
`Jones, Janice L. et al., “Decreased Defilbrillator—In-
`duced Dysfunction with Biphasic Rectangular Wave-
`forms”, Am. J. Physiology, 247 (5 Pt. 2), pp. H792—796,
`Nov. 1984.
`
`Primary Examiner—Francis Jaworski
`Assistant Examiner—~George Manuel
`Attorney, Agent, or Firm—Fleit, Jacobson, Cohn, Price,
`Holman & Stern
`
`ABSTRACT
`[57]
`A circuit for generating a biphasic voltage pulse to
`restore rhythm to a fibrillating heart, the circuit utiliz-
`ing a capacitor for providing the voltage pulse, The
`circuit further comprises first and second thyristors to
`regulate the voltage and first and second electrodes to
`apply the regulated voltage to the fibrillating heart. The
`circuit further comprises an output sensing circuit that
`senses the exponential decay of the capacitor and sig-
`nals a control circuit to switch the thyristors such that
`after one thyristor applies the voltage pulse to the heart
`in a first polarity, the other thyristor applies the voltage
`pulse in the opposite polarity. Therefore, substantially
`all energy in the capacitor is provided to the heart.
`
`6 Claims, 2 Drawing Sheets
`
`
`
`L|FECOR905-1005
`
`1
`
`LIFECOR905-1005
`
`
`
`US. Patent
`
`Jul. 25, 1989
`
`Sheet 1 of 2
`
`4,850,357
`
`
`
`
`
`FIG. 2
`
`34
`
`'
`
`S CR
`
`Thyris’tor
`
`S C R
`
`Thyris’ror
`
`B. Electronic
`
`A- Electronic
`
`32
`
`
`
`20
`
`22
`
`
`
`
`
`
`
`
`
`I4
`
`<13:
`Drive
`
`Control
`Circuit
`
`16
`
`2
`
`
`
`
`
`
`
`
`
`
`
`US. Patent
`
`Jul. 25, 1989
`
`Sheet 2 of 2
`
`4,850,357
`
`
`
`
`
`
`
`
`
`3
`
`
`
`1
`
`BIPHASIC PULSE GENERATOR FOR AN
`IMPLANTABLE DEFIBRILLATOR
`
`BACKGROUND OF THE INVENTION
`
`5
`
`The present invention relates, generally, to the field
`of automatic implantable defibrillators. In such implant-
`able defibrillators, the defibrillation pulse is stored and
`delivered by a high voltage capacitor; this capacitor is 10
`short circuited in order to terminate the defibrillation
`pulse.
`A majority of defibrillators, found in the prior art, are
`short circuiting the charged capacitor which is a waste
`of energy. This energy could easily be applied to the 15
`fibrillating heart. Also, by short circuiting the charged
`capacitor, a significant amount of electrical stress is
`absorbed through the electronic parts of the defibrilla-
`tor circuit. This electrical stress shortens the life of
`these parts.
`One attempt to use the wasted energy of the capaci-
`tor is by using triphasic wave defibrillation. U.S. Pat.
`No. 4,637,397 to Jones et a1 discloses a defibrillator that
`uses a first conditioning pulse, followed by a second
`pulse of opposite polarity used for defibrillating, and 25
`finally a third pulse having the same polarization as the
`first pulse.
`The following description discloses a biphasic pulse
`generator for an implantable defibrillator which uses
`only two pulses to deliver more energy stored in the 30
`charged capacitor to the fibrillating heart and thus,
`lowering defibrillation energy requirements.
`SUMMARY OF THE INVENTION
`
`20
`
`The present invention eliminates the need to short
`circuit the high voltage capacitor. Thus, the stress on
`electronic parts is reduced. Additionally, the energy in
`the high voltage capacitor that was previously wasted is
`provided to the heart in the reverse direction, thereby
`reducing overall defibrillation energy requirements.
`An object of the present invention is to provide a
`pulse generation in which a silicon controlled rectifier
`thyristor is turned off by means of an insulated gate
`transistor.
`Another object of the invention is to allow a “steer-
`ing” of the high voltage side of a charged capacitor to
`one of two electrodes while steering the low voltage
`side to the other electrode.
`
`35
`
`45
`
`55
`
`A further object of the invention is to utilize a low 50
`“on” impedance electronic switch which in the pre-
`ferred embodiment is an insulated gate transistor.
`Another object of the invention is to protect the
`limited reverse voltage handling capability of an insu-
`lated gate transistor with'a diode.
`A feature of the invention is that the low “on” impe-
`dance high voltage electronic switch is positioned in a
`low Potential gate drive circuit which obviates the use
`of large transformers or optical isolators in the circuit.
`An advantage of the invention is that since the short- (,0
`ing of the high voltage capacitor has been eliminated,
`the stress on the electronic parts is reduced.
