Computer-implemented method and system for programming a leadless cardiac pacemaker
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BIOTRONIK SE & CO KG
- Filing Date
- 2023-04-04
- Publication Date
- 2026-03-19
AI Technical Summary
Current methods for programming leadless cardiac pacemakers lack a coordinated and user-friendly approach for managing device replacements, particularly in leadless pacer systems, where interactions with new and old implants require specialized management to ensure reliable electrode engagement and safe replacement therapy.
A computer-implemented method and system for programming leadless cardiac pacemakers that allows for coordinated management of device replacements by using a computing device to set parameters, assign unique identifiers, and preset settings for both old and new devices, enabling wireless communication and user-controlled interface for efficient replacement procedures.
The proposed solution enhances the robustness of bradycardia support during device replacement, improves clinician control and workflow, and allows for flexible implantation timing, reducing the frequency of replacement procedures and ensuring reliable patient support.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a computer-implemented method for programming a leadless cardiac pacemaker and further to a system for programming a leadless cardiac pacemaker.
[0002] WO 2008 / 042610 describes a programming device consisting of a manufacturer-specific telemetry module coupled to a computer.
[0003] EP 2181729 discloses a universal programming device for patient-specific medical devices, e.g. implants. The programmer comprises an RF transceiver (transmitter / receiver), a control device and a man-machine interface or a connector for a man-machine interface. The RF transceiver is configured to transmit and receive data in the MICS band. The control device is connected to the transceiver and has a preconfigured software interface such that the programmer is extensible by a control software module, where the preconfigured software interface defines a uniform interface for controlling the transceiver accessible by the control software module. A human-machine interface, e.g. a keyboard and / or a display or a connector for a human-machine interface, is connected to the control device.
[0004] In conventional IPG (Implantable Pulse Generator) systems, a new implant for replacement is simply configured completely independent of any old implant that needs to be replaced. Such interaction occurs by establishing some form of ON state in the new implant, which takes the new implant out of its shipping settings, often referred to as the shelf state. Depending on the manufacturer, this may be an implant ready state, such as an automatic implant detection ready state, or a state in which the implant is programmed into a particular pacing mode with a particular pace output state and activated, even without being physically attached to the patient's anatomy.
[0005] With these traditional pocket-based implant systems, replacement often requires the clinician to quickly swap out the lead connections from the old device to the new one, which does not deliver therapy to new and unknown tissue interfaces within the heart, but instead simply pipelines the input from the new device to the same leaded connections that previously relayed the output from the old device.
[0006] Leadless implants require additional management because not only is the new device providing bradycardia support to the heart, but it necessarily does so at a new physical interface, albeit in the same chamber of the heart as the old implant. The altered quality of the implant site interacting with the cardiac conduction system adds risk to establishing reliable electrode engagement with the cardiac electrical conduction system and therefore warrants special management / treatment to ensure robust / safe exchange therapy management.
[0007] Conventional IPG systems provide an Elective Replacement Interval (ERI) to indicate when it is time for replacement. The ERI is typically designed to provide low-power therapy for a period long enough to be detected during the next follow-up. It is common to wait until the ERI is detected before scheduling replacement. Since the follow-up period is typically six months, patients can receive several months of reduced therapy and replace the old device without first completely draining the battery.
[0008] The conventional mechanism for controlling which implants interact with a programmer is to control which implants the inductive field of the programmer's wand covers. This is generally limited to a single active implant in a patient. Whereas far-field communication was enabled by RF communication between the programmer and the implant, the standard now requires that near-field inductive communication be used to enable this connection, subsequently limiting the connection to a single implant within the wand field.
[0009] There are currently no known manufacturer-based solutions to facilitate a guided process for device exchange / replacement in a leadless spacer system. Instead, the programmer must actually interact with the old and new implants independently to directly dictate specific behaviors and program settings for each device.
