throbber
0090-6689/88/281-285/$02.00/0
`MEDICAL INSTRUMENTATION
`Copyright © 1988 by the Association for the Advancement of Medical Instrumentation
`
`Vol. 22. No. 6
`
`Comparison of Effectiveness of Relay-Switched,
`One-Cycle Quasisinusoidal Waveform with Critically
`Damped Sinusoid Waveform in Transthoracic
`Defibrillation of lOO-Kilogram Calves
`
`JOHN C. SCHUDER, PHD, WAYNE C. McDANIEL, PHD, HARRY STOECKLE, MD, AND
`DAN YERKOVICH
`
`Studies of 240 transthoracic fibrillation-defibrillation episodes in calves
`of 91—108 kg are reported. The waveform in 120 of the episodes was
`a one-cycle, quasisinusoidal waveform having peak currents of 64 and
`-32 A and half-cycle durations of 4 and 6 ms. The episodes were
`interlaced with 120 others involving critically damped sinusoid wave-
`forms having a 70.2-A peak current at 1.1 ms to peak. Applied after
`30 s of fibrillation, the biphasic shock (201 j of delivered energy) was
`successful on the initial attempt in 106 of 120 episodes (88%), and the
`uniphasic shock (206]) was successful in only 44 of 120 episodes (37%).
`The biphasic waveform, producible by a simple relay-armature shift
`in a passive circuit, yielded significantly better results (p <0.001) and
`should be evaluated clinically.
`
`'
`
`A general belief is that ventricular fibrillation in pa-
`tients with potential for survival can usually be reversed
`by electric shock from widely used defibrillators deliv-
`ering a uniphasic or near-uniphasic waveform. Interest
`in the development of improved devices continues, how-
`ever, partially because the patient load is so large.
`Experimental evidence indicates that 1) both sym-
`metric and asymmetric biphasic rectangular waveforms
`are
`superior
`to
`uniphasic
`rectangular wave-
`forms“; 2) both symmetric and asymmetric biphasic,
`truncated exponential waveforms are superior to uni-
`phasic, truncated exponential waveforms”; and 3) a va-
`riety of biphasic waveforms considerably out perform the
`critically damped, uniphasic shock in transthoracic de—
`fibrillation in the 100—kg-calf model.7 Uniphasic or near-
`uniphasic defibrillators continue to be dominant in the
`clinical environment.
`‘
`
`In this article, we use a circuit having the topology
`described by Negovsky et al.8 that can deliverbiphasic
`waveforms reasonably close to the asymmetric biphasic
`waveforms we have found to be so successful. The wave—
`
`form can be generated by a relay—armature shift in a
`passive circuit instead of with high-current electronic
`devices such as silicon—controlled rectifiers (SCRs).
`
`From the Departments of Surgery and Child Health, University of
`Missouri, Columbia, Missouri and Physio Control Corporation, Red-
`mond, Washington.
`Address correspondence and reprint requests to Dr. John C. Schu-
`der, Department of Surgery. University of Missouri, Columbia, MO
`65212.
`
`281
`
`METHODS
`
`Apparatus
`
`The defibrillator used in this research is a modified
`
`version of one that can provide ultrahigh-energy, uni-
`phasic/biphasic,
`rectangular/truncated exponential
`waveforms. That defibrillator, previously described,9 uses
`hydrogen thyratron/SCR switching. The modifications
`involved replacing two of three electronically controlled
`pulse generators with electromechanical relays and pas-
`sive circuits for generating the waveforms to be tested.
`The operator could easily select the fibrillatory shock,
`the critically damped uniphasic waveform,
`the quasi-
`sinusoidal biphasic waveform, or an electronically gen-
`erated uniphasic rectangular backup waveform of almost
`any desired pulse width or pulse amplitude by front—
`panel controls.
`Circuits used in generating the quasisinusoidal bi-
`phasic and critically damped uniphasic waveforms are
`shown in Figures 1 and 2, respectively. In both circuits,
`the calf chest resistance (average value of some 20 Q with
`the 13-cm diameter electrodes employed) was trimmed
`with a variable resistance in such a way that the combined
`trimmer and calf resistance remained substantially in-
`variant at 25 Q from animal to animal and from episode
`to episode, thus permitting any shifts in delivered energy
`attributable to changes in electrode-skin interface re—
`sistance to be absorbed in the interface region rather
`than in the regions of both the heart and the interface.
`The component values and initial voltage on the ca-
`pacitor used in the circuit of Figure 1 were derived by
`one of us (D.Y.) so as to (a) yield a current waveform
`similar to a biphasic rectangular waveform that had been
`found to be effective in an earlier study,3 (b) be practical,
`component—wise,
`to scale and implement in apparatus
`designed for use on humans, (c) be appropriately scaled
`for use with the 20-0 resistance presented by the chest
`of the calf, and (d) deliver about 200 ] to the subject.
`The waveform of current, as shown in Figure 3, had a
`maximum amplitude of 64 A and a minimum amplitude
`of —32 A; the half-cycle durations were approximately
`
`L|FECOR454-1014
`
`1
`
`LIFECOR454-1014
`
`

