U.S. patent application number 12/969315 was filed with the patent office on 2011-04-07 for package assembly.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to TOM ARTHUR, JAMES M. PECK, BEN PRUSI, KIM ROBERTSON, SAMIR SHRESTHA, DIONA SOMMARIO, TONY SUARDINI.
Application Number | 20110079525 12/969315 |
Document ID | / |
Family ID | 41077733 |
Filed Date | 2011-04-07 |
United States Patent
Application |
20110079525 |
Kind Code |
A1 |
PECK; JAMES M. ; et
al. |
April 7, 2011 |
PACKAGE ASSEMBLY
Abstract
A method and apparatus for packaging a medical device includes a
package assembly that defines a multi-chambered interior. The
interior chambers include a primary and a secondary chamber. A
partition, which has a gas permeable vent, separates the primary
chamber from the secondary chamber. The package is constructed from
a variety of materials that provide the interior with a long term,
low humidity, sterile environment.
Inventors: |
PECK; JAMES M.; (MAPLE
GROVE, MN) ; PRUSI; BEN; (MAPLE GROVE, MN) ;
SOMMARIO; DIONA; (EDEN PRAIRIE, MN) ; ROBERTSON;
KIM; (FOREST LAKE, MN) ; SHRESTHA; SAMIR; (NEW
BRIGHTON, MN) ; ARTHUR; TOM; (CHAMPLIN, MN) ;
SUARDINI; TONY; (ROGERS, MN) |
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
MAPLE GROVE
MN
|
Family ID: |
41077733 |
Appl. No.: |
12/969315 |
Filed: |
December 15, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12143164 |
Jun 20, 2008 |
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12969315 |
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Current U.S.
Class: |
206/438 ;
206/204; 383/40; 53/425 |
Current CPC
Class: |
A61M 25/002 20130101;
A61F 2/0095 20130101; A61L 2/26 20130101; B65D 33/01 20130101; A61B
2050/3014 20160201; A61B 50/30 20160201; A61L 2/206 20130101; B65B
55/10 20130101; A61L 2202/181 20130101; A61B 2050/318 20160201;
A61B 2050/3004 20160201; A61B 2050/316 20160201 |
Class at
Publication: |
206/438 ; 383/40;
206/204; 53/425 |
International
Class: |
A61J 1/00 20060101
A61J001/00; B65D 30/22 20060101 B65D030/22; B65D 81/26 20060101
B65D081/26; B65B 55/18 20060101 B65B055/18 |
Claims
1. A dual compartment pouch comprising: front and back sheets of a
flexible barrier film arranged in opposing face-to-face relation,
each having an inner surface, a top edge, a bottom edge, and
opposite side edges extending longitudinally from said top edge to
said bottom edge; an inner sheet of a flexible barrier film
disposed between the front and back sheets and having a top edge, a
bottom edge, and opposite side edges, the inner sheet defining
first and second compartments within the pouch; side seams
extending longitudinally along said opposite side edges and joining
the front and back sheets to the inner sheet; a bottom seam
extending transversely along said bottom edges and joining the
front and back sheets to the inner sheet; an opening formed in the
inner sheet and providing communication between the first and
second compartments; a breathable membrane disposed on the inner
sheet and covering said opening, said breathable membrane having a
peripheral edge overlying the inner sheet and spaced from said side
seams and bottom seam, the breathable membrane comprising a
moisture vapor permeable, water-impermeable sheet material; and a
seam located at or adjacent the peripheral edge of the breathable
membrane joining the membrane to the inner sheet.
2. The pouch of claim 1, wherein the breathable membrane comprises
paper or a nonwoven fabric.
3. The pouch of claim 1, wherein the barrier film of the inner
sheet includes a heat sealable thermoplastic material.
4. The pouch of claim 1, wherein the top edge of the inner sheet is
unconnected to the front sheet or the back sheet to define access
openings into the first and second compartments.
5. The pouch of claim 1, further comprising a frangible seal
disposed between the front sheet and the inner sheet towards a
bottom end of the pouch.
