Implanted medical device
A time-delayed activation mechanism for implantable medical devices addresses the complexity of manual function activation, enhancing implantation efficiency and safety by automating critical function activation post-implantation.
Patent Information
- Application Number
- JP2022519409
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-10-21
- Filing Date
- 2020-09-24
- Publication Date
- 2025-07-17
- Estimated Expiration
- 2040-09-24
AI Technical Summary
Existing implantable medical devices require complex manual activation of medically critical functions during implantation, necessitating additional non-sterile programming devices and personnel, which complicates the procedure and increases costs.
Implement a time-delayed activation mechanism for critical functions of implantable medical devices, automatically activating them after detection of implantation and fulfillment of predefined criteria such as time elapse or functional tests, eliminating the need for additional programming devices and personnel.
Simplifies the implantation process by reducing equipment and personnel requirements while ensuring medical safety through delayed activation of critical functions only when conditions are met, thereby maintaining operational reliability and reducing the risk of premature function triggers.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to an implantable medical device as described in the preamble of claim 1, a method for controlling the operation of an implantable medical device as described in the preamble of claim 13, and a computer program product suitable for controlling the operation of an implantable medical device as described in the preamble of claim 14. [Background Art]
[0002] Implantable medical devices can perform a wide variety of tasks. It is often appropriate to know when an (active) implantable medical device was actually implanted in a patient. This is typically because the most important functions of an implantable medical device should be activated only at the time of or immediately after implantation. In this way, malfunctions of the implantable medical device during its transport before implantation can be avoided. In addition, if functions that consume energy particularly are activated only after the implantation of the implantable medical device, the energy consumption of the implantable medical device is reduced.
[0003] For example, in a conventional pacemaker, it is known to automatically detect whether the pacemaker has already been implanted. For example, U.S. Patent No. 6,016,447 describes a pacemaker that automatically detects whether the pacemaker is in an implanted state based on various measured parameter values. When it is detected that the pacemaker is in its implanted state, certain treatment functions that were previously deactivated are activated.
[0004] U.S. Patent No. 7,113,827 describes an implantable medical device that emits a test stimulation pulse, measures the corresponding pulse signal, and examines it in more detail in relation to signal analysis. Then, the measured pulse width is used to determine whether an electrode is connected to the implantable medical device. It is also possible to determine the type of the connected electrode within the scope of signal analysis.
[0005] U.S. Patent No. 7,440,801 describes an implantable medical device that periodically monitors the energy consumption of the implantable medical device itself. When the energy consumption increases, a test is performed to determine whether an electrode is connected to the device. If a connected electrode is detected, the treatment function of the implantable medical device is activated.
[0006] All of these solutions known from the prior art enable the simultaneous activation of possible treatment functions. However, there are a number of currently commercially available implantable medical devices that can perform functions that are particularly medically sensitive and that are still manually activated in implantable medical devices.
[0007] In the case of implantable cardioverters / defibrillators (ICDs) or devices for performing cardiac resynchronisation therapy (CRT-D), for example, an employee of the implant manufacturer is routinely present during implantation to activate the defibrillation function of the device by means of a programming device. This procedure is relatively complex. This is because the programming device is not a sterilized device and therefore must not be placed in the operating room. Instead, the programming device is operated by a trained user in a non-sterile area, while the physician implanting the ICD or CRT-D is in a sterile operating area.
Prior Art Documents
Patent Documents
[0008]
Patent Document 1
Patent Document 2
[0009] The problem addressed by the present invention is to provide a simplified means of activating medically particularly critical functions of an implantable medical device without requiring the presence of additional users of a programming device in addition to the physician performing the implantation.
[0010] An obvious solution to this technical problem would be to enable (sterile) remote control of the programming device that can be directly operated by the physician performing the implantation. However, the present invention takes a completely different approach. According to the invention as claimed, the technical problem is solved by enabling a time-delayed activation of different diagnostic or treatment functions of the implantable medical device. The automatic activation of medically particularly critical or relevant diagnostic or treatment functions is only carried out after the implanted state of the implantable medical device has been detected and after additional activation criteria have been met.
[0011] Specifically, the problem is solved by an implantable medical device having the features of claim 1. Such an implantable medical device comprises a processor and a memory unit. The memory unit includes a computer-readable program which, when executed on the processor, causes the processor to perform the steps described below.
