U.S. patent application number 17/553685 was filed with the patent office on 2022-04-07 for pen needle assembly having an outer cover.
The applicant listed for this patent is Becton, Dickinson and Company. Invention is credited to Tingting FAN, Wei HU, Huasheng HUANG, Fei WANG, Xi ZENG.
Application Number | 20220105280 17/553685 |
Document ID | / |
Family ID | 1000006038617 |
Filed Date | 2022-04-07 |
United States Patent
Application |
20220105280 |
Kind Code |
A1 |
ZENG; Xi ; et al. |
April 7, 2022 |
PEN NEEDLE ASSEMBLY HAVING AN OUTER COVER
Abstract
A needle hub assembly for coupling to a pen needle delivery
device (10) includes an outer cover (30) having a first well (40)
receiving the needle hub (16) and inner shield (24) covering a
cannula (20) of the needle hub (16). A second well (42) is spaced
from the first well (40) and has a dimension for receiving the
inner shield (24). In use, the pen delivery device (10) is coupled
to the connecting end of the needle hub (16) to withdraw the needle
hub (16) and inner shield (24) from the first well (40). The inner
shield (24) is inserted into the second well (42) where the inner
shield (24) is gripped so that the inner shield can be separated
from the needle hub (16) without the user handling the outer cover
(30) or the inner shield (24). After use, the needle hub (16) is
inserted into the first well (40) and the pen needle delivery
device is separated from the needle hub (16). The needle hub (16)
is retained within the first well (40) where the outer cover (30)
containing the used needle hub and inner shield can be discarded as
a single unit.
Inventors: |
ZENG; Xi; (Suzhou, CN)
; HUANG; Huasheng; (Suzhou, CN) ; HU; Wei;
(Shanghai, CN) ; WANG; Fei; (Shanghai, CN)
; FAN; Tingting; (Shanghai, CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
|
|
Family ID: |
1000006038617 |
Appl. No.: |
17/553685 |
Filed: |
December 16, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16465753 |
May 31, 2019 |
11229752 |
|
|
PCT/US2017/064706 |
Dec 5, 2017 |
|
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17553685 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/328 20130101;
A61M 5/002 20130101; A61M 5/3202 20130101; A61M 2005/3206 20130101;
A61M 5/3205 20130101; A61M 5/3204 20130101; A61M 5/3278
20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 6, 2016 |
CN |
201611110864.4 |
Dec 6, 2016 |
CN |
201621333821.8 |
Claims
1. A needle assembly comprising: a needle hub having a cannula, an
inner shield covering said cannula, and an outer cover; said outer
cover having a bottom face and a top face opposite said bottom
face, said top face having a first well with a dimension for
receiving said needle hub and inner shield, and a second well with
an inner dimension smaller than an inner dimension of said first
well for receiving said inner shield, where said inner shield can
be retained in said second well by inserting said inner shield into
said second well whereby said inner shield can be separated from
said needle hub.
2. The needle hub assembly of claim 1, further comprising a
removable seal attached to said top face to close the first well
and enclose said needle hub in said first well.
3. The needle hub assembly of claim 2, wherein said seal is a
peelable label.
4. The needle hub assembly of claim 1, wherein said outer cover has
a substantially flat, planar top face and a bottom face formed by
bottom ends of said first well and second well, said bottom face
having a dimension for supporting said outer cover in an upright
manner.
5. The needle hub assembly of claim 1, wherein said first well and
second well are spaced apart, and said outer cover further
comprises a connecting portion extending between said first well
and said second well and having a bottom edge at said bottom face
of said outer cover to stabilize said outer cover.
6. The needle hub assembly of claim 1, further comprising a
plurality of said outer covers coupled together in an array and
where each said outer cover includes a needle hub.
7. The needle hub assembly of claim 6, wherein said plurality of
outer covers are connected to each other by a frangible line
extending between at least two adjacent outer covers.
8. The needle hub assembly of claim 1, wherein said first well has
a dimension to receive said needle hub and inner shield, and where
said first well has a dimension to engage said needle hub without
gripping said inner shield, whereby said needle hub and inner
shield are removable from said first well.
9. The needle hub of claim 8, wherein said second well has an inner
dimension sufficient to grip said inner shield to enable separation
of said inner shield from said needle hub.
