Dry powder dispersing apparatus and methods for their use

Information

  • Patent Grant
  • 6546929
  • Patent Number
    6,546,929
  • Date Filed
    Monday, June 4, 2001
    23 years ago
  • Date Issued
    Tuesday, April 15, 2003
    21 years ago
Abstract
The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position. The second interlock remains engaged if the receptacle is only partially inserted into the carriage assembly.
Description




BACKGROUND OF THE INVENTION




The invention relates generally to the field of pulmonary drug delivery. More specifically, the invention relates to dry powder dispersion devices and methods for dispersing dry powder medicaments for inhalation by a patient.




Pulmonary drug delivery is becoming a promising way to deliver drugs to a patient. Pulmonary drug delivery relies on inhalation of a drug dispersion or an aerosol by the patient so that the active drug within the dispersion can reach the distal (alveolar) regions of the lung. It has been found that certain drugs are readily absorbed through the alveolar regions directly into blood circulation. For example, pulmonary delivery is particularly promising for the delivery of proteins and polypeptides which are difficult to deliver by other routes of administration. Such pulmonary delivery is effective both for systemic delivery and for localized delivery to treat diseases of the lungs.




A variety of approaches have been proposed to achieve pulmonary drug delivery. Such approaches include the use of liquid nebulizers, metered dose inhalers (MDI's) and dry powder dispersion devices. Of these approaches, dry powder dispersion devices are of particular interest. Exemplary embodiments of such dry powder dispersion devices are described in U.S. Pat. No. 5,740,794 and Ser. No. 08/309,691, filed Sep. 21, 1994, the complete disclosures of which are herein incorporated by reference. These patents describe hand-held powder dispersion devices which extract powder from a receptacle and aerosolize the powder so that the aerosolized powder may be inhaled by a patient. Such dry powder dispersion devices have proven to be tremendously successful in adequately aerosolizing dry powders for subsequent inhalation.




Even so, it would be desirable to provide various enhancements to increase the marketability, ease of use, functionality, and other features of such dry powder dispersion devices. Hence, it is an object of the invention to provide improved dry powder dispersion devices and methods for their use.




SUMMARY OF THE INVENTION




The invention provides exemplary systems, apparatus and methods for aerosolizing a powdered medicament. One exemplary apparatus of the invention comprises a pressurization cylinder and a piston that is slidable within the cylinder to pressurize a gas within the cylinder. A handle is coupled to the cylinder and is movable between an extended position and a home or retracted position to pressurize the gas within the cylinder. An aerosolizing mechanism is further provided to aerosolize a powdered medicament that is held within a receptacle using pressurized gas from the cylinder. A carriage assembly is provided to receive the receptacle and to couple the receptacle to the aerosolizing mechanism so that the powder may be extracted from the receptacle and aerosolized. The apparatus further includes a first and a second interlock which may be operated to engage the carriage assembly, thereby preventing coupling of the receptacle with the aerosolizing mechanism. The first interlock is released to allow movement of the carriage when the handle is moved to the fully extended position. The second interlock becomes engaged with the carriage when the receptacle is only partially inserted into the carriage assembly.




With such a configuration, the apparatus is operated to aerosolize the powdered medicament by inserting the receptacle into the carriage assembly to a fully loaded position to ensure that the second interlock is not engaged with the carriage assembly. The handle is then extended to a fully extended position and retracted back to the home position to produce a charge of pressurized gas and to release the first interlock from the carriage assembly. A fire button on the apparatus is then operated to move the carriage assembly toward the aerosolizing mechanism until the receptacle is coupled with the aerosolizing mechanism. Upon coupling of the aerosolizing mechanism, the charge of pressurized gas is released to aerosolize the powdered medicament that is held within the receptacle.




Such a configuration is advantageous in that the aerosolizing apparatus may not be operated if the receptacle is not fully inserted and the handle is not fully extended. In this way, controls are provided to ensure correct operation of the aerosolizion apparatus.




In one particularly preferable aspect, the receptacle has a front end, a back end, and a cavity which holds the medicament. The front end includes at least one notch, and the carriage assembly includes a key so that the receptacle may not be fully inserted into the carriage assembly if the notch does not mate with the key. In this way, the carriage assembly may not be operated to couple the receptacle with the aerosolizing mechanism if the notch does not mate with the key, thereby preventing full insertion of the receptacle into the carriage assembly.




In one particular aspect, the aerosolization apparatus further includes a sensor arm having a roller. The roller rolls over the cavity during insertion of the receptacle into the carriage assembly to move the sensor arm against the second interlock, thereby causing a latch on the second interlock to engage the carriage assembly until the roller rolls over the entire cavity. In this way, the latch will remain engaged with the carriage assembly to prevent its movement as long as the roller is in apposition to the cavity. Once fully inserted, the latch is released to allow operation of the carriage assembly. In still a further aspect, the sensor arm defines a well which receives the cavity when the receptacle is fully inserted. The well aligns the cavity with the aerosolizing mechanism to facilitate coupling of the receptacle to the aerosolizing mechanism.




In one particular aspect, the apparatus further includes a catch which engages the carriage assembly when the carriage assembly is moved to couple the receptacle to the aerosolizing mechanism. A release button is provided to release the carriage assembly from the catch. In this way, the carriage assembly will not accidentally be lowered to decouple the receptacle from the aerosolizing mechanism until the powdered medicament has been aerosolized. In another aspect, a valve is disposed in an airway between the cylinder and the aerosolizing mechanism. The valve has an open position and a closed position, and is generally in the closed (but unlocked) position during extension of the handle to the extended position. Such a configuration is advantageous in that the air employed to fill the cylinder is not drawn through the airway, thereby providing a cleaner supply of air to fill the cylinder.




In one particular embodiment, an aerosolizing apparatus is provided which comprises a housing, a pressurization cylinder, and a piston that is slidable within the cylinder to pressurize a gas within the cylinder. The piston is pivotally attached to the housing, and a handle is operably attached to both the housing and cylinder. The handle is operated to move the cylinder relative to the piston to pressurize a gas within the cylinder. An aerosolization mechanism is provided to receive gas from the cylinder to aerosolize a powdered medicament. Construction of the apparatus in this manner is advantageous in that the piston may pivot relative to the housing as the handle is operated. In this way, the piston remains generally aligned with the cylinder during operation of the handle, thereby facilitating operation of the handle and reducing wear between the components.




In one particular aspect, a linkage is disposed between the handle and the cylinder. The linkage is pivotally attached to the housing and the cylinder to further facilitate operation of the handle. In another aspect, the housing includes a top end and a bottom end, and the aerosolizing mechanism is disposed near the top end. Further, the piston is pivotally attached to the housing at the bottom end. Such a configuration is advantageous when a one-way check valve is disposed in the piston because the check valve will be disposed near the bottom end of the housing to reduce the chances of having any powder which may fall through the housing from accumulating on the check valve.




