Pacing device and method of operation

Abstract

The invention relates to a pacing device, for example an implantable leadless pacemaker 30, a system comprising a pacing device, and a method of operating a pacing device. The pacing device comprises a housing, a processor, and a receiver electrically coupled to the processor, the processor adapted to: deliver signals for electrical stimulation of a patient's heart H according to at least one first stimulation mode; and deliver signals for electrical stimulation of the patient's heart H according to an anti-tachycardia pacing mode (ATP mode), where the ATP mode is initially deactivated and / or to be upgraded, the receiver adapted to receive an ATP confirmation signal transmitted by an external device or generated by operation of an actuator contained in the pacing device housing, and the processor adapted to upgrade and / or activate the ATP mode only if the ATP confirmation signal includes predefined confirmation information.

Description

[Technical Field]

[0001] The invention generally is directed to a pacing device, e.g., an implantable leadless pacemaker, having a housing, the pacing device comprising a processor and a receiver electrically connected to or integrated within the processor, the processor adapted to deliver signals for electrical stimulation of a patient's heart according to at least one first stimulation mode. The invention is further directed to methods of operating the pacing device. [Background technology]

[0002] Implantable stimulation devices, such as pacing devices (e.g., implantable cardiac pacemakers or implantable leadless pacemakers), are well-known medical devices that enable stimulation of a patient's heart. Typically, these medical devices are battery-powered, with the stimulation components implanted directly into the ventricles or atria of the heart. Implantable cardiac pacemakers have at least an elongated stimulation lead that extends from the device housing into the heart chamber to which it is anchored. An ILP is a miniature pacing device that is implanted entirely within a heart chamber.

[0003] Implantable stimulator devices with defibrillation capabilities are known in the art, for example, as implantable cardioverter-defibrillators (ICDs) or subcutaneous implantable cardioverter-defibrillators (SICDs). Such devices typically consist of a device housing and at least one elongated stimulation lead extending from the housing. The housing of an ICD is typically implanted in a skin pocket below the clavicle, and the stimulation lead extends into the ventricle where it is anchored. The housing and stimulation lead of a SICD are implanted under the skin (i.e., subcutaneously) in such a way that a shock vector through the ventricle is created between the stimulation electrode of the lead and the SICD housing.

[0004] The medical device is selected according to the patient's cardiac condition, i.e., the cardiac therapy required.

[0005] Implantable pacemakers, or ILPs, are used for patients with bradycardia, that is, when the heart beats too slowly to meet the patient's physiological needs. Implantable pacemakers, or ILPs, deliver electrical impulses to the heart to generate a physiologically appropriate heartbeat.

[0006] ICDs are used in patients with ventricular tachycardia and fibrillation. They either administer antitachycardia pacing (ATP) therapy to terminate the tachycardia (i.e., pace the heart at a stimulation rate faster than the tachycardia rate) or, if the tachycardia persists after ATP trials, administer shock therapy (i.e., deliver a high-energy electrical shock to the ventricles to terminate the tachycardia and return the heart to a physiological rhythm).

[0007] The SICD is configured to deliver shock therapy but not pacing or ATP therapy because the distance between the stimulation lead and the ventricle does not allow for effective delivery of low-energy stimulation pulses to the cardiac pacing site.

[0008] The ILP can deliver pacing and ATP, but not shock therapy. The device is very limited in size, has a small battery capacity, and does not have the space for the charging capacitors required to deliver shock therapy.

[0009] Furthermore, implantable leads can be problematic because they pose risks to patients. Leads are long, thin, insulated electrode wires that extend from the device housing into the heart's venous system and are anchored within the chambers of the heart. They are subject to various forces and movements with each heartbeat, which can lead to lead dislodgement, insulation failure, or lead breakage. This issue does not arise with SICD and ILP devices, as these devices do not have long, thin leads inside the heart. Long, thin leads cannot be implanted inside the heart, especially in patients who lack adequate vascular access or are at high risk for infection.

[0010] However, there are situations in which a patient suffers from various cardiac arrhythmias that require different cardiac therapies. In such cases, an implantable device system comprising at least two medical devices or units may be implanted.