`

`282
`
`MEDICAL INSTRUMENTATION
`
`Volume 22, No. 6, December 1988
`
`RELAY
`
`l-_————— -—— ..
`
`20 mH
`
`TRIMMER
`
`
`
`FROM
`
`CHARGING
`
`CIRCUIT
`
`
`
`
`
`
`E NERGY STORAGE CAPACITOR
`
`
`CHEST
`
`Figure 1. Circuit for generating biphasic waveform.
`
`4—6 ms, respectively. That this waveform will deliver 200
`] to a 20-!) chest can be demonstrated easily by graphic
`integration of the corresponding current-squared curve,
`and multiplication by 20 Q.
`The component values and initial capacitor voltage of
`the circuit of Figure 2 were derived so as to deliver some
`200 ] to a 20-0 chest; the critically damped sinusoid
`would peak at 70.2 A in 1.1 ms, as shown in Figure 4.
`That this waveform will deliver 200 I to a 20—0 chest
`follows analytically from a simple manipulation of the
`current equation for critically damped waveforms using
`the specified values of peak current and time required
`to reach the peak current. In both circuits, the resistance
`shown in series with the inductive element was primarily
`that of the inductor.
`
`A double-throw, electromechanical relay was used in
`the circuit of Figure l to prevent shunting by the charg-
`ing circuit, which would occur when the storage capacitor
`reversed its polarity during discharge. Because polarity
`reversal does not occur in the circuit shown in Figure
`2, a single—throw relay was adequate.
`The initial polarity of the capacitors differs in the two
`circuits, but this is compensated by the connections to
`the chest electrodes—with the result that in both the
`
`uniphasic shock and in the leading portion of the biphasic
`shock, the lower left electrode was positive with respect
`to the upper right electrode on the chest.
`
`Procedure
`
`Anesthesia was induced with 110 mg of glyceryl guia-
`colate/kg and 4.4 mg of thiopental sodium/kg injected
`
`2
`
`intravenously. The calf was intubated and then main-
`tained in anesthesia with methoxyflurane in 50% N20
`and 50% Oz. Fibrillation was induced with a 1—s, 60-Hz,
`lOO—V (rms) shock applied through the chest electrodes;
`after 30 s, one of the two waveforms being studied was
`applied.
`If defibrillation was accomplished on the first attempt,
`the episode was recorded as a success, and the lead II
`electrocardiogram was observed on an oscilloscope and
`recorded for 21/2 min. Otherwise, the episode was re—
`corded as a failure, and a shock of known high effective-
`ness was used to salvage the animal. With not less than
`3 min between the start of successive episodes, the pro—
`cedure was repeated—but with the other waveform being
`evaluated.
`In a given session, animals were carried
`through not more than 20 episodes (10 episodes involving
`one of the waveforms interlaced with 10 involving the
`other). The waveforms of both current and voltage of the
`shocks being studied were observed on a dual-beam stor-
`age oscilloscope (model 5113, Tektronix, Beaverton, Or-
`egon). The chest resistance associated with each biphasic
`shock was calculated as the mean of the voltage-to-cur-
`rent ratios at the positive and negative peaks. The chest
`resistance to each uniphasic shock was calculated as the
`ratio of the peak voltage to peak current. For both wave-
`forms, and to the extent that the current waveforms were
`
`maintained invariant, the actual delivered energy in joules
`in any episode was given by the calculated resistance for
`the episode divided by 20 and multiplied by 200. The
`mean delivered energy was calculated from the mean
`resistance by the same procedure.
`In addition to the alternating of the waveforms being
`
`2
`
`

