WO1999044663A1 - Medicament dry powder inhaler dispensing device - Google Patents

Abstract

An inhaler disc cartridge comprises a carrier disc with radially outwardly extending resilient fingers, each with a medicament powder dosage. A sealing disc and an indexing ring are bonded to the disc. A cam sequentially and manually deflects a selected finger causing it to snap against an anvil to release the dosage by momentum energy transfer. In other embodiments, a cassette includes a carrier substrate reel of deposited powder dosages with a dosage sealing tape. The substrate comprises a belt with a plurality of transversely extending triangular fingers, each finger tip with a dosage thereon. Each finger is snapped in sequence against an anvil while a clamp secures the belt as the fingers are deflected. The spring fingers are corrugated in one embodiment cooperating with an anvil having channels and a device for inducing agglomeration breakup air streams through the channels. Other embodiments are for impact deflection of a dosage carrying substrate in a cartridge or cassette against an anvil to release the dosages.

Description

Medicament Dry Powder Inhaler Dispensing Device

This is a continuation in part and complete

application of provisional application Serial No.

60/076,787 filed March 4, 1998.

This invention relates to inhalers for medicaments,

and more particularly, to inhalers with arrangements for

breaking up agglomerates of dry powder.

Cross Reference to Related Applications and Patents

Of interest are co-pending applications Serial No.

08/661,213 (PCT/US97/10162) entitled Inhaler Apparatus

with Modified Surfaces for Enhanced Release of Dry Powders

filed June 10, 1996 in the name of Datta et al., Inhaler

Apparatus with an Electronic Means for Enhanced Release of

Dry Powders Serial No. 08/661,212 filed June 10, 1996 in

the name of Sun et al . (PCT/US97/10162) , Serial No.

08/932,489 (PCT/US98/19228) entitled Dry Powder Delivery System filed September 18, 1997 in the name of Leedom et

al., Serial No. 08/467,647 entitled Apparatus for

Electrostatically Depositing and Retaining Materials Upon

a Substrate filed June 6, 1995 now US Pat. No. 5,669,973,

Serial No. 08/506,703 entitled Inhaler Apparatus for Using

a Tribo-Electric Charging Technique filed July 25, 1995

now US Pat. No. 5,642,727, Serial No. 08/659,501 entitled

Methods and Apparatus for Electrostatically Depositing a

Medicament Powder Upon Predefined Regions of a Substrate filed June 6, 1996 in the name of Pletcher et al . , Serial

No. 09/095,246 entitled Dry Powder Deposition Process

filed June 10, 1998 in the name of Poliniak et al . , all of

the foregoing being commonly owned; and Serial No.

09/095,616 entitled Pharmaceutical Product and Method of

Making filed June 10, 1998 in the name of Chrai et al . ,

the latter application being commonly owned with the

assignee of the aforementioned foregoing applications and

with the assignee of the present invention, and US Pat.

Nos. 5,714,007, 5,642,727, 5,669,973 commonly owned with

the aforementioned foregoing applications. All of the

aforementioned are incorporated by reference herein in

their entirety.

In addition, of interest are PCT applications WO

90/13328 and WO 93/09832. These latter applications disclose various inhaler embodiments including impact release of medicament dosages. However, these embodiments involve relatively complex camming and similar arrangements which are costly to implement. These latter

applications are also incorporated by reference herein.

Dry powder inhalers are used as drug delivery devices

for administering pharmaceutical compounds to individuals.

Some of these devices employ a pharmaceutical powder

deposited on a substrate surface and sealed with a sealing

layer. In other devices, the powder may be supplied in a reservoir and then transferred to a dose carrier one dose

at a time . The substrate may be provided as a tape on a reel in cassettes or in cartridges, for example. When the patient requires medication, the ideal dry powder inhaler

forms a fine particle cloud that is to be inhaled and

thereby delivers a high respirable fraction of the stored

dose deeply into the patients lungs. In most cases, the

deep recesses of the lung is the desired site for the

drugs in the inhaled powder cloud.

This can be most efficiently achieved by:

1. Releasing a high fraction of the deposited drug and

2. Insuring that the powder cloud consists of

individual particles or particle aggregates between lμm and 5μm.

As individual particles are reduced below lOμm, both

release and particle aggregation become a serious

hindrance to delivering a high respirable fraction deeply

into the patient ' s lungs .

A common problem addressed by various prior art inhaler apparatuses for dispensing dry powder medicaments

is providing for a controlled reliable release of the

medicament. The dry powder medicaments inhalers may be

loaded with medicaments by filling techniques not

involving electrostatics. In certain other

implementations, the deposited powder tends to form

agglomerated particles resulting in uncontrolled variation

in the amount of medicament released. Several of the

aforementioned applications provide various solutions to this problem.

Numerous approaches have been taken in the design of

dry powder inhalers. In some cases, the powder is

released by impact of a substrate powder carrier, as

disclosed in WO 93/09832. Of interest is an inhaler as

disclosed in WO 90/13328.

In copending applications Serial Nos. 661,213 and

661,212, indentations or raised surfaces are disclosed in

the inhaler interior surfaces having contact with the medicament for inhalation, the surfaces minimizing the area of contact between the medicament and the surfaces of

the inhaler apparatus, promoting the release of the

medicament from the inhaler.

When particles of medicament agglomerate, they impact

the mouth and throat rather than remain in the air flow

for deposition in the lungs. One remedy is to provide

tortuous channels in the inhalers to promote

deagglomeration. However, the medicament may be deposited

along the channels leading to inaccurate dosage

dispensing. Agglomeration also results in the inhaler

tending to dispense the medicament inaccurately so that

greater or lesser amounts are dispensed.

The small particle size, e.g., 2μm to 7μm, required

for transport to the lung presents a number of problems

for release by the inhaler and delivery to deep lung

regions. As the particle size decreases, the relative

bonding force between the particle and other objects

increases. This applies to both particle-to-substrate

bonding and particle-to-particle bonding. As a result,

particle aggregates become more tightly bound and

individual particles more difficult to remove from the

substrate. Aggregation increases the effective size of

the drug released and diminishes the respirable fraction. The increase in relative particle-to-substrate bonding

makes drug release more difficult and also decreases the

respirable fraction.

Additional investigation using ultrasonic frequencies

to agitate the surfaces have been unsuccessful in removing

particles below lOμm from a planar surface. There is a

mismatch between the particle size and the wavelength of

the substrate material in typical polymeric materials.

The wavelengths of the material are a large multiple of

the dimensions of the particles and does not provide

efficient energy coupling. Acoustic frequencies above

100MHz would be required for particle resonance to occur.

Thus, either unrealistically high frequencies to minimize wavelength or high acoustic amplitudes to increase the force differential across the small particles are

required.

The present inventors recognize a need for a drug

inhaler delivery system for dry powder pharmaceutically

active ingredients for breaking up such particle

aggregation should they form. They recognize a need for

delivery of microgram depositions in quantities ranging

from about lOμg to the milligram range with a delivery

accuracy of about 10%.

