Device for sleep-apnea treatment
18 claims: 14 independent, 4 dependent
- 1Medizinisches Gerät (101) zur Implantation in einen Körper, mit einer Stimulationseinheit (118), welche ausgebildet ist, in Abhängigkeit von einem Apnoe-Therapiesignal einen elektrischen Stimulationsimpuls zu erzeugen, einer Schlaf-Detektoreinheit (112) mit mindestens einem Signaleingang welche ausgebildet ist, in Abhängigkeit von mindestens einem Eingangssignal einen Schlafzustand des Körpers zu erkennen und ein Schlaf-Signal zu erzeugen, welches einem Schlaf-Erkennungsergebnis entspricht, einer Apnoe-Detektoreinheit (114), welche ausgebildet ist, in Abhängigkeit von mindestens einem von dem Körper verursachten Körpersignal eine Schlaf-Apnoe zu erkennen und ein Apnoe-Signal zu erzeugen, welches einem Apnoe-Erkennungsergebnis entspricht, einer Therapieeinheit (116), welche mit der Stimulationseinheit (118), der Schlaf-Detektoreinheit (112) und mit der Apnoe-Detektoreinheit (114) mindestens mittelbar verbunden und ausgebildet ist, in Abhängigkeit von dem Apnoe-Signal und dem Schlaf-Signal mindestens ein Apnoe-Therapiesignal zu erzeugen, welches Therapieinformation zur Prävention und/oder Behandlung von Schlaf-Apnoe repräsentiert und dieses an die Stimulationseinheit (118) zu senden, dadurch gekennzeichnet, dass das medizinische Gerät einen Positionssensor (10,30,50,115) aufweist, welcher mit dem Signaleingang der Schlaf-Detektoreinheit (112) wirkverbunden und ausgebildet ist, in Abhängigkeit von seiner Neigung um wenigstens eine durch den Positionssensor (10,30,50,115) verlaufende Raumachse im Verhältnis zur Horizontalen wenigstens eine seiner elektrischen Eigenschaften zu ändern wobei die Therapieeinheit (116) ausgebildet ist, das Apnoe-Therapiesignal in Form einer Zunahme der Stimulationsrate mit einer ansteigenden Flanke über eine Periode von 10 Minuten so zu erzeugen, dass sich eine Gesamtzunahme der Stimulationsrate von 10 Schlägen pro Minute durch einen Anstieg der Stimulationsrate von einem Schlag pro Minute über 10 Minuten ergibt.
- 2Medizinisches Gerät nach Anspruch 1, dadurch gekennzeichnet, dass die Apnoe-Detektoreinheit (114) einen Apnoe-Gewichtungs-Diskriminator (212) mit mindestens einem Eingang für ein Körpersignal enthält wobei der Apnoe-Gewichtungs-Diskriminator (212) ausgebildet ist, gemäß einer vorbestimmten Apnoe-Gewichtungsfunktion das Körpersignal zu bewerten und ein eine Schlaf-Apnoe repräsentierendes Apnoe-Signal zu erzeugen.
- 3Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Schlaf-Detektoreinheit (112) einen Schlaf-Gewichtungs-Diskriminator (210) mit mindestens einem Eingang für ein Eingangssignal enthält, wobei der Schlaf-Gewichtungs-Diskriminator (210) ausgebildet ist, gemäß einer vorbestimmten Schlaf-Gewichtungsfunktion das Eingangssignal zu bewerten und ein einen Schlafzustand repräsentierendes Schlaf-Signal zu erzeugen.
- 4Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät einen Sensor zur Erfassung der intrakardialen Impedanz (216) aufweist, welcher mit dem Schlafdetektor verbunden und ausgebildet ist, anhand der intrakardialen Impedanz ein Ruhen des Körpers zu erkennen und ein den Ruhezustand des Körpers repräsentierendes Ruhezustands-Signal zu erzeugen.
- 5Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät eine Atemminutenvolumen-Erfassungseinheit (220) aufweist, welcher mit der Apnoe-Detektoreinheit (114) verbunden ist.
- 6Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät einen Sauerstoffsensor (222) aufweist, welcher mit der Apnoe-Detektoreinheit (114) verbunden und ausgebildet ist, eine Sauerstoffkonzentration im Blut zu bestimmen und ein die Blut- Sauerstoffkonzentration repräsentierendes Blut-Sauerstoffsignal zu erzeugen.
- 7Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät eine Herzschlagvolumen-Erfassungseinheit aufweist, welche mit der Schlaf-Detektoreinheit und/oder der Therapieeinheit verbunden und ausgebildet ist, ein Herzschlagvolumen zu bestimmen und ein das Herzschlagvolumen repräsentierendes Herzschlagvolumensignal zu erzeugen.
- 8Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät eine Tageszeit-Uhr (122) aufweist, welche mit der Schlaf-Detektoreinheit (112) verbunden und ausgebildet ist, ein Tageszeit-Signal zu erzeugen und dieses an die Schlaf-Detektoreinheit (112) zu senden.
- 9Medizinisches Gerät nach Anspruch 8, dadurch gekennzeichnet, dass das Medizinische Gerät einen Welt-Zeitzonen-Detektor (126) mit einem Satellitenempfänger aufweist, wobei der Welt-Zeitzonen-Detektor (126) mit der Tageszeit-Uhr (122) wirkverbunden und ausgebildet ist, Satellitensignale (129) zu empfangen, durch Auswertung der Satellitensignale (129) eine Position auf der Erde zu ermitteln und anhand der Position auf der Erde ein Welt-Zeitzonensignal zu erzeugen und dieses an die Tageszeit-Uhr (122) zu senden, welche ausgebildet ist, die Tageszeit entsprechend zu korrigieren.