[0011] Furthermore, there are cardiac arrhythmias for which different therapies are appropriate, with one treatment being more preferable, e.g., more comfortable, to the patient. Also, some therapies may induce other arrhythmias, requiring additional therapy to terminate the arrhythmia. In practice, for example, ventricular tachycardia can be treated using ATP therapy or shock therapy, but shock therapy is often uncomfortable for the patient because the shock is delivered suddenly and may be painful. Shock therapy also significantly shortens battery life. Nevertheless, because ATP therapy is not suitable for treating fibrillation, shock therapy is unavoidable if ventricular tachycardia leads to ventricular fibrillation.

[0012] For example, a patient suffering from ventricular tachycardia who has a contraindication for elongated leads in the heart and requires pacing therapy, ATP, and shock therapy may be implanted with an implantable medical device system including at least a first implantable stimulator device and a second implantable stimulator device, where the first implantable stimulator device may be an ILP and the second device may be a SICD.

[0013] Cardiac rhythm management systems that include multiple therapeutic therapies are provided by the combination of an S-ICD and an ILP, as disclosed in prior art publications U.S. Patent Application Publication No. 2019 / 0160285A1 and U.S. Patent No. 10,265,534B2, for example. Coordination of the elements of these systems is essential to provide appropriate therapy, as simultaneous application of therapies may be ineffective.

[0014] However, external or internal communication within a system comprising at least two medical devices, i.e., between one implantable medical device and an external device or between two implantable medical devices, has several drawbacks. These drawbacks are mainly due to the fact that communication requires a communication interface, which results in increased energy consumption. Furthermore, communication interfaces are vulnerable to cyber attacks. Also, an unobstructed communication channel is required for the reliable functioning of such a system.

[0015] Considering the above facts, the use of a system combining pacing devices offers several advantages. Nevertheless, to function properly, such a system requires structured rules for communication and coordination between its members, and also requires reliable adaptation of each pacing device when it is part of a system with several medical devices. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] U.S. Patent Application Publication No. 2019 / 0160285A1 [Patent Document 2] U.S. Patent No. 10,265,534B2 Summary of the Invention [Problem to be solved by the invention]

[0017] The present invention aims to provide an implantable pacing device and method of operating the pacing device that provides reliable stimulation therapy for tachycardia, for example, in combination with ATP therapy and shock delivery.

[0018] It is therefore an object of the present invention to provide a pacing device that can be used individually or in a system of two or more medical devices. It is a further object to define a method of operation for such a pacing device. [Means for solving the problem]

[0019] The above problems are solved by a pacing device, e.g., an implantable leadless pacemaker, having a housing. The pacing device comprises a processor and a receiver electrically coupled to or integrated within the processor, the processor adapted to deliver signals for electrical stimulation of a patient's heart according to at least one first stimulation mode. The pacing device is further adapted to deliver signals for electrical stimulation of the patient's heart according to an anti-tachycardia pacing mode (ATP mode), the ATP mode being initially deactivated and / or to be upgraded, the receiver adapted to receive an ATP confirmation signal transmitted by an external device or generated by operation of an actuator contained within the pacing device housing, and the processor adapted to upgrade and / or activate the ATP mode for use in conjunction with another medical device, e.g., a defibrillator, only if the ATP confirmation signal includes predefined confirmation information. In one example, the predefined confirmation information may include information such as

[0020] The pacing devices of the present invention described above can be used individually or in a system of two or more medical devices. When used in conjunction with a defibrillator, the ATP mode of the pacing device can be used if its use is confirmed by the operator or patient. As described above, if the ATP mode is present (i.e., initially included in the pacing device or upgraded) and activated, ATP therapy is delivered by the pacing device, preferably in coordination with therapy by the defibrillator. This is because ventricular tachycardia can lead to ventricular fibrillation, for which ATP therapy is not suitable. Fibrillation can be treated with shock therapy delivered by the defibrillator.

[0021] In connection with the above invention, both medical devices, i.e., the pacing device and the defibrillation device, may be implanted in the thoracic cavity. More precisely, the pacing device may be implanted in one ventricle or atrium, and the defibrillation device may be implanted outside the heart. Furthermore, at least one pacing device may comprise, for example, a detection unit adapted to be implanted in cardiac tissue and including one or more electrodes adapted to detect the patient's cardiac rhythm, and a processor adapted to analyze the detected patient's cardiac rhythm and transmit a signal when a first anti-tachycardia pacing (ATP) therapy is activated and / or when the ATP therapy mode is upgraded. The pacing device with the detection unit and the processor may be formed as an integrated structure.

