Surgery – Diagnostic testing – Respiratory
Reexamination Certificate
2002-12-05
2004-08-10
Jones, Mary Beth (Department: 3736)
Surgery
Diagnostic testing
Respiratory
C600S536000, C600S529000, C600S595000, C600S301000
Reexamination Certificate
active
06773404
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to “active medical devices” as such devices are defined by the Jun. 14, 1993 Directive 93/42/CEE of the Council of the European Communities. Although described in the case of implantable active medical devices, such as cardiac pacemakers, defibrillators and/or cardiovertors devices that are able to deliver to the heart low energy pulses for treating disorders of the heartbeat rate, it should be understood that the invention is not limited to such implantable active medical devices, but is rather directly applicable to many types of diagnostic and/or therapeutic active medical devices.
BACKGROUND OF THE INVENTION
The invention more particularly relates to improvements in the diagnosis of disorders that occur when a patient is asleep. This includes disorders of a cardiac nature, and disorders of a respiratory nature, including disorders such as apnea or hypopnoea revealing in particular a pathology known as “sleep apnea syndrome” (SAS). An apnea is generally defined as being a respiratory pause of a duration greater than 10 seconds and occurring during a phase of sleep of the patient (because an apnea during phase of awakening (i.e., when the patient is awake) cannot in any case be the cause of an SAS condition).
A diagnosis of sleep-related disorders implies that the device can effectively discriminate between when the patient is awake (i.e., in an awake phase) and asleep (i.e., in a sleep phase). An analysis of the patient's respiration rate and/or cardiac rate to be carried out for this diagnosis is/are to be made only during a sleep phase.
The importance of a precise discrimination between sleep and awakening is made even more necessary when the device not only operates a diagnostic function but also applies a therapy: The therapy should be applied only during a sleep phase, and any therapy must be inhibited if the apnea occurs during an awakening phase, because such an apnea is a normal event and not pathological.
According to published European Patent Application EP-A-0 719 568 and its counterpart U.S. Pat. No. 5,622,428, commonly assigned to the assignee of this invention, Ela Médical, it is known to operate a discrimination between awakening and sleep by analysis of a physiological signal, namely the minute-ventilation (MV) parameter representative of the periodicity and amplitude of successive respiratory cycles of the patient. The minute-ventilation is a known parameter that is defined as the product of the amplitude by the frequency of the respiration. The reader is referred to U.S. Pat. No. 5,622,428, the disclosure of which is expressly incorporated herein by reference in its entirety, for additional details. More precisely, EP-A-O 719 568 and U.S. Pat. No. 5,622,428 disclose a sensor MV which includes circuits to measure an impedance related to the patient's respiratory activity and process that impedance measurement to produce a series of successive samples of a minute ventilation signal (referred to herein as “signal MV”) and to calculate an average of the samples over a given number of respiratory cycles, for example, the last 128 cycles, and to compare this average value with a reference value, for example, the average of signal MV over the last 24 hours. Indeed, the circadian variation of the frequency and amplitude of the respiratory cycles is well reproduced by the signal MV. The calculation of the average ventilation over 24 hours thus makes it possible to operate a satisfactory discrimination between ventilation of an awake patient and a ventilation of an asleep patient.
However, the signal MV has a natural variability because it is at the same time of a vegetative and of a controlled nature of the respiratory system. Thus, for example, none of the sighs, the voluntary apnea during speech, and the apnea of the sleep, that appear in an instantaneous measurement is representative of an effective level of the current minute-ventilation, i.e., of the level making it possible to analyse the state of activity of the patient.
For this reason the diagnosis of awakening or sleep can be operated in a reliable way only if one determines the current minute-ventilation by use of an average of a relatively high number of respiratory cycles, typically the last 128 respiratory cycles; this sample set is used in order to eliminate the natural variation as well as the artifacts that are related to the measuring equipment.
The consequence of proceeding in this manner is that, when the patient state changes based on the respiratory activity passing from a sleep phase to an awakening phase, the system of detection presents a certain delay at the diagnosis of the awakening. This is because the average value of signal MV needs to become higher than the reference threshold to make it possible to discriminate between awakening and sleep phases. The problem arises in the same way at the time of the passage of the patient state from an awakening state to a sleep phase. In certain cases, this delay is not awkward. For example, the progressive reduction in the cardiac stimulation frequency during sleep, intended to respect the natural physiology of the patient, does not require a significant reactivity.
On the other hand, the monitoring of an event or the follow-up of a parameter occurring exclusively during the sleep phase (respiratory disorder such as sleep apnea, particular cardiac events) can require a great reactivity in order not to miss the event. This is particularly significant when the patient has a de-structured sleep that presents many awakenings during the night, especially if these awakenings are, precisely, caused by the events which one seeks to detect (a typical example being sleep apnea).
Moreover, if the incidence of the analysed parameter is calculated as from the time of total sleep (as in the case of the calculation of a sleep apnea syndrome, which is defined as a minimum number of apnea per hour of sleep), it is all the more necessary to quickly identify the transitions between phases of awakening and sleep to evaluate correctly the time of total sleep and to operate a correct diagnosis. Such is the case, for example, the case when one defines that there is SAS when the apnea index exceeds a predetermined threshold, for example, more than ten apnea per hour of sleep.
OBJECTS AND SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to mitigate the disadvantages due to the delay in the diagnosis of an awakening phase or a sleep phase during a phase shift, a delay resulting from the need for averaging the signal MV over a relatively large number of respiratory cycles.
It should be understood, however, that the invention is not limited to the devices proceeding by analysis of a physiological signal such as minute-ventilation, nor even of a signal representative of the respiratory activity of a patient. It is rather the most current configuration, and the present description will be made within the framework of this example. However, the invention applies equally as well to devices implementing other types of physiological sensors having a slow evolution of the signal over time, such as pH or temperature sensors, sensors of oxygen saturation of blood, etc.
It is another object of the invention to improve the reactivity of the active medical device to changes between phases of awakening and sleep, thus to improve the diagnosis, to avoid the false positive detection (i.e., detection of an apnea or an artifact at the beginning of a phase of awakening), and to avoid a false negative detection (non-detection of an apnea at the beginning of a phase of sleep).
The invention also has as an object to improve the conditions for triggering delivery of a therapy, to avoid applying a therapy that should be exclusively applied only during phases of sleep and is inappropriate during phases of awakening.
Broadly, the present invention employs an auxiliary sensor having a relatively fast response time, typically a sensor that is responsive to patient activity or acceleration (“sensor G”), having
Limousin Marcel
Poezevera Yann
ELA Medical S.A.
Jones Mary Beth
Natnithithadha Navin
Orrick Herrington & Sutcliffe LLP
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