Apparatus for the treatment of sleep apnea

• US 7,473,227 B2
• Filed: 09/02/2004
• Issued: 01/06/2009
• Est. Priority Date: 09/02/2003
• Status: Expired due to Fees

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Johnson, Mark, Hsu, William, Czygan, Gerlad
• Primary Examiner(s): Fan; Chieh M
• Assistant Examiner(s): Saidi; Anita
• Application Number:
  US10/932,923
• Publication Number:
  US 20050101833A1
• Time in Patent Office: 1,587 Days
• Field of Search: 600/483, 600/481, 600/328, 600/529, 600/532, 600/533, 600/593, 607/11, 607/17, 607/18, 607/20, 607/30, 607/42, 607/62
• US Class Current: 600/483
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: A61B 5/1126 using a particular sensing technique
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

The invention concerns a medical device for implantation in a body, comprising a stimulation unit, a sleep detector unit having at least one signal input which is adapted to detect a sleep condition of the body and to produce a sleep signal, an apnea detector unit which is adapted to detect sleep apnea in dependence on at least one body signal caused by the body and to produce an apnea signal, a therapy unit which is at least indirectly connected to the stimulation unit! the sleep detector unit and to the apnea detector unit and which is adapted to produce, in dependence on the apnea signal and the sleep signal, at least one apnea therapy signal which represents therapy information for preventing and/or for the treatment of sleep apnea, and to send same to the stimulation unit. The medical device has a position sensor, which is operatively connected to the signal input of the sleep detector unit and adapted in dependence on its inclination about at least one spatial axis extending through the position sensor in relation to the horizontal to alter at least one of its electrical properties.

Claims

1. A medical device for implantation in a body, comprising:

a stimulation unit which is adapted to produce an electrical stimulation pulse in dependence on an apnea therapy signal,

a sleep detector unit having at least one signal input, which is adapted to detect a sleep condition of the body in dependence on at least one input signal and to produce a sleep signal which corresponds to a sleep detection event,

an apnea detector unit which is adapted to detect sleep apnea in dependence on at least one body signal caused by the body and to produce an apnea signal which corresponds to an apnea detection event,

a therapy unit which is at least indirectly connected to the stimulation unit, the sleep detector unit and to the apnea detector unit and which is adapted to produce, in dependence on the apnea signal and the sleep signal, at least one apnea therapy signal which represents therapy information for preventing and/or for the treatment of sleep apnea, and to send same to the stimulation unit,

wherein the medical device has a position sensor which is operatively connected to the signal input of the sleep detector unit and adapted in dependence on its inclination about at least one spatial axis extending through the position sensor in relation to the horizontal to alter at least one of its electrical properties, and

wherein the therapy unit is adapted to produce an apnea therapy signal in the form of an increase in the stimulation rate of 10 beats per minute by increasing the stimulation rate by one beat per minute over 10 minutes, thereby providing an apnea therapy signal that reduces a disturbance in sleep in a patient in which the device is implanted.

2. A medical device as set forth in claim 1, characterized in that the apnea detector unit includes an apnea weighting discriminator with at least one input for a body signal, wherein the apnea weighting discriminator is adapted to assess the body signal in accordance with a predetermined apnea weighting function and to produce an apnea signal representative of sleep apnea.

3. A medical device as set forth in claim 1, characterized in that the sleep detector unit includes a sleep weighting discriminator with at least one input for an input signal, wherein the sleep weighting discriminator is adapted in accordance with a predetermined sleep weighting function to assess the input signal and to produce a sleep signal representative of a sleep condition.

4. A medical device as set forth in claim 1, characterized in that the medical device has a sensor for detecting intracardial impedance, which is connected to the sleep detector and adapted to detect resting of the body on the basis of the intracardial impedance and to produce a rest condition signal representative of the rest condition of the body.

5. A medical device as set forth in claim 1, characterized in that the medical device has a respiration minute volume detection unit connected to the apnea detector unit.

6. A medical device as set forth in claim 1, additionally comprising an oxygen sensor which is connected to the apnea detector unit and adapted to determine a level of oxygen concentration in the blood and to produce a blood oxygen signal representative of the level of blood oxygen concentration.

