US5458135A — Method and device for delivering aerosolized medi…

Claim 1

Independent Claim 128 words

A method for producing an aerosolized dose of a medicament for subsequent inhalation by a patient, said method comprising: dispersing a preselected amount of the medicament in a powdered form in a high velocity air stream having a volume in the range from 10 ml to 750 ml of gas to produce the aerosolized dose; and introducing substantially the entire volume of the aerosolized dose into a chamber having an inlet at one end, an open mouthpiece at an opposite end, and a volume in the range from 100 ml to 750 ml, wherein the inlet and mouthpiece are oriented such that medicament entering the chamber through the inlet displaces air initially present in said chamber without substantial loss of medicament through the mouthpiece or within the chamber.

Claim 2

Independent Claim 128 words

A method for producing an aerosolized dose of a medicament for subsequent inhalation by a patient, said method comprising: dispersing a preselected amount of the medicament in a powdered form in a high velocity air stream having a volume in the range from 10 ml to 750 ml of gas to produce the aerosolized dose; and introducing substantially the entire volume of the aerosolized dose into a chamber having an inlet at one end, an open mouthpiece at an opposite end, and a volume in the range from 100 ml to 750 ml, wherein the inlet and mouthpiece are oriented such that medicament entering the chamber through the inlet displaces air initially present in said chamber without substantial loss of medicament through the mouthpiece or within the chamber.

Claim 3

Dependent Claim 32 words

A method as in claim 1, further comprising capturing at least about 40% by weight of the medicament delivered to the chamber wherein the medicament remains aerosolized and suspended within the chamber.

Claim 4

Dependent Claim 27 words

A method as in claim 1, wherein the medicament is dispersed in an aerosol of particles in the size range of from 1 μm to 5 μm.

Claim 5

Dependent Claim 16 words

A method as in claim 3, wherein the medicament comprises a protein or polypeptide active agent.

Claim 6

Dependent Claim 39 words

A method as in claim 1, wherein the high velocity air stream is introduced axially into the chamber and the medicament captured within the chamber by an internal baffle disposed transversely across the chamber between the inlet and mouthpiece.

Claim 7

Dependent Claim 32 words

A method as in claim 1, wherein the introducing step comprises passing the aerosolized dose through a tangential inlet on the chamber which causes the dose to flow in a vortical pattern.

Claim 8

Independent Claim 173 words

A method for delivering an aerosolized powder medicament to a patient, said method comprising: (a) dispersing a preselected amount of the powder medicament in a high velocity air stream having volume in the range from 10 ml to 750 ml to produce a single aerosolized dose; (b) capturing substantially the entire volume of the aerosolized dose into a chamber having a volume in the range from 100 ml to 750 ml and an open mouthpiece, wherein air initially present in the chamber is displaced without substantial loss of medicament through the mouthpiece and wherein the chamber geometry is such that deposition of medicament against walls within the chamber is minimized; (c) inhaling of the aerosolized dose from the chamber through the mouthpiece by the patient, wherein the patient inhales substantially the entire aerosolized dose followed by ambient air which sweeps the chamber of residual medicament whereby the chamber is refilled with ambient air; and repeating steps (a) through (c) a sufficient number of times to deliver a desired total dosage of the medicament.

Claim 9

Independent Claim 173 words

A method for delivering an aerosolized powder medicament to a patient, said method comprising: (a) dispersing a preselected amount of the powder medicament in a high velocity air stream having volume in the range from 10 ml to 750 ml to produce a single aerosolized dose; (b) capturing substantially the entire volume of the aerosolized dose into a chamber having a volume in the range from 100 ml to 750 ml and an open mouthpiece, wherein air initially present in the chamber is displaced without substantial loss of medicament through the mouthpiece and wherein the chamber geometry is such that deposition of medicament against walls within the chamber is minimized; (c) inhaling of the aerosolized dose from the chamber through the mouthpiece by the patient, wherein the patient inhales substantially the entire aerosolized dose followed by ambient air which sweeps the chamber of residual medicament whereby the chamber is refilled with ambient air; and repeating steps (a) through (c) a sufficient number of times to deliver a desired total dosage of the medicament.

Claim 10

Dependent Claim 27 words

A method as in claim 7, wherein at least about 40% by weight of the medicament delivered to the chamber remains aerosolized and suspended within the chamber.

Claim 11

Dependent Claim 27 words

A method as in claim 7, wherein the medicament is dispersed in an aerosol of particles in the size range of from 1 μm to 5 μm.

Claim 12

Dependent Claim 14 words

A method as in claim 9, wherein the medicament comprises a protein active agent.

