CA2076384C - Implantable electrical nerve stimulator pacemaker with ischemia detector for decreasing cardiac workload - Google Patents
Implantable electrical nerve stimulator pacemaker with ischemia detector for decreasing cardiac workloadInfo
- Publication number
- CA2076384C CA2076384C CA002076384A CA2076384A CA2076384C CA 2076384 C CA2076384 C CA 2076384C CA 002076384 A CA002076384 A CA 002076384A CA 2076384 A CA2076384 A CA 2076384A CA 2076384 C CA2076384 C CA 2076384C
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- CA
- Canada
- Prior art keywords
- patient
- segment
- heart
- stimulation
- blood
- Prior art date
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Classifications
-
- 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
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
-
- 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
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
- A61N1/36557—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by chemical substances in blood
Abstract
A method and apparatus for stimulating the right and/or left carotid sinus nerves or the right stellate ganglion or the epidural space at about T2 with continuous and/or phasic electrical pulses in response to detected myocardial ischemia to decrease cardiac workload as a method to protect the myocardium. The automatic detection of the need for such stimulation is responsive to a change in ST segment variation different from a predetermined or programmed threshold suggesting acute myocardial ischemia and/or other criteria or indicators of myocardial ischemia, including changes if pH and/or oxygen saturation (SO2) detected from a sensor located in the heart, preferably the coronary sinus. The system is implemented with a dual chamber pacemaker with programming and telemetry capabilities for automatically recording in memory the aforementioned values for periods of time preceding and following each instance of stimulation for telemetry out on command and for programming "on" one or more of the sensors.
Description
~ v, 6 s ~ 4 IMPLANTABLE ELECTRICAL NERVE STIMULATOR/PACEMAKER
WITH ISCHEMIA DETECTOR FOR DECREASING CARDIAC WORKLOAD
BACKGROUND OF THE INV~NTION
Field of the Invention This invention relates to apparatus for electrically stimulating the cer~aln nerves ror Ine prevention or interruption of bouts of myocardial ischemia, either automatically or upon external command by the patient or physician.
DescriPtion of the Prior Art Vagal stimulation for the treatment of supraventricular arrhythmias, angina pectoris, and heart failure with an automatic, permanently implantable, medical device has been reported in the literature at least as far back as the early 1960's. The paper "Vagal Tuning" by Bilgutay et al in the Journal of Thoracic and Cardiovascular Surqery, Vol. 56, No.
1, July, 1968, pp. 71-82, described the concepts of vagal stimulation in the treatment of supraventricular arrhythmias, angina pectoris, and heart failure employing an implantable vagal stimulator. Vagal stimulation was effected through the application of electrical stimulation to the vagus nerve by silastic coated, bipolar electrodes (of the type disclosed in Medtronic U.S. Patent No.
3,421,511) surgically placed around the intact nerve or nerves. Bilgutay et al. designed and employed three different models of vagal stimulators, the first one having a magnetic switch by which it could ~e turned on or off from outside the body to study the effects of long term stimulation, the second type also implantable but powered from outside by inductio.: using rf frequency, and the third, external type triggered by the R-wave of the sub~ect's A
~ ~ i, / ~' J ~ 4 electrocardiogram to provide stimulation only upon an achievement of a certain heart rate. Bilgutay et al. found that when a pulsatile current with a frequency of ten pulses per second and 0.2 milliseconds pulse duration was applied to the vagus nerve, long term effective stimulation could be achieved, and also found that by increasing only the voltage amplitude and current, more predictable changes on the electrocardiogram could be obtained. The heart rate could be decreased down to half the resting rate while still preserving sinus rhythm with up to 9 volts applied voltage.
Atriol-Ventricular (AV) conduction dissociation and third degree heart block resulted at amplitudes exceeding 9 volts, and complete asystole with vagal escape resulted when the applied voltage exceeded 20 volts. Low amplitude vagal stimulation was successfully employed to control induced tachycardias and ectopic beats, and the authors noted other advantages of vagal stimulation in alleviating adverse effects of available drug therapies.
Other investigators reported treatment of angina pectoris and paroxysmal atrio-ventricular junctional or supraventricular tachycardias through application of carotid sinus nerve stimulation employing the MedtroniC An~i~tat carotid sinus nerve stimulator (csns) then available from Medtronic, Inc. in papers such as "Carotid Sinus Nerve Stimulation in the Treatment of Angina Pectoris and Supraventricular Tachycardia", California Medicine, 112:41-50, March, 1970, and in papers referenced therein.
These papers describe the system for effecting carotid sinus nerve stimulation by a radio frequency responsive stimulator activated by the patient at will in response to the patient's awareness of the onset of angina and/or supraventricular tachycardia.
Angina pectoris is a chest pain that accompanies and is indicative of myocardial ischemia. Oftentimes myocardial ischemia is "silent" and not accompanied by angina pectoris.
* trade mark ~i ~, 2 07 6~8~
in either case, ischemia is an oxygen starvation of the myocardium that is a precursor to myocardial infarction or the death of the starved myocardial cells. To protect these cells, the cells' oxygen demand must be reduced (or coronary flow increased).
The oxygen demands of the heart are not simply a function of the external work of the heart, that is, the product of arterial pressure and cardiac output. The development by the ventricles of pressure (more strictly speaking, tension) has a high oxygen cost. In addition to tension, the level of myocardial contractility, that is the inotropic or contractual state of the myocardium, is a second important determinant of the heart's oxygen needs. A
third factor, of course, is that the heart's oxygen consumption is a function of cardiac frequency - the number of times the heart contracts per unit of time. A number of other physiologic variables have been studied, but none even approach in importance the three factors mentioned above -tension, contractility and heart rate - in the determination of myocardial oxygen consumption.
It is generally appreciated that angina pectoris results from an imbalance between the heart's oxygen needs and the oxygen supply. In the large majority of patients this imbalance results from a defect in the delivery of oxygen to the myocardium as a consequence of obstruction in the coronary vascular bed secondary to atherosclerosis or coronary spasm. In other patients, however, this imbalance results to a significant extent from increased myocardial oxygen demands, as occurs in aortic stenosis, thyrotoxicosis and tachycardia. Ideal therapy for severe myocardial ischemia would be to restore the balance between supply and demand in as a physiologic a manner as possible - by increasing oxygen delivery when it is limited, and by reducing oxygen demands when these are excessive. In practice, it may be difficult or impossible to increase s ~ ~
oxygen delivery, particularly in patients with diffuse severe atherosclerosis. Some researchers have sought to relieve angina pectoris by reducing myocardial oxygen consumption through stimulation of the vagus nerve.
Investigators focused upon the use of carotid sinus nerve stimulation in the treatment and control of angina pectoris for regulation of the patient's blood pressure, and observed that the effect of the application of carotid sinus nerve stimulation provided a safe means for initiating reflex vagal activity which in turn effected a slowing in a patient's heart rate or even terminating a supraventricular tachycardia.
In U.S. Patent No. 3,650,277, it was also proposed to stimulate the left and right carotid sinus nerves in response to the detection of elevated mean arterial blood pressure to alleviate hypertension.
Thus it is well known that the application of stimulation to the right or left carotid sinus nerves, either directly or indirectly, has the effect of lowering blood pressure which in turn decreases ischemia and attendant angina pectoris symptoms, with the danger that an important brady-arrhythmia may be induced in the process.
Difficulties in detecting ischemia and providing proper amplitudes, frequencies and duration of the electrical stimulation has effectively led to the near abandonment of this therapy in recent years. It has also been shown that many important and significant episodes of ischemia may not be detected by the patient and further cardiac damage may follow. This limits the use of patient activator systems.
SUMMARY OF THF INVENTION
The present invention contemplates an apparatus for detecting ischemia and both affecting stimulation of nerves regulating blood pressure and heart ~ 2 ~J i ~ 3 ~ 4 - -rate to reduce the heart's oxygen requirements while providing pacing therapies to maintain the patient's heart rhythm within acceptable limits. It is thus an object of the present invention to ameliorate myocardial ischemia and maintain adequate cardiac rate through stimulation of the vagal nervous system (or other effective nerves) as well as the heart tissue in a concer~ed fashion dependent upon need as automatically determined by the system.
More particularly, the present invention contemplates the detection of an ischemic condition susceptible to correction by stimulation of such nerves by comparison of the patient's coronary sinus blood pH and/or oxygen saturation and/or electrocardiogram ST elevation to preset, normal thresholds and triggering burst stimulation of the lS nerves until the blood gas and/or ST segment variations have - been returned to non-clinical risk levels.
- Moreover, the apparatus of the present invention contemplates the inclusion of both atrial and ventricular sequential pacing in order to most physiologically overcome bradyarrhythmias and/or unphysiological AV delays induced by the nerve stimulation.
The AV sequential demand pacemaker may be provided with memory capabilities of storing the patient's electrogram and blood gas signals for a predetermined time interval preceding and following each instance that nerve stimulation is found necessary for later telemetry out on command and analysis by the physician. The real time of the event may also be stored in memory for later telemetering out.
The system of the present invention is provided with sensors for detecting blood pH and oxygen saturation content (S~2 and/or heart rate which are indicative of ischemia.
Preferably the sensors are located in the coronary sinus or a coronary vein to measure the dissolved oxygen and/or the lactic acid level of myocardial venous return blood. The system preferably includes programmable thresholds against ~1 63~ ~ ;~ 6 which the signals developed by the sensQrs and the ST
elevation are compared.
In the practice of the invention, a physician may exercise a patient on a treadmill and thereby induce ischemia while measuring the QRS heart rate, ST segment thresholds, blood pH and bl~ood gas values and program the threshold levels of those parameters and the operating characteristics or modes of the implantable device of the present invention.
