Methods of administering inhaled nitric oxide gas
Inventors
Assignees
Mallinckrodt Hospital Products IP Unlimited Co • Mallinckrodt Pharma IP Trading DAC • Therakos Inc • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-11931377-B2
Publication Date
2024-03-19
Expiration Date
Abstract
The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Core Innovation
The disclosed invention relates to methods for treating a pediatric patient experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, where the patient is not dependent on right-to-left shunting of blood. The method includes determining whether the patient has pre-existing left ventricular dysfunction and using that determination to select an inhaled nitric oxide treatment branch or an exclusion branch.
For patients without pre-existing left ventricular dysfunction, the method administers 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation. For patients with pre-existing left ventricular dysfunction, the method administers inhaled supplemental oxygen and excludes the patient from treatment with inhaled nitric oxide.
The invention also covers neonate patients with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, again where the patient is not dependent on right-to-left shunting of blood. In the neonate setting, if the patient does not have pre-existing left ventricular dysfunction, 20 ppm inhaled nitric oxide is administered to improve oxygenation; if the patient does have pre-existing left ventricular dysfunction, inhaled supplemental oxygen is used and inhaled nitric oxide is excluded, and in some formulations the patient is treated with inhaled supplemental oxygen or extracorporeal membrane oxygenation.
Claims Coverage
Independent claims are directed to methods for treating pediatric or neonate patients with idiopathic pulmonary arterial hypertension and oxygen desaturation or hypoxic respiratory failure, where the patient is not dependent on right-to-left shunting, by branching treatment based on whether the patient has pre-existing left ventricular dysfunction. Across the independent claims, the inventive features include determining pre-existing left ventricular dysfunction and selecting 20 ppm inhaled nitric oxide versus exclusion of inhaled nitric oxide with inhaled supplemental oxygen, with additional dependent refinements.
Branching treatment based on pre-existing left ventricular dysfunction
Determining whether the patient has pre-existing left ventricular dysfunction, and for patients without pre-existing left ventricular dysfunction administering 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation, while for patients with pre-existing left ventricular dysfunction administering inhaled supplemental oxygen and excluding the patient from treatment with inhaled nitric oxide.
Administering 20 ppm inhaled nitric oxide to improve oxygenation
Administering 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient.
Excluding inhaled nitric oxide when pre-existing left ventricular dysfunction is present
If the patient does have pre-existing left ventricular dysfunction, administering inhaled supplemental oxygen to the patient and excluding the patient from treatment with inhaled nitric oxide.
Neonate hypoxic respiratory failure method with nitric oxide versus ECMO/supplemental oxygen exclusion
For a neonate patient with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, determining whether the patient has pre-existing left ventricular dysfunction and administering 20 ppm inhaled nitric oxide if absent, and treating with inhaled supplemental oxygen or extracorporeal membrane oxygenation and excluding the patient from treatment with inhaled nitric oxide if pre-existing left ventricular dysfunction is present.
The independent claims consistently center on pre-screening or determining pre-existing left ventricular dysfunction and using that determination to either administer 20 ppm inhaled nitric oxide or exclude inhaled nitric oxide and provide inhaled supplemental oxygen, with some neonate formulations also reciting extracorporeal membrane oxygenation.
Stated Advantages
Reducing or preventing adverse or serious adverse events associated with inhaled nitric oxide by pre-screening for pre-existing left ventricular dysfunction.
Reducing risk of adverse events such as pulmonary edema when patients with elevated pulmonary capillary wedge pressure are excluded.
Reducing other cardiovascular or respiratory adverse events associated with inhaled nitric oxide by excluding patients with elevated baseline PCWP.
Documented Applications
Treating a pediatric patient with idiopathic pulmonary arterial hypertension and oxygen desaturation, where the patient is not dependent on right-to-left shunting of blood.
Treating a neonate patient with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, where the patient is not dependent on right-to-left shunting of blood.
Reducing adverse event risk associated with inhaled nitric oxide (iNO) by excluding patients with elevated pulmonary capillary wedge pressure.
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