ANALYSIS DEVICE FOR SUPPORTING THE IMPLANTATION OF A SYSTEM FOR STIMULATING THE HUMAN OR ANIMAL HEART

Abstract

An analysis device for supporting the implantation of a system for stimulating the human heart or animal heart, comprising a processor and a memory unit. The memory unit includes a computer-readable program, which prompts the processor to carry out the following steps when the program is being executed on the processor: a) receiving an electrocardiogram of a human heart or an animal heart into which a system for stimulating this heart is being implanted; b) automatically identifying signals of the electrocardiogram caused by a His bundle stimulation, a signal being identified which appears between an atrial signal and a ventricular signal; c) marking the previously identified signals in the received electrocardiogram; and d) outputting the electrocardiogram thus marked on an output device. The analysis device comprises a detection unit having a sensitivity of at least 0.25 mV.

Claims

1. An analysis device for supporting the implantation of a system for stimulating the human heart or animal heart, comprising a processor and a memory unit, wherein the memory unit includes a computer-readable program, which prompts the processor to carry out the following steps when the program is being executed on the processor: a) receiving an electrocardiogram of a human heart or an animal heart into which a system for stimulating this heart is being implanted; b) automatically identifying signals of the electrocardiogram caused by a His bundle stimulation, a signal being identified which appears between an atrial signal and a ventricular signal; c) marking the previously identified signals in the received electrocardiogram; and d) outputting the electrocardiogram thus marked on an output device, wherein the analysis device comprises a detection unit having a sensitivity of at least 0.25 mV.

2. The analysis device according to claim 1, further comprising a stimulation unit for stimulating the His bundle of a human heart or an animal heart, and a detection unit for detecting an electrical signal of the same heart, the program prompting the processor to carry out the following steps when the program is being executed on the processor: a) carrying out a cardiac stimulation by way of the stimulation unit, the cardiac stimulation being suitable for ascertaining a stimulus threshold of the His bundle; b) detecting a cardiac electrical signal, which was generated by a cardiac excitation as a result of the cardiac stimulation carried out beforehand, by way of the detection unit; c) ascertaining an excitation state of a heart stimulated by the cardiac stimulation based on the electrical signal; and d) classifying the excitation state into one of at least three classes, the at least three classes including a first class for a first excitation state, a second class for a second excitation state different from the first excitation state, and a third class for an unsuccessful stimulation without a detectable excitation state.

3. The analysis device according to claim 2, wherein the first class and the second class, and an optional further class, with the exception of the third class, are selected from the group consisting of a class that relates to an excitation state for which only a stimulation of the His bundle of the stimulated heart has taken place, a class that relates to an excitation state for which both a stimulation of the His bundle of the stimulated heart and a stimulation of the ventricular myocardium have taken place, a class that relates to an excitation state for which only a stimulation of the ventricular myocardium of the stimulated heart has taken place, a class that relates to an excitation state in which a His bundle stimulation and a stimulation of left ventricular conduction pathways have taken place, and a class that relates to an excitation state in which a His bundle stimulation without stimulation of left ventricular conduction pathways has taken place.

4. The analysis device according to claim 1, further comprising a detection unit that includes a low-pass filter having a cut-off frequency of 100 kHz or greater.

5. The analysis device according to claim 1, further comprising a detection unit having a sampling rate of at least 500 Hz.

6. (canceled)

7. The analysis device according to claim 1, wherein the program prompts the processor to use a morphological analysis criterion of the electrocardiogram for automatically identifying the signals caused by a His bundle stimulation.

8. The analysis device according to claim 1, further comprising a first stimulation unit for stimulating the His bundle of a human heart or an animal heart, a second stimulation unit for stimulating a cardiac region of the same heart different from the His bundle, a first detection unit and a second detection unit, which are each suitable for detecting an electrical signal of the same heart.

9. The analysis device according to claim 8, wherein the program prompts the processor to trigger a stimulation of the His bundle byway of the first stimulation unit upon detection of an intrinsic excitation of one of the two atria of the stimulated heart by the first detection unit or the second detection unit.

10. A computer program product including computer-readable code, which prompts a processor to carry out the following steps when the code is being executed on the processor: a) receiving an electrocardiogram of a human heart or an animal heart into which a system for stimulating this heart is being implanted; b) automatically identifying signals of the electrocardiogram caused by a His bundle stimulation, a signal being identified which appears between an atrial signal and a ventricular signal; c) marking the previously identified signals in the received electrocardiogram; and d) outputting the electrocardiogram thus marked on an output device.

