Patent Application
20250001184
The present invention relates to an implantable medical device for stimulating a human or animal heart according to the preamble of claim 1, to a method for controlling such an implantable medical device according to the preamble of claim 13, and to a computer program product according to the preamble of claim 14.
Implantable medical devices for stimulating a human or animal heart, such as pacemakers, have been known for a long time. They can perform different functions. Among other things, it is known to use such pacemakers for the treatment of atrial arrhythmias. Different stimulation programs can be carried out by an appropriate pacemaker to restore the treated heart to a normal state.
In known implementations, so-called aATP (atrial anti-tachycardia pacing) stimulation pulses are delivered within the atrium of the heart to be stimulated for the termination of atrial tachycardia (AT) or atrial fibrillation (AFib). A temporal synchronization of aATP therapy to a ventricular cardiac action is known.
In further realization examples of aATP therapy, such as described in U.S. Pat. No. 6,876,880 B2, aATP stimulation pulses are delivered when
A prerequisite of a safe and reliable atrial antitachycardie pacing is a stably located atrial stimulation electrode. Thus, it is necessary to identify any undesired electrode dislocation prior to deliver atrial antitachycardie pacing pulses.
The known methods for evaluating an atrial electrode position cannot be used or can only be used to a limited extent in case of atrial tachycardia. For example, the evaluation of temporal sequences (e.g., atrial pace/ventricular sense) is not possible because here the atrial tachycardia leads to a non-physiological conduction behavior. Similarly, evaluation of electrode impedances alone is insufficient for such a situation, since an electrode dislocated into the ventricle could also have a valid electrode impedance there.
The present disclosure is directed toward overcoming one or more of the above-mentioned problems, though not necessarily limited to embodiments that do.
It is an object of the present invention to provide a cardiac stimulator that makes delivery of an atrial ATP safer than prior art cardiac stimulators and prevents erroneous ATP delivery.
At least this object is achieved with an implantable medical device having the features explained in the following. Such an implantable medical device serves for stimulating a human or animal heart. It comprises a processor, a memory unit, a first stimulation unit, a second stimulation unit, a first detection unit, and a second detection unit. The first stimulation unit serves for stimulating an atrium, in particular the right atrium, of a human or animal heart. The second stimulation unit serves for stimulating a ventricle, in particular the right ventricle, of the same heart. The first detection unit serves for detecting an electric signal in the atrium. Finally, the second detection unit serves for detecting an electric signal in the ventricle.
According to an aspect of the present invention, the memory unit comprises a computer-readable program that causes the processor to perform the steps explained in the following when executed on the processor.
First, the first detection unit is used for detecting an electric signal of the heart to be stimulated. This electric signal comprises at least two consecutive amplitudes. Each of the amplitudes correlate with the contraction of the heart to be stimulated. If an electrode of the first detection unit is properly placed within the atrium of the heart to be stimulated, the amplitudes correlate with an atrial contraction of the heart. If, however, a dislocation of the electrode of the first detection unit has been taken place, the amplitudes correlate to both the contraction of the atrium and of the ventricle of the heart to be stimulated. The presently claimed implantable medical device is able to distinguish between these two cases.
For this purpose, it is determined whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes each have a maximum lying within a predetermined intensity range. Alternatively or additionally, it is determined whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other with respect to the intensity
Within the frame of the application the term “a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other with respect to the intensity” is to be understood as maxima which deviate from each other with respect to intensity by at most 50%, in particular by not mor than 40%, in particular by not more than 30%, in particular by not more than 20%, in particular by not more than 15%, in particular not more than 12.5%, in particular by not more than 10%, in particular by not more than 7.5%, in particular by not more than 5%, in particular by not more than 2.5%, in particular by not more than 1% Or maxima which deviate from each other with respect to intensity by at most 2 mV, in particular by not more than 1 mV, in particular by not more than 0.5 mV.
If the maxima of the two amplitudes lie within the predetermined range and/or if the maxima of the two consecutive amplitudes do not significantly deviate from each other with respect to intensity, this is taken as indication that the atrial electrode has not been dislocated, i.e., that it is still appropriate to deliver an atrial antitachycardie pacing. It should be noted in this context that the atrial electrode of the implantable medical device forms part both of the first detection unit and of the first stimulation unit.
If the maxima of both amplitudes do not lie within the predetermined intensity range (if such compliance of the maxima with a given intensity range has been tested at all) and/or if the maxima of the two consecutive amplitudes deviate from each other by more than 20% (if the maxima of the two amplitudes have been compared with each other at all), an atrial stimulation with the first stimulation unit is prevented. Otherwise, an atrial stimulation with the first stimulation unit is allowed. Thus, the implantable medical device tests if the atrial detection and stimulation electrode is properly kept in place. If this is the case, an atrial stimulation can be performed. If, however, a dislocation of the atrial electrode has been determined, such atrial stimulation is prevented in order to avoid severe health risks of the patient carrying the implantable medical device.
