Electrical stimulation for preservation and restoration of diaphragm function

• US 9,682,235 B1
• Filed: 12/14/2016
• Issued: 06/20/2017
• Est. Priority Date: 12/14/2015
• Status: Active Grant

• Current Assignee: Stimdia Medical, Inc.
• Original Assignee: Stimdia Medical, Inc.
• Inventors: O'Mahony, John, Wethington, Patrick J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/378,460
• Publication Number:
  US 20170165480A1
• Time in Patent Office: 188 Days
• Field of Search: None
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 2016/0018 electrical
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2210/1014 Diaphragm
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters

Abstract

A system and method are presented that electrically stimulates the phrenic nerve whereby said stimulation results in muscle activation of the diaphragm as observed by a measurement of work or power of breathing associated with the inspiratory portion of a stimulated breath.

Claims

1. A medical device for use with a mechanical ventilator and breathing circuit coupled to a patient, said medical device comprising:

a subcutaneous electrode pair positioned proximate at least one phrenic nerve in the neck of said patient;

a stimulator/controller connected to said electrode pair via a lead cable, said stimulator/controller delivering electrical stimulation to said electrode pair at a pulse repetition rate, with a current and a waveform sufficient to at least partially activate the patient'"'"'s diaphragm;

an instrumented wye coupled to said patient and coupled to said mechanical ventilator via tubing of the breathing circuit, providing a wye flow measurement and a wye pressure measurement to said stimulator/controller;

said stimulator/controller selecting one of several breaths defining a single selected breath;

said stimulator/controller beginning stimulation at the beginning of an inspiratory event in response to an inspiratory trigger event, said event corresponding to a preset specific flow at said instrumented wye;

said stimulator/controller ending stimulation at the end of an inspiratory event triggered by an end inspiratory trigger event, said event corresponding to a specific flow at said instrumented wye;

said inspiratory event trigger and said end inspiratory event trigger together defining a duration for the stimulation within the inspiratory phase of said single selected breath;

a power/work measuring device coupled to said instrumented wye measuring the instantaneous work throughout the inspiratory phase of said single selected breath, by comparing a predicted pressure at the wye and a measured pressure at the wye, and indicating work only if the predicted pressure differs from the measured pressure at said instrumented wye.

2. The device of claim 1 wherein said inspiratory trigger event is a patient initiated event.

3. The device of claim 1 wherein said end inspiratory trigger event is a patient initiated event.

4. The device of claim 1 wherein said inspiratory trigger event is a mechanical ventilator initiated event.

5. The device of claim 1 wherein said end inspiratory trigger event is a mechanical ventilator initiated event.

6. The device of claim 1 further including:

an indicator presenting the level of stimulation delivered during said duration of the single selected breath.

7. The device of claim 1 further including:

an indicator presenting the measured total power and total work for the level of stimulation delivered during the said duration of said single selected breath.