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APPARATUS AND METHOD FOR INJECTING A PHARMACEUTICAL
BACKGROUND OF THE INVENTION
The present invention pertains to pharmaceutical delivery devices, and, in
particular, to a delivery device that automatically injects a pharmaceutical.
Patients suffering from a number of different diseases frequently must inject
themselves with pharmaceuticals. As some patients find it difficult to insert a needle of
an injector into one's skin, and/or to operate the injector ,to inject the pharmaceutical
through an inserted needle, a variety of devices have been proposed to facilitate these
tasks.
One type of device automatically inserts a needle and then automatically injects a
dose of medication through that inserted needle. With one known version of this type
device, after unlocking the device by manually twisting a handle, a patient needs to
position the device against an injection site, and then operate a trigger of the device by
pressing the device firmly against the site. By such firm pressing, the hand graspable
housing shifts toward the injection site, allowing the portion of the device placed and
remaining against the skin to slide, relative to the shifting housing from which it
proximally extends, distally into the housing to trigger the automatic needle insertion into
the skin, and automatic injection through that inserted needle into the patient.
Another version of this type device requires a similar user interaction other than
the twist unlocking, and further requires an additional safety button pressing during the
firm pressing of the device to trigger the insertion and injection.

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While these devices, as well as other proposed devices, may be useful for some
people, other users may find different aspects of the design of these devices to be
troublesome. For example, where activation requires pressing the entire device toward
the injection site, whereby the hand grasping the housing must move relative to that
injection site, some users may find such controlled hand movement disconcerting or
difficult. Still further, users may worry with some proposed devices about properly
stabilizing the device, in that the device may slip along the skin or the needle may not
remain properly oriented during the entire injection process. Still further, some users may
find it difficult with some proposed devices to inject accurately into precise locations that
they have pre-selected.
Thus, it would be desirable to provide a device that can overcome one or more of
these and other shortcomings of the prior art.
BRIEF SUMMARY OF THE INVENTION
In one form tJiereof, the present invention provides a method of administering a
pharmaceutical, including the step of: providing a delivery device including a housing
having a first end and a second end spaced in an axial direction, a pharmaceutical
containing needled syringe mounted within the housing to be movable in the axial
direction from a first position to a second position, wherein an injection tip of the syringe
needle is recessed within the housing when in the first position and projects from the
housing beyond the first end when in the second position, the syringe having a piston
advanceabJe toward the first end to force pharmaceutical contained in the syringe through
the needle injection tip, wherein a region of the axial length of the housing proximate the
first end is flared radially outward toward the first end, and is at least one of transparent

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and apertured to allow visibility of the needled syringe, wherein a skin-contacting surface
of the housing first end includes a first region and a second region, the first region
comprising a material having a greater coefficient of friction than a material of the second
region to limit slippage along skin, and at least one injection targeting guide at the
housing first end. The method further includes the steps of holding a portion of the
housing with one hand and placing the delivery device with the skin-contacting surface of
the housing against the skin such that the least one targeting guide aligns with an intended
injection site, operating an unlocking system by rotating a part of the delivery device
relative to the held portion of the housing, whereby an activation button disposed at the
second end shifts axially away from the housing, and, without pressing the delivery device
housing toward the injection site with any predetermined force by the one hand holding
the housing portion, with another hand plunging the activation button toward the housing
in the axial direction to trigger an advancing assembly within the device that first
automatically advances the needled syringe from the first position to the second position,
and that second automatically advances the syringe piston toward the second end.
One advantage of the present invention is that a medication delivery device may
be provided which is intuitive and easy to operate.
Another advantage of the present invention is that a medication delivery device
may be provided which does not require the entire apparatus be shifted after being
properly sited for an intended injection.
Yet another advantage of the present invention is that a medication delivery device
may be provided with a grip feature for engaging the skin around an injection site to limit
slippage of the device during siting and injection.

