Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 1 of 76 PageID #: 1114
`Case 1:14—cv—OO113—RGA—MPT Document 53-1 Filed 05/29/14 Page 1 of 76 Page|D #: 1114
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 2 of 76 PageID #: 1115
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US008556864B2
`
`c12) United States Patent
`Veasey et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,556,864 B2
`*Oct. 15, 2013
`
`(54) DRIVE MECHANISMS SUITABLE FOR USE
`IN DRUG DELIVERY DEVICES
`
`(75)
`
`Inventors: Robert Frederick Veasey, Warwickshire
`(GB); Robert Perkins, Warwickshire
`(GB); David Aubrey Plumptre,
`Worcestershire (GB)
`
`(73) Assignee: Sanofi-Aventis Deutschland GmbH,
`Frankfurt am Main (DE)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 301 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/075,212
`
`(22)
`
`Filed:
`
`Mar. 30, 2011
`
`(65)
`
`Prior Publication Data
`
`US 2011/0178474 Al
`
`Jul. 21, 2011
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 11/520,598, filed on
`Sep. 14, 2006, now Pat. No. 7,935,088, which is a
`continuation of application No. 10/790,866, filed on
`Mar. 3, 2004, now abandoned.
`
`(30)
`
`Foreign Application Priority Data
`
`Mar. 3, 2003
`
`(GB) ................................... 0301822.0
`
`(51)
`
`(2006.01)
`
`Int. Cl.
`A61M5100
`(52) U.S. Cl.
`USPC ........................................... 604/207; 604/208
`(58) Field of Classification Search
`USPC .................................. 604/207-211, 224, 246
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,470,317 A
`4,498,904 A
`
`9/1984 Sabloewski eta!.
`2/1985 Turner et al.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`EP
`
`9/1987
`3609555
`9/1995
`0673482
`(Continued)
`
`OTHER PUBLICATIONS
`
`First Office Action on merits mailed Mar. 14, 2006 in U.S. Appl. No.
`10/790,866 (11 pages).
`
`(Continued)
`
`Primary Examiner- Kevin C Sirmons
`Assistant Examiner- Andrew Gilbert
`(74) Attorney, Agent, or Firm- McDonnell Boehnen
`Hulbert & Berghoff LLP
`
`ABSTRACT
`(57)
`A drive mechanism suitable for use in drug delivery devices is
`disclosed. The drive mechanism may be used with injector(cid:173)
`type drug delivery devices, such as those permitting a user to
`set the delivery dose. The drive mechanism may include a
`housing, a dose dial sleeve, and a drive sleeve. A clutch is
`configured to permit rotation of the drive sleeve and the dose
`dial sleeve with respect to the housing when the dose dial
`sleeve and drive sleeve are coupled through the clutch. Con(cid:173)
`versely, when the dose dial sleeve and drive sleeve are in a
`de-coupled state, rotation of the dose dial sleeve with respect
`to the housing is permitted and rotation of the drive sleeve
`with respect to the housing is prevented. In the de-coupled
`state, axial movement of the drive sleeve transfers force in a
`longitudinal direction for actuation of a drug delivery device.