The presently claimed implantable medical device thus ensures a safe implementation of an atrial ATP function, in particular if the device does not have a defibrillation backup. It enables a very reliable dislocation detection of the atrial electrode that can, e.g., be performed immediately before ATP therapy delivery. Then, in the case of an atrial lead dislocated in the ventricle and a resulting over-sensing, an erroneous aATP delivery in the ventricle can be prevented. This is of great physiological importance because aATP delivery in the ventricle could induce ventricular tachycardia or ventricular fibrillation.
In an embodiment, the active implantable medical device is an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), or a device for cardiac resynchronization therapy (CRT).
In an embodiment, the computer-readable program causes the processor to store the maxima of the amplitudes of the detected electric signal in the memory unit. In doing so, it is possible to compare an actual amplitude maximum with one or more precedingly determined amplitude maxima. Then, a dislocating trend of the atrial electrode can be determined. Thus, a movement of the atrial electrode over time can be easily traced by evaluating the determined amplitude maxima.
In an embodiment, the electric signal comprises a plurality of amplitudes, not only two consecutive amplitudes. Also in such a case, it is particularly easy to detect a dislocation of the atrial electrode over time and to compare the maximum of the current amplitude with not only a single other maximum, but with a plurality of maxima of other amplitudes previously detected with the first detection unit.
In an embodiment, the computer-readable program causes the processor to predetermine the intensity range. This is done on the basis of an average value of at least two previously detected amplitudes of the electric signal. In particular, a plurality (more than two) of previously detected amplitudes is used for calculating such an average.
In an embodiment, the calculated average is a floating average. Thus, the average value is a continuously updated average value that is calculated on the basis of a predetermined number of previously detected amplitudes of the electric signal. To give an example, the predetermined number can be any number in the range of 2 to 2000, in particular of 5 to 1500, in particular of 10 to 1000, in particular of 15 to 900, in particular of 20 to 800, in particular of 30 to 700, in particular of 40 to 600, in particular 50 to 500, in particular of 60 to 400, in particular of 70 to 300, in particular of 80 to 200, in particular of 90 to 100 previously detected amplitudes. This enhances the reliability of a dislocation detection of the atrial electrode since this detection is no longer dependent on a single previously detected value that could be an outlier not having a particular physiological relevance.
In an embodiment, the computer-readable program causes the processor to predetermine the intensity range on the basis of a threshold value and a standard deviation. For this purpose, the threshold value is typically calculated from at least two previously determined values of amplitude maxima, wherein the standard deviation between these at least two values is used for spanning up a confidence interval around the threshold value. It is also possible to add a fixed standard deviation (e.g., in form of a fixed relative or absolute value) to the threshold value. In doing so, a tolerance band can be spanned, wherein a location of the detected amplitude maximum within this tolerance band indicates that the atrial electrode is not dislocated but still in its proper place. On the other hand, if the detected amplitudes lie outside the tolerance band, this indicates a dislocation of the atrial electrode. Such lying outside the tolerance band is used as trigger for preventing an intended subsequent delivery of an atrial stimulation.
In an embodiment, the computer-readable program causes the processor to perform the step of determining whether the maxima of the two consecutive amplitudes lie within a predetermined intensity range and/or whether the maxima of the two amplitudes do not differ significantly from each other as well as the step of preventing an atrial stimulation if the preceding criteria have not been fulfilled and otherwise allowing atrial stimulation with the first stimulation unit are performed once a day. In doing so, a movement course of the atrial electrode can be detected early so that a dislocation of the atrial electrode is also detectable at an early stage. The step of detecting an electric signal comprising the at least two consecutive amplitudes can also be done once a day. Typically, this step is regularly done during a day in order to regularly sense the atrial activity of the heart to be stimulated.
In an embodiment, i) the step of detecting an electric signal, ii) the step of determining whether the maxima of the amplitudes lie within a predeterminable range and/or are in terms of intensity comparable to each other and iii) the step of preventing or allowing an atrial stimulation in dependence on the previous determination step are performed directly before an intended atrial stimulation of the heart with the first stimulation unit. In doing so, this step of delivering an atrial stimulation is made particularly safe since the cardiac state directly prior to the intended stimulation is checked. If the atrial electrode is then not properly placed, the atrial stimulation is prevented.
In an embodiment, the atrial stimulation is an atrial antitachycardie stimulation. As explained above, such an atrial antitachycardie stimulation is intended to terminate an atrial tachycardia or an atrial fibrillation.