At the same time, the physician may examine the efficiency of the vagal stimulation parameters in alleviating the patient's induced ischemia and attendant ang~na paln.
It is an object of the present invention therefore to provide an improved apparatus for influencing the blood pressure in a patient, in particular for reducing the blood pressure of a patient suffering from angina pectoris at appropriate times, by electrical stimulation of afferent nerve paths from the baroreceptors of the patient, in particular the carotid sinus nerve or nerves or the right stellate ganglion or the epidural space at about T2. The device according to the invention comprises an electrode or electrodes which can be applied on or close to such nerves or epidural space for stimulation thereof with short electric pulses and a pulse generator connected to said stimulator assembly for supplying the stimulating pulses thereto. Preferably one uses an electrode applied to each one of the carotid sinus nerves of the patient, in which case the pulse generator is provided with two pulse output trains generating circuits connected to said electrodes respectively. The device according to the invention is characterized in that it may further comprise a synchronization signal generator for producing a control signal for the pulse generator dependent on the heart activity of the patient, and that the pulse generator ~'~,i6 J~
produces, ln response to sald control slgnal, a pulse traln of llmlted length, whlch starts at the beglnnlng of the heart cycle and in whlch the ma~orlty of pulses ln the traln are applied durlng the flrst portlon of the heart cycle.
Thus, the present lnventlon seeks to lntegrate the characterlstlcs attendant to the onset of myocardlal lschemla ln order to treat the patlent's myocardlal lschemla and/or anglnal symptoms by stlmulatlon of the speclfled nerves and, where approprlate, the heart.
The lnventlon may be summarlzed, accordlng to one broad aspect as a system for lnfluenclng the natural biologlcal blood pressure regulatory system ln a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse by stlmulatlon of the patlent's nerve system, sald system comprlslng lschemia sensor means adapted to be located wlthln the venous return system of a patlent's heart for senslng a constltuent of the venous return blood dralning from myocardlal tlssue and produclng an electrlcal output slgnal substantlally representlng a chemlcal constltuent of that blood; slgnal transformlng means for recelvlng the sensor means output signal and developlng a stimulation trigger signal in response to an output signal lndlcatlve of a condltlon of lschemla, and means responslve to sald trlgger slgnal for applylng electrlc stlmulation pulses to said nerve system.
Accordlng to another broad aspect, the lnventlon provldes a system for influencing the natural biological blood ,,~' 2iu /
- 7a -pressure regulatory system of a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse stlmulatlon of the patlent's nerve system, sald system comprlslng: electrode means coupled to sald patlent's heart for detectlng the patlent's electrocardlogram; means for recelvlng sald patlent's electrocardlogram and developlng a slgnal representatlve of the ST segment of that electrocardlogram; means for provldlng an ST segment varlatlon threshold value; means for comparlng the derlved ST segment to said ST segment varlatlon threshold level and provldlng an ST
segment output slgnal when the measured ST segment varlatlon varles from the ST segment varlatlon threshold value ln a predetermlned manner; and means responslve to sald ST segment output slgnal for applylng electrlc stlmulatlon pulses to sald nerve system.
Accordlng to yet another aspect, the lnventlon provldes a system for lnfluenclng the natural blologlcal blood pressure regulatory system in a patlent, for reduclng and controlllng lschemia of myocardlal tlssue by electrlcal pulse, stlmulatlon of the patlent's nerve system, sald system comprlslng: means for contlnuously measurlng the electrogram of the patlent's heart; means for detectlng certaln characterlstics of sald electrogram indlcatlve of an lschemlc condltlon of the myocardlum; means for lnltlatlng the storage of a sequence of sald characterlstlcs of sald electrogram upon detectlon of an lschemlc condltlon; means for dellverlng one or more electrlcal stlmulatlon theraples to the patlent's L u i ~ J&4 - 7b -nervous system for depressing the patlent's heart rate; and means for lnltlatlng the storage of a further sequence of sald characterlstlcs of said electrogram followlng dellvery of sald stlmulatlon theraples.
Accordlng to stlll another broad aspect, the lnvention provldes a system for lnfluenclng the natural blologlcal blood pressure regulatory system ln a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse, stlmulatlon of the patlent's nerve system, sald system comprlslng: lschemla sensor means adapted to be located wlthln the venous return system of a patlent's heart for senslng a constltuent of the venous return blood dralnlng from myocardlal tlssue and produclng an electrlcal output slgnal substantlally representlng chemlcal constltuent of that blood; slgnal transformlng means for recelvlng the electrlcal output slgnal and developlng a stlmulatlon trlgger slgnal ln response to sald electrlcal output slgnal lndlcatlve of a condltlon of lschemla; and means responslve to sald trlgger slgnal for applylng electrlc stlmulatlon pulses to sald nerve system and storlng sald output slgnal.
DESCRIPTION OF THE DRAWINGS
These and other advantages of the present lnventlon are best understood wlth reference to the drawlngs, ln whlch:
Flgure 1 ls a dlagrammatlc lllustratlon of the heart, lts assoclated blood vessels and nerves, and the devlce of the present lnventlon coupled thereto; and ~ v I ~, ~&i, - 7c -Flgure 2 ls a block dlagram of a system of the present lnventlon for detectlng lschemla, treatlng the lschemla and provlding paclng theraples to the heart.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
OF THE INVENTION
Before dlscusslng the preferred embodlment of the present lnventlon, lt ls helpful to brlefly dlscuss the natural baroreceptor heart rate control system, whlch is shown in Flg. 1. The heart 10 pumps oxygenated blood out through the aortic arch 12, which leads to the right subclavlan artery 14, the rlght common carotld 16, the left common carotld 18, the left subclavlan artery 20, and the thoraclc aorta 22. The body's system utlllzes stretch receptors located ln the arterlal walls in the aortlc arch 12 and at the bifurcation of the carotld arterles 16, 18 ln the carotid slnus portion of the neck. The blfurcatlon of the carotld arterles 16, 18 leads to exterlor carotld arterles 24, 26 respectlvely, and to lnterlor carotld WO92/16257 PCT/US92/02250' 3Q~
arteries 28, 30, respectively.
Nerve fibers extending from stretch receptors in the aortic arch 12 join'the left and right vagus nerves 32, 34, respectively, with these fibers being referred to as cardiac depressor nerves 36, 38. A number of nerves extend from the stretch receptors at t~he ~lfurcation of the carotid arteries 16, 18 in the carotid sinus, with the areas immediately above the bifurcations being referred to as the carotid bodies 40, 42. Nerve branches 44, 46 extending from the carotid bodies 40, 42, respectively, join the ganglions of vagus 48, 50, respectively. Other nerve fibers comprising the sinus nerve branches 52, 54 (generally referred to as "Hering's nerves") of the glossopharyngeal nerves 56, 58, respectively, also extend from the carotid bodies 40, 42, respectively, to the medulla (not shown).
The rate of the heart is restrained by the right and left vagus nerves 32,34, respectively in conjunction with the cardiac depressor nerves 36, 38, respectively. The cardio-inhibitory center of the nervous system exerts a tonic effect upon the heart, via the vagus nerves, restraining its rate. This effect is better known as vagal tone. The loss of vagal tone may be instrumental in triggering various arrhythmias including paroxysmal atrial tachycardias, premature atrial extra systoles, atrial fibrillation, tachycardia, etc. In either case, selective electrode stimulation of the right or left vagus nerve 32, 34 may, as shown by Bilgutay et all bring into control the tachycardias of ventricular or supraventricular nature without resorting to direct stimulation of the heart. With vagal stimulation, it is possible to slow the heart rate down and allow more complete cardiac relaxation.
It should be understood that for ease of illustration, the heart, the nerves, arteries, veins and pulse generator and lead system are not necessarily depicted in proper scale or proportion. In Fig. 1 the cutaway view of the heart 10 ~ ~ 4 shows the coronary sinus opening 11 into the great coronary vein and associated lesser coronary veins into the right atrium. A pulse generator 60 having an indifferent case electrode 60l and containing the sensing, nerve stimulation and brady pacing pulse generators of the present invention is shown in relation to the heart 10 and the cardiac nerve system. A lead body 66 coupled to pulse generator 60 extends into the coronary sinus 11 and (optionally) deeply within the coronary vein 13 and preferably carries a pH and lo blood oxygen sensor tnot shown in Fig. 1). A second lead 62 extends from the pulse generator 60 through the right atrium and into the right ventricle of the patient's heart to position an electrode 63 deep within the ventricular apex.
The positioning of both the coronary sinus lead 66 and the 1~ right ventricular lead 62 in the heart is well known.
Preferably the lead 66 carries at least one electrode 67 for providing sensing cf the atrial electrogram and stimulation of the atrium. The electrode 67 may be located along lead body 66 to enable it to be positioned within the coronary sinus ll or deeply within the coronary vein 13.
A second pair of electrical leads 68 and 70 extend from the connector block of the pulse generator 60 to respective nerve electrodes 74 and 76 placed around the right and left carotid sinus nerve bodies in a manner described, for ' example, in the aforementioned U.S. Patent Nos. 3, 421,511 and 3,522,811.
The specific location of the nerve electrodes 74 and 76 may be varied, and it is contemplated that in the practice of the present invention it may be possible to place such electrodes at the right or left stellate ganglions (48 and 50). Alternatively, it is cpntemplated that a single lead and electrode could be extended from the pulse generator 60 to a dorsal column stimulating electrode. The electrode may be positioned in the epidural space roughly at level T2 and may be of the type sold by Medtronic, Inc. as part of the 2~u l ~
* *
Resume IIa and Plsces-Sigmaa electrode system or descrlbed ln Medtronlc U.S. Patent No. 4,414,986 and other Medtronlc patents referenced thereln.
