U.S. patent application number 11/911871 was filed with the patent office on 2009-02-12 for injection device.
This patent application is currently assigned to Novo Nordisk A/S. Invention is credited to Kristian Glejbol, Michael Ejstrup Hansen, Steven Linnebjerg, Claus Schmidt Moller.
Application Number | 20090043264 11/911871 |
Document ID | / |
Family ID | 36685844 |
Filed Date | 2009-02-12 |
United States Patent
Application |
20090043264 |
Kind Code |
A1 |
Glejbol; Kristian ; et
al. |
February 12, 2009 |
Injection Device
Abstract
An injection device for injection of set doses of medicine from
a cartridge has a nut (13) that is screwed up along a threaded
piston rod (4) during a dose setting operation. The nut is screwed
along the piston rod by rotating a dose setting member (17. A
rotational coupling mechanism includes an axially displaceable
coupling member (25) which is rotated as a function of axial
displacement. During dose setting, the nut is allowed to rotate
relative to the coupling member. During injection, the coupling
member is rotationally locked to the nut. This provides a dose
setting and injection mechanism wherein the nut member is both
rotated during dose setting and during injection.
Inventors: |
Glejbol; Kristian;
(Glostrup, DK) ; Linnebjerg; Steven; (Skaevinge,
DK) ; Moller; Claus Schmidt; (Fredensborg, DK)
; Hansen; Michael Ejstrup; (Veflinge, DK) |
Correspondence
Address: |
NOVO NORDISK, INC.;INTELLECTUAL PROPERTY DEPARTMENT
100 COLLEGE ROAD WEST
PRINCETON
NJ
08540
US
|
Assignee: |
Novo Nordisk A/S
Bagsvaerd
DK
|
Family ID: |
36685844 |
Appl. No.: |
11/911871 |
Filed: |
April 21, 2006 |
PCT Filed: |
April 21, 2006 |
PCT NO: |
PCT/EP2006/061748 |
371 Date: |
June 19, 2008 |
Current U.S.
Class: |
604/211 |
Current CPC
Class: |
A61M 5/31561 20130101;
A61M 5/31585 20130101; A61M 5/31556 20130101; A61M 5/31573
20130101; A61M 5/31558 20130101; A61M 5/3156 20130101; A61M 5/31551
20130101; A61M 2005/3152 20130101; A61M 5/31575 20130101; A61M
5/3158 20130101; A61M 5/31541 20130101 |
Class at
Publication: |
604/211 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 24, 2005 |
DK |
PA 2005 00589 |
Claims
1. An injection device comprising: a. a housing for a dose setting
and injecting mechanism, the housing having a proximal end and a
distal end, b. a rotatable dose setting member, c. an axially
displaceable piston rod having a first thread and an additional
longitudinally extending track, d. a central opening in the housing
for engaging the additional longitudinally extending track of the
piston rod, thus guiding the angular movement of the piston rod
during axial translation of the piston rod, e. a threaded nut
engaging the first thread of the piston rod, the nut being
rotatably locked to the dose setting member during dose setting, f.
a rotational coupling mechanism having a coupling member which is
axially displaceable from a first position to a second position,
the rotational coupling mechanism allowing angular movement of the
nut relative to the coupling member during dose setting while
preventing angular movement between the nut and the coupling member
during injection, wherein the coupling member is angularly coupled
to the housing so as to be forced to move angularly as a function
of axial displacement of the coupling member relative to the
housing during at least a part of the axial displacement from said
first to said second position.
2. The injection device as defined in claim 1, wherein the dose
setting member is axially displaceable as a result of rotation of
the dose setting member relative to the housing, and that the
coupling member is so coupled to the dose setting member that axial
displacement of the dose setting member substantially corresponds
to axial displacement of the coupling member.
3. The injection device as defined in claim 1, wherein the coupling
member has a thread and is threadedly engaged with a helical thread
disposed in the housing, the thread of the housing having a
constant pitch.
4. The injection device as defined in claim 1, wherein the coupling
member has a protrusion which mates and engages a longitudinally
extending track disposed in the housing the longitudinally
extending track having a variable pitch along the extension of the
track.
5. The injection device as defined in claim 1, wherein the
rotational coupling mechanism comprises an incremental feedback
mechanism providing incremental clicks during dose setting
corresponding to dose volume.
6. The injection device as defined in claim 1, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
7. The injection device as defined in claim 6, wherein the gear box
assembly provides a gearing causing the nut to move a distance in
the distal direction during injection that is less than the
distance moved by the injection button.
8. The injection device as defined in claim 1, wherein the
additional longitudinally extending track on the piston rod is
helically disposed thereby forming a second thread on the piston
rod.
9. The injection device as defined in claim 8, wherein the first
thread and the longitudinally extending track on the piston rod are
oppositely disposed.
10. The injection device as defined in claim 8, wherein the
coupling member has a thread and is threadedly engaged with a
helical thread disposed in the housing, the thread of the housing
having a constant pitch substantially corresponding to the pitch of
the additional longitudinally extending track on the piston
rod.
11. The injection device as defined in claim 2, wherein the
coupling member has a thread and is threadedly engaged with a
helical thread disposed in the housing, the thread of the housing
having a constant pitch.
12. The injection device as defined in claim 2, wherein the
coupling member has a protrusion which mates and engages a
longitudinally extending track disposed in the housing the
longitudinally extending track having a variable pitch along the
extension of the track.
13. The injection device as defined in claim 9, wherein the
coupling member has a thread and is threadedly engaged with a
helical thread disposed in the housing, the thread of the housing
having a constant pitch substantially corresponding to the pitch of
the additional longitudinally extending track on the piston
rod.
14. The injection device as defined in claim 2, wherein the
rotational coupling mechanism comprises an incremental feedback
mechanism providing incremental clicks during dose setting
corresponding to dose volume.
