U.S. patent application number 14/516158 was filed with the patent office on 2015-02-05 for injection device.
The applicant listed for this patent is NOVO NORDISK A/S. Invention is credited to Lars U. Nielsen.
Application Number | 20150038917 14/516158 |
Document ID | / |
Family ID | 35429231 |
Filed Date | 2015-02-05 |
United States Patent
Application |
20150038917 |
Kind Code |
A1 |
Nielsen; Lars U. |
February 5, 2015 |
Injection Device
Abstract
An injection device with a travelling clutch which can be
shifted between two different positions by the activation of an
injection button. In the first position, the injection button and
the driver is allowed to rotate relatively to the piston rod, which
is blocked from rotation by the clicker element. In the second
position, the drive sleeve and the injection button is axially
movable while the piston rod is allowed to rotate.
Inventors: |
Nielsen; Lars U.; (Virum,
DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NOVO NORDISK A/S |
Bagsvaerd |
|
DK |
|
|
Family ID: |
35429231 |
Appl. No.: |
14/516158 |
Filed: |
October 16, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12824632 |
Jun 28, 2010 |
8911411 |
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14516158 |
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12407447 |
Mar 19, 2009 |
7771400 |
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12824632 |
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11995005 |
Jan 28, 2008 |
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PCT/EP2006/063724 |
Jun 30, 2006 |
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12407447 |
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60712553 |
Aug 30, 2005 |
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Current U.S.
Class: |
604/211 |
Current CPC
Class: |
A61M 5/31511 20130101;
A61M 5/31583 20130101; A61M 5/3155 20130101; A61M 5/31541 20130101;
A61M 5/24 20130101; A61M 5/31551 20130101; A61M 5/31585 20130101;
A61M 5/31593 20130101 |
Class at
Publication: |
604/211 |
International
Class: |
A61M 5/315 20060101
A61M005/315; A61M 5/24 20060101 A61M005/24 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 8, 2005 |
EP |
05106254.5 |
Claims
1. A drug delivery device comprising: a housing, a piston rod
having one or more threads, a nut member disposed within the
housing, that cooperates with the piston rod so that the piston rod
is screwed in a distal direction when rotated relatively to the
member, a drive sleeve that rotates the piston rod during dose
administration, a releasable coupling operational between a first
position and a second position to secure the piston rod against
rotation during dose setting, but during dose administration allows
the piston rod to rotate.
2. A drug delivery device according to claim 1 wherein the coupling
comprises a slider slidably connected to the housing.
3. A drug delivery device according to claim 2 wherein the coupling
comprises a clicker element coupled to the slider.
4. A drug delivery device according to claim 3 wherein the clicker
element is both axially and rotational locked to the slider in the
first position.
5. A drug delivery device according to claim 3 wherein the clicker
element is rotational released from the slider in the second
position.
6. A drug delivery device according to claim 5 wherein the clicker
element is shifted between its locked and its released position by
axial movement of an injection button.
7. A drug delivery device according to claim 6 wherein the
injection button is connected to the drive sleeve in a way making
the injection button axially displaceable relatively to the drive
sleeve.
8. A drug delivery device according to claim 1, wherein the
releaseable coupling further locks the drive sleeve to prevent
rotation during dose administration.
9. A drug delivery device according to claim 8, wherein the
coupling comprises a slider that is slidably connected to the
housing.
10. A drug delivery device according to claim 9, wherein the
coupling comprises a clicker element.
11. A drug delivery device according to claim 8, wherein the
clicker element is shifted between its locked and its released
position by axial movement of an injection button (30) which is
located at an end of the device.
12. A drug delivery device according to claim 1, further comprising
an injection button located at an end of the device wherein the
injection button is moveable in an axial direction to shift the
releasable coupling from one position to another position.
13. A drug delivery device according to claim 12, wherein the
injection button rotates during dose setting along with a dose dial
sleeve 40.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/824,632 filed Jun. 28, 2010 (Issue Fee Paid), which is a
continuation of U.S. application Ser. No. 12/407,447 filed Mar. 19,
2009 (U.S. Pat. No. 7,771,400) which is a continuation of U.S.
application Ser. No. 11/995,005, filed Jan. 8, 2008 (now
abandoned), which is a 35 U.S.C. .sctn.371 national stage
application of International Patent Application PCT/EP2006/063724
(published as WO 2007/006662), filed Jun. 30, 2006, which claimed
priority of European Patent Application 05106254.5, filed Jul. 8,
2005; this application further claims priority under 35 U.S.C.
