DE102017009139A1 - Optional Patient Warning System (fPWS) Telemetry Inducor - Google Patents

Abstract

Implantable devices are directly or indirectly equipped with a facultative patient warning system (fPWS) telemetry inductor. The fPWS were in critical situations for the patient. The well-known telemetry is supplemented, relevant events are communicated immediately. Connections with Life-Westen, external sensors and external infusion pump systems are included. The devices are active and communicate directly with the responsible patient. Higher therapy safety improves adherence. Pharmacotherapy can be controlled. For the networking of all implanted devices, a possibly implantable master device is proposed as a meaningful central unit equipped with the fPWS. You can communicate with all telemetry systems. External communication systems (eg MedPhone) should be available to the patient in a wearable manner. Up to the communication level II, an internet connection is not required, there are no hazards due to hacker attacks. The communication levels III (home monitoring) and IV (induction of the rescue chain including GPS location) depend on telemonitoring. Critical emergencies (eg, second heart death) receive a new therapeutic opportunity. Implantable infusion systems communicate directly with the patient using fPWS. They become effective as a component of complex therapy by means of a master device. Further applications: pulmonology, sleep medicine (sleep apnea), orthopedics, neurology and urology

Description

Introduction, history and description

1991 was the patent DE 4213993 A1 "Integrated Patient Alert System for Energy-Driven Implants" has been published. The considerations expressed there continue to be an intellectual component of the new patent in a form adapted to technical progress. However, there is no patent protection, as the deadlines are forfeited.

The simplest integrated patient warning system (patent DE 4213993 A1 ) is characterized in that it emits a single non-programmable stimulus pattern, ie, patterns of individual temporally limited impulsive current, voltage or power waveforms, for one or more (rigid) warning situations (function restriction and / or failure of one or more or all components Pathological measurements (heart rate, heart rhythm, respiration, circulatory system pressures) The patient is then urged to immediately take further diagnostic and therapeutic measures (eg telephone, personal or home monitoring contact the physician / heart center) external communication system in the hands of the patient is not mandatory, the previous home monitoring function is initially sufficient and claimed no significant performance (capability) on the part of the patient, so it is also suitable for beginning demented patients.

Implantable HIVS pacemaker injection pump assemblies for electronically controlled pharmacotherapy of cardiological / angiological and pulmonary diseases, hereafter referred to as HIVS (even though the pacing function is absent in some systems), are characterized by their novel use in cardiac / angiological and pulmonary permanent diagnostics and combine with controllable oral, intravascular, subcutaneous and / or intracardiac pharmacotherapy.

Refill possibilities for HIVS are characterized by the fact that they allow the system to be rinsed, changed or refilled with transcutaneous administration. As a rule, the implant uses somewhat more distant components in analogy to Port-a-cath, which are permanently or interchangeably connected to the HIVS.

Cardiovascular events, particularly rhythmic emergency situations such as ventricular tachycardia, are often time-critical events whose delayed treatments lead to fatal consequences for the patient concerned. The second heart death also describes the critical time interval in time. Again and again, an attempt is made to effectively shorten the essential chain of alarms. Immediately required are electrical and medical therapies.

1991 was the patent DE 4213993 A1 "Integrated Patient Alert System for Energy-Driven Implants" has been published. The considerations expressed there continue to be an intellectual component of the new patent in a form adapted to technical progress.

In a total of now 14 claims, complex systems for both communicative processes and drug therapies (implantable infusion pumps) are collected.

Based on these considerations, further technologies and therapeutic algorithms will be disclosed, taking into account technical progress and current medical developments.

The basic algorithm of a communicative implanted device is applicable to all implantable devices. Each implanted electronic device requires external control systems for its function and its energetic state, which are usually carried out today at timed intervals. Intermittent dysfunctions become clear from symptoms of illness (shortness of breath, arrhythmia, for example), which may possibly also have a life threatening extent. The communicative aspect of implanted devices can make the patient aware of the disorder with appropriate internal monitoring software in the early stages and reduce the complications or avoid the complications by the quick doctor visit.