`
`10 Claims, 13 Drawing Sheets
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 3 of 76 PageID #: 1116
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`US 8,556,864 B2
`Page 2
`
`(56)
`
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`
`

`
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`Page 3
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`(56)
`
`JP
`RU
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`wo
`
`References Cited
`
`OTHER PUBLICATIONS
`
`FOREIGN PATENT DOCUMENTS
`
`06-296691
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`
`* cited by examiner
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 5 of 76 PageID #: 1118
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`U.S. Patent
`
`Oct. 15, 2013
`
`Sheet 1 of 13
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`US 8,556,864 B2
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`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 6 of 76 PageID #: 1119
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`U.S. Patent
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`Sheet 2 of 13
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`US 8,556,864 B2
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`76
`
`76
`
`4
`
`FIG.3
`
`FIG.4
`
`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 7 of 76 PageID #: 1120
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`U.S. Patent
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`Oct. 15, 2013
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`Sheet 3 of 13
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`US 8,556,864 B2
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`8
`
`10
`
`FIG.5
`
`

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`Sheet 4 of 13
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`US 8,556,864 B2
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`FIGJ)
`
`FIG.7
`
`66
`
`FIG.8
`
`

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`Sheet 5 of 13
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`US 8,556,864 B2
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`A{82)
`
`A{82)
`
`FIG.9
`
`36
`
`20
`
`FIG.10
`
`8(76)
`
`F!G.11
`
`E(60)
`
`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 10 of 76 PageID #: 1123
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`U.S. Patent
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`Sheet 6 of 13
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`US 8,556,864 B2
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`70
`
`74
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`106
`
`108
`
`104
`
`FIG.12
`
`106
`
`FIG.13
`
`FIG.14
`
`112
`
`110
`
`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 11 of 76 PageID #: 1124
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`Sheet 7 of 13
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`US 8,556,864 B2
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`46
`
`100
`
`FiG.15
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`102
`
`46
`
`46
`
`FIG.16
`
`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 12 of 76 PageID #: 1125
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`U.S. Patent
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`Sheet 8 of 13
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`US 8,556,864 B2
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`.. _
`
`,.
`CD
`u....
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`

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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 13 of 76 PageID #: 1126
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`U.S. Patent
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`Sheet 9 of 13
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`US 8,556,864 B2
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`N
`""'""
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`N
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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 14 of 76 PageID #: 1127
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`US 8,556,864 B2
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`Sheet 11 of 13
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`US 8,556,864 B2
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`US 8,556,864 B2
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`US 8,556,864 B2
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`Case 1:14-cv-00113-RGA-MPT Document 53-1 Filed 05/29/14 Page 18 of 76 PageID #: 1131
`
`1
`DRIVE MECHANISMS SUITABLE FOR USE
`IN DRUG DELIVERY DEVICES
`
`2
`according to instant invention further provides the advantage
`of intuitive and easy to use correction of a set dose.
`
`US 8,556,864 B2
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`SUMMARY
`
`The present application is a continuation of U.S. patent
`application Ser. No. 11/520,598, filed Sep. 14, 2009, now
`U.S. Pat. No. 7,935,088, which is a continuation application
`of U.S. patent application Ser. No. 10/790,866, filed Mar. 3, 10
`2004, now abandoned, that claims priority to GB 0301822.0
`filed Mar. 3, 2003, the entire contents of which are incorpo(cid:173)
`rated herein by reference.
`
`TECHNICAL FIELD
`
`15
`
`The present invention relates to drive mechanisms suitable
`for use in drug delivery devices, in particular pen-type injec(cid:173)
`tors, having dosage setting means, enabling the administra- 20
`tion of medicinal products from a multi-dose cartridge. In
`particular, the present invention relates to such drug delivery
`devices where a user may set the dose.
`
`BACKGROUND
`
`25
`
`Such drug delivery devices have application where regular
`injection by persons without formal medical training occurs,
`i.e., patients. This is increasingly common amongst those
`having diabetes where self-treatment enables such persons to
`conduct effective management of their diabetes.
`These circumstances set a number of requirements for drug
`delivery devices of this kind. The device must be robust in
`construction, yet easy to use in terms of the manipulation of
`the parts, understanding by a user of its operation and the
`delivery of the required dose of medicament. Dose setting
`must be easy and unambiguous. In the case of those with
`diabetes, many users will be physically infirm and may also
`have impaired vision requiring the drive mechanism to have
`low dispensing force and an easy to read dose setting display. 40
`Where the device is to be disposable rather than reusable, the
`device should be cheap to manufacture and easy to dispose of
`(preferably being suitable for recycling). To meet these
`requirements the number of parts required to assemble the
`device and the number of material types the device is made 45
`from need to be kept to a minimum.
`User operated drug delivery devices are well known within
`the medical field.
`In U.S. Pat. No. 5,304,152 a dispensing device is disclosed
`which has a body length to plunger length ratio of about 1:1 in
`order to allow the dispensing of relatively large doses. Whilst
`this device provides many improvements over the prior art the
`easy correction of a set overdose remains unresolved without
`either dispensing the set amount of fluid or dismantling the
`cartridge.