10. A needle hub array for use with a pen needle delivery device,
comprising: a plurality of outer covers coupled together, each
outer cover having a bottom face and a top face opposite said
bottom face, said top face having a first well and a second well;
and a needle hub received in each first well, said needle hub
having a cannula extending from an end of said needle hub and an
inner shield covering said cannula, where said outer cover encloses
said needle hub and inner shield, said first well having an inner
dimension for receiving and gripping said needle hub and not
gripping said inner shield, and said second well having an inner
dimension and configuration for receiving and gripping said inner
shield.
11. The needle hub array of claim 10, wherein each said outer
covers include a closure member for enclosing said needle hub,
cannula, and inner shield in said first well.
12. The needle hub array of claim 11, wherein said closure member
is a removable seal attached to said top face to close said first
well.
13. The needle hub array of claim 10, wherein said outer covers are
separable from each other.
14. The needle hub array of claim 10, wherein said outer covers are
separable by a frangible line extending between adjacent outer
covers.
15. The needle hub array of claim 10, wherein said first well has a
first portion with a dimension to receive and retain said needle
hub by a friction fit, and a second portion to receive said inner
shield and having a dimension greater than a dimension of said
inner shield.
16. The needle hub array of claim 10, wherein said second well has
a dimension to receive and retain said inner shield by a friction
fit.
17. The needle hub array of claim 10, wherein said first well and
said second well have an open bottom end at said bottom face of
said cover, said needle hub array having a removable seal attached
to said top face and to an open end of said needle hub.
18. The needle hub array of claim 17, further comprising a
connecting portion extending between said first well and said
second well and having a bottom edge at said bottom face of said
outer cover to stabilize said outer cover.
19. A method of coupling and uncoupling a needle hub to an
injection device, said method comprising the steps of: providing an
outer cover having a first well containing the needle hub;
inserting the injection device into said first well and coupling to
a coupling end of said needle hub; removing said injection device
and needle hub from said first well; inserting an inner shield
coupled to said needle hub into a second well of said outer cover,
where said inner shield is gripped by said second well, and
separating said needle hub from said inner shield for use in
delivering the substance to the patient; and positioning the
resulting used needle hub in said first well and uncoupling said
needle hub from said pen needle delivery device.
20. The method of claim 19, wherein said outer cover includes a
removable seal covering said first well and needle hub, and said
method comprises removing said seal before inserting said pen
needle delivery device into said first well.
Description
[0001] This application is a continuation application of U.S. Ser.
No. 16/465,753, filed on May 31, 2019, which is a national stage
application of PCT/US2017/064706, filed on Dec. 5, 2017, which
claims priority under 35 USC .sctn. 119(a) from Chinese Utility
Model Application No. 201621333821.8, filed on Dec. 6, 2016, and
Chinese Invention Patent Application No. 201611110864.4, filed on
Dec. 6, 2016, which are hereby incorporated by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to a pen needle
assembly having an outer cover forming an enclosure for the pen
needle. More particularly, the present invention generally relates
to an outer cover having a first well to retain a needle hub having
an inner shield and to retain the needle hub after use to reduce
the risk of inadvertent needle stick. The outer cover has a second
well to receive the inner shield for separating the inner shield
from the needle hub without the need to handle the inner
shield.
BACKGROUND OF THE INVENTION
[0003] Insulin and other injectable medications are commonly
delivered with drug delivery pens, whereby a disposable pen needle
hub is attached to the pen to facilitate drug container access and
allow fluid egress from the container through the needle into the
patient.
[0004] Various pen needle delivery devices are known in the art for
dispensing the substance to the patient. The delivery devices often
use a disposable needle hub having a cannula or needle extending
from a patient end of the hub for inserting into the patient. A
non-patient end of the hub is coupled to the pen delivery device
for delivering the substance to the patient.
[0005] The needle hub assembly is often packaged in a container
containing several loose needle hubs. A needle hub is selected from
the package and attached to the pen needle delivery device for
injecting the patient and then removed to be discarded. The needle
hub package includes an outer cover that encloses the needle hub
and a removable seal that is peeled from the outer cover to open
the cavity so that the needle hub can be removed. The needle hub
can have threaded non-patient end that is threaded onto the
delivery device. The delivery device with the attached needle hub
is then removed from the outer cover. An inner needle shield is
attached to the needle hub to cover the cannula until the device is
ready for use. The shield is removed to expose the cannula for use
to deliver the substance to the patient. After use, the needle hub
can be inserted back into the outer cover to enclose the exposed
cannula. The pen delivery device is separated from the needle hub
leaving the needle hub within the outer cover.
