U.S. patent application number 13/058649 was filed with the patent office on 2011-06-30 for safety pen needle assembly.
This patent application is currently assigned to BECTON, DICKINSON AND COMPANY. Invention is credited to Robert Bank, Michael Vincent Quinn, Tieming Ruan, Gary Searle, Eliot Zaiken.
Application Number | 20110160675 13/058649 |
Document ID | / |
Family ID | 41669357 |
Filed Date | 2011-06-30 |
United States Patent
Application |
20110160675 |
Kind Code |
A1 |
Ruan; Tieming ; et
al. |
June 30, 2011 |
SAFETY PEN NEEDLE ASSEMBLY
Abstract
In one aspect, a safety pen needle assembly is provided herein
which includes a hub with a needle fixed to the hub, the needle
having a distal end, formed for insertion into a patient, and a
proximal end. The assembly further includes a shield and a biasing
member disposed between the hub and the shield configured to urge
the shield distally. A protrusion extends from at least one of the
hub and the shield with a channel being formed in at least the
other of the hub and the shield. The channel is formed to
accommodate the protrusion. The shield is movable from a first
position to a second position. In the first position, the shield is
spaced from the distal end of the needle such that the distal end
of the needle is exposed. In the second position, the shield covers
the distal end of the needle. The channel guides the protrusion as
the shield moves from the first position to the second position.
With this arrangement, a shield may be directed to move in a
desired path with stability. In addition, the distal end of the
needle may be initially exposed to permit visual confirmation of
priming, while allowing the shield to cover a majority of the
needle to minimize any needle-related anxiety.
Inventors: |
Ruan; Tieming; (Randolph,
NJ) ; Bank; Robert; (Long Valley, NJ) ;
Zaiken; Eliot; (Covington, GA) ; Quinn; Michael
Vincent; (East Hanover, NJ) ; Searle; Gary;
(Norfolk, MA) |
Assignee: |
BECTON, DICKINSON AND
COMPANY
Franklin Lakes
NJ
|
Family ID: |
41669357 |
Appl. No.: |
13/058649 |
Filed: |
August 17, 2009 |
PCT Filed: |
August 17, 2009 |
PCT NO: |
PCT/US09/54001 |
371 Date: |
March 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61089335 |
Aug 15, 2008 |
|
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|
Current U.S.
Class: |
604/198 |
Current CPC
Class: |
A61M 2005/3254 20130101;
A61M 5/326 20130101; A61M 5/3272 20130101; A61M 2005/3247 20130101;
A61M 2005/3267 20130101 |
Class at
Publication: |
604/198 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A safety pen needle assembly comprising: a hub; a needle fixed
to said hub, said needle having a distal end, formed for insertion
into a patient, and a proximal end; a shield; and, a biasing means
disposed between said hub and said shield configured to urge said
shield distally, wherein, a protrusion extends from at least one of
said hub and said shield, a channel is formed in at least the other
of said hub and said shield, said channel formed to accommodate
said protrusion, wherein said shield is movable from a first
position to a second position, wherein, in said first position,
said shield is spaced from said distal end of said needle such that
said distal end of said needle is exposed, wherein, in said second
position, said shield covers said distal end of said needle, and
wherein said channel guides said protrusion as said shield moves
from said first position to said second position; whereby when said
shield is in said first position, a user may visually confirm
proper priming and needle placement during use.
2. The needle assembly of claim 1, wherein said channel is
generally U-shaped, V-shaped, J-shaped, or hook-shaped.
3. The needle assembly of claim 1, wherein said channel has a
proximal and a distal end, and wherein under force of said biasing
means, said protrusion is urged towards said distal end of said
channel.
4. The needle assembly of claim 1, further comprising a locking
means to lock said shield in said second position.
5. The needle assembly of claim 4, wherein said shield may be
locked in said second position through manual manipulation by said
patient.
6. The needle assembly of claim 4, wherein a locking tab extends
from at least one of said hub and said shield, a locking window is
formed in at least the other of said hub and said shield, wherein
said locking tab engages said locking window when said shield is in
said second position.
7. The needle assembly of claim 1, wherein said channel comprises a
first part and a second part, wherein said protrusion is located in
said first part of said channel prior to use and wherein said
protrusion is located in said second part of said channel after
use.
8. The needle assembly of claim 7, wherein a flexible finger
extends into said channel which extends across an axis extending
from said first part of said channel.
9. The needle assembly of claim 8, wherein during use, said
flexible finger deflects said protrusion into said second part of
said channel.
10. The needle assembly of claim 7, wherein the distalmost portion
of said second part of said channel is located distally of the
distalmost portion of said first part of said channel.
11. The needle assembly of claim 10, wherein a locking tab extends
from at least one of said hub and said shield, a locking window is
formed in at least the other of said hub and said shield, wherein
said locking tab engages said locking window when said shield is in
said second position, and wherein said locking window is located
more distally than the distalmost portion of said first part of
said channel.
