DEVICES AND METHODS FOR ELECTRICAL STIMULATION OF THE DIAPHRAGM AND NERVES

• US 20100094376A1
• Filed: 10/13/2009
• Published: 04/15/2010
• Est. Priority Date: 10/13/2008
• Status: Active Grant

• Current Assignee: E-Pacing Inc.
• Original Assignee: E-Pacing Inc.
• Inventors: Penner, Abraham
• Granted Patent: US 8,195,297 B2
• Time in Patent Office: Days
• US Class Current: 607/42
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Medical devices, systems, and methods are provided for providing respiratory therapy by electrically stimulating the phrenic nerves and/or the thoracic diaphragm. In one embodiment, at least one electrode is deployed to a position within the patient'"'"'s airway and placed in proximity to a phrenic nerve or to the diaphragm. The electrode may be attached to a controller housing including a pulse generator using one or more electrical lead or leads or may be in wireless communication with the pulse generator. The controller housing may be implanted at a position within the patient or the controller housing may reside external to the patient.

Claims

1. A diaphragmatic stimulation system, comprising:

a controller housing comprising a pulse generator;

at least one electrode in electrical communication with the pulse generator and positionable and fixable at a selected position within a patient'"'"'s trachea or bronchus in operable proximity to at least one of a thoracic diaphragm or a phrenic nerve.

2. The system of claim 1, wherein the controller housing is adapted to reside external to the patient, and further comprising:

at least one electrical lead attachable to the controller housing to electrically communicate with the pulse generator, wherein the at least one electrode is carried by the at least one electrical lead, and wherein the at least one electrical lead and the at least one electrode are deliverable through the patient'"'"'s mouth or nasal cavity to the selected position within the patient'"'"'s trachea or bronchus.

3. The system of claim 1, wherein the controller housing is adapted to reside external to the patient, and further comprising:

at least one electrical lead attachable to the controller housing to electrically communicate with the pulse generator, wherein the at least one electrode is carried by the at least one electrical lead; and

a tracheal access device insertable through the patient'"'"'s trachea, wherein the at least one electrical lead and the at least one electrode are deliverable through the tracheal access device to the selected position within the patient'"'"'s trachea or bronchus.

4. The system of claim 1, wherein the controller housing is adapted to reside external to the patient, and wherein the at least one electrode comprises at least one wireless electrode operable to wirelessly communicate with the pulse generator.

5. The system of claim 4, wherein the pulse generator is operable to communicate with the at least one wireless electrode utilizing radio frequency communication.

6. The system of claim 4, wherein the at least one wireless electrode is further operable for bi-directional wireless communication with the pulse generator, and wherein the at least one wireless electrode is further operable to sense at least one condition associated with the patient'"'"'s respiratory activity.

7. The system of claim 6, wherein the one or more conditions associated with the patient'"'"'s respiratory activity comprises at least one of:

(a) thoracic diaphragm movement;

(b) costal muscle movement;

or (c) lung movement.

8. The system of claim 1, wherein the controller housing is adapted for implantation at a selected housing position within the patient'"'"'s trachea or bronchus, or at a subcutaneous location within the patient.

9. The system of claim 1, wherein the pulse generator is operable to deliver at least one electrical stimulation signal effective in diaphragmatic pacing.

10. The system of claim 1, wherein the pulse generator is further operable to receive at least one signal indicating an operation of a mechanical ventilation system, and wherein the pulse generator is further operable to deliver at least one electrical stimulation signal based at least in part on the at least one signal indicating an operation of the mechanical ventilation system.

11. The system of claim 10, wherein the at least one stimulation signal is effective to perform at least one of:

(a) ventilation therapy;

or (b) diaphragmatic stimulation to treat or mitigate muscle atrophy.

12. The system of claim 1, wherein the at least one electrode is operable to deliver the at least one electrical stimulation signal to at least one of:

(a) the left side of the patient'"'"'s thoracic diaphragm;

(b) the right side of the patient'"'"'s thoracic diaphragm;

(c) the patient'"'"'s left phrenic nerve;

(d) the patient'"'"'s right phrenic nerve;

or (e) any combination thereof.

13. A method for electrically stimulating a diaphragm, comprising:

positioning and fixing at least one electrode at a selected position within a patient'"'"'s trachea or bronchus in operable proximity to at least one of a thoracic diaphragm or a phrenic nerve, wherein the at least one electrode is in operable electrical communication with a pulse generator housed within a controller housing; and

delivering at least one electrical stimulation signal from the at least one electrode to at least one of the thoracic diaphragm or the phrenic nerve.

14. The method of claim 13, wherein the controller housing is adapted to reside external to the patient, wherein the at least one electrode is carried by at least one electrical lead in electrical communication with the pulse generator, and wherein positioning and fixing the at least one electrode at a selected position within the patient'"'"'s trachea or bronchus comprises delivering the at least one electrical lead and the at least one electrode through the patient'"'"'s mouth or nasal cavity.

