U.S. patent application number 16/859774 was filed with the patent office on 2020-08-13 for pen needle with outer cover.
This patent application is currently assigned to Becton, Dickinson and Company. The applicant listed for this patent is Becton, Dickinson and Company. Invention is credited to Michael DiBiasi, Ganesh Kamble, Keith Knapp, Kunjal Oza, Sudarsan Srinivasan, Sean Sullivan, Sajayesh Vijayachandran.
Application Number | 20200254191 16/859774 |
Document ID | 20200254191 / US20200254191 |
Family ID | 1000004784777 |
Filed Date | 2020-08-13 |
Patent Application | download [pdf] |
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United States Patent
Application |
20200254191 |
Kind Code |
A1 |
Sullivan; Sean ; et
al. |
August 13, 2020 |
Pen Needle with Outer Cover
Abstract
A pen needle is enclosed by an outer cover to facilitate
installation of a needle bearing hub on a medication pen. The outer
cover design reduces or eliminates the likelihood of user contact
with the patient end needle or the non-patient end needle during
installation and disposal, and provides an audible indication when
the hub is fully installed on a medication pen.
Inventors: |
Sullivan; Sean; (Ridgewood,
NJ) ; Srinivasan; Sudarsan; (Glen Allen, VA) ;
DiBiasi; Michael; (Spring Hill, FL) ; Knapp;
Keith; (Warwick, NY) ; Oza; Kunjal; (Danville,
CA) ; Vijayachandran; Sajayesh; (Kannur, IN) ;
Kamble; Ganesh; (Pune, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
|
|
Assignee: |
Becton, Dickinson and
Company
Franklin Lakes
NJ
|
Family ID: |
1000004784777 |
Appl. No.: |
16/859774 |
Filed: |
April 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15100279 |
May 27, 2016 |
10661025 |
|
|
PCT/US14/68567 |
Dec 4, 2014 |
|
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16859774 |
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61912538 |
Dec 5, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/3293 20130101;
A61M 2005/3254 20130101; G06F 9/4416 20130101; A61M 5/002 20130101;
A61M 5/3205 20130101; A61M 5/3202 20130101; A61M 5/3213 20130101;
A61M 5/5086 20130101; H04L 63/0876 20130101; A61M 5/50
20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32; H04L 29/06 20060101 H04L029/06; G06F 9/4401 20060101
G06F009/4401; A61M 5/50 20060101 A61M005/50; A61M 5/00 20060101
A61M005/00 |
Claims
1. A pen needle, comprising: an outer cover having a closed distal
end with gently concave sides and an open proximal end receiving a
needle-bearing hub; longitudinal cut-outs extending to proximal
edge of the outer cover defining a plurality of projections
extending proximally at the proximal open end and curved radially
outwardly from the hub.
2. The pen needle according to claim 1, wherein the plurality of
projections flex outwardly to release the needle bearing hub during
installation of the hub on a medication pen and flex inwardly to
contain the needle bearing hub for storage.
3. The pen needle according to claim 2, further comprising a
cut-out defining a flexible strip in a sidewall of the outer cover
inboard of the open proximal end; and a projection formed on a
radially inward surface of the strip, the projection positioned on
one end of the strip engaging contours on a radially outward
surface of the hub so that when the outer cover is rotated with
respect to the hub the projection makes an audible sound or creates
a tactile sensation by contacting the hub outer surface.
4. The pen needle according to claim 3, wherein the flexible strip
is oriented circumferentially on the hub sidewall.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 15/100,279, filed on May 27, 2016, which is the U.S.
national stage under 35 U.S.C. 371 of International Patent
Application No. PCT/US2014/068567, filed on Dec. 4, 2014, which
claims the benefit of U.S. Provisional Patent Application No.
61/912,538, filed on Dec. 5, 2013, all of said prior applications
being expressly incorporated herein by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The invention is the field of medication delivery devices,
and in particular, the invention is directed to medication pens,
and specifically, a pen needle having an outer cover that
facilitates installation of the pen needle on a medication pen body
and subsequent removal of the pen needle after use with
simultaneous protection of the non-patient end cannula.
