Discussion of the effect of electrical simulation on the diaphragm dates back over 200 years. In 1872, Duchenne (1) concluded that phrenic nerve stimulation was the “best means of imitating natural respiration.” Christoph Hufeland (2) first proposed artificial respiration through electrical stimulation of the phrenic nerve to treat asphyxia in 1873.Despite its documented experimental successes, phrenic nerve stimulation faded to the background as positive pressure ventilation by mechanical ventilation became readily available.
In the late 1940’s, S.J. Sarnoff and colleagues at the Harvard School of Public Health showed that, in the absence of spontaneous respiratory activity, rhythmic stimulation of the phrenic nerve could duplicate minute volume, arterial blood oxygen and carbon dioxide tensions. This was reported in the October 1948 issue of Science (3), in which Sarnoff documented 52 hours of phrenic nerve stimulation as the only means of artificial respiration in a 5 year-old boy with respiratory paralysis following a cerebral aneurysm.
Based on his pioneering research in cardiac pacemakers, William W.L. Glenn and his colleagues at the Yale University School of Medicine set out to create the first practical application of phrenic nerve pacing. Although first mentioned in 1966 (4), the seminal work on the topic was an article titled “Radio-frequency electrophrenic respiration. Long-term application to a patient with primary hypoventilation” which appeared in the March 1968 issue of the Journal of the American Medical Association (5).
In collaboration with Roger E. Avery, Glenn’s prototypes were brought into commercial distribution by Avery Laboratories, Inc. in 1971. The Medical Device Amendment of 1976 mandated the classification and regulation of medical devices and in 1986, under FDA regulations the Medical Device Amendments were enacted into law. In January, 1987 Avery became one of the first to obtain PMA approval under this regulation.
Furthermore, in 1995 Avery breathing pacemaker system was one of the first products to obtain premarket approval as a Class III device under the requirements of the Active Implantable Medical Device Directive (90/385/EEC) for distribution within the European Union.
REFERENCES(1) Duchenne GBA. “De l’electrisation localisée et de son application a la pathologie et a le thérapeutique par courants induits et par courants galvaniques interrompus et continues per le dr. Duchenne.” Paris, Baillière,1872.
(2) Hufeland CW. “Usum uis electriciae in asphyxia experimentis illustratum.” Göttingen, Germany: Dissertatio Inauguralis Medica; 1783.
(3) Sarnoff SJ, Hardenbergh E, Whittenberger JL. “Electrophrenic Respiration.” Science. October 29, 1948. Vol. 108, p. 482.
(4) Glenn WW, Anagnostopoulos CE. “Electronic pacemakers of the heart, gastrointestinal tract, phrenic nerve, bladder, and carotid sinus: current status.” Surgery, 1996 Aug; 60 (2): 480-94.
(5) Glenn WW, Judson JP. “Radio-frequency electrophrenic respiration. Long-term application to a patient with primary hypoventilation.” Journal of the American Medical Association. March 1968, 203(12), pp. 1033-1037.
(6) Shaul DB, Danielson PD, McComb JG, Keens TG. “Thoracoscopic Placement of Phrenic Nerve Electrodes for Diaphragm Pacing in Children.” Journal of Pediatric Surgery. July 2002, Vol.37, No.7, pp.974-978.
(7) Elefteriades JA, Quin JA, Hogan JF, Holcomb WG, Letsou GV, Chlosta WF, Glenn WW. “Long Term Follow-up of Pacing of the Conditioned Diaphragm in Quadriplegia.” Journal of Pacing and Clinical Electrophysiology. June 2002, Vol.25, No.6, pp.897-906.