11. A method for evaluating data obtained during an implantation of a system for stimulating the human or animal heart, comprising the following steps: a) receiving an electrocardiogram of a human heart or an animal heart into which a system for stimulating this heart is being implanted; b) automatically identifying signals of the electrocardiogram caused by a His bundle stimulation; c) marking the previously identified signals in the received electrocardiogram; and d) outputting the electrocardiogram thus marked on an output device, wherein the electrogram is detected by a detection unit having a sensitivity of at least 0.25 mV.

12. A method for implanting a system for stimulating the human or animal heart in a patient in need of such a system, the method comprises the following steps: a) contacting a region of the heart of the patient in which the His bundle of the heart is presumed to be located, with an electrode that is part of a stimulation unit for stimulating the His bundle of a human heart or an animal heart; b) carrying out a stimulation of the His bundle by way of the stimulation unit; c) detecting an electrocardiogram by way of a detection unit; d) automatically identifying signals of the electrocardiogram caused by a His bundle stimulation; e) marking the previously identified signals in the received electrocardiogram; f) outputting the electrocardiogram thus marked on an output device; g) adapting the position of the electrode as a function of the marked signals and optionally repeating steps b) to g) until the marked signals correspond to a selectable criterion; and h) implanting the electrode in the most recently selected position, wherein the detection unit has a sensitivity of at least 0.25 mV.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0202] Further details of aspects of the present invention are described in greater detail hereafter in connection with exemplary embodiments and drawings. In the drawings:

[0203] FIG. 1 shows a block diagram of an exemplary embodiment of an implantable system for stimulating the human heart or animal heart;

[0204] FIG. 2 shows a schematic representation of an exemplary embodiment of an implantable system for stimulation of the human or animal heart;

[0205] FIG. 3 shows a block diagram of an exemplary embodiment of an implantable system for stimulating the human or animal heart, which carries out stimulation outcome monitoring during operation;

[0206] FIG. 4 shows a simplified block diagram of an exemplary embodiment of an analysis device;

[0207] FIG. 5 shows an exemplary embodiment of a representation output by the analysis device from FIG. 4; and

[0208] FIG. 6 shows a block diagram of an exemplary embodiment of an implantable system for stimulating the human or animal heart.

DETAILED DESCRIPTION

[0209] FIG. 1 shows a block diagram of an exemplary embodiment of a cardiac pacemaker 100, which is used as an implantable system for stimulating the human or animal heart. The cardiac pacemaker 100 comprises a power source 101 and a first electrode terminal 102, which serves as a first stimulation output. A first stimulation unit 103, from which stimulation pulses can be conducted through the first electrode terminal 102 to a first electrode, is connected to the electrode terminal 102. Moreover, a first detection unit 104 is connected to the first electrode terminal 102. The first stimulation unit 103 and the first detection unit 104 act as conventional detection and stimulation stages of the cardiac pacemaker 100.

[0210] So as to ensure a defined delivery of stimulation pulses, in terms of time, by the first stimulation unit 103 and to adapt the corresponding stimulation pulses to the signals of a heart detected by the first detection unit 104, the cardiac pacemaker 100 further comprises a first timer 105, which likewise functions in a conventional manner.

[0211] In addition, the cardiac pacemaker 100 comprises a second electrode terminal 110, which serves as a second stimulation output. It is connected to a second stimulation unit 120 and a second detection unit 130. The second stimulation unit is specifically designed and configured to carry out a stimulation of the His bundle of the heart to be treated. The second detection unit 130 is specifically designed and configured to detect an electrical signal of the His bundle of this heart.

[0212] Both the second stimulation unit 120 and the second detection unit 130 are connected to a second timer 140. The timer is additionally operatively connected to the first timer 105. It is possible, by way of the timer 140, to synchronize the stimulation pulses to be delivered by the second stimulation unit 120 with the stimulation pulses being delivered by the first stimulation unit 103. In this way, the His bundle of the heart can be stimulated at a point in time at which the His bundle is particularly receptive to such a stimulation and which is an obvious choice, in a physiologically meaningful manner, for restoring a natural cardiac rhythm. The second timer 140 also opens up the option of achieving synchronization of the delivery, in terms of time, of stimulation pulses delivered by the first stimulation unit 103 with stimulation pulses delivered by the second stimulation unit 120 via signals detected by the second detection unit 130.