12. The needle assembly of claim 7, wherein a locking tab extends
from at least one of said hub and said shield, a locking window is
formed in at least the other of said hub and said shield, wherein
said locking tab engages said locking window when said shield is in
said second position, and wherein said locking window is located
more distally than the distalmost portion of said first part of
said channel.
13. A safety pen needle assembly comprising: a hub; a needle fixed
to said hub, said needle having a distal end, formed for insertion
into a patient, and a proximal end; a shield; and, a biasing means
disposed between said hub and said shield configured to urge said
shield distally, wherein a protrusion extends from at least one of
said hub and said shield, a channel is formed in at least the other
of said hub and said shield, said channel formed to accommodate
said protrusion, wherein said shield is movable from a first
position to a second position, wherein, in said first position,
said shield covers said distal end of said needle, wherein, in said
second position, said distal end of said needle is exposed, and
wherein said channel guides said protrusion as said shield moves
from said first position to said second position; and, wherein said
shield is initially in a locked state with said protrusion being
spaced from said channel, said shield being manually movable out of
said locked state to urge said protrusion into said channel thereby
allowing said shield to move from said first position to said
second position.
14. The needle assembly of claim 13, wherein a locking aperture is
formed in at least one of said hub and said shield formed to
accommodate in snap engagement said protrusion in said locked
state, said locking aperture being spaced from said channel.
15. The needle assembly of claim 13, wherein said shield is
rotatable out of said locked state.
16. The needle assembly of claim 13, wherein said shield is axially
displaceable out of said locked state.
17. A safety pen needle assembly comprising: a hub; a needle fixed
to said hub, said needle having a distal end, formed for insertion
into a patient, and a proximal end; an axially-displaceable shield
for covering said distal end of said needle, said shield having an
angled engagement surface defined thereon; a secondary shield for
covering said proximal end of said needle, said secondary shield
having at least one detent with a ramped surface formed thereon in
axial alignment with said angled engagement surface; and, a biasing
means disposed to urge said secondary shield proximally, wherein,
said detent releasably retains said secondary shield in a first
state with said proximal end of said needle being exposed, and,
wherein, with sufficient proximal movement of said shield, said
engagement surface engages said ramped surface and causes
displacement of said detent thereby releasing said secondary shield
from said first state and allowing said biasing means to urge said
secondary shield proximally.
18. The needle assembly of claim 17, wherein said secondary shield
includes one or more elongated locking arms, said detent being
formed on said locking arm.
19. The needle assembly of claim 18, wherein one or more locking
tabs being configured on said locking arms so as to collectively
snap receive a portion of said hub.
20. A safety pen assembly comprising: a hub; a needle fixed to said
hub, said needle having a distal end, formed for insertion into a
patient, and a proximal end; and, a leafspring secured to said hub
by a frangible connection, said frangible connection being
rupturable, wherein, with rupture of said frangible connection, a
free end of said leafspring is urged to cover said proximal end of
said needle.
21. A medical injector comprising: a needle; and, a slidable body
disposed adjacent to said needle, said body having depth marks
defined thereon, wherein during an injection of said needle into a
patient, said slidable body is depressed by the patient's skin,
said depth marks indicating the extent of depression of said body
during the injection thereby providing an indication of depth of
injection by said needle.
Description
BACKGROUND OF THE INVENTION
[0001] Safety pen needle assemblies are known in the prior art for
providing shielding to a used pen needle to prevent inadvertent
"needle sticks" therewith. These assemblies may be "passive", which
operate through normal use of the associated pen injector, or
"active", which require an additional step or steps to operate
beyond normal operation of the associated pen injector.
[0002] Passive safety pen needle assemblies have been developed in
the prior art which utilize a trigger that is activated upon
sufficient application of force thereto during an injection
procedure. A trigger may be provided which presses against a
patient's skin with sufficient displacement of the trigger causing
the assembly to activate. The activation of the trigger results in
some form of a shield being released which may move distally to a
shielding position covering a used needle. With these designs,
concerns exist of preventing inadvertent trigger activation.
SUMMARY OF THE INVENTION
[0003] In one aspect, safety pen needle assembly is provided herein
which includes a hub with a needle fixed to the hub, the needle
having a distal end, formed for insertion into a patient, and a
proximal end. The assembly further includes a shield and a biasing
member disposed between the hub and the shield configured to urge
the shield distally. A protrusion extends from at least one of the
hub and the shield with a channel being formed in at least the
other of the hub and the shield. The channel is formed to
accommodate the protrusion. The shield is movable from a first
position to a second position. In the first position, the shield is
spaced from the distal end of the needle such that the distal end
of the needle is exposed. In the second position, the shield covers
the distal end of the needle. The channel guides the protrusion as
the shield moves from the first position to the second position.
