U.S. patent application number 11/598969 was filed with the patent office on 2007-06-07 for injection method and apparatus.
Invention is credited to Mark Eaton, Jeremy Marshall.
Application Number | 20070129687 11/598969 |
Document ID | / |
Family ID | 35685947 |
Filed Date | 2007-06-07 |
United States Patent
Application |
20070129687 |
Kind Code |
A1 |
Marshall; Jeremy ; et
al. |
June 7, 2007 |
Injection method and apparatus
Abstract
A pen-type injector for receiving a medication containing
member. The injector comprises a housing 1 and a torsion spring 4
contained within the housing and coupled to a drive member 8. A
dose setting knob 2 is coupled to the spring 4, and rotatably
coupled to the housing 1 such that rotation of the knob relative to
the housing in a first direction results in compression or twisting
of the spring. A user actuable trigger 12 is provided for releasing
the spring 4 to push the drive member 8 through the housing 1. A
user actuable button 6 is coupled to the housing 1 for axial motion
relative thereto, said button 6 being coupled to the torsion spring
4 to cause the spring to unwind or expand in discrete steps with
each press of the button.
Inventors: |
Marshall; Jeremy; (Oxford,
GB) ; Eaton; Mark; (Witney, GB) |
Correspondence
Address: |
JOHN S. PRATT, ESQ;KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET
ATLANTA
GA
30309
US
|
Family ID: |
35685947 |
Appl. No.: |
11/598969 |
Filed: |
November 14, 2006 |
Current U.S.
Class: |
604/207 |
Current CPC
Class: |
A61M 5/20 20130101; A61M
2205/583 20130101; A61M 5/3156 20130101; A61M 2205/581 20130101;
A61M 5/31553 20130101; A61M 5/31583 20130101; A61M 5/31535
20130101; A61M 5/31543 20130101; A61M 5/3155 20130101; A61M
2205/6081 20130101 |
Class at
Publication: |
604/207 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 2, 2005 |
GB |
0524604.6 |
Claims
1. A medication delivery apparatus comprising: a housing for
receiving a medication containing member; a drive member mounted
within the housing for engaging with the medication containing
member and moveable axially within the housing; a spring contained
within the housing and coupled to the drive member; a dose setting
knob coupled to said spring, and rotatably coupled to the housing
such that rotation of the knob relative to the housing in a first
direction results in compression or twisting of the spring; a user
actuable trigger for releasing the spring to push the drive member
through the housing; and a user actuable button coupled to said
housing for axial motion relative thereto, said button being
coupled to said spring to cause the spring to unwind or expand
without causing any substantial movement of said drive member.
2. The apparatus according to claim 1, wherein actuation of said
button causes said spring to unwind or expand in discrete steps
with each press of the button.
3. The apparatus according to claim 1 further comprising a drive
shaft extending through the housing, the drive shaft being coupled
via a ratchet mechanism to a drive element where the drive element
is prevented from moving axially within the housing, and the drive
element being coupled to said drive member, whereby rotation of the
drive element gives rise to axial movement of the drive member.
4. The apparatus according to claim 1, comprising a drive shaft
extending through the housing, the drive shaft being coupled via a
ratchet mechanism to a drive element where the drive element is
prevented from moving axially within the housing, and the drive
element being coupled to said drive member, whereby rotation of the
drive element gives rise to axial movement of the drive member,
wherein said dose setting knob is coupled to the drive shaft for
rotation therewith when the user actuable button is in a released
position, and is decoupled from the drive shaft when the button is
in a depressed position whereupon the dose knob is able to rotate
relative to the drive shaft.
5. The apparatus according to claim 1 and comprising a drive shaft
extending through the housing, the drive shaft being coupled via a
ratchet mechanism to a drive element where the drive element is
prevented from moving axially within the housing, and the drive
element being coupled to said drive member, whereby rotation of the
drive element gives rise to axial movement of the drive member,
wherein said user actuable trigger is configured to release said
drive element for rotation by the spring when the trigger is
actuated, and to secure the drive element when the trigger is in
its resting state.
6. The apparatus according to claim 1, wherein actuation of said
button causes said spring to unwind or expand in discrete steps
with each press of the button, said ratchet mechanism comprising
two complimentary sets of teeth, a first set formed on an end of
the drive shaft and a second formed on the drive element, wherein
with the trigger in its resting state, the teeth of the drive shaft
are able to ride over the teeth of the drive unit to allow rotation
of the drive shaft relative to the drive element when the dose knob
is rotated in a dose setting direction.
