NZ622511B2 - Automatic injection device - Google Patents
Automatic injection device Download PDFInfo
- Publication number
- NZ622511B2 NZ622511B2 NZ622511A NZ62251112A NZ622511B2 NZ 622511 B2 NZ622511 B2 NZ 622511B2 NZ 622511 A NZ622511 A NZ 622511A NZ 62251112 A NZ62251112 A NZ 62251112A NZ 622511 B2 NZ622511 B2 NZ 622511B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- syringe
- housing
- cap
- injection device
- automatic injection
- Prior art date
Links
- 238000002347 injection Methods 0.000 title claims abstract description 125
- 239000007924 injection Substances 0.000 title claims abstract description 125
- 239000000969 carrier Substances 0.000 claims abstract description 78
- 230000000007 visual effect Effects 0.000 claims abstract description 10
- 238000010304 firing Methods 0.000 claims description 49
- 239000007788 liquid Substances 0.000 claims description 21
- 239000003814 drug Substances 0.000 claims description 16
- 230000000875 corresponding Effects 0.000 claims description 15
- 150000002500 ions Chemical class 0.000 claims description 14
- 230000023298 conjugation with cellular fusion Effects 0.000 claims description 9
- 230000013011 mating Effects 0.000 claims description 9
- 230000021037 unidirectional conjugation Effects 0.000 claims description 9
- 230000000414 obstructive Effects 0.000 claims description 7
- 108090000623 proteins and genes Proteins 0.000 claims description 3
- 102000004169 proteins and genes Human genes 0.000 claims description 3
- 229940023488 Pill Drugs 0.000 claims description 2
- 239000006187 pill Substances 0.000 claims description 2
- 230000000717 retained Effects 0.000 claims description 2
- 229940035295 Ting Drugs 0.000 claims 1
- 239000000126 substance Substances 0.000 description 22
- 230000004913 activation Effects 0.000 description 16
- 238000004873 anchoring Methods 0.000 description 11
- 239000000463 material Substances 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 8
- 230000001808 coupling Effects 0.000 description 5
- 238000010168 coupling process Methods 0.000 description 5
- 238000005859 coupling reaction Methods 0.000 description 5
- ASCUXPQGEXGEMJ-GPLGTHOPSA-N [(2R,3S,4S,5R,6S)-3,4,5-triacetyloxy-6-[[(2R,3R,4S,5R,6R)-3,4,5-triacetyloxy-6-(4-methylanilino)oxan-2-yl]methoxy]oxan-2-yl]methyl acetate Chemical compound CC(=O)O[C@@H]1[C@@H](OC(C)=O)[C@@H](OC(C)=O)[C@@H](COC(=O)C)O[C@@H]1OC[C@@H]1[C@@H](OC(C)=O)[C@H](OC(C)=O)[C@@H](OC(C)=O)[C@H](NC=2C=CC(C)=CC=2)O1 ASCUXPQGEXGEMJ-GPLGTHOPSA-N 0.000 description 4
- 230000000994 depressed Effects 0.000 description 4
- 108010007562 Adalimumab Proteins 0.000 description 3
- 229960002964 adalimumab Drugs 0.000 description 3
- 230000000903 blocking Effects 0.000 description 3
- 230000003993 interaction Effects 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000006011 modification reaction Methods 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- 230000001681 protective Effects 0.000 description 3
- 239000002451 tumor necrosis factor inhibitor Substances 0.000 description 3
- 229940090047 Auto-Injector Drugs 0.000 description 2
- 210000001513 Elbow Anatomy 0.000 description 2
- -1 intravenous Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 238000010254 subcutaneous injection Methods 0.000 description 2
- 239000007929 subcutaneous injection Substances 0.000 description 2
- 238000004642 transportation engineering Methods 0.000 description 2
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 1
- UCTWMZQNUQWSLP-VIFPVBQESA-N Epinephrine Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 1
- 206010073753 Fear of injection Diseases 0.000 description 1
- 208000004262 Food Hypersensitivity Diseases 0.000 description 1
- 206010016946 Food allergy Diseases 0.000 description 1
- 206010069803 Injury associated with device Diseases 0.000 description 1
- 208000010125 Myocardial Infarction Diseases 0.000 description 1
- 229940071643 Prefilled Syringe Drugs 0.000 description 1
- 210000000614 Ribs Anatomy 0.000 description 1
- 210000003491 Skin Anatomy 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive Effects 0.000 description 1
- 230000000172 allergic Effects 0.000 description 1
- 230000003288 anthiarrhythmic Effects 0.000 description 1
- 239000003416 antiarrhythmic agent Substances 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 201000008937 atopic dermatitis Diseases 0.000 description 1
- 239000003124 biologic agent Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000004059 degradation Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000001419 dependent Effects 0.000 description 1
- 229940079593 drugs Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229960005139 epinephrine Drugs 0.000 description 1
- 239000003527 fibrinolytic agent Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000020932 food allergy Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 235000015108 pies Nutrition 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000001737 promoting Effects 0.000 description 1
- 230000002829 reduced Effects 0.000 description 1
- 230000036633 rest Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229960000103 thrombolytic agents Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2006—Having specific accessories
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3125—Details specific display means, e.g. to indicate dose setting
- A61M2005/3126—Specific display means related to dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
- A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/041—Controlled or regulated
Abstract
Automatic injection device includes a housing, a syringe, a plunger, and a syringe carrier. The housing includes a barrel. The barrel includes an elongated window to allow viewing of contents inside the housing. The syringe is disposed within the housing and has a reservoir. The plunger is at least partially disposed within the syringe and includes a visual indicator. The syringe carrier is disposed within the housing and configured to contain the syringe and displace the syringe within the housing between a first position and a second position. The syringe carrier has a first opening and a second opening. The first opening is configured to align with the window and the reservoir when the syringe carrier is in the first position, and the second opening is configured to align with the window and the visual indicator when the syringe carrier is in the second position. partially disposed within the syringe and includes a visual indicator. The syringe carrier is disposed within the housing and configured to contain the syringe and displace the syringe within the housing between a first position and a second position. The syringe carrier has a first opening and a second opening. The first opening is configured to align with the window and the reservoir when the syringe carrier is in the first position, and the second opening is configured to align with the window and the visual indicator when the syringe carrier is in the second position.
Description
PCTfUSZOl2/056744
AUTOMATIC INJECTION DEVICE
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to US. ional Application No.
61/538,098, filed on September 22, 2011, which is incorporated by reference herein in
its entirety.
BACKGROUND
Field of the Disclosed t Matter
The present disclosed subject matter relates to an automatic injection
device for injecting a substance, such as a therapeutic agent, into a patient.
ption of Related Art
One of the most common routes of administration for therapeutic
agents, such as medications, is by injection, such as intravenous, subcutaneous or
intramuscular injection. A syringe containing the medication is used for the injection,
which typically is carried out by trained medical personnel. In n instances, a
patient is trained in the use of the e to allow for njection. Moreover, certain
medications are formulated in pie-filled syringes for t use, to avoid the need for
the patient to fill the syringe. Some patients, however, can be averse to carrying out
njection, particularly if the patient has a fear of needles or limited dexterity.
Automatic injection devices offer an ative to a syringe for
delivering a therapeutic agent. Automatic ion devices have been used, for
example, to deliver medications under emergency conditions, such as to administer
epinephrine to counteract the effects of a severe allergic on, for example, as
caused by a food allergy. Automatic injection devices also have been described for
use in administering antiarrhythmic medications and selective thrombolytic agents
during a heart attack (see e.g., US. Pat. Nos. 3,910,260; 4,004,577; 4,689,042;
4,755,169 and 4,795,433). Various types of automatic injection s also are
described in, for example, U.S. Pat. Nos. 3,941,130; 4,261,358; 5,085,642; 5,092,843;
,102,393; 5,267,963; 6,149,626; 6,270,479; and 6,371,939, each of which is incorporated by
reference herein in its entirety.