In accordance wlth the present lnventlon, lt ls contemplated that the lead 66 wlll carry a blood pH sensor of the type descrlbed in U.S. Patent Nos. 4,009,721, 3,577,315, 3,658,053, 3,710,778. A membrane pH sensor electrode ls typlcally placed ln the rlght ventrlcle and senses pH, whlch ls proportlonal to the blood concentration of carbon dloxlde, whlch ln turn ls generated ln lncreaslng amounts by exerclse as explalned ln U.S. Patent 4,716,887. In the '721 patent, a dlmlnutlon ln the pH level ls used to produce a hlgher paced cardlac rate. However, ln the context of the present lnventlon, lt ls contemplated that the pH sensor wlll be placed on lead 66 ~ust lnslde the coronary slnus 11 to detect the level of lactlc acld ln venous return blood whlch ls expected to lncrease wlth exerclse of the cardlac muscle, partlcularly lf the muscle ls stressed by a lack of sufflclent oxygen due to constrlctlon ln the cardlac arterles as a result of cardlac artery dlsease. Myocardlal lschemla ls vlrtually lnvarlably assoclated wlth an lncrease ln the blood lactlc acld level in the coronary slnus. The lncrease ln blood lactlc acld level ls accompanled by a decrease ln pH.
In addltlon to the pH sensor, lt ls contemplated that the lead body 66 wlll also carry a dlssolved blood oxygen * trade mark ~ ù ~
- lOa -sensor of the type described in Medtronic U.S. Patent Nos.
WITH ISCHEMIA DETECTOR FOR DECREASING CARDIAC WORKLOAD
BACKGROUND OF THE INV~NTION
Field of the Invention This invention relates to apparatus for electrically stimulating the cer~aln nerves ror Ine prevention or interruption of bouts of myocardial ischemia, either automatically or upon external command by the patient or physician.
DescriPtion of the Prior Art Vagal stimulation for the treatment of supraventricular arrhythmias, angina pectoris, and heart failure with an automatic, permanently implantable, medical device has been reported in the literature at least as far back as the early 1960's. The paper "Vagal Tuning" by Bilgutay et al in the Journal of Thoracic and Cardiovascular Surqery, Vol. 56, No.
1, July, 1968, pp. 71-82, described the concepts of vagal stimulation in the treatment of supraventricular arrhythmias, angina pectoris, and heart failure employing an implantable vagal stimulator. Vagal stimulation was effected through the application of electrical stimulation to the vagus nerve by silastic coated, bipolar electrodes (of the type disclosed in Medtronic U.S. Patent No.
3,421,511) surgically placed around the intact nerve or nerves. Bilgutay et al. designed and employed three different models of vagal stimulators, the first one having a magnetic switch by which it could ~e turned on or off from outside the body to study the effects of long term stimulation, the second type also implantable but powered from outside by inductio.: using rf frequency, and the third, external type triggered by the R-wave of the sub~ect's A
~ ~ i, / ~' J ~ 4 electrocardiogram to provide stimulation only upon an achievement of a certain heart rate. Bilgutay et al. found that when a pulsatile current with a frequency of ten pulses per second and 0.2 milliseconds pulse duration was applied to the vagus nerve, long term effective stimulation could be achieved, and also found that by increasing only the voltage amplitude and current, more predictable changes on the electrocardiogram could be obtained. The heart rate could be decreased down to half the resting rate while still preserving sinus rhythm with up to 9 volts applied voltage.
Atriol-Ventricular (AV) conduction dissociation and third degree heart block resulted at amplitudes exceeding 9 volts, and complete asystole with vagal escape resulted when the applied voltage exceeded 20 volts. Low amplitude vagal stimulation was successfully employed to control induced tachycardias and ectopic beats, and the authors noted other advantages of vagal stimulation in alleviating adverse effects of available drug therapies.
Other investigators reported treatment of angina pectoris and paroxysmal atrio-ventricular junctional or supraventricular tachycardias through application of carotid sinus nerve stimulation employing the MedtroniC An~i~tat carotid sinus nerve stimulator (csns) then available from Medtronic, Inc. in papers such as "Carotid Sinus Nerve Stimulation in the Treatment of Angina Pectoris and Supraventricular Tachycardia", California Medicine, 112:41-50, March, 1970, and in papers referenced therein.
These papers describe the system for effecting carotid sinus nerve stimulation by a radio frequency responsive stimulator activated by the patient at will in response to the patient's awareness of the onset of angina and/or supraventricular tachycardia.
Angina pectoris is a chest pain that accompanies and is indicative of myocardial ischemia. Oftentimes myocardial ischemia is "silent" and not accompanied by angina pectoris.
* trade mark ~i ~, 2 07 6~8~
in either case, ischemia is an oxygen starvation of the myocardium that is a precursor to myocardial infarction or the death of the starved myocardial cells. To protect these cells, the cells' oxygen demand must be reduced (or coronary flow increased).
The oxygen demands of the heart are not simply a function of the external work of the heart, that is, the product of arterial pressure and cardiac output. The development by the ventricles of pressure (more strictly speaking, tension) has a high oxygen cost. In addition to tension, the level of myocardial contractility, that is the inotropic or contractual state of the myocardium, is a second important determinant of the heart's oxygen needs. A
third factor, of course, is that the heart's oxygen consumption is a function of cardiac frequency - the number of times the heart contracts per unit of time. A number of other physiologic variables have been studied, but none even approach in importance the three factors mentioned above -tension, contractility and heart rate - in the determination of myocardial oxygen consumption.
It is generally appreciated that angina pectoris results from an imbalance between the heart's oxygen needs and the oxygen supply. In the large majority of patients this imbalance results from a defect in the delivery of oxygen to the myocardium as a consequence of obstruction in the coronary vascular bed secondary to atherosclerosis or coronary spasm. In other patients, however, this imbalance results to a significant extent from increased myocardial oxygen demands, as occurs in aortic stenosis, thyrotoxicosis and tachycardia. Ideal therapy for severe myocardial ischemia would be to restore the balance between supply and demand in as a physiologic a manner as possible - by increasing oxygen delivery when it is limited, and by reducing oxygen demands when these are excessive. In practice, it may be difficult or impossible to increase s ~ ~
oxygen delivery, particularly in patients with diffuse severe atherosclerosis. Some researchers have sought to relieve angina pectoris by reducing myocardial oxygen consumption through stimulation of the vagus nerve.
Investigators focused upon the use of carotid sinus nerve stimulation in the treatment and control of angina pectoris for regulation of the patient's blood pressure, and observed that the effect of the application of carotid sinus nerve stimulation provided a safe means for initiating reflex vagal activity which in turn effected a slowing in a patient's heart rate or even terminating a supraventricular tachycardia.
In U.S. Patent No. 3,650,277, it was also proposed to stimulate the left and right carotid sinus nerves in response to the detection of elevated mean arterial blood pressure to alleviate hypertension.
Thus it is well known that the application of stimulation to the right or left carotid sinus nerves, either directly or indirectly, has the effect of lowering blood pressure which in turn decreases ischemia and attendant angina pectoris symptoms, with the danger that an important brady-arrhythmia may be induced in the process.
Difficulties in detecting ischemia and providing proper amplitudes, frequencies and duration of the electrical stimulation has effectively led to the near abandonment of this therapy in recent years. It has also been shown that many important and significant episodes of ischemia may not be detected by the patient and further cardiac damage may follow. This limits the use of patient activator systems.
SUMMARY OF THF INVENTION
The present invention contemplates an apparatus for detecting ischemia and both affecting stimulation of nerves regulating blood pressure and heart ~ 2 ~J i ~ 3 ~ 4 - -rate to reduce the heart's oxygen requirements while providing pacing therapies to maintain the patient's heart rhythm within acceptable limits. It is thus an object of the present invention to ameliorate myocardial ischemia and maintain adequate cardiac rate through stimulation of the vagal nervous system (or other effective nerves) as well as the heart tissue in a concer~ed fashion dependent upon need as automatically determined by the system.
More particularly, the present invention contemplates the detection of an ischemic condition susceptible to correction by stimulation of such nerves by comparison of the patient's coronary sinus blood pH and/or oxygen saturation and/or electrocardiogram ST elevation to preset, normal thresholds and triggering burst stimulation of the lS nerves until the blood gas and/or ST segment variations have - been returned to non-clinical risk levels.
- Moreover, the apparatus of the present invention contemplates the inclusion of both atrial and ventricular sequential pacing in order to most physiologically overcome bradyarrhythmias and/or unphysiological AV delays induced by the nerve stimulation.
The AV sequential demand pacemaker may be provided with memory capabilities of storing the patient's electrogram and blood gas signals for a predetermined time interval preceding and following each instance that nerve stimulation is found necessary for later telemetry out on command and analysis by the physician. The real time of the event may also be stored in memory for later telemetering out.
The system of the present invention is provided with sensors for detecting blood pH and oxygen saturation content (S~2 and/or heart rate which are indicative of ischemia.
Preferably the sensors are located in the coronary sinus or a coronary vein to measure the dissolved oxygen and/or the lactic acid level of myocardial venous return blood. The system preferably includes programmable thresholds against ~1 63~ ~ ;~ 6 which the signals developed by the sensQrs and the ST
elevation are compared.
In the practice of the invention, a physician may exercise a patient on a treadmill and thereby induce ischemia while measuring the QRS heart rate, ST segment thresholds, blood pH and bl~ood gas values and program the threshold levels of those parameters and the operating characteristics or modes of the implantable device of the present invention.
At the same time, the physician may examine the efficiency of the vagal stimulation parameters in alleviating the patient's induced ischemia and attendant ang~na paln.