In a further embodiment, the invention provides an aerosolizing device which comprises a housing and a capture chamber which extends from the housing. An aerosolizing mechanism is disposed in the housing to introduce a powdered medicament into the capture chamber. The aerosolizing mechanism is provided with air channels which allow air to enter into the capture chamber when a patient inhales to extract the powdered medicament from the capture chamber. The aerosolizing mechanism farther includes a structure to distribute air entering into the capture chamber through the air channels such that the powdered medicament is removed from the capture chamber as a bolus that is substantially unmixed with the entering air.




Such a device is operated by dispersing the powdered medicament into the capture chamber and then inhaling from the capture chamber to extract the powdered medicament. Air is allowed to enter into the capture chamber through the air channels in a manner such that substantially none of the incoming air mixes with the powdered medicament to allow the medicament to be removed as a bolus. Hence, by introducing the air in this manner, the air serves as a piston to uniformly lift the aerosolized powder up through the capture chamber where it is inhaled by the patient.




In one particular aspect, the capture chamber has a geometric center and the aerosolizing mechanism is offset from the center because of the inclusion of other component parts within the housing. The structure is fashioned to distribute more air to regions of the capture chamber which are more remote from the geometric center. In this way, the remotest regions of the capture chamber will receive more air so that substantially no mixing of the powdered medicament occurs as air is drawn into the capture chamber during inhalation by the patient. In another aspect, the structure comprises a curved flange member and serves to channel some of the air radially outward as it enters into the capture chamber.




In one particularly preferable aspect, the aerosolizing mechanism includes a cylindrical passage or channel through which the powdered medicament passes to reach the capture chamber. The top end of the housing is generally perpendicular to a distal end of the passage. In this way, as the powdered medicament enters into the capture chamber, it will tend to disperse evenly throughout the capture chamber. In yet another aspect, a flexible seal is coupled to the housing to provide a seal with the capture chamber. The flexible nature of the seal is advantageous in that the capture chamber may easily be slid over the housing without causing excessive wear to the seal.




In one particular embodiment, the invention provides a device for aerosolizing a powdered medicament which comprises a housing having at least one piercing element for piercing a hole in a receptacle that contains a powdered medicament. A core is insertable into the housing and has an extraction lumen or tube and at least one air channel. The air channel is aligned with the piercing element when the core is inserted into the housing to allow air to flow into the receptacle through the air channel. A source of pressurized gas is further provided to extract the powdered medicament through the extraction lumen when the extraction lumen is inserted into the receptacle. Use of the housing and core is advantageous in that the core may be manufactured with a relatively small cost and may be made disposable, while the housing which includes the piercing element may be re-used.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

is an exploded front perspective view of an exemplary apparatus for aerosolizing a powdered medicament according to the invention.





FIG. 2

is a rear perspective view of the apparatus of FIG.


1


.





FIG. 2A

is a cross-sectional side view of a seal for engaging a necked region of the capture chamber of the apparatus of

FIG. 1

according to the invention.





FIG. 3

is a perspective view of an exemplary core of an aerosolization mechanism according to the invention.





FIG. 4

is a housing of an exemplary aerosolization mechanism which is adapted to receive the core of

FIG. 3

according to the invention.





FIGS. 3A and 3B

are cross-sectional side views of the core of

FIG. 3

taken along lines A—A and B—B, respectively.





FIGS. 4A and 4B

are cross-sectional side views of the housing of

FIG. 4

taken along lines A—A and B—B, respectively.





FIG. 5

illustrates the core of

FIG. 3A

inserted into the housing of

FIG. 4A

to form an aerosolization mechanism, with the aerosolization mechanism being coupled to a receptacle and showing the manner of powder extraction from the receptacle according to the invention.





FIG. 6

illustrates the aerosolization mechanism of

FIG. 5

taken along lines


6





6


.





FIG. 7

illustrates the aerosolization mechanism of

FIG. 5

showing the manner of air distribution as a patient inhales to draw air through the aerosolization mechanism according to the invention.





FIG. 8

illustrates the aerosolization mechanism of

FIG. 7

taken along lines


8





8


.





FIG. 9

is a schematic diagram of an air capture chamber showing the pattern of air flow that is produced upon inhalation by a patient according to the invention.





FIG. 9A

is a schematic diagram of a capture chamber illustrating removal of an aerosolized medicament upon inhalation by a patient according to the invention.





FIG. 10

is a cross-sectional side view of a base unit of the apparatus of

FIG. 1

taken along lines


10





10


(when the aerosolization mechanism and a receptacle are inserted into the base unit).





FIGS. 10A-10P

illustrate cross-sectional side views of the base of

FIG. 10

taken along lines A—A through P—P, respectively (with the base unit being in various states of operation).





FIG. 11

is a cross-sectional side view of the aerosolization apparatus of

FIG. 1

showing the handle extended to pressurize a gas within a cylinder according to the invention.





FIG. 11A

illustrates a magnified view of the base of the aerosolization apparatus of FIG.


11


.





FIG. 11B

is a cross-sectional side view of the apparatus of

FIG. 11

taken along lines B—B.





FIG. 11C

is a cross-sectional top view of the aerosolization apparatus of

FIG. 11

taken along the lines C—C.





FIG. 12

is a cross-sectional side view of the aerosolization apparatus of

FIG. 1

showing the handle in a home or retracted position after the pressurized gas has been produced within the cylinder according to the invention.





FIGS. 12A

illustrates a magnified view of the base of the aerosolization apparatus of FIG.


11


.





FIGS. 12B

is a cross-sectional side view of the apparatus of

FIG. 12

taken along lines B—B.





FIGS. 12C

is a cross-sectional top view of the aerosolization apparatus of

FIG. 12

taken along the lines C—C.

FIG. 13

illustrates a top view of one embodiment of a receptacle having a keyed notch to regulate insertion of the receptacle into an aerosolization apparatus according to the invention.





FIG. 14

illustrates another alternative embodiment of a receptacle having a pair of keyed notches according to the invention.