With this arrangement, a shield may be directed to move in a
desired path with stability. In addition, the distal end of the
needle may be initially exposed to permit visual confirmation of
priming, while allowing the shield to cover a majority of the
needle to minimize any needle-related anxiety.
[0004] These and other features of the invention will be better
understood through a study of the following detailed description
and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIGS. 1-61 depict various safety pen needle assemblies, and
components thereof, formed in accordance with the subject
invention.
[0006] FIGS. 1-8 depict hubs or shields with channels that have
moveable protrusions;
[0007] FIGS. 9-14 depict hubs or shields with straight channels
that allow shields to be manually rotated to a locking
position;
[0008] FIGS. 15-16 depict hubs or shields with straight channels
that allow shields to be manually urged in a distal direction to be
locked;
[0009] FIGS. 17-23 depict hubs or shields that allow shields to be
automatically locked with a manual rotation;
[0010] FIGS. 24-25 depict a shield with locking tabs;
[0011] FIGS. 26-27 depict a shield or hub with a locking window and
a curved channel;
[0012] FIGS. 28-32 depict depicts hubs or shields with straight
channels that allow shields to be manually rotated to a locking
position;
[0013] FIGS. 33-35 depict a shield or hub with a locking window and
a curved channel;
[0014] FIG. 35A depicts an alternative arrangement for a curved
channel;
[0015] FIG. 36 depicts a safety pen assembly with a secondary
shield on the proximal end;
[0016] FIGS. 37-43 depict a safety pen assembly with a secondary
shield on the proximal end with one or more locking arms;
[0017] FIGS. 44-45 depict a secondary shield with one or more
locking arms;
[0018] FIGS. 46-48 depict a hub or shield with locking features for
the secondary shield with one or more locking arms;
[0019] FIG. 49 depicts an alternate secondary shield for the
proximal side with one or more locking arms;
[0020] FIG. 50 depicts a hub or shield with an alternative channel
design;
[0021] FIGS. 51-52 depicts a plurality of channels and
protrusions;
[0022] FIG. 53 depicts a shield with a plurality of integral
protrusions and locking windows;
[0023] FIG. 54 depicts a hub with a plurality of channels;
[0024] FIGS. 55-57 depict an alternative secondary shield for the
proximal end;
[0025] FIGS. 58-59 depict a separate embodiment for securely
covering the proximal end of the needle; and
[0026] FIGS. 60-61 depict embodiments for determining the depth of
the protrusion of a needle.
DETAILED DESCRIPTION OF THE INVENTION
[0027] With reference to FIGS. 1-57B, a safety pen needle assembly
10 is shown which generally includes a hub 12, a shield 14, and a
biasing element 16 located therebetween. A needle 18 having a
distal end 20, formed for insertion into a patient during a medical
injection, and a proximal end 22 is provided and fixed to the hub
12. The safety pen needle assembly 10 is configured to have the
shield 14 cover the distal end 20 of the needle 18 after use, i.e.,
after an injection.
[0028] The hub 12 includes a generally tubular body 24 having
spaced apart distal and proximal ends 26, 28. The tubular body 24,
preferably in proximity to the proximal end 28, may be provided
with a mounting arrangement (e.g., threads; luer) configured for
mounting onto the body of a medical injector, e.g., a pen injector.
A channel 30 is provided which may be formed in the hub 12 or the
shield 14. With reference to FIGS. 1-8, the channel 30 may be
formed in the tubular body 24 to generally extend in a longitudinal
direction from the distal end 26 to the proximal end 28 of the
tubular body 24. As shown in the figures, the channel 30 may be a
throughhole, which extends completely through the wall of the
tubular body 24, or may be "blind" and be of limited depth in the
tubular body 24 without extending therethrough. The channel 30 may
have various configurations. With reference to FIGS. 1-8, the
channel 30 may have a hook-, U- V-, J- or L-shape.
[0029] The shield 14 includes a distal end 32, having an aperture
34 (FIG. 5) formed therethrough, and a proximal end 36. The shield
14 may be of various configurations, as will be appreciated by
those skilled in the art.
[0030] A protrusion 38 may be provided on the hub 12 or the shield
14, formed to be accommodated in the channel 30. With reference to
the embodiment of FIGS. 1-8, the protrusion 38 projects from the
shield 14. The biasing element 16 is disposed to urge the shield 14
distally. Under force of the biasing element 16, the protrusion 38
is preferably urged to the distalmost portion of the channel 30.
The interengagement of the protrusion 38 and the tubular body 24,
at the end of the channel 30, limits distal movement of the shield
14 relative to the hub 12.
