IP Library Granted Patent US 10,548,920
Granted Patent B2
US 10,548,920 · App. 15/167,048 · Granted Feb 4, 2020

System and method of administering a pharmaceutical gas to a patient

Inventors: Frederick J. Montgomery (Sun Prairie, WI); Duncan P. Bathe (Fitchburg, WI)
Assignee: Mallinckrodt Hospital Products IP Limited
A61K33/00A61K9/007A61M16/0051A61M16/0057A61M16/04A61M16/0666A61M16/0875A61M16/12A61M16/20G06F19/3456A61M2016/0021A61M2016/0039A61M2202/0233A61M2202/0275A61M2230/42
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Quick Facts
Patent No.
US 10,548,920
App. No.
15/167,048
Granted
Feb 4, 2020
Kind
B2
Abstract

Described are methods and systems for delivering a pharmaceutical gas to a patient. The methods and systems provide varying quantities of pharmaceutical gas delivered to the patient in two or more breaths based on the monitored respiratory rate or changes in the patient's respiratory rate.

Claims (34)

1. A method of administering a pharmaceutical gas comprising nitric oxide to a patient, the method comprising:

delivering a first quantity of pharmaceutical gas comprising nitric oxide to the patient in a first breath;

determining whether the patient's respiratory rate increases or decreases; and

delivering a one or more of:

(i) a quantity of pharmaceutical gas in a subsequent breath that is greater than the first quantity in response to a decrease in the patient's respiratory rate; or

(ii) a quantity of pharmaceutical gas in a subsequent breath that is less than the first quantity in response to an increase in the patient's respiratory rate.

2. The method of claim 1 , wherein the pharmaceutical gas is delivered to the patient every breath.

3. The method of claim 1 , wherein one or more of the first quantity and the quantity delivered in the subsequent breath is delivered during the first half of inspiration.

4. The method of claim 1 , wherein varying the quantity of pharmaceutical gas delivered to the patient avoids high unsafe doses or doses too low to be effective.

5. A nitric oxide delivery system comprising:

an inlet to connect to a source of pharmaceutical gas comprising nitric oxide;

an outlet to connect to a device that introduces the pharmaceutical gas to a patient; and

a gas control system that delivers a varying quantity of pharmaceutical gas to the patient based on changes in the patient's respiratory rate, wherein one or more of:

(i) the quantity delivered in a subsequent breath is greater than the quantity delivered in a previous breath in response to a decrease in the patient's respiratory rate; or

(ii) the quantity delivered in a subsequent breath is less than the quantity delivered in a previous breath in response to an increase in the patient's respiratory rate.

6. The nitric oxide delivery system of claim 5 , further comprising a breath trigger sensor to measure the patient's respiratory rate.

7. The nitric oxide delivery system of claim 5 , wherein the gas control system delivers the quantity of pharmaceutical gas during the first half of the patient's inspiratory cycle.

8. The nitric oxide delivery system of claim 5 , wherein the gas control system delivers the pharmaceutical gas to the patient every breath.

9. The nitric oxide delivery system of claim 5 , wherein the device receives from a user one or more of: mass of drug; mass of drug per unit of time; moles of drug; moles of drug per unit of time; mass of drug per unit of ideal body weight per unit of time; mass of drug per unit of ideal body weight; moles of drug per unit of ideal body weight per unit of time; or moles of drug per unit of ideal body weight.

10. The nitric oxide delivery system of claim 5 , wherein the device receives from a user a mass of drug per unit of ideal body weight per unit of time.

11. The nitric oxide delivery system of claim 5 , wherein the device receives from a user one or more of: time duration of treatment; patient's ideal body weight; patient's height; or patient's sex.

12. A method of administering a pharmaceutical gas comprising nitric oxide to a patient, the method comprising:

receiving a desired quantity of nitric oxide to be delivered to the patient over a plurality of breaths;

delivering a first quantity of pharmaceutical gas comprising to the patient in a first breath;

monitoring the patient's respiratory rate or changes in the patient's respiratory rate; and

varying the quantity of pharmaceutical gas delivered to the patient in one or more subsequent breaths based on the monitored respiratory rate or changes in the patient's respiratory rate.

13. The method of claim 12 , wherein the quantity delivered in the subsequent breath is greater than the first quantity in response to a decrease in the patient's respiratory rate.

14. The method of claim 12 , wherein the quantity delivered in the subsequent breath is less than the first quantity in response to an increase in the patient's respiratory rate.

15. The method of claim 12 , wherein varying the quantity of pharmaceutical gas delivered to the patient avoids high unsafe doses or doses too low to be effective.

16. The method of claim 12 , wherein receiving a desired quantity of nitric oxide to be delivered to the patient comprises receiving one or more of: mass of drug per unit of time; moles of drug per unit of time; mass of drug per unit of ideal body weight per unit of time; or moles of drug per unit of ideal body weight per unit of time.

17. The method of claim 12 , wherein receiving a desired quantity of nitric oxide to be delivered to the patient comprises receiving a mass of drug per unit of ideal body weight per unit of time.

18. The method of claim 12 , further comprising receiving one or more of: time duration of treatment; patient's ideal body weight; patient's height; or patient's sex.

19. The method of claim 12 , wherein one or more of the first quantity and the quantity delivered in the subsequent breath is delivered during the first half of inspiration.

20. The method of claim 12 , wherein the pharmaceutical gas is delivered to the patient every breath.

Assignments (15)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0608 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: SPECGX LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 043601, FRAME 0025 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065610/0233 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded Aug 18, 2017
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 043601/0025 →
Continuity (7)
Continuation 13778596 · Feb 27, 2013
Continuation 13536272 · Jun 28, 2012
Continuation 13287663 · Nov 2, 2011
Continuation 13284433 · Oct 28, 2011
Continuation 12430220 · Apr 27, 2009
Continuation 11231554 · Sep 21, 2005
Related Publication 20160271168A1 · Sep 22, 2016
Cited By (5)
US 12,509,349 US 12,522,501 US 12,569,628 US 12,576,234 US 12,606,436