Device for sleep-apnea treatment
Abstract
Die Erfindung betrifft ein Medizinisches Gerät zur Implantation in einen Körper, mit einer Stimulationseinheit, einer Schlaf-Detektoreinheit mit mindestens einem Signaleingang welche ausgebildet ist, einen Schlafzustand des Körpers zu erkennen und ein Schlaf-Signal zu erzeugen, einer Apnoe-Detektoreinheit, welche ausgebildet ist, in Abhängigkeit von mindestens einem von dem Körper verursachten Körpersignal eine Schlaf-Apnoe zu erkennen und ein Apnoe-Signal zu erzeugen, einer Therapieeinheit, welche mit der Stimulationseinheit, der Schlaf-Detektoreinheit und mit der Apnoe-Detektoreinheit mindestens mittelbar verbunden und ausgebildet ist, in Abhängigkeit von 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 zu senden. Das medizinische Gerät weist einen Positionssensor auf, welcher mit dem Signaleingang der Schlaf-Detektoreinheit wirkverbunden und ausgebildet ist, in Abhängigkeit von seiner Neigung um wenigstens eine durch den Positionssensor verlaufende Raumachse im Verhältnis zur Horizontalen wenigstens eine seiner elektrischen Eigenschaften zu ändern.

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Projected expiry passed 10 June 2024, 2.3 years ago.
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20 claims: 13 independent, 7 dependent
- 1The medical device (101) for implantation in a body, with a stimulation unit (118) which is formed in dependence from an apnea therapy signal an electrical stimulation pulse to create, a sleep detector unit (112) with at least one signal input which is designed, in dependence of at least one input signal to recognize and a sleep state of the body generate Sleep signal a sofa-recognition result corresponds, an apnea detector unit (114) which is formed in dependence of at least one caused by the body body signal to recognize a sleep apnea and to generate an apnea signal which an apnea recognition result corresponds, a therapy unit (116) connected to the stimulation unit (118) Sleep detector unit (112) and the apnea detector unit (114) is at least indirectly connected and formed in dependence on the apnea signal and the sleep signal at least one apnea therapy signal to produce which treatment information for prevention represents and / or treatment of sleep apnea and this at the stimulation unit (118) to send, characterized in that the medical device having a position sensor (10,30,50,115), which is connected to the signal input of the sleep detector unit (112) operatively connected is formed and, depending on its inclination about at least one by the position sensor (10,30,50,115) extending Space axis relative to the horizontal at least one of its electric to change properties.
- 3Medical device according to one of the preceding claims, thereby in that the sleep detector unit (112) a Sleep weighting discriminator (210) having at least one input includes, for an input signal, the sleep weighting discriminator (210) is formed according to a predetermined sleep weighting function to evaluate the input signal and a to produce sleep state representing sleep signal.
- 4Medical device according to one of the preceding claims, thereby in that the medical device includes a sensor for comprises detecting the intracardial impedance (216) connected to the connected and configured sleep detector, based on the intracardiac to detect impedance of suspending the body and Hibernation to produce the body representing Hibernation signal.
- 5Medical device according to one of the preceding claims, thereby in that The medical device a respiratory minute volume detection unit (220), which is connected to the apnea detector unit (114) is connected.
- 6Medical device according to one of the preceding claims, thereby in that the medical device an oxygen sensor (222) which is connected to the apnea detector unit (114) and is formed, an oxygen concentration in the blood determine and the blood oxygen concentration representative to produce blood-oxygen signal.
- 7Medical device according to one of the preceding claims, thereby in that the medical device is a cardiac stroke volume detecting unit has issued according to the sleep detector unit and / or the therapy unit and is implemented to a stroke volume to determine and a stroke volume representing heartbeat volume signal to produce.
- 8Medical device according to one of the preceding claims, thereby in that the medical device is a time of day clock (122) which is connected to the sleep detector unit (112) and is adapted to generate a time of day signal and to the Sleep detector unit (112) to send.
- 10Medical device according to one of the preceding claims, thereby in that the medical device a triaxial accelerometer (113), in which the directional axes form the detectable accelerations an orthogonal and wherein the sleep detector unit (112) operatively connected and is formed, an acceleration r epräsentierendes acceleration time signal to create.
- 13Medical device according to one of the preceding claims, thereby in that the position sensor (10,30,50,115) at least two switch contacts and at least one electrically conductive ball includes, which is arranged in such a way in dependence on the inclination the position sensor to connect the switching contacts electrically conductive or to separate.
- 15Medical device according to one of the preceding claims, thereby in that the therapy unit (116) is formed, the apnea therapy signal in the form of an increase in the pacing rate with a rising edge over a period of 10 to 30 minutes to create.
- 16Medical device according to one of the preceding claims, thereby in that the therapy unit (116) is formed, an overall increase in the pacing rate of 10 beats per minute by an increase in the stimulation rate of one beat per minute to produce over 10 minutes.
- 17Medical device according to one of the preceding claims, thereby in that the stimulation unit, a cardiac pacemaker or defibrillator.
- 18Medical device according to one of the preceding claims, thereby in that the stimulation unit, a respiratory muscle stimulation unit is formed, an electric Stimulation pulse to the stimulation of the diaphragm or the thorax muscles to create.