7. The apparatus according to claim 1, wherein actuation of said
button causes said spring to unwind or expand in discrete steps
with each press of the button, said user actuable button being
coupled to the drive shaft for rotation therewith.
8. The apparatus according to claim 1, wherein actuation of said
button causes said spring to unwind or expand in discrete steps
with each press of the button, said user actuable button being
coupled to the drive shaft for rotation therewith, and the drive
shaft comprising means for locking the drive shaft to the dose
knob, which means is released when the button is depressed by a
user.
9. The apparatus according to claim 1, wherein actuation of said
button causes said spring to unwind or expand in discrete steps
with each press of the button, said user actuable button being
coupled to the drive shaft for rotation therewith; and the drive
shaft comprising means for locking the drive shaft to the dose
knob, which means is released when the button is depressed by a
user; and the locking means comprising one or more teeth for
engaging with teeth of a rack provided around a surface of the dose
knob, which teeth are free to flex inwardly when the button is
depressed.
10. The apparatus according to claim 1, the button comprising means
for inducing rotation of the dose knob in a dose reducing direction
when the button is depressed, and means for defining the dose
reducing steps.
11. The apparatus according to claim 1, the button comprising means
for inducing rotation of the dose knob in a dose reducing direction
when the button is depressed, and means for defining the dose
reducing steps, said means for inducing rotation and for defining
the dose reducing steps comprising an indexing finger depending
from the user actuable button and which engages a rack formed
around a surface of the dose knob.
12. The apparatus according to claim 1, further comprising an
annular member that is removably attachable to an outer surface of
the main body, the annular member being used to identify a
medicament.
13. A medication delivery apparatus for receiving a medication
containing member, the apparatus comprising: spring means for
storing a force which when released causes ejection of the
medication from a received medication containing member; a dose
knob which when rotated in a first direction moves the spring to a
force storing position, the dose setting knob providing a plurality
of discrete setting positions corresponding to respective doses; a
user actuable trigger for releasing said stored force to eject
medication from said medication containing member; and a user
actuable button arranged to reduce a stored force in the spring
with each press of the button without causing ejection of
medication from said medication containing member.
14. The apparatus according to claim 13, wherein said user actuable
button is arranged to reduce a stored force in the spring by a
discrete step with each press of the button.
15. The apparatus according to claim 13 and comprising a drive
means for engaging a medication containing chamber, and a drive
shaft coupled between the drive means and said spring means,
wherein, in a resting state, the dose knob is coupled to the drive
shaft for rotation therewith and, when the button is depressed, the
dose knob is at least temporarily uncoupled from the drive shaft to
allow the dose knob to rotate relative to the drive shaft.
16. A method of setting a dose of medication to be ejected from a
medication containing member received within a dose delivery
apparatus, the method comprising: rotating a dose knob of the
apparatus in a first direction to one of a plurality of discrete
positions corresponding to respective doses; and changing the set
dose to a reduced dose by depressing a button one or more
times.
17. A method according to claim 16, where each press of the button
reduces the dose by a discrete step.
18. A medication delivery apparatus comprising: a housing for
receiving a medication containing member; a drive member mounted
within the housing for engaging with the medication containing
member and moveable axially within the housing; a spring contained
within the housing and coupled to the drive member; a dose setting
knob coupled to said spring, and rotatably coupled to the housing
such that rotation of the knob relative to the housing in a first
direction results in compression or twisting of the spring; spring
retaining means comprising a toothed rack coupled to one of the
housing and the dose knob and at least one spring mounted tooth
coupled to the other of the housing and the dose knob, the or each
tooth engaging the toothed rack to prevent a force stored on the
spring from moving the spring to release the force, whilst allowing
a user to rotate the dose knob in a second, reverse direction, to
reduce a set dose; and a user actuable trigger for releasing the
spring to push the drive member through the housing.
19. The apparatus according to claim 18, wherein the or each spring
mounted tooth has a one piece moulded construction, with a tooth
element mounted on an end of a moulded spring.
20. The apparatus according to claim 18 and comprising an elongate
drive shaft coupling said spring to said drive member, wherein an
end of the drive shaft is coupled to the dose knob for rotation
therewith.
