# US 11,992,620 B2 · Methods of reducing the risk of mortality associated with a medical treatment

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- Number: US 11,992,620 B2
- Document ID: US11992620B2
- Status: Granted
- Kind: B2
- Application number: 15/854,643
- Filed: 2017-12-26
- Published: 2018-07-05
- Granted: 2024-05-28
- Earliest claimed: 2013-06-25
- Assignees: Mallinckrodt Hospital Products IP Limited
- Applicants: Mallinckrodt Hospital Products IP Limited
- Inventors: Jim Potenziano; Joe Stauffer
- Web page: https://patentgrep.com/patent/US11992620B2

## CPC

- A61M 16/12: by mixing different gases
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61M 16/0096: {High frequency jet ventilation}
- A61P 11/00: Drugs for disorders of the respiratory system
- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61M 2016/1035: {the anaesthetic agent concentration}
- A61M 2202/0208: Oxygen
- A61M 2202/025: Helium
- A61M 2202/0275: Nitric oxide [NO]
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Disclosed are methods of treatment that permit a reduction of risk of mortality in infants who are candidates for treatment with inhaled nitric oxide, by identifying a subset of such infants who are at an increased risk of mortality upon treatment with inhaled nitric oxide; also disclosed are related systems for use in administering inhaled nitric oxide and methods of distributing a pharmaceutical product.

## Claims

### Claim 1

A method of treating a plurality of neonates of the same gestational age who are candidates for treatment with inhaled nitric oxide, wherein the plurality includes neonates of less than 27 weeks postmenstrual age who are not white, male neonates and at least one neonate who is a white, male neonate of less than 27 weeks postmenstrual age, the method comprising:
(a) administering inhaled nitric oxide to each of the neonates of the plurality who is less than 27 weeks postmenstrual age and not a white, male neonate;
(b) for each of the neonates of the plurality who is a white, male neonate of less than 27 weeks postmenstrual age, administering a treatment that includes one or more of ventilatory support, intravenous fluids, surfactant, and bicarbonate therapy, and does not initially include inhaled nitric oxide; and
(c) withholding inhaled nitric oxide from each of the neonates of the plurality who is a white, male neonate of less than 27 weeks postmenstrual age until he reaches 27 weeks postmenstrual age; and, when he reaches 27 weeks postmenstrual age, beginning administration of inhaled nitric oxide to him,
wherein each of the white, male neonates of less than 27 weeks postmenstrual age is excluded from inhaled nitric oxide treatment until he reaches 27 weeks postmenstrual age solely because he is a white, male neonate of less than 27 weeks postmenstrual age.

### Claim 2 (depends on 1)

The method of claim 1, wherein the treatment of (b) administered to each of the neonates of the plurality who is a white male neonate of less than 27 weeks postmenstrual age comprises ventilatory support that includes supplemental oxygen.

### Claim 3 (depends on 2)

The method of claim 2, wherein the ventilatory support comprises high-frequency oscillatory ventilation.

### Claim 4 (depends on 2)

The method of claim 2, wherein the treatment of (b) administered to each of the white male neonates of less than 27 weeks postmenstrual age further comprises caffeine, vitamin A, or one or more surfactants.

### Claim 5 (depends on 1)

The method of claim 1, wherein each of the white male neonates of less than 27 weeks postmenstrual age does not have left ventricular dysfunction and is not dependent on right-to-left shunting of blood.