A complex integrated facultative patient warning system (fPWS) telemetry inductor for all implantable electronically controlled devices is presented. Thus, a functional check of the implant and also a guide for the patient to carry out meaningful and currently adapted pharmacotherapy and behaviors are achieved.

Consequences of pacemaker dysfunctions and pacemaker failures as well as dysfunctions of cardiac devices are not known in their frequency. However, the fPWS can certainly significantly reduce the risk as well as the missed pacemaker controls and thus help to avoid serious complications and deaths.

External interference fields are regularly questioned in their meaning. Nevertheless, consensus exists that they pose dangers. Implemented sensors in combination with the fPWS can make the danger potential acutely noticeable and avoidable for the patient.

The therapy of cardiac arrhythmias is permanently changed in the electromedical as well as in the medical therapy field. The therapy can be optimized highly individually. The permanent medication therapy can be avoided if necessary. The side effects of potent antiarrhythmic drugs can be reduced.

The combination of pacemakers / defibrillators with implantable infusion pumps extends the therapeutic arsenal significantly, pharmaceuticals can be applied "just in time" to the second, the "second heart death" can be addressed in this way, possibly considerably intensified. In connection with defibrillations, thermally stable substances (chemically stable up to 42 ° C in the long term) can be given immediate effect at the same time, thus acting rhythmologically and / or hemodynamically effectively in the critical phase.

• • Lebensbedrohlicher Zustand → an- und abschwellende Stimulationen mit ansteigender Intensität
• • Aufforderung zur telemetrischen Abfrage → kurze Impulse, eben spürbar, Intensität ggf. von Dringlichkeit abhängig
• • Aufforderung zur Einnahme von Medikamenten (Dauertherapie ggf. bei „Vergesslichkeit”) und „pill in the pocket”
• • Recorder „triggert” den Patienten „just in time”
• – Mitteilung über Rhythmusstörungen, die ggf. ohne klinische Symptomatik ablaufen (v. a bei asymptomatischem Vorhofflimmern)
• – Einbezug in die telemedizinische Infrastruktur sowie aktive Meldung an Patienten (z. B. über App)
• – Höhere Kommunikationsebenen
• – Entwicklung spezifischer Anwendungssoftware
• – Ist im externen Kontrollgerät geladen und kann telemedizinisch spezifiziert werden
• – Informationen vom Kontrollgerät via Display oder Lautsprecher an den Patienten → direkter Handlungshinweis
• – Bei warnsysteminduzierter Auflage des Kontrollsystems ist kein direkter telemedizinischer Kontakt zum Herzzentrum erforderlich (Vermeidung von Internetstrukturen möglich, keine Hackergefahr)
• – Eine grundsätzliche neue technische Möglichkeit wird mit dem MedPhone beschrieben.

The event recorders available today store the rhythmological events, which are then processed diagnostically at the next (possibly routine) check in the laboratory. The home-monitor system (eg Biotronik) allows for daily controls with appropriate patient compliance so that a therapeutic intervention can be initiated within 24-48 hours. For particularly dangerous events, an immediate detection and treatment is desirable, which is possible with the fPWS. In the expansion stage of level I, home monitoring can take place immediately. The urgency can be determined with different pulse patterns. At higher levels, therapeutic measures can be taken immediately.

• • Life-threatening condition → increasing and decreasing stimulation with increasing intensity
• • Request for telemetric query → short impulses, just palpable, intensity possibly dependent on urgency
• • Request for medication (long-term therapy for forgetfulness if necessary) and "pill in the pocket"
• • Recorder "triggers" the patient "just in time"
• - Notification of arrhythmias, possibly without clinical symptoms (especially in asymptomatic atrial fibrillation)
• - Inclusion in the telemedicine infrastructure as well as active notification to patients (eg via app)
• - Higher communication levels
• - Development of specific application software
• - Is loaded in the external control unit and can be specified by telemedicine
• - Information from the control unit via display or loudspeaker to the patient → direct action instruction
• - In the case of warning system-induced circulation of the control system, there is no need for direct telemedical contact with the heart center (avoidance of Internet structures possible, no danger of hacking)
• - A fundamental new technical possibility is described with the MedPhone.

