U.S. patent application number 10/793019 was filed with the patent office on 2005-09-08 for medical device and information container.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Biddick, Glenn R., Domke, James D., Robinson, Roger J., Spitzley, John J., Wenger, William K., Zanto, Dennis D..
Application Number | 20050194391 10/793019 |
Document ID | / |
Family ID | 34911961 |
Filed Date | 2005-09-08 |
United States Patent
Application |
20050194391 |
Kind Code |
A1 |
Domke, James D. ; et
al. |
September 8, 2005 |
Medical device and information container
Abstract
A dynamically configurable medical device and information
container is disclosed. The container includes ergonomic features
that enable ease of handling and unloading of the contents of the
container. Specifically, a configurable section serves as an
ergonomic gripping section and a containment section. The container
also includes tamper-proof strips that are visible indications of
prior opening or tampering with the container. Furthermore, vent
holes are implemented to release sterilization gas residues to
limit the sterilization gas content of the container.
Inventors: |
Domke, James D.; (Edina,
MN) ; Biddick, Glenn R.; (Minneapolis, MN) ;
Spitzley, John J.; (Stillwater, MN) ; Wenger, William
K.; (Minneapolis, MN) ; Zanto, Dennis D.; (New
Brighton, MN) ; Robinson, Roger J.; (Big Lake,
MN) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS
MN
55432-5604
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
34911961 |
Appl. No.: |
10/793019 |
Filed: |
March 4, 2004 |
Current U.S.
Class: |
220/835 ;
220/4.22 |
Current CPC
Class: |
A61F 15/001 20130101;
A61F 15/004 20130101 |
Class at
Publication: |
220/835 ;
220/004.22 |
International
Class: |
B65D 043/14 |
Claims
What is claimed is:
1. A dynamically configurable medical device and information
container comprising: a first cover with flanges; a second cover
with flanges; a hinge pivotably connecting said first cover and
said second cover; and a configurable section at said first cover
adapted to form a covered containment section and an open
containment section between said first cover and said second
cover.
2. The container of claim 1 wherein said configurable section
includes a living hinge adapted to enable a portion of said first
cover to articulate relative to a remainder portion of said first
cover.
3. The container of claim 2 wherein said remainder portion of said
first cover includes retainer means to retain said remainder
portion of said first cover in fixed relation to said second
cover.
4. The container of claim 1 wherein said first cover and said
second cover are adapted to mate about their perimeters at said
flanges and form a storage compartment therebetween.
5. The container of claim 5 further comprising a snap closure that
provides a lock at a free end of the container.
6. The container of claim 1 wherein said living hinge includes at
least one breakaway strip adapted to break when said living hinge
articulates thereby indicating prior opening of the container.
7. The container of claim 3 wherein said remainder portion forms an
ergonomic grip section for handling the container.
8. The container of claim 3 wherein said remainder portion forms a
configurable section to vary an open volume of the container.
9. The container of claim 4 wherein at least one air vent provides
an outlet for sterilization gases from said storage
compartment.
10. A dynamically configurable medical device and information
container comprising: a lower shell having a plane surface and
upwardly extending flanges around the perimeter thereof; an upper
shell having a plane surface and downwardly extending flanges
around the perimeter thereof; and an operable hinge connecting said
lower shell with said upper shell at said upwardly and downwardly
extending flanges forming an enclosure therebetween and a living
hinge adapted to enable a portion of said upper shell to articulate
in relation to a remainder portion of said upper shell.
11. The container of claim 10 wherein the locking means engageably
locks said lower shell with said upper shell to form an enclosure
therebetween.
12. The container of claim 11 wherein said locking means includes a
tab member to disengage said lower shell from said upper shell and
allow access to the container.
13. The container of claim 10 wherein a section of said upper shell
is engageably locked in place against said lower shell by snap lock
means, forming an ergonomic grip section of the container.
14. The container of claim 13 wherein said snap lock means forms a
structure to maintain a portion of said upper shell in fixed
relations with said lower shell.
15. The container of claim 13 wherein said living hinge enables
access to said enclosure.
16. The container of claim 12 wherein said tab disengages said
lower shell from said upper shell and said living hinge articulates
in relation to a fixed section of said upper shell.
17. The container of claim 13 wherein said flanges include a vent
forming an outlet for gaseous residues contained within said
enclosure.
18. The container of claim 13 wherein said gases include ethylene
oxide, chlorine dioxide and hydrogen peroxide.
19. The container of claim 6 wherein said living hinge includes at
least one breakaway strip to indicate tampering.
20. The container of claim 14 wherein said portion of said upper
shell in fixed relations with said lower shell forms a configurable
section of the container.
21. The container of claim 14 wherein said structure forms an
ergonomic region for handling the container.
22. A dynamically configurable medical device and information
container, comprising: a lower shell forming a floor and upwardly
extending flanges around the perimeter thereof; an upper shell
forming a cover and downwardly extending flanges around the
perimeter thereof; and an operable hinge connecting said lower
shell with said upper shell at said upwardly and downwardly
extending flanges forming an enclosure therebetween.
23. The container of claim 22 wherein a section of said upper shell
includes a pivotable portion.