It is an object of the present invention therefore to provide an improved apparatus for influencing the blood pressure in a patient, in particular for reducing the blood pressure of a patient suffering from angina pectoris at appropriate times, by electrical stimulation of afferent nerve paths from the baroreceptors of the patient, in particular the carotid sinus nerve or nerves or the right stellate ganglion or the epidural space at about T2. The device according to the invention comprises an electrode or electrodes which can be applied on or close to such nerves or epidural space for stimulation thereof with short electric pulses and a pulse generator connected to said stimulator assembly for supplying the stimulating pulses thereto. Preferably one uses an electrode applied to each one of the carotid sinus nerves of the patient, in which case the pulse generator is provided with two pulse output trains generating circuits connected to said electrodes respectively. The device according to the invention is characterized in that it may further comprise a synchronization signal generator for producing a control signal for the pulse generator dependent on the heart activity of the patient, and that the pulse generator ~'~,i6 J~
produces, ln response to sald control slgnal, a pulse traln of llmlted length, whlch starts at the beglnnlng of the heart cycle and in whlch the ma~orlty of pulses ln the traln are applied durlng the flrst portlon of the heart cycle.
Thus, the present lnventlon seeks to lntegrate the characterlstlcs attendant to the onset of myocardlal lschemla ln order to treat the patlent's myocardlal lschemla and/or anglnal symptoms by stlmulatlon of the speclfled nerves and, where approprlate, the heart.
The lnventlon may be summarlzed, accordlng to one broad aspect as a system for lnfluenclng the natural biologlcal blood pressure regulatory system ln a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse by stlmulatlon of the patlent's nerve system, sald system comprlslng lschemia sensor means adapted to be located wlthln the venous return system of a patlent's heart for senslng a constltuent of the venous return blood dralning from myocardlal tlssue and produclng an electrlcal output slgnal substantlally representlng a chemlcal constltuent of that blood; slgnal transformlng means for recelvlng the sensor means output signal and developlng a stimulation trigger signal in response to an output signal lndlcatlve of a condltlon of lschemla, and means responslve to sald trlgger slgnal for applylng electrlc stlmulation pulses to said nerve system.
Accordlng to another broad aspect, the lnventlon provldes a system for influencing the natural biological blood ,,~' 2iu /
- 7a -pressure regulatory system of a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse stlmulatlon of the patlent's nerve system, sald system comprlslng: electrode means coupled to sald patlent's heart for detectlng the patlent's electrocardlogram; means for recelvlng sald patlent's electrocardlogram and developlng a slgnal representatlve of the ST segment of that electrocardlogram; means for provldlng an ST segment varlatlon threshold value; means for comparlng the derlved ST segment to said ST segment varlatlon threshold level and provldlng an ST
segment output slgnal when the measured ST segment varlatlon varles from the ST segment varlatlon threshold value ln a predetermlned manner; and means responslve to sald ST segment output slgnal for applylng electrlc stlmulatlon pulses to sald nerve system.
Accordlng to yet another aspect, the lnventlon provldes a system for lnfluenclng the natural blologlcal blood pressure regulatory system in a patlent, for reduclng and controlllng lschemia of myocardlal tlssue by electrlcal pulse, stlmulatlon of the patlent's nerve system, sald system comprlslng: means for contlnuously measurlng the electrogram of the patlent's heart; means for detectlng certaln characterlstics of sald electrogram indlcatlve of an lschemlc condltlon of the myocardlum; means for lnltlatlng the storage of a sequence of sald characterlstlcs of sald electrogram upon detectlon of an lschemlc condltlon; means for dellverlng one or more electrlcal stlmulatlon theraples to the patlent's L u i ~ J&4 - 7b -nervous system for depressing the patlent's heart rate; and means for lnltlatlng the storage of a further sequence of sald characterlstlcs of said electrogram followlng dellvery of sald stlmulatlon theraples.
Accordlng to stlll another broad aspect, the lnvention provldes a system for lnfluenclng the natural blologlcal blood pressure regulatory system ln a patlent, for reduclng and controlllng lschemla of myocardlal tlssue by electrlcal pulse, stlmulatlon of the patlent's nerve system, sald system comprlslng: lschemla sensor means adapted to be located wlthln the venous return system of a patlent's heart for senslng a constltuent of the venous return blood dralnlng from myocardlal tlssue and produclng an electrlcal output slgnal substantlally representlng chemlcal constltuent of that blood; slgnal transformlng means for recelvlng the electrlcal output slgnal and developlng a stlmulatlon trlgger slgnal ln response to sald electrlcal output slgnal lndlcatlve of a condltlon of lschemla; and means responslve to sald trlgger slgnal for applylng electrlc stlmulatlon pulses to sald nerve system and storlng sald output slgnal.
DESCRIPTION OF THE DRAWINGS
These and other advantages of the present lnventlon are best understood wlth reference to the drawlngs, ln whlch:
Flgure 1 ls a dlagrammatlc lllustratlon of the heart, lts assoclated blood vessels and nerves, and the devlce of the present lnventlon coupled thereto; and ~ v I ~, ~&i, - 7c -Flgure 2 ls a block dlagram of a system of the present lnventlon for detectlng lschemla, treatlng the lschemla and provlding paclng theraples to the heart.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
OF THE INVENTION
Before dlscusslng the preferred embodlment of the present lnventlon, lt ls helpful to brlefly dlscuss the natural baroreceptor heart rate control system, whlch is shown in Flg. 1. The heart 10 pumps oxygenated blood out through the aortic arch 12, which leads to the right subclavlan artery 14, the rlght common carotld 16, the left common carotld 18, the left subclavlan artery 20, and the thoraclc aorta 22. The body's system utlllzes stretch receptors located ln the arterlal walls in the aortlc arch 12 and at the bifurcation of the carotld arterles 16, 18 ln the carotid slnus portion of the neck. The blfurcatlon of the carotld arterles 16, 18 leads to exterlor carotld arterles 24, 26 respectlvely, and to lnterlor carotld WO92/16257 PCT/US92/02250' 3Q~
arteries 28, 30, respectively.
Nerve fibers extending from stretch receptors in the aortic arch 12 join'the left and right vagus nerves 32, 34, respectively, with these fibers being referred to as cardiac depressor nerves 36, 38. A number of nerves extend from the stretch receptors at t~he ~lfurcation of the carotid arteries 16, 18 in the carotid sinus, with the areas immediately above the bifurcations being referred to as the carotid bodies 40, 42. Nerve branches 44, 46 extending from the carotid bodies 40, 42, respectively, join the ganglions of vagus 48, 50, respectively. Other nerve fibers comprising the sinus nerve branches 52, 54 (generally referred to as "Hering's nerves") of the glossopharyngeal nerves 56, 58, respectively, also extend from the carotid bodies 40, 42, respectively, to the medulla (not shown).
The rate of the heart is restrained by the right and left vagus nerves 32,34, respectively in conjunction with the cardiac depressor nerves 36, 38, respectively. The cardio-inhibitory center of the nervous system exerts a tonic effect upon the heart, via the vagus nerves, restraining its rate. This effect is better known as vagal tone. The loss of vagal tone may be instrumental in triggering various arrhythmias including paroxysmal atrial tachycardias, premature atrial extra systoles, atrial fibrillation, tachycardia, etc. In either case, selective electrode stimulation of the right or left vagus nerve 32, 34 may, as shown by Bilgutay et all bring into control the tachycardias of ventricular or supraventricular nature without resorting to direct stimulation of the heart. With vagal stimulation, it is possible to slow the heart rate down and allow more complete cardiac relaxation.
It should be understood that for ease of illustration, the heart, the nerves, arteries, veins and pulse generator and lead system are not necessarily depicted in proper scale or proportion. In Fig. 1 the cutaway view of the heart 10 ~ ~ 4 shows the coronary sinus opening 11 into the great coronary vein and associated lesser coronary veins into the right atrium. A pulse generator 60 having an indifferent case electrode 60l and containing the sensing, nerve stimulation and brady pacing pulse generators of the present invention is shown in relation to the heart 10 and the cardiac nerve system. A lead body 66 coupled to pulse generator 60 extends into the coronary sinus 11 and (optionally) deeply within the coronary vein 13 and preferably carries a pH and lo blood oxygen sensor tnot shown in Fig. 1). A second lead 62 extends from the pulse generator 60 through the right atrium and into the right ventricle of the patient's heart to position an electrode 63 deep within the ventricular apex.
The positioning of both the coronary sinus lead 66 and the 1~ right ventricular lead 62 in the heart is well known.
Preferably the lead 66 carries at least one electrode 67 for providing sensing cf the atrial electrogram and stimulation of the atrium. The electrode 67 may be located along lead body 66 to enable it to be positioned within the coronary sinus ll or deeply within the coronary vein 13.
A second pair of electrical leads 68 and 70 extend from the connector block of the pulse generator 60 to respective nerve electrodes 74 and 76 placed around the right and left carotid sinus nerve bodies in a manner described, for ' example, in the aforementioned U.S. Patent Nos. 3, 421,511 and 3,522,811.
The specific location of the nerve electrodes 74 and 76 may be varied, and it is contemplated that in the practice of the present invention it may be possible to place such electrodes at the right or left stellate ganglions (48 and 50). Alternatively, it is cpntemplated that a single lead and electrode could be extended from the pulse generator 60 to a dorsal column stimulating electrode. The electrode may be positioned in the epidural space roughly at level T2 and may be of the type sold by Medtronic, Inc. as part of the 2~u l ~
* *
Resume IIa and Plsces-Sigmaa electrode system or descrlbed ln Medtronlc U.S. Patent No. 4,414,986 and other Medtronlc patents referenced thereln.