15. The injection device as defined in claim 3, wherein the
rotational coupling mechanism comprises an incremental feedback
mechanism providing incremental clicks during dose setting
corresponding to dose volume.
16. The injection device as defined in claim 4, wherein the
rotational coupling mechanism comprises an incremental feedback
mechanism providing incremental clicks during dose setting
corresponding to dose volume.
17. The injection device as defined in claim 2, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
18. The injection device as defined in claim 3, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
19. The injection device as defined in claim 4, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
20. The injection device as defined in claim 5, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
21. The injection device as defined in claim 6, wherein the
injection device further comprises an injection button and a gear
box assembly coupling axial movement of the injection button with
axial movement of the nut.
Description
[0001] The present invention relates to syringes having a piston
drive element for engaging and moving a piston within a medication
cartridge, by which a dose can be set by rotating a nut along the
piston drive element during dose setting, and wherein a set dose
can be expelled by driving the nut to its initial position.
BACKGROUND OF THE INVENTION
[0002] An almost classic pen which adopts the above described dose
setting and injecting scheme is described in EP 327 910.
[0003] By setting a dose on this pen a tubular member forming an
injection button is screwed up along a threaded piston rod a
distance corresponding to the distance said piston rod must be
moved to inject the set dose. The tubular member simply forms a nut
which is during the dose setting screwed away form a stop and which
is during the injection pressed back to abutment with said stop and
the force exerted on the button is directly transmitted to the a
piston closing one end of an ampoule in the syringe which ampoule
contains the medicament to be injected. When the piston is pressed
into the ampoule the medicament is pressed out through a needle
mounted through a closure at the other end of the ampoule.
[0004] By time it has been wanted to store larger amount in the
ampoules, typically 3 ml instead of 1.5 ml. As it has not been
appropriate to make the syringe longer the ampoule is instead given
a larger diameter, i.e. the area of the piston facing the
medicament in the ampoule has been doubled and consequently the
force which has to be exerted on the piston to provide the same
pressure as previously inside the ampoule has been doubled. Further
the distance the piston has to be moved to inject one unit of the
medicament has been halved.
[0005] This development is not quite favourable, as especially
users having reduced finger strength have their difficulties in
pressing the injection button, a problem that is further increased
when still thinner needles are used to reduce the pain by
injection. Also with quite small movements of the button it is
difficult to feel whether the button is moved at all and by
injection of one unit from a 3 ml ampoule the piston and
consequently the injection button has to be moved only about 0.1
mm.
[0006] Consequently a wish for a gearing between the injection
button and the piston has occurred so that the button has a larger
stroke than has the piston. By such a gearing the movement of the
injection button is made larger and the force, which has to be
exerted on the injection button, is correspondingly reduced.
[0007] In EP 608 343 a gearing is obtained by the fact that a dose
setting element is screwed up along a spindle having a thread with
a high pitch. When said dose setting element is pressed back in its
axial direction the thread will induce a rotation of said dose
setting element, which rotation is via a coupling transmitted to a
driver nut with a fine pitch which driver nut will force a threaded
not rotatable piston rod forward.
[0008] A similar gearing is provided in WO 99/38554 wherein the
thread with the high pitch is cut in the outer surface of a dose
setting member and is engaged by a mating thread on the inner side
of the cylindrical housing. However, by this kind of gearing
relative large surfaces are sliding over each other so that most of
the transformed force is lost due to friction between the sliding
surfaces. Therefore a traditional gearing using mutual engaging
gear wheels and racks is preferred.
[0009] From WO 96/26754 is known an injection device wherein two
integrated gear wheels engages a rack fixed in the housing and a
rack inside a plunger, respectively. When the plunger is moved
axially in the housing the rack inside this plunger can drive the
first gear wheel to make the other integral gear wheel move along
the fixed rack in the housing. Thereby the gear wheel is moved in
the direction of the plunger movement but a shorter distance than
is this plunger and this axial movement of the integrated gear
wheels is via a housing encompassing said gear wheels transmitted
to a piston rod which presses the piston of an ampoule further into
this ampoule. However, the rack inside the plunger is one of a
number axial racks provided inside said plunger. These racks
alternates with untoothed recesses, which allow axial movement of
the plunger without the first gear wheel being in engagement with a
rack in this plunger. This arrangement is provided to allow the
plunger to be moved in a direction out of the housing when a dose
is set. When the plunger is rotated to set a dose it is moved
outward a distance corresponding to one unit during the part of the
rotation where the first gear wheel passes the untoothed recess,
thereafter the first gear wheel engages one of the racks so the set
unit can be injected, or the rotation can be continued to make the
first gear wheel pass the next recess during which passing the set
dose is increased by one more unit and so on until a dose with the
wanted number of units is set.
[0010] A disadvantage by this construction is that the teeth of the
racks and gearwheels alternating have to be brought in and out of
engagement with each other with the inherit danger of clashing. As
only a few racks separated by intermediary untoothed recess can be
placed along the inner surface of the plunger only few increments
can be made during a 360.degree. rotation.
[0011] In U.S. Pat. No. 6,663,602 is disclosed an injection device,
wherein a direct gearing, i.e. a gearing by which more
transformations of rotational movement to linear movement and
linear movement to rotational movement are avoided, between the
injection button and the piston rod.
[0012] The injection device shown in U.S. Pat. No. 6,663,602
comprises a housing wherein a piston rod threaded with a first
pitch is non rotatable but longitudinally displaceable guided, a
nut engaging the thread of the piston rod which nut can be screwed
along the threaded piston rod away from a defined position in the
housing to set a dose and can be pressed back to said defined
position carrying the piston rod with it when the set dose is
injected, a dose setting member which can be screwed outward in the
housing along a thread with a second pitch to lift an injection
button with it up from the proximal end of the housing. This
injection device is provided with a gearbox which provides a
gearing between the axial movements of the injection button and the
nut relative to the housing which gearing has a gearing ratio
corresponding to the ratio of said second and first pitch.
