Use and monitoring of inhaled nitric oxide with left ventricular assist devices
Inventors
Potenziano, Jim • Greene, Douglas Alan • Flanagan, Craig
Assignees
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Publication Number
US-11759620-B2
Publication Date
2023-09-19
Expiration Date
Abstract
Described are systems and methods for administration of nitric oxide (NO) with use of left ventricular assists devices (LVADs), as well as systems and methods for monitoring the NO delivery devices and/or the LVAD.
Core Innovation
The invention provides a method of monitoring the left ventricle of a patient with a left ventricular assist device (LVAD) by using a nitric oxide (NO) delivery device and a display. Clinician entry fields are provided for pump speed, dose of inhaled NO, therapy duration, and number of times per day, and the entered inputs are received by the NO delivery device. The method includes reducing the LVAD pump speed to the received pump speed and preloading the left ventricle by administering the received NO dose for the received therapy duration.
The method measures pulmonary hemodynamic parameters to obtain a first pulmonary hemodynamic value, administers the inhaled NO dose, and then measures pulmonary hemodynamic parameters after or during administration to obtain a second pulmonary hemodynamic value. The measured hemodynamic parameters are compared to a predetermined range, and the dose of inhaled NO is adjusted if the hemodynamic parameters are outside the predetermined range. The pump speed and the NO dose currently being delivered are displayed, thereby linking clinician-configured parameters with measured pulmonary hemodynamics and dose adjustment during therapy.
The invention further includes an exercising workflow that monitors and exercises the heart by providing an exercise initiation button and repeating a cycle for the received number of times per day. The exercising steps include discontinuing inhaled NO administration, and repeating preloading, adjusting, and discontinuation to exercise the left ventricle. The exercising steps are automated by the NO delivery device, with the automation tied to the clinician-entered therapy duration, dose, pump speed, and number of times per day.
Claims Coverage
The document includes one independent claim describing an automated monitoring and exercise method that combines LVAD pump speed control, inhaled NO preloading, pulmonary hemodynamic measurement, and closed-loop dose adjustment within clinician-defined entry fields. Dependent claims further specify selectable pulmonary hemodynamic parameters, a quantitative improvement criterion, an LVAD treatment modification upon improvement, and inclusion of LVAD output parameters in the measuring step.
Clinician entry and display for LVAD pump speed and inhaled NO preloading
Providing, via a display on a NO delivery device, clinician entry fields comprising pump speed, dose of inhaled NO, therapy duration, and number of times per day; receiving input for each of the clinician entry fields; and displaying the pump speed and the NO dose currently being delivered.
LVAD pump speed reduction tied to NO preloading therapy parameters
Reducing the pump speed of the LVAD to the received pump speed and preloading the left ventricle by administering, via the NO delivery device, the received NO dose for the received therapy duration.
Pulmonary hemodynamic measurement with comparison to a predetermined range and dose adjustment
Measuring one or more pulmonary hemodynamic parameters to obtain a first pulmonary hemodynamic value, measuring the one or more pulmonary hemodynamic parameters after or during administration of the dose of inhaled NO to obtain a second pulmonary hemodynamic value, comparing the one or more hemodynamic parameters to a predetermined range, and adjusting the dose of inhaled NO if the one or more hemodynamic parameters are outside of the predetermined range.
Automated exercising workflow with NO discontinuation and repeated preloading/adjusting cycles
Providing an exercise initiation button and receiving input from the exercise initiation button, and exercising the heart comprising discontinuing the inhaled NO administration and repeating the preloading, adjusting, and discontinuation to exercise the left ventricle of the patient's heart for the received number of times per day, wherein the exercising steps are automated by the NO delivery device.
Across the independent claim and its dependent refinements, the core coverage centers on clinician-defined LVAD pump speed and inhaled NO preloading parameters, pulmonary hemodynamic measurement before and after or during NO administration with comparison to a predetermined range, closed-loop adjustment of inhaled NO dose, and an automated exercise workflow that repeats NO discontinuation with repeated preloading and adjustment.
Stated Advantages
Documented Applications
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