24. The container of claim 23 wherein a remainder portion of said
upper shell remains fixed relative to said pivotable portion.
25. The container of claim 24 wherein said pivotable portion
further includes friction connections to pivotally support said
remainder section.
26. The container of claim 24 wherein said remainder section forms
a grip area including a non-skid grip surface.
Description
FIELD OF THE INVENTION
[0001] The invention relates to specialized containers adapted to
hold and contain a medical device and related information.
BACKGROUND OF THE INVENTION
[0002] Containers designed for storing and transporting medical
devices and surgical equipment are well known in the art.
Generally, these types of containers include a container and a
cover with sufficient volume to hold medical devices and components
securely. Various types of attachments such as, for example,
hinges, snap-on grooves or other structures are used to securely
place the cover on the container.
[0003] One of the general performance requirements for medical
device containers is the need to maintain a protection for a
sterilized package from the point of packaging, storage to
delivery. Specifically, the primary features of most sterilized
medical implant packages are to provide protection of the implants
during shipping and enable sterile delivery to the operating room.
However, there are several limitations in most of these packages
and containers. Primarily, most medical device containers are
cumbersome and require various operations to package, deliver and
handle. Further, current medical device containers do not appear to
provide ergonomic features that are compatible with the handling
and delivery of implantable medical devices.
[0004] There is, therefore, a need to provide a container for
sterile delivery of implantable medical devices, with features and
structures that enhance packaging efficiency on the manufacturing
floor, promote ease of handling and complement implant procedure
efficiency in the operating room.
SUMMARY OF THE INVENTION
[0005] The invention is directed to a container for a medical
device and related information that is tailored to house, cradle,
support and protect the medical device in a sterile environment.
Specifically, the container in accordance with the present
invention, is dynamically configurable to enable an efficient high
volume assembly, packaging, shipping and delivery operation while
further enabling safe handling and unpacking of the contents of the
container in an orientation suitable for a quick access and removal
to implant in a patient.
[0006] Among many of the novel features, the invention includes a
container with a partial segment that remains closed while allowing
access to the medical device when the container is opened. Further,
the container includes vent holes to enable a gradual but
continuous release of sterilization gas residues such as ethylene
oxide or hydrogen peroxide that would otherwise accumulate in the
box and may render the package unacceptable in certain
jurisdictions with strict emission standards.
[0007] In yet another aspect of the invention, the container
includes ergonomic features that promote a simple and efficient
handling of the container while enabling a secure hand-off to a
surgeon in an operating room. The container also provides a
tamper-proof indicator that includes a breakaway strip which breaks
away when the cover of the container is opened for the first time,
thus providing visible proof if the container was ever tampered
with or in anyway compromised.
[0008] While multiple embodiments are disclosed, still other
embodiments of the present invention will become apparent to those
skilled in the art from the following detailed description which
shows and describes illustrative embodiments of the invention.
[0009] As will be realized, the invention is capable of
modification in various obvious aspects, all without departing from
the scope of the present invention. Accordingly, the drawings and
detailed description are to be regarded as illustrative in nature
and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective drawing of the container in
accordance with the present invention.
[0011] FIG. 2 is a perspective drawing showing cooperative elements
of the present invention.
[0012] FIGS. 3A shows a prior art container and FIG. 3B provides
the ergonomic aspects of the present invention in comparison
thereof.
[0013] FIG. 4A depicts the ergonomic and ease of handling aspects
of the present invention.
[0014] FIG. 4B is a depiction of the ease of handling provided by
the present invention.
[0015] FIG. 5 illustrates the use of a tray adapted for placement
in the container.
[0016] FIGS. 6A-6D are cross-sectional views of the container in
accordance with the present invention, depicting various elements
and details thereof.
[0017] FIG. 7A is a side view of the container in a fully open
position to accept medical devices in a medical device packaging
operation.
[0018] FIG. 7B is a plan view showing the internal structures and
cooperative elements in accordance with the present invention.
[0019] FIGS. 8A and 8B are perspective drawings of an alternate
embodiment of the invention.
[0020] FIG. 9 is a perspective drawing showing a CD mount.
[0021] FIG. 10 is a perspective drawing showing sectional views A-A
and B-B.
[0022] FIGS. 11A and 1B are sectional views showing support
structures for the grip area in accordance with the invention.
[0023] FIGS. 12A and 12B are alternate sectional views showing
support structures for the grip area in accordance with the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0024] Referring to FIG. 1, container 10 includes bottom shell 12
with flange 14 around the perimeter thereof. Similarly, top shell
16 includes a flange 18 around its perimeter. Bottom shell 12 and
top shell 16 are adapted to fit at the flanges to form a
containment volume therebetween.
[0025] Specifically, bottom shell 12 and top shell 16 are hingeably
connected at hinge 22 to enable pivotable separation to thereby
maintain container 10 in an open position to accept the medical
device. Further, top shell 16 includes living hinge 24 to enable a
section of top shell 16 to pivotally open about living hinge 24.
