Patent Description:
Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This may be increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their disease.

There are basically two types of pen type delivery devices: resettable devices (i.e., reusable) and non-resettable (i.e., disposable). These types of pen delivery devices (so named because they often resemble an enlarged fountain pen) are generally comprised of three primary elements: (i) a cartridge section that includes a cartridge often contained within a housing or holder; (ii) a needle assembly connected to one end of the cartridge section; and (iii) a dosing section connected to the other end of the cartridge section. A cartridge (often referred to as an ampoule) typically includes a reservoir that is filled with a medication (e.g., insulin), a movable rubber type bung or stopper located at one end of the cartridge reservoir, and a top having a pierceable rubber seal located at the other, often necked-down, end. A crimped annular metal band is typically used to hold the rubber seal in place. While the cartridge housing may be typically made of plastic, cartridge reservoirs have historically been made of glass.

The needle assembly is typically a replaceable double-ended needle assembly. Before an injection, a replaceable double-ended needle assembly is attached to one end of the cartridge assembly, a dose is set, and then a dose is administered. Such removable needle assemblies may be threaded onto, or pushed (i.e., snapped) onto the pierceable seal end of the cartridge assembly.

The dosing section or dose setting mechanism is typically the portion of the pen device that is used to set a dose. During an injection, a spindle contained within the dose setting mechanism presses against the bung or stopper of the cartridge. This force causes the medication contained within the cartridge to be injected through an attached needle assembly. After an injection, as generally recommended by most drug delivery device and/or needle assembly manufacturers and suppliers, the needle assembly is removed and discarded.

Different types of pen delivery devices, including disposable (i.e., non-resettable) and reusable (i.e., resettable) varieties, have evolved over the years. For example, disposable pen delivery devices are supplied as self-contained devices. Such self-contained devices do not have removable pre-filled cartridges. Rather, the pre-filled cartridges may not be removed and replaced from these devices without destroying the device itself. Consequently, such disposable devices need not have a resettable dose setting mechanism.

In contrast to typical disposable pen type devices, typical reusable pen delivery devices feature essentially two main reusable components: a cartridge holder and a dose setting mechanism. After a cartridge is inserted into the cartridge holder, this cartridge holder is attached to the dose setting mechanism. The user uses the dose setting mechanism to select a dose. Before the user injects the set dose, a replaceable double-ended needle assembly is attached to the cartridge housing.

This needle assembly may be threaded onto or pushed onto (i.e., snapped onto) a distal end of the cartridge housing. In this manner, a double ended needle mounted on the needle assembly penetrated through a pierceable seal at a distal end of the cartridge. After an injection, the needle assembly is removed and discarded. After the insulin in the cartridge has been exhausted, the user detaches the cartridge housing from the dose setting mechanism. The user can then remove the empty cartridge from the cartridge retainer and replace the empty cartridge with a new (filled) cartridge. Aside from replacing the empty cartridge with a new cartridge, the user must somehow prepare the dose setting mechanism for a new cartridge: the dose setting mechanism must be reset to a starting or initial position. For example, in certain typical resettable devices, in order to reset the dose setting mechanism, the spindle that advances in a distal direction during dose injection must somehow be retracted back into the dose setting mechanism. Certain known methods of retracting this spindle back into the dose setting mechanism to a restart or an initial position are known in the art. As just one example, certain known reset mechanisms require a user to turn back or push back (retract) the spindle or some other portion of the dose setting mechanism. Resetting of known dose setting mechanisms have certain perceived disadvantages. One perceived disadvantage is that the pen device user has to disassemble the device to either remove an empty cartridge or somehow reset the device. As such, another perceived disadvantage is that such devices have a high number of parts and therefore such devices are typically complicated from a manufacturing and from an assembly standpoint. For example, certain typical resettable pen type devices are not intuitive as to how a user must replace an empty cartridge or how a user is to reset the device. In addition, because such resettable devices use a large number of components parts, such resettable devices tend to be large and bulky, and therefore not easy to carry around or easy to conceal.

There is, therefore, a general need to take these disadvantages associated with resetting issues into consideration in the design and development of resettable drug delivery devices. Such desired drug delivery devices would tend to reduce the number of component parts and also tend to reduce manufacturing costs while also making the device less complex to assemble and manufacture. Such desired devices would also tend to simplify the steps required for a user to reset a dose setting mechanism while also making the device less complex and more compact in size.

<CIT> discloses a drug delivery device with a dose setting mechanism according to the state of the art.

The invention is defined according to claim <NUM> and is directed at a dose setting mechanism for a drug delivery device comprising an outer housing and an inner housing having an external groove and a helical groove. The inner housing guides the driver to dispense a dose set by the dose setting mechanism. A dial sleeve is disposed between the outer and inner housing and is rotatably engaged with the inner housing. When a dose is set, the dial sleeve is rotated with respect to both the outer housing and the inner housing. The dial sleeve is translated away from both the outer housing and the inner housing.

These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings.

Exemplary embodiments are described herein with reference to the drawings, in which:.

The terms "drug" or "medication" or "medicinal product" or "medicament", as used herein, mean a pharmaceutical formulation containing at least one pharmaceutically active compound,.

Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in <NPL>, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

Referring to <FIG>, there is shown a drug delivery device <NUM> in accordance with a first arrangement of the present invention. The drug delivery device <NUM> comprises a housing having a first cartridge retaining part <NUM>, and dose setting mechanism <NUM>. A first end of the cartridge retaining part <NUM> and a second end of the dose setting mechanism <NUM> are secured together by retaining features. In this illustrated arrangement, the cartridge retaining part <NUM> is secured within the second end of the dose setting mechanism <NUM>. A removable cap <NUM> is releasably retained over a second end or distal end of a cartridge retaining part. As will be described in greater detail, the dose setting mechanism <NUM> comprises a dose dial grip <NUM> and a window or lens <NUM>. To set a dose of medication contained within the drug delivery device <NUM>, a user rotates the dose dial grip <NUM> and the window allows a user to view the dialed dose by way of a dose scale arrangement <NUM>. <FIG> illustrates the medical delivery device <NUM> of <FIG> with the cover <NUM> removed from the distal end of the medical delivery device. As illustrated, a cartridge <NUM> from which a number of doses of a medicinal product may be dispensed is provided in the cartridge housing <NUM>. Preferably, the cartridge <NUM> contains a type of medicament that is administered often, such as once or more times a day. Once such medicament is insulin. A bung or stopper (not illustrated in <FIG>) is retained in a first end or a proximal end of the cartridge <NUM>.

