Source: http://www.google.com/patents/US6560484?dq=6377161
Timestamp: 2014-09-22 16:17:47
Document Index: 563439268

Matched Legal Cases: ['Application No. 540266', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40']

Patent US6560484 - Method and apparatus for electrically forcing cardiac output in an ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsAn electrical method and apparatus for stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation, hemodynamically compromising tachycardia, or asystole. Forcing fields are applied to the heart to give cardiac output on an emergency basis until the arrhythmia ceases...http://www.google.com/patents/US6560484?utm_source=gb-gplus-sharePatent US6560484 - Method and apparatus for electrically forcing cardiac output in an arrhythmia patientAdvanced Patent SearchPublication numberUS6560484 B1Publication typeGrantApplication numberUS 09/693,455Publication dateMay 6, 2003Filing dateOct 20, 2000Priority dateMay 31, 1994Fee statusPaidAlso published asUS6185457, US7706864, US20040044373, WO2000057955A1Publication number09693455, 693455, US 6560484 B1, US 6560484B1, US-B1-6560484, US6560484 B1, US6560484B1InventorsKai Kroll, Mark W. KrollOriginal AssigneeGalvani, Ltd.Export CitationBiBTeX, EndNote, RefManPatent Citations (29), Non-Patent Citations (18), Referenced by (3), Classifications (14), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetMethod and apparatus for electrically forcing cardiac output in an arrhythmia patientUS 6560484 B1Abstract An electrical method and apparatus for stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation, hemodynamically compromising tachycardia, or asystole. Forcing fields are applied to the heart to give cardiac output on an emergency basis until the arrhythmia ceases or other intervention takes place. The device is used as a stand alone external or internal device, or as a backup to an ICD, atrial defibrillator, or an anti-tachycardia pacemaker. The method and apparatus maintain some cardiac output and not necessarily defibrillation.
What is claimed is: 1. A method for forcing cardiac output during cardiac malfunction in a patient, comprising the steps of:
(a) attaching a plurality of electrodes to external portions of a patient's body proximate the patient's thoracic region so that the electrodes may deliver electrical pulses which will be transmitted through portions of the patient's upper body; (b) detecting the presence of cardiac malfunction in the patient; and (c) delivering electrical current pulses through the patient's body, via said electrodes after detecting the malfunction, at a rate between about 60 and 200 pulses per minute, said electrical current pulses having a voltage less than a normal defibrillation voltage level and more than a normal pacemaker voltage level, to force contraction in the patient's heart and facilitate a minimum level of cardiac output until cessation of the cardiac malfunction or until other medical intervention is provided. 2. The method of claim 1, further comprising the steps of reassessing the presence of a malfunction at predetermined intervals and terminating said delivery of electrical pulses if the malfunction is no longer present.
3. The method of claim 1, wherein each electrical current pulse has a voltage of less than 700 volts.
4. The method of claim 1, further comprising the steps of monitoring cardiac output and adjusting said electrical current pulse with respect to amplitude to maintain a predetermined level of cardiac output, thereby conserving electrical energy.
5. The method of claim 1, wherein a plurality of said electrical current pulses have rounded edges.
6. The method of claim 1 further comprising the step of forming a plurality of said electrical Current pulses as a train of at least about 10 narrow pulses.
7. The method of claim 1 further comprising the step of delivering a defibrillation shock after the steps of claim 1 are performed.
8. The method of claim 1, further comprising the step of delivering a defibrillation shock between step b and step c of claim 1.
9. The method of claim 1, wherein said electrical current pulses are composed of numerous smaller pulses.
10. A method for forcing cardiac output during cardiac malfunction in a patient, comprising the steps of:
(a) attaching a plurality of electrodes to external portions of a patient's body proximate the patient's thoracic region so that the electrodes may deliver electrical pulses which will be transmitted through portions of the patient's upper body; (b) providing circuitry for detecting the presence of cardiac malfunction in the patient; (c) detecting the presence of cardiac malfunction in the patient, using the circuitry for detecting the presence of cardiac malfunction; and (d) delivering electrical current pulses through the patient's body, via said electrodes after detecting tachyarrhythmia, at a rate between about 60 and 200 pulses per minute, said electrical current pulses having a voltage less than a normal defibrillation voltage level and more than a normal pacemaker voltage level, to force contractions in the patient's thoracic region and facilitate a minimum level of cardiac output until cessation of the cardiac malfunction or until other medical intervention is provided; and (e) reassessing the presence of the malfunction at predetermined intervals and terminating said delivery of electrical pulses if the arrhythmia is no longer present. 11. The method of claim 10, further comprising the steps of providing additional circuitry to perform defibrillation and performing defibrillation.
