U.S. patent application number 14/259233 was filed with the patent office on 2015-01-22 for syringe device.
This patent application is currently assigned to NOVO NORDISK A/S. The applicant listed for this patent is NOVO NORDISK A/S. Invention is credited to Asger V. Christiansen, Ramin N. Elahi, Claus U. Gjoedesen, Michael E. Hansen, Nikolaj E. Jakobsen, Claus S. Moeller, Jonas Torry-Smith.
Application Number | 20150025475 14/259233 |
Document ID | / |
Family ID | 38080803 |
Filed Date | 2015-01-22 |
United States Patent
Application |
20150025475 |
Kind Code |
A1 |
Christiansen; Asger V. ; et
al. |
January 22, 2015 |
Syringe Device
Abstract
A medical delivery system comprising a container and a coupling
mechanism movable between a coupling position wherein distal
movement of a drive mechanism is transferred to an actuator, and a
non-coupling position wherein distal movement is not transferred to
the actuator. Moreover the present invention relates to a dosing
assembly for use in the medical delivery system and a container for
use in the medical delivery system. Finally, the present invention
relates to medical delivery system comprising a dosing assembly
having means for preventing a drive stem of the dosing assembly
from being moved in a distal direction.
Inventors: |
Christiansen; Asger V.;
(Guldborg, DK) ; Torry-Smith; Jonas; (Copenhagen
V, DK) ; Hansen; Michael E.; (Morud, DK) ;
Jakobsen; Nikolaj E.; (Valby, DK) ; Elahi; Ramin
N.; (Goerloese, DK) ; Moeller; Claus S.;
(Fredensborg, DK) ; Gjoedesen; Claus U.;
(Copenhagen O, DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NOVO NORDISK A/S |
BAGSVAERD |
|
DK |
|
|
Assignee: |
NOVO NORDISK A/S
BAGSVAERD
DK
|
Family ID: |
38080803 |
Appl. No.: |
14/259233 |
Filed: |
April 23, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12518502 |
Oct 23, 2009 |
8740857 |
|
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PCT/EP2007/064525 |
Dec 21, 2007 |
|
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14259233 |
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60899057 |
Feb 2, 2007 |
|
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Current U.S.
Class: |
604/211 |
Current CPC
Class: |
A61M 5/31543 20130101;
A61M 5/31551 20130101; A61M 2205/6045 20130101; A61M 5/24 20130101;
A61M 5/3129 20130101; A61M 5/31583 20130101 |
Class at
Publication: |
604/211 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 21, 2006 |
EP |
06026567.5 |
Claims
1. A medical delivery system comprising: a container adapted to
contain a medicament in a chamber defined by the container and a
slidably arranged piston which is movable in a distal direction
towards an outlet so as to reduce the volume of the chamber and
expel the medicament through the outlet; a dosing assembly adapted
to be fastened to the container and comprising: an actuator for
advancing the piston in the distal direction, a drive mechanism for
advancing the actuator in the distal direction, and a coupling
mechanism movable between a distal position wherein movement of the
drive mechanism in the distal direction is not transferred to the
actuator, and a proximal position wherein movement of the drive
mechanism in the distal direction is transferred to the actuator
whereby the piston is moved in the distal direction and the
medicament is expelled; and wherein one of the container and the
dosing assembly defines one or more radially extending fastening
projections each of which during fastening of the container to the
dosing assembly engages a corresponding radially extending
fastening groove of the other one of the dosing assembly and the
container whereby the container is fastened to the dosing assembly
by an initial axial movement followed by a relative rotational
movement; and wherein one of the container and the coupling
mechanism defines one or more radially extending retaining
projections each of which during fastening of the container to the
dosing assembly engages a corresponding radially extending
retaining groove of the other one of the coupling mechanism and the
container, whereby the coupling mechanism is moved from the distal
position to the proximal position as the container is rotated
relative to the dosing assembly.
2. A medical delivery system according to claim 1, wherein, when
the container is fastened to the dosing assembly, at least a part
of the dosing assembly encircles at least a part of the container,
and at least a part of the container encircles at least a part of
the coupling mechanism.
3. A medical delivery system according to claim 1, wherein each of
the one or more retaining grooves defines a first groove part
which, during fastening of the container to the dosing assembly, is
adapted to guide the corresponding retaining projection into a
second groove part of the retaining groove, the second groove part
being shaped so as to allow relative rotational movement between
the container and the coupling mechanism.
4. A medical delivery system according to claim 3, wherein the
second groove part is shaped such that, when the retaining
projection is positioned in the second groove part, translational
movement of the container in the proximal direction causes the
coupling mechanism to be moved towards the proximal position.
5. A medical delivery system according to claim 3, wherein the
second groove part extends circumferentially on an inner or outer
surface of the container or coupling mechanism, respectively.
6. A medical delivery system according to claim 5, wherein the
fastening groove, the fastening projection, the retaining groove
and the retaining projection are arranged with respect to each
other, such that upon movement of the fastening projection into an
inlet of the fastening groove, the retaining projection is received
in an inlet of the retaining groove.
7. A medical delivery system according to claim 1, wherein the
actuator is rotatively guided relative to the dosing assembly when
the coupling mechanism is positioned in the proximal position, and
wherein the actuator is allowed to rotate relative to the dosing
assembly when the coupling mechanism is positioned in the distal
position.
8. A medical delivery system according to claim 1, wherein the
actuator is connected to a drive stem adapted to abut the piston,
wherein the drive stem is movable between an initial position and a
distal position and wherein the dosing assembly defines one or more
axially extending protrusion(s) each of which is movable between a
retaining position wherein each of the protrusions retains the
drive stem in the initial position and a non-retaining position in
which the drive stem, when positioned in the initial position, is
allowed to be moved in the distal direction.
9. A medical delivery system according to claim 8, wherein the
container is shaped such that when fastened to the dosing assembly,
each of the axially extending protrusions is allowed to move
between the retaining and non-retaining position whereby the drive
stem, when positioned in the initial position, may be advanced in
the distal direction.
10. A medical delivery system according to claim 1, wherein the
container comprises: a first container adapted to be fastened to a
first dosing assembly according to any of the preceding claims; and
a second container adapted to be fastened to a second dosing
assembly according to any of the preceding claims; and wherein at
least one of the retaining groove, the retaining projection, the
fastening groove and the fastening projection is/are adapted to
prevent the first dosing assembly and second container from being
fastened to each other, and to prevent the second dosing assembly
and the first container from being fastened to each other.
11. A container for use in the medical delivery system according to
claim 1, the container comprising at least one fastening projection
extending in a radial direction from an outer surface the
container, and at least one retaining projection extending in a
radial direction from an inner surface of the container.
12. A dosing assembly for use in the medical delivery system
according to claim 1, comprising an actuator movable in a distal
direction, a drive mechanism for advancing the actuator on the
distal direction and a coupling mechanism movable between a distal
position wherein movement of the drive mechanism in the distal
direction is not transferred to the actuator, and a proximal
position wherein movement of the drive mechanism in the distal
direction is transferred to the actuator, and wherein a retaining
groove is defined on an outer circumferential surface of the
coupling mechanism, and a fastening groove is defined on an inner
surface of the dosing assembly.