A medicament powder delivery device according to the present invention comprises a carrier having at least a flexible portion on which portion is deposited a discrete

medicament dosage and means for imparting an energy pulse to the carrier flexible portion for deflecting the carrier

portion and releasing the dosage from the deflected portion by momentum transfer.

In one aspect, the means for imparting an energy pulse comprises means for flexing and snap releasing the flexed carrier portion. In a further aspect, the carrier portion includes a

finger resiliently extending from a carrier base region,

the means for imparting for flexing the finger relative to the base region.

In a further aspect, a body is included with a cavity for receiving the carrier portion and the means for imparting including an anvil with a bore therethrough

fixed to the body in the cavity for receiving the snap

released finger, the bore for receiving the released

dosage, and including means for causing the finger to

resiliently impact the anvil to rapidly decelerate the

finger to provide the momentum transfer to the dosage.

In a further aspect, the dosage tends to form

aggregates, the anvil including at least one channel,

further including means coupled to the housing for creating an air jet stream through the at least one channel to disintegrate aggregations of the dosage during

the impact .

In a further aspect, the finger is corrugated.

In a still further aspect, the finger extends in a

given direction from the base region, the finger having corrugations extending along the given direction.

The means for creating the jet stream may include a

further resilient finger overlying the carrier finger for initial resilient displacement coincident with initial displacement of the carrier finger, the displaced fingers for snap release in a second displacement, the further finger for creating the air stream during the second

displacement .

In a further aspect, the further finger has a

different spring constant than the carrier finger so as to

accelerate slower than the carrier finger upon the snap

release .

In a still further aspect, the carrier includes a

first disc with a plurality of radially extending fingers, a dosage on each finger, and the means for imparting

comprises cam means for snap flexing a selected finger to release the dosage on the selected finger.

Index means are preferably included for indexing the selected finger to a medicament release position for snap flexing the selected finger by the cam means.

The first disc may include a carrier disc with a

plurality of first fingers each carrying a dosage, a spacer disc overlying the carrier disc with a plurality of second fingers overlying and corresponding to the first

fingers and a ring with index holes and a third plurality of fingers over lying and corresponding to the first and

second fingers, the spacer disc being bonded to the

carrier and ring discs, the indexing means for selectively

engaging the ring index holes .

Cam means are preferably provided for manually flexing the selected fingers .

The cam means may flex the first and second fingers past the third fingers.

In a further aspect, the carrier comprises a belt

portion with a plurality of fingers extending transversely

from the belt portion, each of the fingers having a

separate dosage and arranged for selective resilient

displacement relative to the belt portion.

In a still further aspect, drive means are included

for displacing the belt to increment the fingers

sequentially to a dosage release position.

The means for imparting may include a clamp for clamping the belt portion adjacent to a given finger and a

deflecting member for selectively flexing and snap

releasing the selected given flexed finger relative to the

belt portion.

The carrier may comprise an element, the dosage

comprising a plurality of discrete dosages in spaced

relation on the element, the means for imparting including

a carrier deflection member adjacent to the element, and

means for momentarily bending and deflecting the element

to momentum transfer release a selected dosage from the

element upon release of the deflected element.

In a further aspect, means are included for

selectively aligning successive dosages on the element to

the deflection member.

In a further aspect, a core member is included and

rotatable about an axis, the element comprising an array

of fingers radially extending from the core member about

the core member in a spiral about the axis, means

selectively align and deflect each the finger to snap

release a selected dosage from the selected finger by

momentum transfer.

In a further aspect, the carrier comprises a spring

finger for receiving a dosage and dosage substrate from a

plurality of dosages and dosage substrates in a stack

10 aligned one over another, and means are included for

selectively placing successive dosages and dosage

substrates on the carrier, the" means for imparting

including means for snap deflecting said finger against an

anvil .

IN THE DRAWING:

FIGURE 1 is a side elevation sectional view of an

inhaler according to one embodiment of the present

invention with the inhaler housing open for receiving a

pharmaceutical powdered dosage carrying substrate

cartridge with the cartridge installed;

FIGURE 2 is a plan sectional view of the inhaler of

the embodiment of Fig. 1;

FIGURE 3 is a plan exploded view of the substrate

cartridge for the embodiment of Fig. 1;

FIGURE 3a is a fragmented sectional side elevation

view of the assembled substrate cartridge of Fig. 3;

FIGURE 3b is a fragmented sectional side elevation

view of an alternate embodiment for the cartridge of Fig.

3a;

FIGURE 4 is a side elevation view of a cam and lever

employed in the embodiments of Fig. 1;

FIGURES 5-7 are side elevation sectional views of the

inhaler of Fig. 1 showing various stages of release of the

11 deposited dry powder medicament;

FIGURE 8 is a diagrammatic side elevation view of a

second embodiment of an inhaler apparatus without the

housing or operating mechanism illustrating the medicament

carrying substrate and dosage thereon;

FIGURE 9 is a plan view of a portion of the substrate

of Fig. 14;

FIGURE 10 is a schematic diagram of an actuator for

use in deflecting the fingers in the embodiment of Figs. 8

and 9;

FIGURE 11 is diagrammatic perspective view in more

detail of a dry powder substrate for use in different

embodiments herein;

FIGURE 12 is an isometric fragmented view of a

further substrate embodiment according to the present

invention for use with the substrate embodiment of Fig.

11;

FIGURE 13 is a side elevation fragmented sectional

view of a further embodiment of a substrate and

medicament for use in the embodiment of Figs. 11 and 12;

FIGURE 14 is a diagrammatic isometric view of a

cassette embodiment for use in an impact inhaler;

FIGURE 14a is a side elevation sectional view of the

substrate for use in the embodiment of Fig. 14;

12 FIGURE 15 is a diagrammatic isometric view of a

second cassette embodiment for use in an impact inhaler;

FIGURE 15a is a side elevation sectional view of a

portion of the substrate and the anvil used in the

embodiment of Fig. 15;

FIGURE 15b is a side elevation view similar to that

of Fig. 15a but after the substrate is impacted;

FIGURE 16 is a diagrammatic isometric view of a

spiral embodiment of an impact inhaler medicament dosage

delivery system;

FIGURE 17 is a diagrammatic isometric view of a

second embodiment of a spiral impact inhaler medicament

dosage delivery system;

FIGURE 18 is an isometric diagrammatic view of a

further embodiment of an impact inhaler medicament dosage

delivery system employing stacked dosage packs;

FIGURE 18a is a side sectional elevation view of the

stack of packs employed in the Fig. 18 embodiment;

FIGURE 19 is an isometric diagrammatic view of a

second embodiment of an impact inhaler medicament dosage

delivery system employing stacked substrates and

medicament dosages; and

FIGURE 19a is a side sectional elevation view of the

each substrate of the stack of dosage packs employed in

13 the Fig. 19 embodiment.