In an embodiment, at least one of the first amplitude and the second amplitude reflects a P wave of an atrial contraction of the heart to be stimulated. If both the first amplitude and the second amplitude originate from a P wave of an atrial contraction, both amplitudes should have approximately the same height (i.e., maximum). Then, the atrial electrode is properly located. If, however, one of the first and second amplitudes originates from a P wave and the other amplitude originates from a ventricular signal, the amplitudes will differ with respect to their intensity.
In an embodiment, the computer-readable program causes the processor to combine the above-mentioned conditions (i.e., the first condition according to which the first amplitude and the second amplitude have a maximum lying within a predetermined intensity range and the second condition according to which the maxima of both amplitudes do not deviate significantly from each other in terms of intensity) are combined with at least one further criterion for testing an integrity of an electrode of the first stimulation unit. Then, an atrial stimulation with the first stimulation unit is prevented if at least one of the precedingly mentioned conditions, if tested, and if additionally the at least one further criterion are not fulfilled. Otherwise, an atrial stimulation with the first stimulation unit is allowed. Thus, in this embodiment, the at least one further criterion serves as additional safety net for ensuring a proper placement of the atrial electrode within the atrium of the heart to be stimulated.
In an embodiment, the at least one further criterion is an electrode impedance lying within a predetermined range of 100-2000 Ohm, in particular in the range of 150-1500 Ohm, in particular in the range of 200-1000 Ohm, in particular in the range of 250-500 Ohm. If the electrode impedance lies within this range, this is taken as an additional indication that the atrial electrode is properly placed. If, however, the electrode impedance lies without in this range, this is taken as an indication that the atrial electrode is dislocated.
In an aspect, the present invention relates to a method for controlling an implantable medical device according to the preceding explanations. This method comprises the steps explained in the following.
First, a first detection unit of the implantable medical device is used for detecting an electric signal of the heart to be stimulated. This electric signal comprises at least two consecutive amplitudes.
Then, it is determined whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes each have a maximum lying within a predetermined intensity range. Alternatively or additionally, it is determined whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other with respect to the intensity. If the maxima of the two amplitudes lie within the predetermined range and/or if the maxima of the two consecutive amplitudes do not significantly deviate from each other with respect to intensity, this is taken as indication that the atrial electrode has not been dislocated, i.e., that it is still appropriate to deliver an atrial antitachycardie pacing.
If the maxima of both amplitudes do not lie within the predetermined intensity range (if such compliance of the maxima with a given intensity range has been tested at all) and/or if the maxima of the two consecutive amplitudes do not deviate significantly from each other (if the maxima of the two amplitudes have been compared with each other at all), an atrial stimulation with a first stimulation unit of the implantable medical device is prevented. Otherwise, an atrial stimulation with the first stimulation unit is allowed.
In an aspect, the present invention relates to computer program product comprising computer-readable code that causes the processor to perform the steps explained in the following when executed on the processor.
First, detecting, with a first detection unit of an implantable medical device, an electric signal of the heart to be stimulated. This electric signal comprises at least two consecutive amplitudes.
Then, it is determined whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes each have a maximum lying within a predetermined intensity range. Alternatively or additionally, it is determined whether a maximum of the first amplitude and a maximum of the second amplitude deviate from each other with respect to the intensity by at most 20%.
If the maxima of both amplitudes do not lie within the predetermined intensity range (if such compliance of the maxima with a given intensity range has been tested at all) and/or if the maxima of the two consecutive amplitudes do not deviate significantly from each other (if the maxima of the two amplitudes have been compared with each other at all), an atrial stimulation with a first stimulation unit of the implantable medical device is prevented. Otherwise, an atrial stimulation with the first stimulation unit is allowed.
In an aspect, the present invention relates to medical method for treating a human or animal patient in need of such treatment. This treatment is done with an implantable medical device for stimulating a patient's heart, in particular with an implantable medical device according to the preceding explanations.
Such an implantable medical device serves for stimulating a human or animal heart. It comprises a processor, a memory unit, a first stimulation unit, a second stimulation unit, a first detection unit, and a second detection unit. The first stimulation unit serves for stimulating an atrium, in particular the right atrium, of the patient's heart. The second stimulation unit serves for stimulating a ventricle, in particular the right ventricle, of the same heart. The first detection unit serves for detecting an electric signal in the atrium. Finally, the second detection unit serves for detecting an electric signal in the ventricle.
The method comprises the steps explained in the following.
First, detecting, with the first detection unit, an electric signal of the heart to be stimulated. This electric signal comprises at least two consecutive amplitudes.
