U.S. patent application number 17/240765 was filed with the patent office on 2021-08-12 for pen needle magazine.
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 Michel Bruehwiler, Jeffrey Chagnon, Cole Constantineau, Tyson Montidoro, Sudarsan Srinivasan.
Application Number | 20210244893 17/240765 |
Document ID | / |
Family ID | 1000005539181 |
Filed Date | 2021-08-12 |
United States Patent
Application |
20210244893 |
Kind Code |
A1 |
Srinivasan; Sudarsan ; et
al. |
August 12, 2021 |
PEN NEEDLE MAGAZINE
Abstract
An attachable needle assembly (2) for use on a medication
delivery pen (4), the needle assembly (2) comprising a spike
housing (8) that is configured to engage the medication delivery
pen (4) and pierce a reservoir septum (6) of the medication
delivery pen (4), a needle assembly housing (22) secured to the
spike housing (8), the needle assembly housing (22) enclosing a
septum (40) with a cavity (42) that is in continuous fluid
communication with the spike housing (8), and a plurality of
needles (44) configured to pierce the needle assembly septum (40),
wherein when the needle assembly housing (22) is in a first
position, the plurality of needles (44) are disengaged from the
needle assembly septum (40), and when the needle assembly housing
(22) is in a second position, one of the plurality of needles (46)
enters into fluid communication with the septum cavity (42) and is
exposed for medicament delivery.
Inventors: |
Srinivasan; Sudarsan; (North
Brunswick, NJ) ; Constantineau; Cole; (Cambridge,
MA) ; Bruehwiler; Michel; (Newton, MA) ;
Montidoro; Tyson; (Davie, FL) ; Chagnon; Jeffrey;
(Somerville, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
|
|
Assignee: |
Becton, Dickinson and
Company
Franklin Lakes
NJ
|
Family ID: |
1000005539181 |
Appl. No.: |
17/240765 |
Filed: |
April 26, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16094382 |
Oct 17, 2018 |
11020540 |
|
|
PCT/US2017/025255 |
Mar 31, 2017 |
|
|
|
17240765 |
|
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|
62328646 |
Apr 28, 2016 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/24 20130101; A61M
5/2466 20130101; A61M 5/002 20130101; A61M 5/00 20130101; A61M 5/31
20130101; A61B 5/15 20130101; A61M 5/3202 20130101; A61M 5/345
20130101; A61M 2005/004 20130101; A61M 5/32 20130101 |
International
Class: |
A61M 5/34 20060101
A61M005/34; A61B 5/15 20060101 A61B005/15; A61M 5/00 20060101
A61M005/00; A61M 5/31 20060101 A61M005/31; A61M 5/24 20060101
A61M005/24; A61M 5/32 20060101 A61M005/32 |
Claims
1. An attachable needle assembly for use on a medication delivery
pen, the needle assembly comprising: a plurality of needles; a main
housing having a first curvilinear path; a needle assembly housing
having a second curvilinear path; and a rotating ratchet including
a follower comprising an angled surface, wherein when the needle
assembly housing is in a first position, the follower travels along
the first curvilinear path, and when the needle assembly housing is
in a second position, the follower travels along the second
curvilinear path.
2. The attachable needle assembly of claim 1, wherein when the
needle assembly housing is in the first position, the plurality of
needles are not exposed, and when the needle assembly housing is in
the second position, a selected needle of the plurality of needles
is exposed for medicament delivery.
3. The attachable needle assembly of claim 1, wherein the rotating
ratchet rotates when the needle assembly housing moves from the
first position to the second position.
4. The attachable needle assembly of claim 1, wherein the first and
second curvilinear paths are partially offset with respect to each
other.
5. The attachable needle assembly of claim 1, wherein the second
curvilinear path cooperates with the first curvilinear path and
guides the follower of the rotating ratchet to rotate.
6. The attachable needle assembly of claim 1, wherein the second
curvilinear path aligns the rotating ratchet to a selected needle
of the plurality of needles to expose the selected needle for
medicament delivery.
7. The attachable needle assembly of claim 6, wherein the selected
needle is disposed in the rotating ratchet.
8. The attachable needle assembly of claim 6, wherein when the
needle assembly housing moves from the first position to the second
position, the rotating ratchet moves the selected needle downward
to exposure for medicament delivery.
9. The attachable needle assembly of claim 1, wherein when the
needle assembly housing moves from the first position to the second
position, the rotating ratchet moves downward.
10. The attachable needle assembly of claim 1, wherein when the
needle assembly housing moves from the second position to the first
position, the rotating ratchet moves upward.