[0006] The prior devices require the use of both hands to connect
to and remove the needle hub from the delivery device. During the
placement back into the outer cover, the cannula is exposed and
provides an increased risk of accidental needle stick. The manual
operation of holding the outer cover while positioning the spent
needle hub and cannula into the cavity of the outer cover can be
difficult without accidental needle stick.
[0007] Existing pen needle assemblies are disclosed in U.S. Patent
Application Publication Nos. 2006/0229562 to Marsh et al. and
2007/0149924 to R. Marsh, the entire contents of both of which are
hereby incorporated by reference.
[0008] Although the prior devices have been suitable for the
intended use, there is a continuing need in the industry for
improved packaging for a pen needle hub assembly.
SUMMARY OF THE INVENTION
[0009] The present invention is directed to a pen needle assembly
having an outer cover forming a package for the pen needle
assembly. In particular, the invention is directed to a package or
outer cover for a needle assembly that can be used in a manner to
reduce the risk of inadvertent needle stick.
[0010] In one embodiment, the pen needle assembly includes an outer
cover for receiving a needle hub to retain the needle hub and
cannula in a sterile condition until use. The outer cover has a
recess or well for receiving an inner shield that covers the
cannula extending from the needle hub so that the inner shield can
be removed from the needle hub without the operator handling the
inner shield.
[0011] In accordance with another aspect, the inner shield can be
inserted into a well in the outer cover so that the inner shield is
retained by a friction fit or interference fit. The needle hub and
cannula can then be pulled to separate the inner shield while the
inner shield is retained in the well without the need for the user
to handle the inner shield.
[0012] In accordance with another feature, the needle hub and
cannula can be inserted into a needle hub well in the outer cover
after use of the pen needle where the pen needle delivery device
can be separated from the needle hub. The needle hub is retained in
the needle hub well by a friction fit or interference fit to
enclose the cannula and reduce the risk of inadvertent needle
stick. The outer cover with the retained needle hub can be safely
discarded.
[0013] The various features of the embodiments are basically
attained by providing a package for a pen needle assembly including
an outer cover receiving a needle hub having an inner shield
covering a cannula on the needle hub. The outer cover has a top
face and a bottom face with a configuration and dimension for
contacting a supporting surface for the assembly and supporting the
outer cover in an upright position. The top face of the outer cover
has a first open well with a dimension to receive and store the
needle hub and inner shield until ready for use. The outer cover
can retain the needle hub by a friction fit or by an interference
fit. The top face of the outer cover includes an inner shield well
with a dimension for receiving the inner shield and retaining the
inner shield after separating from the needle hub.
[0014] In one embodiment, the inner shield well has a dimension to
receive the inner shield by a friction fit or interference fit so
that inserting the inner shield into the well grips the inner
shield with a sufficient force that the needle hub when attached to
the pen needle can be pulled outward to separate the inner shield
to expose the cannula for delivering a substance to a patient.
After use of the needle hub and cannula, the needle hub is inserted
into the needle hub well where the needle hub is gripped so that
the pen needle can be separated from the needle hub without the
operator handling the needle hub thereby reducing the risk of
inadvertent needle stick. In one embodiment, the needle hub can be
gripped by a friction fit or interference fit or by other
mechanical connection to attach the used needle hub to the outer
cover.
[0015] The features of the invention are further attained by
providing a pen needle assembly for a pen needle delivery device,
where the assembly includes an outer cover, a needle hub having a
needle cannula, and an inner needle shield covering the cannula.
The needle hub includes a body with a non-patient end for coupling
to the pen needle delivery device where the needle hub has the
cannula extending from a patient end. The inner shield is coupled
to the needle hub to cover the cannula. The outer cover has bottom
face with a dimension and configuration for contacting a support
surface and retaining the outer cover in an upright position. The
outer cover has a top face with a first well forming a needle hub
well receiving the needle hub and inner shield. The top face has a
second well forming an inner needle shield well with a dimension to
receive the inner shield. The second well has a dimension less than
the dimension of the first well. The inner shield can be received
in the second well by a friction or interference fit to grip the
inner shield so that the inner shield can be removed from the
needle hub to expose the cannula without the need for the operator
to manually remove the inner shield. After use, the needle hub can
be inserted back into the first well to grip the needle hub so that
the pen needle can be separated from the needle hub and the spent
or used needle hub can be retained in the outer cover for
disposal.
