NZ616357B2 - Drive assembly for a drug delivery device and corresponding drug delivery device - Google Patents
Drive assembly for a drug delivery device and corresponding drug delivery device Download PDFInfo
- Publication number
- NZ616357B2 NZ616357B2 NZ616357A NZ61635712A NZ616357B2 NZ 616357 B2 NZ616357 B2 NZ 616357B2 NZ 616357 A NZ616357 A NZ 616357A NZ 61635712 A NZ61635712 A NZ 61635712A NZ 616357 B2 NZ616357 B2 NZ 616357B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- guide nut
- locking means
- coupling means
- drive assembly
- piston rod
- Prior art date
Links
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Classifications
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2477—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means to reduce play of ampoule within ampoule holder, e.g. springs
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- A—HUMAN NECESSITIES
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31573—Accuracy improving means
- A61M5/31575—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
Abstract
drive assembly for a drug delivery device (1) is disclosed. The drive assembly is connectable with a cartridge holder (2) and comprises a housing (3), a piston rod (17), the piston rod (17) being movable in a distal direction for drug delivery, and a guide nut (4), the guide nut (4) being rotatable relative to the housing (3) around an axis of the assembly and provided for guiding the piston rod (17). A locking means (9) is provided which is enabled to take an engaged state in which the locking means (9) is engaged with the guide nut (4) in order to prevent rotation of the guide nut (4) and to take a disengaged state in which the locking means (9) is disengaged from the guide nut (4) in order to allow rotation of the guide nut (4). Moreover, a coupling means (14) is provided, the coupling means (14) being rotatable relative to the housing (3) around the axis of the assembly for interaction with the locking means (9) in order to change between the engaged state and the disengaged state of the locking means (9). e relative to the housing (3) around an axis of the assembly and provided for guiding the piston rod (17). A locking means (9) is provided which is enabled to take an engaged state in which the locking means (9) is engaged with the guide nut (4) in order to prevent rotation of the guide nut (4) and to take a disengaged state in which the locking means (9) is disengaged from the guide nut (4) in order to allow rotation of the guide nut (4). Moreover, a coupling means (14) is provided, the coupling means (14) being rotatable relative to the housing (3) around the axis of the assembly for interaction with the locking means (9) in order to change between the engaged state and the disengaged state of the locking means (9).
Description
Description
DRIVE ASSEMBLY FOR A DRUG DELIVERY DEVICE AND CORRESPONDING
DRUG DELIVERY DEVICE
The present sure pertains to a drive assembly for a drug delivery device, the drive
assembly being connectabie with a dge holder. Moreover, the present disclosure
pertains to a drug delivery device with a correSponding drive assembly and a cartridge
holder.
Portable drug delivery s are used for the administration of a medicament or drug,
ally a medicinal fluid that is suitable for self-administration by a patient. A drug
delivery device may comprise a syringe, an injection device, an injector or a pen—type
ion device. In particular, a drug delivery device in the shape of a pen is useful,
since it can be handled easily and kept available everywhere.
There exist different types of drug delivery devices. One type of a drug ry device
comprises a disposable device which may be disposed after having dispensed the
medicament or after the medicament has been expired. Another type of a drug delivery
device comprises a refillable drug delivery device which may be reusable many times.
This kind of drug delivery device may se a drive assembly and a cartridge holder
which is connectable to the drive assembly and which contains a cartridge, ampoule or
via! containing a medicament or drug. Often, a needle assembly may be connected to a
distal end of the cartridge holder for subcutaneous injection of the medicament. A dose
of a drug or medicament is delivered by means of a drive mechanism of the drive
assembly driving a piston rod or lead screw in a distal direction, the piston rod
interacting with a piston within the cartridge for expelling the medicament out of the
device. The drug delivery device may provide a etting mechanism which allows
setting the dose of the ment that is to be dispensed.
In common devices, as disclosed in US 2009/0275914 A1 for example, the piston rod is
guided in the drive assembly by a guide nut, also called body nut or lead screw nut,
which is coupled to the piston rod for moving the piston rod in distal direction during
drug delivery. For this purpose, the guide nut is onally fixed with respect to the
g of the drive assembly in order to urge the piston rod into a predetermined,
mostly helical movement.
In le drug delivery s the situation may arise that the drug ry device
has to be reset. This means, the piston rod has to be moved in a proximal direction
te to the distal direction back into the drive assembly such that a new cartridge
contained within the cartridge holder may be assembled to the drive assembly in order
to start a new cycle of drug delivery. During the reset operation of the piston rod, the
guide nut may preferably be rotatable with respect to the housing in order to enable a
quick and easy shifting of the piston rod back into the drive assembly. Thus, the guide
nut has to fulfill double functionalities, wherein during drug delivery the guide nut has to
be rotationally fixed and during a reset operation the guide nut has to be rotatable with
respect to the housing. This is also disclosed in US 2009/0275914 A1.
According to US 2009/0275914 A1 the drug delivery device provide a locking means for
releasable engagement with the guide nut in order to prevent rotational movement of
the guide nut with respect to the housing during drug delivery and to allow on of
the guide nut with respect to the housing during ing of the . The locking
means may directly be operated by the cartridge holder when the cartridge holder is
led to the drive assembly.
It is an object of the present disclosure to present a new drive assembly for a drug
delivery device and a new drug delivery device providing for a better and safe handling.
This object is achieved by a drive assembly according to claim 1 and a drug delivery
device according to claim 16. Further objects are achieved by variants and alternative or
preferred embodiments according to the dependent claims.
The drive assembly comprises a housing or body and a lead screw or piston rod, the
piston rod being movable in a distal direction for drug delivery. Moreover, the drive
assembly provides a lead screw nut or guide nut being rotatable relative to the housing
around an axis of the assembly and being provided for guiding the piston rod. A locking
means is provided, the locking means being enabled to take an engaged state in which
the locking means is engaged with the guide nut in order to prevent rotation of the guide
nut. Moreover, the locking means is enabled to take a disengaged state in which the
locking means is disengaged from the guide nut in order to allow rotation of the guide
nut. Furthermore, the drive assembly provides a coupling means, the coupling means
being rotatable ve to the housing around the axis of the assembly for interaction
with the locking means in order to change between the engaged state and the
disengaged state of the locking means.
The disclosed drive assembly provides, besides a guide nut and a locking means, a
ng means that may interact with the locking means in such a way as to enable
switching of the locking means between the two states. Thus, the coupling means may
provide better ng or decoupling of the g means with or from the guide nut.
Erroneous engagement of the locking means with the guide nut due to an unstable
ng position of the cartridge holder may, therefore, be prevented. This may aid a
user in better handling the device.
The guide nut can be a single ent or can be composed of two or more parts. It
can especially be formed to guide the movement of the piston rod, providing for
example a screw thread for coupling the piston rod. The guide nut may be provided to
engage with another component of the drive assembly by means of a friction or by
means of a structured surface on the guide nut, which may se one or more
notches, teeth, grooves, spikes or similar structure elements.
The locking means can be any component that is le to engage with the guide nut
in such a way as to prevent rotation of the guide nut with respect to the housing of the
drive assembly. The locking means can be ed according to the requirements of
dual embodiments. Hence, the locking means can comprise a ever- or leaf
spring-structure with a hook. a pawl or an edge for engagement with the structure
elements of the guide nut as explained above. Moreover, the locking means can be
resilient or ently mounted with respect to the guide nut and/or with respect to the
coupling means.
The locking means may take two . A first state represents an engaged state in
which the locking means is engaged with the guide nut in order to prevent rotation of the
guide nut. This state is preferably taken during drug delivery. A second state represents
a disengaged state in which the locking means is disengaged from the guide nut in
order to allow on of the guide nut. This state is preferably taken during a reset
operation as explained above.
The coupling means can be any component that is suitable to effect the engagement of
the locking means with the guide nut. The coupling means can be formed of only one
part or assembled from two or more parts. er, it can be ed to engage or
couple with the locking means in any mechanical way that is suitable to change the
state of the locking means, i.e. the relative position of the locking means with respect to
the guide nut. In particular, the coupling means can be rotated in such a way that an
engagement of the locking means with the guide nut is allowed or prevented. In case,
engagement of the locking means with the guide nut is ted, the locking means is
released from the guide nut and a rotational movement of the guide nut is allowed which
can especially be provided for a reset operation. The coupling means thus may interact
with the locking means in order to switch the state of the locking means between the
engaged state and the disengaged state.
In a preferred embodiment the ng means is rotatable between a first position and
a second position, wherein in the first position the coupling means prevents
ment of the locking means with the guide nut and wherein in the second position
the coupling means allows ment of the locking means with the guide nut. Thus,
the first position of the coupling means represents the engaged state of the locking
means, whereby the second position of the coupling means represents the disengaged
3O state of the locking means. Preferably, the coupling means rests either in the first
position or in the second on without resting in intermediate positions between the
first and second position. That means, the first and second positions describe discrete
states of the coupling means, wherein in the first position the locking means is definitely
engaged with the guide nut and wherein in the second position the locking means is
definitely aged from the guide nut such that ous behavior of the drive
assembly may not occur or at least may be reduced.