Dry powder medicament particles forming unit dosages

may be charged with a given polarity in a conventional

charging mechanism such as tribo-electric chargers,

induction charging and so on. The particles are deposited

in controlled amounts on a substrate wherein the amount of

active pharmaceutical ingredients deposited at each of a

plurality of locations on the substrate does not vary from

a predetermined amount by more than about 5%, for example.

Reference is made to the copending applications

Serial No. 09/095,246 entitled Dry Powder Deposition

Process filed June 10, 1998 in the name of Poliniak et al .

and Serial No. 09/095,616 entitled Pharmaceutical Product

and Method of Making filed June 10, 1998 in the name of

Chrai et al. noted in the introductory portion and

incorporated by reference herein in their entirety. These

applications disclose apparatus and processes for

electrostatically depositing pharmaceutically active

ingredient medicaments on a substrate including charging a

dry powder medicament and electrostatically attracting the

charged powder particles to a substrate. In particular,

the medicament is deposited in controlled amounts at

discrete locations on the substrate wherein the amounts

deposited do not vary from a predetermined amount by more

14 than 5%, for example. This process is preferred.

However, other processes for electrostatically

depositing dry powder medicaments on a substrate are also

disclosed in the aforementioned copending applications and

patents noted in the introductory portion, all of which

are incorporated by reference herein. Those processes

disclose electrostatically depositing controlled amounts

of dry powder medicaments on a substrate at discrete

locations on the substrate. Variations of the disclosed

processes herein may be employed to adapt those processes

to a metal or non-metallic substrate. The substrate may

be a tape, a strip or disk, for example, among other

shaped substrates with or without resilient fingers.

Medicaments are deposited on the fingers as will be

described below as employed in certain of the present

embodiments . Such depositions of dry powder particles on

the various substrates as described hereinbelow are within

the skill of those of ordinary skill in this art.

Particle removal from surfaces tends to be more

difficult as particle size decreases. This is roughly a

consequence of the adhesion force decreasing more slowly

than the volume and surface area as a particle ' s size

decreases . Since the volume and surface are generally

related to removing forces and deaggregation, these forces

15 become increasingly difficult to overcome as the particle

size decreases.

Forces of adhesion and agglomeration caused by van

der Waal ' s force increase as the area of contact between a

particle and substrate or between two particles increase .

To obtain high respirable fractions, electrostatic

deposition is preferred to minimize particle-substrate and

particle-particle contact which minimizes adhesive and

agglomeration forces respectively. Also, similarly

charged particles will repel one another to further

minimize agglomeration.

The substrates in the inhalers described below may be

either metal, e.g., stainless steel, or non-metallic as

known in this art and may be of any material suitable as a

medicament substrate. Non-metallic substrates are

selected to have the desired mechanical flexure properties

in certain of the described embodiments, for use in the

disclosed impact arrangements . The selection of a

substrate material depends upon a given implementation as

discussed later herein in connection with the various

embodiments .

To effectively form a powder cloud for inhalation,

the rudimentary particle must generally be below about 6

μm and large agglomerates disrupted if they form. For low

16 dosages, sufficiently sparse drug layers can be deposited

such that particle-particle interaction is minimal or the

agglomerates that form are sufficiently small to reach the

targeted region of the respiratory track.

For higher dosages of drugs, aggregates will form on

the substrate . These aggregates can be disrupted by the

application of energy during the process of dislodging

the drug and/or through the exposure of the released

aggregates to a sufficiently high gas velocity. The gas

exerts a differential force across the aggregates due to

differences in aerodynamic drag. These differences can

arise due to either a gradient in the gas velocity or

geometrical differences across the aggregate.

In Fig. 1, inhaler apparatus 60 includes a housing 62 defining a chamber 54 and a dispensing chamber 54 ' . A

battery 64, a motor 66 energized selectively by the

battery through a switch not shown, and a fan 68 belt

driven about axis 69 by the motor 66 are located within

the chamber 54. A manually operated lever 70 with a cam

71 is rotatably secured to the housing 62. The lever 70

and cam 71 pass through the dispensing chamber 54'. Lever

70 rotates about axis 73 (Fig. 7) and passes through the

chamber 54. The lever has a manually operated knob 70',

Fig. 7. The cam 71 is integral and one piece with the

17 lever 70 which may be molded thermoplastic. The cam 71 is

located within the chamber 54.

In Fig. 4, the cam 71 has a slot 56 and an ingress

opening 58. Opening 58 comprises two surfaces 59 and 59'

spaced at 90° and symmetrical relative to the plane of the

slot 56. Opening 58 has its normal quiescent position as

shown in Fig. 1 with the slot horizontal and the surfaces

59 and 59' each 45° to the horizontal.

The housing 62, Fig. 1, is preferably a clam shell

comprising two halves 62' and 62" hinged at one end with a

preferably living hinge and is molded one piece

thermoplastic. The housing includes an integral one piece

molded mouthpiece 72 attached to lower half 62". The

mouthpiece 72 has an exit port 74 in fluid communication

with the dispensing chamber 54' through opening 55. A

support 76 is in the dispensing chamber 54 ' . A manually

operated indexing device 78 is at the housing front. The

indexing device 78 includes a knob 80 external chamber 54'

and an index wheel 82 in the chamber 54' adjacent to the

support 76. The index wheel 82 is rotatably secured to

the housing 62 half 62" and includes an annular array of

angularly spaced indexing pins 84. An optional

thermoplastic member 86 is cantilevered from the support

76 in the drug dispensing chamber 54', Figs. 1 and 2. The

18 member 86 may be flat or arcuate. If flat it is

resilient. If arcuate it may be rigid and curves

downwardly as shown, Fig. 5. The member 86 may be made of

other materials if desired.

The mouthpiece 72 has a dispensing chamber 88 in

fluid communication with the chamber 54 ' through the

opening 55. The chamber 88 is fluid coupled through a

channel 90 to air inlet port 92. Air flow actuated

butterfly valves 94 are in channel 90 and chamber 88. The

housing includes a spindle 96 for receiving a drug

delivery disc substrate assembly 98. The received disc 98

is rotated about the spindle 96 by the indexing device 78.

The substrate disc assembly 98, Figs. 3 and 3a, forms

a dosage cartridge. Assembly 98 comprises a multilayer

circular disc including a spring metal, for example, leaf

spring, dosage carrying disc 100. The disc 100 has an

annular array of radially outwardly extending leaf spring

fingers 102 which are resilient in a direction normal to

the plane of the disc 100. A medicament dosage 104 as

described previously hereinabove is deposited as described

on a broad surface of each of the dosage carrier fingers

102 at their extended end region. The disc 100 has a

central opening 106 for receiving the spindle 96, Figs. 1

and 2.

