U.S. patent application number 10/612998 was filed with the patent office on 2004-09-09 for packaging system for medical components.
This patent application is currently assigned to Cobe Cardiovascular, Inc.. Invention is credited to Jacobson, Peter S., Johnson, Jeffrey P., Stoneburner, Joseph H..
Application Number | 20040173487 10/612998 |
Document ID | / |
Family ID | 23865733 |
Filed Date | 2004-09-09 |
United States Patent
Application |
20040173487 |
Kind Code |
A1 |
Johnson, Jeffrey P. ; et
al. |
September 9, 2004 |
Packaging system for medical components
Abstract
An integrated package suited to the packaging of medical devices
and surgical equipment including devices and equipment used in
heart by-pass surgery has a container and a snap-fit lid. The
container and the lid have topographies suitable to conform to the
medical components in the container and hold them securely. The lid
has first and second grooves which engage a projection on the
container and permit the lid to be used in a shipping orientation
and a disposal orientation.
Inventors: |
Johnson, Jeffrey P.;
(Boulder, CO) ; Jacobson, Peter S.; (Lafayette,
CO) ; Stoneburner, Joseph H.; (Loveland, CO) |
Correspondence
Address: |
POPOVICH, WILES & O'CONNELL, PA
650 THIRD AVENUE SOUTH
SUITE 600
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Cobe Cardiovascular, Inc.
|
Family ID: |
23865733 |
Appl. No.: |
10/612998 |
Filed: |
July 2, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10612998 |
Jul 2, 2003 |
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10008390 |
Nov 6, 2001 |
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6588587 |
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10008390 |
Nov 6, 2001 |
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09469965 |
Dec 21, 1999 |
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6311838 |
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Current U.S.
Class: |
206/363 ;
206/438; 206/564 |
Current CPC
Class: |
B25H 3/021 20130101 |
Class at
Publication: |
206/363 ;
206/438; 206/564 |
International
Class: |
A61L 015/00; A61B
017/06; A61B 019/02 |
Claims
What is claimed is:
1. A medical package for shipping medical components and for
disposing of the medical components contaminated with medical waste
after use comprising: a container having a bottom surface and
sidewalls forming an opening; and a lid configured to attach to the
container to cover the opening in a first orientation when the
medical components are enclosed in the container during shipment
and in a second orientation different from the first orientation
when the used medical components contaminated with medical waste
are enclosed in the container during disposal.
2. The medial package of claim 1 wherein a first volume is enclosed
within the container when the lid is in the first orientation and
wherein a second volume is enclosed within the container when the
lid is in the second orientation, the second volume being greater
than the first volume.
3. The medical package of claim 1 wherein the lid forms a seal
about the opening in the container when in the second orientation
such that fluid medical waste can be contained in the
container.
4. A method of disposing of used medical components comprising:
supplying a packaging system for shipment of the medical
components, the packaging system comprising a container having an
interior surface and an opening, and a lid configured to attach to
the container in a manner that covers the opening in one of a
shipping orientation and a disposal orientation which is different
from the shipping orientation; placing the used medical components
in the container in which they were shipped; and covering the
container with the lid attached in the disposal orientation.
5. A method of packaging medical components from shipping to
disposal comprising: providing a packaging system including a
container having an interior surface and an opening, and a lid
configured to be oriented with respect to the container in a first
position when shipping medical components and in a second position,
different from the first position, when disposing of the medical
components; enclosing the medical components in the container with
the lid positioned in the first position; removing the medical
components from the container; using the medical components in a
medical procedure; and placing the used medical components in the
container with the lid positioned in the second position.
6. The method of claim 5 wherein placing the medical components in
the container with the lid in the first position forms a first
enclosed volume within the container and placing the used medical
components in the container with the lid in the second position
forms a second enclosed volume within the container, the second
volume being greater than the first volume.
7. A method of packaging medical components from shipping to
disposal comprising: providing a packaging system including a
container having an interior surface and an opening, and a lid
configured to cover the opening, the lid being shaped to cover the
opening in a shipping position enclosing a first volume within the
container and a disposal position enclosing a second volume within
the container, the second volume being greater than the first
volume; enclosing the medical components within the container with
the lid in the shipping position; removing the medical products
from the container; using the medical components in a medical
procedure; and enclosing the used medical components within the
container with the lid in the disposal position.