[0013] Although broadly being considered state of the art, the
injection device disclosed in U.S. Pat. No. 6,663,602 presents
important mechanical constraints due to the construction principle
of the linear gearing system which acts during dosing. According to
the injection device of U.S. Pat. No. 6,663,602, the length of the
nut/piston rod assembly is increased during the dose setting by
rotating the nut in a thread on the piston rod. During dosing, the
linear displacement of the nut and the injection button are coupled
such that there is proportionality between the movement of the nut
and the injection button, the proportionality given by the
transmission ratio of the gear box. As the nut is rotationally
confined relatively to the piston rod during dosing, the
translation of the nut corresponds to the translation of the piston
rod and thus ultimately to the dose of medication administered.
[0014] As the gear is an integrated part of the construction and as
the gear can only be designed to certain transmission ratios, the
gear implies important constraints on the obtainable ratio of
movement of the injection button relative to the movement of the
piston. Due to the direct proportionality between the movement of
the piston rod and the administered dose of medication, the same
syringe can not easily be adapted to different medications.
Although adaptation is possible by changing the transmission ratio
of the linear gear, this solution will in general be very complex
and imply a complete redesign of the syringe.
DISCLOSURE OF THE INVENTION
[0015] The injection devices disclosed in U.S. Pat. No. 6,663,602
comprises dose setting and injection mechanisms wherein the nut is
held rotationally fixed during dose delivery. However, according to
the present invention, the nut may be rotated relative to the
housing, also during dose delivery.
[0016] According to one aspect of the present invention, the
injection device comprises:
[0017] a. a housing for a dose setting and injecting mechanism, the
housing having a proximal end and a distal end,
[0018] b. a rotatable dose setting member,
[0019] c. an axially displaceable piston rod having a first thread
and an additional longitudinally extending track,
[0020] d. a central opening in the housing for engaging the
additional longitudinally extending track of the piston rod, thus
guiding the angular movement of the piston rod during axial
translation of the piston rod,
[0021] e. a threaded nut engaging the first thread of the piston
rod, the nut being rotatably locked to the dose setting member
during dose setting,
[0022] f. a rotational coupling mechanism having a coupling member
which is axially displaceable from a first position to a second
position, the rotational coupling mechanism allowing rotational
movement of the nut relative to the coupling member during dose
setting while preventing rotational movement during injection. The
coupling member is rotationally coupled to the housing so as to be
urged to rotate as a function of axial displacement of the coupling
member relative to the housing during at least a part of the axial
displacement from said first to said second position.
[0023] According to such a configuration, a prolongation or
reduction of the stroke of the injection button compared to the
stroke of the piston rod may be obtained. Further, as this
configuration implies a change in the rate of rotation of the dose
setting member for a given dose to be injected, a dose scale
reading with a different layout may be obtained. In this way, a
scale reading with increased distance between consecutive numbers
may be obtained, which provides the possibility of increasing the
font size of the labels of the scale reading. Also, this
configuration provides the possibility of fine tuning the gearing
ratio, if the injection device is so configured.
[0024] According to a second aspect of the invention, the dose
setting member is axially displaceable as a result of rotation of
the dose setting member relative to the housing, while the coupling
member is coupled to the dose setting member such that axial
displacement of the dose setting member substantially corresponds
to axial displacement of the coupling member.
[0025] According to a third aspect of the invention, the coupling
member has a thread and is threadedly engaged with a helical thread
disposed in the housing, the thread of the housing having a
constant pitch. According to this aspect, a particularly simple
solution is obtained.
[0026] According to a fourth aspect of the invention, the coupling
member has a thread which engage a longitudinally extending track
disposed in the housing wherein the longitudinally extending track
has a variable pitch along the extension of the track. According to
this aspect, the rotation of the dose setting member is nonlinear
with respect to the various specific dose selections. Thus, a dose
setting member with a nonlinear scale is obtainable, e.g. a scale
can be provided having comparable larger steps for smaller doses to
be injected than for larger doses. This implies improved resolution
in the low range of injectable doses. Also, an injection button can
be provided having a stroke that is nonlinear with respect to the
specific amount of drug to be injected, e.g. having a prolonged
stroke for smaller doses compared to the solutions provided for in
U.S. Pat. No. 6,663,602.
[0027] According to a fifth aspect of the invention, the rotational
coupling mechanism comprises an incremental feedback mechanism
providing incremental clicks during dose setting corresponding to
dose volume. This aspect provides an easy adjustment of the
rotational movement of the dose setting drum for each click,
relatively to the housing part. In combination with the third
aspect, an increase or a decrease of distance between the numbers
on the dose setting drum or dose setting scale and thus the
rotation for each click can be varied by choosing a specific pitch
of the thread of the housing which engages the thread of the
coupling member. By varying the inclination of the track along the
extension of the track, it is possible to vary the rotation per
click in a nonlinear way.
[0028] According to a sixth aspect of the invention, an injection
button is operatively connected to a gear box assembly coupling
axial movement of the injection button with axial movement of the
nut. A gearing between the movements of the injection button and
the nut may be obtained by the gearbox comprising at least one gear
wheel carried by a connector which projects from the gear box
longitudinally displaceable but non rotatable relative to said
gearbox and is integral with the nut, a first rack integral with a
first element of the gearbox, which element is rotational but not
longitudinally displaceable relative to the housing, and second
element carrying a second rack projecting from said gearbox
longitudinally displaceable but non rotatable relative to said
first element and being coupled to the injection button to follow
longitudinal movements of said button, the at least one gear wheel
engaging the first and the second rack, respectively, and being
dimensioned to provide a gearing by which a longitudinal movement
of the second rack is transformed to a longitudinal movement of the
connector with a gearing ratio for the mentioned longitudinal
movements of the second rack and the connector relative to the
housing, which gearing ratio substantially corresponds to the ratio
of said second to said first pitch.