Independent claims13
95 paragraphs, as filed
The invention relates to a medical device for implantation in a body, with a stimulation unit, which is adapted as a function of to produce an apnea therapy signal an electrical stimulation pulse, a sleep detector unit having at least one signal input which is formed, in dependence of at least one input signal to recognize a sleep status of the body and to generate a sleep signal, corresponding to a sleep-recognition result. The medical Device for implantation in a body, hereinafter also implantable called medical devices, also has an apnea detector unit, which is designed, in dependence of at least one of the body caused personal signal to recognize a sleep apnea and an apnea signal to produce, which corresponds to an apnea recognition result. The implantable medical device also includes a treatment unit, which with the sleep detector unit and the apnea detector unit at least is indirectly connected and configured, depending on the Apnea signal and the sleep signal, at least one apnea treatment signal to produce, which treatment information either for the prevention of sleep apnea, represents for the treatment of sleep apnea, or both, and this be sent to the stimulation unit.
Such a system has particular advantage for patients in which already a pacemaker implantation is indicated. Such a system may also be advantageous for patients who suffer from sleep apnea, without that there are other indications for implantation. A significant Population is affected by respiratory disorders. Such breathing disorder For example, sleep apnea, a temporary suspension breathing. The most common phenomenon is the obstructive sleep apnea, of which approximately 6% of the male population in the age affects more than 40 years. collapse In obstructive sleep apnea the upper airways and close, whereby the passage of respiratory air is prevented. This can occur repeatedly during sleep.
Another aspect of the sleep apnea is central sleep apnea syndrome. In this syndrome the airways remain open, but the centralized control of the respiratory muscles is adversely affected. While these Form of apnea in about 10 to 20% of all of sleep apnea sufferers is observed, it has a large overweight in patients with heart failure. Such patients have a the Cheyne-Stokes respiration, which periodic removal and waxing the respiratory amplitude, as depth of breathing designated. The patient in this case periods of lower respiratory depth, that is, central apnea, and periods of increased depth of breathing, also called hyperventilation. Of these respiratory malfunctions are the Heart rate, hemodynamics and blood pressure influenced. For example can Apnea periods stimulate an increase in sympathetic activity, which can affect the heart adversely. The interaction of of sleep apnea with heart failure significantly reduces the quality of life and the performance of the patient. Therefore, it is essential that in such Cases, is monitored to identify and treat sleep apnea.
Generally require respiratory malfunctions, such as sleep apnea, continuous monitoring of a patient and if possible continuous treatment, rather than only during a stay in a medical facility. To monitor this malfunction and treated, the patient must be monitored at home during sleep and be treated. Devices of the prior art include the use of externally mounted sensors and breathing masks a. at These devices will be treated by artificial breathing apparatus, the sleep apnea, which control breathing and the force an inhalation and exhalation. In fact, these devices represent a significant limitation quality of life. Since this therapy by the patient cooperation dependent, the intrusive nature of this device could its everyday use prevent.
In the article "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) is a study described, which on a group of patients has been applied, which already implanted pacemaker for the treatment of sinus bradycardia by atrial overdrive possessed. Based on some of these patients report that they after implantation had less difficulty breathing, 15 patients were selected for examination in a series of nights. During the Tests of the implanted pacemaker was programmed, the heart either or not to be energized by continuous pulses. During the excitement phase was an atrial overdrive of about 15 beats per minute set over the average heart rate at night the patient. In 13 of 15 patients, the observed apnea-hypopnea index decreased by more than 50% during the nights with continuous bicameral excitement by the pacemaker. The apnea-hypopnea index is a Measuring 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 both obstructive and the central apnea are improved.
The end of 2003, the St. Jew Medical Center a new study Evaluation of a pacemaker therapy for Sleep Apnea published. As in Garrigue study, here the plan was the influence of an increased evaluate pacing rate during an idle phase, but the study is obviously on pacemaker patients diagnosed with sleep apnea limited. Obviously, the St. Jew trial wants a secret algorithm use for download in the pacemaker patient.
In the pacing therapy is the use of the stroke volume as input parameters to adjust or adapt the pacing rate known. A tidal volume value is calculated from the frequency and the relative Amplitude of a respiratory signal is calculated, which is one of a measurement intrathoracic impedance may be determined. Obviously used the St. Jew algorithm a time of day clock to the pacing therapy on and off. Of course, an algorithm based on the readout of a time of day clock cause problems if the patient happens when traveling time zones in a row to enter the time change (such also such a time change for the recovery of daylight time) and when the Patient Sleep arrhythmia has.
It is therefore the object of the present invention, an apparatus for the treatment of sleep apnea by an overdriven excitation of the atrium a heart to indicate by means of an implanted pacemaker.
This object is solved by the above-mentioned medical device, having a position sensor, which the sleep detector operatively connected to and adapted to a function of its inclination at least one passing through the position sensor space axis relative to the horizontal at least one of its electrical properties to change.
In 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, the body signal to Rate and sleep apnea representing apnea signal to produce.