Description of the Related Art
[0003] Pen needles are widely used in medication delivery systems
for self-administered injectable drugs. In one popular arrangement,
the pen needle is provided in an outer cap which is sealed with a
layered paper and foil "teardrop label." The user removes the heat
sealed tear-drop label from the outer cap to expose the proximal or
"non-patient" end needle located in a cavity on the proximal end of
the needle-bearing hub. The exposed needle-bearing hub is then
threaded onto a medication pen such that the non-patient end of the
needle pierces the closure of the drug storage compartment of the
medication pen. The cap is removed, and a smaller needle shield,
which slides over a post on the hub supporting the patient-end
needle, is also removed prior to performing an injection. The cap
may also be used to remove the needle-hub assembly. Although this
system has garnered public acceptance, it is nevertheless desirable
to enhance ease of use.
SUMMARY OF THE INVENTION
[0004] To avoid difficulty aligning the non-patient end needle with
the medication pen to thread the pen needle on the pen, one object
of the invention is to provide a pen needle that self-aligns on the
medication pen during installation. Another object of the invention
is to provide a cover over the non-patient end needle that may be
re-closed after use or after opening but prior to installation on
the pen.
[0005] According to one embodiment of the invention, the foregoing
objectives are achieved using a pen needle comprising: an outer
cover having a closed distal end with gently concave sides
affording a finger hold and an open proximal end receiving a
needle-bearing hub. The needle bearing hub according to this
embodiment has an open proximal end defined by a proximal edge
aligned with the open proximal end of the outer cover in the
initial state. A flap hinged to the proximal edge of the hub (or to
the open end of the outer cover) has an open position permitting
installation of the hub on the medication pen and a closed position
enclosing the non-patient end of the needle within the hub (or
within the outer cover).
[0006] The outer cover in this embodiment may be provided with a
cut-out defining a flexible strip in a sidewall of the outer cover
inboard of the open proximal end. A radially inward facing
projection on the strip engages contours on a radially outward
surface of the hub, so that when the outer cover is rotated with
respect to the hub the projection generates an audible sound or
tactile sensation as the projection on the strip snaps against the
contours on the hub. In some embodiments, the strip is oriented
circumferentially and acts as a pawl mechanism, resisting rotation
in the counterclockwise direction.
[0007] In another embodiment according to the invention, a pen
needle is provided with an outer cover having a closed distal end
with tapered sides affording a finger hold and an open proximal end
receiving a needle-bearing hub. The hub has longitudinal cut-outs
extending to the proximal edge of the outer cover defining a
plurality of projections extending proximally from the proximal
open end and curved radially outwardly from the hub. In the initial
state, with the needle-bearing hub contained in the outer cover,
the projections extend beyond the proximal end of the hub and flex
slightly inward to protect the user from needle stick from the
non-patient end needle. Thus, in this embodiment, projections flex
outwardly to release the needle bearing hub during installation and
flex inwardly to contain the needle bearing hub for storage.
[0008] As in the previous embodiment, a flexible strip may be
formed in a sidewall of the outer cover, provided inboard of the
open proximal end, with an inward-facing projection on the strip
engaging contours on a radially outward surface of the hub, so that
when the outer cover is rotated with respect to the hub, the
projection provides sensory feedback as it contacts the contours on
the hub surface. The strip is oriented circumferentially, so that
it acts as a pawl mechanism, resisting rotation in the
counterclockwise direction.
[0009] In another aspect, the invention is directed to a pen needle
outer cover with an extended proximal end side wall, such that the
outer cover side wall on the proximal end extends beyond the end of
the non-patient end needle. Therefore, the needle is recessed in a
cavity on the proximal end of the pen needle and the hub cannot be
mated with the medication pen until the needle is axially aligned
with the medication pen. This arrangement ensures that the hub is
self-aligned with the medication pen, and that the non-patient end
needle is always in the proper axial orientation with respect to
the medication pen before the hub is mated onto the medication
pen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 depicts an outer cover and hub assembly according to
an embodiment of the invention.
[0011] FIG. 2 depicts the outer cover and hub assembly of FIG. 1 in
an exploded view.
[0012] FIG. 3 depicts a perspective view of an outer cover
according to an embodiment of the invention.
