Diagnosis and Prediction of Obstructive Sleep Apnea
A tongue location monitoring system, including, one or more position circuits that respond to transmissions from a transceiver, a transceiver that transmits to the one or more position circuits, a control circuit coupled to the transceiver; wherein the control circuit determines the location of a person's tongue based on the responses of the position circuits; and wherein either the transceiver or the position circuits are implanted in the muscle of the person's tongue or placed on the tongue, and the latter is placed outside the person's head.
The present invention relates generally to a system and method of diagnosing and predicting obstructive sleep apnea based on the position of the tongue muscle.
BACKGROUND OF THE INVENTIONTypically obstructive sleep apnea (OSA) is diagnosed in a sleep laboratory by attaching the patient to various measurement devices, which measure parameters such as an Electroencephalography (EEG), an Electromyography (EMG) of respiratory muscles, a device for measuring blood Oxygen saturation and devices for measuring other parameters while the patient sleeps.
Obstructive sleep apnea is the most common type of sleep apnea. One of its causes is the collapse of the tongue muscle, wherein the collapsed tongue muscle obstructs the airway and causes an OSA event.
Various devices have been designed to enable diagnosing the occurrence of OSA without going to a sleep laboratory. One example is a device that monitors changes in the peripheral arterial tone as manifested by changes in the pulsatile arterial blood volume in a terminal extremity of a body part, e.g., a digit (finger or toe) of the subject, as described in U.S. Pat. No. 7,374,540.
Other methods of diagnosing OSA include implantable systems, for example a system that uses an intra-thoracic pressure sensor that senses breathing movements for treating respiratory disorders as described in U.S. Pat. No. 6,572,543. In US patent application publication no. US 2008/0103407 a system that senses breathing movements by applying an implantable bio-impedance sensor is described. In US patent application publication no. US 2009/0078274 an electro active polymer metal composite sensor is attached to a region in an airway passage of an oral cavity. The electrical output may be wirelessly transmitted to signify an obstructive sleep apnea event.
Other methods include a contact microphone that detects sounds and/or Vibrations, and yet other methods include temperature sensors that detect temperature changes when an obstructive sleep apnea event occurs that result from the event.
Upon detection of the occurrence of the OSA event various remedial measures can he taken, for example activating an implanted stimulator or an external device.
SUMMARY OF THE INVENTIONAn aspect of an embodiment of the invention, relates to a system and method for diagnosing and predicting an OSA event by monitoring the location of the tongue muscle. In an exemplary embodiment of the invention, a reader is placed outside a patient's head and one or more position circuits are placed on the patient's tongue or implanted in the tongue. Optionally, the reader transmits signals to the position circuits and receives a signal back from the position circuits. The returned signal is used to determine the location of the position circuits relative to the reader. Optionally, the reader repeatedly queries the position circuits, so that it can monitor the motion of the tongue muscle.
In some embodiments of the invention, the position circuits are passive RFID tags. Alternatively, the position circuits may be active RFD tags, BT Transceivers, WiFi transceivers or any other type of wireless transmitters/receivers. In an exemplary embodiment of the invention, the position circuits are implanted directly into the tongue muscle. Alternatively, the position circuits are embedded in an implantable encasement that provides other functions such as to stimulate the tongue muscle.
In some embodiments of the invention, the position circuits are embedded in an adhesive biodegradable tape that can be placed on the patient's tongue before going to sleep. Optionally, while the patient is sleeping the position circuits will accept transmissions from the external reader and reply to the transmissions. In an exemplary embodiment of the invention, after a predetermined time the tape will degrade and the position circuits will exit through the digestive system.
In some embodiments of the invention, the position circuits are placed in the external reader. Optionally, the reader wirelessly transmits power to an implant in the patient's tongue and the implant transmits a signal to the position circuits.
In some embodiments of the invention, the reader determines the location of the position circuits and optionally monitors the motion of the position circuits. Optionally, the reader stores the information in a non-volatile memory for analysis at a later date, for example by a practitioner on a computer to diagnose the patient. Alternatively or additionally, the reader may transmit instructions to an implant or to other devices to act upon the information, for example to stimulate the tongue muscle when sensing that an USA event is about to occur and prevent it from occurring.