[0022] Further, at least one defibrillation device may include a second detection unit. The second detection unit may be adapted to detect the patient's cardiac rhythm. The second processor may also be adapted to analyze the detected patient's cardiac rhythm and deliver a signal for a shock therapy or a second anti-tachycardia pacing (ATP) therapy, if applicable, only in the absence of a first anti-tachycardia pacing therapy provided by the pacing device. When the defibrillation device is an S-ICD, the second detection unit may include at least one detection electrode for detecting the patient's cardiac rhythm, and the second processor may be electrically connected to at least one shock coil and / or pulse generator via an electrode lead. The electrode lead may be fixed to the pulse generator or connected via a connector pin. Furthermore, the S-ICD may be implanted entirely subcutaneously, with components positioned around the heart rather than within it. The shock coil and housing of the S-ICD are housed such that electrical shock waves generated by the shock coil are transmitted to the conductive housing of the S-ICD via at least one ventricle. Because no components of the S-ICD are inserted directly into the heart, the advantages of the S-ICD are less cardiac inflammation, lower risk of infection, and less mechanical stress on the components. The S-ICD can be placed according to anatomical guidance and does not require an imaging system, such as an X-ray imaging system. The electrode leads of the S-ICD can be inserted parallel to the sternum, and the housing containing the pulse generator and second processor can be placed on the left chest wall.

[0023] When the ATP mode is upgraded and / or activated, ATP therapy triggered by a corresponding signal generated by the pacing device's processor may be delivered by the pacing device if a predefined first tachycardia criterion is identified by analyzing the patient's cardiac rhythm within a first, preceding, predefined time period. ATP therapy is triggered by the corresponding signal from the processor and provided by a corresponding ATP signal generator of the pacing device, connected to the processor and generating a signal delivered to the patient's heart by at least a subset of two electrodes. Alternatively or additionally, ATP therapy or shock therapy triggered by a corresponding signal generated by a second processor of the defibrillation device may be enabled only if certain predefined conditions are met. In particular, if a predefined second tachycardia criterion is identified by analyzing the patient's cardiac rhythm within a second, preceding, predefined time period, or, if applicable, in the absence of anti-tachycardia pacing therapy provided by the pacing device. The ATP therapy or shock therapy is provided by a corresponding signal generator of the defibrillator device, connected to the second processor and generating signals delivered to the patient's heart by a subset of at least two electrodes connected to the housing of the defibrillator device. The shock therapy may be provided by a shock unit of the defibrillator device, connected to the second processor and generating at least one shock signal via at least one shock coil connected by leads to the housing of the defibrillator device.

[0024] In one example, the processor of the pacing device may be adapted to enable delivery of a signal for ATP therapy only if analysis of the patient's cardiac rhythm within a predefined preceding first time period reveals a predefined first tachycardia criterion and the absence of defibrillation device shock therapy.

[0025] The presence of the predefined first or second tachycardia criterion may be evident, for example, if the patient's detected cardiac rhythm within the first or second time period exceeds a predefined heart rate or QRS duration. Accordingly, the first and second processors may be adapted to analyze the detected patient's cardiac rhythm. The detected patient's cardiac rhythm may be realized by a sensed electrocardiogram (ECG). For example, the predefined heart rate at which ATP therapy is administered may be 120 to 180 beats per minute (bpm). This criterion may be part of the first tachycardia criterion. Furthermore, shock therapy may be administered when the heart rate exceeds 180 to 220 bpm.

[0026] The first or second time period may be considered to be, for example, 5-10, 15, 20, 25, 30, 35, 40, 45, 50, 55-60 seconds, or 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 minutes from the actual / recent time point in the past. The first and second time periods may be of different lengths, for example, the first time period is longer than the second time period.

[0027] The presence or absence of shock therapy delivered by the defibrillator device may also be determined by the processor by analyzing the patient's detected cardiac rhythm. The detected patient's cardiac rhythm may be provided by the sensed ECG. Furthermore, detection of applied shock therapy may be based on detection of an applied high voltage and, optionally, detection of a typical shock waveform (e.g., a biphasic waveform). Whether a shock was applied is determined by the first processor through detailed analysis of the ECG signal, for example, with respect to peak height, peak width, and peak distribution over time. If no shock signal is detected in the ECG within a first time period, the first processor's analysis of the ECG signal indicates that no shock therapy was delivered by the defibrillator device within the first time period.