The onset heart failure is measurable and therefore optimized by other diagnostic parameters (eg thoracic impedance). Already today, pacemaker and defibrillation systems have such communication systems that then point to past and / or current events during laboratory controls. In retrospect, these findings can only be used in the sense of the progress assessment. With HIVS, specific drug therapies can be made available immediately for treatment. The fPWS from level (I) II (-IV) extends the immediate drug therapy option (eg the acute administration of diuretics).

The treatment of coronary heart disease is significantly enriched up to the diagnosis of the infarction. Induction of the rescue chain, including emergency GPS tracking, can greatly enhance survival. Drug therapy can be controlled by external communication system, the app can be constantly updated to guideline-appropriate. HIVS can realize thermostable drug therapy (anticoagulation, thrombolysis, antiarrhythmic drugs etc.).

The treatment of pulmonary hypertension causes considerable difficulties due to the lack of simple measuring methods for a frequent acute pressure determination. Already implemented with pressure sensors (eg in pacemaker systems, etc.), these measurements can be made continuously. By means of fPWS patients in 4 levels are accompanied diagnostically and therapeutically. In the external communication system guideline-specific treatment guidelines can be deposited and regularly updated. The HIVS then makes a significant extension of the titrated infusion therapy with thermostable drugs bypassing the hepatic passage.

The treatment of difficult-to-adjust arterial hypertension is basically optimized by continuous measurement. Short- and ultra-short-acting drugs can have an acute impact on hypertensive spikes and prevent crisis-prone developments. Day rhythms, follow-up curves and other diagnostic parameters can be used with the external communication system to provide guideline-appropriate therapy induction with additional assessment of the current risk potential. Dangers are considerably reduced.

The fPWS as described enables a further qualification of the therapy management.

In the treatment of ventricular tachycardias, defibrillation by the implanted defibrillator initially takes center stage. For some devices, the patient is alerted by sound or vibration before defibrillation. It is proposed to capture these signals using an external sensing and communication system.

This system then drives an external infusion system. Via a venous or subcutaneous approach, the infusion system then applies antiarrhythmic drugs "just in time".

Furthermore, the external perception system / communication system sets the rescue chain in motion and transmits the cardiological findings to an emergency center after consultation. In addition, the current location of the patient is determined via GPS.

The external communication system itself has both a display and a speaker system and microphone for direct contact with the ambulance. The external communication system is placed in telemetric accessibility of the implanted defibrillator with a suitable garment.

In the next stage of development, cardiology devices will be provided with a software solution that automatically triggers this external communication system and, as described above, both triggers the rescue chain and implements connected external infusion systems. Electrical and medical therapies are linked.

Event systems with telemonitoring had been rated unfavorably by the IQWiG. The Biotronik system can be equipped with a generator for warning pulses in its current size quite problem-free and thereby use the existing measuring electrodes as a warning electrodes.

All implantable diagnostic and therapeutic systems can benefit from the basic considerations.

Implantable infusion systems promise increased safety in high-risk patients.

External communication systems that the patient carries with him regularly can improve compliance and therapy safety. With suitable software solutions, the energy requirement of the implanted device can be minimized, it corresponds to the energy requirements for the home monitoring system.

Ultimately, the home monitoring system, as a portable system, can represent the basic system and be in development with the additional functions (control of the external infusion system, initiation of the emergency chain).

The optional Patient Alert System provides an additional option to increase patient safety. If the Home Monitoring System is not available, the patient is alerted to the risk situation. The optional patient alert system is described in the four communication levels.

