Implantable medical device
By using delayed activation and functional testing methods, the implantation status of implantable medical devices can be automatically detected, solving the problem that existing technologies require additional programming equipment to activate medically sensitive functions, thus simplifying the activation process and reducing costs.
Patent Information
- Application Number
- CN202080072282.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-10-21
- Filing Date
- 2020-09-24
- Publication Date
- 2026-02-27
- Estimated Expiration
- 2040-09-24
AI Technical Summary
Activating medically sensitive functions in existing implantable medical devices requires additional programming equipment and complex non-sterile procedures, increasing implantation costs and risks.
By implementing delayed activation and functional testing in implantable medical devices, the second diagnostic or therapeutic function is activated delayed according to activation criteria after the implantation status is automatically detected, avoiding additional programming equipment and non-sterile operations.
It simplifies the activation process of implantable medical devices, reduces implantation costs and risks, and ensures safe activation of functions.
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Figure CN114555181B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present invention relates to an implantable medical device, a method for controlling an operation of an implantable medical device and a computer program product adapted to control an operation of an implantable medical device. BACKGROUND
[0002] Implantable medical devices can perform a variety of tasks. It is often relevant to know when an (active) implantable medical device is actually implanted in a patient. Typically, this is because the most important functions of the implantable medical device should only be activated at or immediately after implantation. In this way, malfunctions of the implantable medical device during transport before its implantation can be avoided. Furthermore, if particularly energy-consuming functions are only activated after implantation of the implantable medical device, the energy consumption of the implantable medical device is reduced.
[0003] For example, for ordinary pacemakers, it is known to automatically detect whether the pacemaker has been implanted. For example, document US 6,016,447 A describes a pacemaker which automatically detects whether it is in an implanted state based on various measured parameters. If it is detected that the pacemaker is in its implanted state, certain therapy functions which were previously disabled are activated.
[0004] Document US 7,113,827 B2 describes an implantable medical device which emits a test stimulation pulse and measures the corresponding pulse signal and examines it more closely in the context of signal analysis. The measured pulse width is then used to determine whether an electrode is connected to the implantable medical device. Within the scope of signal analysis, it is also possible to determine the type of connected electrode.
[0005] Document US 7,440,801 B2 describes an implantable medical device which regularly monitors its own energy consumption. If the energy consumption increases, a test is carried out to determine whether an electrode is connected to the device. If a connected electrode is detected, the therapy functions of the implantable medical device are activated.
[0006] All of the solutions known from the prior art provide for the simultaneous activation of possible therapy functions. However, in implantable medical devices which are currently marketed, there are many implantable medical devices which can perform medically particularly sensitive functions and are still manually activated.
[0007] For example, in the case of implantable cardioverter / defibrillators (ICDs) or devices for performing cardiac resynchronization therapy (CRT-D), an employee of the implant manufacturer is usually present during implantation in order to activate the defibrillation function of the device by programming the device at the time of implantation. This process is relatively complex, since the programming device is a non-sterile device and therefore cannot be placed in the operating room. Instead, the programming device is operated by a trained user in the non-sterile zone, while the physician implanting the ICD or CRT-D is in the sterile operating zone. SUMMARY
[0008] The problem addressed by the present invention is to provide a simplified method of activating a medically particularly sensitive function of an implantable medical device, without the need for an additional user of a programming device to be present in addition to the implanting physician.
[0009] An obvious approach to solving this objective technical problem would be to provide the programming device with a (sterile) remote control, which can be operated directly by the implanting physician himself. However, the present invention pursues a completely different approach. According to the claimed invention, the objective technical problem is solved by implementing a time-delayed activation of different diagnostic or therapeutic functions of the implantable medical device. The automatic activation of a medically particularly sensitive or relevant diagnostic or therapeutic function is only carried out after it has been detected that the implantable medical device is in its implanted state and after additional activation criteria have been met.
[0010] In particular, this problem is solved by an implantable medical device having the features described below. This implantable medical device comprises a processor and a storage unit. The storage unit comprises a computer-readable program which, when executed on the processor, causes the processor to perform the steps explained below.