12. The method of claim 10, wherein the step of delivering electrical current pulses produces a cardiac output of between about 10% and about 90% of the normal maximum cardiac output for the patient.
13. The method of claim 10, wherein the step of delivering electrical current pulses produces a cardiac output of between about 20% and about 80% of the normal maximum cardiac output for the patient.
14. The method of claim 10 wherein the step of delivering electrical current pulsesproduces a cardiac output of greater than about 30% of the normal maximum cardiac output for the patient.
15. The method of claim 10, wherein the step of delivering electrical current pulses comprises delivering electrical current pulses greater than about 250 mA.
This application is a continuation of, commonly assigned patent application entitled Method and apparatus for electrically forcing cardiac output in an arrhythmia patient, Ser. No. 09/277,311, filed on Mar. 26, 1999, now U.S. Pat. No. 6,185,457, issued Feb. 6, 2001, which is in turn a continuation-in-part application of Ser. No. 08/754,712, filed on Dec. 6, 1996, now U.S. Pat. No. 5,978,703, issued Nov. 2, 1999. which is a continuation application of Ser. No. 08/543,001, filed Oct. 13, 1995, now abandoned, which is in turn a FWC of application Ser. No. 08/251,349, filed May 31, 1994, now abandoned.
An ICD includes an electrical pulse generator and an arrhythmia detection circuit coupled to the heart by a series of two or more electrodes implanted in the body. A battery power supply, and one or more charge storage capacitors are used for delivering defibrillation shocks in the form of electrical current pulses to the heart. These devices try to restore normal rhythm from the fibrillation. While it works well at restoring normal function, the ICD is large in size and not practical for a truly prophylactic, device. A small device capable of maintaining minimal cardiac output, in high risk patients, prior to admission into an emergency room is needed.
SUMMARY OF THE INVENTION The invention provides an electrial method of stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation, hemodynamically compromising tachycardia, or asystole. Forcing fields are applied to the heart to give cardiac output on an emergency basis until the arrhythmia ceases or other intervention takes place. The device is usable as a stand alone external or internal device or as a backup to an ICD, atrial defibrillator, or an anti-tachycardia pacemaker.
Insofar as is known, no prior attempts have been made at forcing pulses during any type of fibrillation. Some workers in the field have experimented for research purposes with local pacing during fibrillation. For example, Kirchhof did local pacing during atrial fibrillation in dog hearts (Circulation 1993; 88; 736-749). He used 0.5 mm diameter electrodes and pacing stimuli. As expected, small areas around the heart were captured but no pumping action was expected or detected. Similar results have been obtained in the ventricle by KenKnight (Journal of the American College of Cardiology 1994; 283A).
Various researchers have tried multiple pulse defibrillation without success in reducing the energy thresholds, for example, Schuder (Cardiovascular Research; 1970, 4, 497-501), Kugelberg (Medical & Biological Engineering; 1968, 6, 167-169 and Acta Chirurgica Scandinavia;,1967, 372), Resnekov (Cardiovascular Research; 1968, 2, 261-264), and Geddes (Journal of Applied Physiology; 1973, 34, 8-11).
Some have considered the use of smaller pulses, before the shock to reduce the energy required for a defibrillation shock (Kroll, European Application No. 540266), but never anticipated eliminating the defibrillation shock itself or anticipated tha the pulses themselves could maintain cardiac output. Some have suggested using higher voltage pulses to terminate ventricular tachycardias, but no suggestion was made of an application with fibrillation or of obtaining cardiac output (Kroll WO 93/19809) and Duffin (WO 93/06886).
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram illustrating a system constructed in acordance with the principles of the present invention.
FIG. 2a shows the connection of an implantable embodiment of the device to the heart in an epicardial patch configuration.
FIG. 2b shows the connection of an implantable embodiment of the device to the heart using an endocardial lead system and the device housing as an electrode.
FIG. 3a shows the connection of an external embodiment of the invention.
FIG. 3b shows a representative cardiac output detection configuration.
FIGS. 9a and 9 b show various waveforms useful for the electrical cardiac output forcing method and apparatus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, applicants provide these embodiments so that this disclosure will be thorough and complete, and will convey the scope of the invention to those skilled in the art.