[0016] The objects, advantages, and salient features of the
invention will become apparent from the following detailed
description, which, taken in conjunction with the annexed drawings,
discloses exemplary embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The above benefits and other advantages of the various
embodiments of the present invention will be more apparent from the
following detailed description of exemplary embodiments of the
present invention and from the accompanying figures, in which:
[0018] FIG. 1 is an exploded perspective view of a pen needle
assembly in one embodiment showing the pen delivery device, needle
hub, inner shield and cover;
[0019] FIG. 1A is a perspective view of the outer cover for
containing the needle hub assembly showing the removable seal
enclosing the needle hub and the cavity for the inner shield;
[0020] FIG. 2 is a top view of an array of needle hubs that can be
separated prior to or after use;
[0021] FIG. 3 is a perspective view of the array of FIG. 2;
[0022] FIG. 4 is an end view of the array of FIG. 2;
[0023] FIG. 5 is a cross-sectional view of the array pen needle
hubs of FIG. 2;
[0024] FIG. 6 is a perspective view of the pen needle delivery
device positioned for coupling with a needle hub;
[0025] FIG. 7 is side view of the pen needle delivery device
inserted into the outer cover;
[0026] FIG. 8 is a cross-sectional view of the pen needle delivery
device connected to the needle hub;
[0027] FIG. 9 is a cross-sectional view of the needle hub being
removed from the outer cover;
[0028] FIG. 10 is a cross-sectional view showing the needle hub
positioned above the well for receiving the inner shield of the
needle hub;
[0029] FIG. 11 is a perspective view showing the needle hub
positioned above the well for receiving the inner shield;
[0030] FIG. 12 is a cross-sectional view showing the inner shield
positioned in the well;
[0031] FIG. 13 is perspective view showing the needle hub separated
from the inner shield;
[0032] FIG. 14 is cross-sectional view showing the used needle hub
inserted into the well;
[0033] FIG. 15 is perspective view showing the used needle hub
inserted into the well;
[0034] FIG. 16 is a perspective view showing the pen needle
delivery device separated from the needle hub;
[0035] FIG. 17 is a cross-sectional view showing the pen needle
delivery device separated from the used needle hub; and
[0036] FIG. 18 is a bottom view of the outer cover.
[0037] Throughout the drawings, like reference numbers will be
understood to refer to like parts, components, and structures.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0038] The present invention is directed to a pen needle assembly
for use with a pen delivery device. The invention is further
directed to a pen needle assembly for a needle hub where the needle
hub can be placed in an outer cover that forms an enclosure after
use to reduce the risk of accidental needle stick.
[0039] It will be understood by one skilled in the art that this
disclosure is not limited in its application to the details of
construction and the arrangement of components set forth in the
following description or illustrated in the drawings. The
embodiments herein are capable of being modified, practiced or
carried out in various ways. Features of the disclosure embodiments
can be substituted features of a different embodiment, used with or
combined with features of other embodiments. Also, it will be
understood that the phraseology and terminology used herein is for
the purpose of description and should not be regarded as limiting.
The use of "including," "comprising," or "having" and variations
thereof herein is meant to encompass the items listed thereafter
and equivalents thereof as well as additional items. Unless limited
otherwise, the terms "connected," "coupled," and "mounted," and
variations thereof herein are used broadly and encompass direct and
indirect connections, couplings, and mountings. In addition, the
terms "connected" and "coupled" and variations thereof are not
restricted to physical or mechanical connections or couplings.
Further, terms such as up, down, bottom, and top are relative, and
are employed to aid illustration, but are not limiting.
[0040] The needle hub assembly can enable the convenient and easy
assembly, and removal of the needle hub assembly with respect to a
pen delivery device with reduced handling of the exposed needle
cannula. The outer cover for the needle hub can be placed on a flat
surface, such as a table, so that the pen delivery device can be
attached to the needle hub with one hand thereby reducing the risk
of the needle stick from handling the needle hub with the exposed
needle cannula.