- 10Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Medizinische Gerät einen triaxialen Beschleunigungsaufnehmer (113) aufweist, bei welchem die Richtungsachsen der erfassbaren Beschleunigungen ein Orthogonalsystem bilden und welcher mit der Schlaf-Detektoreinheit (112) wirkverbunden und ausgebildet ist, ein eine Beschleunigung repräsentierendes Beschleunigungs-Zeitsignal zu erzeugen.
- 11Medizinisches Gerät nach Anspruch 10, dadurch gekennzeichnet, dass das Medizinische Gerät einen Beschleunigungsmuster-Klassifizierer (114) aufweist, welcher ausgangsseitig mit der Schlaf-Detektoreinheit (112) und eingangsseitig mit dem Beschleunigungsaufnehmer (113) verbunden und ausgebildet ist, ein Beschleunigungs-Zeitsignal auszuwerten und vorbestimmte Beschleunigungsmuster in dem Beschleunigungs-Zeitsignal zu erkennen, diese zu klassifizieren und ein ein Beschleunigungsmuster repräsentierendes Beschleunigungsmuster-Signal zu erzeugen und dieses auszugeben.
- 12Medizinisches Gerät nach Anspruch 11, dadurch gekennzeichnet, dass der Beschleunigungsmuster-Klassifizierer (114) eingangsseitig einen FFT-Analysator aufweist, welcher ausgebildet ist, aus einem Beschleunigungs-Zeitsignal kontinuierlich Beschleunigungsmuster-Leistungsspektren zu erzeugen und diese an den Beschleunigungsmuster-Klassifizierer zu senden.
- 13Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Positionssensor (10,30,50,115) wenigstens zwei Schaltkontakte und mindestens eine elektrisch leitfähige Kugel umfasst, welche derart angeordnet ist, in Abhängigkeit von der Neigung des Positionssensors die Schaltkontakte elektrisch leitend zu verbinden oder zu trennen.
- 14Medizinisches Gerät nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, dass der Positionssensor (115) eine Hallsonde ist, welche ausgebildet ist, in Abhängigkeit von ihrer Ausrichtung im Erdmagnetfeld eine Hallspannung zu erzeugen.
- 15Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Stimulationseinheit ein Herzschrittmacher oder Defibrillator ist.
- 16Medizinisches Gerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Stimulationseinheit eine Atemmuskulatur-Stimulationseinheit ist, welche ausgebildet ist, einen elektrischen Stimulationsimpuls zur Stimulation des Zwerchfells oder der Thoraxmuskulatur zu erzeugen.
- 17Home-Monitoring-System mit einem implantierbaren medizinischen Gerät (101) nach einem der Ansprüche 1 bis 17 und einem mobilen Patienten-Applikationsgerät (137), wobei das mobile Patienten-Applikationsgerät (137) über eine Telemetrieeinheit (128) schnurlos mit dem implantierbaren medizinischen Gerät (101) verbunden ist.
- 18Patientenüberwachungssystem mit einem implantierbaren medizinischen Gerät (101) nach einem der Ansprüche 1 bis 17 und einem mobilen Patienten-Applikationsgerät (137), welches über eine Telemetrieeinheit (128) schnurlos mit dem implantierbaren medizinischen Gerät (101) verbindbar ist und einem Zentralen-Service-Center (138), wobei das Zentrale-Service-Center (138) zur Datenübertragung patientenbezogener Daten über eine Netzwerkverbindungsleitung (180) oder eine schnurlose Verbindungsleitung mit dem mobilen Patienten-Applikationsgerät (137) wenigstens zeitweise verbunden ist.
Independent claims18
98 paragraphs, as filed
p0001The invention relates to a medical device for implantation in a body, having a stimulation unit, which is adapted to generate in response to an apnea treatment signal an electrical stimulation pulse, a sleep detector unit having at least one signal input, which is adapted in dependence on at least to recognize an input signal a sleeping state of the body and to generate a sleep signal, which corresponds to a sleep recognition result. The medical device for implantation in a body, referred to below as implantable medical device also includes an apnea detector unit, which is designed to recognize sleep apnea as a function of at least one caused by the body body signal, and an apnea signal to produce, which corresponds to an apnea recognition result. The implantable medical device also includes a treatment unit which is at least indirectly connected to the sleep detector unit and to the apnea detector unit and is implemented to generate a function of the apnea signal and the sleep signal, at least one apnea treatment signal therapy information selectively on the prevention of sleep apnea, for the treatment of sleep apnea, or both represents and send it to the stimulation unit.
p0002Such a system has a special advantage for patients in whom a pacemaker implantation is already displayed. Such a system may also be beneficial for patients who suffer from sleep apnea, without there are other indications for implantation. A significant proportion of the population is affected by respiratory disorders. Such breathing disorder, for example, sleep apnea, a temporary cessation of breathing. The most common phenomenon is the obstructive sleep apnea, of which approximately 6% of the male population are affected at an age over 40 years. In obstructive sleep apnea the upper airways collapse and close, whereby the passage vo n breathing air is prevented. This can occur repeatedly during sleep.
p0003Another aspect of the sleep apnea is central sleep apnea syndrome. In this syndrome the airways remain open, but the central control of the respiratory muscles is adversely affected. While this form of apnea is observed at about 10 to 20% of all of sleep apnea sufferers, it has a large overweight in patients with heart failure. Such patients also have the Cheyne-Stokes respiration, which is a periodic removal and waxing the breathing amplitude, also referred to as depth of breathing. The patient in this case periods of lower respiratory depth, which means central apnea, and periods of increased depth of breathing, also known as hyperventilation. Of these respiratory malfunctions, the heart rate, hemodynamics and blood pressure are affected. For example, the apnea periods can stimulate an increase in sympathetic activity, which can affect the heart adversely. The interaction of sleep apnea with heart failure significantly reduces the quality of life and the patient's performance. Therefore, it is essential that in such cases, monitor the sleep apnea, is identified and treated.
