Implantable System for Stimulating a Human Heart or an Animal Heart

Abstract

An implantable system for stimulating a human/animal heart, comprising a processor, a memory unit, a stimulation unit, a sensing unit, and a diagnostic unit. The system carries out: a) detecting whether at least one malfunction state of the system is present; b) checking whether an electrode provided for stimulating a His bundle of a heart is connected to the stimulation unit; c) switching an operating state of the system into a safety mode when a malfunction state was detected, the safety mode selected from a first safety mode and a second safety mode, wherein i) the first safety mode is selected when no electrode provided for stimulating a His bundle of a heart is connected to the stimulation unit, and ii) the second safety mode is selected when an electrode provided for stimulating a His bundle of a heart is connected to the stimulation unit.

Claims

1. An implantable system for stimulating a human heart or an animal heart, comprising a processor, a memory unit, a stimulation unit for stimulating a His bundle or another cardiac region of a human heart or an animal heart, a sensing unit for sensing an electrical signal of this heart, and a diagnostic unit for checking functional parameters of the implantable system, 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) detecting, by means of the diagnostic unit, whether at least one malfunction state of the implantable system is present; b) checking whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit; and c) switching an operating state of the implantable system into a safety mode when a malfunction state was detected, the safety mode being selected at least from a first safety mode and a second safety mode, wherein i) the first safety mode is selected when the checking carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the first safety mode resulting in a first safety operation of the implantable system, in which the implantable system does not meet any specific requirements for His bundle pacing; and ii) the second safety mode is selected when the checking carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the second safety mode resulting in a second safety operation of the implantable system in which the implantable system is able to meet specific requirements for His bundle pacing.

2. The implantable system according to claim 1, wherein the pieces of information that are required for switching the system into the safety mode are stored in a non-volatile memory, a redundant memory or a recoverable memory of the implantable system.

3. The implantable system according to claim 1, wherein the checking as to whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit is carried out based on information stored in the memory unit.

4. The implantable system according to claim 1, wherein the diagnostic unit is configured to detect the malfunction state based on at least one of the following events: a memory error, a software runtime error, a software status error, a detected cyberattack, a parameter error, an activation of a reset state of the implantable system, a battery drainage, and outside electromagnetic interference of the implantable system.

5. An implantable system according to claim 1, wherein the second safety operation is characterized by at least one of the following configurations: a His bundle pacing setting of an electrode terminal of the stimulation unit to which an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected; a stimulation energy of a stimulation to be delivered by an electrode provided for stimulating a His bundle of a human heart or an animal heart; a sensing sensitivity of the sensing unit for sensing His bundle-specific signals; a stimulation operating mode of the implantable system; a stimulation frequency of a stimulation to be delivered by an electrode provided for stimulating a His bundle of a human heart or an animal heart; and a His bundle pacing setting of a second electrode terminal of the stimulation unit to which a second electrode for stimulating a human heart or an animal heart is connected.

6. An implantable system according to claim 1, wherein the program prompts the processor to additionally carry out the following step: a) switching an operating state of the implantable system into a protective mode when the protective mode was activated by an external signal, the protective mode being selected at least from a first and a second protective mode, wherein i) the first protective mode is selected when the checking carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the first protective mode resulting in a first protective operation of the implantable system in which the implantable system does not meet any specific requirements for His bundle pacing; and ii) the second protective mode is selected when the checking carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the second protective mode resulting in a second protective operation of the implantable system in which the implantable system is able to meet specific requirements for His bundle pacing.

7. An implantable system according to claim 1, wherein the second safety operation is characterized by at least one of the following configurations: a His bundle pacing setting of an electrode terminal of the stimulation unit to which an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected; a stimulation energy of a stimulation to be delivered by an electrode provided for stimulating a His bundle of a human heart or an animal heart; a sensing sensitivity of the sensing unit for sensing His bundle-specific signals; a stimulation operating mode of the implantable system; a stimulation frequency of a stimulation to be delivered by an electrode provided for stimulating a His bundle of a human heart or an animal heart; and a His bundle pacing setting of an additional electrode terminal of the stimulation unit to which an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected.

8. The implantable system according to claim 1, wherein the program prompts the processor to establish or individually adapt the configuration of the second safety operation as a function of settable programming parameters.

9. The implantable system according to claim 1, wherein the program prompts the processor to automatically determine the configuration of the second safety operation as a function of pieces of information stored in the implantable system.

10. The implantable system according to claim 1, wherein the implantable system comprises a data remote transmission unit, the program prompting the processor to transmit an activation of the safety mode to a remote monitoring system by means of the data remote transmission unit.

11. A method for controlling the operation of an implantable system for stimulating a human heart or an animal heart according to claim 1, wherein the following steps are performed: a) detecting, by means of a diagnostic unit for checking functional parameters of the implantable system, whether at least one malfunction state of the implantable system is present; b) checking whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to a stimulation unit for stimulating a His bundle or a similar cardiac region of a human heart or an animal heart; and c) switching an operating state of the implantable system into a safety mode when a malfunction state was detected, the safety mode being selected at least from a first safety mode and a second safety mode, wherein i) the first safety mode is selected when the checking carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the first safety mode resulting in a first safety operation of the implantable system in which the implantable system does not meet any specific requirements for His bundle pacing; and ii) the second safety mode is selected when the checking carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the second safety mode resulting in a second safety operation of the implantable system in which the implantable system is able to meet specific requirements for His bundle pacing.

12. 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) detecting, by means of a diagnostic unit for checking functional parameters of an implantable system for stimulating a human heart or an animal heart, whether at least one malfunction state of the implantable system is present; b) checking whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to a stimulation unit for stimulating a His bundle or a similar cardiac region of a human heart or an animal heart; and c) switching an operating state of the implantable system into a safety mode when a malfunction state was detected, the safety mode being selected at least from a first safety mode and a second safety mode, wherein i) the first safety mode is selected when the checking carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the first safety mode resulting in a first safety operation of the implantable system in which the implantable system does not meet any specific requirements for His bundle pacing; and ii) the second safety mode is selected when the checking carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the second safety mode resulting in a second safety operation of the implantable system in which the implantable system is able to meet specific requirements for His bundle pacing.

13. A method for treating a human patient or an animal patient requiring such treatment by means of an implantable system for stimulating a human heart or an animal heart, the implantable system comprising a stimulation unit for stimulating a His bundle or another cardiac region of a human heart or an animal heart, a sensing unit for sensing an electrical signal of this heart, and a diagnostic unit for checking functional parameters of the implantable system, the method comprising the following steps: a) detecting, by means of the diagnostic unit, whether at least one malfunction state of the implantable system is present; b) checking whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit; and c) switching an operating state of the implantable system into a safety mode when a malfunction state was detected, the safety mode being selected at least from a first safety mode and a second safety mode, wherein i) the first safety mode is selected when the checking carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the first safety mode resulting in a first safety operation of the implantable system in which the implantable system does not meet any specific requirements for His bundle pacing; and ii) the second safety mode is selected when the checking carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, the second safety mode resulting in a second safety operation of the implantable system in which the implantable system is able to meet specific requirements for His bundle pacing, d) carrying out a stimulation of the human or animal heart in the safety operation of the implantable system specified by the selected safety mode.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Details of aspects of the present invention are to be described in more detail based on exemplary embodiments and figures. In the drawings:

[0067] FIG. 1 shows a schematic illustration of different electrode configurations for connecting an electrode suitable for His bundle pacing to an implantable system for stimulating the human or animal heart;

[0068] FIG. 2 shows a schematic flow chart of a method for controlling the operation of an implantable system for stimulating the human heart or an animal heart; and

[0069] FIG. 3 shows an implantable system for stimulating a human or animal heart.

DETAILED DESCRIPTION

[0070] FIG. 1 shows a schematic illustration of different electrode configurations that are possible for connecting an electrode suitable for stimulating the His bundle of a human heart or an animal heart to a device for stimulating this heart.

[0071] A single-chamber stimulation is carried out in a first electrode configuration 110. For this purpose, the electrode suitable for His bundle pacing is connected to an electrode terminal for an electrode for stimulating the right atrium RA or for stimulating the right ventricle RV. Such a pacemaker can also be referred to as a single-chamber pacemaker or a demand pacemaker. At least in the safety mode, it is typically operated in a mode in which a stimulation takes place in the right ventricle, and sensing takes place in the right ventricle, and an inhibiting operating mode is carried out (VVI). This means that the pacemaker only applies pacing pulses when no intrinsic activity of the heart can be detected. In this mode, a right ventricular or biventricular stimulation is possible using the His bundle electrode.

[0072] When the electrode provided for His bundle pacing is connected to the RA terminal of such a pacemaker, and such a pacemaker enters a VVI safety mode, adequate His bundle pacing is not possible. The presently described invention is thus suitable, in particular, for improving cardiac pacemakers having the first electrode configuration 110. However, further electrode configurations described hereafter also typically result in an undersupply situation of the patient as a result of the selection of conventional safety modes. The presently claimed invention also offers a corrective action in this regard by ensuring a safety mode configured specifically for His bundle pacing and allowing this safety mode to be activated when a His bundle electrode is connected.

[0073] In a second electrode configuration 120, the electrode used for stimulating the His bundle is connected to the terminal of the right ventricle RV. In addition, an arterial electrode is also connected to the terminal for the right atrium RA. Such a pacemaker can be operated in the DDD mode (dual pacing (that is, atrial and ventricular), dual sensing (that is, atrial and ventricular) with dual operating mode (that is, triggering or inhibition). In this mode as well, a right ventricular or biventricular stimulation is possible using the His bundle electrode. As a result, sequential pacing of the atrium and of the His bundle is possible.

[0074] In a third electrode configuration 130, the electrode suitable for stimulating the His bundle is connected to the terminal for the right ventricle RV or the left ventricle LV of the cardiac pacemaker. In contrast, an electrode provided for stimulating the left ventricle is connected to the, still free, terminal for stimulating the left ventricle LV or the right ventricle RV. Moreover, an atrial electrode is connected to the terminal for the right atrium RA. Such a stimulation device is, in particular, a device for cardiac resynchronization therapy (CRT). It allows biventricular stimulation as well as cardiac resynchronization with optional His bundle pacing.

[0075] In a fourth electrode configuration 140, the electrode used for stimulating the His bundle is connected to the terminal for the right atrium RA of a pacemaker. Moreover, an electrode for stimulating the right ventricle is connected to the corresponding terminal for the right ventricle RV. Such a pacemaker can implement an RV safety mode and is, in particular, suited for operation in the DDD mode.

[0076] In a fifth electrode configuration 150, the electrode provided for His bundle pacing is connected to the terminal for the left ventricle LV. Moreover, an atrial electrode is connected to the terminal for the right atrium RA, and a ventricular electrode is connected to the terminal for the right ventricle RV. Such a device is also, in particular, a CRT device, which allows right ventricular or biventricular stimulation, and moreover enables optional His bundle pacing when carrying out cardiac resynchronization therapy.

[0077] In a sixth electrode configuration 160, the electrode provided for His bundle pacing is, again, connected to the terminal for the right atrium RA. Moreover, two ventricular electrodes are provided, of which the electrode arranged in the right ventricle is connected to the terminal for the right ventricle RV, and the left ventricular electrode is connected to the terminal for the left ventricle LV. Once again, such an electrode configuration is particularly suited for CRT devices, which are able to carry out a biventricular stimulation and cardiac resynchronization with optional His bundle pacing.

[0078] An implementation of the presently claimed invention is useful and contemplated in the various stimulation devices whose electrode configurations are shown in FIG. 1. The reason is that the problem of the patient possibly being undersupplied when conventional safety modes are selected arises in all of these electrode configurations. The option of selecting a safety mode that is tailored to the specific requirements of His bundle pacing makes it possible to avoid such an undersupply situation when an electrode suitable for His bundle pacing is connected to the corresponding stimulation device.

[0079] FIG. 2 shows a schematic flow chart of a method for controlling the operation of an implantable system for stimulating the animal or human heart, which can implement the second safety mode according to the present invention (hereafter referred to as stimulation device).

[0080] This stimulation device is initially active in a regular operating mode 210. When an error state is detected as a result a self-test carried out cyclically by a corresponding diagnostic unit, a check 220 is carried out as to whether an electrode suitable for stimulating the His bundle is connected to the stimulation device. This can be achieved, for example, by querying internal information, which is stored in the stimulation device when an electrode suitable for His bundle pacing is connected.

[0081] If the check 220 shows that no electrode suitable for His bundle pacing is connected to the stimulation device, a first safety mode 230 is selected, by way of which thereafter a first safety operation of the stimulation device is carried out.

[0082] If, in contrast, the check 220 shows that an electrode provided for His bundle pacing is connected to the stimulation device, a second safety mode 240 is selected, which transfers the stimulation device into a second safety operation. This second safety operation is specifically tailored to the needs of His bundle pacing, whereby adequate His bundle pacing is also possible in this safety mode.

[0083] After a restoration procedure 250, which, in particular, removes the error state that results in the stimulation device being transferred into one of the safety modes in the first place, the stimulation device is transferred back into the regular operating mode 210 thereof.

[0084] FIG. 3 shows an implantable system 1 for stimulating a human or animal heart 8, comprising a processor 2, a memory unit 3, a stimulation unit 4 for stimulating a His bundle or another cardiac region of a human heart or an animal heart, a sensing unit 5 for sensing an electrical signal of this heart 8, a diagnostic unit 6 for checking functional parameters of the implantable system, which is according to an embodiment part of the processor 2, and a data remote transmission unit 7. Alternatively, the diagnostic unit 6 is separate to the processor 2 and is configured to communicate with the processor 2. Signals detected via the sensing unit 5 are transmitted to the diagnostic unit 6, where the information is analyzed and where a decision is made with regards to an electrical stimulation, which is delivered via stimulation unit 4. The processor 2 has access to the memory unit 3, and communicates with the remote transmission unit 7, which wirelessly transmits data from the implantable system 1 to an external device or system (not shown).

[0085] 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.