[0031] Prior to use, the shield 14 is configured to be in an
initial pre-use state. In this pre-use state, the shield 14 may be
configured to cover the distal end 20 of the needle 18 (FIG. 4) or
may be configured to leave the distal end 20 exposed (FIG. 28). The
initial state of coverage of the distal end 20 may be determined by
user preference. With the distal end 20 being initially covered,
the needle 18 is not visible, thereby minimizing anxiety,
particularly for a needlephobe. Alternatively, with the distal end
20 being exposed, a user may visually confirm proper priming and
needle placement during an injection. Even with the distal end 20
being exposed, a majority of the needle 18 may still be covered to
minimize anxiety.
[0032] During use, the shield 14 is caused to move proximally while
pressed against a patient's skin, against the force of the biasing
element 16. With sufficient pressure, the needle 18, passing
through the aperture 34, enters the patient's skin the required
depth and an injection is administered as is well known in the art.
The shield 14 is urged proximally during this procedure. During
this proximal movement, the protrusion 38 is guided by the channel
30. After injection, and removal of the shield 14 from the patient,
the biasing element 16 urges the shield 14 distally to a position
where the distal end 20 of the needle 18 is covered. The safety pen
needle assembly 10 may be provided with a locking arrangement to
lock the shield 14 in the final, shielded position covering the
distal end 20. As appreciated by those skilled in the art, various
locking arrangements are useable with the subject invention.
[0033] By way of non-limiting example, and with reference to FIGS.
1-8, the channel 30 is shown to have a general V-shape which
permits for a locking arrangement. Specifically, a flexible finger
40 extends into the channel 30 which is inherently biased to extend
towards a first edge 42 located along the channel 30. A gap 44 is
defined between the flexible finger 40 and the first edge 42 which
is sized to normally have a dimension smaller than the width of the
protrusion 36. The gap 44 may be negligible or non-existent with
the flexible finger 40 contacting the first edge 42. During use,
the protrusion 38 is initially located to be in a first part 46 of
the channel, which is located along the first edge 42. With the
shield 14 being urged proximally, the protrusion 38 is urged
proximally along the first part 46 and towards the gap 44 (FIG. 5).
The protrusion 38 with sufficient proximal movement is forced
through the gap 44, with the flexible finger 40 being deflected.
After passage through the gap 44, the flexible finger 40 returns to
its natural state (FIG. 6). The protrusion 38 passes through the
gap 44 during the injection procedure (i.e., while the needle 18 is
inserted into a patient the required depth for injection). In this
manner, the shield 14 may be retracted to a limited depth (i.e., a
depth corresponding to the protrusion 38 not passing through the
gap 44) without activating the device. Once the protrusion 38
passes through the gap 44, the protrusion 38 cannot return to the
initial state.
[0034] Upon the shield 14 being removed from a patient's skin, the
biasing element 16 causes the shield 14 to move distally. As a
result, the flexible finger 40 deflects the protrusion 38 into a
second part 48 of the channel 30 (FIG. 7). To lock the shield 14 in
the shielding position, a locking aperture 50 may be defined in the
tubular body 24 of the hub 12 (FIG. 8). The locking aperture 50 may
be located proximally of the second part 48 and may be formed to
receive in snap engagement the protrusion 38. Under force of the
biasing element 16, with the shield 14 being completely removed
from a patient's skin, the shield 14 may be urged distally with the
protrusion 38 coming into snap engagement with the locking aperture
50. A ridge 52 may be defined between the second part 48 and the
locking aperture 50 which inhibits the protrusion 38 from
re-entering the channel 30 and allowing the shield 14 to retract
proximally. The biasing element 16 must generate sufficient biasing
force to urge the protrusion 38 past the ridge 52 with this
arrangement. Alternatively, the protrusion 38 may be urged to a
distalmost portion of the second part 48 under force of the biasing
element 16, and the protrusion 38 may be then manually urged into
the locking aperture 50 by forcing the shield 14 a sufficient
distance to permit the protrusion 38 to snap engage the locking
aperture 50. The ridge 52 may be internally ramped or curved on a
proximal edge to facilitate the protrusion 38 passing thereby.
[0035] To permit the distal end 20 of the needle 18 to be initially
exposed, but later fully shielded, the locking aperture 50 may be
located to be more distal of the distalmost portion of the first
part 46 of the channel 30, as shown in FIGS. 1-8. In this manner,
in a final shielding state, the shield 14 is permitted to extend
more distally from the hub 12, than in the initial state, where the
protrusion 38 is received in the distalmost portion of the first
part 46. Optionally, or in the alternative, the second part 48 may
extend more distally than the first part 46, likewise allowing the
needle 18 to be initially exposed, but later fully shielded. This
may be in addition to, or as an alternative to, locating the
locking aperture 50 more distal than the distalmost portion of the
first part 46.