As part of the patent procedure, the module principle, the development of small communication-capable, permanently available monitor systems are to be protected. These monitor systems are based on the current state of development of available cardiology devices. In a step-by-step development process, which must include fundamental research, the implants are conditioned for advanced treatment spectrums, for example in pulmonology, sleep medicine (sleep apnea), orthopedics, neurology and urology, or for therapy support, such as symptom-based medication.

The fPWS places high demands in the approval procedure. For the external communication systems (home monitoring etc.), these basic approvals are available, here the software solution for the control in the device represents a small preliminary stage with a timely implementation possibility.

In the course of the development process, the high value of the optional patient warning system will be particularly important in improving compliance.

For other cardiac emergency indications (acute infarction, heart failure with high progression, rhythmic emergency situations, severe blood pressure crisis, severe pulmonary hypertension, transplant rejection, etc.), the combination of automatic drug therapy with device controlled therapeutic induction and initiation of the rescue chain represents a new therapeutic quality.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 4213993 A1 [0001, 0002, 0006]

Claims (14)

The optional patient warning system (fPWS) telemetry inductor is characterized by the fact that basically all energy-driven implants (implants with integrated electronic assemblies or functional implants or electronic implants) can be expanded by a stimulus generator. The stimulus generator generates in certain situations an acutely perceptible electrical stimulus with different - defined - stimulus patterns / pulse trains that can be interpreted by the patient. If several electronic implants are implanted in a patient, it makes sense to equip each implant additionally with an fPWS, so that the patient can already delimit problem areas by the localization of the stimulus, starting from the respective device. Basically, optional means that it is an additional function that can be switched on and off for the main function of the respective implant by the physician and / or patient. With stable connection to an external communication and display system as part of the measuring system, which is suitable to warn the patient (acoustic, vibration, light, speech), the stimulus pulse pattern system can - at least for uncomplicated situations - be switched off (automatically, semi-automatically, per Hand → if necessary magnet). With a vital indication the fPWS should warn with maximum possibilities. If the connection is interrupted, the stimulation impulse system can automatically switch back on. The fPWS is characterized in that after detecting the situation the patient receives a possibility for the non-invasive termination of the warning pulse delivery. This can be z. B. by magnetic pad, optical impulses or similar manipulations with transcutaneous telemetry as well as by mechanical manipulations (eg., Knock on the device and use of the motion sensor) done. If multiple powered implants are operated, they may function individually and independently, or may be connected via Bluetooth or other developed communications standards for data transmission between short distance devices via Wireless Personal Area Network (WPAN). In this connection, connectionless and connection-dependent transfers from point to point and ad hoc or piconets are possible. Technical faults including external interference fields are being communicated acutely. The new invention is based on four communication channels or levels of an fPWS: I. Warning with an acutely perceptible electrical stimulus with different - defined - stimulus patterns / impulse chains that are interpreted by the patient and can lead or lead to differentiated behavior. II. External communication and display system near the patient with computing functionality (processor), direct communication with the patient via voice (loudspeaker, possibly microphone → talking pacemaker) and / or via display if necessary including touchscreen / keyboard and / or mouse and connection to One or more implants via a Personal Area Network (PAN) and a Touch Area Network (TAN) and possibly to a base station (Application Hosting Devices (AHDs). - With stable connection to a portable external communication system, the stimulus pattern / pulse chain system in the implant can be switched off automatically, semi-automatically or by hand. It should be used for a vital indication. With the aid of the external communication and display system, the patient can also hear or read the information ("speaking or writing device"). Possibly. The patient can also use the external communication system with pre-recorded questions (such as automatic call functions in telecommunications) and then get help with ready-made app responses. Particularly suitable for this purpose are special medical (medical) smartphones (MedPhone,) or corresponding apps on smartphones or tablet computers. III. A home telemonitoring system (remote connection to a health facility or a telemedical center for remote