[0013] FIG. 4 is a cutaway view of the interior of the outer cover
of FIG. 3.
[0014] FIG. 5 is a perspective view of a hub assembly according to
an embodiment of the invention.
[0015] FIG. 6 is a perspective view of an outer cover according to
another embodiment of the invention.
[0016] FIG. 7 is an exploded view of the assembly of FIG. 6.
[0017] FIG. 8 is a view of the needle-bearing hub according to one
embodiment of the invention, showing the distal patient-facing side
with a slot for receiving an inner needle shield.
[0018] FIG. 9 is a view of the outer cover and hub assembly of FIG.
1 in the open position.
[0019] FIG. 10 is a pen needle outer cover having an extended side
wall.
[0020] FIG. 11 is hub adapted to be received in the pen needle
outer cover of FIG. 10.
[0021] FIG. 12 shows the engagement of a medication pen with a hub
according to FIG. 11 received in pen needle outer cover according
to FIG. 10.
[0022] FIG. 13 shows the assembly of FIG. 12 with the hub seated on
the medication pen.
[0023] The figures are schematic for the purpose of illustrating
the invention and not drawn to scale. Features may be enlarged,
made smaller, simplified, or eliminated to show how the parts
operate according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0024] As used herein, the "distal" direction is in the direction
of the injection site, and the "proximal direction" is the opposite
direction. The "axial" direction is along the longitudinal axis of
the injection device and a "diameter" is generally a diameter with
respect to a longitudinal axis. The cannula is generally arranged
axially in the device. "Radially" is a direction perpendicular to
the axial direction. Thus, "radially inward" generally means closer
to the needle. An element extending in the "circumferential
direction" means that the element extends around the circumference;
for example threads on a medication pen are arranged
circumferentially on the distal end of the pen. "Medication pen" is
used broadly herein to refer to any prefilled medication delivery
device. However, in the most preferred embodiments a medication pen
is characterized by having a pen-shaped body and a proximally
located thumb button adapted for automatic dosing. A "cut-out"
refers to a feature on a surface defined by through-openings in the
surface (inner and outer sides of the surface); a cut-out is said
to be "inboard" if the opening(s) do not extend to the edge of the
surface.
[0025] The pen needles according to the invention are provided with
a cover that has tapered sides to facilitate gripping and means to
engage the hub in the outer cover so that the two elements rotate
together as the hub is installed on a pen needle. The tapered sides
are gently concave to conform approximately to a user's fingers to
provide a finger hold. In multiple embodiments, the outer cover is
provided with a flexing strip which contacts contours on the
radially outer surface of the hub to provide an audible indication
when the outer cover rotates with respect to the hub after the
needle-bearing hub is installed on a medication pen. The strip may
have a pawl mechanism so that the outer cover resists rotation with
respect to the hub in the counter-clockwise direction when the hub
is being removed.
[0026] In the embodiment of FIG. 1, outer cover 12 has closed
distal end 14 formed by concave tapered sides 16 terminating at
corners 13. A side of the closed distal end opposite the corners is
rounded. The tapered sides 16 prompt and facilitate gripping with
the thumb and index finger, and may be provided with ribs 18 for
this purpose. Sides 16 are described as "gently concave" which is
intended to convey that they are shaped to hold with the fingers.
Hub 10 is received in the proximal end of the outer cover 12. The
exploded view of FIG. 2 shows the orientation of the hub 10 as it
fits in the outer cover 12, such that the patient end needle 22
projects from the patient-facing surface of hub 10 into the inside
of outer cover 12. The open end of needle-bearing hub 10 is adapted
to be attached to a medication pen. Typically, the hub is adapted
with threads, mating with corresponding threads on the medication
pen. However, the hub may be adapted with one or more groove(s)
and/or protuberance(s) mating with a corresponding groove(s) and/or
protuberance(s) on the medication pen allowing the hub to be
installed, with or without rotation, and snapped in place. A
friction fit between the hub and medication pen may also be
employed. The attachment means are left to the skill of the artisan
to select. Proximal edge 29 defining the open end of hub 10 is
aligned with the open end of the hub cover 12 in the assembled
state. Non-patient end needle 26 is adapted to pierce the septum of
a medication cartridge within a medication pen body when the hub is
installed, and preferably needle 26 does not project beyond the
plane formed by proximal edge 29 of the opening of hub 10.
