1. Field of the Invention
The present invention generally relates to the field of implantable heart stimulation devices, such as pacemakers, implantable cardioverter-defibrillators (ICD), and similar cardiac stimulation devices that also are capable of monitoring and detecting electrical activities and events within the heart. More specifically, the present invention relates to an implantable medical device for monitoring the movements of the valve planes of the heart to determine at least one hemodynamic measure reflecting a mechanical functioning of a heart of a patient.
2. Description of the Prior Art
Implantable heart stimulators that provide stimulation pulses to selected locations in the heart, e.g. selected chambers, have been developed for the treatment of cardiac diseases and dysfunctions. Heart stimulators have also been developed that affect the manner and degree to which the heart chambers contract during a cardiac cycle in order to promote the efficient pumping of blood.
Furthermore, the heart will pump more effectively when a coordinated contraction of both atria and ventricles can be provided. In a healthy heart, the coordinated contraction is provided through conduction pathways in both the atria and the ventricles that enable a very rapid conduction of electrical signals to contractile tissue throughout the myocardium to effectuate the atrial and ventricular contractions. If these conduction pathways do not function properly, a slight or severe delay in the propagation of electrical pulses may arise, causing asynchronous contraction of the ventricles which would greatly diminish the pumping efficiency of the heart. Patients who exhibit pathology of these conduction pathways, such as patients with bundle branch blocks, etc., can thus suffer from compromised pumping performance. For example, asynchronous movements of the valve planes of the right and left side of the heart, e.g. an asynchronous opening and/or closure of the aortic and pulmonary valves, is such an asynchrony that affects the pumping performance in a negative way. This may be caused by right bundle branch block (RBBB), left bundle branch block (LBBB), or A-V block. In a well functioning heart the left and right side of the heart contract more or less simultaneously starting with the contraction of the atria flushing down the blood through the valves separating the atria from the ventricles. In the right side of the heart through the tricuspid valve and in the left side of the heart through the mitral valve. Shortly after the atrial contraction the ventricles contract resulting in increasing blood pressure inside the ventricles that first closes the one way valves to the atria and after that forces the outflow valves to open. In the right side of the heart it is the pulmonary valves, that separates the right ventricle from the pulmonary artery that leads the blood to the lung, which is opened. In the left side of the heart the aortic valve separates the left ventricle from the aorta that transports blood to the whole body. The outflow valves, the pulmonary valve and aortic valve, open when the pressure inside the ventricle exceeds the pressure in the pulmonary artery and aorta, respectively. The ventricles are separated by the intraventricular elastic septum. Hence, for a well functioning heart a substantially synchronous operation of the left and right hand side of the heart, e.g. a synchronous opening and/or closure of the aortic and pulmonary, is of a high importance.
Various procedures have been developed for addressing disorders related to asynchronous function of the heart. For instance, cardiac resynchronization therapy (CRT) can be used for effectuating synchronous atrial and/or ventricular contractions. Furthermore, cardiac stimulators may be provided that deliver stimulation pulses at several locations in the heart simultaneously, such as biventricular stimulators. The stimulation pulses could also be delivered to different locations with a selected delay in an attempt to optimize the hemodynamic performance, e.g. synchronize the closure of the aortic and pulmonary valves, in relation to the specific cardiac dysfunction present at the time of implant.
Information about the mechanical functioning of a heart can be obtained by means electrical signals produced by the heart. In a healthy heart the sinus node, situated in the right atrium, generates electrical signals which propagates throughout the heart and control its mechanical movement. Some medical conditions, however, affect the relationship between the electrical and mechanical activity of the heart and, therefore, measurements of the electrical activity only cannot be relied upon as indicative of the true status of the heart or as suitable for triggering stimulation of the heart.
Consequently, there is a need within the field of methods and devices for obtaining accurate and reliable signals reflecting different aspects of mechanical functioning of the heart.