`

`WAVEFORM COMPARISON (Schuder et 3/.)
`
`283
`
`TRIMMER
`
`
`
`
`FROM
`
`CHARGING
`
`CIRCUIT
`
`TIME IN MILLISECONDS
`
`64
`
`32
`
`l
`
`I
`
`\
`
`\?
`
`8
`
`I2
`
`
`
`
`
`Figure 3. Quasisinusoidal biphasic waveform.
`
`evaluated in successive episodes as described above, the
`initial episode in animals as they were successively en—
`tered into the study alternated between the two wave-
`forms. With no animal being carried through more than
`20 episodes with a particular waveform (nor more than
`40 episodes in total),
`the sessions were ordinarily re-
`peated with at least one day between sessions. A total
`of 7 calves of 91—108 kg were used in the 240—episode
`study.
`
`3
`
`RESULTS
`
`In 120 episodes with each waveform, our study yielded
`chest resistances of20. 1 i- 3.5 0 (mean : SD) with the
`biphasic waveform and 20.6 i 3.1 Q with the uniphasic
`one. The biphasic shock generated by the circuit of Fig—
`ure 1 and sketched in Figure 3 was successful in 106 of
`120 episodes (88%) at an average delivered energy of 201
`J. The uniphasic shock generated by the circuit of Figure
`
`3
`
`

`

`284
`
`0CURRENTINAMPERES O)
`
`MEDICAL INSTRUMENTATION
`
`Volume 22, No. 6, December 1988
`
`
`
`TIME IN MILLISECONDS
`
`Flgure 4. Critically damped uniphasic waveform.
`
`2 and shown in Figure 4 yielded 44 successes in 120
`episodes (37%) at an average delivered energy of 206 J.
`The difference is large, and an unpaired x2 test shows it
`is significant (p < 0.001).
`In terms of the electrocardiographic findings, 28 :t
`1.1 5 (mean : SD) were required for the appearance of
`the first ventricular complex following a successful bi-
`phasic shock, and 6.8 t 4.2 s were required after a
`successful uniphasic shock. An unpaired Student's t test
`showed that this difference is significant (p < 0.05). Sim-
`ilarly, 4.3 t 2.8 s were needed for the return of normal
`sinus rhythm after the biphasic shock, compared with
`12.0 1- 6.8 s after the uniphasic shock (p < 0.05). Thus,
`the electrocardiographic disturbances caused by suc-
`cessful shocks were significantly less severe with biphasic
`than with uniphasic waveforms.
`
`bination of the diode and 135-0 resistor. For example,
`with essentially the same delivered energy, the stored
`energy is 2.73 times as large in the biphasic circuit of
`Figure 1 as in the uniphasic circuit of Figure 2. We
`anticipate that the efficiency of the circuit of Figure 1
`would also compare poorly with that of a defibrillator
`circuit using SCRs or similar switches in providing bi-
`phasic defibrillation.
`
`CONCLUSION
`
`The significantly better defibrillation results in calves
`with the relay-generated biphasic waveform of Figure 1
`compared with the uniphasic waveform of Figure 2 sup-
`port the conclusion that clinical trials should be per-
`formed to see if the results from the calf model translate
`
`DISCUSSION
`
`to human patients.
`
`The results of this study are seen as further confir-
`mation of what seems to be a general superiority of hi-
`phasic over uniphasic waveforms in the defibrillation of
`calves. A series of studies in cultured chicken-embryo
`myocardial cells by Iones et al.“Hz have furnished some
`hypotheses for the superiority of biphasic shocks and can
`be broadly interpreted as compatible with our previous
`results with a biphasic waveform applied to calves, thus
`suggesting that the findings in calves may extend to other
`spec1es.
`
`Although the simplicity of relay switching for gener-
`ating biphasic waveforms may be attractive in many ap-
`plications, a shortcoming of the biphasic circuit of Figure
`1 is the power loss and consequent loss of efiiciency
`associated with the shunt consisting of the series com-
`
`This work was supported by a grant from the Physio Control
`Corporation and was presented in part at the 23rd Annual
`Meeting of the Association for the Advancement of Medical
`Instrumentation, Washington, DC, May 14—18, 1988.
`
`REFERENCES
`
`1. Gold JH, Schuder JC, Stoeckle H, Granberg TA, Hamdani SZ:
`Transthoracic ventricular defibrillation in the 100 kg calf with
`unidirectional rectangular pulses. Circulation 56: 745—750. 1977
`2. Schuder JC. Gold JH, Stoeckle H, McDaniel WC, Cheung KN:
`Transthoracic ventricular defibrillation in the 100 kg calf with
`symmetrical one-cycle bidirectional rectangular wave stilmuli.
`IEEE Trans Biomed Eng 30: 415—422, 1983
`3. Schuder JC, McDaniel WC, Stoeckle H: Defibrillation of 100 kg
`claves with asymmetrical, bidirectional rectangular pulses.
`Cardiovasc Res 18: 419—426, 1984
`4 4. Schuder JC. Gold JH, Stoeckle H, Granberg TA, Dettmer JC,
`
`4
`
`