[0213] A His bundle marker channel 150, a His bundle stimulation threshold test unit, which serves as a first stimulation threshold test device, and a His bundle diagnostic memory 190 are arranged downstream of the second timer 140.

[0214] It is possible, by way of the His bundle marker channel 150, to read out an electrocardiogram (ECG) or an intracardiac electrogram (IEGM) from the cardiac pacemaker 100, wherein the ECG or the IEGM is provided with markings that are specific to a His bundle stimulation by way of the second stimulation unit 120 and/or specific to the detection of a signal of the His bundle by way of the second detection unit 130. In this way, it is possible to retrieve ECGs or IEGMs provided with His bundle-specific information from the cardiac pacemaker 100 via the His bundle marker channel 150.

[0215] The His bundle stimulation threshold test unit 180 is used to determine a stimulus threshold of the His bundle before a corresponding stimulation of the His bundle is carried out by way of the second stimulation unit 120. In this way, it is possible, at all times, to provide a sufficiently strong stimulation pulse by way of the second stimulation unit 120, without having to expend more energy than necessary. The His bundle stimulation threshold test unit 180 is thus used, on the one hand, to ensure that the stimulation pulses delivered by the second stimulation unit 120 are strong enough to achieve an excitation of the His bundle, but, on the other hand, that the stimulation pulses delivered by the second stimulation unit 120 have the lowest possible energy, so that the load posed by the second stimulation unit 120 on the power source 101 of the cardiac pacemaker 100 is minimized.

[0216] Events that relate to the His bundle stimulation or the His bundle activity are stored in the His bundle diagnostic memory 190, which can be configured as a memory area of a larger memory unit, for example. The His bundle diagnostic memory is used, for example, to record stimulation pulses delivered by the second stimulation unit 120, and additionally to also record data detected by the second detection unit 130 with respect to the His bundle of the heart to be treated.

[0217] A His bundle remote monitoring and programming unit 200, which can be used to read out the His bundle diagnostic memory 190, is assigned to the His bundle diagnostic memory 190. In addition, the second stimulation unit 120 and/or the second detection unit 130 can be monitored by way of the His bundle remote monitoring and programming unit 200. It is further possible to adapt the His bundle stimulation to be delivered by the second stimulation unit 120 by way of the His bundle remote monitoring and programming unit 200. This His bundle remote monitoring and programming unit 200 thus allows access to specific components of the cardiac pacemaker 100, wherein it is made possible to both read out data and write data.

[0218] FIG. 2 shows a schematic side view of the cardiac pacemaker 100, of which the block diagram is shown in FIG. 1. Like elements are denoted by like reference numerals.

[0219] A header 160, in which the first electrode terminal 102 and the second electrode terminal 110 are formed, is apparent in the schematic illustration of FIG. 2. A first electrode 106 is plugged into the first electrode terminal 102, a second electrode 170 is plugged into the second electrode terminal 110. The first electrode 106 and the second electrode 107 are shown in sections in the illustration of FIG. 2.

[0220] The first electrode 106 is used to conventionally stimulate an arbitrary cardiac region of one of the ventricles. These are also used to detect electrical signals in one of these ventricles.

[0221] The second electrode 170 is used specifically to stimulate a His bundle and to detect His bundle-specific electrical signals. So as to enable easier use of the cardiac pacemaker 100 for a user, the second electrode 170 is identified as a His bundle electrode by the label “HIS.” To ensure that this second electrode 170 is plugged into the correct electrode terminal, this being the second electrode terminal 110, this terminal is provided with the additional identification “HIS” in the header 160 of the cardiac pacemaker 100.

[0222] It can also be provided that the second electrode terminal 110 is configured to be structurally different from the first electrode terminal 102, so that it is not possible to plug the second electrode 170 (this being the His bundle electrode) into the first electrode terminal 102 in the first place.

[0223] In addition to a label such as “HIS,” color coding of the second electrode 170 and/or the second electrode terminal 110, or of a corresponding region of the header 160, can be provided.

[0224] On the side, the cardiac pacemaker 100 further includes a marking 210, which schematically represents the first electrode terminal 100 and the second electrode terminal 110 and provides it with a corresponding identification. The marking 210 indicates that the first (upper) electrode terminal 102 is provided for connecting a first electrode 106 leading into the right atrium (RA), and the second (lower) electrode terminal 110 is provided for connecting a second electrode 170 leading to the His bundle. This additional marking 210 additionally facilitates the connection of the correct electrodes 106, 170 to the intended electrode terminals 102, 110 for a user of the cardiac pacemaker 100.

[0225] FIG. 3 shows a block diagram of an exemplary embodiment of a cardiac pacemaker 300, which is used as an implantable system for stimulating the human or animal heart. This cardiac pacemaker 300 carries out stimulation outcome monitoring and is able to automatically adapt an internal control parameter as a function of the stimulation outcome monitoring that was carried out.

[0226] The cardiac pacemaker comprises a power source 310 and a His bundle stimulation unit 320, which serves as a stimulation unit. Furthermore, a detection unit 330 is provided, which serves as a detection unit. The His bundle stimulation unit 320 and the detection unit 330 are operatively connected to a processor 340. This processor 340, in turn, can access a memory unit 350 and receive data from or send data to this memory unit 350.

[0227] A program which the processor 340 can use to carry out certain steps is stored in the memory unit 350. For example, the processor 340 prompts the His bundle stimulation unit 320 to carry out a cardiac stimulation (in particular of the His bundle) by way of a stimulation electrode, which is not shown in FIG. 3. Thereafter, the processor 340 prompts the detection unit 330 to detect a cardiac electrical signal from the previously stimulated heart. This signal is then used to ascertain an excitation state of the heart.

[0228] The excitation state is classified into one of at least three different classes. Thereafter, a specific control parameter of the cardiac pacemaker 300 is automatically adapted as a function of the classification that was carried out.

[0229] The steps of ascertaining the excitation state, of classifying the excitation state, and of automatically adapting at least one control parameter can be carried out in a stimulation outcome monitoring module, which can be implemented either as hardware or as software. In the exemplary embodiment of FIG. 3, this stimulation outcome monitoring module is implemented as software, so that it is not shown separately.

[0230] As a result of the automatic adaptation of at least one control parameter of the cardiac pacemaker 300, a therapeutic outcome of a previously carried out His bundle stimulation can be monitored in a particularly simple manner, wherein a particularly safe and effective therapy can be ensured by the automatic adaptation of a control parameter, even over an extended period of time.

[0231] FIG. 4 shows a simplified block diagram of a His bundle pace-sense analyzer (His PSA), which serves as an analysis device. This His PSA comprises a His bundle stimulation unit 410, which includes an electrode interface by way of which a His bundle electrode can be connected to the His bundle stimulation unit 410. The His bundle stimulation unit 410 is used to deliver high energy stimulation, by which the His bundle of a human heart or an animal heart can be easily stimulated.

[0232] The His PSA further comprises a first detection unit 420, which can likewise directly access an electrode, by which a stimulation of the His bundle can be detected. The first detection unit 420 is provided and configured to record an electrocardiogram in the form of a broadband intracardiac electrogram (IEGM) and to subject it to a morphological signal analysis. Using a digital signal processor (DSP), which is an integral part of the first detection device 420, it is possible to identify and mark His bundle-specific signal morphologies within the captured electrocardiogram. The first detection unit 420 then forwards the further processed IEGM to a control and display unit 430, which serves as an output device for outputting the marked IEGM.

[0233] The control and display unit 430 is additionally connected to a processor 440, which, in turn, can access a memory unit 450. In this way, it is possible for the processor 440 to retrieve program information from the memory unit 450 and to transmit this information via the control and display unit 430 to the His bundle stimulation unit 410 and the first detection unit 420.

[0234] In addition, the His PSA comprises one or more further stimulation units 460, which are designed as conventional stimulation units and comprise conventional electrode interfaces for connecting atrial or ventricular electrodes. Conventional stimulation specifications of the corresponding electrodes can be provided in the process. In addition to the further stimulation units 460, one or more further detection units 470 are also provided, which are used to detect and evaluate atrial and ventricular cardiac signals. These further detection units 470 use conventional detection specifications for this purpose. Using these further detection units 470, it is possible to identify and mark ventricular and atrial signal in recorded electrocardiograms. The control and display unit 430 can thus display both His bundle-specific signals and atrial and/or ventricular signals in an electrocardiogram, such as an IEGM. The control and display unit 430 is able to represent different channels (in particular, an atrial channel, a ventricular channel, and a His bundle-specific channel) separately from one another.

[0235] This is shown schematically in FIG. 5 by way of example. For example, from top to bottom, FIG. 5 shows a first marker channel 510 for marking atrial signals As and ventricular signals Vs.

[0236] Beneath, a second marker channel 520 is shown, which is used to mark His bundle-specific signals HIS.

[0237] Only atrial signals 531 are schematically represented in an atrial IEGM channel 530.

[0238] In addition to atrial signals 541 and ventricular signals 542, His bundle-specific signals 543 are represented and separately marked in a His bundle-specific channel 540. This can typically be carried out by highlighting in color. In the illustration of FIG. 5, the His bundle-specific signals 543 are shown circled.

[0239] Finally, only ventricular signals 552 are schematically represented in a ventricular IEGM channel 550.

[0240] A user can have multiple channels 510 to 550 displayed simultaneously, or can have individual channels 510 to 550 displayed separately from other channels 510 to 550. In this way, it is possible to filter the information relevant for the particular problem for the user in a particularly simple manner. As a result of the automatic identification and separate marking of His bundle-specific signals 543, it is particularly easy to verify a correct positioning of a His bundle-specific stimulation electrode, and to optimize it with respect to the best possible contacting of the His bundle.

[0241] FIG. 6 shows a cardiac pacemaker 600, which is used as an implantable system for stimulating the human or animal heart. This cardiac pacemaker 600 is specifically provided and configured for treating an AV nodal reentry tachycardia (AVNRT).

[0242] The cardiac pacemaker 600 comprises a power source 610, a tachycardia identification and classification unit 620, which serves as a detection unit, and a His bundle stimulation unit 630, which serves as a stimulation unit. The tachycardia identification and classification unit 620 and the stimulation unit 630 are connected to a control unit 640. The control unit 640, in turn, is operatively connected to a processor 650, which can access a memory unit 660.

[0243] The tachycardia identification and classification unit 620 comprises an electrode terminal 621 to which a first electrode can be connected. By way of this first electrode, the tachycardia identification and classification unit 620 is able to identify whether tachycardia is present in the heart of the patient wearing the cardiac pacemaker 600. The tachycardia identification and classification unit 620 is additionally able to identify and classify the type of tachycardia. In particular, an AV nodal reentry tachycardia can be distinguished by the tachycardia identification and classification unit 620 from other tachycardias.

[0244] When such an AV nodal reentry tachycardia is identified by the tachycardia identification and classification unit 620, the control unit 640 ensures that the stimulation unit 630 delivers a stimulation that is specifically suitable for stimulating the His bundle of the heart of the patient. For this purpose, the stimulation unit 630 comprises an electrode terminal 631, to which a second electrode, which is arranged in the His bundle or so close to the His bundle that a His bundle stimulation is possible by way of this electrode, is connected during operation of the cardiac pacemaker 600. The control unit 640 transmits the corresponding signal to the stimulation unit 630 after having received a corresponding command from the processor 650. A program which the processor 650 obtains from the memory unit 660 runs on the processor 650.

[0245] The individual components of the cardiac pacemaker 600 are supplied with the power necessary for operation from the power source 610.

[0246] The tachycardia identification and classification unit 620 uses ECG signals, received via the electrode terminal 621, for identifying and classifying a tachycardia, and in particular for identifying an AV nodal reentry tachycardia. The ECG signals can be derived from the atrium and/or the ventricle of the heart of the patient. In addition, it is possible to provide corresponding ECG signals directly via a His bundle electrode, for example via the second electrode, which is also connected to the second electrode terminal 631 of the stimulation unit 630.

[0247] So as to classify the established tachycardia, that is, so as to distinguish different tachycardias from one another, and, in particular, so as to identify an AV nodal reentry tachycardia, the tachycardia identification and classification unit 620 can resort to morphological analysis criteria within the provided electrocardiogram or, instead of such a morphological analysis of the electrocardiogram, can evaluate a chronological sequence of atrial and/or ventricular signals in the electrocardiogram. It is also possible to carry out a morphological analysis of a provided electrocardiogram, and to carry out an analysis of the chronological sequence of the signals present in this electrocardiogram.

[0248] This cardiac pacemaker 600 provides a new, device-based therapy for tachycardias, and in particular, for AV node reentry tachycardia. As a result, the treatment spectrum of active implants is enhanced.

[0249] 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.