The dose setting mechanism <NUM> of the drug delivery device illustrated in <FIG> may be utilized as a reusable (and hence resettable) or a non-reusable (and hence non-resettable) drug delivery device. Where the drug delivery device <NUM> comprises a reusable drug delivery device, the cartridge is removable from the cartridge housing <NUM>. The cartridge <NUM> may be removed from the device without destroying the device by merely the user disconnecting the dose setting mechanism <NUM> from the cartridge holder <NUM>.

In use, once the removable cap <NUM> is removed, a user can attach a suitable needle assembly to the distal end of the cartridge holder. Such needle unit may be screwed onto a distal end of the housing or alternatively may be snapped onto this distal end. A replaceable cap <NUM> is used to cover the cartridge holder <NUM> extending from the dose setting mechanism <NUM>. Preferably, the outer dimensions of the replaceable cap <NUM> are similar or identical to the outer dimensions of the dose setting mechanism <NUM> so as to provide an impression of a unitary whole when the replaceable cap <NUM> is in position covering the cartridge holder <NUM>.

<FIG> illustrates a sectional view of the dose setting mechanism <NUM> removably connected to the cartridge holder <NUM>. The dose setting mechanism <NUM> comprises an outer housing <NUM> containing a spindle <NUM>, a number sleeve <NUM>, a clutch <NUM> a clicker <NUM>, and a driver <NUM>. A first helical groove <NUM> extends from a first end of a spindle <NUM>. In one arrangement, the spindle <NUM> is of generally circular in cross section however other arrangements may also be used. The first end of the spindle <NUM> (a distal end <NUM> of the spindle <NUM>) extends through a pressure plate <NUM>. A spindle bearing <NUM> is located at the distal end <NUM> of the spindle <NUM>. The spindle bearing <NUM> is disposed to abut a second end of the cartridge piston <NUM>. The driver <NUM> extends about the spindle <NUM>.

The clutch <NUM> is disposed about the driver <NUM>, between the driver <NUM> and a number sleeve <NUM>. The clutch <NUM> is located adjacent the second end of the driver <NUM>. A number sleeve <NUM> is provided outside of the clutch <NUM> and radially inward of the housing <NUM>. The main housing <NUM> is provided with a window <NUM> through which a part of an outer surface <NUM> of the number sleeve <NUM> may be viewed.

Returning to <FIG>, a dose dial grip <NUM> is disposed about an outer surface of the second end of the number sleeve <NUM>. An outer diameter of the dose dial grip <NUM> preferably corresponds to the outer diameter of the housing <NUM>. The dose dial grip <NUM> is secured to the number sleeve <NUM> so as to prevent relative movement between these two components. In one preferred arrangement, the dose dial grip <NUM> and number sleeve <NUM> comprise a one piece component that is rotationally coupled to a clutch and drive sleeve and axially coupled to the number sleeve <NUM>. However, alternative coupling arrangements may also be used.

Returning to <FIG>, in this arrangement, driver <NUM> comprises a first driver portion <NUM> and a second driver portion <NUM> and these portions extend about the spindle <NUM>. Both the first and the second driver portions <NUM>, <NUM> are generally cylindrical. As can be seen from <FIG>, the first drive portion <NUM> is provided at a first end with a first radially extending flange <NUM>. A second radially extending flange <NUM> is provided spaced a distance along the first driver portion <NUM> from the first flange <NUM>. An intermediate helical groove <NUM> is provided on an outer part of the first driver portion <NUM> extending between the first flange <NUM> and the second flange <NUM>. A portion or a part helical groove <NUM> extends along an internal surface of the first driver portion <NUM>. The spindle <NUM> is adapted to work within this part helical groove <NUM>.

A dose limiter <NUM> (illustrated in <FIG>) is located between the driver <NUM> and the housing <NUM>, disposed between the first flange <NUM> and the second flange <NUM>. In the illustrated arrangement, the dose limiter <NUM> comprises a nut. The dose limiter <NUM> has an internal helical groove matching the helical groove <NUM> of the driver <NUM>. In one preferred arrangement, the outer surface of the dose limiter <NUM> and an internal surface of the housing <NUM> are keyed together by way of splines 65a, 65b. In this preferred arrangement, splines 65a, 65b comprise linear splines. This prevents relative rotation between the dose limiter <NUM> and the housing <NUM> while allowing relative longitudinal movement between these two components.

Referring back to <FIG>, essentially, in normal use, the operation of the dose setting mechanism <NUM> occurs as follows. To dial a dose in the arrangement illustrated in <FIG>, a user rotates the dose dial grip <NUM>. The driver <NUM>, the clutch <NUM> and the number sleeve <NUM> rotate along with the dose dial grip <NUM>. In this preferred arrangement, the clicker <NUM> is disposed between a distal end of the clutch <NUM> and a flange <NUM> of the drive sleeve <NUM>. The clicker <NUM> and the internal surface of the housing <NUM> are keyed together by way of splines 65a, 65b. This prevents rotation of the clicker <NUM> with respect to the housing <NUM> either during dose selection or during dose administration.

The number sleeve <NUM> extends in a proximal direction away from the housing <NUM>. In this manner, the driver <NUM> climbs the spindle <NUM>. As the driver <NUM> and the clutch rotates, a distal portion <NUM> of the clutch drags over the clicker <NUM> to produce a click. Preferably, the distal portion includes a plurality of splines or features that are disposed such that each click corresponds to a conventional unit dose, or the like.

At the limit of travel, a radial stop on the number sleeve <NUM> engages either a first stop or a second stop provided on the housing <NUM> to prevent further movement. Rotation of the spindle <NUM> is prevented due to the opposing directions of the overhauled and driven threads on the spindle <NUM>. The dose limiter <NUM>, keyed to the housing <NUM>, is advanced along the thread <NUM> by the rotation of the driver <NUM>.

<FIG> illustrates the medical delivery device after a desired dose of <NUM> International Units (IU) has been dialed. When this desired dose has been dialed, the user may then dispense the desired dose of <NUM> IU by depressing the dial grip. As the user depresses the dial grip <NUM>, this displaces the clutch <NUM> axially with respect to the number sleeve <NUM>, causing the clutch <NUM> to disengage. However the clutch <NUM> remains keyed in rotation to the driver <NUM>.

The driver <NUM> is prevented from rotating with respect to the main housing <NUM> but it is free to move axially with respect thereto. The longitudinal axial movement of the driver <NUM> causes the spindle <NUM> to rotate and thereby to advance the piston <NUM> in the cartridge <NUM>.

In normal use, the first and second portions <NUM>, <NUM> of the driver <NUM> are coupled together when the dose dial sleeve <NUM> is rotated. That is, in normal use, the first and second portions <NUM>, <NUM> of the driver <NUM> are coupled together with the dose dial sleeve <NUM> when a user sets a dose by turning the dose dial grip <NUM>. After each dispensed dose, the spindle <NUM> is pushed in a distal direction, acting on the bung <NUM> of the cartridge <NUM> to continue to expel a dialed dose of medication out of an attached needle assembly releasably connected to the distal end <NUM> of the cartridge holder <NUM>.