19 Overlying the disc 100 is a spacer (or sealing layer)

disc 108. Disc 108 serves to separate the substrate disc

100 from overlying sealing ring 114. In the alternative,

the disc 108 may also serve as a sealing layer. Disc 108

may be spring metal or thermoplastic and has holes 110 in

this embodiment for receiving therein the respective

dosages 104 on the disc 100.

In the sealing layer embodiment, the substrate disc

100 has pockets each for receiving a corresponding

discrete dosage. The disc 108 is planar and overlies the

disc 100. This is shown, for example in Fig. 3b. In Fig.

3b, disc 100' comprises spring fingers 102' each having a

dosage receiving dimple or pocket 103 ' . A separate

discrete medicament dosage 104' is in the pocket 103'.

The sealing disc 108' has openings 110 at the pocket 103'

for spacing the dosage 104' from the ring 114' finger

118'. The disc 108' seals the dosage and is generally

planar. When the disc 108' is removed from the disc 100'

to release the dosage, the dosage 104' remains in place in

the pocket 103 rather than possibly removed with the

sealing disc 108' spaced from the dosage.

Disc 108, Fig. 3, also has a central opening and

fingers 112 corresponding to and overlying the respective

opening 106 and fingers 102 of disc 100. Disc 108 bonds

20 the disc 100 thereto employing a conventional bonding

agent for this purpose.

An indexing and sealing ring 114 overlies the disc

108 annular peripheral region. Ring 114 has a larger

diameter than discs 100 and 108 so that an annular portion

116 extends radially outwardly of the underlying

juxtaposed fingers 102 and 112 of the respective discs 100

and 108. A plurality of radially inwardly extending

fingers 118 overly the outer peripheral ends of the underlying fingers 102 and 112 of respective discs 100 and

108. A circular array of disc indexing apertures 120 are

in the ring 114 radially outwardly of the fingers 118.

The apertures 120 selectively engage the indexing pins 84

of the indexing device 78, Fig. 1, one at a time.

The discs 100, 108 and the fingers 118 of ring 114

are bonded together in a laminated structure by a

conventional adhesive bonding agent forming the cartridge

disc assembly 98.

The indexing device 78, Fig. 1, indexing pins 84

selectively engage apertures 120 of ring 114 in the

received disc assembly 98 by manual rotation of the knob

80. The pins 84 place an overlying set of fingers 102,

112 and 118 of the assembly 98 aligned with and overlying

the member 86. The ring 114 peripheral region 116 with

21 the holes 120 are over the support 76 and member 86. The

spindle 96 receives the disc assembly 98 at opening 106.

In operation, apparatus 60 provides a drug removal

method that imparts an energy pulse for momentum transfer

to the deposited powder through an impact mechanism for

both low and high dosages. The disc assembly 98 is placed

in operative position, Fig. 1, and the housing 62 chamber

54 is then closed, Fig. 5. In this position, the cam 71

surfaces 59 and 59' are each 45° to the plane of the

assembly 98 which passes through the slot 56. When a

switch, not shown, is activated, the motor 66 operates the

fan 68. This starts an air flow through the channel 90

via input port 92 and exits port 74 opening the butterfly

valves 94.

The extended tips of the fingers 102 and 112 may

overlie the support 76 and also overlie the member 86

therebelow. The ring 114 is lowermost with the dosage

facing downwardly toward the opening 55. In this

orientation, the other fingers 112 and 102 are over the

ring fingers 118 with the dosage finger 102 uppermost.

The lever 70 is then manually rotated rotating the cam 71

in the directions of the arrows in the sequence from Fig.

5 to Fig. 7. The cam 71 grips one set of aligned

overlying fingers 102 and 112 of the disc assembly 98 that

22 is aligned therewith and with the member 86.

As the cam 71 rotates, it also rotates and bends the

aligned fingers 102 and 112, but not the ring 114 or its

fingers, on the support 76. The downward flexing of the

disc assembly 98 by the cam 71 flexes the two fingers 102

and 112 downwardly. These fingers then flex downwardly

the aligned ring 114 finger 118 and the member 86, Fig. 5.

The member 86 assists in optimizing the shearing

action between the ring 114 and the fingers 102 and 112.

This action bends the flat resilient member 86 and

the aligned fingers accordingly relative to the support 76

as shown, Fig. 5. In the alternative, the member 86 may

be rigid. The disc 98 fingers are bent downwardly from

the upper plane surface of the support 76 and the plane of

disc 98, causing the aligned fingers 102 and 112 to break

their bonds with each other by a relative sliding shearing

action and to break the bond between disc 112 and ring 114

by the relative shear sliding caused by the bending

action. The pin 84 keeps the ring 118 periphery 116

secured to the support 76 as the cam 71 rotates.

In Fig. 6, as the fingers 102 and 112 continue to

rotate in response to rotation of the cam 71, the fingers

102 and 112 snap free of the bonds and slide over and past

the fingers 118 of the ring 114 and the member 86. The

23 spacer disc 108 retains the selected dosage 104 in place on the corresponding finger 102 as the mating ring finger

118 slides over the spacer disc 108. The resilient

retention of the tips of the fingers 102 and 112

overlapping the member 86 and ring 114 finger creates a

snap action of the fingers as the fingers rotate in

response to further rotation of the cam 71, Fig. 6.

This snap action accelerates the substrate finger 102

with the dosage 104 against the bottom surface of the

dispensing chamber 54' which serves as an anvil about

opening 55. This creates a large impact force and rapid

deceleration of the selected dosage finger 102. The

momentum of the medicament during deceleration supplies

energy to free the dosage from the surface 109 of the

finger 102 upon the impact of the finger 102 with the

anvil formed by the chamber 54' bottom surface. This

momentum energy pulse causes the dosage medicament powder

to be released from the disc 100. The dosage is

discharged at the mouthpiece 72 port 74 as a powder cloud

through the discharge opening 55. The valves 94

automatically open in response to an inhalation bolus and

the concurrent air flow caused by the fan 68. The user

inhales the freed powder discharged from the mouthpiece.

The air inlet port 92 permits the inhaled air to draw an

24 airstream in the direction of the arrows at the inlet port

92 through the mouthpiece 72.

The cam opening 58, Fig. 4, permits the cam 71 to

rotate while flexing the fingers 102 and 112 at the slot

56. The particles readily release from the carrier

substrate to provide the anticipated dosage.

In Fig. 7, manual rotation of the cam 70 in the

reverse direction returns the fingers to the disc assembly

98 plane position. The aligned ring finger 118 acts as a

resilient stop and positions the fingers 102 and 112 in

the quiescent spent position below the fingers 118 of the

ring 114. The user may now index the next dosage for use in the next usage period at the support 76.

In the alternative, the member 86 may be rigid and

arcuate having the shape as shown in Fig. 5. This arcuate

shape assists in the relative shearing action of the

fingers as they slide over the member 86. In the

alternative, the member 86 may be omitted.

Thus, drug removal results by a momentum transfer

mechanism that disrupts the drug-substrate/carrier and

particle to particle bonds . Enhanced drug release is

provided for the particles.