Impedance measurements has been shown to provide reliable information regarding the mechanical functioning of the heart. Through the impedance measurements, blood volume changes are detectable. Blood has a higher conductivity (lower impedance) than myocardial tissue and lungs. The impedance-volume relationship is inverse; the more blood—the smaller impedance. In EP 1 561 489, for example, transvalvular impedance measurements are made between an atrium and a ventricle electrode of a implanted electro-catheter to provide information indicative of the mechanical state of the heart. The information is used to control the pacing rate of a rate responsive pacemaker. In particular, the impedance between across the tricuspid valve between the atrium and the ventricle of the right hand side of the heart is measured.
However, in order to be able to optimize the functioning of the heart it is of interest to obtain information that provide a more complete picture of the mechanical functioning and the pumping action of the heart and that provide accurate and reliable information of the mechanical functioning and the pumping action of the heart.
An object of the present invention is to address the problem of obtaining information that reflects the mechanical functioning and the pumping action of the heart.
A further object of the present invention is to provide a device and method that automatically obtains information that reflects the mechanical functioning and the pumping action of the heart in an accurate and reliable way.
According to an aspect of the present invention, there is provided an implantable medical device for determining at least one hemodynamic measure reflecting a mechanical functioning of a heart of a patient including a pace pulse generator adapted to produce cardiac stimulating pacing pulses and being connectable to at least one medical lead for delivering the pulses to cardiac tissue of the heart. The implantable medical device has an impedance measuring circuit that, during impedance measuring sessions, measures impedance between at least a first pair of electrodes of the at least one medical lead. The at least first pair includes at least one electrode located in an atrium of the heart and at least one valve plane electrode located substantially at the level of a valve plane the heart. The impedance measuring circuit also measures impedance between at least a second pair of electrodes of the at least one medical lead, the at least second pair including at least one electrode located in a ventricle of the heart and at least one valve plane electrode located substantially at the level of the valve plane. These measured impedances reflect valve plane movements. A hemodynamic parameter determining circuit determines at least one hemodynamic parameter based on the impedances, wherein the at least one hemodynamic parameter representing the mechanical functioning of a heart.
According to a second aspect of the present invention, there is provided a method for determining at least one hemodynamic measure reflecting a mechanical functioning of a heart of a patient using an implantable medical device including a pace pulse generator adapted to produce cardiac stimulating pacing pulses and being connectable to at least one medical lead for delivering the pulses to cardiac tissue of the heart. The method includes the steps of, during impedance measuring sessions, measuring impedance between at least a first pair of electrodes of the at least one medical lead, the at least first pair including at least one electrode located in an atrium of the heart and at least one valve plane electrode located substantially at the level of a valve plane the heart, and between at least a second pair of electrodes of the at least one medical lead, the at least second pair including at least one electrode located in a ventricle of the heart and at least one valve plane electrode located substantially at the level of the valve plane. These impedances reflect valve plane movements are obtained. At least one hemodynamic parameter based on the impedances is automatically determined, that reflects the mechanical functioning of a heart.
According to a third aspect of the present invention, there is provided a computer readable medium comprising instructions that cause a programmable device to perform steps of a method according to the second aspect of the present invention.
Thus, the present invention is based on the insight of monitoring valve movements using electrodes placed adjacent to or substantially at the level of the valve plane of the heart by measuring impedance variations between at least one electrode placed adjacent to or substantially at the level of the valve plane and at least one electrode attached in an atrium and at least one electrode attached in a ventricle, respectively. The valve plane movements are caused by the pumping action of the heart, i.e. by the increased and decreased volume of the ventricles, and by studying the valve plane movements the contraction pattern and mechanical functioning of the heart can be monitored. The measured impedances can, in turn, be used to determine hemodynamic parameters reflecting the mechanical functioning of the heart. Thereby, it is possible to automatically obtain information that accurately and reliably reflects the mechanical functioning and the pumping action of the heart.
The obtained information regarding the mechanical functioning of the heart may, for example, be used to optimize parameters of the implantable medical device such as the AV or VV delay. In one embodiment of the present invention, the implantable medical comprises an AV and/or VV delay determining circuit adapted to initiate an optimization procedure, wherein the pace pulse generator is controlled to, based on the hemodynamic parameter, iteratively adjust a present AV and/or VV delay to optimize an AV and/or VV delay with respect to the hemodynamic parameter. Thereby, the AV and/or VV delay can be dynamically and automatically adjusted with respect to the present pumping action of the heart. Further, the adjustments of the AV and/or VV delay can be made dynamically as a response to a changing mechanical functioning of the heart.