The sleep detector unit preferably includes a sleep weighting discriminator at least one input for an input signal, wherein the sleep weighting discriminator is formed, according to a predetermined Sleep weighting function to evaluate the input signal and to produce an a sleep state representing sleep signal.
More preferably, the sleep weighting discriminator and / or the Apnea weighting discriminator a fuzzy logic.
The medical device preferably includes a time of day clock, which with the Sleep detector unit is connected and thus as an input parameter for deciding whether a sleep status or not there is available stands.
In a particular embodiment, the medical device comprises a World time zone detector with a satellite receiver, the world time zones Detector operatively connected to the time of day clock and is formed, receiving satellite signals by evaluating the satellite signals a to determine location on the earth, and a reference to the position on the earth to produce world time zone signal and send it to the time of day clock, which is designed to correct the time of day accordingly.
For example, the satellite tracking system, the position in the form of Coordinates represent. Based on the coordinates, the satellite tracking system take an assignment in a world time zone in which the Support of the medical device is currently located. The satellite tracking system is preferably connected to the time of day clock and can thus a Correction of the time of day cause, if the wearer of the medical device is located in a different time zone. Thereby advantageously easily Way to ensure that the support of the medical device not treated when traveling through different time zones around the world at the wrong time is, if a therapy depending on a time of day done should. Preferably, the satellite tracking system includes the prior Technique well-known Global Positioning System (GPS).
The stimulation unit is designed, an electrical stimulation pulse to produce, which is adapted to stimulate a tissue in such a way that a capture threshold is exceeded for a muscle contraction.
In one embodiment, the stimulation unit respiratory muscle stimulation unit on which is formed an electrical stimulation pulse to produce the stimulation of the diaphragm or the thorax muscles. In this embodiment, the implantable medical comprises Device having an output for connection of respiratory muscle stimulation electrodes on.
In a preferred embodiment, the implantable medical comprises Device on a pacemaker or defibrillator. In this embodiment, the therapy unit with the pacemaker or defibrillator be connected and containing at these stimulation therapy information signals send. The pacemaker is thus executing means providing therapy of sleep apnea.
An exemplary embodiment of an activity sensor is an accelerometer or a closed-loop stimulation (CLS).
An idle or load condition of the body is at a closed-loop stimulation derived from an intracardiac impedance signal. This technique is described in the article "Closed Loop Stimulation - A new pacemaker - Concept for frequency adaptation by a Kontraktilitätssensors "in Journal Kardiol, 1999, Vol. 6, Iss.1, S. pp. 21-25 explains.
The implantable medical device, 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 to detect impedance of suspending the body and Hibernation to produce the body representing Hibernation signal. Of the Sensor for detecting the intracardial impedance can also function as Kontraktilitätssensor be formed.
The medical device can for devices with CLS the intracardiac impedance sensor CLS joint use advantageously to an intracardiac impedance signal divert from the CLS.
An accelerometer can advantageously as triaxial accelerometer be formed, in which the directional axes of the collectable Accelerations form an orthogonal system and which with sleep detector operatively connected and configured to accelerate a to produce representing acceleration time signal.
This can be evaluated in such a body movement that implantable medical device in an evaluation of the time signals of the Accelerometer based preferably occurring acceleration directions between normal daily movements and example can distinguish rolling movements during sleep.
The implantable medical device preferably has in this embodiment an acceleration pattern classifier on which is formed, based predetermined acceleration pattern, respectively for all three axes of motion can be saved, while body movements a sleep of which during a daily routine to distinguish.
In this embodiment, the acceleration pattern classifier output side with the sleep detector unit and the input side with the accelerometers and is implemented to an acceleration time signal evaluate and predetermined acceleration patterns in the to detect acceleration time signal, classify them, an a Acceleration pattern representing acceleration pattern signal to generate and output it on the output side.
As an alternative to an accelerometer, the medical device also include a speed sensor.
The measures provided for classifying acceleration patterns can time signals be 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 designed, from a Acceleration time signal continuously acceleration pattern power spectra to generate and submit them to the acceleration pattern classifier to send. The storage of power spectra for classification comparison is compared to the storage of timing signals particularly advantageous economical in memory usage.
In a preferred embodiment, the implantable medical comprises Device on a time of day clock, which is connected to the sleep detector unit is.
More preferably, the implantable medical device in addition to the Daytime watch at least one activity sensor to ensure accuracy to increase the detection of whether a sofa has started or completed and whether should be a stimulation therapy starts or stops.
To activate the stimulation 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 predetermined in a Time interval is to sleep, and that at least one activity sensor indicates the absence of a movement of the patient.
A ersichtliches concern is the ability of the patient when turning asleep the stimulation protocol, which may occur if the Protocol is enabled by the above conditions. The stimulation protocol in this case means an increase in the heart rate. In this Case, many embodiments of the present invention, an increase the stimulation rate having a rising flank over a period derogate from 10 to 30 minutes. In a preferred embodiment, , an overall increase in the pacing rate of 10 beats per minute about by an increase in the stimulation rate of one beat per minute be formed for 10 minutes.