In Figs. 8-10, in an alternative embodiment, inhaler

apparatus 122 (the housing and drive mechanism not being

25 shown) , includes a drive gear and motor (not shown) for

rotating a reel 124 of a preferably metal dosage carrier

substrate 126 carrying a medicament dosage 128 and sealed

with a sealing tape 130. A sealing tape take up reel 132,

also driven by a drive gear and the motor, removes the

sealing tape 130 from the substrate 126 and dosage 128 as

the substrate is removed from the reel 124. A substrate

take up reel 134, driven by a further drive gear and the

motor (not shown) , removes the substrate from the reel

124. The reels may be part of a cartridge or cassette

(the housing of which is not shown) . The drive gears and

circuitry for operating this system need not be shown as

such they are within the skill of those of ordinary skill .

In Fig. 9, the substrate 126 comprises a plurality of

trapezoidal (or in the alternative triangular) fingers 136

and a continuous longitudinal extending belt 138. The

dosage 128 is deposited on the free ends of the carrier

fingers 136. The carrier substrate 126 preferably

comprise metal leaf spring material. The fingers 136

extend transversely from the belt 138.

A clamp and dosage removing assembly 140 receives the

substrate 126 and a selected dosage 128. The assembly 140

includes a clamp 141 for clamping the belt 138 next

adjacent to the finger 136' in the assembly 140. The

26 clamp 141 may comprise a slotted structure for receiving

the belt 138 and prevent the belt 138 in the clamp 141

from displacing in a direction normal to the substrate

(and normal to the drawing paper in Fig. 9) .

The clamping assembly 140 includes an actuator 142,

Fig. 9. The actuator includes a drive 143 which

selectively rotates a pin 144 whose tip 144 ' underlies the

tip of the finger 136' located within the clamp assembly

140. The pin 144 may also underlie the dosage 128' on the

finger 136'. As the pin 144 is rotated, Fig. 10, it also

rotates the finger 136' tip and the associated dosage

128'. As the pin 144 rotates eventually it will release

the finger 136' because they rotate in opposite directions

143 and 143' (The rotated finger and pin being shown in

phantom) . This relative rotation permits the finger 136'

when released from the pin 144 to snap back to its

quiescent position shown in solid line. This snapping

action causes the dosage to be displaced from the

substrate by momentum transfer. While the dosage 128 is

shown on a side of the finger 136 opposite the pin 144 by

way of illustration, they may be on the same side in the

alternative .

Fig. 12 illustrates an alternative carrier substrate

131 which is formed of corrugated metal leaf spring with

27 the corrugations running along the length of the fingers

of the substrate such as the substrate 126, Fig. 9, for

example, or the fingers of the disc substrate 100, Figs. 3

and 3a. The substrate is made stiffer by the corrugations

without increasing the mass of the substrate. This

increases the substrate acceleration for a corresponding

smaller displacement of the finger. When the fingers 136

of Fig. 8, when corrugated, snap, they snap with increased

acceleration over a shorter distance which further

enhances the momentum energy transfer discharge of the

dosage free of the substrate . The same occurs with the

embodiment of Figs. 3 and 3a.

In addition, in Fig. 12, a cylindrical hollow core

preferably metal anvil 133 having a central opening 135 is

positioned to received the returning snapped finger acting

as a stop for the finger in its normal quiescent position.

The anvil 133, for example, in Fig. 1, may be attached to

housing half 62" over opening 55. For example, the anvil

133 may be a molded integral portion of the housing half

62". The anvil 133 central opening 135 receives the

released dosage from the substrate and disperses the

particles into a cloud due to the momentum transfer

forces. When the corrugated snapped finger substrate 131

impacts the anvil 133, Fig. 12, the dosage is flung free

28 of the substrate as a dispersed particle cloud 137.

The anvil 133 may have conduits 139 or channels interior the opening 135 therethrough. When a person

inhales, the breath bolus creates an air stream 146

through each of the conduits 139 which help break up agglomerates of the drug particles. This is particularly

useful for large dosage deposits.

In Fig. 11, an alternative embodiment employing a

corrugated finger includes a corrugated preferably metal stainless steel leaf spring finger 150 extending from a base region not shown, for example, on a disc dosage carrier substrate as described previously. An overlying

second resilient spring finger 152 also extends from the

base region. The finger 152 is flat with no openings

therethrough. The finger 152 is of different material

than finger 150 and has less resiliency than finger 150,

i.e., is not as stiff and, therefore, accelerates from a bent position at a slower rate than the finger 150 for a

given deflection. The finger 152 extends for the length of finger 150

and preferably overlies the entire finger 150. A channel

member 154 defines a channel region 156 which receives the

fingers 150 and 152 in their normal quiescent position

(not shown in this figure) and flexed configuration. This

29 quiescent position is parallel to the member 154 bottom

wall 158 at the bottom of the channel region 156. Wall

158 has a through opening 159 to permit excess flow of air

created by the finger 150 to exit the channel region when

the flexed finger 150 returns to the flat state. This

opening is then covered by the spring finger 150 when it

returns to its quiescent position.

Also anvil 160 is located at the channel region

bottom and secured to wall 158. Anvil 160 may be similar

to the anvil 133 as described above in connection with

Fig. 12.

An actuating pin 160 is rotated in direction 162 by a

drive 164. The pin 160 passes through a slot 165 in the

channel member 154 rear wall 166. The finger 152 has a

spring constant different than that of the finger 150.

This different spring constant is such that finger 150

snaps back to its original quiescent position at a higher

acceleration rate than finger 152.

In operation, the pin 160 is selectively rotated in

direction 162. The tip of the pin 160 (or other shaped

element) is beneath the spring fingers 150 and 152, or in

the alternative, beneath just finger 150 at its end tip

region. As the pin is rotated upwardly in direction 162

the fingers 150 and 152 are flexed upwardly bending them

30 about a pivot at which the fingers are secured to a base

member (not shown) .

The corrugated finger 150 is stiffer than finger 152

and accelerates at a higher rate, hitting the anvil 160

first. The slower moving finger 152 lags the finger 150

during the return motion to the quiescent state . The

finger 152 acts as an air pump within the channel region

156 which closely receives the finger 152 and creates an

air flow toward the anvil 160. This air flow creates air

streams through the apertures 160" in the anvil to break

up aggregations of the powder dosage. This action insures

that the dosage is in proper particle size format when

inhaled maximizing its effectiveness. In Fig. 11 it

should be appreciated that the dosage is on the underside

of the corrugated finger 150 and is not shown. The spring

150 causes its created air flow to flow through the

opening 159.

