TELEIVi ETRY-SYNCH RON ϊZE D PHYSIOLOGICAL MONITORING AND THERAPY DELIVERY SYSTEMS

BACKGROUND OF THC INVENTION

This in\ ention relates to implantable medical devices (LVlDs) for sensing physiological signals, monitoring and recording physiological events, and delivering therap) In particular, the ins ention relates to telemetry~s\ nchroni/ed operation of multiple IMDs

Pacemakers, cardioverter defibrillators, nerve stimulators, and drug delivery devices ase examples of IMDs used to pιo\ide therapy ovei extended periods of time to a patient These devices typically include sensors that are located on or in the IMD housing or are connected to the !MD b> electrical leads The IMl) includes signal processing circuitry for processing physiologic signals from the sensors, and therapy delivery circuiUy foi controlling the delivery of therapy based upon the sensed physiologic signals The therapx. may include electrical stimulation of nerves, muscles, organs, or may be the deli very of theiapeutie substances such as insulin or drugs

The monitoring and recording of physiologic events in a patient ^' s body oxer extended peiiods of time has important diagnostic, therapeutic, and research benefits Ambulatory recorders have been developed for electrocardiogram (IXXi), clectrυcncephalogiam (£EG), blood pressure, and oilier physiologic signals Both externally worn monitors and implantable monitors have been developed For example, the Klein et al I ¹ S Patent No 5,987,352 describes an implantable long term ECG monitor that automatically detects arrhythmia and records IXXJ signals in memory The recorded ECO signals can later be transferred b> telemetry to an external device The human body is a complex organism with, many interrelated systems A physiologic condition may manifest itself concuss entiy or sequentially at different places in the bod\ Improved diagnosis and treatment may be aided by capturing data and delivering therapy based upon sensed physiologic signals from different portions of the bod>

BRIEF SUMMARY OF THC INVENTION

\ system of autonomous implantable medical devices uses an inter-device telemetry link to trigger synchronized action A physiologic event within a first region of

a patient's body, or an external device activation, sensed by a first IMD can trigger a synchronized action by a second IMD that interacts with a second region of a patient ^' s body

The telemetry-synchronized system can he used to provide synchronized data capture, sensing, or therapy delivery involving implantable medical devices located in different parts of the body. Telemetry-synchronized operation of autonomous LVlDs is particularly useful when sensing or therapy delivery occur in locations within the body- that are distant from one another so that it is undesirable to provide physical links between the LMDs for communication or transfer /deli very of energy or drugs.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. S A shows a telemetry-synchronized monitoring system including implantable ECG and EEG monitors.

FIG. IB shows a telemetry-synchronized monitoring system including implantable monitors and an external relay unit.

FIG. 2 is a block diagram of an example of an implantable monitor for use in the systems of FIGS IA and I B.

FIG. 3 shows a telemetry-synchronized system for treating obstructive sleep apnea.

FKJ, 4 is a diagram showing a telemetry-synchronized leg control system

FIG. 5 is a diagram of a telemetry -synchronized arterial monitoring system.

DETAILED DESCRIPTION

FKJ, IA shows seizure/ syncope monitoring system 10, which includes implantable ECG monitor 12, implantable EEG monitor 14, external telemetry head 16, external programmer 18, data display 20, and patient-carried wireless activator 22, which the patient can use to communicate to the implant(s) to trigger the capture of symptomatic data. Monitoring system 10 is used to help diagnose and monitor infrequent syncopal /seizure patients by using two chronically implantable autonomous, wirelessly- 1 inked devices. ECG monitor 12 and EEG monitor 14.

ECG monitor 12 is implanted in the chest region of patient P, and includes electrodes and signal processing circuitry for sensing ECG signals and detecting cardiac

arrhythmias. An example of an implantable ECG monitor is the Medtronic Reveal Pius® lnsertabie Loop Recorder.

EEG monitor 14 is implanted in the head region of patient P. Monitor 14 includes electrodes and signal processing circuitry for sensing EEG signals representing electrical activity of the brain and detecting seizures based upon the EEG signals Both ECG monitor 12 and EEG monitor 14 include memory for storing sensed physiological signals, and internal clocks for providing time stamps in conjunction with the stored data. Monitors 12 and 14 can generate a trigger signal automatically based upon a detected event, or based on a trigger signai received by telemetry from the other monitor Patient P can also trigger simultaneous capture of EEG and ECG data by placing patient activator 22 near either EEG monitor 14 or EX ¹ G monitor 12 and transmitting a trigger signal Both, monitors 12 and 14 may receive the trigger signal and initiate simultaneous data capture, or one monitor may receive the trigger signal from patient activator 22 and relay the trigger wirelessly to the other monitor.