13. A medical delivery system comprising: a container adapted to
contain a medicament in a chamber defined by the container and a
slidably arranged piston which is movable in a distal direction
towards an outlet so as to reduce the volume of the chamber and
expel the medicament through the outlet; a dosing assembly adapted
to be fastened to the container and comprising: an actuator for
advancing the piston in the distal direction, a drive mechanism for
advancing the actuator in the distal direction, and a coupling
mechanism including a rotatable guide member which engages the
actuator, the rotatable guide member being either rotationally
locked with respect to the actuator or being threadedly engaged
with the actuator, the coupling mechanism being movable between a
distal position wherein the rotatable guide member is free to
rotate in the dosing assembly and wherein movement of the drive
mechanism in the distal direction is not transferred to the
actuator and a proximal position wherein the rotatable guide member
is rotationally locked in the dosing assembly and wherein movement
of the drive mechanism in the distal direction is transferred to
the actuator whereby the piston is moved in the distal direction
and the medicament is expelled; and wherein one of the container
and the dosing assembly defines one or more radially extending
fastening projections each of which during fastening of the
container to the dosing assembly engages a corresponding radially
extending fastening groove of the other one of the dosing assembly
and the container whereby the container is fastened to the dosing
assembly, the fastening projections and grooves being adapted to
fasten the container to the dosing assembly by a relative
translational movement along an axis followed by a relative
rotational locking movement around the axis; and wherein one of the
container and the coupling mechanism comprises an inclined surface
portion adapted to engage upon said relative locking movement an
engagement surface of the other of the container and the coupling
mechanism, the inclined surface portion being arranged to move the
coupling mechanism from the distal position to the proximal
position upon said relative rotational locking movement.
14. A medical delivery system according to claim 1, wherein the
dosing assembly comprises a rotatable guide member which engages
the actuator, the rotatable guide member being either rotationally
locked with respect to the actuator or being threadedly engaged
with the actuator, and wherein the rotatable guide member is free
to rotate in the dosing assembly when the coupling mechanism is in
the distal position and wherein the rotatable guide member is
rotationally locked in the dosing assembly when the coupling
mechanism is in the proximal position.
15. A medical delivery system comprising: a container adapted to
contain a medicament in a chamber defined by the container and a
slidably arranged piston which is movable in a distal direction
towards an outlet so as to reduce the volume of the chamber and
expel the medicament through the outlet; a dosing assembly adapted
to be fastened to the container and comprising: an actuator for
advancing the piston in the distal direction, a rotatable guide
member which engages the actuator, the rotatable guide member being
either rotationally locked with respect to the actuator or being
threadedly engaged with the actuator, a drive mechanism for
advancing the actuator in the distal direction, and a coupling
mechanism comprising an axially movable coupling member adapted to
cooperate with the rotatable guide member, the axially movable
coupling member being movable between a distal position wherein the
rotatable guide member is free to rotate in the dosing assembly and
wherein movement of the drive mechanism in the distal direction is
not transferred to the actuator and a proximal position wherein the
rotatable guide member is rotationally locked in the dosing
assembly and wherein movement of the drive mechanism in the distal
direction is transferred to the actuator whereby the piston is
moved in the distal direction and the medicament is expelled; and
wherein one of the container and the dosing assembly defines one or
more radially extending fastening projections each of which during
fastening of the container to the dosing assembly engages a
corresponding radially extending fastening groove of the other one
of the dosing assembly and the container whereby the container is
fastened to the dosing assembly, the fastening projections and
grooves being adapted to fasten the container to the dosing
assembly by a relative translational movement along an axis
followed by a relative rotational locking movement around the axis;
and wherein one of the container and the coupling mechanism
comprises an inclined surface portion adapted to engage upon said
relative locking movement an engagement surface of the other of the
container and the coupling mechanism, the inclined surface portion
being arranged to move the coupling mechanism from the distal
position to the proximal position upon said relative rotational
locking movement.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. application Ser.
No. 12/518,502, filed Oct. 23, 2009, which is a 35 U.S.C. .sctn.371
national stage application of International Patent Application
PCT/EP2007/064525 (published as WO 2008/074897), filed Dec. 21,
2007, which claimed priority of European Patent Application
06026567.5, filed Dec. 21, 2006; this application further claims
priority under 35 U.S.C. .sctn.119 of U.S. Provisional Application
60/899,057, filed Feb. 2, 2007, incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a medical delivery system
comprising a dosing assembly and a container. In particular the
present invention relates to a dosing assembly comprising a
coupling mechanism movable between a coupling position wherein
movement of a drive mechanism in a distal direction is transferred
to an actuator and a non-retaining position wherein such movement
is not transferred to the actuator. Moreover the present invention
relates to a dosing assembly for use in the medical delivery system
and a container for use in the medical delivery system. Finally,
the present invention relates to medical delivery system comprising
a dosing assembly having means for preventing a drive stem of the
dosing assembly from being moved in a distal direction.
BACKGROUND OF THE INVENTION
[0003] Generally, in order to provide superior medication delivery
devices which are likely to be well received by particular groups
of patients, a greater diversity in drug delivery systems have been
launched to the benefit of patients. As the number of commercially
available delivery systems increase, numerous different types of
medication holding cartridges or containers are distributed. Most
of these types of containers differ in various aspects.
[0004] Each medicament container may be filled with a particular
type of medicament selected from a large variety of different
medicaments, but also different kinds of the same class of
medicament (e.g. rapid or long acting insulin) and different
concentrations of each particular medicament may be accommodated in
the containers.
[0005] Moreover, different container volumes may be introduced in
order to customize each container, and thus the delivery system, to
the needs of particular users. Variation of container volume may be
provided by changing the length or diameter of the container. These
modifications usually imply corresponding modifications of the
dosing assembly of a medication delivery system, so as to provide a
particular stroke of a driving element for expelling the medicament
from the container or to provide optimal dosing precision. Further
discrimination between different medicament containers may be
occasioned by the design requirements for each particular delivery
system, such as required sliding friction of the piston
accommodated in the container.
[0006] In order to discriminate between a larger variety of
available containers, numerous container coding and coupling
systems have been developed. The following mechanical coding and
coupling systems are known in the art:
[0007] U.S. Pat. No. 5,611,783 relates to a pen shaped syringe
comprising a distal part which may comprise an ampoule and a
proximal part containing a dose setting and drive mechanism. The
proximal and distal parts have interlocking bayonet coupling means.
Protrusions may be provided to form a pattern ensuring that a
certain distal part may only be used in connection with a certain
proximal part.
[0008] WO 03/017915 A1 discloses a cartridge having a distal end
provided with a mechanical coding. The mechanical coding has the
form of a circular protrusion where the circular outer diameter is
dedicated a specific concentration of insulin contained in the
cartridge.
[0009] U.S. Pat. No. 5,693,027 discloses a plastic top for adapting
a standard cartridge to a chosen syringe. The plastic top may be
provided with means for keyed engagement with corresponding means
in a syringe to keep it unrotatable when mounted with a cartridge
in the syringe. In some types of syringes such keyed engagement
between cartridge and syringe is further used to ensure that only a
certain type of cartridge is used.