telemedical care) is being staged acutely. (Definition with urgency). The fPWS provides the only way to IMMEDIATELY shorten the time from the clinical event (eg arrhythmia) to the telemedicine response. - With existing Bluetooth function (see below), the external communication and display system system can be housed in a MedPhone IV. GPS positioning and automatic initiation of the rescue system with defined communication with the control center (eg ECG forwarding, physiological parameters such as blood pressure, etc.). The communication is triggered via the fPWS and the external communication system establishes the connections. Data protection regulations are complied with. The complex fPWS is characterized in that it is programmable via known telemetric procedures and thereby adaptable to the individual patient and the current disease situation. The patient warning system of all variants contains a test section that serves both the function control and the learning process of the patient. To communicate with the implant, the patient has an external communication and display system. As a rule, the external communication system is technically similar to a SmartPhone and can be connected to the implant by means of Bluetooth or another conventional telemetric query. Part of the fPWS can be the reminder algorithm. It is fixed by linking an integrated clock module with a programmable date / time complex, the next control appointment and the patient is remembered at this time. The reminder is repeated daily until the patient has fulfilled the corresponding control obligation. This reminder logistics can not be verified by the patient. The extension of the remembrance logistics is characterized in that with its help the patient is reminded of the regularly necessary medication. For home telemonitoring systems, the MedPhone (MiPhone) should be used. A master device is characterized in that, in the optimal therapy with one or more electronic devices (eg CardioMems, event recorders, implanted infusion pumps, implanted blood glucose meters) these are networked together. By means of Bluetooth or other developed communication standards for data transmission between devices, the devices are connected via short distance via wireless technology (WPAN). In this connection, connectionless and connection-dependent transfers from point to point and ad hoc or piconets are possible. Using an induction loop, an intravascular device without its own energy source can be controlled continuously or at least discontinuously, and the measured values in the master device can be evaluated according to the installed app. The integrated optional patient warning system uses a correspondingly known warning pulse pattern to signal the patient, who will then be informed and protected using the external communication system. • All devices can be queried individually using a uniform communication structure. • The implanted master device can communicate via a uniform platform. • The master device can also control external electronic systems (eg external infusion systems) directly. • The external communication system is portable, directly controllable with appropriate spatial proximity (1 m with Bluetooth 5 III) connected continuously or discontinuously. The emergency circuit of each device can "wake up" the master device. The master device can have an accumulator. Charging takes place by means of wireless (contactless) energy transfer. In this case, electrical energy is transmitted without contact from one object to another in order to operate or supply that. The essential feature is that the electrical energy required for operation is not supplied along electrical lines and by means of electrical contacts, but by non-wired electromagnetic fields. A discharge state is indicated to the patient through the integrated optional patient alert system. The master device can be equipped with new apps or updates during the check in a heart center and can control and monitor according to the respective state of the art (today at least up to 8 devices). Already in the master device, highly effective and qualitative information processing can take place, which then mediate the corresponding urgency of a need for action by processing all information of all devices by means of the fPWS to the patient. The external communication system can, if placed within range of the master device, activate the communication channels II-IV and set the rescue chain in critical condition. The patient is asked for feedback. If he can not comply with this, the "dead man's circuit" comes into force. The medical (medical) SmartPhone (MedPhone) is characterized in that in addition to a normal telephone unit, which should have no further own Internet connection for security reasons, via an additional communication system for a secure remote connection, eg. As the Internet, has electronic devices. By means of Bluetooth or other developed communication standards for data transmission between devices, the devices are connected via short distance via wireless technology (WPAN). In this connection, connectionless and connection-dependent transfers from point to point and ad hoc or piconets are possible. Via a secure encrypted channel via the Internet, the MedPhone is connected via the remote connection unit with