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(11) Patent Number: KE 421

( 45) Date of grant: 21/01/2011
                           
(51) Int.Cl.7:    A61M5/315       

(73) Owner:SANOFI AVENTIS DEUTSCHLAND GMB of bruningstrasse SO, 65929 Frankfurt, Germany
   
(2l)Application Number:KElP! 2007/000566           

(72) Inventor:VEASEY, Robert of 35 Hitchman Road, CV311QH,eamington Spa United Kingdom and WIMPENNY,Steven of 2 Granville Street, Leamington SpaUnited Kingdom

(22) Filing Date:26/08/2005            .
               
(30) Priority data: 04020877.9  02/09/2004  EP       

(74) Agent/address for correspondence: Kaplan & Stratton Advocates, P.O. Box 40111-00100,Nairobi
   
(86)  PCT data    PCT/EP05/009217    26/08/2005 W0/2006/024461    09/03/2006           
                   
(54)Title:METHOD OF ASSEMBLY OF DRUG DELIVERY DEVICES (57) Abstract:

The present invention relates to a method for the assembly of drug delivery devices, in particular of pen-type drug delivery devices, having a dose-dial mechanism and a drive mechanism, enabling the administration of medicinal products from a multidose cartridge and the drug delivery devices obtainable according to the said method.

71

Method of assembly of drug delivery devices


The present invention relates to a method for the assembly of drug delivery devices, in particular of pen-type drug delivery devices, having a dose dial mechanism and a drive

5    mechanism, enabling the administration of medicinal products from a multidose cartridge and the drug delivery devices obtainable according to the said method.

Such drug delivery devices have application where regular injection by persons without

formal !lledical training occurs, i.e.~ patients. This is increasingly common amongst

10    those having diabetes where self-treatment enables such persons to conduct effective management of their diabetes.

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

kind.  The device must be robust in construction, yet easy to use in terms of the

15    manipulation of the parts, understanding by a user of its operation and the delivery of the required dose of medicament. Dose setting must be easy and unambiguous. In the case of those with diabetes, many users will be physically infirm and may also have impaired vision requiring the drive mechanism to have low dispensing force and an easy to read dose setting display. In case of disposable devices, the device should

20    be cheap to manufacture and easy to dispose of {preferably being suitable for recycling). To meet these requirements the number of parts required for assembling the device and the number of material types the device is made from need to be kept to a minimum.

25    User operated drug delivery devices and their methods of assembly are well known within the medical field.

Most prior art technologies have the disadvantage that the drug delivery devices comprise a two part housing, which weakens the mechanical stability of the device,

30    e.g., between cartridge and drive mechanism, which may result in unsatisfactory user safety issues.

US Patent 5,226,895 discloses a syringe comprising a unitary housing for holding a container of liquid and a plunger rod •having a non-cylindrical cross-section. The syringe further comprises a collar received within the housing having a non-cylindrical cross-section corresponding to the piston rod. The dose dial mechanism of the

5    disclosed concept is mechanically engaged with the unitary housing. W09813085A1 discloses a needle-less injector device having a unitary housing,
comprising a chamber for the drug to be applied,. a liquid outlet, a dispensing member, an impacting member, a drive means, and a pressure sensor, where the chamber, the
10    liquid outlet and the drive means are-immobile with respect to the housing. This device does not comprise a dose dial mechanism.

Surprisingly, it was found that the use of a unitary housing in the method of assembling

a drug delivery device according to.instant invention overcomes the above

15    shortcomings by increasing the mechanical and structural stability of the device. Therefore, the method according to instant invention provides a drug delivery device having a reduced number of joints making assembly of the device more efficient and providing a drug delivery device having increased user comfort and safety.

For example, PCT/EP2004/002116, which disclosure content is hereby incorporated

20    by reference, discloses a certain type of a drive mechanism, a dose dial mechanism, and a drug delivery mechanism particularly suitable for instant method of assembly.