There is thus provided according to an exemplary embodiment of the invention, a tongue location monitoring system, comprising:
one or more position circuits that respond to transmissions from a transceiver;
a transceiver that transmits to the one or more position circuits;
a control circuit coupled to the transceiver;
wherein the control circuit determines the location of a person's tongue based on the responses of the position circuits; and
wherein either the transceiver or the position circuits are implanted in the person's tongue or placed on the tongue, and the latter is placed outside the person's head.
In an exemplary embodiment of the invention, the position circuits are implanted in the tongue muscle. Optionally, the transceiver is implanted in the tongue muscle. In an exemplary embodiment of the invention, the position circuits are embedded in an implantable stimulator that is implanted in the tongue muscle and the implantable stimulator is adapted to stimulate the tongue muscle. Optionally, the position circuits are embedded in a biodegradable tape that is adhesively attached to the tongue. In an exemplary embodiment of the invention, the control circuit determines the location of the tongue based on the travel time of the signal to the position circuit and back. Optionally, the control circuit determines the location of the tongue based on the strength of the signal returning to the transceiver. In an exemplary embodiment of the invention, an obstructive sleep apnea event is detected by monitoring the location of the tongue. Optionally, an obstructive sleep apnea event is detected by monitoring the angle of arrival of a response signal from the position circuits. In an exemplary embodiment of the invention, the position circuits are queried sequentially. Alternatively, the position circuits are queried in parallel. Further alternatively, the position circuits are queried continuously. Further alternatively, the position circuits are queried periodically. In an exemplary embodiment of the invention, the transceiver is provided power wirelessly and the transceiver queries the position circuits as long as it is provided power wirelessly.
There is further provided according to an exemplary embodiment of the invention, a method of monitoring the location of the tongue, comprising:
positioning either a transceiver or one or more position circuits as implants in a person's tongue or on the tongue, and positioning the latter outside the person's head;
transmitting signals from the transceiver to the position circuits;
receiving a response from the position circuits;
calculating the location of the position circuits relative to the transceiver from the response;
determining if an obstructive sleep apnea event is about to occur based on the calculated locations.
In an exemplary embodiment of the invention, the position circuits are implanted in the tongue or on the tongue. Alternatively, the position circuits are positioned outside the head. In an exemplary embodiment of the invention, the muscle of the tongue is stimulated responsive to the determining.
The present invention will be understood and better appreciated from the following detailed description taken in conjunction with the drawings. Identical structures, elements or parts, which appear in more than one figure, are generally labeled with the same or similar number in all the figures in which they appear, wherein:
and
The present disclosure incorporates by reference U.S. patent application Ser. No. 12/581,907 tiled Oct. 20, 2009 by the instant inventor, the disclosure of which is incorporated herein by reference describing a small implantable stimulator for dealing with an OSA event.
In some embodiments of the invention, position circuits 120 may be passive circuits with or without an internal power source that respond to an external signal without requiring an internal power source. Alternatively, position circuits 120 may be active transmitters using an internal power source to function, for example an active RFID tag, a Bluetooth transmitter, a WiFi transmitter, or other types of transmitters.
In an exemplary embodiment of the invention, reader 150 is positioned outside of the user's head 105, for example in the form of a patch that can be adhesively attached to the patient's neck, cheek or below the patient's jaw, or to the vicinity thereof. Optionally, reader 150 may be in the form of a necklace or a necktie or other wearable items to make it less conspicuous.
In an exemplary embodiment of the invention, reader 150 includes a transceiver 152 that transmits and/or receives signals to/from position circuits 120. In some embodiments of the invention, position circuits 120 are RFID tags, which respond to a specific signal. Optionally, position circuits 120 are relatively small so that they can easily be implanted in the tongue muscle, for example some RFID circuits are smaller than 0.05 mm X 0.0 5mm. In some embodiments of the invention, position circuits 120 are placed inside implant 110, which provides additional functions, for example stimulating the tongue muscle responsive to internal or external instructions. Optionally, implant 110 includes a control circuit 130 to provide the additional functions (e.g. stimulation, or communications with other external devices). In some embodiments of the invention, determination of the location of the position circuits 120 can be used to more accurately determine the location of implant 110, for example based on the location of multiple position circuits 120.
in an exemplary embodiment of the invention, reader 150 includes a power source 154 (e.g. a battery) and an activation switch 159. Optionally, reader 150 also includes a control circuit 156 and a memory 158 to control reader 150. Optionally, control circuit 156 includes a processor and is programmed to instruct transceiver 152 to transmit a specific signal for each position circuits 120, receive a response to the transmitted signal and calculate the distance based on the transmission.
