Hemodynamic performance enhancement through asymptomatic diaphragm stimulation

• US 9,694,185 B2
• Filed: 09/22/2016
• Issued: 07/04/2017
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: Viscardia, Inc.
• Original Assignee: Viscardia, Inc.
• Inventors: Bauer, Peter T.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US15/273,643
• Publication Number:
  US 20170007832A1
• Time in Patent Office: 285 Days
• CPC Class Codes: A61B 2562/063 in a linear array
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

An implantable system, and methodology, for improving a heart'"'"'s hemodynamic performance featuring (a) bimodal electrodes placeable on the diaphragm, out of contact with the heart, possessing one mode for sensing cardiac electrical activity, and another for applying cardiac-cycle-synchronized, asymptomatic electrical stimulation to the diaphragm to trigger biphasic, diaphragmatic motion, (b) an accelerometer adjacent the electrodes for sensing both heart sounds, and stimulation-induced diaphragmatic motion, and (c) circuit structure, connected both to the electrodes and the accelerometer, operable, in predetermined timed relationships to the presences of valid V-events noted in one of sensed electrical and sensed mechanical, cardiac activity, to deliver diaphragmatic stimulation. The circuit structure includes accelerometer-linked computer structure for enabling selective review, for later operational modifications, of stimulation-produced diaphragmatic motions, and in a modified form, may additionally include timing-adjustment substructure capable of making adjustments in the mentioned timed relationships.

Claims

1. A method for improving a hemodynamic performance of a subject'"'"'s heart, the method comprising:

from adjacent a selected surface region of the subject'"'"'s diaphragm, sensing and noting a presence in the subject'"'"'s cardiac cycles of a selected one of (a) a valid electrical cardiac event that occurs on a per-cardiac-cycle basis, and (b) a valid mechanical cardiac event that occurs on a per-cardiac-cycle basis; and

upon noting a presence of a selected cardiac event, applying in a predetermined timed relationship to the noted selected cardiac event, and for a duration less than a cardiac cycle, an asymptomatic electrical stimulation directly to the diaphragm, wherein the electrical stimulation triggers motion of the diaphragm.

2. The method of claim 1, wherein the valid electrical cardiac event corresponds to one of a R wave and a Q wave.

3. The method of claim 1, wherein the valid mechanical cardiac event corresponds to a S1 heart sound.

4. The method of claim 1, wherein the predetermined timed relationship is one that:

(a) anticipates a next-expected presence of the selected valid cardiac event, or (b) follows a last sensed presence of the selected valid cardiac event.

5. The method of claim 1, wherein the electrical stimulation is applied at the selected surface region of the subject'"'"'s diaphragm.

6. The method of claim 1, wherein the selected surface region of the subject'"'"'s diaphragm is spaced from the heart.

7. The method of claim 1, wherein the selected surface region comprises one of an inferior side of the diaphragm, and a superior side of the diaphragm.

8. The method of claim 1, further comprising:

from adjacent a selected surface region of the subject'"'"'s diaphragm, sensing and noting a presence in a cardiac cycle of an errant electrical cardiac event; and

based upon the noting of the errant electrical cardiac event, withholding delivery of asymptomatic electrical stimulation during the cardiac cycle.

9. The method of claim 1, further comprising:

following the applying, monitoring a waveform of diaphragmatic motion resulting from the applying;

comparing the monitored waveform with a reference waveform; and

recording the monitored waveform for later review.

10. The method of claim 1, wherein the motion of the diaphragm induced by an asymptomatic electrical stimulation directly to the diaphragm is characterized by biphasic, caudal-followed-by-cranial motion.