Therefore, it is a first object of instant invention to provide a method of assembling a

drug delivery device comprising the steps of a) providing a unitary housing, a cartridge,

25    a drive mechanism, a dose dial mechanism, and optionally a drug delivery mechanism; and b) inserting or introducing the cartridge, the drive mechanism, the dose dial mechanism, and optionally the drug delivery mechanism into the unitary housing, whereby said cartridge, said drive mechanism, and said dose dial mechanism and

optionally said drug delivery mechanism are not mechanically engaged with the said

30    unitary housing. In a preferred embodiment, the cartridge is first inserted or introduced into the unitary housing. In another preferred embodiment, one or more of the components of the drug delivery device (such as the cartridge, the drive mechanism,


the dose dial mechanism, and/or the drug delivery mechanism or any components thereof) may be pre-assembled and/or are modular allowing them to be introduced or inserted into the unitary housing.

5    A second object of instant invention is to provide the drug delivery device obtainable by the method of assembly according to instant invention.

The term "drug delivery device•according to meaning of instant invention is a single-

dose or multi-dose, disposable or re-usable device designed to dispense a selected

10    dose of a medicinal product, preferably multiple selected doses, more preferred pharmaceutical formulations for subcutaneous or intramuscular administration, most preferred of insulin, growth hormones, heparin (low molecular weight heparin), and their analogues and/or derivatives or any other drug, which is to be administered

intramuscularly or subcutaneously. The drug delivery device may be of any shape, e.g.

15    compact (e.g. non-pen-type) 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, motor, etc.. Drug delivery may be provided by an actuation button, switch, knob, etc. Dose selection may be provided by a dose dial

mechanism, which may be a manual mechanism or electronic mechanism.

20    Additionally, said devic;~ may optionally contain components designed to monitor physiological properties such as blood glucose levels, etc..

Furthermore, the said device may comprise a needle or may be needle-free. In particular preferred embodiment the term drug delivery device shall mean a disposable multi-dose pen-type device having mechanical and manual dose delivery and dose dial

25    mechanisms, which is designed for regular use by persons without formal medical training such as patients. Preferably, the drug delivery device is of the injector-type.

The term "unitary housing" according to instant invention means any drug delivery

device outer housing, which covers the cartridge, the drive mechanism, the dose dial

30    mechanism, and optionally the drug delivery mechanism of the drug delivery device. The term "unitary housing" according to instant invention shall preferably mean an exterior housing ("main housing", "body", "shell"). The unitary housing may be

designed to enable the safe, correct, and comfortable handling of the drug delivery device or any of its mechanisms. Usually, it is designed to house, fiX, andlor protect any of the inner components of the drug delivery device (e.g., the drive or dose dial mechanism, cartridge, plunger, piston rod) by limiting the exposure to contaminants,

5    such as liquid, dust, dirt, etc. In general, the housing is a one-piece component of tubular ("pen-type") or non-tubular ("non-pen-type") shape, preferably manufactured as one single piece (e.g., moulded, extruded etc.). Usually, the unitary housing serves to house a cartridge from which a number of doses of a medicinal product may by

dispensed. Accordingly, the unitary housing may also serve as a cartridge holder and

10    as a drive and dose dial mechanism holder.•Preferably, the unitary housing may have one or more openings (windows, apertures) tp allow the handling and/or operation of the device.

The term "engaged" according to instant invention shall particularly mean the

15    interlocking of two or more components ofthe drug delivery device, e.g. a spline or thread connection, preferably the interlocking of helical threads of components ("threadedly engaged").
The term "mechanically engaged" according to instant invention means any

engagement of the cartridge, the drive mechanism, the dose dial mechanism, and/or

20    optionally the drug dellvery mechanism with the unitary housing by threaded or splined interaction, whereby relative movement with respect to the unitary housing is allowed. Therefore, the term "mechanically engaged" does not mean any press or fit engagement, or the like in order to fix (or hold) the cartridge, the drive mechanism, the dose dial mechanism, and/or optionally the drug delivery mechanism to the unitary

25    housing.

The term ''firstend" according to instant invention shall mean the proximal end. The proximal end of the device or a component of the device shall mean the end, which is
closest to the dispensing end of the device.

30    The term "second end" according to instant invention shall mean the distal end.

The distal 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.
 