[0029] In such a device only the forces necessary to drive the dose
setting member are transformed by a thread with a high pitch
whereas the forces necessary to move the piston by injection is
transmitted to said piston through a conventional gear with
constantly engaging gears and racks.
[0030] In a seventh aspect of the invention, the piston rod is
provided with a stop for the movement of the nut along the thread
of said piston rod, thereby forming an end-of-content stop. This
way a dose setting limiter is provided in the classic way, which
involves no additional members to prevent setting of a dose
exceeding the amount of liquid left in the ampoule.
[0031] According to an eighth aspect of the invention, the
additional longitudinally extending track on the piston rod is
helically disposed on the external surface of the piston rod
thereby forming a second thread on the piston rod. By forming this
track in a helical fashion, the piston rod is rotated as a result
of axial displacement of the piston rod relative to the housing. By
rotating the piston rod and the coupling member a similar angle
during dosing, it is possible to set smaller or bigger dose volume
per click, and still have an EOC (End-Of-Content) stop between the
piston rod and the nut.
[0032] As used herein, the term "drug delivery device" according to
the instant invention shall mean a single-dose or multi-dose,
disposable or re-useable device designed to dispense a selected
dose of a medicinal product, preferably multiple selected doses,
e.g. insulin, growth hormones, low molecular weight heparins, and
their analogues and/or derivatives etc. Said device may be of any
shape, e.g. compact or pen-type. Dose delivery may be provided
through a mechanical (optionally manual) or electrical drive
mechanism or stored energy drive mechanism, such as a spring, etc.
Dose selection may be provided through a manual mechanism or
electronic mechanism. Additionally, said device may contain
components designed to monitor physiological properties such as
blood glucose levels, etc. Furthermore, the said device may
comprise a needle or may be needle-free. In particular, preferred
embodiment the term drug delivery device shall mean a disposable
multi-dose pen-type device having mechanical and manual dose
delivery and dose selection mechanisms, which is designed for
regular use by persons without formal medical training such as
patients. Preferably, the drug delivery device is of the
injector-type.
[0033] The term "housing" according to instant invention shall
preferably mean an exterior housing ("main housing", "body",
"shell") or interior housing ("inner body", "insert") having
internal and external threads. The housing may be designed to
enable the safe, correct, and comfortable handling of the drug
delivery device or any of its mechanisms. Usually, it is designed
to house, fix, protect, guide, and/or engage with any of the inner
components of the drug delivery device (e.g., the drive mechanism,
cartridge, plunger, piston rod) by limiting the exposure to
contaminants, such as liquid, dust, dirt etc. In general, the
housing may be unitary or a multipart component of tubular or
non-tubular shape. Usually, the exterior housing serves to house a
cartridge from which a number of doses of a medicinal product may
by dispensed. However, a cartridge may be directly coupled to the
housing so as to be partly or fully external to the housing.
[0034] The term "engaged" according to instant invention shall
particularly mean the interlocking of two or more components of the
drive mechanism/drug delivery device, e.g. a spline or thread
connection, preferably the interlocking of helical threads of
components ("threadedly engaged"). The term "engaged" encompasses
the use of intermediary components coupling threadedly engaged
threads.
[0035] The term "thread" according to instant invention shall
preferably mean a full or part thread, e.g., a cylindrical spiral
rib/groove, usually of helical nature or comprising linear inclined
parts, located on the internal and/or external surface of a
component of the drug delivery device ("internal thread" and/or
"external thread"), having an essentially triangular or square or
rounded section designed to allow continuous free rotational and/or
axial movement between components. Optionally, a thread may be
further designed to prevent rotational or axial movement of certain
components in one direction.
[0036] The term "dose setting member" according to instant
invention shall mean an essentially tubular component of
essentially circular cross-section having either: a) both an
internal and external thread, or b) an internal thread, or c) an
external thread. The dose setting member may be designed to
indicate a selected dose of a dispensable product. This may be
achieved by use of markings, symbols, numerals, etc., e.g. printed
on the external surface of the dose setting member or an odometer,
or the like. Also, a separate dose scale may be used, either
comprising a mechanical or an electronic display.
[0037] The term "lead" according to instant invention shall
preferably mean the axial distance a nut would advance in one
complete revolution; preferably "lead" shall mean the axial
distance through which a component having a helical thread, i.e.
dose setting member, nut, piston rod, etc., of the drive mechanism
travels during one rotation. Therefore lead is a function of the
pitch of the thread of the relevant component.
[0038] The term "pitch" according to instant invention shall
preferably mean the distance between consecutive contours on a
helical thread, measured parallel to the axis of the helical
thread.
[0039] The term "piston rod" according to instant invention shall
mean a component adapted to operate through/within the housing,
designed to translate axial movement through/within the drug
delivery device, preferably from the nut to the piston, for the
purpose of discharging/dispensing an injectable product. Said
piston rod may be flexible or not. It may be a simple rod, a
lead-screw, or the like. The "piston rod" according to instant
invention shall further mean a component having a non-circular
cross-section and preferably having one or more threads located
partly or fully extending along its length. It may be made of any
suitable material known by a person skilled in the art.
[0040] The term "incremental feedback mechanism" according to
instant invention shall mean a mechanism providing the dose setting
to occur in a number of discrete incremental steps, e.g. one
incremental click for each international unit being set, the
incremental feedback mechanism preferably providing a tactile or
audible click which can be sensed or heard by a user operating the
pen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] In the following the invention is described in further
details with references to the drawing, wherein
[0042] FIG. 1 schematically shows a sectional view of an injection
device according to the invention, and
[0043] FIG. 2 shows schematically a sectional view of the gear box
along the line I-I in FIG. 1,
[0044] FIG. 3 shows a longitudinal sectional view in the dose
setting part of another embodiment of an injection device according
to the invention,
[0045] FIG. 4 shows a longitudinal sectional view perpendicular to
the view in FIG. 3,
[0046] FIG. 5 shows an exploded view of the of the device shown in
FIGS. 3 and 4,
[0047] FIG. 6a shows a large scale view of the tubular part 105 of
FIG. 5 according to one embodiment of the invention, and
[0048] FIG. 6b shows a large scale view of the corresponding part
105 of a prior art injection device.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0049] The device shown in the appended drawings is shown as an
injector pen, which pen has an elongated body with a central axis.