8. The method of claim 7 wherein the shipping position is different
from the disposal position.
Description
[0001] This application is a continuation of application Ser. No.
10/008,390, filed Nov. 6, 2001, now U.S. Pat. No. 6,588,587, which
is a continuation of application Ser. No. 09/469,965, filed Dec.
21, 1999, now U.S. Pat. No. 6,311,838, the contents of which are
hereby incorporated herein in their entirety.
FIELD OF THE INVENTION
[0002] This invention relates to the packaging of medical
components. More particularly, this invention relates to sterile
packages of medical equipment and devices used in heart
surgery.
BACKGROUND OF THE INVENTION
[0003] Various sterile packages are used to hold medical components
(i.e., devices and equipment) or instruments for surgical
procedures. One type of packaging is a molded or thermo-formed
sterilized substantially rigid plastic container capable of holding
various components. Another type is a flexible pouch into which
equipment and supplies can be inserted. The necessary supplies and
equipment for a particular surgery are packaged together,
sterilized, and delivered to the operating room ready for use.
[0004] The current method of packaging oxygenators (i.e., equipment
to substitute for lung function during heart by-pass surgery)
typically is "bagging" the device in a flexible permeable bag. The
device in the bag may be supported by formed plastic within the
bag. Supports outside the bag may also be used. Such include formed
or die-cut foam, die-cut corrugated paperboard, or formed plastic.
The flexible permeable bag seals in the oxygenator and acts as a
sterile barrier. However, maintaining a sterile barrier with a
flexible bag is difficult for a device such as an oxygenator, which
may weigh as much as about 6 lb. (2.7 kg), and which contains
multiple sharp protrusions (e.g., ports, stopcock manifolds, and
mating edges of rigid plastics). Moreover, a flexible bag functions
poorly in distributing forces of the oxygenator within the bag,
creating pressure points vulnerable to vibrational friction and
shock. In addition, the bag can be damaged during handling (before
surgery) when the bag and its contents are removed from its
shipping container.
[0005] Oxygenators are part of perfusion systems used in heart
surgery. Similar packaging issues have arisen for perfusion
equipment other than oxygenators. Perfusion systems typically
contain one or more of an oxygenator, tubing sets, filters, blood
reservoirs, sensors, connectors, blood cooling coils and other
items comprising an extracorporeal blood circuit that may be used
in heart by-pass procedures.
[0006] A technician assembles and packages the components of a
perfusion system to the specifications of a particular hospital,
typically as defined by the surgical team. Thus there are a variety
of types of such packages on the market and the components of these
packages may very greatly. For example, in addition to the
variability in the number and type of components present in the
package, the components may be connected in a sequence and with
varying lengths of tubing as specified by the surgical team. It is
frequently desirable to provide the packages "pre-connected", so
that very little, if any, set up of the packaged components is
required.
[0007] One currently available perfusion package is a rigid
thermoformed container with a rigid inner tray securely taped
within the container. The inner tray holds the necessary components
and devices of the perfusion package by various shaped holders,
adhesive tapes, and fasteners. The container is sealed with a
breathable covering, such as a polyethylene membrane (such as that
commercially available under the trade designation TYVEK.TM. from
E.I. DuPont deNemours and Co.). A breathable covering permits
sterilization of the package with ethylene gas.
[0008] Another commercial product is a two-tiered system having a
rigid thermoformed plate separating the tubing sets on the bottom
tier of a rigid container from the oxygenator and pump lines on the
top tier. The contents of the package are secured by using
shrink-wrap film. The entire tray is covered with sterile surgical
paper and sealed in a breathable bag. The system is sterilized and
then shipped to the customer.
[0009] Yet another packaging system is a semi-rigid corrugated
plastic tray that has metal framing to provide added support to the
tray. Devices and components are strapped within holders or formed
parts that are adhered to the floor of the tray and secured with
mechanical fasteners. Once the tray has been packed, it is covered
with a corrugated plastic lid. The entire system is placed into a
breathable sterile barrier bag for sterilization before use.
