U.S. patent number RE41,956 [Application Number 11/122,211] was granted by the patent office on 2010-11-23 for dose setting limiter.
This patent grant is currently assigned to Novo Nordisk A/S. Invention is credited to Steffen Hansen, Peter Christian Klitgaard, Claus Schmidt Moller, Bo Radmer.
United States Patent |
RE41,956 |
Klitgaard , et al. |
November 23, 2010 |
Dose setting limiter
Abstract
A limiting mechanism which prevents the setting of a dose, which
exceeds the amount of liquid left in a cartridge of an injection
device, is disclosed. The injection device is the type where a dose
is set by rotating a dose setting member relative to a driver and
away from a fixed stop in the injection device. The dose setting
member interfaces the driver such that the dose setting member can
be rotated in one direction without rotating the driver. The dose
is injected by rotating back the dose setting member which during
the backward rotation carries the driver with it. Rotating the
driver causes the piston rod to move forward inside the cartridge
and expel some of the liquid contained in the cartridge. The driver
is provided with a track having a length which is related to the
total amount of liquid in the cartridge and which track is engaged
by a track follower coupled to the dose setting member to follow
rotation of this dose setting member. Each time a dose is set and
injected, the track follower moves further into the track. When the
track follower reaches the end of the track the dose setting member
can not be rotated further, and a dose larger than the remaining
liquid in the cartridge cannot be set.
Inventors: |
Klitgaard; Peter Christian
(Glostrup, DK), Hansen; Steffen (Hillerod,
DK), Radmer; Bo (Hillerod, DK), Moller;
Claus Schmidt (Fredensborg, DK) |
Assignee: |
Novo Nordisk A/S (Bagsvaerd,
DK)
|
Family
ID: |
8103418 |
Appl.
No.: |
11/122,211 |
Filed: |
May 4, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60155612 |
Sep 23, 1999 |
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Reissue of: |
09655922 |
Sep 6, 2000 |
06582404 |
Jun 24, 2003 |
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Foreign Application Priority Data
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Sep 16, 1999 [DK] |
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1999 01309 |
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Current U.S.
Class: |
604/181; 604/211;
604/186; 604/208; 604/207; 604/224 |
Current CPC
Class: |
A61M
5/31511 (20130101); A61M 5/31585 (20130101); A61M
5/31541 (20130101); A61M 5/31555 (20130101); A61M
5/31553 (20130101); A61M 5/3158 (20130101); A61M
5/31525 (20130101); A61M 2005/3152 (20130101); A61M
5/31568 (20130101); A61M 5/31535 (20130101); A61M
2005/3125 (20130101); A61M 5/24 (20130101); A61M
5/31551 (20130101); A61M 5/31575 (20130101); A61M
2005/3126 (20130101); A61M 2005/31518 (20130101) |
Current International
Class: |
A61M
5/00 (20060101); A61M 5/315 (20060101); A61M
5/178 (20060101) |
Field of
Search: |
;604/181,186,187,207-208,211,224 |
References Cited
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|
Primary Examiner: Sirmons; Kevin C
Assistant Examiner: Gilbert; Andrew M
Attorney, Agent or Firm: Began; Marc A.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application .Iadd.is a reissue of U.S. Pat. No 6,582,404,
which .Iaddend.claims priority under 35 U.S.C. 119 of U.S.
provisional application No. 60/155,612 filed on Sep. 23, 1999 and
Danish application no. PA 1999 01309 filed on Sep. 16, 1999, the
contents of which are fully incorporated herein by reference.
Claims
What is claimed is:
1. A limiting mechanism that prevents setting of a dose that
exceeds the .Iadd.injectable .Iaddend.amount of liquid left in a
cartridge of an injection device wherein a dose is set by rotating
a dose setting member relative to a driver and away from a fixed
stop in the injection device, and the dose is injected by
.[.rotating.]. .Iadd.pressing an injection button which rotates
.Iaddend.back the dose setting member which during this rotation
carries the driver with it to rotate this driver which moves the
piston rod forward, wherein the driver is provided with a track
having a length which is related to the total .Iadd.injectable
.Iaddend.amount of medicament in the cartridge and which track is
engaged by a track follower coupled to the dose setting member to
follow rotation of this dose setting member and wherein the driver
is disk shaped and the track has a spiral shape which is engaged by
the track follower which is flexibly coupled to the dose setting
member so that the track follower can be moved radially when it
follows the track of the driver element.