`WO 9938554 A2 teaches an injection syringe for appor(cid:173)
`tioning set doses of a medicine from a cartridge wherein a
`drive mechanism comprising a unidirectional coupling (i.e., a
`ratchet) is disclosed which allows correction of a set overdose
`without dispensing the set amount of fluid or requiring the
`dismantling of the cartridge.
`Surprisingly it was found that the drive mechanism accord(cid:173)
`ing to instant invention without having a unidirectional cou(cid:173)
`pling provides a valuable technical alternative for drive
`mechanisms, wherein reduced force is needed to actuate the
`mechanism. This is achieved by the introduction of a clutch
`means as defined by instant invention. The drive mechanism
`
`According to a first aspect of the present invention, a drive
`mechanism for use in a drug delivery device is provided
`comprising:
`a housing having a helical thread;
`a dose dial sleeve having a helical thread engaged with the
`helical thread of the said housing;
`a drive sleeve releasably connected to the said dose dial
`sleeve;
`and a clutch means located between the dose dial sleeve
`and the drive sleeve;
`characterized in that,
`a) when the dose dial sleeve and the drive sleeve are
`coupled, the dose dial sleeve and the drive sleeve are
`allowed to rotate with respect to the housing; and
`b) when the dose dial sleeve and the drive sleeve are
`de-coupled, rotation of the dose dial sleeve with
`respect to the housing is allowed, whilst rotation of
`the drive sleeve with respect to the housing is not
`allowed, whereby axial movement of the drive sleeve
`is allowed so that a force is transferred in the longitu(cid:173)
`dinal direction to the proximal end of the drug deliv-
`ery device.
`In a preferred embodiment of the drive mechanism of
`instant invention the said drive mechanism further comprises
`30 a piston rod adapted to operate through the housing and
`transfer the said force in the said longitudinal direction to the
`proximal end of the drug delivery device.
`In another preferred embodiment of the drive mechanism
`of instant invention the said dose dial sleeve further comprises
`35 a helical thread, which has the same lead as the lead of the
`helical thread of the said drive sleeve.
`In a more specific embodiment of instant invention, the
`drive mechanism further comprises a nut, which is rotatable
`with respect to the drive sleeve and axially displaceable but
`not rotatable with respect to the housing.
`The term "drug delivery device" according to instant
`invention shall mean a single-dose or multi-dose, disposable
`or re-useable device designed to dispense a selected dose of a
`medicinal product, preferably multiple selected doses, e.g.
`insulin, growth hormones, low molecular weight heparins,
`and their analogues and/or derivatives etc. Said device may be
`of any shape, e.g. compact or pen-type. Dose delivery may be
`provided through a mechanical (optionally manual) or elec(cid:173)
`trical drive mechanism or stored energy drive mechanism,
`50 such as a spring, etc. Dose selection may be provided through
`a manual mechanism or electronic mechanism. Additionally,
`said device may contain components designed to monitor
`physiological properties such as blood glucose levels, etc.
`Furthermore, the said device may comprise a needle or may
`55 be needle-free. In particular, the term "drug delivery device"
`shall mean a disposable multi-dose pen-type device having
`mechanical and manual dose delivery and dose selection
`mechanisms, which is designed for regular use by persons
`without formal medical training such as patients. Preferably,
`60 the drug delivery device is of the injector-type.
`The term "housing" according to instant invention shall
`preferably mean any exterior housing ("main housing",
`"body", "shell") or interior housing ("insert", "inner body")
`having a helical thread. The housing may be designed to
`65 enable the safe, correct, and comfortable handling of the drug
`delivery device or any of its mechanism. Usually, it is
`designed to house, fix, protect, guide, and/or engage with any
`
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`US 8,556,864 B2
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`3
`of the inner components of the drug delivery device (e.g., the
`drive mechanism, cartridge, plunger, piston rod) by limiting
`the exposure to contaminants, such as liquid, dust, dirt etc. In
`general, the housing may be unitary or a multipart component
`of tubular or non-tubular shape. Usually, the exterior housing
`serves to house a cartridge from which a number of doses of
`a medicinal product may by dispensed.