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Yet another advantage of the present invention is that a medication delivery device
may be provided with targeting guides to assist a user in confirming the injection is to be
delivered where desired.
Still another advantage of the present invention is that a medication delivery
device may be provided which has an enlarged end to stabilize the device over an
injection site, which enlarged end is transparent or otherwise configured to allow visibility
of components such as a needle disposed therein, and which enlarged end may faciJitate
application of axial force against die injection site.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned and other advantages and objects of this invention, and the
manner of attaining them, will become more apparent, and the invention itself will be
better understood, by reference to the following description of embodiments of the
invention taken in conjunction with the accompanying drawings, wherein:
Fig. 1 is a front perspective view of a pharmaceutical delivery device of the
present invention, wherein a cap of the device is shown mounted to the proximal end of
the device housing;
Fig. 2 is a perspective view of the pharmaceutical delivery device of Fig. 1 with
the cap removed, and after the device has manipulated to an unlocked condition;
Fig. 3 is a diagrammatic view in longitudinal cross-section of one suitable
configuration of interna] components of a delivery device of the present invention;
Fig. 4 is a diagrammatic view in longitudinal cross-section of another suitable
configuration of internal components of a delivery device of the present invention in a
ready state;

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Fig. 5 is a diagrammatic view of the device of Fig. 4 at a point after activation at
which the needle has been automatically inserted but before automatic injection has
occurred;
Fig. 6 is a diagrammatic view of the device of Fig. 5 after automatic injection has
occurred; and
Fig. 7 is a schematic showing additional details of a flared housing end.
Corresponding reference characters indicate corresponding parts throughout the
several views. Although the drawings represent embodiments of the present invention,
the drawings are not necessarily to scale, and certain features may be exaggerated or
omitted in some of the drawings in order to better illustrate and explain the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to Figs. 1 and 2, there is shown a first embodiment of a
pharmaceutical delivery device of the present invention. Any directional references in
this detailed description with respect to the Figures, such as up or down, or top or bottom,
are intended for convenience of description, and by itself does not limit the present
invention or any of its components to any particular positional or spatial orientation.
The deliver)' device, generally designated 20, is designed to allow a user, with one
hand on the device, to comfortably position the device on the skin at a pre-selected site
before initiating the injection sequence. After such siting, the user's hand on the device
can remain motionless, while keeping the device stable and comfortable, as needle
insertion and injection can be activated with the other hand. The hand holding the device
need not firmly press the entire device toward the injection site with any required trigger

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unlocking or trigger firing pressure. Device 20 provides feedback that needle insertion
will take place at the intended location. The interaction strategy of the user with device
20 aids in providing accurate targeting of insertion, as well as stability and comfort during
the injection procedure. Device 20 is single use delivery device based on a standard
prefilled syringe primary containment. The injector system is delivered ready to use and
provides a single fixed dose delivery.
The delivery device, generally designated 20, includes an outer housing 22 having
a distal end 24 and a proximal end 26. As used herein, distal and proximal refer to axial
locations on the delivery device relative to an injection site when the device is oriented for
use at such site, whereby, for example, proximal end of the housing refers to the housing
end that is closest to such injection site.
The exterior periphery of outer housing 22 is sized, shaped and/or constructed of
materials to facilitate being gripped within one hand by a user or a caregiver during site
selection and injection, and may accommodate reduced dexterity in users such as
rheumatoid arthritis patients. The shown housing periphery is described herein as having
a plastic construction that changes in size but not overall shape along its axial length. The
largest transverse dimension or girth of housing 22, other that at its flared base, is between
20 and 30 millimeters, such as about 25 millimeters. Along its entire axial length, the
shown housing exterior periphery is non-circular and lobular in transverse cross-sectional
shape. The tri-lobular shape shown, which may be held by and within the space between
digits of a user's hand, may be replaced with other shapes known in the art, including
circular or rectilinear shapes, or shapes having fewer or additional lobes, within the scope
of the invention. Other configurations, such as a less uniform shaping along its length, or