After a user uses the drug delivery device <NUM> to dispense all of the medication contained in the cartridge <NUM>, the user may wish to replace the empty cartridge in the cartridge holder <NUM> with a new cartridge. The user must then also reset the dose setting mechanism <NUM>: for example, the user must then retract or push the spindle <NUM> back into the dose setting mechanism <NUM>.

If the user decides to replace an empty cartridge and reset the device <NUM>, the first and second driver portions <NUM>, <NUM> must be de-coupled from one another. After decoupling the first driver portion <NUM> from the second driver portion <NUM>, the first driver portion <NUM> will be free to rotate while the second driver portion <NUM> will not be free to rotate.

During a device resetting step, rotating the first driver portion <NUM> achieves at least two results. First, rotation of the first driver portion <NUM> will reset the axial position of the spindle <NUM> with respect to the dose setting mechanism <NUM> since rotation of the first driver portion <NUM> causes the spindle <NUM> to rotate. Rotation of the spindle <NUM> (because the spindle is splined with the spindle guide <NUM>) moves the spindle in a proximal direction back into the dose setting mechanism. For example, <FIG> illustrates one arrangement for connecting the spindle <NUM> to the spindle guide <NUM>. In <FIG>, the spindle <NUM> comprises a first <NUM> spline and a second spline <NUM>. The spindle guide <NUM> comprises an essentially circular member having an aperture. The aperture includes two inner protruding members <NUM>, <NUM> that engage the first and second splines <NUM>, <NUM> respectively, so that the spindle guide <NUM> locks onto the spindle and rotates along with the spindle during spindle rotation.

Second, rotation of the first driver portion <NUM> will also axial move or reset a dose limiter <NUM> to an initial or start position. That is, as the first driver portion <NUM> is rotated back to an initial start position, because the dose limiter <NUM> is threadedly engaged to the outer groove and splined to an inner surface of a housing portion, such as the outer housing <NUM>. In this configuration, the dose limiter <NUM> is prevented from rotating but will move along the outer groove <NUM> of the first driver portion <NUM> as this portion is rotated during a resetting step. In addition, because it is splined to longitudinal splines 65a, 65b of the outer housing <NUM>, the clicker <NUM> is also prevented from rotating during this resetting step.

Referring to a first driver arrangement illustrated in <FIG>, the two portions of the driver <NUM> are decoupled when the first driver portion <NUM> is pulled axially away from the second driver portion <NUM>. This may be achieved by the use of a biasing means (such as at least one spring) that interacts together when the cartridge holder <NUM> is removed from the front or distal end of the device to first lock the relative rotation between the spindle <NUM> and a spindle guide <NUM> through which the spindle passes, and then to push this spindle guide <NUM> and also nut <NUM> axially a fixed distance. Because the spindle <NUM> is rotationally locked to this spindle guide <NUM> and is threadedly engaged with the spindle nut <NUM>, the spindle <NUM> will move axially.

The spindle <NUM> is coupled via a groove engaged to the first driver portion <NUM>. The first driver portion <NUM> is prevented from rotation by a clutched connection to the second driver portion <NUM>. In one preferred arrangement, the second driver portion <NUM> is prevented from rotation by the clicker 75which resides between the clutch and the flange <NUM> of the drive sleeve <NUM>. Therefore, axial movement of the spindle <NUM> decouples the two driver portions <NUM>, <NUM> so that the clutched connection becomes de-coupled.

This sequence of operation as the cartridge holder <NUM> is removed or disconnected from the dose setting mechanism <NUM> is illustrated in <FIG>. In <FIG>, the various component parts of the drug delivery device include: a dose setting housing <NUM>, a cartridge <NUM>, a spindle <NUM>, first driver portion <NUM>; second driver portion <NUM>, spindle bearing <NUM>, spindle guide <NUM> spring plate <NUM>; a main spring <NUM>, a pressure plate <NUM>, a cartridge holder <NUM>; a spindle nut <NUM>; and a second spring <NUM>. In this preferred arrangement, the spindle guide <NUM> is rotationally fixed relative to the spindle <NUM>. In addition, the spring plate <NUM> pressure plate <NUM> and spindle nut <NUM> are all rotationally fixed relative to the outer housing.

In <FIG>, the cartridge holder <NUM> is fitted via apertures in the pressure plate <NUM> and applies a load to the spring plate <NUM>. This compresses the first biasing means or main spring <NUM>. These apertures in the pressure plate <NUM> (not shown) allow the pressure plate <NUM> to move away from the spring plate <NUM> (in a distal direction towards the cartridge holder <NUM>) under the action of the second biasing means or second spring <NUM>. This will open up a Gap "A" as shown in <FIG>. Gap "A" is a gap created between the pressure plate <NUM> and the spring plate <NUM>. This will also open Gap "B", a gap between the spindle nut <NUM> and the spring plate <NUM>. This Gap B is illustrated in <FIG>. The Gap B in conjunction with the light force from the second spring or biasing means <NUM> moves the spindle nut <NUM> towards the distal end of the drug delivery device <NUM>. This applies light pressure to the spindle guide <NUM>.

The spindle guide <NUM> is compressed under the action of the second spring <NUM> between the spindle nut <NUM> and pressure plate <NUM>. This light force coupled with the friction coefficient on either side of a flange of the spindle guide <NUM> through which this force acts, provides a resistance to rotation of the spindle guide <NUM> and therefore a resistance to rotation of spindle <NUM> as well. One advantage of this configuration is that at the end of a dose, it is advantageous to prevent the spindle <NUM> from back-winding into the dose setting mechanism <NUM> under light residual loads that may remain from the cartridge bung <NUM>. By preventing the spindle <NUM> from back-winding in a proximal direction, a distal end <NUM> of the spindle <NUM> (and hence the spindle bearing <NUM>) remains on the bung <NUM>. Maintaining the distal end <NUM> of the spindle <NUM> on the bung <NUM> helps to prevent a user from administrating a potential under-dose.

When the user delivers a dose, as the dispense force increases, the rearward load on the spindle nut <NUM> increases to a point at which the spindle nut <NUM> travels back in a proximal direction and compresses the second spring <NUM>. This releases the axial force acting on the spindle guide <NUM>. This removes the resistance to rotation of the spindle guide <NUM> and hence spindle <NUM>. This configuration therefore prevents back-winding of the spindle <NUM> under low loads caused by the cartridge bung <NUM> but does not add to the dispense force once this dispense force has increased above a certain threshold level.