`

`WAVEFOFIM COMPARISON (Schuder et al.)
`
`285
`
`Larwill MH: Transthoracic ventricular defibrillation in the 100
`kg calf with untruncated and truncated exponential stimuli.
`lEEE Trans Biomed Eng 27: 37—43, 1980
`5. Schuder JC, McDaniel WC. Stoeckle H: Transthoracic defibril-
`lation of 100 kg calves with bidirectional tmncated exponential
`shocks. Trans Am Soc Artif Intern Organs 30: 520—525, 1984
`6. Schuder JC, McDaniel WC, Stoeckle H: Bidirectional truncated
`exponential shocks of extended current range in the trans-
`thoracic defibrillation of 100 kg calves. Am Soc Artif Intern
`Organs Abstracts 15: 76. 1986
`7. Schuder JC. McDaniel WC, Stoeckle H: Transthoracic ventric-
`ular defibrillation of 100 kilogram calves with critically damped
`sinusoidal shocks. Proceedings of the Association for the Ad-
`vancement of Medical Instrumentation, 21 st Annual Meeting,
`p 67, 1986
`
`8. Negovsky VA, Smerdov AA. Tabak VY, Venin IV. Bogushevich
`MS: Criteria of efficiency and safety of the defibrillating im-
`pulse. Resuscitation 8: 53—67, 1980
`9. SchuderJC. Gold JH, McDaniel WC: Ultrahigh-energy hydrogen
`thyratron/SCFl bidirectional waveform defibrillator. Med Biol
`Eng Comput 20: 419—424. 1982
`10. Jones JL, Jones FtE: Improved defibrillator waveform safety fac-
`tor with biphasic waveforms. Am J Physiol 245: H60—H65,
`1983
`11. Jones JL, Jones RE: Decreased defibrillator-induced dysfunction
`with biphasic rectangular waveforms. Am J Physiol 247: H792—
`H796, 1984
`12. Jones JL, Jones RE, Balasky G: Improved cardiac cell excitation
`with symmetrical biphasic defibrillator waveforms. Am J Phys-
`iol 253: H1418—H1424. 1987
`
`5
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket