Electrical stimulation for preservation and restoration of diaphragm function

• US 10,300,272 B2
• Filed: 05/22/2017
• Issued: 05/28/2019
• 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:
  US15/601,315
• Publication Number:
  US 20170296812A1
• Time in Patent Office: 736 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 method of stimulating a diaphragm to provoke motion of the diaphragm of a patient during inspiration comprising:

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

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

c. modifying the stimulation signal in response to the actual value of the measurement of the diaphragm work being outside of a selected range of a value of diaphragm work exerted by the patient.

2. The method of claim 1, wherein obtaining the measurement of the work exerted by the patient includes sensing mechanical characteristics of air flow generated by the patient'"'"'s lungs.

3. The method of claim 2, wherein obtaining the measurement of the work exerted by the patient includes using the sensed characteristics of air flow relative to the patient'"'"'s lungs to determine a measurement of work carried out by the patient'"'"'s diaphragm.

4. The method of claim 1, wherein obtaining the measurement of the work exerted by the patient includes sensing characteristics of air flow for a plurality of breaths taken by the patient, and determining an average measurement of work exerted over the plurality of breaths.

5. The method of claim 1, wherein obtaining the measurement of the work exerted by the patient includes obtaining the measurement of work exerted during a breath taken by the patient without stimulation of the patient'"'"'s phrenic nerve.

6. The method of claim 1, further including repeating step a using the modified stimulation signal.

7. The method of claim 1, wherein stimulating the phrenic nerve with the stimulation signal includes using the modified stimulation signal.

8. The method of claim 1, wherein modifying the stimulation signal includes training the patient'"'"'s diaphragm by reducing the stimulation signal to a reduced level of stimulation determined for operating the diaphragm of the patient.

9. The method of claim 8, wherein the reduced level of stimulation is a level of stimulation below a level determined to be required to obtain gross motion of the diaphragm and lungs in a normal healthy patient.

10. The method of claim 1, wherein stimulating the phrenic nerve includes using an electrical lead to apply the stimulation signal to the patient'"'"'s phrenic nerve, further including identifying a type of the electrical lead based on a resistance characteristic of the electrical lead, and configuring the stimulation signal based on the identified type of the electrical lead.

11. The method of claim 1, wherein obtaining the measurement of the work exerted by the patient includes determining the measurement of work utilizing air flow and pressure generated by the patient'"'"'s lungs and based on mechanics of the patient'"'"'s lungs including lung compliance and resistance.

12. The method of claim 1, wherein obtaining the measurement of the work exerted by the patient includes sensing characteristics of work for a plurality of breaths taken by the patient, and determining an average measurement of work exerted over the plurality of breaths.