As described above, the locking means is preferably engaged with the guide nut for
moving the piston rod in the distal direction during drug delivery. That means, the guide
nut is rotationally fixed with respect to the housing and may urge the piston rod into a
predetermined movement in distal direction. Preferably, the locking means is
disengaged from the guide nut for enabling a reset operation, y moving the piston
rod in a proximal direction opposite to the distal direction, the guide nut being enabled to
rotate relative to the housing. When the locking means is disengaged from the guide nut,
the guide nut may be d such that the piston rod may be axially shifted in proximal
ion, in order to allow simple and quick resetting of the drive assembly.
Preferably, the locking means is rotationally fixed with respect to the housing.
Independent of any state or position the locking means remains rotationally fixed to the
housing. Hence, a change of on of the locking means caused by a rotation of the
locking means with respect to the housing may not occur. Also, any rotational
movement of the guide nut with respect to the housing is therefore ted when the
guide nut is coupled to the locking means, in particular during drug delivery, wherein the
guide nut is expected to remain rotationally fixed to the housing.
According to one embodiment the coupling means es one or more first fastening
s for engagement with one or more correSponding second fastening members
of a cartridge holder, the coupling means being rotatable by actuation of the first
fastening members. The first fastening members of the coupling means are designed
such that they may interact with at least a part of a cartridge holder when the dge
holder is assembled to the drive assembly. That means, the first fastening members are
3O directed in distal direction towards an opening of the housing of the drive assembly such
that second fastening members of a dge holder may couple to and interact with the
first fastening members.
It is conceivable that the coupling means is rotated via the first fastening members
caused by a rotational mounting movement of the dge holder upon engagement of
the first and second fastening members when the cartridge holder is d on a
distal end of the assembly. That means, switching between the engaged state and the
disengaged state of the locking means via the coupling means may be effected by a
rotational mounting movement during assembly of a cartridge holder. Thus,
ment n the locking means and the guide nut may be operated by
mounting the dge holder to the drive assembly. According to this, the coupling
1O means may act as an intermediary between the cartridge holder and the assembly of
the locking means and the guide nut.
According to one embodiment, the guide nut is at least partially encompassed by the
coupling means and the locking means. In particular, the locking means is designed to
perform radial nt during switching between the engaged state and the
disengaged state. A rotational movement of the coupling means may effect the radial
movement of the locking means. Thus, the locking means may interact with the guide
nut when the locking means moves in radial direction towards the axis of the assembly
caused by rotational movement of the coupling means.
Preferably, the coupling means is designed as a haped member providing one or
more radial recesses. The locking means may be circumferentially arranged on at least
a part of the exterior of the coupling means. According to this arrangement the locking
means may pass the radial recesses of the coupling means in order to engage with the
guide nut. Preferably, the locking means may be a resilient or resiliently mounted
member that is tensioned in radial direction towards the axis of the assembly. This has
the effect that during the disengaged state of the g means the ng means
holds the locking means out of engagement with the guide nut, whereby for switching
into the engaged state of the locking means the coupling means releases the locking
means such that the locking means may be urged to pass the es of the coupling
means caused by spring forces and may engage with the guide nut.
It is also conceivable to arrange the ng means circumferentially on at least a part
of the exterior of the locking means. In this case, the locking means may be resilient or
resiliently mounted and ned in radial ion away from the axis of the assembly.
Contrary to the above-explained embodiment, during the engaged state the coupling
means urges the locking means into engagement with the guide nut against a spring
force, whereby for switching in the disengaged state the coupling means releases the
locking means out of engagement with the guide nut, the locking means passing the
radial es of the coupling means in radial direction away from the axis of the drive
assembly caused by spring forces, thereby aging from the guide nut.
According to one embodiment, a part of the interior of the coupling means near the one
or more radial recesses is designed as a ramp providing a transition from a narrowed
diameter to a broader er of the interior of the coupling means towards the one or
more radial recesses. The ramp provides a kind of angled cut-out which smoothly
receives at least a part of the locking means and prevents the locking means to scratch
with a sharp edge on the wall of the coupling means and to damage the coupling means.
In particular, torsional moments may occur on the guide nut during interaction with a
piston rod guided by the guide nut during drug delivery or while trying to deliver a drug
when the needle is blocked, which means an increased application of force. These
nal moments may urge the locking means into radial movement away from the
axis ofthe assembly. This movement does not lead to a disengagement of the locking
means from the guide nut, but provokes heavy contact forces between the locking
means and the coupling means, the effect of which is y attenuated due to the
above explained ramp-shape of the ng means near the radial es of the
coupling means. Additionally or alternatively, the ramp may be shaped such that when
the locking means is urged radially outwards, a contact between the locking means and
the coupling means is established in an area different from the sharp edge of the
locking means. Thereby, a damage of the coupling means by a contact with the sharp
edge of the locking means can be prevented.
According to one embodiment, the coupling means comprises one or more retaining
means for retaining the coupling means within the housing and for preventing axial
movement of the coupling means with respect to the housing. This means, the coupling
means are exclusively rotatable with respect to the housing, thereby actuating the
iocking means in order to switch the locking means between the engaged state
ement with the guide nut) and the disengaged state (disengagement from the
guide nut).
According to another embodiment, the locking means comprise two members arranged
on opposite sides of a r, wherein the carrier is rotationally fixed with respect to the
housing. The members may be designed as two arms or cantilevers which are arranged
on opposite sides of the r. The locking means may be designed such that one end
of the locking means is fixed to the carrier and the other end of the locking means is
free. At a respective free end, a locking means may provide an edge, pawl or hook for
engagement with corresponding notches or paces of a guide nut. ably, as
explained above, the locking means are ently mounted on the carrier. Thus, the
‘15 locking means may be pivoted on their free ends with the hooks thereon towards the
centre of the r. Thus, the locking means may m a radial nt for
engagement with the guide nut.
According to one embodiment, the free end of the cantilever provides a sinusoidal
shape with at least two reverse loops, n a first loop is molded towards the axis of
the assembly and forms the edge, pawl or hook and wherein a second loop is molded
away from the axis of the assembly and finishes in the free end of the cantilever, the
second loop being designed to at least partially contact with a part of the coupling
means in the engaged state of the locking means. This embodiment may also provide
for a save engagement and contact between the locking means and the coupling means
without the risk of any damage of the coupling means due to scratching of one end of
the tocking means on the coupling means during torsional moments as explained above.
In further embodiments of the drive assembly, the guide nut comprises a screw thread
for coupling the piston rod and enabling a helical movement of the piston rod relative to
the guide nut. The helical movement thereby comprises a concurrent axial and
rotational movement of the piston rod. That means the piston rod is threaded through
the guide nut during drug delivery according to a ermined, e.g. helical movement.
The drive assembly may further se a drive sleeve for driving the piston rod,
wherein the drive sleeve is arranged within the housing and is d with the piston
rod by means of a further screw thread. Preferably the screw thread of the guide nut
and the further screw thread have opposite senses of rotation. A clutch may be provided
within the drive assembly allowing the drive sleeve to be rotationally locked with respect
to the housing in a releasable . This may affect a shift of the drive sleeve relative
1O to the housing along the axis, the shift of the drive sleeve being converted into a l
nt of a piston rod relative to the housing when the drive sleeve is rotationally
locked relative to the housing and the locking means is engaged with the guide nut.
Thus, the piston rod may be urged into helical movement for drug delivery.
The disclosure further relates to a drug delivery device comprising a drive assembly as
explained above and a cartridge holder. The cartridge holder may be releasably
mounted on a distai end of the assembly and may be engaged with the coupling means,
the coupling means interacting with the g means such that the locking means is in
the engaged state. The cartridge holder may comprise a cartridge ning a
medicament or drug to be dispensed.
The drug delivery device can generally be a disposable or reusable device designed to
dispense a dose of a drug. The device may be designed to be operated manually or
electrically and may comprise a mechanism for setting a dose. The device may be
further designed to monitor physiological properties like blood glucose , for
example. Furthermore, said device may comprise a needle or may be needle-free.
The term “medicament” or , as used herein, means a pharmaceutical formulation
containing at least one pharmaceutically active compound,
wherein in one embodiment the pharmaceutically active compound has a molecular
weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a
~10-
DNA, a RNA, an or a fragment a e or an
, an enzyme, antibody f,
oligonucleotide, or a mixture of the above-mentioned pharmaceuticaliy active compound,
wherein in a further embodiment the pharmaceutically active compound is useful for the
treatment and/or prophylaxis of diabetes us or complications associated with
diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as
deep vein or pulmonary thromboembolism, acute coronary me (ACS), angina,
myocardial infarction, cancer, macular degeneration, inflammation, hay fever,
atherosclerosis and/or rheumatoid arthritis,
n in a further embodiment the pharmaceutically active compound comprises at
least one peptide for the treatment and/or prophylaxis of diabetes mellitus or
complications associated with diabetes mellitus such as diabetic retinopathy,
wherein in a r embodiment the pharmaceutically active compound comprises at
least one human insulin or a human insulin analogue or derivative, glucagon-Iike
peptide (GLPA) or an analogue or derivative thereof, or exedin—3 or —4 or an
analogue or derivative of exedin-S 0r exedin-4.