DESCRIPTION OF THE SPECIFIC EMBODIMENTS




Referring now to

FIGS. 1 and 2

, an exemplary embodiment of an apparatus


10


for aerosolizing a powdered medicament will be described. Apparatus


10


comprises a base unit


12


and a capture chamber


14


which is removably attachable to base unit


12


. Capture chamber


14


is configured to slide over base unit


12


to reduce the overall size of apparatus


10


during storage and to protect the components within base unit


12


. Shown exploded from base unit


12


is an aerosolization mechanism


16


which comprises a core


18


and a housing


20


. Base unit


12


includes an opening


21


to receive aerosolization mechanism


16


. Base unit


12


is configured to receive a receptacle


22


which holds a powdered medicament. Apparatus


10


is operated to couple aerosolization mechanism


16


with receptacle


22


, and then to extract the powdered medicament from receptacle


22


. The extracted powder is then deagglomerated and dispersed and delivered into capture chamber


14


where it will be available for inhalation by a patient.




Capture chamber


14


includes a mouthpiece


24


that is rotatable between an open position and a closed position. During aerosolization, mouthpiece


24


is in the closed position as shown in

FIGS. 1 and 2

. When the patient is ready to inhale the aerosolized medicament, mouthpiece


24


is rotated 180 to the open position where the patient may place his mouth over the mouthpiece and inhale the powdered medicament from capture chamber


14


.




As previously mentioned, capture chamber


14


is slidable over base unit


12


to reduce the size of apparatus


10


during storage and to protect the components of base unit


12


. Base unit


12


includes a seal


26


which extends radially outward from base unit


12


and engages the walls of capture chamber


14


so that a seal is provided between base unit


12


and capture chamber


14


. As best shown in

FIG. 2A

, capture chamber


14


includes a necked region


28


which comes into contact with seal


26


as capture chamber


14


is moved to a fully extended position. Seal


26


is preferably constructed of a rubber using a two-shot molding process to attach seal


26


to base unit


12


. Use of necked region


28


is particularly advantageous in that seal


26


disengages from capture chamber


14


as capture chamber


14


is slid over base unit


12


to a closed or storage position. In this way, wear of seal


26


is significantly reduced.




Referring back to

FIGS. 1 and 2

, necked region


28


further includes a pair of apertures


30


into which a pair of latches


32


on base unit


12


are received when capture chamber


14


is moved to the extended position. Upon reaching the extended position, the latches, which are spring-biased, slide into apertures


30


to prevent capture chamber


14


from being pulled from base unit


12


. Further, engagement of latches


32


with apertures


30


maintain the capture chamber


14


in the extended position so that it will not accidentally slide back over base unit


12


. To disengage latches


32


from apertures


30


, a chamber release button


34


is depressed. Upon depression of chamber release button


34


, latches


32


are moved back into base unit


12


where capture chamber


14


may be removed from base unit


12


or slid back over base unit


12


to the storage position.




Conveniently, base unit


12


includes a pull ring


36


which may be grasped with a finger of one hand while capture chamber


14


is grasped with the other hand to facilitate movement of capture chamber


14


from the storage position to the extended position. Pull ring


36


is attached to base unit


12


by a spring-loaded hinge mechanism so that pull ring


36


will return to a flush position with base unit


12


when not in use.




Apparatus


10


is operated by inserting receptacle


22


into a carriage assembly


38


of base unit


12


. Optionally, apparatus


10


may be operated without inserting a receptacle if it is desire to do a “dry fire.” As described in greater detail hereinafter, apparatus


10


cannot be operated unless receptacle


22


is fully inserted into carriage assembly


38


. Hence, such a configuration provides a way to prevent coupling of aerosolization mechanism


16


to receptacle


22


unless receptacle


22


is properly inserted.




To aerosolize the medicament, a pump handle


40


is extended away from base unit


12


. As described in greater detail hereinafter, when pump handle


40


is extended to a fully extended position and then pushed inwardly back to the home or retracted position (as illustrated in FIGS.


1


and


2


), a compressed gas is provided within a cylinder in base unit


12


. The compressed gas is then released where it will flow through aerosolization mechanism


16


when a fire button


42


(see

FIG. 2

) is pressed. When fire button


42


is pressed, carriage assembly


38


is operated to move receptacle


22


into engagement with aerosolization mechanism


16


where holes


44


are pierced into receptacle


22


. Just after holes


44


are pierced with aerosolization mechanism


16


, the pressurized gas within base unit


12


is released to extract the powdered medicament from receptacle


22


, deagglomerate and disperse the powdered medicament, and deliver the powdered medicament in aerosolized form into capture chamber


14


in a manner similar to that described in U.S. Pat. No. 5,740,794, previously incorporated by reference.




As described in greater detail hereinafter, one feature of apparatus


10


is that, in addition to preventing coupling of receptacle


22


to aerosolization mechanism


16


if receptacle


22


is not fully inserted into carriage assembly


38


, fire button


42


may not be operated if pump handle


40


has not been extended to the fully extended position. In this way, operation of apparatus


10


is prevented unless the user has fully extended handle


40


so that a proper amount of pressurized gas may be provided (upon retraction of handle


40


to the retracted position) to allow aerosolization mechanism


16


to operate properly.




Hence, apparatus


10


is provided with two compliance features to help ensure the proper production of the aerosolized medicament within capture chamber


14


. First, receptacle


22


must be fully inserted into carriage assembly


38


. Second, handle


40


must be fully extended to the extended position. If both of these conditions are not satisfied, fire button


42


cannot be pressed to couple receptacle


22


to aerosolization mechanism


16


and to release the pressurized gas to extract the powder from receptacle


22


.




When fire button


42


is pressed, carriage assembly


38


is lifted to couple receptacle


22


with aerosolization mechanism


16


which aerosolizes the powder within receptacle


22


. Following operation of fire button


42


to aerosolize the medicament, receptacle


22


remains coupled with aerosolization mechanism


16


and therefore cannot removed from carriage assembly


38


. To uncouple receptacle


22


from aerosolization mechanism


16


, a release button


46


is pressed to lower carriage assembly


38


. Receptacle


22


may then be removed from carriage assembly


38


where it will include holes


44


.




One particular advantage of releasing the pressurized gas immediately after holes


44


are pierced in receptacle


22


is that the user is prevented from coupling receptacle


22


with aerosolization mechanism


16


and then delaying the release of the pressurized gas. In this way, the powdered medicament within receptacle


22


will not experience prolonged exposure to the environment which may degrade the medicament.




Referring now to

FIGS. 3-3B

and


4


-


4


B, construction of aerosolization mechanism


16


will be described in greater detail, with core


18


being illustrated in

FIGS. 3-3B

and housing


20


being, illustrated in

FIGS. 4-4B

. Core


18


includes an extraction tube


48


having a pointed tip


50


which is adapted to pierce a hole within a receptacle, such as for example the center hole


44


in receptacle


22


(see FIG.


1


). Pointed tip


50


includes a pair of apertures


52


which allow the powdered medicament within the receptacle to be drawn into extraction tube


48


. Coupled to extraction tube


48


is a nozzle


54


which in turn is in communication with a high-pressure gas inlet


56


(see FIG.