<FIG> illustrates the dose setting mechanism <NUM> of <FIG> with the cartridge holder <NUM> rotated to release a connection type between the housing <NUM> of dose setting mechanism <NUM> and the cartridge holder <NUM>. In one arrangement, this connection type <NUM> is a bayonet connection. However, those of ordinary skill in the art will recognize that other connection types <NUM> may be used as well such as threads, snap locks, snap fits, luer locks and other similar connection types. In the arrangement illustrated in <FIG>, by rotating the cartridge holder <NUM> with respect to housing <NUM>, features that were initially acting on the spring plate <NUM> to compress the main biasing means <NUM> through apertures in the pressure plate <NUM>, rotate so that they now release this force created by the main biasing means <NUM>. This allows the spring plate <NUM> to move in a distal direction until the spring plate <NUM> contacts the spindle nut <NUM> on an inside face of the spindle nut <NUM>.

In this second condition, the previous discussed Gap "A" (from <FIG>) has now been reduced to a Gap "C" (as seen in <FIG>). In this manner, the relative high axial force from the main biasing means <NUM> acts through the spring plate <NUM> to the spindle nut <NUM> and from the spindle nut <NUM> through the spindle guide <NUM> to the pressure plate <NUM>.

This relative high axial force from the main biasing means <NUM> is sufficient to prevent the spindle guide <NUM>, and hence spindle <NUM>, from rotating.

After sufficient rotation of the cartridge holder <NUM>, the cartridge holder <NUM> disengages from the connection type <NUM> with the housing <NUM>. The cartridge holder <NUM> is then driven in an axial direction away from the housing <NUM> by the main biasing means <NUM> (i.e., in a distal direction). However, during this movement, the main spring <NUM> continues to load the cartridge holder <NUM> through the spindle guide <NUM> and therefore the spindle <NUM> is prevented from rotation. As the spindle <NUM> is also threaded to the first driver portion <NUM>, the first driver portion <NUM> is also pulled axially in a distal direction and in this manner becomes disengaged from the second driver portion <NUM>. The second driver portion <NUM> is axially fixed and is prevented from rotation. In one arrangement, the second driver portion <NUM> is prevented from rotation by clicker elements and prevented from axial movement by its axial coupling to the number sleeve.

<FIG> illustrates the dose setting mechanism illustrated in <FIG> in a third position, that is, with the cartridge holder <NUM> removed. As the cartridge holder <NUM> is removed from the housing <NUM>, the bayonet features shown in <FIG> (illustrated as round pegs extending radially inwards on inside of inner housing), limit travel of the pressure plate <NUM> but allows Gap "C" (as shown in <FIG>) to increase to a wider Gap "D" (as shown in <FIG>). As a result, Gap "E" develops. Gap "E" removes the high spring force created by the main biasing means <NUM> from the spindle guide <NUM>. The dose setting mechanism <NUM> in <FIG> is now ready to be reset.

To reset this dose setting mechanism <NUM>, a user retracts the spindle <NUM> in a proximal direction back into the housing <NUM> by pushing on the distal end <NUM> of the spindle <NUM>. Therefore, during this re-setting step of the dose setting mechanism <NUM>, as the spindle <NUM> is pushed back into the dose setting mechanism <NUM>, the movement of the spindle <NUM> causes the spindle nut <NUM> to move back against a light spring force created by the second biasing means <NUM>. This movement releases the axial load and hence resistance to rotation from the spindle guide <NUM>. Therefore, as the dose setting mechanism <NUM> is reset by the spindle <NUM> rotating back into the dose setting mechanism <NUM>, the spindle guide <NUM> also rotates.

As the spindle <NUM> is pushed back further into the dose setting mechanism <NUM>, the spindle <NUM> rotates through the spindle nut <NUM>. As the first driver portion <NUM> is de-coupled from the second driver portion <NUM>, the first driver portion <NUM> rotates (with the flexible elements <NUM>, <NUM> running on a conical surface groove <NUM> formed by the first annular ring <NUM> on the second half of the drive sleeve <NUM>, <FIG> and <FIG>). This accommodates the axial and rotational movement of the spindle <NUM>.

As the first driver portion <NUM> rotates during reset, first driver portion <NUM> also re-sets the dose nut. More specifically, as the first driver portion <NUM> rotates, the dose nut which is not rotatable since it is splined to an inner surface of the housing <NUM>, traverses along the helical groove <NUM> provided along an outer surface of the first driver portion <NUM> and traverses back to an initial or starting position. In one preferred arrangement, this starting position of the dose nut resides along the first radial <NUM> flange of the first driver portion <NUM>.

After the dose setting mechanism <NUM> has been reset, the dose setting mechanism <NUM> must be re-connected to the cartridge holder <NUM>. When re-connecting these two components, the process generally works in reverse. However, this time the axial compression of the main spring <NUM> causes the first driver portion <NUM> to re-engage with the second driver portion <NUM>. In this manner, the flexible elements re-engage with the second annular ring <NUM> on the second driver portion <NUM>.

<FIG> illustrates a first arrangement of the second driver portion <NUM> and the first driver portion <NUM> illustrated in <FIG>. As shown in <FIG>, second driver portion <NUM> is generally tubular in shape and comprises a first annular groove <NUM> at a distal end of the second driver portion <NUM>. The first annular groove <NUM> comprises a conical face <NUM>. The second driver portion further comprises a second annular groove <NUM> and at least one spline <NUM> positioned along a surface of the second driver portion.

The first driver portion <NUM> is also generally tubular in shape and comprises a first and a second flexible element <NUM>, <NUM> and a plurality of spline recesses <NUM>. These plurality of recesses <NUM> releasably connect the longitudinal spline <NUM> of the first driver portion <NUM> to second driver portion <NUM> when both first and second driver portions <NUM>, <NUM> are pushed axially together so that they releasably engage one another. When pushed together, the flexible elements <NUM>, <NUM> of the first driver portion <NUM> are pushed over the first annular groove <NUM> of the second driver portion <NUM> and then stop when the flange <NUM> of the second driver portion abuts the first axial flange <NUM> of the first driver portion <NUM>.

The first driver portion <NUM> also includes a plurality of ratchet features <NUM>. These ratchet features <NUM> are provided at a distal end <NUM> of the first driver portion <NUM>. These ratchet features <NUM> engage similar ratchet features on the spring plate <NUM> which are splined to the housing <NUM>. (See e.g., <FIG>) At the end of the re-setting step, these ratchet features engage one another so as to prevent the first driver portion <NUM> from rotating. This ensures that as the spindle <NUM> is reset further, the first driver portion moves axially to re-engage the second driver portion <NUM> rather than rotate on the conical face <NUM>. These features also orientate the spring plate <NUM> relative to the second driver portion <NUM> so that the two driver portions <NUM>, <NUM> engage easily during assembly or after reset. Therefore, these ratchet features also prevent the coupling features <NUM>, <NUM> from clashing with one another.