6. The pouch of claim 5, wherein the frangible seal has a chevron
shape with an apex directed towards the bottom edges of the back
and inner sheets.
7. The pouch of claim 1, wherein the breathable membrane has a
surface area of at least about 1 square inch.
8. The pouch of claim 1, wherein the breathable membrane has a
surface area of at least about 9 square inches.
9. The pouch of claim 1, wherein the top edges of the inner sheet
and the back sheet extend beyond the top edge of the front
sheet.
10. The pouch of claim 1, wherein the opening in the inner sheet
and the breathable membrane are circular, and are joined to each
other by a continuous seam that is located at or adjacent the
peripheral edge of the breathable membrane.
11. A sterilizable dual compartment pouch comprising: front and
back sheets of a flexible barrier film arranged in opposing
face-to-face relation, each having an inner surface, a top edge, a
bottom edge, and opposite side edges extending longitudinally from
said top edge to said bottom edge; an inner sheet of a flexible
barrier film disposed between the front and back sheets and having
a top edge, a bottom edge, and opposite side edges, the inner sheet
defining first and second compartments within the pouch; side seams
extending longitudinally along said opposite side edges and joining
the front and back sheets to the inner sheet; a bottom seam
extending transversely along said bottom edges and joining the
front and back sheets to the inner sheet; a top seam extending
transversely along said top edges and joining the front and back
sheets to the inner sheet and an opening formed in the inner sheet
and providing communication between the first and second
compartments; a breathable membrane disposed on the inner sheet and
covering said opening, said breathable membrane having a peripheral
edge overlying the inner sheet and spaced from said side seams, top
seam, and bottom seam, the breathable membrane comprising a
moisture vapor permeable, water-impermeable sheet material; and a
continuous seam located at or adjacent the peripheral edge of the
breathable membrane joining the membrane to the inner sheet.
12. The sterilizable dual compartment pouch of claim 11, further
comprising a medical device disposed in the second compartment.
13. The sterilizable dual compartment pouch of claim 12, wherein
the medical device is a stent that is coated with a therapeutic
drug agent.
14. The sterilizable dual compartment pouch of claim 11, further
comprising one or more of a desiccant or scavenging agent disposed
in the first compartment.
15. A method of sterilizing an article comprising providing the
pouch of claim 1; introducing an article into the second
compartment; sealing the top edges of the inner sheet and the back
sheet to each other; introducing a sterilizing gas into the first
compartment; passing the sterilizing gas from the first compartment
to the second compartment via the breathable membrane; introducing
one or more absorbents into the first compartment; and sealing the
top edge of the front sheet to the inner sheet.
16. The method of claim 15, further comprising the step of flushing
the first and second compartments with an inert gas prior to the
introduction of one or more absorbents.
17. The method of claim 15, wherein the article is a stent that is
coated with a therapeutic drug agent.
18. The method of claim 15, wherein the breathable membrane
comprises paper or a nonwoven.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/143,164, filed Jun. 22, 2008, the entire disclosures of
which is hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1 . Field of the Invention
[0003] In some embodiments this invention relates to a package
assembly suitable for use with environmentally sensitive products,
and more particularly for use with one or more medical devices.
[0004] 2. Description of the Related Art
[0005] Packages suitable for use with environmentally sensitive
products such as medical devices employ various configurations
and/or mechanisms to provide the package interior, and the medical
device contained therein, with a secure and sterile storage
environment. Modern medical devices however, often employ a drug
component that can complicate the packaging solution by requiring
more than just a sterile environment.
[0006] From providing moisture control, to physical protection, the
addition of a drug component, such as a coating, upon a medical
device to be packaged requires more dynamic packaging solutions
than those presently available.
[0007] Some examples of known packaging solutions that are directed
to medical devices include:
[0008] U.S. Pat. No. 5,577,368 to Hamilton et al. and U.S. Pat. No.