[0010] Current packaging systems share some disadvantages. Current
systems typically are packed to each customer's specifications so
each package may have different components in it. There is no
defined position in the package for a component. Typically the
technician who is packing perfusion equipment loads in the medical
components and restrains them from movement by means of various
fasteners. Because of this, the systems are not only time-consuming
to pack but operator inconsistencies develop because of variable
placement of the components. These disadvantages also lead to more
costly assembly time.
[0011] Disposal of the package, once the components in the package
have served their use in surgery, can also be problematic.
Typically, the components and the package are placed in bags or
pouches for removal and disposal. This also is an additional
expense and can be time consuming.
[0012] Thus, a need in the art exists for a packaging system for
medical components which provides ease of assembly and use,
adequate support and cushioning for the components, the ability to
vary the types of components without changing the package, and a
way to dispose of the package inexpensively and conveniently.
SUMMARY OF THE INVENTION
[0013] This invention is an integrated package particularly suited
to the packaging of medical devices and surgical equipment
including devices and equipment used in heart by-pass surgery. The
package comprises a container and a snap-fit lid. The lid is
positioned in the opening of the container and pushed into
position. A projection on the container and a groove on the lid
provide a "snap-fit" of the lid to the container.
[0014] In a first aspect, this invention is a packaging system for
medical components comprising a container having a bottom surface,
first and second opposing sidewalls and third and fourth opposing
sidewalls, the bottom surface and sidewalls being connected to form
an interior surface of the container such that an opening is formed
in the container opposite the bottom surface, the opening being
defined by a top edge of the sidewalls, the sidewalls having a
circumferential projection in the direction of the interior
surface; and a lid having a first side and a second side and a
perimeter section sized to fit within the opening in the container,
the perimeter section having at least one circumferential groove,
the lid being configured to attach to the container in a manner
that covers the opening in one of a first mode where the second
side of the lid is oriented toward the interior surface of the
container and a second mode where the first side of the lid is
oriented toward the interior surface of the container, the at least
one groove being configured to accommodate the projection when the
lid is attached in the first mode and when the lid is attached in
the second mode.
[0015] The circumferential projection may be continuous and the
groove may be continuous. In a preferred embodiment, there are two
grooves on the lid. In another preferred embodiment, one of these
grooves is continuous and the other groove is provided with at
least one channel. Preferably, the projection is substantially
parallel to the top edge of the sidewalls and the projection is
located adjacent the top edge of the sidewalls. When the lid is
attached in the first mode, the interior surface of the container
and the second side of the lid define a first enclosed volume and
when the lid is attached in the second mode, the interior surface
of the container and the first side of the lid define a second
enclosed volume wherein the first volume is less than the second
volume.
[0016] In a second aspect, this invention is a packaging system for
medical components comprising a container having an interior
surface and an opening; a lid configured to attach to the container
in a manner that covers the opening, the lid having a shipping side
and a disposal side; and means for attaching the lid to the
container such that the lid may be attached to the container with
the disposal side facing the interior surface or with the shipping
side facing the interior surface.
[0017] In a third aspect, this invention is a packaging system for
medical components comprising a container having a bottom surface,
and sidewalls including first and second sidewalls, the bottom
surface and sidewalls being connected such that an opening in the
container is formed opposite the bottom surface, the first and
second sidewalls including at least one rib; a lid configured to
cover the opening in the container; and an insert configured for
mounting on one of the first and second sidewalls, the insert
having a surface configured to be securely affixed to the rib of
the first sidewall when the insert is mounted on the first sidewall
and to be securely affixed to the rib of the second sidewall when
the insert is mounted on the second sidewall.
[0018] Preferably, the insert is removably secured to the at least
one rib. The rib may have a V-shape. The insert may be a folding
plate. The lid may have a topography adapted to conform to the
shape of the medical components in the container and the insert may
have a topography adapted to conform to the shape of medical
components held by the insert.
[0019] In a fourth aspect, this invention is a packaging system for
medical components, comprising a container having an interior
surface and an opening; a lid configured to attach to the container
in a manner that covers the opening; and means for securing the
medical components within the container.
[0020] In a fifth aspect, this invention is a packaging system for
medical components comprising a container having an interior
surface and an opening, the interior surface having first and
second protrusions; a lid configured to attach to the container in
a manner that covers the opening; and an insert configured for
selective mounting in multiple locations within the container
including adjacent one of the first and second protrusions, the
insert having a surface configured to be securely affixed to the
first protrusion when the insert is mounted adjacent the first
protrusion and to be securely affixed to the second protrusion when
the insert is to be mounted adjacent the second protrusion.
