U.S. patent application number 17/369666 was filed with the patent office on 2021-10-28 for sterilization fluid path with barrier removal.
This patent application is currently assigned to FLEX LTD.. The applicant listed for this patent is FLEX LTD.. Invention is credited to Eyal BARMAIMON, Tommaso BORGHI, Shai FINKMAN, Christian RIVA, Lior SHTRAM, David WARD.
Application Number | 20210330552 17/369666 |
Document ID | / |
Family ID | 1000005698847 |
Filed Date | 2021-10-28 |
United States Patent
Application |
20210330552 |
Kind Code |
A1 |
BARMAIMON; Eyal ; et
al. |
October 28, 2021 |
STERILIZATION FLUID PATH WITH BARRIER REMOVAL
Abstract
A device and method is disclosed for assembling a container
holder in a clean environment, aseptically adding a solution to a
primary container, inserting the primary container into the
container holder, applying a first barrier to the container holder,
sterilizing the container holder comprising the primary container
and the applied first barrier to provide a sterilized container
holder, assembling a fluid path module in a clean environment, the
assembling comprising applying a second barrier to a first end of
the sterilized fluid path module, sterilizing the fluid path module
to provide a sterilized fluid path module and assembling a delivery
device comprising the sterilized container holder and the
sterilized fluid path module.
Inventors: |
BARMAIMON; Eyal; (Haifa,
IL) ; SHTRAM; Lior; (Tel-Aviv, IL) ; FINKMAN;
Shai; (Haifa, IL) ; RIVA; Christian; (Milan,
IT) ; BORGHI; Tommaso; (Milan, IT) ; WARD;
David; (Milan, IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FLEX LTD. |
Singapore |
|
SG |
|
|
Assignee: |
FLEX LTD.
Singapore
SG
|
Family ID: |
1000005698847 |
Appl. No.: |
17/369666 |
Filed: |
July 7, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16295818 |
Mar 7, 2019 |
11058605 |
|
|
17369666 |
|
|
|
|
62640421 |
Mar 8, 2018 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 2/26 20130101; A61L
2202/24 20130101; A61L 2/18 20130101; A61L 2/07 20130101; A61J
1/1443 20130101; A61L 2/20 20130101; A61L 2202/23 20130101; A61M
2005/14573 20130101; A61M 2005/14252 20130101; A61L 2202/18
20130101 |
International
Class: |
A61J 1/14 20060101
A61J001/14; A61L 2/26 20060101 A61L002/26; A61L 2/07 20060101
A61L002/07; A61L 2/18 20060101 A61L002/18; A61L 2/20 20060101
A61L002/20 |
Claims
1. A delivery device comprising: a sterilized container holder
comprising: a sterilized primary container comprising an
aseptically added solution; a first barrier; and a sterilized fluid
path module comprising: a sterilized penetration needle; a
sterilized channel; a sterilized user needle; and a second barrier
at a first end of the sterilized fluid path module.
2. The delivery device of claim 1, further comprising a third
barrier at a second end of the sterilized fluid path module.
3. The delivery device of claim 1, wherein the sterilized fluid
path module is configured to connect to the sterilized container
holder via the sterilized penetration needle.
4. The delivery device of claim 1, wherein at least one of the
first barrier and the second barrier is a septum material.
5. The delivery device of claim 4, wherein the septum material is
at least one of an aluminum foil, Tyvek and a thermoplastic
elastomer (TPE).
6. A sterilized fluid path module comprising: a sterilized
penetration needle; a sterilized channel; a sterilized user needle;
and a second barrier at a first end of the sterilized fluid path
module.
7. The sterilized fluid path module of claim 6, further comprising
a drive module.
8. The sterilized fluid path module of claim 6, further comprising
a third barrier at a second end of the sterilized fluid path
module.
Description
[0001] This application is a divisional of U.S. patent application
Ser. No. 16/295,818, filed on Mar. 7, 2019, which claims the
benefit of U.S. Provisional Patent Application No. 62/640,421,
filed on Mar. 8, 2018, the contents of which are hereby
incorporated by reference herein.