The sleeping algorithm of the present invention, the stimulation protocol set to "Off" when the predetermined time interval is reached and a motion is recognized by at least one activity sensor. As well as a preferred sleep algorithm, the pacing rate according to a ramp function may increase when turning the stimulation protocol, can the preferred sleep algorithm, the stimulation rate similar on a absolute rate lower. For example, if the stimulation rate when switching increases by one beat per minute, the loss should also Bpm amount on exit.
If more than one activity sensor is present, a plurality of Algorithms provided for detecting whether a "NO MOVEMENT status" is reached. Otherwise, a positive recognition of the "NO MOVEMENT status" one of the aforementioned sensing means sufficient. In a further preferred third algorithm can the various sensing means each a weighting factor and the prevalence of "NO MOVEMENT" weighted be assigned to signals, which may be sufficient.
In each of the sleep algorithms of the present invention is the ability to the increase / decrease in pacing rate and the predetermined programmed sleep period extracorporeally, considered essential.
In some embodiments of the present invention, the algorithm reads also the patient's breathing pattern via the signal shape of the minute ventilation or Closed Loop Stimulation (CLS) waveform to a sleep apnea to recognize. In this embodiment, a stimulation only the detection of sleep apnea are set to "On".
In some further embodiments, a simple position detector formed, in which case the status of the position detector in a Part of the sleeping algorithm can be used to detect whether a started sleeping.
overwhelmed An implantable monitoring system of the present invention all limits of previously known systems. The system can monitor the breathing and respiration information with other diagnostic data to a Send remote monitoring center. In this example, a doctor in the Able to monitor the patient without the patient continuously observe. The breathing monitor can be integrated into a therapeutic device be that an implantable pacemaker or a defibrillator (ICD, ICD: Implantable cardioverter / defibrillator), or it can be used as stand-alone diagnostic device work.
Respiration is measured by the intrathoracic impedance.
A monitor can be combined with various therapeutic agents be. For example, a sleep apnea therapy in a resynchronization therapy using a heart pacemaker or defibrillator (ICD) be involved for patients with heart failure.
The implantable respiration monitor comprising means for measuring the impedance, a means for long-distance telemetry (LDT), means for storing of data, means for measuring a cardiac action signal, and a central Control unit. Many of the monitors can be an electro-therapeutic include module such as a pacemaker, a defibrillator (ICD) or both.
In one embodiment, the means for measuring the impedance of a under-reizschwelligen electrical current between two electrodes which are selected from the available lines, inject. Of the Current can of biphasic pulses consist of constant amplitude. to Measuring a voltage, a pair of electrodes are used.
The measured voltage is proportional in this case to the impedance of Tissue in the measurement region. In some embodiments, the CURRENT and Voltage electrodes the same electrodes. Before an analog-to-digital conversion the voltage is amplified and filtered. A bandpass filter this preference. The filter may be selected so that the respiration signal happened, but attenuated, higher and lower frequency components are.
The medical device preferably comprises an oxygen sensor, which is connected to the apnea detector unit and is implemented, an oxygen concentration to determine in the blood and the blood-oxygen concentration generate representing blood oxygen signal. The oxygen concentration thus serves in blood as an input to the apnea detector unit.
In one embodiment, the implantable medical device is a Respiratory minute volume detection unit, which with the apnea detector unit connected is. Preferably, the respiratory minute volume detection unit Means for determining the thoracic impedance.
In 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 according to a different Air content changed. The thoracic impedance will also change accordingly geometric differences.
A preferred embodiment of a detector of the thoracic impedance A tripolar measurement configuration uses the housing or the socket of the implant as a common electrode for current and voltage. Between the Box and a ring electrode of the right ventricular lead or the left ventricular lead a current is injected. The resulting voltage is measured between the electrode tip and the can, so to a certain extent the impedance of the thoracic tissue is measured. Also one Line to the stimulation of the left ventricle, either a coronary sinus lead or epicardial leads can with the corresponding tripolar Configuration may be used. In this case, the left part of the lung is in the measurement region included. In some embodiments, a defibrillator management (ICD-line), including the excitation coil, for impedance measurements are used.
In one embodiment, the medical device comprises a cardiac stroke volume detecting unit on which the sleep detector unit and / or connected and formed the therapy unit, a stroke volume to determine and a stroke volume representing heartbeat volume signal to create. The stroke volume can thus as an input variable to sleep detection or as an actual state amount for the therapy unit used to control the stroke volume.
In a preferred embodiment, the position sensor comprises at least two switch contacts and at least one electrically conductive ball which is arranged in such a way in dependence on the inclination of the position sensor to connect the switching contacts electrically conductive or disconnect. The electrically conductive balls are preferably metal balls.
Alternatively, a position sensor instead of metal balls and coal balls contain. Preferably, the carbon spheres contain compressed activated carbon dust, more preferably in addition a binder. The advantage of using of activated carbon spheres is that the number of short circuit involved coal balls from the position angle of the position sensor over the horizontal depends. This results in dependence of the angular position a different electrical resistance between the contacts of the position sensor. Alternatively, to achieve the same effect as the coal balls, a ball material with a predetermined ohmic Resistance are used. Preferred balls are Plastic beads or glass beads, which vapor-coated with a thin metal layer are. The conductivity of the metal layer over the layer thickness and the textural properties set.
