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(21) Application Number: KFJP/2009/ 000908   
   
(22) Filing Date: 08/11/2007   
   
(30) Priority data: 06023951.4  17/1112006  EP
   
(86)  PCT data     PCT/EP07/009674    08/11/2007 wo 2008/058666    22/05/2008

(73) Owner: SANOFI-A VENTIS  DEUTSCHLAND GMBH of Brunningstrasse 50, 0~65929 FranJ...'furt am Main., Germany

(72) Inventors: VEASEY, Robert of3 I Lonsdale Road, Lillington, Leamington Spa, Warwickshire, CV32 7EPUnited Kingdom; LETHAM, Richard of 128 Regents Court, Sopwith Way, Kingston Upon Thames, Surrey KT25AQ United Kingdom; PLUMPTRE, David of 36 Shire Way, Droihvich, Worcesteshire, WR9 7RQ, United Kingdom; MAY, James of 55 Mickleton Road, Earlsdon, Coventry CV5 PP, United Kingdom and BOYD, Malcom  of 26 Commander Close Bishop Tach brook Leamington Spa, CV32 9RS, Ireland

(74) Agent/address for correspondence: Kaplan & Stratton Advocates, P. 0. Box 40 I I l ~00 100, Nairobi

54) Title: IMPROVEMENTS IN AND RELATING TO DRIVE MECHANISMS SUITABLE FOR USE IN DRUG DELIVERY DEVICES

(57) Abstract: A drive mechanism for use in a drug delivery device comprising: a housing; a drive member movable longitudinally and non~rotatable with respect to the housing; a piston rod that is non~rotatable with respect to the housing; a rotating means releasably engaged with the piston rod and engaged to the drive member and engaged to the housing wherein the rotating means is selected from the group of(i) to (iii), (i) a carrier plate having pawl arms and a gear, (ii) a carrier plate having pawl arms and a lever, (iii) a lever assembly. When the drive member moves proximally with respect to the housing the rotating means moves proximally with respect to the piston rod, and when the drive member moves distally the rotating means moves distally displacing the piston rod towards the distal end of the device.
 
Improvements in and relating to drive mechanisms suitable for use in drug delivery devices

The technical field of the invention

The present invention relates to drive mechanisms suitable for use in drug delivery devices, in particular pen-type injectors, wherein a number of pre-set doses of medicinal product can be administered. In particular, the present invention relates to such drug delivery devices where a user may activate the drug delivery device.

10

Description of related art

Such drug delivery devices have application where person~ without formal medicai training, i.e., patients, need to administer an accurate and predefined dose oi a

15    medicinal product, such as heparin or insulin. In particular, such devices have application where medicinal product is administered on an irregular basis over a short-term or long~term period.

These circumstances set a number of requirements for drug delivery devices of this

20    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.

Where the device is to be disposable rather ttian reusable, the device should be cheap

to manufacture and easy to dispose of {preferably being suitable for recycling). To

25    meet these requirements the number of parts required to assemble the device and the number of material types the device is made from need to be kept to a minimum.

User operated drug delivery devices are well known within the medical field.

30    WO 9626754 A2 teaches a mechanism for accurate dispensing of pre-set quantities of medicament from a syringe wherein a rotatable plunger has a number of parallel racks on its internal surface each of which comes into engagement with a first tooth wheel as
 
Description of the invention

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 proximal and a distal end;

a drive member located within the said housing such that the said drive member is movable longitudinally;
a piston  rod  adapted to  operate through  the  housing  and  transfer a force  in the

10    longitudinal direction to the distal end of the drug delivery device;

a rotating means releasably engaged with the said piston rod and engaged to the said drive member and engaged to the said housing;
characterized in that,

a)    when the said drive member moves proximally with respect to the said housing

15    the said rotating means moves proximally with respect to the said piston rod;

b)    when the said drive member moves distally the said rotating means moves distally displaCing the said piston rod towards th•e distal end of the device.

In a preferred embodiment of the drive mechanism of instant invention the said drive

20    member is non-rotatable with respect to the said housing.

In another preferred embodiment of the drive mechanism of instant invention the said piston rod is non-rotatable with respect to the said housing.

25    In a further preferred embodiment of the drive mechanism of instant invention the rotating means is a gear.

In yet a further preferred embodiment of the drive mechanism of instant invention the gear is free to translate relative to the said piston rod.
 
In another further preferred embodiment of the drive mechanism of instant invention the engagement betwee•n the piston rod and the gear acts through the axle of the said

gear.

In yet another further preferred embodiment of the drive mechanism of instant invention the gear is designed .to be engaged with a rack located on the drive member and a rack located on the housing.

In a further embodiment of the drive mechanism of instant invention the rotating means is a lever.

10

In yet another embodiment of the drive mechanism of instant invention the rotating means is a pulley.

In yet a further embodiment of the drive. mechanism of instant invention the rotating

15    means is a lever assembly.

The 'inve•n\~on further relates to a drive mechanism for a drug delivery device with a lever assembly which comprises a lever which is designed to pivot with respect to a carrier around a rotational axis. The carrier is movable in a proximal direction with

20 respect to the piston rod. The lever is provided with a first pivot and a second pivot. The first pivot interacts with the housing and the second pivot interacts with the drive member such that the lever is pivoted when the drive member is moved axially with respect to the housing. The distance Y between the rotational axis of the lever and the second pivot is different than the distance X between the rotational axis of the lever
25    and the first pivot which results in a mechanical advantage different than 2:1 ..

The tenm "drug delivery device" according to instant invention shall mean a single-dose or multi-dose or pre-set dose or pre-defined, disposable or re-useable device designed to dispense a user selectable or pre-defined dose of a medicinal product, preferably
30    multiple pre-defined 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 electrical drive mechanism or stored energy drive mechanism, 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 be n~edle-free. In particular, the term "cjrug delivery device" shall mean a disposable needle-based pen-type device providing multiple pre-defined doses having mechanical and .manual dose deliver)! and dose selection mechanisms, which is designed for use by persons without formal medical training such as patients. Preferably, the drug delivery device is of the injector-type.

10

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 unidirectional axial coupling to prevent proximal .movement .of specific components. The housing may be designed to enable the safe, correct, and

15    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 of the inner components of the drug delivery device (e.9••ilie drive mechanism,"cartr\dge, 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.

20    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 an axial stop provided on the drive member.
25

The term "engaged" according to instant invention shall particularly mean the interlocking of two or more components of the drive mechanism/drug delivery device, e.g. a spline, thread, or meshed teeth connection, preferably the interlocking of meshed teeth of components.

30

The term "drive member" according to instant invention shall mean any component adapted to operate through/within the housing, designed to translate axial movement
 
through/within the drug delivery device, preferably from an actuation means to the piston rod. In a preferred -embodiment the drive member is further releasably engaged with the piston rod. The drive member may be of unitary or multipart construction.

The term "releasably engaged". according to instant invention shall preferably mean

that two components of instant mechanism or device are joined for translation of fore~

or movement in one direction only, preferably during dispense.