[0012] First, a detection is carried out in order to determine whether the implantable medical device is in its implanted state. A number of different procedures are already known from the prior art for this basic detection of the implanted state of the implantable medical device.
[0013] When an implanted medical device is detected as being in its implanted state, a first diagnostic or therapeutic function of the implanted medical device is activated. If additional activation criteria are met, then a second diagnostic or therapeutic function of the implanted medical device is activated in addition to the first diagnostic or therapeutic function. According to the present invention, the activation criteria are the elapse of a first period from the activation of the first diagnostic or therapeutic function, and / or the elapse of a second period from the detection that the implanted medical device is in its implanted state, and / or passing a functional test of the implanted medical device.
[0014] Thus, in a first operating state of the implanted medical device, if a predetermined or definable time (optionally starting with different events) has elapsed, it is sufficient for the activation of the second diagnostic or therapeutic function. This is because it is then normally assumed that the implanted medical device is in the desired implanted state, i.e., for example, all electrodes of the implanted medical device are correctly positioned and can perform the functions of those electrodes that affect the body of the patient in whom the implanted medical device is implanted.
[0015] On the other hand, in a second operating state of the implanted medical device, a functional test is performed. This enables different functions of the implanted medical device to be tested before the second diagnostic or therapeutic function is activated. In this way, it is positively confirmed not only that the implanted medical device is in its implanted state, but also that it can further enter into a specific desired interaction with the body of the patient in whom the implanted medical device is implanted. The functional test may also be a functional test within the device itself that does not take into account any specific interaction with the body of the patient in whom the implanted medical device is implanted.
[0016] Finally, in the third operating state of the implantable medical device, combinations of the first operating state and combinations of the second operating state are conceivable. Thus, in this operating state, the second diagnostic or therapeutic function can be activated only if a predetermined or predefined time has elapsed and furthermore the functional test of the implantable medical device has been successfully passed.
[0017] In this way, for example, it is possible that after automatic detection of the implanted state of the implantable medical device, the normal pacemaker function is first activated as the first diagnostic or therapeutic function. This ensures a basic level of care for the patient in question. In contrast, the shock function (defibrillation function) of the implantable medical device is activated only after a certain time has elapsed and / or after passing a test to determine whether the electrodes of the implantable medical device are actually correctly positioned and the stimulation pulses are delivering the desired response signal. This is to prevent an undesirably early trigger of the second diagnostic or therapeutic function during implantation of the implantable medical device. Such an early trigger is conceivable, for example, when the implantable medical device makes an incorrect diagnosis of the medical condition of the patient in whom it is implanted, for example due to certain circumstances of the implantation, and as a result activates an important medical function such as the cardiac defibrillation function.
[0018] In the case of an implantable cardioverter / defibrillator or an implantable device for performing cardiac resynchronization therapy, with the aid of the implantable medical device described in the claims of the present case, the presence of an additional programming device at the time of implantation of the implantable medical device for manually activating the defibrillation function or any other second diagnostic or therapeutic function is no longer necessary at all. This considerably reduces both the expenditure for equipment and the expenditure for personnel required for the implantation of the corresponding implantable medical device. At the same time, the medical safety is maintained because the second diagnostic or therapeutic function is activated only when the corresponding activation criteria have been met.
[0019] In one variation, the implantable medical device has a manually operable device that indicates the implanted state of the implantable medical device. Such a device may be, for example, a switch that is actuated during implantation by a physician implanting the implantable medical device. The state of the switch may then be read from a computer-readable program stored in the memory unit of the implantable medical device. This means that even when the switch is manually activated, an automatic reading and thus automatic detection of whether the implantable medical device is in its implanted state is possible.
[0020] In one variation, the detection (implant detection) of whether the implantable medical device is in its implanted state is based on impedance measurement, temperature measurement, measurement of data from an activity sensor, signal evaluation of a test signal generated by a test stimulation pulse, and / or measurement of the energy consumption of the implantable medical device. These different methods are in themselves already known from the prior art and are described in the prior art in a manner that can be modified by a person skilled in the art.