2. A limiting mechanism that prevents setting of a dose that
exceeds the amount of liquid left in a cartridge of an injection
device wherein a dose is set by rotating a dose setting member
relative to a driver and away from a fixed stop in the injection
device, and the dose is injected by rotating back the dose setting
member which during this rotation carries the driver with it to
rotate this driver which moves the piston rod forward, wherein the
driver is provided with a track having a length which is related to
the total amount of medicament in the cartridge and which track is
engaged by a track follower coupled to the dose setting member to
follow rotation of this dose setting member and wherein the driver
is cylindrical and the track has a helical shape which is engaged
by the track follower which is coupled to the dose setting member
so that the track follower can be moved rotationally when it
follows the track of the driver element.
3. The limiting mechanism of claim 2, wherein the dose setting
element is a cylinder concentric with the driver.
4. The limiting mechanism of claim 3, wherein the track comprises a
thread in the driver and that the track follower comprises a nut
shaped member coupled to the dose setting member and provided with
a thread engaging the thread of the driver.
.Iadd.5. A dose setting limiter assembly that prevents the setting
of a dose which exceeds the remaining injectable amount of
medication in a multiple dose cartridge in an injection device
which comprises: a cylindrical dose setting member having an outer
wall provided with a helical groove which allows the cylindrical
dose setting member to be screwed out of the injection device and
away from an initial position when the cylindrical dose setting
member is rotated during dose setting and screwed into the device
and toward the initial position to reduce the size of a set dose,
wherein during injection of the set dose the cylindrical dose
setting member is pressed back into the device and as a result of
the helical groove it rotates back toward the initial position;
wherein the dose setting limiter assembly comprises: (a) a helical
track disposed on the outer surface of a hollow cylindrical driver
that drives a separate piston rod forward; and (b) a follower that
engages the helical track; wherein the follower moves along the
helical track when the dose setting member is rotated during dose
setting; but wherein the follower does not move along the track
during injection of the set dose; wherein the injection of the set
dose is carried out by pressing an injection button which: (i)
presses the cylindrical dose setting member back into the device,
and (ii) causes the cylindrical dose setting member to rotate back
to the initial position, wherein the rotation back is cause by the
helical groove on the dose setting member; wherein the position of
the follower along the track is indicative of the total sum of the
set and injected doses; wherein the length of the helical track
that the follower can move along corresponds to the amount of
medication in the cartridge that is available to be injected; and
wherein the follower abuts a stop at the end of the track during
dose setting before the cylindrical dose setting element can be
rotated to dial up a dose that would exceed the injectable amount
of medication remaining in the cartridge..Iaddend.
.Iadd.6. The dose setting limiter assembly of claim 5, wherein when
the follower abuts the stop at the end of the track during dialing
up of a dose, the cylindrical dose setting member cannot be rotated
further to increase the size of the dose..Iaddend.
.Iadd.7. The dose limiter assembly of claim 6, wherein the follower
is a nut like element and the helical track is a thread and wherein
the follower engages the thread..Iaddend.
.Iadd.8. The dose limiter assembly of claim 7, wherein the driver,
the helical grove, the helical track, and the dose setting member
are oriented so that they are all coaxial..Iaddend.
.Iadd.9. A dose limiter mechanism for use with in an injection
device, which comprises: (i) a rotatable hollow cylindrical dose
setting member containing a threaded groove on its outer surface so
that it screws out of the injection device during setting of a dose
when it is rotated, screws back into the housing to reduce the size
of a set dose when it is rotated back, and screws back into the
housing when an injection button is pressed during injection, and
(ii) a hollow cylindrical piston rod driver that is coaxial with
the hollow cylindrical dose setting member; wherein the dose
limiting mechanism operates within the injection device to prevent
the setting of a dose that exceeds the injectable amount of
medication remaining in a multiple dose cartridge in the device;
and wherein the dose limiter mechanism comprises: a helical track
disposed on the outer surface of the piston rod driver, the helical
track having a length that corresponds to the injectable amount of
medication in the cartridge; a follower that engages the helical
track and moves along the helical track when the dose setting
member is rotated during dose setting but that remains in a fixed
position on the helical track when the dose setting member is
rotated back when the injection button is pressed during injecting
of medication, and wherein the distance the follower moves during
dose setting corresponds to the size of the set dose and wherein
the follower abuts a stop at the end of the helical track when an
attempt is made to rotate the dose setting member during dose
setting that would result in a dose being set that exceeds the
remaining injectable amount of medication in the
cartridge..Iaddend.
.Iadd.10. The mechanism of claim 9, wherein the hollow cylindrical
dose setting member is prevented from rotating to increase the size
of a set dose when the follower hits the stop..Iaddend.
.Iadd.11. The mechanism of claim 9, wherein the track on the hollow
cylindrical piston rod driver forms a thread and follower comprises
a nut like element that threadly engages the thread..Iaddend.