[0010] This process largely leaves the clinician with an "understanding" based on past IPG clinical engagements. Unfortunately, this approach results in the end-of-service use case being treated as one use case where two separate processes must be addressed to result in what ultimately becomes the need for coordinated care management.
[0011] It is therefore an object of the invention to provide an improved method for programming a leadless cardiac pacemaker in which device exchange / replacement is coordinated and coordinated in a more coordinated and user-friendly manner.
[0012] The problem is solved by a computer-implemented method for programming a leadless cardiac pacemaker having the features of claim 1.
[0013] Additionally, the above object is achieved by a system for programming a leadless cardiac pacemaker having the features of claim 13, a computer program product according to claim 14, and a computer-readable data carrier according to claim 15. Further developments and advantageous embodiments are defined in the dependent claims.
[0014] The invention provides a computer-implemented method for programming a leadless cardiac pacemaker comprising providing a computing device, in particular a programmer, configured to set parameters of at least a first leadless cardiac pacemaker and a second leadless cardiac pacemaker, the second leadless cardiac pacemaker intended to replace the first leadless cardiac pacemaker, the computing device in communication with the first and second leadless cardiac pacemakers via wireless transceiver units and having a user control interface.
[0015] The method further includes assigning, by the computing device, a unique identifier to each of the first and second leadless cardiac pacemaker and preconfiguring, by the computing device, parameters of the first and / or second leadless cardiac pacemaker regardless of location of the first and second leadless cardiac pacemaker relative to a transceiver unit of the computing device.
[0016] The method additionally comprises configuring the preset parameters when the first pre-configured leadless cardiac pacemaker and / or the second pre-configured leadless cardiac pacemaker are within communication range of the transceiver unit of the computing device.
[0017] The invention further provides a system for programming a leadless cardiac pacemaker comprising a computing device, particularly a programmer, a first leadless cardiac pacemaker, and a second leadless cardiac pacemaker configured to set parameters of at least the first and second leadless cardiac pacemakers, the second leadless cardiac pacemaker intended to replace the first leadless cardiac pacemaker, where the computing device is configured to communicate with the first and second leadless cardiac pacemakers via wireless transceiver units and have a user control interface.
[0018] Further, the computing device is configured to assign a unique identifier to each of the first and second leadless cardiac pacemakers, the computing device configured to pre-configure parameters of the first and / or second leadless cardiac pacemaker regardless of location of the first and second leadless cardiac pacemakers relative to the computing device transceiver unit, and the computing device configured to set the pre-configured parameters when the pre-configured first leadless cardiac pacemaker and / or the pre-configured second leadless cardiac pacemaker are within communication range of the computing device transceiver unit.
[0019] The invention further provides a computer readable data carrier comprising a program code of a computer program for performing the method according to the invention when the computer program is run on a computer.
[0020] The idea of the present invention is to treat the exchange / replacement process as a single system routine that handles new and old device therapy in a coordinated manner that brings together the separate behaviors of new and old device therapy into a more interactive approach.
[0021] Because the data transmission capabilities of the leadless cardiac pacemakers are limited (due to their relatively deep implantation depth within the patient's anatomy), when two leadless cardiac pacemakers are within range of the programmer, rather than transmitting their respective device serial numbers with every communication, the serial numbers are shortened to a unique identifier that can be as simple as designating the first leadless cardiac pacemaker as device 1 and the second leadless cardiac pacemaker as device 2, where the first and second leadless cardiac pacemakers each have a serial number associated with an abbreviated unique identifier.
[0022] Thus, a scheme is provided for a wireless transmit / receive unit, or wand, to communicate with a first leadless cardiac pacemaker and a second leadless cardiac pacemaker without necessarily having to simultaneously have both pacemakers within range of the programmer's communications wand.
[0023] If the device the user wants to program is out of communication range of the programmer, the user will be presented with a message that he or she needs to place the programmer closer to the device the user wants to program.