A second arrangement of resettable dose setting mechanism is illustrated in <FIG>. <FIG> illustrates a section view of a second arrangement of a dose setting mechanism <NUM>. Those of skill in the art will recognize that dose setting mechanism <NUM> may include a connection mechanism for releasably connecting to a cartridge holder, like the cartridge holder <NUM> illustrated in <FIG>. However, as those of ordinary skill in the art will recognize, the dose setting mechanism may also include a permanent connection mechanism for permanently connecting to a cartridge holder. <FIG> illustrates a portion of the dose setting mechanism illustrating the driver operation. <FIG> illustrates a close up view of the coupling between the first driver portion and the second driver portion illustrated in <FIG>. The second arrangement of the dose setting mechanism <NUM> operates in generally a similar fashion to the first arrangement of the dose setting mechanism <NUM> illustrated in <FIG>.

With reference to <FIG>, the dose setting mechanism <NUM> comprises a dose dial grip <NUM>, a spring <NUM>, an outer housing <NUM>, a clutch <NUM>, a driver <NUM>, a number sleeve <NUM>, a clicker <NUM>, and an inner housing <NUM>. Similar to the driver <NUM> illustrated in <FIG>, driver <NUM> of dose setting mechanism <NUM> comprises a first driver portion <NUM> and a second driver portion <NUM>. In one arrangement, the first driver portion <NUM> comprises a first component part <NUM> and a second component part <NUM>. Alternatively, the first driver portion <NUM> is an integral component part.

Where the dose setting mechanism <NUM> illustrated in <FIG> and <FIG> comprises a resettable dose setting mechanism, the first driver portion <NUM> is de-coupled from the dose setting mechanism <NUM> when the first driver portion <NUM> is pushed axially towards the second driver portion <NUM> (i.e., pushed in a proximal direction). In one arrangement, this may be achieved by pushing axially on a distal end of the spindle <NUM>. This does not require any mechanism associated with removal of a cartridge holder. The mechanism is also designed such that the first and second driver portions <NUM>, <NUM> remain locked together rotationally during dose setting as well as during dose administration.

An axial force on the spindle <NUM> causes the spindle <NUM> to rotate due to its threaded connection to the inner housing <NUM>. This rotation and axial movement of the spindle <NUM> in turn causes the first driver portion <NUM> to move axially towards the second driver portion <NUM>. This will eventually de-couple the coupling elements <NUM> between the first driver portion <NUM> and second driver portion <NUM>. This can be seen from <FIG>. This axial movement of the first driver portion <NUM> towards the second driver portion <NUM> results in certain advantages. For example, one advantage is that the metal spring <NUM> will compress and will therefore close the Gap A illustrated in <FIG>. This in turn prevents the clutch <NUM> from disengaging from the clicker <NUM> or from the number sleeve <NUM>. As illustrated in <FIG>, a distal end of the clutch <NUM> comprise a plurality of clutch teeth <NUM>. These clutch teeth <NUM> engage a plurality of clicker teeth <NUM> disposed at a proximal end of the clicker <NUM>. As such, when a user dials a dose, these clutch and clicker teeth <NUM>, <NUM> respectively, engage one another to produce an audible click (and perhaps a tactile click indication). Preferably, the clicker teeth <NUM> are geometrically disposed so that each click corresponds to a conventional unit dose, or the like. Therefore, when the dose dial grip <NUM> and hence the clutch <NUM> are rotated, an audible sound is heard as the clutch teeth ride <NUM> over the clicker teeth <NUM>.

The second driver <NUM> is prevented from rotating since it is splined to the clutch <NUM>. The clicker <NUM> comprises a plurality of splines <NUM>. These splines <NUM> are splined to an inner surface of the inner housing <NUM>. Therefore, when the Gap A is reduced or closed up, the second driver portion <NUM> cannot rotate relative to either the housing <NUM> or the number sleeve <NUM>. As a consequence, the number sleeve <NUM> cannot rotate relative to the housing <NUM>. If the number sleeve <NUM> is prevented from rotating then, as the spindle <NUM> is retracted back into the dose setting mechanism <NUM> and thereby re-set, there will be no risk of the number sleeve <NUM> being pushed out of the proximal side of the dose setting mechanism <NUM> as a result of a force being applied on the spindle <NUM>.

Similarly, when the drug delivery device is being dispensed, the user applies an axial load to a dose button <NUM>. The dose dial grip <NUM> is rotatably coupled to the dial sleeve but non-rotatably coupled to the dose button. The dose button <NUM> is axially coupled to the clutch <NUM> and this prevents relative axial movement. Therefore, the clutch <NUM> moves axially towards the cartridge end or the distal end of the dose setting mechanism <NUM>. This movement disengages the clutch <NUM> from the number sleeve <NUM>, allowing for relative rotation while closing up the Gap A.

As described above, this prevents the clutch <NUM> from rotating relative to the clicker <NUM> and hence relative to the housing <NUM>. However, in this scenario, it also prevents the coupling between the first driver portion <NUM> and the second driver portion <NUM> from becoming disengaged. Therefore, any axial load on the spindle <NUM> only disengages the first and second driver portions <NUM>, <NUM> when the dose button <NUM> is not axially loaded. This therefore does not happen during dispense.

With the dose setting mechanism <NUM>, as a user dials a dose with the dose dial grip <NUM>, the metal spring <NUM> is selected to be strong enough to maintain engagement of both clutched couplings: the clutched coupling between the clutch <NUM> and the number sleeve <NUM> and clutched coupling between the first driver portion <NUM> and second driver portion <NUM>.

<FIG> shows in detail of a first arrangement of the first driver portion <NUM> and the second driver portion <NUM> illustrated in <FIG>. As illustrated in <FIG>, the second driver portion <NUM> is generally tubular in shape and comprises at least one drive dog <NUM> located at a distal end of the second driver portion <NUM>. The first driver portion <NUM> also has a generally tubular shape and comprises a plurality of recesses <NUM> sized to engage with the drive dog <NUM> on the second driver portion <NUM>. The construction of the drive dog and recesses allow disengagement with the drive dog <NUM> when the first and second driver portions are axially pushed together. This construction also creates a rotational coupling when these components are sprung apart. A dose limiter may be provided on first driver portion <NUM> and operates similarly to the dose limiter <NUM> illustrated in <FIG>.