21. The apparatus according to claim 18 and comprising an elongate
drive shaft coupling said spring to said drive member, wherein an
end of the drive shaft is coupled to the dose knob for rotation
therewith, and wherein the other end of the drive shaft provides
part of said spring retaining means, either said at least one
sprung tooth or said toothed rack, and the other of said at least
one sprung tooth and said toothed rack is provided on a drive
element which is coupled to the housing via said user actuable
trigger, the drive element in turn being coupled to the drive
member, wherein actuation of the trigger releases the drive element
to rotate within the housing under the action of the spring via the
drive shaft, and rotation of the drive element produces axial
movement of the drive member through the housing.
22. A medication delivery apparatus comprising: a housing for
receiving a medication containing member; a drive member mounted
within the housing for engaging with the medication containing
member and moveable axially within the housing; a torsion spring
contained within the housing and coupled to the drive member; a
dose setting knob coupled to said spring, and rotatably coupled to
the housing such that rotation of the knob relative to the housing
in a first direction results in loading of the spring; a user
actuable trigger for releasing the spring to push the drive member
through the housing; and a rotatably mounted visual indicator for
indicating the dose to be delivered, the rotatably mounted visual
indicator being rotatable over at least one complete
revolution.
23. A medication delivery apparatus comprising: a housing for
receiving a medication containing member; a drive member mounted
within the housing for engaging with the medication containing
member and moveable axially within the housing; a torsion spring
contained within the housing and coupled to the drive member; a
dose setting knob coupled to said spring, and rotatably coupled to
the housing such that rotation of the knob relative to the housing
in a first direction results in loading of the spring; a dial cam
configured to co-operate with a dial key, such that upon rotation
of the dose setting knob, the dial cam and the dial key co-operate
to strain or release the torsion spring, depending upon the
direction of rotation of the dose setting knob.
Description
RELATED APPLICATION DATA
[0001] This application claims priority to United Kingdom Patent
Application No. GB0524604.6 filed on Dec. 2, 2005, the contents of
which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to an injection method and
apparatus, and more particularly to an injection method and
apparatus which provides for automatic medication delivery and for
variable dose setting.
BACKGROUND
[0003] U.S. Pat. No. 5,104,380 describes a generally pen-like
syringe which incorporates a dose metering device provided by a cap
or "dose knob" which is rotatable with respect to the pen body to a
position related to the dose of medication to be injected. Rotation
loads (by twisting) a coil spring which is prevented from unwinding
by cooperating teeth. The user disengages the ratchet teeth by
means of a sliding trigger coupled to the outside of the pen body,
resulting in the unwinding of the spring. This in turn causes
rotation of a drive gear which is coupled to a syringe plunger via
a quick pitch screw thread. Rotation of the gear results in axial
movement of the plunger through the pen body. The plunger acts on a
"bung" of a medicament containing cartridge, driving medicament
from the cartridge as it travels. The structure of the syringe of
U.S. Pat. No. 5,104,380 is such that, once a dose has been set by a
user dialing the dose knob to a given position, the user cannot
reduce the setting by winding the dose knob in the reverse
direction. If the dose has been overset, the user must activate the
trigger to expel the set dose, and redial the correct dose.
[0004] WO02/053214 describes a syringe comprising a similar dose
setting mechanism. The design described in this document is claimed
to allow the dose knob to be rotated in the reverse direction to
allow an overset dose to be reduced.
[0005] According to a first aspect of the present invention there
is provided medication delivery apparatus comprising: [0006] a
housing for receiving a medication containing member; [0007] a
drive member mounted within the housing for engaging with the
medication containing member and moveable axially within the
housing; [0008] a spring contained within the housing and coupled
to the drive member; [0009] a dose setting knob coupled to said
spring, and rotatably coupled to the housing such that rotation of
the knob relative to the housing in a first direction results in
compression or twisting of the spring; [0010] a user actuable
trigger for releasing the spring to push the drive member through
the housing; and [0011] a user actuable button coupled to said
housing for axial motion relative thereto, said button being
coupled to said spring to cause the spring to unwind or expand
without causing any substantial movement of said drive member.