[0021] In one variation, the implant detection is performed by impedance measurements that are periodically carried out at at least one electrode connection. In one variation, the implant detection is performed by impedance measurements that are periodically carried out at the right ventricular electrode connection.
[0022] In one variation, the implantable medical device is a pacemaker implant, a cardioverter / defibrillator (ICD), a cardiac resynchronization therapy device (CRT-D), a spinal cord stimulator, a deep brain stimulation device, or an implantable drug pump. All of these different types of implantable medical devices have different diagnostic and treatment functions that can be activated in a medically appropriate manner in a time sequence. For example, for a drug pump, the first diagnostic or treatment function may be designed such that a first active substance can be delivered, while the second diagnostic or treatment function may be designed such that a second active substance can be delivered. It is further contemplated that within the scope of the first diagnostic or treatment function, a small amount of the first active substance may be carried or delivered by such a drug pump, while within the scope of the second diagnostic or treatment function, a larger amount (more than the small amount) of the same first active substance may be carried or delivered by such a drug pump.
[0023] In the case of a device that can perform electrical stimulation of a specific area of a patient's tissue, the first diagnostic or treatment function and the second diagnostic or treatment function may differ, for example, with respect to the type and / or intensity of the electrical pulses delivered. In particular, when the implantable medical device is designed as an ICD or a CRT-D, in one variation, the first diagnostic or treatment function represents or includes the normal pacemaker function (i.e., in particular, the function for anti-bradycardia stimulation of the human or animal heart), while the second diagnostic or treatment function represents or includes the function for cardiac defibrillation (shock function).
[0024] In one variation, the program causes the processor to activate the first diagnostic or treatment function only after a third period has elapsed since it was detected that the implantable medical device is in its implanted state. Thus, in this variation, the first diagnostic or treatment function is not activated immediately after detection of the implanted state of the implantable medical device, but is activated with a time delay. Thereby, the risk that the device detects interference signals during the implantation process and then illicitly executes a specific diagnostic or treatment function based on those signals is reduced. This is because in this variation, the first diagnostic or treatment function is actually activated only when the risk of detecting such interference signals has significantly decreased due to the time elapsed since the actual implantation process.
[0025] In one variation, the first period (i.e., the time elapsed between the activation of the first diagnostic or treatment function and the activation of the second diagnostic or treatment function) and / or the second period (i.e., the time from the detection that the implantable medical device is in its implanted state) has a length of 5 minutes to 48 hours, particularly 10 minutes to 36 hours, particularly 15 minutes to 24 hours, particularly 20 minutes to 12 hours, particularly 30 minutes to 10 hours, particularly 40 minutes to 8 hours, particularly 50 minutes to 6 hours, particularly 1 hour to 5 hours, particularly 2 hours to 4 hours.
[0026] In one variation, the third period (i.e., the time elapsed in one variation from the detection of the implanted state until the first diagnostic or treatment function is activated) has a length, and that length is also within one of the aforementioned time intervals. The first period, the second period, and the third period can be selected independently of each other from these time intervals. The first period, the second period, and / or the third period can be considered to be of different or the same length.
[0027] In one variation, the implantable medical device has a time measurement device that is used to measure a first period and / or a second period. This time measurement device may be, for example, a normal timer. In one variation, the time measurement device is also used to measure a third period. In another variation, the device has a first time measurement device for measuring the first period, a second time measurement device for measuring the second period, and a third time measurement device for measuring the third period. It is possible with such a time measurement device to internally record within the device the time that must elapse before the first diagnostic or treatment function or the second diagnostic or treatment function is activated. In that case, the implantable medical device does not rely on an external time signal to monitor the elapse of the corresponding time.
[0028] In one variation, the program causes the processor to stop, modify, or reset the time measurement device when a start event is detected. If the device is designed according to a variation in which a third period is determined, then this operation of the time measurement device can then be used to start measuring the first period and / or the second period and / or the third period. The start event here depends on the type of period being measured. When the first period is measured, the start event is the activation of the first diagnostic or treatment function. When the second period is measured, the start event is the detection that the implantable medical device is in its implanted state. When the third period is measured, the start event is also the detection that the implantable medical device is in its implanted state. Different timer ranges of the time measurement device may be handled by a particular state event such that it is basically possible to determine at least partially simultaneously two or more periods, for example the first period, the second period, and the third period, with a single time measurement device.