[0024] Further advantages of the present invention are improved robustness in the management of bradycardia support following a device exchange / replacement procedure, improved clinician control and workflow of the details associated with exchange / replacement providing a means to meet a go-forward approach to individual patient needs, and greater freedom to implant a replacement device well before end of service since the new device can be configured to switch on when needed without concern that the old device's battery will not be fully utilized.
[0025] According to one aspect of the invention, while the first leadless cardiac pacemaker and the second leadless cardiac pacemaker are operating simultaneously, the first leadless cardiac pacemaker is programmed to pace at a rate lower than a previous pacing rate while performing a sensing test, impedance test and / or pacing uptake test of the second leadless cardiac pacemaker.
[0026] In other words, for a nominal follow-up test configuration, any pacing output from the second leadless cardiac pacemaker is test specific and occurs temporarily while necessary to perform the test. Preferably, the two approaches can be combined in one embodiment where pacing is performed according to test needs while the test is being performed, and at the end of the test the implant reverts to permanently programmed operation that may or may not be performed depending on the state of the master therapy switch.
[0027] In other words, if the master therapy switch is on, at the end of the test termination the second leadless cardiac pacemaker will pace according to its permanently programmed settings, and if the master therapy switch is off, at the end of the test termination the second leadless cardiac pacemaker will cease any pacing output according to the pre-prescribed therapy settings despite containing a permanent program.
[0028] According to another aspect of the invention, the first leadless cardiac pacemaker is placed in a sensing mode accompanied by pacing by the second leadless cardiac pacemaker until the battery is depleted, and pacing is resumed by the first leadless cardiac pacemaker only in the event of malfunction of the second leadless cardiac pacemaker, advantageously providing an additional level of security in the event of malfunction of the second leadless cardiac pacemaker.
[0029] Another aspect of the invention comprises setting the first leadless cardiac pacemaker in a non-permanent disabled state in which it neither senses nor paces but can still receive commands from and be activated by a computing device, or setting the first leadless cardiac pacemaker in a permanently disabled state in which the first leadless cardiac pacemaker is not activatable by the computing device.
[0030] Configuring the first leadless cardiac pacemaker in either a permanent or non-permanent override state advantageously avoids unintended pacing by the first leadless cardiac pacemaker.
[0031] According to another aspect of the invention, a pacing program is preset in a second leadless cardiac pacemaker, the preset pacing program is disabled during a first predetermined time period, particularly during routing into a patient, and the preset pacing program is enabled during a subsequent second predetermined time period, particularly when the second leadless cardiac pacemaker is secured in a patient's cardiac wall.
[0032] Thus, a scheme is provided for placing a program in a second leadless cardiac pacemaker that allows the second leadless cardiac pacemaker to exist in a state with its pacing output turned off, thereby allowing safe routing to the patient and anchoring within the cardiac wall without causing electrical stimulation that would tend to recoil and / or retract the cardiac wall.
[0033] The procedure used to physically route the second cardiac leadless pacemaker from the venous groin access is performed without the device managing the stimulation output. Such an approach helps to avoid the implant electrically interacting with the patient's physiology in an unwanted and potentially problematic manner. In particular, this feature helps to deploy and secure the implant within the heart without introducing the competing challenges associated with initiating and depolarizing action potentials within the targeted physiological implantation site. Such depolarizations tend to cause contractile responses that risk physically recoiling / retreating the implant from the implant site, potentially compromising robust mechanical interfaces and / or causing unintended harm to the patient's physiology.
[0034] According to another aspect of the invention, the pacing output of the second leadless cardiac pacemaker is turned off by a user control interface of the computing device, particularly via a master switch. In a preferred embodiment, however, this master switch setting does not negate the performance of sensing, impedance, and / or pacing capture threshold tests by the second leadless cardiac pacemaker. This approach nominally prevents the device from delivering a pacing output except in situations where such output is used to determine electrical characteristics at the fixed site of the second leadless cardiac pacemaker. This allows a user to easily evaluate multiple implantation sites without having to intentionally manage the paced output settings from the second implant when the second implant is relocated from one fixed site to another.