`These, together with other objects and advantages
`which will become subsequently apparent, reside in the
`details of construction and operation as more fully here- 65
`inafter described and claimed, reference being had to
`the accompanying drawings forming a part hereof,
`wherein like numbers refer to like parts throughout.
`
`4,850,357
`
`2
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 shows a biphasic defibrillation pulse from a
`single capacitor as delivered from a circuit forming a
`part of the present invention;
`FIG. 2 shows a block diagram of the circuit of the
`present invention; and
`FIG. 3 shows a schematic drawing of the circuit of
`the present invention.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`Referring to the figures, the circuit of the present
`invention is designed to deliver a biphasic defibrillation
`pulse from a single capacitor as shown in FIG. 1. The
`voltage at peak 1, or Vpkl, is equal to 25 to 1000 volts
`delivered to the heart. After reaching Vpkl, the voltage
`will exponentially decay until an SCR thyristor is
`turned off and the high voltage side of the charged
`capacitor is steered to the other electrode. Now, Vpk2
`is delivered to the heart in the reverse direction and is
`equal to 50 to 95% of Vpkl. Thus, the short circuiting
`of the high voltage capacitor is eliminated.
`FIG. 2 shows the biphasic pulse generator block
`diagram. Control circuit 16 is a simple Four State Se-
`quencer specifically designed to provide wait 1, phase 1,
`wait 2, and phase 2 states by monitoring the capacitor
`voltage and providing timed stimulation to the elec-
`tronic switches via circuits 20 and 22. When drive cir-
`cuit 20 is set high, the electronic switch 30 is allowed to
`conduct and thyristor 34 is turned on from drive circuit
`20. At this point, the charge stored across capacitor 40
`is delivered to the heart across electrodes 10 and 12 in a
`first polarity. After a short period of time, sensed by
`circuit 14, drive circuit 20 is forced low turning off
`electronic switch 30 and SCR 34. After a short delay,
`less than 500 microseconds generally indicated by nu-
`meral 15, drive circuit 22 is set high turning on elec—
`tronic switch 32 and SCR 36 thus, providing an oppo-
`site current through the heart. After another period of
`time sensed by circuit 14, the electronic switch 32 is
`turned off which turns off SCR 36.
`In other words, the electronic switch 30 conducts to
`steer the low voltage side of the main storage capacitor
`40 to electrode 12 while the high side is connected to
`electrode 10. Electronic switch 32 conducts to steer the
`low voltage side of the main storage capacitor 40 to
`electrode 10 while the high side is connected to elec-
`trode 12.
`The SCR thyristor 34, when switched “on”, provides
`the high voltage to electrode 10. The SCR thyristor 36,
`when switched “on”, provides the high voltage to elec-
`trode 12.
`Output sense circuit 14 monitors the output to elec-
`trode 10. When the output voltage at electrode 10 falls
`to a suitable low level, the output sense circuit 14 will
`signal the control circuit 16, which then forces drive
`circuit 20 to a low. This shuts off electronic switch 30
`and, therefore, SCR thyristor 34. When the output volt-
`age to electrode 10 falls still further, the output sense
`circuit 14 signals the control circuit 16. This forces
`drive circuit 22 to be switched to a low, which shuts off
`electronic switch 32 and, therefore, the SCR thyristor
`36.
`The high voltage isolation transformers 24 and 26 are
`used to isolate the SCR system drive circuits and pre-
`vent the transmission of undesired currents to them.
`Also, the high voltage isolation transformers are used to
`
`4
`
`
`
`3
`separate one section of the system from undesired influ-
`ences of the other sections.
`Referring to the detailed schematic shown in FIG. 3,
`the operation of the system is as follows. The drive
`circuit 20 is set high (about 10 volts) which allows the
`electronic switch 30 shown as an insulated gate transis-
`tor Q4 to conduct when the silicon controlled rectifier
`Q5, thyristor 34, is turned on from the drive circuit 20.
`There is a 20 microsecond delay through the network
`preceding the Schmidt trigger circuits 1C1 and 1C2 to
`allow switch 30 to be completely on before thyristor 34
`is fired. This results in the high voltage side of the main
`storage capacitor 40 being switched to electrode 10
`while the low side is connected to electrode 12. Now
`the high voltage Vpkl is delivered to the heart.
`When the output voltage falls to a suitable low level,
`the drive circuit 20 is set low, turning off electronic
`switch 30 as shown as an insulated gate transistor Q4
`and, therefore, the SCR thyristor 34.
`Next, after a 500 microsecond delay and drive circuit
`20 has gone low, drive circuit 22 is switched to a high
`(i.e., approximately 10 volts). This allows electronic
`switch 32 shown as an insulated gate transistor Q3 to be
`operational and silicon controlled rectifier thyristor 36
`is fired by its nominal 20 microsecond delay circuit
`(103—4 and network). The delay is again necessary to
`allow switch 32 to be fully on before SCR 36 is fired.