The term "piston rod" according to 'instantinvention shall mean a component adapted

10    to operate through/within the housing, designed to trans[ate axial movement through/within the drug delivery device, preferably from the drive member to the piston, for t~~ purp~se of discharging/dispensing a_n 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
15    a circular or non-circular cross-section. It may be made of any suitable material known by a person skilled in the art and may bi> of unitary or multipart construction. In a preferred embodiment, the piston rod compris~s a series of erie or niore sets of• longitudinally spaced ribs and/or indentations.

20    The term "rotating means" according to instant invention shall mean any rotating component that transfers force and/or movement from the drive member to the piston rod. It may be made of any suitable material known by a person skilled in the art and may be of unitary or multipart construction. In a preferred embodiment the rotating
means may be a gear component, more preferably a spur gear. In another preferred

25    embodiment the rotating means may be a lever. In yet another preferred embodiment the rotating means may be a pulley. In yet a further preferred embodiment the rotating means may be a lever assembly.

The term "gear" according to instant invention shall mean a toothed wheel used in

30    conjunction with a rack and/or another gear, preferably a rack, to transmit force and/or motion. In a preferred embodiment the gear may be a spur gear. In yet another preferred embodiment the term ugear''means a gearwheel mounted within a carrier.
 The term "!eve( according to instant invention shall mean any beam component pivoted about a fulcrum to transmit force and/or motion. In a preferred embodiment the fulcrum point is located on the housing and load is applied through the drive member. In yet another preferred embodiment the term "!eye~• shall_mean any beam component that moves essentially proximally with respect to the piston rod during dose setting and that moves essentially distally with respect to the piston rod during dose delivery.

The term "pulley" according to instant invention shall meari any wheel and/or belt•

10    component that is designed to transmit force and/or motion. In a preferred embodiment the pulley comprises a wheel arid belt. In a more preferred embodiment the belt of the
pulley is attached to the housing and the drive 'memberand the wheel of. the pulley
-    .
engages with the piston rod and the belt of the pulley. In _yet another preferred embodiment the wheel of the pulley is releas.ably engaged with the piston rod.

15

The term "lever assembly" according to instant invention shall mean any component

consisting of a lever arid a carrier designed to tra•nsmit foi"Ce arid/or motion.

The term "rack" according to instant invention shall mean any component having a

20    linear array of ribs and/or indentations and/or gear-form teeth. In a preferred embodiment a rack is located in the housing and a further rack is located in the drive member. In a further preferred embodiment one and/or both, more preferably one, of the racks located on the housing or on the drive member is flexible and/or pivoted and/or movable in one or more axis, more preferably one.

25

The term "graphical status indicate~• according to instant invention shall preferably mean any markings, symbols, numerals, etc., e.g. printed on the external surface of a component of the device, for example the drive sleeve or an odometer or a dose dial sleeve, or the like, preferably the drive sleeve, for indicating to the user when the

30    device has been activated and/or is in operation and/or direction of operation and/or a dose of medicament has been delivered.
 
The "distal end" of the device or a component of the device shall mean lhe end, which is closest lo the dispensing end of the device,

The "proximal end" of the device or a component of the device shall mean the end, which is furthest away from the dispensing end of the device.

A second aspect of instant invention provides an assembly for use in a drug delivery

deVice comprising the drive mechanism according to instant invention.

10    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 lhe present invention provides a method of assembling a dri.Jg delivery device comprising the ste.p of providing a drive mechanism or an assembly

15    according to instant invention.

A fifth aspe~t of instant invention is"the use of a drug delivery device according to• instant invention for dispensing a medicinal produci preferably dispensing• a pharmaceutical formulation (e.g. solution, suspension etc.) comprising an active

20    compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, their analogues and their derivatives.

Brief Description of the Drawings:

Without any limitation, the instant invention will be explained in greater detail below in

25    connection wilh a preferred embodiment and with reference to the drawings in which:

Figure 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;

Figure 1A shows a further sectional view of a first embodiment of the drug delivery

30    device in accordance with the present invention in a first, cartridge full, position;

Figure 2 shows a sectional view of a first embodiment of the drug delivery device in accordance with the present invention in a s~cond, first dose set, position;
 
Figure 3 shows a sectional view of a first embodiment of the drug delivery device in accordance with the present invention in a third, final dose dispensed, position;• - Figure 4 shows a sectional view of a second embodiment of the drug delivery device in accordance with the present invention in a first, cartridge full, position;

Figure 5 shows a sectional view of a second embodiment of the drug delivery device in

accordance with the present invention in a second; first dose set, position;

Figure 6 shows a sectional view"of a third embodiment of the drug delivery•device in accordance with the present invention in a first, cartridge full, position;

Figure 7 shows a sectional view of a third embodiment of the drug delivery device in

10    accordance ~ith the present invention in a second: first dose set, position;

Figure B shows a sectional view of a fourth embodiment of the drug delivery device in

accordance with the present in"vention in a first, cartridge full, positiOn;

Figure 9 sho;.,; a furth~r sectional ~iew of a fourth enib;;dimeni of the drug delivery

device in accordance with the present invention in a first, cartridge full, position;

15    Figure 10 shows a sectional view of a fourth embodiment of the drug delivery device in accordance with the present invention in a second, first dose set, position.

Figure ~ 1 shows a sectional view of"a fifth emboaiment 6f the drug delivery device in

accordance with the present invention in a first, cartridge full, position;

Figure 12 shows a sectional view of a fifth embodiment of the drug delivery device in

20    accordance with the present invention in a second, first dose set, position.

Figures 13 to 15 show a sectional view of three further embodiments of a drive mechanism for a drug delivery device according to the present invention comprising a lever assembly.

25    Detailed Description of the Embodiments: Example 1

Referring first to Figures 1 to 3, there is shown a drug delivery device in accordance 30 with the present invention.
 The drug delivery device (1) comprises a cartridge retaining part (2), and a main (exterior) housing part (3). The proximal end of the cartridge retaining part (2) and the distal end of lhe main housing (3) are secured together by any suitable means known to the person skilled in the art. In the illustrated embodiment, the cartridge retaining part (2) !s secured within the distal end of the main housing part (3).

A cartridge (4) from which•a number of doses of a medicinal product may be dispensed is p;ovided in ihe cartri~ge retaining part (2). A piston (5) is retained in the proximal
end of the cartridge (4).

10

A removable cap (22) is releasably retained over the distal end of the cartridge retaining part (2). The removable cap (22) may be optionally provided with one or niore windo_;; a pert~ res through which the position. of the piston (5) wiihin the cartridge (4)

can be viewed.

15

The distal end of the cartridge retaining part (2) in the illustrated embodiment, is provided with.: a distal threaded region (6) designed for the attachment of•a suitable needle assembly to enable medicament to be dispensed from the cartridge (4).

20    In the illustrated embodiment, the main housing part (3) is provided with an internal housing (7). The internal housing (7) is secured against rotational and/or axial movement with respect to the main housing part (3). The internal housing (7) is provided with a rack (8) extending along the main axis of the internal housing (7). Alternatively, the internal housing (7) may be formed integrally with the main housing

25    part (3). Additionally, the internal housing (7) is provided with a plurality of guide lugs (not shown) and pawl means (not shown). The pawl means may be an integrated part of the internal hou~ing (7) or may be a separate component as illustrated.