In a further embodiment of the present invention, the impedance measuring circuit, during impedance measuring sessions, measures impedance between the at least first pair of electrodes of the at least one medical lead including an electrode located in an atrium of the heart and at least one first valve plane electrode located substantially at the level of the valve plane in close proximity to the right atrium of the heart and at least one second valve plane electrode located substantially at the level of the valve plane in close proximity to the left atrium of the heart, respectively, as well as between the at least second pair of electrodes of the at least one medical lead including an electrode located in a ventricle of the heart and the valve plane electrodes located substantially at the level of the valve plane, respectively. These impedance signals reflect valve plane movements at respective sides of the heart and the hemodynamic parameter determining circuit determines a synchronicity measure based on the impedances, the synchronicity measure reflecting a synchronicity between the valve plane movements of the right hand side and the left hand side of the heart, respectively, during the measurement sessions. In embodiments of the present invention, synchronicity between a closure of the aortic valve and the pulmonary valve and/or an opening of the aortic valve and the pulmonary valve is/are determined.
Thereby, it is possible to monitor the parallelity or synchronicity of the left and right hand side of the heart in an accurate and reliable way as well as the operation of the aortic valve and the pulmonary valves. In a well functioning heart the left and right side of the heart contract more or less simultaneously starting with the contraction of the atria flushing down the blood through the valves separating the atria from the ventricles. In the right side of the heart through the tricuspid valve and in the left side of the heart through the mitral valve. Shortly after the atrial contraction the ventricles contract resulting in increasing blood pressure inside the ventricles that first closes the one way valves to the atria and after that forces the outflow valves to open. In the right side of the heart it is the pulmonary valves, that separates the right ventricle from the pulmonary artery that leads the blood to the lung, which is opened. In the left side of the heart the aortic valve separates the left ventricle from the aorta that transports blood to the whole body. The outflow valves, the pulmonary valve and aortic valve, open when the pressure inside the ventricle exceeds the pressure in the pulmonary artery and aorta, respectively. Hence, for a well functioning heart a substantially synchronous opening and/or closure of the aortic and pulmonary is of a high importance.
In another embodiment of the present invention, a synchronicity between a closure of the mitral valve and the tricuspid valve, respectively, is determined based on the impedances.
According to a further example of the present invention, the AV and/or VV delay determining circuit initiates an optimization procedure, wherein the pace pulse generator is controlled, based on the synchronicity measure, to iteratively adjust a present AV and/or VV delay to identify an AV and/or VV delay that causes substantially synchronized valve plane movements of the right hand side and the left hand side of the heart, respectively, during a cardiac cycle.
In yet another example of the present invention, the AV and/or VV delay determining circuit initiates an optimization procedure, wherein the pace pulse generator is controlled, based on the synchronicity between a closure of the aortic valve and the pulmonary valve and/or the synchronicity between an opening of the aortic valve and the pulmonary valve, to iteratively adjust a present AV and/or VV delay to identify an AV and/or VV delay that causes a substantially synchronized closure and/or opening of the aortic valve and the pulmonary valves.
Moreover, the AV and/or VV delay determining circuit may be adapted to initiate an optimization procedure, wherein the pace pulse generator is controlled to, based on the synchronicity between a closure of the mitral valve and the tricuspid valve, iteratively adjust a present AV and/or VV delay to identify an AV and/or VV delay that causes a substantially synchronized closure of the mitral and tricuspid valves.
In embodiments of the present invention, the impedance measuring circuit determines a maximum and/or minimum impedance of each respective impedance for each cardiac cycle. Moreover, the impedance measuring circuit may be adapted to determine a maximum absolute derivative of each respective impedance for each cardiac cycle.
In still another example, the impedance measuring circuit performs the impedance measuring sessions during successive cardiac cycles, wherein impedance signals reflecting valve plane movements during the successive cardiac cycles are obtained.
According to embodiments of the present invention, the at least one valve plane electrode is placed endocardially.