6,174,934 to Sun et al. The packages and packaging procedures
described in these references seek to remove the oxygen/atmosphere
from the packaging prior to radiation sterilization of medical
implants made of polymeric material in order to reduce the wear
resistance of the polymeric implant.
[0009] U.S. Pat. No. 4,941,308 to Grabenkort et al. discloses
sterilizing the interior of a package before placing the product in
an inner package, sterilizing the product in the inner package, and
then placing the inner package into an outer package. Grabenkort et
al. uses ethylene oxide gas (EtO) for the sterilization.
[0010] U.S. Pat. No. 7,040,485 to Gupta and U.S. Publication
2007/0084144 A1 to Labrecque et al. describe pouches that employ
gas permeable headers intended to allow transfer of gasses between
the pouch interior and the header before and during sterilization.
These headers extend out from the pouch and may be optionally
removed.
[0011] Despite the availability of such packaging solutions, there
remains a need for an efficient packaging assembly and method
suitable for use with particularly specialized products such as
medical devices, and particularly medical devices having a drug
coating or similar therapeutic component.
[0012] The art referred to and/or described above is not intended
to constitute an admission that any patent, publication or other
information referred to herein is "prior art" with respect to this
invention. In addition, this section should not be construed to
mean that a search has been made or that no other pertinent
information as defined in 37 C.F.R. .sctn. 1.56(a) exists.
[0013] All US patents and applications and all other published
documents mentioned anywhere in this application are incorporated
herein by reference in their entirety.
[0014] Without limiting the scope of the invention a brief summary
of some of the claimed embodiments of the invention is set forth
below. Additional details of the summarized embodiments of the
invention and/or additional embodiments of the invention may be
found in the Detailed Description of the Invention below.
[0015] A brief abstract of the technical disclosure in the
specification is provided as well only for the purposes of
complying with 37 C.F.R. 1.72. The abstract is not intended to be
used for interpreting the scope of the claims.
BRIEF SUMMARY OF THE INVENTION
[0016] In at least one embodiment, the invention is directed to a
package assembly constructed from a gas impermeable shell or walls
that define the package interior. The interior is divided into
chambers by a partition. The partition defines a vent of at least
one gas permeable material. In some embodiments the vent allows gas
to flow only from a primary chamber (a product containment chamber)
to an adjacent, secondary chamber (which may contain or include a
desiccant or moisture absorbing substance).
[0017] The interior comprises two or more chambers as desired. The
chambers of the assembly are separately accessible and can be
individually sealed to allow one chamber (and/or its contents) to
be manipulated without compromising the sterile environment of the
adjacent chamber.
[0018] In some embodiments the outer shell of the assembly is
characterized has having first (i.e., front) and second (i.e.,
back) walls. The walls may be of identical or significantly
different construction, and may include a variety of materials and
characteristics in their construction. For example, in some
embodiments the package assembly comprises a UV barrier in the
make-up of one wall while such a barrier may be considered an
unnecessary expense on the opposing wall. Depending on the nature
of the product to be contained in the assembly, the environment
where it is to be stored, etc., embodiments of the invention will
include walls having one or more layers of material to provide at
least one oxygen barrier layer, at least one puncture resistant
layer, at least one moisture vapor barrier layer, at least one
ultraviolet barrier layer, and any combination thereof.
[0019] In at least one embodiment the vent is positioned in an
opening of a partition wall. The partition wall is constructed of
one or more polymer materials that define the vent opening. The
vent can be constructed out of a variety of gas permeable
materials, and may include materials such as TYVEK.RTM.. In some
embodiments the vent includes one or more valve mechanisms, (e.g.
perforation(s), diaphragm(s), degassing valve(s), etc.) to provide
the vent with a one-way direction of potential gas flow.
[0020] As indicated above, one of the chambers of the assembly is
configured to contain a desiccant. The desiccant can be of any
desired configuration and include any known moisture absorber
and/or oxygen scavenger. Also as indicated above, one of the
chambers is configured to contain a product such as a medical
device. Embodiments of the present invention are particularly
suited for the long term stable containment of medical devices that
employ one or more therapeutic agents (i.e., drug(s), etc.).