[0035] Alternatively or additionally, the pacing output of the second leadless cardiac pacemaker can be turned off by a user control interface of the computing device, particularly via the master switch, while sensing, impedance, and / or pacing uptake tests of the second leadless cardiac pacemaker are being performed.
[0036] Another aspect of the invention programs the first leadless cardiac pacemaker to deliver pacing output until the battery is dead or until the battery voltage falls below a predetermined threshold at which the first leadless cardiac pacemaker transitions to a disabled state, and activates the second leadless cardiac pacemaker using a configuration set specifically during a replacement procedure when no pacing by the first leadless cardiac pacemaker is sensed by the second leadless cardiac pacemaker for a predetermined amount of time.
[0037] Thus, upon battery degradation below a certain limit, the first leadless cardiac pacemaker locks the output into a non-therapeutic state to avoid pacing at a later time if the battery somehow recovers to some degree.
[0038] The benefit of this extended support option is that the system can maximize the available therapy output from the previous implant before calling on a new device to provide patient support. Such an approach maximizes the useful service time of any single implant and provides the best means to reduce the frequency of replacement procedures. Such a capability additionally provides the clinician with more flexibility as to when a second leadless cardiac pacemaker can be implanted. Typically, such procedures are performed during the last 6 months of battery service for an expiring implant, but the present invention allows the clinician to implant a second device before the first device reaches ERI (if doing so serves the needs of a particular patient) without significantly compromising the device life of the second device. The second leadless spacer simply resides in the patient ready to provide restorative therapy for bradycardia symptoms until called upon under the influence of a sufficiently deteriorated state of the first leadless spacer.
[0039] According to another aspect of the invention, the first leadless cardiac pacemaker delivers a pacing output at a rate higher than a set pacing rate of the second leadless cardiac pacemaker and sets or substantially inhibits the second leadless cardiac pacemaker in a sensing mode until the first leadless cardiac pacemaker's battery is drained or the battery voltage of the first leadless cardiac pacemaker falls below a predetermined threshold at which the first leadless cardiac pacemaker transitions to a disabled state. In this manner, the first leadless cardiac pacemaker can advantageously operate until its battery is drained.
[0040] According to another aspect of the invention, a first leadless cardiac pacemaker codes its pacing output during a post-replacement procedure period such that the pacing output delivered by the first leadless cardiac pacemaker is detected by a second leadless cardiac pacemaker. This approach advantageously allows the second leadless cardiac pacemaker to recognize the pacing of the first leadless cardiac pacemaker.
[0041] Another aspect of the invention features a first leadless cardiac pacemaker delivering a pacing output at a rate lower than its set therapeutic pacing rate when the battery voltage of the first leadless cardiac pacemaker falls below a predetermined threshold and a second leadless cardiac pacemaker detecting the reduced pacing rate of the first leadless cardiac pacemaker and initiating a pacing output at a higher rate than the first leadless cardiac pacemaker.
[0042] This allows go-forward therapy from the older device, i.e., the first leadless cardiac pacemaker, thereby employing the intended therapy rate rather than a constant elevated therapy rate to overdrive the new implant, i.e., the second leadless cardiac pacemaker. When the new device recognizes that the pace output from the older device no longer exhibits the encoded signature or that the older device is pacing slower than a minimum rate, it detects that it must take over and provide therapy support.
[0043] Another aspect of the invention provides a means for a clinician to implant a therapy program operating the first leadless cardiac pacemaker into a second leadless cardiac pacemaker as part of an in-clinic device replacement procedure via a user control interface of a computing device.
[0044] Alternatively or additionally, a message can be displayed on a user control interface of the computing device indicating whether or not the therapy program operating the first leadless cardiac pacemaker should be implanted in the second leadless cardiac pacemaker.
[0045] This transfers the settings from the old device to the programmer, which then transfers these settings, upon confirmation from the user, to the new device. Thus, the system provides a means to extract the last good, working, permanent programming configuration from the old device, and a means to push / port this programming configuration to the new implant as the starting setup.