[0011] First, a detection is carried out to determine whether the implantable medical device is in its implanted state. Many different procedures for this basic detection of the implanted state of an implantable medical device are known from the prior art.
[0012] If it is detected that the implantable medical device is in its implanted state, a first diagnostic or therapeutic function of the implantable medical device is activated. If additional activation criteria are met, a second diagnostic or therapeutic function of the implantable medical device is activated in addition to the first diagnostic or therapeutic function. According to the invention, the activation criteria are that a first time period has elapsed since the activation of the first diagnostic or therapeutic function and / or a second time period has elapsed since the detection that the implantable medical device is in the implanted state and / or a functional test of the implantable medical device is passed.
[0013] Thus, in the first operating state of the implantable medical device, it is sufficient to activate the second diagnostic or therapeutic function if a predetermined or predeterminable time has elapsed (optionally after the start of a different event). This is because it can then regularly be assumed that the implantable medical device is in the desired implanted state, i.e. for example all electrodes of the implantable medical device are correctly positioned and its function to influence the body of a patient in which the implantable medical device has been implanted can be implemented.
[0014] On the other hand, in a second operating state of the implantable medical device, a function test is performed. This allows different functions of the implantable medical device to be tested before the second diagnostic or therapeutic function is activated. In this way, it can be positively checked that the implantable medical device is not only in its implanted state, but can also, for example, interact in certain desired ways with the patient's body into which the implantable medical device has been implanted. The function test can also be a function test within the device itself, which does not take into account any specific interaction with the patient's body into which the implantable medical device has been implanted.
[0015] Finally, in a third operating state of the implantable medical device, a combination of the first operating state and the second operating state is conceivable. In this operating state, the second diagnostic or therapeutic function can thus be activated only if a predetermined or predeterminable time has elapsed and, in addition, the function test of the implantable medical device has been successfully passed.
[0016] In this way, for example after automatic detection of the implanted state of the implantable medical device, the normal pacemaker function can initially be activated as the first diagnostic or therapeutic function. This ensures a basic level of care for the relevant patient. In contrast, the shock function (defibrillation function) of the implantable medical device is only activated after a certain time has elapsed and / or after a test to determine whether the electrodes of the implantable medical device are actually positioned correctly and whether the stimulation pulses are transmitting the desired response signal. This is to prevent an undesired premature triggering of the second diagnostic or therapeutic function during the implantation of the implantable medical device. For example, if the implantable medical device makes a false diagnosis of the medical condition of the patient into which it has been implanted due to the specific circumstances of the implantation and thus activates a severe medical function such as a heart defibrillation function, such a premature triggering is conceivable.
[0017] 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 claimed in the present case, it is no longer necessary for an additional programming device to be present at the time of implantation of the implantable medical device to manually activate the defibrillation function or any other second diagnostic or therapeutic function. This significantly reduces the costs of equipment and personnel required for implanting the respective implantable medical device. At the same time, medical safety is maintained, since the second diagnostic or therapeutic function is only activated if the respective activation criteria are met.
[0018] In a variant, the implantable medical device has a manual actuation means which indicates the implanted state of the implantable medical device. Such a means can be, for example, a switch which is actuated by the doctor implanting the implantable medical device during the implantation process. The state of the switch can then be read from a computer-readable program stored in a storage unit of the implantable medical device. This means that it is possible to automatically read and thus automatically detect whether the implantable medical device is in its implanted state even if the switch is activated manually.
[0019] In a variant, the detection of whether the implantable medical device is in its implanted state (implant detection) is based on a measurement of impedance, a measurement of temperature, a measurement of data from an activity sensor, a signal evaluation of a test signal generated by a test stimulation pulse and / or a measurement of the energy consumption of the implantable medical device. These different methods are known per se in the prior art and are described in a manner which can be modified by the person skilled in the art.