Then, it is determined whether a first amplitude of the two consecutive amplitudes and a second amplitude of the two consecutive amplitudes each have a maximum lying within a predetermined intensity range. Alternatively or additionally, it is determined whether a maximum of the first amplitude and a maximum of the second amplitude do not deviate significantly from each other with respect to their intensity
If the maxima of both amplitudes do not lie within the predetermined intensity range (if such compliance of the maxima with a given intensity range has been tested at all) and/or if the maxima of the two consecutive amplitudes do not deviate significantly from each other (if the maxima of the two amplitudes have been compared with each other at all), an atrial stimulation with a first stimulation unit of the implantable medical device is prevented. Otherwise, an atrial stimulation with the first stimulation unit is allowed.
Finally, an atrial stimulation is performed on the patient's heart if such stimulation is allowed in the precedingly explained step.
All embodiments of the implantable medical device can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the described methods and the described computer program product. Likewise, all embodiments of the described methods can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the respective other method, to the implantable medical device and to the computer program product. Finally, all embodiments described with respect to the computer program product can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the described implantable medical device or to the described methods.
Additional features, aspects, objects, advantages, and possible applications of the present disclosure will become apparent from a study of the exemplary embodiments and examples described below, in combination with the Figures and the appended claims.
Further details of aspects of the present invention will be explained in the following with respect to exemplary embodiments and accompanying Figures. In the Figures:
The maximum of the amplitudes of these P waves P coincide so that a test whether two consecutive maxima deviate from each other by not more than 20% will be successfully passed. Furthermore, the maxima of the amplitudes of the P waves P lie within a tolerance band spanned between a lower threshold 5 and an upper threshold 6. The tolerance band lies around an average intensity value of the detected P wave amplitudes. It constitutes a predeterminable intensity range.
Thus, also when checking whether the maxima of the amplitudes of the P waves P of the atrial tachycardia observed in the second portion 4 of the atrial ECG signal A lie within the tolerance band, such test would be passed successfully. Consequently, it is apparent from the obtained ECG that the atrial electrode 1 (cf.
Since the detected P wave is stable, the criterion for allowing a delivery of an atrial stimulation is fulfilled. Consequently, the implantable medical device is allowed to deliver an atrial antitachycardie pacing pulse in order to terminate the atrial tachycardia.
The situation is different in case of a dislocated atrial electrode. This will be explained in more detail referring to
The atrial electrode 1 is now located-due to an undesired dislocation—in the area of the tricuspid valve (i.e., between the right atrium and the right ventricle). The ventricular electrode 2 is correctly positioned within the apex of the right ventricle.
A simulated electrocardiogram (ECG) reflecting identical physiologic conditions as in case of the exemplary embodiment explained with respect
Even though the ventricular signals P′ do not originate from P waves, they are considered by the implantable medical device to be the result of an atrial P wave. The cardiac rhythm detection applied by a prior art implantable medical device would recognize in such a case erroneously an atrial tachycardia since the rate of P waves P and apparent P waves P′ is too high for a regular sinus rhythm. Consequently, a cardiac pacemaker known from prior art would initiate an atrial antitachycardie pacing therapy. Such a therapy would be connected with the risk to induce a life-threatening ventricular tachyarrhythmia in the ventricle of the heart to be stimulated.
However, when checking the maximum of the amplitudes P and P′ of the electric cardiac signal, it is apparent that the P wave signal P does not fall within the tolerance band spanned between the lower threshold 5 and the upper threshold 6. Even though the subsequent ventricular signal P′ falls within this tolerance band, the criterion that the maximum of both consecutive amplitudes needs to lie within this range, is not fulfilled. Likewise, by direct comparison of the P wave signal P and the subsequent ventricular signal P′, it is apparent that the intensity of the maximum of both amplitudes differs significantly, in particular by more than 20%. Consequently, also this criterion is not fulfilled.
The implantable medical device according to this embodiment thus prevents the delivery of an atrial stimulation to react on the apparent atrial tachycardia since in fact no atrial tachycardia is present. Rather, the apparent atrial tachycardia is correctly classified as an incorrectly determined atrial tachycardia due to a dislocation of the atrial electrode.
It is apparent from these exemplary embodiments that aspects of the present invention reliably prevent, in case of an undesired dislocation of an atrial electrode of the implantable medical device, a therapy delivery in a cardiac chamber not assigned to this therapy. Aspects of the present invention enable the application of an atrial antitachycardic pacing also by cardiac implants without defibrillation function (backup shock function).
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21195672.7 | Sep 2021 | EP | regional |
This application is the United States National Phase under 35 U.S.C. § 371 of PCT International Patent Application No. PCT/EP2022/074603, filed on Sep. 5, 2022, which claims the benefit of European Patent Application No. 21195672.7, filed on Sep. 9, 2021, the disclosures of which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/074603 | 9/5/2022 | WO |