[0046] According to another aspect of the invention, resetting the first leadless cardiac pacemaker reverts the first leadless cardiac pacemaker to its previous therapy program rather than a default program. In particular, if the first leadless cardiac pacemaker is permanently disabled, after reset the first leadless pacemaker can be configured to remain in a permanently disabled state and not "wake up" to provide therapy.
[0047] Therefore the device will remember the previous operating state / program and will not revert to the default / factory program.
[0048] The system's reset process can also be extended so that the old implant has access to information about what settings were configured by the clinician during the exchange / replacement procedure and retains them after recovery from reset, thus avoiding undesirable behavior such as competitive pacing post-reset from the old implant.
[0049] In another advantageous embodiment of a method according to the invention, the pacing status of the first leadless cardiac pacemaker or the second leadless cardiac pacemaker can be reported via a pacing status indicator in a computing device.
[0050] In another advantageous embodiment of the invention, the fields (programmer screens) in the computing device can be preloaded such that when a decision is made to program the first or second leadless cardiac pacemaker, the user configuration program is received by the first or second leadless cardiac pacemaker, in other words, all preconfiguration can be done on the computing device side (programmer side).
[0051] Features of the computer-implemented methods for programming a leadless cardiac pacemaker described herein also are disclosed for systems for programming a leadless cardiac pacemaker, and vice versa.
[0052] For a more complete understanding of the invention and its advantages, reference is made to the following description taken in conjunction with the accompanying drawings, in which: In the following, the invention is explained in more detail using exemplary embodiments illustrated in the schematic diagrams of the drawings, in which: [Brief description of the drawings]
[0053] [Figure 1] FIG. 1 is a flowchart of a computer-implemented method for programming a leadless cardiac pacemaker in accordance with a preferred embodiment of the invention. [Diagram 2] FIG. 1 is a schematic diagram of a system for programming a leadless cardiac pacemaker in accordance with a preferred embodiment of the invention.
[0054] The computer-implemented method of FIGURE 1 comprises the step S1 of providing a computing device 10, in particular a programmer, configured for use in programming a leadless cardiac pacemaker 12, 14 to set multiple parameters 12a, 14a of at least a first leadless cardiac pacemaker 12 and a second leadless cardiac pacemaker 14 intended to replace the first leadless cardiac pacemaker 12, where the computing device 10 communicates with the first and second leadless cardiac pacemakers 12, 14 via a wireless transceiver unit 16 and has a user control interface 18.
[0055] The method further comprises assigning S2, by the computing device 10, a unique identifier 12b, 14b to the first leadless cardiac pacemaker 12 and the second leadless cardiac pacemaker 14, respectively.
[0056] The method further comprises preprogramming S3, by the computing device 10, parameters 12a, 14a of the first leadless cardiac pacemaker 12 and / or the second leadless cardiac pacemaker 14 regardless of location of the first leadless cardiac pacemaker 12 and / or the second leadless cardiac pacemaker 14 relative to the transceiver unit 16 of the computing device 10, and setting S4 the preprogrammed parameters 12a, 14a when the preprogrammed first leadless cardiac pacemaker 12 and / or the preprogrammed second leadless cardiac pacemaker 14 are within communication range of the transceiver unit 16 of the computing device 10.
[0057] According to a preferred embodiment, while the first leadless cardiac pacemaker 12 and the second leadless cardiac pacemaker 14 are operating simultaneously, the first leadless cardiac pacemaker 12 is programmed to pace at a rate lower than a previous pacing rate while performing a sensing test, impedance test and / or pacing uptake test of the second leadless cardiac pacemaker 14.
[0058] The first leadless cardiac pacemaker 12 is placed in a sensing mode along with pacing by the second leadless cardiac pacemaker 14 until the battery runs out, and pacing is resumed by the first leadless cardiac pacemaker 12 only in the event of a malfunction of the second leadless cardiac pacemaker 14.