[0029] In one variant, the first diagnostic or therapeutic function, and / or the second diagnostic or therapeutic function, includes detection of the patient's cardiac signals, stimulation of the patient's cardiac region within the scope of a pacemaker stimulation (in particular, in a right ventricular pacing mode), stimulation of the patient's cardiac region within the scope of cardiac resynchronization therapy, a function for detecting electrode errors and / or electrode dislocations, and / or a function for remote implant monitoring (so-called home monitoring). It is particularly provided here that the first diagnostic or therapeutic function includes detection of the patient's cardiac signals and stimulation of the patient's cardiac region within the scope of a pacemaker stimulation (anti-bradycardia stimulation). In contrast, one variant particularly provides that the second diagnostic or therapeutic function includes stimulation of the patient's cardiac region within the scope of cardiac resynchronization therapy.
[0030] In one variant, when the implantable medical device is a cardiac stimulation device, the first diagnostic or therapeutic function includes a standard stimulation program related to a specific type of the implantable medical device. In this case, as soon as the implant detection is positively completed, the device-specific standard stimulation program is activated.
[0031] In one variant, when it has been previously detected that the implantable medical device is in its implanted state, in addition to the first diagnostic or therapeutic function, a diagnostic function, an automatic algorithm for anti-bradycardia stimulation adaptation, an electrode error detection or electrode dislocation detection and / or an algorithm for remote implant monitoring are activated.
[0032] In one variant, the first diagnostic or therapeutic function, and / or the second diagnostic or therapeutic function, has a function for cardiac defibrillation, a function for anti-tachycardia stimulation of the patient's cardiac region, and / or a function for automatic adaptation of an algorithm used for anti-tachycardia stimulation.
[0033] In one variation, the implantable medical device is designed as a device for cardiac resynchronization therapy or as a cardioverter / defibrillator, and the second diagnostic or therapeutic function includes a cardiac defibrillation function. As a result, the defibrillation function, which typically constitutes a procedure involving patient pain and should only be performed when actually medically necessary, is guaranteed in this variation to be activated only when certain conditions are met. First, it must be detected that the implantable medical device is in its implanted state. Only then may the first diagnostic or therapeutic function be activated, and in this variation, the first diagnostic or therapeutic function does not include a defibrillation function. If additional activation criteria are met here, the second diagnostic or therapeutic function may be activated in the form of a cardiac defibrillation function so that defibrillation of the heart of the patient in whom the implantable medical device is implanted becomes possible.
[0034] In one variation, in addition to the second diagnostic or therapeutic function, an additional diagnostic function, a function for anti-tachycardia pacing, an automatic algorithm for anti-tachycardia pacing adjustment, an algorithm for electrode error detection or electrode dislocation detection, and / or a function for remote implant monitoring are activated.
[0035] In one variation, a functional test that can be used as an activation criterion for the activation of the second diagnostic or therapeutic function is a test intended for the detection of electrical signals and / or the delivery of electrical pulses to determine whether the electrodes of the implantable medical device are correctly positioned, a test to determine whether the electrodes intended for the detection of electrical signals and / or the delivery of electrical pulses have electrode damage, and / or a test to examine signal quality criteria and / or a test to examine the type of detected physiological electrical signals.
[0036] The signal quality criteria can include, for example, the amplitude of the detected signal and / or the width of the detected signal and / or signal stability and / or electrode impedance. For example, the different types of detected physiological electrical signals can be different cardiac signals from a patient (such as QRS complex signals or the amplitude of such QRS complex signals) detected by an implantable medical device.
[0037] In one variation, the program causes the processor to determine a shock vector available for defibrillation function after the activation criteria are met. Such determination of the shock vector is particularly useful when the cardiac defibrillation function is selected as a second diagnostic or treatment function. Such a shock vector can pass, for example, between a first electrode and the housing of the implantable medical device, between a second electrode and the housing of the implantable medical device, or between a first electrode of the implantable medical device and a second electrode of the implantable medical device. The number of possible shock vectors, and even their specific design, depends in particular on whether so-called single coil defibrillation electrodes are used or so-called dual coil defibrillation electrodes are used. The specific position of the individual electrode poles of the defibrillation electrodes also affects the possible available shock vectors.