In this arrangement, the first driver portion <NUM> comprises a first portion <NUM> that is permanently clipped to a second portion <NUM>. In this arrangement, the first portion <NUM> comprises the drive dogs <NUM> and the second component <NUM> includes the outer groove for the last dose nut as well as an internal groove <NUM>. This internal groove <NUM> is used to connect to the spindle <NUM> and drives the spindle <NUM> during dose administration.

In the illustrated arrangement, the internal groove <NUM> comprises a part helical groove rather than a complete helical groove. One advantage of this arrangement is that it is generally easier to manufacture.

As may be seen from the arrangement illustrated in <FIG> there is, in addition, certain feature enhancements over the dose setting mechanism <NUM> lustrated in <FIG>. These can be added independently of the ability to re-set the device to replace an empty cartridge with a new cartridge. These enhancements, therefore, are relevant to both a re-settable and non-re-settable dose setting mechanism.

One of the advantages of both arrangements illustrated but perhaps in particular in the arrangement illustrated in <FIG> is that the dose setting mechanism <NUM> has a reduced number of components over other known dose setting mechanisms. In addition, apart from the metal coil spring <NUM> (see <FIG> and <FIG>), all of these components making up the dose setting mechanism <NUM> may be injection molded using inexpensive and unsophisticated tooling. As just one example, these components making up the dose setting mechanism <NUM> may be injection molded without the expense and sophistication of a rotating core.

Another advantage of a dose setting mechanism <NUM> comprising an inner housing <NUM> such as that illustrated in <FIG> is that the dose setting mechanism <NUM> can be designed, with a slight modification, as a drug delivery device platform that is now capable of supporting both re-settable and non-resettable drug delivery devices. As just one example, to modify the re-settable dose setting mechanism <NUM> variant illustrated in <FIG> into a non-resettable drug delivery device, the first driver portion <NUM> and <NUM> and the second driver portion <NUM> can be molded as one unitary part. This reduces the total number of drug delivery device components by two. Otherwise, the drug delivery device illustrated in <FIG> could remain unchanged. In such a disposable device, the cartridge holder would be fixed to the housing or alternatively, made as a single one piece body and cartridge holder.

The illustration in <FIG> shows an inner housing <NUM> having a length "L" <NUM> generally similar in overall length to the dose setting mechanism <NUM>. As will be described, providing the inner housing <NUM> with a length of "L" has a number of advantages over other known dose setting mechanisms that do not utilize an inner body or an inner body having a length generally equal to that of the length of a dose setting mechanism.

The inner housing <NUM> comprises a groove <NUM> provided along an external surface <NUM> of the inner housing. A groove guide <NUM> provided on an inner surface <NUM> of the number sleeve <NUM> is rotatably engaged with this groove <NUM>.

One advantage of this dose setting mechanism <NUM> utilizing the inner housing <NUM> is that the inner housing <NUM> can be made from an engineering plastic that minimizes friction relative to the number sleeve <NUM>, groove guide <NUM> and the groove <NUM>. For example, one such an engineering plastic could comprise Acetal. However, those of ordinary skill in the art will recognize that other comparable engineering plastics having a low coefficient of friction could also be used. Using such an engineering plastic enables the material for the outer housing <NUM> to be chosen for aesthetic or tactile reasons with no friction related requirements since the outer housing <NUM> does not engage any moving components during normal operation.

The inner housing <NUM> also enables the number sleeve <NUM> to be provided with a helical groove on an inner surface <NUM> of the number sleeve <NUM>, rather than providing such a helical groove on an external surface <NUM> of the number sleeve <NUM>. Providing such an internal groove results in a number of advantages. For example, this results in one advantage of providing more surface area along the outer surface <NUM> of number sleeve <NUM> so as to provide the scale arrangement <NUM>. Increased number sleeve surface area may be used for drug or device identification purposes. Another advantage of providing the helical groove <NUM> on the inner surface <NUM> of the drive sleeve <NUM> is that this inner groove <NUM> is now protected from dirt ingress. In other words, it is more difficult for dirt to become logged in this inner groove interface than if the groove were provided along the outer surface <NUM> of the number sleeve <NUM>. This feature is particularly important for a re-settable drug delivery device which will have to function over a much longer period of time compared to a non-resettable device.

The effective driving diameter (represented by 'D') of the grooved interface between the number sleeve <NUM> and the inner housing <NUM> is reduced compared to certain known drug delivery devices for the same outer body diameter. This improves efficiency and enables the drug delivery device to function with a lower pitch (represented by 'P') for this groove and groove guide connection. In other words, as the helix angle of the thread determines whether when pushed axially, the number sleeve will rotate or lock to the inner body wherein this helix angle is proportional to the ratio of P/D.

The number sleeve <NUM> can be made the length of the mechanism "L" <NUM> rather than having to split this length into the space required for the number sleeve <NUM> and a space required for a clicker and a dose limiter. One advantage of this configuration is that it ensures a good axial engagement between the number sleeve <NUM> and the outer housing <NUM>. This improves the functionality (and perceived quality) of the dose setting mechanism when a user uses the drug delivery device to dial out a maximum settable dose. <FIG> illustrates the dose setting mechanism <NUM> dialed out to a maximum settable dose of <NUM> International Units ("IU").

Another advantage is that it enables the scale arrangement <NUM> to be hidden within the outer housing <NUM> even when the number sleeve <NUM> is fully dialed out as may be seen from <FIG>. However, the design does not limit the position of the window <NUM> to that shown in <FIG> but allows this window <NUM> to be positioned at near the dose dial grip <NUM> of the device. In arrangements illustrated in <FIG> and <FIG>, the scale arrangement <NUM> will only be visible by way of the window <NUM>.

Also the driver <NUM> (whether made in two portions or just one unitary component) can be made with a plain internal through hole plus a thread form that can be molded with axially moving core pins. This avoids the disadvantage of a driver having an internal thread with more than one turn and therefore requires a core pin to be rotated out several turns during a de-molding process.

One potential disadvantage of utilizing a dose setting mechanism comprising the inner housing <NUM> is that the use of the inner housing <NUM> adds a component part to the overall dose setting mechanism <NUM>. Consequently, this inner housing <NUM> will tend to increase the overall wall thickness that must be designed to fit between the clutch <NUM> and number sleeve <NUM>. One way to work around this design issue, as illustrated in <FIG>, is to reduce the diameter of the clutch <NUM> and number sleeve <NUM>. This in turn can be achieved because the thread form between the driver <NUM> and the spindle <NUM> comprises a male internal feature on the driver <NUM> and a female external groove form on the spindle <NUM> that are overlapping with (on a similar diameter with) the spindle groove form that interfaces with the groove along the inner surface <NUM> of the inner housing <NUM> or body portion.