However, other forms are within the scope of the invention.
[0050] In the device shown in FIG. 1 an elongated cylindrical
housing 1 has a partitioning wall 2 which divides the housing in a
compartment containing a dose setting mechanism and a compartment 3
designed for the accommodation of a not shown ampoule. The
partitioning wall 2 is provided with an opening extending there
through. Alternatively, the wall may be replaced by an insert which
is secured against rotational and axial motion with respect to the
main structure of the housing 1, the opening being formed in said
insert. A piston rod 4 having a first thread 4a and an additional
longitudinally extending track 4b formed in or on the piston rod 4,
extends through the opening 2b, which is provided with one or more
ribs which mates and engages the additional longitudinal extending
track 4b.
[0051] In accordance with the specific design of the additional
longitudinally extending track 4b and the mating opening 2b in
partition wall 2, the piston rod 4 is rotationally guided as a
function of axial displacement of the piston rod. To obtain a
piston rod 4 which is longitudinally displaceable while being
rotationally locked relative to the housing, the additional
longitudinally extending track 4b is formed as a rectilinear track
which extends parallel to the axis of the piston rod 4.
Alternatively, to obtain a piston rod 4 which is being rotated as a
function of axial displacement of the piston rod 4, the additional
longitudinal track 4b is formed as a helical groove or thread which
mates and engages with helical ribs or threads formed in opening 2b
in the partition wall 2.
[0052] In accordance with the specific design of the injection
device, the first thread 4a and the additional longitudinally
extending track 4b may be disposed on opposite ends of the piston
rod 4, may be partly overlapping or fully overlapping in the axial
direction of the piston rod 4. Furthermore, the thread 4a may be
disposed with a larger depth than the additional longitudinally
extending track 4b or vice versa. In FIG. 1, the threads 4a and 4b
and the threaded opening 2b are schematically represented.
[0053] Concentrically with the housing 1 the wall 2 carries on its
side turning away from the compartment 3 a tubular element 5 which
is at a part of it adjacent to the wall 2 provided with an outer
thread 6 and which has at its free end a circumferential recess 7.
A ring shaped coupling element 8 on a gear box 9 engages the recess
7. By this coupling the gearbox is fixed in the housing 1 in a way
that allows the gearbox 9 to rotate in the housing but not to be
axially displaced relative to said housing.
[0054] In the gearbox 9 a gear wheel assembly comprising two
integral gear wheels is journaled on a shaft 11, which runs
perpendicular to the longitudinal axis of the device between two
axial connection bars 12. The connection bars 12 project from the
gear box towards the partition wall 2 and are connected to a nut 13
which engages the first thread 4a of the piston rod 4. The gear
wheel assembly comprises a gear wheel 14 with a large diameter
engaging the teeth of a rack 15 which is guided in the gear box to
be displaced in the longitudinal direction of the device, and a
gear wheel 16 with a small diameter engaging a rack 10 in FIG. 2
extending in the longitudinal direction of the device on the inner
wall of the gearbox 9. The gear wheel 16 with the small diameter
may be divided into two gear wheels placed on each side of the of
the gear wheel 14, and the rack on the inner wall of the gearbox 9
may have a longitudinal recess without any teeth to make room for
the gear wheel 14.
[0055] A tubular dose setting member 17 fitting into the housing 2
is at an end provided with an internal thread mating and engaging
the outer thread 6 of the tubular element 5 and has at its other
end a part with enlarged diameter forming a dose setting button 18.
Due to the engagement with the thread 6 the dose setting member 17
may be screwed in and out of the housing to show a number on a not
shown helical scale on its outer surface in a not shown window in
the housing 1.
[0056] A bottom 19 in a deep cup shaped element, which has a
tubular part 20 fitting into the dose setting member 17 and
encompassing the gearbox 9, forms an injection button. Coupling
means between the dose setting member 17 and the cup shaped element
ensures that rotation of the dose setting member 17 is transmitted
to the cup shaped element. Further the inner wall of the tubular
part 20 has longitudinal recesses 22 engaged by protrusions 23 on
the gearbox 9 so that rotation of the dose setting member 17 via
the cup shaped element is transmitted to the gearbox 9.
[0057] At the edge of the open end of the cup shaped element a
rosette of V-shaped teeth are provided, which teeth engage a
corresponding rosette of V-shaped teeth 24 on a coupling member 25
which is pressed against the edge of the cup shaped element by a
spring 26 which is compressed between a not toothed side of the
coupling member 25 and a round going shoulder 27 on the inner wall
of the dose setting member 17 at an inner end of the inner thread
of this member. The coupling member 25 is provided with one or more
inner protrusions forming a thread 28, which is engaged by a thread
or track 37 on the tubular element 5 so that the coupling member 25
will be forced to rotate when it is displaced axially relative to
the housing. The track 37 may be designed as a helical thread with
a constant pitch along the extension of the track. Alternatively,
the layout of the pitch may be formed with a variable pitch along
the extension of the track, e.g. by forming a track with inclined
as well non-inclined rectilinear steps, or curved parts.
[0058] The track 37 is so shaped that the dose setting member 17
rotates relative to the coupling member 25, when a user dials a
dose by rotating the dose setting button 18. In this way a click
coupling is established which makes a click noise when the V-shaped
teeth at the edge of the cup shaped element by rotation of this
element rides over the V-shaped teeth of the coupling member 25,
i.e. an incremental feedback mechanism is provided.
[0059] A head 29 on the projecting end of the rack 15 is with a
play fixed at the bottom of the cup shaped element between the
bottom 19 forming the injection button and an inner wall 30 near
this bottom. The rack is fixed in a position with its head pressed
against the wall 30 by a spring 31 between the bottom 19 and the
head 29.