A piston rod (10) extending through the main housing (3) has a first set of indentations

30    (not shown) extending longitudinally along external surfaces of the piston rod (1 0). A second set of indentations (11) extend longitudinally along internal surfaces of the piston rod (10). The first set of indentations of the piston rod (10) extend through and
 are engaged wi!h the pawl means of the internal housing (7) to prevent movement of the piston rod (10) in the proximal direction during setting of the device. A bearing surface (12) located at the distal end of the piston rod (10) is disposed to abut the proximal face of the piston (5). In the illustrated embodiment the longitudinal spacing of the first set of indentations and the second set of indentation~ (11) is essentially equal..

A gear (13), consisting of a carrier (28) and a gear wheel (27), free to rotate within the carrier (28), is located within a channel within the pis!on rod (10). Pawl arms (29) located on the carrier (28) are releasably engaged with the second set of indentations

10    (11) of the pis.ton rod (10). The pawl arms (29) qf the carrier (28) are designed to

transmit force to the piston rod (1 0) in the distal direction during dispense and to allow relative movel]le~t betw~en th.e gear (13) and• t~e pisto~. rod (io) in the proximal direction during setting. The teeth of the gear wheel (27) are permanently engaged with the teeth of the rack (B) of the internal housing (7).

15

A drive member (14) extends about the piston rod (10). The drive member (14) comprises a rack part (15) and ?n 'activationpart (16). the rae~ part (15) and the activation part (16) are secured to each other to prevent rotational and/or axial movement there between. Alternatively, the drive member (14) may be a unitary

20    component consisting of an integrated rack part (15) and activation part (16).

The rack part (15) is provided with a rack (17) extending along the main axis of the rack part (15). The teeth of the rack (17) of the rack part (15) are penmanently engaged with the teeth of the gear wheel (27).

25

The drive member (14) has a plurality of guide slots (not shown) in which the guide lugs (not shown) of the internal housing (7) are located. These guide slots define the extent of penmissible axial movement of the drive member (14) with respect to the housing part (3). In the illustrated embodiment the guide slots also prevent rotational
30    movement of the drive member (14) relative to the main housing part (3).
 

The activation part (16) of the drive member (14) has a plurality of grip surfaces (18) and a dispensing face (19).

To increase intuitiveness of the operation of the device, the main housing part (3) may optionally be provided with a window aperture through which graphical status •indicators provided on the drive member (14), can be viewed.

Operation of the drug defivery device in accordance with the present invention will now be described.
10

To set a dose a user grips the grip surfaces (18) of the drive member (14). The user _then pu!~s the ~rive member (14) in a proxima! direction away from the main housing part (3) thereby moving the. rack part (15) in a proximal direction.

15    The proximal movement of the rack part (15) causes the gear wheel (27) to rotate and move proximally by virtue of the engagement of_the teeth of the gear wheel (27) of the
gear (13) wiih .jhe.teeth of the rack (17j of the rack part (15)_ and the "teeth of the rack

(B) of the internal housing (7) thus moving the gear (13) in the proximal direction.

20    The piston rod (10) is prevented from moving proximally by interaction of pawl means of the internal housing (7) with a first set of indentations on the piston rod (1 0). As the drive member (14) travels in the proximal direction relative to the piston rod (10), the pawl arms (29) of the carrier (28) are displaced inwardly by interaction with the second set of indentations (11) of the piston rod (1 0).

25

The proximal travel of the drive member (14) is limited by the guide slots of the rack part (15). At the end of the travel of the drive member (14), the pawl arms (29) of the carrier (28) engage with the next sequential indentation of the second set of indentations (11) of the piston rod (1 0) as indicated in Figure 2. The action of the pawl

30    arms (29) of the carrier (28) positively engaging the second set of indentations (11) of the piston rod (10) creates an audible and tactile feedback to the user to indicate that the dose has been set. Additionally, visual feedback regarding dose setting may
 optionally be indicated by a graphical status indicator provided on the drive member (14), which can be viewed through an optional window aperture in the main housing part(3).

When the dose has been set, the user may then dispense th~s dose. by depressing the. dispensing face (19) of the activation _part (16) of the drive member (14). By this action the drive member (14) and the rack part (15) are moved axially in the distal direction relative to the main housing part (3). As the teeth ~~ th~ gear wheel (27) of the gear (13) are engaged with the teeth of the rack (17) of the rack part (15) and the teeth of

10    the rack (8) of !he internal housing (7), the gear wh~el (27) of the gear (13) is caused to rotate and move in the distal direction thus moving the gear (13) longitudinally in the
distal direction. As the pawl amis (29) of the carrier (28) of the geai (13) are engaged
.    .    .    -    ..    .

with the second set of indentations (11) of the piston rod (10), the piston rod. (10) is caused to move longitudinally in the distal direction with respect to the internal housing

15    (7).

The distal axial move merit of the pisto"ri rod (10) causes the bearing" surface (12) of the piston rod (10) to bear against the piston (5) of the cartridge (4) causing a dose of medicament to be dispensed through the attached needle (not shown).

20

The distal travel of the drive member (14) is limited by the guide slots (not shown) of the rack part (15). Audible and tactile feedback to indicate that the dose has been dispensed is provided by the interaction of the pawi means (not shown) of the internal housing (7) with the first set of indentations (not shown) of the piston rod (10).

25    Additionally, visual feedback regarding dose dispensing may optionally be indicated by a graphical status indicator, provided on the drive member (14), which can be viewed through an optional window aperture in the main housing part (3).

Further doses may be delivered as required up to a pre-determined maximum number

30    of doses. Figure 3 shows the drug delivery device of instant invention in a condition where the maximum number of doses has been delivered. In this condition the proximal face (32) of the carrier (28) abuts an internal distal face (33) of the piston rod
 

(10) to prevent further axial movement of the gear (13) and thus the drive member {14)

in proximal direction.

Example 2

Referring to Figures 4 to 5, there is shown an alternative embodiment of the drug delivery device in accordance with the present invention.

The drug delivery device (101) comprises a cartridge retaining part (102), and a main

10    (exterior) housing part (103). The proximal end of the cartridge retai~ing part (102) and the distal end of the main housing (1 03) are secured together by any suitable means
known to the person skilled in the art.    .    In the illustrated embodiment, the cartridge   
        .    .   
retaining part (1.02) is secured within the distal end of the main housing part (103).

15    A cartridge (104) from which a number of doses of a medicinal product may be dispensed is provided in the cartridge retaininQ.Part (102). A piston (105) is retained in the proximal en~ of the cartridge (104).

The distal end of the cartridge retaining part (1 02) in the illustrated embodiment, is

20    provided with a distal threaded region (1 06) designed for the attachment of a suitable needle assembly (not shown) to enable medicament to be dispensed from the cartridge (1 04 ).