[0010] U.S. Pat. No. 6,648,859 B2 discloses a drug cartridge
assembly for use with a reuseable pen body assembly of a medication
delivery pen. In order to eliminate cross-use the pen body assembly
and the drug cartridge are keyed i.e. they may be threadedly
engaged by corresponding threads and grooves, bayonet threads, and
grooves, snap fits or a pair of lugs that mate in reverse Luer-Lock
manner. The mating members are selected so as to prevent cross-use
with other assemblies, e.g., the pitch of the threads may be angled
so as to mate only with one another and not with other
assemblies.
[0011] Yet another prior art system is described in DE 201 10
690.
[0012] U.S. Pat. No. 5,584,815 discloses a lock and pullback
mechanism which prevents rotation of a lead screw upon metering and
injection. The pullback sleeve unloads a pullback key during
cartridge change in order to enable the leadscrew to be spun freely
back to its home position.
[0013] It is an object of a preferred embodiment of the present
invention to provide an alternative to the known systems.
Furthermore, it is an object of a preferred embodiment of the
present invention to provide a medication delivery system with a
large number of possible coding geometries.
[0014] Furthermore, it is an object of a preferred embodiment of
the present invention to provide a coding system wherein the user
experiences substantially the same operational
fastening/coupling/locking movement when the container and dosing
assembly of a predetermined medical delivery system are
coupled/uncoupled (locked/unlocked) to each other regardless of the
specific choice among sets of compatible container/dosing
assemblies.
[0015] Furthermore, it is an object of a preferred embodiment of
the present invention to provide an intuitive and simple fastening
mechanism for fastening the container to the dosing assembly.
[0016] Furthermore, it is an object of the present invention to
provide a medical delivery system wherein the influence of the
tolerances of a glass cartridge may be reduced or even
eliminated.
[0017] Furthermore, it is an object of the present invention to
provide a medical delivery system having an alternative mechanism
for allowing resetting of an actuator during a container
change.
BRIEF DESCRIPTION OF THE INVENTION
[0018] In a FIRST aspect the present invention relates to a medical
delivery system comprising: [0019] a container adapted to contain a
medicament in a chamber defined by the container and a slidably
arranged piston which is movable in a distal direction towards an
outlet so as to reduce the volume of the chamber and expel the
medicament through the outlet; [0020] a dosing assembly adapted to
be fastened to the container and comprising: [0021] an actuator for
advancing the piston in the distal direction, [0022] a drive
mechanism for advancing the actuator in the distal direction, and
[0023] a coupling mechanism movable between a distal position
wherein movement of the drive mechanism in the distal direction is
not transferred to the actuator, and a proximal position wherein
movement of the drive mechanism in the distal direction is
transferred to the actuator whereby the piston is moved in the
distal direction and the medicament is expelled; and [0024] wherein
one of the container and the dosing assembly defines one or more
radially extending fastening projections each of which during
fastening of the container to the dosing assembly engages a
corresponding radially extending fastening groove of the other one
of the dosing assembly and the container whereby the container is
fastened to the dosing assembly; and [0025] wherein one of the
container and the coupling mechanism defines one or more radially
extending retaining projections each of which during fastening of
the container to the dosing assembly engages a corresponding
radially extending retaining groove of the other one of the
coupling mechanism and the container, whereby the coupling
mechanism is moved from the distal position to the proximal
position.
[0026] Compared to medical delivery systems wherein a glass
cartridge of the container is adapted to move the coupling
mechanism from the distal to the proximal position, the present
invention provides the advantage that the chain of tolerances is
reduced. In conventional systems the chain of tolerances between
the dosing assembly and the coupling mechanism is dependent on the
tolerances of the cartridge holder and a glass cartridge. As a
predetermined level of tolerances are cheaper to achieve by use of
plastic moulding than by glass moulding, the present invention
provides a cheap alternative to known systems.
[0027] In the context of the present invention the term "medical
delivery system" shall be understood as any system capable of
administering a medicament-containing flowable drug. Examples of
medical delivery systems are infusion pump applications, dosers,
pen-shaped dosers, motor-dosers, and automated syringes such as the
AutoPen.TM..
[0028] The invention is applicable to all kinds of medicament
delivery devices capable of delivering a medicament to a user from
a container which is adapted to be coupled to a dosing assembly of
the delivery device. The delivery device may include any delivery
device for transcutaneous, subcutaneous, intravenous, intra
muscular or pulmonary administration of a drug.
[0029] As used herein, the term "medicament" is meant to encompass
any medicament-containing flowable drug capable of being passed
through a delivery means such as a hollow needle in a controlled
manner, such as a liquid, solution, gel or fine suspension.
Representative medicaments includes pharmaceuticals such as
peptides, proteins (e.g. insulin, insulin analogues and C-peptide),
and hormones, biologically derived or active agents, hormonal and
gene based agents, nutritional formulas and other substances in
both solid (dispensed) or liquid form.
[0030] The chamber of the container may be defined by one or more
sidewalls of the container and the slidably arranged piston. In
most embodiments at least a part of the container is ringshaped
(i.e. having a cylindrical cross-section) and defines a cylindrical
cavity in which the piston is received. The distal end of the
container may comprise a seal for penetration by a cannula so as to
allow a medicament contained in the chamber to be expelled through
the cannula. The distal end of the container may be adapted to be
attached to a holder holding a cannula. As an example the distal
end of the container may comprise a thread adapted to cooperate
with a corresponding thread of the cannula holder so as to allow
the cannula holder to be screwed onto the container.
[0031] In one embodiment the container comprises a cartridge holder
and a cartridge defining said chamber. The cartridge and the
cartridge holder may be two separate elements, and the cartridge
may be frictionally retained in the cartridge holder. In one
embodiment the cartridge is made of glass and the cartridge holder
is made of a non-glass material for protecting the glass cartridge.
The cartridge may be non-removably retained in the cartridge
holder, such that if the cartridge is removed from the cartridge
holder it cannot be reattached by hand and without tools. This
provides the advantage that the cartridge holder cannot be reused
when the cartridge has been emptied, accordingly a cartridge with a
wrong medicament cannot be inserted into the cartridge holder and
be dispensed by use of the dosing assembly. The cartridge holder
and the cartridge may define a monolithic element, i.e. forming one
element without seams. Such a monolithic element may be formed as a
moulded article made of a synthetic resin such as Topas.RTM. or
polypropylene. Such a moulded article may include the fastening and
coding geometries which are formed during moulding. However, any
material which is suitable for long-term storage of the specific
medication to be accommodated in the container may be used.
[0032] The outlet of the container may be adapted to cooperate with
or be defined by a cannula or a needle or a needle hub or an
infusion set, or any other fluid communicating conduit adapted to
provide fluid access to a medicament accommodated in the
container.
[0033] In the context of the present invention the terms
"depression" and "projection" are only used in connection with
radially extending members/elements/means, and "indentation" and
"protrusion" are only used in connection with axially extending
members/elements/means. However, "depression" and "indentation"
shall be seen as synonyms and "protrusion" and "projection" shall
be seen as synonyms. The actuator may be adapted to abut/engage the
piston such that movement of the actuator in the distal direction
causes the piston to be moved in the distal direction. In most
embodiments movement of the actuator in the proximal direction
causes the actuator to disengage the piston, while the piston
remains in same axial position, whereby movement of the actuator in
the proximal direction does not cause air to be sucked into the
chamber of the container.