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a construction including a soft touch or rubber-like gripping layer covering a more rigid
base, may be employed within the scope of the invention.
The proximal region or base 28 of the exterior periphery is flared outward relative
to the housing to provide for stabilization and to enhance the user's application of a small
downward force on the device housing during siting and injection. This downward force
promotes stability against tipping and promotes locating the device by increasing friction
forces that limit slippage along the skin. The shown flared region 28 starts at an axial
position of about fourteen millimeters from proximal end 26, and ends at an axial position
that is adjacent proximal end 26. Adjacent, as user herein with respect to the shown flare,
means that the flaring ends no more than one millimeter from the injection site skin-
contacting surface 30. Due to the housing being tapered slightly inward leading into the
flared region 28 for the shown embodiment, the flared region 28 starts at the inflexion
point of the axial contour. In alternate embodiments, the shown flared region 28 can
begin flaring at a point which is at the proximal end of a non-tapering or uniformly shaped
axial segment of the housing, or a slightly tapering outward housing body where the flared
end is more pronounced. Along its axial length, flared region 28 is shown bowed in or
concave.
The shown shaping and axial positioning of flared region 28 provides for a more
ready and comfortable holding of the housing that allows a user to provide an axial force
in the proximal direction without requiring large gripping forces being applied by the
user. The flaring is of such as size to provide a proximal end face having a larger area
that allows device 20 to be stabilized more easily by a user at the injection site to facilitate
injection confidence. Although the maximum transverse dimension of the shown flared
end is larger than the maximum transverse dimension of the rest of the housing, a flared

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end smaller than the maximum transverse dimension of some other part of the housing
may be employed within the scope of the invention.
With additional reference to Fig. 7, there is schematically shown a type of flared
housing end closely related to the concave housing shown with respect to Figs. 1 and 2,
and which is provided with several dimensions.
The height from the proximal end of the flare (Hf), relative to the proximal end of
the housing, is from 0-20mm, more preferably from 0-10mm, and most preferably 0-
5mm. The difference in the transverse width of the largest dimension of the flared end,
and the transverse width of the smallest dimension of the flared end, (WmiU< Wm-,n) is
within the range of 5-50mm, and more preferably the range of 10-30mm, and preferably
around 15mm. The angle the proximal end of the flaring makes with horizontal (6f) is
within the range of 0-70 degrees. Naturally, this angle refers to me flare prior to any
convex radiusing at the outer periphery that softens its edge.
Other flared end shapings may be provided within the scope of the invention to
facilitate handling of the device during siting and injecting. These flaring include
circumferential flanges at or near the proximal end of the housing, or flarings that are
convex instead of concave.
The injection site skin-contacting surface 30 of the housing is formed of a
circumferential flange that inwardly projects from the flared region 28 at housing
proximal end 26. The flange 30 defines a central aperture 32, aligned with the
longitudinal axis of device 20, through which a needle is moved from within housing 22
during insertion.
As best shown in Fig. 2, skin-contacting surface 30 is provided with an over-
molded ring 55 around the entire perimeter of the surface. Ring 55 is formed of a higher

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friction material, such as a Shore A, 50 durometer thermoplastic elastomer, which serves
to engage the user's skin against which it is placed around the injection site to reduce the
chance of device 20 moving with respect to the patient's body during the insertion and
injection process. Readily visible guides, such as of a change in color or transparency,
and such as a ring 57 around aperture 32, and radially extending lines 58 aligned with the
housing lobes, provide a targeting feature that allow a user to accurately see where the
needle is to enter the skin. In the preferred embodiment, targeting guides 57 and 58 are
overmolded to surface 30 of the same gripping material as is ring 55 to further limit
slippage. The proximal end region of housing 22 is preferably transparent around its
entire circumference to allow visibility of the targeting guides 57, 58 to facilitate the user
precisely locating the intended needle insertion, as well as visibility as necessary for a
user to confirm a full syringe of medication prior to using device 20, and to confirm that
all the medication has been delivered and that the needle has safely retracted into the
housing after injection.
A needle cap 35 that covers aperture 32 is diagrammatically shown in Fig. 1 and
is designed to be removed with lower dexterity or grip. Cap 35 includes a base 36 and an
upstanding, blind bored member 38. Base 36 covers all of flange 30 and is sized to
laterally project beyond the perimeter of the housing proximal end 26. Sealing member
38 fits through aperture 32 and sealing fits around the syringe needle to limit
contamination. Rather than the shown one-piece cap construction, member 38 may be an
existing rubber needle cap that comes as part of the primary container closure system,
while base 36 may be a plastic part that fits around and engages member 38. Cap 35 can
be removed from the covering arrangement shown in Fig. 1 by pulling it off the housing
completely manually, or, for example, by pulling device 20 away as the cap 35 is braced