In the illustrated embodiment, the main housing part {103) is provided with an internal

25    housing (107). The internal housing (107) is secured against rotatiomil and/or axial movement with respect to the main housing part (1 03). The internal housing (1 07) is provided with a flexible rack (108) extending along the main axis of the internal housing (107). Alternatively, the internal housing (107) may be formed integrally with the main housing part (103). Additionally, the internal housing (107) is provided wilh a
30    plurality of guide slots (not shown) and pawl means (121 ).
 A piston rod (11 0) extending through the main housing (1 03) has a set of teeth (1 09) extending longitudinally along a surface of the piston rod (11 0). The set of teeth (1 09) of the piston rod (110) extend through and are engaged with the pawl means (121) of the internal housing (107) to prevent movement of the piston rod (110) in the proximal direction during setting of the device. A bearing surface (112) located. at the distal end of the piston rod (110) is disposed to abut the proximal face of the piston (1 05).

A gear (113) is located within a channel within the piston rod (110). An axle (128) of the gear (113) is releasably engaged with the set of teeth (1 09) of the piston rod (11 0).
10    The set of teeth ~1 09) are designed to allow force transmission to the piston rod (11 0) in the distal direction during dispense and to allow •relative movement between the gear (113) and the piston rod (1 fO) in the proximal direction during setting. The teeth of the gear (113) are permanently engaged with the teeth of the fle~ible rack (108) of the internal housing (1 07).

15

A drive member (114) extends about the piston rod (110). The drive member (114) comprises a rack (r15) and an activation part (116). The rack" (115) and the activation part (116) are secured to each other to prevent rotational and/or axial movement there between. Alternatively, the drive member (114) may be a unitary component consisting

20    of an integrated rack (115) and activation part (116).

The teeth of the rack (115) are permanently engaged with the teeth of the gear (113).

The drive member (114) has a plurality of guide lugs •(not shown) which are located in

the guide slots (not shown) of the internal housing (1 07). This defines the extent of

25    permissible axial movement of the drive member (114) with respect to the housing part• (103). In the illustrated embodiment the guide slots also prevent rotational movement of the drive member (114) relative to the main housing part (1 03).

The activation part (116) of the drive member (114) has a grip surface (118) and a

30    dispensing face (119).
 
To increase intuitiveness of the operation of the device, the main housing part (103) may optionally be provided with-a window aperture through which optional graphical status indicators, provided on the drive member (114), can be viewed.

Operation of the drug delivery device. in accordance with the present invention will now be described.

To set a dose a user grips the grip surfaces (118) of the drive member (114 ). The user then pulls the drive member (114) in a proximal direction away from the main housing

10    part (1 03) thereby moving the rack (115) in a proximal direction.

•Tbe proxif!lal movement of the rack (115) caus':sthe gear (113) to rotate and move proximally by virtue of the engagement of the teeth of the gear (113) with the teeth of rack (115) and the teeth of the flexible rack (1 08) of the internal housing (1 07).
15

The piston rod (110) is prevented from moving P.f~imally by interaction of pawl means (i-21) of the internal housing (107) with set of teeth (109) of the piston rod (110); As the drive member (114) travels in the proximal direction relative to the piston rod (110), the axle (128j of the gear (113) is displaced transversely by interaction with the set of teeth

20    (1 09) of the piston rod (11 0) thus deflecting the flexible rack (1 08) of the internal housing (1 07).

The proximal travel of the drive member (114) is limited by the guide slots (not shown) of the internal housing (107). At the end of the travel of the drive member (114), the

25    axle (128) of the gear (113) engages with the next sequential tooth of the set of teeth

(109)    of the piston rod (110) as indicated in Figure 5. The action of the axle (128) of the gear (113) positively engaging the set of teeth (109) of the piston rod (110) under the force provided by the flexible rack (108) of the internal housing (107) creates an

audible and  tactHe feedback to  the  user to  indicate that the  dose  has  been  set.

30    Additionally, visual feedback regarding dose setting may optionally be indicated by a graphical status indicator, provided on the drive member (114), which can be viewed through an optional window aperture in the main housing part (103).
 
When the dose has been set, the user may then dispense this dose by depressing the dispensing face (119) of the activation part (116) of the drive member (114). By this action the drive member (114) and the rack (115) are moved axially in the distal direction relative to the main housing part (103). As.the teeth of the gear (113) are engaged with the teeth of the rack (115) and the teeth of the flexible rack (1 08) of the
internal housing (1 07) the gear (113i is rotated and moved in the distal direction. The axle (128) of the gear (113) is engaged with the set. of t~eth (1 09) ~f the piston rod

(110), thereby causing the piston rod (110) to move longitudinally in the distal direction

10    with respect to th~ internal housing (1 07).

The distal axial movement ~fthe pistonrod (110) ca~ses the?earing surface (112) of the piston rod (110) to bear against the piston (105) of the cartridge (104) causing a dose of medicament to be dispensed through the attached needle (not shown).

15

The distal travel of the drive member (114) is limited by the guide slots (not shown) of the internal housing (107). Audible and.iactile feedback to indicate t.hat the dose has been dispensed is provided by the interaction of the pawl means (121) of the internal housing (1 07) with the set of teeth (109) of the piston rod (110). Additionally, visual

20    feedback regarding dose dispensing may optionally be indicated by a graphical status indicator, provided• on the drive member (114), which can be viewed through an optional window aperture in the main housing part (1 03).

Further doses may be delivered as required up to a pre-determined maximum number

25    of doses. Example 3
Referring to Figures 6 to 7, there is shown a further alternative embodiment of the drug 30 delivery device in accordance with the present invention.
 
The drug delivery device (201) comprises a cartridge retaining part (202), and a main (exterior) housing part (203). Tlie•proximal end of the cartridge retaining part (202) and the distal end of the main housing (203) are secured together by any suitable means known to the person skilled in the art. In the illustrated embodiment, the cartridge retaining part (202} is secured within t.he distal end of the main housing part (203).

A cartrirjge (204) from which a number of doses of a medicinal product may be dispensed is provided in the cartridge retaining part (202). A piston (205) is retained in the proximal end of the cartridge (204 ).

10

The distal end of the cartridge retaining part (202) in the illustrated embodiment, is provided with a distal threaded region (206) designed for the attachment of a suitable needle assembly to enable medicament to be dispensed from the cartridge (204 ).

IS In the illustrated embodiment, the main housing part (203) is provided with an internal housing (207). The internal housing (207) is se.c~red against rotational and/or axial movemenfwith. r~spect to the main housing part•(203). The internal ho•using (207) is provided with a fixing point (208) for attaching a pulley (240). Alternatively, the internal housing (207) may be formed integrally with the main housing part (203). Additionally,

20    the internal housing (207) is provided with a guide slot (not shown) and pawl means (not shown).

