Dry powder inhaler devices, multi-dose dry powder drug packages, control systems, and associated methods
First Claim
1. A multi-dose dry powder blister package, comprising:
- a platform body comprising a piezoelectric material layer with opposing first and second major surfaces;
a first plurality of spatially separated metal traces disposed on said first major surface of said piezoelectric material layer, said first plurality of metal traces configured to include a transmission line and an active pad region;
a second plurality of spatially separated metal traces disposed on said second major surface of said piezoelectric material, said second plurality of metal traces configured to include a transmission line and an active pad region, each of said second plurality of traces being positioned such it is aligned with a corresponding one of said first plurality of separated metal traces to define a corresponding pair of opposing metal traces with an individually operable electrical excitation path therebetween; and
a plurality of depressed wells formed in said platform body configured to hold a predetermined quantity of dry powder pharmaceutical drug therein, wherein each of said depressed wells is positioned on said platform body to substantially overlie a respective active pad region of one pair of corresponding first and second metal traces.
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Accused Products
Abstract
Dry powder inhalers with integrated active energy patient assist dispersal systems are configured with control systems which provide adjustable energy output responsive to the user'"'"'s inspiratory capabilities and/or the flowability of the dry powder drug being administered. The multi-dose dry drug package includes a piezoelectric polymer substrate (such as PVDF) which flexes to deform and provide mechanical oscillation in a selected region of the package corresponding to the dry powder drug dose in the exit flow path and is thus actively dispersed into the exit flow path of the inhaler during the user'"'"'s inspiratory activity. Control systems employ fuzzy logic models of the flowability of particular drug formulations (also being able to compensate or allow for the particular type of excipient used) and/or adjust for the real-time measured inspiratory efforts of the user. Manufacturing process control systems can adjust certain parameters in response to a fuzzy logic model of the flowability of the dry powder and other conditions associated with the dry powder drug being produced and/or dispensed.
31 Citations
49 Claims
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1. A multi-dose dry powder blister package, comprising:
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a platform body comprising a piezoelectric material layer with opposing first and second major surfaces;
a first plurality of spatially separated metal traces disposed on said first major surface of said piezoelectric material layer, said first plurality of metal traces configured to include a transmission line and an active pad region;
a second plurality of spatially separated metal traces disposed on said second major surface of said piezoelectric material, said second plurality of metal traces configured to include a transmission line and an active pad region, each of said second plurality of traces being positioned such it is aligned with a corresponding one of said first plurality of separated metal traces to define a corresponding pair of opposing metal traces with an individually operable electrical excitation path therebetween; and
a plurality of depressed wells formed in said platform body configured to hold a predetermined quantity of dry powder pharmaceutical drug therein, wherein each of said depressed wells is positioned on said platform body to substantially overlie a respective active pad region of one pair of corresponding first and second metal traces. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A disposable multi-dose dry powder package, with an integrated active element formed thereon, comprising:
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a piezoelectric polymer film having a substantially planar profile and an upper and lower surface;
a first metal trace pattern positioned onto said upper surface, said first metal trace pattern having a plurality of first pad regions, and a plurality of first linear transmission lines, wherein said first pad region is connected to a respective one first linear transmission line;
a second metal trace pattern positioned onto said lower surface, said second metal trace pattern having a plurality of second pad regions, and a plurality of second linear transmission lines, wherein each second pad region is connected to a respective one second linear transmission line, and wherein said first and second metal trace patterns are aligned across said piezoelectric polymer material layer;
a plurality of individual quantities of dry powder drug positioned to substantially overlie each of said first pad regions on said upper surface; and
a sealant layer positioned to overlay each of said unitized quantities of dry powder drug to secure it in said disposable dry powder package. - View Dependent Claims (24, 25, 26)
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27. A method of dispersing an inhalable quantity of a dry powder pharmaceutical drug to a patient'"'"'s airstream, comprising the steps of:
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positioning and holding a dry powder inhaler such that it is in fluid communication with a user and ready to direct a quantity of dry powder pharmaceutical drug into the airstream of a user during inhalation, wherein the package holds at least one unitized quantity of dry powder pharmaceutical drug in a receptacle portion of thereon, the receptacle portion including a piezoelectric polymer material layer;
repeatedly applying a voltage differential across the piezoelectric polymer film in the region of the receptacle to deform the receptacle; and
expelling the dry powder drug held in the receptacle portion of the package such that it is dispersed into the airstream of a user during the user'"'"'s inspiratory inhalation cycle. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. A method of facilitating the dispersion of a dose of a dry powder drug into an inhalation delivery path, comprising the steps of:
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positioning a quantity of dry powder drug in a package having an piezoelectric polymer material layer, the piezoelectric polymer material layer having a plurality of receptacle regions configured and sized to hold the dry powder drug proximate thereto, the piezoelectric polymer material layer configured with a plurality of selectively excitable regions corresponding to the plurality of receptacle regions;
selectively applying an excitation signal to at least one of the selectively excitable regions to rapidly flex the piezoelectric polymer material layer thereat to deform at least one receptacle region to thereby facilitate the dispersal of the dry powder drug into the inhalation delivery path. - View Dependent Claims (42, 43, 44, 45)
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46. A method of controlling a dry powder inhaler, comprising the steps of:
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providing a dry powder inhaler having an active delivery system and an air flow sensor positioned in the exit flow path;
measuring the air flow associated with the inspiratory efforts of a user using the dry powder inhaler proximate to the desired administration of the dry powder drug; and
adjusting the energy directed to the active delivery system responsive to said measuring step to thereby facilitate increased dose dispersion uniformity corresponding to the capabilities of a user.
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47. A method of fabricating a disposable multi-dose dry powder package having integrated active elements formed thereon, comprising the steps of:
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forming a package with at least one piezoelectric polymer film layer into a desired geometric shape with an upper and lower surface;
dispensing a quantity of dry powder drug to substantially overlie a plurality of spatially separate selected upper surface regions of the piezoelectric polymer film layer; and
sealing said dispensed dry powder drug to secure it against the dry powder package. - View Dependent Claims (48, 49)
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Specification