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against a flat surface, such as a table. The base 36 may be overmolded with an
elastomeric material to make easier the gripping of the cap.
At the distal end of device 20, an activation button 50 for the automatic needle
insertion and pharmaceutical injection is provided. In the shown embodiment, the top of
activation button 50 is initially generally flush with the top of the device housing, and the
device is locked. Such locking is indicated to the user by the vertical non-alignment of
markings 42 and 43 on the lock sleeve 45 of the housing and the housing main body 46,
respectively, but other locking indicating systems, such as plastic features, may be
employed. When lock sleeve 45 sleeve is rotated such that markings 42 and 43 vertically
align, button 50 pops up distally, and device 20 is unlocked and ready to use as shown in
Fig. 2. Lock sleeve 45 is designed to be large and formed of a grippable material, such as
a rubber coated plastic sleeve, to be twistable by users with limited dexterity. A coloring
of the radial periphery along the height of button 50 makes noticing that the button is
popped out easier for the user. The safety lock system is located at the distal end of
device 20 to facilitate easy activation while the device is being held on the body with the
other hand. The activation button is designed to facilitate use by patients with sensitive
hands and limited dexterity. The shape and size of the button allow gross activation
motion by the palm of a hand rather than the tips of fingers.
In alternate embodiments, the activation button can be a piece that is directly
rotated to unlock, and plungable proximally to activate. One such variation may involve
an activation button that has an outer periphery coextensive with the housing that it faces,
which button, when rotated to unlock, shifts distally, and from that distal position can be
plunged proximally to effect activation.

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Various manners of providing a pop up button may be employed within the scope
of the invention. The button may be designed to pop up at the moment when the lock
sleeve rotation to the unlocked arrangement is essentially completed, or when such lock
sleeve rotation is commenced, or at a time therebetween. In the case where the button is
to pop- up only at the end of the unlocking rotation of the lock sleeve, such design may be
accomplished by the button being configured to rotate with the lock sleeve during such
motion, and at the end of such lock sleeve rotation, the button being biased to further
rotate and cam upward along the lock sleeve to an operational position at which its
subsequent plunging produces proper operation of the internal workings of the device. If
the button is to pop out near the commencement of lock sleeve rotation, such button can
be configured, for example, as described further below with respect to the embodiment of
Fig. 3. In addition, in alternate embodiments, the button need not pop up or move when
unlocked.
When activation button 50 is plunged, a needled syringe, generally designated 65,
within housing is automatically driven proximally, causing the needle of that syringe to
pass through flange aperture 32 and insert into the injection site. Delivery of die contents
of the syringe then automatically proceed as a piston of the syringe is driven proximally
within the syringe to force the contents through the inserted needle.
After needle insert and injection is complete, device 20 is configured to
automatically withdraw the needle inside the device housing 22, indicating to the user the
completion of the injection as well as shielding the needle from the user.
The components of delivery device 20 which are internal to housing 22 may be
provided in a variety of manners to achieve the functionality described above. A wide
assortment of automatic injecting mechanisms to first automatically insert a needle and to

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then automatically inject medicine through that needle are known and may be selectively
employed. For example, a compressed spring or system of springs, possibly including a
damping system, such as an annular foam member, to reduce noise and vibration at the
end of insertion travel, may be employed. Similarly, a wide assortment of mechanisms to
retract a needled syringe within the housing,'or to extend a needle shield over the
extended needled syringe, after the pharmaceutical within that syringe has been injected
are also known and may be employed.
Referring now to Fig. 3, there is shown diagrammatically the internal workings of
one delivery device within the scope of the present invention. The delivery device 70
includes a needled syringe 75 of a standard type mounted to a carriage 77. Syringe 75 is
axially slidable within a guide collar 80 within the housing body 82. Carriage 77 is
spring-biased upwardly by a helical spring 84. A pair of retraction ramps 86 are formed
on the interior of the housing body 82 distally of guide collar 80. A plunger 89 that is
rotatably fixed with respect to the housing extends longitudinally within the device and
has a proximal end 90 that abuts the piston 76 of the syringe 75. The distal end of plunger
89 includes a pair of resilient fingers 95 with latch ends 97 that fit through and secure to
an apertured flange 100 of a safety Jock sleeve 102 that is rotatably mounted to the
housing body 82. An insertion and delivery spring 105 has one end that abuts the
housing, such as an inturned lip of sleeve 102, and an opposite end that abuts collar 110.
Collar 110 includes a not shown portion that rides within a not shown track in the housing
body. Collar 110 has a proximal face that, at a first angular orientation of the collar
relative to the housing body, abuts radially projecting ears 91 of the plunger 89.
An activation button 112 is mounted within a hollow of the distal portion of sleeve
102 . Button 112 includes a depending flange 114 having a portion not shown in Fig. 3