In accordance wlth the present lnventlon, lt ls contemplated that the lead 66 wlll carry a blood pH sensor of the type descrlbed in U.S. Patent Nos. 4,009,721, 3,577,315, 3,658,053, 3,710,778. A membrane pH sensor electrode ls typlcally placed ln the rlght ventrlcle and senses pH, whlch ls proportlonal to the blood concentration of carbon dloxlde, whlch ln turn ls generated ln lncreaslng amounts by exerclse as explalned ln U.S. Patent 4,716,887. In the '721 patent, a dlmlnutlon ln the pH level ls used to produce a hlgher paced cardlac rate. However, ln the context of the present lnventlon, lt ls contemplated that the pH sensor wlll be placed on lead 66 ~ust lnslde the coronary slnus 11 to detect the level of lactlc acld ln venous return blood whlch ls expected to lncrease wlth exerclse of the cardlac muscle, partlcularly lf the muscle ls stressed by a lack of sufflclent oxygen due to constrlctlon ln the cardlac arterles as a result of cardlac artery dlsease. Myocardlal lschemla ls vlrtually lnvarlably assoclated wlth an lncrease ln the blood lactlc acld level in the coronary slnus. The lncrease ln blood lactlc acld level ls accompanled by a decrease ln pH.
In addltlon to the pH sensor, lt ls contemplated that the lead body 66 wlll also carry a dlssolved blood oxygen * trade mark ~ ù ~
- lOa -sensor of the type described in Medtronic U.S. Patent Nos.
4,750,495, 4,467,807 and 5,791,935. An optlcal detector ls used to measure the mlxed venous oxygen saturatlon. In the aforementloned lncorporated patents, a dlmlnutlon ln the mlxed venous oxygen saturatlon ls used to produce a hlgher paced cardlac rate.
In the context of the present lnventlon, lt ls expected that the oxygen tenslon wlthln the coronary slnus may be ! .
WO92/162~7 PCT/US92/02250 207638~
either increased or decreased during ischemia, although most times it would be decreased or remain the same. The reason for the increase would be that if a large area of the myocardium is ischemic and oxygen is not being supplied to that area, then the coronary sinus oxygen content might indeed increase. On the other hand, it would normally be expected that the oxygen content would decrease as dissolved oxygen decreases in those circumstances.
ln the context of the present invention, it is expected that during the workup of the patient conducted by the physician, it would be determined whether or not the patient's heart condition would cause the change in oxygen saturation measured in the coronary sinus to be a meaningful predictor or indicator of ischemia or not. If not, then the lS system would be programmed to not employ the signal developed by the oxygen sensor or it would be in any case insufficient to. trigger the detection of ischemia in a manner to be described hereafter. In either case, the system be configured to store the actual signal developed by the blood oxygen sensor in the event that the blood pH
and/or ST segment variation satisfy the programmed ischemia thresholds for those sensors or values.
Turning to the ST segment variation detection, the pulse generator 60 is provided with a system for measuring the ST segment variation of the far field QRST complex measured between electrodes on leads 66 and 62. Myocardial ischemia is frequently associated with variation of ST
segments of the QRST electrocardiogram measured both by surface EKG electrodes and by cardiac ECG electrodes.
Again, the physician would determine and program into the implantable device 60 the ST variation threshold established in the workup of the patient during exercise and induced systems of angina pectoris.
Turning now to Fig. 2, 'he overall system for detecting conditions o~ ischemia, stimulating the aforementioned ~ 6~ 12 nerves, providing backup brady and tachycardia pacing therapies and storing ischemic episodes is depicted. The system of Fig. 2 is preferably implemented in custom integrated circuit technology and may optionally be embodied S in microprocessor architecture.
In Fig. 2, the pH sensor 90 and SO2 sensor 92 develop output signals which are conducted by conductors within lead 66 to interfaces 94 and 96 which condition the signals as is well known in the art. The electrocardiogram ECG is measured between a coronary sinus electrode 67 and the right ventricular electrode 63 and applied through interface 97 to differential amplifier 98. The outputs of the interfaces 94 and 96 and the differential amplifier 98 are coupled through the signal processing circuits to the programmable logic array 100 in a fashion such that if one or more of the indicators of ischemia are present, the gate array lO0 provides an output signal to a timing one shot 102, the DDD
backup pacemaker 104 and the transfer logic block 106 so that the burst stimulator 108 is enabled to provide a burst of stimulating pulses to one or both electrodes 74 and 76 through respective leads 68 and 70, to effect transfer of data from the pH buffer 110, the SO2 buffer 112 and the ST
segment buffer 114 to permanent memory (not shown), and to switch on the DDD backup brady pacing.
Returning to the signal developed by the pH sensor 90 through interface 94, it is stored in pH buffer 110 and differentiated in differentiator 116 and thereafter applied to a first input terminal of the pH comparator 118 to determine whether or not the differentiated value of the blood pH falls below the rate of change of pH threshold, established by programmable set point 120, over a given period of time, e.g., 30 seconds. The output of the pH
comparator is applied to one input of programmable array 100 .
Similarly, the signal developed by the S0-2 sensor 92 W O 92/162~7 PC~r/US92/02250 207~381 processed by interface 96 is stored in S~O2 buffer 112, differentiated by differentiator 124 and applied to a first input terminal of the S02 comparator 126. The second input of the S02 comparator 126 is coupled to a programmable set point 128 for establishing a rate of change of S02 threshold. In the event that the differentiated S02 value falls above or below the set point 128, the output signal of comparator 126 is applied to a second input of logic array 100 .
The measurement of the ST segment variation is somewhat. more complicated inasmuch as it is necessary to provide a measurement window for the ST segment of the electrocardiogram which eliminates the possibility of inadvertently measuring the amplitude of the QRS complex itself. In order to accomplish this, it is contemplated that the QRS complex is sensed by a further sense amplifier 136 within the DDD pacemaker 104 having a first input terminal connected to the electrode 63 and a second input terminal connected to the case electrode 60 of the pulse generator 60 or to a further electrode on lead body 62 to develop an R-wave out signal RS each time the QRS complex occurs, in a manner well known in the pacing art. The signal RS is applied to one input of gate 138 which passes it to a timing window circuit 140. The gate 138 also receives at a second input terminal the ventricular stimulating pulse VP of the DDD backup pacemaker 104, in the event that it has been switched on either by the logic lO0 or by the failure of the patient's heart to beat at the lower rate of the DDD pacemaker. In any event, the VP pulse is likewise passed through the gate 138 and can start the timing window circuit 140. The output of the circuit 140 provides the timing window commencing at the end of a delay after either a RS or VP signal and ending at the end of the programmed timing window. For example, the timing window may extend from 50 milliseconds following the production of 2~i, 6S~-elther an RS or a VP slgnal and end 150 to 200 mllllseconds thereafter. Wlthln that tlme wlndow, lt would be expected that the electrocardlogram would exhlblt the patlent's ST
segment so that lts amplltude could be measured.
The output of the tlmlng clrcult 140 ls applled to an lnverter 144 and to gate clrcult 146 for enabllng the passage of the ST segment of the ECG slgnal to the lnput of the lntegrator 148. The lntegrator 148 lntegrates the voltage of the ST segment over the tlmlng wlndow and applles lt to one input of the ST comparator 150. At the same tlme, the ST
segment of the ECG ls stored ln ST buffer 114.
The second lnput of the ST comparator 150 ls coupled to the programmable ST varlatlon threshold set polnt 152. The output of the ST comparator 150 ls coupled to the thlrd lnput termlnal of loglc array 100. When the value of the lntegrated ST segment exceeds the threshold, the ST comparator 150 provldes a further slgnal lndlcatlve of the onset of lschemla to loglc 100.
The programmable loglc array 100, may be programmed from outslde the patlent's body by a programmer of the type descrlbed ln Medtronlc U.S. Patent No. 4,550,370. Thus the physlclan can choose to use one or more of the output slgnals of the three sensors ln comblnatlon. If more than one sensor ls selected, then loglc 100 operates as an AND gate requlrlng that all selected sensor outputs lndlcate the onset of lschemla before providlng an output trlggerlng slgnal to the DDD pacemaker 104, the one-shot 102 and the transfer loglc ~ .
~ ~ ~ UJ~, 106.
When the condltlons programmed lnto loglc array 100 are satlsfled lt lssues an output to one-shot 102 whlch ln turn lssues a start command pulse to programmable stlmulator 108. Programmed electrlcal stlmulatlon pulse tralns are applled to the electrodes 74, 76. If programmed "on", the pulse tralns may be synchronlzed to the next detected RS out from ampllfler 136.
Slmllarly, the external programmer can be used to control the settlng of the thresholds of the programmable set polnts 120, 128 and 152 as well as the tlmlng of the tlmlng wlndow clrcult 140 and the synchronlzatlon delay of 108 to a ventrlcular event.
The DDD pacemaker depicted ln block 104 also may lnclude a dlscrete dlgltal loglc or mlcroprocessor based tlmlng and control clrcult 154, an atrlal sense ampllfler 156 coupled to the coronary slnus electrode (or separate atrlal electrode bearlng lead) for developlng a P-wave out signal AS, and atrlal and ventrlcular pulse generator 158 and 160 for 20 produclng the atrial and ventrlcular stlmulatlng pulses AP and VP. The sense ampllflers and output pulse generators are coupled through blanking and refractory lnterfaces 97, 162 and 164 ln a manner well known ln the paclng art. The DDD
pacemaker may have programmable parameters and modes as well as upllnk and downllnk telemetry as ls well known ln the art.