[0034] The drive mechanism may comprise a dosing knob accessible
from an outer surface of the medical delivery system in order to
allow a user to set a dose. The dosing knob may define a proximal
end of the dosing assembly. In one embodiment the user sets a dose
by rotating the dosing knob about the main axis of the medical
delivery system, whereby the dosing knob is moved in the proximal
direction. When the dose is set, it may be ejected by forcing the
dosing knob in the distal direction, whereby the medicament is
ejected.
[0035] One of the container and the dosing assembly defines one or
more radially extending fastening projections each of which during
fastening of the container to the dosing assembly engages a
corresponding radially extending fastening groove of the other one
of the dosing assembly and the container whereby the container is
fastened to the dosing assembly. In one embodiment the container
defines a plurality of radially extending fastening projections
such as one, two, three, four or five, and the dosing assembly
defines a corresponding number of radially extending fastening
grooves. In another embodiment the dosing assembly defines a
plurality of fastening projections and the container defines a
corresponding number of fastening grooves.
[0036] The particular set of fastening projections and fastening
grooves may be so configured that the fastening procedure of the
container to the dosing assembly includes an initial relative axial
movement followed by a relative rotational locking movement. In
some embodiments, the fastening procedure includes an intermediary
movement between the initial axial movement and the rotational
locking movement, where the intermediary movement includes a
concurrent relative rotational and axial movement.
[0037] Moreover, one of the container and the coupling mechanism
defines one or more radially extending retaining projections each
of which during fastening of the container to the dosing assembly
engages a corresponding radially extending retaining groove of the
other one of the coupling mechanism and the container, whereby the
coupling mechanism is moved from the proximal position to the
distal position.
[0038] In one embodiment the container defines a plurality of
retaining projections such as two, three, four or five, on its
inner surface, and the coupling mechanism defines a corresponding
number of retaining grooves on its outer circumferential surface.
In another embodiment the retaining projections are defined on the
outer surface of the coupling mechanism and the retaining grooves
are defined on an inner surface of the container.
[0039] In one embodiment the retaining groove is defined in an
outer surface of the coupling mechanism such that the groove
extends radially into the coupling mechanism from an outer surface
thereof (and towards the centre axis of the coupling mechanism).
Moreover in said embodiment, the retaining projection is defined on
an inner surface of the container, i.e. such that it extends away
from said surface and towards a centre axis of the container.
[0040] In another embodiment the retaining groove is defined in an
inner surface of the container such that the groove extends
radially into the container from its inner surface, i.e. away from
the centre axis of the container. In said other embodiment, the
retaining projection extends radially outwards from the outer
surface of the coupling mechanism, i.e. away from the centre axis
of the coupling mechanism.
[0041] In one embodiment at least a part of the dosing assembly
encircles at least a part of the container when the container is
fastened to the dosing assembly, e.g. a distal end/part of the
dosing assembly may encircle a proximal end/part of the container.
Moreover, at least a part of the container may encircle at least a
part of the coupling mechanism, when the container is fastened to
the dosing assembly. As an example a proximal part/end of the
container may encircle a distal part of the coupling mechanism. At
least a part of the coupling mechanism may be received in the
dosing assembly, e.g. such that most of or the entire coupling
mechanism is encircled by the dosing assembly. It will be
appreciated, that the abovementioned radial order of elements may
be reversed e.g. such that the container encircles the dosing
assembly when said two elements are fastened to each other.
[0042] In one embodiment the container is inserted between the
coupling mechanism and the dosing assembly during fastening, such
that an outer part of the container is coupled to the dosing
assembly and such that an inner part of the container is coupled to
the coupling mechanism. Said outer part may be the fastening
projection. Said inner part may be the retaining projection.
[0043] Each of the one or more retaining grooves may define a first
groove part which, during fastening of the container to the dosing
assembly, is adapted to guide the corresponding retaining
projection into a second groove part of the retaining groove. The
second groove part may be shaped so as to allow relative rotational
movement between the container and the coupling mechanism.
[0044] The general direction of the first groove part and the
general direction of the second groove part may define an angle
different from 180 degrees. In the present context the term
"general direction" shall be understood as the direction of a line
positioned in the groove such that the distance at any point along
the line to each of two opposing sidewalls of the groove is
identical. In one embodiment the general direction of the first
groove part defines an angle of between 20 and 80 degrees (such as
between 30 and 60 degrees) relative to the general direction of the
second groove part.
[0045] In order to allow the retaining projection to be received in
the retaining groove, the first groove part may define an inlet of
the retaining groove. At least a part of the inlet may be defined
on a distal facing surface of the coupling mechanism. In one
embodiment the retaining groove is defined in an outer
circumferential surface of the coupling mechanism such that the
groove extends into the coupling mechanism from a surface thereof.
In the latter embodiment the first groove part commences at the
distal end of the dosing assembly such that an inlet is defined in
the distal end surface of the coupling mechanism. Accordingly, by
advancing the container in a proximal direction (towards the dosing
assembly) a corresponding retaining projection of the container is
received in the first groove part by being moved into said groove
part through the inlet. Upon further axial and/or rotational
movement, the retaining projection is moved from the first groove
part and into the second groove part.
[0046] The second groove part may be shaped such that, when the
retaining projection is positioned in the second groove part,
translational/axial movement of the container in the proximal
direction causes the coupling mechanism to be moved towards the
proximal position. The second groove part may define a proximal
and/or a distal facing sidewall. Upon proximal movement of the
container relative to the dosing assembly a proximal facing surface
of the retaining projection may abut the distal facing sidewall of
the second groove part, whereby said proximal movement of the
container is transferred to the coupling mechanism. Accordingly,
the coupling mechanism may be moved from the distal position into
the proximal position during fastening of the container to the
dosing assembly.
[0047] The second groove part may extend circumferentially on an
inner or outer surface of the container or coupling mechanism,
respectively. In one embodiment the second groove part defines a
circular groove extending on the outer surface of the coupling
mechanism or on the inner surface of the container. The circular
groove may define a geometrical centre coinciding with the centre
axis of the coupling mechanism or the container. In another
embodiment, the second groove part defines an arc shaped groove,
i.e. defining a segment of a circle, having a geometrical centre
point coinciding with the centre axis of the container or the
coupling mechanism. The angular extent of the segment (about its
geometrical centre point) may be less than 180 degrees, such as
less than 120 degrees, such as less than 90 degrees, such as less
than 45 degrees, such as less than 30 degrees.
[0048] The fastening groove, the fastening projection, the
retaining groove and the retaining projection may be arranged with
respect to each other, such that upon movement of the fastening
projection into the inlet of the fastening groove, the retaining
projection is received in the inlet of the retaining groove. In one
embodiment the fastening groove, the fastening projection, the
retaining projection and the retaining groove are arranged with
respect to each other such that the fastening projection is
received in the fastening groove prior to the retaining projection
is received in the retaining groove. In a further embodiment the
order is reversed such that the retaining projection is received in
the retaining groove prior to the fastening projection is received
in the fastening groove.
