Systems and methods for providing a pulse of a therapeutic gas with a desired flow profile to maximize therapeutic effectiveness

Patent metadata

Field	Value
Publication number	US-10758703-B2
Application number	US-201514886556-A
Country	US
Kind code	B2
Filing date	Oct 19, 2015
Priority date	Oct 17, 2014
Publication date	Sep 1, 2020
Grant date	Sep 1, 2020

Abstract

Described are systems and methods for providing a pulse of a therapeutic gas with a desired flow profile to maximize therapeutic effectiveness. Systems and methods of the present disclosure can generate and/or provide desired flow profiles with various shapes and/or properties by configuring, modifying, optimizing, and/or factoring in aspects of at least one fixed flow rate assembly of a therapeutic gas delivery system such as, but not limited to, spatial relationships of elements of the fixed flow rate assembly, rate of valve closure and opening, latent flows, transient wave generation and/or propagation, to name a few.

First claim

What is claimed is:

1. A system for providing a pulse of a pharmaceutical gas having a desired flow profile to deliver to a patient, the system comprising:
a first fixed flow rate assembly including a first fixed flow valve in fluid communication with a first fixed flow orifice, the first fixed flow valve being (1) a fixed flow valve that rapidly opens and rapidly closes, (2) located upstream of the first fixed flow orifice and (3) at a volumetric offset from the first fixed flow orifice, wherein the volumetric offset has a volume of less than 0.1 mL; and
a flow delivery control that rapidly opens and rapidly closes the first fixed flow valve located upstream of, and at the volumetric offset from, the first fixed flow orifice to provide a pulse of a pharmaceutical gas having a desired flow profile to a patient.

2. The system of claim 1 , wherein the first fixed flow orifice downstream to the first fixed flow valve provides at least one of (1) a sharp turn on when the first fixed flow valve is opened rapidly, or (2) a waning flow having a volume substantially equal to a volume in the volumetric offset when the first fixed flow valve is closed rapidly.

3. The system of claim 1 , wherein the volumetric offset is substantially minimized to decrease duration of a waning flow generated when the first fixed flow valve is closed rapidly.

4. The system of claim 1 , wherein the volumetric offset has a volume of less than 0.05 mL.

5. The system of claim 1 , wherein the volumetric offset has a volume in the range of 0.0005 mL to 0.05 mL.

6. The system of claim 1 , wherein the desired flow profile for the pulse of pharmaceutical gas is one that minimizes the time that the first fixed flow valve is open.

7. The system of claim 6 , wherein the first fixed flow valve provides a pulse having a pulse width of less than 500 milliseconds.

8. A method of providing a pulse of a pharmaceutical gas with a desired flow profile to deliver to a patient, the method comprising:
rapidly opening a first fixed flow valve that is located upstream from a first fixed flow orifice to commence delivery of a first dose of a pharmaceutical gas in a pulse having a desired flow profile to a patient that abruptly increases flow to a desired initial flow rate over negligible time;
rapidly closing the first fixed flow valve to end flow, through the first fixed flow valve, of the pharmaceutical gas; and
providing a waning flow of the pharmaceutical gas after rapidly closing the first fixed flow valve to complete delivery, to the patient, of the pulse of the pharmaceutical gas with the desired flow profile, wherein the waning flow is generated in response to arranging the first fixed flow valve at a volumetric offset from the first fixed flow orifice, wherein the volumetric offset has a volume of less than 0.1 mL.

9. The method of claim 8 , wherein the pulse of a pharmaceutical gas having a desired flow profile is provided to a patient to treat at least one of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and pulmonary hypertension (PH).

10. The method of claim 8 , wherein the desired flow profile is downwardly sloped triangular shaped.

11. The method of claim 8 , further comprising:
maintaining open the first fixed flow valve to continue delivery, to the patient, of the pulse of the pharmaceutical gas with the desired flow profile at a desired continued flow rate for a period of time.

12. The method of claim 11 , wherein the desired flow profile is quadrilateral shaped.

13. The method of claim 12 , wherein the volumetric offset has a volume of less than 0.05 mL and the quadrilateral is substantially rectangular shaped.

14. The method of claim 8 , wherein the pharmaceutical gas comprises nitric oxide.

15. The method of claim 14 , wherein the concentration of nitric oxide in the pharmaceutical gas is 100 ppm to 5,000 ppm.

16. A method of providing a pulse of a pharmaceutical gas with a desired flow profile to deliver to a patient, the method comprising:
rapidly opening a first fixed flow valve that is located downstream from a first fixed flow orifice to commence delivery of a first dose of a pharmaceutical gas in a pulse having a desired flow profile to a patient that abruptly increases flow to a desired initial flow rate including an initial flow spike over negligible time, wherein the initial flow spike is generated in response to arranging the first fixed flow valve at a volumetric offset from the first fixed flow orifice, wherein the volumetric offset has a volume of less than 0.1 mL; and
rapidly closing the first fixed flow valve to end flow, through the first fixed flow valve, of the pharmaceutical gas to complete delivery, to the patient, of the pulse of the pharmaceutical gas with the desired flow profile.

17. The method of claim 16 , wherein the pulse of a pharmaceutical gas having a desired flow profile is provided to a patient to treat at least one of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and pulmonary hypertension (PH).

18. The method of claim 16 , further comprising:
maintaining open the first fixed flow valve to continue delivery, to the patient, of the pulse of the pharmaceutical gas with the desired flow profile at a desired continued flow rate for a period of time.

19. The method of claim 16 , wherein the desired flow profile is substantially rectangular shaped.

Assignees

• Ino Therapeutics Llc
• Mallinckrodt Hospital Products Ip Ltd

Inventors

• Kohlmann Thomas
• Klaus John

Classifications

• A61M2202/0275

  Nitric oxide [NO] · CPC title

• A61M16/12

  by mixing different gases · CPC title

• A61M2016/0021

  with a proportional output signal, e.g. from a thermistor · CPC title

• A61M16/202 Primary

  electrically actuated · CPC title

• A61M16/107

  in the inspiratory path · CPC title