In some embodiments of the invention, reader 150 includes a motion sensor 145. Motion sensor 145 is preferably coupled to control circuit 130. Motion sensor 145 can be an accelerometer, gyroscope, or any other device capable of indicating the implant 110 has changed its position, and optionally the directional vector of such change.
In some embodiments of the invention, calculation of the distance is based on the signal strength. Alternatively or additionally, the calculation is based on the travel time of the signal to position circuits 120 or the time for the round trip of the signal to position circuits 120 and back to reader 150. Optionally, when reader 150 is initially activated it is calibrated relative to position circuits 120 assuming that the tongue muscle is in a normal state. Optionally, the use of multiple position circuits 120 positioned at pre-selected locations relative to each other allows more accurate three-dimensional determination of the location of position circuits 120 relative to reader 150.
in an exemplary embodiment of the invention, an increase in distance beyond a threshold value in pre-determined directions will be an indication of an OSA event. In other exemplary embodiment of the invention, a decrease in distance beyond a threshold value in pre-determined directions will be an indication of an OSA event.
In some embodiments of the invention, the angle of arrival may be used to determine an OSA event. Optionally, reader 150 is calibrated upon activation to an initial angle between the reader and the position circuits 120. Optionally, a change in the angle of arrival of the signal that indicates movement of the tongue muscle toward the patient's back beyond a threshold value will indicate an OSA event.
In some other embodiments of the invention, the time of arrival (TOA) of the signal from the position circuits 120 to the reader 150 may indicate an OSA event. In some embodiments of the invention, the signal strength received by the reader 150 may indicate an OSA event. In some other embodiments of the invention, the signal strength correlated with TOA or time of travel, between the position circuit 120 and the reader 150, received by the reader 150 may indicate an USA event. In some embodiments of the invention, the first detected signal received by the reader 150 after the activation of the position circuits 120 may indicate an OSA event.
In the previous examples, each indication noted as an indication of an OSA event may also be considered as a precursor or the onset of an USA event. Thus, the present indications may provide an indication that an OSA event is likely to occur. In some embodiments of the present invention, any one or any combination of the above indications can be used to indicate the onset or the occurrence of an OSA event. Such indications or any combination thereof can also he reviewed post an OSA occurrence such that the control circuit 130 is reprogrammed automatically post an OSA event to identify the sequence of indications leading to an OSA event that occurred with the specific patient.
In an exemplary embodiment of the invention, the position circuits 120 respond (320) to the signal from reader 150. In some embodiments of the invention, each position circuit 120 responds with a different pre-selected delay time relative to the signal from reader 150, so that reader 150 will receive the responses one after another even if all the position circuits 120 receive the signal simultaneously.
In an exemplary embodiment of the invention, control 156 of reader 150 processes the responses from position circuits 120 and calculates (330) from the responses the relative location of each position circuit 120. Optionally, control 156 takes into account pre-selected delay times and if the position circuits are positioned with a non-varying distance or if their relative position is variable. In an exemplary embodiment of the invention, control 156 stores the details of the position in memory 158 and keeps track of the current position relative to the previous positions based on previous readings.
Optionally, control 156 can then determine (340) if an OSA event is about to take place, for example if the tongue muscle is collapsing so that it will block the airway. Optionally, control 156 can then determine (340) if an OSA event is about to take place based on the trajectory of the position circuits 120. Optionally, control 156 can then determine (340) if an OSA event is about to take place based on one or more indications as described here in above in conjunction with the description of
Optionally, in step 340 the reader 150 can determine if an onset of an OSA event is likely, or if an OSA event has occurred in the past based on the various indications received. In an exemplary embodiment of the invention, as long as an OSA event is not about to occur, reader 150 will continue to query position circuits 120. In some embodiments of the invention, the querying is performed continuously. Alternatively, the querying may be performed periodically, for example 1000 times a second or 100 times a second. In some other embodiments of the invention, the reader will not query the position circuits, and the position circuits will continuously send indication or emit energy in response to which the reader 150 can determine the position of position circuits 120.