[0038] In one variation, the program causes the processor to activate all of the implanted defibrillation electrodes of the implanted medical device for defibrillation and for electrode diagnosis after detecting that the implantable medical device is in its implanted state. Within the scope of the electrode diagnosis, it is particularly determined whether the electrodes are correctly positioned and whether the electrodes have electrode defects such as electrode breakage. This variation of activating all of the implanted defibrillation electrodes is particularly useful in combination with the variation of determining a shock vector available for the defibrillation function as a second diagnostic or treatment function.
[0039] One aspect of the present invention relates to a method for controlling the operation of an implantable medical device, which method is particularly suitable for an implantable medical device as described above. The control method includes the steps described below.
[0040] First, it is detected whether the implantable medical device is in its implanted state.
[0041] If it is positively detected that the implantable medical device is in its implanted state, the first diagnostic or treatment function of the implantable medical device is activated. If the activation criteria are further met, subsequently the second diagnostic or treatment function of the implantable medical device is activated. The activation criteria may be the elapse of a first period since the activation of the first diagnostic or treatment function, and / or the elapse of a second period since the detection that the implantable medical device is in its implanted state, and / or passing a function test.
[0042] One aspect of the present invention relates to a computer program product including computer-readable code which, when executed on a processor, causes the processor to execute the steps described below.
[0043] First, it is detected whether the implantable medical device is in its implanted state.
[0044] If it is positively detected that the implantable medical device is in its implanted state, the first diagnostic or treatment function of the implantable medical device is activated. If additional activation criteria are met, subsequently the second diagnostic or treatment function of the implantable medical device is activated. The activation criteria may be the elapse of a first period since the activation of the first diagnostic or treatment function, and / or the elapse of a second period since the detection that the implantable medical device is in its implanted state, and / or passing a function test.
[0045] One aspect of the present invention relates to a medical method for implanting an implantable medical device. The device is to be implanted into a human or animal patient, where the patient requires such an implant. The implantable medical device comprises a processor and a memory unit. The implantation method is characterized by the steps described below.
[0046] First, the implantable medical device is implanted into the patient.
[0047] Here, detection is performed to determine whether the implantable medical device is in its implanted state. A program executed on the processor is used to do this. This may be based on measured values indicating the implantation of the implantable medical device, such as a substantially constant temperature corresponding to the patient's body temperature, and / or the characteristic impedance of electrodes forming part of the implantable medical device, and / or the signal quality criteria of electrical signals detected by the implantable medical device.
[0048] If the implantable medical device is detected as being in its implanted state, then the first diagnostic or treatment function of the implantable medical device is activated. Further, if an activation criterion is achieved, then the second diagnostic or treatment function is activated. The first diagnostic or treatment function and the second diagnostic or treatment function are each activated by a program executed on the processor. Here, the activation criterion is selected from the group consisting of the elapse of a first period from the activation of the first diagnostic or treatment function, the elapse of a second period from the detection that the implantable medical device is in its implanted state, and passing a function test.
[0049] All variations and alternative designs described in connection with the implantable medical device may be combined with one another in any manner and may be transferred to the methods and computer program products described. Further, the described variations of the method may be combined with one another in any manner and may be transferred to other methods, and further to computer program products and devices. Similarly, the described variations of the computer program products may be combined with one another in any manner and may be transferred to the methods and devices described.
[0050] Further details of aspects of the present invention are described below in conjunction with exemplary embodiments and the drawings.
Brief Description of the Drawings
[0051]
Figure 1
Figure 2
Modes for Carrying Out the Invention
[0052] FIG. 1 shows an implantable defibrillator 100 that functions as an implantable medical device. The defibrillator 100 has an energy source 110 and an implant detection unit 120 based on impedance. This implant detection unit 120 based on impedance is connected to a connector for the right ventricle detection and stimulation electrode RV (RV connector). A combined detection and stimulation unit 130 is also connected to this RV connector. This combined detection and stimulation unit 130 can detect and classify the heart rhythm of the patient in whom the defibrillator 100 is implanted. The detection and stimulation unit 130 is designed and equipped to deliver anti-bradycardia and anti-tachycardia stimulation sequences.