The position sensor may be a Hall probe, which is adapted in Depending on their orientation in the Earth's magnetic field, a Hall voltage to produce.
Alternative to this embodiment of the position sensor, a position sensor within the meaning of the invention, a well-known from the prior art be mercury switches.
The remote monitoring system, which for the present invention may use, is known from the prior art. The implant can diagnostic data on the long-distance telemetry means (LDTM) Send to a device outside of the patient, typically a device, which is positioned laterally of a patient bed. From there, the Sending data to a central service center, where a doctor on the data can access.
The respiration signal of a patient provides many parameters ready for what diagnostic purposes can be extracted. These data are in the stored implant and can be sent in a compressed form. The stored values can also with an external device from Doctors are queried. The external device can access the received data a display in the form of numbers, trends, histograms or comparable Ads. For a remote monitoring the data in long-term averages, Numbers etc. compressed, which for example, every 24 to a service center or a normal basis are sent. additionally the device can be equipped such that it is allowed the patient, to cause a broadcast. The apparatus of the invention would can also be equipped with threshold switches based on different possible alarm criteria.
Various diagnostic parameters can be extracted from the respiration signal are stored and as apnea statistical information. The skill be the following parameters, without being limited thereto:
Respiratory 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.
From the implant detected heart action signals can also use the respiratory signals are correlated. This is especially important for monitoring central sleep apnea and for patients with heart failure, which at Sleep apnea suffer. Some of the cardiac signal data can the heart rate, event counter included etc., but are not limited to these. changes of the heart rate may prove to be particularly useful in connection with Respiratory data, since it is known that the obstructive sleep apnea often of is accompanied alternating phases of bradycardia and tachycardia. The diagnostic functionality of the implant can with therapeutic options be combined, for example, an atrial overstimulation. The respiratory sensor can trigger a pacing therapy, if an apnea was detected.
The device can also be used as therapy monitor for use. A long-term success or short-term success of pacemaker therapy can be monitored will. In addition, a drug therapy according to a Respiratory malfunctioning come into contact with the implant used.
The invention will now be explained in more detail by means of figures:<sl><li>1 shows - schematically - an embodiment of implantable medical Device, the interaction of its characteristics and its effect with devices in its vicinity.</li><li>2 shows -schematisch - elements of the sleep detector unit and the apnea detector unit together with sensors in a waveform chart.</li><li>Figures 3, 4 and 5 show embodiments for position sensors.</li></sl>
Figure 1 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 in the right atrium of the heart 132 opens and at the distal end portion of a ring electrode 134 and a tip electrode 136 is mounted.
The impedance sensor 120 is adapted for detecting an intrathoracic A current impedance between the housing of the implantable medical to allow 134 to flow device 101 and the ring electrode, and a resulting resulting voltage between the housing and the tip electrode 136 capture. For this, the impedance sensor 120 is a casing pipe 169 to the housing of the implantable medical device 101 and, via a connecting line 168 to the pacemaker unit 118, said pacemaker unit is configured 118, during a stimulation break an electrical connection between the Impendanzsensor 120 and ring electrode 134 and tip electrode 136 produce when the electrode line 130 at pacing output 131 is the implantable medical device 101 is connected.
The apnea detector unit 114 is connected via a connecting line 170 to the and is implemented impedance sensor 120, the time course of a the impedance sensor 120 detected evaluate intrathoracic impedance signal and to generate a respiration signal, this respiration signal evaluate after his timing and an appropriate - for example, Respite Information containing - generate evaluation result.
As output, the apnea detector unit 114 an apnea detector signal produce, which for example in the evaluation result Form an apnea status information and an apnea therapy information represents and send it to the central control unit 110th Is to the apnea detector unit 114 on the output side via a connecting line 172 connected to the central control unit 110th The apnea detector unit 114 is also for sending apnea statistical information via a connecting line 171 with the central Control unit 110 is connected and adapted a statistical evaluation result to generate the respiratory signal and the evaluation result representing apnea statistics signal via the connection line 171 be sent to the central control unit 110th
The apnea statistics signal may contain the following parameters:<dl tsize="35"><dt>Respiration rate:</dt><dd>Trend, histogram, minimum, maximum, Mean, breathing amplitude;</dd><dt>Respiratory minute ventilation:</dt><dd>Trend, histogram, minimum, maximum, Average;</dd><dt>Apnea events:</dt><dd>Absolute number, number per night;</dd><dt>Duration of apnea events:</dt><dd>Trend, histogram, minimum, maximum, Mean, shot during a Night;</dd><dt>Number of hyperventilation phases:</dt><dd>Absolute number, number per night;</dd><dt>Classification of breathing phases:</dt><dd>normal breathing, obstructive apnea, Central apnea, hyperventilation, Cheyne-Stokes respiration.</dd></dl>
The central control unit 110 is, for example, as a programmable microprocessor formed and can in this implemented control program run.