[0049] The actuator may comprise a piston rod which is connected to
a drive stem adapted to abut the piston. The drive stem may have
larger diameter than the piston rod such as a diameter above 75% of
the diameter of the piston and/or a diameter at least three times
larger than the piston rod.
[0050] In one embodiment the piston rod has a threaded outer
surface which is adapted to engage a corresponding surface of the
dosing assembly and/or the coupling mechanism. Upon rotation
between the piston rod and the dosing assembly and/or the coupling
mechanism, the piston rod is moved axially. In a further
embodiment, the piston rod is locked for rotation relative to the
dosing assembly and/or the coupling mechanism when the coupling
mechanism is positioned in the proximal position, whereby a piston
rod with a threaded outer surface, is retained axially. Moreover in
said embodiment, the piston rod is allowed to rotate relative to
the dosing assembly and/or the coupling mechanism, when the
coupling mechanism is positioned in the distal position, thus
allowing the piston rod to be moved axially in the distal and/or
proximal direction. Accordingly in the latter embodiment, the
piston rod is locked for movement in the proximal direction when
the container is fastened to the dosing assembly, while the piston
rod may be moved/rotated into its initial/proximal position when
the container has been removed e.g. during replacement of a
container so as to reset the piston rod.
[0051] In each of the above embodiments, the coupling mechanism
comprises a rotatable guide member disposed circumferentially with
respect to the piston rod. When the coupling mechanism is
positioned in the proximal position, the rotatable guide member is
rotationally locked with respect to a housing section of the dosing
assembly whereas when the coupling mechanism is positioned in the
distal position, the rotatable guide member is free to rotate with
respect to the housing.
[0052] The piston rod and the rotatable guide member may form a
keyed engagement allowing relative axial movements between the
piston rod and the rotatable guide member but constraining relative
rotational movements. In embodiments where the drive mechanism of
the dosing assembly is configured to move the piston rod purely
axially when expelling a medicament, the piston rod may be formed
with one or more axially extending tracks each of which is adapted
to receive a radially inwards extending protrusion formed in the
rotatable guide member. In embodiments where the drive mechanism is
configured to move the piston rod rotationally during expelling of
a medicament, the piston rod is formed with one or more threaded
portions engaging corresponding one or more threaded segments of
the rotatable guide member.
[0053] Fastening of a wrong container to the dosing assembly may
have serious consequences as a wrong dose of a medicament or a
wrong medicament may be ejected. Accordingly, it is desirable that
a medicament of a container wrongly connected to the dosing
assembly of the present invention is prevented from being expelled.
This may be achieved by preventing the drive stem from being
advanced in the distal direction when a wrong container is fastened
to the dosing assembly.
[0054] In one embodiment the effect is achieved by providing a
dosing assembly which defines one or more axially extending
protrusion(s) each of which is movable/bendable between a retaining
position wherein each of the protrusions retains the drive stem in
an initial position and a non-retaining position in which the drive
stem, when positioned in the initial position, is allowed to be
moved in the distal direction. Accordingly, only medicaments of
containers shaped so as to allow the axially extending
projection(s) to be positioned in the non-retaining position can be
expelled by means of the dosing assembly. As an example, the one or
more axially extending protrusions may be defined by/on the
coupling mechanism. Each of protrusions may be adapted to bend
about a bending axis which is parallel with a tangent of the
coupling mechanism and/or the dosing assembly.
[0055] In one embodiment the container is shaped such that when
fastened to the dosing assembly, each of the axially extending
protrusions is allowed to move between the retaining and
non-retaining position, whereby the drive stem, when positioned in
the initial position, may be advanced in the distal direction. In a
further embodiment the axially extending protrusion extend from a
distal facing surface of the coupling mechanism and is bendable
between the retaining and the non-retaining position such that when
bended towards the centre of the coupling mechanism the protrusions
are moved into the retaining position. Moreover, the distal end of
each of the protrusions may define an inclined surface such that a
container abutting the inclined surface forces the protrusions
towards the retaining position.
[0056] Accordingly, in one embodiment the container is shaped such
that when fastened to the dosing assembly, the container does not
abut the inclined surface(s) and thus the axially extending
protrusions are not forced towards/into the retaining position.
[0057] In one embodiment the distal end of the coupling mechanism
may define first areas in which the axially extending projections
are defined and second areas in which no axially extending
projections are defined. Moreover in the latter embodiment, the
container may be adapted to abut the coupling mechanism in one or
more of the second areas when the container is fastened to the
dosing assembly, while at the same time the container does not abut
any of the axially extending projections.
[0058] In one embodiment the one of the container and the dosing
assembly comprises one or more radially coding projection(s) each
of which during fastening of the container to the dosing assembly
is adapted to be received in a corresponding radially extending
coding groove defined in the other one the container and the dosing
assembly. In one embodiment, the coding projections and the
fastening projections are identical, i.e. each fastening projection
defines a coding projection. In another embodiment, the coding
projections and the fastening projections are defined by different
projections of the container or the dosing assembly. Additionally,
the fastening grooves and the coding grooves may be identical or
define separate grooves of the container or the dosing
assembly.
[0059] The coding projection(s) and/or the coding groove(s) may
define predetermined coding geometries preventing the container
from being fastened to the dosing assembly unless each of the
coding projections and/or coding grooves defines a predetermined
coding geometry which is selected from a predetermined group of
coding geometries. The coding geometry of each of the coding
projections and/or the coding grooves may be defined by at least
one of: [0060] a circumferential extent of the coding projection
and/or the coding groove, [0061] an axial extent of the coding
projection and/or the coding groove, [0062] a radial extent of the
coding projection and/or the coding groove and [0063] a
circumferential position of the coding projection and/or the coding
groove.
[0064] Moreover, the retaining projection(s) and/or the retaining
groove(s) may define predetermined coding geometries preventing the
container from being fastened to the dosing assembly unless each of
the retaining projections and/or retaining grooves defines a
predetermined coding geometry which is selected from a
predetermined group of coding geometries. The coding geometry of
each of the retaining projections and/or the retaining grooves may
be defined by at least one of: [0065] a circumferential extent of
the retaining projection and/or the retaining groove, [0066] an
axial extent of the retaining projection and/or the retaining
groove, [0067] a radial extent of the retaining projection and/or
the retaining groove and [0068] a circumferential position of the
retaining projection and/or the retaining groove.
[0069] In one embodiment the medical delivery system comprises:
[0070] a first container according to the first aspect of the
invention adapted to be fastened to a first dosing assembly
according to the first aspect of the invention; and [0071] a second
container according the first aspect of the invention adapted to be
fastened to a second dosing assembly according to the first aspect
of the invention; and wherein at least one of the retaining groove,
the retaining projection, the fastening groove and the fastening
projection is/are adapted to prevent the first dosing assembly and
second container from being fastened to each other, and to prevent
the second dosing assembly and the first container from being
fastened to each other.
[0072] The medical delivery system according to first aspect of the
invention may comprise any combination of features and elements of
the invention according to the second and/or third, and/or fourth
aspect of the invention.
[0073] In a SECOND aspect the present invention relates to a
container for use in the medical delivery system according to the
first aspect of the invention, the container comprising at least
one fastening projection extending in a radial direction from an
outer surface the container, and at least one retaining projection
extending in a radial direction from an inner surface of the
container.