15. The method of claim 14, wherein positioning and fixing the at least one electrode at a selected position within a patient'"'"'s trachea or bronchus further comprises inserting a catheter into the patient'"'"'s mouth or nasal cavity, wherein the at least one electrical lead and the at least one electrode are delivered through a lumen in the catheter.

16. The method of claim 15, wherein the catheter comprises an intubation tube.

17. The method of claim 13, wherein the controller housing is adapted to reside external to the patient, and further comprising inserting a tracheal access device through the patient'"'"'s trachea, wherein positioning and fixing the at least one electrode at the selected position within the patient'"'"'s trachea or bronchus comprises delivering the at least one electrical lead and the at least one electrode through the tracheal access device.

18. The method of claim 13, further comprising positioning and fixing the controller housing at a selected housing position within the patient'"'"'s trachea or bronchus, or at a subcutaneous location within the patient.

19. The method of claim 13, wherein the controller housing is adapted to reside external to the patient, and wherein the at least one electrode comprises at least one wireless electrode in wireless communication with the pulse generator, and wherein delivering the at least one electrical stimulation signal comprises:

wirelessly transmitting at least one command from the pulse generator to the at least one electrode;

generating the at least one electrical stimulation signal at the at least one electrode upon receiving the at least one command; and

delivering the at least one electrical stimulation signal from the at least one electrode.

20. The method of claim 19, wherein wirelessly transmitting the at least one command comprises transmitting the at least one command utilizing radio frequency communication.

21. The method of claim 19, further comprising:

sensing at least one condition associated with the patient'"'"'s respiratory activity; and

wirelessly transmitting a signal to the pulse generator containing data associated with the at least one condition from the at least one electrode.

22. The method of claim 21, further comprising:

generating at least one additional command based at least in part on the data associated with the at least one condition;

wirelessly transmitting the at least one additional command from the pulse generator to the at least one electrode; and

generating and delivering at least one additional electrical stimulation signal upon receiving the at least one additional command at the at least one electrode.

23. The method of claim 21, wherein the one or more conditions associated with the patient'"'"'s respiratory activity comprises at least one of:

(a) thoracic diaphragm movement;

(b) costal muscle movement;

or (c) lung movement

24. The method of claim 13, wherein delivering the at least one electrical stimulation signal comprises delivering at least one electrical stimulation signal effective in diaphragmatic pacing.

25. The method of claim 13, wherein delivering the at least one electrical stimulation signal comprises delivering the at least one electrical stimulation signal to at least one of:

(a) the left side of the patient'"'"'s thoracic diaphragm;

(b) the right side of the patient'"'"'s thoracic diaphragm;

(c) the patient'"'"'s left phrenic nerve;

(d) the patient'"'"'s right phrenic nerve;

or (e) any combination thereof.

26. The method of claim 13, further comprising receiving, at the pulse generator, at least one signal indicating an operation of a mechanical ventilation system, wherein delivering the at least one electrical stimulation signal is based at least in part on the at least one signal indicating the operation of the mechanical ventilation system.

27. The method of claim 26, wherein the at least one electrical stimulation signal is effective to perform at least one of:

(a) ventilation therapy;

or (b) diaphragmatic stimulation to treat muscle atrophy.

28. A method for operably associating a stimulation system with a patient in need thereof comprising:

deploying at least one electrode to a selected position within a patient'"'"'s trachea or bronchus in operable proximity to at least one of a thoracic diaphragm or a phrenic nerve, wherein the at least one electrode is in electrical communication with a pulse generator housed within a controller housing.

29. The method of claim 28, further comprising deploying the controller housing to a selected housing position within the patient'"'"'s trachea or bronchus, or at a subcutaneous location within the patient, wherein the at least one electrode is carried by at least one electrical lead in electrical communication with the pulse generator.

30. The method of claim 28, wherein the controller housing is adapted to reside external to the patient.

31. The method of claim 30, wherein the at least one electrode comprises at least one wireless electrode operable to communicate wirelessly with the pulse generator.

32. The method of claim 30, wherein the at least one electrode is carried by at least one electrical lead in electrical communication with the pulse generator, and wherein deploying the at least one electrode at the selected position within the patient'"'"'s trachea or bronchus comprises one of:

(a) deploying the at least one electrical lead and the at least one electrode through the patient'"'"'s mouth or nasal cavity;

or (b) deploying the at least one electrical lead and the at least one electrode through a tracheal access device inserted through the patient'"'"'s trachea.

33. The method of claim 28, further comprising implanting the controller housing at a subcutaneous location within the patient, wherein the at least one electrode is carried by at least one electrical lead in electrical communication with the pulse generator.