BACKGROUND
[0002] In medical devices such as combination patch pumps, which
include a pump and a solution (e.g., drug), the solution, while
inside the pump, cannot pass a sterilization process for a fluid
path that transports the solution. Using an unsterilized fluid path
can cause adverse effects such as infections and is unacceptable
from a risk management perspective
SUMMARY
[0003] A device and method is disclosed for assembling a container
holder in a clean environment, aseptically adding a solution to a
primary container, inserting the primary container into the
container holder, applying a first barrier to the container holder,
sterilizing the container holder comprising the primary container
and the applied first barrier to provide a sterilized container
holder, assembling a fluid path module in a clean environment, the
assembling comprising applying a second barrier to a first end of
the sterilized fluid path module, sterilizing the fluid path module
to provide a sterilized fluid path module and assembling a delivery
device comprising the sterilized container holder and the
sterilized fluid path module.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] A more detailed understanding may be had from the following
description, given by way of example in conjunction with the
accompanying drawings wherein:
[0005] FIG. 1A is a graphic depiction of a patch pump for a
user.
[0006] FIG. 1B is a graphic depiction of the outer casing of an
example of a patch pump.
[0007] FIG. 1C is a graphic depiction of an example of a patch pump
with the outer casing removed.
[0008] FIG. 2A is a graphical depiction of a container holder;
[0009] FIG. 2B is a graphical depiction of primary container with
solution, inserted into a container holder;
[0010] FIG. 2C is a graphical depiction of a sterilized fluid path
module;
[0011] FIG. 2D is a graphical depiction of barriers associated with
a sterilized container holder and fluid path;
[0012] FIG. 3 is a graphical depiction of a sterilization process;
and
[0013] FIG. 4A is a graphical depiction of a penetration needle and
a user needle penetrating barriers;
[0014] FIG. 4B is a graphical depiction of a penetration needle and
a user needle penetrating surfaces; and
[0015] FIG. 5 is a graphical description of assembling a delivery
device.
DETAILED DESCRIPTION
[0016] Examples of sterilized delivery device implementations will
be described more fully hereinafter with reference to the
accompanying drawings. These examples are not mutually exclusive,
and features found in one example can be combined with features
found in one or more other examples to achieve additional
implementations. Accordingly, it will be understood that the
examples shown in the accompanying drawings are provided for
illustrative purposes only and they are not intended to limit the
disclosure in any way. Like numbers refer to like elements
throughout.
[0017] Below are described an apparatus and methods for delivering
solutions such as pharmaceutical drugs and/or biologics to a
patient. The apparatus and methods may allow for prescription or
standard off-the-shelf drug cartridges, vials, syringes, or other
containers (hereinafter generally referred to as a container), to
be utilized without compromising the sterility of the solution.
This may enable a patient to self-administer a solution in a
self-contained wearable patch pump form factor that is cost
effective and comfortable to wear. The disclosure subject matter
provided herein may allow the manufacturing and use of a drug
delivery device that includes a sterilized fluid path and container
holder.
[0018] FIGS. 1A-1C show an example delivery device is shown via
patch pump 100, which may be used with the sterilized container
holder and sterilized fluid path as further described herein. A
sterilized container holder may be provided in accordance with the
subject matter disclosed herein. A delivery device may include such
a sterilized container holder, which may connect to a sterilized
container holder, in accordance with the subject matter disclosed
herein. It will be understood, however, that patch pump 100 is an
example, and other patch pumps or delivery devices may be used to
implement a sterilized fluid path and sterilized container holder,
as disclosed herein.
[0019] FIG. 1A is a graphic depiction of a patch pump 100 on a
patient 115. The patch pump 100 includes a base 125 that contacts
the patient's skin. In some embodiments, the base 125 includes an
adhesive liner that affixes the patch pump 100 to the patient 115.
The patch pump 100 may further include a user flow control switch
135. The user flow control switch 135 may enable a user to pause
and control the flow rate of a solution. The patch pump 100 further
includes a start button 105 that may be pressed by a user to cause
a cannula and/or needle to be inserted into the patient and the
solution to flow from a drug container 130 through the cannula
and/or needle into the patient.
[0020] As shown in FIG. 1B, the patch pump 100 may further include
a drug viewing window 145. This viewing window may enable a user to
view the amount of a solution that remains in the drug container
130. The patch pump 100 may also include one or more visual
indicators 155. The visual indicators 155 provide feedback on the
operational status of the system. The operational status of the
system may include warnings such as an over/under temperature
warning, drug expiration warning and over/under pressure warning.