the heart center and via this, if necessary, with the rescue coordination center if an induced rescue chain is required - in this case also short-term use of the GPS system for determination of the emergency location. The MedPhone communicates with all implanted devices and external network systems (life vest, infusion pumps, etc.). In the presence of a master device, it may only be necessary to communicate with it in energy-saving mode. The analytical functions and the diagnostic relevance are constantly updated by means of apps. With available high-security communication with the heart center, these apps can also be updated via telemonitoring. If the MedPhone also uses the Bluetooth hands-free system in the car, it may be necessary to provide a separate Bluetooth unit for the sake of security. The facultative patient warning system (fPWS) telemetry inductor for cardiac pacemakers / AICDs with extended diagnostic function is characterized in that it evaluates arrhythmic events according to pre-programmable key data (matrix individually adaptable to the clinical picture of the patient) and by appropriate means Communication Pulse Pattern recommends meaningful behaviors to the patient including medication intake, stress reduction, or immediate hospitalization, etc. This requires more memory. One of these storage complexes should be sized to store a short period before, the event itself, and a short period thereafter, and preserved until the next laboratory inspection. With suitable algorithms also an ECG shape analysis (comparable to the end distance analysis in the known long-term ECG) becomes possible. This means diagnostics in coronary heart disease as well as permanently improved diagnostics in transplant rejection after heart transplantation. For this, however, the intracardiac ECG is preferably subjected to a comparable procedure. Further processing of the improved diagnostics is possible in the external communication system by appropriate computer programs or apps. The medical evaluation can be done by home monitoring. The Optional Patent Warning System (fPWS) telemetry inductor for implantable long-term ECG (Event Recorder) units is characterized by functioning in a manner analogous to that of claim 6. Possibly. For example, the stimulus pattern at communication level I may correspond to the heart rhythm (each R-wave triggers a warning impulse). By creating an thereby induced connection to the external communication and display system, the communication can be initiated as described. Known Bluetooth algorithms are not at risk from hacker attacks because of their short range. With the current claims, this vulnerability, which is caused by the telemetry in a cardiac center through an Internet connection, be ruled out that evaluated according to the communication level II, the automatic ECG analysis in the external communication system and the patient instructions, including the immediate need for medical reassignment be communicated can. Further clarification is added to the effect that all event recorders already have 2 surface electrodes for recording the ECG. If the event recorder additionally has a warning pulse generator with the lowest possible energy consumption, it can generate already noticeable electrical warning pulses which correspond to the fPWS and initiate the communication cascade (until home telemonitoring). Due to their size, these event recorders are able to integrate the technical extension and master the energetic problem. In principle, the integrative optional patient warning system can also be integrated into the much smaller event recorder. Here then particularly small pulse generators must be used for the generation of the warning pulse. The additional energy requirement is extremely low. From the communication level III, the MedPhone is used. The optional patient warning system (fPWS) telemetry inductor in respiratory devices is characterized by monitoring the respiratory rhythm by means of suitable sensors (respiratory impedance, oxygen partial pressure, respiratory vibration impulse) and by exceeding the respiratory rate (eg frequent hysterical hyperventilation tetany with significant risk moment) or underruns ( eg sleep apnea, narcolepsy) the patient was intensively (possibly awakens). Hypoxia, hypocapnia, hypercapnia, pH shifts and consequences of unconsciousness can be avoided. The facultative patient warning system (fPWS) telemetry inductor in conjunction with pressure sensors in one or more circulatory sections is characterized in that it outputs differentiated warning signals in case of exceeding or falling below predefined key data of the temporal pressure curve and thus z. B. helps to end a physical stress situation as well as controls drug therapy. The regulation of the blood pressure in the large and small circulatory system can thus be adapted to the highest individual. From the communication level II, even highly differentiated therapies can be mediated acutely to the patient. Side effects of antihypertensive therapy are significantly reduced. New therapeutic strategies are opened, which may allow the partial reversal of drug therapies with very long-acting drugs. The external communication and display system allows the highly differentiated and situation-appropriate therapy with the aim of