The sleep detector unit 112 is formed, in dependence on the input side, via the connecting lines 151, 158, 160, 162, and 176 signals to receive, evaluate them, an the evaluation result corresponding to produce sleep signal and the output side via the connecting line 152 to be sent to the central control unit 110th
The sleep detector unit 112 is on the input side via a heart-rate connection line 158 connected to the pacemaker unit 118, which output a a detected heart rate appropriate heart rate signal generated and this through the connection line 158 to the sleep detector unit can send 112th
The sleep detector unit 112 is on the input side via a connecting line 160 connected to a position sensor 115, which is formed, as a function of its angular position in relation to the horizontal, its electrical resistance to change. The sleep detector unit 112 is formed, query the angular position of the position sensor 115 and to about Connecting line 160, an electrical voltage to the position sensor 115 to create and detect a resulting electricity.
The sleep detector unit 112 is on the input side via a connecting line 162 connected to an acceleration pattern classifier 114, which is connected to a triaxial accelerometer 113th Of the Acceleration pattern classifier 114 is formed, a time signal of evaluate triaxial acceleration sensor 113 and between different Acceleration patterns which patterns of movement of a carrier the implantable medical device 101 correspond to distinguish. For this purpose the acceleration pattern classifier 114 is via a connecting line associated with a acceleration pattern storage unit 117 and formed from this stored there acceleration pattern read and detected by the triaxial acceleration sensor 113 over the compare acceleration patterns and the detected acceleration pattern classify. The acceleration pattern classifier 114, a pattern representing an acceleration acceleration pattern signal generate and this through the connection line 162 to the sleep detector unit 112 to send.
The acceleration pattern classifier 114 may include an FFT analyzer have, which is formed from the time signal of the triaxial acceleration sensor 113 continuously a sequence of acceleration pattern power spectra to create. The classification is then based the acceleration pattern performance spectra and in the acceleration pattern storage unit 117 are predetermined acceleration pattern power spectra stored.
As an alternative to this embodiment, the acceleration pattern classification also based on time signals occur, but this compared to the acceleration pattern power spectra increased storage capacity requires.
The sleep detector unit via a connecting line 176 with a time of day clock 122, which is formed, one of a time corresponding generate daytime signal and the output side via the to send connection line 176 to the sleep detector unit. The time of day clock is via a connecting line 174 with a world time zone detector connected, which has a satellite receiver, for example a comprising GPS receivers.
The satellite receiver is configured, a transmitted from satellite 128 Satellite signal receiving 129 to evaluate this and from a geo-location to calculate, for example in the form of coordinates. The world time zone detector is formed, for example with a look-up table assign a determined geo-location of a world time zone and a world time zone signal to produce and this on the output side via the connecting line 174 to send to the time of day clock 122nd
The central control unit 110 is connected via a connecting line 154 with the connected Therapy Unit 116 and, depending on requirement of a therapy, controlled by the control program in response to the via the connecting line 172 received apnea detector signal and on the Connecting pipe 152 received sleep signal a therapy information produce containing therapy signal and this signal through the therapy Send connecting line 154 to the therapy unit 116th The therapy unit 116 is connected via a connecting line 156 to the pacemaker unit 118 and is implemented to depending from the central control unit via the connecting line 154 requested therapy because of treatment signal to produce a heart rate request signal and this on the to send connection line 156 to the pacemaker unit 118, which then the step rate can adjust accordingly.
The central control unit 110 is for storing for example the the connecting line 171 received apnea statistics information about a connecting line 178 connected to a memory unit 124th
The central control unit 110 is connected via a bidirectional data bus 150 with a telemetry unit for wireless data transmission (long-distance telemetry system) 128 connected. For example, the telemetry unit 128 Bluetooth telemetry unit.
The central control unit 110 may thus apnea statistics information and from the pacemaker unit 118 detected cardiac signal information 182 on the Telemetry unit 128 cordless mobile to a patient application device 137 send. About the telemetry unit 128 may receive a control program and via the bidirectional data bus 150 to the central control unit 110 sent and stored there, the central control unit 110 and the telemetry unit 128 may be formed in accordance therewith.
The mobile patient application device 137, for example, near a patient bed to be set up. The mobile patient application device 137 is for data transmission of patient-related data over a network connection line 180 connected to a central service center 138th From there, a physician can call, for example, patient information and monitor. Alternatively, the network connection line 180, the mobile Patient application device 137 and the central service center 138 a have wireless interface, such as a Bluetooth interface, and this Bluetooth interface cordless patient-related Data transfer.
2 shows - schematically illustrated - the cooperation of a sleep weighting discriminator 210, which in the sleep detector unit 112 can be included, with an apnea weighting discriminator 212 which may be contained in an apnea detector unit 114th
The sleep weighting discriminator 210 has signal inputs to which via connecting lines 270, 272, 274, 276 and 278 of sensors or are connected in a broader sense signal generator. Of the Sleep weighting discriminator 210 is formed according to a predetermined Weighting function the signals present at the signal inputs signals evaluate and review the result representing sleep signal to produce and this on the output side via a connecting line 256 send to a therapy discriminator 214th
The apnea weighting discriminator 212 also includes signal inputs, which via connecting lines 260, 262, 264 and 268 with signal generators are connected. The apnea weighting discriminator 212 evaluates the applied to the signal inputs of signals according to a predetermined Weighting function and generates an apnea signal and sends the output side via a connected connecting line 254 to the therapy discriminator 214th
The sleep weighting discriminator 210 is connected via a connecting line 270 connected to a heart rate sensor 234, which in the pacemaker unit may be contained 118th Via the connecting line 270 thus emitted an actual state heart rate from the heart rate sensor 234 and received from the sleep weighting discriminator 210th Of the Sleep weighting discriminator 210 is connected via a connecting line 272 input connected to an impedance sensor 216th The impedance sensor 216 is via a connecting line 241 to a ring electrode 240 and connected via a connecting line 239 with a tip electrode 238, which placed an electrode line 242 at the distal end are.