[0060] To set a dose the dose setting button 18 is rotated to
advance the dose-setting member 17 in the proximal direction in
accordance with the thread 6. Due to the coupling 21 the cup shaped
element will follow the rotation of the dose-setting member 17 and
will be lifted concurrently with this member up from the end of the
housing 1. During dose setting, the respective amount of axial
displacement of the dose setting member 17 and the injection button
19 depends on the pitch of the thread 6, the pitch of the first
thread on the piston rod 4 and the gear ratio. Also, if the piston
rod 4 is allowed to move during dose setting, the axial and
rotational movement of the piston rod 4 influences the amount that
the injection button will be displaced. By the rotation of the cup
shaped element the V-shaped teeth 24 at the edge of its open end
will ride over the V-shaped teeth of the coupling member 25 to make
a click sound for each unit the dose is changed. A too high set
dose can be reduced by rotating the dose setting button 18 in the
opposite direction of the direction for increasing the dose. When
the dose setting member is screwed along the thread 6 on the
tubular element 5, the coupling member 25 will follow the dose
setting member in its axial movement as the spring 26 is supported
on the shoulder 27. The spring will keep the V-shaped teeth of the
coupling member 25 and the cup shaped element in engagement and
maintain in engagement the coupling 21, which may comprise A-shaped
protrusions 32 on the cup shaped element engaging .LAMBDA.-shaped
recesses in an inner ring 33 in the dose setting button 18.
[0061] Due to the axial displacement of the dose setting member 17
during dose setting, the coupling member 25 is axially displaced as
well. According to the specific design of the threads or tracks 28
and 37, the coupling member 25 is forced to rotate as the coupling
member 25 is axially displaced. In some embodiments, the thread 37
is formed as a helical thread which has a constant pitch along the
length of the total axial distance that the coupling member is
allowed to move. Depending on the direction of rotation of track
37, the dose setting button 18 has to be rotated a larger or
smaller angle for each click to occur compared to a situation where
the coupling member is kept rotationally fixed. A corresponding
amendment of the layout of the scale reading may be provided, e.g.
by forming the dose scale with larger or smaller spaces between
neighboring dose values.
[0062] The rotation of the dose setting button 18 and the cup
shaped element is further transmitted to the gearbox 9 through the
protrusions 23 on this gearbox engaging the longitudinal recesses
22 in the inner wall of the tubular part 20 of said cup shaped
element. The rotation of the gearbox 9 is through the connection
bars 12 transmitted to the nut 13, which in this way is advanced
along the first thread 4a of the piston rod 4 and lifted away from
its abutment with the wall 2 when a dose it set. As the dose is set
by moving the nut 13 on the piston rod which operates the piston in
the not shown ampoule in the compartment 3, a dose setting limiter,
which ensures that the size of the set dose does not exceed the
amount of medicament left in the ampoule, can easily be established
by providing the piston rod 4 with a stop 35 which limits the
movement of the nut 13 up along the piston rod 4.
[0063] Due to the confinement of the head 29 in the space between
the bottom 19 and the wall 30 of the cup shaped element, the rack
15 is drawn with the injection button outward. Depending on the
specific gear ratio of the gear assembly, the outward movement of
the rack 15 corresponds to an outward movement of nut 13. As the
nut 13 is rotated during dose setting, the length of the piston
rod/nut assembly is prolonged, depending on the mutual pitch of the
piston rod/nut threads and depending on the actual design of the
additional longitudinally extending track 4b. By varying the pitch
of the different threads or the gear ratio, the piston rod is
either moved distally, proximally or held stationary during dose
setting.
[0064] Ideally, if no axial movement of the piston rod 4 is wanted
during dose setting the pitch of the thread 6 and the thread formed
in the piston rod 4a as well as the pitch of the outer recess (6)
should be matched exactly to the gearing ratio of the gear box
depicted in FIG. 2.
[0065] However, tolerances in the machining of the components
comprising the pen may lead to a slight unintended mismatch of the
pitches relatively to the transmission ratio of the gearbox 9.
Especially the situation where the piston rod 4 advances slightly
during dose setting is highly undesirable as the injection device
during dose setting will expel a small amount of medication.
[0066] This situation is avoided by mismatching one or more of the
above mentioned pitches to the transmission ratio of the gearbox
such that the piston rod 4 is slightly withdrawn during dose
setting. The mismatch of pitches is most simply implemented by
modification of the pitch of the recess 4a made in the piston rod 4
and the corresponding thread in the nut 13. In addition, if the
additional longitudinally extending track 4b on piston rod forms a
helical thread, i.e. allowing the piston rod 4 to rotate with
respect to the housing (1), this threaded connection has to be
taken into account when designing the mechanism.
[0067] Alternatively, the injection device is designed such that
the recess in the piston rod is initially designed to be axially
aligned with the piston rod. On assembled production prototypes the
advance of the piston rod during dose setting is measured.
Hereafter the axial aligned recess is redesigned to a helical
recess where the superimposed rotation of the piston rod during
dose setting compensates for the tolerances in the machining.
[0068] According to one embodiment of the invention the pitches of
the threaded parts and the linear gearing are matched such that the
piston rod retracts between 0% and 2% of the full linear
translation relatively to the cartridge during dose setting.
[0069] A corresponding solution can be provided in the injection
device shown in U.S. Pat. No. 6,663,602 which contains an injection
device having a coupling member 25, which is kept rotationally
locked with respect to the housing. For that particular injection
device, a slight mismatch of either the thread 6 or the thread of
piston rod 4 to the transmission ratio of the gearbox can be
provided such that the piston rod 4 is slightly withdrawn during
dose setting.
[0070] In the device according to the instant invention, to inject
a set dose the injection button is pressed by pressing on the
bottom 19. In the initial phase of the pressing, the spring 31 is
compressed where after the pressing force is directly transmitted
to the head 29 of the rack 15 and this way to the rack 15 itself.