[0074] The container according to the second aspect of the
invention may comprise any combination of features and elements of
the invention according to the first or fourth aspect of the
invention. As an example the container may comprise a coding
projection extending in a radial direction from the outer surface
of the container. The position of any of the fastening projections
and the position of any of the coding projections are arranged so
that they do not coincide.
[0075] In one embodiment the fastening projection(s) are proximal
relative to the retaining projection(s) or vice versa.
Alternatively, the axial position of at least one fastening
projection and the axial position of at least one retaining
projection are substantially identical.
[0076] In a THIRD aspect the present invention relates to a dosing
assembly for use in the medical delivery system according to the
first aspect of the invention, comprising an actuator movable in a
distal direction, a drive mechanism for advancing the actuator on
the distal direction and a coupling mechanism (axially) movable
between a distal position wherein movement of the drive mechanism
in the distal direction is not transferred to the actuator, and a
proximal position wherein movement of the drive mechanism in the
distal direction is transferred to the actuator, and wherein [0077]
a retaining groove is defined on an outer circumferential surface
of the coupling mechanism, and [0078] a fastening groove is defined
on an inner surface of the dosing assembly.
[0079] The invention according to the third aspect may comprise any
combination of features and elements of the invention according to
the first or fourth aspect of the invention. As an example the
retaining groove may define a first and a second groove part. The
second groove part may extend circumferentially on the outer
surface of the coupling mechanism and may cover an angular segment
of at least 45 degrees of the circumference of the coupling
mechanism.
[0080] In a FOURTH aspect the present invention relates to a
medical delivery system comprising: [0081] a container adapted to
contain a medicament in a chamber defined by the container and a
slidably arranged piston which is movable in a distal direction
towards an outlet so as to reduce the volume of the chamber and
expel the medicament through the outlet; [0082] a drive stem for
advancing the piston in the distal direction; [0083] a dosing
assembly adapted to be fastened to the container and to accommodate
the drive stem when said drive stem is positioned in an initial
position; [0084] wherein the dosing assembly defines one or more
axially extending protrusion(s) each of which is movable between a
retaining position wherein each of the protrusions prevents the
drive stem, when positioned in the initial position, from being
moved in the distal direction, and a non-retaining position wherein
the drive stem, when positioned in the initial position, is allowed
to be moved in the distal direction; and [0085] wherein the
container is shaped such that when fastened to the dosing assembly,
each of the axially extending protrusions is free to move between
the retaining and non-retaining position whereby the drive stem,
when positioned in the initial position, may be advanced in the
distal direction.
[0086] The invention according to the fourth aspect of the
invention may comprise any combination of features or elements of
the invention according to the first aspect of the invention.
[0087] In a FIFTH aspect the present invention relates to a medical
delivery system comprising: [0088] a container adapted to contain a
medicament in a chamber defined by the container and a slidably
arranged piston which is movable in a distal direction towards an
outlet so as to reduce the volume of the chamber and expel the
medicament through the outlet; [0089] a dosing assembly adapted to
be fastened to the container and comprising: [0090] an actuator for
advancing the piston in the distal direction, [0091] a drive
mechanism for advancing the actuator in the distal direction, and
[0092] a coupling mechanism including a rotatable guide member
which engages the actuator, the rotatable guide member being either
rotationally locked with respect to the actuator or being
threadedly engaged with the actuator, the coupling mechanism being
movable between a distal position wherein the rotatable guide
member is free to rotate in the dosing assembly and wherein
movement of the drive mechanism in the distal direction is not
transferred to a distal movement of the actuator and a proximal
position wherein the rotatable guide member is rotationally locked
in the dosing assembly and wherein movement of the drive mechanism
in the distal direction is transferred to the actuator whereby the
piston is moved in the distal direction and the medicament is
expelled; and [0093] wherein one of the container and the dosing
assembly defines one or more radially extending fastening
projections each of which during fastening of the container to the
dosing assembly engages a corresponding radially extending
fastening groove of the other one of the dosing assembly and the
container whereby the container is fastened to the dosing assembly,
the fastening projections and grooves being adapted to fasten the
container to the dosing assembly by a relative translational
movement along an axis followed by a relative rotational locking
movement around the axis; and [0094] wherein one of the container
and the coupling mechanism comprises an inclined surface portion
adapted, responsive to said relative locking movement, to engage an
engagement surface of the other of the container and the coupling
mechanism, the inclined surface portion being arranged to move the
coupling mechanism from the distal position to the proximal
position upon said relative locking movement.
[0095] Compared to medical delivery systems of the type having a
rotatable guide member in engagement with the actuator/piston rod,
where the rotatable guide member is adapted to become rotationally
locked relative to a housing part of the dosing assembly upon
axially coupling the container to the dosing assembly, the
invention according to the fifth aspect provides for an improved
resetting of the actuator/piston rod upon container/cartridge
change where pressure build-up in the container. According to the
fifth aspect of the invention, the coupling mechanism ensures that
rotational locking of the rotatable guide member is postponed until
the moment where a user locks the container to the dosing assembly
by the relative rotational locking movement, i.e. after the
container has been substantially or fully axially engaged with the
dosing assembly.
[0096] The container and/or the dosing assembly may in some
embodiments comprise more than one inclined surface, such as two,
three or more, each adapted to engage respective engagement
surfaces of the other of the container and the dosing assembly.
[0097] In some embodiments, one or more of the inclined surfaces
are arranged on the container part. The inclined surfaces may be
formed as ramp shaped protrusions arranged on a proximal rim
portion of the container. Alternatively, the or each of the
inclined surfaces may be formed as an inclined groove formed in an
inner wall section of the container. Still, alternatively, the
inclined surface feature may be provided as a radially inwards
projection forming an inclined track along an inner surface of the
container arranged to move the coupling mechanism of the dosing
assembly into its proximal position upon relative rotation between
the container and the dosing assembly.
[0098] The invention according to the fifth aspect of the invention
may comprise any combination of features or elements of the
invention according to the first and fourth aspect of the invention
provided that they form a compatible combination with the fifth
aspect.
BRIEF DESCRIPTION OF THE DRAWINGS
[0099] In the following the invention will be described with
reference to the drawings in which:
[0100] FIG. 1 discloses an isometric view of an embodiment of the
invention according to the first aspect,
[0101] FIG. 2 discloses a sectional view of FIG. 1,
[0102] FIG. 3 discloses an isometric view of the coupling
mechanism,
[0103] FIG. 4 discloses an isometric view of a part of the dosing
assembly,
[0104] FIG. 5 discloses an isometric and exploded view of two parts
of the dosing assembly,
[0105] FIGS. 6-8 disclose the process of fastening the container to
the dosing assembly,
[0106] FIGS. 9-10 disclose two medical delivery systems,
[0107] FIGS. 11-13 disclose an embodiment of the invention
according to the first and fourth aspect of the invention, and
[0108] FIGS. 14-16 disclose an embodiment of the invention
according to the fifth aspect of the invention.
[0109] FIG. 17 discloses an embodiment of the invention according
to an aspect of the invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0110] FIGS. 1 and 2 disclose a medical delivery system 100
comprising a container 102 and a dosing assembly 104. The container
102 is adapted to be fastened to the dosing assembly 104 by
engagement between a fastening projection 106 of the container 102
and a corresponding fastening groove 108 of the dosing assembly
104. Container 102 forms a distally arranged expelling portion
adapted to engage patient access means such as an injection
needle.