Typically, the patient end needle and the non-patient end needle
are opposite ends of a single stainless steel cannula which is
beveled to a point on each end and is affixed in an axial bore in
the hub by adhesive or other means. Reference to a "patient end
needle" and a "non-patient end needle" refers to the needle
points--typically (but not necessarily) they are opposite ends of
the same cannula.
[0027] In the embodiment depicted, guard flap 28 is attached to
proximal edge 29 of hub 10 by hinge 27 which is capable of
maintaining at least two positions: a first open position for
installing the hub and a second closed position for transporting
the hub or discarding after use. In the closed position, shown in
FIG. 1, flap 28 shields the non-patient end needle 26 from
accidental needle stick. In the open state shown in FIG. 2,
non-patient end needle 26 is exposed, the flap 28 is parallel with
the axis of the needle, and the hub can be threaded onto a
medication delivery device. Plastic camming and locking elements
(not shown) may be provided on the hinge, bearing against the hub
or outer cover to retain the flap in the first or second position
and providing resistance when the flap is moved from the first to
the second position or from the second position to the first.
Various hinge constructions are known in the art which can be
adapted for use with injection molded parts, such as a one-piece
living hinge, which may be molded with hub 10, including flap 28 in
the same process. Hinges, including camming elements and locking
fixtures, are disclosed, for example, in U.S. Pat. No. 8,887,912,
which is incorporated by reference for this purpose. The hinge
design may be left to the person of ordinary skill in the art. In
embodiments, flap 28 may be hinged to outer cover 12 instead of the
hub.
[0028] In embodiments, flap 28 may be provided with two closed
positions: a first closed position where the flap is held
releasably (against the resistance of a camming surface, for
example), which allows the hub to be transported and later opened,
so that the needle-bearing hub can be installed on a medication
pen; and a second position in which the flap is permanently locked
in the closed position for disposal. As shown in FIG. 1, a portion
30 of the flap 28 may project outwardly beyond an outer periphery
of the outer cover 12 in the first and/or second closed
position.
[0029] In the embodiment shown in FIG. 9, outer surface of hub 10
is preferably provided with a series of longitudinally arranged
grooves 24 which cooperate with a strip 33 formed on outer cover 12
to provide an audible indication when the hub is fully installed on
the medication pen. In the embodiment shown in FIG. 3, strip 32 is
formed between cuts 34 formed at the open proximal end of the outer
cover 12 such that the strip 32 can be flexed with respect to the
outer cover 12. As shown in the interior cutaway view of FIG. 4,
the inside of the outer cover 12 includes a projection 38 formed on
a radially inward surface of the strip 32. A similar projection
(not shown) may be provided on a radially inward surface of strip
33 in the embodiment of FIG. 9. In the case where the hub is
attached to the medication pen by rotating the hub onto a threaded
connection, the hub and outer cover initially rotate in unison.
This may be ensured by providing an interference fit between hub 10
and outer cover 12. Optionally, longitudinal ribs 36 on an interior
surface of outer cover 12 engage hub 10 to provide the interference
fit. However, once hub 10 is fully threaded onto the medication
pen, turning the outer cover further causes the outer cover 12 to
rotate with respect to the hub. Flexible strip 32 flexes as the
projection 38 is dragged across the grooves 24 making an audible
ratchet sound and/or providing a tactile sensation which indicates
that the hub is fully installed on the medication pen.
[0030] In FIG. 9, strip 33 is oriented circumferentially on the
outer cover inboard of the open proximal end, so that strip 33 acts
as a pawl mechanism. In this configuration an inward facing
projection on strip 33 (not shown in FIG. 9) is dragged across
contours 24 on the hub when the outer cover is rotated in a
clockwise direction after the hub is fully seated on a medication
pen, but reversing the direction causes outer cover 12 and hub 10
to rotate together when hub 10 is uninstalled from the medication
pen for disposal.
[0031] Distal face 52 of needle-bearing hub 10 according to
different embodiments of the invention is shown in FIG. 5 and FIG.
