Hemodynamic performance enhancement through asymptomatic diaphragm stimulation

• US 9,498,625 B2
• Filed: 12/16/2013
• Issued: 11/22/2016
• 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:
  US14/107,976
• Publication Number:
  US 20140172040A1
• Time in Patent Office: 1,072 Days
• US Class Current: 1/1
• 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 fully implantable medical system comprising:

bimodal electrode structure, placeable in contact with a selected surface region of a subject'"'"'s diaphragm at a location out of contact with the subject'"'"'s heart, and having one operating mode for sensing cardiac-cycle electrical activity discernible at the selected surface region, and another, independent, operating mode for applying asymptomatic electrical stimulation to the diaphragm at the selected surface region; and

electrical circuit structure operatively connected to the electrode structure for receiving therefrom information corresponding to the subject'"'"'s cardiac-cycle electrical activity sensed by the electrode structure, the electrical circuit structure operable to note a presence of a valid electrical V-event in such received cardiac-cycle electrical-activity information, and to deliver asymptomatic, cardiac-cycle-synchronized, electrical stimulation through the electrode structure to the diaphragm in a predetermined timed relationship to the valid electrical V-event, the electrical stimulation for a purpose of triggering a biphasic motion of the diaphragm, which biphasic motion comprises a caudal motion of the diaphragm followed by a cranial motion of the diaphragm.

2. The system of claim 1, wherein the predetermined timed relationship is one of (a) one which anticipates a next-expected, valid, cardiac-cycle, electrical V-event, and (b), one which follows a last-sensed, valid, cardiac-cycle, electrical V-event.

3. The system of claim 1 which is one of (a) self-contained as a singular, overall unit, and (b) distributed between a spaced pair of component assemblies operatively interconnected by communication lead structure, and wherein the selected surface region is disposed on one of (a) an inferior side, and (b) a superior side, of the diaphragm.

4. The system of claim 1 with respect to which the valid electrical V-event is one of (a) a R wave, and (b) a Q wave in the subject'"'"'s electrical cardiac-cycle activity.

5. The system of claim 1 further comprising an accelerometer which is (a) disposed adjacent, and operatively associated with, the electrode structure for contact-associated disposition in a motion-sensing relationship with respect to the subject'"'"'s diaphragm, (b) operatively connected to the circuit structure, and (c) constructed to respond to electrical-stimulation-induced motion produced in the subject'"'"'s diaphragm by generating, and communicating to the circuit structure, a diaphragmatic-motion confirmation signal possessing a waveform which is directly indicative of such motion.

6. The system of claim 5, wherein the accelerometer is a multi-axis accelerometer.

7. The system of claim 5 which is one of (a) self-contained as a singular, overall unit, and (b) distributed between a spaced pair of component assemblies operatively interconnected by communication lead structure, and wherein the selected surface region is disposed on one of (a) an inferior side, and (b) a superior side, of the diaphragm.

8. The system of claim 5 with respect to which the electrical V-event is one of (a) a R wave, and (b) a Q wave in the subject'"'"'s electrical cardiac-cycle activity.

9. The system of claim 5, wherein the circuit structure includes algorithmically programmed computer structure having a waveform monitoring and a recording substructure for comparing the waveform of a communicated confirmation signal with a reference waveform, and recording the confirmation-signal waveform for subsequent review.

10. The system of claim 5, wherein the circuit structure includes algorithmically programmed computer structure having timing-adjustment substructure capable of making an adjustment in the mentioned predetermined timed relationships.