[0041] Pen needle delivery device 10, as shown in FIG. 1 typically
comprises a dose knob/button, an outer sleeve 12, and a cap. A dose
knob/button allows a user to set the dosage of medication to be
injected. The outer sleeve 12 is gripped by the user when injecting
medication. The cap is used by the user to securely hold the pen
injector device 10 in a shirt pocket, purse or other suitable
location and provide cover/protection from accidental needle
injury.
[0042] In standard pen needle delivery devices the dosing and
delivery mechanisms are all found within the outer sleeve 12 and is
not described in greater detail here as they are understood by
those knowledgeable of the prior art. A medicament cartridge is
typically attached to a standard pen injector housing via known
attachment means. The distal movement of a plunger or stopper
within the medicament cartridge causes medication to be forced into
the reservoir housing. The medicament cartridge is sealed by a
septum and punctured by a septum penetrating needle cannula located
within a reservoir or housing. Reservoir housing is preferably
screwed onto the medicament cartridge although other attachment
means can be used. The pen needle delivery device can be a standard
pen delivery device known in the industry so that the pen needle
delivery device is not shown in detail.
[0043] The pen needle delivery device 10 is connected to needle hub
16 shown in FIG. 1 that is has a connecting non-patient end with
internal threads that screw onto a threaded end 18 of the delivery
device 10. A needle cannula 20 extends from the patient end of the
needle hub 16 for delivering the substance to the patient. An outer
cover 22 can be provided to cover the needle cannula to protect the
patient from accidental needle stick before and after use. An inner
shield 24 is provided over a post extending from the end of the
needle hub 16 to enclose the cannula. During use, the needle hub 16
is connected to the pen delivery device and the inner shield is
removed. After use, the outer cover is generally placed back on
needle hub to cover the needle cannula. The needle hub with the
cover is then removed from the pen needle delivery device and
discarded.
[0044] In the present assembly, the pen needle delivery device is
adapted for connecting to the needle hub of a pen needle assembly.
The pen needle assembly includes an outer cover 30, as shown in
FIG. 1A, needle hub 16, inner shield 24, and a removable seal 44.
In one embodiment, the outer cover 30 forms and enclosure or a
packaging system of the needle hub 16 for the pen needle assembly.
Outer cover 30 forms the enclosure or packaging for the needle hub
16 during shipping and handling of the needle hub. The outer cover
30 can be a single unit as shown in FIG. 1A for a single needle hub
having a single pen needle assembly. In other embodiments shown in
FIGS. 2-5, the outer cover 30 can be an array 32 of a plurality of
outer covers 30 each containing a single needle hub 16 to form an
array of pen needle assemblies. The array 32 of pen needle
assemblies and the outer covers 30 can be connected together by a
frangible line 34, perforated lines or other mechanism that enable
separation of the individual outer covers 30 before or after use of
the pen needle. The outer cover 30 can be separated into
sub-assemblies of individual pen needle assemblies as desired.
[0045] Each outer cover 30 includes a top face 36 and a bottom face
38. In one embodiment, the top face 36 is defined by a
substantially flat, planar member 37. A recess forming a first well
40 with a dimension for receiving and storing a needle hub 16 and a
second recess forming a second well 42 spaced to form the second
well for receiving the inner shield 24 of the needle hub assembly
are formed in top face 36. As shown, well 42 for inner shield 24
has a diameter less than a dimension of well 40 for needle hub
16.
[0046] A seal 44 forming a closure member as shown in FIG. 1A is
attached to the top face 36 to overlie the first well 40 to enclose
the needle hub assembly until ready for use. The seal 44 in one
embodiment can be attached to the open end of the needle hub 16 and
to the top face 36 of the outer cover to provide a sterile and
clean enclosure for the cannula 20. In the embodiment shown, the
seal 44 is a flexible seal attached by an adhesive, such as a heat
sensitive or activated adhesive or a pressure sensitive adhesive
that can be easily removed by the user at the time of use. The seal
44 is preferably a seal that is removable and can be peeled and
separated from the open first well 40 and the top face by the user
to expose the needle hub 16. The seal 44 can be removable or peel
label. In other embodiments, the seal can be other forms of a
suitable seal that is able to close the well 40 and maintain the
needle hub 16 in a clean and sterile condition until use. The array
32 also has a seal 44 closing each well 40 of the outer covers 30
containing the needle hub 16. For ease of illustration, the seals
44 are not shown in FIGS. 2 and 3 although it will be understood
that prior to use of the needle hub 16 each well 40 is closed by a
respective seal 44 to maintain the needle hub 16 in a clean and
sterile condition until ready for use. As shown, top face 36 has a
recess or indicia indicating the location and position of the seal
44.