In the embodiment shown in FIG. IA, synchronized data acquisition is achieved with implanted ECG monitor 12 and implanted KEG monitor 14. When one device senses an event to be recorded, it sends a telemetry signal to the other device to initiate data storage during the recorded event. This type of intra body telemetry requires good transmitters and receivers. Transmit power should be high enough to be able to propagate the signal through the tissue of a patient ^' s body to the other device. The signal-to-noise ratio of the receiver needs to be high enough so that the received signal is not corrupted. Upon detecting an arrhythmia or detecting an external patient activation, ECG monitor i 2 transmits a trigger signal via a wireless link to EKG monitor 14 to trigger simultaneous capture of EEG data. Conversely, upon detecting a seizure event or by external patient activation, EEG monitor 14 will provide a wireless trigger signal to ECXJ monitor 12 to trigger simultaneous capture of ECG data.

External telemetry head 16. together with external programmer 18, can retrieve the recorded data from both monitors 12 and 14. and display them in parallel on data display 20 for diagnosis. The clock values (e.g. a real time stamp or a clock count) recorded by both monitors 12 and 14 as a result of a trigger used to synchronize the captured EECJ and ECG data allow the data to be viewed in parallel.

The wireless link between monitors 12 and 14 provides a simple wireless communication with the goal of synchronizing recording of ECG and EEG data. Since

continuous transmission is not required, the instantaneous power of wireless transmission can he high, while the average continuous current is low, because episodes of arrhythmias and seizures aie infrequent.

In the past, there has been no long-term diagnostic method for capturing both ECG and EEG data during infrequent symptomatic events such as vasovagal syncope and seizures Thus, there has not been a reliable diagnostic method to distinguish between an event in which a seizure leads to cardiac arrhythmia, and an event in which cardiac arrhythmia results in syncope and an associated seizure-like behavior In many patients, the spells of syncope or seizure-like behavior are too infrequent for short term monitoring methods to be effective.

System 10 provides synchronized simultaneous recording of EEG and ECG signals during symptomatic events such as syncope and/or seizures to help identify the underlying causes of the patient's symptoms To the extent that the cardiac arrhythmias are a primary cause of infrequent symptomatic events, the effectiveness and side effects of anti -seizure medications for the patient can be evaluated

Another issue with patients having infrequent syncopal/seizure events is a high incidence of sudden death, referred to as sudden death in epilepsy patients or SUDEP. Simultaneous capture of ECG and EEG data during arrhythmia may provide important diagnostic and research information regarding SUDEP.

The use of separate implantable monitors 12 and 14 allows each IMD to be small and easy to implant in the particular area where the physiological signal of interest (ECG or EEG) can be easily measured In contrast, the use of a single IMD would require that all circuitry be contained in a single housing, and that leads be tunneled between the head and the chest, throueh the neck resion.

FIG. IB shows another embodiment including ECG monitor 12 and EEG monitor 14, together with implanted aortic aneurysm monitor 24, wristwatch physiologic sensor 26, and pager 28 System 10 ^' uses an externally wearable relay unit (in this case pager 28) to communicate with and synchronize the operation of monitors 12, 14, 24, and 26.

Because pager 28 is an externally wearable unit, additional complexity needed to provide a low noise receiver and a high power transmitter can more easily be achieved than with implantable devices. Power consumption of implantable monitors 12. 14, and 24 is reduced by the use of an external relay device such as pager 28

Upon receiving an event trigger signal from any one of monitors 12. 14, 24, or 26, pager 28 can transmit data acquisition start triggers for all of the monitors at once Pager 28 can also contain memory tor storing data received from monitors ! 2, 14, 24, and 26, as well as wireless links to data networks, such as Wl-Fl or cell phones Pager 28 can also contain electronics to receive accurate clock signals, such as from GPS, and update the clocks of monitors 12, 14, 24, and 26 on a periodic basis.

As shown in FiG IB, pager 28 communicates with wireless tower T to send data gathered by monitors 12, 14, 24, and 26 for review and analysis by medical personnel. Although in FIG. IB pager 28 acts as the externally wearable relay unit, other devices can be used to perform the relay function. For example, a vvristvvatch monitor 26 can be configured to perform the relay function The external relay unit could also be in the form of a pendant connected to a necklace. The external relay unit {i.e. pager 28) can also include an additional physiologic sensor within its housing to augment the monitoring of patient P

FIG. 2 shows a block diagram of representative circuitry of an implantable monitor, such as ECG monitor 12 or EEG monitor 14. The circuitry includes sensing electrodes 30, signal processing circuitry 32, event detection circuit 34. analog-to-digital (A/D) converter 36, data compression circuit 38, memory control 40, memory 42, trigger circuit 44, real time clock 46, and telemetry 48

Physiologic signals representing ECG activity (in the case of ECG monitor 12) or EEG activity (in the case of EEG monitor 14) are sensed by electrodes 30. For ECG monitor 12, electrodes 30 may be any number of electrodes (at least 2) carried on the outer surface near opposite ends of the housing of monitor 12 or short leads extending from the housing carrying one or more electrodes. EEG monitor 14 may have a similar arrangement of electrodes on its housing, or may also include a lead (or leads) extending from the housing and carrying one or more EEG electrodes. These KEG electrodes can be located in the subcutaneous space or implanted through the skull into the dura space to provide better signal amplitude and quality.

Signal processing circuitry 32 amplifies and filters the physiologic signals received from electrodes 30. The output of signal processing circuitry 32 is provided to detection circuitry 34 and to A/D converter 36. Detection circuitry 34 provides signal analysis of the physiologic signals for detecting a physiologic event. In the case of ECG monitor 12, detection circuitry 34 detects the QRS complex of the ECG signals, and determines heart

rate. which is then used to detect cardiac arrhythmia. HCG monitor 12 also uses morphological features to detect abnormalities, such as S-T segment elevation. In the case of EEG monitor 14, detection circuitry 34 analyzes the EEG signals in order to delect a seizure event.

The physiologic signal (ECG or EEG) is converted to digital form by A. ^' D converter 36 and may be compressed by compression circuitry 38 for storage in memory 42. Because storage is limited, a looping memory organization may be used for storing and rewriting data, so that only data corresponding to detected events is retained in memory 42. A description of a method of storing data in a looping memory structure is found in the Klein et al. U.S. Patent No. 5,987,352.

Upon detection of a physiologic event, detection circuit 34 provides a detection input to trigger circuit 44. The output of trigger circuit 44 is a trigger signal that is provided to memory control 40, real time clock 46, and telemetry 48

The trigger signal from trigger circuit 44 is used fay memory control 42 to define data within memory 42 stored before and after the trigger event that will be retained for later transmission to telemetry head 16 and external programmer 18 The trigger signal also causes real time clock 46 to provide to memory 42 a clock value indicating the time or clock count at which the trigger signal occurred.

The trigger signal from trigger circuit 44 is supplied to telemetry circuit 48, and is transmitted to the other monitor in order to synchronize data capture between monitors 12 and 14. When a telemetry -delivered trigger is received from an externa! source (i.e either the other monitor or patient activator 22), trigger circuit 44 supplies a trigger signal to real time clock 46 and memory circuit 40 This causes storage and retention of data in memory 42. along with a time stamp or clock count indicating when the telemetry-delivered trigger was received.

Later, data is retrieved from KCG monitor 12 and KEG monitor 14 using external telemetry head 16 (FlG. IA), pager 28 (FIG. IB), or another external telemetry device. At that time, data is retrieved from memory 42 and is supplied by telemetry circuit 48 to the external device. In addition, the current time of transmission (or clock, count) is supplied by real time clock 46 and transmitted by telemetry circuit 48.

External programmer I S (or another external device that receives the data) can determine the time at which the trigger event corresponding to the captured data occurred by using clock value (the time stamp or clock count) at the time of the trigger event, and

the clock value at the time of transmission of the data as well as the time indicated by a real time clock of external programmer i 8, By knowing the clock value at time of transmission, the corresponding real lime and the clock frequency of monitor 12 or 14, external programmer can calculate the time of the event based on the trigger event clock- value. After data has been retrieved from one monitor, external telemetry head 16 is placed near the other monitor to repeat the data retrieval process

When the data retrieval is complete, each of the monitors 12 and 14 will ha\e provided its captured data with a trigger time stamp, together with the time of transmission (and also possibly via an event ID transmitted from one device to the other at the time of the synchronized trigger). With that information, external programmer 18 can correlate the data, so that EEG and ECG data corresponding to the same trigger event can be displayed in a time-correlated fashion on data display 20

Systems 10 and 10 ^" do not require that the real-time clocks 46 of monitor 12 and 14 be synchronized via a common clock. Rather, it is only necessary that time of the events by tracked by the separate monitors accurately enough to correlate the events {generally within several minutes will suffice). Alternatively, event ϊD ^λ s could be passed from device-to-device on the triggers and kept with the events to correlate them later. In that case, the correlation is done independent of the clocks themselves. It is important that each monitoring device in conjunction with the retrieval times as indicated by external programmer 18, keep track of the time of events to within minutes of the event to help correlate to the symptoms remembered by patient P.