[0111] Dosing assembly 104 includes an actuator/piston rod (not
shown) being driveable by a suitable drive mechanism (not shown) to
force a piston arranged in container 102 towards a distal end of
the medical delivery system 100. As non-limiting examples of
suitable drive mechanisms, reference is made to WO 01/95959 and WO
WO 2006/114395.
[0112] During fastening, a proximal end 110 the container 102 is
moved axially into a distal end 112 of the dosing assembly 104 such
that the fastening projection 106 is received in the fastening
groove 108. In order to fasten the container 102 to the dosing
assembly 104, the container 102 is rotated clockwise relative to
the dosing assembly 104, whereby the fastening projection 106 is
moved into an end part 114 of the fastening groove 108.
Accordingly, the container 102 is fastened to the dosing assembly
104 by an initial axial movement followed by a combined axial and
rotational movement.
[0113] The dosing assembly 104 comprises a coupling mechanism 120
which is adapted to restrain rotational movement of an
actuator/piston rod with respect to a housing part of the dosing
assembly, when the container 102 is properly connected to the
dosing assembly 104.
[0114] During fastening, a retaining projection 116 of the
container 102 engages a retaining groove 118 of a coupling
mechanism 120 of the dosing assembly 104. The retaining groove 118
comprises a first part 122 and a second part 124. The first part
defines an inlet 126 on a distal surface 128 of the coupling
mechanism 120. During fastening the retaining projection 116 is
advanced into the first part 122 through the inlet 126. Upon
further axial and rotational movement the retaining projection 116
is moved from the first part 122 into the second part 124. When the
retaining projection 116 is positioned in the second part 124 axial
movement of the container 102 relative to the dosing assembly 104
causes the coupling mechanism 120 to be moved from a distal
position (shown in FIGS. 1, 2 and 7) and into a proximal position
(shown in FIG. 9).
[0115] The coupling mechanism 120 includes a rotatable guide member
130 which encircles the actuator/piston rod. On an internal
radially inwards facing surface of the rotatable guide member 130,
the rotatable guide member includes a plurality of protrusions
forming a keyed engagement with tracks formed in the
actuator/piston rod. The tracks of the actuator/piston rod is
provided as axially extending tracks whereby the actuator/piston
rod is rotationally fixed but axially translatable with respect to
the rotatable guide member 130. Alternatively, the actuator/piston
rod forms one or more helical tracks into which the protrusions of
the rotatable guide member 130 are adapted to be received. In such
an embodiment, during expelling of medicament from a container, the
actuator/piston rod is adapted to be rotationally guided, i.e. the
rotation of the actuator/piston rod is a function of the axial
displacement.
[0116] When the coupling mechanism 120 is positioned in the distal
position, the rotatable guide member 130 is free to rotate whereby
movement of the drive mechanism (not shown) in the distal direction
is not transferred to the actuator/piston rod. When the rotatable
guide member is free to rotate, the actuator/piston rod may be
rotated back to a proximal home position.
[0117] Moreover, when the coupling mechanism 120 is positioned in
the proximal position, the rotatable guide member 130 is
rotationally locked with respect to housing of the dosing assembly
104 and movement of the drive mechanism in the distal direction is
transferred to the actuator/piston rod whereby the piston is moved
in the distal direction and the medicament is expelled.
[0118] When the coupling mechanism 120 is positioned in the distal
direction, rotatable guide member 130 is free to rotate relative to
the housing of the dosing assembly 104, as teeth 131 of rotatable
guide member 130 (receiving the piston rod) do not engage
corresponding teeth 132 of the dosing assembly 104. Hence, the
actuator/piston rod (not shown) is allowed to be rotated relative
to the dosing assembly 104. When the coupling mechanism 120 is
positioned in the proximal position the aforementioned teeth engage
and lock the rotatable guide member 130 against rotation. In the
latter position the actuator/piston rod is rotatively guided as
determined by the axial track of the actuator/piston rod and
movement of a drive mechanism in the distal direction causes the
actuator/piston rod to be moved in the distal direction.
[0119] The coupling mechanism 120 is biased towards the distal
position due to the spring 134, accordingly when a container 102 is
not fastened to the dosing assembly 104, the coupling mechanism 120
is positioned in the distal position and the actuator/piston rod is
free to be moved in the proximal (and distal) direction by the
user. Thus, when a container 102 has been emptied the user may
"rewind" the actuator/piston rod by removing the container and
resetting the actuator/piston rod by forcing it in the distal
direction by finger pressure. Alternatively, resetting of the
actuator/piston rod occurs by allowing the new container to push
the actuator/piston rod to its home position when axially engaging
the new container with the dosing assembly.
[0120] The actuator comprises a piston rod (not shown) received in
a drive stem 136. The drive stem 136 and the piston rod are locked
axially to each other but allowed to be rotated relative to each
other about a centre axis of the piston rod.
[0121] In order to ensure that only predetermined containers 102
are fastened to predetermined dosing assemblies 104, the container
102 defines at least one coding projection 138 each of which are
adapted to be received in a corresponding coding groove 140 of the
dosing assembly 104 as shown in FIG. 4.
[0122] FIG. 3 discloses a part of the coupling mechanism 120 which
defines the retaining groove 118. As described above, the retaining
groove 118 defines a first part 122 and a second part 124. The
first part 122 defines an inlet 126 of the retaining groove 118.
The first part 122 is adapted to guide the retaining projection 116
from the inlet 126 into to the second part 124. When the retaining
projection 116 has entered the second part 124 clockwise rotation
of the container 102 relative to the coupling mechanism 120 moves
the retaining projection 116 towards a bottom surface 142 of the
second part 124. When the retaining projection 116 abut the bottom
surface 142, the container 102 is locked for clockwise rotation
relative to the dosing assembly 104.
[0123] The coding groove 140 is visible in the embodiment of FIG.
4. In the latter embodiment movement of the coding projection 138
in the coding groove 140 causes the coding projection 138 to be
moved into a part of the fastening groove 108. However, in other
embodiments the coding groove 140 and the fastening groove 108 are
not connected. As described in the aforementioned, the dosing
assembly 104 comprises teeth 132 which are engaged by teeth 131 of
the coupling mechanism 120, when the latter is moved from the
distal position to the proximal position. The teeth 131 of the
coupling mechanism 120 are visible in FIG. 5.
[0124] FIGS. 6-8 disclose the fastening process wherein the
container 102 is fastened to the dosing assembly 104. Initially the
proximal end 110 (cf. FIGS. 1 and 2) of the container 102 is
advanced towards the distal end 112 (cf. FIGS. 1 and 2) of the
dosing assembly 104. In order to be able to fasten the container
102 to the dosing assembly 104, the container must be rotated until
the coding projections 138 of the container 102 are aligned with
the coding grooves 140 of the dosing assembly 104. When this is the
case, the container 102 may be moved further towards the dosing
assembly 104, whereby the fastening projections 106 of the
container 102 are received in corresponding fastening grooves 108
of the dosing assembly 104 and the coding projections 138 are
received in the coding grooves 140.