[0036] As will be appreciated by those skilled in the art, any
number of protrusions 38 and the channels 30 may be used consistent
with the subject invention. Likewise, any number of elements
discussed with respect to the other features may likewise be used
in various quantities in conjunction with the subject
invention.
[0037] Further, as will be appreciated by those skilled in the art,
the protrusion 38 may be formed on the hub 12 with the channel 30
being formed on the shield 14, for example, as shown in FIGS. 9-14.
As such, the channel 30 may move relative to the protrusion 38.
Preferably, the shield 14 is located inside of the hub 12 where the
protrusion 38 is formed on the shield 14. Also, preferably, the
shield 14 is located externally of the hub 12 where the protrusion
38 is located on the hub 12.
[0038] In an alternate configuration, and with reference to FIGS.
9-23, the channel 30 may be straight and parallel to a longitudinal
axis of the pen needle assembly 10. The straight shape of the
channel 30 allows the protrusion 38 to move back and forth,
proximally and distally. Different locking arrangements are
available for use with this configuration. With reference to the
configuration of FIGS. 9-14, after use, the shield 14 may be
manually rotated to have the protrusion 38 snap engage with the
locking aperture 50.
[0039] With reference to FIGS. 15-16, the locking aperture 50 may
be located longitudinally spaced from the channel 30 in a proximal
direction. With this arrangement, after use, the shield 14 may be
urged manually in a distal direction with the protrusion 38 snap
engaging the locking aperture 50.
[0040] With reference to FIGS. 9-16, the protrusion 38 may be
initially seated in the channel 30 without any locking thereof. As
such, the protrusion 38 may be freely movable before use.
Optionally, a cover 53, having at least one inwardly extending
element 55, may be provided configured to have the element 55
prevent the channel 30 from moving proximally prematurely. In
addition or alternatively, the protrusion 38 may be releasably
locked prior to use. For example, with reference to FIGS. 9-14, the
protrusion 38 may be seated in the locking aperture 50 before use.
To use the assembly 10, the shield 14 is manually rotated to urge
the protrusion 38 into the channel 30. After use, reverse manual
rotation of the shield 14 returns the protrusion 38 into snap
engagement with the locking aperture 50.
[0041] The arrangements of FIGS. 9-16 require manual intervention
to achieve locking. To avoid manual locking, and with reference to
FIGS. 17-23, the channel 30 may have the first part 46 disposed
transversely relative to the second part 48 which is parallel to
the longitudinal axis of the pen needle assembly 10. In an initial
state, as shown in FIG. 19, the protrusion 38 is seated in the
channel 30, particularly the first part 46, to prevent proximal or
distal movement of the shield 14 relative to the hub 12. With
manual rotation of the shield 14, the protrusion 38 is moved
through the first part 46 of the channel 30 and into the second
part 48 (FIG. 20), where the shield 14 is free to move distally
under force of the biasing element 16. The biasing element 16 is
selected such that sufficient force is provided to force the
protrusion 38 from the channel 30 (FIG. 21) and into snap
engagement with the locking aperture 50 after use (FIG. 22).
Preferably, with this arrangement, the shield 14 is not rotated
until the needle 18 has been removed from a patient's skin after an
injection. To enhance the user's ability to rotate the shield,
textured regions 54 (FIG. 11) may be provided on the tubular body
24 and/or outwardly projecting wings 56 (FIG. 23) may be provided.
In addition, the cover 53 (FIG. 17), having the at least one
inwardly extending element 55, may be provided configured to have
the element 55 prevent the protrusion 38 from entering the second
part 48 prematurely.
[0042] The safety pen needle assembly 10 may be configured to have
an automatically rotating arrangement where the shield 14 moves
rotationally relative to the hub 12, such as to achieve locking,
without manual intervention beyond the normal injection procedure.
With reference to FIGS. 24-25, the shield 14 may be provided with a
locking tab 58 in addition to the protrusion 38. Correspondingly,
locking window 60 may be formed in the tubular body 24 (FIGS.
26-27) formed to receive the locking tab 58. With reference to
FIGS. 28-32, the arrangement of the channel 30, with the flexible
finger 40, as described above, may be utilized. With reference to
FIGS. 33-35, the protrusion 38 moving from the first part 46 to the
second part 48 of the channel 30, the shield 14 is caused to rotate
relative to the hub 12. With the protrusion 38 moving through the
second part 48 of the channel 30, the locking tab 58 and the
locking window 60 are configured such that the locking tab 58 snap
engages the locking window 60 and, thus, locks the shield 14. To
facilitate proper operation of this locking arrangement,
cantilevered tongues 62 may be defined in the tubular body 24
proximally of the locking windows 60 to allow resilience with the
locking tabs 58 traversing thereacross. As discussed above, with
the second part 48 being formed longer than the first part 46, the
shield 14 may permit exposure of the distal end 20 of the needle 18
prior to use (FIG. 28) with full shielding thereof after use (FIG.