[0059] Alternatively, pacing by the second leadless cardiac pacemaker 14 can effectively inhibit the first leadless cardiac pacemaker 12 until the battery is depleted, and pacing can be resumed by the first leadless cardiac pacemaker 12 only in the event of a malfunction of the second leadless cardiac pacemaker 14.
[0060] A further preferred embodiment sets the first leadless cardiac pacemaker 12 in a non-permanent disabled state in which it neither senses nor paces, but can still receive commands from and be activated by the computing device 10, or sets the first leadless cardiac pacemaker 12 in a permanently disabled state in which the first leadless cardiac pacemaker 12 is not activatable by the computing device 10.
[0061] Disabling a preset pacing program in the second leadless cardiac pacemaker 14 during a first predetermined time period, particularly during routing to the patient, and enabling the preset pacing program during a second subsequent predetermined time period, particularly when the second leadless cardiac pacemaker 14 is anchored in the patient's cardiac wall or particularly when the second leadless cardiac pacemaker 14 is anchored viably in its go-forward final implantation site in the patient's cardiac wall.
[0062] In particular, the user control interface 18 of the computing device 10 via the master switch can be used to turn off the pacing output of the second leadless cardiac pacemaker 14 while performing sensing, impedance, and / or pacing uptake tests of the second leadless cardiac pacemaker 14 (preventing test-related outputs and nominally disabling pacing from the second device), in this manner supporting the ability to test multiple potential fixation sites before configuring the second implant with a go-forward permanent programmed therapy output state.
[0063] According to yet another preferred embodiment, the first leadless cardiac pacemaker 12 is programmed to deliver pacing output until the battery is dead or until the battery voltage falls below a predetermined threshold at which the first leadless cardiac pacemaker 12 transitions to a disabled state, and activates the second leadless cardiac pacemaker 14 using a configuration set specifically during a replacement procedure when no pacing by the first leadless cardiac pacemaker 12 is sensed by the second leadless cardiac pacemaker 14 for a predetermined amount of time.
[0064] According to yet another embodiment, the first leadless cardiac pacemaker 12 delivers a pacing output at a rate greater than a set pacing rate of the second leadless cardiac pacemaker 14, inhibiting the second leadless cardiac pacemaker 14 until the first leadless cardiac pacemaker 12 battery is depleted or the battery voltage of the first leadless cardiac pacemaker 12 falls below a predetermined threshold at which the first leadless cardiac pacemaker 12 transitions to a disabled state.
[0065] The first leadless cardiac pacemaker 12 encodes its pacing output during a post-replacement procedure period such that pacing output delivered by the first leadless cardiac pacemaker 12 is sensed by the second leadless cardiac pacemaker 14.
[0066] Furthermore, if the battery voltage of the first leadless cardiac pacemaker 12 falls below a predetermined threshold, the first leadless cardiac pacemaker 12 delivers a pacing output at a rate lower than its set therapeutic pacing rate and the second leadless cardiac pacemaker 14 detects the reduced pacing rate of the first leadless cardiac pacemaker 12 and initiates a pacing output at a higher rate than the first leadless cardiac pacemaker 12.
[0067] The user control interface 18 of the computing device 10 provides the means for a clinician to implant the therapy program that operated the first leadless cardiac pacemaker 12 into the second leadless cardiac pacemaker 14 as part of an in-clinic device replacement procedure. Resetting the first leadless cardiac pacemaker 12 reverts the first leadless cardiac pacemaker 12 to its previous therapy program rather than to a default program.
[0068] FIGURE 2 shows a schematic diagram of a system for programming a leadless cardiac pacemaker in accordance with a preferred embodiment of the invention.
[0069] The system 1 for programming a leadless cardiac pacemaker comprises a computing device 10, particularly a programmer, a first leadless cardiac pacemaker 12, and a second leadless cardiac pacemaker 14.