[0020] In a variant, the implant detection is performed by impedance measurements performed cyclically at least at one electrode connection. In a variant, the implant detection is performed by impedance measurements performed cyclically at the right ventricular electrode connection.
[0021] In a variant, the implantable medical device is a pacemaker implant, an implantable 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 these different types of implantable medical devices have different diagnostic and therapeutic functions which can be activated in a chronological order in a medically expedient manner. For example, for a drug pump, a first diagnostic or therapeutic function can be designed such that a first active substance can be delivered, while a second diagnostic or therapeutic function can be designed such that a second active substance can be delivered. It is also conceivable that within the scope of the first diagnostic or therapeutic function, a small amount of the first active substance can be delivered or conveyed by such a drug pump, while within the scope of the second diagnostic or therapeutic function, a larger amount (more than the small amount) of the same first active substance can be delivered or conveyed by the drug pump.
[0022] In case the device is capable of electrically stimulating a specific region of the patient's tissue, the first diagnostic or therapeutic function and the second diagnostic or therapeutic function can differ, for example with respect to the type and / or intensity of the electrical pulses to be delivered. In particular, if the implantable medical device is designed as an ICD or a CRT-D, it is provided in a variant that the first diagnostic or therapeutic function represents or comprises a normal pacemaker function (i.e. in particular a function for anti- bradycardia stimulation of a human or animal heart), while the second diagnostic or therapeutic function represents or comprises a cardiac defibrillation function (shock function).
[0023] In a variant, the program causes the processor to activate the first diagnostic or therapeutic function only after a third time period has elapsed from the moment at which the implantable medical device was detected in its implanted state. Thus, in this variant, the first diagnostic or therapeutic function is not activated immediately upon detection of the implanted state of the implantable medical device, but there is a time delay. This reduces the risk that the device detects interference signals during the implantation process and then incorrectly performs a certain diagnostic or therapeutic function on the basis of these signals. This is because in this variant the first diagnostic or therapeutic function is only actually activated if the risk of detecting such interference signals is significantly reduced due to the time that has elapsed since the actual implantation process.
[0024] In a variant, the first time period (i.e. the time elapsed between activation of the first diagnostic or therapeutic function and activation of the second diagnostic or therapeutic function) and / or the second time period (i.e. the time from detection of the implantable medical device in its implanted state) has a length of between 5 minutes and 48 hours, in particular between 10 minutes and 36 hours, in particular between 15 minutes and 24 hours, in particular between 20 minutes and 12 hours, in particular between 30 minutes and 10 hours, in particular between 40 minutes and 8 hours, in particular between 50 minutes and 6 hours, in particular between 1 hour and 5 hours, in particular between 2 hours and 4 hours.
[0025] In a variant, the third time period (i.e. the time elapsed after detection of the implanted state until the first diagnostic or therapeutic function is activated in a variant) also has a length within one of the aforementioned time intervals. The first time period, the second time period and the third time period can be chosen independently of one another from these time intervals. It is conceivable that the first time period, the second time period and / or the third time period are different or have the same length.
[0026] In a variant, the implantable medical device has a time measurement device for measuring the first time period and / or the second time period. This time measurement device can be, for example, a normal timer. In a variant, the time measurement device is also used to measure the third time period. In another variant, the device has a first time measurement device for measuring the first time period, a second time measurement device for measuring the second time period and a third time measurement device for measuring the third time period. With such a time measurement device, it is possible to record internally in the device the time that must elapse before the first diagnostic or therapeutic function or the second diagnostic or therapeutic function is activated. The implantable medical device then monitors the passage of the respective time independently of an external time signal.
[0027] In a variant, when the start event is detected, the program causes the processor to stop, modify or reset the time measuring device. If the time measuring device is designed according to the variant in which the third time period is determined, this manipulation of the time measuring device can be used to start the measurement of the first time period and / or the second time period and / or the third time period. The start event here depends on the type of time period to be measured. If the first time period is to be measured, the start event is the activation of the first diagnostic or therapeutic function. If the second time period is to be measured, the start event is the detection that the implantable medical device is in its implanted state. If the third time period is to be measured, the start event is again the detection that the implantable medical device is in its implanted state. Different timer ranges of the time measuring device can be addressed by specific state events, so that more than one time period, for example the first time period, the second time period and the third time period, can essentially be determined at least partially simultaneously with a single time measuring device.
[0028] In a variant, the first diagnostic or therapeutic function and / or the second diagnostic or therapeutic function comprises a detection of a patient's cardiac signal, a stimulation of a patient's cardiac region in the range of a pacemaker stimulation, in particular in a right ventricular stimulation mode, a stimulation of a patient's cardiac region in the range of a cardiac resynchronization therapy, a function for detecting an electrode error and / or an electrode mispositioning and / or a function for remote implant monitoring, the so-called home monitoring. It is particularly provided here that the first diagnostic or therapeutic function comprises a detection of a patient's cardiac signal and a stimulation of a patient's cardiac region in the range of a pacemaker stimulation (antibradycardia stimulation). In contrast thereto, a variant particularly provides that the second diagnostic or therapeutic function comprises a stimulation of a patient's cardiac region in the range of a cardiac resynchronization therapy.
[0029] In a variant, if the implantable medical device is a cardiac stimulation device, the first diagnostic or therapeutic function comprises a standard stimulation program related to the specific type of implantable medical device. In this case, the device-specific standard stimulation program is activated as soon as the implant detection has been positively completed.
[0030] In a variant, if the implantable medical device has previously been detected to be in its implanted state, a diagnostic function, an automatic algorithm for antibradycardia stimulation adaptation, an algorithm for electrode error detection or electrode mispositioning detection and / or remote implant monitoring is activated in addition to the first diagnostic or therapeutic function.
[0031] In a variant, the first diagnostic or therapeutic function and / or the second diagnostic or therapeutic function has a function for cardiac defibrillation, a function for antitachycardia stimulation of a patient's cardiac region and / or a function for automatic adaptation of an algorithm for antitachycardia stimulation.
[0032] In a variant, the implantable medical device is designed as a device for cardiac resynchronization therapy or a cardioverter / defibrillator with a second diagnostic or therapy function including a cardiac defibrillation function. Thus, in this variant, it is ensured that the defibrillation function, which usually constitutes a painful therapy for the patient and should only be performed if there is actually a medical necessity, is activated only if a plurality of conditions are met. First, it must be detected that the implantable medical device is in its implanted state. Only then can the first diagnostic or therapy function, which in this variant does not include a defibrillation function, be activated. If now additional activation criteria are met, the second diagnostic or therapy function can be activated in the form of a cardiac defibrillation function, so that a cardiac defibrillation of a patient in which the implantable medical device is implanted is possible.
[0033] In a variant, in addition to the second diagnostic or therapy function, an additional diagnostic function, a function for anti-tachycardia stimulation, an automatic algorithm for anti-tachycardia stimulation adjustment, an algorithm for electrode error detection or electrode misplacement detection and / or a function for remote implant monitoring is activated.
[0034] In a variant, the passing of a function test, which is a test for determining whether the electrodes of the implantable medical device for detecting electrical signals and / or delivering electrical pulses are correctly positioned, a test for determining whether the electrodes for detecting electrical signals and / or delivering electrical pulses have an electrode breakage and / or a test for checking a signal quality criterion and / or a test for checking the type of a detected physiological electrical signal, can be used as an activation criterion for activating the second diagnostic or therapy function.
[0035] The signal quality criterion can include, for example, the amplitude of a detected signal and / or the width of a detected signal and / or the signal stability and / or the electrode impedance. Different types of detected physiological electrical signals can be, for example, different cardiac signals from a patient detected by the implantable medical device, such as a QRS complex signal or the amplitude of such a QRS complex signal.
[0036] In a variant, after the activation criteria are met, the program causes the processor to determine a shock vector available for the defibrillation function. This determination of a shock vector is particularly useful when the cardiac defibrillation function is selected as the second diagnostic or therapy 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 and a second electrode of the implantable medical device. The number of possible shock vectors and their specific design depend, inter alia, on whether a so-called single-coil defibrillation electrode or a so-called double-coil defibrillation electrode is used. The specific position of the individual electrodes of the defibrillation electrode also has an influence on the possible available shock vectors.
[0037] In a variant, upon detection that the implantable medical device is in its implanted state, the program causes the processor to activate all implanted defibrillation electrodes of the implantable medical device for defibrillation and electrode diagnostics. Within the scope of the electrode diagnostics, it is in particular determined whether the electrodes are correctly positioned and whether the electrodes have an electrode fault, such as an electrode breakage. This variant of activating all implanted defibrillation electrodes is particularly useful in combination with the variant of determining the available shock vectors of the defibrillation function as a second diagnostic or therapy function.
[0038] An aspect of the invention relates to a method of controlling the operation of an implantable medical device, wherein the method is in particular suitable for use with an implantable medical device as explained above. The control method comprises the steps explained below.
[0039] First, it is detected whether the implantable medical device is in its implanted state.
[0040] If it is positively detected that the implantable medical device is in its implanted state, a first diagnostic or therapy function of the implantable medical device is activated. If in addition an activation criterion is fulfilled, a second diagnostic or therapy function of the implantable medical device is subsequently activated. The activation criterion can be that a first time period has elapsed since the activation of the first diagnostic or therapy function and / or a second time period has elapsed since the detection that the implantable medical device is in its implanted state and / or a function test is passed.
[0041] An aspect of the invention relates to a computer program product comprising computer readable code which, when run on a processor, causes the processor to perform the steps explained below.
[0042] First, it is detected whether the implantable medical device is in its implanted state.
[0043] If it is positively detected that the implantable medical device is in its implanted state, a first diagnostic or therapy function of the implantable medical device is activated. If in addition an activation criterion is fulfilled, a second diagnostic or therapy function of the implantable medical device is subsequently activated. The activation criterion can be that a first time period has elapsed since the activation of the first diagnostic or therapy function and / or a second time period has elapsed since the detection that the implantable medical device is in its implanted state and / or a function test is passed.
[0044] An aspect of the invention relates to a medical method for implanting an implantable medical device. The device is implanted in a human or animal patient in need of such an implant. The implantable medical device comprises a processor and a storage unit. The implantation method is characterized by the steps explained below.
[0045] First, the implantable medical device is implanted in the patient.
[0046] Now, a detection is performed to determine whether the implantable medical device is in its implanted state. A program running on the processor is used to do this. This can be based on a measured value indicative of the implantation of the implantable medical device, such as a temperature corresponding to a substantially constant temperature of the body temperature of the patient and / or a characteristic impedance of an electrode forming part of the implantable medical device and / or a signal quality criterion of an electrical signal detected by the implantable medical device.
[0047] Once the implantable medical device is detected to be in its implanted state, a first diagnostic or therapeutic function of the implantable medical device is activated. If, in addition, an activation criterion is fulfilled, a second diagnostic or therapeutic function is activated. The first diagnostic or therapeutic function and the second diagnostic or therapeutic function are activated by a program running on the processor, respectively. Here, the activation criterion is selected from the group consisting of a first time period lapsed from the activation of the first diagnostic or therapeutic function, a second time period lapsed from the detection of the implantable medical device being in its implanted state, and a functional test.
[0048] All variants and alternative designs described in connection with the implantable medical device can be combined with each other in any way and can be transferred to the described methods and computer program products. Furthermore, the described method variants can be combined with each other in any way and can be transferred to other methods as well as computer program products and devices. Likewise, the described computer program product variants can be combined with each other in any way and can be transferred to the described methods and the described devices. BRIEF DESCRIPTION OF DRAWINGS
[0049] Further details of the application will be explained in the following with reference to exemplary embodiments and to the accompanying drawings, in which:
[0050] Figure 1 A block diagram of an implantable medical device is shown; and
[0051] Figure 2 A flow chart of a method for operating an implantable medical device is shown. DETAILED DESCRIPTION
[0052] Figure 1 An implantable defibrillator 100 is shown which serves as an implantable medical device. The defibrillator 100 has an energy source 110 and an impedance-based implant detection unit 120. The impedance-based implant detection unit 120 is connected to a connector for a right ventricular detection and stimulation electrode RV (RV connector). A combined detection and stimulation unit 130 is also connected to the RV connector. The combined detection and stimulation unit 130 can detect and classify the heart rhythm of a patient in which the defibrillator 100 has been 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 implant 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 implant detection unit 120 is activated. This implant detection unit 120 is able to detect the connection of the implanted right ventricular electrode RV within a time period of from 0.1 to 5 seconds and signal this to the control unit 150. The control unit 150 then immediately activates the detection and stimulation unit 130 which, as a result of this activation, performs its functions using standard settings stored in a storage unit 160 of the defibrillator 100.
[0055] The storage unit 160 is operatively connected to the processor 170, thereby enabling the control unit 150 to control the individual elements of the defibrillator 100.
[0056] After a waiting period of, for example, 12 hours and the confirmation test of the implant detection unit 120 has positively confirmed that the RV electrode has been permanently connected to the RV connector and the signal quality of the test signal recorded by the RV electrode after the respective test stimulation pulse meets the predetermined criteria, the control unit 150 also activates the defibrillation unit 140. This leads to the activation of the defibrillation function as a second diagnostic or therapeutic function.
[0057] At the same time, when the detection and stimulation unit 130 activates the anti-tachycardia stimulation, the additional therapeutic function of the detection and stimulation unit 130 is activated. The defibrillator can thus now be activated by its detection and stimulation unit 130 on the basis of standard settings and anti-tachycardia stimulation, the standard settings usually including anti-bradycardia stimulation. In addition, the defibrillator 100 can be used to perform defibrillation if this is required by the patient.
[0058] Figure 2 A schematic flow chart is shown which illustrates the automatic activation of two different diagnostic or therapeutic functions of an implantable defibrillator (for example Figure 1 the defibrillator 100 of Fig. 1).
[0059] First, a cyclically performed electrode impedance measurement 210 is used to test whether the implanted RV electrode is connected to the defibrillator and can be detected. If the result 220 of this cyclically performed electrode impedance measurement 210 is positive, a simple anti-bradycardia pacemaker function 230 is activated. In addition, a confirmation phase 240 is automatically started during which a test is performed within a predetermined time to determine whether the implanted RV electrode is still present and whether suitable signal conditions for safe defibrillator activation are present. If both conditions are fulfilled after the predetermined time has elapsed, a decision step 250 is followed by the activation of the defibrillation function 260 of the defibrillator. Once the defibrillation function has been activated, the system does not test again whether the conditions required for activation are still fulfilled. Rather, the defibrillation function remains implemented even if one of the conditions necessary for activation is no longer fulfilled later.
[0060] If, on the other hand, it is determined during the test 250 that the implanted RV electrode is no longer detected or that suitable signal conditions for reliable activation of the defibrillation function are not present after the specified time has elapsed, the test method returns to the cyclically performed electrode impedance measurement 210 in order to again test whether the electrode is connected to the defibrillator. For safety reasons, it can optionally be provided that the already activated anti-bradycardia stimulation activity of the defibrillator remains activated. In this case, it is still possible to perform anti-bradycardia stimulation, although the conditions for safe defibrillation are not sufficient, so that life-support measures for the patient are taken if necessary.
Claims
1. An implantable medical device comprising a processor (170) and a storage unit (160), wherein the storage unit (160) comprises a computer-readable program which, when run on the processor (170), causes the processor to perform the following steps: a) performing a detection (210) to determine whether the implantable medical device (100) is in an implanted state, b) if it is detected that the implantable medical device (100) is in an implanted state (220), activating a first diagnostic or therapeutic function (230) of the implantable medical device (100) and subsequently activating a second diagnostic or therapeutic function (260) of the implantable medical device (100), wherein the second diagnostic or therapeutic function (260) is activated only after fulfilling (250) at least one activation criterion selected from the group consisting of a first time period elapsing from activating the first diagnostic or therapeutic function (230), a second time period elapsing from the detection (210) that the implantable medical device (100) is in an implanted state, and a functional test, characterized in that the first diagnostic or therapeutic function (230) and / or the second diagnostic or therapeutic function (260) comprises a function for cardiac defibrillation, a function for anti-tachycardia stimulation of a region of the patient's heart, and / or a function for automatic adaptation of an algorithm for anti-tachycardia stimulation.
2. The implantable medical device of 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.
3. The implantable medical device of claim 1 or 2, wherein, the program causes the processor (170) to activate the first diagnostic or therapeutic function (230) only after a third time period elapsing from the detection (210) that the implantable medical device (100) is in an implanted state.
4. The implantable medical device of claim 1 or 2, wherein, the first time period and / or the second time period each has a length between 5 minutes and 48 hours.
5. The implantable medical device according to claim 1 or 2, characterized in that, the implantable medical device (100) comprises a time measuring device for measuring the first time period and / or the second time period.
6. The implantable medical device of claim 5, wherein, the program causes the processor (170) to stop, change, or reset the time measuring device in dependence on a start event in order to start measuring the first time period and / or the second time period.
7. The implantable medical device of claim 1 or 2, wherein, the first diagnostic or therapeutic function (230) and / or the second diagnostic or therapeutic function (260) comprises a function for detecting a cardiac signal of the patient, stimulating a region of the patient's heart in a pacemaker stimulation range, stimulating a region of the patient's heart in a cardiac resynchronization therapy range, detecting an electrode error and / or an electrode misplacement, and / or a function for remote implant monitoring.
8. The implantable medical device of claim 1 or 2, wherein, the implantable medical device (100) is a cardiac resynchronization therapy device or a cardioverter / defibrillator, and the second diagnostic or therapeutic function (260) comprises a cardiac defibrillation function.
9. The implantable medical device of claim 1 or 2, wherein, The functional tests are selected from the group consisting of tests aiming at determining whether electrodes of the implantable medical device (100) provided for detecting electrical signals and / or emitting electrical pulses are correctly positioned, tests aiming at determining whether electrodes provided for detecting electrical signals and / or emitting electrical pulses have an electrode breakage, tests aiming at determining a compliance with signal quality criteria and tests aiming at determining a type of detected physiological electrical signals.
10. The implantable medical device of claim 1 or 2, wherein, The program causes the processor (170) to determine an available shock vector after meeting (250) an activation criterion of a defibrillation function.
11. The implantable medical device of claim 1 or 2, wherein, The program causes the processor to activate all implanted defibrillation electrodes of the implantable medical device (100) for defibrillation and electrode diagnostics upon detecting (210) that the implantable medical device is in its implanted state.
12. A computer program product comprising computer readable code which, when run on a processor, causes the processor to perform the steps of: a) performing a detection to determine whether an implantable medical device (100) is in an implanted state, b) if the implantable medical device (100) is detected to be in an implanted state (220), activating a first diagnostic or therapeutic function (230) of the implantable medical device (100) and subsequently activating a second diagnostic or therapeutic function (260) of the implantable medical device, wherein the second diagnostic or therapeutic function (260) is activated only after meeting (250) at least one activation criterion selected from the group consisting of a first time period elapsed from activating the first diagnostic or therapeutic function (230), a second time period elapsed from detecting (210) that the implantable medical device (100) is in an implanted state and a functional test, characterized in that the first diagnostic or therapeutic function (230) and / or the second diagnostic or therapeutic function (260) comprises a function for cardiac defibrillation, a function for anti-tachycardia pacing of a region of the patient's heart and / or a function for automatic adaptation of an anti-tachycardia pacing algorithm.
Citation Information
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