The invention will now be described, by way of example only, with reference to the accompanying 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;

5    Figure 2 shows a sectional view of the drug delivery device of Figure 1 in a second, maximum first dose dialed, position;

Figure 3 shows a sectional view of the drug delivery device of Figure 1 in a third, maximum first dose dispensed, position;

Figure 4 shows a sectional view of the drug delivery device of Figure 1 in a fourth, final

10    dose dialed, position;

Figure 5 shows a sectional view of the drug delivery device of Figure 1 in a fifth, final dose dispensed, position;

Figure 6 shows a sectional view of a second embodiment of the drug delivery device in

accordance with the present invention;

15    Figure 7 shows a sectional side view of a third embodiment of the drug delivery device in accordance with the present invention;

Figure 8 shows a perspective view of a dose dial sleeve for use in conjunction with the present invention;
Figure 9 shows a perspective view of an insert for use with the dose dial sleeve of

20    Figur~ 8;

Figure 10 shows a sectional side view of a fourth embodiment of the drug delivery device in accordance with the present invention; and

Figure 11 shows a sectional side view of a fifth embodiment of the drive mechanism according to instant invention in a first, cartridge full, position.


wo 2006/024461    PCT/EP2005/009217


Detailed Description of the Embodiments:


Example 1

Referring to Figures 1 to 5 there is seen a drug delivery device assembled in

5    accordance with the first embodiment of the present invention. The device comprises a housing 2 within which are located a cartridge 4 containing a medicinal product, means for setting or selecting the dose of medicinal product to be expelled and means for

expelling the selected dose of medicinal product. The housing 2 is generally cylindrical

in shape and is divided into two compartments by a web 6 to be described in more

10    detail below. The cartridge 4 is located within a first compartment of the housing 2. The dose setting means and the means for expelling the selected dose of medicinal product are retained, that is held, within a second compartment of the housing 2. An advantage of a one piece housing enclosing the cartridge 4 together with the dose setting and dose expelling means lies in the ease of assembly of the product. This is

15    in part due to the reduced number of components in the pen-type injector. Also, the unitary nature of the housing 2 means that the pen-type injector is more robust.

The cartridge 4 may be secured in position in the first compartment of the housing 2 by any suitable means. A needle unit may be secured to the first end of the cartridge 4.

20    A temporary covering 8 is shown in this position in the Figures. The cartridge 4 is sealed by a displaceable piston 10. Advancing the piston 10 towards the first end of the cartridge 4 causes the medicinal product to be expelled from the cartridge 4 through the needle unit. A cap 12 is provided to cover the needle unit when the

injector is not in use. The cap 12 may be releasably secured to the housing 2 by any

25    suitable means.

The dose setting means and the means for expelling the selected dose of medicinal product will now be described in more detail. The web 6 dividing the housing 2 is a part of an insert 141ocated within the housing 2. The insert 14 comprises a first

30    cylindrical portion 16 extending from a first side of the web 6 and second and third cylindrical portions 18, 20 extending from a second side of the web 6. The web 6 is provided with a circular opening 22 extending through the web 6.

wo 2006/024461    PCTIEP2005/009217


The first cylindrical portion 16 extends from a periphery of the web 6. The insert 14 is secured to the housing 2 by way of the first cylindrical portion 16 by any suitable means. In the illustrated embodiment features 24 are provided within the housing 2 and on an outer surface of the first cylindrical portion 16 to enable the insert to be a

5    snap frt to the housing 2.

The second cylindrical portion 18 extends a small distance from the second side of the web 6 about a periphery of the opening 22. An internal surface of the second cylindrical portion is provided with a thread 26.

10

The third cylindrical portion 20 extends substantially within the housing 2 from the second side of the web 6. The diameter of the third cylindrical portion 20 is such that a first channel 28 is formed between an outer surface of the second cylindrical portion 20 and an inner surface of the third cylindrical portion. A second channel 30 is formed

15    between an outer surtace of the third cylindrical portion 20 and the housing 2.

A piston rod 32 extends through the opening in the web 6. The piston rod 32 is generally elongate and is provided with a thread 34 extending from a first end of the piston rod 32. The thread 34 of the piston rod 32 engages the thread of the inner

20    surface of the second .cylindrical portion 18 of the insert 14. The first end of the piston rod 32 is provided with'a pressure foot 36. In use the pressure foot 36 is disposed on the first side of the web 6 to abut the cartridge piston 10.

Ratchet means 40 are located adjacent the web 6 on the first side of the web 6.  The

25    ratchet means 40 serve the purpose of allowing the piston rod 32 only to rotate through the insert 14 in a single direction. Due to the unitary housing, the ratchet means can be made larger than in known devices and so is stronger (more rigid).