The corrugated springs may form stand alone

components or joined together by or formed as a tape or

formed into a pin wheel or disc for purposes of advancing

dosages into an inhalation chamber. Once in the chamber,

the deflected spring is released so that the drug is

accelerated and leads the advancing spring end. At the

peak velocity, the free end of the spring strikes the

31 rigid anvil 160 and is rapidly decelerated. The impact with the anvil 160 and the rapid deceleration result in forces sufficiently high to release the individual and

aggregate drug particles from the spring by momentum transfer forming a powder cloud. Aggregate particles are disrupted once they leave the substrate by the jets of gas

through which the dislodged particles must pass . Due to

rapid motion of the aggregates through the jets, a timed

jet is provided that represents only a fraction of the inhaled bolus. This permits aggregate disruption without disruption to the patient's breathing pattern.

In a further embodiment, in the alternative, corrugations in the region of the deposited dosage may be

replaced with cupped shaped substrates, such as

illustrated by fingers 102', Fig. 3b, for example, to

provide the desired stiffness and flexibility in a manner

similar to that of the corrugated substrate. This

configuration provides additional stiffness without

increasing the mass and results in more rapid deceleration and improved drug release. This provides the desired energy pulse to the substrate to release the drug rapidly. In the alternative, a piston, not shown, may receive

the impact of the spring 152 to create an air flow through

the anvil 160 apertures 160'.

32 In Fig. 13, a corrugated substrate 150' has pockets

151 in each of which is disposed a medicament powder

dosage 153. A sealing tape 155 seals the dosages in the

pockets 151. The sealing tape must then be selectively

removed prior to release of the dosage. The tape does not contact the dosage so as to not remove any of the dosage

when the tape is removed.

It should be understood that the transfer of the

dosages in the various embodiments is by imparting an

energy pulse to the powder on the carrier substrate by

deflecting the carrier substrate and the subsequent rapid

deceleration of the substrate. Upon resilient return of

the deflected substrate, it impacts a stationary anvil or

its equivalent imparting a momentum or inertial energy

pulse to the moving dosage. This energy pulse transfers

the dosage by way of its momentum energy induced when its

support substrate rapidly decelerates upon impact with a

stationary object.

This is to be distinguished from impact transfer in

the prior art attributed to shock energy imparted to a

relatively stationary substrate. The impact shock waves

travel through the substrate to the particles thereon,

releasing the particles by a direct impact force on the

stationary particles. This is different than momentum

33 transfer in which the momentum inertial energy in the

moving dosage is what separates the dosage from the

rapidly decelerating carrier substrate. In contrast,

shock waves impart motion to the otherwise stationary

powder carried on the substrate . The shock waves

incident on the powder impel the powder from the carrier

substrate .

The separation mechanism forces are different in the

two arrangements . One is an impelling force similar to a

golf club hitting a stationary ball and the other is

inertial wherein the moving object tends to remain in

motion when its carrier suddenly ceases motion as in a

catapult .

In Fig. 14, a further embodiment of a cassette for a

tape substrate is shown. The cassette 170, dashed lines,

contains three reels 172, 174 and 176. Reel 176 stores a

coil 178 of a dosage carrier substrate 180 covered with a

sealing tape 182. Sealing tape 182 seals the medicament

dosages 194 in blisters 195, Fig. 141, formed in the

substrate 180. Reel 174 takes up the sealing tape 182

into a coil, removing it from the substrate 180 exposing

the dosage 194. Reel 172 takes up the substrate 180 after

the dosages 194 are removed.

A hollow mouthpiece 184 for the inhaler (the

34 remainder of which is not shown) is aligned with the

dosage 194 to be dispensed. The mouthpiece 184 is

adjacent to anvil 197. The anvil 197 is a flat metal

plate with an aperture 199 for passing the dosage 194

therethrough. The anvil 197 is next to the uncovered

substrate 180 and dosage 194 to be dispensed, but spaced

slightly therefrom. The inhaler includes a reel drive 186

for operating the reels 172, 174 and 176.

An impact mechanism 188 includes a cantilevered

spring 190 driven by a spring deflection drive 192. The

drive 192 may be a rotating pin or element as discussed

above in the embodiments of Figs. 10 or 11. A powder

dosage 194 deposited by a deposition technique as

disclosed, for example, in the aforementioned applications

and patents in the introductory portion is on the carrier

substrate 180 blister 195 at a dose release position 191

aligned with the spring 190. The spring 190 has an

aperture 193 for receiving and seating the blister 195

therein. The aperture 193 aligns the dosage 194 at the

anvil aperture 199.

Drive 192 deflects the spring 190 and carrier

substrate which impacts the dosage carrying substrate 180

against the anvil 197. The impacted substrate 180 imparts

a momentum transfer motion to the dosage 194. This action

35 releases the dosage into a powder cloud upon impact of the

substrate with the anvil . The cloud is inhaled by the

user via the mouthpiece 184.

In Fig. 15, a reel drive and deflection drive (not

shown) as described in connection with Fig. 14 are also

employed. Most of the elements in Fig. 15 are the same or

similar to those in Fig. 14. The difference is that the

substrate 180' has a blister pocket 195', Fig. 15a, for

receiving a dosage 194 ' surrounded by an annular

depression 189. The sealing tape 187 has a score over

each blister pocket 195'. The anvil 177 is a flat plate

with an annular outer depending ring rib 179 that mates in

the depression 189. The anvil has a central aperture 181

for receiving the dosage therethrough. As a result, the

sealing tape rides directly on and over the anvil 177 and

the dosage carrier substrate rides directly on and over

the spring 190'. The sealing tape 187 and substrate 180'

are coiled and taken up in a take up rewind reel 172 ' . In

Fig. 14, the reel 172 only takes up and coils the

substrate 180.

In operation, during an index cycle, the web of the

carrier substrate, dosage and sealing tape is advanced.

The blister pocket 195' is inserted into the leaf spring

190' aperture 193', loaded and fired against the anvil

36 177. The anvil 177 outer ring rib 179 forces the cover

sealing tape 187 to rupture along the score 185, Fig. 15b,

and be pulled into the outer ring depression 189 of the

dosage substrate exposing the powdered dosage 194'. The

spring 190' continues in its travel and the impact with

the anvil 177 releases the dosage 194', Fig. 15b, from the

substrate 180 ' .

In Fig. 16, a cartridge 196 is employed with an

inhaler (not shown) . The cartridge comprises a central

core 198 and a spiral array of cantilevered spring fingers

200. The fingers 200 extend radially outwardly from the

core 198 and may be molded thermoplastic or metal. Each

finger 200 includes a deposited medicament powder dosage

202. The dosages are deposited in any known technique as

discussed hereinabove. The dosages are sealed with a

sealing tape 204. The dosages may be deposited in a

pocket in the finger dosage carrier substrate or the

sealing tape may have preformed pockets for receiving the

dosage so there is no contact of the tape with the

powdered dosage. The tape 204 is removed by reel 205 with

a reel take up drive (not shown) selectively exposing the

dosages one at a time as they are to be dispensed.

By way of example, the fingers 200 may be supplied as

a strip with the dosages thereon. The core 198 in this

37 case has a spiral groove (not shown) in its side wall .

The finger strip is then inserted in the spiral groove.