Handle grip 26 provides a sure-grip surface for handling container
10. Grip 26 may be selected from various friction surfaces
including indentations to fit the fingers, raised strips or
regions, shaped depressions, non-skid sinewy surfaces or
equivalent.
[0026] Referring to FIG. 2, container 10 is dynamically
configurable to enable full separation between top shell 16 and
bottom shell 12 to load a device in container 10. Specifically,
hinge 22 enables a full exposure of the storage and containment
region in which the medical device will be stored. After placement
of the medical device in container 10, a portion of top shell 16 is
secured by means of a plurality of snap-on plugs 32. Plugs 32
provide secure fixation of section 38 by providing a mating between
portions of flange 14 and flange 18.
[0027] Some elements of the present invention are shown in FIG. 3B
for comparison with the prior art container structure of FIG. 3A.
Among several innovative aspects, the present invention provides
significant ergonomic features in sharp contrast to the prior art.
For example, the secure grip area/fixable section 38 of the present
invention, enables the hand to grip at the thinnest dimension of
the box FIG. 3B as compared to the prior art that would require the
hand to span across the bottom of container 10 thus making the
handling unstable and cumbersome. Further, this innovative feature
enables container 10 to be opened in such a way that the
orientation of the implantable device remains in a position
suitable for a quick inspection and implant.
[0028] Referring to FIG. 4A, container 10 is depicted in its normal
closed position with the hand placed in grip area/fixable section
38. FIG. 4B illustrates unlocking latching mechanism/snap-on lock
34 which releases a section of top shell 16 from the closed
position to pivot about living hinge 24. This section of top shell
16 is operable while maintaining a grip on the secure grip area 38.
This permits the presentation of the device in a sterile condition
while providing stability from dislodgement partly because of the
support provided in fixable section 38. More specifically, fixable
section 38 provides an enclosed pocket in which a portion of the
contents of container 10 are sheltered and supported. This
arrangement is likely to protect the contents from damage in the
event container 10 is dropped or otherwise mishandled while top
shell 16 is open.
[0029] Further, fixable section 38 provides dynamic configurability
to container 10. Specifically, before fixable section 38 is fixed,
container 10 is fully open. In this position, contents are placed
in container 10. Thereafter, fixable section 38 is anchored
yielding a different configuration displaying less than a full
volume of container 10.
[0030] FIG. 5 depicts an embodiment of a self-supporting tray 36 in
which the implantable medical device may be stored. Tray 36 is
sterile and may be made from foam or plastic material, including a
hollow central interior portion with a flange extending thereabout
for placing the medical device and other information therein.
[0031] Referring to FIGS. 6A-6D, various details, including vent 28
and the cooperation of living hinge/opening hinge 24, are shown.
Specifically, referring to FIG. 6D, at least one breakaway strip 44
is shown in opposition to hinge 24. Breakaway strip 44 operates as
a tamper-proof indicator. When latch mechanism 34 is unlocked and
opening hinge 24 angulates upward a tensile force is exerted on
breakaway strip 44 which ultimately breaks to allow hinge 24 to
flex while opening container 10. A broken strip serves as visible
proof that container 10 has been opened and/or tampered with thus
enabling the end user to reject the package.
[0032] FIGS. 7A and 7B depict various features of container 10.
Snap-on plug structure 32 permanently locks fixable section 38 in
place. FIG. 7A shows, the bottom half of container 12 that could be
loaded when hinge 22 is fully open. Thereafter, the device and
information is placed in bottom shell 12 and hinge 22 is actuated,
snap on plug structure 32 locks together to permanently fix grip
area/fixable section 38 as described hereinabove.
[0033] Referring to FIG. 7B, an alternate embodiment of vent 28 is
shown, including latching mechanism 34 having engageable parts
attached both at the bottom shell 12 and top shell 16.
[0034] Referring to FIG. 8A, another embodiment of container 10 is
shown. Specifically, fix grip area 46 is a cantilevered section
with hinge 22a fixed across the extent of grip area 46.
[0035] With reference to FIG. 8B, when latching mechanism 34 is
released to biasingly pop up top shell 16, fix grip area 46 remains
fixed in relation to top shell 16. Top shell 16 is pivotally
connected at hinges 50. This arrangement enables the pivoting
movement of top shell 16 while maintaining grip area 46 in a fixed
position.
[0036] FIG. 9 is a representative of yet another embodiment where
CD retainer hub 52 is formed on the inner side of top shell 16.
Retainer hub 52 is sized and shaped to receive and retain CD
54.
[0037] Referring to FIG. 10 in connection with FIGS. 11A and 11B, a
cross-section view of container 10 is shown. Specifically, friction
fit 56 is formed from mating extrusions to provide support to grip
area 46 and retain it fixed in a cantilevered position.
[0038] Similarly, FIGS. 12A and 12B depict another embodiment in
which slidable section 58 frictionally engages side wall 14 to
provide support to fix grip area 46. Other forms of cantilever
connections that support grip area 46 include pegs, posts and other
equivalent structures on which grip area 46 may be mounted.
[0039] While some selected and representative embodiments have been
shown in accordance with the present invention, it should be clear
to those skilled in the art that further embodiments may be made
without departing from the scope of the present invention.
* * * * *