.Iadd.12. The mechanism of claim 10, wherein the track on the
hollow cylindrical piston rod driver forms a thread and the
follower comprises a nut like element that threadly engages the
thread..Iaddend.
.Iadd.13. An injection device dose limiter assembly for use with
both (a) a rotatable cylindrical dose setting member, which
threadly engages an injection device housing element so that (i)
when it is rotated to set the size of a dose it screws out of an
injection device housing, (ii) when it is rotated back to reduce
the size of a set dose it screws back into the housing, and (iii)
when an injection button is pressed during injecting of medication
the cylindrical dose setting member is pressed back into the
housing and rotates back, and (b) a hollow cylindrical piston rod
driver that drives a separate piston rod during injection of the
set dose; wherein the injection device dose limiter prevents the
setting of a dose that is larger than the injectable amount of
medication remaining in a multi dose cartridge and wherein the
injection device dose limiter assembly comprises: a helical track
disposed on the outside of the hollow cylindrical piston rod
driver; and a follower that moves along the track during dose
setting but remains stationary with respect to the helical track
during dose injecting when an injection button is pressed which
causes the cylindrical dose setting member to be screwed back into
the housing; wherein the length of the track that the follower is
capable of moving along corresponds to the injectable amount of
medication in an injection device multiple dose cartridge; and
wherein during dose setting: the follower moves a distance along
the track that corresponds to the size of the dose being set; and
wherein the follower abuts a stop before the size of the set dose
exceeds the injectable amount of medication remaining in the
cartridge..Iaddend.
.Iadd.14. The assembly of claims 5 or 13, wherein the follower
abuts the stop when the size of the set dose equals the injectable
amount of medication remaining in the cartridge..Iaddend.
.Iadd.15. The assembly of claims 5 or 13, wherein the helical track
has a length adapted to ensure that the follower stops advancing
when the size of a set dose is equal to that remaining for
injection..Iaddend.
.Iadd.16. The assembly of claims 1, 5, or 13, wherein the injection
button moves a distance proportional to, but a number of times
greater than, the distance a piston in the cartridge moves during
delivery of the set dose during dose injecting..Iaddend.
.Iadd.17. The mechanism of claim 9, wherein the follower abuts the
stop when the size of the set dose equals the injectable amount of
medication remaining in the cartridge..Iaddend.
.Iadd.18. The mechanism of claim 9, wherein the helical track has a
length adapted to ensure that the follower stops advancing when the
size of a set dose is equal to that remaining for
injection..Iaddend.
.Iadd.19. The mechanism of claim 9, wherein the injection button
moves a distance proportional to, but a number of times greater
than, the distance a piston in the cartridge moves during delivery
of the set dose during dose injecting..Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates to injection devices wherein the
contents of a cartridge are injected as a number of individually
set doses.
Such devices have a dose setting mechanism by which the doses are
set for subsequent injecting when an injection button is operated.
This can be obtained by moving a carrier along a piston rod a
distance proportional to the wanted dose and subsequently moving
the carrier back to its original position so that the carrier
carries the piston rod with it instead of being moved along said
piston rod.
SCOPE OF THE RELATED ART
From EP 327 910 is known a syringe by which a dose is set by
screwing a nut member up along a threaded piston rod away from a
stop in a housing. The set dose is injected by pressing the end of
the nut member that forms an injection button whereby the nut
member is moved back to abutment with the stop again. During the
latter movement of the nut member the piston rod is carried along
by the nut that does not move relative to this piston rod during
the injection.
When a dose is set it is convenient if a limiting device is
provided which makes it impossible to set a dose that exceeds the
amount of medicament which is left in the cartridge. In EP 327 910
this is obtained by the fact that the thread of the piston rod has
such a length that the cartridge is just emptied when the nut is
screwed to the end of the thread and then pressed home to its
abutment with the stop. By setting a dose the nut can only be
screwed to the end of the thread and thereby the size of the last
dose is limited to comprise the remaining amount in the
cartridge.
The distance the injection button has to be moved corresponds to
the distance the piston in the cartridge has to be moved to inject
the set dose. Especially by larger cartridges with a large cross
section diameter this distance can be very short. To obtain a
larger movement of the injection button a sort of gearing may be
used so that the distance the injection button has to be moved is
proportional with the injected dose but is a number of times the
movement of the piston in the cartridge.