[0028] Additionally, the presence or absence of ATP therapy delivered by the pacing device may also be determined by the second processor through analysis of the patient's detected cardiac rhythm. The detected patient's cardiac rhythm may be provided by the sensed ECG. For example, ATP delivery may be detected based on recognition of a typical ATP pattern (5-10 pacing pulses with a regular interval [burst] or decreasing interval length for each inter-pulse interval [ramp]). Whether a shock was delivered may be determined by the second processor through detailed analysis of the ECG signal, for example, regarding peak height, peak width, and peak distribution over time. If no ATP therapy signal is detected in the ECG within the second time period, the analysis of the ECG signal by the second processor indicates that ATP therapy was not delivered by the pacing device within the second time period.

[0029] The pacing and defibrillating devices of the system use the electrical signals of the corresponding other devices to detect whether a therapy was delivered by the other device within a corresponding predefined period prior to the actual / recent time. No additional communication between the devices, e.g., using radio waves or other communication channels, is required. Therefore, no additional communication unit / interface or energy consumption to keep separate communication or communication units active is required. Therapy of at least two devices is coordinated / managed using electrical signals generated by corresponding patients or implantable devices for therapy on the same patient. The associated electrical signals are, for example, pacing pulses (amplitude 0.2-10 V, pulse width 0.1-1.5 ms) and defibrillation shocks (monophasic or biphasic waveform, 100-1400 V, pulse duration 4-80 ms). Furthermore, the use of the system of the present invention is not only user-friendly, but also simple and cost-effective in its construction.

[0030] Some communication with an external device (e.g., a computer) is required only when activating or upgrading the pacing device through the ATP mode. This communication can be reduced to initializing the pacing device or a predefined or activated service date. Additionally, the receiver and communication are required only for connection with the pacing device and not with the defibrillator device. The external device may include a display that displays predefined information regarding the upgrade or activation of the ATP mode. The predefined information may include additional notes, such as warning notes, or references to notes in at least one documentation accompanying the pacing device required for co-implantation of a defibrillator device, such as an S-ICD. If the user provides confirmation and indicates that the ATP mode should be upgraded or activated, a corresponding predefined confirmation signal is transmitted to the receiver and then to the pacing device processor. The confirmation signal may include a confirmation date, time, and / or a confirmation code, and / or specific parameter settings for ATP implementation (e.g., a specific ATP mode, cycle length, pacing amplitude, pulse duration, etc.). Alternatively, the confirmation signal may be generated by operation of an actuator contained in the housing of the pacing device, for example, prior to or during replacement or implantation of the pacing device. A second confirmation may be required from the operator / patient before a corresponding predefined confirmation signal is transmitted to the receiver of the pacing device.

[0031] In one example, the pacing device further comprises a transmitter, which may be separate from or integrated with the receiver (thereby forming a transceiver). The processor is adapted to provide predefined warning information data including warning information regarding use of the ATP mode, and the transmitter is adapted to transmit the warning information data to an external device. It may be beneficial if the receiver is adapted to receive a predefined ATP confirmation signal in response to the transmitted warning information data.

[0032] In one embodiment, the receiver or transceiver of the pacing device is adapted to receive the ATP confirmation signal and / or ATP mode upgrade information wirelessly, for example, using near field communication or Bluetooth™, or over a telecommunications channel using, for example, 4G, 5G, UMTS, or GSM, or over a lead electrically connected to the pacing device.

[0033] In one embodiment, the receiver of the pacing device is adapted to receive the ATP confirmation signal before, during, or after implantation of the pacing device.

[0034] In one example, the predefined verification information may additionally include at least one parameter of an additional anti-tachycardia device type, e.g., a defibrillator type, where the pacing device and the additional anti-tachycardia device are adapted to be implanted in the same patient, such that the processor of the pacing device is adapted to signals receivable from the additional anti-tachycardia device, particularly with respect to analysis of the detected cardiac rhythm signal.

[0035] In one embodiment, the processor is adapted to apply at least one criterion for ventricular / supraventricular tachycardia discrimination with respect to the cardiac rhythm detected by the detection unit of the pacing device.

[0036] In one embodiment, the ATP mode includes at least two different anti-tachycardia pacing pattern elements that are usable during electrical stimulation of the patient's heart according to the ATP mode.

[0037] Furthermore, the ATP therapy delivered by the corresponding impulse generator of the pacing and / or defibrillating device may include pattern elements, e.g., bursts, ramps, and / or bursts with additional stimuli. Preferably, the number of pattern elements may be at least five, preferably at least eight. This allows the ATP therapy to be better adapted to the patient's needs.

[0038] In one example, the first anti-tachycardia pacing pattern element includes at least one burst, and / or the second anti-tachycardia pacing pattern element includes at least one ramp, and / or the third anti-tachycardia pacing pattern element includes at least one burst in combination with an additional stimulus.

[0039] The above problem is further solved by a cardiac therapy system comprising the above pacing device and an additional anti-tachycardia device, for example, a subcutaneous implantable cardioverter-defibrillator (S-ICD).

[0040] Additionally, the above limitations and system details also apply to the method embodiments described below.

[0041] The above problems are further solved by a method of operating a pacing device, e.g., an implantable leadless pacemaker, having a housing. The pacing device comprises a processor and a receiver electrically connected to or integrated within the processor, the processor adapted to deliver signals for electrical stimulation of a patient's heart according to at least one first stimulation mode. The processor is further adapted to deliver signals for electrical stimulation of the patient's heart according to an anti-tachycardia pacing mode (ATP mode), the ATP mode being initially deactivated and / or to be upgraded, the receiver receiving an ATP confirmation signal transmitted by an external device or generated by operation of an actuator contained within the pacing device housing, and the processor upgrading and / or activating the ATP mode only if the received ATP confirmation signal includes predefined confirmation information.

[0042] In one embodiment of the method, the pacing device further comprises a transmitter, wherein the processor is adapted to provide predefined warning information data including warning information regarding use of the ATP mode, the transmitter transmits the warning information data to the external device, and the receiver can receive an ATP confirmation signal in response to the transmitted warning information data.

[0043] In one embodiment of the method, a receiver receives an ATP confirmation signal before, during, or after implantation of a pacing device.

[0044] In one embodiment of the method, a receiver in the pacing device receives the ATP confirmation signal and / or ATP mode upgrade information wirelessly or via a lead electrically connected to the pacing device.

[0045] The invention will now be explained in more detail with reference to the accompanying schematic drawings. [Brief explanation of the drawings]

[0046] [Figure 1] 1 illustrates an exemplary implantation of a cardiac rhythm management system of the present invention in a human patient. [Figure 2] 1 shows a flow chart of a first embodiment of the present invention's method of operating a pacing device. [Figure 3] 10 shows a flow chart of a second embodiment of the present invention's method of operating a pacing device. [Figure 4] 4 shows an example of a warning notification according to step 251 of the flowchart of FIG. 2 or FIG. 3. [Figure 5] 4 shows an example of a warning notification according to step 255 of the flowchart of FIG. [Figure 6] 1 shows an electrocardiogram including an anti-tachycardia pacing therapy signal. [Figure 7] 1 shows an electrocardiogram including a shock therapy signal. [Example]

[0047] Figure 1 shows a first embodiment of a cardiac rhythm management system implanted in a human patient. The system includes a subcutaneously implantable cardioverter-defibrillator (S-ICD) 1 as a defibrillation device having a housing 10 and an electrode-lead 2 connected to the housing 10. The system also includes an implantable leadless pacemaker (ILP) 30 as a pacing device implanted in one ventricle of the heart H, e.g., the right ventricle.

[0048] The ILP 30 includes one or more electrodes as a detection unit for detecting electrical signals from the heart H. Another electrode can be used to apply anti-tachycardia pacing (ATP) therapy or other cardiac therapy. The detected electrical signals are transmitted to a processor housed within the ILP 30. The processor analyzes the cardiac electrical signals (e.g., ECG signals) and thereby determines the patient's cardiac rhythm. The cardiac rhythm can include a normal cardiac rhythm 420, a ventricular tachyarrhythmia 400, or a shock 430 delivered by the S-ICD as anti-tachycardia therapy, as shown in FIG. 7 . The processor is further adapted to generate and deliver an ATP therapy signal to one or more electrodes of the ILP 30. The processor's functionality related to ATP therapy can be activated by an operator, for example, via a communication link to an external control unit.