In addition, the operational status may include information
indicating that the drug is being administered, how much time is
remaining for the drug dosage to be completed and the current flow
rate. The visual indicators may include LEDS, LCD displays or other
similar display technologies known in the art. The information that
is displayed by visual indicators may also be wirelessly
transmitted to a mobile computing device such as a smart phone
utilizing any of the wireless communication methods known in the
art.
[0021] The patch pump 100 may further include a removable safety
170. The removable safety mechanically engages the start button 105
and prohibits the start button 105 from being involuntary
pressed.
[0022] FIG. 1C shows additional components of a patch pump 100. The
patch pump 100 may also include a needle insertion component 185
that is mechanically connected to the start button 105. In
addition, the patch pump 100 includes an electronic circuit board
140 that includes control circuitry for the visual indicators 155,
user flow control switch 135 and a pressurization system 150. In
addition, the electronic circuit board 140 may be communicatively
connected to one or more sensors. These sensors may include
pressure sensor 165 and proximity sensor 175 or any other
applicable sensor such as a haptic feedback sensor (not shown) or
other indicator. The electronic circuit board 140 may also include
a memory 190. The memory 190 may store dosing instructions for the
administration of the solution. In addition, the memory 190 may
also store information regarding the administration of the
solution. This information IT may include, time, date, and flow
rate when the solution was administered. The electronic circuit
board 140 may control the visual indicators 155 and the
pressurization system 150 based on the information stored in the
memory and the feedback from the sensors. The electronic circuit
board 140 may include a communication module that enables the
transmission of information stored in the memory 190 to a wireless
computing device. In addition, the communication module may also
receive updated dosing instructions that are subsequently stored in
the memory 190.
[0023] According to the implementations disclosed herein, a
delivery device may be assembled such that a sterilized container
holder and a sterilized fluid path are provided to operate the
delivery device. The sterilized container holder and the sterilized
fluid path may be assembled via two separate processes such that
they may be provided as separately packaged components. By
providing the sterilized container holder and the sterilized fluid
path as separately packaged components, a user may be able to use
combinations two or more different container holders (e.g., two or
more different drugs) with different sterilized fluid path
components. For example, a first sterilized container holder and a
first sterilized fluid path may be used in conjunction with a patch
pump at a first time. Subsequently, a second sterilized container
holder with a different drug than the first sterilized container
holder and a second sterilized fluid path that is similar to the
first sterilized fluid path may be provided. For example, multiple
sterilized fluid path components may be bought as a pack of two or
more sterilized fluid path components such that they can be used
with different drugs via different sterilized container
holders.
[0024] As disclosed herein, a septic process may be used when
transferring or handling a solution (e.g., a drug) and a
sterilization process may apply to components where the transfer or
contamination of a solution is not applicable.
[0025] A sterilized container holder may be assembled such that a
non-sterilized container holder may be provided in a clean
environment. A clean environment may be, for example, an ISO
certified clean room. The container holder may go through a
sterilization process either inside or outside the clean
environment. A solution, such as a drug, may be inserted into a
primary container, inside a septic environment. The primary
container may be a sterilized primary container. The solution may
be inserted into the primary container via an aseptic filling
technique. The aseptically filled primary container containing the
solution may then be stoppered to seal the solution inside of the
primary container, resulting in an overall aseptic insertion of the
solution into the primary container. The stoppered primary
container with the aseptically filled solution may be inserted into
the container holder after the container holder is sterilized,
resulting in a sterilized container holder with a primary container
including a solution. The sterilized container holder may include a
barrier, as further disclosed herein, that seals the sterilized
container holder such that the sterilized container holder
maintains its sterilization.
[0026] A sterilized fluid path may be assembled in a clean room.