The core 198 is rotatable about two spindles (not shown)

at opposite axial ends of the core .

The take-up reel 205 removes the sealing tape 204

over the dosages 202 and fingers 200 as the dosages are

rotated to a dispensing position 206 at a given angular

position relative to the core 198.

A finger deflecting device 208 deflects the fingers

200 one at a time after the selected finger is rotated to

the dispensing position 206. Such a deflecting device may

be as shown in Figs. 10 and 11, for example. An apertured

flat anvil 203 is fixed over and adjacent to the finger at

position 206. As the core is rotated, the spiral path of

the fingers 200 containing a dosage to be dispensed

displaces relatively downwardly in axial direction 210 at

position 206.

A guide 212 is connected to the finger deflecting

device 208 represented by the dashed line 213 and slides

in direction 210 in a channel in the inhaler housing (not

shown) . The guide axially positions the finger deflecting

device as the selected dosage and finger relatively

displace axially as the spiral is rotated. The guide 212

engages the spring fingers at a location spaced from the

38 deflecting device and associated deflected finger. The

guide 212 is positioned axially in direction 210 as the

fingers are rotated about axis 214. The guide 212 for

example has a slot (not shown) which receives the edges of

the fingers as the fingers are rotated about axis 214.

The fingers 200 hold the guide 212 in the axial position.

An axial channel (not shown) in the housing holds the

guide in its annular position 206 about the axis 214.

In operation, a user rotates the core 198 to locate a

dosage and its corresponding carrier finger to the desired

axial and angular position relative to axis 214 at angular

position 206 of the deflecting device 208. The sealing

tape 204 is peeled free of the dosage as the core is

rotated by take up reel 205. A detent device, e.g., a

spring loaded ball attached to the housing (not shown) and

a depression in the core 198 corresponding to each finger

200 angular position about axis 214, may provide such a

position for a manually rotatable core.

Manually operated finger 200 deflecting device 208

deflects the selected dosage carrier finger 200 at

position 206 downwardly direction 210. When the displaced

finger 200 is released it snaps back against the anvil 203

carried by the device 208, releasing the selected dosage

202 in a manner described previously by momentum transfer.

39 The released powder cloud is inhaled via mouthpiece 218.

The mouthpiece is schematically illustrated as having a vertical orientation along axis 214. In practice, the mouthpiece may be horizontal transverse to the axis 214.

The mouthpiece may be coupled to a channel (not shown) in

the housing interior side wall for flowing the released

powder cloud to the mouthpiece at the edge of the spiral

substrate fingers at position 206.

A fan and/or additional air flow paths for providing an auxiliary air flow to assist in exhausting the powder

cloud during inhalation may also be provided as in Fig. 1 for this and the embodiments of Figs. 14 and 15. The reel 205 is also coupled to the guide 212 for displacement therewith in the axial direction. A mouthpiece 211

receives the discharged powdered dosage.

In Fig. 17, an embodiment similar to that of Fig. 16

employing a spiral dosage carrier substrate with resilient

cantilevered fingers is shown. In this embodiment all of the elements of Fig. 16 are utilized except that the dosages 202 are encapsulated at each finger 200' by a

discrete sealing cover sheet 215. The sealing cover sheet

preferably has a pocket for receiving the dosage. In this

case the take up reel 205 of Fig. 16 is not utilized. In

its place, a device (not shown) peels back the discrete

40 cover sheet 215' next prior to the deposition position

206' .

In Figs. 18 and 18a, a further embodiment of an

inhaler dispenser 218 includes a housing (not shown)

having a chamber for receiving a cartridge 220. The

cartridge 220 comprises a stack 222 of dosage packs 223.

Each pack 223 comprises a circular cylindrical (or other

shapes) dosage wafer blister type substrates 224. The

substrates 224 each comprise a thermoplastic blister

forming a pocket for the powdered dosage 228. The

substrates may be any conventional material, and

preferably formed thermoplastic. The powdered medicament

dosage 228 is deposited in the pocket of each substrate

224 by any known process as discussed above.

The cartridge 220, which may be any convenient

packaging for the packs is inserted into the inhaler

chamber. During an index cycle, the lead pack 223' is

separated from the cartridge and stack by a dispensing

device (not shown) and placed on the cantilevered dosage

carrier leaf spring 226 in a mating pocket 227 or aperture

(not shown) in the spring 226. A flat anvil 230, for

example metal or plastic, has a dosage receiving aperture

232. A mouthpiece 234 is adjacent to the aperture 232 for

receiving a powder cloud dosage .

41 An impact mechanism including a spring deflection

drive (not shown) is at station 236 for deflecting the

spring 226 and impacting the dosage 228 and substrate 224

against the anvil 230 to impart the desired energy pulse

to release the dosage. The anvil 230 aperture 232 is

smaller than the substrate so the dosage substrate will

impact against the anvil when the spring is directed

toward the anvil 230.

The deflection drive (not shown) selectively rotates

and snap releases the spring 226. Drive 238 may be manual

or electrically operated. The released spring 226 impacts

the deflected substrate 224' against the anvil 230 on a

side facing the spring 226 to release the dosage by

momentum transfer. The released dosage passes through the

anvil aperture 232 into the mouthpiece 234. The relative

orientations and positions are given by way of

illustration and may differ from that shown in a given

implementation. After the dosage is released, the empty

pack 223 ' substrate 224 is displaced to a storage location

(not shown) by a displacement device (not shown) .

In Figs. 19 and 19a, a further embodiment of a

cartridge dispenser for stacked substrates includes a

cartridge 240 mounted in an inhaler chamber (not shown) .

Cartridge 240 is any convenient packaging for stacked

42 substrates which comprises a stack 242 of separate

substrate-dosage packs 241. Each pack 241 comprises like

discrete formed thermoplastic blister type substrates 243

each having a dosage 246 receiving pocket 244. A

medicament dosage 246 is in each pocket. The dosages 246

are sealed by a discrete sealing cover 248 over each

substrate 242 forming the completed pack 241.

A flat anvil 254 is adjacent to the mouthpiece 256.

The anvil 254 has a dosage receiving aperture 258. The

anvil is secured fixed to the inhaler housing (not shown)

as in the prior embodiments discussed above herein.

During indexing, the cover 248 is removed from the

substrate 243 by a device (not shown) . The exposed dosage

246 and substrate 243 of the pack 241 are then placed in

a pocket 250 in dosage carrier spring 252 by a mechanism

(not shown) . Mouthpiece 256 is at the dosage dispensing

station. The spring 252 and carried dosage are displaced

by a deflection device (not shown) which deflects the

spring to the position shown in the Fig. with the

substrate and dosage thereon. The displaced spring upon

snap release by the deflection device, will impact the

anvil 254, and release the dosage 246 from the substrate

243. The substrate 243 is smaller than the aperture 258

in the anvil so that the anvil restrains the substrate

43 upon impact. This action provides momentum transfer energy to the dosage which forms a power cloud that is dispensed through the mouthpiece 256.