`In a more specific embodiment of instant invention, the
`exterior housing is provided with a plurality of maximum
`dose stops adapted to be abutted by a radial stop provided on 10
`the dose dial sleeve. Preferably, at least one of the maximum
`dose stops comprises a radial stop located between a helical
`thread and spline means provided at a second end of the
`housing. Alternatively, at least one of the maximum dose
`stops comprises a part of a raised window portion provided at 15
`a second end of the housing.
`The term "engaged" according to instant invention shall
`particularly mean the interlocking of two or more compo(cid:173)
`nents of the drive mechanism/drug delivery device, e.g. a
`spline, thread, or meshed teeth connection, preferably the 20
`interlocking of helical threads of components ("threadedly
`engaged").
`The term "helical thread" according to instant invention
`shall preferably mean a full or part thread, e.g., a cylindrical
`spiral rib/groove, located on the internal and/or external sur- 25
`face of a component of the drug delivery device, having an
`essentially triangular or square or rounded section designed
`to allow continuous free rotational and/or axial movement
`between components. Optionally, a thread may be further
`designed to prevent rotational or axial movement of certain 30
`components in one direction.
`The term "dose dial sleeve" according to instant invention
`shall mean an essentially tubular component of essentially
`circular cross-section having either:
`a) both an internal and external thread, or
`b) an internal thread, or
`c) an external thread.
`Preferably, the dose dial sleeve according to instant inven(cid:173)
`tion comprises a helical thread having a lead, which is similar
`to, preferably the same as the lead of the helical thread of the 40
`drive sleeve. In yet another preferred embodiment the dose
`dial sleeve is designed to indicate a selected dose of a dis(cid:173)
`pensable product. This may be achieved by use of markings,
`symbols, numerals, etc., e.g. printed on the external surface of
`the dose dial sleeve or an odometer, or the like.
`In a more specific embodiment of instant invention, the
`dose dial sleeve is provided with a plurality of radially extend(cid:173)
`ing members adapted to about a corresponding plurality of
`radial stops provided at a second end of the housing.
`The term "lead" according to instant invention shall pref- 50
`erably mean the axial distance a nut would advance in one
`complete revolution; preferably "lead" shall mean the axial
`distance through which a component having a helical thread,
`i.e. dose dial sleeve, drive sleeve, piston rod, etc., of the drive
`mechanism travels during one rotation. Therefore lead is a 55
`function of the pitch of the thread of the relevant component.
`The term "pitch" according to instant invention shall pref(cid:173)
`erably mean the distance between consecutive contours on a
`helical thread, measured parallel to the axis of the helical
`thread.
`The term "drive sleeve" according to instant invention shall
`mean any essentially tubular component of essentially circu(cid:173)
`lar cross-section and which is further releasably connected to
`the dose dial sleeve. In a preferred embodiment the drive
`sleeve is further engaged with the piston rod.
`In a more particular embodiment of instant invention, the
`drive sleeve is provided at a first end with first and second
`
`4
`flanges with an intermediate helical thread between the first
`and second flanges, having a nut disposed between the first
`and second flanges and keyed to the housing by spline means.
`Optionally, a first radial stop may be provided on a second
`face of the nut and a second radial stop may be provided on a
`first face of the second flange.
`The term "releasably connected" according to instant
`invention shall preferably mean that two components of
`instant mechanism or device are reversibly joined to each
`other, which allows coupling and decoupling, e.g. by means
`of a clutch.
`The term "piston rod" according to instant invention shall
`mean a component adapted to operate through/within the
`housing, designed to translate axial movement through/
`within the drug delivery device, preferably from the drive
`sleeve to the piston, for the purpose of discharging/dispensing
`an injectable product. Said piston rod may be flexible or not.