The fluid path may include a penetration needle, a channel via
which the solution traverses, and a user needle configured to
insert into a user or into a cannula to provide the solution to a
user. The penetration needle may, as further disclosed herein,
receive and/or draw solution from a primary container. The channel
may be a line, pipe, hose, or other mode to transport fluid from at
least the penetration needle to the user needle. The user needle
may be configured to insert into a user or to provide fluid to a
cannula or other needle that provides the solution to a user. As
used herein, the sterilized fluid path and/or fluid path may also
include a drive module. The drive module may be configured to cause
the solution to be driven from the primary container, through the
sterilized fluid path, and to a user. The sterilized fluid pathway
may include one or two barriers, as further disclosed herein, that
seal the sterilized fluid path such that the sterilized fluid path
maintains its sterilization. A first such barrier may be on the end
where the penetration needle is located and a second such barrier
may be on the end where the user needle is located.
[0027] As described herein, a clean environment may be a clean room
or other environment that meets a given standard. Clean rooms may
be classified according to the cleanliness level of the air inside
them. The clean room class may correspond to the level of
cleanliness the room complies with, according to the quantity and
size of particles per volume of air. The primary authority in the
US and Canada is the ISO classification system ISO 14644-1, though
it will be understood that the clean environment disclosed herein
is not limited to the ISO classification. This standard includes
the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO
7, ISO 8 and ISO 9, with ISO 1 being the "cleanest" and ISO 9 the
"dirtiest" class (but still cleaner than a regular room). The most
common classes are ISO 7 and ISO 8.
[0028] FIG. 2A shows an empty container holder 211 sterilization
process 210. The empty container holder 211 may be assembled,
manufactured, prepared or otherwise provided in a clean environment
such as an ISO certified clean room (e.g., ISO 8), as disclosed
herein. During the sterilization process 210, the container holder
may be handled or otherwise manipulated by a robotic arm or other
machine, or may be handled or otherwise manipulated by a user. As
shown, the empty container holder 211 may experience sterilization
at 212 such that the container holder may be sterilized to remove
particles, dust, bacteria, contaminants, or other components that
are not desirable.
[0029] FIG. 2B shows a clean assembly 220 during which solution 221
is aseptically inserted and stored in a primary container 222,
stoppered, and inserted into a sterilized container holder 227. The
container holder 227 may be assembled, manufactured, prepared or
otherwise provided in a clean environment such as an ISO certified
clean room (e.g., ISO 5), as disclosed herein. As shown, a solution
221 may be inserted into primary container 222 via an aseptic
filling 223. Aseptic filling 223 may also include sterilization of
the solution 221, sterilization of the primary container 222, and
conservation of sterility during the filling. Equipment and
packaging materials used during the aseptic filing 223 may be
sterilized with various medium or combination of mediums such as
via saturated steam, superheated steam, hydrogen peroxide, heat,
and/or other treatments.
[0030] As shown in FIG. 2B, a stopper 226 may be applied to an
aseptically filled primary container 224 at the stoppering step
225. The stoppering step 225 may include applying the stopper 226
to the aseptically filled primary container 224 via any applicable
technique such as forced or mechanical stoppering such that the
stopper 226 seals the solution 221 inside the aseptically filled
primary container 224.
[0031] The sterilized container 211 of FIG. 2A may be provided such
that the stoppered aseptically filled primary container 224 is
inserted into the empty container holder 211 to provide a
sterilized container holder 227. The aseptically filled primary
container 224 may be inserted into the empty container holder 211
in a clean environment, which may be the same as or different from
the clean environment in which the solution 221 is aseptically
filled into the primary container 222. As further disclosed herein,
a barrier may be applied to the sterilized container holder
227.
[0032] FIG. 2C shows a penetration needle 231, a channel 232, and a
user needle 233 such that the channel 232 connects the penetration
needle 231 to the user needle 233. As disclosed herein, the
penetration needle 231 is configured to puncture a primary
container (e.g., aseptically filled primary container 224 of FIG.
2B) inside a container holder (e.g., the sterilized container
holder 227 of FIG. 2B) such that solution (e.g., solution 221 of
FIG. 2B) is provided to the channel 232 and to a user via the user
needle 233.
[0033] The fluid path module 230 may include drive module 234,
penetration needle 231, channel 232, and user needle 233 that are
assembled, manufactured, prepared or otherwise provided in a clean
environment such as an ISO certified clean room (e.g., ISO 7), as
disclosed herein. The drive module 234 may include components that
cause a solution to be inserted into and/or traverse through the
fluid path module 230 and, specifically, via the penetration needle
231, channel 232, and user needle 233. The device module may
include on or more electronic components, mechanical components, or
a combination of the same. According to an implementation, a drive
module 234 may not be provided such that a patch pump, patch pump
component(s), or other component may substitute for the
functionality provided by the drive module 234.