[0125] Upon further movement, the retaining projections 116 of the
container 102 are received in the retaining grooves 118 of the
coupling mechanism 120. In FIG. 7 the retaining projections 116
have been advanced into the second part 124 (cf. FIG. 3) of the
retaining groove 118 whereby further axial movement of the
container 102 in the proximal direction i.e. downwards in the
figure, causes the coupling mechanism 120 to be moved in the
proximal direction, whereby the teeth 131 of the coupling mechanism
120 engages the teeth 132 of the dosing assembly 104 as described
previously.
[0126] In the embodiment of FIGS. 6-8, the container 102 comprises
a cartridge holder 144 and a glass cartridge 146. The cartridge
holder 144 defines the fastening projection 106, the coding
projection 138 and the retaining projection 116, and thus the glass
cartridge 146 is not used to move the coupling mechanism 120 from
the distal position into the proximal position. Accordingly, when
the container 102 is fastened to the dosing assembly 104 an air gap
148 is present between the glass cartridge 146 and the coupling
mechanism 120. The advantage is that the chain of tolerances
between the dosing assembly 104 and the coupling mechanism 120 is
only dependent on the tolerances of the fastening projection/groove
106,108 and the tolerances of the retaining projection/groove
116,118. Accordingly, the tolerances of the glass cartridge 146 and
the cartridge holder 144 are irrelevant. In FIG. 10 a conventional
system is illustrated wherein the glass cartridge 146 is used to
move the coupling mechanism 120 from the distal position to the
proximal end 110. As high tolerances of glass products are
expensive to achieve compared to similar tolerances of plastic
products, the present invention provides an economic alternative to
known systems.
[0127] FIGS. 11-13 disclose embodiments of the coupling mechanism
120 having axially extending protrusions 150 bendable between a
retaining position wherein the axially extending protrusions 150
prevent a drive stem (not shown) from being moved in the distal
direction (i.e. upwards in the drawing), and a non-retaining
position (as shown in FIGS. 11-13) wherein the drive stem, when
positioned in the initial position is allowed to be moved in the
distal direction, as indicated by arrow 152. In the present
context, the term "initial position" shall be understood the
position in which coupling mechanism 120 encircles the entire drive
stem as illustrated in FIG. 6 or wherein the drive stem 136 is
positioned proximally relative to the axially extending protrusions
150. The axially extending protrusions 150 define an inclined
surface 154 adapted to force the axially extending protrusions 150
towards their retaining position when a glass cartridge is moved
axially towards the inclined surface 154 (i.e. in the proximal
direction). Accordingly, if the container of FIG. 10 is fastened to
a dosing assembly 104 comprising the coupling mechanism 120 of
FIGS. 11-13, the drive stem is locked in the initial position and
the medicament cannot be expelled. Thus, the present invention
provides a system for preventing a wrong medicament from being
dispensed by the dosing assembly of the present invention. This
improves user safety.
[0128] Accordingly, in order for a container to be useable with a
dosing assembly 104 comprising the axially extending protrusions
150, the container must be shaped such that when fastened to the
dosing assembly, each of the axially extending protrusions is free
to move between the retaining and non-retaining position whereby
the drive stem, when positioned in the initial position, may be
advanced in the distal direction.
[0129] Each of the axially extending protrusions 150 defines narrow
part 156 defining a bending axis of the axially extending
protrusions 150. Accordingly, each of the axially extending
protrusions 150 may be bend in the radial direction towards and
away from the centre axis of the coupling mechanism 120.
[0130] FIGS. 14-16 disclose an embodiment of a medical delivery
system where the coupling mechanism is modified to be actuatable by
a rotational movement between the container 102 and the dosing
assembly. In this embodiment, the fastening procedure for fastening
the container to the dosing assembly includes an initial relative
axial movement followed by a relative rotational locking movement
between container 102 and dosing assembly 104. The fastening
projection 106 of container 102 is received in a fastening groove
(not shown) of the dosing assembly. The fastening groove of the
dosing assembly 104 may be "L"-shaped to provide the
above-mentioned fastening procedure.
[0131] In FIG. 14, the coupling mechanism comprises an axially
moveable pusher member 170 and an axially moveable coupling member
160. Pusher member 170 and coupling member 160 is so shaped that
limited relative axial movement is possible, but pusher member 170
is rotationally fixed with respect to coupling member 160. Coupling
member 160 comprises radially protrusions 161 adapted to be
received in longitudinal tracks (not shown) formed in a housing
section of dosing assembly 104. Coupling member 160 is axially
moveable between a distal position and a proximal position.
[0132] Coupling member 160 accommodates a rotatable guide member
130 (cf. FIG. 16) so that rotatable guide member 130 is free to
rotate relative to coupling member 160 but rotatable guide member
130 follows axial movements of coupling member 160.
[0133] Rotatable guide member 130 engages and encircle an
actuator/piston rod 135 in the same way as disclosed in the
embodiment shown referring to aspect 1. Likewise, rotatable guide
member 130 includes teeth 131 adapted to engage corresponding teeth
of the dosing assembly 104 when the coupling mechanism is
positioned in the proximal position. Also, in the embodiment shown
in FIGS. 14-16, the pusher member 170 is biased by a spring 134
urging the pusher member 170 towards the distal end. Further
biasing means (not visible in FIGS. 14 and 15) urges the coupling
member 160 in distal direction.
[0134] The container 102 incorporates two inclined surface portions
formed as axially protrusions 117 which during rotationally locking
of the container 102 to the dosing assembly 104 engages
corresponding inclined surface portions 162 formed in coupling
member 160.
[0135] In the state shown in FIG. 14, the container 102 has been
axially moved to abut dosing assembly 104. The pusher member 170,
biased by spring 134, exerts a distal force to a cartridge
accommodated into a cartridge holder portion of container 102.
However, coupling member 160 still remains in its distal position
allowing the rotatable guide member 130 to rotate freely with
respect to the housing part of the dosing assembly.
[0136] In the condition shown in FIG. 15, container 102 has been
moved rotationally clockwise with respect to the dosing assembly to
properly interlock the two parts. Due to the rotational movement of
inclined surfaces 117 with respect to corresponding inclined
surfaces 162, the coupling member 160 has been forced into its
proximal position whereby rotatable guide member 130 is
rotationally locked relative to the hosing section of the dosing
assembly. In this state, the drive mechanism of the dosing assembly
is able to transfer forces to the actuator/piston rod 135 to move
it in the distal direction in accordance with operation of the
drive mechanism.
[0137] Upon release of the container 102 from the dosing assembly
104 by initially rotating the container in a counter clockwise
direction to unlock the two parts, the coupling member 160 is
automatically moved in the distal direction allowing the rotatable
guide member 130 to spin freely inside the dosing assembly 104. In
this state, the resetting of the actuator/piston rod may be carried
out by axially displacing the actuator/piston rod 135 in the
proximal direction by using a new full container/cartridge 102.
[0138] FIG. 16 further depicts additional details of the coupling
member 160, the pusher member 170 and the rotatable guide member
130.
[0139] FIG. 17 further depicts additional details of drive
mechanism 180, showing actuator/piston rod 135, guide member 130,
drive stem 136, and container 102.
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