`It may be a simple rod, a lead-screw, a rack and pinion system,
`a worm gear system, or the like. The "piston rod" shall further
`mean a component having a circular or non-circular cross-
`section. It may be made of any suitable material known by a
`person skilled in the art.
`In a preferred embodiment, the piston rod comprises at
`least one, more preferably two, external and/or internal heli(cid:173)
`cal threads. In another preferred embodiment of the piston rod
`according to instant invention, a first helical thread is located
`at a first end and a second helical thread is located at a second
`end of the said piston rod, whereby the said threads may have
`the same or, preferably, opposite dispositions. In another
`preferred embodiment the piston rod of instant invention
`comprises threads having the same leads at the first and the
`second end.
`In yet another preferred embodiment of instant invention
`the lead of the first helical thread of the piston rod shall be
`greater than the lead of the second helical thread. More pre(cid:173)
`ferred, the ratio of the leads of the helical threads of the said
`first and the second helical threads is 1:1.01 to 1:20, even
`more preferred 1:1.1 to 1:10. Preferably, one of the said
`threads is designed to engage with the drive sleeve.
`Alternatively, in another preferred embodiment of the pis(cid:173)
`ton rod of instant invention, the piston rod is designed to have
`attached, optionally by means of a journal bearing, a toothed
`45 gear, and wherein said toothed gear is designed to mesh with
`the threads of the drive sleeve and the teeth of a toothed rack,
`whereby said toothed rack is fixed to the housing.
`The term "first end" according to instant invention shall
`mean the proximal end. The proximal end of the device or a
`component of the device shall mean the end, which is closest
`to the dispensing end of the device.
`The term "second end" according to instant invention shall
`mean the distal end. The distal end of the device or a compo(cid:173)
`nent of the device shall mean the end, which is furthest away
`from the dispensing end of the device.
`The term "clutch means" according to instant invention
`shall mean any means, which releasably connects the dose
`dial sleeve and the drive sleeve and which is designed to allow
`rotation of the dose dial sleeve and the drive sleeve with
`60 respect to the housing when the dose dial sleeve and the drive
`sleeve are coupled and, when both are de-coupled, allows
`rotation of the dose dial sleeve with respect to the housing, but
`does not allow rotation of the drive sleeve with respect to the
`housing and allows axial movement of the drive sleeve. Pref-
`65 erably, the clutch means releasably connects the drive sleeve
`to the housing. Accordingly, the term clutch means is any
`clutch engaging for the purpose of reversibly locking two
`
`35
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`US 8,556,864 B2
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`5
`components in rotation, e.g., by use of axial forces to engage
`a set of face teeth (saw teeth, dog teeth, crown teeth) or any
`other suitable frictional faces.
`In a more specific embodiment of instant invention, a sec(cid:173)
`ond end of the clutch means is provided with a plurality of dog
`teeth adapted to engage with a second end of the dose dial
`sleeve.
`In an alternative embodiment, the clutch means of instant
`invention is a locking spring, operable, e.g., by means of a
`dose dial button, between a first, relaxed position, in which 10
`the dose dial sleeve is locked with respect to rotation with the
`drive sleeve and a second, deformed position, in which the
`dose dial sleeve is locked with respect to rotation with the
`housing.
`In still another embodiment of instant invention, the drive
`mechanism further comprises a clicker means, optionally
`disposed between the clutch means and spline means pro(cid:173)
`vided on the housing.
`Optionally, the clicker means comprises a sleeve provided
`at a first end with a helically extending arm, a free end of the 20
`arm having a toothed member, and at a second end with a
`plurality of circumferentially directed saw teeth adapted to
`engage a corresponding plurality of circumferentially saw
`teeth provided on the clutch means. Alternatively, the clicker
`means comprises a sleeve provided at a first end with at least 25
`one helically extending arm and at least one spring member,
`a free end of the arm having a toothed member, and at a
`second end with a plurality of circumferentially directed saw
`teeth adapted to engage a corresponding plurality of circum(cid:173)
`ferentially directed saw teeth provided on the clutch means. 30
`In still another embodiment of the drive mechanism of the
`invention, the drive mechanism is provided with a first stop
`means, preferably in the form of an external flange on the dose
`dial sleeve, adapted to engage limiting means associated with
`the housing, preferably in the form of an internal flange in the
`housing, to limit the maximum dose which can be dialed. In
`yet another embodiment of the drive mechanism of the inven(cid:173)
`tion, the drive mechanism is further provided with a second
`stop means, preferably in the form of an external flange on the
`drive sleeve, adapted to engage limiting means, preferably in 40
`the form of a limiting nut keyed to the housing and mounted
`for rotation on an external threaded section of the drive sleeve,
`to provide an end of life stop.