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which engages the latches 97 when button 112 is rotated into a plungable position
described below. Such not shown portion of flange 114 may be in the same radial
position and depend farther proximally than the flange portion shown, or may be of the
same height but radially closer to the axis of the device than the flange portion shown.
The shown portion of flange 114 does not itself engage the latches, but rather helps to
locate spring 116 arid provide rigidity to the button.
To inject, and after cap 120 has been manually removed, when safety lock sleeve
102 is rotated relative to the housing body by a user, activation button co-rotates therewith
and is released from a restraining engagement with a not shown finger of the housing,
which release allows spring 116 to force activation button 112 distally. When sleeve 102
has been fully rotated, the farther depending or radially inward not shown portion of
flange 114 is oriented such that when button 112 is subsequently manually plunged, latch
ends 94 are abutted and squeezed inward to allow passage through flange 102. Spring
105 then drives collar 110, and therefore plunger 89, proximally, which first causes
syringe needle 73 to project proximally from the housing and insert into a user, and then
forces medication from the cartridge through the inserted needle. After plunger 89 has
been shifted sufficiently proximally to cause an appropriate injection, collar 110 reaches
the axial position at which camming ramps 86 are located, which ramps rotate collar 110
into an angular orientation that allows ears 91 to pass through collar. At this time, spring
84, which is weaker than spring 105, is free to force carriage 77 and the needle syringe 75
and plunger 89 distally through the collar 110 until the needle tip is withdrawn into
housing body 82.
In another embodiment shown in various stages of its operation in Figs. 4-6, a
device 130 of the present invention is shown which, when triggered by a single plunging

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of an activation button, utilizes one spring to cause a needle insertion and a second spring
to cause an injection through that needle. Device 130 is not shown with the trigger button
that springs up when unlocked, or a flared proximal end, or as having a needle retraction
after injection is complete, but one or more of such may be provided within the scope of
the invention if desired.
In this embodiment, carriage 132 is releaseably retained by flexible latches 134
that extend through an opening in a housing cap 136 that is fixedly secured to housing
body 138. Carriage 132 includes a shoulder 140 that radially projects outward. Insertion
spring 142 is compressed between the housing at 144 and shoulder 140. Within a hollow
interior of carriage 132, an injection spring 146 is disposed between an upper end of the
carriage and a disk portion 148 of a plunger 150. A pair of plunger arms 152 with
cammable latches 154 at their ends extend distally and radially from disk portion 148.
Latches 154 extend through openings in the side wall of carriage 132. By the engagement
of latches 154 with the carriage wall, plunger 150 is prevented from shifting proximally
relative to the carriage. Plunger 150 includes a rod 156 that depends from disk portion
148 and axially extends and inserts within a needled syringe 160 to abut syringe piston
162. The barrel and needle of syringe 160 is mounted in the proximal end of carriage 132
to be movable therewith. When the delivery devicel30 is in a ready condition, it is
arranged as shown in Fig. 4.
When a user wishes to utilize delivery device 130, a pressing of the trigger button
166 that is retained in housing cap 136 causes button flange 170 to cam inwardly the
latches 134. Spring 168 biases button 166 distally to keep flange 170 clear of latches 134
until a button plunging occurs. This inward movement of the latches releases carriage
132 to allow insertion spring 142 to drive the carriage proximally. During this driving

