Stimulation suspension in response to patient discomfort or state

Inventors

Libbus, Imad • Stubbs, Scott R. • Kenknight, Bruce H.

Assignees

Livanova USA Inc

Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients. Stimulation from an implantable medical device (IMD) may be suspended in response to detecting a patient discomfort event, such as a cough, throat irritation, or voice alteration. The suspension period may be based on at least one of a severity level of the patient discomfort event and a patient physical state, such as being asleep or lying down. Detection of a patient discomfort event may be calibrated.

Core Innovation

The invention relates to neurostimulation therapy using an implantable medical device, including cervical vagus nerve stimulation, where stimulation is suspended in response to detecting a patient discomfort event. The patient discomfort event comprises at least one of a cough, a throat irritation, or a voice alteration, and the stimulation is suspended for a suspension period.

Subsequent to the suspension period, a subsequent patient discomfort event is detected that comprises at least one of a cough, a throat irritation, or a voice alteration. The invention determines an elapsed time between an end of the suspension period and the subsequent patient discomfort event and adjusts a duration of the suspension period based on the elapsed time.

In further described implementations, detection and suspension operation are tied to stimulation timing cycles, including an OFF cycle and an ON cycle, such that suspension is implemented by stopping stimulation and delaying initiation of a next ON cycle. The described approaches also include determining or adjusting suspension timing using severity level and/or proximity to target stimulation parameters, and adjusting using patient discomfort event response levels relative to patient discomfort event response thresholds.

The invention further describes sensor-based detection of patient discomfort events using sensor modalities such as an accelerometer, an acoustic sensor, an impedance sensor, a piezoelectric sensor, and a transthoracic impedance sensor, together with calibration and qualification that include clinician-led interactive training sessions, determining a qualification window, and root-cause analysis to reduce false positives.

Claims Coverage

The independent claims cover methods and an implantable medical device that detect patient discomfort events and suspend stimulation, with subsequent elapsed-time measurement and adjustment of the suspension period duration, including severity- and threshold-based refinements. Across the independent claims, there are two primary inventive feature clusters: event-detection-driven stimulation suspension with elapsed-time-based adjustment, and severity-based determination and response-time or duration control, including cycle-linked suspension implementation and sensor modality specification.

Across the independent claims, the core coverage is directed to detecting cough, throat irritation, or voice alteration events, suspending neurostimulation from an IMD for a suspension period, then detecting a subsequent discomfort event to measure elapsed time since suspension ended and adjusting the suspension duration accordingly, with additional claim refinements involving severity- and threshold-based control of suspension behavior and, in described dependent refinements, cycle-linked suspension and specific sensor modalities.

Stated Advantages

Documented Applications