EP 608 343 describes an example of such a geared dose setting and
injection mechanism. In this device the carrier does not cooperate
directly with the threaded piston rod but with a driver element
which can move the piston rod when a set dose is injected. In this
device the driver element comprises a nut member which is fixed
against axial displacement in the injection device. The thread of
the nut member engages an outer thread of the piston rod which is
secured against rotation in the injection device. By the setting of
a dose the carrier is rotated away from a stop to which it is
returned when the injection button is operated. During its return
the carrier rotates the driver element that moves the piston rod
further into the cartridge to press the piston of this cartridge so
that a set amount of the medicament in the cartridge is pressed out
through an injection needle at the distal end of the cartridge. As
the nut member is not moved relative to the piston rod during the
setting of a dose, a limiting construction as described above
cannot be provided limiting the dose so it does not exceed the
amount of liquid left in the injection device.
OBJECT AND SUMMARY OF THE INVENTION
An object of the invention is to provide a limiting mechanism which
prevents setting of a dose that exceeds the amount of liquid left
in a cartridge of an injection device of the geared type wherein a
dose is set by rotating a dose setting member relative to a driver
and away from a fixed stop in the injection device, and the dose is
injected by rotating back the dose setting member which during this
rotation carries the driver element with it to rotate this driver
element which moves the piston rod forward.
Such a mechanism is according to the invention characterized in
that the driver element is provided with a track having a length
which is related to the total amount of medicament in the cartridge
and which track is engaged by a track follower coupled to the dose
setting member to follow rotation of said dose setting member.
During the setting of a dose the track follower will be advanced in
the track of the driver to a position depending on the set dose as
during dose setting the dose setting member and the driver are
rotated relative to each other. As during the injection the driver
follows the rotation of the dose setting member, the pin of the
dose setting member will keep its position in the track of the
driver when the set dose is injected. The length of the track is so
adapted that the pin reaches the end of the track and makes an
increase of the set dose impossible when a dose is set which
corresponds to the amount of liquid remaining in the cartridge.
According to the invention the driver may be disk shaped and have a
spiral shaped track which is engaged by a cam on a member which is
flexibly coupled to the dose setting member so that the pin can be
moved radially when it follows the track of the driver.
In another embodiment of the invention the driver may be
cylindrical and have a helical track which is engaged by a cam on
the dose setting member which is a cylinder concentric with the
driver.
The track may be provided as a thread in the driver and the track
follower may be a nut shaped member coupled to the dose setting
member and provided with a thread engaging the thread of the
driver. When a dose is set the dose setting member is screwed with
its thread along the thread of the driver. The limitation of the
set dose is obtained by giving the threads an appropriate
length.
BRIEF DESCRIPTION OF THE DRAWINGS
In the following the invention will be explained in further details
with references to the drawing, wherein
FIG. 1 shows an exploded view of a syringe with a dose limiter
according to the invention;
FIG. 2 shows an enlarged view of the dose setting element and the
driver element of the syringe in FIG. 1; and
FIG. 3 shows the dose setting member, the driver, and the track
follower of another embodiment of an injection syringe.
DETAILED DESCRIPTION OF THE INVENTION
The syringe in FIG. 1 comprises a housing 1 accommodating a
cartridge 2 from which the content can be pressed out by a piston
rod 3 which is by injection via gear wheels 4 and 5 advanced a
distance corresponding to a dose set by dose setting. A dose
setting member 6 is provided with a toothed wheel 7 surrounding a
central bore through which a pinion 8 on a driver 9 projects as it
is shown in FIG. 2. The dose setting element 6 is operated through
an operation element 10 which has a finger grip 11, a carrier 12
which engages the dose setting member 6, and a arrow 13 pointing on
a scale 14 provided on a lid 15 which forms a part of the housing
1. FIG. 1 further shows a cap 25 which can be put on to protect a
not shown needle which may be mounted on the syringe, and an
injection button 16 which is sliding mounted in the housing 1 and
which has a recess 17 which is on one of its side surfaces provided
with a cogging 18.
In the assembled syringe the toothed wheel 7 on the dose setting
member 6 engages the cogging 18 of the button element 16 whereas
the pinion 8 on the driver 9 engages the part with the large
diameter of the gear wheel 5 the part of which with the small
diameter engages the other gear wheel 4 which further engages a
cogging 19 on the piston rod 3.
The driver member 9 is provided with pawl 26 which with not shown
teeth in the housing forms an unidirectional coupling allowing the
driver 9 to rotate only in the direction by which the piston rod 3
is advanced into the cartridge 2. A ratchet is provided by saw
tooth shaped protrusions on the dose setting element 6 engaging a
saw tooth cogging 27 at the perimeter of the driver 9, this ratchet
being so oriented that only rotation of the dose setting member 6
in the direction in which the driver 9 can move is transmitted from
the dose setting member 6 to the driver 9. By rotation of the dose
setting member 6 in the opposite direction the teeth of the ratchet
parts will ride over each other.