`A second aspect of instant invention provides an assembly
`for use in a drug delivery device comprising the drive mecha- 45
`nism according to instant invention.
`A third aspect of the present invention provides a drug
`delivery device comprising the drive mechanism or the
`assembly according to instant invention.
`A fourth aspect of the present invention provides a method 50
`of assembling a drug delivery device comprising the step of
`providing a drive mechanism or an assembly according to
`instant invention.
`A fifth aspect of instant invention is the use of a drug
`delivery device according to instant invention for dispensing
`a medicinal product preferably dispensing a pharmaceutical
`formulation (e.g. solution, suspension etc.) comprising an
`active compound selected from the group consisting of insu(cid:173)
`lin, growth hormone, low molecular weight heparin, their
`analogues and their derivatives.
`
`6
`FIG.1 shows a sectional view of a first embodiment of the
`drug delivery device in accordance with the present invention
`in a first, cartridge full, position;
`FIG. 2 shows a sectional view of the drug delivery device of
`FIG. 1 in a second, maximum first dose dialed, position;
`FIG. 3 shows a sectional view of the drug delivery device of
`FIG. 1 in a third, maximum first dose dispensed, position;
`FIG. 4 shows a sectional view of the drug delivery device of
`FIG. 1 in a fourth, final dose dialed, position;
`FIG. 5 shows a sectional view of the drug delivery device of
`FIG. 1 in a fifth, final dose dispensed, position;
`FIG. 6 shows a cut-away view of a first detail of the drug
`delivery device of FIG. 1;
`FIG. 7 shows a partially cut-away view of a second detail of
`15 the drug delivery device of FIG. 1;
`FIG. 8 shows a partially cut-away view of a third detail of
`the drug delivery device of FIG. 1;
`FIG. 9 shows the relative movement of parts of the drug
`delivery device shown in FIG. 1 during dialing up of a dose;
`FIG. 10 shows the relative movement of parts of the drug
`delivery device shown in FIG. 1 during dialing down of a
`dose;
`FIG. 11 shows the relative movement of parts of the drug
`delivery device shown in FIG. 1 during dispensing of a dose;
`FIG. 12 shows a partially cut-away view of the drug deliv(cid:173)
`ery device ofFIG.1 in the second, maximum first dose dialed,
`position;
`FIG. 13 shows a partially cut-away view of the drug deliv(cid:173)
`ery device of FIG. 1 in the fourth, final dose dialed, position;
`FIG. 14 shows a partially cut-away view of the drug deliv(cid:173)
`ery device of FIG. 1 in one of the first, third or fifth positions;
`FIG. 15 shows a cut-away view of a first part of a main
`housing of the drug delivery device of FIG. 1; and
`FIG. 16 shows a cut -away view of a second part of the main
`35 housing of the drug delivery device of FIG. 1;
`FIG. 17 shows a sectional view of a second embodiment of
`the drive mechanism according to instant invention in a first,
`cartridge full, position.
`FIG. 18 shows a sectional side view of a third embodiment
`of the drug delivery device in accordance with the present
`invention in a first, cartridge full, position;
`FIG. 19 shows a sectional side view of the drug delivery
`device of FIG. 18 in a second, maximum first dose dialed,
`position;
`FIG. 20 shows a sectional side view of the drug delivery
`device of FIG. 18 in a third, maximum first dose dispensed,
`position;
`FIG. 21 shows a sectional side view of the drug delivery
`device of FIG. 18 in a fourth, final dose dialed, position;
`F