[0049] The S-ICD 1 includes a second processor and a shock unit within its housing 10. The lead 2 is subcutaneously implanted along the sternum 20 and includes two sensing electrodes 200, 203 as a second sensing unit and a shock coil 202 for delivering a cardioversion or defibrillation shock. The sensing electrodes 200, 203 detect electrical signals from the heart H and its surroundings and transmit these signals to the second processor housed within the housing 10. The second processor analyzes the cardiac electrical signals (e.g., ECG signals) and thereby determines the patient's cardiac rhythm. The cardiac rhythm may include a normal cardiac rhythm 520, a tachyarrhythmia 500, or an ATP signal 510 provided by the ILP 30 as anti-tachycardia therapy, as shown in FIG. 6 . The second processor is further adapted to generate and deliver signals to the shock unit. The shock unit generates at least one cardioversion or defibrillation shock to the shock coil 202 for anti-tachycardia therapy. The shock unit must undergo a loading / charging period during which the voltage required for one or more shocks to be delivered by the shock coil 202 as a shock therapy is generated.

[0050] During initialization of the ILP after implantation, initial programming is performed (see step 250 in FIG. 2 ). Next, a warning notification is displayed on an external device communicatively connected to the ILP 30 (see step 251), as shown in FIG. 4 . This warning notification informs the operator that the ATP mode can be activated only if a defibrillator (e.g., S-ICD1) is also implanted. The warning notification shown in FIG. 4 further asks whether a defibrillator device is actually implanted. Next, in step 252, the operator provides a response to the warning notification by selecting one of the boxes, each containing one of the answers to the question. If the “yes” box is selected, the method continues with step 253, where predefined confirmation information is transmitted by the external device's transmitter to the ILP 30's receiver. As a result, the ILP 30's processor activates its ATP mode. If the “no” box is selected, the method continues with step 254, where the method ends without activating the ILP 30's ATP mode. In an alternative embodiment shown in FIG. 3, after selecting the "Yes" box in step 255, the external device displays a confirmation notice to the operator confirming that the ATP mode of the ILP 30 has been activated. FIG. 5 shows an example of such a confirmation notice. The operator can confirm the selection by clicking the "Yes" box, which provides predefined confirmation information to the receiver of the ILP 30 (step 256). If the operator does not confirm the selection by selecting "No," the method continues with step 257, terminating the method without activating the ATP mode. A second confirmation requested from the operator ensures that the operator provided an intentional response to the warning notice. The warning notice may reference additional information provided by documentation accompanying the pacing device.

[0051] The above-described pacing devices, systems, and methods allow for variable use of the pacing device, either separately or in conjunction with a defibrillator device, with the ATP mode being activated and / or upgraded only when the pacing device receiver receives a corresponding predefined confirmation information signal.

[0052] Furthermore, the above-described pacing devices, systems, and methods enhance patient safety relative to pacing devices that can deliver ATP but do not deliver defibrillation shocks, such as ILPs. Ventricular tachycardia is typically treated first with ATP. If multiple attempts of ATP fail, a shock must be delivered as a last resort to terminate the life-threatening tachycardia. If a pacing device can only deliver ATP, it must ensure that shock therapy is available to the patient via another device, such as a SICD. Activating the ATP function of a pacing device without the possibility of additional shock therapy could result in an inadequately treated ventricular tachycardia, putting the patient at risk. The present invention ensures that ATP must be activated in the pacing device by a confirmation signal sent from an external device or generated by actuator operation. This additional confirmation step provides additional safety for the use of pacing devices with ATP functionality. [Explanation of symbols]

[0053] 1 S-ICD 2-electrode lead H Heart 10. Housing 20 Sternum 30 ILP 200 detection electrode 202 Shock Coil 203 Detection electrode 250 Steps of the Present Method of Operating a Pacing Device 251 Steps of the present invention's method of operating a pacing device 252 Steps of the present invention's method of operating a pacing device 253 Steps of the present invention's method of operating a pacing device 254 Steps of the present invention's method of operating a pacing device 255 Steps of the present invention's method of operating a pacing device 256 Steps of the present invention's method of operating a pacing device 257 Steps of the present invention's method of operating a pacing device 400 Tachyarrhythmia 410 ATP therapy 420 Normal Heart Rhythm 430 Shock Therapy 500 Tachyarrhythmia 510 ATP signal 520 Normal Heart Rhythm