Alternatively, the at least one valve plane electrode is placed epicardially.
In certain embodiments of the present invention, the at least one valve plane electrode is placed intrapericardially on the surface of the heart.
According to further examples of the present invention, the first valve plane electrode is placed endocardially in the right atrium, or in the left atrium, or in the left ventricle, or in the right ventricle, or epicardially and the second valve plane electrode is placed endocardially in the right atrium, or in the left atrium, or in the left ventricle, or in the right ventricle or epicardially.
As the skilled person realizes, steps of the methods according to the present invention, as well as preferred embodiments thereof, are suitable to realize as computer program or as a computer readable medium.
Further objects and advantages of the present invention will be discussed below by means of exemplifying embodiments.
The following is a description of exemplifying embodiments in accordance with the present invention. This description is not to be taken in limiting sense, but is made merely for the purposes of describing the general principles of the invention. Thus, even though particular types of implantable medical devices such as heart stimulators will be described, e.g. biventricular pacemakers, the invention is also applicable to other types of cardiac stimulators such as dual chamber stimulators, implantable cardioverter defibrillators (ICDs), etc.
In the following a number of different electrode configurations suitable for obtaining impedances reflecting the mechanical functioning of the heart, and in particular movements of the valve plane, will be discussed.
With reference first to
In order to sense right ventricular and atrium cardiac signals and impedances and to provide stimulation therapy to the right ventricle RV, the stimulation device 10 is coupled to an implantable right ventricular lead 20 having a ventricular tip electrode 22, a ventricular annular or ring electrode 24, and a first valve plane electrode 26. The ring electrode 24 is arranged for sensing electrical activity, intrinsic or evoked, in the right ventricle RV. The right ventricular tip electrode 22 is arranged to be implanted in the endocardium of the right ventricle, e.g. near the apex 8 of the heart. Thereby, the tip electrode 22 becomes attached to cardiac wall. In this example, the tip electrode 22 is fixedly mounted in a distal header portion of the lead 20. Furthermore, the first valve plane electrode 26, which may a annular or ring electrode, is located substantially at the level of the valve plane 6.
In order to sense left atrium and ventricular cardiac signals and impedances and to provide pacing therapy for the left ventricle LV, the stimulation device 10 is coupled to a “coronary sinus” lead 30 designed for placement via the coronary sinus in veins located distally thereof, so as to place a distal electrode adjacent to the left ventricle and an electrode adjacent to the right atrium RA. The coronary sinus lead 30 is designed to received ventricular cardiac signals from the cardiac stimulator 10 and to deliver left ventricular LV pacing therapy using at least a left ventricular tip electrode 32 to the heart 1. In the illustrated example, the LV lead 30 has an annular ring electrode 34 for sensing electrical activity related to the left ventricle LV of the heart. Moreover, a second valve plane electrode 36, which may a annular or ring electrode, is located substantially at the level of the valve plane 6 and measurement electrode 35, which may a annular or ring electrode, is located adjacent to the right atrium RA.
With reference to
Thus, the impedance Z26-35 and the impedance Z26-22, respectively, will vary during the cardiac cycle as a response to the movements of the valve plane 6 at the right hand side of the heart 1. Similarly, at the left hand side of the heart 1, the impedance Z36-35 the impedance Z36-32 will vary during the cardiac cycle as a response to the movements of the valve plane 6.
Moreover, the impedance Z36-22 will be substantially constant over the cardiac cycle, which also is the case for the impedance Z36-32. By comparing the detected impedances of the respective sides of the heart, asynchronicity or parallelity of the valve plane movements of the respective sides of the valve plane 6 can be determined. In case of an asynchronous depolarization sequence of the heart, the valve plane may move asynchronously and be bent during the heart cycle which will be reflected by an asynchronicity between the detected impedance at the right hand side and the left hand side, respectively.
Turning briefly to
With reference now to
Referring now to
In
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In
Referring now to
In
Even though a number of examples have been illustrated in
Turning now to
The pulse generator 126 and the detector 128 are controlled by a control unit 140 which regulates the stimulation pulses with respect to amplitude, duration and stimulation interval, the sensitivity of the detector 128 etc.