The pacemaker may, for example, take the form of the J ~ ~t Medtronica SYMBOISa Model 7005 or llke pacemaker and the DDD
pacemaker dlsclosed in Medtronic U.S. Patent 4,390,020. One speclfic operatlng mode for the pacemaker 104 may be to program lt to operate only after recelvlng a trlgger slgnal lndlcatlng lschemla at trlgger lnput 166 and then only untll the heart's own rate rlses above a programmable lower rate.
Although a DDD pacemaker 104 ls deplcted, lt wlll be understood that a slngle chamber pacemaker could also be used to stlmulate only the ventrlcle and serve only the QRS
complex. The pacemaker may take the form of any of the programmable pacemakers avallable ln the prlor art.
A further programmable feature of the system of the present lnventlon lles ln the selectlon of the burst pulse traln stlmulatlon frequency, amplltude and number of lmpulses ln each burst as well as the spaclng between lmpulses through the programmable stlmulator 108. Agaln wlth the ald of an external programmer, the physlclan may select each of the parameters of the burst stlmulatlon from an avallable menu at the tlme of patlent workup. In addltlon, ln thls regard, the programmer may select one or both of the electrodes 74 and 76 for appllcatlon of stlmulatlon pulses to the deslred nerves or the epldural space. The programmable lmplantable stlmulator 108 may take the form of the Medtronlca Itrela lmplantable neurologlcal devlce Model 7424 programmed by the Model 7432 console programmer.
* trade mark ~ ' I U~ 4 - 16a -In use of the system deplcted ln Flgure 2, lt ls contemplated that a patlent would be selected for lmplantatlon of such a system by a workup procedure employlng temporary pH
and oxygen sensor bearlng leads placed wlthln the patlent's coronary slnus and rlght ventrlcle coupled to an external verslon of the system deplcted ln Flgure 2 ln order to ascertaln the patlent's thresholds at the onset of symptoms of anglna pectorls. Durlng thls procedure the physlclan would select the parameters of the flrst stlmulatlon from the menu (that would llkewlse be avallable ln the lmplanted stlmulator) and, from the effect on the heart rate settle on the lnltial therapies and senslng thresholds to be programmed ln the lmplanted devlce.
A system deplcted ln Flgure 2 ls contemplated to possess radlo frequency telemetry 190, 192 for both the aforementloned downllnk telemetry of programmable modes and parameters as well as upllnk telemetry (as shown, for example ln U.S. Patent No. 4,556,063) of data derlved from the sensors and the electrocardlogram. To thls end, the transfer-to-memory loglc 106 effects the transfer of the contents of thebuffers 110, 112 and 114 as well as the real tlme ~date and tlme of day) clock 200 data lnto memory for a WO92/162~7 PCT/US92/02250 207~38~ ;.
later telemetry out of the pulse generator upon command.
Such uplink telemetry systems are in current use in implantable pacemakers and other implantable medical devices.
s The system depicted in Figure 2 may advantageously also be combined with an anti-tachycardia pacing system where certain of the sensors may advantageously be employed to detect or confirm the detection of the supraventricular tachyarrhythmia. It will be understood that at times ischemia is accompanied by a supraventricular tachycardia and that the stimulation of the carotid sinus nerves or other nerves related thereto may effect both the lowering of the blood pressure as well as the heart rate and create AV
block or prolongation. The DDD backup pacing in the system of the present invention is primarily intended to restore sequential heartbeat at the lower rate. However, the system may incorporate the anti-tachycardia pacing therapies in the event that the logic circuit 100 does not trigger the stimulator 108 because one or more of the sense conditions does not meet the ischemia threshold for that sensor.
The system may further include a patient-initiated storage of the aforementioned physiological conditions and treatment by delivery of stimulation. Failure of stimulation to prev~nt recurrences within a programmable period of time after detection of each episode is stored in memory and triggers an increase in stimulation amplitude and/or duration. Stimulation frequency may be varied in a predetermined manner from the optimum stimulation frequency, amplitude and duration determined during patient workup and a patient override may be provided to turn the stimulation on or off.
It will be apparent to those skilled in the art that the electronics of the system described above are easily attainable using available technology. The electronics may be embodied in custom integrated circuit and software based ~ 63Q~
microprocessor technology. It will be understood that while the major components of the system, e.g. the pacemaker and nerve stimulator, have been referenced to existing discrete implantable devices, they and the remaining described components of Figure 2 may all be incorporated within a single implantable device (with the elimination of duplicated features) and programmed by a single external programmer and telemetry receiver.
It will thus be appreciated that the present invention as described above defines a system having distinct advantages over previously existing systems for reducing ischemia by stimulation of nerves typically the carotid sinus nerves. This system features a high degree of specificity to ischemic conditions and a high degree of flexibility for recognizing and treating conditions and arrhythmias of a heart frequently associated with coronary artery disease and myocardial insufficiency.
Although an exemplary embodiment of the present invention has been shown and described, it will be apparent to those having ordinary skill in the art that a number of changes, modifications, or alterations to the invention as described herein may be made, none of which depart from the spirit of the present invention. All such changes, modifications and alterations should therefore be seen within the scope of the present invention.
In the context of the present lnventlon, lt ls expected that the oxygen tenslon wlthln the coronary slnus may be ! .
WO92/162~7 PCT/US92/02250 207638~
either increased or decreased during ischemia, although most times it would be decreased or remain the same. The reason for the increase would be that if a large area of the myocardium is ischemic and oxygen is not being supplied to that area, then the coronary sinus oxygen content might indeed increase. On the other hand, it would normally be expected that the oxygen content would decrease as dissolved oxygen decreases in those circumstances.
ln the context of the present invention, it is expected that during the workup of the patient conducted by the physician, it would be determined whether or not the patient's heart condition would cause the change in oxygen saturation measured in the coronary sinus to be a meaningful predictor or indicator of ischemia or not. If not, then the lS system would be programmed to not employ the signal developed by the oxygen sensor or it would be in any case insufficient to. trigger the detection of ischemia in a manner to be described hereafter. In either case, the system be configured to store the actual signal developed by the blood oxygen sensor in the event that the blood pH
and/or ST segment variation satisfy the programmed ischemia thresholds for those sensors or values.
Turning to the ST segment variation detection, the pulse generator 60 is provided with a system for measuring the ST segment variation of the far field QRST complex measured between electrodes on leads 66 and 62. Myocardial ischemia is frequently associated with variation of ST
segments of the QRST electrocardiogram measured both by surface EKG electrodes and by cardiac ECG electrodes.
Again, the physician would determine and program into the implantable device 60 the ST variation threshold established in the workup of the patient during exercise and induced systems of angina pectoris.
Turning now to Fig. 2, 'he overall system for detecting conditions o~ ischemia, stimulating the aforementioned ~ 6~ 12 nerves, providing backup brady and tachycardia pacing therapies and storing ischemic episodes is depicted. The system of Fig. 2 is preferably implemented in custom integrated circuit technology and may optionally be embodied S in microprocessor architecture.
In Fig. 2, the pH sensor 90 and SO2 sensor 92 develop output signals which are conducted by conductors within lead 66 to interfaces 94 and 96 which condition the signals as is well known in the art. The electrocardiogram ECG is measured between a coronary sinus electrode 67 and the right ventricular electrode 63 and applied through interface 97 to differential amplifier 98. The outputs of the interfaces 94 and 96 and the differential amplifier 98 are coupled through the signal processing circuits to the programmable logic array 100 in a fashion such that if one or more of the indicators of ischemia are present, the gate array lO0 provides an output signal to a timing one shot 102, the DDD
backup pacemaker 104 and the transfer logic block 106 so that the burst stimulator 108 is enabled to provide a burst of stimulating pulses to one or both electrodes 74 and 76 through respective leads 68 and 70, to effect transfer of data from the pH buffer 110, the SO2 buffer 112 and the ST
segment buffer 114 to permanent memory (not shown), and to switch on the DDD backup brady pacing.
Returning to the signal developed by the pH sensor 90 through interface 94, it is stored in pH buffer 110 and differentiated in differentiator 116 and thereafter applied to a first input terminal of the pH comparator 118 to determine whether or not the differentiated value of the blood pH falls below the rate of change of pH threshold, established by programmable set point 120, over a given period of time, e.g., 30 seconds. The output of the pH
comparator is applied to one input of programmable array 100 .
Similarly, the signal developed by the S0-2 sensor 92 W O 92/162~7 PC~r/US92/02250 207~381 processed by interface 96 is stored in S~O2 buffer 112, differentiated by differentiator 124 and applied to a first input terminal of the S02 comparator 126. The second input of the S02 comparator 126 is coupled to a programmable set point 128 for establishing a rate of change of S02 threshold. In the event that the differentiated S02 value falls above or below the set point 128, the output signal of comparator 126 is applied to a second input of logic array 100 .
The measurement of the ST segment variation is somewhat. more complicated inasmuch as it is necessary to provide a measurement window for the ST segment of the electrocardiogram which eliminates the possibility of inadvertently measuring the amplitude of the QRS complex itself. In order to accomplish this, it is contemplated that the QRS complex is sensed by a further sense amplifier 136 within the DDD pacemaker 104 having a first input terminal connected to the electrode 63 and a second input terminal connected to the case electrode 60 of the pulse generator 60 or to a further electrode on lead body 62 to develop an R-wave out signal RS each time the QRS complex occurs, in a manner well known in the pacing art. The signal RS is applied to one input of gate 138 which passes it to a timing window circuit 140. The gate 138 also receives at a second input terminal the ventricular stimulating pulse VP of the DDD backup pacemaker 104, in the event that it has been switched on either by the logic lO0 or by the failure of the patient's heart to beat at the lower rate of the DDD pacemaker. In any event, the VP pulse is likewise passed through the gate 138 and can start the timing window circuit 140. The output of the circuit 140 provides the timing window commencing at the end of a delay after either a RS or VP signal and ending at the end of the programmed timing window. For example, the timing window may extend from 50 milliseconds following the production of 2~i, 6S~-elther an RS or a VP slgnal and end 150 to 200 mllllseconds thereafter. Wlthln that tlme wlndow, lt would be expected that the electrocardlogram would exhlblt the patlent's ST
segment so that lts amplltude could be measured.