[0047] Bottom face 38 of outer cover 30 and array 32 form a
substantially flat bottom configured to lay on a substantially flat
surface, such as a table top, during use so that the outer cover
and array are stable and able to be used in a stand-alone manner.
The bottom face 38 has dimension so that the outer cover 30 and/or
the array 32 are supported in an upright position. Bottom face 38
can have a textured surface or a suitable coating of a slip
resistant material to inhibit sliding movement of the outer cover
when placed on a supporting surface. In one embodiment, the outer
cover stabilizes the assembly so that the operator can connect a
needle hub assembly to the pen delivery device using one hand to
reduce the risk of accidental needle stick.
[0048] As shown in FIG. 18, well 40 and well 42 are spaced apart
from each other and have substantially the same depth to form a
supporting surface. A connecting portion 46 extends directly
between the well 40 and well 42. In one embodiment, a connection
portion 48 extends between the well 40 and well 42 and has a
substantially L-shape to assist in providing a stabilizing
configuration. Each connecting portion 46 and 48 has a height
corresponding to the height of well 40 and well 42 to form a
supporting surface and the bottom face with a dimension able to
support the outer cover 30 in an upright position. The connecting
portions 46 and 48 have a bottom edge at the bottom face 38 of
cover 30 to form a stabilizing surface for the cover when placed on
a supporting surface. The bottom end of the connecting portions 46,
48 can also have a textured or slip-resistant material or
coating.
[0049] Referring to FIG. 2, well 40 in outer cover 30 has a
dimension to receive and support the needle hub 16 and inner shield
24 as a stand-alone assembly or package. As shown FIGS. 5 and 9,
well 40 has a first portion 50 with a substantially annular or
circular side wall 53 forming the well receiving the needle hub 16.
In the embodiment show, needle hub 16 has a substantially
cylindrical side wall 52 that mates with a circular side wall 53 of
the first portion 50 of well 40. In one embodiment, side wall 53 of
first portion 50 has a shape and dimension to engage the outer
surface of side wall 52 to retain needle hub 16 within well 40
during storage and after use. In one embodiment, side wall 52 of
well 40 can be formed with a longitudinally extending rib 54 as
shown in FIG. 9 that can grip the outer surface of needle hub 16.
Ribs 54 can be oriented to engage recesses formed in the outer wall
52 of needle hub 16 to resist rotation with respect to outer cover
30 for screwing delivery device 10 onto needle hub 16. In other
embodiments, side wall 53 of well 40 can have a gradual taper to
engage the outer surface 52 of needle hub 16. The open top end of
the well 40 at the top face 36 can have a chamfered inner edge
forming an inclined surface for assisting in inserting the used
needle hub into the well 40. The engaging force between the side
wall 53 and/or ribs 54 of the well 40 and the side wall 52 of the
needle hub 16 can be a friction fit to retain needle hub within
well 40. In other embodiments, the engaging force can be by an
interference fit or other mechanical connection.
[0050] A conical shaped portion 56 extends from a bottom end of
first portion 50 as shown in FIG. 9 to a longitudinally extending
portion 58. In the embodiment shown, the longitudinally extending
portion 58 has an open bottom end 60 at bottom face 38. In other
embodiments, the bottom end portion 58 can be closed.
Longitudinally extending portion 58 has a shape and dimension to
receive the inner shield 24 in the original arrangement to maintain
the cannula and needle hub in a clean and sterile condition.
Longitudinally extending portion 58 can have gradual taper
converging toward bottom face 38. Longitudinally extending portion
58 receives the inner shield without capturing the inner shield so
that the inner shield remains connected to needle hub 16 when
needle hub 16 is removed.