In general, prior automatic injection devices, when operated, have a needle of a
e configured to move forward and project from a protective housing prior to actuation of
the piston of the syringe to eject a dose of liquid through the needle. Movement of the syringe
toward the patient's skin such that the needle is exposed before pressurizing a liquid charge
inside the syringe can help prevent the liquid from being discharged from the needle before the
actual injection takes place.
However, there remains a need for further improvement of known automatic
injection devices. For example, it can be desirable to inspect the contents of the automatic
injection device prior to use. Also, it can be desirable to indicate when injection is completed.
Such features are available in certain automatic ion s, the features depend upon
larger volume doses. However, there s a need for an automatic injection device suitable
for different volume doses and/or a wider range of dose volumes.
OBJECT
It is an object of the present ion to at least substantially satisfy one or more
of the above needs.
SUMMARY
In accordance with the present invention, there is provided an automatic injection
device comprising:
a housing having a first end, a second end, and a barrel between the first end and
the second end, the barrel comprising an elongated window to allow viewing of contents inside
the housing;
a syringe ed within the housing and having a first end, a second end, and a
reservoir between the first end and the second end;
a plunger at least partially disposed within the syringe and sing a visual
tor on a portion of the plunger; and
a syringe carrier disposed within the housing and configured to contain the
syringe and displace the syringe within the housing between a first position and a second
position, the e r having a first g and a second opening, the first opening
configured to align with the window and the reservoir when the syringe carrier is in the first
(11046283_1):MSL
on, and the second opening configured to align with the window and the visual indicator
when the e carrier is in the second on.
For example and as embodied here, the at least one opening can include a first
opening and a second opening, and the syringe carrier can e a middle portion between the
first and second openings. The middle portion can be sized to resist deformation of the syringe
carrier. The first opening can be positioned nearer to the first end of the housing than the second
opening, wherein the first end is to be positioned proximate an injection site. The syringe carrier
can include additional openings to correspond with the window or windows of the housing. For
example, if a window is ed on a front and a rear of the housing, then corresponding first
and second openings can be provided on the front and rear of the syringe carrier, respectively.
Additionally and as embodied here, the autoinjection device includes a liquid
cial agent in the reservoir. The syringe carrier can be configured to allow viewing of
substantially all of the liquid beneficial agent in the reservoir when the syringe carrier is in the
first position. For example and not limitation, the liquid beneficial agent can have a volume of
0.4 mL. Alternatively, in some embodiments, the liquid cial agent can have a volume of
0.8 mL. The liquid beneficial agent can include a protein. In some embodiments, the liquid
beneficial agent can include a TNF inhibitor or the like, such as adalimumab.
Furthermore and as ed here, the automatic injection device can include a
cap having an outer portion, and the first end of the housing can be ured to receive the
outer portion of the cap. The outer portion of the cap can include a cap notch to align with a
portion of the elongated window when the cap is received by the housing to prevent obstruction
of the window. The cap can also include an inner portion. The inner portion can include a split
hub projecting beyond the outer portion, and the split hub can define a hub g. The hub
opening can be aligned with at least a portion of the elongated window when the cap is received
by the housing to prevent obstruction of the window. The inner portion of the cap can also
include a circumferential ridge. The automatic injection device can include a needle projecting
from the first end of the syringe and a needle shield surrounding at least a portion of the needle.
The circumferential ridge can be ured to capture the needle shield within the inner portion
of the cap when the cap is ed by the housing. The needle shield can be retained in the
inner portion of the cap when the cap is d from the housing.
(11046283_1):MSL
It is to be understood that both the foregoing general ption and the
following detailed description are exemplary and are intended to provide further explanation of
the disclosed subject matter claimed.
The accompanying drawings, which are incorporated in and constitute part of this
specification, are included to rate and provide a further tanding of the sed
subject matter. Together with the description, the drawings serve to explain the principles of the
disclosed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the present invention will now be described, by way of
e only, with nce to the accompanying drawings n:
is a front view of the automatic injection device according to an
illustrative embodiment of the disclosed subject matter.
is a cross-sectional side view taken along line B-B of .
is a perspective view of the automatic injection device of according
to an illustrative embodiment of the disclosed subject matter.
is a front view of a syringe g assembly of automatic injection
device of an embodiment of the disclosed subject matter in a jection stage, shown without
the plunger for purpose of clarity.
is a cross-sectional side view taken along line B-B of .
is a front view of the syringe housing assembly of during an
initial stage of operation with the stepped shroud depressed against an injection site.
is a cross-sectional side view taken along line B-B of .
is a front view of the syringe housing assembly of at the end of
the injection stage with the stepped shroud pressed against the injection site.
is a cross-sectional side view taken along line B-B of .
is a front view of the syringe housing assembly of in a jection
stage with the shroud deployed.
is a cross-sectional side view taken along line B-B of .
(11046283_1):MSL
PCT/U82012/056744
is a front View of an automatic injection device similar to that of
but having a bulbous housing and showing the device in the post~injection
stage with the tor visible in the .
is an exploded perspective View of an embodiment of an
automatic injection device according to one embodiment of the disclosed subject
matter.
is an exploded perspective View of an embodiment of the firing
ism ly of the automatic injection device of according to an
illustrative ment of the disclosed subject matter.
A is a perspective View of an embodiment of the activation
button cap of the firing mechanism assembly of
B is a cross—sectional side View of the activation button cap of
A.
A is a perspective View of an embodiment of the firing body of
the firing mechanism assembly of
B is a front view of the firing body of A.
A is a perspective View of an embodiment of the plunger of the
firing mechanism assembly of
B is a front view of the r of A.
C is a detail view of region C of 3
is an exploded perspective View of an ment of the
syringe housing assembly of the automatic injection device of according to an
illustrative embodiment of the disclosed subject matter.
A is a perspective View of an embodiment of the syringe carrier
of the e housing assembly of .
B is an exploded View from a different perspective of the
syringe carrier of A, including an exemplary damping structure according to
an illustrative embodiment of the disclosed subject matter.
C is a front View of the syringe carrier of A.
D is a side view of the syringe carrier of A.
E is a cross-sectional side view taken along line E—E of B.
F is a cross—sectional front View taken along line F-F of D.
2012/056744
0 is a crosswsectional top view taken along line G~G of 13.
H is a cross-sectional side View taken along line H—H at a
bottom portion of 6.
1 is a bottom view of the syringe carrier damper of B.
] is a cross-sectional side View of the syringe housing assembly
of illustrating further details of the interaction n the syringe carrier of
A and the housing.
K is a detail View of region K of ].
L is a cross-sectional side View of the syringe housing
assembly of illustrating further details of the interaction between the syringe
Gamer of A and the housing.
M is a detail view of region M of the L.
FIG. MN is a cross—sectional side view of the syn'nge housing
assembly of illustrating further details of the ction between the syringe
r of A and the housing.
0 is a detail view of region 0 of N.
FIG. MP is a cross-sectional side view of the syringe housing
assembly of illustrating further details of the interaction between the e
carrier of A and the housing.
Q is a detail View of region Q of ?.
A is a perspective View of an embodiment of the housing of the
syringe housing assembly of .
3 is a front View of the housing of A.
C is a top View of the housing of A.
FIG. ISD is a cross~sectional front View of the housing of A.
A is an ment of the stepped shroud of the syringe
housing assembly of .
B is a front View of the stepped shroud of A.
A is a perspective View of an embodiment of the needle shroud
cap of the syringe g assembly of .
B is a cross-sectional front View of the needle shroud cap of
A.
