Device and method for treating disorders of the cardiovascular system or heart

• US 8,265,759 B2
• Filed: 04/08/2008
• Issued: 09/11/2012
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Tehrani, Amir J., Province, Rose
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Alter, Alyssa M
• Application Number:
  US12/082,057
• Publication Number:
  US 20080188904A1
• Time in Patent Office: 1,617 Days
• Field of Search: 607/42, 607/20
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

A device and method are provided to treat heart failure by stimulating to cause diaphragm contraction.

Claims

1. A method for treating a subject comprising:

sensing an initial respiration parameter during intrinsic breathing of a subject via at least one electrode positioned internally within the patient;

synchronizing an electrical stimulation protocol with the sensed respiration parameter via a processor in communication with the at least one electrode; and

,

increasing functional residual lung capacity of the subject by applying the electrical stimulation protocol which comprises a burst or series of pulses to tissue associated with a phrenic nerve or diaphragm tissue to contract a diaphragm at a beginning or during an onset of each intrinsic breathing cycle and sustaining the electrical stimulation protocol such that an intrathoracic pressure is stabilized by increasing a resting lung volume.

2. The method of claim 1 wherein increasing functional residual lung capacity comprises applying the electrical stimulation protocol to the phrenic nerve or diaphragm tissue within a region of the subject selected from the group consisting of an abdomen, a thoracic cavity, a neck region, and a ziphoid region.

3. The method of claim 1 wherein increasing functional residual lung capacity comprises applying the electrical stimulation protocol transvenously to the phrenic nerve or diaphragm tissue.

4. The method of claim 1 further comprising controlling an additional therapeutic electrical stimulation device within the subject independently of or in combination with increasing functional residual lung capacity of the subject.

5. The method of claim 4 wherein controlling an additional therapeutic electrical stimulation device comprises controlling via a second controller.

6. The method of claim 4 wherein the additional electrical stimulation device is selected from the group consisting of a CRT, pacemaker, and ICD.

7. The method of claim 1 wherein increasing functional residual lung capacity comprises sustaining the electrical stimulation protocol such that a respiration rate is reduced.

8. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises electrically stimulating the tissue such that inspiration is augmented.

9. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises pacing each intrinsic breathing cycle such that minute ventilation is maintained or reduced.

10. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises further applying the electrical stimulation protocol during a beginning portion of an inspiration cycle.

11. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises further applying the electrical stimulation protocol at least during an end portion of an inspiration cycle.

12. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that tidal volume is increased during a reduced respiration relative to intrinsic breathing.

13. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that functional residual capacity is increased relative to a non-stimulated breathing.

14. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises improving a gas exchange during pulmonary edema.

15. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises causing a lung inflation gradient such that liquid movement from an alveolar space to an extra-interstitium is improved and pulmonary edema is reduced.

16. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that an exhalation rate is slowed relative to the intrinsic breathing.

17. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol during the subject'"'"'s sleep or awake cycle.

18. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises providing a low energy stimulation.

19. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that a resting lung volume is increased relative to the intrinsic breathing.

20. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol to at least one hemidiaphragm.

21. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol in a subject having sleep disorder breathing.

22. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that gas exchange in improved.

23. The method of claim 1 wherein the step of increasing functional residual lung capacity comprises applying the electrical stimulation protocol such that hypertension is reduced.

24. The method of claim 1 wherein the intrathoracic pressure is stabilized by increasing the resting lung volume such that a change in the intrathoracic pressure is increased for a given volume through inspiration relative to a non-stimulated breathing cycle.

25. The method of claim 1 wherein the subject comprises a patient having heart failure.