8. As seen in FIG. 5 and FIG. 8, distal face 52 of hub 10 is
predominately flat, from the needle to the periphery of the hub,
except for an annular channel 54 around the needle. A needle
bearing post is recessed in the hub and the annular channel 54 is
formed radially around patient end needle 22. This annular channel
54 receives an inner needle shield 72 which is provided with flange
137 (inner shield 72 including flange 137 may be substantially
identical to the embodiment shown in FIG. 7) to situate the inner
shield 72 in the annular channel 54. A hub with a flat pressure pad
area is disclosed in U.S. Patent Application Publication No.
2009/0069755, which is incorporated by reference in its entirety
for this purpose.
[0032] To install a needle bearing hub 10 onto a medication pen
using the outer cover of FIG. 1, flap 28 is opened from the closed
position shown in FIG. 1, until it aligns with the longitudinal
axis of the pen needle, in the position shown in FIG. 9. In this
state, the user holds the hub by outer cover 12 and installs
internally threaded hub 10 on a medication pen by rotating the
assembly clockwise onto the threaded end of the pen. At a certain
point, when hub 10 is fully seated, outer cover 12 rotates with
respect to hub 10 after the hub has been fully installed, and the
projection on strip 33 makes a ratchet sound as it drags across the
grooves 24 on the hub. The outer cover is removed by pulling
distally, leaving the hub secured on the medication pen. In this
state, the medication pen is readied for administering an
injection. The outer cover is replaced and turned counterclockwise
to remove the hub from the pen. Flap 28 may thereafter be closed to
prevent accidental needle stick during disposal.
[0033] FIG. 6 depicts another embodiment of the invention wherein
the open proximal end of outer cover 60 assists in grasping the pen
needle. Outer cover 60 has tapered sides adapted to be gripped by
thumb and forefinger, meeting at a curved closed distal end 61. The
tapered sides are gently concave to provide a finger hold, as in
the previous embodiment. The tapered sides on the outer cover may
be provided with ribs 82 to enhance the user's finger hold, meeting
at a curved distal end, as shown in FIG. 6. The open proximal end
is configured with longitudinal cut-outs 62 extending to the
proximal edge of the outer cover defining a plurality of
projections 64 extending proximally and curved radially outwardly
from the hub. The projections 64 extend beyond the hub in the
proximal direction when the hub is received fully within the outer
cover, which protects the user from accidental needle stick from
the non-patient end needle. Projections 64 are formed to flex
outwardly when cover 60 is pulled off the hub, for example.
[0034] The exploded view of FIG. 7 shows hub 10 aligned with inner
needle shield 72 in the orientation that these elements are
inserted in outer cover 60. As in the previous embodiment and as
shown in FIG. 7, the outer radial surface of hub 10 may be provided
with contours. As shown in FIG. 6, cut-out 84 forms a flap 104
inboard of the open proximal end. The flap is provided with a
projection facing radially inward toward the hub (not shown in the
FIG.). The circumferential orientation of inboard flap 104 acts as
a pawl, resisting rotation of the outer cover with respect to the
hub in the counterclockwise direction.
[0035] Distal patient-facing side 52 of hub 10 according to one
embodiment of the invention is shown in FIG. 8. The effective
penetration depth of the needle is not critical and may be 4 mm to
8 mm, or other standard length known in the art, or a non-standard
length. In the embodiment shown, the hub post 57 bearing the needle
is embedded in the hub. Annular slot 54 is provided around the hub
post to accommodate inner needle shield 72. Inner needle shield is
provided with a flange 137 to fit securely in the annular slot.
[0036] The installation sequence for the needle-bearing hub with
the outer cover of FIG. 6 is similar to the sequence for the outer
cover of FIG. 1. Before use, hub 10 is within outer cover 60 and
projections 64 on outer cover 60 extend beyond the distal end of
the hub and bend slightly inwardly to protect the user from the
non-patient end of the needle on the hub. Pressing outer cover 60
onto the threaded end of a medication pen causes projections 64 to
flare outward, which allows medication pen to access hub 10 and for
hub 10 to be threaded onto a pen with a clockwise turn of outer
cover 60. Turning outer cover 60 beyond the point at which the hub
is fully installed on the pen, causes outer cover 60 to rotate with
respect to hub 10, creating an audible and/or tactile indication as
the flexible strip 104 on the sidewall of the outer cover drags
across the contoured surface of hub 10. At this point, outer cover
60 can be removed by pulling it in the distal direction. The user
removes inner shield 72 covering the needle and the pen is
injection-ready. To remove and store hub 10 for disposal, cover 60
is placed proximally over the hub, rotated counter-clockwise, and
pulled distally with hub 10 substantially enclosed within
projections 64 of the outer cover.
