Claims for Patent: 11,931,377

Summary for Patent: 11,931,377

Title:	Methods of administering inhaled nitric oxide gas
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.
Inventor(s):	James S. Baldassarre
Assignee:	Mallinckrodt Hospital Products IP Unlimited Co , Mallinckrodt Pharma IP Trading DAC , Therakos Inc , Mallinckrodt Critical Care Finance Inc
Application Number:	US16/378,361
Patent Claims:	1. A method for treating a pediatric patient who is experiencing idiopathic pulmonary arterial hypertension resulting in oxygen desaturation, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: determining whether the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and (b) 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. 2. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: determining whether the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide and supplemental oxygen for a length of time sufficient to increase the partial pressure of arterial oxygen (PaO2) in the patient by dilating pulmonary vessels, and (b) 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. 3. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: evaluating the patient, or having the patient evaluated, to determine if the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and (b) 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. 4. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: administering supplemental oxygen to the patient; determining whether the patient has pre-existing left ventricular dysfunction; and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide and supplemental oxygen for a length of time sufficient to increase PaO2 in the patient by dilating pulmonary vessels, and (b) if the patient does have pre-existing left ventricular dysfunction, continuing to administer inhaled supplemental oxygen to the patient, and excluding the patient from treatment with inhaled nitric oxide. 5. The method of claim 1, wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction. 6. The method of claim 2, wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction. 7. The method of claim 3, wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction. 8. The method of claim 4, wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction. 9. The method of claim 1, wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left vermicular dysfunction. 10. The method of claim 2, wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction. 11. The method of claim 3, wherein the evaluating step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction. 12. The method of claim 1, wherein the determining step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening. 13. The method of claim 2, wherein the determining step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening. 14. The method of claim 3, wherein the evaluation step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening. 15. The method of claim 1, wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease. 16. The method of claim 2, wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease. 17. The method of claim 3, wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease. 18. The method of claim 1, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 19. The method of claim 2, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 20. The method of claim 3, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 21. The method of claim 4, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 22. The method of claim 1, wherein the pediatric patient is a neonate. 23. The method of claim 2, wherein the pediatric patient is a neonate. 24. The method of claim 3, wherein the pediatric patient is a neonate. 25. The method of claim 1, wherein the pediatric patient is 4 weeks to 18 years of age. 26. The method of claim 2, wherein the pediatric patient is 4 weeks to 18 years of age. 27. The method of claim 3, wherein the pediatric patient is 4 weeks to 18 years of age. 28. The method of claim 22, wherein the neonate has persistent pulmonary hypertension of the newborn (PPHN). 29. The method of claim 23, wherein the neonate has PPHN. 30. The method of claim 24, wherein the neonate has PPHN. 31. The method of claim 1, wherein the improvement in oxygenation of (a) is as indicated by an increase in the patient's PaO2. 32. The method of claim 3, wherein the improvement in oxygenation of (a) is as indicated by an increase in the patient's PaO2. 33. A method for treating a neonate patient with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: determining whether the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and (b) 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. 34. The method of claim 33, wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction. 35. The method of claim 33, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 36. The method of claim 33, wherein the improvement in oxygenation of (a) is as indicated by an increase in the patient's PaO2. 37. A method for treating a neonate patient with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: determining whether the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide and supplemental oxygen for a length of time sufficient to increase PaO2 in the patient by dilating pulmonary vessels, and (b) 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. 38. The method of claim 37, wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction. 39. The method of claim 37, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 40. A method for treating a neonate patient with hypoxic respiratory failure associated with clinical or echocardiographic evidence of idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising: determining whether the patient has pre-existing left ventricular dysfunction, and (a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and (b) if the patient does have pre-existing left ventricular dysfunction, treating the patient with inhaled supplemental oxygen or extracorporeal membrane oxygenation, and excluding the patient from treatment with inhaled nitric oxide. 41. The method of claim 40, wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary ca.pillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction. 42. The method of claim 40, wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction. 43. The method of claim 40, wherein the improvement in oxygenation of (a) is as indicated by an increase in the patient's PaO2.