[0053] The defibrillator 100 also has a defibrillation unit 140, to which up to three shock electrodes HV1, HV2, and HV3 can be connected. The implantation detection unit 120, the combined detection and stimulation unit 130, and the defibrillation unit 140 are connected to a common control unit 150.
[0054] When the defibrillator 100 is delivered, only the implantation detection unit 120 is activated. This implantation detection unit 120 can detect the connection of the implanted right ventricular electrode RV within a period of 0.1 to 5 seconds and can signal this to the control unit 150. The control unit 150 then immediately activates the detection and stimulation unit 130, which executes its functions in the standard settings stored in the memory unit 160 of the defibrillator 100 as a result of this activation.
[0055] The memory unit 160 is operatively connected to the processor 170 and thus enables the control unit 150 to control the individual elements of the defibrillator 100.
[0056] For example, after a waiting period of 12 hours has elapsed and the confirmation test by the implantation detection unit 120 has positively confirmed that the RV electrode is permanently connected to the RV connector and that the signal quality of the test signal recorded by the RV electrode after the corresponding test stimulation pulse meets a predetermined criterion, the control unit 150 also activates the defibrillation unit 140. This results in the activation of the defibrillation function as a second diagnostic or therapeutic function.
[0057] At the same time, when the anti-tachycardia stimulation is activated by the detection and stimulation unit 130, an additional therapeutic function of this detection and stimulation unit 130 is activated. Thus, here the defibrillator can be activated by its detection and stimulation unit 130 both based on standard settings typically including anti-bradycardia stimulation and with anti-tachycardia stimulation. In addition, the defibrillator 100 may be used to perform defibrillation as required by the patient.
[0058] Figure 2 shows a schematic flow diagram of the automatic activation of two different diagnostic or therapeutic functions of an implantable defibrillator, such as defibrillator 100 of FIG. 1.
[0059] First, using the periodically executed electrode impedance measurement 210, it is tested whether the implanted RV electrode is connected to the defibrillator and can be detected. If the result 220 of this periodically executed electrode impedance measurement 210 is positive, a simple anti-bradycardia pacemaker function 230 is activated. In addition, a verification phase 240 is automatically started, during which tests are performed over a predetermined time to determine whether the implanted RV electrode is still present and whether the appropriate signal conditions for safe defibrillator activation are met. If both conditions are met after the predetermined time has elapsed, the defibrillator's defibrillation function 260 is activated after the decision step 250. Once the defibrillation function is activated, the system does not test again whether the conditions required for activation are still met. Rather, even if one of the conditions required for activation is no longer met later, the defibrillation function remains implemented.
[0060] On the other hand, during the test 250, if it is determined that the implanted RV electrode may no longer be detected or the appropriate signal conditions for reliable activation of the defibrillation function are not met after the specified time has elapsed, the test method returns to the periodically executed electrode impedance measurement 210 to detect again whether the electrode is connected to the defibrillator. For safety reasons, it may optionally be provided that the already activated anti-bradycardia stimulation activity of the defibrillator remains activated. In this case, the possibility of performing anti-bradycardia stimulation, and thus, if necessary, life support measures for the patient, remains possible even though the conditions for safe execution of defibrillation are insufficient.