The impedance sensor 216 is also via a connecting line 237 with a Housing 236 of the implantable medical device 101 is connected and formed on the output side via the connecting lines 237 and 241 to flow a current and the input side via the connecting line 239 and to detect the connection line 237, a resulting voltage and from the sensed voltage and current to form an impedance. The impedance sensor 216 is formed, one from these detected impedance to calculate intracardiac impedance and an intracardiac impedance representing Output via the connection line 272 to the Sleep weighting discriminator to send 210th
An illustrated already in figure 1 acceleration pattern classifier 114 via a connecting line 252 with a triaxial accelerometer 113 and is implemented to output a result of the classification representing signal via the connection line 274 to the sleep weighting discriminator to send 210th
The sleep weighting discriminator 210 is via a connecting line 276 on the input side with a - as in Figure 1 already explained - Position Sensor 115..
A time of day clock 122 is input side to a world time zone detector 126 connected and configured accordingly a world-pied corrected time signal on the output side via a connecting line 278 to send to the sleep weighting discriminator 210th
The apnea weighting discriminator is connected via a connecting line 260 input connected with a blood-oxygen sensor 222, via a Connecting line 262 on the input side with a respiratory minute volume detection unit 220 connected on the input side and via a connecting line 264 connected to an impedance-evaluation 218th
The impedance evaluation unit 218 is connected via a connecting line 250 the impedance sensor 216 and is implemented to a one Breathability characterizing impedance signal of time evaluate the impedance sensor 216, and the number and duration of create breathing spaces characterizing respiratory signal and on the output side via the connection line 264 to the apnea weighting discriminator 212 to send. The apnea weighting discriminator 212 is connected via a connecting line 268 input side connected to the heart rate sensor 234 and can thus receiving a generated by this heart rate signal as an input variable.
The apnea weighting discriminator is formed, based on a predetermined to produce apnea weighting function is an apnea signal and this on the output side via the connection line 254 to the therapy discriminator 214 to send.
The therapy discriminator assessed on a therapy-weighting function the input side available apnea signal and the input side available sleep signal and assigns the evaluation result a therapeutic result to that of the Therapiediskriminator the output side via the connecting line 258 to a discriminator output 213 can be issued. At the discriminator output 213 the therapy unit shown in Figure 1 via the connection line 154 be connected.
As shown schematically in Figure 3, the position sensor 10 of the present Invention, a hexagonal-shaped object with a plurality of metal balls 12 may be contained in an internal cavity fourteenth If the patient lies, the position sensor 10 is positioned such that the metal balls 12 is an electrical connection between the lower side walls 16 and 18 to produce, so that the electrical connection is detected as a short circuit is. 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 a illustrated embodiment are shown contact surfaces A and B on a Board 20 is mounted. Although the connection of the lower sidewalls 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 below the base surface of the sensor is performed so that a simple connection wire-free Soldering of the sensor is made possible in a Lötwellenbad. It is expected that the position sensor in the size of a 0806-capacitor is executed or a 0603 capacitor. A primary advantage the position sensor is that it does not consume energy.
Figure 4 shows a further exemplary embodiment of a position sensor 30th The position sensor 30 includes electrically conductive balls 38 which in itself a cavity are 40th The cavity 40 is electrically conductive sidewalls 42 and 44 and formed by a top face 46th Unlike the position sensor illustrated in Figure 3, the contact surfaces 42 and 44 also on a portion of the intended for mounting on a printed circuit board Bottom surface running. Also shown are the contact surfaces of conductor tracks 32 and 33, on each of which one of the contact surfaces 42 and 44 with Solder 36 is soldered.
Figure 5 shows an embodiment of a cylindrically-shaped position sensor 50 with a cavity 51 which by a cylindrical wall 56 is enclosed. The cylindrical wall 56 has two longitudinal axial direction from each other spaced on electrically conductive ring contacts 54 and 52nd cavity 51 is partly filled with electrically conductive balls 58th Is the cylindrical position sensor 50 longitudinally and axially in a horizontal orientation, so the electrically conductive ring contacts 52 and 54 through the electrically conductive Balls 58 are electrically connected together. Depending on the level of Cavity 51 with electrically conductive balls 58 can be an angle to Setting the horizontal, in which the ring contacts 52 and 54 still - or not - are electrically connected together.