p0004Generally require respiratory malfunctions, such as sleep apnea, a continuous monitoring of a patient and if possible a continuous treatment, rather than only during a stay in a medical facility. To monitor this malfunction and treat the patient should be monitored and treated during sleep at home. Devices of the prior art include the use of externally-mounted respiratory sensors, and respiratory masks. In these devices, the sleep apnea is treated by artificial breathing apparatus, which control breathing and the force an inhalation and exhalation. In fact, these devices represent a significant limitation of the quality of life. Since this therapy depends on the cooperation of the patient, the intrusive nature of this device could prevent its everyday use.
p0005In the article "<nplcit id="ncit0001" npl-type="s"><text>. Benefit of atrial pacing in sleep apnea syndrome "of Garrigue, et al, published in the magazine New England Journal of Medicine (vol 346, No. 6, pp 404 -... 412, February 7, 2002</text></nplcit>) Is a study described, which has been applied to a patient group, which already implanted pacemaker to treat a sinus bradycardia possessed by atrial overdrive. Based on some reports of these patients that they had less difficulty breathing after implantation, 15 patients were selected for investigation in a series of nights. During the test, the implanted pacemaker was programmed or not to energize the heart either by continuous pulses. During the excitement phase atrial overdrive of about 15 beats per minute was set over the average heart rate at night the patient. In 13 of 15 patients, the observed apnea-hypopnea index fell by more than 50% during the nights with continuous bicameral excitation by the pacemaker. The apnea-hypopnea index is a measurement of the frequency of bush-hammered or slow respiratory rate at night. The reason for the observed improvement is not cited, but by pacer apparatus could be improved both obstructive and central apnea.
p0006The end of 2003, the St. Jew Medical Center a new study to evaluate a pacemaker therapy for sleep apnea published. As with the Garrigue study, here was the plan to evaluate the impact of an increased pacing rate during an idle phase, but the study is obviously limited to pacemaker patients diagnosed with sleep apnea. Obviously, the St. Jew study will use a secret algorithm for download in the pacemaker patient.
p0007Out <patcit id="pcit0001" dnum="US20030153953A"><text>US 2003/0153953</text></patcit> is an implantable heart stimulator is known, which is able to detect a sleep apnea and then to raise the base pacing rate.
p0008Out <patcit id="pcit0002" dnum="US4846195A"><text>US 4,846,195</text></patcit> is a pacemaker is known having a position and motion sensor for adapting the stimulation rate to the physiologic needs of the patient.
p0009In the pacing therapy, the use of the stroke volume as an input parameter to adjust or adapt the pacing rate is known. A tidal volume value is calculated from the frequency and the relative amplitude of a breathing-signal, which can be determined from a measurement of an intrathoracic impedance. Obviously the St. Jew algorithm uses a time of day clock to turn on and off the pacing therapy. Of course, an algorithm, prepare based on the reading of a daily time clock problems if the patient happens when traveling time zones in a row to enter the time change (as well as such a time change for the recovery of daylight time) and if the patient has sleep rhythm disorders.
p0010It is therefore an object of the present invention to provide a device for treating sleep apnea by an overdriven excitation of the atrium of a heart by means of an implanted pacemaker.
p0011This object is achieved by the features specified in claim. 1
p0012In a preferred embodiment, the apnea detector unit contains an apnea weighting discriminator having at least one input for a body signal contains. The apnea weighting discriminator is formed, according to a predetermined apnea weighting function to evaluate the body signal and generate a sleep apnea representing apnea signal.
p0013The sleep detector unit preferably contains a sleep weighting discriminator having at least one input for an input signal, the sleep weighting discriminator is formed, according to a predetermined sleep weighting function to evaluate the input signal and to generate an a sleep state representing sleep signal ,
p0014More preferably, the sleep weighting discriminator and / or the apnea weighting discriminator includes a fuzzy logic.
p0015The medical device preferably includes a time of day clock, which is connected to the sleep detector unit and hence, is available as an input parameter for deciding whether a sleep status or not.
p0016In a particular embodiment, the medical device has a world time zone detector with a satellite receiver, the world time zone detector with the time of day clock operatively connected and configured to receive satellite signals, a position on the earth by evaluating the satellite signals identify and generate based on the position on the earth, a world time zone signal and send it to the time of day clock, which is designed to correct the time of day accordingly.
p0017For example, the satellite tracking system to determine the position in the form of coordinates. Based on the coordinates, the satellite tracking system take an assignment in a world time zone in which the carrier of the medical device is currently located. The satellite tracking system is preferably connected to the time of day clock and can thus cause a correction of the time of day when the support of the medical device is in a different time zone. This can advantageously be ensured in a simple manner that the support of the medical device is not treated when traveling through different time zones around the world at the wrong time, as long as a therapy in response to a time of day is to take place. Preferably, the satellite tracking system includes the method known from the prior art Global Positioning System (GPS).
p0018The stimulation unit is designed to generate an electrical stimulation pulse, which is suitable in order to stimulate a tissue such that a capture threshold is exceeded for a muscle contraction.
p0019In one embodiment, the stimulation unit on respiratory muscle stimulation unit, which is designed to generate an electrical stimulation pulse for stimulating the diaphragm or the thorax musculature. In this embodiment, the implantable medical device has an output for connection of respiratory muscle stimulation electrodes.
p0020In a preferred embodiment, the implantable medical device comprises a cardiac pacemaker or defibrillator. In this embodiment, the treatment unit can be connected to the pacemaker or defibrillator and send containing at these stimulation therapy information signals. The pacemaker is thus an executive agent for therapy of sleep apnea.
p0021An exemplary embodiment of an activity sensor is an accelerometer or a Closed Loop Stimulation (CLS).
p0022An idle or load condition of the body is discharged in a closed-loop stimulation of an intracardiac impedance signal. This technique is described in the article "<nplcit id="ncit0002" npl-type="s"><text>Closed Loop Stimulation - A new pacemaker -.. Approach to frequency adaptation by a Kontraktilitätssensors "in the Journal Kardiol 1999, Vol 6, Iss.1, p pp 21-25</text></nplcit> explained.