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motion, the needled syringe 160 moves as a unit with the carriage, but the medicine is not
ejected from the syringe as plunger 150 remains axially fixed relative to the carriage due
to its latching engagement therewith. Spring 142 continues to drive proximal motion
until the housing with a damping member 175, such as a ring-shaped foam or elastic
element disposed on housing shoulder 177, halts the carriage motion with the needle of
syringe 160 extending through the opening of the housing at its proximal end.
Immediately before the carriage is so halted, however, plunger latches 154 reach a
point at which displacement triggers 180 mounted to or formed within the housing body
are abutted by the latches. This abutment forces latches 154 radially inward so as to be
forced inward into the interior of the carriage when the injection spring 146 begins to
drive plunger 150 proximally. At this point, device 130 is arranged as shown in Fig. 5.
Spring 146 continues to drive plunger 150 proximally and thereby drive the
syringe piston 162 proximally to force medication from the syringe. When spring 146 has
completed its extension such that the stroke of the plunger is completed, delivery device
130 is arranged as shown in Fig. 6.
While this invention has been shown and described as having preferred designs,
the present invention may be modified within the spirit and scope of this disclosure. This
application is therefore intended to cover any. variations, uses or adaptations of the
invention using its general principles. Further, this application is intended to cover such
departures from the present disclosure as come within known or customary practice in the
art to which this invention pertains.

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CLAIMS
WE CLAIM:
1. A method of administering a pharmaceutical, comprising the steps of;
providing a delivery device including;
a housing having a first end and a second end spaced in an axial direction;
a pharmaceutical containing needled syringe mounted within the housing
to be movable in the axial direction from a first position to a second position, wherein an
injection tip of the syringe needle is recessed within the housing when in the first position
and projects from the housing beyond the first end when in the second position, the
syringe having a piston advanceable toward the first end to force pharmaceutical
contained in the syringe through the needle injection tip;
wherein a region of the axial length of the housing proximate the first end
is flared radially outward toward the first end, and is at least one of transparent and
apertured to allow visibility of the needled syringe;
wherein a skin-contacting surface of the housing first end includes a first
region and a second region, the first region comprising a material having a greater
coefficient of friction than a material of the second region to limit slippage along skin;
and
at least one injection targeting guide at the housing first end;
holding a portion of the housing with one hand and placing the delivery device
with the skin-contacting surface of the housing against the skin such that the least one
targeting guide aligns with an intended injection site;

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operating an unlocking system by rotating a part of the delivery device relative to
the held portion of the housing, whereby an activation button disposed at the second end
shifts axially away from the housing; and
without pressing the delivery device housing toward the injection site with any
predetermined force by the one hand holding the housing portion, with another hand
plunging the activation button toward the housing in the axial direction to trigger an
advancing assembly within the device diat first automatically advances the needled
syringe from the first position to the second position, and that second automatically
advances the syringe piston toward the second end.
2. The method of claim 1 wherein the step of operating the unlocking system
is performed while the delivery device is positioned with the skin contacting surface of
the housing against the skin.
3. The method of claim 1 wherein the at least one targeting guide comprises
the first region of the skin-contacting surface of the housing.
4. The method of claim 1 wherein the step of holding the housing portion
with one hand involves, after placing the delivery device with the skin-contacting surface
of the housing against the skin such that the least one targeting guide aligns with an
intended injection site, adjusting the holding hand to cover at least substantially all of the
region of an axial length of the housing which is transparent to otherwise allow visibility
of the needled syringe.
-19-
5. A method of administering a pharmaceutical such as herein described with
reference to the given examples.
Dated this 14th day of December 2007

A method and apparatus for administering a pharmaceutical. The method employs a delivery
device including a housing, a pharmaceutical containing needled syringe movable within the
housing, an activation button disposed at one of the housing, and wherein the housing is
flared radially outward at the other end and designed to allow visibility of the needled
syringe. A skin contacting surface of the housing at the flared end is designed to limit
slippage along the skin, and at least one injection targeting guide is provided. When the device is sited for injection, and without pressing the delivery device housing toward the
injection site with any predetermined force by the one hand holding the housing, the
activation button may be plunged with the other hand toward the housing to trigger an
advancing assembly within the device that first automatically advances the needled syringe to
insert a needle into the injection site and that second automatically advances the syringe piston to force pharmaceutical through the inserted needle.