[0012] Preferably, actuation of said button causes said spring to
unwind or expand in discrete steps with each press of the
button
[0013] In an embodiment of the present invention, the apparatus
further comprises a drive shaft extending through the housing, the
drive shaft being coupled via a ratchet mechanism to a drive
element, and the drive element being coupled to said drive member,
whereby rotation of the drive element gives rise to axial movement
of the drive member. Said dose setting knob is coupled to the drive
shaft for rotation therewith when the user actuable button is in a
released position, and is decoupled from the drive shaft when the
button is in a depressed position whereupon the dose knob is able
to rotate relative to the drive shaft.
[0014] Said user actuable trigger is configured to release said
drive element for rotation by the spring when the trigger is
actuated, and to secure the drive element when the trigger is in
its resting state.
[0015] Said ratchet mechanism preferably comprises two
complimentary sets of teeth, a first set formed on an end of the
drive shaft and a second formed on the drive element. With the
trigger in its resting state, the teeth of the drive shaft are able
to ride over the teeth of the drive unit to allow rotation of the
drive shaft relative to the drive element when the dose knob is
rotated in a dose setting direction.
[0016] Preferably, said user actuable button is coupled to the
drive shaft for rotation therewith. The drive shaft comprises means
for locking the drive shaft to the dose knob, which means is
released when the button is depressed by a user. The locking means
may comprise one or more teeth for engaging with teeth of a rack
provided around a surface of the dose knob, which teeth are free to
flex inwardly when the button is depressed. The button may further
comprise means for inducing rotation of the dose knob in a dose
reducing direction when the button is depressed, and means for
defining the dose reducing steps. These means may be provided by an
indexing finger depending from the user actuable button and which
engages a rack formed around a surface of the dose knob.
[0017] In order to assist a user who requires more than one type of
medicament, the apparatus may further comprise an annular member
that is removably attachable to an outer surface of the main body,
the annular member being used to identify a medicament.
[0018] According to a second aspect of the present invention there
is provided medication delivery apparatus for receiving a
medication containing member, the apparatus comprising: [0019]
spring means for storing a force which when released causes
ejection of the medication from a received medication containing
member; [0020] a dose knob which when rotated in a first direction
moves the spring to a force storing position, the dose setting knob
providing a plurality of discrete setting positions corresponding
to respective doses; [0021] a user actuable trigger for releasing
said stored force to eject medication from said medication
containing member; and [0022] a user actuable button arranged to
reduce a stored force in the spring without causing ejection of
medication from said medication containing member.
[0023] Preferably, the apparatus comprises a drive means for
engaging a medication containing chamber, and a drive shaft coupled
between the drive means and said spring means. In a resting state,
the dose knob is coupled to the drive shaft for rotation therewith.
When the button is depressed, the dose knob is at least temporarily
uncoupled from the drive shaft to allow the dose knob to rotate
relative to the drive shaft.
[0024] According to a third aspect of the present invention there
is provided a method of setting a dose of medication to be ejected
from a medication containing member received within a dose delivery
apparatus, the method comprising: [0025] rotating a dose knob of
the apparatus in a first direction to one of a plurality of
discrete positions corresponding to respective doses; and [0026]
changing the set dose to a reduced dose by depressing a button one
or more times.
[0027] According to a fourth aspect of the present invention there
is provided medication delivery apparatus comprising: [0028] a
housing for receiving a medication containing member; [0029] a
drive member mounted within the housing for engaging with the
medication containing member and moveable axially within the
housing; [0030] a spring contained within the housing and coupled
to the drive member; [0031] a dose setting knob coupled to said
spring, and rotatably coupled to the housing such that rotation of
the knob relative to the housing in a first direction results in
compression or twisting of the spring; [0032] spring retaining
means comprising a toothed rack coupled to one of the housing and
the dose knob and at least one spring mounted tooth coupled to the
other of the housing and the dose knob, the or each tooth engaging
the toothed rack to prevent a force stored on the spring from
moving the spring to release the force, whilst allowing a user to
rotate the dose knob in a second, reverse direction, to reduce a
set dose; and [0033] a user actuable trigger for releasing the
spring to push the drive member through the housing.
[0034] In a preferred embodiment of the invention, the or each
spring mounted tooth has a one piece moulded construction, with a
tooth element mounted on an end of a moulded spring.