p0023The implantable medical device includes in a preferred embodiment, a sensor for detecting the intracardial impedance, which is connected to the sleep detector and is adapted on the basis of intracardial impedance to detect a resting of the body and generate an idle status of the body representing idle state signal. The sensor for detecting the intracardial impedance can also be formed as Kontraktilitätssensor.
p0024The medical device may allowed to use the intracardiac impedance sensor of the CLS advantageous for devices with CLS to shunt an intracardiac impedance signal from the CLS.
p0025An accelerometer can be advantageously designed as a triaxial accelerometer, wherein the directional axes of the detectable accelerations form an orthogonal system and which is operatively connected and configured with the sleep detector is to generate an acceleration representing acceleration time signal.
p0026As a result, a body motion are evaluated such that the implantable medical device may differ in an evaluation of the time signals of the accelerometer based preferably occurring acceleration directions between normal daily movements and rolling movements, for example during a sleep.
p0027The implantable medical device has in this embodiment preferably an acceleration pattern classifier on, which is formed, using predetermined acceleration pattern, which may be stored in each case for all three axes of movement to distinguish body movements during sleep of which during a daily routine.
p0028In this embodiment, the acceleration pattern classifier is the output side to the sleep detector unit and the input side connected to the accelerometer and implemented to analyze an acceleration time signal and recognize predetermined acceleration patterns in the acceleration time signal, classify them, and an acceleration pattern representing acceleration pattern signal to generate and output it on the output side.
p0029As an alternative to an accelerometer, the medical device may also include a speed sensor.
p0030The measures provided for classifying acceleration pattern may be time signals or power spectra in the case of power spectra, the acceleration pattern classifier input side, an FFT analyzer (FFT: fast Fourier transform) on which is formed from an acceleration time signal continuously acceleration pattern performance spectra generate and send it to the acceleration pattern classifier. The storage of power spectra for classification comparison is compared to storing time signals advantageously particularly efficient in memory usage.
p0031In a preferred embodiment, the implantable medical device has a time of day clock, which is connected to the sleep detector unit.
p0032More preferably, the implantable medical device in addition to the daily time clock at least one activity sensor to increase the accuracy of detecting whether a sleep has begun or completed and whether a stimulation therapy should be started or ended.
p0033To activate the pacing algorithm of the present invention, the means for switching the stimulation protocol to "On", the algorithm requires that the time of day clock must show that the time is within a predetermined time interval to sleep and that at least one activity sensor, the absence indicates a movement of the patient.
p0034A ersichtliches concern is the patient's ability to fall asleep when you switch the stimulation protocol, which can occur if the protocol is enabled by the above conditions. The stimulation protocol means an increase in heart rate in this case. For this purpose, an increase in the pacing rate is provided with a rising edge over a period of 10 minutes, according to the invention. The total increase in the pacing rate is 10 beats per minute and is achieved by an increase in the stimulation rate of one beat per minute over 10 minutes.
p0035The sleeping algorithm of the present invention can set the stimulation protocol to Off "when the predetermined time interval is reached and a movement of at least one activity sensor is detected. As a preferred sleep algorithm, the pacing rate can increase in accordance with a ramp function when turning on the stimulation protocol, the preferred sleep algorithm also lower the stimulation rate in a similar absolute rate. for example, if the pacing rate increases when switching to a beat per minute, the decrease should be even a beat per minute when you exit.
p0036If more than one activity sensor is present, a variety of algorithms are provided for detecting whether a "NO-MOTION" status is reached. Otherwise, a positive recognition of the "NO MOVEMENT status" one of the aforementioned sensing means is sufficient. In a further preferred third algorithm may the various sensing means in each case a weighting factor and the prevalence of "NO" movement weighted signals are assigned, which can be sufficient.
p0037In each of the sleeping algorithms of the present invention is the possibility of the increase / decrease in pacing rate and the predetermined sleep time period to program extracorporeally, considered essential.
p0038In some embodiments of the present invention, the algorithm reads also the patient's breathing pattern via the signal shape of the minute ventilation or the closed-loop stimulation (CLS) waveform to detect sleep apnea. In this embodiment, a stimulation only be connected via the detection of sleep apnea to "On".
p0039In some other embodiments, a simple position detector is formed, in which case the status of the position detector can be used in a part of the sleeping algorithm to detect whether a sleep has begun.
p0040An implantable monitoring system of the present invention overcome all limits of previously known systems. The system can monitor respiration and respiratory send information with other diagnostic data to a remote monitoring center. In this manner, a physician will be able to monitor the patient without continuously observe the patient. The breathing monitor can be integrated into a therapeutic device that is an implantable pacemaker or defibrillator (ICD, ICD: cardioverter / defibrillator Implantable) is, or it can operate as a stand-alone diagnostic device.
p0041Respiration is measured by the intrathoracic impedance.
p0042A monitor may be combined with various therapeutic agents. For example, a sleep apnea therapy in a resynchronization therapy using a heart pacemaker or defibrillator (ICD) may be incorporated for patients with heart failure.
p0043The implantable respiration monitor comprising means for measuring the impedance, a means for a long-distance telemetry (LDT), means for storing data, means for measuring a cardiac action signal, and a central control unit. Many of the monitors can also include an electro-therapeutic module, such as a pacemaker, a defibrillator (ICD) or both.
p0044In one embodiment, the means for measuring the impedance can have a below-reizschwelligen electrical current between two electrodes which are selected from the available lines inject. The current can of biphasic pulses consist of constant amplitude. For measuring a voltage a pair of electrodes may be used.