A dose dial sleeve 50 of generally cylindrical form comprises a first section of first

30    diameter and a second section of second diameter. The first section is located within the second channel 30. An inner surface of the first section and the outer surface of the third cylindrical portion 20 are provided with interengaging features to provide a
 




wo 2006/024461    PCT/EP2005/009217


8

helical thread 52 between the insert 14 and the dose dial sleeve 50. In the illustrated embodiment this was achieved by a helical track provided on the outer surface of the third cylindrical portion 20 within which a helical rib provided on the inner surface of the dose dial sleeve 50 may run. This enables the dose dial sleeve 50 to rotate about and
5    along the third cylindrical portion 20 of the insert 14.

An outer surface of the first section of the dose dial sleeve 50 is provided with graphics 53. The graphics are typically a sequence of reference numerals. The housing 2 is

provided with an apertu~e or window 54 through which a portion of the graphics,

10    representing a dosage value selected by the user, may be viewed.

The graphics 53 may be applied to the dose dial sleeve 50 by any suitable means. In the illustrated embodiment, the graphics 53 are provided in the form of a printed label encircling the dose dial sleeve 50. Alternatively the graphics may take the form of a

15    marked sleeve clipped to the dose dial sleeve 50. The graphics may be marked in any suitable manner, for example by laser marking.

It is an advantage of this arrangement that the helical thread 52 is formed wfthin the

dose dial sleeve between the dose dial sleeve and the insert.  As can be seen this

20    means there is no direct route from outside the device to the working surfaces of the helical thread. Should'dust or dirt enter the device this will tend to occur between the unitary housing and the dose dial sleeve where there are no working parts with which to interfere. This is not the case for known devices in which a helical thread is formed between the housing and an interior moving surface.
25

The second section of the dose dial sleeve 50 is preferably of the same outer diameter as the housing 2. Within the dose dial sleeve 50 there is a shoulder 56 between the first section of the dose dial sleeve 50 and the second section of the dose dial sleeve 50.

30

A drive sleeve 60 of generally cylindrical form comprises a first part of first diameter and a second part of second diameter. A first end of the first part is located within the
 




wo 2006/024461    PCT/EP2005/00921 7


9

first channel 28 of the insert 14 in the position shown in Figure 1. The first part of the drive sleeve 60 may be considered as comprising a first portion aligned with a second portion. More generally in the position shown in Figure 1 the first portion ofthe drive sleeve 60 is located between the insert 14 and the piston rod 32 while the second

5    portion is located between the piston rod 32 and the dose dial sleeve 50.

A second end of the piston rod 32 and an internal surface of the drive sleeve 60 are splined together such that no relative rotation may occur between these parts, only longitudinal displacement.

10

The outer surface of the second portion of the first part of the drive sleeve 60 is provided with a helical thread 62. A nut 64 is provided on the helical thread 62 between the drive sleeve 60 and the dose dial sleeve 50. The dose dial sleeve 50 and the nut 64 are splined together by spline means to prevent relative rotation between

15    the nut 64 and the dose dial sleeve 50.

The second part of the drive sleeve 60 is of larger diameter than the first part of the drive sleeve 60. There is a step 66 between the first part of the drive sleeve 60 and the second part. The second part of the drive sleeve 60 is seated within the second
20    section of the dose di~l sleeve 50. Thf? shoulder 56 of the dose dial sleeve 50 and the step 66 of the drive sleeve 60 are adapted to be releasably engagable with one ano1her .to form a clutch means. When, as in Figure 1, the dose dial sleeve 50 and the drive sleeve 60 are not in engagement the dose dial sleeve 50 is able to rotate with

respect to the drive sleeve 60. Conveniently, the clutch means comprises a plurality of

25    radially extending longitudinally directed teeth provided respectively on the shoulder 56 of 1he dose dial sleeve 50 and the step 66 of the drive sleeve 60. When the dose dial sleeve 50 and the drive sleeve 60 are not forced together the respective teeth will ride over one another. Preferably, the radial separation of 1he respective teeth corresponds to a unit dosage.

30

The second part of the drive sleeve 60 further comprises a central receiving area 68 having a peripheral recess. A button 70 of generally 'Tshaped configuration is

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