SBIR-STTR Award

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project, in which a new device and approach to weaning patients from mechanical ventilation is proposed, is a reduction in public health care expenditure and a reduction in morbidity for the half a million patients who have difficulty weaning from mechanical ventilation each year in the US. This project promises to improve our scientific understanding of the role of the expiratory muscles in weaning failure patients and improve our technical understanding of non-invasive respiratory sensors for online triggering of external systems. These patients suffer from an array of clinical complications and cost the US health care system $16 billion annually. The majority of these costs are borne by Medicare and Medicaid whose reimbursement policies provide an incentive to reduce weaning time in this patient group. Given the severe health consequences of prolonged mechanical ventilation, the large and expanding number of treatable patients, and the favorable reimbursement landscape, we reason that the device that will be developed in this proposal will positively benefit society and will be commercially valuable. The proposed project will develop a non-invasive electrical stimulator that automatically applies stimulation to the respiratory muscles in synchrony with a patient?s voluntary breathing pattern. Based on previous research it is expected that this device will reduce the load placed on the respiratory muscles while at the same time training them. Since the imbalance between the strength of the respiratory muscles and the mechanical load they face is a major factor contributing to weaning difficulty, it is hypothesized that the proposed device will reduce the time, and improve the probability, to wean from mechanical ventilation. In this phase one proposal the device stimulation trigger will be developed and tested and combined with a commercially available stimulator, the clinical effect of the developed device on breathing when used acutely will be established, and the feasibility of using the developed device in mechanically ventilated patients will be determined. The successful completion of this phase one proposal will be followed by phase two in which both the development of a stimulator with integrated trigger and a fully powered clinical trial will be completed, ultimately allowing the device to be submitted for FDA clearance.

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project, in which a non-invasive respiratory muscle stimulation device and approach to weaning patients from mechanical ventilation will be developed, is a reduction in public health care expenditure and a reduction in morbidity for the half a million patients who have difficulty weaning from mechanical ventilation each year in the US. These patients suffer from an array of clinical complications (for example, pneumonia) and cost the US health care system $16 billion annually, a great deal of which is borne by Medicare and Medicaid. In addition, the current reimbursement landscape economically incentivizes hospitals to wean patients at the earliest possible time. The proposed innovation has the potential to positively benefit society by providing a solution to this serious healthcare problem. In addition, it promises to improve our scientific understanding of respiratory muscle physiology and mechanics in difficult to wean patients. It will also improve our technical understanding of non-invasive respiratory sensors and biofeedback algorithms for the purposes of electrical muscle stimulation. Finally, as demonstrated by the number and cost of difficult to wean patients, as well as current healthcare reimbursement policies, the proposed innovation has potential to results in a considerable commercial impact. The proposed project will develop a non-invasive electrical stimulator that automatically applies stimulation to the respiratory muscles in synchrony with a patient?s voluntary breathing pattern. This approach is expected to address the imbalance between respiratory muscle strength and respiratory muscle load - a major factor responsible for weaning difficulty - by assisting ventilation during weaning sessions and strengthening the breathing muscles that have become weakened as a result of mechanical ventilation. In Phase 1 a functional prototype was developed; clinical feasibility of the approach was also demonstrated. The Phase II proposal focuses on refining the stimulation algorithm to maximize its clinical effectiveness and on developing a novel stimulation electrode system so that the device can be quickly applied to patients. In addition, methods will be developed to interface the technology with a mechanical ventilator to expand its clinical application. Finally, a complete works-like, looks-like prototype will be developed that is designed to international standards and is safe for clinical testing. The work completed in this Phase of the project will enable a controlled clinical trial of the proposed approach and ultimately allow the device to gain FDA regulatory clearance.