[0035] Preferably, the apparatus comprises an elongate drive shaft
coupling said spring to said drive member. An end of the drive
shaft is coupled to the dose knob for rotation therewith. The other
end of the drive shaft provides part of said spring retaining
means, either said at least one sprung tooth or said toothed rack.
The other of said at least one sprung tooth and said toothed rack
is provided on a drive element which is coupled to the housing via
said user actuable trigger. The drive element is in turn coupled to
the drive member. Actuation of the trigger releases the drive
element to rotate within the housing under the action of the spring
via the drive shaft. Rotation of the drive element produces axial
movement of the drive member through the housing.
[0036] According to a fifth aspect of the present invention there
is provided medication delivery apparatus comprising: [0037] a
housing for receiving a medication containing member; [0038] a
drive member mounted within the housing for engaging with the
medication containing member and moveable axially within the
housing; [0039] a torsion spring contained within the housing and
coupled to the drive member; [0040] a dose setting knob coupled to
said spring, and rotatably coupled to the housing such that
rotation of the knob relative to the housing in a first direction
results in loading of the spring; [0041] a user actuable trigger
for releasing the spring to push the drive member through the
housing; and [0042] a rotatably mounted visual indicator for
indicating the dose to be delivered, the rotatably mounted visual
indicator being rotatable over at least one complete
revolution.
[0043] According to a sixth aspect of the present invention, there
is provided medication delivery apparatus comprising: [0044] a
housing for receiving a medication containing member; [0045] a
drive member mounted within the housing for engaging with the
medication containing member and moveable axially within the
housing; [0046] a torsion spring contained within the housing and
coupled to the drive member; [0047] a dose setting knob coupled to
said spring, and rotatably coupled to the housing such that
rotation of the knob relative to the housing in a first direction
results in loading of the spring; [0048] a dial cam configured to
co-operate with a dial key, such that upon rotation of the dose
setting knob, the dial cam and the dial key co-operate to strain or
release the torsion spring, depending upon the direction of
rotation of the dose setting knob.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] For a better understanding of the present invention and in
order to show how the same may be carried into effect reference
will now be made by way of example to the accompanying drawings in
which:
[0050] FIG. 1 shows schematically a pen-type injector;
[0051] FIG. 2 shows a horizontal cross-section through the injector
of FIG. 1;
[0052] FIG. 2A shows an enlarged view of a retaining and trigger
portion of the injector taken at A of FIG. 2;
[0053] FIG. 3 shows a vertical cross-section through the injector
of FIG. 1;
[0054] FIG. 4 is a perspective exploded view of the injector of
FIG. 1;
[0055] FIG. 5 shows a dose knob of the injector of FIG. 1;
[0056] FIG. 6 shows a clutch collet of the injector of FIG. 1;
[0057] FIG. 7 shows in partial cross-section of an end of the
injector of FIG. 1;
[0058] FIG. 8 illustrates an operating sequence of the injector of
FIG. 1;
[0059] FIG. 9 shows a horizontal side elevation view of a dose
knob
[0060] FIG. 10 is a perspective view of a locking bush and a
leadscrew;
[0061] FIG. 11 shows a horizontal cross-section through an
alternative internal construction of the injector;
[0062] FIG. 11A shows an enlarged view of a retaining and trigger
portion of the injector taken at A of FIG. 11;
[0063] FIG. 12 shows a vertical cross-section through the
alternative injector of FIG. 9;
[0064] FIG. 13 is a perspective exploded view of the injector of
FIG. 9; and
[0065] FIG. 14 shows perspective views of an end of a drive shaft
of the injector of FIG. 9.
DETAILED DESCRIPTION
[0066] There is illustrated in FIG. 1 a pen-type injector having a
user operable dose setting mechanism. With reference to FIGS. 2 to
7, it can be seen that the injector comprises a main body 1 and a
cap 20 which snap fit together. Identity ring 19 is colour coded to
indicate the type of medicament to be delivered by the injector. A
screw thread is provided on an inner surface of the main body 1 at
its upper end. This internal screw thread is engaged by an external
screw thread 2a provided on an outer surface of a dose knob 2. The
dose knob 2 is illustrated in detail in FIG. 5. Longitudinal
movement of the dose knob 2 within the pen body 1 is limited in
both directions.