To set a dose the finger grip 11 of the operation element 10 is
gripped and the element 10 is rotated clockwise until the arrow
points at the wanted dose on the scale 14. As mentioned this
rotation will make the ratchet parts of the dose setting element
and the driver ride over each other. If the dose setting member 6
is rotated in the clockwise direction to reduce the set dose, the
ratchet will cause transmission of the rotation from the dose
setting member 6 to the driver 9, but the when a torque in this
direction is transmitted from the operating element through the
carrier 12 to the dose setting member 6, this dose setting member
is deformed so that the protrusion on the dose setting member 6 is
drawn out of its engagement with the toothing 27 of the driver 9
and an anticlockwise rotation of the dose setting member 6 is
allowed without the rotation being transmitted to the driver 9.
Due to the engagement between the toothed wheel 7 on the dose
setting member 6 and the cogging 18 of the injection button 16 this
button will be lifted from the end of the housing 1 when a dose is
set and will be lowered when a dose is reduced.
When the injection button 16 is pressed to inject a set dose the
engagement between the toothed wheel 7 on the dose setting member 6
and the cogging 18 of the injection button 16 will cause the dose
setting member 6 to rotate in an anticlockwise direction. As the
torque is not transmitted to the dose setting member 6 by the
operating element 10, the ratchet coupling between the dose setting
member 6 and the driver 9 will be active and the driver 9 will be
rotated with the dose setting member 6 in the anticlockwise
direction and will drive the piston rod 3 into the cartridge.
As it is seen in FIG. 2 the disk shaped driver 9 has in its side
facing the dose setting member 6 a spiral shaped track 20 which is
engaged by a cam 21 provided at the end of an arm 22 which is by a
flexible beam 23 fastened to the dose setting member 6 so that the
arm 22 can swing to let the cam 21 move in the radial direction of
the driver 9. When the dose setting member 6 during the setting of
a dose is rotated relative to the driver 9 the cam is moved along
the track 20 whereas the cam during the injection due to the
concomitant rotation of the dose setting member 6 and the driver 9
remains in its position in the track 20 obtained during the dose
setting. This way the position of the cam in the track reflects the
total amount of medicine administered. When the cam 21 abuts the
end wall 24 of the track 20 the set dose cannot be increased and by
adapting the length of the track to the total amount of medicine in
the cartridge it is ensured that a dose larger than the amount of
medicine remaining in the cartridge cannot be set.
FIG. 3 shows a dose setting member 30 surrounding a driver 31 of
another embodiment of a dose setting limiter. The dose setting
member 30 is cylindrical and is on its outer wall provided with a
helical track 29 which is designed to co-operate with a helical
inner ridge in a not shown housing so that the dose setting member
30 is screwed outward in said housing when rotated to set a dose
and inward in said housing when rotated to reduce a too large set
dose. During the dose setting rotation the dose setting member 30
is rotated freely relative to the driver 31 which it surrounds.
Between the dose setting member 30 and the driver 31 a nut member
32 is coupled which can when it is rotated relative to the driver
31 be screwed up along this driver which is at its outer surface
provided with a helical track 33. At its outer wall the nut member
32 is in the axial direction provided with a recess 34 which is
engaged by a ridge 35 in the axial direction on the inner side of
the dose setting element 30.
During the setting of a dose the nut member 32 is due to the
engagement between the ridge 35 and the recess 34 rotated with the
dose setting member 30 relative to the driver 31 so that the
position of the nut member 32 on this driver is dependent on the
dose set. When the dose is injected by pressing a not shown
injection button which is placed in an end part 36 of the dose
setting member 30 this button presses a flange 37 at an end of the
driver 31 into engagement with coupling teeth 38 at the bottom of
the end part 36 of the dose setting member 30. On its lower not
visible side the flange 37 is provided with coupling teeth
corresponding to the coupling teeth 38 of the dose setting member
30 and when the dose setting member 30 is due to the engagement
between the track 29 in the dose setting member 30 and the ridge in
the housing forced to rotate relative to the housing when it is
pressed into the housing the rotation will be transmitted to the
driver 31 which due to the engaging coupling teeth is forced to
rotated with the dose setting member and during this rotation the
nut member 32 will maintain its position on the driver 31. This way
the position of the nut member 32 on the driver 31 will always
indicate the total sum of set and injected doses. When the length
of the helical track 33 in the driver 31 is adapted to the amount
of medicine in a cartridge the nut member 32 will reach the end of
the track 33 and stop for setting a dose larger than the amount
remaining in the cartridge.
* * * * *
References