If such a cylindrical position sensor 50 part of an implantable medical device and the longitudinal axis of the cylindrical Position sensor 50 parallel to the longitudinal axis of the body of a wearer of the implantable medical device aligned so the electrically conductive Ring contacts 52 and 54 are always electrically connected with each other when the Support the implantable medical device is horizontal in a Position, regardless of whether the support is a supine, prone position or side position occupies.
is in a not shown embodiment of a position sensor an electrically conductive ball in a cavity defined by a Hollow sphere wall is enclosed. On the inside wall of the hollow sphere a plurality of electrically conductive contacts. The ball diameter the electrically conductive ball in the cavity and the spacing of the electrically conductive contacts are on the inside wall of the position sensor dimensioned such that at least in any position of the position sensor two of the electrically conductive contacts on the electrically conductive ball are joined together when, for example, on the electrically conductive ball a gravitational force acts.
5 sheets
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Every citation, both ways
| Document | Relation | Office | Category | Cited during | Relevant claims |
|---|---|---|---|---|---|
| US8758243B2 | Cited by | United States of America | – | Applicant | – |
| WO2011097296A1 | Cited by | World Intellectual Property Organization (WIPO) | – | International search | – |
| EP0515319A2 | Cites | European Patent Office (EPO) | A | Search report | 14 |
| US2002193939A1 | Cites | United States of America | A | Search report | 8 |
| US2003130589A1 | Cites | United States of America | A | Search report | 1,2,5,6,10,17 |
| US2003153953A1 | Cites | United States of America | Y | Search report | 1-20 |
| US4846195A | Cites | United States of America | Y | Search report | 1-20 |
| US4869251A | Cites | United States of America | A | Search report | 1,13 |
| US4926863A | Cites | United States of America | A | Search report | 11,12 |
| US5562711A | Cites | United States of America | A | Search report | 2,3 |
| US6083248A | Cites | United States of America | A | Search report | 9,20 |
| US6574507B1 | Cites | United States of America | A | Search report | 16,1,4-6,10,15-18 |
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 | |
|---|---|---|---|
| EP1512430A1This record | European Patent Office (EPO) | A1 | |
| DE10347294A1 | Germany | A1 | |
| US2005101833A1 | United States of America | A1 | |
| EP1512430B1 | European Patent Office (EPO) | B1 | |
| AT385830T | Austria | T | |
| ATE385830T1 | Austria | T1 | |
| DE502004006169D1 | Germany | D1 | |
| US7473227B2 | United States of America | B2 |
67 legal events, as 7 offices reported them to INPADOC
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|---|---|---|---|
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Patent ceasedCeasedPL | PL | CH | |
| Application deemed withdrawn, or ip right lapsed, due to non-payment of renewal feeWithdrawnR119 | R119 | DE | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Notification of lapseLapsedST | ST | FR | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Gb: european patent ceased through non-payment of renewal feeCeasedGBPC | GBPC | EP | |
| Ep patent has lapsedLapsedEUG | EUG | SE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Change of applicant/patenteeR081 | R081 | DE | |
| Change of representativeR082 | R082 | DE | |
| Change of representativeR082 | R082 | DE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
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| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Nl: lapsed or anulled due to non-payment of the annual feeLapsedNLV4 | NLV4 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
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| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
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| No opposition filed within time limitOppositionORIGINAL CODE: 0009261PLBE | PLBE | EP | |
| Information on the status of an ep patent application or granted ep patentGrantedSTATUS: NO OPPOSITION FILED WITHIN TIME LIMITSTAA | STAA | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| European patents designating ireland treated as always having been voidFD4D | FD4D | IE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Fr: translation filedET | ET | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Corresponds to:REF | REF | EP | |
| Gb: translation of ep patent filed (gb section 77(6)(a)/1977)GBT | GBT | EP | |
| European patents granted designating irelandGrantedLANGUAGE OF EP DOCUMENT: GERMANFG4D | FG4D | IE | |
| Translation of granted ep patentGrantedTRGR | TRGR | SE | |
| European patent takes effect as a national patent in ch/liEP | EP | CH | |
| Designated contracting statesAK | AK | EP | |
| European patent grantedGrantedNOT ENGLISHFG4D | FG4D | GB | |
| (expected) grantORIGINAL CODE: 0009210GRAA | GRAA | EP | |
| Grant fee paidORIGINAL CODE: EPIDOSNIGR3GRAS | GRAS | EP | |
| Despatch of communication of intention to grant a patentORIGINAL CODE: EPIDOSNIGR1GRAP | GRAP | EP | |
| Title (correction)DEVICE FOR SLEEP-APNEA TREATMENTRTI1 | RTI1 | EP | |
| First examination report despatched17Q | 17Q | EP | |
| Designation fees paidAKX | AKX | EP | |
| Request for examination filed17P | 17P | EP | |
| Designated contracting statesAK | AK | EP | |
| Request for extension of the european patentAX | AX | EP | |
| Public reference made under article 153(3) epc to a published international application that has entered the european phaseORIGINAL CODE: 0009012PUAI | PUAI | EP |
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 slep-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
- A61B5 00
- A61B5 0205
- A61B5 0245
- A61B5 029
- A61B5 07
- A61B5 11
- A61B5 363
- A61N1 365
Designated states2
- Contracting states, 1
- Türkiye
- Extension states, 1
- North Macedonia