7. A medical device as set forth in claim 1, additionally comprising a heartbeat volume detection unit which is connected to at least one of the sleep detector unit and the therapy unit and is adapted to determine a heartbeat volume and to produce a heartbeat volume signal representative of the heartbeat volume.

8. A medical device as set forth in claim 1, additionally comprising a time-of-day clock which is connected to the sleep detector unit and is adapted to produce a time-of-day signal and to send same to the sleep detector unit.

9. A medical device as set forth in claim 8, characterized in that the medical device has a world time zone detector with a satellite receiver, wherein the world time zone detector is operatively connected to the time-of-day clock and is adapted to receive satellite signals, to ascertain a position on the Earth by evaluation of the satellite signals and to produce a world time zone signal on the basis of the position on the Earth and to send said signal to the time-of-day clock which is adapted to suitably correct the time of day.

10. A medical device as set forth in claim 1, additionally comprising a triaxial acceleration sensor in which the directional axes of the accelerations which can be detected form an orthogonal system and which is operatively connected to the sleep detector unit and adapted to produce an acceleration time signal representative of an acceleration.

11. A medical device as set forth in claim 10, characterized in that the medical device has an acceleration pattern classifier which is connected on the output side to the sleep detector unit and on the input side to the acceleration sensor and is adapted to evaluate an acceleration time signal and to recognize predetermined acceleration patterns in the acceleration time signal, to classify them and to produce an acceleration pattern signal representative of an acceleration pattern and to output said signal.

12. A medical device as set forth in claim 11, characterized in that the acceleration pattern classifier has at the input side an FFT analyzer which is adapted to continuously produce acceleration pattern power spectra from an acceleration time signal and to send said acceleration pattern power spectra to the acceleration pattern classifier.

13. A medical device as set forth in claim 1, characterized in that the position sensor includes at least two switching contacts and at least one electrically conductive ball which is arranged in such a way as to electrically conductively connect or separate the switching contacts in dependence on the inclination of the position sensor.

14. A medical device as set forth in of claim 1, characterized in that the position sensor is a Hall probe which is adapted to produce a Hall voltage in dependence on its orientation in the magnetic field of the Earth.

15. A medical device as set forth in claim 1, characterized in that the stimulation unit is a cardiac pacemaker or defibrillator.

16. A medical device as set forth in claim 1, characterized in that the stimulation unit is a respiration musculature stimulation unit which is adapted to produce an electrical stimulation pulse for stimulation of the diaphragm or the thorax musculature.

17. A home monitoring system comprising an implantable medical device as set forth in claim 1, and a mobile patient application device, wherein the mobile patient application device is connected wirelessly by way of a telemetry unit to the implantable medical device.

18. A patient monitoring system comprising an implantable medical device as set forth in claim 1, and a mobile patient application device connectable wirelessly by way of a telemetry unit to the implantable medical device and a central service center, wherein the central service center is connected at least at times to the mobile patient application device for the data transfer of patient-related data by way of a network connecting line or a wireless connection.

19. A method of treating sleep apnea in a patient, the method comprising implanting a medical device in the patient, the medical device comprising:

a stimulation unit adapted to produce an electrical stimulation pulse in dependence on an apnea therapy signal,

a sleep detector unit having at least one signal input, adapted to detect a sleep condition of the body in dependence on at least one input signal and to produce a sleep signal which corresponds to a sleep detection event,

an apnea detector unit which is adapted to detect sleep apnea in dependence on at least one body signal caused by the body and to produce an apnea signal which corresponds to an apnea detection event,

a therapy unit which is at least indirectly connected to the stimulation unit, the sleep detector unit and to the apnea detector unit and which is adapted to produce, in dependence on the apnea signal and the sleep signal, at least one apnea therapy signal which represents therapy information for preventing and/or for the treatment of sleep apnea, and to send same to the stimulation unit,

wherein the medical device has a position sensor which is operatively connected to the signal input of the sleep detector unit and adapted in dependence on its inclination about at least one spatial axis extending through the position sensor in relation to the horizontal to alter at least one of its electrical properties, and

producing an apnea therapy signal using the therapy unit, in the form of an increase in the stimulation rate of 10 beats per minute by increasing the stimulation rate by one beat per minute over 10 minutes, thereby providing an apnea therapy signal that reduces a disturbance in sleep in the patient.

20. The method of claim 19, wherein the stimulation unit is a cardiac pacemaker or defibrillator.