[0037] A further aspect of the invention is depicted in FIG. 10
through FIG. 13. In FIG. 10, outer cover 100 is provided with an
extended proximal side wall 101 extending beyond the tip of
non-patient end needle 126 when hub 110 is received in outer cover
100. FIG. 11 depicts hub 110, which, in this embodiment, is
likewise provided with an extension 111 beyond proximal end of
non-patient end needle 126. Extended side wall 101 prevents
inadvertent contact of medication pen 120 with non-patient end
needle 126. As shown in FIG. 12 and FIG. 13, the extended flange
features 101, 111 are provided so that cover 100 and hub 110,
assembled together, self-align when installed on medication pen
120. Some clearance is provided between cover 100 and medication
pen 120 to permit hub 110 to be installed on medication pen 120, by
threading or the like. Therefore, the diameter of the proximal end
side wall of the outer cover is larger than the diameter of the
proximal end of the hub.
[0038] In order to prevent non-patient end needle 126 from entering
medication pen 120 at an angle, bending, and possibly failing to
reach medication in a medication compartment therein, extended side
wall 101 orients the medication pen as it is inserted in the
opening. Any extension of the outer cover in the proximal direction
beyond the proximal end of the hub will assist in guiding outer
cover 100, and therefore hub 110, onto a medication pen. For
example, an extended side wall of 0.01 inch to 1.00 inch is
operable. Preferably the side wall extends about 0.20 inch to about
1.00 inch beyond the needle, and more preferably the extended
flange has a length of about 0.25 inch to about 0.50 inch beyond
the proximal end of the non-patient end needle. These dimensions
apply to the proximal end flange portions of cover 101 and proximal
end flange portion of hub 111. Sloped sides 121 on an internal
surface of cover 100 between proximal end sidewall 101 and a distal
portion of cover 100 guide medication pen 120 into place
irrespective of the angle at which the user initially places the
assembly on medication pen 120. Where hub 110 is provided with
extended proximal end sidewall 111, engagement of hub extended
sidewall 111 and outer cover extended sidewall 101 prevents hub 110
from moving during installation on a medication pen. Alternatively,
or in addition, for this purpose, a friction fit may be provided
between hub 110 and cover 100, for example using sloped inward
projecting ribs on cover 100 which fit against hub 110.
Alternatively a locking feature such as a protuberance or groove on
hub 110 may cooperate with a cooperating feature on outer cover 100
to retain hub 110 in place during installation. A locking feature,
if used, may be overcome by pulling the outer cover distally from
the hub after installation.
[0039] Cover 100 may be made transparent so a user can view the
status of the medication in pen 120. The installed state is
depicted in FIG. 13.
[0040] The plastic parts described herein, including the hub and
outer cover in all the embodiments, are made of polymers suitable
for injection molding, including without limitation, polypropylene
and others known in the art. Likewise, techniques for injection
molding, draw molding and the like, are well known to those having
skill in the art of manufacturing medication pens. However, the
invention is not limited to any particular production method. The
needle is typically a standard gauge surgical stainless steel part.
Pen needles according to the invention are designed to be
user-friendly, adapted for self-administered medications, such as
insulin, but the invention is not limited to any particular
medication. Likewise, although the 4 mm-8 mm injection depth needle
described above is suited for subcutaneous injection, the invention
may also be adapted for use with intradermal injection.
[0041] The foregoing description of the preferred embodiments is
not to be deemed to limit the invention, which is defined by the
following claims. The different embodiments are related, such that
features recited in the dependent claims are capable of combination
with each other, with other independent claims, and with other
embodiments.
* * * * *