Claims
Claim 1 An implantable medical device comprising a processor (170) and a memory unit (160), wherein the memory unit (160) is a computer-readable program which, when executed on the processor, a) determines (210) whether the implantable medical device (100) is implanted; b) when it is determined (220) that the implantable medical device (100) is implanted, activates the first diagnostic or treatment function (230) of the implantable medical device (100), and subsequently activates the second diagnostic or treatment function (260) of the implantable medical device (100), the second diagnostic or treatment function (260) being activated only after achievement (250) of at least one activation criterion selected from the group consisting of: elapse of a first period from said activation of the first diagnostic or treatment function (230), elapse of a second period from said determination (210) that the implantable medical device (100) is implanted, and passing a functional test, in a step, a test for determining whether the electrodes of the implantable medical device (100), provided for detecting electrical signals and / or emitting electrical pulses, are correctly positioned so as to achieve a desired function, a test for determining whether the electrodes provided for detecting electrical signals and / or emitting electrical pulses have electrode breakage caused by an electrode defect, a test for determining compliance with a signal quality criterion, and a test for determining the type of the detected physiological electrical signal, the functional test being selected from the group consisting of: In an implantable medical device comprising a computer-readable program for causing the processor (170) to execute, wherein the first diagnostic or treatment function (230) and / or the second diagnostic or treatment function (260) includes a function for defibrillation of the heart, a function for anti-tachycardia stimulation of a patient's heart region, and / or a function for automatic adaptation of an algorithm used for anti-tachycardia stimulation, The implantable medical device, wherein the first diagnostic or treatment function and the second diagnostic or treatment function are different with respect to the type and / or intensity of the delivered electrical pulses. Claim 2 The implantable medical device (100) according to claim 1, wherein the implantable medical device (100) is a device selected from the group consisting of a pacemaker implant, a cardioverter-defibrillator, a cardiac resynchronization therapy device, a spinal cord stimulator, a deep brain stimulation device, and an implantable drug pump. Claim 3 The program causes the processor (170) to activate the first diagnostic or treatment function (230) only after a third period has elapsed from the determination (210) that the implantable medical device (100) is in an implanted state, The implantable medical device according to claim 1 or 2. Claim 4 The implantable medical device according to any one of claims 1 to 3, wherein the first period and / or the second period each have a length of 5 minutes to 48 hours. Claim 5 The implantable medical device according to any one of claims 1 to 4, wherein the implantable medical device (100) includes a time measurement device for measuring the first period and / or the second period. Claim 6 The program causes the processor (170) to change or reset the time measurement device in response to a start event in order to start measuring the first period and / or the second period, The implantable medical device according to claim 5, wherein the start event is the activation of the first diagnostic or treatment function when the first period is measured, and the determination that the implantable medical device is in an implanted state when the second period is measured. Claim 7 The first diagnostic or treatment function (230) and / or the second diagnostic or treatment function (260) includes detection of a patient's cardiac signal, stimulation of the patient's cardiac region within the range of pacemaker stimulation, The implantable medical device according to any one of claims 1 to 6, characterized in that it includes stimulation of the patient's cardiac region within the range of cardiac resynchronization therapy, a function for detecting electrode errors and / or electrode dislocations, and / or a function for remote implant monitoring. Claim 8 The implantable medical device (100) is a cardiac resynchronization therapy device or a cardioverter / defibrillator, and the second diagnostic or therapeutic function (260) includes a cardiac defibrillation function, characterized in that the implantable medical device according to any one of claims 1 to 7.
9. The program causes the processor (170) to determine an available shock vector after achievement (250) of the activation criteria for the defibrillation function, characterized in that the implantable medical device according to any one of claims 1 to 8.
10. A computer-readable code that, when executed on a processor, a) determining (210) whether the implantable medical device (100) is implanted; b) when it is determined (220) that the implantable medical device (100) is implanted, activating the first diagnostic or therapeutic function (230) of the implantable medical device (100), and subsequently activating the second diagnostic or therapeutic function (260) of the implantable medical device, wherein the second diagnostic or therapeutic function (260) is activated only after achievement (250) of at least one activation criterion selected from the group consisting of elapse of a first period from the activation of the first diagnostic or therapeutic function (230), elapse of a second period from the determination (210) that the implantable medical device (100) is implanted, and passing a functional test; in the step, a test for determining whether the electrodes of the implantable medical device (100) provided for detecting an electrical signal and / or emitting an electrical pulse are correctly positioned so that the electrodes achieve a desired function, a test for determining whether the electrodes provided for detecting an electrical signal and / or emitting an electrical pulse have an electrode breakage caused by an electrode defect, a test for determining compliance with a signal quality criterion, and a test for determining the type of the detected physiological electrical signal, and the functional test is selected from the group consisting of steps; In a computer program product comprising a computer-readable code that causes the processor to execute The first diagnostic or therapeutic function (230), and / or the second diagnostic or therapeutic function (260) includes a function for defibrillation of the heart, a function for anti-tachycardia stimulation of a patient's cardiac region, and / or a function for automatic adaptation of an algorithm used for anti-tachycardia stimulation. The first diagnostic or therapeutic function and the second diagnostic or therapeutic function are different with respect to the type and / or intensity of the electrical pulses delivered, computer program product.
Citation Information
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