p0045The measured voltage is proportional to the impedance of the tissue in the measurement region in this case. In some embodiments, the current and voltage electrodes are the same electrodes. Before an analog-digital conversion, the voltage is amplified and filtered. A band pass filter is preferred for this purpose. The filter may be selected so that the respiration signal passes, but higher and lower frequency components are attenuated.
p0046The medical device preferably comprises an oxygen sensor, which is connected to the apnea detector unit and is implemented to determine an oxygen concentration in blood and to generate a blood oxygen concentration representative of blood-oxygen signal. The oxygen concentration in blood thus serves as an input variable for the apnea detector unit.
p0047In one embodiment, the implantable medical device has a respiratory minute volume detection unit, which is connected to the apnea detector unit. Preferably, the respiratory minute volume detection unit includes means for determining the thoracic impedance.
p0048In order to detect a respiration, the thoracic impedance must be determined. The impedance of the thorax changes during the respiration cycle because the electrical conductivity of the lungs varies according to a different air content. The thoracic impedance will also change accordingly geometric differences.
p0049A preferred embodiment for a detector of the thoracic impedance is a tripolar measurement configuration uses the housing or the socket of the implant as a common electrode for current and voltage. a current is injected between the can and a ring electrode of the right ventricular lead or the left ventricular lead. The resulting voltage is measured between the electrode tip and the can so that in a sense the impedance of the thoracic tissue is measured. Also a line for stimulation of the left ventricle, either a coronary sinus lead or epicardial leads may be used with the corresponding tripolar configuration. In this case, the left part of the lungs in the measurement region is contained. In some embodiments, a defibrillator lead (ICD-line), including the excitation coil, come for impedance measurements are used.
p0050In one embodiment, the medical device comprises a cardiac stroke volume detecting unit, which is connected to the sleep detector unit and / or the therapy unit and configured to determine a heartbeat volume and to generate a stroke volume representing heartbeat volume signal. The stroke volume can serve as input to the sleep detection or as an actual state amount for the therapy unit for controlling the stroke volume.
p0051In a preferred embodiment, the position sensor comprises at least two switch contacts and at least one electrically conductive ball which is arranged to connect, depending on the inclination of the position sensor, the switching contacts in an electrically conductive or disconnect. The electrically conductive balls are preferably metal balls.
p0052Alternatively, a position sensor instead of metal balls contain coal balls. Preferably containing carbon pellets compressed activated carbon dust, more preferably in addition a binder. The advantage of using the activated carbon spheres is that the number of participating in the short-circuit coal balls from the position angle of the position sensor relative to the horizontal depends. This results in dependence of the angular position of a different electrical resistance between the contacts of the position sensor. Alternatively, a ball may also material with a predetermined ohmic resistance is used to achieve the same effect as that of the carbon pellets. Preferred balls plastic balls or glass beads, which are vapor-coated with a thin metal layer. The conductivity of the metal layer can be adjusted by the layer thickness and the textural properties.
p0053The position sensor may be a Hall probe which is designed to generate a Hall voltage as a function of its orientation in the Earth's magnetic field.
p0054As an alternative to this embodiment, the position sensor may also be a well-known from the prior art, mercury switch, a position sensor according to the invention.
p0055The remote monitoring system which can be used with the present invention, is known from the prior art. The implant can send diagnostic data through the long-distance telemetry means (LDTM) to a device external to the patient, typically a device which is positioned laterally of a patient bed. From there, the data is sent to a central service center, where a doctor can access the data.
p0056The respiration signal of a patient is ready many parameters which can be extracted for diagnostic purposes. These data are stored in the implant and can be sent in a compressed form. The stored values can be retrieved by an external device by the physician. The external device, the received data on a display in the form of numbers, trends, histograms or similar displays. For a remote monitoring data in long-term averages, numbers, etc. compressed, which are transmitted, for example, every 24 hours to a service center or a normal basis. In addition, the device can be equipped such that it allows the patient to initiate a transmission. The intended device according to the invention may also be equipped with threshold switches based on various possible alarm criteria.
p0057Various diagnostic parameters can be extracted from the respiratory signal and stored as apnea statistics information. This may be the following parameters, without being limited thereto:
p0058Respiratory rate; Respiratory minute volume (relative to a reference value); Count of breathing pauses (apnea or events); Duration of breathing pauses; Counter of hyperventilation phases; Duration of hyperventilation phases; Classification of respiratory phases (normal, obstructive apnea, central apnea, hyperventilation, Cheyne-Stokes respiration). Monitoring of pulmonary edema is also conceivable.
p0059From the implant detected heart action signals can also be correlated with the respiratory signals. This is especially important for monitoring of central sleep apnea and heart failure patients who suffer from sleep apnea. Some of the cardiac signal data may include heart rate, event counters, etc., but are not limited to these. Changes in heart rate may prove to be particularly useful in conjunction with breathing information, since it is known that the obstructive sleep apnea is often accompanied by alternating phases of bradycardia and tachycardia. The diagnostic functionality of the implant may be combined with therapeutic options, such as an atrial overstimulation. The respiration sensor can trigger a pacing therapy when an apnea is detected.
p0060The device can also be used as therapy monitor for use. A long-term success or short-term success of pacemaker therapy can be monitored. Additionally can be used in accordance with drug therapy of respiratory dysfunction in connection with the implant.
p0061The invention will now be explained in more detail by means of figures:<ul><li><figref idrefs="f0001">figure 1</figref> shows - schematically - an embodiment of the implantable medical device, the interaction of its characteristics and its effect with devices in its vicinity.</li><li><figref idrefs="f0002">figure 2</figref> shows -schematisch - elements of the sleep detector unit and the apnea detector unit together with sensors in a waveform chart.</li></ul>
p0062The <figref idrefs="f0003">figures 3</figref>. <figref idrefs="f0004">4 and 5</figref> show embodiments for position sensors.