The overlapping of groove forms on the spindle <NUM> reduces the effective diameter of the thread interface with the driver <NUM>. This also reduces the potential outer diameter of the driver <NUM> enabling the addition of the inner housing <NUM> without increasing the overall outer diameter of the dose setting mechanism <NUM>. Another added benefit of the reduced effective diameter of the thread interface with the driver <NUM> is that it improves efficiency of the drug delivery device during dispense as explained above. The window <NUM> through which the scale arrangement <NUM> may be viewed can either be just an aperture in the outer housing <NUM> or can include a clear lens or window designed to magnify the scale arrangement (i.e., printed or laser marked dose numbers) along a portion of the outer surface <NUM> on the number sleeve <NUM>.

The connection of a cartridge holder into the outer housing <NUM> can be achieved using either a screw or bayonet type connection. Alternatively, any similarly robust design used in drug delivery devices requiring a largely cylindrical part to be removed and then reattached could also be used.

With the limited choice of mechanical advantages available with the overlapping helical spindle <NUM> in the arrangement illustrated in <FIG>, often an optimum choice of mechanical advantage for the length of the dose setting mechanism (and hence overall length of the drug delivery device) required is difficult to achieve. Hence, an alternative arrangement for this dose setting mechanism having a multi-component drive sleeve may be desired. Therefore, there may be a need for an enhanced dose setting mechanism that enables a mechanical advantage to be varied without changing the ratio of the pitches of the grooves on the spindle, such as the multi-groove spindle illustrated in <FIG>. Such an enhanced dose setting mechanism is illustrated in <FIG> and <FIG>.

For example, <FIG> illustrates a sectional view of another embodiment of a dose setting mechanism of the drug delivery device illustrated in <FIG>. <FIG> illustrates a partial sectional view of the embodiment of the dose setting mechanism illustrated in <FIG>. This alternative arrangement of the dose setting mechanism <NUM> operates in generally a similar fashion to the dose setting mechanism <NUM> illustrated in <FIG>. That is, the dose setting and dose injecting operations are generally the same. One difference between these two dose setting mechanisms, however, is in what occurs when a user resets the dose setting mechanism <NUM>.

With reference to <FIG> and <FIG>, the dose setting mechanism <NUM> comprises a dose dial grip <NUM>, a spring <NUM>, an outer housing <NUM>, a clutch <NUM>, a driver <NUM>, a number sleeve <NUM>, a clicker <NUM>, a dose limiter <NUM>, and an inner housing <NUM>. Similar to the driver <NUM> illustrated in <FIG>, driver <NUM> of dose setting mechanism <NUM> comprises a first driver portion <NUM> and a second driver portion <NUM>.

In one arrangement, the first driver portion <NUM> comprises a first component part <NUM> and a second component part <NUM> (see generally, <FIG>). Alternatively, the first driver portion <NUM> is an integral component part.

Where the dose setting mechanism <NUM> illustrated in <FIG> and <FIG> comprises a resettable dose setting mechanism, the first driver portion <NUM> is de-coupled from the dose setting mechanism <NUM> when the first driver portion <NUM> is pushed axially towards the second driver portion <NUM> (i.e., pushed in a proximal direction). This does not require any mechanism associated with removal of a cartridge holder. The mechanism is also designed such that the first and second driver portions <NUM>, <NUM> remain locked together rotationally during dose setting as well as during dose administration. Returning to the arrangements illustrated in <FIG>, the multi-component driver <NUM> moves axially without rotation relative to the internal housing <NUM> during dose dispense. In the alternative arrangement illustrated in <FIG>, the driver <NUM> does not just move axially during dispense but is constrained to move along a helical path. Such a helical path may be defined by one or more helical splines <NUM> molded into an inner surface of the inner housing <NUM>. In such an arrangement, the path of the driver <NUM> may be controlled through a rotational coupling between a clicker <NUM> (preferably, by way of a second clicker portion <NUM>) with at least one helical groove <NUM> provided along an inner surface of the inner housing <NUM>.

If these helical grooves provided along the inside of the inner housing <NUM> rotate in the opposite sense to the thread form on the first driver portion <NUM> or the number sleeve <NUM>, then the mechanical advantage may be reduced. However, if these helical grooves rotate in the same sense to the thread form on the first driver portion <NUM> or the number sleeve <NUM>, and with a larger pitch, then the mechanical advantage may be increased.

With such a proposed dose setting mechanism <NUM>, an equation for the resulting mechanical advantage may be calculated via the following equation: (A+B)/[A x (<NUM>-B/C)]. In this equation, A is the groove pitch between the spindle <NUM> and inner housing <NUM>, B is the groove pitch between the spindle <NUM> and the first driver portion <NUM>, and C is the pitch of the helical grooves <NUM> with a positive notation depicting in the same sense as B.

In this arrangement and as illustrated in <FIG> and <FIG>, the clicker <NUM> comprises a multi-component clicker. Specifically, clicker <NUM> comprises a first clicker portion <NUM> and a second clicker portion <NUM>. The first and second clicker portions <NUM>, <NUM> comprise clicker teeth <NUM> and <NUM>, respectively. Both first and second clicker portions <NUM>, <NUM> are placed on a distal side of the metal coil spring <NUM>. This is in contrast to the location of the clicker in the dose setting mechanism <NUM> illustrated in <FIG>. In the arrangement illustrated in <FIG>, the clicker arrangement <NUM> is positioned on a proximal side of the spring <NUM>.

Positioning the clicker <NUM> on the distal side of the metal coil spring <NUM> achieves a number of advantages. For example, it helps to ensure that the second clicker portion <NUM> that is rotationally coupled to the helical grooves provided along the inner housing <NUM> does not move axially and hence does not rotate relative to the housing when the button <NUM> is depressed to thereby disengage the clutch <NUM> from the number sleeve <NUM>. If the clicker <NUM> were allowed to rotate, the clicker <NUM> would cause the clutch <NUM> to rotate. If this were to occur, this may prevent the clutch <NUM> from re-engaging with the dose dial sleeve <NUM> at the end of dose. Also, if the clutch <NUM> were allowed to rotate when the button <NUM> is depressed, the driver <NUM> would rotate as well and this would affect dose accuracy when a user releases the button <NUM> and the driver <NUM> rotates.

Again, with this alternative arrangement of a dose setting mechanism <NUM>, rather than having the clicker teeth between the clicker <NUM> and the first driver portion <NUM>, the clicker <NUM> has been split into two parts <NUM>, <NUM>. In this arrangement, the first driver portion <NUM> can rotate on a circular bearing surface during resetting of the spindle <NUM> and the clicker teeth are instead placed between the first and second clicker portions <NUM>, <NUM>, respectively. The first clicker portion <NUM> may be rotationally coupled to either the driver <NUM> or the clutch <NUM>. Therefore, during dose dialing, the first clicker portion <NUM> rotates relative to the second clicker portion <NUM> which is rotationally coupled to the helical grooves <NUM> in the inner housing <NUM> as mentioned above.