A .piston rod (210) extending through the main housing (203) has a first set of teeth

(209)    and a second set of teeth (211) extending longitudinally along surfaces of the

25    piston rod (21 0). The second set of teeth (211) of the piston rod (21 0) extends through and is engaged with the pawl means (not shown) of the internal housing (207) to prevent movement of the piston rod (21 0) in the proximal direction during setting of the device. A bearing surface (212) located at the distal end of the piston rod (210) is disposed to abut the proximal face of the piston (205).
30

A pulley (240), comprising a belt (241) and a wheel (242) is located within a channel within the piston rod (210). An axle (228) of the wheel (242) is releasably engaged with
 
the first set of teeth (209) of the piston rod (210). The first set of teeth (209) are designed to allow force transmission to the piston rod (21 0) in the distal direction during dispense and to allow relative movement between the pulley (240) and the piston rod (210) in the proximal direction during setting. The teeth of the wheel (242) are permanently engaged with the Ieeth of the belt (241) of pulley (240).

A drive member (214) extends about•the piston rod (210). The drive member (214) comprises a fixing point (215) and an activation part (216). The fixing point (215) and the activation part (216) are secured to each other to prevent rotational and/or axial
10    movement there between. Alternatively, the drive member (214) may be a unitary component consisting of an integrated fixing point (215iand activation part (216).

The belt (241) of the pulley (240) is attacned to the drive member (21 4) at the fixing point (215).
15

The drive member (214) has a guide Jug (not shown) which is located in the guide slot (not shown) of the internal housing (207), This defines the extent of permissible axial movement oi the drive member (214j with respect to the housing part (203). In the illustrated embodiment the guide slot also prevents rotational movement of the drive
20    member (214) relative to the main housing part (203).

The activation part (216) of the drive member (214) has a grip surface (218) and a dispensing face (219).

25    To increase intuitiveness of the operation of the device, the main housing part (203) may be provided with an optional window aperture through which optional graphical status indicators, provided on the drive member (214), can be viewed.

Operation of the drug delivery device in accordance with the present invention will now

30    be described.
 
To set a dose a user grips the grip surfaces (218) of the drive member (214). The user then pulls the drive member (214fin a proximal direction away from the main housing part (203) thereby moving the fixing point (215) in a proximal direction.

The•proximal movement of the drive .member (214) causes the wheel (242) of the pulley (240) to rotate and move proximally by virtue of the attachment of the belt (241) of t~e puJiey (240) to both the fixing point (215)'of the drive member (214) and the fixing point (208) of the internal housing (207).

10    The. piston rod (21 0) is prevented from moving proximally by the int~raction of pawl means (not shown) .of the internal housing (207) with the second set of teeth (211) of the. piston fpd (21,0). As the •drive member (21~) travels in the proximal direction relative to the piston rod (21 0), the a.xle {228) of the wheel (242) is displaced transversely by interaction with the first set of teeth (209) of the piston rod (210) thus

15    deflecting the belt (241) of the pulley (240).

The proximal travel of the drive member (214) is limited by the guide sloi (not s~own)

of the internal housing (207). At the end of the travel of the drive member (214 ), the axle {228) of the wheel (242) engages with the next sequential tooth of the first set of

20    teeth (209) of the piston rod (21 0) as indicated in Figure 7. The action of the axle (228) of the wheel (242) positively engaging the first set of teeth (209) of the piston rod (210) under the force provided by the belt (241) of the pulley (240) creates an audible and tactile feedback to the user to indicate that the dose has been set. Additionally, visual feedback regarding dose setting may optionally be indicated by a graphical status

25    indicator, provided on the drive member (214), which can be viewed through an optional window aperture in the main housing part (203).

When the dose has been set, the user may then dispense this dose by depressing the

dispensing face (219) of the activation part (216) of the drive member (214). By this

30    action the drive member (214) and the fixing point (215) are moved axially in the distal direction relative to the main housing part (203). As the belt (241) of the pulley (240) is attached to the fixing point (215) of the drive member (214) and the belt (241) of the
 





21

pulley (240) is also attached to the fixing point (208) of !he internal housing (207) the wheel (242) of the pulley (240) is rotated and moved in the distal direction by t~e­ engagement of the teeth of the belt (241) with the teeth of the wheel (242). The axle (228) of the wheel (242) of the pulley (240) is engaged with the first set of teeth (20g) of the piston rod (210), thereby causing the piston rod (210) to move axially in the distal direction with respect to the internal housing (207)."

The distal axial movement of !he piston nod (210) causes !he bearing surface (212) of the piston rod •(210) io bear against the piston (205) 'ofthe cartridge (204) causing a
10    dose of medicament to be dispensed through the attached needle (not shown).

_The distal travel of.!h~ drive member (214) is limited b~ the gui~e slot_inot shown) of the internal housing (207). Audible and tactile feedback to indicate that the dose haS been dispensed is provided by the interaction of the pawl means (not shown) of the
15    internal housing (207) with the second set of teeth (211) of the piston  nod (210) .

.(ldditional/y, visual feedback regarding dose dispensing may optionally be indicated by a graphical s\atus indicator, provided on the drive member (214)", which: can be viewed through an optional window aperture in the main housing part (203).

20    Further doses may be delivered as required up to a pre-determined maximum number of doses.

Example4

25    Referring to Figures 8 to 10, there is shown a further alternative embodiment of the drug delivery device in accordance with the present invention.

The drug delivery device (301) comprises a cartridge retaining part (302), and a main

(exterior) housing part (303). The proximal end of the cartridge retaining part (302) and

30    the distal end of the main housing (303) are secured together by any suitable means known to the person skilled in the art. In the illustrated embodiment, the cartridge retaining part (302) is secured within the distal end of !he main housing part (303).
 





22


A cartridge (304) from which a number of doses of a medicinal product may be dispensed is provided in the cartridge retaining part (302). A piston (305) is retained in the proximal end of the cartridge (304).

The distal•end of the cartridge. retaining part (302) in the illustrated embodiment, is provided with a dista! threaded region (306) designed for the attachment of a suitable needle assembly (not shown) to enable medicament to be dispensed from the cartridge (304 ).

10

In th~ illu~trated embodiment, the main housing part (303) is provided with an internal housing (307). The .internal housing (307) is secu~d against rotation?! ?nd/or ~xial movement with respect to the rnain housing part (303). The internal housing (307) is provided with a fulcrum point. (308) for attaching a lever (340). Alternatively, the

15    internal housing (307) may be formed integrally with the rnain housing part (303). Additionally,.the internal housing (307) is provided.wjth a guide slots (not shown) and pawl'means (345).

A piston  rod  (310)  extending through  the main  housing  (303)  has  a  first set of

20    indentations (309 and 309')and a second set of indentations (311 and 311 ')extending longitudinally along surfaces of the piston rod (310). The second set of indentations (311. and 311')of the piston rod (310) extends through and is engaged with the pawl

means (345) of the internal housing (307) to prevent movement of the piston rod (31 0) in the proximal direction during setting of the device. A bearing surface (312) located at
25    the distal end of the piston rod (31 D) is disposed to abut the proximal face of the piston (305).