`The Schmidt trigger circuits 1C3 and 1C4 are for squar-
`ing the pulses for good logic operations. The process
`steers the high voltage side of capacitor 40 to electrode
`12 and the low voltage side of capacitor 40 to electrode
`10. Therefore, the voltage to the load is reversed and
`the high voltage Vpk2 is delivered to the heart.
`As soon as the voltage falls to another low level,
`drive circuit 22 will be forced to a low and shut off
`electronic switch 32 shown as an insulated gate transis-
`tor Q3. Therefore, the SCR Q6 thyristor 36 will also be
`off.
`Drive circuit 20 and drive circuit 22 are derived from
`a simple electronic sequence circuit which incorporates
`a chip such as the 14017B manufactured by Motorola.
`These circuits are also used to monitor the main capaci-
`tor voltage.
`The foregoing is considered as illustrative only of the
`principles of the invention. Further, since numerous
`modifications and changes will readily occur to those
`skilled in the art, it is not desired to limit the invention
`to the exact construction and operation shown and
`described, and accordingly, all suitable modifications
`and equivalencies may be resorted to, falling within the
`scope of the invention. One such modification is that the
`electronic switches 32 and 30 shown in FIG. 3 as insu-
`lated gate transistors, could also be power field effect
`transistors or high voltage bipolar transistors. The block
`diagram emphasizes the generalities by illustrating the
`central idea of the circuit without reference to specific
`circuit elements. It is, therefore, the intent that the pres-
`ent invention not be limited to the above but be limited
`only as defined in the appended claims.
`What is claimed:
`1. A circuit for generating a biphasic pulse to restore
`rhythm to a fibrillating heart, said circuit comprising:
`capacitor means for providing a voltage to restore
`rhythm to a fibrillating heart;
`thyristor means, connected to said capacitor means,
`for regulating said voltage and providing a regu-
`lated voltage;
`first electrode means, connected to said thyristor
`means, for receiving and applying said regulated
`voltage to said fibrillating heart;
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`4,850,357
`
`4
`second electrode means, connected to said thyristor
`means, for receiving and applying said regulated
`voltage to said fibrillating heart;
`output sensing means, connected to said thyristor
`means and one of said electrode means, for sensing
`an exponential decay of said regulated voltage and
`providing a sensed signal corresponding to said
`sensed exponential decay; and
`control circuit means, connected to said output sens-
`ing means, for controlling said thyristor means for
`delivering said regulated voltage in a first polarity
`and subsequently in a second polarity opposite said
`first polarity to said fibrillating heart via said first
`and second electrode means.
`2. A circuit for generating a biphasic pulse to restore
`rhythm to a fibrillating heart, said circuit comprising:
`capacitor means for providing a voltage to restore
`rhythm to a fibrillating heart, said capacitor means
`having first and second terminals;
`first and second thyristor means, both connected to
`said first terminal of said capacitor means, for regu-
`lating said voltage and providing a regulated volt-
`age;
`first electrode means, connected to said first thyristor
`means, for receiving and applying said regulated
`voltage to said fibrillating heart;
`second electrode means, connected to said second
`thyristor means, for receiving and applying said
`regulated voltage to said fibrillating heart;
`output sensing means, connected to said first thyristor
`means and said first electrode means, for sensing an
`exponential decay of said regulated voltage and
`providing a sensed signal corresponding to said
`sensed exponential decay; and
`control circuit means, connected to said output sens-
`ing means, for controlling which of said first and
`second thyristor means is on such that when said
`first thyristor is on, current flows through said
`capacitor means for delivering said regulated volt-
`age to the heart in a first polarity via said first and
`second electrode means, and when said second
`thyristor is on, current flows through said capaci-
`tor means for delivering said regulated voltage to
`the heart in a second polarity opposite said first
`polarity via said first and second electrode means,
`to restore rhythm to said fibrillating heart
`3 The circuit of claim 2, and further comprising:
`first and second drive circuits, connected to said con-
`trol circuit, said first drive circuit for driving said
`first thyristor means and said second drive circuit
`for driving said second thyristor means.
`4. The circuit of claim 3, and further comprising:
`a first electronic switch connected to said first drive
`circuit, said second electrode means, said first thy-
`ristor means, and said second terminal of said ca-
`pacitor means, for forming a first circuit such that
`said first circuit delivers said voltage to said fibril-
`lating heart; and
`a second electronic switch connected to said second
`drive circuit, said first electrode means, said second
`thyristor means, and said second terminal of said
`capacitor means, for forming a second circuit such
`that said second circuit delivers said voltage to said
`fibrillating heart.
`5. The circuit of claim 2, and further comprising a
`capacitor discharge means for discharging said capaci-
`tor means, and wherein said capacitor means charges to
`a high voltage and then discharges to a low voltage.
`6. The circuit of claim 2, wherein said first and second
`thyristor means further comprise first and second high
`voltage isolation transformer for isolating said first and
`second thyristor means.
`i
`it
`lk
`1k
`*
`
`5
`
`