CARDIAC RHYTHM MANAGEMENT SYSTEM AND METHOD

Abstract

Modular cardiac rhythm management system and method, including:

a first implantable stimulation device (ISD), and
a second ISD,
wherein the first ISD comprises a first detection unit detecting a patient's cardiac rhythm and a first processor analyzing the detected patient's cardiac rhythm and delivering a first antitachycardia pacing therapy (APT),
wherein the second ISD comprises a second detection unit detecting the patient's cardiac rhythm and a second processor analyzing the detected patient's cardiac rhythm and delivering shock therapy or a second APT, and
wherein the first processor allows delivery of APT only if analysis of the patient's cardiac rhythm within preceding time period A reveals tachycardia criterion A′ and absence of shock therapy, and/or
wherein the second processor allows delivery of shock therapy or second APT only if analysis of the patient's cardiac rhythm within preceding time period B reveals tachycardia criterion B′ and absence of first APT.

Claims

1. A cardiac rhythm management system, comprising: at least one first implantable stimulation device and at least one second implantable stimulation device, wherein the at least one first implantable stimulation device comprises a first detection unit adapted to detect a patient's cardiac rhythm and a first processor adapted to analyze the detected patient's cardiac rhythm and to deliver signals for a first antitachycardia pacing therapy, wherein the at least one second implantable stimulation device comprises a second detection unit adapted to detect the patient's cardiac rhythm and a second processor adapted to analyze the detected patient's cardiac rhythm and to deliver signals for shock therapy or a second antitachycardia pacing therapy, and wherein the first processor is adapted to allow delivery of signals for antitachycardia pacing therapy only if the analysis of the patient's cardiac rhythm within a pre-defined preceding time period A reveals a pre-defined tachycardia criterion A′ and an absence of a shock therapy, and/or wherein the second processor is adapted to allow delivery of signals for shock therapy or a second antitachycardia therapy only if the analysis of the patient's cardiac rhythm within a pre-defined preceding time period B reveals a pre-defined tachycardia criterion B′ and an absence of a first antitachycardia pacing therapy provided by the at least one first implantable stimulation device.

2. The cardiac rhythm management system according to claim 1, wherein the first processor is adapted to prevent delivery of signals for antitachycardia pacing therapy for a time period C if the analysis of the patient's cardiac rhythm within the time period A reveals delivery of a shock therapy.

3. The cardiac rhythm management system according to claim 1, wherein the second processor is adapted to prevent delivery of signals for shock therapy or a second antitachycardia pacing therapy for a time period D the analysis of the patient's cardiac rhythm within the time period B reveals delivery of a first antitachycardia pacing therapy.

4. The cardiac rhythm management system according to claim 2, wherein the first processor is adapted to re-analyze the patient's cardiac rhythm according to the pre-defined tachycardia criterion A′ during the time period C and/or the second processor is adapted to re-analyze the patient's cardiac rhythm according to the pre-defined tachycardia criterion B′ during the time period D.

5. The cardiac rhythm management system according to claim 2, wherein the first processor is adapted to re-analyze the patient's cardiac rhythm according to a pre-defined tachycardia criterion C′ during the time period C and/or the second processor is adapted to re-analyze the patient's cardiac rhythm according to a pre-defined tachycardia criterion D′ during the time period D, wherein the pre-defined tachycardia criterion C′ is different from the pre-defined tachycardia criterion A′ and the pre-defined tachycardia criterion D′ is different from the second pre-defined tachycardia criterion.

6. The cardiac rhythm management system according to claim 2, wherein the first and/or second processor are/is adapted to terminate the time period C and/or the time period D upon receipt of a termination signal.

7. The cardiac rhythm management system according to claim 1, wherein the delivery of at least one shock during the shock therapy by a shock unit of the second implantable stimulation device comprises a loading time period prior the at least one shock is applied by the shock unit to the patient, wherein the application of the at least one shock by the shock unit is prevented if the patient's cardiac rhythm within a time period E during or after the loading time period does not correspond to a pre-defined tachycardia criterion E′.

8. The cardiac rhythm management system according to claim 1, wherein the first implantable stimulation device is an implantable leadless pacemaker (ILP), and the second implantable stimulation device is a subcutaneous implantable cardioverter defibrillator or a second ILP.

9. A cardiac rhythm management method for a cardiac rhythm management system, comprising at least one first implantable stimulation device, including an ILP, and at least one second implantable stimulation device, including a subcutaneous implantable cardioverter defibrillator or a second ILP, wherein a first detection unit of the at least one first implantable stimulation device detects a patient's cardiac rhythm and a first processor of the at least one first implantable stimulation device analyzes the detected patient's cardiac rhythm, wherein a second detection unit of the at least one second implantable stimulation device detects the patient's cardiac rhythm and a second processor of the at least one second implantable stimulation device analyzes the detected patient's cardiac rhythm, and wherein the first processor delivers signals for a first antitachycardia pacing therapy only if the analysis of the patient's cardiac rhythm within a pre-defined preceding time period A reveals a pre-defined tachycardia criterion A′ and an absence of a shock therapy, and/or wherein the second processor delivers of signals for shock therapy or a second antitachycardia pacing therapy only if the analysis of the patient's cardiac rhythm within a pre-defined preceding time period B reveals a pre-defined tachycardia criterion B′ and an absence of a first antitachycardia pacing therapy.

10. The cardiac rhythm management method according to claim 9, wherein the first processor prevents delivery of signals for antitachycardia pacing therapy for a time period C if the analysis of the patient's cardiac rhythm within the time period A reveals delivery of a shock therapy.

11. The cardiac rhythm management method according to claim 9, wherein the second processor prevents delivery of signals for shock therapy or a second antitachycardia pacing therapy for a time period D the analysis of the patient's cardiac rhythm within the time period B reveals delivery of a first antitachycardia pacing therapy.

12. The cardiac rhythm management method according to claim 9, wherein the first processor re-analyzes the patient's cardiac rhythm according to the pre-defined tachycardia criterion A′ during the time period C and/or the second processor re-analyzes the patient's cardiac rhythm according to the pre-defined tachycardia criterion B′ during the time period.

13. The cardiac rhythm management method according to claim 9, wherein the first processor re-analyzes the patient's cardiac rhythm according to a pre-defined tachycardia criterion C′ during the time period C and/or the second processor re-analyzes the patient's cardiac rhythm according to a pre-defined tachycardia criterion D′ during the time period D, wherein the pre-defined tachycardia criterion C′ is different from the pre-defined tachycardia criterion A′ and the pre-defined tachycardia criterion D′ is different from the pre-defined tachycardia criterion B′.

14. The cardiac rhythm management method according to claim 10, wherein the first and/or second processor terminates the time period C and/or the time period D upon receipt of a termination signal.

15. The cardiac rhythm management method according to claim 9, wherein the delivery of at least one shock during the shock therapy by a shock unit of the defibrillation device comprises waiting for a loading time period prior the at least one shock is applied by the shock unit to the patient, wherein the shock unit does not deliver the at least one shock if the patient's cardiac rhythm within a time period E during or after the loading time period does not correspond to a pre-defined tachycardia criterion E′.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The present invention will now be described in further detail with reference to the accompanying schematic drawings, wherein:

[0063] FIG. 1 shows an exemplary implantation of an inventive cardiac rhythm management system within a human patient's body,

[0064] FIG. 2 depicts a flow chart of an inventive cardiac rhythm management method,

[0065] FIGS. 3 to 5 show the operation of another embodiment of the cardiac rhythm management method during shock therapy,

[0066] FIG. 6 shows an electrocardiogram containing signals of an antitachycardia pacing therapy, and

[0067] FIG. 7 shows an electrocardiogram containing a signal of a shock therapy.

DETAILED DESCRIPTION

[0068] FIG. 1 shows a first embodiment of a cardiac rhythm management system implanted in a human patient's body. The system comprises a subcutaneous implantable cardioverter defibrillator (S-ICD) 1 as a second implantable stimulation device with a housing 10 and an electrode lead 2 connected to the housing 10. Further, the system comprises an ILP (ILP) 30 as a first implantable stimulation device implanted within one, e.g., the right, ventricle of the heart H.

[0069] The ILP 30 comprises one or more electrodes as a first detection unit for sensing electric signals of the heart H. Further, the one more electrodes may be used for application antitachycardia pacing (ATP) therapy or other cardiac therapy. The detected electric signals are transmitted to a first processor accommodated within the ILP 30. The first processor analyzes the electric signals of the heart (e.g., ECG signals) and thereby determines the patient's cardiac rhythm which may comprise, as shown in FIG. 7, a normal cardiac rhythm 420, a ventricular tachyarrhythmia 400 or a shock 430 provided by the S-ICD as an antitachycardia therapy. The first processor is further adapted to generate and deliver signals for ATP therapy to the one or more electrodes of the ILP 30. The functions of the first processor regarding the ATP therapy may be activatable by an operator, for example, via a communication link to an external control unit.

[0070] The S-ICD 1 comprises within its housing 10 a second processor and a shock unit. The lead 2 is implanted subcutaneous along the sternum 20 and comprises two detection electrodes 200, 203 as a second detection unit and a shock coil 202 for application of a cardioversion or defibrillation shock. The detection electrodes 200, 203 detect electric signals of and around the heart H and transmit these signals to the second processor accommodated within the housing 10. The second processor analyzes the electric signals of the heart (e.g., the ECG signals) and thereby determines the patient's cardiac rhythm which may comprise, as shown in FIG. 6, a normal cardiac rhythm 520, a tachyarrhythmia 500 or ATP signals 510 provided by the ILP 30 as an antitachycardia therapy. The second processor is further adapted to generate and deliver signals transmitted to the shock unit which generates at least one cardioversion or defibrillation shock for antitachycardia therapy to shock coil 202. The shock unit has to run through a loading/charging time in which the necessary electric voltage is generated for the one or more shocks delivered by the shock coil 202 as shock therapy.

[0071] The flow chart of FIG. 2 shows the inventive cardiac rhythm management method with regard using ECG signals as signals showing the patient's cardiac rhythm to the ILP 30. In the first step (see step 208 in FIG. 2), the one more electrodes of the first detection unit of the ILP 30 receive electric signals of the heart H and transmit them to the first processor which analyzes the respective ECG. If the ECG contains a tachycardia, the first processor detects this tachycardia initially. In the next step 210, the first processor then checks whether there is any application of shock therapy by a respective shock signal (see signal 430 in FIG. 7) during a preceding time period A. If there is no shock therapy during the time period A, in the next step 220 an ATP therapy may be provided by the ILP 30. Accordingly, the first processor generates signals based on which the one or more electrodes of the ILP 30 apply ATP pulses to the heart H. In the following steps 230 and 240, the first processor further checks whether the tachycardia is terminated and/or the maximum number of ATP therapy units is applied. If none of these criteria is fulfilled, the method continues with step 210 (see above). If at least one of these criteria is fulfilled, the application of any ATP therapy is prevented until the next tachycardia of the heart H is detected by the first processor (see step 260). If there is any shock therapy revealed during the time period A, in the step 250 the ATP therapy is prevented during a time period C. The time period C may continue over a pre-defined time or until the next operator's check of the ILP 30.

[0072] Analog to the flow chart of FIG. 2 the inventive cardiac rhythm management method may be realized also with regard to the S-ICD 1. If the detected ECG signals show a tachycardia the second processor detects this tachycardia initially. In the next step the second processor then checks whether there is any application of ATP therapy by respective ATP signals (see signals 510 in FIG. 6) during a preceding time period B (see time period denoted reference number 300 in FIG. 3). If there is no ATP therapy during the time period B, in the next step a shock therapy may be provided by the S-ICD 1. Accordingly, the second processor generates signals based on which the shock coil 202 of the S-ICD applies one or more shock pulses to the heart H. The shock application (see lighting symbol 320 in FIG. 3) is provided after running through a loading time which is depicted in FIG. 3 by the reference number 310. In the following steps, the second processor further checks whether the tachycardia is terminated and/or the maximum number of shock therapy units is applied. If none of these criteria is fulfilled, the method continues with checking whether there is any ATP therapy or any tachyarrhythmia during the time period B (see above). If at least one of these criteria is fulfilled, the application of any ATP therapy is prevented until the next tachycardia of the heart H is detected by the second processor. If there is any ATP therapy revealed during the time period B 300, the shock therapy is prevented during a time period D which is in the embodiment shown in FIG. 4 denoted with reference number 300′. The time period D may continue over a pre-defined time period which may be identical to the time period B in length in order to have enough time to check whether after the ATP therapy any tachycardia is still existent, or until the next operator's check of the S-ICD 1.

[0073] Further, as indicated in FIG. 5, in one embodiment the delivery of ATP therapy by ILP 30 may be detected during the loading time 310. In this case, after finishing loading time 310 the shock application by the shock unit is prevented during a time period D 330 (confirmation period) in order to check whether after ATP therapy a tachycardia is still detected which needs shock therapy. Only if the tachycardia is still in a dangerous level for the patient, the shock 320 is applied after the time period D 330 has elapsed.

[0074] The above system and method provide a modular cardiac rhythm management of two devices providing antitachycardia therapy implanted in the same patient without the necessity of providing any separate communication channel. The system and method just use the analysis of the patient's cardia rhythm provided anyway for co-ordination of the operation of each device. Accordingly, the system is cost-effective and power-saving as well as reliable and user-friendly. The inventive system and method avoids cyber-attacks.

[0075] 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.

REFERENCE NUMERALS

[0076] 1 S-ICD [0077] 2 electrode lead [0078] H heart [0079] 10 housing [0080] 20 sternum [0081] 30 ILP [0082] 200 detection electrode [0083] 202 shock coil [0084] 203 detection electrode [0085] 208 step of an inventive method for cardiac rhythm management [0086] 210 step of an inventive method for cardiac rhythm management [0087] 220 step of an inventive method for cardiac rhythm management [0088] 230 step of an inventive method for cardiac rhythm management [0089] 240 step of an inventive method for cardiac rhythm management [0090] 250 step of an inventive method for cardiac rhythm management [0091] 260 step of an inventive method for cardiac rhythm management [0092] 300 time period B in which an initial tachycardia is detected [0093] 300′ time period D during which a shock therapy is prevented for check of tachycardiac properties of the cardiac signal [0094] 310 loading time [0095] 320 shock [0096] 330 time period D during which a shock therapy is prevented for check of tachycardiac properties of the cardiac signal [0097] 340 time point of detected ATP therapy [0098] 400 tachyarrhythmia [0099] 410 ATP therapy [0100] 420 normal cardiac rhythm [0101] 430 shock therapy [0102] 500 tachyarrhythmia [0103] 510 ATP signal [0104] 520 normal cardiac rhythm