A lever (340), comprising a plurality of lugs (341) and a first pivot (342) and a second

pivot (343), is located within a channel within the piston rod (310). The lugs (341) of

30    the lever (340) are releasably engaged with the first set of indentations (309 and 309') of the piston rod (310). The first set of indentations (309 and 309')are designed to allow force transmission to the piston rod (310) in the distal direction during dispense
 




23

and to allow relative movement between the lever (340) and the piston rod (31 0) in the proximal direction during setting. The first pivot (342) of the lever (340) is attached to - the Fulcrum (308) of the internal housing (307) for pivotable movement there between.

A drive member (314) extends about the piston rod (310). The drive member (314) comprises a slot (315) and an activation part (316). The•slot (315) and the activation part (316) are secured to each other to prevent rotational and/or axial movement there between. Alternatively, the drive member (314) may be a imita[y component consisting of an integrated slof(315) and activation part (316).
10

The second pivot (343) of the lever (340) is located within the slot (315) of the drive member (314). The slot (315) of the drive memb~r '(314) is designed to allow transverse movemen't,but not longitudinal movement, onhe second piv<;it (343) of the lever (340) relative to the drive member (314).
15

The drive member (314) has guide lugs (346) which are located in the guide slots (not shown) of the internal•housing (307). This defines the. extent .. of permissible axial movement of the drive member (314) with respect to the housing part• (303). In the illustrated embodiment the guide slots also prevent rotational movement of the drive

20    member (314) relative to the main housing part (303).

The activation part (316) of the drive member (314) has a grip surface (318) and a dispensing face (319).

25    To increase intuitiveness of the operation of the device, the main housing part (303) may be provided with an optional window aperture through which optional graphical status indicators, provided on the drive member (314), can be viewed.

Operation of the drug delivery device in accordance with the present invention wilt now

30    be described.
 





24

To set a dose a user grips the grip surfaces (318) of the drive member (314). The user then pulls the drive member (314) ina proximal direction away from the main housing part (303) thereby moving the fixing point (315) in a proximal direction.

The proximal movement of !he drive member (314) causes the lever (340) to rotate about the fulcrum (308) of the internal housing (307) in a proximal direction by virtue of the loc?tion of the second pivot (343) of the lever (340) within the slot (315) of the drive member (314 ).

10    The piston rod (310) is prevented from moving proximally by interaction of pawl means

(345)    df the internal housing (307) with the second set of indentations (311 and 311 ')

of the_piston (9d (319). As the drive member (314).travels in the proximal direct~on relative to the piston rod (31 0),. the lugs (341) of the lever (340) are displaced transversely by interaction with the first set of indentations (309 and 309')of the piston
15    rod (310).

The proximal travel o{the drive member (314).is limited by the guide slots (riot shown) of the internal housing (307). At the end of the travel of the drive member (314), the lugs (341) of the lever (340) engage with the next sequential indentation of the first set

20    of indentations (309 and 309')of the piston rod (31 0) as indicated in Figure 10. The action of the lugs (341) of lhe lever (340) positively engaging the first set of indentations (309 and 309')of the piston rod (310) under a force provided by the transverse deflection of the lever (340) creales an audible and tactile feedback to the
user to indicate that the dose has been set. Additionally, visual feedback regarding

25    dose setting may optionally be indicated by a graphical status indicator, provided on the drive member (314), which can be viewed through an optional window aperture in the main housing part (303).

When the dose has been set, the user may then dispense this dose by depressing the

30    dispensing face (319) of the activation part (316) of the drive member (314). By this action the drive member (314) and the slot (315) are moved axially in the distal direction relative to the main housing part (303). As the second pivot (343) of the lever
 





25

(340) is located within the slot (315) of the drive member (314), the lever (340) is rotated about the fulcrum (308) of the internal housing (307) in the distal direction. The lugs (341) of the lever (340) are engaged with the first set of indentations (309 and •309')of the piston rod (310), thereby causing the piston rod (310} to move axially in the distal direction wilh respect to the internal housing (307).

The distal axial movement of the piston rod (310) causes the bearing surface (312) of the piston rod (310) to bear against the piston (305) of the cartridge {304) causing a dose of medicament to be dispensed through the atlached needle (not shown).

10

The distal travel of the drive member (314) is limited by the guide slots (not shown) of t~e internal housing (30!). Audjble and tactile feedback [o indica!!'that !he dose has been dispensed is provided by the interaction of the pawl means (345) of the internal housing (307) with the second set of indentations (311 and 311 ')of the piston rod

15    (310). Additionally, visual feedback regarding dose dispensing may optionally be ind_icated by a graphical status indicator, provided on the drive member (314}, which c~n be viewed !hrough an optional windo:-v aperture in the main housing p.art (303).

Further doses may be delivered as required up to a pre-determined maximum number

20    of doses. Example 5
Referring to Figures 11 to 12, there is shown a further alternative embodiment of the

25    drug delivery device in accordance with the present invention.

The drug delivery device (401) comprises a cartridge retaining part (402), and a main (exterior) housing part (403). The proximal end of the cartridge relaining part (402) and the distal end of the main housing (403) are secured together by any suitable means
30    known to the person skilled in the art. In the illustrated embodiment, the cartridge retaining part (402) is secured within the distal end of the main housing part (403).
 





26

A cartridge (404) from which a number of doses of a medicinal product may be dispensed is provided in the cartridge-retaining part (402). A piston (405) is retained in •the proximal end of the cartridge (404).

A removable c~p (422) is releasably retained over the distal end of the cartridge retaining part (402). The removable cap (422) is optionally provided with one or more window apertures through which ihe position of the piston (405) within the cartridge

(404) can be viewed.

10    The di~tal end of the cartridge retaining part (402) in the illustrated em~odiment, is provided with a distal threaded region (406) designed for the attachment of a suitable needle_ assem~.ly (no~ shown) to enable medicament to be dispensed from the cartridge (404).

IS In the illustrated embodiment, the main housing part (403) is provided with an internal housing (407). The internal housing (407) is secur~d _against rotational and/or axial movement witti. respe6t to the main housing part (403). The internal housing (407) "is provided with a fulcrum (408). Alternatively, the internal housing (407) may be formed integrally with the main housing part (403). Additionally, the internal housing (407) is

20    provided with a plurality of guide lugs (not shown) and pawl means (not shown). The pawl means may be an integrated part of the internal housJng (407) or may be a separate component as illustrated.

A piston  rod  (410)  extending  through  the  main  housing  (403)  has  a  first set of

25    indentations (not shown) extending longitudinally along external surfaces of the piston rod (410). A second set of indentations (411) extend longitudinally along internal surfaces of the piston rod (410). The first set of indentations of the piston rod (410) extend through and are engaged with the pawl means of the internal housing (407) to

prevent movement of the piston rod (410) in the proximal direction during setting of the

30    device. A bearing surface (412) located at the distal end of the piston rod (410) is disposed to abut the proximal face of the piston (405). In the illustrated embodiment
 





27

the longitudinal spacing of the first set of indentations and the second set of indentations (411) is essentially equal.