32).
[0043] As will be appreciated by those skilled in the art, the
shape of the channel 30 directs the rotation of the shield 14. With
reference to FIGS. 1-8, the first part 46 may be formed generally
parallel to the longitudinal axis of the pen needle assembly 10.
Accordingly, the shield 14 does not rotate with the protrusion 38
passing through the first part 46. Rotation is caused with the
protrusion 38 passing through the second part 48, which is disposed
transversely to the longitudinal axis of the pen needle assembly
10. Alternatively, as shown in FIG. 50, the first part 46 may be
disposed transversely to the longitudinal axis of the pen needle
assembly 10. As such, the shield 14 will rotate with the protrusion
38 traversing the first part 46--this results in the shield 14
rotating during insertion of the needle 18 into a patient. Rotation
may be desired through both the first and second parts 46, 48. By
angularly arranging the first and second parts 46, 48, rotation of
the shield 14 may be controlled.
[0044] With reference to FIGS. 33-35, as an alternative to the
flexible finger 40, the channel 30 may be provided with a
stationary finger 64 separating the first part 46 from the second
part 48. To ensure that the protrusion 38 moves into the second
part 48 properly, it is preferred that the protrusion 38 be
initially urged in the opposite direction from the desired
rotational direction, while traversing the first part 46. For
example, with reference to FIGS. 33-35, the stationary finger 64 is
shown to be bent towards the left. As the protrusion 38 is urged
proximally, the protrusion 38 also rotates to the left. In this
manner, a torsional force is generated in the biasing element 16
which urges the protrusion 38 in a rightward direction. Preferably,
the amount of rotation of the shield 14 (i.e., rotation of the
protrusion 38) is limited during the injection. The travel of the
protrusion 38 through the first part of the channel 30 coincides
with the injection process. With the second part 48 being
hook-shaped, once the protrusion 38 passes the stationary finger 64
and is under force of the generated torsion force, the protrusion
38 is urged into the second part 48. The protrusion 38, however,
preferably does not traverse the second part 48 until after the
injection, particularly after removal of the pen needle assembly 10
from the patient's skin. Upon removal of the shield 14 from the
patient's skin, the biasing element 16 urges the shield 14 distally
with the protrusion 38 traversing the second part 48. The locking
arrangement as described above with the locking tab 58 and the
locking window 60 may be utilized with this configuration.
[0045] FIG. 35A depicts an alternate arrangement for the channel 30
where the stationary finger 64 is generally straight. In this
arrangement, as the pen needle assembly 10 is removed from the
patient's skin, the shield 14 advances linearly through the first
part 46, and the protrusion 38 contacts angular surfaces 39a, 39b,
directing the protrusion 38 along the channel 30 into the second
part 48. A locking arrangement may be utilized herewith such as,
with angular surface 39c being provided to direct the protrusion 38
into the locking window 60. The angular surfaces 39a, 39b, 39c may
be formed with straight and/or arcuate sections.
[0046] As depicted in FIGS. 51-54, a plurality of the channels 30
(30A, 30B, . . . ) and a plurality of the protrusions 38 (38A, 38B,
. . . ) may be utilized. The entire circumference of the hub 12 and
the shield 14 may be provided with the channels 30 and the
protrusions 38.
[0047] The channels 30 may be provided in a repeated pattern with
like configurations. As shown in FIG. 51, the channels 30 may have
different configurations, such as the channels 30A, 30B. The
channel 30B includes the first part 46 and the second part 48
separated by the stationary finger 64. The first channel 30A is
shown to include the first part 46 and the second part 48, with the
angular surfaces 39a, 39b, but with no separating finger. With
movement of the protrusion 38B about the stationary finger 64, the
protrusion 38A moves simultaneously along the channel 30A. As shown
in dashed lines, in a final state, the protrusions 38A, 38B are
located adjacent the ridges 52 (52A, 52B). The ridges 52 are
positioned so as to limit axial movement in either axial direction.
For example, the protrusion 38A is located above the ridge 52A
while the protrusion 38B is located below the ridge 52B. The
collective effect of this arrangement is to prevent axial movement,
proximally or distally.
[0048] Angled surface 39c may be provided to restrict backward
movement of the protrusion 38A (and possibly movement out of a
locked position). To enhance this restrictive effect, gap 41 may be
defined adjacent to the angled surface 39c. Preferably, the gap 41
is smaller than the diameter of the protrusion 38A. In addition,
the stationary finger 64 and/or the angled surface 39c may be
defined to be deflectable, as shown in dashed lines. By being
formed deflectable, the stationary finger 64 and the angled surface
39c further resist backward movement of the protrusions 38A,
38B.