The output of the tlmlng clrcult 140 ls applled to an lnverter 144 and to gate clrcult 146 for enabllng the passage of the ST segment of the ECG slgnal to the lnput of the lntegrator 148. The lntegrator 148 lntegrates the voltage of the ST segment over the tlmlng wlndow and applles lt to one input of the ST comparator 150. At the same tlme, the ST
segment of the ECG ls stored ln ST buffer 114.
The second lnput of the ST comparator 150 ls coupled to the programmable ST varlatlon threshold set polnt 152. The output of the ST comparator 150 ls coupled to the thlrd lnput termlnal of loglc array 100. When the value of the lntegrated ST segment exceeds the threshold, the ST comparator 150 provldes a further slgnal lndlcatlve of the onset of lschemla to loglc 100.
The programmable loglc array 100, may be programmed from outslde the patlent's body by a programmer of the type descrlbed ln Medtronlc U.S. Patent No. 4,550,370. Thus the physlclan can choose to use one or more of the output slgnals of the three sensors ln comblnatlon. If more than one sensor ls selected, then loglc 100 operates as an AND gate requlrlng that all selected sensor outputs lndlcate the onset of lschemla before providlng an output trlggerlng slgnal to the DDD pacemaker 104, the one-shot 102 and the transfer loglc ~ .
~ ~ ~ UJ~, 106.
When the condltlons programmed lnto loglc array 100 are satlsfled lt lssues an output to one-shot 102 whlch ln turn lssues a start command pulse to programmable stlmulator 108. Programmed electrlcal stlmulatlon pulse tralns are applled to the electrodes 74, 76. If programmed "on", the pulse tralns may be synchronlzed to the next detected RS out from ampllfler 136.
Slmllarly, the external programmer can be used to control the settlng of the thresholds of the programmable set polnts 120, 128 and 152 as well as the tlmlng of the tlmlng wlndow clrcult 140 and the synchronlzatlon delay of 108 to a ventrlcular event.
The DDD pacemaker depicted ln block 104 also may lnclude a dlscrete dlgltal loglc or mlcroprocessor based tlmlng and control clrcult 154, an atrlal sense ampllfler 156 coupled to the coronary slnus electrode (or separate atrlal electrode bearlng lead) for developlng a P-wave out signal AS, and atrlal and ventrlcular pulse generator 158 and 160 for 20 produclng the atrial and ventrlcular stlmulatlng pulses AP and VP. The sense ampllflers and output pulse generators are coupled through blanking and refractory lnterfaces 97, 162 and 164 ln a manner well known ln the paclng art. The DDD
pacemaker may have programmable parameters and modes as well as upllnk and downllnk telemetry as ls well known ln the art.
The pacemaker may, for example, take the form of the J ~ ~t Medtronica SYMBOISa Model 7005 or llke pacemaker and the DDD
pacemaker dlsclosed in Medtronic U.S. Patent 4,390,020. One speclfic operatlng mode for the pacemaker 104 may be to program lt to operate only after recelvlng a trlgger slgnal lndlcatlng lschemla at trlgger lnput 166 and then only untll the heart's own rate rlses above a programmable lower rate.
Although a DDD pacemaker 104 ls deplcted, lt wlll be understood that a slngle chamber pacemaker could also be used to stlmulate only the ventrlcle and serve only the QRS
complex. The pacemaker may take the form of any of the programmable pacemakers avallable ln the prlor art.
A further programmable feature of the system of the present lnventlon lles ln the selectlon of the burst pulse traln stlmulatlon frequency, amplltude and number of lmpulses ln each burst as well as the spaclng between lmpulses through the programmable stlmulator 108. Agaln wlth the ald of an external programmer, the physlclan may select each of the parameters of the burst stlmulatlon from an avallable menu at the tlme of patlent workup. In addltlon, ln thls regard, the programmer may select one or both of the electrodes 74 and 76 for appllcatlon of stlmulatlon pulses to the deslred nerves or the epldural space. The programmable lmplantable stlmulator 108 may take the form of the Medtronlca Itrela lmplantable neurologlcal devlce Model 7424 programmed by the Model 7432 console programmer.
* trade mark ~ ' I U~ 4 - 16a -In use of the system deplcted ln Flgure 2, lt ls contemplated that a patlent would be selected for lmplantatlon of such a system by a workup procedure employlng temporary pH
and oxygen sensor bearlng leads placed wlthln the patlent's coronary slnus and rlght ventrlcle coupled to an external verslon of the system deplcted ln Flgure 2 ln order to ascertaln the patlent's thresholds at the onset of symptoms of anglna pectorls. Durlng thls procedure the physlclan would select the parameters of the flrst stlmulatlon from the menu (that would llkewlse be avallable ln the lmplanted stlmulator) and, from the effect on the heart rate settle on the lnltial therapies and senslng thresholds to be programmed ln the lmplanted devlce.
A system deplcted ln Flgure 2 ls contemplated to possess radlo frequency telemetry 190, 192 for both the aforementloned downllnk telemetry of programmable modes and parameters as well as upllnk telemetry (as shown, for example ln U.S. Patent No. 4,556,063) of data derlved from the sensors and the electrocardlogram. To thls end, the transfer-to-memory loglc 106 effects the transfer of the contents of thebuffers 110, 112 and 114 as well as the real tlme ~date and tlme of day) clock 200 data lnto memory for a WO92/162~7 PCT/US92/02250 207~38~ ;.
later telemetry out of the pulse generator upon command.
Such uplink telemetry systems are in current use in implantable pacemakers and other implantable medical devices.
s The system depicted in Figure 2 may advantageously also be combined with an anti-tachycardia pacing system where certain of the sensors may advantageously be employed to detect or confirm the detection of the supraventricular tachyarrhythmia. It will be understood that at times ischemia is accompanied by a supraventricular tachycardia and that the stimulation of the carotid sinus nerves or other nerves related thereto may effect both the lowering of the blood pressure as well as the heart rate and create AV
block or prolongation. The DDD backup pacing in the system of the present invention is primarily intended to restore sequential heartbeat at the lower rate. However, the system may incorporate the anti-tachycardia pacing therapies in the event that the logic circuit 100 does not trigger the stimulator 108 because one or more of the sense conditions does not meet the ischemia threshold for that sensor.
The system may further include a patient-initiated storage of the aforementioned physiological conditions and treatment by delivery of stimulation. Failure of stimulation to prev~nt recurrences within a programmable period of time after detection of each episode is stored in memory and triggers an increase in stimulation amplitude and/or duration. Stimulation frequency may be varied in a predetermined manner from the optimum stimulation frequency, amplitude and duration determined during patient workup and a patient override may be provided to turn the stimulation on or off.
It will be apparent to those skilled in the art that the electronics of the system described above are easily attainable using available technology. The electronics may be embodied in custom integrated circuit and software based ~ 63Q~
microprocessor technology. It will be understood that while the major components of the system, e.g. the pacemaker and nerve stimulator, have been referenced to existing discrete implantable devices, they and the remaining described components of Figure 2 may all be incorporated within a single implantable device (with the elimination of duplicated features) and programmed by a single external programmer and telemetry receiver.
It will thus be appreciated that the present invention as described above defines a system having distinct advantages over previously existing systems for reducing ischemia by stimulation of nerves typically the carotid sinus nerves. This system features a high degree of specificity to ischemic conditions and a high degree of flexibility for recognizing and treating conditions and arrhythmias of a heart frequently associated with coronary artery disease and myocardial insufficiency.
Although an exemplary embodiment of the present invention has been shown and described, it will be apparent to those having ordinary skill in the art that a number of changes, modifications, or alterations to the invention as described herein may be made, none of which depart from the spirit of the present invention. All such changes, modifications and alterations should therefore be seen within the scope of the present invention.
Claims (17)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A system for influencing the natural biological blood pressure regulatory system in a patient, for reducing and controlling ischemia of myocardial tissue by electrical pulse by stimulation of the patient's nerve system, said system comprising:
ischemia sensor means adapted to be located within the venous return system of a patient's heart for sensing a constituent of the venous return blood draining from myocardial tissue and producing an electrical output signal substantially representing a chemical constituent of that blood;
signal transforming means for receiving the sensor means output signal and developing a stimulation trigger signal in response to an output signal indicative of a condition of ischemia, and means responsive to said trigger signal for applying electric stimulation pulses to said nerve system.
ischemia sensor means adapted to be located within the venous return system of a patient's heart for sensing a constituent of the venous return blood draining from myocardial tissue and producing an electrical output signal substantially representing a chemical constituent of that blood;
signal transforming means for receiving the sensor means output signal and developing a stimulation trigger signal in response to an output signal indicative of a condition of ischemia, and means responsive to said trigger signal for applying electric stimulation pulses to said nerve system.
2. The system of claim 1 further comprising:
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means responsive to said patient's electrocardiogram for developing a signal representative of the ST segment variation of that electrocardiogram;
means for comparing the measured ST segment variation to an ST segment variation threshold level and providing an ST
segment output signal when the measured ST segment varies from the ST segment variation threshold in a predetermined manner;
and means responsive to both said ST segment output signal and said trigger signal for triggering said stimulation means.
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means responsive to said patient's electrocardiogram for developing a signal representative of the ST segment variation of that electrocardiogram;
means for comparing the measured ST segment variation to an ST segment variation threshold level and providing an ST
segment output signal when the measured ST segment varies from the ST segment variation threshold in a predetermined manner;
and means responsive to both said ST segment output signal and said trigger signal for triggering said stimulation means.