A lever assembly (413), consisting of a carrier (428) and a lever (427), free to rotate within the carrier (428), is located within a channel within. the piston rod•{410). The lever (427) is provided with a first pivot (442) and a second pivot (443). Pawl arms (429) located on the carrier (428) are releasably engaged w~th the second set oi indentations (411) of the p_iston rod (410). The pawl arms (429) of the canrier (428) are designed to transmit force to the piston rod (410) in the distal direction during dispense

10    and to allow relative IT]Ovement between the lever assemb)y (413) and the piston rod

(410)    in the proximal direction during setti~g. The first pivot (442) of the lever (427) is

atl~ched to the fulcrum (408) of the internal housing (40l)  for p_iyotable movement

there between.

15    A drive member (414) extends about the piston rod (410). The drive member (414) comprises a slotted part (415) and an activation part {416). The slotted part {415) and th~ activation P'!rt(416) 'aresec'uredto eacli'otherto prevent roiational.~nd/or axial movement there between. Alternatively, the drive member (414) may be a unitary component consisting of an integrated slotted part (415) and activation part (416).

20

The slotted part (415) is provided with a slot (417) that is essentially perpendicular to the main axis of the drive member (414). The second pivot (443) of the lever (427) is located within the slot (417) of the internal housing (407). The slot (415) of the drive member (414) is designed to allow transverse movement, but not longitudinal

25    movement, of the second pivot (443) of the lever (427) relative to the drive member (414).

The drive member (414) has a plurality of guide slots (not shown) in which the guide

lugs (not shown) of the internal housing (407) are located. These guide slots define the

30    extent of permissible axial movement of the drive member (414) with respect to the housing part (403). In the illustrated embodiment the guide slots also prevent rotational movement ofthe drive member (414) relative to the main housing part (403).
 





28


The activation part (416) of the drive-member (414) has a plurality of grip surfaces (418) and a dispensing face (419).

To increase intui)iveness of the operation.of the device, the main housing part (403) may be provided with an optional window aperture through which optional graphical status indicaiors, provided on the drive member (414), can be viewed.

Operation of the drug delivery device in accordance with the present invention will now

10    be described.

To set a dose a user grips the grip.surfaces (418) of the drive member (414). The user then pulls the drive member (414) in a proximal direction away from the main housing part (403) thereby moving the slotted part (415) in a proximal direction.
15

The proximal movement of the drive member (414) .9a_uses the lever (427) to rotate about the fulcrum (408i of the internal housing (407) in"a proximal direction by virtue of the location of the second pivot (443) of the lever (427) within the slot (417) of the drive member (414).
20

The piston rod (410) is prevented from moving proximally by interaction of pawl means (not shown) of the internal housing (407) with the first set of indentations (not shown) of the piston rod (410). As the drive member (414) travels in the proximal direction relative to the piston rod (410), the pawl arms (429) of the carrier (428) are displaced
25    inwardly by interaction with the second set of indentations (411) of the piston rod (410). The proximal travel of the drive member (414) is limited by the guide slots (not shown)

of the slotted part (415). At the end of the travel of the drive member (414 ), the pawl

arms (429) of the carrier (428) engage with the nex1 sequential indentation of the

30    second set of indentations (411) of the piston rod (410) as indicated in Figure 12. The action of the pawl arms (429) of the carrier (428) positively engaging the second set of indentations (411) of the piston rod (410) creates an audible and tactile feedback to the
 





29

user to indicate that the dose has been set. Additionally, visual feedback regarding dose setting may optionally be indicated by a graphical status indicator, provided on the drive member {414), which can be viewed through an optional window aperture in the main housing part (403).

When the dose has been set, the user may then dispense tliis dose by depressing the dispensing face (419) of the activation pari (416) of the drive member (414). By this action the drive member (414) and the slotted part (415) are moved axially in. the distal• direction relative to the main housing part (403). As the second pivot (443) of the lever

10    (427) is located within .the slot (417) of the drive member. (414), the lever (427) is rotated about the fulcrum (408) of the internal housing (407) in the distal direction. As the pawl arms (429) of the. carrier(428) of the.lever assem~Jy (413) are engaged with .. the second set of indentations (411) of the piston rod (410), the piston r9d (410) is caused to move longitudinally In the distal direction with respect to the internal housing

IS    (407).

The dist?l axial movemeni of the piston ro~ (4.1'0)causes tlie bearirig suiiace (412) of the piston rod (410) to bear against the piston (405) of the cartridge (404) causing a dose of medicament to be dispensed through the attached needle.

20

The distal travel of the drive member (414) is limited by the guide slots (not shown) of the slotted part (415). Audible and tactile feedback to indicate that the dose has been dispensed is provided by the interaction of the pawl means (not shown) ofthe internal housing (407) with the first set of indentations (not shown) of the piston rod (410).
25    Additionally, visual feedback regarding dose dispensing may optionally be indicated by a graphical status indicator, provided on the drive member (414), which can be viewed through an optional window aperture in the main housing part (403).

Further doses may be delivered as required up to a pre-determined maximum number

30    of doses. Examples 6A to 6C
 




30


The  examples  6A  to  6C  refer  to  alternative  embodiments  of drive  mechanisms'

according  to  the  present  invention  comprising  a  rotating  means  which  is  a  lever

assembly.

The lever assembly 513 according to figure 13 (example 6A) works essentially similarly to the lever assembly which has been described with reference to figures 11 and 12. It comprises a carrier 528 and a lever 527 which is designed to rotate with respect to the carrier 528 around a rotational axis 555. The-carrier 528 is located within a channel

10    within a piston rod 510. The lever 527 is provided with a first pivot 542 and a second pivot 543. Pawl arms 529 located on the carrier 528 are releasably engaged with a
second ~et of in_~entatic:ns 511 which extend longitudinally along internal surfaces of the piston rod 510. The pawl arms 529 of the carrier 528 are designed to transmit force to the piston rod 510 in the distal direction during dispense and to allow a movement of

15    the lever assembly 513 with respect to the piston rod 510 in the proximal direction during dose setting.

The first pivot 542 of the lever 527 is located within a slot 508 of an internal housing

507 for pivotable movement there between. The second pivot 543 of the lever 527 is

20    located within another slot 517 of a slotted part 515 of a drive member 514, the drive member 514 moving axially with respect to a main housing part 503 during dose setting and dose delivery.

The lever 527 has an essentially mirror-symmetrical form. It comprises two opposing

25    flat sides 551 which lie essentially parallel with the longitudinal axis of the drug delivery device before a dose to be dispensed is set and two further opposing flat sides 550 which lie essentially parallel with the longitudinal axis of the drug delivery device when

the dose has been set and before it is dispensed. This design of the lever 527 has the

advantage of aiding the initial assembly of the drive mechanism. Furthermore, the

30    (except for the flat sides 550 and 551) nearly round form of the lever 527 which provides an area of contact with the internal surfaces of the drive member 514 and the
 




31

internal housing 507, thereby providing guidance for the axial movement of the carrier 528.

