Active medical device for the selective and early treatment of hypopneas

Patent metadata

Field	Value
Publication number	US-2016113571-A1
Application number	US-201514922539-A
Country	US
Kind code	A1
Filing date	Oct 26, 2015
Priority date	Oct 27, 2014
Publication date	Apr 28, 2016
Grant date	—

Abstract

The invention relates to an active implantable medical device. The device measures for respiratory activity and for detection of a ventilation rate fall event below a predetermined threshold. The device analyzes in real time the various parameters of the ventilation rate fall event and determines whether they satisfy predefined criteria, so as to allocate or not a priori hypopnea suspicion indicator to the event. An anti-hypopnea therapy is selectively triggered on detection of respiratory collapse, but only in the case of current events indicating a priori hypopnea suspicion. The criteria may include: history of intervals between successive events constituting hypopnea episodes; severity of the current event; conformity of a current event profile with a reference profile; physiological, obstructive or central, origin of the event; patient's current sleep stage; and history of the degree of efficacy of the therapies.

First claim

What is claimed is:

1 . An active medical device, comprising:
a processor configured to:
measure respiratory activity, the measurement providing a representative value of the instantaneous ventilatory flow rate of a patient;
detect a ventilatory fall event by detecting in real time a decrease in the value of the instantaneous ventilatory flow rate below a predetermined threshold; and
provide anti-hypopnea therapy, wherein the processor is configured to:
assess at least one parameter of the ventilatory fall event, the processor adapted to analyze in real time during the ventilatory fall event and determine if the parameter satisfies at least one predetermined criterion, for assigning to the ventilatory fall event a hypopnea suspicion indicator or a non-hypopnea suspicion indicator; and
selectively applying an anti-hypopnea therapy in the case of attribution to the current ventilatory fall event the hypopnea suspicion indicator, the anti-hypopnea therapy triggered before the end of the ventilatory fall event.

2 . The device of claim 1 , wherein the processor is further configured to:
inhibit the anti-hypopnea therapy in case of attribution to the current ventilatory fall event of the non-hypopnea suspicion indicator.

3 . The device of claim 1 , wherein:
the at least one predefined criterion comprises the value of a counter of successive ventilatory fall events detected within the range of a predetermined period corresponding to the duration of an episode of hypopneas; assessing the at least one parameter further comprises assigning a suspicion indicator of hypopnea to the current ventilatory fall event only if the counter value exceeds a minimum predetermined value; and the counter is reset if the time between successive ventilatory fall events exceeds the predetermined period corresponding to the duration of an episode of hypopneas.

4 . The device of claim 3 , wherein the processor is further configured to:
measure a physiological signal as a function of the respiratory activity; detect the crossing of a threshold limit by the physiological signal; and increment the counter at any detection of a ventilatory fall event.

5 . The device of claim 3 , wherein the predetermined period and/or the predetermined minimum value are variable adaptive values, and wherein the processor is further configured to:
calculate, respectively, the predetermined period and/or the predetermined minimum value during the night.

6 . The device of claim 1 , wherein the processor is further configured to:
measure a physiological signal as a function of the respiratory activity; detect the crossing of a threshold limit by a respiratory signal or by the physiological signal; and trigger the anti-hypopnea therapy at the crossing of the limit threshold.

7 . The device of claim 6 , wherein the physiological signal is at least one of a level of blood oxygen saturation, a blood oxygen desaturation rate, a heart rate, a blood pressure, a pulse wave, an electroencephalogram, an electromyogram or any combination thereof.

8 . The device of claim 1 , wherein:
the at least one predefined criterion comprises a reference profile of hypopnea stored in memory; the processor is further configured to determine a current profile for the current ventilatory fall event and for evaluate a correlation between the current profile and the reference profile; and the processor is further configured to assign a hypopnea suspicion indicator to the current event if the correlation between the current profile and the reference profile exceeds a predetermined correlation minimum value.

9 . The device of claim 8 , wherein the processor is further configured to:
determine, after the end of the suspected hypopnea event, the presence of an hypopnea consecutive to the detection of the ventilatory fall event; and update the hypopnea reference profile stored in memory, in case of a determined hypopnea.

10 . The device of claim 1 , wherein the discrimination of at least one parameter of the current ventilatory fall event comprises:
analyzing a plurality of parameters of the current ventilatory fall event according to a plurality of predefined criteria; assigning, for the current ventilatory fall event, a respective specific score to each of the predefined criteria; determining an overall composite score based on a combination of specific scores; and assigning to the current event suspicion an a priori suspicion indicator of hypopnea or non-hypopnea based on the result of a comparison of the overall score to a predetermined score threshold.

11 . The device of claim 10 , wherein the discrimination of at least one parameter of the current ventilatory fall event comprises:
selecting, depending on the value of the global score, a particular therapy among several possible therapies.

12 . The device of claim 1 , wherein the at least one predefined criterion is at least one of a history of intervals between successive events constituting the ventilatory fall hypopnea episodes; a severity of the current ventilatory fall event; a conformity of a profile of the current ventilatory fall event with a reference profile; a physiological origin, obstructive or central, of the ventilatory fall event; the patient's current sleep stage; and a history of the degree of efficacy of the applied therapies.

Assignees

• Sorin Crm Sas
• Inserm Inst De La Rech Médicale
• Université De Rennes 1
• Université Joseph Fourier

Inventors

• Amblard Amel
• Graindorge Laurence
• Feuerstein Delphine
• Hernandez Alfredo
• Pépin Jean-Louis

Classifications

• A61H2230/405

  used as a control parameter for the apparatus · CPC title

• A61N1/3611

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title

• A61B5/4836 Primary

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title

• A61H23/00

  Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms {(apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B)} · CPC title

• A61N1/36521

  the parameter being derived from measurement of an electrical impedance · CPC title