3


B). Extending from nozzle


54


is a deagglomeration channel


58


which terminates in an exit opening


60


. Core


18


further includes a plurality of air channels


62


which serve both to allow air into a pierced receptacle during aerosolization and to provide an air passageway into the capture chamber when a patient inhales the aerosolized medicament as described in greater detail hereinafter. When coupled with housing


20


, core


18


aerosolizes a powdered medicament within a receptacle in a manner similar to that described in U.S. Pat. No. 5,740,794 and Ser. No. 08/309,691, filed Sep. 21, 1994, previously incorporated by reference. Operation of aerosolization mechanism


16


to aerosolize a powdered medicament will also be described in greater detail hereinafter with reference to

FIGS. 5-8

.




Disposed over air channels


62


by a set of ribs


64


is a curved flange member


66


. Curved flange member


66


serves to distribute chase air into the aerosolization chamber with an axial and a radial component to facilitate removal of the aerosolized medicament as described in greater detail hereinafter. Conveniently, ribs


64


divide air channels


62


into four quadrants. As described in greater detail hereinafter, the size of the four quadrants may be varied to vary the volume of air that passes through each of the quadrants.




Core


18


further includes a flat surface


68


which is aligned with a flat surface


70


of housing


20


to facilitate proper alignment of core


18


when inserted into housing


20


. When core


18


is inserted into housing


20


, an edge


72


of core


18


rests upon a top end


74


of housing


20


. Core


18


also includes a lip


76


which rests upon a top end of base unit


12


when aerosolization mechanism


16


is inserted into opening


21


of base unit


12


. Conveniently, housing


20


includes a key


78


to assist in proper orientation of aerosolization mechanism


16


into base unit


12


.




Referring now to

FIGS. 4-4B

, construction of housing


20


will be described in greater detail. Housing


20


includes a pair of side punches


80


which are configured to punch a pair of holes into a receptacle, such as the outer holes in receptacle


22


of FIG.


1


. Side punches


80


are angled so that they will peel back the receptacle as they enter. A pair of openings


82


are provided in housing


20


and are in fluid communication with air channels


62


when core


18


is inserted into housing


20


. In this way, air may travel through air channels


62


, through openings


82


and into the receptacle to assist in the extraction of the powdered medicament. Housing


20


further includes a hole


84


(see

FIG. 4B

) through which pointed tip


50


of core


18


is received when core


18


is coupled to housing


20


. A stop


86


is provided on housing


20


and serves to stop penetration of side punches


80


and pointed tip


50


when coupling aerosolization mechanism


16


to a receptacle. A seal


87


is provided to form a seal between aerosolization mechanism


16


and receptacle


22


.




As best shown in

FIGS. 4A and 4B

, a port


88


is disposed in housing


20


and is aligned with high-pressure gas inlet


56


when core


18


is inserted into housing


20


. As best shown in

FIG. 4B

, housing


20


is constructed of a resilient material in the region around port


88


and stop


86


to provide an overmold seal


90


. Seal


90


provides a seal between port


88


and a valve through which the high-pressure gas is provided to extract and deagglomerate the powder from the receptacle, and to provide a seal between stop


86


and the receptacle. Overmold seal


90


may be constructed using a two-shot molding process as is known in the art. Further, the angled nature of seal


90


in the vicinity of port


88


assists in properly aligning port


88


with the air flow tube which delivers the pressurized gas through nozzle


54


. As best shown in

FIGS. 4 and 4B

, housing


20


further includes an inlet check valve


92


which allows air into housing


20


when a patient inhales from the capture chamber to extract the aerosolized medicament from the capture chamber. Check valve


92


is constructed as a mushroom valve which opens after experiencing a threshold pressure. Use of such a valve is advantageous in that a pressure drop is created when a patient begins to inhale so that a generally uniform pressure may be produced within a plenum


94


(see FIG.


6


). As described in greater detail hereinafter, by providing a generally uniform pressure within plenum


94


, the management of air flow into the capture chamber may be better controlled.




One particular advantage of constructing core


18


so that it is removable from housing


20


is that core


18


may be periodically removed and replaced with a new core. In this way, the life of the aerosolization apparatus may be greatly increased. Further, by including the more expensive components on housing


20


, the cost of replacing the core can be greatly reduced. Although shown as being constructed from two components, it will be appreciated that aerosolization mechanism


16


may also be constructed as an integral system.




Referring now to

FIGS. 5-8

, operation of aerosolization mechanism


16


to extract a powdered medicament from receptacle


22


, to deagglomerate the powdered medicament, and to deliver the powdered medicament in aerosolized form into a capture chamber will be described. When receptacle


22


is coupled to aerosolization mechanism


16


, seal


87


is placed adjacent to a top surface


96


of receptacle


22


to form a seal between aerosolization mechanism


16


and top surface


96


. Further, stop


86


engages carriage assembly


38


(see

FIG. 10N

) to prevent further upward travel of carriage assembly


38


. Pointed tip


50


and side punches


80


penetrate top surface


96


and are disposed within a cavity or pocket


98


which holds the powdered medicament. To extract the powdered medicament, a high-pressurized gas is supplied through port


88


and high-pressure gas inlet


56


as shown by the arrows. The high-pressurized gas passes through nozzle


54


causing air to entrain through air channels


62


, through pocket


98


and through extraction tube


48


as indicated by the arrows. The entrained air is included in a closed air circuit which includes air in the capture chamber, in the aerosolization mechanism, and in the receptacle. Such a process is essentially identical to that described in U.S. Pat. No. 5,740,794, previously incorporated by reference.




The powdered medicament within extraction tube


48


then enters deagglomeration channel


58


which serves to deagglomerate the powder so that it will be suitable for inhalation. Deagglomeration channel


58


preferably has a constant diameter with a length that is approximately one times the diameter to about ten times the diameter, more preferably three times the diameter to about seven times the diameter, and most preferably at about five times the diameter. As shown in the drawings, deagglomeration channel


58


terminates abruptly at exit opening


60


. In this way, a “dump diffuser” is provided so that the gas flow out of deagglomeration channel


58


will tend to further break apart the powdered medicament and not slow down. In this manner, the dispersement of the aerosolized medicament into the capture chamber is improved.




Following dispersement of the powdered medicament into the capture chamber, the patient inhales to extract the powdered medicament from the capture chamber, causing chase air to flow through aerosolization mechanism


16


as illustrated in

FIGS. 7 and 8

. When the patient inhales, replacement (or chase) air needs to be introduced into the capture chamber to allow the aerosolized medicament to be removed. Such chase air passes through aerosolization mechanism


16


after entering into plenum


94


through inlet check valve


92


. An opening


100


(see

FIG. 8

) is provided in housing


20


to allow the chase air to open inlet valve


92


and pass through air channels


62


as indicated by the arrows.