FIG. 1 is a block diagram illustrating a system 10 constructed in accordance with the principles of the present invention. The device circuitry is connected to the heart 40 via a series of leads; output lead 32, presure sense lead 34, and ECG sense lead 36. The electronic circuit includes a conventional ECG amplifier 30 for amplifying cardiac signals. The amplified cardiac signals are analyzed by a conventional arrhythmia detector 20 which determines if an arrhythmia is present. The arrhythmia detector 20 may be one of several types well known to those skilled in the art and is preferably able to distinguish between different types of arrhythmias. For example; fibrillation, tachycardia or asystole. The circuit also contains an optional pressure sensing section 28 which amplifies and conditions a signal from an optional pressure sensor from within the heart or artery. The output of the pressure sense circuit 28 is fed to a cardiac output detection circuit 18 which analyzes the data and determines an estimate of the cardiac output. Data from the arrhythmia detector circuit 20 and the cardiac output detection circuit 18 is fed to the microprocessor 16. The microprocessor 16 determines if Electrical Cardiac Output Forcing (ECOF) is appropriate. If forcing is indicated, the microprocessor 16 prompts the output controll 22 to charge a capacitor within the output circuit 26 via the capacitor charger 24. The output control 22 directs the output circuitry 26 to deliver the pulses to the heart 40 via the output leads 32. The microporcesor 16 may communicate with external sources via a telemetry circuit 14 within the device 10. The power-for the device 10 is supplied by an internal battery 12.
FIG. 2a is a diagram showing the connection of an implantable embodiment of the device 130 to the heart 40 in an epicardial patch configuration. In this thoracotomy configuration, current passes through an output lead pair 32 to electrode patches 42 which direct the current through the heart 40. There is an optional pressure sense lead 34 which passes the signal from an optional pressure transducer 46 which lies in the heart 40. The ECG is monitored by sense electrodes 44 and passed to the device 130 by a lead 36. The area of the electrodes 42 is at least 0.5 cm2. The size of the electrode is greater than that of a pacing lead and no more than that of a defibrillation electrode or between approximately 0.5 cm2 and 20 cm2 each.
FIG. 2b shows a non-thoracotomy system embodiment of the invention. In this system, the current passes from a coil electrode 52 in the heart 40 to the housing of the device 140. An endocardial lead 50 combines the ECG sensing lead and the pulse output lead. The ECG is monitored by sense electrodes 44 in the heart 40 and passes through the endocardial lead 50. There is an optional pressure transducer 46 in the heart 40 which passes a signal to the device 140 via optional lead 34.
FIG. 3a shows an external embodiment of the invention. External patch electrodes 54 are placed on the chest to deliver current to the heart 40 through output lead 32. The ECG is monitored by surface electrodes 56 and passed to the device 150 by a lead 36. Alternately, the ECG could be monitored by the external patch electrodes 54. An optional pressure sensor 46 passes a pressure signal via an optional pressure sense lead 34. This embodiment could be used as a substitute (due to its small size) for an external defibrillator and keep a patient alive until arrival at a hospital. Also, the system could precede the external defibrillator by generating output in patients in asystole until blood flow and rhythm are restored.
FIG. 3b shows another means of detecting cardiac output which may be useful to the external embodiment, in particular, of this invention. FIG. 3b illustrates use of a relatively high frequency (such as about 10-50 kHz) impedance measurement across the chest area of the patient, with either 2 or more electrodes, for example patch electrodes 54 b. Surface electrodes 56 b sense and deliver the signal, which may be rectified to highlight the cardiac mechanical frequencies (1-10 Hz) at amplifier 57′. In one embodiment, this may be a 30 kHz selective amplifier. Processing circuitry may further include rectifier means 57″ and filter 57′″, which could include a 1-20 Hz filter or similar filter means.
Implantable batteries are also limited to a certain power output and energy storage. If an output pulse is 50 V and the electrode impedance is 50Ω, the power during the pulse is P=V2/R=50V*50V/50Ω=50W. If the pulse has a duration of 2 ms then the energy per pulse is 0.1 J. If two pulses are delivered every second, the charger must be capable of delivering 0.2 J per second which is 200 mW. This is well within the limits of an implantable battery. An implantable battery can typically deliver 5 W of power. However, 200 V pulses at 3 per second would require 4.8 W which is near the limit of the battery and charging circuitry. A typical implantable battery energy capacity is 10,000 J. Delivering forcing pulses at a rate of 4.8 W would deplete the battery in only 35 minutes (10,000 J/4.8W=2083 seconds). Thirty five minutes may not be enough time to transport the patient to a hospital. Therefore 200 V represents the highest practical voltage for continuous operation in an implantable embodiment, although voltages of up to 350 V could be used for short periods and adjusted down when hemodynamic output is verified. A practical lower limit is about 10 A. During normal sinus rhythm, 10 V delivered through the patches would pace. However, during fibrillation the 10 V could not pace and only cells very near the electrodes would be captured. This would be insufficient for forcing cardiac output.