p0063<figref idrefs="f0001">figure 1</figref> shows an implantable medical device 101 with a central control unit 110, a sleep detector unit 112, an apnea detector unit 114, a pacing unit 118 and an impedance sensor 120. The implantable medical device 101 also includes a stimulation electrode output 131 which via a connecting line 164 is connected to the pacemaker unit 118th Shown is also a heart 132, an electrode line 130 which opens into the right atrium of the heart 132 and at the distal end portion of a ring electrode 134 and tip electrode 136 is mounted.
p0064The impedance sensor 120 is designed to let flow 134 for detecting an intrathoracic impedance a current between the housing of the implantable medical device 101 and the ring electrode and detecting a resulting voltage between the housing and the tip electrode 136th For this purpose, the impedance sensor 120 is connected via a housing conduit 169 to the housing of the implantable medical device 101 and connected via a connecting line 168 to the pacemaker unit 118, wherein the pacing unit is formed 118 while a stimulation break an electrical connection between the Impendanzsensor 120 and the ring electrode 134 and tip electrode produce 136 when the electrode line 130 is connected to the stimulation output 131 of the implantable medical device one hundred and first
p0065The apnea detector unit 114 is connected via a connecting line 170 to the impedance sensor 120 and adapted to evaluate the time course of a 120 detected by the impedance sensor intrathoracic impedance signal and to generate a respiration signal to evaluate this respiration signal according to its time history and a corresponding - for example, breath pause information containing - generate analysis results.
p0066As output, the apnea detector unit 114 generate an apnea detector signal representing the evaluation result, for example in the form of an apnea status information and an apnea therapy information and send it to the central control unit 110th Given the apnea detector unit 114 has its output connected via a connecting line 172 to the central control unit 110th The apnea detector unit 114 is also connected to send apnea statistical information via a connecting line 171 to the central control unit 110 and configured to generate a statistical evaluation result of the respiratory signal and the evaluation result representative apnea statistics signal via the connecting line 171 to the central control unit 110 to send.
p0067The apnea statistics signal may contain the following parameters:<tables id="tabl0001" num="0001"><table frame="none"><tgroup cols="2" colsep="0" rowsep="0"><colspec colnum="1" colname="col1" colwidth="57mm" /><colspec colnum="2" colname="col2" colwidth="109mm" /><tbody><row><entry>Respiration rate:</entry><entry>Trend, histogram, minimum, maximum, mean, breathing amplitude;</entry></row><row><entry>Respiratory minute ventilation:</entry><entry>Trend, histogram, minimum, maximum, average;</entry></row><row><entry>Apnea events:</entry><entry>Absolute number, number per night;</entry></row><row><entry>Duration of apnea events:</entry><entry>Trend, histogram, minimum, maximum, mean, shot during a night;</entry></row><row><entry>Number of hyperventilation phases:</entry><entry>Absolute number, number per night;</entry></row><row><entry>Classification of breathing phases:</entry><entry>normal breathing, obstructive apnea, central apnea, hyperventilation, Cheyne-Stokes respiration.</entry></row></tbody></tgroup></table></tables>
p0068The central control unit 110 is designed for example as a programmable microprocessor and can perform an implemented in this control program.
p0069The sleep detector unit 112 is adapted to receive in response to the input side via the connecting lines 151, 158, 160, 162, and 176 signals to evaluate these to produce a the evaluation result corresponding sleep signal and the output side via the connection line 152 to the central control unit to send 110th
p0070The sleep detector unit 112 whose input is connected via a heart-rate connection line 158 to the pacemaker unit 118 which can output side generates a detected heart rate appropriate heart rate signal and send this via the connecting line 158 to the sleep detector unit 112th
p0071The sleep detector unit 112 is connected on the input side via a connecting line 160 with a position sensor 115, which is designed to change its electrical resistance as a function of its angular position in relation to the horizontal. The sleep detector unit 112 is configured to sense the angular position of the position sensor 115 and to apply an electric voltage to the position sensor 115 via the connecting line 160 and to detect a resulting electricity.
p0072The sleep detector unit 112 is connected on the input side via a connection line 162 with an acceleration pattern classifier 114, which is connected to a triaxial acceleration sensor 113th The acceleration pattern classifier 114 is implemented to analyze a time signal of the triaxial acceleration sensor 113 and acceleration between different patterns which patterns of movement of a wearer of the implantable medical device 101 correspond to distinguish. For this purpose the acceleration pattern classifier 114 is connected and formed by a connecting line with an acceleration pattern storage unit 117, read out from this stored there acceleration pattern and comparing it with the acceleration pattern detected through the triaxial acceleration sensor 113, and to classify the detected acceleration pattern. The acceleration pattern classifier 114 may generate an acceleration pattern representing an acceleration pattern signal and to send this via the connection line 162 to the sleep detector unit 112th
p0073The acceleration pattern classifier 114 may comprise an FFT analyzer, which is designed to continuously generate a sequence of acceleration pattern performance spectra from the time signal of the triaxial acceleration sensor 113th The classification is then based on the acceleration pattern power spectra and in the acceleration pattern storage unit 117 are predetermined stored acceleration pattern power spectra.
p0074Alternative to this embodiment may also be effected on the basis of time signals the acceleration pattern classification, which, however, in comparison with the acceleration pattern performance spectra requires significantly more space.
p0075The sleep detector unit is connected via a connecting line 176 with a time of day clock 122, which is configured to generate one of a time corresponding to the time of day signal and to send this on the output side via the connection line 176 to the sleep detector unit. The time of day clock is connected via a connecting line 174 with a world time zone detector having a satellite receiver, such as a GPS receiver.