[0070] The computing device 10 is configured for configuring at least multiple parameters 12a, 14a of a first leadless cardiac pacemaker 12 and a second leadless cardiac pacemaker 14 intended to replace the first leadless cardiac pacemaker 12. The computing device 10 is further configured for communication with the first leadless cardiac pacemaker 12 and the second leadless cardiac pacemaker 14 via the wireless transceiver unit 16 and has a user control interface 18.
[0071] The computing device 10 is further configured to assign a unique identifier 12b, 14b to each of the first and second leadless cardiac pacemakers 12, 14. The computing device 10 is further configured to pre-configure parameters 12a, 14a of the first and / or second leadless cardiac pacemaker 12, 14 regardless of location of the first and / or second leadless cardiac pacemaker 12, 14 relative to the transceiver unit 16 of the computing device 10. Additionally, the computing device 10 is configured to set the pre-configured parameters 12a, 14a when the pre-configured first leadless cardiac pacemaker 12 and / or pre-configured second leadless cardiac pacemaker 14 is present within communication range of the transceiver unit 16 of the computing device 10. [Explanation of symbols]
[0072] 1 System 10 Computing equipment 12 Primary leadless cardiac pacemaker 12a Parameters 12b Unique Identifier 14 Secondary leadless cardiac pacemaker 14a Parameters 14b Unique Identifier 16 Transmitting and Receiving Unit 18 User Control Interface S1~S4 steps
Claims
1. A computer-implemented method for programming a leadless cardiac pacemaker (12, 14), comprising the steps, namely, Step (S1) provides a computing device (10), particularly a programmer, configured to set a plurality of parameters (12a, 14a) of at least a first leadless cardiac pacemaker (12) and a second leadless cardiac pacemaker (14), wherein the second leadless cardiac pacemaker (14) is intended to replace the first leadless cardiac pacemaker (12), and the computing device (10) communicates with the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) by a wireless transceiver unit (16) and has a user control interface (18), Step (S2) of assigning unique identifiers (12b, 14b) to the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) respectively using the computing device (10), Regardless of the position of the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) relative to the transmitting / receiving unit (16) of the computing device (10), the computing device (10) pre-sets the parameters (12a, 14a) of the first leadless cardiac pacemaker (12) and / or the second leadless cardiac pacemaker (14) in step (S3), A computer-implemented method comprising the step (S4) of setting the pre-configured parameters (12a, 14a) if the pre-configured first leadless cardiac pacemaker (12) and / or the pre-configured second leadless cardiac pacemaker (14) are within the communication range of the transmitting / receiving unit (16) of the computing device (10).
2. The computer-implemented method according to claim 1, wherein while the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) are operating simultaneously, the first leadless cardiac pacemaker (12) is programmed to pace at a lower rate than the previous pacing rate while a sensing test, impedance test and / or pacing take-up test of the second leadless cardiac pacemaker (14) is performed.
3. The computer-implemented method according to claim 1, wherein, in conjunction with pacing by the second leadless cardiac pacemaker (14), the first leadless cardiac pacemaker (12) is set to sensing mode or substantially suppressed until the battery runs out, and pacing is resumed by the first leadless cardiac pacemaker (12) only in the event of a malfunction of the second leadless cardiac pacemaker (14).
4. The computer-implemented method according to claim 1, wherein the first leadless cardiac pacemaker (12) is set to a non-permanently disabled state in which it does not sense or pace but can continue to receive commands from the computing device (10) and can be activated by the computing device (10), or the first leadless cardiac pacemaker (12) is set to a permanently disabled state in which it cannot be activated by the computing device (10).
5. The computer-implemented method according to claim 1, wherein a pacing program is pre-set in the second leadless cardiac pacemaker (14), the pre-set pacing program is deactivated during a predetermined first period, particularly during routing to the patient, and the pre-set pacing program is activated during a subsequent predetermined second period, particularly when the second leadless cardiac pacemaker (14) is fixed within the heart wall of the patient.