For an external ECOF the calculations are similar, but scaled up. The typical ECOF pulse would have a voltage of 100 V with a range of 25-500 V. With electrode impedances of 50Ω the power during the pulse is P=V2/R=100V*100V/50Ω=200 W with a range of 12.5-5,000 W. If the pulse has a duration of 2-5 ms, then the energy per pulse is 0.02-25 J. This is much less than the American Heart Association recommended output of 360 J for an external defibrillator.
However, it is now recognized that use of external defibrillation has a homogeneous current-advantage over ICDs, due to the relatively poor electrical field coverage of the ICDs. Accordingly, it is believed that the external ECOF-type of pulses described herein have an added advantage over pulses delivered with implantable systems. A further advantage of external delivery of pulses exists with regard to the potential for skeletal muscle and diaphragm contraction to assist with cardiac output. This type of contraction augments the cardiac contraction normally attributed to both implanted and external pulse delivery. These advantages accumulate to present an external ECOF ratio which allows for use of voltage levels between a range of about 20-2000 volts in a combined external ECOF and defibrillation device. However, without the traditional higher voltage defibrillation requirement, it is likely that an external ECOF-type device may only require a delivery capability of between about 20-1000 volts, with possible initial capture pulses that may be higher or lower than that upper range. For example, if an external ECOF-type ratio is no longer considered to be between 5-10, and is only assigned a value of 2, then the 10 volt internal minimum becomes a 20 volt external minimum, and the internal typical delivery range of 20-200 volts becomes a typical external delivery range of 40-400 volts. In similar manner, a representative value for a maximum internal delivery of an ECOF-type pulse might be 350 V, with a comparable external value being only 700 V using this ratio. When considered in the context of being a non-invasive therapy, the external ECOF-type of application is quite advantageous and energy efficient. This is particularly so in view of the unexpected ratio described above which is improved over the previous known ratios of AED/ICD voltage ratio values of between about 4-10.
FIG. 7 is a diagram showing the effect of a 50 V forcing pulse on the heart during electrical systole (cells already stimulated). The current is passed through the heart 40 by the electrodes 42. Approximately 20% of cardiac cells 100 would be captured by a 50 V pulse if the cells were in systole. The captured cells 100 are nearest each electrode 42 where the field strengths are highest. Capture in systolic cells means that their activation potential is extended. This capture requires significantly higher fields (10V/cm) than those required for diastolic cell capture (1 V/cm).
FIG. 8 is a diagram showing the effect of a 50 V forcing pulse on the heart during fibrillation. During fibrillation there are always cells in systole and diastole simultaneously. But, the vast majority are in systole. This diagram assumes 50% of the cells are in diastole which applies only after several capturing pulses. The current is passed through the heart 40 by the electrodes 42. 100% of the cells 110 nearest the electrodes 42 would be captured due to the high field strength. As shown in FIG. 7, even systolic cells are captured by high field strengths. 50% of the cells 112 in the direct path betwen the electrodes 42 would be captured if it is assumed that 50% of all cells are in diastole. If roughly 60% of cardiac cells are captured by a 50 V pulse when the cells are in diastole, and 20% are captured when in systole, and if 50% are in systole and 50% in diastole, 40% would be captured during fibrillation. This calculation is shown in the following table. The last two columns give the mechanical action resulting and the contribution to forcing a cardiac output.
Forcing Cardiac
60% of 50%
80% of 50%
20% of 50%
FIG. 9 depicts examples of waveforms designed to minimize the twitching of the chest muscles which can be very uncomfortable to the patient. In FIG. 9a is seen a low harmonic pulse waveform 120 which has a very gradual �foot� 122 and a gradual peak 124. Such a pulse has less high frequency energy components and thus is less likely to stimulate the skeletal muscle.
FIG. 9b shows a technique of going to the opposite extreme. Here, each compount forcing pulse 126 is actually composed of 50 very short spikes 128 each of which is 20 μs in width with a 20 μs spacing. The heart will tend to average out these thin pulses and �see� a 2 ms wide forcing pulse. The skeletal muscle, however, is not efficiently stimulated by these extremely narrow pulses. The skeletal muscle will not average out this 'signal either. This approach could help minimize skeletal muscle twitching and discomfort.
An alternative system would be to charge the capacitor to 300 V for the first pulse to capture many cells therefore putting those cells into diastole after a delay of 100-200 ms. At this point the voltage could be lowered to 100 V and delivered every 100 ms. A 3 watt DC-DC converter with a 67% efficiency could provide 100 ms interval forcing pulses assuming a 50Ω resistance and 1 ms pulse (0.2 J). This rate is too fast for forcing cardiac output due to mechanical limitations, but is very effective for electrical capture. After sufficient capture, the rate of forcing pulses could be slowed down to 100-170 beats per minute for optimum cardiac output.