[0049] In some embodiments, as set forth in FIGS. 53-54, the shield
14 may be molded with a plurality of integral protrusions 38 along
the lower edge 15 of the inside diameter. If desired, the top edge
of the shield 14 may be provided with a plurality of openings 43
for each protrusion 38 to facilitate formation of the protrusion
38, particularly by molding. The protrusions 38 may be incorporated
as a part of a latch feature 45, which is designed to flex as it
passes over tapered leads or other raised sections of the channels
30 to engage with the body of the hub 12 and be properly positioned
in the channels 30 ready for use.
[0050] As will be appreciated by those skilled in the art, the
safety pen needle assembly 10 may be utilized with other features,
including a shielding arrangement for shielding the proximal end 22
of the needle 18 after use. With reference to FIGS. 36-49, the
arrangement of the channel 30 generally discussed with respect to
FIGS. 1-8 is shown. In addition, a secondary shield 66 is shown.
The secondary shield 66 includes one or more locking arms 68 that
pass through openings 71 of bulkhead 70 formed in the tubular body
24 of the hub 12. The locking arms 68 each include a detent 72
which latches onto a portion of the bulkhead 70 in a pre-use state.
As shown in FIGS. 37-40, the proximal end 22 of the needle 18 is
exposed during use.
[0051] Preferably, the detent 72 includes a ramped surface 74 which
faces generally distally. An angled engagement surface 76 is formed
on the proximal end 36 of the shield 14 in axial alignment with the
ramped surface 74. The ramped surface 74 and the engagement surface
76 are configured and arranged such that, upon sufficient proximal
movement of the shield 14, the engagement surface 76 presses
against the ramped surface 74 and causes outward displacement of
the ramped surface 74. With sufficient outward displacement, the
detent 72 unlatches from the bulkhead 70. The biasing element 16
may be located between the locking arms 68 and the shield 14 such
as in a retaining channel 78. With the locking arms 68 being
unlatched, the secondary shield 66 is free to move proximally under
force of the biasing element 16. As shown in FIG. 42, the secondary
shield 66 is urged to a shielding position where the proximal end
22 of the needle 18 is covered. The secondary shield 66 is free to
move upon removal of the pen needle assembly 10 from an injector
body B (FIG. 55). To lock the secondary shield 66 in this shielding
position, one or more of the locking tabs 58 may be provided on the
secondary shield 66 with an associated number of the locking
windows 60 being formed in the tubular body 24. With the locking
tabs 58 being in snap engagement with the locking windows 60,
proximal or distal movement of the secondary shield 66 is limited.
Alternatively, and with reference to FIGS. 55-57, the locking arms
68 may be formed with at least one secondary locking tab 86 and at
least one tertiary locking tab 88. As shown in FIGS. 57A and 57B,
the secondary locking tabs 86 and the tertiary locking tabs 88 are
located on different locking arms 68 and spaced apart so as to
sandwich the bulkhead 70 therebetween. During use, the bulkhead 70
is snap received in the collective gap formed by the secondary and
tertiary locking tabs 86, 88. The secondary locking tabs 86 may be
defined by the detents 72.
[0052] In addition, as shown in FIG. 56B, one or more latches 90
may be provided in addition to the locking arms 68 for latching the
secondary shield 66 to the bulkhead 70 prior to use. The detents
72, with the ramped surfaces 74, may be formed on the latches 90,
in addition, or alternatively, to the locking arms 68.
[0053] With reference to FIGS. 58a-59, a further useable shield for
covering the proximal end 22 of the needle 18 is depicted. Here, a
leafspring 100 is utilized which is secured to the pen needle
assembly 10, preferably at the hub 12. As shown in FIG. 58a, the
leafspring 100 in a pre-use state is configured to be spaced from
the proximal end 22 of the needle 18. Preferably, the leafspring
100 is retained by a frangible connection 102. With reference to
FIG. 58, it is preferred that the connection 102 rupture upon the
pen needle assembly 10 being mounted onto the injector body B. For
example, the hub 12 may be formed with a slightly smaller inner
diameter, which expands upon being mounted, thus causing rupture of
the connection 102.
[0054] As shown in FIG. 59, the leafspring 100 is formed with
inherent memory to cover the proximal end 22 of the needle 18.
Thus, with the connection 102 being ruptured, and the pen needle
assembly 10 being removed from the injector body B, the leafspring
100 is free to move and shield the proximal end 22. Inherent
resilience of the leafspring 100 shall cause the leafspring 100 to
remain over the proximal end 22.
[0055] As will be appreciated by those skilled in the art, the
leafspring 100 may be formed of various materials which provide
internal resilience to urge the leafspring 100 to the shielding
state. Preferably, the leafspring 100 is formed of a thermoplastic
material and more preferably formed unitarily with the hub 12.