Also in this arrangement where it is the first clicker portion <NUM> that oscillates axially (in a proximal direction and then a distal direction) during dialing the clicker teeth <NUM>, <NUM> can be symmetric. On advantage of symmetrical clicker teeth is that the user is provided with a similar tactile response when he or she is either dialing up a dose compared with dialing down a dose. If the first clicker portion <NUM> were to be rotationally coupled to the inner housing <NUM>, as this first clicker portion <NUM> oscillated proximally and distally during dialing it would also oscillate rotationally. One perceived disadvantage of such an arrangement is that the resulting dialing torque would be substantially different when the user would be dialing up to dialing down a dose.

Note that with the dose setting arrangement <NUM> illustrated in <FIG> and <FIG>, the number of clicker teeth on the first and second clicker portions <NUM>, <NUM> has to be altered to account for the thread pitches B and C in order to get the correct number of clicks per rotation to match the numbers or other similar dose setting indicia provided on the dose dial sleeve <NUM>. In addition, the dose limiter <NUM> also comprises splines <NUM> that run in the same helical grooves <NUM> in the inner housing <NUM> as the second clicker portion <NUM>. Therefore, during dose dispense, the dose limiter <NUM> will not rotate relative to the driver <NUM> thereby ensuring that no further doses can be dialed after the dose limiter <NUM> has come up against a stop on the first driver portion <NUM>.

Similar to the driver illustrated in <FIG>, the first driver portion <NUM> of dose setting mechanism <NUM> comprises two parts clipped together.

Although the dose setting mechanism <NUM> illustrated in <FIG> and <FIG> provides a number of advantages, there are also certain limitations associated with such an arrangement. For example, one issue with dose setting mechanism <NUM> is that when mechanism is reset so as to replace a used cartridge, the spindle <NUM> is pressed back proximally. Pressing the spindle back proximally moves the first driver portion <NUM> and hence the clicker <NUM> proximally relative to the outer housing <NUM>. If the clicker <NUM> moves relative to the housing <NUM>, then the clicker <NUM> also has to rotate. Therefore, during the resetting step, the first driver portion <NUM> not only compresses the spring <NUM> but has to rotate the clicker <NUM> and hence driver <NUM>, the clutch <NUM>, and dose dial sleeve <NUM> relative to the housing <NUM>. This increases the force required to reset the dose setting mechanism <NUM>.

<FIG> illustrates a partial view of yet another embodiment of a dose setting mechanism of the drug delivery device illustrated in <FIG>. In this illustration, the dose setting mechanism <NUM> is illustrated with a dose setting button pressed in. <FIG> illustrates the partial sectional view of embodiment of the dose setting mechanism <NUM> illustrated in <FIG> in a second position with the dose setting button being pressed out. <FIG> illustrates the partial sectional view of embodiment of the dose setting mechanism <NUM> illustrated in <FIG> with a second clicker portion <NUM> removed.

The alternative embodiment of the dose setting mechanism <NUM> comprises a clutch <NUM>, a clicker <NUM>, and a spring <NUM>. As shown in <FIG>, the clicker <NUM> comprises a first clicker portion <NUM> and a second clicker portion <NUM>. In this arrangement, the first clicker portion <NUM> is similar to the clicker illustrated in <FIG> in that the first clicker portion <NUM> comprises a plurality of clicker teeth <NUM>. These clicker teeth <NUM> engage a plurality of clutch teeth <NUM>.

However, unlike the clicker <NUM> of <FIG> comprising splines that engage the helical groove <NUM> provided on the inner housing <NUM>, the first clicker portion <NUM> of dose setting mechanism <NUM> is not splined to an inner housing. Rather, the second clicker portion <NUM> is rotationally coupled to the first clicker portion <NUM>, axially coupled to the driver <NUM> and rotationally coupled to the helical grooves provided on an inner housing.

In this dose setting mechanism <NUM> arrangement, neither the driver <NUM>, the clutch <NUM>, nor clicker rotate, when a dose button is depressed. Similarly, neither the driver <NUM>, the clutch <NUM>, nor the clicker rotate when the dose setting mechanism <NUM> is reset. One advantage of such an arrangement is that this mechanism ensures a low force to reset the pen and good dose accuracy.

<FIG> illustrates the second clicker portion <NUM> that may be used with the dose setting mechanism illustrated in <FIG>. As can be seen from <FIG>, the second clicker portion <NUM> comprises a plurality of splines <NUM> that engage a helical groove provided along an inner surface of the inner housing. In addition, the second clicker portion <NUM> further comprises a recess <NUM>. This recess <NUM> engages a rib provided on the second driver portion <NUM>. When this recess <NUM> engages this rib, the second clicker portion <NUM> is axially secured to the second driver portion <NUM>.

In particular, the various clicker arrangements shown in embodiments <NUM>, <NUM> and <NUM> can be mounted either internally to the inner body, as shown, or externally, with ribs or grooves in the clicker engaging with ribs or grooves on the outer surface of the inner body or as shown in the first embodiment (ref <FIG>) on the inner surface of the outer body. Where an inner body exists, in these alternative arrangements the clutch, spring and clicker components would have to lie outside the inner body, but the driver could still be rotationally coupled to the clutch and lie inside the inner body so as to drive the spindle forwards.

Claim 1:
A dose setting mechanism for a drug delivery device, said mechanism comprising:
a driver (<NUM>);
a clicker (<NUM>);
an outer housing (<NUM>);
an inner housing (<NUM>) having an external groove (<NUM>) provided along an external surface (<NUM>) of the inner housing (<NUM>) and an internal helical spline (<NUM>), said inner housing configured to guide said driver (<NUM>) to dispense a dose set by said dose setting mechanism; and
a dial sleeve which is a number sleeve (<NUM>) disposed between said outer housing (<NUM>) and said inner housing (<NUM>), wherein a groove guide (<NUM>) provided on an inner surface (<NUM>) of the number sleeve (<NUM>) is rotatably engaged with said external groove (<NUM>) of said inner housing;
wherein said dial sleeve (<NUM>) is configured to rotate with respect to both said outer housing (<NUM>) and said inner housing (<NUM>) during dose setting and configured to be translated away from both said outer housing (<NUM>) and said inner housing (<NUM>);
wherein the clicker (<NUM>) comprises a plurality of splines (<NUM>) which splines (<NUM>) are configured to be splined to an inner surface of the inner housing (<NUM>),
characterized in that the clicker (<NUM>) is axially secured to said driver (<NUM>) and in that the clicker (<NUM>) is configured to rotate during a dose setting step.