Aerosolization mechanism


16


is designed so that the chase air entering the capture chamber is managed to minimize the amount of mixing of the aerosolized medicament with the entering chase air. In this way, the powdered medicament may be extracted from the chamber in a bolus followed by the chase air passing through aerosolization mechanism


16


. Such distribution of the chase air in the capture chamber is accomplished in part by providing check valve


92


which provides a pressure drop so that the air within plenum


94


will be at a substantially constant pressure. Proper air distribution is also provided by curved flange member


66


which divides the air flow within air channels


62


into an axial and a radial component. Hence, as the patient inhales from the mouthpiece of the capture chamber, the chase air flowing through aerosolization mechanism


16


is distributed into the capture chamber in a manner such that the amount of air that mixes with the powdered medicament is minimized.




Such a feature is illustrated in

FIGS. 9 and 9A

which illustrate how the powdered medicament remains in a bolus that is evenly removed from the capture chamber. In

FIG. 9

, the arrows illustrate the flow path of the incoming chase air as it moves through the capture chamber. As shown, the flow paths are generally parallel, indicating that substantially none of the chase air mixes with the aerosolized medicament.

FIG. 9A

illustrates the mass fraction of air within a capture chamber at approximately 100 milliseconds after inhalation is initiated. Contours C


1


-C


10


illustrate contours of mass fraction of air. Contour C


1


illustrates the powdered medicament bolus, and contour C


10


illustrates the incoming chase air. As shown, almost no mixing of the incoming chase air occurs with the bolus. As a result, the bolus is lifted evenly upward and out of the mouthpiece where it will be followed. by the chase air. In this manner, in the first part of the tidal volume, the patient receives the powdered medicament. During the remainder of the tidal volume, the chase air flows into the patient's lungs to assist in delivering the powdered medicament into the deep regions of the lungs. Hence, the front end of the inhalation cycle is employed to extract the powdered medicament from the chamber while the remainder of the inhalation cycle serves to further deliver the powdered medicament to the lungs.




As illustrated in

FIG. 1

, aerosolization mechanism


16


is offset from a center of base unit


12


. To produce the proper air flow into the aerosolization chamber, the location of ribs


64


(see

FIG. 3

) may be varied to allow more chase air to pass through the quadrant facing the larger area of the capture chamber so that the air flow may be more evenly distributed within the capture chamber.




Referring now to

FIG. 10

, a cross-sectional side view of apparatus


10


of

FIG. 1

taken along lines


10





10


is shown. In the view of

FIG. 10

, aerosolization mechanism


16


is disposed within base unit


12


, and receptacle


22


is inserted into carriage assembly


38


.

FIG. 10

is provided to serve as a reference to illustrate the various views of

FIGS. 10A-10P

, which describe the method of operation of apparatus


10


. As previously mentioned, apparatus


10


includes a receptacle interlock that prevents operation of fire button


42


if receptacle


22


is only partially inserted into carriage assembly


38


. Such a feature is illustrated in

FIGS. 10A-10E

. For convenience of illustration, aerosolization mechanism


16


is not shown in base unit


12


.




In

FIG. 10A

, base unit


12


is in a home or ready state. In the ready state, a receptacle interlock


102


is in a rest position. When in the rest position, a lifter


104


of carriage assembly


38


is able to pivot upwardly about a pivot pin


106


. Fire button


42


is also pivotally attached to base unit


12


by a pivot pin


108


which allows a set of gear teeth


110


on fire button


42


to move when fire button


42


is depressed. In turn, a set of gear teeth


112


on lifter


104


are moved by gear teeth


110


to lift litter


104


vertically upward. Base unit


12


further includes a sensor arm


114


which is biased by a spring


116


in a rest position. As described in greater detail hereinafter, when sensor arm


114


is in the rest position, receptacle interlock


102


is also in the rest position where fire button


42


may be operated to lift lifter


104


. Conveniently, sensor arm


114


includes a roller


118


over which receptacle


22


passes when inserted into carriage assembly


38


. Although shown with a roller, it will be appreciated that a stationary mechanism may also be disposed in place of roller


118


. Conveniently, a guide


120


is provided to facilitate introduction of receptacle


22


into carriage assembly


38


.




As shown in

FIG. 10B

, receptacle


22


is partially inserted into carriage assembly


38


. When only partially inserted, pocket


98


of receptacle


22


contacts roller


118


, causing spring


116


to compress and sensor arm


114


to pivot downward as shown. In turn, sensor arm


114


pivots receptacle interlock


102


about a pivot pin


122


. As shown in

FIG. 10C

, receptacle interlock


102


includes a latch


124


which moves over a boss


126


on lifter


104


. When latch


124


is disposed over boss


126


, lifter


104


is unable to pivot about pivot pin


106


. In turn, fire button


42


is unable to be depressed. Hence, if receptacle


22


is only partially inserted as illustrated in

FIG. 10B

, fire button


42


may not be operated to lift carriage assembly


38


, thereby preventing receptacle


22


from being coupled with aerosolization mechanism


16


.




When receptacle


22


is fully inserted into carriage assembly


38


, pocket


98


is positioned beyond roller


118


and is disposed within a well


128


of sensor arm


114


. When pocket


98


is disposed within well


128


, spring


116


moves sensor arm


114


back to the rest position as illustrated in FIG.


10


D. In turn, receptacle interlock


102


pivots back to the rest position. As illustrated in

FIG. 10E

, when receptacle interlock


102


is rotated back to the rest position, latch


124


is now clear of boss


126


on lifter


104


. In this way, lifter


104


is not restricted by receptacle interlock


102


. However, as described in greater detail hereinafter, fire button


42


may still not be operated until a valve interlock is released.




In summary, sensor arm


114


and receptacle interlock


102


serve to prevent operation of fire button


42


if receptacle


22


is only partially inserted. If not inserted, or if fully inserted, receptacle interlock


102


is in a rest position where it does not prevent movement of lifter


104


of carriage assembly


38


. When a valve interlock, as described hereinafter, is released, fire button


42


may be depressed to move carriage assembly


38


upward so that receptacle


22


may engage with aerosolization mechanism


16


. In this way, a compliance feature is provided to prevent operation of aerosolization apparatus


10


if receptacle


22


is not correctly inserted. Moreover, by providing well


128


in sensor arm


114


, an alignment mechanism is provided to ensure that pocket


98


will be properly aligned with aerosolization mechanism


16


. In this way, receptacle


22


is properly coupled to aerosolization mechanism


16


each time apparatus


10


is operated to produce the aerosolized medicament.