Biasing force to urge the leafspring 100 to the shielding state may
be generated about junction 104 formed at the intersection of the
leafspring 100 and the pen needle assembly 10. Preferably, free end
106 of the leafspring 100 biases outwardly upon rupture of the
connection 102 to be clear of other portions of the pen needle
assembly 10. In this manner, the free end 106 is urged by the
biasing force generated about the junction 104 to cover the
proximal end 22 of the needle 18.
[0056] Preferably, the various locking apertures or windows
discussed above for receiving in snap engagement a locking element
(e.g., the locking aperture 50; the locking window 60) are
preferably through holes which extend through a respective surface
to permit visual confirmation of a locked arrangement from an
external vantage point. The apertures or windows may be formed
blind with limited depth so as to not fully extend through a
respective surface. This is less desirable since visual
confirmation may not be achievable. However, an audible or tactile
click may be relied to indicate snap engagement.
[0057] As depicted in FIGS. 60A-60C, the present invention may
include one or more indicia for determining the depth of protrusion
(insertion) of the needle 18 into the patient's body. This may be
important, for example, when the medication being injected is
desirably administered to a particular depth into the body of the
patient. The invention may include an outer shield assembly 120
that is slidably attached to the outer surface 128 of a portion of
a medical injector, preferably the outer surface 128 of a needle
assembly (e.g. the outer surface of the hub 12). The outer shield
assembly 120 may include a small diameter cylinder 122, which is
offset from the axis of the needle 18. At the top of the cylinder
122 is a shield portion 124, which may cantilever from the cylinder
122. The cylinder 122 may include one or more depth markings 126 to
allow control of the insertion depth of the needle 108.
[0058] In this embodiment, as the distal end 20 of the needle 18 is
inserted into the skin of the patient, the outer shield assembly
120 is pressed by a patient's skin and moved away from the distal
end 20 of the needle 108 down the outer surface 128 of the
assembly. As the outer shield assembly 120 is pressed down by the
patient's skin, the depth markings 126 are likewise pressed down
away from the distal end 110 of the needle 18. The user can thus
view the depth markings 126 as the needle 18 is inserted into the
skin, or after injection, and determine the proper insertion depth
for the needle 18.
[0059] If desired, the outer shield assembly 120 may provide a
shield for the distal end 110 of the needle 18 after use. The
shield portion 124 may be formed to cover the distal end 110 of the
needle 18. The shield portion 124 may be manually adjusted after
use to cover the distal end 20. Preferably, the outer shield
assembly 120 includes a spring 130, which biases the outer shield
assembly 120 along the outer surface 128 of the assembly towards
the distal end 20 of the needle 18. Prior to use, the outer shield
assembly 120 may be disposed such that the distal end 20 of the
needle 18 is exposed (FIG. 60A). During use, the distal end 20 of
the needle 18 is pressed into the skin of the patient, thus forcing
the outer shield assembly 120 down along the outer surface 128 of
the assembly (FIG. 60B). Once the injection is complete, the needle
18 is removed from the skin of the patient. As the force of the
skin against the outer shield assembly 120 is removed, the spring
130 forces the outer shield assembly 120 towards the distal end 20
of the needle 18, covering the tip of the distal end 20 (FIG. 60C).
If desired, the outer shield assembly 120 may include a locking
arrangement to secure the outer shield assembly 120 in place once
it has covered the distal end 20 of the needle 18.
[0060] It will be understood by those of skill in the art that the
cylinder 122 need not have a circular cross-section, rather it may
be oval, ellipsoidal, or any other shape that matches up to the
outer surface 128 of the assembly. For example, the cylinder 122
may be crescent shaped so as to aid in the sliding engagement with
the outer surface 128 of the assembly. Further, the shield 124 need
not completely surround the needle, and may include two prong-like
arms that extend alongside the distal end 110 of the needle 108,
preventing accidental contact.
[0061] The depth markings 126 may include a series of markings on
the cylinder 122, or may include one single depth mark that is used
to indicate that the needle 18 has been inserted the proper depth
into the patient. Alternatively, a single depth mark may indicate
that the needle 18 has been inserted a sufficient distance to
engage the safety mechanism of the outer shield assembly 120 (i.e.,
the spring has been depressed enough to allow the shield portion
124 to cover the distal end 20 of the needle). The depth markings
126 may be etched into the cylinder 122, or they may be drawn onto
the cylinder 122 with ink or any suitable material.
[0062] In an alternate embodiment, the outer shield assembly 120
may include an additional protruding member parallel to the
cylinder 122 such that the outer shield assembly 120 rests along
the outside of the hub. In this case, the hub may be restrained and
move between the cylinder 122 and protrusions.
[0063] As will be appreciated by those skilled in the art, the
various features described herein may be used in various
combinations. For example, and with reference to FIG. 61, the
non-patient shield may be used in conjunction with the depth
markings and shield.
* * * * *