Development of Lungpacer-PROTECT, a Neurostimulation Device to Improve Respiratory Health and Outcomes for Mechanically Ventilated Patients
Abstract
FY20 PRMRP Topic: Respiratory Health. Focus Area Alignment: “Ventilation and Extracorporeal Life Support approaches and technologies to support lung function or airway management in response to COVID-19 that increase survivability and/or minimize care provider burden or exposure.” Problem: Positive-pressure mechanical ventilation (MV) is a life-saving intervention for many patients who are in intensive care units due to severe lung infections. Over one-third of the COVID-19 patients admitted to New York City hospitals required invasive MV. Traditional MV utilizes positive pressure to cyclically “inflate” a patient’s lungs while the patient’s own diaphragmatic breathing is suppressed. As a result, MV patients, particularly those with respiratory diseases, have a severely weakened diaphragm muscle and are at risk for acute respiratory distress syndrome (ARDS), and both lung and cognitive injury. For these patients, their risk of death increases with each hour on MV. With remarkably rapid progression, Ventilator-Induced Diaphragm Dysfunction (VIDD) occurs within the first 18 to 24 hours of MV. VIDD most often occurs when patients must be on MV for a long time. Because the diaphragm muscle weakens so quickly with MV, patients suffer delayed weaning from ventilation and some are never able to breathe again on their own. Mechanically ventilated COVID-19 patients frequently also experience ventilator-induced lung injury (VILI), due to high positive pressure from MV injuring the fragile cells in the upper lungs, and cells in the lower lung collapsing as a result of a low-pressure injury. Patients who experience VILI have a higher risk of death and may fail to breathe again on their own. Solution: Lungpacer is developing a novel technology called the Lungpacer Diaphragm Pacing Therapy System (DPTS). Using electrical stimulation, Lungpacer-DPTS activates the diaphragm muscle to support respiration in a manner similar to the way we breathe naturally. This prevents weakening of the diaphragm muscle, meaning that patients can more easily breathe on their own after being on MV. The first-generation device is currently undergoing clinical trials for approval to be used in patients already on MV who have failed to wean, as a way to “rescue” these patients from MV by rebuilding their weakened respiratory, or breathing, muscles through periodic daily pacing therapy sessions. The patient’s primary respiratory support is maintained by traditional MV. The FDA designated the Lungpacer DPTS a “Breakthrough Device,” providing an expedited pathway for development, assessment, and approval. In addition, the FDA recently granted Lungpacer-DPTS an Emergency Use Authorization to also allow for treatment of COVID-19 patients, meaning that this device, although not yet approved, is available to COVID-19 patients due to the current lack of adequate, approved, and available alternatives. For this project, Lungpacer Medical proposes to create a next-generation, integrated ventilation system. This would adapt our existing, first-generation DPTS device for use in combination with mechanical ventilation, to enable continuous diaphragm pacing therapy from the onset of MV. This device will communicate with the mechanical ventilator that is providing airflow into the patient’s lungs and will enable the diaphragm muscle contractions to work in concert with the ventilator, thus drawing air into the patient in a manner similar to natural breathing. This innovation will improve current MV outcomes by 1) allowing ventilation at lower pressures, believed to reduce injury to the upper lungs, 2) increasing airflow into the lower lung regions, which is expected to reduce lower-lung injury, and 3) reducing risk of VIDD by maintaining diaphragm activity. An early prototype of the Lungpacer-PROTECT-Plus, tested in animal models, produced significant reductions in lung injury and demonstrated its ability to maintain and/or build diaphragm muscle strength. This nex
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110035
Entities
People
- Matthew Gani
Organizations
- United States Army