It will occur to one of ordinary skill that modifications may be made to the disclosed embodiments

without departing from the scope of the invention as defined in the appended claims. The description given herein is by way of illustration and not limitation. For example, the shape of the fingers and the particular

actuating mechanisms are by way of example. Numerous

other actuating mechanisms may be provided for flexing a spring finger to impart an energy pulse to a dosage on a substrate to transfer the dosage by momentum transfer forces.

44

Claims

What is claimed is:

1. A medicament powder delivery device comprising: a carrier having at least a flexible portion on which

portion is a discrete medicament dosage; and means for imparting an energy pulse to the carrier

flexible portion for deflecting the carrier portion and

releasing the dosage from the deflected carrier portion by momentum transfer.

2. The device of claim 1 wherein the means for imparting an energy pulse comprises means for flexing and snap

releasing the flexed carrier portion.

3. The device of claim 2 wherein the carrier portion

includes a dosage carrier finger resiliently extending

from a base region, the means for imparting for flexing

the finger relative to the base region.

4. The device of claim 3 including a body with a cavity

for receiving the flexible portion and the means for imparting, the device including an anvil with a bore

therethrough fixed to the body in the cavity for impact

receiving the snap released finger, the bore for receiving

said released dosage, and including means for causing said

45 finger to resiliently impact said anvil to rapidly

decelerate the finger to provide said momentum transfer to

the dosage.

5. The device of claim 4 wherein said dosage tends to

form aggregates, said anvil including at least one

channel, further including means coupled to the housing

for creating an air jet stream through said at least one

channel to disintegrate aggregations of said dosage during

said impact.

6. The device of claim 3 wherein the finger is

corrugated.

7. The device of claim 6 wherein the carrier finger

extends in a given direction from the base region, the

finger having corrugations extending along said direction.

8. The device of claim 5 wherein the means for creating

said jet stream includes a further resilient finger

overlying the substrate finger for initial resilient

displacement coincident with initial displacement of the

carrier finger, said displaced fingers for snap release in

a second displacement, said further finger for creating

46 said air stream during said second displacement .

9. The device of claim 8 wherein the further finger has a

different relaxation time than the carrier finger so as to

accelerate slower than the carrier finger upon said snap

release .

10. The device of claim 1 wherein the carrier includes a

first disc with a plurality of radially extending fingers,

a dosage on each finger, and the means for imparting

comprises cam means for snap flexing a selected finger to

release the dosage on the selected finger.

11. The device of claim 10 including index means for

indexing the selected finger to a medicament release

position for snap flexing the selected finger by said cam

means .

12. The device of claim 11 wherein the first disc

includes a dosage carrier disc with a plurality of first

fingers each carrying a dosage, a spacer disc overlying

the carrier disc with a plurality of second fingers

overlying and corresponding to the first fingers and a

ring with index holes and a third plurality of fingers

47 over lying and corresponding to the first and second

fingers, said spacer disc being bonded to the substrate

and ring discs, said indexing means for selectively

engaging said ring index holes .

13. The device of claim 12 including cam means for

manually flexing the selected fingers.

14. The device of claim 13 wherein the cam means flexes

the first and second fingers past the third fingers.

15. The device of claim 1 wherein the carrier comprises a

belt portion with a plurality of fingers extending

transversely from the belt portion, each said fingers

having a separate dosage and arranged for selective

resilient displacement relative to said belt portion.

16. The device of claim 15 further including drive means

for displacing said belt to increment said fingers

sequentially to a dosage release position.

17. The device of claim 15 wherein the means for

imparting includes a clamp for clamping the belt portion

adjacent to a given finger and a deflecting member for

48 selectively flexing and snap releasing the selected given

flexed finger relative to the belt portion.

18. The device of claim 1 wherein the carrier comprises

an element, said dosage comprising a plurality of discrete

dosages in spaced relation on said element, said means for

imparting including a carrier deflection member adjacent

to said element, and means for momentarily bending and

deflecting the element to momentum transfer release a

selected dosage from the element upon release of the

deflected element .

19. The device of claim 18 including means for

selectively aligning successive dosages on said element to

said deflection member.

20. The device of claim 18 including a core member

rotatable about an axis, said element comprising an array

of fingers radially extending from the core member about

the core member in a spiral about said axis, said device

including means for selectively aligning and deflecting

each said finger to snap release a selected dosage from

the selected finger by said momentum transfer.

49

21. The device of claim 1 wherein said carrier comprises

a spring finger for receiving a dosage and dosage

substrate from a plurality of dosages and dosage

substrates in a stack aligned one over another, and means

for selectively placing successive dosages and dosage

substrates on said carrier, said means for imparting

including means for snap deflecting said finger against an

anvil .

22. A dry powder delivery device comprising:

a cartridge containing at least one dosage carrier

substrate;

a dry powder in an array of discrete locations on the

at least one substrate;

a housing for receiving the cartridge; and

means for momentarily deflecting the carrier

substrate to accelerate and rapidly decelerate the

substrate to momentum transfer and discharge the powder

from the substrate at a selected location.

23. The device of claim 22 wherein the cartridge

comprises a plurality of reels with the carrier substrate

suspended between the reels, the means for deflecting

comprising a cantilevered spring member for said

50 momentarily deflecting the carrier substrate between said reels and a fixed anvil for impact receiving the deflected

substrate.

24. The device of claim 22 where the cartridge comprises a cylindrical core member and a plurality of fingers

extending radially from the cylindrical core member in a

spiral array, said means for deflecting comprising means

for selectively deflecting each finger including anvil means for rapidly decelerating the deflected finger.

25. The device of claim 24 wherein the means for selectively deflecting includes a core member drive means for selectively rotating the core member about an axis to locate each finger at a given angular and axial position

about the axis and a finger deflecting device at said

given position, said selectively deflecting means

including means at said angular position for displacing

the finger along said axis.

26. The device of claim 22 wherein the cartridge

comprises a disc having a plurality of radially outwardly extending fingers, each finger having a dosage thereon

and the means for deflecting including means for

51 selectively deflecting each said finger.

27. The device of claim 22 wherein the cartridge

comprises a stack of medicament dosages each on a discrete

substrate, a spring for receiving a selected dosages on a

substrate from the stack, said means for deflecting for

selectively deflecting each substrate in a sequence.

28. The device of claim 22 wherein the cartridge comprises

a member having a base and a linear array of fingers

extending from the base, each finger being flexible

relative to the base and including a medicament powder

dosage, said means for deflecting for selectively

deflecting each finger in a sequence.

29. The device of claim 28 wherein the fingers are

rectangular and parallel .

30. The device of claim 28 wherein the fingers are

triangular and parallel.

31. The device of claim 22 wherein the at least one

substrate has a plurality of depressions each containing a

separate powder dosage and a sealing tape bonded to the

52 substrate over the depressions and spaced from the dosages .

53