Medical device and information container
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.
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The invention relates to specialized containers adapted to hold and contain a medical device and related information.
BACKGROUND OF THE INVENTIONContainers 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.
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.
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 INVENTIONThe 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.
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.
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.
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.
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
Referring to
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.
Referring to
Some elements of the present invention are shown in
Referring to
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.
Referring to
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With reference to
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Similarly,
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.
Claims
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.
Type: Application
Filed: Mar 4, 2004
Publication Date: Sep 8, 2005
Applicant:
Inventors: James Domke (Edina, MN), Glenn Biddick (Minneapolis, MN), John Spitzley (Stillwater, MN), William Wenger (Minneapolis, MN), Dennis Zanto (New Brighton, MN), Roger Robinson (Big Lake, MN)
Application Number: 10/793,019