Devices and methods for electrical stimulation of the diaphragm and nerves

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.

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; and   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,   wherein the at least one electrical lead and the at least one electrode are configured to be deliverable through the patient's mouth or nasal cavity to the selected position within the patient's tracheal or bronchus and the at least one electrode comprises at least one radially expandable member effective to promote electrical coupling of the electrode with epithelial tissue at the selected position.   
     
     
         2 . The system of  claim 1 , further comprising a catheter insertable through the patient's nasal cavity or mouth, wherein the at least one electrical lead and the at least one electrode are deliverable through the catheter to the selected position within the patient's bronchus. 
     
     
         3 . The system of  claim 1 , wherein the at least one electrode comprises at least one wireless electrode operable to wirelessly communicate with the pulse generator. 
     
     
         4 . The system of  claim 3 , wherein the pulse generator is operable to communicate with the at least one wireless electrode utilizing radio frequency communication. 
     
     
         5 . The system of  claim 3 , 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. 
     
     
         6 . The system of  claim 5 , 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. 
     
     
         7 . The system of  claim 1 , wherein the pulse generator is operable to deliver at least one electrical stimulation signal effective in diaphragmatic pacing. 
     
     
         8 . 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. 
     
     
         9 . The system of  claim 8 , 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 or mitigate muscle atrophy. 
     
     
         10 . 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. 
     
     
         11 . The system of  claim 1 , wherein the controller housing is configured to be operably deployed external to the patient. 
     
     
         12 . The system of  claim 1 , wherein the controller housing is configured to be operably deployed at a selected housing position within the patient's trachea or bronchus, or at a subcutaneous location within the patient. 
     
     
         13 . 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 bronchus in operable proximity to at least one of a thoracic diaphragm or a phrenic nerve; and   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,   wherein the at least one electrical lead and the at least one electrode are configured to be deliverable through the patient's mouth or nasal cavity to the selected position within the patient's bronchus and the at least one electrode is proportioned to have a diameter larger or approximately the same size as the inner bronchi at the selected position, effective to substantially lodge the at least one electrode within the inner bronchi.   
     
     
         14 . The stimulation system of  claim 13 , wherein the electrode comprises a passageway to permit airflow through the at least one electrode when lodged in the bronchi. 
     
     
         15 . 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 bronchus in operable proximity to at least one of a thoracic diaphragm or a phrenic nerve;   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 catheter insertable through the patient's nasal cavity or mouth, wherein the at least one electrical lead and the at least one electrode are deliverable through the catheter to the selected position within the patient's bronchus, wherein the at least one electrical lead extends from the distal end of the catheter to allow the at least one electrode to be positionable and fixable within the patient's bronchus,   wherein the at least one electrode (i) comprises at least one radially expandable member effective to promote electrical coupling of the at least one electrode with epithelial tissue at the selected position, or (ii) is proportioned to have a diameter larger or approximately the same size as the inner bronchi at the selected position, effective to substantially lodge the at least one electrode within the inner bronchi.