Referring now to

FIGS. 10F-10K

, operation of a valve interlock


130


will be described. In order to extract an aerosolization medicament within receptacle


22


, a pressurized gas must be supplied to aerosolization mechanism


16


(see FIG.


10


). As described in greater detail hereinafter, the pressurized gas is provided by operating handle


40


to pressurize the gas within a cylinder. Before the gas can be pressurized in the cylinder, a valve


132


must be closed and locked to allow the pressure to build up within the cylinder. As shown in

FIG. 10F

, valve interlock


130


is in a ready state. In the ready state, valve


132


is unlocked and valve interlock


130


prevents operation of fire button


42


. As described in greater detail hereinafter, valve interlock


130


is not released to allow fire button


42


to be operated until handle


40


is extended to a fully extended position. Upon reaching the fully extended position, valve


132


is locked and valve interlock


130


is released so that, as handle


40


is moved back to the home or retracted position, the precise amount of pressurized gas is produced and may be released upon operation of fire button


42


.




As shown in

FIG. 10G

, receptacle


22


is fully inserted so that receptacle interlock


102


(see

FIG. 10A

) is in the ready state and is not engaged with lifter


104


. Handle


40


is in the home or retracted position and valve


132


is unlocked so that there is no pressurized gas within base unit


12


. As shown in

FIG. 10F

, valve interlock


130


includes a latch


134


which is positioned over a boss


136


on lifter


104


when valve interlock


130


is in the rest or ready state. In the rest state, an actuator arm


138


, which is pivotally attached to base unit


12


by a pivot pin


140


, is in an unlocked position so that valve


132


is unlocked. Base unit


12


further includes a valve set arm


142


. As shown in

FIGS. 10F and 10G

, valve set arm


142


is in an open position where valve set arm


142


engages valve interlock


130


to position latch


134


over boss


136


. As best shown in

FIG. 10G

, handle


40


includes a pump link


144


which is pivotally attached to base unit


12


by a pivot pin


146


. Pump link


144


includes a nose


148


which is spaced apart from valve set arm


142


when in the open position.




As handle


40


is extended from the home position toward an extended position, pump link


144


pivots about pivot pin


146


causing nose


148


to engage valve set arm


142


, as illustrated in FIG.


10


H. Base unit


12


includes a chassis


150


having a boss


152


. As nose


148


pushes on valve set arm


142


, valve set arm


142


slides under boss


152


on chassis


150


to lock valve set arm


142


in place. In turn, actuator arm


138


is rotated about pivot pin


140


(see

FIG. 10I

) to move actuator arm


138


to a locked position. In this way, valve


132


(see

FIG. 10I

) is closed and locked so that, as handle


40


is moved back toward base unit


12


, a pressurized gas may be produced.




As best illustrated in

FIG. 10I

, as handle


40


is moved to the fully extended position, actuator arm


138


is moved over center to the locked position where valve


132


is closed and locked. In the fully extended position, valve set arm


142


rotates valve interlock


130


to clear latch


134


from boss


136


. At this point, both valve interlock


130


and receptacle interlock


102


are disengaged so that fire button


42


may be operated to operate carriage assembly


38


and to open valve


132


to allow the pressurized gas to be delivered to aerosolization mechanism


16


as described in greater detail hereinafter.




Referring now to

FIG. 10J

, construction of valve


132


will be described in greater detail. In

FIG. 10J

, receptacle is fully inserted and handle


40


has moved to the fully extended position so that both interlocks


130


and


102


have been released. Valve


132


is constructed of a housing


154


having a passage


156


which is aligned with port


88


(see

FIG. 6

) when aerosolization mechanism is inserted into base unit


12


. Disposed across passage


156


is a valve seat


158


. Extending from valve seat


158


is a rolling diaphragm


160


which terminates in an O-ring


162


. In

FIG. 10J

, a valve actuator


164


of actuator arm


138


(see

FIG. 10I

) is firmly pressed against valve seat


158


. As such, valve


132


is in the closed, locked position. Housing


154


further includes a lumen


166


for receiving a high pressurized gas from a pressurization cylinder within base unit


12


as described in greater detail hereinafter. Conveniently, a fitting


168


is provided on housing


154


to allow a tube to be coupled to housing


154


.




When valve


132


is in the closed and locked position, gasses are prevented from travelling from lumen


166


through passage


156


. As such, when handle


40


is moved back to the home or retracted position, a pressurized gas will be produced. When valve


132


is opened, the high pressurized gas will pass through passage


156


and into aerosolization mechanism


16


to extract the powdered medicament from receptacle


22


.




Referring back to

FIG. 10D

, valve actuator


164


is shown in an unlocked position where handle


40


has not yet been fully extended. In the unlocked position, valve seat


158


still covers passage


156


. In this way, when handle


40


is being extended, air is prevented from being drawn through passage


156


and lumen


166


. Instead, the pressurization cylinder which pressurizes the air upon operation of handle


40


is filled with air through a check valve in a bottom of base unit


12


as described in greater detail hereinafter. In this manner, any residual powdered medicament which is disposed within aerosolization mechanism


16


will be generally prevented from being drawn through valve


132


and into the pressurization cylinder where it may hinder operation of apparatus


10


. Although in the closed state prior to full extension of handle


40


, valve seat


158


does not provide a seal to allow pressurized gas to be produced within the cylinder until valve actuator


164


is in the locked position. In this manner, if handle


40


is only partially extended and then moved back to the home position, gasses from the cylinder will be free to move through lumen


166


and through valve


132


.




Referring now to

FIG. 10K

, apparatus


10


is shown with aerosolization mechanism


16


inserted into base unit


12


. Receptacle


22


is fully inserted and handle


40


has been moved back to the home position after being fully extended so that both interlocks


102


and


130


have been released. With both interlocks clear, fire button


42


is ready to be pushed to begin the aerosolization process. As shown, when receptacle


22


is fully inserted, pocket


98


is aligned with pointed tip


50


and side punches


80


.




As illustrated in

FIG. 10L

, when fire button


42


is pushed, gear teeth


110


are pivoted about pivot pin


108


, causing lifter


104


of carriage assembly


38


to move receptacle


22


toward aerosolization mechanism


16


. When fully depressed, pointed tip


50


and side punches


80


pierce through receptacle


22


and enter into pocket


98


as shown. Stop


86


engages carriage assembly


38


(see

FIG. 10N

) to ensure that pointed tip


50


and side punches


80


are not pressed through the bottom of pocket


98


while seal


87


provides a seal between aerosolization mechanism


16


and receptacle


22


. Depression of fire button


42


causes valve actuator


164


of actuator arm


138


to be released from its over-center position, thereby unlocking valve


132


. The high pressurized gas stored within base unit


12


then flows through lumen


166


as shown by the arrow, causing valve


132


to “pop open.” More specifically, the release of valve actuator


164


causes the high pressurized gas to come into contact with the underside of diaphragm


160


causing valve seat


158


to be lifted from passage


156


. In this manner, air is allowed to flow through passage


156


and into aerosolization mechanism


16


. The high pressurized gas then extracts the powdered medicament from pocket


98


, deagglomerates the powdered medicament and disperses the powdered medicament into the capture chamber as previously described.