11. The attachable needle assembly of claim 1, wherein when the
needle assembly housing moves from the second position to the first
position, the rotating ratchet rotates as the follower transitions
from the second curvilinear path to the first curvilinear path.
12. The attachable needle assembly of claim 1, further comprising a
spring to move the needle assembly housing from the second position
to the first position.
13. The attachable needle assembly of claim 1, wherein the spring
ensures that the follower of the rotating ratchet contacts at least
one of the first and second curvilinear paths.
14. The attachable needle assembly of claim 1, wherein the main
housing is disposed in the needle assembly housing.
15. The attachable needle assembly of claim 1, wherein the needle
assembly housing moves axially relative to the main housing.
16. A method of operating an attachable needle assembly on a
medication delivery pen, the method comprising: moving a needle
assembly housing from a first position to a second position;
rotating a rotating ratchet while moving downward; aligning the
rotating ratchet to a selected needle of a plurality of needles;
amd moving the selected needle downward to expose the selected
needle for medicament delivery.
17. The method of claim 16, further comprising applying a spring
force to move the needle assembly housing from the second position
to the first position.
18. The method of claim 16, further comprising rotating the
rotating ratchet while moving upward when the needle assembly
housing moves from the second position to the first position.
19. The method of claim 16, wherein the rotating ratchet moves the
selected needle downward.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/094,382 filed on Oct. 17, 2018, which is a
U.S. national stage application under 35 U.S.C. .sctn. 371 of
International Application No. PCT/US2017/025255, filed on Mar. 31,
2017, which claims the benefit under 35 U.S.C. .sctn. 119(e) of
U.S. Provisional Patent Application Ser. 62/328,646, filed on Apr.
28, 2016, which are hereby incorporated by reference in their
entirety.
FIELD
[0002] Various exemplary embodiments of the invention relate to
medication pens.
BACKGROUND
[0003] Medication pens are typically used to inject medication into
a patient. A person who must periodically self-inject doses of
medication will typically carry a medication pen and several
single-use pen needles. A medication pen is designed for safety and
sterility. However, inefficiencies and inconveniences arise.
SUMMARY OF THE INVENTION
[0004] It is an aspect of the present invention to provide a needle
assembly that is attachable to a medication delivery pen to provide
a magazine of needles for use. Such a needle assembly provides
advantages in separating a patient end and a non-patient end and
allows for engagement and disengagement to the medication delivery
pen. Moreover, improvements in sterility, simplicity and safety are
achieved by the needle assembly such that none of the needles in
the magazine pierce a vial, cartridge or a reservoir septum of the
medication delivery pen during operation, the plurality of needles
only move axially and do not substantially move radially and do not
substantially rotate, and the needles are unable to be reused.
[0005] Having a magazine of needles available for medication
delivery reduces needle reuse. Needle reuse is undesired for at
least the following reasons. The needle dulls after a single use
and so subsequent use may cause pain to the patient. Multiple
needle use can also reduce the strength of the needle tip which may
cause a potential fracture. Also, needle reuse increases sanitary
concerns and health risks to the patient.
[0006] The needle assembly of the present invention advantageously
reduces reuse for at least the following reasons. Although patients
may desire to financially benefit from using a needle multiple
times, the needle assembly is configured to prevent each of the
plurality of needles from being used more than once. Convenience is
another reason patients reuse needles. Patients may also be
concerned about not having another needle available for use or not
having access to supplies. However, the needle assembly
conveniently provides multiple needles so that an unused needle is
more readily available.
[0007] The foregoing and/or other aspects of the present invention
can be achieved by providing an attachable needle assembly for use
on a medication delivery pen, the needle assembly comprising a
spike housing that is configured to engage the medication delivery
pen and pierce a vial, cartridge or a reservoir septum of the
medication delivery pen, a needle assembly housing secured to the
spike housing, the needle assembly housing enclosing a needle
assembly septum having a septum cavity, the septum cavity being in
continuous fluid communication with the spike housing, and a
plurality of needles configured to pierce the needle assembly
septum, wherein when the needle assembly housing is in a first
position, the plurality of needles are disengaged from the needle
assembly septum, and when the needle assembly housing is in a
second position, one of the plurality of needles enters into fluid
communication with the septum cavity and is exposed for medicament
delivery.
[0008] The foregoing and/or other aspects of the present invention
can also be achieved by a method of operating an attachable needle
assembly for a medication delivery pen, the method comprising
securing the medication delivery pen to a spike housing, piercing a
vial, cartridge or a reservoir septum of the medication delivery
pen by the spike housing, the spike housing secured by a needle
assembly housing, and establishing fluid communication between a
septum cavity of a needle assembly septum and the spike housing,
wherein when the needle assembly housing is in a first position,
the plurality of needles are disengaged from the needle assembly
septum, and when the needle assembly housing is in a second
position, one of the plurality of needles enters into fluid
communication with the septum cavity and is exposed for medicament
delivery.
[0009] Additional and/or other aspects and advantages of the
present invention will be set forth in the description that
follows, or will be apparent from the description, or may be
learned by practice of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The above aspects and features of the present invention will
be more apparent from the description for the exemplary embodiments
of the present invention taken with reference to the accompanying
drawings, in which:
[0011] FIG. 1 illustrates a right side perspective view of an
exemplary medication delivery pen connected to a needle
assembly;
[0012] FIG. 2 illustrates a partial cross sectional view of the
medication delivery pen connected to the needle assembly;
[0013] FIG. 3 illustrates a cross sectional view of a first
position of the needle assembly;
[0014] FIG. 4 illustrates a partial cross sectional view of a
rotating ratchet traveling from the first position to a second
position of the needle assembly;
[0015] FIG. 5 illustrates a partial cross sectional view of the
rotating ratchet traveling from the first position to the second
position of the needle assembly;
[0016] FIG. 6 illustrates a partial cross sectional view of the
rotating ratchet contacting one of a plurality of needles;
[0017] FIG. 7 illustrates a partial cross sectional view of the
rotating ratchet engaging one of a plurality of needles;
[0018] FIG. 8 illustrates a cross sectional view of the second
position of the needle assembly;
[0019] FIG. 9 illustrates a partial cross sectional view of the
rotating ratchet traveling from the second position to the first
position of the needle assembly;
[0020] FIG. 10 illustrates a partial cross sectional view of the
rotating ratchet traveling from the second position to the first
position of the needle assembly;
[0021] FIG. 11 illustrates a cross sectional view of the needle
assembly traveling from the second position to the first
position;
[0022] FIG. 12 illustrates a cross sectional view of the needle
assembly returning to the first position;
[0023] FIG. 12A illustrates a left side perspective partial cross
sectional view of a needle assembly housing;
[0024] FIG. 12B illustrates a front cross sectional view of the
needle assembly housing;
[0025] FIG. 12C illustrates a top elevation view of the needle
assembly housing;
[0026] FIG. 13 illustrates a front perspective view of a spike
housing;
[0027] FIG. 14 illustrates a right side perspective view of a main
housing;
[0028] FIG. 15 illustrates a left perspective view of a needle
assembly septum;
[0029] FIG. 16 illustrates a front perspective view of the rotating
ratchet;
[0030] FIG. 17 illustrates a right side perspective view of a
needle retriever;
[0031] FIG. 18 illustrates a right side perspective view of a
needle post;
[0032] FIG. 19 illustrates a right side perspective view of a first
sterility barrier;
[0033] FIG. 20 illustrates a front perspective view of a needle
housing; and
[0034] FIG. 21 illustrates a right side perspective view of a cover
and teardrop label enclosing the needle assembly.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0035] FIG. 1 illustrates a medication delivery pen 4 used for
injecting medicament, such as liquid drugs, into a living body. The
needle assembly 2 is mounted on the medication delivery pen 4 to
enhance medication delivery. According to one embodiment, FIG. 2
illustrates the needle assembly 2 including a spike housing 8 that
threadably engages the medication delivery pen 4, although other
forms of engagement are contemplated. Benefits and advantages of
the needle assembly 2 are described below.
[0036] According to one embodiment, FIG. 3 illustrates a cross
sectional view of a first position of the needle assembly 2 where
none of a plurality of needles 44 are exposed for medicament
delivery. The needle assembly 2 preferably includes a magazine of
needles 44. The plurality of needles 44 includes eight hollow
needles, although more or less needles are contemplated.
[0037] The needle assembly 2 includes the spike housing 8 that is
also illustrated in FIG. 13. The spike housing 8 includes a hollow
spike 9, spike openings 10 and a spike septum 12. The hollow spike
9 is configured to pierce a vial, cartridge or a reservoir septum 6
of the medication delivery pen 4 to establish fluid communication
with the needle assembly 2. When the reservoir septum 6 is pierced,
medicament travels through the hollow spike 9. The spike openings
10 are configured to engage a main housing 16 to secure the spike
housing 8 to the needle assembly 2. The spike septum 12 is disposed
at a bottom portion of the spike housing 8 and cooperates with the
hollow spike 9 to regulate the flow of medicament to and from the
spike housing 8.
[0038] According to one embodiment, the main housing 16 is disposed
in a needle assembly housing 22 but the needle assembly housing 22
is configured to move axially relative to the main housing 16. As
illustrated in FIG. 14, the main housing 16 includes flanges 18
that are received by the spike openings 10. The flanges 18 and the
spike openings 10 secure the main housing 16 to the spike housing
8. The main housing 16 of FIG. 3 also includes a first curvilinear
path 20. The first curvilinear path 20 includes a series of
protrusions having a plurality of vertical and angled surfaces that
define a particular path via. Operation of the first curvilinear
path 20 in the needle assembly 2 is further described below.
[0039] FIG. 3 illustrates that the spike housing 8 is disposed in
the needle assembly housing 22. The needle assembly housing 22,
according to one embodiment illustrated in FIGS. 12A-12C, encloses
the main components of the needle assembly 2. The needle assembly
housing 22 includes a second curvilinear path 24. The second
curvilinear path 24 includes a plurality of pointed or triangular
shaped teeth having angled surfaces in between each tooth. The
second curvilinear path 24 cooperates with the first curvilinear
path 20 of the main housing 16 for operation of the needle assembly
2. The needle assembly housing 22 also includes a mounting surface
26 that engages the bottom surface of the spike housing 8, and an
inner wall 28 that contacts a needle retriever 54. An inner flange
25 connects the inner diameter of the needle assembly housing 22 to
the second curvilinear path 24. A plurality of hollow cavities 27
is disposed between portions of the inner flange 25. The plurality
of cavities 27 allows the needle assembly housing 22 to move
axially relative to the main housing 16. However, the needle
assembly housing 22 does not rotate relative to the main housing
16. Specifically, each pair of flanges 18 of the main housing 16 is
disposed in each respective cavity 27 of the needle assembly
housing 22. These features are further described in detail
below.
[0040] The needle assembly housing 22 of FIG. 3 further encloses a
needle assembly septum 40 which is disposed in a rotating ratchet
30. According to one embodiment, FIG. 15 illustrates the needle
assembly septum 40 which includes a hole 41 for establishing fluid
communication with the hollow spike 9. The needle assembly septum
40 also includes a longitudinal septum cavity 42 (or septum cavity)
as illustrated in FIGS. 6 and 7 for the purpose of distributing
medicament.
[0041] According to one embodiment, the needle assembly septum 40
is disposed in a cavity 36 of the rotating ratchet 30. The rotating
ratchet 30, as illustrated in FIG. 16, also includes a follower 32,
a hollow opening 34 and a ratchet hole 38. The follower 32 includes
a plurality of pointed or triangular shaped teeth having angled
surfaces in between the teeth. The follower 32 engages and travels
along the first and second curvilinear paths 20, 24 to rotate the
rotating ratchet 30 during axial movement of the needle assembly
housing 22 between the first position and a second position. In
other words, the first and second curvilinear paths 20, 24 guide
the follower 32 of the rotating ratchet 30 to selectively rotate.
The hollow opening 34 provides an area for a plurality of needles
44 to enter during operation when one of the plurality of needles
44 is engaged with the needle assembly septum 40. Finally, the
ratchet hole 38 is configured to establish fluid communication
between the needle assembly septum 40 and the hollow spike 9 by a
fluid communication needle 14.
[0042] Specifically, according to one embodiment, the fluid
communication needle 14 is bonded or fixed to the ratchet hole 38
of the rotating ratchet 30. A distal end of the fluid communication
needle 14 is fixedly positioned to be in fluid communication with
the longitudinal septum cavity 42. During assembly, the fluid
communication needle 14 enters the ratchet hole 38, the spike
septum 12 and the hollow spike 9 so that a proximal end of the
fluid communication needle 14 is in fluid communication with the
medication delivery pen 4. The fluid communication needle 14 moves
axially through the spike septum 12 and along with the rotating
ratchet 30 and the needle assembly housing 22 when the needle
assembly 2 travels between the first and second positions.
[0043] The plurality of needles 44, according to one embodiment, is
configured to pierce the needle assembly septum 40. When the
plurality of needles 44 is in the first position of the needle
assembly 2, none of the needles pierce the needle assembly septum
40. In the second position of the needle assembly 2, only one
needle of the plurality of needles 44 pierces the needle assembly
septum 40 at a single time. Accordingly, a remaining plurality of
needles 44 enters into the hollow opening 34 of the rotating
ratchet 30 when the one needle pierces the needle assembly septum
40.
[0044] The needle assembly 2 of FIG. 3 further includes a spring 52
and the needle retriever 54 that surround the plurality of needles
44. The needle retriever 54, as further illustrated in FIG. 17,
includes flanges 56 that contact the inner wall 28 of the needle
assembly housing 22 to compress the spring 54 in the first position
of the needle assembly 2. When the needle assembly 2 is in the
second position, the needle retriever 54 cooperates with the spring
52 to move the needle assembly 2 back to the first position.
[0045] In the first position of the needle assembly 2, the spring
52 is compressed between a bottom surface of the rotating ratchet
30 where the needle assembly septum 40 is disposed and a bottom
interior surface of the needle retriever 54. A top surface of the
needle retriever 54 contacts a bottom surface of the main housing
16 to place the spring 52 in a compressed state in the first
position of the needle assembly 2. Specifically, the portion of the
needle assembly housing 22 at the second curvilinear path 24
forcibly contacts the bottom surface of the spike housing 8 because
of the compressed spring 52. The rotating ratchet 30 also forcibly
contacts the second curvilinear path 24 because of the compressed
spring 52. The second curvilinear path 24 is fixed in the first
position of the needle assembly 2 via the spike housing 8 being
secured to the main housing 16 as described above. The second
curvilinear path 24 does not move between the first and second
positions of the needle assembly 2, whereas the needle assembly
housing 22 travels between the first and second positions of the
needle assembly 2.
[0046] The plurality of needles 44 is disposed in the needle
retriever 54. Specifically, according to one embodiment, each of
the plurality of needles 44 is fixed to a needle post 70 via a
needle hole 78 as illustrated in FIG. 18. The needle post 70 of
FIG. 18 is illustrated in an original state and is configured to
elastically deflect when the needle assembly 2 moves between the
first and second positions. The needle post 70 further includes
side cavities 71 and a projection 76. The side cavities 71 engage
with needle housing protrusions 62 of a needle housing 60 to secure
each of the needle posts 70. The needle housing 60 is further
illustrated in FIG. 20. The projection 76 locks the needle post 70
in each of a top position and a bottom position with respect to an
inner diameter 64 of the needle housing 60 when the needle assembly
2 moves between the first and second positions. All needle posts 70
are in the original state in both of the top and bottom positions.
However, the needle post 70 of the one needle of the plurality of
needles 44 elastically deflects when moving between the top and
bottom positions. During assembly, the needle housing 60 is secured
to the main housing 16 via snaps, a Luer ock, ultrasonic welding or
adhesives, for example. A bottom surface of the plurality of needle
posts 70 rests on the bottom inner surface of the needle retriever
54.
[0047] According to one embodiment, each of the plurality of
needles 44 includes a first sterility barrier 72 at a proximal end
of the needle 44 and a second sterility barrier 74 at a sharpened
distal end of the needle 44. The first sterility barrier 72 is
illustrated in FIG. 19. The plurality of second sterility barriers
74 is disposed at a bottom inner surface of the needle housing 60,
and along an outer surface of the inner diameter 64 of the needle
housing 60. The sterility barriers 72, 74 are composed of, for
example, a soft non-coring elastomer such as silicone, isoprene or
butyl.
[0048] In the first position of the needle assembly 2, all of the
plurality of needles 44 is protected and sterilized by the first
and second sterility barriers 72, 74. Additionally, in the first
position of the needle assembly 2, the plurality of first sterility
barriers 72 is assembled on each of the plurality of needles 44
with a gap between a bottom surface of the plurality of first
sterility barriers 72 and a top surface of the plurality of needle
posts 70. On the other hand, a top surface of each of the plurality
of second sterility barriers 74 contacts the bottom surface of the
plurality of needle posts 70, and a bottom surface of the plurality
of needle posts 70 contacts the bottom inner surface of the needle
housing 60.
[0049] Operation of the needle assembly 2 is described as follows.
As iterated above, FIG. 3 illustrates the first position of the
needle assembly 2. Due to the compression of the spring 52, the
first position of the needle assembly 2 places the needle assembly
housing 22 in a compressed state. A user pulls the needle assembly
housing 22 away from the medication delivery pen 4 to move the
needle assembly 2 from the first position to the second
position.
[0050] FIG. 4 illustrates the user pulling the needle assembly
housing 22 downward toward the second position of the needle
assembly 2. During this point in operation of the needle assembly
2, the second curvilinear path 24 of the needle assembly housing 22
also moves downward to further compress the spring 52. The follower
32 of the rotating ratchet 30 is pushed downward by the second
curvilinear path 24 of the needle assembly housing 22 and travels
along the first curvilinear path 20 of the main housing 16.
[0051] FIG. 5 illustrates the rotating ratchet 30 continuing
downward toward the second position of the needle assembly 2. As
the rotating ratchet 30 moves downward, the spring 52 is compressed
and applies a counteracting upward axial force. After the follower
32 of the rotating ratchet 30 exits the first curvilinear path 20
of the main housing 16, the rotating ratchet 30 continues to rotate
since the follower 32 is guided along the second curvilinear path
24 of the needle assembly housing 22. The upward axial force from
the spring 52 ensures that the rotating ratchet 30 continues to
contact and be guided by the first and second curvilinear paths 20,
24. The first and second curvilinear paths 20, 24 are
advantageously arranged to be partially offset with respect to each
other. This offset causes the additional rotation of the rotating
ratchet 30 as the follower 32 transitions and travels from the
first curvilinear path 20 to the second curvilinear path 24. The
offset is configured so that the follower 32 is predominately
guided and traveling along one of the first and second curvilinear
paths 20, 24.
[0052] FIG. 6 illustrates the follower 32 of the rotating ratchet
30 reaching a stopping point along the second curvilinear path 24.
At this time, the rotating ratchet 30 is aligned for engagement
with a selected needle 46 of the plurality of needles 44. The
rotating ratchet 30 continues to move downward until the bottom
surface of the rotating ratchet 30 contacts the first sterility
barrier 72 of the selected needle 46. The remaining needles of the
plurality of needles 44 do not contact the bottom surface of the
rotating ratchet 30. Instead, the remaining needles of the
plurality of needles 44 are aligned with the hollow opening 34 of
the rotating ratchet 30.
[0053] FIG. 7 illustrates the rotating ratchet 30 continuing to
move downward toward the second position of the needle assembly 2.
A proximal end 48 of the selected needle 46 pierces the first
sterility barrier 72 and is exposed. Specifically, the bottom
surface of the rotating ratchet 30 contacts an outside
circumferential portion of a top surface of the first sterility
barrier 72. As the rotating ratchet 30 moves downward, the first
sterility barrier 72 of the selected needle 46 also moves downward
and the proximal end 48 of the selected needle 46 pierces through
the top surface of the first sterility barrier 72.
[0054] The proximal end 48 of the selected needle 46 travels into
the cavity 36 of the rotating ratchet 30 where the needle assembly
septum 40 is disposed. Specifically, the proximal end 48 of the
selected needle 46 pierces the needle assembly septum 40 and
establishes fluid communication with the longitudinal septum cavity
42 of the needle assembly septum 40. When the proximal end 48 of
the selected needle 46 pierces the needle assembly septum 40, the
remaining needles of the plurality of needles 44 and their
respective first sterility barriers 72 enter further into the
hollow opening 34 of the rotating ratchet 30. Additionally, when
the proximal end 48 of the selected needle 46 pierces the needle
assembly septum 40, a bottom surface of the first sterility barrier
72 of the selected needle 46 contacts the top surface of the
respective needle post 70.
[0055] FIG. 8 illustrates the second position of the needle
assembly 2. When the needle assembly housing 22 enters into the
second position of the needle assembly 2, the rotating ratchet 30
and the first sterility barrier 72 of the selected needle 46 moves
the respective needle post 70 from the top position to the bottom
position. Moving the needle post 70 of the selected needle 46 to
the bottom position causes a distal end 50 of the selected needle
46 to pierce the respective second sterility barrier 74. The distal
end 50 of the selected needle 46 is now exposed for medication
delivery.
[0056] At the top position, the needle post 70 of the selected
needle 46 is snap locked to the inner diameter 64 of the needle
housing 60 via the projection 76 in the first position of the
needle assembly 2. When the needle post 70 of the selected needle
46 travels downward to the bottom position, the needle post 70
slides along the side cavities 71 that engage the needle housing
protrusions 62. The projection 76 elastically deflects and
disengages from the inner diameter 64. When the needle assembly 2
is in the second position, the needle post 70 of the selected
needle 46 elastically deflects back to its original state in the
bottom position and engages the inner diameter 64 again.
[0057] The needle posts 70 of the remaining plurality of needles 44
do not move and instead stay in the top position. This is because
the plurality of first sterility barriers 72 of each of the
remaining plurality of needles 44 extends further into the hollow
opening 34 of the rotating ratchet 30. The remaining plurality of
needles 44 does not pierce each of the respective second plurality
of sterility barrier 74. Thus, the remaining plurality of needles
74 continues to be sealed and sterilized by both the first and
second plurality of sterility barriers 72, 74.
[0058] The user is unable to move the needle assembly 2 beyond the
second position because the needle assembly housing 22 will not be
able to move down any further. Specifically, this is because the
second curvilinear path 24 of the needle assembly housing 22
contacts the follower 32 of the rotating ratchet 30 and the bottom
surface of the rotating ratchet 30 contacts the first sterility
barrier 72 of the selected needle 46. The bottom surface of the
first sterility barrier 72 of the selected needle 46 contacts the
needle post 70 of the selected needle 46 and the bottom surface of
the needle post 70 of the selected needle 46 contacts the bottom
inner surface of the needle retainer 54. Finally, a bottom outer
surface of the needle retainer 54 contacts the bottom inner surface
of the needle housing 60 thus creating a defined and fixed movement
path. The spring 52 is in the most compressed state when the needle
assembly 2 is in the second position.
[0059] FIG. 8 further illustrates that, as the rotating ratchet 30
moves downward, the fluid communication needle 14 simultaneously
moves downward because the fluid communication needle 14 is fixed
to the needle assembly septum 40. Although the fluid communication
needle 14 moves downward, the spike septum 12 remains pierced so
that fluid communication between the needle assembly septum 40 and
the hollow spike 9 is maintained. Accordingly, the second position
of the needle assembly 2 allows medicament to be delivered from the
medication delivery pen 4 to the distal end 50 of the selected
needle 46.
[0060] When the user releases the needle assembly housing 22, the
needle assembly 2 begins to move from the second position back to
the first position. The spring 52 is released which causes the
rotating ratchet 30 and the second curvilinear path 24 of the
needle assembly housing 22 to move upward and toward the medication
delivery pen 4.
[0061] FIGS. 9 and 10 illustrate how the rotating ratchet 30 moves
axially and rotates as the needle assembly 2 returns to the first
position. Specifically, the follower 32 of the rotating ratchet 30
engages the angled surface of the first curvilinear path 20 of the
main housing 16 to move upward and rotate. After the follower 32
travels beyond the first curvilinear path 20, the follower 32
transitions and engages the second curvilinear path 24 of the
needle assembly housing 22 and continues to rotate until it
contacts another portion of the first curvilinear path 20 (FIG.
10). As described above, the upward axial force from the spring 52
ensures that the rotating ratchet 30 continues to contact and be
guided by the first and second curvilinear paths 20, 24. The first
and second curvilinear paths 20, 24 are offset to provide the
continuous rotation and axial movement of the rotating ratchet
30.
[0062] The rotating ratchet 30 subsequently continues to move
upward until the mounting surface 26 of the needle assembly housing
22 contacts the bottom surface of the spike housing 8. The rotating
ratchet 30 has now rotated a specific angle but is not yet aligned
to an adjacent needle of the plurality of needles 44. The rotating
ratchet 30 will only be aligned to the adjacent needle when the
needle assembly 2 moves again to the first position.
[0063] FIG. 11 illustrates the needle assembly 2 in the process of
returning to the first position from the second position. As the
needle assembly housing 22 returns to the first position of the
needle assembly 2, the inner wall 28 of the needle assembly housing
22 contacts the flange 56 of the needle retriever 54. This contact
causes the needle assembly housing 22 to pull the needle retriever
54 upward. The spring force 52 is greater than the frictional
forces of the needle assembly 2 in the second position to cause the
needle assembly 2 to return back to the first position.
[0064] When the needle retriever 54 moves upward, the needle post
70 of the selected needle 46 moves upward from the bottom position
and toward the top position. The needle post 70 moves to the top
position because the bottom surface of the needle post 70 contacts
the bottom inner surface of the needle retriever 54. The side
cavities 71 of the needle post 70 travel upward along the
respective needle housing protrusion 62. The projection 78 of the
needle post 70 will disengage from the inner diameter 64 of the
needle housing 60 via elastic deformation and travel upward.
Subsequently, the projection 78 of the needle post 70 engages a top
portion of the inner diameter 64 of the needle housing 60 in the
first position of the needle assembly 2. Since the selected needle
46 is fixed to the needle post 70, the selected needle 46 will also
move upward. The distal end 50 of the selected needle 46 will
reenter the second sterility barrier 74 and protect the user from
inadvertent operation.
[0065] FIG. 12 illustrates the needle assembly 2 back in the first
position. The proximal end 48 of the selected needle 46 is still
exposed but it is contained within the needle assembly housing 22.
The first sterility barrier 72 of the selected needle 46 still
contacts the top surface of the needle post 70 but this does not
affect the normal operation of the needle assembly 2.
[0066] The fluid communication needle 14 also moves when the needle
assembly 2 returns from the second position to the first position.
Since the fluid communication needle 14 is fixed to the needle
assembly septum 40 disposed in the rotating ratchet 30, the fluid
communication needle 14 also moves upward and continues to maintain
fluid communication between the hollow spike 9 and the needle
assembly septum 40.
[0067] The process of moving between the first and second positions
repeats so that each of the plurality of needles 44 of the needle
assembly 2 is used. In other words, the selected needle changes
based on the alignment of the needle assembly septum 40 in the
rotating ratchet 30. The selected needle alternates to an adjacent
needle of the plurality of needles 44 based on the rotation of the
rotating ratchet 30. Accordingly, when each selected needle engages
the needle assembly septum 40, the remainder of the plurality of
needles 44 enters into the hollow opening 34 of the rotating
ratchet 30.
[0068] The first and second curvilinear paths 20, 24 are configured
such that no needle is selected after the last needle of the
plurality of needles 44 is used. In other words, when the rotating
ratchet 30 rotates after use of the last needle of the plurality of
needles 44, the first and second curvilinear paths 20, 24 are
configured not to rotate the rotating ratchet 30 any further.
Specifically, the rotating ratchet 30 stops on the last needle
because no curvilinear path 20 exists for the last needle. Thus,
the last needle is reusable, while the remaining plurality of
needles 44 is configured for a single use and not reusable.
Alternatively, the rotating ratchet 30 locks the last needle in
place by rotating the rotating ratchet 30 half its normal distance
so that the last needle and the first needle are both not
engaged.
[0069] During operation, the plurality of needles 44 does not
substantially move radially. Rather, the needle assembly housing 22
moves axially to engage and move the selected needle 46 of the
plurality of the needles 44 each time the needle assembly 2 enters
into the second position. Such a design advantageously simplifies
the assembly, improves robustness and increases reliability. No
substantial radial or rotational movement in this regard is
understood as 0.+-.5% with respect to a center axis of the needle
assembly 2. Preferably, one skilled in the art understands that
substantial in this context means that no radial of rotational
movement is required to perform the intended function. Slight
radial or rotational movement is desired to ensure the proper
spacing of parts for smooth operation and proper movement of the
needles axially without jamming.
[0070] Each of the plurality of needles 44 is advantageously
isolated from the reservoir septum 6 of the medication delivery pen
4 throughout the operation of the needle assembly 2. That is, none
of the plurality of needles 44 pierces the reservoir septum 6 of
the medication delivery pen 4 at any point during the operation of
the needle assembly 2. Such an arrangement advantageously provides
simplicity in design, improves sterility and provides a separation
between a patient end and a non-patient end.
[0071] According to one embodiment, FIG. 21 illustrates the cover
80 enclosing the needle assembly 2. The cover 80 is sealed with a
teardrop label 82 to seal the needle assembly 2 and maintain its
sterility for transportation and security purposes prior to
operating with the medication delivery pen 4. When the needle
assembly 2 is ready for use, the user peels off the teardrop label
82 and removes the needle assembly 2 from the cover 80.
[0072] The foregoing detailed description of the certain exemplary
embodiments has been provided for the purpose of explaining the
principles of the invention and its practical application, thereby
enabling others skilled in the art to understand the invention for
various embodiments and with various modifications as are suited to
the particular use contemplated. This description is not
necessarily intended to be exhaustive or to limit the invention to
the precise embodiments disclosed. Any of the embodiments and/or
elements disclosed herein may be combined with one another to form
various additional embodiments not specifically disclosed, as long
as they do not contradict each other. Accordingly, additional
embodiments are possible and are intended to be encompassed within
this specification and the scope of the invention. The
specification describes specific examples to accomplish a more
general goal that may be accomplished in another way.
[0073] As used in this application, the terms "front," "rear,"
"upper," "lower," "upwardly," "downwardly," and other orientational
descriptors are intended to facilitate the description of the
exemplary embodiments of the present invention, and are not
intended to limit the structure of the exemplary embodiments of the
present invention to any particular position or orientation. Terms
of degree, such as "substantially" or "approximately" are
understood by those of ordinary skill to refer to reasonable ranges
outside of the given value, for example, general tolerances
associated with manufacturing, assembly, and use of the described
embodiments.
* * * * *