Systems and methods for providing a pulse of a therapeutic gas with a desired flow profile to maximize therapeutic effectiveness
Inventors
Kohlmann, Thomas • Klaus, John
Assignees
Mallinckrodt Pharamaceutials Ireland Ltd Co • Mallinckrodt Pharma IP Trading DAC • Therakos Inc • INO Therapeutics LLC • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-10758703-B2
Publication Date
2020-09-01
Expiration Date
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.
Core Innovation
The invention provides a system and method for providing a pulse of a pharmaceutical gas having a desired flow profile to deliver to a patient. The system includes a first fixed flow rate assembly with a first fixed flow valve in fluid communication with a first fixed flow orifice, where the first fixed flow valve rapidly opens and rapidly closes. The first fixed flow valve is located upstream of the first fixed flow orifice and is positioned at a volumetric offset from the first fixed flow orifice, producing a pulse of pharmaceutical gas having the desired flow profile for delivery to the patient.
A key aspect of the invention is arranging the first fixed flow valve at a volumetric offset from the first fixed flow orifice such that rapid opening and rapid closing generate desired pulse flow behavior. The desired flow profile is characterized in the claims as including abruptly increasing flow to a desired initial flow rate over negligible time and generating an initial flow spike and/or subsequent waning flow after rapidly closing the first fixed flow valve. The volumetric offset has a volume of less than 0.1 mL, and it is used to generate the waning flow or the initial flow spike.
The claims further specify constraints on the volumetric offset and the resulting flow profile shape and timing. The desired flow profile may include a sharp flow turn, a waning flow portion, or a pulse with substantially rectangular, triangular, or quadrilateral flow characteristics, depending on how the valve and orifice are arranged. Additional constraints include minimizing the time the first fixed flow valve remains open and limiting a pulse width to less than 500 milliseconds.
Claims Coverage
The partial content includes three independent claims: a system claim and two method claims. Collectively, the inventive features focus on fixed flow valve/orifice pulse delivery using rapid valve opening/closing, with a volumetric offset (less than 0.1 mL) to generate a desired initial flow spike and/or waning flow, and further constrain pulse shape and timing.
Fixed-flow valve/orifice pulse delivery with rapid opening and rapid closing
A system including a first fixed flow rate assembly with a first fixed flow valve in fluid communication with a first fixed flow orifice, where the first fixed flow valve rapidly opens and rapidly closes; the first fixed flow valve is located upstream of the first fixed flow orifice and is positioned at a volumetric offset from the first fixed flow orifice; and the flow delivery control 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.
Volumetric-offset-generated waning flow after rapid valve closing
A method including rapidly opening a first fixed flow valve 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 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; and providing a waning flow after rapidly closing, 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 having a volume of less than 0.1 mL.
Volumetric-offset-generated initial flow spike with pulse completion by rapid valve closing
A method including rapidly opening a first fixed flow valve 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 that abruptly increases flow to a desired initial flow rate including an initial flow spike over negligible time, where 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 having 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 to complete delivery of the pulse to the patient.
Across the independent claims, the coverage centers on using rapid opening and rapid closing of a fixed flow valve relative to a fixed flow orifice, where a volumetric offset (less than 0.1 mL) is arranged to generate the desired pulse flow behavior, including an abrupt initial increase and an initial flow spike and/or a subsequent waning flow. The partial content also supports further dependent-claim refinements that constrain the volumetric offset magnitude and specify flow profile geometry and pulse timing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Providing a pulse of pharmaceutical gas to a patient to treat chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and/or pulmonary hypertension (PH).
Providing a pulse of pharmaceutical gas to a patient, where the pharmaceutical gas is nitric oxide, including example concentration ranges described in the dependent claim text.
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