Systems and related methods for optimization of multi-electrode nerve pacing

• US 10,391,314 B2
• Filed: 02/08/2017
• Issued: 08/27/2019
• Est. Priority Date: 01/21/2014
• Status: Active Grant

• Current Assignee: Lungpacer Medical Inc.
• Original Assignee: Lungpacer Medical Inc.
• Inventors: Hoffer, Joaquin Andres, Sadarangani, Gautam, Nolette, Marc-Andre, Thakkar, Viral, Tran, Bao Dung
• Primary Examiner(s): Kahelin, Michael W
• Application Number:
  US15/427,924
• Publication Number:
  US 20170143975A1
• Time in Patent Office: 930 Days
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

This disclosure describes, among other embodiments, systems and related methods for selecting electrode combinations to be used during nerve pacing procedures. A first set of electrode combinations of a nerve pacing system, such as a phrenic nerve pacing system for diaphragm activation, may be mapped (or tested) to determine the location of the electrode combinations relative to a target nerve. Once the general location of the target nerve is known, a more localized second set of electrode combinations may be tested to determine the most suitable electrode combinations for nerve stimulation. At various stages of the mapping process, electrode combinations that are non-optimal may be discarded as candidates for use in a nerve pacing procedure. The systems and methods described herein may allow for the selection of electrode combinations that are most suitable for stimulation of the left and right phrenic nerves during diaphragm pacing.

Claims

1. A method for determining a relationship between charge and diaphragm response for an electrode combination, comprising:

inserting a plurality of electrodes into one or more blood vessels of a patient, wherein the plurality of electrodes include the electrode combination;

using the electrode combination, stimulating a phrenic nerve with a plurality of stimulation pulses, wherein each stimulation pulse includes a corresponding charge, and the corresponding charges differ among the plurality of stimulation pulses;

determining a recruitment curve relating the corresponding charges to diaphragm responses resulting from the corresponding charges, wherein the recruitment curve also relates undelivered charges to diaphragm responses expected from the undelivered charges; and

after determining the recruitment curve;

a) stimulating the phrenic nerve with the electrode combination, b) using the recruitment curve, determining an expected diaphragm response, to the stimulation, and c) comparing an actual diaphragm response to the expected diaphragm response.

2. The method of claim 1, wherein diaphragm response reflects at least one of a change in:

airway pressure, airway flow, electromyography, or chest wall acceleration.

3. The method of claim 1, wherein determining the recruitment curve includes determining an activation threshold, and the activation threshold is a charge level that has a predefined chance of causing a contraction of the diaphragm.

4. The method of claim 1, wherein determining the recruitment curve includes determining a range of charges that result in diaphragm responses that increase proportionally.

5. The method of claim 1, wherein determining the recruitment curve includes determining a charge causing zero recruitment of the phrenic nerve.

6. The method of claim 1, wherein stimulating the phrenic nerve with the plurality of stimulation pulses occurs during a plurality of end-expiratory phases of patient breaths.

7. The method of claim 1, wherein the patient is receiving breathing assistance from a ventilator.

8. The method of claim 1, wherein the charge of each stimulation pulse is a function of at least one of current amplitude, pulse width, or voltage.

9. The method of claim 1, wherein the plurality of electrodes are supported by a catheter, the phrenic nerve is a left phrenic nerve, and the method further comprises positioning a first portion of the plurality of electrodes proximate the left phrenic nerve and positioning a second portion of the plurality of electrodes proximate a right phrenic nerve.

10. The method of claim 9, further comprising positioning the first portion of the plurality of electrodes in a left subclavian vein, and positioning the second portion of the plurality of electrodes in a superior vena cava.

11. The method of claim 1, wherein the plurality of electrodes are supported by a catheter, and the method further comprises identifying a subsection of the catheter in proximity to the phrenic nerve prior to determining the relationship.

12. A method for determining a relationship between charge and diaphragm response for an electrode combination, comprising:

with a ventilator, assisting a plurality of breaths of a patient;

inserting a plurality of electrodes into one or more blood vessels of the patient, wherein the plurality of electrodes include the electrode combination;

during end-expiratory phases of a plurality of breaths, emitting a plurality of stimulation pulses from the electrode combination, wherein each stimulation pulse includes a corresponding charge, and the corresponding charges differ among the plurality of stimulation pulses;

measuring diaphragm responses to the plurality of stimulation pulses;

determining a recruitment curve relating the corresponding charges to the measured diaphragm responses and relating other undelivered charges to a plurality of expected diaphragm responses; and

after determining the recruitment curve;

a) stimulating the phrenic nerve with the electrode combination, b) using the recruitment curve, determining an expected diaphragm response of the plurality of expected responses to the stimulation, and c) comparing an actual diaphragm response to the expected diaphragm response.

13. The method of claim 12, wherein a portion of the plurality of stimulation pulses is delivered during a single end-expiratory phase of a patient breath, and the portion includes pulses having a same charge.

14. The method of claim 12, wherein a portion of the plurality of stimulation pulses is delivered during a single end-expiratory phase of a patient breath, and each pulse of the portion increases in charge relative to a previous pulse.

15. The method of claim 12, wherein a first portion of the plurality of stimulation pulses includes pulses having a first same charge, a second portion of the plurality of stimulation pulses includes pulses having a second same charge, the second same charge being higher than the first same charge, and a third portion of the plurality of stimulation pulses includes pulses having a third same charge, the third same charge being higher than the second same charge.

16. The method of claim 12, wherein the electrode combination is a first electrode combination, the plurality of breaths is a first plurality of breaths, and the method further includes repeating the emitting step, the measuring step, and the determining step with a second electrode combination of the plurality of electrodes during a second plurality of breaths.

17. The method of claim 12, wherein at least one pulse of the plurality of stimulation pulses does not cause a diaphragm response.

18. The method of claim 12, wherein one expected diaphragm response of the plurality of expected diaphragm responses is no response.

19. The method of claim 12, further comprising, if the actual diaphragm response differs from the expected diaphragm response, halting stimulation of the phrenic nerve with the electrode combination and re-executing the steps of emitting a plurality of stimulation pulses, measuring diaphragm responses, and determining the recruitment curve.

20. The method of claim 12, further comprising, at preset time intervals, halting stimulation of the phrenic nerve with the electrode combination and re-executing the steps of emitting a plurality of stimulation pulses, measuring diaphragm responses, and determining the recruitment curve.