optimal blood pressure adjustment in the corresponding cardiovascular section while largely maintaining the physiological blood pressure setting. On the basis of claims 1 to 14 different complex systems can be derived. In the case of the most complex interpretation, cardiological, tensoric and respiratory problems can be solved by means of a system. Heart failure is detected promptly and optimally treated. New generation implantable infusion pump systems (IIPS) are characterized by having an fPWS. Furthermore, they have an additional event recorder system. If necessary, the second electrode next to the electrode in the pump housing can even be placed close to the heart as a combined catheter ring electrode. Cardiovascular drug therapies can be controlled via this system combination. When combined with a pacemaker or AICD, the cavities of the electrodes may be used as catheters after appropriate modification with irrigation systems and occlusion systems. Implantable infusion pump systems (IIPS) not connected to the pacemaker or ICD usually have intravenous, possibly also intramuscular, subcutaneous or intracavitary application catheters. New is the equipment of the IIPS with the fPWS. So far, no implantable infusion systems are used in cardiology. Now they are proposed as an integral component in the therapeutic arsenal of cardiology for critical indications (second heart rate, infarction, recurrent pulmonary embolism, pulmonary hypertension, critical heart failure, if necessary, in transplant preparations, uncontrollable arterial hypertension). Known implantable pump systems can benefit from the fPWS while being combined with known cardiology devices. Also metabolic diseases (eg) can be treated with the use of suitable implantable sensors in the highest physiological adaptation. Elements of IIPS are characterized in that they can be used individually, in combinations as well as in the building block principle and can be exchanged individually or in multiple in the case of multiple parts. Electronic components are usually equipped with the patient warning system. The external communication system is adapted via app (corresponding matrices are programmed). Sensors used in IIPS for measurement recording are characterized in that they are used in frequency-adaptive systems in the singular and are practically tested. For the realization of the diagnostic functions they are conceptualized individually or in multiple combinations. From communication level II there is the direct adaptation via App. From communication level III the MedPhone is used. Implantable venous, intramuscular, subcutaneous pump systems may also be used independently of cardiac devices (with intracardiac electrodes) and may facilitate drug therapy by means of suitable short venous catheters. These pumps can also be equipped with an integrated optional patient warning system. They can be connected to the master device via information technology and are then controlled by it. Unimplanted venous, (intramuscular) or subcutaneous pump / infusion systems can be controlled by the above-mentioned information technologies from the master device. New Defiweste with additional drug therapy and / or fPWS The wearable defibrillator vest can be connected directly to the portable telemetry system and an external pump system. Patients can also benefit from the GPS-based system in the event of an emergency. If a master device is present, the wearable defibrillator vest can be connected to the implanted devices and, if necessary, controlled. The MedPhone can be used. The optional patient warning system is basically suitable for all electronic implants. For urological patients with bladder innervation disorders and especially for patients with a neobladder after cystectomy, the complex patient warning system is a system of a device with strain sensors, pressure sensors, warning electrode and possibly urethral valve dar. The patient is informed with a bladder filling of more than 300 ml, with critical bladder filling warned. So far frequent (especially nocturnal) self-catheter can be optimized. Further, the bladder can be used with a catheter-based plastic implant and implanted volume pumping systems that aid bladder emptying. Orthopedic patients notice prosthetic loosening only when clinical symptoms appear. Various implanted electronic communication systems are implanted in conjunction with endoprostheses to detect loosening of the prosthetic components. These systems can alert the patient immediately to incipient relaxations / instabilities via the patient warning system and prompt the patient to promptly resume their presentation to the specialist. With appropriate existing ones. The patient warning system can also warn measuring systems of overloading of the prosthesis and, if necessary, provide the patient with instructions for avoidance via the communication and display system. Today, neurological patients are supplied with implanted intracranial pressure sensors and implanted infusion systems (pain therapy, intracranial pressure therapy). Brain pressure sensors and associated devices can optimize direct diagnostics and therapy by means of patient warning systems and communication structures with 4 communication levels. In emergencies, the rescue chain can be initiated immediately.