A physician using an extracorporeal programmer 144 can communicate, via a telemetry unit 142, with the heart stimulator 10 and thereby obtain information on identified conditions and also reprogram the different functions of the heart stimulator 10.
Furthermore, the heart stimulator 10 has an impedance measuring circuit 146 adapted to, during impedance measuring sessions, measure impedance signals between at least a first pair of electrodes, which at least first pair includes at least one electrode located in an atrium of the heart and at least one valve plane electrode located substantially at the level of a valve plane the heart. Further, the impedance measuring circuit 146 is adapted to, during the impedance measuring sessions, measure impedance signals between at least a second pair of electrodes, which at least second pair includes at least one electrode located in at least one ventricle of the heart and at least one valve plane electrode located substantially at the level of the valve plane. In
Moreover, the heart stimulator 10 has a hemodynamic parameter determining circuit 152 adapted to determine at least one hemodynamic parameter based on impedances received from the impedance measuring circuit 146. The hemodynamic parameter determining circuit 152 includes a microprocessor, which may, for example, control the impedance measuring circuit 146 to, inter alia, initiate an impedance measuring session, the length and/or amplitude of the generated current pulses. The at least one hemodynamic parameter based on the measured impedances reflects the mechanical functioning of the heart. A number of different parameters may be extracted from the measured impedances and monitored including pre-ejection period, a contraction patter, mitral regurgitation, a synchronicity between the left and right hand sides of the heart, etc.
In one embodiment, the hemodynamic parameter determining circuit 152 is adapted to determine a synchronicity measure based on the impedances reflecting the synchronicity between the valve plane movements of the right hand side and the left hand side of the heart, respectively, during impedance measurement sessions. Through the impedance measurements, blood volume changes are detected. Blood has a higher conductivity (lower impedance) than myocardial tissue and lungs. The impedance-volume relationship is inverse; the more blood—the smaller impedance. Accordingly, the impedance will vary over the cardiac cycle in connection with the contraction and filling of the atria and ventricles, respectively, in, hence, in connection with the pressure variations during the cycle. For example, the ventricle volume is at a maximum level at the onset of the systolic phase of the ventricles, which corresponds to a minimum impedance measured over the ventricles, and the ventricle volume is at a minimum level at onset of diastolic phase of the ventricles, which corresponds to a maximum impedance measured over the ventricles.
In one embodiment, the synchronicity between a closure of the aortic valve and the pulmonary valve and/or a synchronicity between an opening of the aortic valve and the pulmonary valve is determined using the measured impedances. For example, if the electrode configuration illustrated in
The heart stimulator 10 further has an AV and/or VV delay determining circuit 154 adapted to determine a AV and/or VV delay with respect to a determined hemodynamic parameter, for example, a synchronicity between an opening and/or a closure of the pulmonary and aortic valves. In one embodiment, the AV and/or VV delay determining circuit 154 is integrated in the control circuit 140. The AV and/or VV delay determining circuit 154 is adapted to initiate an optimization procedure (e.g. via the control circuit 140), wherein the pace pulse generator 126 is controlled to iteratively adjust a present AV and/or VV delay to optimize an AV and/or VV delay with respect to the determined hemodynamic parameter starting from the determined AV and/or VV delay. For example, if it is determined that the movements of the valve plane at the right hand side of the heart is ahead the movements of the left hand side in the cardiac cycle, the VV delay may be adjusted such that the left ventricle is stimulated first and vice versa. However, it is important that AV delay of the left side has a sufficient length, i.e. if the different between the right side and the left side is large there is a risk that the effective AV delay on the left side becomes too short. In such a case, the AV delay should also be lengthened.
Turning now to
In further embodiments, the indication of an asynchronicity between valve plane movements of the right and left side of the heart, for example, between the opening and/or closing of the aortic and pulmonary valves, could be used for triggering an alarm signal to the patient. This alarm signal could be intended for prompting the patient to seek medical assistance for care of follow-up. The alarm signal may alternatively, or as a compliment, be transferred to an extracorporeal unit 144 or a care institution via the telemetry unit 142.
Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/SE2007/000411 | 4/27/2007 | WO | 00 | 10/23/2009 |