Claim 13

Dependent Claim 64 words

A method as in claim 7, wherein the high velocity air stream is introduced axially through an inlet in the chamber and the medicament is captured within the chamber by an internal baffle disposed transversely across the chamber between the inlet and mouthpiece, and wherein the ambient air enters the chamber is a vortical pattern which sweeps the medicament past the-baffle to the mouthpiece.

Claim 14

Dependent Claim 32 words

A method as in claim 7, wherein the introducing step comprises passing the aerosolized dose through a tangential inlet on the chamber which causes the dose to flow in a vortical pattern.

Claim 15

Independent Claim 142 words

An apparatus for producing aerosolized doses of a dry powder medicament, said apparatus comprising: means for introducing a preselected amount of the dry powder medicament into a predetermined volume of flowing air to produce an aerosolized quantity of medicament; a chamber having an ambient air inlet and a patient mouthpiece; means for transferring substantially the entire aerosolized quantity of medicament from the introducing means to an entry point in the chamber; and an internal baffle within the chamber, wherein the transferring means directs the aerosol axially within the chamber and the internal baffle contains the medicament within the aerosol with in a region between the transferring means and the baffle; wherein the volume and geometry of the chamber are selected so that air initially present in said chamber is displaced without substantial loss of medicament through the mouthpiece or within the chamber.

Claim 16

Independent Claim 142 words

An apparatus for producing aerosolized doses of a dry powder medicament, said apparatus comprising: means for introducing a preselected amount of the dry powder medicament into a predetermined volume of flowing air to produce an aerosolized quantity of medicament; a chamber having an ambient air inlet and a patient mouthpiece; means for transferring substantially the entire aerosolized quantity of medicament from the introducing means to an entry point in the chamber; and an internal baffle within the chamber, wherein the transferring means directs the aerosol axially within the chamber and the internal baffle contains the medicament within the aerosol with in a region between the transferring means and the baffle; wherein the volume and geometry of the chamber are selected so that air initially present in said chamber is displaced without substantial loss of medicament through the mouthpiece or within the chamber.

Claim 17

Dependent Claim 33 words

An apparatus as in claim 13, wherein the means for aerosolizing the medicament comprises a dry powder reservoir and means for introducing preselected amounts of the dry powder into the flowing air stream.

Claim 18

Dependent Claim 43 words

An apparatus as in claim 13, wherein the ambient air inlet is disposed tangentially on the chamber between the transferring means and the baffle, whereby inhalation on the mouthpiece will induce a vortical flow of ambient air to sweep medicament past the baffle.

Claim 19

Dependent Claim 20 words

An apparatus as in claim 15, wherein the baffle is hemispherical with a concave surface disposed toward the transferring means.

Claim 20

Dependent Claim 54 words

An apparatus as in claim 16, wherein the chamber has a generally cylindrical interior and the means for transferring introduces the aerosolized medicament at a tangential angle so that a vortical flow is established, and wherein the aerosolized medicament enters at one end of the chamber and the mouthpiece is at the other end.

Claim 21

Dependent Claim 23 words

An apparatus as in claim 17, wherein the chamber has a spacer tube disposed axially therein to help establish the vortical flow pattern.

Claim 22

Dependent Claim 22 words

An apparatus as in claim 13, wherein the chamber has an internal volume in the range from 100 ml to 750 ml.

Claim 23

Dependent Claim 37 words

An apparatus as in claim 13, wherein the air inlet is located on the same end of the chamber as the aerosolized medicament entry point, whereby patient inspiration sweeps the chamber with air from the air inlet.

Claim 24

Dependent Claim 20 words

An apparatus as in claim 13, wherein the air inlet includes a one-way valve which permits inflow and prevents outflow.

Claim 25

Independent Claim 117 words

An apparatus for producing aerosolized doses of a medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having an ambient air inlet at one end and a mouthpiece at the other end; a spacer tube disposed axially in the chamber to help establish the vortical flow pattern; and means for tangentially introducing the aerosolized quantity of medicament from the dispersing means into the chamber so that the medicament will flow along a vortical path in the cylindrical chamber, whereby air is displaced from the chamber without substantial mixing as the chamber is being filled with medicament.

Claim 26

Independent Claim 117 words

An apparatus for producing aerosolized doses of a medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having an ambient air inlet at one end and a mouthpiece at the other end; a spacer tube disposed axially in the chamber to help establish the vortical flow pattern; and means for tangentially introducing the aerosolized quantity of medicament from the dispersing means into the chamber so that the medicament will flow along a vortical path in the cylindrical chamber, whereby air is displaced from the chamber without substantial mixing as the chamber is being filled with medicament.

Claim 27

Dependent Claim 33 words

An apparatus as in claim 22, wherein the means for dispersing the medicament comprises a dry powder reservoir and means for introducing preselected amounts of the dry powder into the flowing gas stream.

Claim 28

Dependent Claim 22 words

An apparatus as in claim 22, wherein the chamber has an internal volume in the range from 100 ml to 750 ml.

Claim 29

Dependent Claim 20 words

An apparatus as in claim 22, wherein the air inlet includes a one-way valve which permits inflow and prevents outflow.

Claim 30

Independent Claim 151 words

An apparatus for producing aerosolized doses of a powdered medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having a tangential ambient air inlet at one end and a mouthpiece at the other end, wherein the dispersing means is connected to the chamber through an inlet which is on the same end as the ambient air inlet and which is axially aligned with the mouthpiece; and an internal baffle disposed transversely within the chamber so that the internal baffle contains the aerosolized medicament within a region between the introducing means and the baffle, wherein the ambient air inlet is disposed tangentially on the chamber between the introducing means and the baffle, whereby inhalation on the mouthpiece will induce a vortical flow of ambient air to sweep medicament past the baffle.

Claim 31

Independent Claim 151 words

An apparatus for producing aerosolized doses of a powdered medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having a tangential ambient air inlet at one end and a mouthpiece at the other end, wherein the dispersing means is connected to the chamber through an inlet which is on the same end as the ambient air inlet and which is axially aligned with the mouthpiece; and an internal baffle disposed transversely within the chamber so that the internal baffle contains the aerosolized medicament within a region between the introducing means and the baffle, wherein the ambient air inlet is disposed tangentially on the chamber between the introducing means and the baffle, whereby inhalation on the mouthpiece will induce a vortical flow of ambient air to sweep medicament past the baffle.

Claim 32

Dependent Claim 33 words

An apparatus as in claim 26, wherein the means for dispersing the medicament comprises a dry powder reservoir and means for introducing preselected amounts of the dry powder into a flowing gas stream.

Claim 33

Dependent Claim 20 words

An apparatus as in claim 26, wherein the baffle is hemispherical with a concave surface disposed toward the introducing means.

Claim 34

Dependent Claim 22 words

An apparatus as in claim 26, wherein the chamber has an internal volume in the range from 100 ml to 750 ml.

Claim 35

Dependent Claim 20 words

An apparatus as in claim 26, wherein the air inlet includes a one-way valve which permits inflow and prevents outflow.

Claim 36

Independent Claim 143 words

An apparatus for producing aerosolized doses of a powdered medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having a tangential ambient air inlet at one end and a mouthpiece at the other end, wherein the dispersing means is connected to the chamber through an inlet which is on the same end as the ambient air inlet; and an internal baffle disposed transversely within the chamber so that the internal baffle contains the aerosolized medicament within a region between the introducing means and the baffle, wherein the ambient air inlet is disposed tangentially on the chamber between the introducing means and the baffle, whereby inhalation on the mouthpiece will induce a vortical flow of ambient air to sweep medicament past the baffle.

Claim 37

Independent Claim 143 words

An apparatus for producing aerosolized doses of a powdered medicament, said apparatus comprising: means for dispersing a predetermined amount of the medicament in a preselected volume of flowing gas to produce an aerosolized quantity of medicament; a cylindrical chamber having a tangential ambient air inlet at one end and a mouthpiece at the other end, wherein the dispersing means is connected to the chamber through an inlet which is on the same end as the ambient air inlet; and an internal baffle disposed transversely within the chamber so that the internal baffle contains the aerosolized medicament within a region between the introducing means and the baffle, wherein the ambient air inlet is disposed tangentially on the chamber between the introducing means and the baffle, whereby inhalation on the mouthpiece will induce a vortical flow of ambient air to sweep medicament past the baffle.

Claim 38

Dependent Claim 33 words

An apparatus as in claim 31, wherein the means for dispersing the medicament comprises a dry powder reservoir and means for introducing preselected amounts of the dry powder into a flowing gas stream.

Claim 39

Dependent Claim 20 words

An apparatus as in claim 31, wherein the baffle is hemispherical with a concave surface disposed toward the introducing means.

Claim 40

Dependent Claim 22 words

An apparatus as in claim 31, wherein the chamber has an internal volume in the range from 100 ml to 750 ml.

Claim 41

Dependent Claim 20 words

An apparatus as in claim 31, wherein the air inlet includes a one-way valve which permits inflow and prevents outflow.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1998-10-16	1999-04-17	1999-10-17	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2002-10-16	2003-04-17	2003-10-17	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2006-10-16	2007-04-17	2007-10-17	$7700.00	Window Closed / Lapsed

Method and device for delivering aerosolized medicaments

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