Claims

1. 1. An implantable pacing device having a housing, The pacing device comprises a processor, a transmitter and a receiver electrically connected to or integrated within the processor, the processor comprising: - transmitting signals for electrical stimulation of the patient's heart (H) according to at least one first stimulation mode; - delivering signals for electrical stimulation of the patient's heart according to an anti-tachycardia pacing mode (ATP mode), the ATP mode being initially deactivated; - adapted to provide predefined warning information data, including warning information indicating that the ATP mode can be activated only if an additional anti-tachycardia device is implanted; the transmitter is adapted to transmit the warning information data to an external device; the receiver is adapted to receive an ATP confirmation signal transmitted by the external device in response to the predefined alert information data; The implantable pacing device, wherein the processor is adapted to activate the ATP mode for use in conjunction with the additional anti-tachycardia device only when the receiver receives the ATP confirmation signal including predefined confirmation information transmitted by the external device, the predefined confirmation information indicating operator confirmation that the ATP mode should be activated.

2. The pacing device of claim 1 , wherein the receiver is adapted to receive the ATP confirmation signal before, during, or after implantation of the pacing device.

3. 3. The pacing device of claim 1, wherein the predefined identification information includes at least one parameter of the anti-tachycardia device, and wherein the pacing device and the anti-tachycardia device are adapted to be implanted in the same patient.

4. 4. The pacing device of claim 1, wherein the receiver of the pacing device is adapted to receive the ATP confirmation signal in the ATP mode wirelessly or via a lead electrically connected to the pacing device.

5. 5. The pacing device of claim 1, wherein the processor is adapted to apply at least one criterion for ventricular / supraventricular tachycardia discrimination to the cardiac rhythm detected by the detection unit of the pacing device.

6. 6. The pacing device of claim 1, wherein the ATP mode includes at least two different anti-tachycardia pacing pattern elements that are usable during electrical stimulation of the patient's heart in accordance with the ATP mode.

7. 7. The pacing device of claim 6, wherein the first anti-tachycardia pacing pattern element includes at least one burst, and / or the second anti-tachycardia pacing pattern element includes at least one ramp, and / or the third anti-tachycardia pacing pattern element includes at least one burst in combination with an additional stimulus.

8. A cardiac therapy system comprising the pacing device of any one of claims 1 to 7 and the anti-tachycardia device.

9. 1. A method of operating an implantable pacing device having a housing, comprising: the pacing device comprises a processor, a transmitter and a receiver electrically connected to or integrated within the processor; The processor: - adapted to deliver signals for electrical stimulation of the patient's heart according to at least one first stimulation mode; - adapted to deliver signals for electrical stimulation of the patient's heart according to an anti-tachycardia pacing mode (ATP mode), the ATP mode being initially deactivated; - providing predefined warning information data including warning information indicating that the ATP mode can be activated only if an additional anti-tachycardia device is implanted; The transmitter transmits the warning information data to an external device, the receiver receives an ATP confirmation signal transmitted by the external device in response to the predefined alert information data; The method, wherein the processor activates the ATP mode for use in conjunction with the additional anti-tachycardia device only if the receiver receives the ATP confirmation signal including predefined confirmation information transmitted by the external device, the predefined confirmation information indicating operator confirmation that the ATP mode should be activated.

10. 10. The method of claim 9, wherein the receiver receives the ATP confirmation signal before, during, or after implantation of the pacing device.

11. 11. The method of claim 9 or 10, wherein the receiver of the pacing device receives the ATP confirmation signal in the ATP mode wirelessly or via a lead electrically connected to the pacing device.

12. 12. The method of claim 9, wherein the processor applies at least one criterion for ventricular / supraventricular tachycardia discrimination to the cardiac rhythm detected by the detection unit of the pacing device.

13. 13. The method of any one of claims 9 to 12, wherein the ATP mode includes at least two different anti-tachycardia pacing pattern elements.

Images