[0051] Second well 42 has a dimension and shape sufficient to
receive and engage inner shield 24 in a manner where inner shield
can be captured and retained within well 42 to separate inner
shield 24 from pen needle delivery device 10. As shown in FIG. 10,
well 42 has a longitudinal dimension with an inner wall 62 and an
open bottom end 64. In the embodiment shown, inner wall 62 has a
first substantially cylindrical portion 66 at a top end at top face
36 and a second tapered portion 68 converging toward bottom face
38. The tapered portion 68 forms a gripping face for engaging the
outer surface of inner shield 24 when inserted into well 42. The
open top end of the second well 42 at the top face 36 has a
chamfered inner edge to assist in inserting the inner shield 24
into the well 42.
[0052] The outer cover 30 contains the needle hub 16 as a packaged
assembly to form the needle assembly that can be stored until ready
for use. When needle hub 16 is ready for use, seal 44 is peeled
from outer cover 30 and/or the needle hub 16 to expose well 40 and
needle hub 16 contained in the well 40. FIGS. 2 and 3 show the
seals removed from each of the individual outer covers 30 although
typically the seal is separated one at a time when a needle hub is
needed for injecting a substance to the patient.
[0053] During use, as shown in FIGS. 6-8, the pen needle delivery
device 10 is positioned over the open well 40 and inserted into the
well 40 to couple the delivery device 10 to needle hub 16. In one
embodiment, needle hub 16 is retained in well 40 by sufficient
force so that the delivery device 10 can be coupled to the needle
hub 16 with limited movement between the needle hub and the outer
cover. Generally the coupling mechanism of the delivery device 10
has a threaded end that engages internal threads of the needle hub
16 as known in the art. The well 40 engages the needle hub 16 with
sufficient force so that the delivery device 10 can be screwed onto
the needle hub 16 while the needle hub 16 is retained in the well
40 with limited movement between the needle hub 16 and the outer
cover 30.
[0054] After the delivery device is threaded onto the needle hub
16, the needle hub is withdrawn from the well 40 as shown in FIG. 9
with the inner shield 24 attached. The delivery device 10 is then
positioned over the second well 42 with inner shield 24 aligned
with well 42 as shown in FIGS. 10 and 11. The inner shield 24 is
then inserted into the second well 42 as shown in FIG. 12 where the
side wall of well 42 engages the outer surface of inner shield with
sufficient force so that when pen needle delivery device 10 is
pulled away from cover 30, inner shield 24 is retained within well
42. In this manner, the needle hub 16 can be connected to the
delivery device 10 and the inner shield 24 can be separated from
the post of the needle hub 16 without the need for the user to
handle the cover or inner shield and with minimum exposure to the
cannula and minimum risk of accidental needle stick. The delivery
device with the attached needle hub 16 shown in FIG. 13 is ready
for use to inject and deliver the substance to the patient.
[0055] After the needle hub 16 is used, it is necessary to discard
the used needle hub in a safe manner. As shown in FIG. 14, the used
needle hub 16 while still attached to the delivery device 10 is
inserted back into the well 40 where the needle hub 16 is gripped
by sufficient pressure to enable the delivery device 10 to be
separated from the used needle hub 16. In this embodiment, the
delivery device 10 can be unscrewed from the needle hub 16. The
delivery device 10 is then separated from the needle hub 16 as
shown in FIGS. 16 and 17. As shown in FIG. 17, the used needle hub
16 and the inner shield 24 are retained within the respective wells
40 and 42 after use. The delivery device 10 can then be used again
by coupling to a clean, unused needle hub 16. The outer cover 30
retaining the used needle hub 16 and inner shield can then be
discarded in a safe location. The needle hub 16 is preferably
retained within the well of the outer cover for proper disposal.
The outer cover 30 with the respective needle hub 16 and inner
shield 24 can be separated from the array 32 and discarded
individually. Alternatively, each needle hub can be used and
returned to the respective well and the array discarded as unit
when all the needle hubs are used.
[0056] It will be appreciated by those skilled in the art that
changes may be made to the embodiments described herein without
departing from the scope of the invention. It is particularly noted
that the features of different embodiments and claims may be
combined with each other as long as they do not contradict each
other. All such changes and combinations are considered to be
within the scope of the invention, which is defined by the appended
claims and their equivalents.
[0057] The foregoing embodiments and advantages are merely
exemplary and are not to be construed as limiting the scope of the
present invention. The description of an exemplary embodiment of
the present invention is intended to be illustrative, and not to
limit the scope of the present invention. Various modifications,
alternatives, and variations will be apparent to those of ordinary
skill in the art, and are intended to fall within the scope of the
invention.
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