Hemodynamic performance enhancement through asymptomatic diaphragm stimulation

• US 9,968,786 B2
• Filed: 06/02/2017
• Issued: 05/15/2018
• 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:
  US15/612,690
• Publication Number:
  US 20170266444A1
• Time in Patent Office: 347 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. An implantable medical system for improving a cardiovascular performance of a subject through electrical diaphragmatic stimulation, the implantable medical system comprising:

a sensing and stimulation structure configured to be coupled to a diaphragm of the subject, to sense cardiac activity through the diaphragm, and to deliver electrical stimulation to the diaphragm, and

a circuit structure coupled to the sensing and stimulation structure, the circuit structure configured to receive sensed cardiac activity from the sensing and stimulation structure, to note a cardiac event in a cardiac cycle of the subject based on the sensed cardiac activity, and to apply, in response to the noted cardiac event, an electrical stimulation to the sensing and stimulation structure in a timed relationship to the noted cardiac event to thereby induce motion of the diaphragm.

2. The implantable medical system of claim 1, wherein the sensing and stimulation structure comprises one or more electrodes and the noted cardiac event comprises an electrical cardiac event that occurs on a per-cardiac-cycle basis.

3. The implantable medical system of claim 2, wherein the electrical cardiac event corresponds to one of a R wave and a Q wave.

4. The implantable medical system of claim 1, wherein the sensing and stimulation structure comprises a motion sensor and the noted cardiac event comprises a mechanical cardiac event that occurs on a per-cardiac-cycle basis.

5. The implantable medical system of claim 4, wherein the mechanical cardiac event corresponds to a S1 heart sound.

6. The implantable medical system of claim 4, wherein the motion sensor comprises an accelerometer.

7. The implantable medical system of claim 1, wherein the electrical stimulation has a duration less than a cardiac cycle.

8. The implantable medical system of claim 7, wherein the electrical stimulation is configured to induce asymptomatic motion of the diaphragm.

9. The implantable medical system of claim 8, wherein the asymptomatic motion of the diaphragm is characterized by biphasic, caudal-followed-by-cranial motion.

10. The implantable medical system of claim 1, wherein the timed relationship is one that:

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

11. The implantable medical system of claim 1, wherein the sensing and stimulation structure is configured to be coupled to one of an inferior side of the diaphragm, and a superior side of the diaphragm.

12. The implantable medical system of claim 1, wherein the circuit structure is further configured to:

note an occurrence of an errant cardiac event in a cardiac cycle of the subject; and

based upon the occurrence of the errant cardiac event, withhold application of an electrical stimulation during the cardiac cycle.

13. The implantable medical system of claim 1, wherein:

the sensing and stimulation structure is associated with a lead,

the circuit structure is associated with a housing, and

the lead and housing are configured to couple together to thereby couple the circuit structure to the sensing and stimulation structure.

14. The implantable medical system of claim 1, wherein the sensing and stimulation structure and the circuit structure are associated with a capsule structure.