The lever assembly 613 according to figure 14 (example 6B) works essentially similarly to the lever assemblies which have been described with reference to figures 1.1 to 13. It comprises a carrier 628 and a lever 627 which is designed to rotate with respect to the carrier 628 around a rotational axis 655. The carrier 628 is located within a channel within a piston rod 610. The lever 627is pro~ided with a first"pivot"642 and a•second pivot 643. Pawl arms 629"Jocated on the carrier 628 are releasably engaged with a

10    second set of indentations 611 which extend longitudinally along internal surfaces of the piston rod 610. The pawl arms 629 of the carrier 628 are designed to transmit force to the. piston rod 610 in the distal direction during dispense and to allow a movement of the lever assembly 613 with respect to the pist~n rod 610 in the proximal direction during dose setting.

15

The. fir§it pivot 642 of the lever 627 is located within a slot 608 of an internal housing 607 ior piyotable movement there between. The! second pivot 643 of the Je~er 627 is

located within a slot 617 of a slotted part 615 of a drive member 614, the drive member 614 moving axially with respect to a main housing part 603 during dose setting and
20    dose delivery.

The distance Y between the rotational axis 655 of the lever 627 and the second pivot 643 is different than the distance X between the rotational axis 655 of the lever 627 and the first pivot 642. Therefore this lever assembly 613 is designed to have a
25    mechanical advantage different to the 2:1 advantage e.g. of a gear assembly. The mechanical advantage of the shown lever assembly 613 is equal to (X+Y) divided by
X.

The  lever assembly  713  according  to  figure  15 (example  6C) works  essentially

30    similarly to the lever assemblies which have been described with reference to figures 1\ to 14. It comprises a carrier 728 and a lever 727 which is designed to rotate with respect to the carrier 728 around a rotational axis 755. The carrier 728 is located within
 





32

a channel within a piston rod 710. The lever 727 is provided with a first pivot 742 and a second pivot 7 43. Pawl arms 729 located on the carrier 728 are releasably engaged with a second set of indentations 711 which extend longitudinally along internal surfaces of the piston rod 710. The pawl arms 729 of the carrier 728 are designed to transmit force to th~ piston rod 710 in the dis)al direction during dispense and to allow a movement of the lever assembly 713 with respect to the piston rod 710 in the proximal direction during dose setting:

The first pivot 7 42 of the lever 727 is located in•a slot 708 of an internal housing 707

10    for pivotal)le movement there between. The second pivot 743  of the lever 727  is

located within a slot 717 of a slotted part 715 of a drive member 714, the drive member 714 movi~g axiallY. with respect to a. main housing part 703 during dose setting and dose delivery.

15    The distance Y between the rotational axis 755 of the lever 727 and the second pivot

743 is different than the distance X between the rotational axis 755 of the lever 727 and the first pivoi 74:2. _lherefore this lever assembl~• l13 is .designed to have a• mechanical advantage different to the 2:1 advantage e.g. of a gear •assembly. The mechanical advantage of the shown lever assembly 713 is equal to (X+Y) divided by
20    x.

The lever 727 according to this embodiment has a symmetrical design such that it carries features which can be used as first and second pivots 742, 743 on both sides, even though the drive mechanism only makes use of one of these features on each

25    side. The fulcrum 708 of the internal housing 707 interacts with a first pivot 742 which is a feature located at the distance X from the rotational axis 755 of the lever 727 on one side. The slotted part 715 of the drive member 714 interacts with a second pivot
7 43 which is a feature located at the distance Y from the rotational axis 755 of the lever 727 on the other side. The two remaining features 760 are not used in the

30    assembled drive mechanism. This symmetrical design has the advantage of reducing the costs and the complexity of assembling the drive mechanism because the feeding of the lever to an assembly line in the correct orientation is simplified.
 




Amended claims

1. A drive mechanism for use in a drug delivery device (1) is provided comprising: a housing (3, 7) having a proximal and a distal end;

a drtve member (14) located within the said housing (3, 7) such that the said drive member (14) is movable longitudinally and is non-rotatable wit.h respect to the said housing (3, 7);

a piston rod (10) that Is non-rotatable with respect to the said housing (3, 7) and is adapted to operate through the housing (3, 7) and transfer a force in the longitudinal
10    direction to the distal end of the drug delivery device (1);

a rotating means (13) releasably engaged with the said piston rod (10) and engaged to the said drive member (14) and engaged to the said housing (3, 7) wherein the rotating means (13) is selected from the group of (i) to (iii).

(i)    a carrier plate (28) having pawl arms (29) and a gear (27),

15    (ii)    a carrier plate (28) having pawl arms (29) and a lever (427),

(iii)    a lever assembly;

characterized in that,

a)    when the said drive member (14) moves proximally with respect to the said

housing (3, 7) the said rotating means (13) moves proximally with respect to the

20    said piston rod (10);

b)    when the said drive member (14) moves distally the said rotating means (13) moves distally displacing the said piston rod (1 0) towards the distal end of the device.

25    2. The drive mechanism according to claim 1, wherein the engagement between the said piston rod (10) and the said gear (27) ads through the axle of the said gear
(27).

3.    The drive mechanism according to claim 2, wherein the said gear is designed to 30 be engaged with a rack (17) located on the said drive member (14) and a raqk (8)
located on the said housing (3. 7).
 

2

4.    The drive mechanism according to claim 1, wherein the said lever assembly comprises a lever (340) with lugs (341).

5.    The drive mechanism according to claim 1, wherein the lever assembly comprises a lever (627) which Is designed to pivot with respect to a carrier (628) around a rotational axis (655), the carrier (628) being movable in a proximal direction with respect to the piston rod (10), the lever (627) being provided with a first pivot (642) and a second pivot (643), wherein the first pivot (642) Interacts with the housing (3, 7) and the second pivot (643) interacts with the drive member (14) such that the lever

10    (627) Is pivoted when the drive member (14) is moved axially with respect to the housing (3, 7), wherein the distance Y between the rotational axis of the lever (627) and the second pivot (643) is different than the distance X between the rotational axis (655) of the lever (627) and the first pivot (842).

15    6. An assembly for use in a drug delivery device (1} comprising the drive mechanism as defined in any of claims 1 to 5.

7.    A drug delivery device (1) comprising the drive mechanism as defined in any of

claims 1 to 5 or the assembly of claim 6.

20

8.    The drug delivery device (1) according to claim 7, which is a pen-type device.

9.    The drug delivery device (1) according to any of claim 7 to 8, which is an injector-type device.

25

1o.    The drug delivery device (1) according to any of claim 7 to 9, which comprises a

needle.

11.    The drug delivery device (1) according to any of claim 7 to 9, which is a needle-

30    free device.
 



12.    The use of a drug delivery device (1) as defined in any of claims 7 to 11 for dispensing a medicinal product.

13.    The use of a drug delivery device (1) according to claim 12 for dispensing a pharmaceutical formulation comprising an active compound selected from the group consisting of insulin, growth hormone, low molecular weight heparin, their analogues, and their derivatives.

14.    The  method  of  manufacturing  or assembling  a  drug  delivery  device  (1),

10    comprising the step of providing a drive mechanism as defined in any of claims 1 to 5 or an assembly as defined in claim 7.

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