The Electrical Cardiac Output Forcing device (ECOF) could also be used to help patients with atrial fibrillation. As an alternative embodiment to the ventricular placement of FIG. 2b, the electrode coil 52 and sensing electrodes 44 could be placed in the atrium. The device could then function to force atrial output. Even though atrial fibrillation is not instantly fatal like ventricular fibrillation is, clots can build up in the atria which can eventually lead to strokes. Cardiac output forcing of the atria on a daily basis may limit this problem. It is also possible that after a number of forcing pulses the atria would return to a normal rhythm. There is however, no urgency as is the case with ventricular fibrillation.
A second use of this invention for atrial defibrillation is shown in FIG. 10. As before in FIG. 2b, the ECOF 160 is shown connected to the heart 40 via endocardial lead 50. Again forcing coil electrode 52 and sensing electrodes 44 are in the right ventricle. In addition a large atrial coil electrode 130 and atrial sensing electrodes 132 are in the right atrium. These would be used for conventional atrial defibrillation. One of the big concerns with atrial defibrillation is that in a few cases, an atrial defibrillation shock causes ventricular fibrillation. If this happens, the patient dies within minutes. With the ECOF approach, for the left ventricle, one could maintain output in the patient for several hours and thus have enough time for transport to a hospital or external defibrillation. Thus the ECOF approach in the ventricle could provide a safety backup to atrial defibrillation.
Many cardiac patients have no known risk of ventricular fibrillation, but suffer regularly from ventricular tachycardia. Accordingly, these people can be treated with anti-tachycardia pacing (ATP). Unfortunately, occasionally ATP will cause a ventricular fibrillation. Then a large defibrillation shock must be applied. Thus it is not considered safe to implant a pure ATP device and these patients instead receive a full size ICD. The ECOF approach also serves as a safety backup and thus allow the implantation of true ATP devices. The system is depicted in FIG. 2b, although the pressure sensor 46 would typically not be needed.
Low energy cardioverters can also be used to treat ventricular tachycardias. These devices are also not considered safe as stand alone devices due to the fact that they may not terminate the rhythm or that they may cause fibrillation. The ECOF method also could be used as a safety backup thus allowing the implantation of cardioverters without defibrillation capabilities. Such a system is shown in FIG. 2b. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. For example, while most of the discussion is in the context of an implantable device, the concepts of the invention are also applicable to external delivery systems. The use of ECOF-type of low voltage forcing pulses allows the choice of optimum therapy for different patient needs while only delivering the minimum voltage necessary to a patient in order to achieve the desired outcome. It is intended that the following claims define the scope of the invention and that structures and methods within the scope of these claims and their equivalents be covered thereby.
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Geddes, et al., Journal of Applied Physiology, vol. 34, No. 1 (Jan. 1973).17Ventricular Defibrillation-A New Aspect Jan Kugelberg, ACTA CHIRURGICA SCANDINAVICA, Supplementum 372 (1967).18Ventricular Defibrillation�A New Aspect Jan Kugelberg, ACTA CHIRURGICA SCANDINAVICA, Supplementum 372 (1967).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8401637Nov 22, 2005Mar 19, 2013Galvani, Ltd.Medium voltage therapy applications in treating cardiac arrestUS8483822Jul 2, 2010Jul 9, 2013Galvani, Ltd.Adaptive medium voltage therapy for cardiac arrhythmiasUS8731658Jan 31, 2005May 20, 2014Physio-Control, IncSystem and method for using diagnostic pulses in connection with defibrillation therapyClassifications U.S. Classification607/5, 607/10, 607/4International ClassificationA61N1/39, A61N1/362Cooperative ClassificationA61N1/3962, A61N1/3625, A61N1/3918, A61N1/3622, A61N1/395European ClassificationA61N1/362B, A61N1/39M2, A61N1/362A2, A61N1/39BLegal EventsDateCodeEventDescriptionNov 8, 2010FPAYFee paymentYear of fee payment: 8Sep 10, 2007PRDPPatent reinstated due to the acceptance of a late maintenance feeEffective date: 20070912Jul 3, 2007FPExpired due to failure to pay maintenance feeEffective date: 20070506Jun 11, 2007FPAYFee paymentYear of fee payment: 4Jun 11, 2007SULPSurcharge for late paymentMay 6, 2007REINReinstatement after maintenance fee payment confirmedNov 22, 2006REMIMaintenance fee reminder mailedRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google