[0034] The fluid path module 230 may experience sterilization, to
provide a serialized fluid path module 240, such that the
components of the fluid path module 230 including the penetration
needle 231, channel 232, user needle 233 and drive module 234 are
sterilized to remove particles, dust, bacteria, contaminants, or
other components that are not desirable. As shown, the sterilized
fluid path module 240 may include a sterilized penetration 241, a
sterilized channel 242, sterilized user needle 243 and sterilized
drive module 244. The sterilized fluid path module 240 may be
sealed or otherwise treated to mitigate contamination.
[0035] As shown in FIG. 2D, a delivery device 250 may be assembled
and may include the sterilized container holder 227 and a
sterilized fluid path 240 including sterilized penetration 241, a
sterilized channel 242, and sterilized user needle 243. The
delivery device 250 may be a standalone device or may be configured
to incorporate the sterilized container holder 227 and sterilized
fluid path 240 into its operation. For example, the delivery device
250 may be patch pump 100 of FIG. 1A-FIG. 1C, a different patch
pump or a different device configured to provide a solution.
[0036] As shown in FIG. 2D, one or more barriers may be applied to
the sterilized container holder 227 and/or sterilized fluid path
240. A container holder barrier 251 may be applied to the container
holder 227. A penetration needle barrier 252 may be applied to a
first end of the sterilized fluid path 240 (e.g., on the end
closest to the sterilized penetration needle 241). A user needle
barrier 253 may be applied to a second end of the sterilized fluid
path 240. The barriers 251, 252, and 253 may all be the same or may
be similar or, alternatively, may be different from each other. The
material for barriers 251, 252, and 253 may be any applicable
single layer or multi layer material configured to provide a seal
or barrier between the component that the respective barrier 251,
252 or 253 is attached to and anything external to the component.
As non-limiting examples, the material for barriers 251, 252, and
253 may be aluminum foil, Tyvek or material with properties the
same as or similar to Tyvek (collectively referred to as "Tyvek"
herein), or a thermoplastic elastomer (TPE).
[0037] FIG. 3 shows a complete diagram including the components and
steps provided in FIG. 2A-D. As shown, at 210, an empty primary
container 211 is provided in a clean environment and is sterilized
at 212. A solution 221 is aseptically inserted, at 223, into a
primary container 222. The primary container 222 is filled with the
solution 221 and is stoppered 225 via stopper 226. The stoppered
and aseptically filed primary container 224 is placed inside the
container holder (after sterilization 212) such that a sterilized
container holder 227 includes a primary container 224 including the
solution 221.
[0038] A penetration needle 231, channel 232, and user needle 233
is assembled with a drive module 234 and sterilized in a clean
environment to result in a sterilized fluid path 240 that includes
a sterilized penetration needle 241, sterilized channel 242,
sterilized user needle 243 and sterilized drive module 244.
[0039] A delivery device 250 includes the sterilized container
holder 227 and sterilized fluid path 240 as well as container
holder barrier 251 attached to the sterilized container holder 227,
penetration needle barrier 252 attached to a first end of the
sterilized fluid path 240 near the sterilized penetration needle
241, and a user needle barrier 253 attached to a second end of the
sterilized fluid path 240 near the sterilized user needle 243.
[0040] The barrier(s) (i.e., container holder barrier 251,
penetration needle barrier 252, and/or user needle barrier 253) may
be configured to seal the components that they are attached to and
may further be configured to maintain the sterility of a component
that they are attached to. For example, the container holder
barrier 251 may be configured to seal the sterilized container
holder 227 such that the sterility of the sterilized container
holder 227 is maintained as a result of seal provided by the
container holder barrier 251.
[0041] It should be noted that the sterilized container holder 227
and the sterilized fluid path 240 may be manufactured and/or
shipped at the same time or may be manufactured/and or shipped as
separately packaged items. Such flexibility may reduce cost and
allow separate uses of the sterilized container holder 227 and the
sterilized fluid path 240.