Through the gear box 9 the force is transformed and is transmitted
through the connection bars 12 to the nut 13 which will press the
piston rod 4 into the compartment 3 until the dose-setting member
17 abuts the wall 2.
[0071] During the initial phase of the movement of the injection
button the .DELTA.-shaped protrusions 32 on the cup shaped element
will be drawn out of their engagement with the .LAMBDA.-shaped
recesses in the ring 33. The dose-setting member 17 can now rotate
relative to the injection button and will do so when the
.DELTA.-shaped protrusions 32 press against a shoulder 34 at the
bottom of the dose setting button 18. Only a force sufficient to
make the dose setting member rotate to screw itself downward along
the thread 6 is necessary as the force necessary to make the
injection is transmitted to the piston rod 4 through the gearbox 9.
A helical reset spring 36 concentric with the dose setting member
can be mounted at the lower end of this member and can have one end
anchored in the dose setting member 17 and the other end anchored
in the wall 2. During setting of a dose this spring may be tighter
coiled so that on the dose setting member it exerts a torque
approximately corresponding to the torque necessary to overcome the
friction in the movement of the dose setting member along the
thread 6 that the force which the user have to exert on the
injection button is only the force necessary to drive the piston
rod into an ampoule to inject the set dose.
[0072] It shall be noticed that use of only one size gear wheel
which engages as well the rack 15, which is movable relative to the
gear box 9, as the rack 10, which is unmovable relative to the gear
box, provides a gearing ratio of 2:1 for the longitudinal movement
relative to the syringe housing 1 for the movable rack 15 and the
connector 12, which carries the shaft 11 of the gear wheel.
[0073] FIGS. 3 and 4 shows an embodiment wherein only one size gear
wheel is used and wherein elements corresponding to elements in
FIGS. 1 and 2 are given the same references as these elements with
a prefixed "1".
[0074] For manufacturing reasons minor changes are made. So the
partitioning wall 102 and the tubular element 105 are made as two
parts which are by the assembling of the device connected to each
other to make the assembled parts act as one integral part. The
same way the dose setting member 117 and the dose setting button
118 are made as two parts, which are fixed firmly together.
[0075] A circumferential recess 107 is provided as an outer recess
at the free end of the tubular part 105 and a ring shaped coupling
element is provided as an inner bead 108 on the gearbox element 109
which bead engages the recess 107 to provide a rotatable but not
axially displaceable connection between the tubular part 105 and
the gearbox.
[0076] A tubular element 120 having ridges 122 which engages
recesses 123 on the gearbox is at its upper end closed by a button
119 from which a force provided by pressing this button is
transmitted to the tubular element 120.
[0077] The gearbox is formed by two shells, which together form a
cylinder fitting into the tubular element where the shells are
guided by the engagement between the ridges 122 and the recesses
123. Racks 110 and 115 are provided along edges of the shells
facing each other. One shell forming the gearbox part 109 is
provided with the inner bead 108, which engages the circumferential
recess 107 at the end of the central tubular part 105 and carries
the rack 110. The other shell is axially displaceable in the
tubular element 120 and forms the rack 115. At its outer end
projecting from the gearbox the shell carrying the rack 115 is
provided with a flange 140 which is positioned in a cut out 141 in
the end of the tubular element 120 carrying the button 119 so that
this button and the tubular element 120 can be moved so far inward
in the device that the engagement of the teeth 132 and 133 can be
released before the button 119 abuts the flange 140.
[0078] A tubular connection element 112 connects the threaded
piston rod 104 with the gearbox. At its end engaging the piston rod
104 the connection element has a nut 113 with an internal thread
mating the external thread 104a of the piston rod 104. At its end
engaging the gear box the connection element is provided with two
pins 111 projecting perpendicular to the longitudinal axis of the
connection element 112 at each side of this element. Each pin 111
carries a gear wheel 114 which is placed between and engages the
two racks 110 and 115. This way the connection element 112 will be
rotated with the gear box but can be displaced axially relative to
said gear box when the racks 110 and 115 are moved relative to each
other. In practice it will be the rack 115, which is moved relative
to the gearbox element 109 and the housing 1 and will by the shown
construction result in a movement of the connection element 112
relative to housing a distance which is half the distance which the
rack 115 is moved. A coupling member 125 which is at its periphery
provided with a rosette of teeth 124 and has a central bore fitting
over the central tube in the housing 101 so that this coupling
member 125 can be axially displaced along said central tube 105.
One or more internal protrusions 128 on the central bore of the
coupling member 125 is shown in FIGS. 3 and 4. The protrusions
engage mating helical recessed tracks or threads 137 (not shown in
FIGS. 3 and 4) in the central tube to make the coupling member 125
confined with respect to rotational movements, that is, the
coupling member 125 being angularly moved in accordance with the
axial displacement of the coupling member 125 along the tracks or
threads 137. Due to this rotational confinement or rotational
guiding in the housing, a rosette of teeth at the edge of the
tubular element 120 can click over the teeth 124 of the coupling
member when said tubular element is rotated together with the dose
setting member 117. A spring 126 working between the coupling
member 125 and an internal shoulder 127 provided in the dose
setting member 117 makes the coupling member follow the tubular
element 120 when this element with the dose setting member is moved
longitudinally in the housing. To make the dose setting member easy
rotatable, especially when said dose setting member is pressed
inward in the housing, a roller bearing having an outer ring 142
supported by the shoulder 127 and an inner ring 143 supporting a
pressure bushing 144 which supports the spring 126. By the
provision of this smooth running support only very small axial
forces are needed to rotate the dose setting member 117 back to its
zero position when a set dose is injected. This solution replaces
the provision of a reset spring as the spring 36 in FIG. 1. The
bearing is shown as a radial bearing but can be replaced by an
axial bearing.