6. The computer-implemented method according to claim 1, wherein the pacing output of the second leadless cardiac pacemaker (14) is turned off via a master switch and the user control interface (18) of the computing device (10).
7. The computer-implemented method according to claim 1, comprising programming the first leadless cardiac pacemaker (12) to supply pacing output until the battery runs out or until the battery voltage of the first leadless cardiac pacemaker (12) falls below a predetermined threshold at which the first leadless cardiac pacemaker (12) transitions to a deactivated state, and activating the second leadless cardiac pacemaker (14) using a set of settings, particularly during replacement procedures, if no pacing is detected by the first leadless cardiac pacemaker (12) for a predetermined period of time.
8. The computer-implemented method according to claim 1, wherein the first leadless cardiac pacemaker (12) supplies pacing output at a rate higher than the set pacing rate of the second leadless cardiac pacemaker (14), and sets or substantially suppresses the second leadless cardiac pacemaker (14) to sensing mode until the battery of the first leadless cardiac pacemaker (12) is depleted or until the battery voltage of the first leadless cardiac pacemaker (12) falls below a predetermined threshold at which the first leadless cardiac pacemaker (12) transitions to an inactive state.
9. The computer-implemented method according to claim 1, wherein the first leadless cardiac pacemaker (12) encodes the pacing output of the first leadless cardiac pacemaker (12) during the period after replacement, and thereby the second leadless cardiac pacemaker (14) detects that the first leadless cardiac pacemaker (12) is supplying pacing output.
10. The computer-implemented method according to claim 1, wherein when the battery voltage of the first leadless cardiac pacemaker (12) falls below a predetermined threshold, the first leadless cardiac pacemaker (12) supplies pacing output at a rate lower than the set therapeutic pacing rate of the first leadless cardiac pacemaker (12), and the second leadless cardiac pacemaker (14) detects the reduced pacing rate of the first leadless cardiac pacemaker (12) and starts pacing output at a rate higher than that of the first leadless cardiac pacemaker (12).
11. The computer-implemented method according to claim 1, wherein a message regarding whether or not a treatment program for operating the first leadless cardiac pacemaker (12) should be transferred to the second leadless cardiac pacemaker (14) is displayed on the user control interface (18) of the computing device (10).
12. The computer-implemented method according to claim 1, wherein when the first leadless cardiac pacemaker (12) is reset, the first leadless cardiac pacemaker (12) is returned to a previous treatment program rather than the default program.
13. A system (1) for programming a leadless cardiac pacemaker, comprising a computing device (10), particularly a programmer, a first leadless cardiac pacemaker (12), and a second leadless cardiac pacemaker (14), wherein the computing device (10) is configured to set a plurality of parameters (12a, 14a) of at least the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14), the second leadless cardiac pacemaker (14) is intended to replace the first leadless cardiac pacemaker (12), the computing device (10) is configured to communicate with the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) by a wireless transceiver unit (16), and has a user control interface (18), and the computing device (10) is configured to communicate with the first leadless cardiac pacemaker System (1), wherein each of the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) is configured to be assigned a unique identifier (12b, 14b), the computing device (10) is configured to pre-set the parameters (12a, 14a) of the first leadless cardiac pacemaker (12) and / or the second leadless cardiac pacemaker (14) regardless of the position of the first leadless cardiac pacemaker (12) and the second leadless cardiac pacemaker (14) relative to the transmitting / receiving unit (16) of the computing device (10), and the computing device (10) is configured to set the pre-set parameters (12a, 14a) if the pre-set first leadless cardiac pacemaker (12) and / or the pre-set second leadless cardiac pacemaker (14) are within the communication range of the transmitting / receiving unit (16) of the computing device (10).
14. A computer program having program code for carrying out the method of any one of claims 1 to 12 when the computer program is executed on a computer.
15. A computer-readable data carrier comprising program code of a computer program for carrying out the method of any one of claims 1 to 12 when the computer program is executed on a computer.