3. The system of claim 1 or 2 wherein said ischemia sensor means further comprises:
a blood gas sensor means for detecting a value related to blood gas within the venous return system of said patient's heart and developing a blood gas signal in response to;
means for establishing a blood gas threshold value;
comparator means for comparing said blood gas signal to said blood gas threshold value and developing a blood gas difference signal;
and wherein said signal transforming means further comprises:
means for triggering said stimulating means in response to a predetermined value of said blood gas difference signal.
a blood gas sensor means for detecting a value related to blood gas within the venous return system of said patient's heart and developing a blood gas signal in response to;
means for establishing a blood gas threshold value;
comparator means for comparing said blood gas signal to said blood gas threshold value and developing a blood gas difference signal;
and wherein said signal transforming means further comprises:
means for triggering said stimulating means in response to a predetermined value of said blood gas difference signal.
4. The system of claims 1 or 2 wherein said sensor means comprises means for detecting the pH of the patient's blood in the coronary sinus of the patient's heart.
5. The system of claims 1 or 2 wherein said sensor means comprises means for sensing dissolved blood oxygen (SO2) in venous return blood in the coronary sinus region of said patient's heart.
6. The system according to claims 1 or 2 further comprising:
means for providing pacing stimulation energy pulses to said patient's heart in response to a low heart rate;
electrode means for coupling said pacing stimulation pulses to said patient's heart; and sensing means coupled to said electrode means for sensing the electrocardiogram of the patient's heart and determining that a bradycardia condition exists.
means for providing pacing stimulation energy pulses to said patient's heart in response to a low heart rate;
electrode means for coupling said pacing stimulation pulses to said patient's heart; and sensing means coupled to said electrode means for sensing the electrocardiogram of the patient's heart and determining that a bradycardia condition exists.
7. The system according to claim 1 further comprising:
means for storing values of said ischemia sensor means upon confirmation of ischemia; and means for telemetering said stored values to a remote location upon command.
means for storing values of said ischemia sensor means upon confirmation of ischemia; and means for telemetering said stored values to a remote location upon command.
8. The system according to claim 2 further comprising:
means for storing said measured ST segment signal; and means for telemetering said stored ST segment signal to a remote location on command.
means for storing said measured ST segment signal; and means for telemetering said stored ST segment signal to a remote location on command.
9. A system for influencing the natural biological blood pressure regulatory system of a patient, for reducing and controlling ischemia of myocardial tissue by electrical pulse stimulation of the patient's nerve system, said system comprising:
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means for receiving said patient's electrocardiogram and developing a signal representative of the ST segment of that electrocardiogram;
means for providing an ST segment variation threshold value;
means for comparing the derived ST segment to said ST
segment variation threshold level and providing an ST segment output signal when the measured ST segment variation varies from the ST segment variation threshold value in a predetermined manner; and means responsive to said ST segment output signal for applying electric stimulation pulses to said nerve system.
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means for receiving said patient's electrocardiogram and developing a signal representative of the ST segment of that electrocardiogram;
means for providing an ST segment variation threshold value;
means for comparing the derived ST segment to said ST
segment variation threshold level and providing an ST segment output signal when the measured ST segment variation varies from the ST segment variation threshold value in a predetermined manner; and means responsive to said ST segment output signal for applying electric stimulation pulses to said nerve system.
10. The system according to claim 9 further comprising:
means for providing pacing stimulation energy pulses to said patient's heart in response to a low heart rate;
electrode means for coupling said pacing stimulation pulses to said patient's heart; and sensing means coupled to said electrode means for sensing the electrocardiogram of the patient's heart and determining that a bradycardia condition exists.
means for providing pacing stimulation energy pulses to said patient's heart in response to a low heart rate;
electrode means for coupling said pacing stimulation pulses to said patient's heart; and sensing means coupled to said electrode means for sensing the electrocardiogram of the patient's heart and determining that a bradycardia condition exists.
11. The system according to claim 9 further comprising:
means for storing values of the ST segments upon confirmation of ischemia; and means for telemetering said stored values to a remote location on command.
means for storing values of the ST segments upon confirmation of ischemia; and means for telemetering said stored values to a remote location on command.
12. A system for influencing the natural biological blood pressure regulatory system in a patient, for reducing and controlling ischemia of myocardial tissue by electrical pulse, stimulation of the patient's nerve system, said system comprising means for continuously measuring the electrogram of the patient's heart;
means for detecting certain characteristics of said electrogram indicative of an ischemic condition of the myocardium;
means for initiating the storage of a sequence of said characteristics of said electrogram upon detection of an ischemic condition;
means for delivering one or more electrical stimulation therapies to the patient's nervous system for depressing the patient's heart rate; and means for initiating the storage of a further sequence of said characteristics of said electrogram following delivery of said stimulation therapies.
means for detecting certain characteristics of said electrogram indicative of an ischemic condition of the myocardium;
means for initiating the storage of a sequence of said characteristics of said electrogram upon detection of an ischemic condition;
means for delivering one or more electrical stimulation therapies to the patient's nervous system for depressing the patient's heart rate; and means for initiating the storage of a further sequence of said characteristics of said electrogram following delivery of said stimulation therapies.
13. The apparatus of claim 12 further comprising:
means for examining the QRST segment of the patient's electrogram;
means for measuring the ST segment variation of said QRST
components of said electrogram;
means for comparing the measured ST segment variations to a threshold ST segment variation and providing a trigger signal when said ST segment variation differs from the threshold ST segment variation in a predetermined manner; and means for delivering said stimulation therapies in response to said trigger signal.
means for examining the QRST segment of the patient's electrogram;
means for measuring the ST segment variation of said QRST
components of said electrogram;
means for comparing the measured ST segment variations to a threshold ST segment variation and providing a trigger signal when said ST segment variation differs from the threshold ST segment variation in a predetermined manner; and means for delivering said stimulation therapies in response to said trigger signal.
14. A system for influencing the natural biological blood pressure regulatory system in a patient, for reducing and controlling ischemia of myocardial tissue by electrical pulse, stimulation of the patient's nerve system, said system comprising:
ischemia sensor means adapted to be located within the venous return system of a patient's heart for sensing a constituent of the venous return blood draining from myocardial tissue and producing an electrical output signal substantially representing chemical constituent of that blood;
signal transforming means for receiving the electrical output signal and developing a stimulation trigger signal in response to said electrical output signal indicative of a condition of ischemia; and means responsive to said trigger signal for applying electric stimulation pulses to said nerve system and storing said output signal.
ischemia sensor means adapted to be located within the venous return system of a patient's heart for sensing a constituent of the venous return blood draining from myocardial tissue and producing an electrical output signal substantially representing chemical constituent of that blood;
signal transforming means for receiving the electrical output signal and developing a stimulation trigger signal in response to said electrical output signal indicative of a condition of ischemia; and means responsive to said trigger signal for applying electric stimulation pulses to said nerve system and storing said output signal.
15. The system of claim 14 wherein said sensor means comprises means for detecting the pH of the patient's blood in the coronary sinus of the patient's heart.
16. The system of claims 14 or 15 wherein said sensor means comprises means for sensing dissolved blood oxygen (SO2) in venous return blood in the coronary sinus region of said patient's heart.
17. The system of claim 14 further comprising:
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means responsive to said patient's electrocardiogram for developing a signal representative of the ST segment variation of that electrocardiogram;
means for comparing the measured ST segment variation to an ST segment variation threshold level and providing an ST
segment output signal when the measured ST segment variation differs from the ST segment variation threshold in a predetermined manner; and means responsive to both said ST segment output signal and said trigger signal for triggering said stimulation means.
electrode means coupled to said patient's heart for detecting the patient's electrocardiogram;
means responsive to said patient's electrocardiogram for developing a signal representative of the ST segment variation of that electrocardiogram;
means for comparing the measured ST segment variation to an ST segment variation threshold level and providing an ST
segment output signal when the measured ST segment variation differs from the ST segment variation threshold in a predetermined manner; and means responsive to both said ST segment output signal and said trigger signal for triggering said stimulation means.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/673,883 | 1991-03-22 | ||
US07/673,883 US5199428A (en) | 1991-03-22 | 1991-03-22 | Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload |
Publications (2)
Publication Number | Publication Date |
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CA2076384A1 CA2076384A1 (en) | 1992-09-23 |
CA2076384C true CA2076384C (en) | 1998-05-26 |
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ID=24704478
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Application Number | Title | Priority Date | Filing Date |
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CA002076384A Expired - Fee Related CA2076384C (en) | 1991-03-22 | 1992-03-18 | Implantable electrical nerve stimulator pacemaker with ischemia detector for decreasing cardiac workload |
Country Status (7)
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US (1) | US5199428A (en) |
EP (2) | EP0530354B1 (en) |
JP (1) | JP2620819B2 (en) |
AU (1) | AU648167B2 (en) |
CA (1) | CA2076384C (en) |
DE (2) | DE69225813D1 (en) |
WO (1) | WO1992016257A1 (en) |
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1991
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1992
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- 1992-03-18 EP EP96200600A patent/EP0721786B1/en not_active Expired - Lifetime
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JP2620819B2 (en) | 1997-06-18 |
EP0721786A2 (en) | 1996-07-17 |
DE69225813D1 (en) | 1998-07-09 |
DE69223703T2 (en) | 1998-07-16 |
AU648167B2 (en) | 1994-04-14 |
JPH06502571A (en) | 1994-03-24 |
AU1647992A (en) | 1992-10-21 |
EP0721786A3 (en) | 1996-08-07 |
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