p0076The satellite receiver is configured, a transmitted from satellite 128 satellite signal receiving 129 to evaluate this and to calculate therefrom a geo-location, for example in the form of coordinates. The world time zone detector is configured to assign, for example, a look-up table, a determined geo-location of a world time zone and to create a world time zone signal and send this on the output side via the connecting line 174 to the time of day clock 122nd
p0077The central control unit 110 is connected via a connecting line 154 with the therapy unit 116 and, depending on requirement of a therapy, controlled by the control program in response to the apnea detector signal and the received via the connection line 152 sleep signal received via the connection line 172 a, a generate information containing therapy treatment signal and send this signal therapy via the connecting line 154 to the therapy unit 116th The treatment unit 116 is connected and formed, depending from the central control unit via the connecting line 154 requested therapy due to the treatment signal over a connecting line 156 to the pacemaker unit 118 to produce a heart rate request signal and this through the connection line 156 to the pacemaker unit to send 118, which then may adjust the pacing rate accordingly.
p0078The central control unit 110 is connected to the storage of, for example, via the connecting line 171 received apnea statistics information via a connecting line 178 with a memory unit 124th
p0079The central control unit 110 is connected via a bidirectional data bus 150 to a telemetry unit for wireless data transmission (long-distance telemetry system) 128th For example, the telemetry unit 128 is a Bluetooth telemetry unit.
p0080The central control unit 110 may thus apnea statistics information and of the pacemaker unit 118 detected cardiac signal information 182 send via the telemetry unit 128 wirelessly to a mobile patient application device 137th About the telemetry unit 128, a control program received and sent via the bidirectional data bus 150 to the central control unit 110 and stored there, the central control unit 110 and the telemetry unit 128 may be formed in accordance therewith.
p0081The mobile patient application device 137 can be installed for example near a patient's bed. The mobile patient application device 137 is connected to the data transmission of patient-related data over a network connection line 180 with a central service center 138th From there, a physician can call up and monitor, for example, patient information. Alternatively, the network connection line 180, the mobile patient application device 137 and the central service center 138 include a wireless interface, such as a Bluetooth interface, and transmitted wirelessly patient-related data on this Bluetooth interface.
p0082<figref idrefs="f0002">figure 2</figref> shows - schematically illustrated - the cooperation of a sleep weighting discriminator 210, which may be included in the sleep detector unit 112, with an apnea weighting discriminator 212, which may be contained in an apnea detector unit 114th
p0083The sleep weighting discriminator 210 has signal inputs, to which via connecting lines 270, 272, 274, 276 and 278 are respectively connected to sensors in the broad sense signal generator. The sleep weighting discriminator 210 is configured according to a predetermined weighting function to evaluate the signals at the signal inputs signals and generate an evaluation result representing Sleep signal and send this on the output side via a connecting line 256 to a therapy discriminator 214th
p0084The apnea weighting discriminator 212 also has signal inputs which are connected via connecting lines 260, 262, 264 and 268 with signal generators. The apnea weighting discriminator 212 evaluates the signals present at the signal inputs signals according to a predetermined weighting function and generates an apnea signal and sends the output side via an attached connecting line 254 to the therapy discriminator 214th
p0085The sleep weighting discriminator 210 is connected via a connecting line 270 with a heart rate sensor 234, which may be included in the pacemaker unit 118th can be sent out from the heart rate sensor 234 and received by the sleep weighting discriminator 210 via the connection line 270 thus is an actual-state heart rate. The sleep weighting discriminator 210 is connected via a connecting line 272 on the input side with an impedance sensor 216th The impedance sensor 216 is connected via a connecting line 241 to a ring electrode 240, and via a connection line 239 having a tip electrode 238, which are arranged 242 an electrode line in the region of the distal end.
p0086The impedance sensor 216 is connected and also formed by a connecting line 237 with a housing 236 of the implantable medical device 101 to leave on the output side a current to flow via the connection lines 237 and 241 and to detect the input side via the connection line 239 and the connection line 237, a resulting voltage and to form an impedance of the detected voltage and current. The impedance sensor 216 is adapted to calculate from this detected impedance an intracardiac impedance and a cardiac impedance, the intra output signal representing via the connection line 272 to send to the sleep weighting discriminator 210th
p0087One already in <figref idrefs="f0001">figure 1</figref> Illustrated acceleration pattern classifier 114 is connected and configured, the output side to send a signal representative of the classification result of the connecting line 274 to the sleep weighting discriminator 210 via a connecting line 252 with a triaxial accelerometer 113th
p0088The sleep weighting discriminator 210 is the input side via a connecting line 276 with a - as in <figref idrefs="f0001">figure 1</figref> already explained - position sensor 115 connected.
p0089A time of day clock 122 is connected on the input side with a world time zone detector 126 and is designed to transmit a correspondingly a world-pied corrected time signal on the output side via a connecting line 278 to the sleep weighting discriminator 210th
p0090The apnea weighting discriminator is connected via a connecting line 260 on the input side with a blood-oxygen sensor 222, connected via a connecting line 262 on the input side with a respiratory minute volume detection unit 220 and connected via a connecting line 264 on the input side with an impedance evaluation unit 218th
p0091The impedance evaluation unit 218 is connected and formed by a connecting line 250 to the impedance sensor 216 to evaluate a breathability characterizing impedance-time signal of the impedance sensor 216 and to generate the number and duration characterizing respiratory pauses respiratory signal and the output side via the connection line 264 to the apnea weighting discriminator to send 212th The apnea weighting discriminator 212 is connected via a connecting line 268 input side to the heart-rate sensor 234 and thus can receive a signal generated by this heart rate as an input variable.