Insulin ues are for example Gly(A21), Arg(B3i), 2) human insulin; Lys(B3),
Giu(829) human n; Lys(BZ8), Pro(829) human insulin; Asp(828) human insulin;
human insulin, wherein proline in position 828 is replaced by Asp, Lys, Leu, Val or Ala
and wherein in position 829 Lys may be replaced by Pro; A|a(826) human insulin;
Des(BZ8-B30) human insulin; Des(827) human insulin and Des(BBO) human insulin.
Insulin derivates are for exampie BZQ—N-myristoyl-des(830) human n; 829-N-
palmitoyi-des(B30) human insulin; BZQ-N-myristoyl human insulin; BZQ-N-palmitoyl
human insulin; BZB-N-myristoyl LysE328Pr0829 human insulin; BZ8—N—palmitoyl-
Pr0829 human insulin; BBO-N-myristoyl-ThrBZQLysBBO human insulin; BBO-N-
palmitoyl- ThrBZQLysBso human insulin; BZQ-N-(N-palmitoyl-Y-glutamyl)-des(B30)
human insulin; B29uN—(N-lithocholyi-Y-glutamyl)-des(B30) human n; BZQ-N-(ou—
-11..
carboxyheptadecanoyl)-des(830) human insulin and BZQ-N-(w-carboxyheptadecanoyl)
human insulin.
Exendin-4 for example means Exendin-4(1-39), a e of the sequence H-His-Gly-
y-Thr~Phe-Thr-Ser—Asp-Leu-Ser—Lys—GIn—Met—GIu—GIu—Glu~Ala-Val-Arg—Leu—Phe—
lie—Glu—Trp—Leu—Lys—Asn-Gly-GIy-Pro-Ser-Ser-Gly—AIa—Pro—Pro—Pro-Ser—NH2.
Exendin—4 derivatives are for example ed from the following list of compounds:
1O H-(Lys)4—des Pr038, des Pr037 Exendin-4(1-39)—NH2,
H—(Lys)5—des Pr036, des Pr037 Exendin-4(t -39)-N H2,
des Pr036 ] n-4(1~39),
des Pr036 [lsoAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14, Asp28] Exendin-4(1—39),
des Pr036 [Met(O)14. lsoAsp28] Exendin-4(‘|-39),
des Pr036 [Trp(02)25, Asp28] Exendin-4(1-39),
des Pr036 [Trp(02)25, lsoAsp28] nr4(1—39),
des Pr036 [Met(O)14 Trp(02)25, Asp28] Exendin-4(‘l-39),
des Pr036 {Met(O)‘l4 Trp(02)25, lsoAsp28] n-4(1-39); or
des Pr036 [Asp281 Exendin-4(1-39),
des Pr036 [lsoAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14, Asp28] Exendin—4(1-39),
des Pr036 [Met(O)14, lsoAsp28] Exendin-4(1-39),
des Pr036 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pr036 [Trp(02)25, lsoAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, lsoAsp28] Exendin-4(i-39),
wherein the group -Lys€>-NH2 may be bound to the C-terminus of the Exendin—4
derivative;
or an Exendin-4 derivative of the sequence
H-(Lys)6-des Pr036 ] Exendin-4(1-39)-Ly36-NH2,
des Asp28 Pr036, Pr037, Pro38Exendin-4(1—39)-NH2,
H-(Lys)6-des Pro36, Pr038 [Asp28] n-4(1-39)-NH2,
H-Asn—(Glu)5des Pr036, Pro37, Pro38 [Asp28] Exendin-4(1-39)—NH2,
des Pro36, Pro37, Pr038 [Asp28] Exendin—4(1—39)—(Lys)6—NH2,
H-(Lys)6-des Pr088, Pr037, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6—NH2,
H—Asn—(Glu)5-des Pr036, Pro37, Pro38 ] Exendin—4(1-39)—(Lys)6—NH2,
H-(Lys)6—des Pr036 [Trp(02)25, Asp28] Exendin—4(1—39)-Ly56-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin—4(1—39)—NH2,
1O H-(Lys)6-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin—4(1—39)—NH2,
H‘Asn—(Glu)5-des Pr036, Pro37, Pr038 Urp(02)25, Asp28] Exendin-4(1-39)—NH2,
des Pro36. Pr037, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6~des Pr036, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn~(Glu)5udes Pr036, Pro37, Pro38 [Trp(02)25, Asp28] Exendin—4(1—39)—(Lys)6-NH2,
H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Ly86-NH2,
des Met(O)14 Asp28 Pr036, Pro37, Pr038 Exendin-4(1-39)-NH2,
)6—desPro36, Pr037, Pr038 [Met(O)14, Asp28] Exendin—4(1—39)-NH2,
H-Asn-(GIu)5-des Pr036, Pro37, Pr038 [Met(O)14, Asp28] Exendm—4(1-39)-NH2,
des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin—4(1-39)-(Lys)6—NH2,
H~(Lys)6~des Pr036, Pro37, Pro38 [Met(O)14, Asp28] Exendin—4(1—39)—(Lys)6—NH2,
H-Asn-(Glu)5 des Pro36, Pr037, Pr038 [Met(O)14, Asp28] Exendin—4(1-39)-(Lys)6~NH2,
H—LysG-des Pr036 [Met(O)14, Trp(02)25, Asp28] n-4(1-39)-Ly86-NH2,
H-des Asp28 Pr036, Pro37, Pr038 [Met(O)14, Trp(02)25] Exendin-4(1—39)—NH2,
H-(Lys)6-des Pro36, Pro37, Pr038 [Met(O)14, Asp28] n-4(‘I-39)-NH2,
H-Asn—(Glu)5-des Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] n-4(1-39)—
NH2,
des Pr036, Pr037, Pro38 )14, Trp(02)25, Asp28] Exendin-4(1-39)—(Lys)6-NH2,
H—(Lys)6-des Pr036, Pro37, Pr038 [Met(O)14, Trp(02)25, Asp28] Exendin—4(S1-39)-
(Lys)6-NH2,
3O H-Asn-(GIu)5-des Pro36, Pr037, Pro38 [Met(O)14, Trp(02)25, Asp28] Exendin-4(1-39)-
(Lys)6—NH2;
or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned
Exedin-4 derivative.
Hormones are for example hypophysis hormones or hypothalamus hormones or
regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008,
r 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
Menotropin), Somatropine (Somatropin), Desmopressln, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for e a glucosaminoglycane, a hyaluronic acid, a heparin, a
low molecular weight heparin or an ultra low molecular weight n or a derivative
thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a
pharmaceutically acceptable salt of a poly—sulphated low molecular weight heparin is
enoxaparin sodium.
Antibodies are globular plasma proteins (~150 kDa) that are also known as
globulins which share a basic ure. As they have sugar chains added to
amino acid residues, they are glycoproteins. The basic functional unit of each antibody
is an immunoglobulin (lg) monomer (containing only one lg unit); secreted antibodies
can also be dimeric with two lg units as with lgA, tetrameric with four lg units like teleost
fish lgM, or pentameric with five lg units, like mammalian lgM.
The lg monomer is a "Y"-shaped le that consists of four polypeptide chains; two
identical heavy chains and two identical light chains connected by disulfide bonds
between cysteine residues. Each heavy chain is about 440 amino acids long; each light
chain is about 220 amino acids long. Heavy and light chains each contain intrachain
disulfide bonds which stabilize their folding. Each chain is composed of structural
domains called lg domains. These domains n about 70-110 amino acids and are
3O classified into ent categories (for example, variable or V, and constant or C)
according to their size and function. They have a teristic immunogiobulin fold in
which two B sheets create a “sandwich” shape, held together by interactions between
conserved cysteines and other charged amino acids.
There are five types of mammalian Ig heavy chain denoted by d, 5, s, y, and p. The type
of heavy chain present defines the e of antibody; these chains are found in lgA,
lgD, lgE, lgG, and IgM antibodies, respectively.
Distinct heavy chains differ in size and composition; a and y contain approximately 450
amino acids and 6 approximately 500 amino acids, while p and a have approximately
1O 550 amino acids. Each heavy chain has two regions, the constant region (CH) and the
variable region (VH). In one species, the constant region is essentially identical in all
antibodies of the same isotype, but differs in dies of different isotypes. Heavy
chains v, a and 6 have a constant region composed of three tandem lg domains, and a
hinge region for added flexibility; heavy chains ii and a have a constant region
composed of four lmmunoglobulin domains. The variable region of the heavy chain
differs in antibodies ed by ent B cells, but is the same for all antibodies
produced by a single B cell or B cell clone. The variable region of each heavy chain is
approximately 110 amino acids long and is composed of a single lg domain.
2O In mammals, there are two types of immunoglobulin light chain denoted by A and K. A
light chain has two successive domains: one constant domain (CL) and one variable
domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each
antibody contains two light chains that are always identical; only one type of light chain,
K or A, is present per antibody in mammals.
Although the general structure of all antibodies is very similar, the unique property of a
given antibody is ined by the le (V) regions, as detailed above. More
specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain,
are responsible for binding to the antigen, i.e. for its n specificity. These loops are
ed to as the Complementarity Determining Regions (CDRs). Because CDRs from
both VH and VL domains contribute to the n-binding site, it is the combination of
the heavy and the light chains, and not either alone, that determines the final antigen
specificity.
An “antibody fragment” contains at least one antigen g fragment as defined above,
and exhibits essentially the same function and specificity as the complete antibody of
which the fragment is derived from. Limited proteolytic digestion with papain s the
lg prototype into three fragments. Two identical amino terminal fragments, each
containing one entire L chain and about half an H chain, are the antigen binding
fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal
1O half of both heavy chains with their interchain ide bond, is the crystalizable
nt (Fc). The Fc ns carbohydrates, ment-binding, and FOR-binding
sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both Fab
pieces and the hinge region, including the H—H interchain disulfide bond. F(ab')2 is
divalent for antigen binding. The disulfide bond of F(ab‘)2 may be cleaved in order to
obtain Fab'. Moreover. the variable regions of the heavy and light chains can be fused
together to form a single chain variable fragment (scFv).
ceutically acceptable salts are for example acid addition salts and basic salts.
Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation
selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen,
an optionally substituted C‘l-CB-alkyl group, an optionally substituted CZ-CB-alkenyl
group, an optionally substituted C6—C10-aryl group, or an optionally substituted 06
heteroaryl group. Further examples of pharmaceutically acceptable salts are described
in "Remington's ceutical Sciences" 17. ed. Aifonso R. o (Ed.), Mark
Publishing Company, , Pa., USA, 1985 and in Encyclopedia of Pharmaceutical
Technology.
ceutically acceptable solvates are for example hydrates.
The features as explained above as well as other features will become apparent from
the following description of drawings, Same ts are d with same reference
numerals.
Figure 1 shows an embodiment of a drug delivery device in a capped and uncapped
state.
Figure 2 shows a perspective view of several parts of the drug delivery device according
to Figure 1.
Figure 3 shows a perspective view of a coupling means of a drive assembly of the drug
delivery device.
Figure 4 shows a perspective view of a guide nut of the drive assembly of the drug
delivery .
Figure 5A shows a ctive view of a first embodiment of a mounting device
providing locking means of the drive assembly.
Figure 58 shows a perspective view of a second embodiment of a mounting device
providing locking means of the drive assembly.
Figure 50 shows a perspective view of a third embodiment of a mounting device
ing locking means of the drive assembly.
Figure 6A shows a perspective view of an assembled coupling means, guide nut and
mounting device according to Figures 3 through 5A.
Figure 6B shows a top view of an assembled coupling means, guide nut and mounting
device according to a second embodiment in the disengaged state.
Figure 60 shows a top view of an assembled coupling means, guide nut and mounting
device according to the embodiment of Figure 6B in the engaged state.
Figure 60 shows a top view of a part of an assembled coupling means, guide nut and
mounting device according to a third embodiment in the disengaged state.
Figure 6E shows a top view of a part of an assembled coupling means, guide nut and
mounting device according to the embodiment of Figure 6D in the engaged state.
Figure 7 shows a ctive view of a part of the drug delivery device with a dge
holder being partially inserted into the drive assembly.
Figure 8 shows a cross-section of an embodiment of the drug delivery .
Figure 1 shows an embodiment of a drug delivery device 1. The drug delivery device 1
according to this ment is a pen-shaped injection device providing a housing 3 of
a drive assembly. A protective cap 50 may be slid over a cartridge holder 2 which is
mounted on a distal end of the housing 3 of the drive assembly. The protective cap 50
may cover at least a part of the cartridge holder 2 in order to cover and protect the
cartridge holder 2 from environmental influences. The drug delivery device 1 may be a
so-called reusable device, wherein the dge holder 2 may be releasably d to
the housing 3 and wherein the drive assembly within the housing 3 may be reused
many times.
Figure 2 shows a perspective view of several parts of the drug delivery device 1
according to Figure i. In particular, the drug delivery device 1 es the housing 3
and the cartridge holder 2 as explained above. Moreover, a mounting device 10 and
coupling means 14 are provided which, according to this embodiment, are hollow or
ring—shaped members that may encompass a guide nut 4 when led within the
housing 3.
Moreover, two bias springs 51 are provided in order to provide a spring force against a
cartridge (not shown in detail) contained within the cartridge holder 2 in order to hold the
dge in a predetermined position at a distal end of the dge holder 2. In
particular, the coupling means 14, the guide nut 4, and the ng device 10 are
described in the following.
Figure 3 shows a perspective view of the coupling means 14 according to Figure 2. The
coupling means 14 is a ring-shaped member which may be assembled within the
housing 3 of the drive assembly such that it is rotatable with respect to the axis of the
drive assembly. Hence, the coupling means 14 may act as a so called turning ring.
Moreover, the coupling means 14 provides retaining means 54 that are arranged on
opposite sides of the haped body of the coupling means 14 in order to retain the
coupling means 14 within the housing and to prevent axial movement of the coupling
means 14 within the housing 3.
The coupling means 14 according to the ment of Figure 3 provides radial
recesses 53 on opposite sides of its main body. Thus, the coupling means 14 is a
hollow member, not only in axial direction, but also in radial direction. The recesses 53
have the effect that the locking means 61 of a mounting device 10 (as shown in greater
detail in Figures 5A and 6A) may pass the radial recesses 53 towards the center of the
coupling means 14 in order to engage with a guide nut 4 as explained below.
Moreover, the coupling means provides a ramp-shaped or surface providing two
ramps 55 arranged at opposite sides of the exterior of the coupling means 14. The
ramps 55 are angled ramps providing a transition from a broader diameter to a
narrowed diameter of the exterior of the coupling means 14. The ramps 55 are arranged
substantially at the positions of the corresponding radial recesses 53. The ramps 55 are
designed in order to enable a locking means 61 of a mounting devrce 10 to slide along
the exterior surface of the ng means 14 from the r part to the narrowed part
3O and to m a radial movement towards the center of the coupling means 14 when
reaching the narrowed diameter of the ng means 14. Interaction between the
coupling means 14 and the locking means 61 of the mounting device 10 will be
explained in greater detail with regard to Figure 6A.
Moreover, the coupling means 14 provides a protrusion 56 that may ct with a
corresponding member of the mounting device 10 in order to hold and secure the
coupling means 14, either in a first or in a second position, wherein the coupling means
14 may be rotated between the first and the second position. The protrusion 56 may aid
the ng means 14 in resting in either of the both positions, not g in but only
traversing positions between the first and the second position. The protrusion 56 is
wedge-shaped wherein the coupling means 14 may rest in the first position, the
corresponding element of the mounting device being ed at one side of the
wedge-shaped protrusion 56, and wherein the coupling means 14 may rest in the
second position, the corresponding element of the mounting device being arranged at
the other side of the shaped protrusion 56. This may aid in defining two discrete
positions of the coupling means 14 with respect to the housing. See also general
ations with regard to Figures 5A, 5B, and 5C.
Furthermore, the coupling means 14 provides first fastening members 52 arranged on
opposite sides at the top of the ring-shaped body of the ng means 14. The first
fastening members 52 are provided for interaction and engagement with corresponding
second fastening members 63 of a cartridge holder 2 (see also Figure 7). The coupling
means 14 may be operated e.g. rotated, via the first fastening members 52. According
to this embodiment, the coupling means 14 may be d during a mounting
nt of a cartridge holder 2 when assembled to the drive assembly as explained
with regard to Figure 7.
Figure 4 shows a perspective view of a guide nut 4 ing a centered hole 5. Within
the centered hole 5 a screw thread 8 is designed for coupling a piston rod of the drive
assembly in order to urge the piston rod in a predetermined helical movement as
3O explained in greater detail with regard to Figure 8. Moreover, according to this
embodiment, the guide nut 4 is designed as a toothed wheel providing teeth 57 and
notches 58 on the exterior circumference of the guide nut 4. The teeth 57 and notches
58 may be d to individual embodiments of the guide nut 4. Thus, the teeth 57
may be designed as spikes, whereby the notches 58 may be designed as interspaces
between the teeth 57 or spikes. The guide nut 4 may be rotationally arranged within the
housing 3 of the drive assembly. In one state of the drive assembly, preferably during
drug delivery, the guide nut 4 may be rotationally fixed by g means 9 of a
mounting device 10 as explained with regard to Figures 6A, 60, and 6E. In another
state of the drive assembly, preferably during a resetting operation, the guide nut may
be rotatable with respect to the housing 3 of the drive assembly as explained with
regard to Figures 6A, 6B and 6D. The ng means 14, according to Figure 3 (and
1O according to other embodiments as explained with regard to Figures 68 h 6E),
may act as an actuation means in orderto enabte a ing between an engaged
state and a disengaged state of the locking means 9 of the mounting device 10 with
respect to the guide nut 4.
Figures 5A through SC show different embodiments of a mounting device 10 providing a
ring-shaped r 11 on which locking means 9 are formed. In detail the g
means 9 comprise two arms or cantilevers which are arranged on te sides of the
carrier 11. With one end, the locking means 9 are fixed to the carrier 11 and with the
other end the locking means 9 are free. At a tive free end, a locking means 9
provides an edge or a book 61 for engagement with corresponding notches 58 or
interspaces of a guide nut 4 according to Figure 4. The locking means 9 are ently
mounted on the carrier 11. Thus, the locking means 9 may be pivoted on their free ends
with the hooks 61 thereon towards the centre of the carrier 11. Thus, the g means
9 may perform a radial movement.
Furthermore, the mounting device 10 provides a retaining means 62 being formed as
another cantilever-structure with a fixed end on the carrier 11 and a free and pointing
substantially in a tangential ion with respect to the ring-shaped carrier 11. The
retaining means 62 provides a protrusion 60 for interaction with the wedge-shaped
protrusion 56 ofthe coupling means 14 according to Figures 3, 6B, and 60 in order to
hold the coupling means 14 in either a first position or in a second position, the
protrusion 60 sliding aiong the wedge—shaped protrusion 56 of the coupling means 14
with the effect on the ng means as explained with regard to Figure 3. Thus, the
mounting device may act as a so called multi-spring element providing ent g
means 9 as well as resilient ing means 62.
According to a first ment of the mounting device 10 as shown in Figure 5A, the
locking means 9 provide protrusions 59 which are molded on the cantilever—formed
locking means 9 and which are directed towards the centre of the carrier 11. The
protrusions 59 are designed for sliding along the ramps 55 on the exterior of the
coupling means 14 (see Figure 3). For further details see Figure 6A.
A second embodiment of the mounting device 10 as shown in Figure SB differs from the
first embodiment as shown in Figure 5A in that the free ends of the cantilever—formed
locking means 9 are bent such that an edge is provided forming protrusions 59 for
engagement with a part of the coupling means 14 in order to actuate the g means
9. Moreover, the respective free ends of the cantilever-formed locking means 9 provide
a sinusoidal shape with at least two reverse loops 61a and 61 b, wherein a first loop 61a
is molded towards the axis of the assembly and forms the hook, edge or pawl 61 for
engagement with respective teeth 57 of the guide nut 4 (see Figure 4) and wherein a
second loop 61 b is molded away from the axis of the assembly and finishes in the free
2O end of the cantilever. The second loop 61 b is designed to at least partially contact with a
part of the coupling means 14 in the engaged state of the tocking means 9, Le. when
the locking means 9 are actuated by the ng means 14 and engage with the guide
nut 4. In ular, in the engaged state, the second loop 61b may be tangentially
arranged with respect to a corresponding part of the coupling means 14, thereby
providing for a smooth contact with the coupling means 14.This embodiment may
provide for a save engagement and contact between the locking means 9 and the
coupling means 14 without the risk of any damage of the coupling means 14 due to
scratching of a sharp edge of a free end of the locking means 9 on the ng means
14 during torsional moments.
In the first and second embodiments of the mounting device 10, the resilient g
means 9 may be tensioned in radial direction towards the axis of the carrier 11 such that
spring forces may urge the locking means 9 towards the axis of the assembly for
engagement with teeth 57 of the guide nut 4 (see Figure 4). That means, the coupling
means 14 may engage with the locking means 9 in order to urge the locking means 9 in
radial direction away from the axis and out of engagement with the guide nut 4 opposite
to the spring forces of the ned locking means 9. In the contrary, when the locking
means 9 are to be brought into the engaged state, the coupiing means 14 may release
the locking means 9 such that the locking means 9 are urged in radial direction s
the axis of the assembly due to the radial spring forces of the locking means 9.
A third embodiment of the mounting device 10 as shown in Figure 50 differs from the
first and second embodiments as shown in Figures 5A and 513 in that the locking means
9 with its cantilevers are arranged such that the interaction of the coupling means 14
and the locking means 9 works in opposite manner according to the principle of the
embodiments of Figures 5A and SB. That means, according to the embodiment of
Figure 50, the ent g means 9 are tensioned in radial ion away from the
axis of the carrier 11 such that spring forces may urge the locking means 9 away from
the axis of the assembly for disengagement from teeth 57 of the guide nut 4 (see Figure
4). That means, the coupling means 14 may engage with the locking means 9 in order
to urge the locking means 9 in radial direction towards the axis and into engagement
with the guide nut 4 opposite to the spring forces of the tensioned g means 9. In
the ry, when the g means 9 are to be brought in the disengaged state, the
coupling means 14 may release the locking means 9 such that the locking means 9 are
urged in radial direction away from the axis of the assembly due to the spring forces of
the locking means 9. For further explanation in this , see Figures BB and BC and
their respective description below.
Figure 6A shows an assembly of the coupling means 14, the mounting device 10 and
the guide nut 4 according to Figures 3 through 5A. The guide nut 4 is encompassed by
the coupling means 14 and the mounting device 10. The coupling means 14 provides a
ledge on the inner circumference of the ring-shaped body in order to hold the guide nut
4 within the coupling means 14 and to prevent upward movement of the guide nut 4 out
of the ring-shaped body of the coupling means. Moreover, the guide nut 4 may
additionally be hold by a part of the r 11 of the mounting device 10 or by a part of
the housing 3, eg. a web-shaped part within the housing 3, in order to prevent
rd movement of the guide nut 4. This means, the guide nut 4 is securely
embedded between the coupling means 14 and the carrier 11 of the mounting device 10
or a part of the housing 3.
Furthermore, the locking means 9 of the mounting device 10 are circumferentially
arranged on at least a part of the exterior of the ng means 14. Thereby, the
protrusions 59 (see also Figure 5A) of the cantilever-formed g means 9 are
‘IO directed towards the exterior surface of the coupling means 14. This may have the
effect that the locking means 9 may slide via the protrusions 59 along the ramps 55 on
the exterior of the coupling means 14.
Figure 6A shows a position of the coupling means 14 representing an engaged state of
the locking means 9. The locking means 9 have passed with their free ends the radial
recesses 53 of the coupling means 14 as explained in the context of Figure 3. This is
enabled due to the fact that the protrusions 59 are lying on the narrowed part of the
er of the coupling means 14.
in the depicted position, the locking means 9 engage via their hooks 61 with the guide
nut 4. In particular, the hooks 61 rest between the teeth 57 in respective notches 58.
Moreover, in this on the hooks 61 engage behind a corresponding edge of the
radial recesses of the coupling means 14. This has the effect that a radial movement of
the hooks 61 out of engagement with the teeth 57 and away from the guide nut 4 due to
torsional moments is prevented in order to enable a secure engagement between the
locking means 9 and the guide nut 4. In ular, torsional moments may occur during
interaction with the guide nut 4 and a piston rod guided by the guide nut 4 during drug
delivery or while trying to deliver a drug but having a bent needle, which means an
increased application of force.
In the position as depicted in Figure 6A rotational movement of the guide nut4 with
respect to the mounting device 10 is prevented. In other words, the guide nut is
rotationally fixed with respect to the mounting device 10. Since the mounting device 10
may be arranged within the housing 3 of the drive assembly in a rotationally fixed
manner, the guide nut 4 may also be onally fixed with respect to the housing 3 of
the drive assembly. In this position which preferably may be taken during drug delivery,
the guide nut 4 may urge a piston rod to be moved in a predetermined nt, is a
helical movement, thereby being threaded through the inner screw thread 8 of the guide
nut 4 (see Figure 4).
In case, the coupling means 14 according to Figure 6A is rotated counter clockwise, the
protrusions 59 of the locking means 9 will slide along the angled ramp 55 of the
coupling means 14 from the narrowed part to the broader part of the diameter of the
coupling means 14. Hence, the locking means 9. i.e. the hooks 61, will be urged out of
engagement with the s 58 of the guide nut 4, the locking means 9 pivoting in
radial direction away from the centre of the assembly. Thus, by rotating the coupling
means 14, the locking means 9 may be released out of engagement with the guide nut
4. This may allow the guide nut 4 to rotate with respect to the mounting device 10.
When the assembly is arranged within the housing 3 of the device, the guide out 4 is
allowed to rotate with respect to the g 3 of the drive assembly such that a reset
operation of the piston rod being coupled with the guide nut 4 may be started. This
2O means, the piston rod may be shifted in proximal direction, the guide out 4 being
enabled to rotate with t to the housing 3.
The Figures BB and 6C respectively show a top view of an assembled ng means
14, guide nut 4 and mounting device 10 according to a second ment in the
disengaged state and the engaged state as well. In particular, the mounting device 10 is
designed according to its embodiment shown in Figure 50. In contrast to the assembly
according to Figure 6A, in the assembly of Figures BB and BC, the coupling means 14 is
circumferentially arranged on at least a part of the exterior of the locking means 9 of the
mounting device 10. The locking means 9. according to this embodiment may be
3O resilient and may be ned in radial direction away from the axis of the assembly (in
contrast to the embodiment of Figure 6A, wherein the locking means 9 may be
tensioned in radial direction towards the axis of the assembly).
Figure BB illustrates the disengaged state of the assembly. The locking means 9, Le.
the hooks 61, are d at least partially in recesses 53 of the coupling means 14 and,
therefore, are out of engagement with the s 58 and the teeth 57 respectively of
the guide nut 4. This state allows the guide nut 4 to rotate with respect to the mounting
device 10. When the assembly is arranged within the housing 3 of the device, the guide
nut 4 is allowed to rotate with respect to the housing 3 of the drive assembly such that a
reset operation of the piston rod being coupled with the guide nut 4 may be started. This
means, the piston rod may be shifted in proximal direction, the guide nut 4 being
enabled to rotate with respect to the housing 3.
Moreover, as rated in Figure 6B, the protrusion 56 of the coupling means 14 is
arranged on one side of the protrusion 60 of the retaining means 62 of the ng
device 10 defining the disengaged state as a discrete state (see also the general
ation in context of Figures 5A through 50 .
Figure BC rates the engaged state of the assembly. Starting from the position of the
coupling means 14 according to Figure BB, the engaged state may be taken by ng
the coupling means 14 clockwise, the angled ramps 55 of the coupling means 14 sliding
along the cantilevers of the locking means 9. Hence, the locking means 9, Le. the hooks
61, will be urged into engagement with the notches 58 and teeth 57 respectively of the
guide nut 4, the locking means 9 pivoting in radial direction towards the centre of the
assembly.
In the depicted position, the locking means 9 engage via their hooks 61 with the guide
nut 4. in particular, the hooks 61 rest between the teeth 57 in respective notches 58.
Moreover, in this position the hooks 61, especially the free ends of the cantilevers of the
locking means 9 may be enclosed by sidewalls of the coupling means 14. This has the
effect that a radial movement of the hooks 61 out of engagement with the teeth 57 and
away from the guide nut 4 due to torsional moments is prevented in order to enable a
secure engagement n the locking means 9 and the guide nut 4. In particular,
torsional moments may occur during interaction with the guide nut 4 and a piston rod
guided by the guide nut 4 during drug delivery or while trying to deliver a drug but
having a blocked needle, which means an increased application of force.
In the position as depicted in Figure 60, the same effects occur as already explained
with respect to Figure 6A, i.e. rotational nt of the guide nut 4 with respect to the
mounting device 10 is prevented. [n this position which preferably may be taken during
drug delivery, the guide nut 4 may urge a piston rod to be moved in a predetermined
movement, i.e. a helical movement, thereby being threaded through the inner screw
thread 8 of the guide nut 4 (see Figure 4).
Moreover, as illustrated in Figure 60, the protrusion 56 of the coupling means 14 is now
ed on the other side of the protrusion 60 of the ing means 62 of the
mounting device 10 defining the engaged state as a discrete state (see also the general
explanation in context of Figures 5A through SC above).
The Figures 6D and 6E respectively show a top view of a part of an assembled coupling
means 14, guide nut 4 and mounting device 10 according to a third ment in the
disengaged state and the engaged state as well. The principle of the assembly
according to Figures SD and SE is basically the same as explained in context with
2O Figure 6A. This means, the locking means 9 of the ng device 10 are
circumferentially arranged on at least a part of the exterior of the coupling means 14
and may pass radial recesses 53 of the coupling means 14 in order to engage with or
disengage from the guide nut 4. According to this ment, a part of the interior of
the coupling means 14 near the radial recess 53 is designed as a ramp 64 ing a
transition from a narrowed diameter to a broader diameter of the interior ofthe coupling
means 14 towards the radial recess 53 as explained below.
Figure 6D shows the disengaged state, the hook 61 of the locking means 9 being out of
engagement with a notch 58 and teeth 57 of the guide nut 4. Figure 6E shows the
engaged state, the hook 61 of the g means 9 being in engagement with a notch
58 and teeth 57 of the guide nut 4.
The ramp 64 provides a kind of angled cut-out which smoothly receives at least a part of
the g means 9 (see Figure 6E) and prevents the locking means 9 to h with a
sharp edge of the free end of the hook 61 on the wall of the coupling means 14 and to
damage the ng means 14. in particular, torsional moments may occur on the
guide nut 4 during interaction with a piston rod guided by the guide nut 4 during drug
delivery or while trying to deliver a drug but having a bent or otherwise blocked needle,
which means an increased application of force. These torsional s may urge the
locking means 9 and hooks 61 into radial nt away from the axis of the ly.
This movement does not lead to a agement of the locking means 9 from the
guide nut 4, but provokes heavy contact forces between the locking means 9 and inner
side walls of the coupling means 14. Due to the above explained angled ramp 64 of the
coupling means 14 near the radial recess 53 of the coupling means 14, only a bent
edge of the cantilever 9 and not the sharp edge of the hook 61 comes into contact with
the inner side walls of the coupling means 14, the effect of heavy contact forces being
notably attenuated and damage of the coulding means 14 being prevented.
Figure 7 shows a perspective view of a part of the drive assembly 1, Le. the cartridge
holder 2 and the housing 3, wherein the cartridge holder 2 is partially inserted into an
opening of the housing 3 at a distal end of the housing 3. Figure 7, furthermore, shows
the assembly of the coupling means 14 and the mounting device 10 according to Figure
6A, arranged within the housing 3. According to Figure 7, the coupling means is in a
position, wherein the locking means 9 is disengaged from the guide nut 4 as explained
in the context of Figure 6A.
With respect to Figure 7, the dge holder 2 may be further moved into the housing 3
such that first fastening members 52 of the coupling means 14 as explained above and
second fastening s 63 of the cartridge holder 2 may interact and engage with
each other. This may effect a rotational movement of the coupling means 14 caused by
a rotational movement of the cartridge holder 2 during mounting the cartridge holder 2
within the housing 3 of the drive assembly. Thus, the cartridge holder 2 may e the
coupling means 14 in order to switch the locking means 9 from the disengaged state to
the engaged state as depicted in Figure 6A via the coupling means 14 acting as an
intermediary between the cartridge holder 2 and the locking means 9. By mounting a
cartridge holder 2 with the housing 3, engagement of the g means 9 of the
mounting device 10 with the guide nut 4 may be enabled. Due to an engagement of the
coupling means 14 with the cartridge holder 2, the coupling means 14 may be switched
from the first position into the second position, wherein the first and second ons
represent discrete and stable positions. Hence, the mechanism of rotationally fixing the
guide nut 4 within the housing 3 according to the mechanism as explained above may
be established in a secure and easy manner in order to prepare the drug delivery device
for drug delivery. The cartridge holder 2 may provide fastening means like a thread,
bayonet coupling or the like corresponding with respective fastening means arranged on
the or of the housing 3 for mounting the cartridge holder 2 to the housing 3.
The drug delivery device will further be described in greater detail with regard to Figure
Figure 8 shows a cross-section of an embodiment of the drug delivery device 1. The
drug delivery device 1 comprises a body or housing 3 with a distal end 20 and a
proximal end 30 and a removable cartridge holder 2 at the distal end 20. The housing 3
forms an exterior housing of the drug ry device. The cartridge holder 2 is attached
by a screw thread 12 mating a screw thread 13 of the main part of the housing 3. Other
means of fastening the cartridge holder 2, like a bayonet joint, are not precluded. The
cartridge holder 2 is provided for a dge 6 containing a drug. A piston or bung 7 is
arranged in the cartridge 6 to be used to expel the drug. The distal end 20 may be
provided with a nozzle 21, which can comprise a screw thread for the ation of a
needle assembly.
The drug ry device 1 ses a dosing mechanism, which includes a piston rod
17. The piston rod 17 has a distal end, which is nearest to the distal end 20 of the
housing 3 and engages the bung 7 or a bearing 18 that is arranged between the bung 7
and the piston rod 17 to reduce s that may be caused by friction. The piston rod
17 is e in the distal direction, i. e. towards the distal end 20, by means of a drive
device, the piston rod 17 pushing the bung 7 within the cartridge 6 in the distal direction
_29_
to expel the drug from the cartridge 6 h the nozzle 21. A first screw thread 15 of
the piston rod 17 is formed towards the distal end, and a second screw thread 16 ofthe
piston rod 17 is formed nearer to the proximal end of the piston rod 17. The first screw
thread 15 and the second screw thread 16 have opposite senses of rotation in this
embodiment. One or both of these screw threads 15, 16 may comprise two or more
single screw threads in helical alignment, forming a so-called multi-start thread, which is
known per se from other mechanical devices.
The drive device comprises a drive sleeve 19, which forms a tube through which the
1O piston rod 17 is moved. The drive sleeve 19 is generally rical and provided with a
bearing 22 carrying a radially extending flange 23 at the proximal end. The second
screw thread 16 of the piston rod 17 is coupled with a corresponding screw thread on
the inner wall of the drive sleeve 19 to guide a helical relative movement of the piston
rod 17 with respect to the drive sleeve 19.
A lly cylindrical clutch 24 is disposed around the drive sleeve 19, and the clutch
24 is at least partially surrounded by a unit stop or end stop 28. The clutch 24 is located
adjacent to the proximal end of the drive sleeve 19. Saw teeth 29 are ed in
azimuthal sequence at the distal end of the clutch 24, and further saw teeth 31 are
arranged in azimuthal sequence at the proximal end of the clutch 24. The clutch 24 is
keyed to the drive sleeve 19 by splines preventing a on of the clutch 24 relatively to
the drive sleeve 19. The clutch 24 is provided with a plurality of flexible arms that
engage a plurality of splines on an or surface of a number sleeve or dose dial
sleeve 27.
A clutch plate 25 and a biasing means 26 are located between the distal end of the
clutch 24 and a radially extending flange at the distal end of the drive sleeve 19. The
biasing means 26 may be a helical spring, for instance. The clutch plate 25 is
onally locked to the housing 3. The proximal face of the clutch plate 25 is provided
3O with saw teeth interacting with the saw teeth 29 at the distal end of the clutch 24 during
the operation of dose setting.
The end stop 28 is disposed between the drive sleeve 19 and the dose dial sleeve 27.
The end stop 28 is rotationally locked to the housing 3 and is free to move y with
respect to the housing 3. In this embodiment, the external surface of the end stop 28 is
provided with a helical groove or thread, which is engaged with a threaded insert 33 of
the dose dial sleeve 27. The insert 33 is retained within the dose dial sleeve 27 by
means of an end cap 34, which is locked both rotationally and axially with respect to the
dose dial sleeve 27. Splines of the end stop 28 may be provided to engage with the
clutch plate 25, thus locking the clutch plate 25 rotationally with respect to the housing 3.
The dose dial sleeve 27 is provided with an outer helical thread 41 guiding a helical
movement of the dose dial sleeve 27 with respect to the g 3. A dose dial grip 46
is disposed at the proximal end 30 of the dose dial sleeve 27 and is ed with a
central opening. A button 49 is provided at the proximal end 30 of the drug delivery
device 1. The button 49 extends through the central opening of the dose dial grip 46
and enters the bearing 22 of the drive sleeve 19.
The first screw thread 15 of the piston rod 17 is guided by the screw thread 8 on the
inner wall of the hole 5 of the guide nut 4. The guide nut 4 is prevented from axial
movement with respect to the housing 3 by means of a web 32 and a part of the
coupling means 14 (not shown in , see context of Figure 6A). This means, a part of
the coupling means 14 prevents axial movement of the guide nut 14 in distal direction,
whereby the web 32 prevents axial movement of the guide nut 4 in proximal direction.
The web 32 can be provided by interfaces or protruding elements formed by al
parts of the housing 3 extending transversely to the axis of the piston rod 17 into the
interior volume of the housing 3. The web 32 can instead be formed by separate
ents that are fastened to the g 3, e.g. by parts of the carrier 11 of the
mounting device 10 (e.g. see Figure 5A). The form of the web 32 is only restricted by its
function to secure the guide nut 4 against an axial shift in proximal direction with respect
to the housing 3. To this end, the web 32 comprises parts d on the proximal side
3O of the guide nut 4, as can be seen from Figure 8.
The locking means 9 can be mounted on the inner wall of the housing 3 or to an insert
that is stationary with respect to the housing 3, eg. the carrier 11 of the mounting
device 10. The coupling means 14 is arranged such that it can operate the locking
means 9 according to the ple explained in the context of Figure 6A. In particular,
the cartridge holder 2 may interact with the ng means 14 such that the ng
means 14 may be rotated via a rotation of the cartridge holder 2, when the cartridge
holder 2 is screwed to the housing 3 by means of the screw threads 12, 13. When the
cartridge holder 2 is attached, the guide nut 4 is onally locked to the housing 3 by
the engaged locking means 9. When the cartridge holder 2 is removed, the guide nut 4
is released and free to rotate relatively to the g 3.
When the guide nut 4 is rotationally locked to the housing 3, the movement of the piston
rod 17 is guided by the screw thread 8 of the guide nut 4 engaging the first screw thread
of the piston rod 17. The movement of the piston rod 17 is thus restricted to a helical
movement relatively to the housing 3. When the guide nut 4 is not rotationally locked to
the housing 3, the movement of the piston rod 17 is no longer cted by the guide nut
4. As the guide nut 4 is still not able to move axially because of the coupling means 14
and the web 32, an axial shift of the piston rod 17 with respect to the housing 3 requires
a corresponding helical movement with respect to the guide nut 4. This helical
movement is easily ted, because the disengagement of the guide nut 4 from the
locking means 9 enables the guide nut 4 to rotate freely and with low friction with
respect to the housing 3 in a way to permit the movement of the piston rod 17.
The operation of the bed embodiment of the drug delivery device will be described
in the following.
To set a dose to be delivered, a user rotates the dose dial grip 46, thereby rotating the
dose dial sleeve 27. The clutch 24 is engaged with the dose dial sleeve 27 by means of
the saw teeth 31 at the proximal end of the clutch 24. This engagement and the d
3O engagement of the clutch 24 and the drive sleeve 19 make the clutch 24 and the drive
sleeve 19 rotate with the dose dial sleeve 27. The clutch plate 25 is pushed towards the
clutch 24 by the biasing means 26 in order to keep the saw teeth 29 of the clutch 24 and
the saw teeth of the clutch plate 25 in contact. The profile of the saw teeth enables the
relative movement of the clutch 24 and the clutch plate 25, which is onally locked
to the housing 3, and this relative movement provides an audible and tactile feedback of
the set operation. The setting of a unit or a specified subunit of a dose can thereby be
indicated, if the saw teeth are ioned accordingly.
The larger the dose to be set. the farther the dose dial sleeve 27 is moved out of the
housing 3. The relative movement of the dose dial sleeve 27 with respect to the housing
3 is helical, because the ng is effected by means of a screw thread. The pitch of
the outer helical thread 41 of the dose dial sleeve 27, the pitch of the second screw
thread 16 of the piston rod 17, and the coupling n the dose dial sleeve 27 and
the piston rod 17 are adapted to enable the helical movement of the dose dial sleeve 27
with respect to the housing 3 while leaving the piston rod 17 stationary with respect to
the housing 3. The piston rod 17 is ined at its position during the set operation,
because the movement of the piston rod 17 is restricted by the engaged guide nut 4.
The end stop 28, which is coupled to the dose dial sleeve 27 but prevented from
rotating with respect to the housing 3, moves in the proximal ion when the dose
dial sleeve 27 is rotated out of the housing 3. When a dose is set equal to the remaining
dispensable contents of the cartridge 6, the end stop 28 abuts a stop means 36 of the
piston rod 17, which prevents the end stop 28 and simultaneously the dose dial sleeve
27 from moving further in the proximal direction, and the set operation is stopped.
It the set dose is too large, the set operation can be corrected by rotating the dose dial
grip 46 in the opposite direction. The reverse rotation of the clutch 24 makes the saw
teeth of the clutch 24 override the saw teeth of the clutch plate 25.
When the d dose has been set, it can be dispensed by pressing the button 49 in
the distal direction. This displaces the clutch 24 in the distal direction with respect to the
dose dial sleeve 27, thereby decoupling the clutch 24 and simultaneously the drive
sleeve 19 from the dose dial sleeve 27. The clutch 24 remains rotationally locked to the
drive sleeve 19. The dose dial sleeve 27 is now free to move helically back in the distal
direction without causing a rotational or helical movement of the drive sleeve. The
displacement of the clutch 24 also moves the clutch plate 25 in the distal direction
against the biasing means 26, until the clutch plate 25 abuts a shoulder on the drive
sleeve 19. The clutch 24 and the clutch plate 25 are thereby engaged, so that a rotation
of the clutch 24 relatively to the clutch plate 25 is prevented. A rotation of the clutch 24
and the drive sleeve 19 with t to the housing 3 is thus also inhibited, because the
clutch plate 25 is rotationally locked to the housing 3 by means of the end stop 28. The
clutch plate 25, the clutch 24 and the drive sleeve 19 are moved together in the distal
direction but do not rotate with respect to the housing 3.
The movement of the drive sleeve 19 causes a helical movement of the piston rod 17
with respect to the housing 3 by means of the second screw thread 16 engaging the
inner screw thread of the drive sleeve 19. As the movement of the piston rod 17 is also
guided by the first screw thread 15 engaging the inner screw thread 8 of the guide nut 4,
and the guide nut 4 is presently engaged with the locking means 9 and thus rotationally
locked to the housing 3, the l movement of piston rod 17 advances the piston rod
17 in the distal direction. The ratio of the s of the first screw thread 15 and the
second screw thread 16 can be ed ing to a desired proportion between the
distance by which the drive sleeve 19 is shifted and the ce by which the piston rod
2O 17 is d relatively to the g 3 during the dispense operation. The movement of
the dose dial sleeve 27 in the distal direction causes the end stop 28 to move back to its
initial position within the housing 3.
When the cartridge 6 is empty, it may be substituted with a new one. For this purpose,
the cartridge holder 2 is removed from the housing 3, the empty cartridge 6 is taken out
of the cartridge holder 2, and a new cartridge is inserted. Before the cartridge holder 2 is
attached to the housing 3, the piston rod 17 is reset to a start position, which is
appropriate in view of the location that is occupied by the bung 7 when the cartridge
holder 2 is attached, which means the piston rod 17 is moved backwards in proximal
direction.
The piston rod 17 is reset in the proximal direction. The movement of the piston rod 17
is cted by the first screw thread 15 and the second screw thread 16 engaging the
guide nut 4 and the drive sleeve 19, respectively. When both the guide nut 4 and the
drive sleeve 19 are stationary with respect to the housing 3, a movement of the piston
rod 17 vely to the g 3 is not possible because the first screw thread 15 and
the second screw thread 16 do not have the same pitch and sense of rotation. The reset
of the piston rod 17 by an axiai movement in the proximal direction is possible when the
guide nut 4 is free to rotate relatively to the housing 3, thus enabling a helical movement
of the guide nut 4 with respect to the piston rod 17 irrespective of the position and
1O movement of the piston rod 17 with respect to the housing 3.
The reset operation is therefore made possible by a release of the guide nut 4. As the
coupling means 14 is operated by the cartridge holder 2, the locking means 9 is
disengaged from the guide nut 4 due to interaction with the coupling means 14, as long
as the cartridge holder 2 is not attached to the housing 3. When the piston rod 17 is
d in the proximal direction, the guide nut 4 rotates according to the required helical
movement of the guide nut 4 with respect to the piston rod 17. When the piston rod 17
is reset, the cartridge holder 2 is attached to the housing 3. The coupling means 14 is
rotated via a onal mounting movement ofthe cartridge holder 2 (see Figure 7) and
enables the locking means 9 to engage with the guide nut 4, so that the guide nut 4 is
rotationally locked to the housing 3. The drug delivery device is then ready for further
operation as described above.
The reset of the piston rod 17 can be performed manually, while the dge holder 2
stays tely removed. The reset can be achieved by pushing the piston rod 17
towards the proximal end 30 or by holding the device with the proximal end 30 ng
down to have the gravitational force move the piston rod 17 to the reset position.
Instead, the piston rod 17 can be pushed by the bung 7 to the reset position, when the
cartridge hoider 2 is being attached and approaches the proximal end 30.
If the cartridge holder 2 is provided with a screw thread 12, it approaches the proximal
end 30 slowly and steadily with every turn of the cartridge holder 2 with respect to the
housing 3 in the course of the attachment. The helical nt of the cartridge
holder 2 with respect to the housing 3, generated by a screw thread, has the
advantage of not building up a load on the bung 7, which might shift the bung 7
before the drug delivery device 1 is used. If the cartridge holder 2 is provided with
a bayonet coupling and there is no screw thread to control the smooth attachment
of the cartridge holder 2, the reset of the piston rod 17 can be supported by
means preventing a premature shift of the bung 7 towards the distal end 20.
An embodiment of the drug delivery device was described in detail in conjunction
with Figure 8, in order to make the drive assembly completely clear. The details of
this embodiment in their ty do not represent the essential features of the
disclosure and do not restrict the scope of the disclosure as claimed. Various
modifications, alterations and substitutions of the drive assembly and the drug
delivery device are within the scope of the disclosure.
The drug delivery device has many advantages, among them the enablement of
an easy ement of the cartridge and a particularly easy reset of the piston
rod. The reset operation thus need not be affected by s of the drive
mechanism concerning the operations of setting and dispensing. The piston rod
can therefore be provided with various functions and realized in various different
embodiments, all of them ng the reset operation as described. The drive
assembly according to the disclosure renders the reset Operation independent of
the other operations of the drive ism and the piston rod.
Comprises/comprising and tical variations thereof when used in this
specification are to be taken to y the presence of stated features, integers,
steps or components or groups thereof, but do not preclude the presence or
addition of one or more other features, integers, steps, ents or groups
thereof.
Reference numerals
drug delivery device
cartridge holder
housing
guide nut
hole of the guide nut
bung
(OOONOUUI-me—X screw thread
locking means
.._\_L_L_\_\—_x m-hCON—AO mounting device
carrier
screw thread
screw thread
coupling means
first screw thread of the piston rod
second screw thread of the piston rod
piston rod
beanng
drive sleeve
distal end
nozzle
beanng
flange
clutch
clutch plate
biasing means
dose dial sleeve
OJQJMNMMNNMNMMA—X—K—k AOCOOONCDO‘IAQJN—‘OCOOOVG end stop
saw teeth at the distal end of the clutch
proximal end
saw teeth at the proximal end of clutch
32 web
33 threaded insert of dose dial sleeve
34 end cap
36 stop means of the piston rod
41 outer helical thread of the dose dial sleeve
46 dose dial grip
49 button
50 protecting cap
51 bias springs
52 first ing members
53 radial recess
54 retaining means
55 ramp
56 protrusion on coupling means
57 tooth
58 notch
59 protrusion on locking means
60 protrusion on retaining means of mounting device
61 hook
61a, 61b sinusoidal loops
62 retaining means
63 second fastening members
64 ramp
Claims (17)
1. A drive ly for a drug delivery device, the drive assembly being connectabie with a cartridge holder and comprising: a housing a piston rod, the piston rod being movable in a distal direction for drug a guide nut, the guide nut being rotatable relative to the housing around an axis of the assembly and provided for guiding the piston rod, a locking means, the locking means being enabled to take an engaged state in which the locking means is engaged with the guide nut in order to prevent rotation of the guide nut and to take a disengaged state in which the locking means is disengaged from the guide nut in order to allow on of the guide nut, and a coupling means, the coupling means being rotatable relative to the housing around the axis of the assembly for interaction with the locking means in order to change between the engaged state and the disengaged state of the g means.
2. The drive assembly according to claim 1, wherein the coupling means is rotatable between a first position and a second position, wherein in the first position the coupling means prevents engagement of the locking means with the guide nut and n in the second position the coupling means allows engagement of the locking means with the guide nut.
3. The drive assembly according to claim 1 or 2, wherein the g means is engaged with the guide nut for moving the piston rod in the distal direction during drug delivery and wherein the locking means is disengaged from the guide nut for enabling a reset Operation, thereby moving the piston rod in a proximal direction te to the distal ion, the guide nut being enabled to rotate relative to the housing.
4. The drive assembly according to one of claims 1 to 3, wherein the coupling means provides one or more first fastening members for engagement with one or more corresponding second fastening members of a cartridge holder, the coupling means being rotatable by ion of the first fastening s.
5. The drive assembly according to one of claims 1 to 4, wherein the guide nut is at least partially encompassed by the coupling means and the locking means, wherein the g means interacts with the guide nut when the locking means moves in radial direction towards the axis of the assembly.
6. The drive assembly according to claim 5, wherein the coupling means is designed as a ring-shaped member, providing one or more radial recesses, the locking means being circumferentially arranged on at least a part of the exterior of the coupling means and provided for passing the recesses of the coupling means in orderto engage with the guide nut.
7. The drive assembly according to claim 5, wherein the coupling means is designed as a ring—shaped member, ing one or more radial es and being circumferentiaily arranged on at least a part of the exterior of the locking means, the locking means being provided for at least partially passing the es of the coupling means in order to disengage from the guide nut.
8. The drive assembly according to claim 6 or 7, wherein a part of the or of the coupling means near the one or more radial recesses is designed as a ramp providing a transition from a narrowed diameter to a broader diameter of the interior of the coupling means towards the one or more radial recesses.
9. The drive assembly according to one of claims 1 to 8, wherein the coupling means comprises one or more ing means for preventing axial nt of the coupling means with respect to the housing.
10. The drive assembly according to one of claims 1 to 9, wherein the locking means comprises two members arranged on opposite sides of a carrier, wherein the r is rotationally fixed with respect to the housing.
11. The drive assembly according to one of claims 1 to 10, wherein the guide nut is a toothed wheel having s between the teeth and wherein the locking means is at least one resilient or resiliently mounted cantilever comprising a hook for engagement with the notches of the guide nut.
12. The drive assembly according to claim 11, wherein the free end of the cantilever provides a sinusoidal shape with at least two reverse loops, n a first loop is molded towards the axis of the assembly and forms the hook and wherein a second |00p is molded away from the axis of the assembly and finishes in the free end of the cantilever, the second loop being designed to at least partially contact with a part of the coupling means in the engaged state of the locking means.
13. The drive assembly according to one of claims 1 to 12, wherein the guide nut comprises a screw thread for ng the piston rod and enabling a helical movement of the piston rod relative to the guide nut.
14. A drug delivery device comprising a drive assembly according to one of claims 1 to 13 and a dge holder, the cartridge holder being releasably mounted on a distal end of the assembly and being engaged with the coupling means, the coupling means interacting with the locking means such that the locking means is in the engaged state when the cartridge holder is assembled to the drive assembly.
15. A drug delivery device according to claim 14, having a shape of an injection pen.
16. A drive ly for a drug delivery device substantially as herein described with reference to any embodiment shown in the anying drawings.
17. A drug delivery device substantially as herein described with nce to any embodiment shown in the accompanying drawings.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11165045 | 2011-05-06 | ||
EP11165045.3 | 2011-05-06 | ||
PCT/EP2012/058181 WO2012152667A1 (en) | 2011-05-06 | 2012-05-04 | Drive assembly for a drug delivery device and corresponding drug delivery device |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ616357A NZ616357A (en) | 2015-03-27 |
NZ616357B2 true NZ616357B2 (en) | 2015-06-30 |
Family
ID=
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