[0021] In a sixth aspect, this invention is a method of packaging
medical components comprising supplying a packaging system
including a container having an interior surface and an opening,
the interior surface having at least one protrusion, a lid
configured to attach to the container in a manner that covers the
opening, and an insert having a surface configured to connect with
the at least one protrusion and to conform to the surface contour
of a medical component; placing a medical component within the
container with a surface contour of the medical component
conforming to the surface of an insert which is connected to the
protrusion; and attaching the lid to the container to secure the
medical component within the container.
[0022] In a seventh aspect, this invention is a method of disposing
of used medical components comprising supplying a packaging system
for shipment of the medical components, the packaging system
comprising a container having an interior surface and an opening,
and a lid configured to attach to the container in a manner that
covers the opening in both a shipping mode in which a first side of
the lid faces the interior surface and a disposal mode in which a
second side of the lid faces the interior surface; placing the used
medical components in the container in which they were shipped;
covering the container with the lid oriented in the disposal mode
such that the second side of the lid faces the interior
surface.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is an exploded perspective view of a first embodiment
of the lid and container of the packaging system of this invention
with medical components shown housed in the container.
[0024] FIG. 2A is a perspective view of the container of FIG. 1 and
FIG. 2B is a partial top view of the container.
[0025] FIGS. 3A and 3B are perspective views of a plate designed to
hold various components within the container of FIG. 1.
[0026] FIG. 4A is a partial view of the container of FIG. 1
illustrating a type of formed insert holding a medical component;
FIG. 4B is a perspective view of the formed insert of FIG. 4A; FIG.
4C is a perspective view of another type of formed insert; and FIG.
4D is a back view of a medical component held by the insert of FIG.
4C.
[0027] FIG. 5 is a perspective view of a second embodiment of the
packaging system of this invention.
[0028] FIGS. 6A and 6B are perspective views of the packaging
system of FIG. 5 in shipping mode and disposal mode,
respectively.
[0029] FIGS. 7A and 7B are partial cross-sectional views of the
packaging system of FIGS. 6A and 6B, respectively.
[0030] FIG. 8 is a perspective view of a third embodiment of the
packaging system of this invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0031] This invention is a packaging system particularly suited to
the packaging of medical components such as medical devices and
equipment used in surgery. In a preferred embodiment, the packaging
system contains devices and equipment comprising an extracorporeal
blood circuit used in heart by-pass surgery. The packaging system
comprises a container and a snap-fit lid. The container is provided
with a projection that matingly engages with a groove on the
snap-fit lid. Alternately, a groove on the container could matingly
engage with a projection on the lid. The container is designed to
hold various medical components, including one or more of
oxygenators, tubing sets, filters, blood reservoirs, sensors,
connectors, and blood cooling coils. The components may be joined
together by tubing, i.e., pre-connected, for immediate use in
surgery. The packaging system minimizes the use of tapes and straps
to restrain the medical components from movement and preferably
omits the use of tapes and straps.
[0032] In a preferred embodiment, first and second parallel grooves
on the snap-fit lid are designed to engage with the projection on
the container depending on the orientation of the lid. When a first
groove engages the projection, the packaging system is in shipping
mode. When the second groove engages the projection, the system is
in disposal mode. The second groove is designed so that it is very
difficult to remove the lid once it has been placed on the
container in its disposal mode.
[0033] Any suitable inert, sterilizable material may be used to
form the packaging system of this invention. Preferably, the
container and the lid are each formed from plastic materials to a
desired shape, size, and topography. Formed plastic materials
include, for example, thermoformed and injection molded polymers.
Suitable plastic materials for use in this invention include, for
example, polyethylene, polyester, polycarbonate, polyethylene
terephthlate, polystyrene, and polyvinylchloride.
[0034] The lid and container are manufactured to any desired
dimension. A typical packaging system for perfusion equipment may
be, for example, about 30 inches wide by 24 inches long by 13
inches high (76 cm by 61 cm by 33 cm).