[0067] A cartridge housing 18 is secured to a lower end of the main
body 1 and is arranged to receive a disposable medication filled
cartridge (not shown). Such a cartridge has a rubber bung sealing
one end of the cartridge, with the other end being arranged to
receive a disposable needle. The cartridge is typically multi-use,
with a user attaching a new needle for each injection.
[0068] A torsion spring 4 is located coaxially within the main body
1 and is arranged to provide the drive force for ejecting
medication from a loaded cartridge. The spring 4 is fixed at its
upper end to the dose knob 5. At its lower end, the spring 4 is
fixed to the housing via a retaining ring moulded integrally with
the housing 1.
[0069] A generally cylindrical ratchet drive shaft 3 extends
through the centre of the spring 4. An enlarged end portion 3a of
the shaft 3 has three sprung legs 3b formed around its periphery,
the legs being spaced equiangularly around the shaft. At the
outermost end of each leg, a tooth 3c is provided. The teeth 3c
engage teeth of a rack 11a (not visible in FIG. 4) formed around
the inner surface of a generally cylindrical drive gear component
11 which sits within the main body 1 at a fixed axial position. The
drive gear 11 has a second toothed rack 11b formed around a lower
outer surface portion. This rack sits within a correspondingly
sized rack 12a formed on an inner surface of a retaining ring 12.
The ring 12 is formed integrally with a trigger 12b, with the
component being slidably mounted within a slot formed in the main
body 1, separated from the body by a pair of thrust washers 10. A
spring 13 urges the trigger 12b in an upward direction, maintaining
the racks 11b, 12a in locking engagement in the absence of a user
force applied to the trigger. The dose knob 2 and the trigger 12b
may be provided with a soft rubber overmolding. This provides the
user with a more comfortable and better grip.
[0070] Considering further the ratchet drive shaft 3, this is
coupled at its upper end to a clutch collet 5. The clutch collet,
illustrated in FIG. 6 (viewed from above A and below B) rotates
with the drive shaft 3 and is provided with a pair of sprung
fingers 5a. The sprung fingers are shaped in cross-section to
provide respective teeth for engaging teeth of a rack 2c formed
around an inner surface of the dose knob 2. The fingers 5a are
biased outwardly.
[0071] A rewind button 6 is located within the dose knob 2,
projecting therefrom. The button 6 is coupled to the ratchet drive
shaft 3, rotating with the drive shaft but being able to slide
longitudinally within the drive shaft. A spring 7 is coupled
between the button 6 and the drive shaft 3 and biases the button
outwardly relative to the main body 1. The lower portion of the
button 6 is generally cross-shaped, with two opposed arms of the
cross opposing the sprung fingers 5a of the clutch collet 5. These
arms taper inwardly such that they prevent any radially inward
flexing of the sprung fingers 5a when the button is in its outer
position, whilst allowing inward flexing when the button is fully
depressed against the bias of the button spring 7. This arrangement
is best illustrated in FIG. 7, where FIG. 7A illustrates the button
6 in situ whilst FIG. 7B illustrates the end of the injector with a
cross-section taken through the button 6.
[0072] A leadscrew 8 has a screw thread formed along the length of
its outer surface. The leadscrew is located within the ratchet
drive shaft 3, and engages a complimentary screw thread formed on
the inner surface of the drive gear 11. The end portion of the
leadscrew 8 projecting from the ratchet drive shaft 3 has a
leadscrew cap secured thereto. Rotational movement of the leadscrew
relative to the drive shaft is prevented by the engagement of
recesses formed along the length of the leadscrew with
complimentary splines provided on an inner surface of a locking
bush 14. The locking bush is held within a mid-body compartment 17
which itself is secured to the end of the main body 1 via a pair of
complimentary screw threads. On coupling with a medicament
containing cartridge, the cartridge compression cup 16 will
compress the spring 15 and transmit the loading onto the locking
bush 14. The serrated edge of the locking bush engages with the
mating features of the body 1 preventing the locking bush from
rotating and ensuring that the leadscrew 8 moves forward when
subjected to rotation following release of the drive gear 11.
[0073] An indexing finger 6a depends from an inner surface of the
button 6. The finger is provided at its end with a ramp shaped
tooth 6b having a vertical, blocking surface and a sloping drive
surface. The tooth 6b engages teeth of an indexing rack 2b formed
around an inner surface of the dose knob 2, when the button is
pressed into the dose knob 2.
[0074] In order for a user to set the amount of medicament to be
delivered, the dose knob 2 has a barrel 2d formed integrally with
the dose knob 2. The barrel 2d has a series of numbers printed
around its circumference, so that as the dose knob 2 is rotated,
the barrel 2d also rotates. A window in the main body 1 allows the
user to see one of the printed numbers, and the printed number
relates to the amount of medicament that will be delivered.
[0075] When the dose knob 2 is rotated, screw thread 2d ensures
that the dose knob moves linearly with respect to the longitudinal
axis of the main body 1, and allows the dose knob to be rotated
over more than one revolution. This allows both higher loading of
the torsion spring, and also allows the barrel 2d to indicate doses
over more than one revolution of the barrel, provided that the
printed numbers relating to a medicament dose setting are printed
in a helical pattern around the outer surface of the barrel 2d, as
shown in FIG. 13.
[0076] As shown in FIG. 10, the leadscrew 8 comprises a pair of
channels 21 running along its longitudinal axis. At one end of each
channel is a ramp 22. The locking bush 14 comprises a pair of
fingers 23 that engage with a corresponding leadscrew channel 21.
This ensures that when the device is assembled, the leadscrew 8 and
the locking bush 14 are located correctly together. The fingers 23
are flexible such that when the leadscrew is passed through the
centre of the locking bush 14, the fingers ride up the
corresponding ramps 22 and flex outwards. Once the fingers 23 have
passed over the ramps 22, they snap into engagement with the
channels 21. During resetting, the fingers 23 abut against the
corresponding ramps 22 to ensure that the locking bush 14 does not
move out of engagement with the leadscrew 8.
[0077] A full list of injector components with their reference
numbers as shown in FIGS. 1 to 8 is contained within Table 1
below.
[0078] Considering now the operation of the injector, a user sets a
dose by rotating the dose knob 2 in a clockwise direction. As the
dose knob 2 is rotated, the top of the spring 4 rotates with it
creating torsion of the spring. Engagement of the sprung fingers 5a
at the top of the ratchet drive shaft 3 with the rack 2c formed on
the inner surface of the dose knob 2 also causes the ratchet drive
shaft 3 to rotate. At the lower end of the ratchet drive shaft 3,
the teeth of the sprung legs 5a "click" around the teeth of the
rack 11a. The engagement of the teeth with the rack 11a prevents
the spring 4 unwinding after each click. Each click corresponds to
a predefined angular rotation of the spring and therefore to a
predefined ejection dose. It will be readily appreciated that,
during the dose setting action, the drive gear 11 is not rotated so
no axial movement of the leadscrew 8 is induced. No medication is
therefore ejected from the cartridge during the dose setting
operation (or indeed air introduced due to back filling).
[0079] When the user applies a downward force to the trigger 12b,
this disengages the racks of the trigger 12b and the drive gear 11.
This frees the drive gear 11 and the torsion spring 4 to rotate. As
the drive gear 11 rotates about the leadscrew 8, the leadscrew is
driven down through the drive gear causing the leadscrew cap 9 to
push the bung of the cartridge through the cartridge body,
expelling medication from the cartridge through the attached
syringe.
[0080] In the event that a user oversets a dose, i.e. over-rotates
the dose knob 2, the user fully presses the button 6 into the dose
knob 2 against the action of the biasing spring 7. As the button 6
is depressed, the drive surface of the tooth 6b comes into contact
with one of the teeth formed on the indexing rack 2b (from the
starting position of FIG. 8A to the position shown in FIG. 8B).
Further pressure induces a rotational force on the dose knob 2 in
the counter-clockwise direction until the fully depressed position
of FIG. 8C is reached. At substantially the same time, the downward
movement of the cross-arms of the button 6 results in the sprung
fingers 5a being free to flex inwardly, freeing the dose knob 2 and
the spring 4 to rotate under one or both of the force stored in the
spring and the force induced by the tooth. The dose knob 2 is able
to rotate until the blocking surface of the tooth engages the next
stop surface of the upper rack. Neither the ratchet drive shaft 3
nor the drive gear 11 rotate during this resetting operation. No
axial movement of the leadscrew 8 is therefore induced and no
medication ejected from the cartridge. The dose resetting mechanism
operates by temporarily decoupling the dose knob and the torsion
spring from the ratchet drive shaft allowing the former to rotate
relative to the drive shaft. Upon removal of the pressure from the
button 6, the rewind button spring 7 returns the button to its
outermost position, whereupon the teeth of the sprung fingers 5a
reengage with the teeth of the rack 2c.
[0081] An alternative pen-type injector will now be described with
reference to FIGS. 11 to 14. Externally, this injector has a
similar external appearance to the injector illustrated in FIG. 1.
The operating principle of the alternative injector is similar to
that of the injector of FIGS. 2 to 10 in terms of both the dose
setting and firing functionality. However, the dose resetting
mechanism differs.
[0082] The injector comprises a dose setting knob 2' which is
coupled to the main body 1' via complimentary screw threads. The
end of the dose knob 2' is closed by a dose knob cap 7' which
rotates with the dose knob. Considering now the ratchet drive shaft
3', this has an end collar 3a' having three radial extending slots
formed therein (FIG. 14, where FIG. 14A shows the knob 2 with a
ratchet retainer removed, FIG. 14B shows the knob with the retainer
in situ, and FIG. 14C shows the knob with the retainer in place but
shown transparent). These slots receive respective arms (also
referred to as a dial key) 5a' of a ratchet plunger component 5'
having a cylindrical body. The body sits tightly within the
circular opening in the end of the collar 3a'. Each arm 5a'
comprises a moulded spring body and an end tooth, the surfaces of
the tooth sloping at the same angle. A ratchet retainer 6' snaps
over the end of the collar 3a' to secure the ratchet plungers in
place. The teeth of the ratchet plunger project from the ends of
their respective slots by approximately 0.5 mm, and can be
deflected radially inwards (by approximately 0.25 mm) as a result
of the moulded springs.
[0083] In the assembled injector, the teeth of the ratchet plunger
5' engage the rack (also referred to as a dial cam) formed around
the inner surface of the drive gear 11'. The teeth surfaces of the
rack are also equiangular, corresponding to the teeth of the
ratchet plunger.
[0084] A full list of injector components with their reference
numbers as shown in FIGS. 11 to 14 is contained within Table 2
below.
[0085] In use, a user dials up a dose by rotating the dose knob 2'
in a clockwise direction. The user applied force is sufficient to
overcome the resistance between the teeth of the ratchet plunger
11' and those of the rack of the drive gear 11', the drive gear
being held in place against rotation by the trigger 12'. During
this action, the teeth of the ratchet plunger are pushed inward
into the end collar of the ratchet drive shaft to allow them to
ride over the teeth of the rack within the drive gear. In the same
way, if a user wishes to reduce a set dose, he or she rotates the
dose knob in an anti-clockwise direction. The shape of the ratchet
plunger teeth permits this. Thus according to this design, there is
no need for a rewind button separate from the dose knob in order to
facilitate resetting of the dose.
[0086] It will be appreciated by the person of skill in the art
that various modifications may be made to the above described
embodiments without departing from the scope of the present
invention. TABLE-US-00001 TABLE 1 Reference numeral Description 1
Main Body 2 Dose Knob - Rewind Button 3 Ratchet Drive Shaft - No
Rewind 4 Torsion Spring - Rewind Button 5 Clutch Collet 6 Rewind
Button 7 Rewind Button Spring 8 Leadscrew 9 Leadscrew Cap 10 Thrust
Washer 11 Drive Gear - No Rewind (1 Unit) 12 Trigger 13 Trigger
Spring 14 Locking Bush 15 Compression Cup Spring 16 Cartridge
Compression Cup 17 Mid-Body 18 Cartridge Housing 19 Identity Ring
20 Cap 21 Leadscrew channel 22 Leadscrew ramp 23 Locking bush
finger
[0087] TABLE-US-00002 TABLE 2 Reference numeral Description 1 Main
Body 2 Dose Knob 3 Ratchet Drive Shaft 4 Torsion Spring 5 Ratchet
Plungers 6 Ratchet Retainer 7 Dose Knob Cap 8 Leadscrew 9 Leadscrew
Cap 10 Thrust Washer 11 Drive Gear 12 Trigger 13 Trigger Spring 14
Locking Bush 15 Compression Cup Spring 16 Cartridge Compression Cup
17 Mid-Body 18 Cartridge Housing 19 Identity Ring 20 Cap
* * * * *