[0042] FIG. 4A shows an implementation of the disclosed subject
matter where the penetration needle 241 is configured to penetrate
a surface of the sterilized fluid path 240, penetration needle
barrier 252, and a surface of the sterilized container holder 227
after the container holder barrier 251 is removed. As shown, the
sterilized penetration needle 241 may be inserted through a surface
of the fluid path 240 that is adjacent or proximal to the
sterilized penetration needle 241 and through the container holder
barrier 251, and into the sterilized container holder 227. Note
that the container holder barrier 251 may be removed to avoid
contamination associated with the outside of the container holder
barrier 251. The penetration by the penetration needle 241 may be a
result of an electronic or mechanical force applied to the
sterilized penetration needle 241 (e.g., via which the sterilized
penetration needle 241 is pushed or pulled towards the sterilized
container holder 227) and/or an electronic or mechanical force
applied to the sterilized container holder 227 (e.g., via which the
sterilized container holder is pushed or pulled towards the
penetration needle 241).
[0043] According to the implementation shown in FIG. 4A, the
sterilized user needle 243 is configured to penetrate a surface of
the sterilized fluid path 240 and sterilized user needle barrier
253. As shown, the sterilized user needle 243 may be inserted
through a surface of the fluid path 240 that is distal from the
sterilized penetration needle 241 and through the user needle
barrier 253. The penetration by the sterilized user needle 243 may
be a result of an electronic or mechanical force applied to the
sterilized user needle 243 (e.g., via which the sterilized user
needle 243 is pushed or pulled towards user needle barrier 253)
and/or an electronic or mechanical force applied in the direction
from the user needle barrier 253 towards sterilized user needle
243.
[0044] FIG. 4B shows an implementation of the disclosed subject
matter where the barrier(s) (i.e., container holder barrier 251,
penetration needle barrier 252, and/or user needle barrier 253) are
removed prior to penetration by the sterilized penetration needle
241 and/or sterilized user needle 243. The barrier(s) may be
removed by, for example, a user or may be removed automatically
based on an electrical or mechanical movement, which causes removal
of the barrier(s). For example, a patch pump (e.g., such as patch
pump 100 of FIG. 1A-FIG. 1C) may include mechanisms to remove
barriers such as the container holder barrier 251, penetration
needle barrier 252, and/or user needle barrier 253. One or more
barriers may be removed at the same time or each barrier of the
multiple barriers may be removed at different times.
[0045] According to the implementation shown in FIG. 4B, the
sterilized penetration needle 241 may penetrate one or more
sterilized fluid path 240 surfaces, and one or more surfaces of the
sterilized container holder 227 and may be configured to provide
solution contained in the sterilized container holder 227 into the
sterilized channel 242. The user needle may be configured to
penetrate one or more sterilized fluid path 240 surfaces and may be
configured to provide solution from the sterilized channel 242 to a
user or other component(s) which then provide the solution to a
user.
[0046] FIG. 5 shows a process with components in accordance with an
implementation disclosed herein. As shown, a container holder may
be assembled at 501 and may include primary container 510,
container holder 511, and container holder barrier 512. At 502, the
assembled container holder may be sterilized. The assembly 501
and/or sterilization may occur in a clean room, as disclosed
herein. A solution 514 may be aseptically added to the primary
container 510, at 503. The solution 514 may be sealed via a stopper
513 at 503.
[0047] As shown at 504 in FIG. 5, components of a fluid path 520
along with a penetration needle barrier 521 may be assembled. The
fluid path 520 and penetration needle barrier 521 may be sterilized
at 505. The assembly 504 and/or sterilization may occur in a clean
room, as disclosed herein.
[0048] As noted herein, the sterilized primary container 510 and/or
container holder 511 assembled at step 503 may be manufactured and
shipped at the same location and time or at a different location
and time than the sterilized fluid path assembled at 505.
[0049] A delivery device 530 may be assembled at 507 and 508 such
that a device component 531, the sterilized primary container 510,
container holder 511, container holder barrier 512, fluid path 520,
and penetration needle barrier 521 may be assembled to provide a
delivery device 530.
[0050] Although features and elements are described above in
particular combinations, one of ordinary skill in the art will
appreciate that each feature or element can be used alone or in any
combination with the other features and elements.
* * * * *