One particular advantage of aerosolization apparatus


10


is that the powdered medicament is extracted from receptacle


22


almost immediately after it has been pierced by aerosolization mechanism


16


. In this manner, the powdered medicament within receptacle


22


remains fresh until it is aerosolized.




Referring now to

FIGS. 10M and 10N

, operation of fire button


42


to release actuator arm


138


from the locked position will be described. Fire button


42


includes a tab


170


which engages a post


172


on valve set arm


142


. As fire button


42


is further depressed, tab


170


pushes valve set arm


142


out from under boss


152


on chassis


150


(see FIG.


10


H). In turn, valve actuator arm


138


is allowed to move back away from its over-center position, unclamping diaphragm


160


(see FIG.


10


L). As illustrated in

FIG. 10N

, fire button


42


is fully depressed so that post


172


on set arm


142


is in a released position.




Still referring to

FIGS. 10M and 10N

, as fire button


42


is pressed, gear teeth


110


and


112


operate to transfer trigger motion from fire button


42


to lifter


104


. A spring beam


174


is included on lifter


104


and engages a notch


176


in carriage assembly


38


. Spring beam


174


is employed to raise carriage assembly


38


so that receptacle


22


may be coupled to aerosolization mechanism


16


. As illustrated in

FIG. 10M

, stop


86


on aerosolization mechanism


16


has not quite come into contact with carriage assembly


38


. In

FIG. 10N

, carriage assembly has engaged stop


86


to stop motion of carriage assembly


38


. Further, spring beam


174


is deformed due to the further upward travel of lifter


104


. In this way, spring beam


174


will serve to lower carriage assembly


38


back to the starting position after inhalation is complete as described hereinafter.




Base unit


12


includes a hook


178


which is coupled to release button


46


(see FIG.


10


L). Hook


178


catches a tab


180


on lifter


104


when carriage assembly


38


is fully raised and the pressurized gas has been released as illustrated in FIG.


10


O. When release button


46


is pressed, hook


178


is released from tab


180


so that carriage assembly


38


may be lowered to the starting position. As previously described, spring beam


174


assists in moving carriage assembly


38


back to the starting position. As shown in

FIG. 10P

, carriage assembly


38


has been returned to the starting or ready position where receptacle


22


may be removed by pulling it from carriage assembly


38


.




One particular advantage of employing release button


46


is that aerosolization mechanism


16


remains coupled to receptacle


22


until fire button


42


is pressed. In this way, a user is prevented from piercing a receptacle and then lowering carriage assembly


38


without aerosolizing the medicament.




Referring now to

FIGS. 11-11B

and


12


-


12


B, operation of handle


40


to produce a pressurized gas for delivery aerosolization mechanism


16


will be described. Handle


40


is coupled to pump link


144


via a screw


182


. Pump link


144


is further coupled by a pivot pin


184


to a cylinder


186


. A piston


188


is pivotally attached by a pivot pin


190


to chassis


150


of base unit


12


. Piston


188


is slidable within cylinder


186


to produce a pressurized gas. Cylinder


186


further includes an opening


192


to which a tube (not shown) is connected. The tube extends through base unit


12


and is coupled to fitting


168


to hydraulically couple cylinder


186


with valve


132


. If valve


132


is not in the locked position, translation of piston


188


within cylinder


186


causes diaphragm


160


to flex, thereby allowing air to pass through valve


132


as previously described. If, however, valve


132


is locked, translation of piston


188


within cylinder


186


produces a pressurized charge of gas within cylinder


186


. In

FIGS. 11-11B

, handle


40


has not quite reached the fully extended position. As such, valve actuator


164


is not yet in the locked position. In

FIGS. 12-12B

, handle


40


has been extended to the fully extended position to lock valve actuator


164


of actuator arm


138


and then moved back to the home position. As such, a pressurized as exists within cylinder


186


and is ready for delivery to aerosolization mechanism


16


upon operation of fire button


42


as previously described.




As best shown in

FIG. 11A

, use of pivot pins


184


and


190


allows cylinder


186


to remain generally aligned with piston


188


during extension and retraction of handle


40


. As such, the amount of wear between cylinder


186


and piston


188


is greatly reduced. Further, maintaining proper alignment between cylinder


186


and piston


188


reduces the amount of force required to move handle


40


when pressurizing the gas. For example, when cylinder


186


has a volume of approximately 8 ml at the fully extended position, a force of approximately ten pounds will be required to move handle


40


back to the home position and pressurize the gas. Maintaining piston


188


generally aligned with cylinder


186


during operation of handle also allows a generally constant or smooth force to be employed when operating handle


40


.




Still referring to

FIG. 11A

, piston


188


includes a check valve


194


and filter


196


. Check valve


194


is configured so that, as handle


40


is extended, air is allowed to enter into cylinder


186


through check valve


194


. When handle


40


is moved back to the home position, check valve


194


closes so that the pressurized gas may be produced within cylinder


186


. Filter


196


is provided to filter the air entering into cylinder


186


. Errant powder from previous operations may fall into bottom of base unit


12


. Filter


196


prevents such powder from entering into cylinder


186


. To further assist in preventing errant powder from entering into cylinder


186


, cylinder


186


is mounted such that an open end


198


of cylinder


186


is pointed generally downward. In this way, errant powder falling through base unit


12


will not fall directly onto piston


188


where it may tend to be drawn into cylinder


186


during operation.




As previously described, if receptacle


22


is not fully inserted into carriage assembly


38


, fire button


42


may not be operated to couple receptacle


22


to aerosolization mechanism


16


. Hence, receptacles used with aerosolization apparatus


10


may be keyed to prevent complete insertion of the receptacle into carriage assembly


38


unless the proper receptacle is being inserted. In this way, the receptacles may be keyed according to the powdered medicament they contain so that a patient will not receive an improper medication. An exemplary scheme for keying the receptacles is illustrated in

FIGS. 13 and 14

. In

FIG. 13

, a receptacle


22


′ includes a notch


200


. Receptacle


22


′ is used with an aerosolization apparatus where the carriage assembly includes a key which is received within notch


200


when receptacle


22


′ is inserted into the carriage assembly. If the receptacle does not include notch


200


, the receptacle may not be fully inserted, thereby preventing operation of the carriage assembly as previously described. As illustrated in

FIG. 14

, a receptacle


22


″ includes a pair of notches


202


and


204


. With such a configuration, the carriage assembly will include a pair of keys that are aligned with notches


202


and


204


to allow receptacle


22


″ to be fully inserted. By increasing the number and placement of the various notches, a wide variety of combinations may be produced so that receptacles with a wide assortment of drugs may be keyed to particular aerosolization apparatus to prevent incorrect delivery to a patient. Although shown with rectangular notches, it will be appreciated that any geometry of notch or indentation may be employed as long as full insertion of the receptacle is prevented unless the receptacle is intended for a particular aerosolization apparatus.