Examples of such medical devices include drug eluting stents and/or
the delivery systems (catheters, etc.) upon which they are
mounted.
[0021] In some embodiments the assembly is configured to provide a
relatively low humidity environment (relative humidity (RH) of
about 5 percent or less) for at least one month. In some
embodiments the low humidity environment is maintained for at least
18 months.
[0022] In addition to providing a unique package assembly having
the features described thus far, some embodiments of the present
invention are also directed to packaging processes and methods.
[0023] These and other embodiments which characterize the invention
are pointed out with particularity in the claims annexed hereto and
forming a part hereof. However, for further understanding of the
invention, its advantages and objectives obtained by its use,
reference should be made to the drawings which form a further part
hereof and the accompanying descriptive matter, in which there is
illustrated and described a embodiments of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0024] A detailed description of the invention is hereafter
described with specific reference being made to the drawings.
[0025] FIG. 1 is a perspective view of an embodiment of the
invention including the package assembly with a product contained
therein and desiccant depicted externally.
[0026] FIG. 2 is a lateral cross-sectional view of the embodiment
of FIG. 1.
[0027] FIG. 3 is a longitudinal cross-sectional view of the
embodiment of FIG. 1 wherein the partition structure is
illustrated.
[0028] FIG. 4 is a close-up view of an embodiment of the partition
shown in FIGS. 2 and 3.
[0029] FIG. 5 is a longitudinal cross-sectional view of an
embodiment wherein the header region includes a gas permeable
header.
[0030] FIG. 6 is a line graph showing the relative humidity of the
assembly interior over time.
[0031] FIG. 7 is a block diagram depicting the steps of a packaging
process.
DETAILED DESCRIPTION OF THE INVENTION
[0032] While this invention may be embodied in many different
forms, there are described in detail herein specific preferred
embodiments of the invention. This description is an
exemplification of the principles of the invention and is not
intended to limit the invention to the particular embodiments
illustrated.
[0033] For the purposes of this disclosure, like reference numerals
in the figures shall refer to like features unless otherwise
indicated.
[0034] As described above, various embodiments of the present
invention are directed to package assemblies. An example of a
package assembly 10 is shown in FIG. 1. In some embodiments the
assembly 10 is particularly suited for use in the packaging of
medical devices, particularly those incorporating a therapeutic
agent or drug component. Such medical devices may be of any type,
and include implantable medical devices such as stents, and/or the
catheters or other delivery systems used to deploy them.
[0035] An example of such a medical device product 100 is shown
positioned in the interior 12 of a primary chamber 14 of the
assembly 10. The interior 12 of assembly 10 also includes a
secondary chamber 16, which can be configured to house at least one
desiccant 110 (shown externally).
[0036] Desiccant 110 can be of any type or configuration known,
including but not limited to: silica gel, clay, molecular sieves,
potassium permanganate, activated carbon and activated alumina.
Examples of oxygen and/or moisture scavengers that may comprise or
be incorporated into the desiccant include but are not limited to:
calcium oxide, iron oxide powders, sulfites, bisulfites, butylated
hydroxytoluene (BHT), butylated hydroxyanisole (BHA), oxygen
absorbable polymers, etc.
[0037] The division of the package interior 12 into a primary
chamber 14 and a secondary chamber 16 is best shown in FIG. 2. As
shown, each chamber is defined on its outer perimeter by a wall 24
and 26. Walls 24 and 26 can be of the same materials and/or
construction, or distinctly different, depending on a variety of
factors that will be discussed in greater detail below. The inner
perimeter of each chamber 14 and 16 is defined by a partition
28.
[0038] Prior to the closing and sealing of the chambers 14 and 16,
each chamber is provided with respective opening 40a and 40b.
Openings 40a and 40b can be of any type or mechanism desired. In
the embodiment shown in FIGS. 1-2, each of the walls 24 and 26 and
partition 28 have corresponding sealed or closed borders 42 that
are sealed together during the manufacture of the assembly 10. In
the depicted embodiment opening 40a is provided into the primary
chamber 14 and defined by the corresponding unsealed or open
borders 44 (FIG. 1) of the wall 24 and of the partition 28. Opening
40a is closed by sealing the open borders 44 of wall 24 and
partition 28 together. Similarly, opening 40b is provided into the
secondary chamber 16 and defined by the corresponding unsealed or
open borders 46 (FIG. 1 only) of the wall 26 and of the partition
28. Opening 40b is closed by sealing the open borders 46 of wall 26
and partition 28 together.
[0039] The closing and sealing of openings 40a and 40b can be by
mechanical engagement, adhesive engagement, by application of a
heat seal, etc. In some embodiments opening 40b is capable of being
easily and repeatedly being opened and resealed.
[0040] In at least one embodiment, an example of which is shown in
FIG. 5, the assembly 10 includes a header 41 which includes one or
more vented region (see vent 32) similar to that discussed below in
regard to the partition 28. The header 41 is a region of the
assembly 10 adjacent to the chambers 14 and/or 16. The header 41
can include the region of the assembly defining the openings 40a
and/or 40b or be positioned on the opposing end of the assembly 10
such as in the manner shown. The header 41 can be entirely or
partially constructed of a gas permeable material such as, for
example, TYVEK.RTM. thereby allowing increased Ethylene Oxide (EtO)
ingress during sterilization of the package assembly 10.
Sterilization processes involving the assembly 10 are discussed in
greater detail below.
[0041] In some embodiments the shape and arrangement of the walls
24 and 26, and the partition 28 can be arranged such that more than
one border of a given wall and/or the partition defines the
openings 40a and 40b.
[0042] Walls 24 and 26 are constructed from at least one layer of
polymer material(s), such as for example: polyethylene, which allow
the adjacent walls 24 and 26 to be engaged and sealed to one
another as well as to the material of the partition 28.
[0043] Walls 24 and 26 can be supplemented with a variety of
additional material layers (via co-extrusion, lamination, etc.),
wherein each layer is selected for desired performance
characteristics. For example, embodiments of the invention will
include walls 24 and/or 26 having at least one oxygen barrier
layer, at least one puncture/tear resistant layer, at least one
moisture vapor barrier layer, at least one ultraviolet barrier
layer, and any combination thereof
[0044] Some non-limiting examples of materials that provide a
desired characteristic are represented as follows: [0045] Oxygen
barrier layer: Ethylene-vinyl alcohol copolymer (EVOH),
polyvinylidenechloride (PVDC), foil, metalized polyethylene
terephthalate (PET)/biaxially oriented nylon (BON), aluminum oxide
coatings, silica oxide coatings, polyvinyl alcohol (PVOH), TOP
AS.RTM., and any combinations thereof. [0046] Puncture/Tear
resistant layer: BON, bi-axially oriented polypropylene (BOPP),
bi-axially oriented polyester (BOPET), linear low-density
polyethylene (LLDPE), Ultra Low Density Polyethylene (ULDPE),
TYVEK.RTM. and any combinations thereof. [0047] Moisture vapor
barrier layer: metalized polypropene (PP)/PET/BON, aluminum oxide
coated polymers, silica oxide coated polymers,
ALCAR.RTM.-flourocarbons, and any combinations thereof. [0048] UV
barrier layer: foil, metalized PP/PET/BON, polymers with UV
blockers.
[0049] The particular combination of materials and/or layers of
materials in the formation of walls 24 and 26 is tailored to
specific packaging requirements of the device to be packaged, the
storage environment of the assembly 10, etc. Multiple layers of
similar or dissimilar materials, the relative thickness selected
for each layer of material, etc., can be modified as desired in
order to vary the characteristic properties of the individual
materials, the structure of the walls 24 and/or 26, and thus, the
performance of the assembly 10 itself.
[0050] In at least one embodiment, the partition 28 comprises at
least one sterile, gas permeable or breathable, material(s). In
some embodiments, an example of which is shown in FIG. 3 in order
to improve the seal between walls 24 and 26 to the partition 28,
the partition 28 comprises a housing or housing material 30 that
defines an opening 32 therethrough. The housing material 30 may be
any type of material selected for flexibility and ease in bonding
or sealing with the material of the walls 24 and 26. Some examples
of suitable materials include: LLDPE, Nylon, TYVEK.RTM., Foil,
etc.
[0051] Secured to the housing material 30 across the opening 32 is
positioned a vent 34 which is constructed of the previously
mentioned gas permeable material(s).
[0052] Vent 34 is configured to allow gases to pass from the
primary chamber 14 into the secondary chamber 16 both during the
packaging process and throughout the shelf-life of the assembly 10.
In some embodiments the vent 34 is configured to allow gases as
well as moisture to pass in only one direction from the primary
chamber 14 and into the secondary chamber 16. While the presence of
the desiccant 110, such as is illustrated in FIG. 2, within chamber
16 will facilitate this pathway, vent 34 can also be configured to
include a valve, diaphragm or other mechanism to prevent gas or
moisture from reentering chamber 14.
[0053] One non limiting example of a degassing valve mechanism
suitable for use in partition 38 is described in U.S. Pat. No.
7,178,555 the entire contents of whish is incorporated herein by
reference. In at least one embodiment, an example of which is shown
in FIG. 4, the partition 28 includes at least one ingress valve 35
and at least one egress valve 37. Another example of a valve
mechanism for use in partition 28 includes film and/or tape
membranes fabricated on the partition and which overlay pores,
slits, holes or other openings through the partition. Other types
and configuration of valve mechanisms can alternatively or
additionally be incorporated into the partition 28.
[0054] In some embodiments the vent has a minimum surface area of
about 1 square inch (6.45 cm.sup.2). In at least one embodiment the
vent has a surface area of at least 9 square inches (58
cm.sup.2).
[0055] Some examples of sterile, breathable materials that the vent
34 can be constructed from include but are not limited to: medical
grade paper, micro-perforated polymer film or films,
micro-perforated foil or foils, etc. More specific examples of
materials include, but are not limited to: polyethylene,
polystyrene, polypropylene, high density polyethylene (HDPE), etc.
In at least one embodiment the vent is constructed from a
TYVEK.RTM..
[0056] With the ability to customize and configure the material
composition of the walls 24 and 26, as well as the construction of
the partition 28 in mind, an example embodiment of the assembly 10,
such as is illustrated in FIG. 2, and which is particularly suited
for use with a drug coated medical device is described as
follows:
EXAMPLE 1
TABLE-US-00001 [0057] Layer Material Approx. Thickness (mil) Walls
24 and 26 constructed of: LDPE-EVA (peelable interior) 2 LDPE 0.75
BON 0.60 LDPE 0.75 Foil 0.70 White LDPE 1 PET (exterior) 0.48
Partition housing material 30 constructed of: LLDPE 1.6 Nylon 0.8
LLDPE 1.6 Vent 34 is constructed of TYVEK .RTM.
[0058] In the above example, the various properties that the
materials of walls 24 and 26 exhibit, as well as the functional
aspect of the partition 28 and desiccant 110; provide a near
optimum environment for minimizing potential degradation of a
therapeutic coating that a medical device 110 includes. By
providing the package assembly interior with total or near total UV
protection, optimum moisture protection, and a sterile, sealed
environment, the shelf-life of drugs and/or their respective
polymer matrices can be maintained for extended periods of
time.
[0059] For example, as illustrated by the chart of FIG. 6,
following sterilization and the final sealing of the package
assembly, the relative humidity of the primary chamber 14, as well
as the secondary chamber 16, is maintained at less than 5% for a
duration of at least 1 month. While the example illustrated in FIG.
6 is merely one representative example of the initial performance
characteristics of assembly 10 in maintaining a low moisture
environment for the short term (about 1 month depicted), in some
embodiments similar performance of the assembly 10 is maintained
for periods up to and exceeding 18 months.
[0060] It should also be noted that FIG. 6 illustrates that shortly
after final sealing of the package (approximately 70 hours) the
actual relative humidity maintained within the package interior can
drop to as low as about 3 percent to about 2 percent over the long
term.
[0061] Providing a sealed and relatively low humidity environment
is a clear benefit to numerous sensitive compositions, such as many
of the therapeutic agents utilized with implantable medical
devices. Some examples of therapeutic agents that benefit from
storage in assembly 10 include but are not limited to the following
drugs: Paclitaxel, Evorolimus, Sirolimus, etc. Similarly, polymer
matrix materials that are often utilized for the elution of such
drugs from a medical device will benefit from the internal
environment of assembly 10. Non-limiting examples of such matrix
materials include but are not limited to: poly(lactic-co-glycolic
acid) (PLGA), Polylactic Acid (PLA),
Poly(styrene-b-isobutylene-b-styrene) (SIBS), Poly(dioxanone);
poly(trimethylene); poly(caprolactone); polyanhidrides;
polyphosphozene; etc.
[0062] When used to package an environmentally sensitive product,
the insertion of the product into the assembly 10 is but one step
in a variety of possible packaging methods or processes.
[0063] For example, in block diagram depicted in FIG. 7, a process
for packaging a medical device is depicted.
[0064] Such a process includes the initial step of a pre-sterile
seal represented at block 50 wherein the medical device 100 is
inserted into the primary chamber 14 of the assembly 10 (shown in
FIGS. 1-2) and then the chamber 14 is sealed in the manner
previously described. As will be made clear below, step 50 need not
be undertaken in a sterile environment, though it can be if
desired.
[0065] As represented by block 52 once chamber 14 is sealed,
secondary chamber 16 remains open and the entire assembly along
with the product contained therein is sterilized. The sterilization
process may be in accordance with any known sterilization
technique, in accordance with the limitations of the product. For
example, the assembly can be subjected to e-beam sterilization,
Ethylene Oxide (EtO) sterilization, etc.
[0066] Depending on the sterilization process utilized, following
sterilization the assembly is subjected to vacuum drying as
represented by block 54.
[0067] As represented by block 56, following the sterilization
procedure 52, and optional drying 54, the desiccant 110 is inserted
into the secondary chamber 16 (shown in FIGS. 1-2).
[0068] Once the desiccant is in position within the secondary
chamber the final seal, represented by block 58, is applied to the
opening 40b of chamber 16. In some embodiments final seal of the
assembly includes the additional steps of applying vacuum to the
assembly and/or flushing the assembly interior with an inert gas
before the opening of the secondary chamber is sealed.
[0069] It is recognized that maintenance of a sterile environment
during the entire sealing process is important, particularly where
the product in question is an implantable medical device. In some
embodiments, the assembly is transferred or kept in a nitrogen cart
between the steps of the packaging process described above.
[0070] Once the assembly is finally sealed, a label 112 can be
applied to the assembly exterior (as depicted in FIG. 1) and the
assembly is then boxed for shipment as represented by block 60.
[0071] This completes the description of representative embodiments
of the invention. Those skilled in the art may recognize other
equivalents to the specific embodiment described herein which
equivalents are intended to be encompassed by the claims attached
hereto.
[0072] The above disclosure is intended to be illustrative and not
exhaustive. This description will suggest many variations and
alternatives to one of ordinary skill in this art. The various
elements shown in the individual figures and described above may be
combined or modified for combination as desired. All these
alternatives and variations are intended to be included within the
scope of the claims where the term "comprising" means "including,
but not limited to".
[0073] Further, the particular features presented in the dependent
claims can be combined with each other in other manners within the
scope of the invention such that the invention should be recognized
as also specifically directed to other embodiments having any other
possible combination of the features of the dependent claims.
* * * * *