[0035] The lid and the container are designed to hold various
components and may have cavities, recesses, partitions, or other
features formed into them, producing the desired topography for the
system, as described further below. Alternatively, other features
can be added to the container or to the lid by use of adhesives or
by sonic welding. Preferably, at least some of the medical
components are held securely in the container by means of one or
more removable inserts. The molded inserts may fit along a
sidewall, at a corner, or on the bottom of the container. They can
be used as necessary to hold various components. It is preferred
that the medical components are held securely in the container by
fitting components into designed recesses. This is important
particularly after medical components have been pre-connected. In
this way, they are ready for use when the container is opened.
However, they may alternatively, or additionally, be secured by
adhesive, adhesive tapes, mechanical fasteners, and the like.
Mechanical fasteners preferably include hook and loop fasteners
such as those commercially available under the trade designation
VELCRO.TM. fasteners.
[0036] Medical components and devices are placed into the container
in a desired arrangement and the lid is positioned onto the
container. A permeable "lid-stock" or membrane, such as a permeable
high density polyethylene is affixed to the container, typically by
heat sealing with a platen. A suitable and conventionally used
permeable, as well as tear resistant, material is a polyethylene
commercially available under the trade designation TYVEK.TM. from
DuPont.
[0037] The packaging system is sterilized by exposing the container
to a sterilizing gas, such as ethylene oxide, or to gamma
radiation, as is known to those of skill in the art. Sterilizing
gas passes through the permeable membrane and into the container.
If ethylene oxide is the sterilization method used there may be
channels or interruptions in the groove that engages with the
projection so that gas may flow through. The lid of the container
may be provided with passages or throughways so that gas can flow
into the container. After sterilization, the packaging system is
placed in a container such as a cardboard box and shipped to the
user.
[0038] Turning now to the Figures, the features of the packaging
system are described in detail. FIGS. 1 and 2A illustrate a
perspective view of container 10, medical components W, X, Y, and Z
in container 10, and lid 20. Container 10 is formed from bottom
surface 2, opposing sidewalls 4 and 6, and opposing sidewalls 5 and
7. The bottom surface and the sidewalls form an interior surface
and define a space that holds medical components. The sidewalls
join each other; the top edges of the sidewalls define opening 8
opposite bottom surface 2. Facing the interior of and near the
opening of container 10 is projection 11. Projection 11 may be
continuous about the circumference of the inside of container 10 or
it may be interrupted, for example, at the corners. The projection
can be located any distance from the top of the container. FIG. 1
illustrates a projection located about 0.5 inches (1.2 cm) from the
opening. Typically, it is desirable to maximize the space within
the container. Projection 11, as seen in cross-section in FIGS. 7A
and 7B, has portion 13 substantially perpendicular to the plane of
the sidewall of container 10 and portion 15 disposed at an angle
relative to the plane of the sidewall.
[0039] In an alternate embodiment of the packaging system, the
container may be provided with more than one projection. A
projection nearest the top opening would be used to engage a groove
on a lid. Another projection could be located on one or more walls
of the container farther away from the top opening. This projection
could be used to engage a groove on a plate or a divider. In this
way, a partial or full plate or divider could be positioned within
the container. For example, a horizontal plate or divider could be
positioned in the container using a projection in the container to
engage with a groove on a plate or divider.
[0040] Container 10 also has sealing flange 19 disposed about
opening 8. The sealing flange permits heat-sealing of a permeable
membrane (not shown) over the top of the lid once the components
are loaded into the container.
[0041] Lid 20 may be provided with various shapes or contours which
conform to the shape of the medical components in the container to
facilitate holding the components in the container as described
further below. Lid 20 has major surfaces or sides 50 and 51 and
sidewalls 52, 54, 56, and 58. The perimeter of lid 20 is sized to
fit within the opening in the container. The shipping mode of the
container is shown with major surface or side 50 facing upward in
FIG. 1 and major surface or side 51 facing downward, into the
interior of container 10. Lid 20 is provided with groove 22 along
the outside perimeter, i.e., the circumference, of the lid
sidewalls 52, 54, 56, and 58. Groove 22 engages projection 11 when
the lid is pushed onto the container. The preferred orientation for
lid 20 is as shown in FIG. 1, with major surface 50 facing upward.
A less preferred orientation (not shown) for lid 20 has major
surface 51 facing upward, thus providing greater volume of the
packaging system, useful for the disposal orientation of the
system.