In some other embodiments of the present invention, the motion sensor 145 located in the implant 110 activates the position circuits 120 which in response emit energy or transmission upon in response to which the reader may determine the position of the position circuits 120.
In some embodiments of the invention, transceiver 152 transmits the signal from multiple positions along the length of reader 150. Optionally, the location of position circuits 120 are determined by comparing the timing of the responses or through an analysis of any one or more of the indications disclosed herein above.
In an exemplary embodiment of the invention, if reader 150 determines that an OSA event is about to take place (340) it may take (350) various remedial actions, for example notify an implanted stimulator (e.g. implant 110) to stimulate the muscle and prevent it from occurring. Alternatively or additionally, reader 150 may include a buzzer (not shown) that provides an audible or tactile alarm to alert the patient to the occurrence of an OSA event, for example in the diagnostic stage of treating the patient. Optionally, reader 150 records information regarding the occurrence of an OSA event in its memory 158, for example the time and date of the occurrence. In some embodiments of the invention, reader 150 may be connected either during usage or after usage to a computer to analyze data stored in memory 158. Optionally, reader 150 may record a sequence of indications leading to an OSA event in memory 158. Optionally, reader 150 may further in step 350 reprogram itself to identify a future OSA event or the onset of such an event based on previous sequences of events which led to an OSA event. Optionally, memory 158 may be a non-volatile memory so that the data is available even if power source 154 is depleted. In some embodiments of the invention, memory 158 is removable and can be read using a memory card reader, for example with a USB memory card reader.
In some embodiments of the invention, reader 150 is initially calibrated when it is first deployed, for example by requiring the patient to push his tongue forward and/or back during the first few minutes from activation, so that reader 150 can record the extreme possible locations occurring as a result of natural use of the tongue and use the data to compare with locations occurring later that result from muscle collapse during an OSA event.
In some embodiments of the invention, reader 150 is designed to be able to record a response from position circuits 120 in allowable or preapproved positions, when the tongue muscle is functioning. Optionally, if the tongue muscle collapses, position circuits 120 move out of range and reader 150 does not receive a response. In an exemplary embodiment of the invention, reader 150 determines if an OSA event is about to occur, based on the previous motion of position circuits 120, and optionally also from the fact that position circuits 120 stopped responding. Optionally, reader 150 may signal implant 110 to stimulate the tongue muscle, causing the tongue to return to its correct position and communications from position circuits 120 to resume.
In some embodiments of the invention, implant 110 may monitor the communications with position circuits 120 and if the communications cease since position circuits 120 are out of range, implant 110 will stimulate the tongue muscle without receiving an instruction from an external source. Alternatively, reader 150 may have separate communication systems for communicating with position circuits 120 and a separate communication system for communicating with implant 110. Optionally, the communication system for communicating with implant 110 has a greater range than the communication system for communicating with position circuits 120, so that if communications with position circuits 120 fail reader 150 can still provide instructions to implant 110 to take remedial actions.
In some embodiments of the invention, multiple readers 150 are used to monitor the location of position circuits 120, for example one reader may be positioned on the patient's cheek and the second reader under the patient's chin. Optionally the multiple readers 150 communicate with each other via transceiver 152, for example to compare the responses received from position circuits 120. In some cases one may receive a response from a specific position circuit 120 while the other does not due to the position of the tongue muscle. Optionally, implant 110 may be instructed to stimulate the tongue muscle only if there is a loss of a signal from more than one reader or only if all readers 150 don't provide a signal. Alternatively, implant 110 may be instructed to stimulate the tongue muscle if a single reader 150 doesn't provide a signal. Optionally, implant 110 may be instructed to stimulate the tongue muscle based on additional information, for example the trajectory of motion of the tongue.