C is a top View of the needle shroud cap of A.
PCT/U52012/056744
D is a cross—sectional side View of the needle shroud cap taken
along line D—D of C.
A is a front View of an embodiment of the syringe housing
assembly of according to an illustrative embodiment of the disclosed subject
matter.
FIG .l8B is a cross-sectional side View taken along line B-B of A.
is a front view of a further embodiment of the syringe housing
assembly of according to an illustrative embodiment of the disclosed t
matter.
DETAILED PTION OF THE PREFERRED EMBODIMENT
Reference will now be made in detail to the various exemplary
embodiments of the disclosed subject matter, exemplary embodiments of which are
illustrated in the accompanying drawings. The structure and corresponding method of
operation of the disclosed subject matter will be described in conjunction with the
detailed description of the system.
The apparatus and methods presented herein can be used for ing
any of a variety of suitable therapeutic agents or substances, such as a drug, into a
patient. In one embodiment, the automatic injection device can be configured in the
form of a pen, i.e., an autoinjector pen or autoinjection pen (used interchangeably
herein). As used herein, an “automatic injection device” or “autoinjector” (used
interchangeably ) is intended to refer generally to a device that s an
individual (also referred to herein as a user or a patient) to self-administer a dosage of
a liquid substance, such as a eutic agent, including a ation in liquid form,
wherein the device differs from a standard syringe by the inclusion of a mechanism
for automatically delivering the medication to the individual by injection when the
mechanism is activated. In some embodiments, the liquid eutic agent can
include one or more biological agents, such as a protein. For example and without
tion, one such liquid therapeutic agent can be a TNF inhibitor, such as
adalimumab. Additional details ing possible therapeutic agents, including
adalimumab, are provided in US. Patent Application Serial No. 12/074,704, the
ts of which are incorporated by nce herein in its entirety.
W0 2013/044161 PCT/USZOI2/056744
In accordance with the sed subject matter , the automatic
injection device lly includes a housing, a syringe, a plunger, and a syringe
carrier. The housing es a first end, a second end, and a barrel between the first
end and the second end. The barrel includes an elongated window to allow g of
contents inside the housing. The syringe is ed within the housing and has a first
end, a second end, and a reservoir between the first end and the second end. The
plunger is at least partially disposed within the syringe and includes a visual indicator
on a portion of the plunger. The syringe carrier is disposed within the housing and
configured to contain the syringe and displace the syringe within the housing between
a first position and a second position. The automatic injection device can also include
a cap, having an outer portion and an inner portion, and a shroud.
The syringe carrier can further have one or more gs configured
to align with the window and the reservoir when the syringe carrier is in the first
position, and/or to align with the window and the visual indicator when the syringe
r is in the second position.
The accompanying figures, where like reference numerals refer to
identical or functionally similar elements throughout the separate views, serve to
further illustrate various ments and to explain various principles and
advantages all in accordance with the disclosed subject matter. For purpose of
explanation and illustration, and not limitation, exemplary embodiments of the
tic injection device in accordance with the disclosed subject matter are shown
in FIGS. lAvl9. While the present disclosed subject matter is described with respect
to using the device to provide a subcutaneous injection of a dose of a TNF inhibitor,
one skilled in the art will recognize that the disclosed subject matter is not limited to
the illustrative embodiment, and that the ion device can be used to inject any
suitable substance into a user. In addition, the components and the method of using
the automatic injection device are not limited to the illustrative embodiments
described or depicted .
Generally, and unless otherwise noted, the term "first end" refers to the
portion or end of an automatic injection device or ent in the automatic
injection device to be disposed or positioned at or near to an injection site when the
device is held against a person for an injection or for mimicking an injection. The
term "second end" refers to the portion or end of an automatic injection device or a
component of the automatic injection device spaced from an injection site during an injection.
Referring to an illustrative embodiment of FIGS. 1A-1B and 2, an automatic
injection device 10 includes a g 12, at least for housing a container, such as a syringe or
cartridge, containing a dose of a substance to be ed into a patient. As described further
below, the housing 12 embodied herein includes a first housing component 12a for housing a
syringe housing assembly 121 and a second g component, for example, a firing body
12b for housing a firing mechanism assembly 122. The housing 12 generally has a tubular
configuration, though one skilled in the art will recognize that the housing 12 can have any
number of suitable shapes and configurations for g a syringe or other container of a
substance to be injected. While the disclosed t matter will be described with respect to a
syringe mounted in the housing 12, one skilled in the art will recognize that the tic
injection device 10 can employ other suitable containers for storing and dispensing a substance.
For example, the container for storing and dispensing a substance can be a cartridge.
Additionally, the container, whether a syringe 12 or cartridge, can be made of glass, a polymer,
or a variety of other suitable materials for storing and sing a substance.
Referring to FIGS. 1A-1B, the syringe is preferably slidably mounted in the
housing 12, as described in detail below. In an inactivated position, the syringe is sheathed and
retracted within the housing 12. When the device is actuated, the syringe is extended such that a
needle of the syringe projects from a first end 20 of the housing 12 to allow ejection of a
substance from the e into a patient. As shown, the first end of the g 20 includes an
opening 28 through which the needle of the e ts during actuation of the device 10.
Continuing to refer to FIGS. 1A-1B and 2, a firing ism assembly 122 is
ed in housing 12 and includes an activation button 32, exposed through a second
end 30 of the housing 12, for actuating the syringe to move from the sheathed position within
the g 12 to a projecting on with the needle projecting from the housing and/or expel
the substance from the syringe needle into the patient. The housing 12 can house one or more
actuators to perform the function of moving the syringe and expelling the substance from the
syringe.
The illustrative automatic injection device 10 shown in FIGS. 1A-1B, 2 can also
include a needle shroud cap 24, as shown for example in FIGS. 17A-17D, to cover the first
end 20 of the housing 12, and thus prevent exposure of or access to
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PCT/U82012/056744
the needle in the e prior to use. In the illustrative embodiment, the needle
shroud cap 24 can include a boss or hub 26 for locking and/or covering the interior
components of the device 10 until the user is ready to activate the device 10.
Alternatively, the needle shroud cap 24 can comprise a ed screw portion and the
first end 20 of the housing 12 at opening 28 can comprise mating screw thread.
Alternative suitable mating or ng mechanisms can be used in accordance with
the teachings of the disclosed subject matter. As shown for example in FIGS. 10A—
108 and discussed further below, an actuator cap 34 can also be provided to cover the
second end 30 of the housing 12 and thus prevent accidental ion of the
activation button 32.
In the illustrative embodiment of FIGS. lA—lB and 2, and with
reference to FIGS. lOA—lOB and l7A~l7D, the housing 12 and caps 24 and 34 can
further include graphics, symbols and/or s to facilitate use of the automatic
injection device 10. For example, the housing 12 can include an arrow or other indicia
on an outer surface pointing towards the first end 20 of the device to indicate the
direction in which the device 10 should be held relative to the injection site. In
on, the needle shroud cap 24 can be labeled with a " l " to indicate that a user
should first remove the needle shroud cap 24 of the device first, and the actuator
34 can be labeled with a "2" to indicate that the actuator cap 34 should be removed
second after the needle shroud cap 24 is removed during preparation for and
subsequent injection using the illustrative automatic injection device 10. Furthermore,
either or both caps 24, 34 can be labeled with one or more arrows indicating the
direction of removal. Additionally, the needle shroud cap 24 can be a different color
than actuator cap 34, and labels, such as numbers and/or arrows can be accented with
a highlighted or contrasting color from the corresponding cap 24, 34, such as white, to
allow the user to more easily fy the caps 24, 34 and understand the ce of
removal of caps 24, 34 for preparation of the device 10. Further, the needle shroud
cap 24 and/or the actuator cap 34 can include one or more contours or indentations 23,
sized and shaped to tate gripping and removal of the caps 24, 34 by the user.
One skilled in the art will recognize that the automatic injection device 10 can have
onal or alternative suitable graphics, symbols and/0r numbers to tate user
instruction, or the automatic injection device can omit such graphics, symbols and/or
numbers .
PCTIUSZ012/056744
As illustrated in FIGS. lA-lB and 2, the housing 12 embodied herein
includes at least one elongated window 130 to allow a user to View the contents of the
syringe housed within the housing 12, as described in detail below. The window 130
can comprise an opening in the sidewall of the housing 12, and/or can comprise a
translucent or transparent material in the housing 12 to allow viewing of the interior
of the device 10. A second window can be provided diametrically opposite the first
window to allow Viewing through the g and syringe if desired. Additional or
alternative window embodiments likewise can be provided, for example and as further
described below, wherein the window 130 is sufficient in length to function as
described herein.
The housing 12 can be formed of any suitable al or medical
device material, including, but not limited to, plastic and other known materials.
As previously noted and described in further detail below, the
automatic injection device 10 sed herein generally comprises two components, a
syringe housing assembly 121 and a firing mechanism assembly 122. For purpose of
illustration and not limitation, reference is first made to the sequence of operation of
the automatic injection device 10, and particularly to the operation of the syringe
g assembly 121 of the disclosed subject matter.
FIGS. 3A-6B are front and cross-sectional side views of interior
2O components of a syringe housing assembly 121 for an automatic injection device 10
according to one embodiment of the disclosed subject matter. As shown, a syringe 50
or other suitable container for a substance is ed within the interior of the
g 12. The illustrative syringe 50 includes a hollow barrel portion 53 for holding
a dose of a liquid substance to be injected. The illustrative barrel portion 53 is
substantially cylindrical in shape, though one d in the art will ize that the
barrel portion 53 can have a y of le shapes or rations. A seal,
illustrated as a bung 54, substantially seals the liquid substance within the barrel
portion 53. The e 50 can further e a hollow needle 55 connected to and in
fluid ication with the barrel portion 53, through which the dose of liquid
substance can be ejected by applying pressure to the bung 54. The hollow needle 55
extends from a first end 53a of the barrel portion 53. The second end 53b of the barrel
portion 53 can include a flange 56, or other suitable mechanism, for abutting a stop,
represented schematically as 123, in the housing 12 to limit the movement of the
syringe 50 within the housing 12, as described below. One skilled in the art will
recognize that the sed subject matter is not limited to the illustrative embodiment of the
syringe 50 and that other suitable containers for containing a dose of a substance to be injected
can be used in accordance with the sed subject matter. In the illustrative embodiment
of FIGS. 3A-6B, the needle 55 can be a fixed twenty-seven gauge one-half inch needle. The tip
of the illustrative hollow needle 55 can include five bevels to facilitate insertion. However, the
needle 55 can have any size, shape and configuration suitable for the intended use as known in
the art and is not limited to the illustrative embodiment. The automatic injection
device 10 further includes a syringe ion component to selectively move and/or actuate the
syringe 50 to inject the dose of liquid substance contained in the syringe 50 into a user. As
embodied herein, the e actuation component 700 is a plunger (shown in and forms
a part of the firing mechanism ly 122. The syringe actuation component 700 can further
have an indicator 190 (shown in to indicate completion of the injection, as discussed
below.
FIGS. 3A-6B illustrate the syringe housing assembly 121 in various stages of
operation. In a pre-injection position, as shown in , the syringe 50 is in a ed
position within the housing 12. The needle shroud cap 24 is disposed on the first end 20 of the
g 12 to prevent access to or exposure of the needle 55. As evident from , the
ts of the syringe 50 are visible through the window 130. FIGS. 4A-4B illustrate the
syringe housing assembly 121 in an initial stage of deployment, showing a transition between
the pre-injection position and the post-injection position. At this initial stage, the stepped
shroud 12d is depressed against the injection site, and the syringe carrier 500 has moved relative
the window 130 toward the first end 20 of the housing 12. FIGS. 5A-5B show the syringe
housing assembly 121 at the end of the injection stage with the d shroud 12d still
depressed against the injection site, such that the needle 55 is extending from the
housing 12 into the injection site. Upon completion of the stroke or movement of the e 50,
the contents of the e 50 are no longer visible through the window 130. As described
herein, however, the indicator 190 on the plunger or actuation component 700 will then be
visible for indication that injection is complete and that the device 10 can be removed from the
injection site. FIGS. 6A-6B show the syringe housing assembly 121 in the post-injection
on, with the device 10 removed from the injection site g the stepped shroud 12d to
deploy, as r described below. As described herein, the indicator 190 on the plunger or
actuation ent 700 remains visible to indicate that the device has been deployed.
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As previously noted, and with reference to the automatic ion
device 10 can comprise two interlocking components: a e housing assembly 121 and a
firing mechanism assembly 122. The e housing assembly 121 and the firing mechanism
ly 122 can be coupled through any suitable means. In the illustrative embodiment, a first
end 122a of the firing mechanism assembly 122 can be sized and configured to be inserted into a
second end 121b of the syringe housing assembly 121. In addition, one or more tabs 127 on the
first end 122a of the firing mechanism assembly 122 can snap-fit into corresponding
openings 126 on the second end 121b of the syringe housing assembly 122 to ensure alignment
and coupling of the two assemblies 121, 122 and the components housed therein.
is an exploded view of the firing mechanism assembly 122, for illustration
and not limitation, according to a representative embodiment of the disclosed t matter. As
shown, the firing mechanism assembly 122 includes an activation button 32, a second
removable cap, for e, the actuator cap 34, firing body 12b and a coil spring 88 or other
biasing mechanism. The illustrative firing mechanism assembly 122 further includes a syringe
actuator, such as a syringe actuation ent 700, that extends from the first end 122a of the
firing body 12b. As embodied herein, the syringe actuation component 700 can be configured to
move the syringe 50 in a first phase and e the syringe 50 to expel its ts in a second
phase.
FIGS. 10A-10B rate the actuator cap 34 according to illustrative
embodiments of the disclosed subject matter. The actuator cap 34 can e a locking
pin 36 to engage the activation button 32 and prevent inadvertent actuation of the activation
button 32 before actuator cap 34 is removed. The actuator cap 34 can be mounted on the
housing in a y of ways. For example, and as shown in the second end of the
housing 12 can be provided with a er smaller than the an adjacent section of the housing.
A step 29 can be formed at the transition between the two diameters to facilitate seating of the
actuator cap 34 on the second end 30 of the housing.
The actuator cap 34 can have a distinctive color to differentiate the first
end 20 and second end 30 of the device, though one skilled in the art will recognize that the
actuator cap 34 and housing 12 can have any suitable color, size and configuration.
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As shown in FIGS. 1A-1B and 10A-12B, the firing body 12b includes a
substantially tubular body, which can include taper and/or contours 128 to facilitate gripping of
the device 10 by a user. A step 29 can be formed in a distal region, for example, a second
end 30 to facilitate seating of the actuator cap 34, as described above. Additionally, a mating
feature can be provided to secure the actuator cap 34 to the firing body 12b. For example, and as
depicted in mating tabs 33 on the firing body 12b can be configured to be received
within receptacles 22 of actuator cap 34, for example by an engagement or snap-fit or the like,
and thus lock the or cap 34 to the firing body 12b and activation button 32 and prevent
inadvertent removal of the actuator cap 34. Mating tabs 33 can also align actuator cap 34 with
the housing 12 during assembly and prevent on of the actuator cap 34 relative to the firing
body 12b during transportation or handling of the device 10, which can prevent accidental firing
of the device 10. As embodied herein, the mating tabs 33 and corresponding receptacles 22 can
have a petal shape, although other configurations can be used. Forward of the step 29, the firing
body 12b has a size and shape configured to be inserted into the distal end of the syringe
housing 121. Tabs 127 are formed to facilitate coupling and/or locking of the two housing
components 12a and 12b together. As shown in FIGS. 11A-11B, the tabs 127 can be formed in a
depression 127a on the surface of the proximate end of the firing body 12b, and can also or
alternatively include ribs 127b for guiding the tabs into a locking position relative to the
proximate g component 12a. One skilled in the art will recognize that any suitable means
for coupling the two lies together can be used and that the invention is not d to the
illustrative coupling means.
As shown in FIGS. 11A-11B, the firing body 12b can e an ing
cap 12c coupled to a smaller diameter distal end of the firing body 12b for anchoring the firing
mechanisms for actuating the device 10 to the firing body 12b. The interface of the anchoring
cap 12 c and the firing body 12b can form a groove 1234 to tate a snap fit of the activation
button 32 on the distal end of the firing body 12b, or can be joined by other suitable joining
means as described above.
Referring to FIGS. 3B and 12A-12C, the syringe actuation component 700 can be
an integrated component formed of any suitable material, such as an -based plastic, though
other suitable als can also be used. The syringe actuation component 700 ses a
pressurizing end, for example, pressurizer 754 for applying pressure to the bung 54 of a
corresponding syringe 50, and a plunger rod portion 70 with a compressible expanded central
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portion, illustrated as the r elbows 78. Additional components, such as components for
anchoring the coil spring 88 to the syringe actuation component 700, can also be provided as
described below. The compressible ed central portion 76 facilitates movement of a
corresponding syringe 50 toward the injection site and expulsion of the contents of the
e 50 in two separate steps, as described above. Alternatively, the e actuator can
comprise multiple ors for moving and/or promoting expulsion of the syringe 50.
The syringe actuation ent 700 of FIGS. 3B and 12A-12C can further
include an indicator 190 in a solid rod portion 70 distal from the elbows 78. During operation of
the device 10 and after completion of an injection, the indicator 190 is configured to align with
the window 130 on the housing 12 to indicate completion of the injection. The
indicator 190 preferably has a distinctive color or design to represent completion of an injection.
As shown in FIGS. 1B, 8 and 12A-12C, the illustrative syringe actuation
component 700 further includes a retaining flange 720 for holding the actuating coil spring 88 in
a compressed position until actuation. The retaining flange 720 is sized, dimensioned and
formed of a material that preferably allows the syringe actuation component 700 to slidably and
easily move within the housing 12 when the device 10 is actuated. Extending distally from the
retaining flange 720, the syringe actuation component 700 forms a base 788 for the actuating
coil spring 88. The base 788 terminates in a trigger anchoring portion 789. For example, and as
depicted , the illustrative base 788 can comprise flexible legs 788a, 788b around which
the spring 88 is disposed. The trigger ing portion 789 can se tabbed feet
7891 extending from the base 788 and configured to selectively engage the anchoring
cap 12c and/or firing body 12b. The tabbed feet 7891 can include one or more angled surfaces to
define a cam or the like. For example, and as shown in C, the tabbed feet 7891 can have
a substantially arcuate shape formed by multiple edge segments, each having a different angle
relative to the length of the base 788. As embodied , for purpose of ration and not
limitation, from the end of the tabbed feet 7891 towards the base 788, the edge segments can
have successively sing angles α, β, γ of 82°, 45° and 23°, respectively. The activation
button 32 coupled to the distal end of the firing body 12b is configured to hold the trigger
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PCT/U$2012/056744
anchoring portion 789 until activation. When activated, the activation button 32
es the trigger anchoring portion 789, allowing the spring 88 to
urge the syringe
actuation component 700 toward the proximal end 20 of the device 10 in an operation
described above.
In a retracted, anchored position shown FIGS. 1B, 3B and lZA-IZC,
the trigger anchoring portion 789 interacts with the housing 12, which holds the
tabbed feet 7891 in a latched position, against the biasing force of the coil spring 88,
to maintain the syringe actuation ent 700 in a retracted position. In this
position, the flange 720 retracts the spring 88 against the back, distal wall 712 of the
firing body 12b. An g 713 in the anchoring cap 12c allows the activation button
32 access to the anchoring portion 789. In the retracted position, the pressurizer 754
of the syringe actuation component 700 extends out of an opening 228 on the
proximal end 122a of the firing body 121). When the firing body 12b s to a
corresponding e ion mechanism 121, the pressurizer 754 extends into the
barrel portion of a syringe housed therein. The pressurizer 754 can be integral with,
the same as, connected to, or otherwise in ication with the bung 54 of a
syringe 50 housed in the device 10 and can be provided with any suitable size, shape
and configuration suitable for applying pressure to the bung 54. In one embodiment,
the pressurizer 754 has a section corresponding to the shape of the barrel
n 53 of a corresponding syringe 50 so as to substantially seal the barrel portion
53, and the pres surizer 754 is configured to slidably move within the barrel portion 53
to apply re to the bung 54 and actuate the syringe 50.
In the illustrafive ment of the syringe actuation
ent 700 constitutes a single, ated mechanism for anchoring a
corresponding syringe 50, spring 88 and other components, actuating and moving the
syringe 50 to an extended position, and expelling the contents of the syringe 50.
Additional details of the illustrative firing mechanism ly 122 and related
aspects of the automatic injection device 10 are provided in US. Patent Application
Sen‘ a] No. 12/074,704, which is incorporated by reference herein in its entirety.
is an exploded view of the syringe g assembly 121 of an
illustrative embodiment of the disclosed subject matter, which for purpose of example
and not limitation is configured to couple to and interact with the firing mechanism
assembly 122 of The illustrative syringe housing assembly 121 includes a
housing component 12a, a needle shroud cap 24, a biasing mechanism 89, a syringe
carrier 500, and a stepped shroud 12d at the first end 20 of the housing 12 when
assembled and includes the first opening 28, as also shown in The components
12a, 12d, 89, 500 and 24 cooperate to house a syringe 50 containing a substance to be
injected and facilitate operation of the device 10 as bed above. Additional
s of the illustrative syringe housing assembly 121, firing mechanism assembly
122 and related aSpects of the automatic injection device 10 are provided in US.
Patent Application Serial Nos. 13/443,384; 12/968,744; 12/770,557 and 12/074,704
and US. Patent Nos. 8,162,887; 7,938,802; 432 and 6,805,686, each of which is
incorporated by reference herein in its entirety.
Illustrative embodiments of the syringe carrier 500, housing 12, the
stepped shroud 12d and the needle shroud cap 24 are shown in detail in FIGS. 14A—
14Q, D, 16A~l6B and l7A—17D, respectively. FIGS. 18A and 18B are a
perspective side view and a cross—sectional side view, respectively, of the assembled
spring housing assembly 121 according to one embodiment of the disclosed subject
matter. One skilled in the art will recognize that the disclosed subject matter is not
limited to the illustrative embodiments only.
Referring now to FIGS. lA-lB, 2, 13, i4A-l4Q, and ISA-188, the
syringe carrier 500 of the rative embodiment holds or contains at least a portion
of a syringe 50 used in the device 10. The syringe 50 rests in the r 500, which in
turn is contained in the housing 12. During operation, the syringe 50 and carrier 500
move forward (e.g., towards the first end 20 proximate the injection site) within the
housing 12. The housing 12 is configured to limit the nt of the carrier 500
beyond the first end 20, and the carrier 500 in turn limits the movement of the syringe
50. The syringe r 500 embodied herein has a substantially tubular structure
including at least a first opening 505 ate the first end of the carrier 500 and a
second opening 501 space from the first end of the carrier 500.
In ance with another aspect of the disclosed subject matter, and
with reference to the embodiment of FIGS. l4A-l4l, the first opening 505 can be
defined by legs 506 extending from a middle portion 507 disposed between the first
opening 505 and the second opening 501. In the assembled state, the first opening 505
is located closer to the first end of the housing 12a than the second opening 501. The
middle portion 507 is sized and configured to provide suitable th to the syringe
carrier 500 to prevent breaking or deformation of the e carrier 500 during
operation of the device. Furthermore, additional openings can be provided to
correspond with the window 130 or windows of the housing. For example, for either or both of
the first g 505 or second opening 501, a front opening can be provided diametrically
opposite a rear opening to allow viewing through the syringe carrier 500.
For example, an as illustrated in FIGS. 14A-14Q, the legs 506 embodied herein
each also include an anchor n 503 at a first end of each leg 506. The anchor portion 503 of
each leg 506 includes a first projection 508 and a second projection 509 to define a generally
radial groove. In the illustrative embodiment, in the pre-injection position, the first and second
projections 508, 509 engage an interior stop 256 within the radial groove, as shown in FIGS.
15C-15D and 18B. The first tion 508 can be larger than second projection 509 and sized
to prevent movement of the first projection 508 past the interior stop 256, thus preventing
movement of the syringe carrier away from the injection site.
As shown in FIGS. 14J-14Q, the second projection 509 can be configured to pass
the interior stop 256 when the e carrier 500 is urged toward the injection site, as bed
below. The second projection 509 can be configured such that the onal force to move the
second projection 509 past the interior stop 256 can be less than the force to advance the syringe
actuation component 700 within the e, and thus prevent advancement of the syringe
actuation component 700 and expulsion of the syringe ts before the syringe 50 and
needle 55 are moved to the injection site. For example, and as embodied herein, the surface of
second projection 509 can be substantially arcuate or include an arcuate n configured to
abut the interior stop 256, and interior stop 256 can include a chamfered edge portion configured
to abut the second projection 509 to reduce the amount of force to urge the second
projection 509 past the interior stop 259. Additionally or alternatively, legs 506 can act as a
living hinge, which can e for easier assembly of the e carrier 500 into the syringe
housing assembly 121 and also allow the syringe carrier 500 to move past the interior 259.
Additionally, for purpose of illustration and not limitation, and as embodied
, syringe carrier 500 can be configured with two pairs of legs 506 distributed substantially
symmetrically about the barrel of the syringe carrier 500, which can provide substantially even
distribution of the force applied to the syringe carrier legs 506 when ng interior
stops 256 of the housing 12, and thus prevent damage to legs 506 during assembly,
transportation or handling. Further, force can be distributed substantially evenly to each
leg 506 when a force is applied to the syringe
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PCT/U52012/056744
carrier 500 to move the second projection 509 of each leg 506 past each or
stop
256 of the housing 12. In this manner, the legs 506 can be released from the housing
12 at substantially the same time for improved activation, including, for example,
when syringe 50 is tilted and contacts the syringe carrier 500 at the start of the device
activation and firing.
A syringe carrier coupler 504, formed as two beams extending from
the middle portion 507, extends forward beyond the anchor portion 503 to facilitate
coupling of the syringe carrier 500 with an end of the spring 89 and/or the stepped
shroud 12d
The legs 506 are sized and shaped for added durability and th.
For example, either or both of the first and second projections 508, 509 of legs 506
can be wedge—shaped and have a thickness to provided added strength. onally,
the legs 506 can be tapered for greater width or thickness ate the middle
portion 507, and/or the legs 506 can be angled slightly radially outward relative a
longitudinal axis of the syringe carrier 500 to more securely engage the interior stop
256.
The syringe carrier 500 can e a flanged second end 562
configured to interface with a flanged second end 56 (shown in B) of the
syringe 50. The flanged second end 562 can serve as a damper for the syringe 50.
Additionally, the flanged second end 562 can include a damping structure 564, such
as an elastomeric member mounted on or formed ally with the second end 562
of the syringe carrier 500. The syringe carrier 500 can r include one or more
intermediate flanges 563, which in the illustrative embodiment forms a stop for the
syringe 50 to interact with an interior stop 256 on the housing component 12a to limit
forward motion of the e 50.
As depicted herein, the syringe carrier 500 is slidably disposed within
the housing 12 and selectively carries the syringe 50 within the housing 12.
Alternatively, the syringe carrier 500 can be stationary within the housing 12 and
configured to allow the syringe 50 to selectively and controllably slide within and
relative to the e carrier 500. The syringe carrier 500 can have other suitable
configurations and sizes for carrying or guiding the syringe 50 within the housing 12.
Referring to FIGS. l6Av16B and 18B, the illustrative stepped shroud
12d is disposed at the first end 20 of the housing 12. The illustrative d shroud
12d has a substantially tubular body, ing a hub 112 defining the opening 28 at
the first end 20 of the device 10, through which the syringe needle 55 can t during
ion of the device 10. A step 113 from the main tubular body portion 116 forms the
hub 112 of smaller diameter than the main tubular body portion 116 of the stepped shroud 12d.
As shown in B, the step 113 forms a d stop for the spring 89 to confine the
spring 89. In the illustrative ment, shown in FIGS. 16A-16B and 18B, a shroud
notch 115 is formed in a rim at the second end of the stepped shroud 12d. The rim of the d
shroud 12d abuts the first side of the stop 256 of the housing component 12a. The shroud
notch 115 can align with a portion of the window 130 to prevent obstruction of the window 130.
Additionally, arms 114 extend from the stepped shroud 12d to lock in the stepped shroud 12d to
prevent accidental needle sticks. The stepped shroud 12d can further include a guide, such as a
groove and/or slot 118 as shown in FIGS. 16A-16B to receive corresponding projections or
keys 257, as shown in FIGS. 15C-15D, and thus allow for coaxial movement of the stepped
shroud 12d and the e r 500 without on relative the housing 12. The
configuration and operation of the stepped shroud 12d is described further in U.S. ation
Ser. No. 12/074,704, and U.S. Patent Nos. 7,229,432 and 6,805,686, each of which is
incorporated by reference herein in its entirety.
Referring again to FIGS. 14A-16B and 18B and to the stages of operation of the
device shown in FIGS. 3A-6B, with the device in the pre-injection position, the cap 24 is
removed and the stepped shroud 12d is depressed against the injection site and thus ted
within the housing 12. Upon activation of the firing assembly mechanism 121, the syringe
carrier 500 is urged forward, toward the first end of the device 10, and the legs 506 deflect
radially outward causing the anchor portions 503 to disengage from the stop 256 to allow the
syringe carrier 500 to move forward. As the syringe carrier 500 is urged forward, beams of the
syringe carrier coupler 504 compress spring 89 and engage the second end of stepped
shroud 12d. After syringe actuation component 700 is fully deployed, and completion of the
injection is confirmed as described below, the device 10 can be removed from the injection site.
At this point, the device is in the post-injection position with stepped shroud 12d extended
beyond the needle 55 due to spring 89 and locked in the extended position by arms 114 abutting
the stop 256.
Referring to FIGS. 17A-17D and 18A-18B, the interior of the illustrative needle
shroud cap 24 can include a plurality of radial s 241, 243 for receiving protruding
portions of the stepped shroud 12d and the housing component 12a. For example, as illustrated
(11046283_1):MSL
in B, a first radially outer groove 241 receives a first end of the sidewall 242 of the
housing component 12a. A second, ly inner groove 243 receives the first end of the
hub 112 of the stepped shroud 12d. The second end of needle shroud cap 24 includes a cap
notch 250 to align with a portion of the window 130 to prevent obstruction of the
window 130 when the needle shroud cap 24 receives the housing 12 (as best shown in FIGS.
3A-3B). The radial grooves 241, 243 can be separated by a radial inner wall 245, which can be
formed as a ring, or alternatively can be formed as a ity of arcuate wall portions.
The needle shroud cap 24 r includes a cap hub 26. Cap hub 26 is
configured to extend into the inner lumen 1012 of the housing 12 and surround the first end of a
syringe 50 loaded therein when the needle shroud cap 24 is coupled to the housing 12. The cap
hub 26 can include two or more members, if desired, to define a hub opening 249. When the
needle shroud cap 24 receives the housing 12, the hub opening 249 can align with the at least a
portion of the window 130 to prevent ction of the window by the cap hub 26.
Additionally, and as shown in B, a second end of the cap hub 26 can be configured with
a reduced thickness to fit between syringe 50 and the first end of legs 506. In this manner, the
legs 506 are radially deflected inward into engagement with the g stop 256 to prevent
premature ment of the stepped shroud 12d when the cap 24 is removed.
As embodied herein, a separate interior needle cover 246 (shown in B),
such as a conventional rigid needle shield, sheaths the syringe needle 55. When the cap 24 is
placed onto the housing 12, a circumferential ridge 247 can engage and secure the interior
needle cover 246 within the cap 24. When the cap 24 is removed, the syringe needle 55 is
exposed within the lumen 1012 of the housing 12. The cap 24 can also include an opening in a
first end 248 thereof. The cap 24 can r include one or more slots or apertures in a side
thereof to allow for ion of the radial grooves 241, 243 or the hub 26 and/or to tate
the needle cover 246 passing the circumferential ridge 247 when the cap 24 is placed onto the
housing 12.
Referring again to the stages of operation of the automatic injection
device 10 shown in FIGS. 3A-6B, the alignment of the openings 501, 505 of the syringe
carrier 500 with the window 130 and other components of device 10 is described. In the preinjection
position shown in FIGS. 3A-6B, the first opening 505 of the syringe r 500 in the
first position is aligned with the window 130, the cap
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notch 250, and the shroud notch 115. This alignment allows viewing of the e
barrel 53 through the window 130 to permit viewing of the contents of the syringe 50.
In the initially deployed on shown in FIGS. 4A—4B, the middle portion 507 of
the syringe carrier 500 is visible in the window 130, along with portions of the first
opening 505 and the second opening 501. The shroud notch 115 can be aligned with
the window 130 if the shroud 12d is pressed t the injection site. This alignment
can indicate that the device 10 is currently in operation. At the end of the injection,
shown in FIGS. 5A—5B, the second opening 501 of the syringe carrier 500 is in the
second position and aligned with the window 130 and the tor 190 of the syringe
actuation component 700 to indicate that the injection is ted. The shroud notch
115 can be d with the window 130 if the shroud 12d is pressed against the
injection site. In the post injection position, shown in FIGS. 6A—6B, with the shroud
12d deployed, the second opening 501 of the syringe carrier 500 in the second
on remains aligned with the window 130 and the indicator 190 of the syringe
actuation component 700 to indicate that the device 10 has been deployed, as
described further.
As described above and shown in A, openings 126 in the
housing component 123 receive tabs 127 of the firing mechanism assembly 122 to
facilitate assembly of the device 10. The window 130 described above for allowing a
user to view the contents of a syringe contained in the ly 121, as well as to
View an indicator 190 that fills the window 130 after completion of an injection can
be formed only in the first housing component 12a if sufficient length is available to
function as described.
With reference now to the indicator 190, is a front View of the
automatic injection device 10 of an embodiment of the disclosed subject matter,
illustrating the syringe actuation component 700 according to one embodiment of the
sed subject matter. The e actuation component 700 can form or otherwise
include an indicator 190 visible through the window 130. The indicator 190 can be
ed with a ctive color, shape, and/or design to indicate to a user that an
injection is complete. The indicator 190 is configured to align with the window 130 of
the housing 12 after the syringe actuation component 700 completes an injection and
fully or substantially fully expels the contents of the syringe 50 out of the needle 55
and into a patient. Thus, prior to operation of the device 10, the syringe barrel 53
aligns with the window 130 and the contents are viewable therein through the first
opening 505 of the syringe carrier 500 in its first position. After injection, the e barrel
portion 53 has moved towards the first end 20 of the device 10, such that the needle 55 des
from the first end 20 of the g 12, and the syringe actuation component 700 has moved
forward within the syringe barrel portion 53. In this position, the indicator 190 is aligned with
and visible in the window 130 h the second opening 501 of the syringe carrier 500 to
indicate completion of an injection. Therefore, and in accordance with this embodiment, even
when the syringe 50 has moved into an exposed position with the needle 55 protruding from the
housing 12, the indicator 190 will not align with the window 130 or otherwise indicate
completion of an injection until the syringe actuation component 700 has expelled the contents
of the syringe 50 out of the barrel 53.
Referring to FIGS. D, the illustrative housing 12 includes a
window 130 formed in a side wall of the housing 12 to allow a user to view the contents of the
syringe prior to ion and to allow a user to view the indicator 190 after the device operation
is completed. As embodied herein, as shown in FIGS. 15A-15D, the illustrative
window 130 ably has an elongated shape of ient length for visibility of the first
opening 505 of the syringe carrier 500 in the first position and the second g 501 of the
syringe carrier 500 in the second position. For example, the window 130 can have an oval shape
with a first end 132 that is narrower than a second end 134, and the first end can align with a cap
notch 250 when the cap 24 receives or is positioned in the housing 12. The second end 134 of
the window 130 can be ntially semi-circular in shape and wider than the first end 132 of
the window 130 for better visibility of indicator 190, if provided.
shows an alternate embodiment of device 10 with an alternative
window 130 configuration. In contrast to the tapered or tear-drop configuration previously
described, window 130 is generally oval-shaped. As shown in , the window 130 can
have a substantially symmetrical oval shape or pill shape and can preferably be configured as an
open slot, or can alternatively be configured to include a transparent window cover to protect the
contents of the device 10 and allow viewing of the syringe contents therethrough, as well as to
view an indicator 190 that fills the window 130 after completion of an injection. Further, the
window 130 configuration of can be ed with any of the embodiments of
device 10 and syringe carrier 500 described herein. The window 130 can include a fill
line 135 to allow verification of the proper dosage within the syringe.
(11046283_1):MSL
2012/056744
The housing 12 can also include a beveled edge 136 surrounding the
window 130. The beveled edge 136 can be used to receive and secure an optional
shield 137. The shield 137 can be ly attached to cover the window 130, if made
of an opaque material, or can be made of any suitable transparent material and
secured to the housing 12 to allow the user to see through the shield 137. The shield
137 can also have properties to absorb or reflect, or otherwise prevent ultraviolet or
other light wavelengths from entering the housing and damaging the contents of the
syringe 50. For example, the shield 137 can include a transparent protective film with
properties to block or absorb ultraviolet light, and the film can also include an
adhesive layer for application to the shield 137 and/or to a pre-filled syringe.
onally or alternatively, a chemical having ultraviolet blocking or absorbing
properties can be added to a transparent resin to form the shield 1.37. The ultraviolet
blocking or absorbing chemical can be added either by mpounding or tumble
blending before molding the resin. As a further alternative, a transparent protective
film or chemical having ultraviolet blocking or absorbing properties can be added to a
product packaging for device 10 to further prevent degradation of the contents of the
syringe 50.
The housing 12 can also include a portion 139 of increased strength
proximate the window 130. For example, and as depicted in the portion 139
can be provided with a non-cylindrical configuration, such as a bulbous or »
shaped portion, for additional strength. The n 139 of the housing 12 can be
wider near the window 130 relative to the remainder of the housing 12. The portion
139 can increase the th and thus resist deformation of the housing 12, which can
otherwise be weakened by the loss of material in the housing 12 to form the window
130. Additionally, the contoured housing can improve ergonomics and aesthetics of
the automatic ion device 10.
Although reference is made to certain es on a front of the device
or components, such as window 130, first and second openings 505, 501, shroud
notch 115, cap notch 250, such es can include, for e, a corresponding,
diametrically opposed feature on a rear of the device, or other suitable location on the
device 10.
The tic injection device of the disclosed subject matter can be
used for injection or delivery of any of a variety of suitable liquid nces of
corresponding volume or dose.
While the disclosed subject matter is described herein in terms of
certain preferred embodiments, those skilled in the art will ize that various
modifications and improvements can be made to the disclosed subject matter t
departing from the scope thereof. Moreover, gh individual features of one
embodiment of the disclosed subject matter can be discussed herein or shown in the
gs of the one embodiment and not in other embodiments, it should be apparent
that individual features of one embodiment can be combined with one or more
features of another embodiment or features from a plurality of embodiments.
In addition to the specific embodiments claimed below, the disclosed
subject matter is also directed to other embodiments having any other possible
combination of the ent features d below and those disclosed above. As
such, the particular features presented in the dependent claims and disclosed above
can be combined with each other in other manners within the scope of the disclosed
subject matter such that the sed subject matter should be recognized as also
specifically ed to other embodiments having any other possible combinations.
Thus, the ing description of specific embodiments of the disclosed subject
matter has been presented for purposes of illustration and description. It is not
intended to be exhaustive or to limit the disclosed subject matter to those
embodiments disclosed.
It will be apparent to those skilled in the art that various modifications
and variations can be made in the method and system of the disclosed subject matter
without departing from the spirit or scope of the sed subject matter. Thus, it is
intended that the disclosed subject matter include modifications and variations that are
within the scope of the appended claims and their equivalents.
PCT/U52012/056744
Claims (23)
1. An automatic injection device comprising: a g having a first end, a second end, and a barrel between the first end and the second end, the barrel sing an elongated window to allow viewing of contents inside the housing; a syringe disposed within the housing and having a first end, a second end, and a oir between the first end and the second end; a plunger at least partially disposed within the syringe and comprising a visual 10 indicator on a portion of the r; and a syringe carrier disposed within the housing and configured to contain the e and displace the syringe within the housing between a first on and a second position, the syringe r having a first opening and a second opening, the first opening configured to align with the window and the reservoir when the syringe 15 carrier is in the first position, and the second opening configured to align with the window and the visual indicator when the syringe carrier is in the second position.
2. The automatic injection device of claim I, wherein the elongated window has a substantially symmetrical oval shape or pill shape.
3. The automatic injection device of claim I, the housing further comprising a 20 beveled edge surrounding the elongated window to receive a shield.
4. The automatic injection device of claim 3, wherein the shield is ured to prevent UV radiation from entering the housing through the ted window.
5. The automatic injection device of claim 1, further comprising a firing body having a first end and a second end, the first end of the firing body engaged to the housing 25 proximate to the second end of the housing, the firing body comprising one or more mating tabs disposed between the first end and the second end.
6. The automatic injection device of claim 5, r comprising a cap having one or more receptacles sized and shaped to receive the one or more mating tabs of the firing body to align and prevent inadvertent removal of the cap. PCTfU52012/056744
7. The automatic injection device of claim 6, n the one or more receptacle and the one or more mating tabs are petal—shaped,
8. The automatic injection device of claim 1, the syringe carrier further comprising a middle portion between the first and second openings, the middle portion sized to resist ation of the syringe carrier.
9. The automatic injection device of claim 1, wherein the first opening is positioned nearer to the first end of the housing than the second opening.
10. The tic injection device of claim 1, wherein the first position is a pre- injection position. 10
11. The automatic injection device of claim 1, wherein the second position is a post— ion position.
12. The automatic injection device of claim 1 further comprising a cap having an outer portion, the first end of the housing ured to receive the outer portion of the cap, the outer n of the cap comprising a cap notch, a portion of the elongated 15 window being aligned with the cap notch when the cap receives the housing to prevent obstruction of the window
13. The automatic injection device of claim 12, the cap further comprising an inner portion, the inner portion compu‘sing a split hub projecting beyond the outer portion, the split hub defining a hub opening, the hub opening being aligned with at least a 20 portion of the elongated window when the cap receives the housing to prevent obstruction of the window.
14. The automatic injection device of claim 13, the inner portion of the cap further comprising a circumferential ridge.
15. The automatic injection device of claim 14, further comprising a needle 25 ting from the first end of the syringe and a needle shield surrounding a portion of the needle, n the circumferential ridge is configured to secure the needle shield within the inner portion of the cap.
16, The automatic injection device of claim 15, wherein the needle shield is retained in the inner portion of the cap when the cap is removed from the housing. PCT/U32012/056744
17. The automatic ion device of claim 12, n the cap comprises an inner radial groove, an outer radial groove and a radial wall between the inner radial groove and the outer radial groove.
18. The automatic injection device of claim 17, wherein the radial wall comprises two or more arcuate wall segments.
19. The automatic injection device of claim 1, further comprising a shroud at least partially disposed within the housing, a portion of the shroud disposed within the housing having a shroud notch, the shroud notch being aligned with at least a portion of the elongated window to prevent obstruction of the window. 10
20. The tic ion device of claim 1, further comprising a first cap disposed proximate a first end of the device and a second cap disposed proximate a second end of the device, the first cap and the second cap each having one or more indicium to indicate a stage of a removal sequence or a removal direction, the one or more indicium having a highlighted color or a contrasting color compared to the 15 corresponding cap.
21. The tic injection device of claim 1, further sing a liquid therapeutic agent in the reservoir.
22. The automatic injection device of claim 21, wherein the liquid therapeutic agent comprises a protein. 20
23. The automatic injection device of claim 21 , wherein the liquid therapeutic agent comprises adalimuma‘o. PCT/U52012/056744 /,.‘.....::{!5\-‘\\\\\m\\\\\\\\\\\\\\\\\\\\\\\‘\\(111,111;11111.”11746511110111111.a\\\\\\—' nun“nu"..unnuuuu.u\.-u_.__-. m.,.\\\\\‘\‘\mm~\\““_\\“\ ........... unuu uuuunnuunu \\\ f ”'3’"\—-.v——//|/ll-| —Ill"u”N')” fig:._/"””” x\\\\\\\\\\\\\\\\\\\\\\\\\\\\“a,(31111111111:'Ill'll’"-1.:h— m , Ill/ll/Il'fiilll/Ig“‘_ -- - -5";;;/-/-/-/-/_/:;;[/l...... il/l'l'llll --‘:‘~bu‘>\\\\““\\\\\\\\\\\\\\\\w:::.....‘«~u\““““““‘\-. ____.;\\-_ _- _. “ “MI.‘I ‘3‘”__\N”,,,,,,,—_..0Wm“““\\\\\\\\\\‘\\\\‘\\\\\\\\\\\\§- I'lnnpt'n . cé'azazazaaiamma......_-' — ‘
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161538098P | 2011-09-22 | 2011-09-22 | |
US61/538,098 | 2011-09-22 | ||
PCT/US2012/056744 WO2013044161A1 (en) | 2011-09-22 | 2012-09-21 | Automatic injection device |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ622511A NZ622511A (en) | 2016-03-31 |
NZ622511B2 true NZ622511B2 (en) | 2016-07-01 |
Family
ID=
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