.sctn.119 of U.S. Provisional Application 60/712,553, filed Aug.
30, 2005; the contents of which are incorporated herein by
reference.
THE TECHNICAL FIELD OF THE INVENTION
[0002] The invention relates to an apparatus such as an injection
pen for delivering a liquid drug to the human body preferably in a
subcutaneous way and especially to an injection device with a
piston rod having two threads.
DESCRIPTION OF RELATED ART
[0003] In the disclosure of the present invention reference is
mainly made to the treatment of diabetes by injection of insulin;
however this is only an exemplary use of the present invention.
[0004] Injection pens are mainly made for users who have to inject
themselves frequently, e.g. people suffering from diabetes. A
number of demands are set to such injection pens. The setting of a
dose must be easy an unambiguous and it must be easy to read the
set dose. It must be possible with a minimum of trouble to cancel
or change a wrongly set dose and when the dose is injected the dose
setting must return to zero. When a prefilled injection pen is in
question, i.e. an injection pen which is disposed of when the
reservoir is empty, the injection pen must further be cheap and
made of materials suitable for recycling.
[0005] Most dose setting devices work with a threaded piston rod
co-operating with a nut where the nut and the piston rod may be
rotated relative to each other. The dose setting may be obtained by
screwing the nut away from a stop to which it is return during
injection by pressing the piston rod forward until the nut member
abuts the stop. By other dose setting devices one of the elements,
the nut or the piston rod, is kept inrotatable and the other is
allowed to rotate a set angle depending on the set dose, whereby
the piston rod is screwed forward a distance through the nut
member.
[0006] A prior art delivery apparatus fulfilling the above is
disclosed in U.S. Pat. No. 6,004,297. The apparatus disclosed in
the embodiment depictured in FIGS. 6 to 10 comprises a piston rod
having a proximal thread and a distal thread. The proximal thread
is engaged by a driver and the distal thread is engaged by a thread
in the part of the housing bridging the dose setting and injection
part with the cartridge holder part.
[0007] A dose is set by rotating the driver up the proximal thread
of the piston rod and injected by returning the driver axially. In
order to secure that the set number of doses are actually expelled
it is important that the driver is only axially returned i.e. it is
important to prevent the driver from rotating down the proximal
thread during injection.
[0008] In order to secure the driver against rotation when
injecting, a number of grooves are provided on the driver which
grooves are engages by one or more protrusions on the inside
surface of the housing.
[0009] A similar injection pen is disclosed in WO 04/078239. This
injection pen also comprises a threaded piston rod having two
different threads. Here the driver is axially locked during
injection by use of a clicker element engaging the clutch.
DESCRIPTION OF THE INVENTION
[0010] Having regard to the above-identified prior art devices, it
is an object of the present invention to provide a drug delivery
device which eliminates disadvantages in the prior art drug
delivery device and provides an improved locking of the driver
during injection.
[0011] The coupling or travelling clutch located between the piston
rod, the drive sleeve and the injection button is designed such
that the drive sleeve and the injection button is allowed to rotate
relatively to the piston rod, which is blocked from rotation by the
clicker element, when setting a dose.
[0012] During injection, the drive sleeve and the injection button
is moved axially back while forcing the piston rod to rotate.
[0013] The coupling or clutch comprises a slider element which is
secured in the housing such that the slider can only move axially
relatively to the housing.
[0014] Further a clicker element is provided which is connected to
the slider to follow the axial movement of the slider however the
clicker element can rotate relatively to the slider. A movable
element of the clicker element is engaged by the slider such the
clicker element can be shifted between two different positions
relatively to the slider; A first position where the clicker
element is both axially and rotational locked to the slider and a
second position where the clicker element is only axially locked to
slider but free to rotate relatively to the slider.
[0015] To shift the engagement of the clicker element and the
slider from the first position to the second position, the
injection button is used, preferably, such that an axial movement
of the injection button accomplish the shift.
DEFINITIONS
[0016] An "injection pen" is typically a mechanical i.e. user
energized injection apparatus having an oblong or elongated shape
somewhat like a pen for writing. Although such pens usually have a
tubular cross-section, they could easily have a different
cross-section such as triangular, rectangular or square.
[0017] As used herein, the term "drug" is meant to encompass any
drug-containing flowable medicine 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 drugs
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.
[0018] Correspondingly, the term "subcutaneous" injection is meant
to encompass any method of transcutaneous delivery to a
subject.
[0019] Further the term "injection needle" defines a piercing
member adapted to penetrate the skin of a subject for the purpose
of delivering or removing a liquid.
[0020] All references, including publications, patent applications,
and patents, cited herein are incorporated by reference in their
entirety and to the same extent as if each reference were
individually and specifically indicated to be incorporated by
reference and were set forth in its entirety herein.
[0021] All headings and sub-headings are used herein for
convenience only and should not be constructed as limiting the
invention in any way.
[0022] The use of any and all examples, or exemplary language (e.g.
such as) provided herein, is intended merely to better illuminate
the invention and does not pose a limitation on the scope of the
invention unless otherwise claimed. No language in the
specification should be construed as indicating any non-claimed
element as essential to the practice of the invention.
[0023] The citation and incorporation of patent documents herein is
done for convenience only and does not reflect any view of the
validity, patentability, and/or enforceability of such patent
documents.
[0024] This invention includes all modifications and equivalents of
the subject matter recited in the claims appended hereto as
permitted by applicable law.
[0025] In an example of the present invention an embodiment may be
a drug delivery device comprising a housing, a piston rod having a
proximal thread and a distal thread, a nut member which is not
axially displaceable in the housing and which has an inner thread
mating the distal thread of the piston rod such that the piston rod
is screwed in a distal direction when rotated relatively to the nut
member, a drive sleeve which has an inner thread mating the
proximal thread of the piston rod such that the piston rod is
rotated when the driver sleeve is axially moved relatively to the
piston rod wherein a releasable coupling operational between a
first position and a second position is provided between the piston
rod and the drive sleeve which coupling in the first position
prevents rotation of the piston rod while allowing rotation of the
drive sleeve and in the second position prevents rotation of the
drive sleeve whilst allowing rotation of the piston rod. The
coupling may comprises a slider slidable connected to the housing
or a clicker element coupled to the slider. The clicker element
maybe both axially and rotationally locked to the slider in the
first position and the clicker maybe rotationally released in the
second position. The injection button maybe connected to the drive
sleeve in a way making the injection button axially displaceable
relative to the drive sleeve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The invention will be explained more fully below in
connection with a preferred embodiment and with reference to the
drawings in which:
[0027] FIG. 1 Shows a cross section of an injection device
according to the present invention.
[0028] FIG. 2 Shows a cross section of a part of FIG. 1.
[0029] The figures are schematic and simplified for clarity, and
they just show details, which are essential to the understanding of
the invention, while other details are left out. Throughout, the
same reference numerals are used for identical or corresponding
parts.
DETAILED DESCRIPTION OF EMBODIMENT
[0030] When in the following terms as "upper" and "lower", "right"
and "left", "horizontal" and "vertical", "clockwise" and "counter
clockwise" or similar relative expressions are used, these only
refer to the appended figures and not to an actual situation of
use. The shown figures are schematic representations for which
reason the configuration of the different structures as well as
there relative dimensions are intended to serve illustrative
purposes only.
[0031] In that context it may be convenient to define that the term
"distal end" in the appended figures is meant to refer to the end
of the injection device carrying the injection needle whereas the
term "proximal end" is meant to refer to the opposite end pointing
away from the injection needle.
[0032] FIG. 1 discloses a pen-shaped injection device 1 comprising
a proximal housing 10 holding the dose setting and injection
mechanics at its proximal end and a distal cartridge holder 20
holding a cartridge 21 containing the liquid drug at its distal
end. The housing 10 is provided with an internal thread 11 and an
opening 12 through which a user can view the dose setting
preferably through a magnifier.
[0033] At the most proximal end of the housing 10, an injection
button 30 is supported. This injection button 30 has a longitudinal
shape and is interfaced with a dose dial sleeve 40 through a
rotatable connection 31/41. The dose dial sleeve 40 is at its
distal end 42 guided in the internal thread 11 of the housing 10.
The dose dial sleeve 40 is covered by a transparent shield 50 which
is inrotatable connected to the injection button 30 or
alternatively moulded as a part of the injection button 30.
