Electrical Stimulation for Preservation and Restoration of Diaphragm Function

• US 20170165480A1
• Filed: 12/14/2016
• Published: 06/15/2017
• 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.
• Granted Patent: US 9,682,235 B1
• Time in Patent Office: Days
• 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 lead system for use with a PEPNS system comprising:

a first lead, the first lead having a housing, the housing containing at least two or more pacing electrodes spaced apart in a linear arrangement and an identifying resistor, each of the pacing electrodes and identifying resistor being in separate electrical communication with a controller of the PEPNS system.

2. The system of claim 1 further comprising a second lead.

3. The system of claim 2 wherein the controller comprises an electrical pulse generator, each electrode being in electrical communication with electrical pulse generator.

4. The system of claim 3 wherein the controller comprises a CPU and a GUI,

the CPU being in electrical communication with each electrode, each identifying resistor and the pulse generator, the CPU controlling the characteristics of an electrical pulse sent to the first lead and the second lead;

the GUI in electronic communication with the CPU.

5. 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.

6. The device of claim 5 wherein said inspiratory trigger event is a patient initiated event.

7. The device of claim 5 wherein said end inspiratory trigger event is a patient initiated event.

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

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

10. The device of claim 5 further including:

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

11. The device of claim 5 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.

12. A method of stimulating a diaphragm to provoke motion of the diaphragm of a patient during inspiration comprising:

a. stimulating the phrenic nerve at a set level during a single selected breath of a patient;

b. obtaining a measurement of the diaphragm work exerted by the patient for the inspiratory breath cycle of a selected breath of a patient;

c. modifying the stimulation signal if the actual value of diaphragm work is outside the selected range of the desired value of diaphragm work exerted by the patient; and

repeating steps a-c.