Another application of telemetry -synchronized operation of multiple IMDs provides synchronized therapy in response to a detected physiologic, event rather than data capture. ^' The synchronized therapy can be any type of stimulus that affects an organ, tissues, or nerves. Examples of stimuli produced in response to a telemetry trigger include electrical, thermal, optical, chemical, mechanical, or magnetic stimuli. Telemetry- synchronized operation of IMDs for therapy delivery can be used to synchronize any physiologic function occurring remotely that is not being controlled by normal synchronizing body signals (e.g. neuropaths or neuro-hoπnonal signals in the bloodstream), or by physical relationships (e g. breathing muscle movement causing pressure drops in the chest, pulling air through the pharynx)

An example of telemetry-synchronized therapy deliver)' is sleep apnea treatment system 50, shown in FlG 3 System 50 includes respiration sensor 52, implantable sensor

detector 54. implantable stimulator 56, and stimulator lead 58 System 50 provides treatment for obstructive sleep apnea by sensing a characteristic of respiratory effort, detecting an event based upon the sensed respiratory eiTort characteristic, producing a wireless trigger signal based upon the detected event, and providing inspiration synchronized stimulation in response to the trigger signal.

Respiration sensor 52 is surgically implanted in the chest wall near the lungs, and is connected by lead 60 to inspiration detector 54 Respiration sensor 52 may be, for example, a pressure sensor placed just below the dicrotic notch in manubrium M. Signal processing circuitry and detection logic of inspiration detector 54 processes the respiratory effort signal produced by respiration sensor 52. Based upon the respiratory effort signal, inspiration detector 54 produces a trigger signal having a synchronized relationship to the onset of inspiration. Inspiration detector 54 transmits the trigger signal by a wireless synchronizing link to stimulator 56.

As shown in FlG. 3, stimulator 56 is implanted in or near the base of tongue T. to response to the wireless trigger signal stimulator 56 produces an electrical stimulus that is delivered through stimulator lead 58 to hypoglossal nerve H. The stimulus causes tongue T to he pulled forward to avoid an apnea event.

System 50 operates in a manner similar to the sleep apnea treatment system described in the Christ opherson et al. U S Patent No 6, 132,384 System 50, however, uses two implantable devices (inspiration detector 54 and stimulator 56) rather than a single implantable pulse generator as described in the Christopher son et al. patent. By using two small implantable devices and a wireless synchronizing link, the tunneling of leads through the neck region of patient P is avoided

FKJ. 4 shows another implementation of telemetry synchronization of IMDs timed to provide staggered delivery of therapy to organs, tissues, or nerves. FlG. 4 shows an example of telemetry-synchronized therapy with leg control system 70 used to help a paralyzed person (e.g a stroke victim) walk.

Leg control system 70 includes as many as six implanted devices interconnected with wireless links. Sensor/controller 72 is implanted in the upper leg region, sensor 74 is implanted in the chest, sensor 76 is implanted in the lower leg above the ankle, and sensor 7S is implanted in the foot Sensors 72. 74, 76, and 78 may be aecelerometers that provide outputs related to orientation or inclination of particular parts of the body Stimulators 80 and 82 are implanted in the lower ieg on or near the deep peroneal and superficial peroneal

nerves to provide drop foot stimulation Deep peroneal nerve stimulation controls muscles that lift and invert the foot, while superficial peroneal nerve stimulation controls muscles thai evert the foot.

Sensor/controller 72 acts as the master control for leg eontrol system 70, Sensor/controller 72 detects an urge to walk by sensing when the upper leg is elevated. Sensor/controller 72 receives wireless signals from sensors 74, 76 ₅ and 78 indicating body posture, lower leg orientation and foot orientation. Sensor/controller 72 provides wireless trigger signals to stimulators 80 and 82, in a sequence required to provide a normal gait for the patient F,

In leg control system 70, the signals from different implantable sensors 72, 74, 76, and 78 require more complex coding, so that sensor/controller 72 can identify which sensor is providing the signals. In addition, the trigger signals from sensor/controller 72 must be coded so that stimulators 80 and 82 can identify the wireless trigger signal to which it will respond

FIG. 5 shows arterial monitoring system 90, which illustrates the use of telemetry- synchronized operation of multiple IMDs in measuring timing differences between pressure measurements made by different IMDs Arterial monitoring system ^Q O includes implantable monitor 92 and implantable pressure sensors ^c >4 and % located on different segments of the same artery A. When upstream sensor 94 detects a pressure pulse in artery A, it provides a synchronizing trigger to monitor 92 and downstream sensor 96. The wireless trigger allows the downstream sensor % to measure time until it detects the same pressure pulse in its segment of artery A. The time difference information can be transmitted to monitor 92, and stored for later transmission

Alternatively, monitor 92 can provide a trigger to sensors 04 and 96 to cause a time measurement cycle to begin. Sensors ^Q - ^: i and 96, in turn, produce wireless trigger signals upon sensing a pressure pulse in artery A. Monitor 92 measures the time difference between the trigger signal from upstream sensor 94 and the trigger signal from downstream sensor 96 The time differences can be used as a measure of transmission characteristics of the blood vessel to assess hardening of the arteries (i.e atherosclerosis) Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention