NZ617357B2 - Assembly for a drug delivery device and drug delivery device - Google Patents
Assembly for a drug delivery device and drug delivery device Download PDFInfo
- Publication number
- NZ617357B2 NZ617357B2 NZ617357A NZ61735712A NZ617357B2 NZ 617357 B2 NZ617357 B2 NZ 617357B2 NZ 617357 A NZ617357 A NZ 617357A NZ 61735712 A NZ61735712 A NZ 61735712A NZ 617357 B2 NZ617357 B2 NZ 617357B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- cartridge holder
- housing
- interaction
- assembly
- interaction member
- Prior art date
Links
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- 238000010168 coupling process Methods 0.000 claims description 36
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- 150000002500 ions Chemical class 0.000 claims description 19
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Classifications
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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
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
-
- 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
-
- 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
- A61M2005/2485—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
-
- 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
- A61M5/31525—Dosing
-
- 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
assembly for a drug delivery device (1) is provided comprising a housing (3), a cartridge holder (2) releasably connectable to the housing (3), a resilient member (10), and an interaction member (14) which is configured to mechanically cooperate with the resilient member (10) and with the cartridge holder (2). The resilient member (10) is configured to rotationally bias the interaction member (14). The assembly has a locked state where the cartridge holder (2) is connected to the housing (3), the cartridge holder (2) being obstructed from movement with respect to the housing (3), and an unlocked state where the connection between the cartridge holder (2) and the housing (3) is released, the cartridge holder (2) being freely moveable with respect to the housing (3). For switching from the unlocked state into the locked state, the cartridge holder (2) is brought into mechanical cooperation with the interaction member (14), the cartridge holder (2) is rotated in a first direction with respect to the housing (3), the interaction member (14) thereby being rotated in the first direction such that the interaction member (14) mechanically cooperates with the resilient member (10) and such that a rotational force exerted on the interaction member (14) by means of the resilient member (10) is overcome for switching the assembly from the unlocked state into the locked state. Furthermore, a drug delivery device (1) is provided. The interaction member may comprise an indent or protrusion, wherein the indent or protrusion interacts with a corresponding protrusion or indent of the interaction member. When the interaction member is rotated, by the cartridge holder, past an angle representing a locked position the indent and protrusion pair interact to resist an unlocking rotation. ge holder (2). The resilient member (10) is configured to rotationally bias the interaction member (14). The assembly has a locked state where the cartridge holder (2) is connected to the housing (3), the cartridge holder (2) being obstructed from movement with respect to the housing (3), and an unlocked state where the connection between the cartridge holder (2) and the housing (3) is released, the cartridge holder (2) being freely moveable with respect to the housing (3). For switching from the unlocked state into the locked state, the cartridge holder (2) is brought into mechanical cooperation with the interaction member (14), the cartridge holder (2) is rotated in a first direction with respect to the housing (3), the interaction member (14) thereby being rotated in the first direction such that the interaction member (14) mechanically cooperates with the resilient member (10) and such that a rotational force exerted on the interaction member (14) by means of the resilient member (10) is overcome for switching the assembly from the unlocked state into the locked state. Furthermore, a drug delivery device (1) is provided. The interaction member may comprise an indent or protrusion, wherein the indent or protrusion interacts with a corresponding protrusion or indent of the interaction member. When the interaction member is rotated, by the cartridge holder, past an angle representing a locked position the indent and protrusion pair interact to resist an unlocking rotation.
Description
Description
ly for a drug delivery device and drug delivery device
This disclosure relates to an assembly for a drug delivery . Furthermore, the
disclosure relates to a drug delivery device sing such an assembly.
In a drug delivery device. often. a bung within a cartridge containing a plurality of doses
of a drug is displaced by a piston rod. Thereby, a dose of the drug is expelled from the
dge.
A drug delivery device is described in document EP 1 923 083 A1, for example.
It is an object of the present disclosure to provide an assembly for an improved drug
delivery device, for example a device with increased safety for the user. rmore, an
improved drug delivery device is provided, or to at least provide the public with a useful
choice.
This object may be achieved by the subject matter of the independent .
Advantageous embodiments and refinements are subject matter of the dependent
claims.
One aspect relates to an assembly for a drug delivery device. The assembly may
comprise a housing. Furthermore. the assembly may comprise a cartridge holder. The
cartridge holder may be connectable, preferably able connectable, to the housing.
Furthermore. the assembly may comprise a resilient member. Furthermore. the assembly
may comprise an interaction member. The interaction member may be configured to
mechanically cooperate with the resilient member. The interaction member may be
ured to ically cooperate with the cartridge holder. The resilient member or
an additional resilient member may be configured to rotationally bias the interaction
member. The assembly may have a locked state and an unlocked state. In the locked
state, the cartridge holder is preferably releasable connected to the housing. In the
locked state, the cartridge holder may be obstructed from movement with respect to the
g. in the unlocked state. the connection between the cartridge holder and the
housing may be released. in the unlocked state, the cartridge holder may be moveable
with t to the housing. For switching from the unlocked state into the locked state,
the cartridge holder may be brought into mechanical ation with the interaction
member. The cartridge holder may be rotated in a first ion with respect to the
housing. Thereby, the interaction member may be d in the first direction such that
the interaction member ically cooperates with the resilient member. Thereby, a
rotational force exerted on the interaction member by means of the resilient member may
be overcome for switching the assembly from the unlocked state into the locked state.
The assembly may be configured to provide an axially directed force onto the cartridge
holder, such that, in the unlocked state, the cartridge is set apart from the housing.
Comprises/comprising and grammatical variations thereof when used in this specification
are to be taken to specify 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, components or groups thereof.
Afurtheraspect,describedbutnotclaimedherein,relatestoanassemblyforadrug
delivery device comprising a housing, a cartridge holder ably connectable to the
housing, a resilient member, an interaction member which is configured to mechanically
cooperate with the resilient member and with the cartridge , wherein the resilient
member or an additional resilient member is configured to rotationally bias the interaction
member, wherein the assembly has a locked state where the cartridge holder is
connected to the housing, the cartridge holder being obstructed from movement with
respect to the housing, and an unlocked state where the connection between the
dge holder and the housing is released, the cartridge holder being freely moveable
with respect to the g, n, for switching from the unlocked state into the locked
state, the cartridge holder is t into mechanical cooperation with the interaction
member, the cartridge holder is rotated in a first direction with respect to the housing, the
ction member thereby being rotated in the first direction such that the interaction
member ically cooperates with the resilient member and such that a rotational
force exerted on the interaction member by means of the resilient member is overcome
for switching the assembly from the unlocked state into the locked state, and wherein the
resilient member is configured to provide a radially s directed force onto the
interaction member which is great enough to rotationally lock the interaction member and
the resilient member such that on of the interaction member in the second direction
is prevented when the assembly is in the locked state.
An additional aspect, described but not claimed herein, relates to an assembly for a drug
delivery device sing a housing, a cartridge holder releasably connectable to the
housing, a resilient member, an interaction member which is configured to mechanically
cooperate with the resilient member and with the cartridge holder, wherein the ent
member or an additional resilient member is configured to rotationally bias the interaction
member, wherein the assembly has a locked state where the cartridge holder is
connected to the housing, the cartridge holder being obstructed from movement with
respect to the housing, and an unlocked state where the connection between the
cartridge holder and the housing is released, the cartridge holder being freely moveable
with respect to the housing, wherein, for switching from the unlocked state into the locked
state, the cartridge holder is brought into mechanical cooperation with the interaction
member, the cartridge holder is rotated in a first direction with respect to the housing, the
interaction member thereby being rotated in the first direction such that the interaction
member mechanically cooperates with the resilient member and such that a rotational
force exerted on the interaction member by means of the resilient member is overcome
for switching the assembly from the unlocked state into the locked state, and wherein the
ent member is at least in parts circumferentially arranged on at least a part of the
or of the interaction .
eraspect,describedbutnotclaimedherein,relatestoanassemblyforadrug
delivery device comprising a housing, a cartridge holder releasably connectable to the
housing, a resilient member, an interaction member which is configured to mechanically
cooperate with the resilient member and with the dge holder, wherein the resilient
member or an additional resilient member is configured to rotationally bias the interaction
, wherein the assembly has a locked state where the dge holder is
connected to the housing, the cartridge holder being obstructed from movement with
respect to the housing, and an ed state where the connection between the
cartridge holder and the g is released, the cartridge holder being freely moveable
with respect to the g, wherein, for switching from the unlocked state into the locked
state, the cartridge holder is brought into mechanical cooperation with the ction
member, the cartridge holder is d in a first direction with respect to the housing, the
interaction member thereby being rotated in the first direction such that the interaction
member mechanically cooperates with the ent member and such that a rotational
force exerted on the interaction member by means of the resilient member is overcome
for ing the assembly from the unlocked state into the locked state, and wherein the
interaction member is rotationally locked with respect to the housing by mechanical
cooperation with the ent member and wherein when the assembly is switched from
the locked state to the unlocked state the resilient member or a further resilient member
rotationally biases the interaction member into a second direction opposite to the first
direction.
The ly may have two defined states, which are the locked state and the ed
state. The user can immediately realize when the assembly is in the unlocked state as, in
the unlocked state, the cartridge holder is freely moveable with respect to the housing. In
this way, an erroneous dose setting or delivery ion when the assembly is in the
unlocked state, which may lead to osing, can be ted. User safety is
increased in this way.
The resilient member may comprise a spring force. The resilient member may be
configured to exert a temporary rotational force on the interaction member. Especially
during the switching procedure, e.g. when switching the assembly from the unlocked
state into the locked state, a rotational force is exerted on the interaction member. The
rotational force may be dependent on the angular path travelled by the interaction
member when the assembly is switched from the locked state into the unlocked state.
This rotational force must be overcome by the rotational force exerted onto the cartridge
holder for tely performing the switching operation, i.e. for firmly securing the
cartridge holder to the g. In particular, the rotational force exerted onto the
interaction member may provide a threshold value for the torque to perform the switching
operation. Hence, the ly may stay in the unlocked state unless a sufficiently high
rotational force is exerted onto the cartridge holder for switching the assembly into the
locked state. In this way, unintentional switching of the assembly from
the unlocked state into the locked state can be prevented. This may further help to
increase user safety of the assembly.
For switching the assembly from the unlocked state into the locked state, the interaction
member may be rotationally locked to the cartridge holder. Thus, the interaction
member can easily be brought into mechanical cooperation with the resilient member
when the cartridge holder is rotated in the first ion. No further steps for achieving
the mechanical cooperation n the interaction member and the resilient member
are needed.
According to an embodiment, in the locked state, the interaction member is rotationally
locked with respect to the g by mechanical cooperation with the resilient member,
in particular by means of the spring force provided by the resilient member. In the
unlocked state, the interaction member is rotatable with respect to the housing, in
particular by mechanical cooperation with the cartridge holder. The resilient member
may be secured against rotation with respect to the housing in the locked state and in
the unlocked state. According to an embodiment the interaction member is rotationally
locked with respect to the housing by mechanical cooperation with the resilient member
and when the assembly is switched from the locked state to the unlocked state the
resilient member or a further ent member onally biases the interaction
member into a second ion opposite to the first direction.
The rotational lock between the interaction member and the resilient member in the
locked state may prevent unintentional switching of the ly from the locked state
into the unlocked state. User safety may be sed in this way. In the unlocked state,
the interaction member may be easily rotatable with respect to the housing such that the
user can immediately e the assembly being in the unlocked state. Furthermore, in
the unlocked state, the interaction member may be configured for separating the
cartridge holder from the housing such that the user can realize at once that the
cartridge holder is not firmly connected to the housing. This may further help to se
user safety.
According to an embodiment, the assembly provides an axially directed force onto the
cartridge holder, in ular onto a cartridge inside the cartridge holder. In this way, in
the unlocked state, the cartridge holder may be set apart from the g. The axially
directed force may be provided by the ent member or by at least one additional
spring member.
In the unlocked state. the cartridge holder may be automatically y separated from
the g due to the axially directed force. This force helps the user to take notice of
the unlocked state. An unintentional dose setting or dose ry operation by the user,
who ously believes that the cartridge holder is firmly connected to the housing,
can be ted in this way. The user can realize at once, that the assembly is in the
unlocked state.
According to an embodiment, the resilient member is configured to provide a radially
inwards directed force onto the interaction member. The radially inwards directed force
may be great enough to rotationally lock the interaction member and the resilient
member such that rotation of the interaction member in the second direction is
prevented when the assembly is in the locked state.
Due to the radially inwards directed force, the interaction member may be secured in a
defined rotational position with respect to the housing when the assembly is in the
locked state. When the assembly is in the unlocked state. the radially inwards directed
force may not have a corresponding effect onto the interaction member such that, in the
ed state, rotational lock between the resilient member and the interaction
member may be prevented. Thus, the interaction member may be freely moveable in
the unlocked state.
According to an ment, for switching from the locked state into the unlocked state,
the cartridge holder is rotated in the second direction. The second direction may be
opposite to the first ion. The rotational force provided on the cartridge holder may
thereby be greater than a rotational counter force provided onto the interaction member
by means of the resilient member. In this way, said counterforce may be overcome and
the rotational lock between the ction member and the resilient member may be
released.
According to an embodiment, the resilient member comprises at least one snap feature.
The snap feature may be part of or may be integrally formed with the resilient member,
in particular with a resilient spring arm of the resilient member. Said spring arm may be
radially resilient. The snap e may comprise a protrusion, eg. a bump. The
interaction member may comprise at least one corresponding ction snap e.
The interaction snap feature may be part of or may be integrally formed with the
interaction member. The interaction snap feature may comprise a protrusion, eg. a
bump. The ction snap feature may be ed on an outer surface of the
interaction member. In the locked state, the snap feature and the interaction snap
feature may be configured to abut.
Abutment of the snap feature and the interaction snap feature may rotationally lock the
interaction member and the resilient member in the locked state. In the unlocked state,
the snap feature and the interaction snap feature may be separated, e.g. angularly
separated, from one another such that mechanical interaction of the snap feature and
the interaction snap feature for onally locking the ction member and the
resilient member may be prevented. When the assembly is switched from the unlocked
state into the locked state and vice versa, mechanical cooperation of the snap feature
and the interaction snap feature may lead to the onal force tending to bias the
interaction member in a specific rotational direction, eg. the first direction when the
assembly is ed from the locked state into the ed state and the second
direction when the assembly is switched from the unlocked state into the locked state.
According to an embodiment, in the locked state of the assembly, axial movement of the
cartridge holder with respect to the housing is prevented. Axial movement may be
prevented by mechanical cooperation of a first fastening means of the cartridge holder
and a second fastening means of the housing.
In this way, a firm connection of the dge holder and the housing may be enabled
when the assembly is in the locked state. In particular, any unintentional movement of
the cartridge holder in the locked state may be prevented.
According to an embodiment, mechanical cooperation of the first fastening means and
the second fastening means is configured to limit the rotation of the cartridge holder in
the first and in the second direction with respect to the housing.
The first and the second ing means may be configured such that rotation of the
cartridge holder in the first direction may be ted when the assembly is in the
locked state. Rotation of the cartridge holder in the second direction may be
counteracted when the assembly is in the locked state by the rotational force exerted on
the ction member by the resilient member.
In the unlocked state, the first and the second fastening means may be configured such
that rotation of the cartridge holder in the first and in the second direction is, at least in a
limited fashion, enabled. Accordingly, in the unlocked state, the user may rotate the
dge holder in any of the first and the second direction, thereby realizing that the
cartridge holder is not firmly connected to the g.
According to an embodiment, the first and the second fastening means are configured
such that axial movement of the cartridge holder with respect to the g is allowed
when the assembly is switched from the locked state into the unlocked state.
Accordingly, the cartridge holder may be, at least in a limited fashion, axially le
with respect to the housing when the assembly is in the unlocked state.
According to an embodiment, the interaction member comprises at least one first
coupling member. The first coupling member may be d and arranged for
engagement with at least one corresponding second coupling member of the cartridge
holder for rotationally locking the interaction member and the cartridge holder.
The first and the second coupling member may mechanically interact for switching the
assembly between the locked state and the unlocked state. Furthermore, the first and
the second ng member may mechanically interact when the assembly is in the
locked state. in the unlocked state, the first and the second coupling member may
mechanically interact only in a limited fashion, eg. for switching the assembly from the
unlocked state into the locked state.
According to an embodiment, the interaction member is secured against axial
movement with respect to the housing. The interaction member may comprise a ring-
Iike shape. The resilient member may be at least in parts circumferentially ed on
at least a part of the exterior of the interaction member. Alternatively, the resilient
member may be arranged circumferentially on at least a part of the interior of the
interaction member. The resilient member may also comprise a ring-like shape.
A further aspect relates to a drug delivery device. The device may comprise the
previously described assembly. The device may se a dge. The cartridge
may be, preferably releasably, retained in the cartridge holder. The cartridge may
comprise a drug, ably a plurality of doses of the drug. The device may be a pentype
device, eg. a pen-type injector.
When the assembly is in the unlocked state, the cartridge holder and, thus, the cartridge
is not firmly connected to the g of the device. In this way, a dose setting and a
dose delivery ion of the device, which could lead to the dispense of a dose which
does not mach the desired dose, in particular to osing, may be prevented when
the assembly is in the unlocked state. This may help to facilitate provision of a device
having increased dose accuracy and thus, increased user safety.
Of course, features described above in connection with different aspects and
embodiments may be combined with each other and with features described below.
Further features and refinements become nt from the ing description of the
exemplary embodiments in tion with the accompanying figures.
Figure 1 shows an embodiment of a drug delivery device,
Figure 2 shows a perspective view of several parts of the drug delivery device of Figure
Figure 3 shows a perspective view of an interaction member of the drug delivery device,
Figure 4 shows a perspective view of a guide nut of the drug delivery device,
Figure 5 shows a perspective view of a resilient member of the drug delivery device,
Figure 6 shows a ctive view of an assembled interaction , guide nut and
resilient member according to Figures 3 to 5,
Figure 7 shows a perspective view of a part of the drug delivery device with a cartridge
holder being partially ed into the housing,
Figure 8 shows a perspective view of the housing of the drug delivery device,
Figure 9 shows a perspective view of the cartridge holder of the drug delivery device,
Figure 10 shows a ctive view of a resilient member of the drug ry device
according to a further embodiment,
Figure 11 shows a perspective view of several parts of the drug delivery device of
Figure 1 according to a further embodiment,
Figure 12 shows a cross-section of an embodiment of the drug delivery device.
Figure 1 shows an embodiment of a drug delivery device 1. The drug delivery device 1
is a pen-type device, in particular a pen-type injector. The drug delivery device
comprises a housing 3. The drug delivery device 1 comprises a dge holder 2.
The drug delivery device 1 and the housing 3 have a distal end and a proximal end. The
distal end is indicated by arrow 20 (see Figure 12). The term "distal end" designates that
end of the drug delivery device 1 or a component thereof which is or is to be arranged
closest to a dispensing end of the drug delivery device 1. The proximal end is indicated
by arrow 30 (see Figure 12).The term “proximal end" designates that end of the device
1O 1 or a component thereof which is or is to be arranged furthest away from the
dispensing end of the device 1. The distal end 20 and the proximal end 30 are spaced
apart from one another in the ion of an axis. The axis may be the udinal axis
of the device 1.
The device 1 is a reusable device, i.e. it is configured for setting and dispensing a
plurality of doses of a drug. The drug may be a fluid drug. The term "drug“, as used
herein, means a ceutical formulation containing at least one pharmaceuticaliy
active compound,
wherein in one ment the pharmaceuticaliy active compound has a molecular
weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a e, a
DNA, a RNA, an enzyme,
, an antibody or a fragment thereof, a hormone or an
ucleotide, or a mixture of the above-mentioned pharmaceuticaliy active compound,
wherein in a further embodiment the pharmaceuticaliy active compound is useful for the
treatment and/or prophylaxis of diabetes mellitus or complications associated with
diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as
deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina,
myocardial infarction, cancer, r ration, inflammation, hay fever,
sclerosis and/or rheumatoid arthritis,
wherein in a further embodiment the pharmaceutically active compound comprises at
least one peptide for the treatment and/or prophylaxis of diabetes us or
complications associated with diabetes mellitus such as diabetic retinopathy,
wherein in a further embodiment the pharmaceutically active compound comprises at
least one human insulin or a human insulin analogue or derivative, glucagon-like
peptide (GLP-1) or an analogue or tive thereof, or exedin-3 or exedin-4 or an
analogue or derivative of exedin-3 or exedin-4.
lnsulin analogues are for example Gly(A21), Arg(B31), Arg(832) human insulin; Lys(83),
Glu(829) human insulin; Lys(BZ8), 9) 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; Ala(826) human n;
Des(BZS-BBO) human insulin; 7) human insulin and Des(BBO) human insulin.
lnsulin derivates are for example BZQ-N-myristoyl-des(B30) human insulin; BZQ-N-
palmitoyl-des(B30) human insulin; BZQ-N-myristoyl human insulin; palmitoyl
human n; BZ8-N-myristoyl LysBZ8ProBZQ human insulin; B28-N-palmitoyl-
LysBZBProBZQ human insulin; B30-N-myristoyl-Thr829LysBSO human insulin; B30-N-
palmitoyl- ThrBZQLysBSO human insulin; BZQ-N-(N-palmitoyl-Y-glutamyl)-des(B30)
human n; BZQ-N-(N-lithocholyl-Y-glutamyl)-des(BSO) human insulin; BZQ-N-(w-
carboxyheptadecanoyl)-des(BSO) human insulin and (w-carboxyheptadecanoyl)
human insulin.
Exendin-4 for e means Exendin-4(1-39), a peptide of the sequence H-His—Gly-
Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser—Lys-GIn-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-
lle-Glu-Trp-Leu-Lys-Asn-GIy-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser—NH2.
Exendin-4 derivatives are for example selected from the following list of compounds:
H-(Lys)4-des Pro36, des Pr037 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pr036, des Pro37 Exendin-4(1-39)-NH2,
des Pr036 [Asp28] 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(02)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(1-39); or
des Pr036 [Asp28] 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] n-4(1-39),
des Pr036 [Trp(02)25, Asp28] n-4(1-39),
des Pr036 [Trp(02)25, lsoAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, Asp28] n—4(1-39),
des Pr036 [Met(O)14 Trp(02)25, lsoAsp28] Exendin-4(1-39),
wherein the group 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 [Asp28] Exendin-4(1-39)-Ly36-NH2,
des Asp28 Pr036, Pr037, Pr038Exendin-4(1-39)-NH2,
H-(Lys)6-des Pr036, Pr038 ] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1-39)-NH2,
des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1~39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pr036 [Trp(02)25, Asp28] n-4(1-39)-Ly56-NH2,
H-des Asp28 Pr036, Pr037, Pr038 2)25] Exendin-4(1-39)—NH2,
H-(Lys)6-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2.
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,
des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pr037, Pr038 2)25, Asp28] n-4(1-39)—(Lys)6-NH2,
H-(Lys)6-des Pro36 )14, Asp28] Exendin-4(1-39)-Lys6-NH2,
des Met(O)14 Asp28 Pro36. Pr037, Pr038 Exendin-4(1—39)-NH2,
H-(Lys)6-desPro36, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1—39)-NH2,
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1—39)-NH2,
des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1-39)—(Lys)6-NH2,
1O H-(Lys)6—des Pr036, Pr037, Pr038 [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 Pro36 [Met(O)14, )25, Asp28] Exendin-4(1-39)-LysB-NH2,
H-des Asp28 Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25] Exendin-4(1-39)~NH2,
H-(Lys)6-des Pr036. Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] Exendin-4(1-39)-
NH2,
des Pro36, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] Exendin-4(‘l-39)-(Lys)6-NH2,
H-(Lys)6-des Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] n-4(S1-39)-
(Lys)6-NH2,
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 )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.
es are for example hypophysis hormones or hypothalamus hormones or
regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008,
Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
-13..
A polysaccharide is for example 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 pharrnaceutically able salt thereof. An example of a
pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is
enoxaparin sodium.
Antibodies are globular plasma ns (~150
kDahttpz/Ien.wikipediabrgwiki/Dalton %28unit%29) that are also known as
immunoglobulins which share a basic structure. As they have sugar chains added to
amino acid residues, they are glycoproteins. The basic onal 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 IgA, 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 molecule that consists of four polypeptide chains; two
identical heavy chains and two cal 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 n intrachain
disulfide bonds which stabilize their folding. Each chain is composed of structural
domains called lg domains. These domains contain about 70-110 amino acids and are
fied into different categories (for example, variable or V. and constant or C)
according to their size and function. They have a characteristic immunoglobulin fold in
which two 6 sheets create a “sandwich” shape, held together by interactions n
conserved cysteines and other charged amino acids.
There are five types of mammalian lg heavy chain denoted by d, 6, a, v, and p. The type
of heavy chain present defines the isotype of dy; these chains are found in lgA,
lgD, lgE, lgG, and lgM 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 ,u and e have approximately
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 antibodies of different es. 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 p and e have a constant region
composed of four immunoglobulin domains. The variable region of the heavy chain
differs in antibodies produced by different 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.
in mammals, there are two types of immunoglobulin light chain denoted by A and K. A
light chain has two successive s: one constant domain (CL) and one le
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 dy in mammals.
Although the general structure of all antibodies is very similar, the unique property of a
given antibody is determined 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 antigen specificity. These loops are
referred to as the Complementarity Determining s (CDRs). Because CDRs from
both VH and VL domains contribute to the antigen-binding site, it is the combination of
the heavy and the light chains, and not either alone, that ines the final antigen
specificity.
An “antibody fragment" contains at least one antigen binding 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 ion with papain cleaves the
Ig 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, r in size but containing the yl terminal
half of both heavy chains with their interchain ide bond, is the crystalizable
fragment (F0). The Fc contains carbohydrates, complement-binding, and FcR-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
togetherto form a single chain variable fragment (scFv).
Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
Acid on 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 C1-CB-alkyl group, an optionally substituted alkenyl
group, an optionally substituted C6-C10-aryl group, or an ally substituted 06
heteroaryl group. r examples of ceutically acceptable salts are described
in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark
Publishing Company, , Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical
Technology.
Pharmaceutically acceptable es are for example hydrates.
A protective cap 50 can be slid over the cartridge holder 2 of the device 1.The protective
cap 50 covers at least a part of the cartridge holder 2 for protecting the dge holder
2 from environmental influences.
Figure 2 shows a perspective view of several parts of the drug ry device 1
according to Figure 1.
The device comprises a resilient member 10. The device 1 comprises an interaction
member 14. The resilient member 10 and the interaction member 14 are hollow or ring-
shaped members. The resilient member 10 and the interaction member 14 encompass
a guide nut 4 when assembled within the housing 3 of the device 1. which is described
later on in more detail.
The drug delivery device 1 comprises two spring members 51. Alternatively, the device
1 can comprise only one spring member 51, or even more spring members 51, Le. three
or four spring members 51. The spring s 51 comprise disc springs. In an
assembled state of the device 1, the spring members 51 are ed n the
interaction member 14 and the cartridge 6 inside the cartridge holder 2. The spring
members 51 are coupled to one another. Accordingly, axial and rotational movement of
one spring member 51 relative to the other spring member 51 is prevented. The spring
member 51 which is arranged closer to the interaction member 14 is secured against
1O movement with respect to the interaction member 14 by mechanical cooperation with a
locking feature 12 of the interaction member 14 (see Figure 3). According to this
embodiment, the spring members 51 comprise a separate ent of the device 1.
Alternatively, the spring members 51 can be part of or can be integrally formed with the
ent member 10, for example.
The respective spring member 51 is provided in order to provide a spring force against
a cartridge 6 (see Figure 12). The respective spring member 51 holds the cartridge 6 in
a predetermined on at the distal end of the cartridge holder 2, which is explained
later on in more detail. The cartridge 6 comprises the drug, in particular a plurality of
doses of the drug.The dge 6 is retained within the cartridge holder 2. The cartridge
holder 2 stabilizes the position of the cartridge 6 mechanically.
Furthermore, the spring members 51 exert a distally directed force onto the cartridge
holder 2 such that, when the cartridge holder 2 in not firmly connected, i.e. secured
against axial and rotational movement, to the housing 3, the cartridge holder 2 is
pushed away from the housing 3. Said functionality of the spring members 51 is
explained in connection with the ion for connecting the cartridge holder 2 to the
housing 3 as describe below.
Figure 3 shows a perspective view of the interaction member 14.
The interaction member 14 is a ring-shaped member. The ction member 14 is
assembled within the housing 3 such that it is ble with t to the longitudinal
axis of the device 1. In an unlocked state of the device 1, i.e. when the cartridge holder
2 is not firmly connected to the g 3, the interaction member 14 is rotatable
between a first and a second position. When the device 1 is in a locked state, i.e. when
the cartridge holder 2 is firmly connected to the housing 3, the interaction member 14 is
in the first position, the interaction member 14 being secured against rotation with
respect to the housing 3 by mechanical cooperation with the resilient member 10 which
is explained later in detail.
The interaction member 14 es retaining means 54. The retaining means 54 are
arranged on opposite sides of the ring-shaped body of the interaction member 14. The
retaining means retains the ction member 14 within the housing 3 and prevents
axial movement of the interaction member 14 with respect to the housing 3.
In the embodiment shown, the interaction member 14 comprises radial recesses 53.
The recesses 53 are arranged on opposite sides of the main body of the interaction
member 14. Thus, the interaction member 14 is a hollow member, not only in axial
direction, but also in radial ion with respect to the housing 3. The recesses 53
enable a locking means 9 (see Figure 5) of the resilient member 10 to pass the radial
recesses 53 towards the center of the interaction member 14 in order to engage with
the guide nut 4. In a further embodiment, the locking means 9 are located on the inner
side of the interaction member 14 (not explicitly shown). In this case, the radial recesses
53 may be redundant and the locking means 9 could be moveable via a ramp on the
interaction member 14 for engaging with the guide nut 4. ment of the locking
means 4 and the guide nut 4 is explained below in detail.
The interaction member 14 comprises a ramp—shaped exterior e. Said surface
comprises two ramps 55. The ramps 55 are arranged at opposite sides of the exterior of
the interaction member 14. The ramps 55 are angled ramps providing a transition from
a broader diameter to a narrowed diameter of the exterior of the interaction member 14.
The ramps 55 are ed substantially at the positions of the corresponding radial
es 53. The ramps 55 are designed in order to enable the previously mentioned
locking means 9 of the resilient member 10 to slide along the exterior surface of the
interaction member 14 from the broader part to the narrowed part and to perform a
radial movement towards the center of the interaction member 14 when reaching the
narrowed diameter of the interaction member 14. ction between the interaction
member 14 and the locking means 9 is explained in greater detail in connection with
Figure 6.
The interaction member 14 comprises an interaction snap feature 56. The interaction
snap feature 56 may interact with a corresponding snap feature 60 (see Figure 5) of the
resilient member 10 for rotationally g the interaction member 14 in the first position
with t to the housing 3. The interaction snap e 56 is wedge—shaped. The
interaction snap feature 56 comprises a bump. The ction snap feature 56 is
arranged on the outer surface of the interaction member 14.
The interaction member 14 comprises first coupling members 52. The first coupling
members 52 are arranged on opposite sides at the top of the ring-shaped body of the
interaction member 14. The first coupling s 52 are formed trapezoidal and
protrude in the distal direction from the interaction member 14.
The first coupling members 52 are provided for interaction and engagement with
corresponding second coupling members 63 (see Figures 7 and 10) of the cartridge
holder 2. When the first coupling members 52 mechanically cooperate with the second
coupling members 63, the interaction member 14 is rotationally locked to the cartridge
holder 2. The interaction member 14 can be operated, e.g. rotated, by mechanical
cooperation of the first and second ng s 52, 63. The interaction member
14 is rotatable during a mounting movement of the cartridge holder 2, when said
cartridge holder 2 is assembled to the housing 3, Le. when switching the device 1 from
the unlocked state into the locked state, as explained in connection with Figure 7.
Figure 4 shows a perspective view of a guide nut 4.
The guide nut 4 comprises a centered hole 5. Within the ed hole 5 a screw thread
8 is ed. The screw thread 8 is used for being coupled to a piston rod 17 (see
Figure 12) in order to urge the piston rod 17 in a predetermined helical nt as
explained in greater detail in connection with Figure 12.The guide nut 4 ses a
toothed wheel. The guide nut 4 comprises teeth 57 and notches 58 on the exterior
circumference of the guide nut 4. The teeth 57 may be designed as spikes. 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 device 1. in one state of the
device 1, in particular in the locked state, the guide nut 4 is rotationally fixed by the
1O locking means 9 of the ent member 10 as ned in connection with Figure 6. In
another state, preferably in the unlocked state during which a resetting operation can be
performed, the guide nut 4 is rotatable with respect to the housing 3. The interaction
member 14, according to Figure 3, may act as an actuation means in orderto enable a
switching between the locked state and the unlocked state.
Figure 5 shows the resilient member 10.
The resilient member 10 is secured against rotational movement with respect to the
housing 3, e.g. by mechanical cooperation of retaining members 66 (see Figure 10) with
corresponding retaining s, e.g. nuts, of the housing 3 (not explicitly shown in the
Figures). The ent member 10 comprises a ring-shaped carrier 11. The ent
member 10 comprises the previously mentioned locking means 9. The locking means 9
is formed in the carrier 11. The locking means 9 comprises at least one spring arm. In
this embodiment, the locking means 9 comprises two arms or cantilevers which are
arranged on opposite sides of the carrier 11. Alternatively, the locking means 9 could
comprise three or more spring arms. 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 respective free end,
the respective locking means 9 comprises an edge or a hook 61 for engagement with
corresponding notches 58 or interspaces of the guide nut 4. The locking means 9 are
resiliently mounted on the r 11. Thus, the locking means 9 are ble on their
free ends with the hooks 61 thereon towards the centre of the carrier 11. Thus, the
locking means 9 may perform a radial movement.
The locking means 9 provide protrusions 59. The protrusions 59 are molded on the
cantilever-formed locking means 9. The protrusions 9 are directed towards the centre of
the r 11. The protrusions 59 are designed for sliding along the ramps 55 on the
exterior of the ction member 14 (see Figure 3). For further details see Figure 6.
The resilient member 10 provides a retaining means 62. The retaining means 62 may
comprise a further spring arm. In particular, the retaining means 62 may be formed as
another cantilever-structure. The ing means 62 comprises a fixed end on the
1O carrier 11 and a free end pointing substantially in a tangential direction with respect to
the haped carrier 11. The retaining means 62 comprises the previously ned
snap feature 60. The snap e 60 mechanically interacts with the wedge-shaped
interaction snap feature 56 of the interaction member 14 in order to hold the interaction
member 14 in a fixed, in particular rotationally secured on, with respect to the
resilient member 10 when the device 1 is in the locked state.
The retaining means 62 is biased in the radial inward direction with respect to the
longitudinal axis of the device 1. In particular, the retaining means 62 is configured to
exert a radially inwards directed force onto the interaction member 14. Said force must
be overcome for rotating the interaction member 14 into the first position, in ular
for rotationally looking the ction member 14 and the resilient member 10 by
abutment of the snap features 56, 60. Accordingly, in the locked state of the device 1,
the radially inwards directed force must be overcome for releasing the rotational lock
between the interaction member 14 and the ent member 10 and for rotating the
interaction member 14 out of the first position. This is explained later on in detail.
Figure 6 shows an assembly of the interaction member 14, the resilient member 10 and
the guide nut 4.
3O The guide nut 4 is encompassed by the interaction member 14 and the resilient member
. The interaction member 14 provides a ledge on the inner circumference of the ring-
shaped body in order to hold the guide nut 4 within the interaction member 14 and to
prevent upward movement of the guide nut 4 out of the ring-shaped body of the
ction member 14. The guide nut 4 is securely embedded between the interaction
member 14 and the carrier 11 of the resilient member 10. The guide nut 4 may be
prevented from axial nt with respect to the housing 3 by means of a web 32 of
the housing 3 which is explained in detail in connection with Figure 12.
Furthermore, the locking means 9 of the resilient member 10 are circumferentially
arranged on at least a part of the exterior of the interaction member 14. Thereby, the
protrusions 59 (see also Figure 5) of the cantilever-formed locking means 9 are directed
towards the exterior surface of the interaction member 14. This may have the effect that
the locking means 9 can slide via the protrusions 59 along the ramps 55 on the exterior
of the interaction member 14.
Figure 6 shows a position of the interaction member 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 interaction member 14 as explained in connection with of Figure 3.
This is enabled due to the fact that the protrusions 59 are lying on the narrowed part of
the diameter of the interaction member 14.
In Figure 6, 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 tive notches 58. er,
in this position, the hooks 61 engage behind a corresponding edge of the radial
recesses 53 of the interaction member 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 ted in order to enable a secure ment between the
g means 9 and the guide nut 4. Torsional moments may, for example, occur
during interaction with the guide nut 4 and a piston rod 17 guided by the guide nut 4
during drug delivery or while trying to inject a dose but having a bent needle.
in Figure 6, rotational movement of the guide nut 4 with respect to the resilient member
is prevented. In other words, the guide nut 4 is onally fixed with respect to the
resilient member 10. Since the resilient member 10 is arranged within the housing 3 in a
rotationally fixed manner, the guide nut 4 is also rotationally fixed with respect to the
housing 3. In this position, which preferably may be taken during drug delivery, the
guide nut 4 urges the piston rod to perform a predetermined movement, i.e. a helical
movement, the piston rod 17 thereby being threaded through the inner screw thread 8
of the guide nut 4 (see Figure 4).
In case the ction member 14 is rotated counter clockwise, i.e. in the ion the
cartridge holder 2 is rotated for being released from the device 1, i.e. for switching the
device 1 in the unlocked state, the sions 59 of the g means 9 slide along the
1O angled ramp 55 of the interaction member 14 from the narrowed part to the r part
of the diameter of the interaction member 14. Hence, the locking means 9, in particular
the hooks 61, are urged out of engagement with the notches 58 of the guide nut 4, the
locking means 9 ng in radial direction away from the centre of the assembly. Thus,
by rotating the interaction member 14, the locking means 9 is released out of
engagement with the guide nut 4. This may allow the guide nut 4 to rotate with respect
to the resilient member 10. When the guide nut 4 is allowed to rotate with respect to the
g 3, the device 1 is in the ed state. When the guide nut 4 is allowed to
rotate with respect to the housing 3, a reset operation of the piston rod 17 being coupled
with the guide nut 4 may be started. This means, the piston rod 17 may be shifted in
proximal direction.
Figure 7 shows a perspective view of a part of the drug delivery device 1 with the
cartridge holder 2 being partially inserted into the housing 3. Figure 7, furthermore,
shows the assembly of the interaction member 14 and the resilient member 10
according to Figure 6, arranged within the housing 3.
In Figure 7, the interaction member 14 is in a position, wherein the g means 9 is
disengaged from the guide nut 4 as explained in connection with Figure 6.
With respect to Figure 7, the cartridge holder 2 is further moved into the housing 3 such
that the first coupling member 52 of the interaction member 14 and the second coupling
member 63 of the cartridge holder 2 interact and engage with each other. This effects a
rotational movement of the interaction member 14 caused by a onal movement of
the cartridge holder 2 during mounting the cartridge holder 2 within the housing 3. Thus,
the cartridge holder 2 operates the interaction member 14 in order to switch the device
1 from the unlocked state to the locked state as depicted in Figure 6 with the interaction
member 14 acting as an intermediary between the cartridge holder 2 and the locking
means 9. This is explained in connection with Figures 8 and 9 in more detail.
By mounting the cartridge holder 2 with the housing 3, engagement of the locking
means 9 of the resilient member 10 with the guide nut 4 is enabled. Due to the
engagement of the interaction member 14 with the cartridge holder 2, the interaction
member 14 is switched from the second position with respect to the g 3 into the
first position with respect to the g 3 where it is rotationally locked to the resilient
member10 wherein the first and second positions ent discrete and stable
positions. Hence, the mechanism of rotationally fixing the guide nut 4 within the housing
3 as explained above is ished in a secure and easy manner in order to prepare
the drug delivery device 1 for drug delivery.
Figure 8 shows the housing 3 of the drug ry device 1. Figure 9 shows the
dge holder 10 of the drug delivery device 1.
The cartridge holder 2 is releasably table to the housing 3 of the drug delivery
device 1. The housing 3 comprises two second fastening means 65, wherein only one
of the second fastening means 65 is shown in Figure 8. Alternatively, the housing 3 can
comprise only one second fastening means 65 or even more. eg. three or four second
fastening means 65. The second fastening means 65 are arranged in the distal end
section of the housing 3, Le. the end section which is to be connected to the cartridge
holder 2. The second fastening means 65 are arranged on the inner surface of the
housing 3. The two second fastening means 65 are ed tely with respect to
one another.
The second fastening means 65 comprises a pin. The pin protrudes radially inwards
from the inner surface of the housing 3. In the embodiment shown in Figure 8, the
angular extent of the second fastening means 65 is greater than its axial extent.
However, the situation may be vice versa, as well, i.e. the axial extent of the second
fastening means 65 may be greater than its r extent. Alternatively, the second
fastening means 65 can comprise a square or circular shape. The respective second
fastening means 65 is adapted to mechanically cooperate with the corresponding first
fastening means 64, e.g. a guide track, of the cartridge holder 2 (see Figure 9).
The cartridge holder 2 comprises two first fastening means 64. atively, the
cartridge holder 2 can comprise only one first fastening means 64 or even more, e.g.
three or four first ing means 64. The number of first ing means 64
corresponds to the number of second fastening means 65. The first fastening means 64
are arranged in the proximal end section of the cartridge holder 2, i.e. the end section
which is to be connected to the housing 3. The first fastening means 64 are arranged on
the outer surface of the cartridge holder 2. The two first fastening means 64 are
arranged oppositely with respect to one another.
The respective first fastening means 64 comprises a first section 64A. The first
fastening means 64 ses a second section 64B. The path defined by the first
n 64A encloses an angle with the longitudinal axis of the device 1. The angle
which is enclosed by the path defined by the first section 64A with the longitudinal axis
s to by 45 degrees in the embodiment shown in Figure 9. However, also other
angles are conceivable, e.g. the angle can amount to a minimum value of 10 degrees or
a maximum value of 120 degrees. The second section 648 runs less ely with
respect to the longitudinal axis than the first section 64A. The angle enclosed by the
path defined by the first section 64A with the udinal axis of the device 1 is smaller
than the angle enclosed by the path d by the second section 648 with the
longitudinal axis. The angle which is enclosed by the path defined by the second section
648 with the longitudinal axis amounts to 90 degrees in the embodiments shown in
Figure 9.
The first section 64A and the second section 648 form a continuous guide track. In
other words, for connecting or disconnecting the cartridge holder 2 to the housing 3, i.e.
-25..
for switching the device 1 from the unlocked state into the locked state and vice versa,
the second fastening means 65 can pass from the first section 64A directly into the
second section 64B and vice versa.
The second section 648 comprises an angular stop face 64C. The angular stop face
640 is formed by a sidewall of the second section 648. When the second fastening
means 65 mechanically cooperates with the angular stop face 640, r rotation of
the cartridge holder 2 with respect to the housing 3 for connecting the cartridge holder 2
and the housing 3 is prevented.
The cartridge holder 2 further ses two of the previously mentioned second
coupling members 63. The second coupling members 63 are arranged in the proximal
end n of the cartridge holder 2. The two second coupling members 63 are
arranged oppositely with t to one another. The second coupling members 63
comprise trapezoidal indentations. The respective second coupling member 63
comprises sloped edges. The second coupling member 63 comprises an angular extent
which is greater than the r extent of the first n 64A. The distal end of the
respective second coupling member 63 passes over into the proximal end of the first
section 64A of the respective first ing means 64.
In the following, the operation of switching the device 1 from the unlocked state into the
locked state, i.e. of firmly connecting the cartridge holder 2 to the housing 3, is
described in detail.
For connecting the cartridge holder 2 to the housing 3, the cartridge holder 2 is moved,
in ular at least one of axially moved and rotated, with respect to the housing 3.
Thereby, the second fastening means 65 is introduced into the respective second
coupling member 63. In particular, the cartridge holder 2 is moved with respect to the
housing 3 until the second fastening means 65 mechanically cooperates with the
3O second coupling member 63. Upon further nt of the cartridge holder 2 with
respect to the housing 3, the second fastening means 65 is brought into ical
cooperation with the first section 64A. When the second fastening means 65
~26-
mechanically cooperates with the first section 64A, the cartridge holder 2 is moved
ally with t to the housing 3 such that the first section 64A slides along the
second fastening means 65. Thereby, the first coupling member 63 is moved towards
the second coupling member 52 of the interaction member 14.
Upon axial movement, the cartridge holder 2 is rotated in a first direction, which is in the
following referred to as connection direction, with respect to the housing 3 by
mechanical cooperation of the first section 64A and the second fastening means 65.
The interaction member 14 does not yet rotate with respect to the housing 3 as it is not
yet onally locked to the cartridge holder 2 by mechanical cooperation of the first
and second coupling members 52, 63.
The cartridge holder 2 is rotated by an angle of less than 45 degrees with respect to the
housing 3 while the second fastening means 65 mechanically ates with the first
section 64A. The angle is defined by the angle which the path defined by the first
n 64A encloses with the longitudinal axis of the device 1 as bed above.
At the distal end of the first section 64A, the first section 64A directly passes over into
the second section 648. When the second fastening means 65 mechanically
cooperates with the distal end of the first section 64A, the second coupling member 63
ically cooperates with the first coupling member 52, in particular, the first and
second coupling members 52, 63 are engaged. ingly, as described above, the
interaction member 14 is now rotationally locked to the cartridge holder 2.
At the distal end of the first section 64A, the second fastening means 65 is brought into
mechanical ation with a distal and a proximal wall of the second section 648
such that further axial movement of the cartridge holder 2 with respect to the housing 3
is prevented. In particular, mechanical cooperation of the second fastening means 65
with the distal wall of the second n 64B prevents further proximal movement of the
cartridge holder 2 with respect to the housing 3 during the connection operation.
The cartridge holder 2 is now further rotated in the first direction, but no longer axially
moved with respect to the housing 3. Thereby, the interaction member 14 is rotated in
the first direction, the locking means 9 of the resilient member 10 sliding along the
exterior surface of the interaction member 14 from the r part to the narrowed part
as well as the retaining means 62 sliding along the exterior part of the interaction
member 14.
The cartridge holder 2 is rotated such that the second section 64B slides along the
second fastening means 65 until the second fastening means 65 mechanically
cooperates with the angular and stop 64C. The cartridge holder 2 is rotated in the same
direction when the second fastening means 65 ically cooperates with the first
and the second section 64A, 648 for connecting the cartridge holder 2 to the housing 3,
Le. in the connection direction.
While ng the cartridge holder 2, and thus, the interaction member 14 further in the
first direction, in particular while the angular end stop 640 is rotated towards the second
fastening means 65, the snap feature 60 starts to mechanically cooperate with the
interaction snap feature 56, in particular the first sloped section 56A of the ction
snap feature 56 (see Figure 3) mechanically cooperates with the first sloped section
60A of the snap feature 60 (see Figure 5). Thereby, the retaining means 62 is bowed in
the radial outward direction with respect to the housing 3 against the radially inwards
directed force provided by the retaining means 62. Due to mechanical cooperation of
the sloped sections 56A, 60A, the radially inwards ed force is converted into a
tangential, i.e. onal force, in particular into a rotational force directed into the
disconnection ion. The rotational force provided onto the interaction member 14 by
means of the rotation of the cartridge holder 2 must be great enough such that said
rotational counter force is overcome for the interaction snap feature 56 to pass the snap
feature 60 and, hence, forthe device 1 to be ed from the unlocked state into the
locked state.
When the onal force provided onto the dge holder 2 in the connection
direction is greater than the rotational rforce, the interaction snap feature 56
slides over, i.e. , the snap feature 60 such that. once the ction snap feature
56 has passed the snap feature 60, the retaining means 62 automatically moves back
radially inwards and the snap features 56, 60 abut with one another, in particular the
second sloped sections 568, 608 (see Figures 3 and 5) of the snap features 56, 60 abut.
Rotation of the ction member 14 in the direction opposite to the tion
direction, which is in the following referred to as disconnection direction, is now
prevented by ical cooperation of the snap features 56, 60. In particular, the
interaction member 14 is rotationally locked to the ent member 10 by mechanical
cooperation of the snap features 56. 60, in particular of the sloped sections 568, 608.
Now, the interaction member 14 is in a predetermined, i.e. the first, position with respect
to the housing 3 such that axial and rotational movement with respect to the housing 3
is prevented. As the interaction member 14 is rotational locked to the cartridge holder 2,
rotation of the cartridge holder 2 in the nection ion is prevented, as well.
When the interaction member 14 is rotationally locked to the ent member 10, the
second fastening means 65 mechanically cooperates with the angular end stop 64C as
described above, further rotation of the cartridge holder 2 in the connection direction
thus being prevented, as well. Hence, a rotational force provided onto the interaction
member 14 in the connection direction due to mechanical cooperation of the second
sloped edges 56B, 608 of the snap features 56, 60 after the interaction snap e 56
has passed the snap feature 60 cannot lead to further rotational movement of the
interaction member 14, and hence, of the cartridge holder 2, in the connection direction.
Accordingly, the device 1 is in the locked state. the dge holder 2 being firmly
connected to the housing 3.
Mechanical cooperation of the second fastening means 65 and the angular end stop
640 can provide an audible or tactile feedback indicating to the user that the cartridge
holder 2 is firmly connected to the housing 3. Also, when the interaction snap feature 56
passes the snap feature 60, an audible or tactile feedback can be provided indicating to
the user that the interaction member 14 is rotationally locked and, thus, that the
cartridge holder 2 is firmly connected to the housing 3.
The second fastening means 65 as well as the first section 64A and the second section
64B comprise a dimension such that the second fastening means 65 mechanically
cooperates with the walls of the sections 64A, 648 at any time during the connecting
operation. In particular, when the second fastening means 65 mechanically ates
with the first section 64A, the second fastening means 65 abuts the side walls of the first
section 64A. When the second fastening means 65 mechanically cooperates with the
second section 648, it abuts the distal and proximal walls of the second section 648. As
the first and second section 64A, 64B pass over into one another, i.e. the side walls of
the first section 64A pass over into the distal and proximal walls of the second section
64B, the second fastening means 65 is at any time in ical contact with the wall
of one of the sections 64A, 648 during the connection ion.
When the rotational force ed onto the cartridge holder 2 in the connection
direction is not greater than the rotational counterforce provided onto the ction
member 14 such that the interaction snap feature 65 does not pass the snap feature 60,
the resilient member 10 automatically rotates the interaction member 14 and, hence, the
cartridge 2 which is rotationally locked to the interaction member 14, in the
disconnection direction, due to the rotational counter force provided onto the interaction
member 14. Thereby, the second section 64B of the first fastening means 64 slides
back along the second fastening means 65 until reaching the distal end of the first
n 64A. Once having reached the distal end of the first section 64A, the cartridge 2
is y moveable with respect to the g 3. The previously mentioned spring
members 51 now push the cartridge holder 2 in the distal direction, in particular away
from the housing 3 and, thus, the first section 64A slides along the second fastening
means 65, the cartridge holder 2 thereby being rotated further in the disconnection
ion. The coupling means 63 of the cartridge holder 2 is thereby moved out of
engagement with the coupling means 52 of the interaction member 14 such that the
cartridge holder 2 and the interaction member 14 are no longer rotationally locked with
one another.
As an alternative to the spring members 51, the distally directed force may be exerted
by the resilient member 10. In this case, the spring members 51 may be redundant and
the resilient member 10 may comprise one, preferably two or more, spring arms 67 (see
Figure 10). Said spring arms 67 or cantilevers are arranged on opposite sides of the
carrier 11. With one end, the spring arms 67 are fixed to the carrier 11 and with the
other end the spring arms 67 are free. The spring arms 67 distally bias the cartridge
holder 2, pushing the cartridge holder 2 away from the housing 3 when the cartridge
holder 2 is not firmly connected to the housing 3, Le. when the device 1 is in the
unlocked state.
In an ative embodiment (see Figure 11), an additional resilient member, e.g. a
torsion spring 68, is provided. Said torsion spring 68 is used for rotationally biasing the
interaction member 14. In this case, a onal bias provided on the interaction
member 14 by means of the ent member 10 may be redundant and the resilient
member 10 may be provided only for rotationally g the interaction member 14 and
the guide nut 4, for example. The torsion spring 68 rotationally may bias the interaction
member 14 in the disconnection direction. ingly, the torsion spring 68
tically rotates the interaction member 14, and hence, the cartridge holder 2, in
the disconnection direction when the rotational force provided on the cartridge holder 2
in the connection direction for connecting the cartridge holder 2 to the housing 3 is not
great enough for onally locking the interaction member 14 to the resilient member
in the embodiment shown in Figure 11, a further spring element 69, e.g. a coil spring, is
provided. Said spring element 69 is provided for exerting the previously described
distally ed force onto the cartridge holder 2. Hence, in said ment, the
previously described spring members 51 are redundant, as well. The spring element 69
is covered by a cover 70. Said cover 70 is used for preventing damage to the cartridge
holder 2 or to the cartridge 6 when the spring element 69 mechanically cooperates with
the proximal end of the cartridge holder 2 or the cartridge 6 for biasing the cartridge
holder 2 and the cartridge 6 distally. The cover 70 is arranged between the spring
element 60 and the cartridge holder 2.
The previously described automatic rotation of the interaction member 14 in the
disconnection direction automatically holds the device 1 into the unlocked state, i.e. the
state where the cartridge holder 2 is not firmly connected to the device 1, in particular
where the cartridge holder 2 is at least one of axially and rotationally moveable with
respect to the device 1, when the force provided onto the cartridge holder 2 is not
sufficient for overcoming the rotational counter force provided onto the interaction
member 14.
In the following, the operation of ing the device 1 from the locked state into the
unlocked state, i.e. of disconnecting the cartridge holder 2 to the housing 3, is described
in detail.
For disconnecting the cartridge holder 2 from the housing 3, a rotational force is
provided onto the cartridge holder 2, the force being ed into the disconnection
direction. Thereby, the retaining means 62 is bowed again in the radial outward
direction with respect to the housing 3 against the radially inwards directed force
provide by the retaining means 62. Due to mechanical cooperation of the sloped
ns 568, 608, the radially s directed force results in a tangential, i.e.
rotational component, in particular a component ed into the connection direction.
The rotational force in the disconnection direction provided onto the interaction member
14 by means of the dge holder 2 must be great enough such that said rotational
counter force onto the ction member 14 in the connection direction is me for
the interaction member 14 to be rotated in the disconnection direction, i.e. forthe
ction snap e 56 to pass the snap feature 60.
When the rotational force provided onto the cartridge holder 2 in the disconnection
direction is greater than the rotational counterforce provided by the ent member 10,
the interaction snap feature 56 slides over, i.e. passes, the snap feature 60 such that,
once the interaction snap feature 56 has passed the snap feature 60, the retaining
means 62 automatically moves back radially inwards and the snap features 56, 60, in
particular the first sloped sections 56A, 60A abut with one another. Now, the resilient
member 10 rotates the interaction member 14 and, hence, the cartridge holder 2 which
is onally locked to the interaction member 14, in the disconnection direction, due to
the rotational force provided onto the ction member 14 arising from mechanical
cooperation of the first sloped ns 56A, 60A. The further steps of the disconnection
operation proceed in accordance with the previously described steps of the connection
ion in case that rotation of the cartridge holder 2 in the connection direction is not
completely performed, in particular in case that the rotational force provided onto the
cartridge holder 2 in the connection direction is smaller than the rotational counter force
provided onto the interaction member 14.
The drug delivery device is further described in greater detail with regard to Figure 12.
Figure 12 shows a cross-section of an embodiment of the drug delivery device 1.
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 an engaging means 21, which can comprise a screw
thread for the application of a needle assembly.
The drug delivery device 1 comprises a dosing mechanism, which includes the
previously mentioned 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
ed n the bung 7 and the piston rod 17 to reduce damages that may be
caused by friction. The piston rod 17 is movable in the distal direction, i. e. towards the
distal end 20, by means of a drive member 19, the piston rod 17 pushing the bung 7
within the cartridge 6 in the distal direction to expel the drug from the cartridge 6 through
the engaging means 21. A first screw thread 15 of the piston rod 17 is formed towards
the distal end, and a second screw thread 16 of the piston rod 17 is formed nearerto
the proximal end of the piston rod 17. The first screw thread 15 and the second screw
thread 16 have te senses of rotation in this embodiment. One or both of these
screw s 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 member 19 forms a tube through which the piston rod 17 is moved. The drive
member 19 is generally cylindrical and provided with a g 22 ng a ly
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 member
19 to guide a helical relative movement of the piston rod 17 with respect to the drive
member 19.
A generally cylindrical clutch 24 is disposed around the drive member 19, and the clutch
24 is at least partially nded by an end stop 28. The clutch 24 is located adjacent
to the proximal end of the drive member 19. Saw teeth 29 are arranged 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 member 19 by splines ting a rotation of the clutch 24 relatively to the drive
member 19. The clutch 24 is provided with a plurality of flexible arms that engage a
plurality of splines on an interior surface of a 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 ing flange at the distal end of the drive member 19. The
biasing means 26 may be a helical spring, for instance. The clutch plate 25 is
rotationally locked to the housing 3. The proximal face of the clutch plate 25 is provided
with saw teeth interacting with the saw teeth 29 at the distal end of the clutch 24 during
the operation of dose setting.
An end stop 28 is disposed between the drive member 19 and the dose dial sleeve 27.
The end stop 28 is rotationally locked to the g 3 and is free to move axially with
respect to the housing 3. In this embodiment, the external e 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 housing 3. A dose dial grip 46
is ed at the proximal end 30 of the dose dial sleeve 27 and is provided with a
central opening. A button 49 is ed 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 member 19.
The first screw thread 15 of the piston rod 17 is guided by the screw thread 8 on the
1O inner wall of the hole 5 of the guide nut 4. The guide nut 4 is ted from axial
movement with t to the housing 3 by means of a web 32 and a part of the
interaction member 14 (not shown in detail, see context of Figure 6). This means, a part
of the interaction member 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
integral 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
components that are fastened to the housing 3, eg. by parts of the carrier 11 of the
resilient member 10 (see Figure 5). The form of the web 32 is only restricted by its
function to secure the guide nut 4 against an axial shift in proximal ion with respect
to the housing 3. To this end, the web 32 comprises parts d on the proximal side
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 resilient
member 10. The interaction member 14 is arranged such that it can operate the g
means 9 according to the principle explained in the context of Figure 6. In particular, the
cartridge holder 2 may interact with the interaction member 14 such that the interaction
member 14 may be rotated via a rotation of the cartridge holder 2, when the dge
holder 2 is ted to the housing 3 as described in connection with Figures 8 to 11.
When the cartridge holder 2 is firmly connected to the housing 3, the guide nut 4 is
onally locked to the housing 3 by the engaged locking means 9. When the
dge holder 2 is removed, the guide nut 4 is released and free to rotate relatively to
the housing 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 ng the first screw thread
of the piston rod 17. The movement of the piston rod 17 is thus restricted to a helical
movement vely 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 restricted by the guide nut
4. As the guide nut 4 is still not able to move axially because of the ction member
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 l
movement is easily generated, 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, the 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 splined
engagement of the clutch 24 and the drive member 19 make the clutch 24 and the drive
member 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 rotationally
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 dimensioned ingly.
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
~36-
3 is helical, because the coupling 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 between 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 g the piston rod 17 stationary with t to
the housing 3. The piston rod 17 is maintained at its position during the set operation,
because the movement of the piston rod 17 is restricted by the d 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 direction 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.
if the set dose is too large, the set operation can be ted 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 desired dose has been set, it can be dispensed by pressing the button 49 in
the distal direction. This ces the clutch 24 in the distal direction with respect to the
dose dial sleeve 27, thereby decoupling the clutch 24 and simultaneously the drive
member 19 from the dose dial sleeve 27. The clutch 24 remains rotationally locked to
the drive member 19. The dose dial sleeve 27 is now free to move helically back in the
distal direction without g a rotational or helical movement of the drive member.
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 er on the drive
member 19. The clutch 24 and the clutch plate 25 are thereby d, 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 member 19 with respect 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 member 19 are moved together
in the distal direction but do not rotate with respect to the housing 3.
The nt of the drive member 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 member 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 g 3, the helical movement of piston rod 17 advances the
piston rod 17 in the distal direction. The ratio of the pitches of the first screw thread 15
and the second screw thread 16 can be selected ing to a desired tion
between the distance by which the drive member 19 is shifted and the distance by
which the piston rod 17 is shifted vely to the housing 3 during the dispense
ion. 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. To this purpose,
the cartridge holder 2 is removed from the housing 3 as described above, 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.
The piston rod 17 is reset in the al direction. The movement of the piston rod 17
is restricted by the first screw thread 15 and the second screw thread 16 engaging the
guide nut 4 and the drive member 19, respectively. When both the guide nut 4 and the
drive member 19 are stationary with respect to the housing 3, a movement of the piston
rod 17 relatively 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 axial 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
-38..
of the guide nut 4 with respect to the piston rod 17 irrespective of the position and
nt 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
interaction member 14 is operated by the cartridge holder 2, the locking means 9 is
disengaged from the guide nut 4 due to ction with the interaction member 14, as
long as the cartridge holder 2 is not ed to the housing 3. When the piston rod 17
is shifted 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
1O rod 17 is reset, the cartridge holder 2 is attached to the housing 3. The interaction
member 14 is rotated by means of mechanical cooperation with the cartridge holder 2
as bed above, 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 forfurther operation as bed above.
The reset of the piston rod 17 can be performed manually, while the cartridge holder 2
stays completely removed. The reset can be achieved by pushing the piston rod 17
towards the proximal end 30 or by holding the device 1 with the proximal end 30
pointing 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 holder 2 is being attached and approaches the proximal end 30.
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. s
cations, alterations and substitutions of the drive assembly and the drug delivery
device are within the scope of the disclosure.
Reference numerals
Drug delivery device
Cartridge holder
Housing
Guide nut
Hole
Cartridge
Bung
mVODU'l-F-OON—K Screw thread
Locking means
ent member
11 Carrier
12 Locking feature
14 Interaction member
First screw thread of the piston rod
16 Second screw thread of the piston rod
17 Piston rod
18 Bearing member
19 Drive member
Distal end
21 Engaging means
22 Beanng
23 Flange
24 Clutch
Clutch plate
26 Biasing means
27 Dose dial sleeve
28 End stop
29 Saw teeth at the distal end of the clutch
Proximal end
31 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 Bufion
50 Protecting cap
51 Spring member
52 First coupling member
53 Radial recess
54 Retaining means
55 Ramp
56 interaction snap feature
56A First sloped section
568 Second sloped section
57 Tooth
58 Notch
59 sion on locking means
60 Snap feature
60A First sloped n
608 Second sloped section
61 Hook
62 Retaining means
63 Second coupling member
64 First fastening means
64A First section
64B Second section
64C Angular end stop
3O 65 Second fastening means
66 Retaining member
67 Spring arm
68 n spring
69 Spring element
70 Cover
Claims (20)
1. An assembly for a drug delivery device comprising - a housing, - a cartridge holder releasably table to the housing, - a resilient member, - an interaction member which is configured to mechanically ate with the resilient member and with the cartridge holder, wherein the ent member or an onal resilient member is configured to rotationally bias the interaction member, wherein the assembly has a locked state where 1O the cartridge holder is ted to the housing, the cartridge holder being obstructed from movement with respect to the g, and an unlocked state where the connection between the cartridge holder and the housing is released, the cartridge holder being freely moveable with respect to the housing, wherein, for switching from the unlocked state into the locked state, the cartridge holder 15 is brought into mechanical cooperation with the interaction member, the cartridge holder is rotated in a first direction with respect to the housing, the interaction member thereby being rotated in the first direction such that the interaction member ically cooperates with the resilient member and such that a rotational force exerted on the interaction member by means of the resilient member is overcome for switching the 20 assembly from the unlocked state into the locked state, and wherein the assembly is configured to provide an axially directed force onto the cartridge holder such that, in the unlocked state, the cartridge holder is set apart from the housing.
2. The assembly according to claim 1, n in the locked state, the interaction member is rotationally locked with respect to 25 the housing by mechanical ation with the resilient member, and wherein in the unlocked state, the interaction member is rotatable with t to the housing.
3. The assembly ing to claim 1 or 2, wherein the axially directed force is provided by the resilient member or by at least one additional spring member.
4. The assembly according to any one of the us claims, wherein the resilient member is configured to provide a radially inwards directed force onto the interaction member which is great enough to rotationally lock the interaction member and the resilient member such that rotation of the interaction member in the second direction is prevented when the assembly is in the locked state.
5. The assembly according to claim 4 when dependent on claim 2. wherein, for switching from the locked state into the ed state, the cartridge holder is rotated in the second direction, the rotational force provided on the cartridge holder thereby being greater than a rotational counter force provided onto the interaction 1O member by means of the resilient member such that said counterforce is overcome and such that the rotational lock between the interaction member and the resilient member is released.
6. The assembly ing to any one of the previous claims, wherein the ent member is d against rotation with respect to the housing. 15
7. The assembly ing to any one of the previous claims, n the resilient member comprises at least one snap e and. the interaction member comprises at least one corresponding interaction snap feature, and wherein, in the locked state, the snap feature and the interaction snap feature are configured to abut.
8. The ly according to claim 7, 20 wherein the snap feature is part of or is integrally formed with a radially resilient spring arm of the resilient member.
9. The assembly according to claim 7 or claim 8. wherein the interaction snap feature comprises a bump. and wherein the interaction snap e is arranged on an outer surface of the interaction member, and wherein the snap 25 feature comprises a bump.
10. The assembly according to any one of the previous claims. wherein, in the locked state of the assembly. axial movement of the cartridge holder with respect to the housing is prevented by mechanical cooperation of a first fastening means of the cartridge holder and a second fastening means of the housing .
11. The assembly according to claim 10, n mechanical cooperation of the first fastening means and the second fastening means is configured to limit the rotation of the cartridge holder in the first and in the second direction with respect to the housing.
12. The ly according to claim 10 or claim 11, wherein the first and the second fastening means are configured such that axial movement of the cartridge holder with respect to the housing is allowed when the 10 assembly is switched from the locked state into the unlocked state.
13. The assembly ing to any one of the previous claims, wherein the interaction member comprises at least one first ng member adapted and arranged for engagement with at least one corresponding second coupling member of the cartridge holder for rotationally locking the interaction member and the cartridge 15 holder.
14. The assembly according to any one of the previous claims. n the interaction member is secured against axial movement with respect to the
15. The assembly according to any one of the previous claims, 20 wherein the interaction member comprises a ring-like shape.
16. The assembly according to any one of the previous claims, wherein the ent member is at least in parts ferentially arranged on at least a part of the exterior of the interaction member.
17. The assembly according to any one of the previous claims, wherein 25 the ction member is rotationally locked with respect to the housing by mechanical cooperation with the resilient member and wherein when the assembly is switched from the locked state to the unlocked state the resilient member or a further resilient member rotationally biases the interaction member into a second direction opposite to the first ion.
18. A drug delivery device comprising the assembly according to any one of claims 1 to 17 and a dge, wherein the cartridge is retained in the cartridge holder, and n the cartridge comprises a plurality of doses of a drug.
19. An ly for a drug delivery device, the assembly substantially as herein described with reference to any embodiment shown in the accompanying drawings.
20. A drug delivery device substantially as herein described with reference to any 10 embodiment shown in the accompanying drawings.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11165042.0 | 2011-05-06 | ||
EP11165042 | 2011-05-06 | ||
PCT/EP2012/058178 WO2012152666A1 (en) | 2011-05-06 | 2012-05-04 | Assembly for a drug delivery device and drug delivery device |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ617357A NZ617357A (en) | 2015-03-27 |
NZ617357B2 true NZ617357B2 (en) | 2015-06-30 |
Family
ID=
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