[0042] FIG. 2A shows container 10 having sidewalls with various
shapes formed or otherwise attached to them. In FIG. 2A, sidewalls
4, 5, 6 and 7 are provided with ridge or step 9, integral with
sidewall 4 and portions of sidewalls 5 and 7, and partition 3,
integral with sidewall 4 and bottom surface 2. Ridges, partitions,
and ribs serve to support various components within the container,
as described further below. The ridges, partitions, and ribs in
FIG. 2 are intended to be illustrative of the topography of the
inside of the container, and are not intended to limit the contours
that are useful and can be obtained, as known to those of skill in
the art. Sidewall ribs are preferred in the container in order to
provide additional structural support to the container as well as
to allow various components to be held securely in container 10.
Such ribs may have a variety of lengths along the sidewalls as well
as various widths and shapes. Preferably, sidewalls 4, 5, 6, and 7
are provided with at least one V-shaped rib such as dovetail
ribbing 14 and 16. Ribbing 14 extends from near the top of sidewall
7 and adjoins ledge 9. Ribbing 16 extends from near the top of
sidewall 7 to bottom 2. FIG. 2B is a top view of a portion of the
container, showing a preferred shape of the dovetail ribbing.
Preferably, the ribbing is angled inwardly, toward the sidewalls of
container 10, though it may be angled outwardly or be perpendicular
to the sidewalls.
[0043] FIGS. 3A and 3B illustrate rigid folding plate 30 which is
provided with a geometry useful for mating with various products to
be held in container 10. Plate 30 is formed with various features
in it in order to support and contain a desired medical component.
For example, in FIGS. 3A and 3B, plate 30 is shown contoured to
accommodate oxygenator X. Plate 30 is also provided with tabs 34
and 36, which are adapted to fit between the ribbing on the
sidewalls of container 10. Plate 30 lies flat, as shown in FIG. 3A,
while medical components are loaded into it. Once loaded, plate 30
is folded in half, as shown in FIG. 3B, and placed into container
10. Partition 3 on the bottom surface of the container separates
molded protrusions 33 and 35. In addition, the dovetail ribbing 14
and 16 mates with tabs 34 and 36, respectively, along the side of
plate 30, thus holding plate 30 firmly in place. Plate 30 also may
easily be removed from container 10, if desired. The use of plate
30 avoids the need for mechanical fasteners, tapes, or
adhesives.
[0044] FIG. 4A shows a perspective view of a portion of container
10 having removable molded insert 40 at a corner holding medical
component W, which could be, for example, a blood recovery system.
Insert 40 has side flanges 41 and 42 adapted to mate with dovetail
ribbing 14 and 16 on the sidewalls. FIG. 4B is a perspective view
of insert 40, showing the shape of footprints 41 and 42, concavity
44, and shelf 46. Shelf 46 is shaped to fit the neck of medical
component W. FIG. 4C shows another form of molded insert 110 having
V-shaped footprints 111, 112, 113, and 114 adapted to mate with
dovetail ribbing 14 and 16 on the sidewalls. The topography of
molded insert 110 is shaped with circular cut-out 115 and holes 116
to 119 to accommodate medical devices Y and Z (such as, for
example, cardioplegia devices) as shown in FIG. 4D. Thus components
Y and Z are secured between the insert and the lid once the lid is
secured onto the container. As will be appreciated by those of
skill in the art, various forms of molded inserts can be configured
in order to accommodate and secure the shape of any desired medical
device. The mating configuration of the V-shaped footprints and the
ribbing serves to secure or lock the insert and hence the component
in place.
[0045] FIG. 5 illustrates another embodiment of the invention,
similar to the first embodiment except for lid 20a. Lid 20a is
configured to be used in one orientation in a shipping mode and in
a second orientation in a disposal mode; that is, one side faces
the interior of the container in shipping mode and the other side
faces the interior of the container in disposal mode. Lid 20a has
major surfaces 60 and 61 joined to sidewalls 62, 64, 66, and 68.