In an exemplary embodiment of the invention, reader 150 may include additional sensors, for example:
1. Sensors that provide surface EMG to detect movement of the tongue;
2. Sensors that provide ultrasound imaging of the tongue and its location;
3. Sensors that provide infrared imaging to sense temperature changes;
4. Sensors that provide temperature measurements to detect changes in temperature due to decreased breathing;
5. A contact microphone to detect vibrations due to snoring and obstruction of the air path;
6. A contact microphone to record breathing sounds;
7. Sensors that provide ECG measurements;
8. Sensors that provide EEG measurements;
9. Sensors that sense heart rate variability;
10. Sensors that measure oxygen saturation;
11 Sensors that measure movement;
12. Sensors that measure motion; and
13. Sensors that measure vector acceleration.
Optionally, reader 150 may incorporate any of the above measurements to enhance accuracy of the diagnosis and prediction of an OSA event.
Optionally, reader 550 is similar to reader 150 by including a control 556, a memory 558, a power source 554, an activation switch 559 and a transceiver 552. Optionally, biodegradable tape 510 is a biocompatible adhesive tape that is dissolvable, for example when in contact with the patient's saliva it dissolves within a few hours (e.g. between 1-8 hours; during the patient's sleep). Optionally, different tapes may be used with different lifetimes before being completely dissolved. In an exemplary embodiment of the invention, position circuits 520 (e.g. an RFID circuit) embedded therein are coated with a biocompatible enclosure 530 that is resistant to digestive fluids. Optionally, during the patient's sleep tape 510 dissolves and position circuits 520 are swallowed and later extracted through the digestive system. In an exemplary embodiment of the invention, a constant distance 540 is set between each position circuit 520. Alternatively, position circuits 120 may be positioned randomly on tape 510.
In an exemplary embodiment of the invention, biodegradable tape 510 is attached to a patient's tongue before going to sleep. Optionally, reader 550 is attached to the patient's head 105, or positioned or worn by the patient near his head 105, so that the transmissions from reader 550 will be received by position circuits 520 on tape 510. Optionally, reader 550 is activated and monitors the position of the patient's tongue during his/her sleep by transmitting signals to position circuits 520 as described above.
In an exemplary embodiment of the invention, the location data is stored in memory 558 to be taken out later and analyzed by a computer to diagnose obstructive sleep apnea. Alternatively or additionally, the data may be transmitted live by reader 558 to an external computer using a wireless connection (e.g. BT or WiFi or a cellular wan connection). In some embodiments of the invention, reader 558 is connected with a data cable to a computer (e.g. using a USB connection) to transmit the data while it is being collected. Optionally, the data is encrypted, compressed or manipulated by other methods (e.g. error correction schemes) to ensure its safe delivery to the correct target. Optionally, the data recorded by reader 558 may be used to determine if implantation of a stimulator is feasible for the patient. Additionally, the data recorded by reader 558 may be used to initially program an implantable stimulator based on the measurements, for example programming the intensity of stimulation based on the degree of collapse of the tongue for the specific patient.
In some embodiments of the invention, other measured data is combined to the data collected by reader 558, for example ECG or EEG data, to enhance the accuracy of the measurements.
In an exemplary embodiment of the invention, position circuits 520 may include surface EMG (electromyography) electrodes. Optionally, the electrodes sense EMG data from the tongue muscle and transmit the data to reader 558 with the other data from position circuits 520 (e.g. RFID tag ID information).
It should be appreciated that the above described methods and apparatus may be varied in many ways, including omitting or adding steps, changing the order of steps and the type of devices used. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every embodiment of the invention. Further combinations of the above features are also considered to be within the scope of some embodiments of the invention.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.
Claims
1. A tongue location monitoring system, comprising:
- one or more position circuits that respond to transmissions from a transceiver;
- a transceiver that transmits to the one or more position circuits;
- a control circuit coupled to the transceiver;
- wherein said control circuit determines the location of a person's tongue based on the responses of the position circuits; and
- wherein either the transceiver or the position circuits are implanted in the person's tongue or placed on the tongue, and the latter is placed outside the person's head.
2-18. (canceled)
Type: Application
Filed: Sep 30, 2013
Publication Date: Feb 13, 2014
Inventors: Adi Mashiach (Tel Aviv), Yossef Mashiach (Ra'anana)
Application Number: 14/041,460
International Classification: A61B 5/00 (20060101); A61N 1/36 (20060101); A61N 1/05 (20060101); A61B 5/11 (20060101);