p0092The apnea weighting discriminator is configured to generate on the basis of a predetermined apnea weighting function is an apnea signal and to send the output side via the connection line 254 to the therapy discriminator 214th
p0093The therapy discriminator assessed on a therapy-weighting function on the input side available apnea signal and the input side available sleep signal and assigns the result of evaluation a therapeutic result to that of the Therapiediskriminator output side via the connecting line 258 to a discriminator output 213 can be output. At the discriminator output 213 in can<figref idrefs="f0001">figure 1</figref> Therapy unit shown may be connected via the connecting line 154th
p0094As in <figref idrefs="f0003">figure 3</figref> shown schematically, the position sensor 10 of the present invention may be a hexagonal shaped object with a plurality of metal balls 12 which are contained in an internal cavity fourteenth If the patient is located, the position sensor 10 is positioned such that the metal balls 12 an electrical connection between the lower side walls 16 and 18 to produce, so that the electrical connection is detected as a short circuit. If the patient is touching the balls 12, only one of the lower side walls 16 or 18, which is detected as an open circuit. In an illustrated embodiment shown contact surfaces A and B are mounted on a circuit board of the 20th Although the connection of the lower side walls 16 and 18 are shown as wires to the contact areas, there are other known ways to make this connection. The side walls may also be provided with a contact surface which is designed to below the base surface of the sensor, so that a simple, connection-free soldering of wire of the sensor is made possible in a Lötwellenbad. It is expected that the position sensor is embodied in the size of a 0806 or a 0603-capacitor capacitor. A primary advantage of the position sensor is that it does not consume energy.
p0095<figref idrefs="f0004">figure 4</figref> shows another embodiment of a position sensor 30. The position sensor 30 includes electrically conductive balls 38 which are located in a cavity 40th The cavity 40 is formed by electrically conductive side walls 42 and 44 and by a cover surface 46th Unlike the in<figref idrefs="f0003">figure 3</figref> Position sensor illustrated are 42 and 44 run on a portion of the assembly provided on a board bottom surface, the contact surfaces. Also shown are the contact surfaces of conductor tracks 32 and 33, on each of which one of the contact surfaces 42 and 44 are soldered with solder 36th
p0096<figref idrefs="f0004">figure 5</figref> shows an embodiment of a cylindrically-shaped position sensor 50 with a cavity 51 which is enclosed by a cylindrical wall 56th The cylindrical wall 56 has two longitudinally axially spaced apart electrically conductive ring contacts 54 and 52. The cavity 51 is partly filled with electrically conductive balls 58th the cylindrical position sensor 50 Located longitudinally and axially in a horizontal orientation, as the electrically conductive ring contacts 52 and 54 are connected by the electrically conductive balls 58 are electrically connected together. Depending on the level of the cavity 51 with electrically conductive balls 58 at which the ring contacts 52 and 54 can be an angle to the horizontal set yet - or not - are electrically interconnected.
p0097If such a cylindrical position sensor 50 part of an implantable medical device and the longitudinal axis of the cylindrical position sensor 50 is aligned parallel to the body longitudinal axis of a wearer of the implantable medical device, the electrically conductive ring contacts 52 and 54 are always electrically connected to each other when the carrier of the implantable medical device is in a horizontal position, regardless of whether the carrier assumes a supine, prone or side position.
p0098In a not shown embodiment of a position sensor, an electrically conductive ball situated in a cavity which is enclosed by a hollow sphere wall. there are a plurality of electrically conductive contacts on the inside of the hollow sphere wall. The ball diameter of the electrically conductive ball in the cavity and the spacing of the electrically conductive contacts on the inside of the position sensor wall are dimensioned such that in any position of the position sensor at least two of the electrically conductive contacts are connected to each other via the electrically conductive ball when on the electrically conductive sphere, for example, a gravitational force acts.
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| Document | Relation | Office |
|---|---|---|
| EP0515319A | Cites | European Patent Office (EPO) |
| US4846195A | Cites | United States of America |
| US4869251A | Cites | United States of America |
| US4926863A | Cites | United States of America |
| US5562711A | Cites | United States of America |
| US6083248A | Cites | United States of America |
| US2002193939A1 | Cites | United States of America |
| US2003130589A1 | Cites | United States of America |
| US2003153953A1 | Cites | United States of America |
| US6574507B1 | Cites | United States of America |
8 members in 4 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 499631P | United States of America | – | |
| 49963103 | United States of America | P | |
| 49963103 | United States of America | P | |
| 10347294 | Germany | A | |
| 10347294 | Germany | A | |
| 10347294 | Germany | – | |
| 10347294 | – | – | – |
| 499631P | – | – | – |
| DE2003147294 | – | – | – |
| US20030499631P | – | – | – |
Members8
| Document | Office | Kind | |
|---|---|---|---|
| EP1512430A1 | European Patent Office (EPO) | A1 | |
| DE10347294A1 | Germany | A1 | |
| US2005101833A1 | United States of America | A1 | |
| EP1512430B1This record | European Patent Office (EPO) | B1 | |
| AT385830T | Austria | T | |
| ATE385830T1 | Austria | T1 | |
| DE502004006169D1 | Germany | D1 | |
| US7473227B2 | United States of America | B2 |
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| Title (correction)DEVICE FOR SLEEP-APNEA TREATMENTRTI1 | RTI1 | EP | |
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Numbers
- Publication
- 1512430
- Publication, DOCDB
- 1512430
- Publication, EPODOC
- EP1512430
- Application
- 4090229
- Application, DOCDB
- 04090229
- Application, EPODOC
- EP20040090229
Titles3
- German
- Vorrichtung zur Behandlung von Schlaf-Apnoe
- English
- Device for sleep-apnea treatment
- French
- Dispositif de traitement des apnées du sommeil
Classification
- CPC, 16
- A61B5/0538
- A61B5/0031
- A61B5/02028
- A61B5/0205
- A61B5/0245
- A61B5/029
- A61B5/07
- A61B5/1112
- A61B5/1118
- A61B5/1123
- A61B5/1126
- A61B5/4818
- A61N1/36514
- A61B5/686
- A61B2562/0219
- A61B5/363
- IPC, 8
- A61N1 365
- A61B5 11
- A61B5 00
- A61B5 0205
- A61B5 0245
- A61B5 029
- A61B5 07
- A61B5 363
Designated states1
- Contracting states, 1
- Türkiye