Two parallel grooves 24 and 26 are disposed along the outside
perimeter of lid 20a. FIG. 5 shows the disposal orientation of the
lid. The topography of the surface of lid 20a is designed to match
the medical components (e.g., components W, X, Y, and Z) in
container 10 that are supported by folding plate 30 and molded
inserts 40 and 110 (as illustrated in FIGS. 4A, 4B, 4C, and 4D). In
the shipping mode or orientation, first surface or side 60 faces
upward and second surface or side 61 faces the container. In the
disposal mode or orientation, as shown in FIG. 6B, the lid is
flipped over (i.e., inverted or rotated 180.degree.), so that first
surface or side 60 faces the container.
[0046] FIGS. 6A and 6B show the shipping and disposal modes of the
packaging system, respectively. FIGS. 7A and 7B are partial
cross-sectional views of an exploded section of the lid and
container showing the orientation and alignment of the projection
and the grooves. FIGS. 6A and 7A illustrate the shipping
orientation of the package, with first surface 60 facing upward.
FIGS. 6B and 7B illustrate the system in disposal mode, with first
surface 60 of the lid facing downward, toward container 10, and
second surface 61 facing upward.
[0047] FIGS. 7A and 7B illustrate the geometry of projection 11 and
grooves 24 and 26 in cross-section. Projection 11 has portion 13
substantially perpendicular to the plane of the sidewall of
container 10 and portion 15, disposed at an angle relative to the
plane of the sidewall. When the packaging system is in shipping
mode, first groove 24 engages projection 11 on container 10, as
illustrated in FIG. 7A. Groove 24 can be viewed as being comprised
of two angled surfaces 73 and 75; that is, neither of these
surfaces is substantially perpendicular to the plane of the lid
sidewall. This results in a snap-fit when the lid is placed into
position over the container, but also results in the lid being
removable. The shape of groove 24, in combination with the natural
flex of the container sidewalls, allows minimal force to be used
when assembling the package.
[0048] In contrast, the cross-section of groove 24 is not the same
as that of groove 26. Groove 26 can be viewed as comprised of two
surfaces 83 and 85. Surface 83 is substantially perpendicular to
the plane of the lid sidewall. This results in a tight fitting
engagement of the lid on the container when the lid is positioned
for disposal mode and much more difficulty in removing the lid.
[0049] During shipment, the combination of permeable barrier
(sealed to the top perimeter of the container) and a corrugated
over-wrap (not shown) prevent excessive flexing of the container
sidewalls. The lid-stock and over-wrap also assist in restraining
the lid, and thus also restrain the components in the package. In
disposal mode, the used medical components are returned to the
container, and the lid is placed on the container in a 180.degree.
orientation from the shipping mode. This results in a larger volume
for the enclosed container, as can be seen in FIGS. 6A and 6B. This
is an advantage because the medical components may not be carefully
repacked when they are disposed of and greater volume may be
necessary. The disposal orientation also produces a vessel for the
safe temporary removal of medical waste because the contents inside
the container are sealed. The lid is difficult to remove in
disposal mode and leakage of fluids is minimized.
[0050] A gasket also could be provided on the lid of the packaging
system. This would be useful in disposal mode so that the system
can be used as a primary vessel for waste disposal.
[0051] FIG. 8 illustrates an alternate embodiment of the packaging
system of this invention. Container 10 supports various perfusion
equipment. Lid 20b has major surfaces 70 and 71 provided with a
topography to match the components lying beneath it. Lid 20b has
sidewalls 72, 74, 76, and 78. Two parallel grooves 24b and 26b are
provided around the perimeter of lid 20b. Groove 24b is interrupted
by one or more channels 100 disposed around the perimeter of the
lid. The channels permit the flow of sterilizing gases (e.g.,
ethylene oxide) into and out of the container when the lid is in
shipping mode, that is, when the lid is positioned on container 10
and groove 24b engages projection 11. The channels do not pass
through the plane of groove 26b, so that when the lid is inverted
and groove 26b engages projection 11 (the orientation shown in FIG.
8), there can be no leakage of fluid from the container when it is
in disposal mode.
[0052] Although a particular embodiment of the invention has been
disclosed herein in detail, this has been done for the purposes of
illustration only, and is not intended to be limiting with respect
to the scope of the appended claims. It is contemplated that
various substitutions, alterations, and modifications may be made
to the embodiment of the invention described herein without
departing from the spirit and scope of the invention as defined by
the claims.
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