[0079] Whereas the track 137 is not shown in FIGS. 3 and 4, this
track can be viewed in FIG. 5 which depicts an exploded view of the
embodiment shown in FIGS. 3 and 4. The central tubular part 105 is
further shown in a greater scale in FIG. 6a while FIG. 6b the
corresponding part of prior art injection shown in U.S. Pat. No.
6,663,602.
[0080] Table 1 is a list showing different configurations of the
above-described injection device. In table 1, configuration no. 1
corresponds to the device which is disclosed in U.S. Pat. No.
6,663,602, i.e. a device having a piston rod that is non-rotational
but axially displaceable and having a track 37, 137 which is a
rectilinear track which extends parallel to the axis of the
injection device. Configurations no. 2-6 correspond to embodiments
having the same pitch of the threads 6, 106 on the dose setting
member and the first thread 4a, 104a on the piston rod as in
configuration no. 1. In configuration no. 2-6, the track 37, 137 is
formed as a helical track having a constant pitch along the
extension of the track, each of the configurations corresponding to
specific pitches of the track. Configurations 1-4 have a piston rod
that is non-rotational but axially displaceable. Configurations no.
5 and 6 has a helical track 4b, 104b which mates and engages the
threaded opening 2b in the housing.
TABLE-US-00001 TABLE 1 (Positive pitch values indicates left handed
threads, negative pitch values indicates right handed threads, 0
(Zero) indicates a non rotational longitudinally track). Pitch (28,
128) on Pitch of dose setting coupling member Pitch of piston rod
Pitch of piston rod member relative to relative to housing relative
to nut (13, relative to housing housing Second pitch on 113) Second
pitch (4b, First pitch (6, 106) on the tubular part First pitch
(4a, 104a) 104b) on the piston Configuration the tubular part (37,
137) on the piston rod rod 1 7.2 0 3.6 0 2 7.2 -14.4 3.6 0 3 7.2
-7.2 3.6 0 4 7.2 14.4 3.6 0 5 7.2 -7.2 3.6 -3.6 6 7.2 -14.4 3.6
-7.2
TABLE-US-00002 TABLE 2 Output Output Input Relative rotation
between Delivered axial Rotation of the dose the dose setting
member displacement setting member (17, and the coupling member of
the Example 117) (25, 125) piston rod (4, 104) # Configuration (in
degrees) (in degrees) (in mm) 1 1 15 15 0.15 2 2 10 15 0.15 3 3 7.5
15 0.15 4 3 15 30 0.3 5 4 30 15 0.15 6 5 7.5 15 0.075 7 6 10 15
0.1
[0081] Table 2 lists examples with different dose settings for the
configurations 1-6 wherein the third column of table 2 shows the
angular amount that the dose setting drum 17, 117 has been dialed.
Corresponding rotational movement of the dose setting drum relative
to the coupling member 25, 125 is listed in column 4 and the
resulting axial displacement of the piston rod is listed in column
5.
[0082] Comparing examples 1-3 and 5 in table 2, it becomes clear
that variation of the pitch of track 37, 137 changes the amount of
the rotation that the dose setting member has to be dialed in order
to expel a desired dose. Thereby an easy adjustment method is
provided where the amount that the dose setting member has to be
rotated for advancing the dose setting button one click, can be
altered. Also, this provides the possibility of changing the
angular distance between consecutive numbers on the dose scale.
Hence, to obtain a dose scale layout with enlarged font size or,
alternatively, a decreased font size, the pitch of the track 37,
137 is chosen in accordance herewith.
[0083] Comparing example 3 and 6, it is readily apparent that
introducing a threaded coupling between the piston rod and the
housing, i.e. making the piston rod rotatable with respect to the
housing, provides for the possibility of obtaining an injection
device with altered dosing amounts, e.g. a half-increment injection
device.
[0084] When introducing a coupling member 25, 125 that rotates
relative to the housing, the end-of-content mechanism as described
above may not work in an optimal way. However, by choosing the same
pitch for the additional longitudinally extending track 4b, 104b on
the piston rod as for the pitch of the track 37, 137 it is ensured
that the end-of-content limitation that the user may experience
when setting a dose for injection, corresponds to the exact amount
that will be expelled during dosing. In this way, a cartridge may
be fully emptied when injecting the dose which corresponds to the
end-of-content setting, i.e. the situation where the piston rod 4,
104 is fully retracted relative to the nut 13, 113,
[0085] In further embodiments, the track 37, 137 may be designed to
have a varying pitch along the track, i.e. having linear parts with
inclined or non-inclined stretches as well as curved stretches.
Also, the rotational direction of the track may be changed from one
part of the track to another part of the track. One specific
embodiment may be designed for larger relative dose button
movements for small dose settings than for dose settings
corresponding to large doses. Thereby it is ensured that the
resolution for small dose settings is held at a comparative high
level.
[0086] Although the above described embodiments show different
specific gearbox assemblies, it is to be noted that, within the
scope of the present invention, various other types of gearboxes
can be used. Also, the functionality of the gearbox can be omitted
while the injection device still being within the scope of the
present invention.
[0087] In addition, alternative embodiments having a dose setting
member which is kept axially fixed during dose setting/dosing will
be applicable with the present invention and within the scope of
the appended claims. One non-limiting embodiment comprises an
additional slave member which is rotationally coupled to the dose
setting member, and which can be used for inducing axial movement
on the coupling member during dose setting.
[0088] Further, a frictional coupling may be provided instead of
the above-described incremental feedback mechanism, whereby doses
may be set among a continuous selection of dose amounts.
[0089] All references, including publications, patent applications,
and patents, cited herein are hereby 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 (to the maximum
extent permitted by law).
[0090] All headings and sub-headings are used herein for
convenience only and should not be construed as limiting the
invention in any way.
[0091] 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. 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.
[0092] This invention includes all modifications and equivalents of
the subject matter recited in the claims appended hereto as
permitted by applicable law.
* * * * *