[0034] Centrally in the injection device 1 a piston rod 60 is
provided. This piston rod 60, which preferably has a non-circular
cross-section, has a proximal thread 61 and a distal thread 62,
which preferably has a different pitch. The distal thread 62 is
engaged by a thread 16 internally in the part 15 of the housing 10
bridging the housing 10 to the cartridge holder 20 such that the
piston rod 60 can be screwed out of this thread 16 and into the
cartridge holder 20 by rotation.
[0035] The part 15 of the housing 10 bridging the housing 10 to the
cartridge holder 20 could be provided as a separate part 15
connected either to the housing 10 or to the cartridge holder 20 in
a way making it not axially displaceable. The proximal thread 61 is
engaged by a driver 70 having an internal thread 71 engaging the
proximal thread 61. Further the driver 70 is connected to the
injection button 30 through a connection 32/72 making the driver 70
rotatable with the injection button 30 but axially
displaceable.
[0036] A clicker element 80 which is inrotatable secured to the
piston rod 60 through a coupling 64/84 is located distally in the
housing 10. The clicker element 80 comprises a distal ring element
81 and a proximal ring element 82. The distal ring element 81 is
secured in a slider 90 in a way making the clicker element 80
rotatable relatively to the slider 90 but axially coupled to the
slider 90.
[0037] The proximal ring element 82 engages the slider 90 such that
the clicker element 80 is locked to the slider 90 which again is
locked to the housing 10 through the axially displaceable
connection 14/94, however since the proximal ring element 82 is
flexible it can be pushed out of engagement with the slider 90 by
providing an axially force on the proximal ring element 82.
[0038] The clicker element 80 is further provided with a circular
track 83 which is engaged by a similar protrusion 73 on the driver
70 making the clicker element 80 and the driver 70 relatively
rotatable but axially connected.
[0039] The injection button 30 is distally provided with an
End-of-Content (EoC) thread 34 engaged by an EoC nut member 100
slidable in a longitudinal track 14 in the housing 10. A
description of a similar EoC mechanism is provided in EP
1.250.167.
[0040] When a user wants to set a dose, the injection button 30 is
rotated which due to the connection 32/72 forces the driver 70 to
rotate up the proximal thread 61 on the piston rod 60. During dose
setting, the piston rod 60 is secured against rotation by the
connection 64/84 with the clicker element 80 which is locked to the
housing 10 by the engagement between the proximal ring element 82
and the slider 90.
[0041] As the driver 70 rotates up the proximal thread 61, the dose
dial sleeve 40 is pulled backwards out of the housing 10 by the
engagement 31/41, however since the dose dial sleeve 40 is guided
in the internal thread 11 in the housing 10 it rotates. The shield
50 surrounding the dose dial sleeve 40 is also rotated with the
injection button 30.
[0042] The clicker element 80 which is rotatable mounted to the
driver 70 is moved axially in the proximal direction without
rotation due to the engagement with the slider 90 which slides in a
track 14 on the inside surface of the housing 10.
[0043] In order to inject the set dose, the user places a finger on
the injection button 30 and exerts an axial force. This will first
move the injection button 30 a few millimetres relatively to the
driver 70 and an axial force will be exerted on the proximal ring
element 82 of the clicker element 80 which will release the clicker
element 80 from the slider 90. At the same time the distal
protrusion 33 on the injection button 30 will engage the slider 90
such that the injection button 30 is forced to move axially without
rotating.
[0044] With the driver 70 rotational locked to the injection button
30 through the connection 32/72 and a continuous axial movement of
the injection button 30, the piston rod 60 is forced to rotate.
Since the coupling is rotational, locked to the piston rod 60, the
coupling will rotate as well. This rotation being allowed since the
clicker element 80 is no longer locked to the slider 90.
[0045] The continuous axial forward movement of the injection
button 30 and the driver 70 will force the piston rod 60 to rotate
and be screwed forward in the thread 16. A forward movement of the
piston rod 60 will force a rubber plunger 22 to move forward inside
the cartridge 21 and expel a volume of the liquid drug inside in
the cartridge 21 out through a not shown conduit such as an
injection needle mounted to the distal end of the cartridge 21.
[0046] Some preferred embodiments have been shown in the foregoing,
but it should be stressed that the invention is not limited to
these, but may be embodied in other ways within the subject matter
defined in the following claims.
* * * * *