The foregoing invention has now been described in detail by way of illustration and example, for purposes of clarity of understanding. However, it will be appreciated that certain changes and modifications may be practiced within the scope of the dependent claims.



Claims
  • 1. An apparatus for aerosolizing a powdered medicament, the apparatus comprising:a pressurization cylinder, a piston slidable within the cylinder to pressurize a gas within the cylinder; a handle coupled to the cylinder, the handle being movable between an extended position and a home position to pressurize the gas within the cylinder; a carriage assembly adapted to receive a receptacle which holds a powdered medicament, the carriage assembly also being adapted to couple the receptacle to an aerosolizing mechanism; and an interlock which is operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolizing mechanism, wherein the interlock is released to allow movement of the carriage upon movement of the handle to the extended position.
  • 2. An apparatus as in claim 1, further comprising a catch which engages the carriage assembly when moved to couple the receptacle to the aerosolizing mechanism, and a release button to release the catch from the carriage assembly.
  • 3. An apparatus as in claim 1, further comprising a valve disposed in an airway between the cylinder and the aerosolizing mechanism, wherein the valve has an open position and a closed position, and wherein the valve is generally in the closed position during extension of the handle to the extended position.
  • 4. A method for aerosolizing a powdered medicament that is held within a receptacle, the method comprising:receiving the receptacle in a carriage assembly; releasing an interlock from the carriage assembly when a handle is extended a predetermined amount; producing a charge of pressurized gas when the handle is retracted; and aerosolizing the powdered medicament with the pressurized gas when a button is operated.
  • 5. An apparatus for aerosolizing a powdered medicament, the apparatus comprising:a housing; a pressurization cylinder; a piston slidable within the cylinder, wherein the piston is pivotally attached to the housing; and a handle operative to cause relative movement between the cylinder and the piston to pressurize a gas within the cylinder; whereby the pressurized gas may be used to aerosolize a powder medicament.
  • 6. An apparatus as in claim 5, further comprising a linkage disposed between the handle and the cylinder, wherein the linkage is pivotally attached to the housing and the cylinder.
  • 7. An apparatus as in claim 5, wherein the housing has a top end and a bottom end, wherein an aerosolizing mechanism is disposed near the top end, and wherein the piston is pivotally attached to the housing at the bottom end.
  • 8. An apparatus as in claim 5, further comprising a one-way check valve disposed in the piston.
  • 9. An apparatus as in claim 5, further comprising a valve disposed in an airway between the piston and an aerosolizing mechanism, wherein the valve has an open position and a closed position, and wherein the valve is in the closed position during extension of the handle to an extended position.
  • 10. A system for aerosolizing a powdered medicament, the system comprising:a carriage having an opening to receive a receptacle having a powdered medicament; an aerosolizing mechanism to aerosolize the medicament in the receptacle upon delivery of the receptacle to the aerosolizing mechanism by the carriage; and an interlock which is movable to engage the carriage to prevent movement of the carriage toward the aerosolizing mechanism, wherein the interlock engages the carriage when the receptacle is not properly inserted into the carriage.
  • 11. A system as in claim 10, wherein the carriage includes a key such that the receptacle is properly inserted into the carriage only if a portion of the receptacle is aligned with the key.
  • 12. A system as in claim 10, further comprising a sensor arm having a roller, wherein the interlock includes a latch, and wherein the roller rolls over a portion of the receptacle during insertion of the receptacle into the carriage to move the sensor arm against the interlock to cause the latch to engage the carriage until the roller rolls a desired amount.
  • 13. A system as in claim 12, wherein the sensor arm defines a well that aligns the portion of the receptacle with the aerosolizing mechanism.
  • 14. A device for aerosolizing a powdered medicament, the device comprising:a capture chamber; an aerosolizing mechanism positioned to introduce a powdered medicament into the capture chamber, wherein the aerosolizing mechanism includes air channels to allow air to enter into the capture chamber when a patient inhales to extract the powdered medicament from the capture chamber, and wherein the aerosolizing mechanism further includes a structure to distribute air entering into the capture chamber through the air channels such that the powdered medicament is removed from the capture chamber as a bolus that is substantially unmixed with the entering air.
  • 15. A device as in claim 14, wherein the capture chamber has a center, wherein the aerosolizing mechanism is offset from the center, and wherein the structure is fashioned to distribute more air to regions of the capture chamber which are on an opposite side of the center.
  • 16. A device as in claim 14, wherein the structure is further configured to distribute the air into the chamber such that the bolus is extracted before substantially any of the entering air is extracted from die capture chamber.
  • 17. A device as in claim 14, wherein the structure comprises a curved flange member.
  • 18. A device as in claim 14, wherein the aerosolizing mechanism defines a cylindrical passage through which the powdered medicament passes to reach the capture chamber.
  • 19. A device as in claim 14, further comprising a flexible seal to provide a seal for the capture chamber.
  • 20. A method for supplying a powdered medicament to a patient, the method comprising:dispersing a powdered medicament within a capture chamber; delivering the powdered medicament to the patient from the capture chamber during inhalation by the patient; and allowing air to enter the capture chamber in a manner such that the powdered medicament is extracted from the chamber followed by the entering air, the flow of the entering air being regulated.
  • 21. A method for supplying a powdered medicament to a patient, the method comprising:dispersing a powdered medicament within a capture chamber; delivering the powdered medicament to the patient from the capture chamber during inhalation by the patient; and allowing air to enter the capture chamber and diverting the entering air into channels with an air flow divided as the powdered medicament is extracted from the capture chamber.
CROSS-REFERENCES TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 09/312,434, filed May 14, 1989, now U.S. Pat. No. 6,257,233. This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/087,929, filed Jun. 4, 1998, the complete disclosure of which is herein incorporated by reference.

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Provisional Applications (1)
Number Date Country
60/087929 Jun 1998 US
Continuations (1)
Number Date Country
Parent 09/312434 May 1999 US
Child 09/873946 US